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Contraceptive Conversations: Pharmacists as Partners in Birth Control Prescribing

Learning Objectives

  After completing this application-based continuing education activity, pharmacists will be able to
Explain the benefits to women, children, and society when contraceptives are easily accessible
  • Compare available hormonal contraception by pharmacology, efficacy, clinical use, and patient variables
  • Paraphrase the CDC’s United States Medical Eligibility Criteria (MEC) for Contraceptive Use to guide prescribing for women with various medical conditions and other characteristics
  • Customize a prescription for appropriate hormonal contraceptive products based on each patient's medical status, age, and medications
  • Describe necessary counseling points when prescribing pharmacist-prescribed hormonal contraceptives in Connecticut
  • Identify situations in which pharmacist prescribing of hormonal contraceptives is not allowed in Connecticut
  • Review the hormonal contraceptive screening and prescribing process required by Connecticut law

Release Date:

Release Date:  November 27, 2024

Expiration Date: November 27, 2027

Course Fee

Pharmacist $40

There is no funding for this CPE activity.

ACPE UANs

Pharmacist: 0009-0000-24-054-H01-P

Session Code

Pharmacist:  24BC54-CBA36

Accreditation Hours

4.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-24-054-H01-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

Faculty

 

Kelsey Giara, Pharm.D.
UConn Adjunct Faculty
University of Connecticut
Storrs, CT

 

Faculty Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

Dr. Giara has no financial relationships with ineligible companies.

ABSTRACT

This continuing education module was developed to meet the State of Connecticut pharmacist contraceptive prescribing requirements. Pharmacists who wish to prescribe contraceptives in this state can complete this activity. They should note that after reading the content, they must take an 80-question post-test and pass with a score of at least 80%. They should be prepared to use the materials included as Appendices. They should also visit the state’s web page on this topic (https://portal.ct.gov/dcp/drug-control-division/drug-control/drug-control---pharmacist-contraceptive-prescribing?language=en_US) where they will find additional documents, including the link to the questionnaires for prescribing hormonal contraceptives and emergency contraceptives.

CONTENT

Content

INTRODUCTION

More than 72 million individuals of reproductive age (15 to 49 years old) live in the United States (U.S.), and about 43 million of them are at risk of unintended pregnancy.1 This means they are sexually active and could experience unwanted pregnancy if they and their partners fail to use contraceptives consistently and correctly.

Here is a striking but under-reported fact: about one in two pregnancies in the U.S. is unintended (i.e., mistimed or unwanted at the time of conception).2 Compared to intentional pregnancies, people experiencing unintended pregnancy experience more mental health problems, have less stable romantic relationships, and sometimes delay initiation of prenatal care.3 Ideally, those who unintentionally conceive should ideally be in good health and ready to care for a new child, but sometimes that is not the case.

Children born as a result of unintended pregnancies are at an elevated risk of experiencing both mental and physical health challenges and are more likely to struggle in school.3 While the overall rate of unintended pregnancies is on the decline, disparities based on factors such as race/ethnicity, age, income, and education level persist.3

It is crucial to implement interventions that promote the use of contraception methods to prevent unintended pregnancies. While over the counter (OTC) options for pregnancy prevention exist, hormonal methods requiring a prescription (pill, patch, ring, and injection) are more effective than OTC products, withdrawal, or fertility-awareness methods for pregnancy prevention.4 Recent laws make it possible for pharmacists to prescribe hormonal contraceptives in some states, increasing access to these more effective therapies.

Note that this activity will employ the terms "woman/women" to align with the biological expectations of ovulation.

 

Understanding the Menstrual Cycle

The length of a woman’s menstrual cycle is a commonly misunderstood concept. While most people consider a natural 28-day cycle “normal,” this is only true for about 13% of women.5 The first day of menstrual bleeding is considered cycle day 1 and cycles range from about 21 to 40 days in length.

Hormone levels regulate the menstrual cycle. The pituitary gland produces luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which promote ovulation and release of estrogen and progesterone from the ovaries.6 This hormone fluctuation splits the menstrual cycle into three phases; note that the timeframes described below are approximate length based on a 28-day cycle6:

  • Follicular phase (before egg release)
    • Lasts from cycle day 1 to ovulation
    • FSH levels rise to recruit a small group of follicles for growth and development
    • Between days 5 to 7, one follicle dominates and secretes estradiol to stop menstrual flow
  • Ovulatory phase (egg release)
    • Occurs on or around day 14
    • Sustained FSH levels cause an LH surge about 28 to 32 hours before the dominant follicle ruptures, also known as ovulation, releasing the mature oocyte (egg)
  • Luteal phase (after egg release)
    • Lasts from ovulation to the last day of the cycle
    • Remaining luteinized (matured) follicles become the corpus luteum, which produces progesterone to prepare the uterus for embryo (fertilized egg) implantation

 

Following the luteal phase, if no egg is fertilized or the egg does not implant, the corpus luteum degenerates after 14 days, estrogen and progesterone levels drop, and a new menstrual cycle begins.6 However, if a fertilized embryo is implanted, the cells around the embryo produce human chorionic gonadotropin (HCG). HCG maintains the corpus luteum, which continues to produce progesterone until the fetus can produce its own hormones. Pregnancy tests detect an increase in HCG in the blood or urine, indicating a fertilized embryo is present.6

PHARMACY-BASED HORMONAL AND EMERGENCY CONTRACEPTIVES

Contraception refers to the strategies employed to prevent pregnancy after sexual intercourse, which can be categorized into two main approaches7:

  1. Inhibiting the encounter of viable sperm with a mature ovum, achieved through methods such as barriers or ovulation prevention
  2. Preventing the implantation of a fertilized ovum in the endometrium, accomplished through methods that create an unfavorable uterine environment

It is crucial for sexually active individuals to be well-informed about the various contraceptive options available. This knowledge is essential in assisting patients in effectively preventing unintended pregnancies.

This activity will only discuss the birth control methods that pharmacists are directly involved in prescribing.

 

Hormonal Contraceptive Basics

As the name implies, hormonal contraceptives employ hormones—specifically, progestins and estrogens—to prevent pregnancy.7 Hormonal contraceptives do not protect patients from sexually transmitted infections, including human immunodeficiency virus, and this is a point that pharmacists need to stress at every visit. Estrogens’ role in birth control is to stabilize the endometrial lining and provide cycle control. However, estrogens also suppress FSH release from the pituitary gland to help block the LH surge and prevent ovulation. Progestins provide most contraceptive effect. They block the LH surge, which inhibits ovulation. Progestins also thicken cervical mucus to7

  • prevent sperm penetration
  • slow tubal motility
  • delay sperm transport
  • induce endometrial atrophy (thinning), reducing its receptivity to embryo implantation

Achieving the right balance between progestogens and estrogens is vital in hormonal contraceptives. Some hormonal contraceptives contain only a progestin, while others combine an estrogen and a progestin.7 Importantly, estrogen alone—or “unopposed estrogen”—does not protect against pregnancy and pose significant safety concerns. Patients with an intact uterus who take unopposed estrogen are at risk of cancer, endometrial hyperplasia, polyps, endometriosis, and adenomyosis.8

 

PAUSE AND PONDER: What is the difference between a CHC, a COC, and a POP?

 

Combined hormonal contraceptives (CHCs)—any contraceptive containing both an estrogen and progestin—are not appropriate for women7

  • older than 35 years who smoke
  • with obesity (body mass index 30 or greater)
  • with untreated hypertension (greater than 160/100 mm Hg)
  • with migraines (especially with aura)
  • at risk for deep vein thrombosis

The estrogen component of most CHCs is ethinyl estradiol.7 Many different progestins of differing androgenicity and similarity to testosterone exist, but no evidence suggests that a particular progestin is superior to others. Traditionally, experts classified progestins into “generations” based on parent compound and decade of development, but data shows this is not clinically useful.7

A woman can start CHCs at any time during her cycle if it is reasonably certain that she is not pregnant.9 If a patient starts CHCs within the first five days of menstrual bleeding, no additional protection is needed, but if it has been longer than five days from the start of menses, she should abstain from intercourse or use backup contraception for the next seven days.9 Table 1 outlines missed dose guidance for all contraceptive types.

 

Table 1. Missed Dose Guidance for Contraceptives7,10,11

Missed Dose/Failure Guidance
COCs: 1 pill late (< 24 hours overdue) or missed (24 to < 48 hours overdue) ·  Take the late/missed pill ASAP

·  Continue taking remaining pills at the same time (even if 2 doses in 1 day)

·  No back-up contraception needed

·  Consider emergency contraception if previous late/missed dose in same cycle or in the last week of the previous cycle

COCs: ≥ 2 consecutive pills missed (≥ 48 hours have passed since last pill) ·  Take the most recently missed pill ASAP

·  Discard any other missed pills

·  Continue therapy as usual

·  Use back-up contraception (e.g., condoms) or remain abstinent until they’ve taken hormonal pills for 7 consecutive days

·  If in last week of hormonal pills, skip placebo interval and start new pack immediately

·  Consider emergency contraception if pills missed in 1st week and unprotected intercourse occurred

POP: more than 3 hours late ·  Take missed pill ASAP, then go back to regularly scheduled time

·  Use back-up contraception until POP taken consistently for at least 48 hours

·  If vomiting occurs soon after taking, use back-up contraceptive for at least 48 hours

Transdermal patch: partially or completely detached ·  Reapply ASAP

·  If no longer sticky or becomes dirty, use a new patch (do not use supplemental wraps or adhesives)

·  If detached ≥ 24 hours, may no longer be protected from pregnancy; stop the current contraceptive cycle and start a new one (use back-up contraception for at least 1 week)

·  If unsure how long it was detached, treat it as if it was ≥ 24 hours

Transdermal patch: forget to change patch ·  At start of a patch cycle (week 1/day 1), apply a patch as soon as possible; this becomes the new “patch change day” and back-up contraception is needed for 1st week

·  In middle of a patch cycle (week 2/day 8 or week 3/day 15) < 48 hours late, apply new patch immediately; no change in “patch change day” and no back-up needed

·  In middle of a patch cycle (week 2/day 8 or week 3/day 15) ≥ 48 hours late, stop current cycle and start a new one with a new patch; this is new “patch change day” and should use back-up for 1 week

EE/E vaginal ring: falls out or removed ≥ 3 hours ·  Weeks 1 or 2: use back-up contraception until ring is in place for 7 consecutive days

·  Week 3: discard ring and either (1) insert new ring immediately to start next 3-week use or (2) insert a new ring ≤ 7 days from removal (only if ring was in for 7 consecutive days before removal)

·  Always use back-up contraception until the ring has been placed for 7 consecutive days

·  If removed < 3 hours, efficacy is not affected; rinse ring with cool/lukewarm water and reinsert ASAP

SAEE vaginal ring: falls out or removed ≥ 2 hours ·  Rinse ring with cool/lukewarm water and reinsert ASAP

·  Use back-up contraception until the ring has been placed for 7 consecutive days

·  If removed < 2 hours, efficacy is not affected

ASAP, as soon as possible; COC, combined oral contraceptive; EE/E, ethinyl estradiol/etonogestrel; POP, progestin-only pill; SAEE, segesterone acetate/ethinyl estradiol.

 

Combined Oral Contraceptives

Combined oral contraceptives (COCs)—meaning oral products containing both an estrogen (e.g., ethinyl estradiol) and a progestin (e.g., norethindrone, levonorgestrel, norgestimate)—come in many forms. COCs are about 91% effective, meaning that 9 of 100 women will become pregnant in a year with typical use.12 A major distinction in product selection is monophasic versus multiphasic7:

  • Monophasic COCs contain the same amounts of estrogen and progestin for 21 days, followed by seven days of placebo
  • Multiphasic COCs—including bi- and triphasic regimens—contain variable amounts of estrogen and progestin for 21 days, also followed by a 7-day placebo phase

 

Monophasic and multiphasic COCs boast similar safety and efficacy profiles, so product selection relies on hormonal content, patient-preference, and coexisting conditions.7 Women should typically initiate a COC containing 35 mcg or less of ethinyl estradiol and less than 0.5 mg of norethindrone (or an equivalent).7 Estradiol levels control the incidence of breakthrough bleeding. Few patients require doses of ethinyl estradiol greater than 35 mcg daily to prevent breakthrough bleeding. While some clinicians advocate for starting patients at the lowest possible estradiol dose to minimize risks, data suggests that 10 to 20 mcg of ethinyl estradiol daily is no safer than the 35-mcg dose and lower doses are associated with more breakthrough bleeding.7

 

Monophasic COCs are preferred over multiphasic upon initiation, as adverse effects (AEs) are easier to identify and manage. Monophasic COCs also allow for easy cycle extension (continuing the active moiety to bypass a period, an indication for which pharmacists are not authorized to prescribe) by simply skipping the placebo week and starting the next pack of active pills. When attempting this with multiphasic regimens, the variation in drug levels between phases often leads to breakthrough bleeding.7

 

Extended- and continuous-cycle COCs contain 84 days of active hormone tablets followed by seven days of inactive tablets, which may be more convenient with fewer AEs.7 Extended-cycle COCs are commercially available. Of note, some patients skip the 7-day placebo week of monophasic 28-day COCs to mimic extended-cycle products, but pharmacists are only legally authorized to prescribe hormonal contraceptives as indicated. Continuous-cycle COCs shorten the pill-free interval (e.g., two to four days versus seven days), thus reducing period-related symptoms. Patients using extended- and continuous-cycle regimens have fewer menstrual cycles annually, which is helpful for women with severe premenstrual syndrome (PMS), dysmenorrhea (menstrual cramps), and menstrual migraines.

 

Progestin-Only Pills

Progestin-only pills (POPs)—“minipills”—contain 28 days of active hormone (norethindrone or drospirenone) per cycle.7 They are generally less effective than COCs and associated with irregular, unpredictable menstrual bleeding. Patients must take POPs at approximately the same time (within three hours) every day for effective pregnancy prevention. The progestin dose in POPs is about one-third of that in COCs, resulting is less consistent suppression of ovulation. This leaves women at greater risk of breakthrough bleeding and ectopic pregnancy—pregnancy outside the uterus—because women on POPs often continue to ovulate regularly.7

 

Despite being less effective, POPs are appropriate for certain women. Postpartum women, for example, can experience hypercoagulability, and should avoid CHCs for at least 30 to 42 days postpartum due to risk of venous thromboembolism. Therefore, those who take contraceptives commonly take POPs.7 Women who breastfeed should also avoid CHCs, as the estrogen component can affect lactation, making POPs a better option.

 

POPs can be started at any time during a woman’s cycle if it is reasonably certain she is not pregnant.9 If a patient starts POPs within the first five days of menstrual bleeding, she need not use additional protection , but if it has been longer than five days from the start of menses, she should abstain from intercourse or use backup contraception for the next two days.9

 

ORAL CONTRACEPTIVE TAKEAWAYS:

  • COCs: Initiating a monophasic formulation containing 30 to 35 mcg of ethinyl estradiol and less than 0.5 mg of norethindrone (or an equivalent) offers the best chance of establishing a consistent menstrual pattern without raising AE risk. If patients experience estrogen- or progesterone-related AEs (listed in Table 2), dose adjustment is warranted.
  • Extended- or continuous cycle: Patients have fewer menstrual cycles each year, making them ideal for patients with severe PMS, dysmenorrhea, or menstrual migraines.
  • POPs: Less effective than COCs, but appropriate for patients within 42 days postpartum and women who breastfeed, as estrogen can affect lactation.

 

Table 2. Hormone-Related Adverse Effects13

Too Much Not Enough
Estrogen ·  Nausea

·  Breast tenderness

·  Weight gain

·  Headaches

·  Menstruation changes

·  Vasomotor symptoms (night sweats, hot flashes)

·  Early cycle (days 1-9) breakthrough bleeding or spotting

·  Amenorrhea

Progestins ·  Breast tenderness

·  Headache

·  Fatigue

·  Mood changes (depression, irritability)

·  Weight gain

·  Acne/oily skin

·  Hirsutism

·  Dysmenorrhea (painful periods)

·  Menorrhagia (heavy menstrual bleeding)

·  Late cycle (days 10-21) breakthrough bleeding or spotting

 

 

Non-Oral Hormonal Contraceptives

Some patients—particularly those who struggle with daily adherence to oral therapies—may benefit from alternative delivery mechanisms administered less frequently, including transdermal patch, vaginal ring, and injectable contraceptives.

 

The only transdermal CHC patch available in the U.S. contains ethinyl estradiol and norelgestromin (norgestimate’s active metabolite). The transdermal patch has comparable efficacy to COCs.12 It may be less effective, however, for patients weighing more than 198 lbs (90 kg).14 Patients apply the patch to the abdomen, buttocks, upper torso, or upper arm at the beginning of the menstrual cycle, avoiding areas where the patch could be rubbed by tight clothing.14 Patients replace the patch once weekly for 3 weeks, followed by a patch-free week. The patch is formulated to release hormones for nine days, allowing a 48-hour grace period for adherence.14

 

The CHC patch’s adverse effects are similar to those of COCs, but some patients experience application-site reactions. Patients can prevent these reactions by rotating application sites. Dysmenorrhea and breast discomfort are also possible, as the patch causes higher estrogen exposure compared to COCs.14

 

Vaginal ring contraceptives offer excellent cycle control, as patients can insert and remove them, and fertility returns rapidly after removal.15 Two vaginal ring contraceptives are available:

  • an ethinyl estradiol/etonogestrel (EE/E) ring that patients replace monthly
  • a segesterone acetate/ethinyl estradiol (SAEE) ring that patients replace yearly

 

The EE/E vaginal ring delivers 0.015 mg of ethinyl estradiol and 12 mcg of etonogestrel (desogestrel’s active metabolite) every 24 hours.16 Estrogen exposure with the EE/E ring is lower than that associated with COCs, so incidence of estrogen-related adverse effects is also decreased. Local reactions, like vaginal irritation and discharge, are more common.16 The SAEE vaginal system is slightly larger in diameter than the EE/E ring and contains two drug reservoirs delivering 0.15 mg and 13 mcg of segesterone and ethinyl estradiol, respectively, every 24 hours.15,10 The SAEE ring’s most common adverse effects are headache/migraine, nausea, vomiting, vaginal infections, abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast discomfort, bleeding irregularities, diarrhea, and genital itching.10

 

To insert a vaginal contraceptive ring, patients should compress the ring between the thumb and index finger, then push the ring into the vagina.16,10 There is no danger of inserting too far; the cervix will prevent the ring from traveling up the genital tract. Additionally, precise ring placement is not an issue, as the hormones are absorbed anywhere in the vagina. Patients should leave the ring in place for three weeks, then remove it for one week.

 

If using the EE/E monthly ring, patients should discard the ring (but not flush it down the toilet) after removal and insert a new one on the same day of the week as the previous cycle.16 Alternatively, the same SAEE ring can be used for up to one year. During the ring-free week, patients should store the SAEE ring only in the provided case away from children, pets, and extreme temperatures.15,10 They should also wash the ring after removal and again before reinsertion using mild soap and water and pat dry with a clean cloth or paper towel. Patients should never use the same SAEE ring for more than 13 menstrual cycles.15,10

 

If a vaginal contraceptive ring is removed from the vagina, intentionally or otherwise, no backup contraception is needed if the patient reinserts the ring within three hours for the EE/E ring and two hours for the SAEE ring.16,10 If the ring remains out of the vagina for longer than these recommended time periods, backup contraception (e.g., male condoms, spermicide) is recommended for seven days after ring reinsertion. Patients should also avoid oil-based lubricants, as these can decrease the effectiveness of vaginal contraceptive rings.

 

Both vaginal ring systems carry risks for toxic shock syndrome (TSS), a rare, potentially life-threatening vital organ failure caused by bacterial infection.16,10 Items that remain in the vagina for an extended period of time are implicated in TSS because bacteria can be trapped in the vagina and enter the uterus via the cervix or objects in the vagina can also cause tiny cuts through which bacteria can enter the bloodstream. Advise patients to seek medical attention if they experience signs/symptoms of TSS17:

  • nausea or vomiting
  • sudden high fever and chills
  • watery diarrhea
  • rash resembling a bad sunburn or red dots
  • dizziness, light-headedness, or fainting
  • hypotension
  • red eyes (conjunctivitis)
  • peeling on the soles of feet or palms of hands

 

Depo-medroxyprogesterone acetate (DMPA) is a longer-lasting injectable contraceptive injected every three months either intramuscularly into the gluteal or deltoid muscle or subcutaneously into the abdomen or thigh.18 This eliminates daily adherence concerns. DMPA is about 94% effective with typical use.9 Note that Connecticut law prohibits pharmacists from administering DMPA injections without a collaborative practice agreement, but patients may self-administer DMPA subcutaneously if desired and indicated.

 

Injection timing is somewhat flexible. Early DMPA injection is safe if women cannot follow routine intervals, and patients can inject up to two weeks late without requiring back-up contraception.18 Women who are more than two weeks late, however, should use back-up contraception for seven days after receiving the injection. Return to fertility may be delayed six to 12 months after discontinuation, so DMPA is not recommended for women desiring pregnancy in the near future.18

 

DMPA’s most common adverse effects are weight gain, decreased bone mineral density, and bleeding irregularities (e.g., spotting, prolonged bleeding, amenorrhea).18 DMPA carries a Boxed Warning indicating patients should not use the drug for more than two years due to bone mineral density loss, which may be irreversible.18 Patients should only use DMPA for more than two years if all other contraceptive methods are inadequate. Ensure patients are adequately trained to self-inject DMPA before leaving the pharmacy.

 

Emergency Contraceptives

Two oral emergency contraceptives (ECs) are currently available: a single dose of progestin (levonorgestrel 1.5 mg) or an anti-progestin (ulipristal acetate 30 mg).7 Levonorgestrel is available over the counter, while ulipristal requires a prescription.19,20 Neither of these is abortifacient (i.e., they do not end an existing pregnancy), rather they work by blocking or delaying ovulation.

 

Women should take oral EC as soon as possible following unprotected intercourse, levonorgestrel within 72 hours and ulipristal acetate within five days.19,20 Repeat levonorgestrel use shows no serious adverse effects, but studies have not examined repeat use of ulipristal acetate.7 Upon prescribing emergency contraception, pharmacists should evaluate women for long-term contraceptive eligibility to prevent repeat use of EC.

 

EC may alter the next expected menses.19,20 Patients whose cycles are delayed more than one week should test for pregnancy. Additionally, women who become pregnant after using EC who experience lower abdominal pain should be evaluated for ectopic pregnancy (pregnancy occurring outside the uterus, most often in the fallopian tube).19,20

 

PAUSE AND PONDER: Where can you find the living document called the United States Medical Eligibility Criteria (U.S. MEC) for Contraceptive Use and how often should you review its contents? (Note that some questions in the post-test will require you to access this document, so you must review it thoroughly.)

 

ELIGIBILITY AND PRESCRIBING

 

CDC Eligibility Criteria

The CDC publishes the United States Medical Eligibility Criteria (U.S. MEC) for Contraceptive Use to guide safe use of contraceptive methods for women with various medical conditions and other characteristics.21 The most current version of these guidelines (as of February 2024) can be found at https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html. Appendix A of this activity includes the entire U.S. MEC and the 2020 update. The CDC has also created a summary chart, included in Appendix B, and pharmacists should note that the summary chart is a convenience that does not replace a responsibility to access the entire document when necessary. Pharmacists actively prescribing hormonal contraceptives should regularly monitor for updates to this living document.

 

The U.S. MEC includes recommendations for contraceptive use based on patient characteristics or medical conditions.21 While many off label uses exist for contraceptives, these CDC recommendations apply only to these products’ indicated use to prevent pregnancy.

 

Four categories of medical eligibility criteria for contraceptive use exist within the U.S. MEC:

  • Category 1: conditions for which no restrictions exist for use of the contraceptive method
  • Category 2: conditions for which the advantages of using the method generally outweigh the theoretical or proven risks; the method can generally be used, but careful follow-up might be required
  • Category 3: conditions for which the theoretical or proven risks usually outweigh the advantages of using the method; use is not recommended unless other more appropriate methods are not available or acceptable, so condition severity and the availability, practicality, and acceptability of alternative methods should be considered, and careful follow-up is required
  • Category 4: conditions that represent an unacceptable health risk if the contraceptive method is used

 

Be mindful that provision of a contraceptive method to a woman with a condition classified as category 3 requires careful clinical judgement and access to clinical services that may be unavailable to pharmacists. Referral may be needed. Pharmacists should never prescribe a hormonal contraceptive method to a patient with a category 4 health condition related to its use.

 

Pharmacists should also take note of whether continuation criteria exist for the product prescribed.21 Continuation criteria is clinically relevant when a medical condition develops or worsens during use of a contraceptive method. When risk categories differ for initiation and continuation, the differences are noted in the Initiation and Continuation columns. When these distinctions are not indicated, the category is the same for initiation and continuation of use.21

 

Additionally, these categories only concern safety, but many other factors must be considered when choosing a contraceptive method. Classification as a category 1 means that the method can be used with no regard to safety but does not necessarily mean that method is the best choice for that patient. Consider other factors, including effectiveness, availability, and acceptability.

 

Determining Pregnancy Status

The Centers for Disease Control and Prevention (CDC) recognizes that routine pregnancy testing for women is not necessary before the initiation of contraception in all cases. Based on clinical judgment, healthcare providers can omit a pregnancy test if a woman has no signs or symptoms of pregnancy and meets any of the following criteria21:

  • Is fewer than seven days after the start of normal menses
  • Has not had sexual intercourse since the start of last normal menses
  • Has correctly and consistently used a reliable contraception method
  • Is fewer than seven days after spontaneous or induced abortion
  • Is within four weeks postpartum
  • Is fully or nearly-fully breastfeeding (exclusively or at least 85% of feeds), amenorrhoeic, and less than six months postpartum

 

Screening Documents Simplify the Process

A prescribing pharmacist must assist the patient in completing a screening document for hormonal contraceptives or emergency contraceptives, as applicable. These and all documents related to prescribing of hormonal contraceptives by pharmacists in the state of Connecticut are available at the Department of Consumer Protection’s (DCP) website: https://portal.ct.gov/DCP/Drug-Control-Division/Drug-Control/Drug-Control---Pharmacist-Contraceptive-Prescribing. Prescribing pharmacists are responsible for ensuring their pharmacies use the most current version of all screening documents at all times.

 

When an individual requests a hormonal contraceptive, pharmacists must first determine the patient’s age. If the patient is 18 years or older, the pharmacist may continue to prescribe with this guidance, but if the patient is younger than 18 years, the pharmacist may only issue a prescription upon confirming the patient has previously been prescribed a contraceptive by another provider through one of the following means:

  • With the patient’s permission, contact the office or clinic where the patient visited a healthcare provider via telephone, facsimile, or shared health record system
  • With the patient’s permission, contact the pharmacy that previously dispensed a contraceptive prescription to the patient via telephone, facsimile, or shared health record system
  • Other acceptable documentation or evidence that demonstrates the patient has received prescription contraceptives (e.g., visit summary from the clinic that prescribed it, old prescription package/label)

 

The pharmacist must keep an electronic or written record of the action taken to confirm prior prescription for a minimum of 3 years. Whether prescribing a continuation of hormonal contraceptive therapy or initiating a new one, confirm the patient has been seen by a provider within the last 3 years either through written documentation (e.g., a visit summary) or contacting the office or clinic with the patient’s permission. Without this confirmation, pharmacists may not prescribe hormonal contraception.

 

Individuals with obesity (body mass index 30 kg/m2 or greater) and patients using drugs that inhibit CYP3A4 (e.g., bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, efavirenz, lumacaftor) may experience decreased efficacy with EC.21 Patients ineligible for EC prescribing include those who

  • are confirmed pregnant (though no harm to the woman, the course of her pregnancy, or the fetus if EC is inadvertently used is known to exist)
  • have undergone bariatric surgery that may affect EC absorption (e.g., Roux-en-Y gastric bypass, biliopancreatic diversion); an emergency intrauterine device may be more appropriate

 

If a patient seeking EC is deemed ineligible for prescribing, the pharmacist should not prescribe the EC, refer the individual to a primary care provider (PCP), and document the reason(s) for refusal on the screening documents. If the patient has no PCP, the pharmacist should provide information regarding local providers.

 

Hormonal Contraceptive Screening and Prescribing

Upon determining patient eligibility, have the patient complete the Connecticut Hormonal Contraceptive Self- Screening Questionnaire found on the DCP website. The questionnaire addresses

  • patient demographics (e.g., insurance status, allergies, preferences)
  • background information (e.g., last menstrual period, history of contraceptive use)
  • medical history (e.g., smoking status, preexisting conditions)
  • pregnancy status

 

Review this screening tool with the patient and clarify responses if needed. If a patient is requesting CHCs or they are recommended, measure and record the patient’s seated blood pressure. If the patient does not complete the questionnaire, a pharmacist cannot issue the prescription. Pharmacists should keep the completed questionnaire on file for at least three years. Patients must fill out a new questionnaire at least once every 12 months, but pharmacists can request this more frequently if desired.

 

Pharmacists should then use patient questionnaire responses to follow the Standard Procedures Algorithm for Connecticut Pharmacist Prescribing of Contraceptives found on the DCP website. This algorithm, with its clinical assessment sections summarized in Figure 1, assists in screening for red flags requiring provider referral. Pharmacists should access the complete document on the DCP website before attempting to take the post-test.

 

Figure 1. Simplified Assessment Sections of the Algorithm for Contraceptive Prescribing

*Anticonvulsants, antiretrovirals, antimicrobials, barbiturates, herbs and supplements, including but not limited to: carbamazepine, felbamate, phenobarbital, lamotrigine, oxcarbazepine, ritonavir, primidone, griseofulvin, St. Jonh’s wort, topiramate, phenytoin, lumacaftor/ivacaftor, and rifampin/rifabutin.

 

Pharmacists should pay special attention to steps 6 and 7 of the Standard Procedures Algorithm (and take a moment to access it now). It describes counseling points on starting hormonal contraception, managing expected and unexpected side effects, and appropriate adherence. Not that Step 7 is critical! Women need to be reminded about routine healthcare and sexually transmitted infection prevention. And the pharmacist’s job isn’t done until the paperwork is filed.

 

If hormonal contraceptives are not clinically appropriate based on the treatment algorithm, the pharmacist should refer the patient to a practitioner, not prescribe the hormonal contraceptive, and document the reason(s) for refusal on the screening documents. The State of Connecticut provides a Pharmacist Referral and Visit Summary template that may be used for this purpose. If hormonal contraceptives are clinically appropriate, pharmacists may prescribe a total of no more than 12 months including initial filling of the prescription along with refills. Refills may be transferred to another pharmacy if desired, as a pharmacy that does not have a prescribing pharmacist may dispense a prescription written by a prescribing pharmacist. Pharmacies may not, however, fill prescriptions written by pharmacists authorized to prescribe in other states but not in Connecticut.

 

Emergency Contraceptive Screening and Prescribing

To be eligible for a self-administered EC prescription, an individual must complete the Connecticut Emergency Contraception Self-Screening Questionnaire found on the DCP website indicating that the last day of unprotected intercourse was within the previous five days (120 hours). Pharmacies may create and use an electronic version of this self-screening tool if the collection of patient information and assessment process is at minimum identical to the state-provided questionnaire. The pharmacist must review the screening tool with the patient, clarify responses if needed, and measure and record the patient’s seated blood pressure.

 

Pharmacists should consider the following when choosing between levonorgestrel and ulipristal acetate for EC:

  • Levonorgestrel may be less effective than ulipristal acetate for women who weigh more than 165 lbs
  • Levonorgestrel may be preferable for patients who need EC due to missed or late administration of existing hormonal contraception
  • Starting hormonal contraceptives immediately after taking ulipristal acetate (within 5 days) may make it ineffective
  • Insurance may still cover OTC levonorgestrel if a pharmacist prescribes the product
  • Ulipristal acetate is more effective than levonorgestrel if more than 72 hours have passed since the last day of unprotected intercourse

 

Prescriptions for EC may not have any refills. Upon prescribing EC, counsel patients on the product’s proper use and potential adverse effects and provide written educational materials. The pharmacist must also notify the patient’s PCP and obstetrician/gynecologist (OB/GYN) with the patient's consent. If the patient does not have a PCP, the pharmacist should counsel the patient regarding the benefits of establishing such a relationship and, upon request, provide information regarding local providers. The pharmacist should also counsel the patient regarding the importance of preventive care, including routine well-woman visits, testing for sexually transmitted infections, and pap smears. Additionally, consider whether patients should also be evaluated for ongoing hormonal contraception, especially if they visit the pharmacy repeatedly for EC.

 

STICKING TO THE LAW

 

PAUSE AND PONDER: Are you ready for pharmacy-based contraceptive prescribing? Where will you maintain your documentation?

 

Documentation and Recordkeeping

Pharmacies must maintain appropriate records of hormonal contraceptive and EC prescribing:

  • All completed screening documents must be maintained at the prescribing pharmacy in the same manner as the prescription itself for at least three years.
  • All records created as part of the prescribing process must be maintained for at least three years and be readable retrievable and provided to DCP within 48 hours

 

Prohibited Acts

A prescribing pharmacist shall not

  • prescribe any hormonal contraceptive or EC in an instance where the screening document for hormonal contraceptive or screening document emergency contraceptives indicates that referral to a practitioner is clinically appropriate
  • prescribe any hormonal contraceptive or EC without a completed screening document for hormonal contraceptive or completed screening document for emergency contraceptive, as applicable
  • issue a prescription for a total supply period exceeding 12 months based on the directions of use provided on the prescription
  • prescribe any hormonal contraceptive or EC outside of the approved use stated in the product’s FDA-approved package insert
  • prescribe a medical device, with or without hormonal contraceptives, that is implanted by a practitioner for the purpose of preventing pregnancy, including intrauterine and implantable devices

 

Pharmacy Technician and Intern Involvement

Pharmacy technicians who have completed an approved training course for prescribing of hormonal contraceptives may, at the pharmacist's request, assist the pharmacist in prescribing a hormonal contraceptive by:

  • providing the screening document to the patient
  • taking and recording the patient's blood pressure
  • documenting the patient's medical history

 

A registered pharmacist intern may prepare a prescription for a hormonal contraceptive under the direct supervision of a trained prescribing pharmacist, but a pharmacist authorized to prescribe under this protocol must review, approve, and sign the prescription before the prescription is processed or dispensed.

 

CONCLUSION

Pharmacist prescribing removes significant barriers to patient access and use of hormonal contraceptives and EC to prevent pregnancy especially for those with limited access to healthcare services or busy schedules. More than 90% of Americans live within five miles of a pharmacy, making pharmacists the most accessible healthcare professionals and perfectly positioned to improve contraceptive access.22 Pharmacist involvement can lead to better education and counseling on contraceptive options, promoting informed decision-making and improving therapy uptake and adherence.

APPENDIX A – CDC US Medical Eligibility Criteria for Contraceptive Use, 2016

 

APPENDIX B – CDC US Medical Eligibility Criteria for Contraceptive Use, 2016, SUMMARY CHART

 

 

APPENDIX A-U.S. MEC 2024_UPDATE full text pdf

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APPENDIX B-U.S. MEC 2024 Summary Chart

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Pharmacist Post Test (for viewing only)

Pharmacist Post-test

1. What is the rate of unintended (mistimed or unwanted at the time of conception) pregnancy in the United States?
A. It's about 30%
B. It's about 50%
C. It's about 65%

2. Compared to intentional pregnancy, which of the following conditions is more likely to occur with unintentional pregnancy?
A. Women who experience unintended pregnancy also experience more mental health problems.
B. Women who experience unintended pregnancy also experience higher rates of iron deficiency.
C. Women who experience unintended pregnancy are more likely to be married or in stable relationships.

3. When researchers looked at children born as the result of an unintended pregnancy, what did they find?
A. Their mental and physical challenges are similar to other children's.
B. They are more likely to have mental challenges than physical challenges.
C. They are more likely than other children to struggle in school.

4. Which of the following approaches to contraception prevents implantation of a fertilized ovum in the endometrium?
A. Using a barrier method of contraception
B. Creating an unfavorable uterine environment
C. Preventing ovulation from occurring

5. Hormonal contraceptives use two hormones to prevent pregnancy. What are they?
A. Testosterone and estrogens
B. Progestins and testosterone
C. Progestins and estrogens

6. Which of the following correctly identifies estrogen’s role in birth control?
A. Promote the LH surge, which inhibits ovulation
B. Stabilize the endometrial lining and provide cycle control
C. Increase endometrial thickness to delay implantation

7. Which of the following correctly identifies progestin’s role in birth control?
A. Block the LH surge, which inhibits ovulation
B. Stabilize the endometrial lining and provide cycle control
C. Increase endometrial thickness to delay implementation

8. Why is estrogen never used alone as a contraceptive?
A. This is a trick question. Several FDA approved contraceptives employ estrogen alone to prevent contraception.
B. Unopposed estrogen increases the risk of hormonal imbalance and subsequently, the risk of pregnancy.
C. Unopposed estrogen increases risk of cancer, endometrial hyperplasia, polyps, endometriosis, and adenomyosis in women who have an intact uterus.

9. Anne Marie is 42-year-old woman who comes to the pharmacy seeking hormonal contraception. Your technician takes her blood pressure and records it as 152/93. Anne Marie smells like she has recently smoked a cigarette. Which of the following would be an appropriate choice of contraceptives?
A. A progestin only contraceptive
B. A combined hormonal contraceptive
C. Any hormonal contraceptive would be inappropriate

10. A primary care provider calls the pharmacy and asks you which progestin is the best in terms of contraceptive efficacy. What do you say?
A. No evidence indicates that a particular progestin is superior to others
B. Some evidence indicates any oral progestin is better than injectable forms
C. Norgestimate is more effective than any other progestin

11. When discussing possible hormonal contraceptives, the patient asks about the efficacy of combined oral contraceptives. What do you tell her?
A. With typical use, COCs are about 91% effective, meaning that 9 of 100 women will become pregnant in a year with typical use.
B. With typical use, COCs are about 95% effective, meaning that 5 of 100 women will become pregnant in a year with typical use.
C. With typical use, COCs are about 99% effective, meaning that 1 of 100 women will become pregnant in a year with typical use.

12. You are considering a combined hormonal contraceptive for a patient whose last menstrual period started seven days ago. She will start taking the contraceptive today. What should you tell her about intercourse?
A. She needs no additional protection and can have unprotected intercourse.
B. She should abstain or use backup contraception until her next menses.
C. She should abstain or use backup contraception for the next seven days.

13. Which of the following contains 84 days of active hormone tablets followed by 7 days of inactive tablets?
A. Extended- and continuous-cycle COCs
B. Extended- and continuous-cycle POPs
C. No hormonal contraception is formulated like this

14. A patient expresses a preference for a combined oral contraceptive pill that contains 40 mcg of ethinyl estradiol daily because her friend takes such a pill. She is new to hormonal contraceptives. What do you tell her?
A. You should start a COC containing 35 mcg or less of ethinyl estradiol.
B. You should start a COC containing 20 mcg or less of ethinyl estradiol.
C. You should start a COC containing 50 mcg or more of ethinyl estradiol.

15. The patient in the previous question asks why you selected the answer you did. What do you say?
A. Estradiol levels affect the incidence of blood clotting.
B. Estradiol levels affect the incidence of migraine headache.
C. Estradiol levels affect the incidence of breakthrough bleeding.

16. Why do the guidelines prefer monophasic COCs over multiphasic COCs when women start contraception?
A. Adverse effects are considerably less likely to occur.
B. Monophasic COCs always contain low estradiol doses.
C. Adverse effects are easier to identify and manage.

17. After discussing various options with a patient, she mentions that she works swing shifts in the same week and will sometimes have to take her pill before her night shift and sometimes after her evening shift. She asks if that will be a problem if she prefers the “minipill.” What is the MOST APPROPRIATE question for you to ask?
A. Will that keep you from taking it in the same 3-hour window every day?
B. How long does it take you to drive to and from work?
C. What about the “minipill” do you find so attractive?

18. In which populations of women are progestin-only pills preferred?
A. Postpartum women who have delivered in the last 30 to 42 days and breastfeeding women
B. Women who are older than 42 and smokers and women with body weights less than 127 lbs
C. Women who experience breakthrough bleeding and those with adherence challenges

20. Why do vaginal ring systems carry a risk of toxic shock syndrome?
A. They can trap bacteria on the cervix, allowing it to enter the fallopian tubes via the uterus.
B. The patient handles them multiple times during use, posing a risk of bacterial contamination.
C. They can trap bacteria in the vagina or create tiny cuts, allowing bacteria to enter the uterus via the cervix.

21. What warning is included in depo-medroxyprogesterone acetate’s labeling as a Boxed Warning?
A. Patients should not use the drug for more than two years due to bone mineral density loss, which may be irreversible
B. Return to fertility may be delayed six to 12 months after discontinuation, so DMPA is not recommended for women desiring pregnancy in the near future
C. DMPA is about 89% effective with typical use so women should use a backup method of contraception.

22. Which of the following emergency contraceptives requires a prescription?
A. Levonorgestrel 1.5 mg
B. Ulipristal acetate 30 mg
C. Neither

23. The CDC’s MEC uses “categories” based on evidence to describe its recommendation. Which of the following is paired correctly?
A. 1 = Theoretical or proven risks usually outweigh the advantages
B. 2 = Advantages generally outweigh theoretical or proven risks
C. 4 = No restriction (method can be used)

24. Your patient has sickle cell disease. According to the CDC’s MEC, what category do POPs fall into?
A. 1
B. 2
C. 3

25. Your patient has a history of gallbladder disease and had a cholecystectomy six months ago. Which of the following contraceptive methods are considered appropriate for this patient?
A. Any IUD, implants, or CHCs
B. DMPA, POPs, and CHCs
C. Benefits generally outweigh the risks for all methods

26. You look at the CDC’s MEC summary chart and you find that the category you are considering is marked with an asterisk (*). What does that mean?
A. Condition that exposes a woman to increased risk as a result of pregnancy.
B. See the complete guidance for a clarification to this classification.
C. Advantages generally outweigh theoretical or proven risks.

27. You look at the CDC’s MEC summary chart and you find that the category you are considering is marked with a dagger (‡). What does that mean?
A. Condition that exposes a woman to increased risk as a result of pregnancy.
B. See the complete guidance for a clarification to this classification.
C. Advantages generally outweigh theoretical or proven risks.

28. In the CDC’s MEC, what is the daily threshold for number of cigarettes at which the risk of using a CHC increases to “Unacceptable health risk (method not to be used)” for women age 35 and older?
A. 15
B. 20
C. 30

29. What does the CDC’s MEC say about the evidence to support the use of progestin-only injectable contraceptives in women at high risk for HIV?
A. Eleven observational studies suggested no association between their use and HIV acquisition
B. Eleven observational studies suggested their use increased risk for HIV acquisition 3-fold
C. Insufficient evidence exists to conclude that they increase the risk of HIV acquisition

30. In a woman who has rheumatoid arthritis and takes immunosuppressives, which of the following poses the highest risk?
A. DMPA
B. POP
C. CHC

31. What is the U.S. MEC’s reason for classifying the class of drugs referred to in the previous question as they did?
A. Risk for breakthrough bleeding increases
B. Risk for osteoporosis increases
C. Risk for drug interactions increases

32. What does the U.S. MEC, indicate about the use of emergency contraceptive pills (ECPs) in women who have experienced sexual assault?
A. ECPs might be less effective among women with BMI < 25 kg/m2 than among women with BMI > 30 kg/m2.
B. Frequently repeated ECP use might be harmful for women with conditions classified as 1, 2, or 3 for CHC or POP use.
C. Women with obesity might experience an increased risk for pregnancy after use of ulipristal acetate compared with women of healthy weight.

33. Carmen is a 44-year-old mother of four. She recently experienced a pulmonary embolism. Which hormonal contraceptive is LEAST appropriate for her?
A. Depo-medroxyprogesterone acetate
B. Combined hormonal contraceptives
C. Progestin-only pills

34. Alexis is on a COC and is experiencing early cycle (days 1-9) breakthrough bleeding. What change to her COC might resolve this issue?
A. Using a COC with more progestin
B. Using a COC with more estrogen
C. Changing her to a POP

35. Justine has been using DMPA for two years, and really likes it for its convenience. She asks you to renew the prescription. What do you do?
A. Screen her for adverse effects and renew the prescription if she has none.
B. Renew the prescription and advise her to increase her calcium and vitamin D intake.
C. Explain why it’s necessary to find an alternative birth control at this point.

36. Rory comes to the pharmacy requesting a prescription for emergency contraception following unprotected sex 48 hours ago. She weighs 150 lbs and has missed the first three doses of her COC because she forgot to refill it on time. Which of the following is the BEST choice for Rory?
A. Prescribe levonorgestrel
B. Prescribe ulipristal acetate
C. Referral for an emergency IUD

37. Tina is a 27-year-old woman who is six months postpartum and requesting a prescription for hormonal contraceptives. Her baby is formula-fed, she weighs 205 lbs, and she takes sertraline (an SSRI) for postpartum depression. She explains that she has had trouble with daily medication adherence in the past and expresses concerns about intolerable adverse effects. Which of the following hormonal contraceptives is MOST appropriate for Tina?
A. Continuous-cycle COCs
B. Transdermal CHC patch
C. EE/E vaginal ring system

38. In addition to verbal counseling, what must a pharmacist provide when prescribing hormonal contraception?
A. A document describing storage
B. A fact sheet specific to the drug
C. A receipt indicating the drug’s cost

39. In addition to the document described in the previous question, what else should the patient have in her possession before leaving the pharmacy?
A. A copy of documentation that the pharmacist passed this test
B. The pharmacist’s business card that includes a phone number
C. A written record of the contraceptive prescribed

40. Which of the following is a critical counseling point when counseling a woman who is starting hormonal contraception after using ECP?
A. Hormonal contraceptives do not protect against sexually transmitted diseases.
B. Using hormonal contraceptives routinely is less expensive than using ECPs.
C. Once you start hormonal contraception, you cannot use ECPs again.

41. You are prescribing POPs to a patient who started her last menstrual period 10 days ago. The last time she had sexual intercourse was 14 days ago. Which of the following counseling points is appropriate?
A. Start this medication today, and no backup contraception is needed.
B. Start this medication today and use backup contraception for 2 days.
C. Do not start this medication until after you’ve taken a pregnancy test.

42. You are prescribing transdermal CHCs to a patient who was previously on COCs but had poor adherence. Which of the following counseling points is appropriate?
A. If the patch detaches for three or more hours, use backup contraception for seven days
B. If you plan to exercise, use medical tape to reinforce the patch and prevent detachment
C. You may experience more adverse effects due to higher estrogen exposure

43. A patient consults with you for emergency contraception. You decide that ulipristal acetate is the best choice. The patient asks you to give her four refills. What do you tell her?
A. Yes, I can give you four refills but you must use them within a year.
B. Ulipristal is an OTC drug; you don’t need a prescription or refills.
C. The law doesn’t allow refills, so let’s discuss a better contraceptive plan.

44. Your patient is interested in hormonal contraception. She indicates that she doesn’t remember when she last saw a healthcare provider for a women’s health visit. Under what circumstance can you prescribe hormonal contraception?
A. She has an empty package of oral contraceptives and the last refill was expended this month.
B. She is younger than 18 years of age and accompanied by her mother who says it’s OK to prescribe to her.
C. She has a package of ECPs prescribed by a pharmacist in another state about two and a half years ago.

45. It’s August and a college student visits and asks for a prescription for a hormonal contraceptive. She’s excited because she is going to study abroad for one year starting in October. She asks for 14 months of an OCP. What do you do?
A. Write a prescription with 14 one-month refills and tell her to have her parent refill it and mail it as necessary
B. Issue a prescription for three months, and ask her to return before she leaves for a new 1-year prescription
C. Fill it in bulk for 14 months and make a note in the record indicating this is an exception to policy allowed by law
46. A 16-year-old high school student asks for a prescription for a hormonal contraceptive. In what way is this situation different than handling a prescription for a patient older than 18?
A. The patient must have previously been prescribed a contraceptive by another provider.
B. The patient needs permission from a parent or guardian before a pharmacist can prescribe.
C. The patient must take an OTC pregnancy test before a pharmacist can prescribe.

47. A woman comes to the pharmacy with a prescription for hormonal contraception written by another pharmacist. Can you fill it?
A. Yes, if I know the pharmacist.
B. No, she needs to go back to the pharmacy where the prescribing pharmacist works.
C. Yes, if the prescribing pharmacist is authorized to write for hormonal contraception.

48. Which of the following is a red flag requiring pharmacist referral to a practitioner for evaluation before prescribing DMPA?
A. Blood pressure > 140/90 mmHg
B. Taking escitalopram for depression
C. Gave birth 3 weeks ago

49. After prescribing hormonal contraceptives, which of the following is required?
A. Maintain completed screening documents at the prescribing pharmacy for 1 year
B. Transmit dispensing information to the electronic prescription drug monitoring program within 72 hours
C. Maintain all records created as part of the prescribing process for three years

50. Your pharmacy is located in a college town, and you are inundated with requests for hormonal contraceptive prescriptions. One of the pharmacy technicians completed an approved training course and would like to help. Which of the following is an appropriate way for the technician to contribute?
A. Provide screening documents and take and record the patient’s blood pressure
B. Take and record the patient’s blood pressure and review screening documents for contraindications
C. Supervise patients performing OTC pregnancy tests and provide educational materials about contraceptives

References

Full List of References

REFERENCES

    1. Guttmacher Institute. Contraceptive use in the United States by demographics. May 2021. Accessed October 18, 2023. https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
    2. Office on Women’s Health. Unplanned pregnancy. Updated February 22, 2021. Accessed October 18, 2023. https://www.womenshealth.gov/pregnancy/you-get-pregnant/unplanned-pregnancy
    3. Office of Disease Prevention and Health Promotion. Healthy People 2030: Reduce the proportion of unintended pregnancies — FP‑01. Accessed October 18, 2023. https://health.gov/healthypeople/objectives-and-data/browse-objectives/family-planning/reduce-proportion-unintended-pregnancies-fp-01
    4. Centers for Disease Control and Prevention. Contraception. Updated May 1, 2023. Accessed October 18, 2023. https://www.cdc.gov/reproductivehealth/contraception/index.htm
    5. Bull JR, Rowland SP, Scherwitzl EB, Scherwitzl R, Danielsson KG, Harper J. Real-world menstrual cycle characteristics of more than 600,000 menstrual cycles. NPJ Digit Med. 2019;2:83. doi:10.1038/s41746-019-0152-7
    6. Reed BG, Carr BR. The normal menstrual cycle and the control of ovulation. In: Feingold KR, Anawalt B, Blackman MR, et al., eds. Endotext. South Dartmouth (MA): MDText.com, Inc.; August 5, 2018.
    7. Teal S, Edelman A. Contraception selection, effectiveness, and adverse effects: A Review. JAMA. 2021;326(24):2507-2518. doi:10.1001/jama.2021.21392
    8. Montanino Oliva M, Gambioli R, Forte G, Porcaro G, Aragona C, Unfer V. Unopposed estrogens: current and future perspectives. Eur Rev Med Pharmacol Sci. 2022;26(8):2975-2989. doi:10.26355/eurrev_202204_28629
    9. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66. doi:10.15585/mmwr.rr6504a1
    10. Annovera (prescribing information). TherapeuticsMD, Inc.;2022.
    11. Centers for Disease Control and Prevention. Recommended Actions After Late or Missed Combined Oral Contraceptives. Accessed February 28, 2024. https://www.cdc.gov/reproductivehealth/contraception/pdf/recommended-actions-late-missed_508tagged.pdf
    12. American College of Obstetricians and Gynecologists. Effectiveness of birth control methods. April 2023. Accessed February 20, 2024. https://www.acog.org/womens-health/infographics/effectiveness-of-birth-control-methods
    13. Darney PD. OC practice guidelines: minimizing side effects. Int J Fertil Womens Med. 1997;Suppl 1:158-169.
    14. Ortho Evra (prescribing information). Janssen Pharmaceuticals, Inc.;2017.
    15. Annovera - a new contraceptive vaginal ring. Med Lett Drugs Ther. 2019;61(1587):197-198.
    16. NuvaRing (prescribing information). Organon & Co.; 2022.
    17. Cleveland Clinic. Toxic shock syndrome. Updated August 12, 2022. Accessed February 20, 2024. https://my.clevelandclinic.org/health/diseases/15437-toxic-shock-syndrome
    18. Depo-subQ Provera 104 (prescribing information). Pfizer Inc.; 2020.
    19. Plan B One-Step (prescribing information). Barr Laboratories; 2009. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf
    20. Ella (prescribing information). HRA Pharma America Inc.; 2021.
    21. Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use, 2016 (US MEC). Reviewed March 27, 2023. Accessed February 20, 2024. https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html22. National Association of Chain Drug Stores. Pharmacies - The Face of Neighborhood Health Care Since Well Before the Pandemic. Accessed March 1, 2024. https://www.nacds.org/pdfs/about/rximpact-leavebehind.pdf

    Patient Safety: Cheers to the Beers: Unpacking the Latest Updates for Safer Prescribing -RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    Review the role of the Beers Criteria in reducing potentially inappropriate medication (PIM) use and enhancing patient safety in older adults
    Identify recent updates to the Beers Criteria and their implications for medication management in geriatric care
    Apply the updated Beers Criteria to real-world scenarios, optimizing medication selection and minimizing risks in older adults

    Release and Expiration Dates

    Released:  December 13, 2024
    Expires:  December 13, 2027

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-24-045-H05-P

    Session Code

    24RW45-XTY89

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-045-H05-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Kelsey Giara, PharmD
    Freelance Medical Writer
    Adjunct Faculty
    University of Connecticut School of Pharmacy
    Pelham, NH

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    • Dr. Giara has no financial relationships with ineligible companies.

    Disclaimer

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Content

    Handouts

    Post Test

    Learning Objectives
    • Review the role of the Beers Criteria in reducing potentially inappropriate medication (PIM) use and enhancing patient safety in older adults
    • Identify recent updates to the Beers Criteria and their implications for medication management in geriatric care
    • Apply the updated Beers Criteria to real-world scenarios, optimizing medication selection and minimizing risks in older adults

    1. About how many older adults are prescribed potentially inappropriate medications?
    A. One in seven
    B. One in five
    C. One in three

    2. Which of the following describes how age-related physiologic changes affect older adults?
    A. Decreased renal and hepatic blood flow slows drug excretion, causing toxicity
    B. Frailty increases activity in drug metabolizing pathways, making drugs less effective
    C. Decreased body fat and dehydration affect drug distribution and cause toxicity

    3. Which of the following best describes a potentially inappropriate medication?
    A. A drug that is contraindicated in patients older than 65 years
    B. A drug for which risks outweigh benefits in older adults
    C. A drug that should only be used in hospice or end-of-life care

    4. Which of the following is TRUE?
    A. Older adults should always avoid SGLT2 inhibitors
    B. The updated criteria removes doxepin < 6 mg/day C. Dabigatran is the safest anticoagulant for older adults 5. Which of the following best describes Beers Criteria guidance on proton pump inhibitors (PPIs)? A. Deprescribe after 8 weeks of scheduled use, unless the patient is high-risk B. After 8 weeks of scheduled use, reevaluate risks and benefits and continue if tolerated C. Avoid scheduled use completely and advise patients to use intermittent antacids 6. Which of the following is a reason to deprescribe a medication found on the Beers Criteria? A. The drug is being used to treat cancer but carries a risk of acid reflux B. The drug is being used to treat two indications at once C. The drug was prescribed to address the adverse effect of another drug 7. Mrs. Taylor, a 78-year-old woman with a history of AFib and diabetes, is prescribed rivaroxaban for stroke prevention and glyburide for glycemic control. During a consultation, she reports episodes of dizziness and has a recent lab result showing a creatinine clearance of 35 mL/min. Which of the following is the BEST plan of action? A. Recommend switching glyburide to glipizide B. Advise switching rivaroxaban to warfarin C. Continue both medications with increased monitoring for AEs

    VIDEO

    Immunization: Our Best Shot – Tips and Tools to Vaccinate Older Adults – RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    1.     RECOGNIZE appropriate vaccine recommendations for the older adult population
    2.      IDENTIFY potential barriers to vaccinations
    3.     ANALYZE current methods used to improve vaccination rates
    4.     DISCUSS ways to improve vaccine compliance in your patient population

    Release and Expiration Dates

    Released:  December 13, 2024
    Expires:  December 13, 2027

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-24-047-H06-P

    Session Code

    24RW47-FXY23

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-047-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Jack Vinciguerra, PharmD
    Express Scripts
    St Louis, MO

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    • Dr. Vinciguerra has no financial relationships with ineligible companies.

    Disclaimer

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Content

    Handouts

    Post Test

    Immunization: Our Best Shot - Tips and Tools to Vaccinate Older Adults

    After completing this continuing education activity, pharmacists will be able to

    • Recognize appropriate vaccine recommendations for the older adult population
    • Identify potential barriers to vaccinations
    • Analyze current methods used to improve vaccination rates
    • Discuss ways to improve vaccine compliance in your patient population

    1. How many vaccines does the CDC strongly recommend for older adults?
    a. Just two: influenza and COVID
    b. Three: influenza, COVID, and RSV
    c. Six-ish!!! (It depends)

    2. New patient, ES, age 60, has recently moved to Connecticut from Ontario, Canada. The patient reports receiving Zostavax 1 month ago. Which of the following recommendations regarding the administration of Shingrix is correct?
    a. Shingrix is contraindicated in those who have received Zostavax.
    b. It is recommended to administer the Shingrix vaccine immediately.
    c. It is recommended to wait at least 8 weeks after receiving Zostavax.

    3. Which of the following situations might act as a barrier to vaccine uptake in older adults?
    a. The nearest pharmacy and healthcare facilities are miles away and not on a bus route.
    b. Other people at the senior center have had COVID, the flu, or shingles recently and been quite ill.
    c. Pharmacy staff asks pleasantly and often if they might be ready to be vaccinated.

    4. Which of the following is an example of a contextual influence as defined by the Vaccine Hesitancy Determinants Matrix?
    a. Personal experience with vaccinations
    b. Communication and media environment
    c. Mode of vaccine administration

    5. Which of these programs is a federal program that uses digital outreach, television, print, and radio to decrease vaccine hesitancy among older adults?
    a. Risk Less, Do More
    b. It’s a Sure Shot
    c. No Shot in the Dark

    6. You’re monitoring vaccine uptake in your community and it is alarmingly low. You decide to use the S-H-A-R-E method of encouraging vaccine uptake. What does the R stand for?
    a. Remind patients that getting a vaccine-preventable disease is costly
    b. Remind patients that vaccines protect them and their loved ones
    c. Remind patients that you have the vaccines they need in stock

    Share the tailored reasons why the recommended vaccine is right for the patient
    Highlight positive experiences with vaccines (anecdotal or in practice) to strengthen confidence
    Address patient questions and concerns about the vaccine
    Remind patients that vaccines protect them and their loved ones
    Explain the potential costs of getting the disease

    VIDEO

    Breaking the Mold: Novel Mechanisms in Psychiatry’s New Kids on the Block-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2025 CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    • Describe the unique mechanisms of action of xanomeline-trospium in the management of schizophrenia and dextromethorphan-containing medications in the management of major depressive disorder
    • Distinguish between adverse effect profiles of new psychiatric medications compared to traditional antipsychotics and antidepressants
    • Identify appropriate candidates for new psychiatric medications based on knowledge of efficacy, safety, and patient-specific factors

     

    Release and Expiration Dates

    Released:  December 19, 2025
    Expires:  December 19, 2028

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-25-068-H01-P

    Session Code

    25RW68-PBJ53

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-25-068-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Kristin Waters, PharmD, BCPS, BCPP
    Assistant Clinical Professor
    UConn School of Pharmacy
    Storrs, CT

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    • Dr. Waters is on the Johnson and Johnson speakers' bureau, but the information discussed here has no overlap. All financial relationships with ineligible companies have been mitigated.

    Disclaimer

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Content

    Handouts

    Post Test

    NKOTB: Breaking the Mold: Novel Mechanisms in Psychiatry’s New Kids on the Block Assessment Questions

    25-068

      Posttest

      1. What is the purpose of pairing trospium with xanomeline in the combination drug used in the management of schizophrenia?
          1. Trospium reduces the amount of weight gain associated with xanomeline.
          2. Trospium effectively treats the cognitive symptoms associated with schizophrenia.
          3. Trospium reduces the amount of gastrointestinal adverse effects associated with xanomeline.
      2. Compared with standard antipsychotic medications, xanomeline/trospium is associated with less:
          1. Weight gain
          2. Constipation
          3. Hypertension
      3. Which of the following patients would be the best candidate for treatment with xanomeline/trospium?
          1. A patient with newly diagnosed schizophrenia who has never been treated with an antipsychotic.
          2. A patient with schizophrenia who has developed significant movement-related adverse effects during treatment with risperidone.
          3. A patient with schizophrenia who prefers treatment with long-acting injectable medications due to problems remembering to take oral medications.
      4. The mechanism of action of dextromethorphan is different from other medications used to manage depression because it antagonizes which receptor type?
          1. Serotonin
          2. NMDA
          3. Glutamate
      5. Which of the following is a common adverse effect associated with dextromethorphan/bupropion?
          1. Dizziness
          2. Sexual dysfunction
          3. Weight gain
      6. Which of the following patients would be the best candidate for treatment with dextromethorphan/bupropion?
          1. A patient with major depressive disorder and epilepsy who was previously treated with fluoxetine.
          2. A patient with major depressive disorder who has had seven previous antidepressant trials that were not effective.
          3. A patient with major depressive disorder and diabetes mellitus type 2 who has had previous trials with escitalopram and venlafaxine.

      VIDEO

      Opioids: Impact of Palliative Care on Total Pain in the Older Adult-RECORDED WEBINAR

      About this Course

      This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

       

      Learning Objectives

      Upon completion of this application based CE Activity, a pharmacist will be able to:

      Describe Palliative Care and its importance in the healthcare system today
      Define the concept of “total pain” and the importance of whole person care in pain and symptom management
      Recognize the physiologic changes that occur with aging and how those impact pain and symptom management
      Determine the role of the pharmacist in total pain management in the older adult

      Release and Expiration Dates

      Released:  December 13, 2024
      Expires:  December 13, 2027

      Course Fee

      $17 Pharmacist

      ACPE UAN

      0009-0000-24-046-H08-P

      Session Code

      24RW46-TXV63

      Accreditation Hours

      1.0 hours of CE

      Additional Information

       

      How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

      Accreditation Statement

      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

      Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-046-H08-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

      Grant Funding

      There is no grant funding for this activity.

      Faculty

      Megan Mitchell, PharmD, MS
      Pharmacy Clinical Coordinator Pain Management and Palliative Care
      University of Connecticut Healthcare
      Farmington, CT

      Faculty Disclosure

      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

      • Dr. Mitchell has no financial relationships with ineligible companies.

      Disclaimer

      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

      Content

      Handouts

      Post Test

      Opioids: Impact of Palliative Care on Total Pain in the Older Adult

      Post Test Questions

       

      1. Which of the following are goals of palliative care?
        1. Convince patients to enroll with hospice for end-of-life care
        2. Stop curative intent therapies to focus on comfort
        3. Improve quality of life for patients and families

       

      1. Which of the following is true regarding the differences between primary palliative care and specialty palliative care?
        1. Any individual healthcare provider can provide primary palliative care
        2. Primary palliative care always comes first
        3. Specialty palliative care always requires insurance prior authorization

       

      1. Which of the following is the IASP definition of pain?
        1. An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage
        2. An unpleasant physical experience associated with, or resembling that associated with, actual or potential tissue damage
        3. An unpleasant emotional experience associated with, or resembling that associated with, actual tissue damage

       

      1. Approximately how much money is spent annually via direct medical costs, lost productivity and disability related to chronic pain in the United States?
        1. $5.6 billion
        2. $56 billion
        3. $560 billion

       

      1. Which of the following pain types is defined as maladaptive changes in pain processing and modulation without evidence of tissue or nerve damage?
        1. Nociceptive pain
        2. Nociplastic pain
        3. Neuropathic pain

       

      1. Which of the following is the correct definition of “total pain”?
        1. The total suffering of one’s physical, social, psychological and spiritual self that is experienced when dealing with serious illness
        2. The total suffering of one’s physical, social, psychological and spiritual self that is experienced with first time home buying
        3. The total suffering of one’s physical, social, psychological and spiritual self that is experienced when taking CE post-tests

       

      1. How does non-physical pain and suffering often manifest?
        1. Reports of worsening mood
        2. Reports of physical pain
        3. Reports of fear of dying

      VIDEO

      Law: Seniors Self-Diagnosing and Treating: A Brave (and scary) New World-RECORDED WEBINAR

      About this Course

      This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

       

      Learning Objectives

      Upon completion of this application based CE Activity, a pharmacist will be able to:

      Describe the reasons seniors are increasingly diagnosing and treating themselves with therapies
      Describe the legal and regulatory pathways that provide seniors access to therapies outside the drug supply chain
      Describe the ways that pharmacists can recommend dietary supplements that are free of adulterants and contaminants
      Describe the risks associated with self-treatment with dietary supplements, “peptides”, and counterfeit drug

      Release and Expiration Dates

      Released:  December 13, 2024
      Expires:  December 13, 2027

      Course Fee

      $17 Pharmacist

      ACPE UAN

      0009-0000-24-044-H03-P

      Session Code

      24RW44-BVF28

      Accreditation Hours

      1.0 hours of CE

      Additional Information

       

      How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

      Accreditation Statement

      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

      Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-044-H03-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

      Grant Funding

      There is no grant funding for this activity.

      Faculty

      C. Michael White, PharmD, FCCP, FCP
      BOT Distinguished Professor and Chair of Pharmacy Practice
      University of Connecticut School of Pharmacy
      Storrs, CT

      Faculty Disclosure

      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

      • Dr. White has no financial relationships with ineligible companies.

      Disclaimer

      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

      Content

      Handouts

      Post Test

        Pharmacist Post Test

         

        1. Don is a 72-year-old who is looking online for alternatives to self-manage his pain. His prescriber told him he would not write any other prescriptions for oxycodone with APAP. He is looking at kratom and for Canadian Pharmacies that don’t require a prescription. Which of the following is the motivator for Don to transcend the normal medication supply chain?
        1. Cost of prescription options
        2. Circumvent prescriber gatekeeping restrictions
        3. Embarrassment over his health issue

         

        1. You are a pharmacist at a community pharmacy and a patient asks you which supplements to buy. What is a validated way to assure the dietary supplement you recommend does not have excessive microbial or heavy metal contamination and has the ingredients in the tablets/capsules advertised on the label?
        1. USP certification
        2. Better Homes and Gardens Certification
        3. The most expensive one

         

        1. Sylvia is a 68-year-old woman who weighs 120 pounds but wants to weigh 108 pounds like she did when she was 40 years old. Which of the following is a good counseling point if she reveals she is using a “peptide” GLP-1 product?
        1. Her obesity is a disorder that requires a GLP-1 product, so the benefits outweigh the risks
        2. These products are known to contain lead and arsenic in too high a level
        3. The labeled dose could vary, and she could overdose or underdose as a result

         

        1. Don from question 1 finds a “pharmacy” willing to sell him oxycodone with APAP for $7 a pill without a prescription. The site says it is a best seller in Canada. What is the main risk of Don getting his opioids from the unlicensed online site?
        1. Fentanyl adulteration and dose variability could lead to respiratory depression
        2. It is more expensive than the brand name prescription version he now takes
        3. The company offers no certificate of analysis or money back guarantee

         

        1. A company says its melatonin supplement can “support a restful sleep” and that “this product is not intended to diagnose, evaluate, or treat any disease.” What would the FDA call this?
        1. A legitimate health claim
        2. A legitimate quasi health claim
        3. A legitimate semi-health claim

         

        1. A woman calls a company that sells “Energy Macha” to complain that her newborn has an extra arm with seven fingers. How long does the company have to alert the FDA about this serious potential adverse event?
        1. 1-day
        2. 5-days
        3. 15-days

         

        1. Which of the following common adulterants is matched with the type of dietary supplement it is associated with?
        1. Weight Loss – human growth hormone
        2. Muscle Building – sildenafil
        3. Sexual Enhancement – tadalafil

         

        1. What is the name of the law that controls FDA authority over dietary supplements?
        1. DSHEA 1994
        2. OBRA 1990
        3. FDCA 1927

         

        VIDEO

        Beyond Memory Loss: Mastering the Management of Behavioral Symptoms in Dementia-RECORDED WEBINAR

        About this Course

        This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

         

        Learning Objectives

        Upon completion of this application based CE Activity, a pharmacist will be able to:

        1.      Identify clinical characteristics of the behavioral symptoms of dementia (BSD) including agitation, psychosis, and sleep disturbances
        2.      Discuss medications currently used in the management of BSD along with emerging pharmacologic therapy options
        3.      Determine the most appropriate pharmacologic treatment option for a patient with behavioral symptoms of dementia based on patient-specific factors

        Release and Expiration Dates

        Released:  December 13, 2024
        Expires:  December 13, 2027

        Course Fee

        $17 Pharmacist

        ACPE UAN

        0009-0000-24-048-H01-P

        Session Code

        24RW48-YXF98

        Accreditation Hours

        1.0 hours of CE

        Additional Information

         

        How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

        Accreditation Statement

        The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

        Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-048-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

        Grant Funding

        There is no grant funding for this activity.

        Faculty

        Kristin Waters, PharmD, BCPS, BCPP
        Assistant Clinical Professor
        UConn School of Pharmacy
        Storrs, CT

        Faculty Disclosure

        In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

        • Dr. Waters is on the Johnson and Johnson speakers' bureau, but the information discussed here has no overlap. All financial relationships with ineligible companies have been mitigated.

        Disclaimer

        The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

        Content

        Handouts

        Post Test

          Behavioral Symptoms of Dementia Assessment Questions

          1. Which of the following is a symptom of agitation in dementia?
          1. Hallucinations
          2. Restless leg syndrome
          3. Throwing objects

           

          1. A 64-year-old patient has a PMH of AD, hypertension, urinary incontinence, and insomnia. Recently, they have been increasingly agitated throughout both the day and night. Symptoms primarily include pacing and verbally repeating the same phrases many times. Non-pharmacologic intervention is mildly effective, but the patient’s caregiver is requesting pharmacologic intervention as well.

          Current medications:

          Amlodipine 10 mg po daily

          Oxybutynin 10 mg po daily

          Diphenhydramine 25 mg po nightly prn insomnia

          Cetirizine 10 mg po daily

          Melatonin 6 mg po nightly Which of the following is the best first step in managing the patient’s agitation?

          1. Discontinue melatonin
          2. Reduce anticholinergic load
          3. Reduce dose of amlodipine

           

          3. The patient and caregiver agree to discontinuation of the cetirizine and diphenhydramine. They feel strongly that the oxybutynin improves their quality of life by allowing them to not become incontinent of urine overnight. Unfortunately, several weeks later the agitation symptoms persist. Which of the following is the best recommendations at this time?

          a. Initiate citalopram

          b. Initiate haloperidol

          c. Initiate risperidone

          1. A 71-year-old patient with vascular dementia recently started insisting that unknown people were living in his attic. He says he can hear the intruders talking during the night but they hide whenever someone goes up to check. The patient is extremely distressed about this and is trying to obtain a firearm to protect his family from these intruders.

          Which of the following pharmacologic recommendations may be appropriate?

          1. Brexpiprazole
          2. Trazodone
          3. Haloperidol

           

          1. The patient’s symptoms improve significantly after starting brexpiprazole. However, he is still very restless at night and wakes up frequently. He reports being “exhausted” each day. Which of the following would be the best pharmacologic option?
          1. Melatonin
          2. Eszopiclone
          3. Suvorexant

           

          6. Which medication approved for Parkinson’s disease psychosis has demonstrated the ability to prolong time to relapse of psychosis in Alzheimer’s disease?

          a. Brexpiprazole

          b. Pimavanserin

          c. Dexmedetomidine

           

          7. Which of the following behavioral symptoms of dementia is the most common?

          a. Apathy

          b. Psychosis

          c. Anxiety

          VIDEO

          LAW: Call 1-800-Get-Cash Fast: Drug-Related Advertisements about Litigation RECORDED WEBINAR

          About this Course

          This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

           

          Learning Objectives

          Upon completion of this application based CE Activity, a pharmacist will be able to:

          1.      Explain common terminology associated with commercials targeting older Americans
          2.      Describe legal processes associated with lawsuits generated against companies that make products alleged to cause harm
          3.      Discuss generalities in potential lawsuits associated with media promotion campaigns
          4.      Identify areas where no information is available to provide good, valid answers for patients who ask questions

          Release and Expiration Dates

          Released:  December 13, 2024
          Expires:  December 13, 2027

          Course Fee

          $17 Pharmacist

          ACPE UAN

          0009-0000-24-049-H03-P

          Session Code

          24RW49-ABC84

          Accreditation Hours

          1.0 hours of CE

          Additional Information

           

          How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

          Accreditation Statement

          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

          Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-049-H03-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

          Grant Funding

          There is no grant funding for this activity.

          Faculty

          Jeannette Y. Wick, RPh, MBA
          Director Office of Professional Pharmacy Development
          UConn School of Pharmacy
          Storrs, CT

          Faculty Disclosure

          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

          • Ms. Wick has no financial relationships with ineligible companies.

          Disclaimer

          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

          Content

          Handouts

          Post Test

            LAW: Call  1-800-Get-Cash Fast

             

            After completing this continuing education activity, learners will be able to

            • Explain common terminology associated with commercials targeting older Americans
            • Describe legal processes associated with lawsuits generated against companies that make products alleged to cause harm
            • Discuss generalities in potential lawsuits associated with media promotion campaigns
            • Identify areas where no information is available to provide good, valid answers for patients who ask questions

             

             

            1. What is the legal lingo for cases that are solicited on television using 1-800 numbers?
            1. Class action suits
            2. Torte claims
            3. Product liability suits

             

            1. What groups have traditionally been represented in parens patriae suits?
            2. State residents who appeal to the state to represent them
            3. Smokers and people who have opioid or alcohol use disorder
            4. Children, the mentally ill, people who are legally incompetent

             

            1. What is usury law?
            1. Laws pertaining to the use of a commercial product that results in alleged harm to a group of people who become plaintiffs
            2. Laws pertaining to  lending money at an interest rate that is unreasonably high or higher than the rate permitted by law
            3. Laws pertaining to any claim that arises in civil court, with the exception of contractual disputes, property, or criminal activity

             

            1. When discussing multi-district litigation (MDL), what does the adjective “generic” mean?
            1. It means that most torte claims do not include generic drugs; they focus on brand names
            2. It means assets (documents, expert opinion, interviews, etc) that apply to all plaintiffs
            3. It means developing charts, timelines, and visuals that a judge and jury will understand

             

            1. A patient asks you if you can determine how much money he might get if he joins a multi-district litigation on ranitidine. What do you say?
            1. Call the 1-800 number advertised on TV; the operator can provide that information.
            2. Go to the local library and access LegalTrac; settlement amounts are tracked closely.
            3. That information is guarded closely by nondisclosure agreements; it’s hard to tell.

             

            1. What is the Texas Two-Step in the legal arena?
            2. A term describing division of assets and liabilities between two companies
            3. A term describing a non-opt-out settlement for mass tort liability
            4. A term describing companies’ tendency to declare bankruptcy swiftly

             

            1. In a case against a major pharmaceutical company that made a liquid cherry flavored gastroprokinetic drug for adults, who received the lion’s share of the settlement?
            1. The patients/plaintiff
            2. The attorneys
            3. Others

            VIDEO

            DON’T SKIP A BEAT: TAKING THE PULSE OF ATRIAL FIBRILLATION

            Learning Objectives

              After completing this application-based continuing education activity, pharmacists will be able to
            •        Explain the definition, clinical presentation, and types of atrial fibrillation
            •        Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
            •        Describe the role of anticoagulation in atrial fibrillation management
            •        Identify interventions that could improve outcomes in atrial fibrillation patients
            After completing this application-based continuing education activity, pharmacy technicians will be able to:
            •        Explain the definition, clinical presentation, and types of atrial fibrillation
            •        Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
            •        Describe the role of anticoagulation in atrial fibrillation management
            •        Identify programs designed to promote medication adherence in patients with atrial fibrillation

            Anatomical structure of the heart centered in front of multiple electrocardiogram readings.

            Release Date:

            Release Date:  January 15, 2025

            Expiration Date: January 15, 2028

            Course Fee

            Pharmacist $7

            Pharmacy Technician $4

            There is no funding for this CPE activity.

            ACPE UANs

            Pharmacist: 0009-0000-25-001-H01-P

            Pharmacy Technician: 0009-0000-25-001-H01-T

            Session Codes

            Pharmacist:  25YC01-DSB29

            Pharmacy Technician:  25YC01-BSD92

            Accreditation Hours

            2.0 hours of CE

            Accreditation Statements

            The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-25-001-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

             

            Disclosure of Discussions of Off-label and Investigational Drug Use

            The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

            Faculty

            Brian L. Gaul, B.S., PharmD, RPh
            Freelance Medical Writer
            Gaul Communications
            Tomah, WI


             

            Faculty Disclosure

            In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

            Dr. Gaul has no financial relationships with ineligible companies.

            ABSTRACT

            Atrial fibrillation (AFib) is a growing problem in the United States and globally. AFib occurs when the electric impulses of the heart’s upper chambers become chaotic and irregular. The result is a fast heart rate, pooling of blood in the atria, and erratic pumping of blood by the ventricles. The treatments for AFib include rate-control medications, rhythm-control drugs, anticoagulants, and nonpharmacologic procedures. A standardized scoring system determines the need for anticoagulation, with direct oral anticoagulants preferred over warfarin in most cases. Providers choose rate-control medications like beta-blockers, calcium channel blockers, and digoxin in selected patients; however, they may opt for rhythm-control antiarrhythmics like flecainide, sotalol, and dofetilide for others. Nonpharmacologic options include cardiac ablation, Watchman LLA and AtriClip devices, and electrical cardioversion. Pharmacists are well-positioned to monitor therapy, adjust anticoagulant dosing, and assist in the diagnosis of patients with AFib. Pharmacy technicians can coordinate compliance mechanisms like medication synchronization and refill reminders.

            CONTENT

            Content

            INTRODUCTION

            “My heart feels like it is pounding out of my chest.”

            Dan Reeves, a 79-year-old white male, makes this statement to the pharmacy technician at the counter while waiting to pick up his prescriptions for flecainide and apixaban. He has his hand over his chest and states he feels tired and short of breath when doing any activity. The pharmacy technician requests help from the pharmacist, who notes that Daniel is showing signs of an arrhythmia. A check of his records shows that he is two weeks late for his refill of flecainide, a medicine to treat atrial fibrillation (AFib). Upon questioning by the pharmacist, Dan says the doctor has told him how important it is to take the medication properly. However, he admits that he sometimes forgets to take the second dose at bedtime.

             

            AFib is the most common type of sustained heart rhythm disorder, also called an arrhythmia.1 It occurs when the heart's electrical activity is abnormal or irregular, usually resulting in a fast heart rate.1 If the rate does not return to normal, it can lead to stroke, heart failure, or other medical problems.2 AFib is a leading cause of stroke.1

             

            An estimated 2.3 million people in the United States have AFib, according to the most recent data available.3 Given the association between advanced age and AFib occurrence, an estimated 5.6 million will experience AFib by the year 2050.3 It affects fewer than 1% of people under the age of 60 to 65 but 8% to 10% of those older than 80.3 It happens more often in males and Caucasians.1

             

            Risk factors for developing AFib include the following1:

            • Advancing age
            • Chronic Inflammation
            • Congenital heart disease
            • Endocrine disorders
            • Genetic factors
            • High blood pressure
            • Increased alcohol consumption
            • Neurological disorders
            • Obstructive sleep apnea
            • Underlying heart and lung disease.

             

            Athletes who overtrain in intense cardiovascular sports, like competitive bikers and marathon runners, also are at an increased risk of developing AFib (see SIDEBAR).

             

            SIDEBAR: IS OVERTRAINING TO BLAME FOR AFIB IN ATHLETES?

            According to studies, the prevalence of AFib in athletes is about 2 to 10 times higher than in the general population.4 Most cases occur in endurance athletes, such as marathoners, and may result from overtraining. In one study, a group of middle-aged men who ran marathons had a higher incidence of AFib than their sedentary counterparts.5 The disease also occurs five times more often in aging cyclists (average age of 66 years old) who continue training.6 The duration and intensity of exercise correlate to the development of paroxysmal AFib.4

             

            Reports cite “irrational” regimens involving overtraining as the primary factors, along with obesity and diabetes.4 Treatment consists of removing the physical stress and prescribing flecainide or propafenone.7 Athletes may return to training in four to six weeks but should remain on a beta-blocker to prevent recurrence.8,9 Providers should consider the cardioselectivity of the beta-blocker and the athlete’s sport when choosing a therapy.4 Prevention and treatment of future episodes may include a “pill-in-pocket” approach or cardiac ablation.7

             

            AFib occurs when electrical impulses in the heart’s upper chambers, called the atria, come from multiple foci, rather than just the sinoatrial (SA) node. The atrial and ventricular depolarization rate becomes rapid and chaotic rather than their normal, consistent firing and propagation (called normal sinus rhythm).10,11 When different atrial defibrillation waves collide, they cancel each other out meaning no one pacemaker exists. This causes the atrial chambers to quiver, or “fibrillate” instead of contracting in a normal manner from the top of the atria to the bottom. As a result, blood pools in the left atrial appendage (a tissue sack attached to the left atria) which can lead to blood clots. The clots may dislodge from the left atrial appendage, travel to the brain, and cause embolic strokes.11

             

            The atrial depolarizations bombard the atrioventricular (AV) node separating the atria from the ventricle with approximately 300 depolarization stimuli per minute. The AV node tries to prevent some of these depolarizations from reaching the ventricles, but the resulting ventricular contractions become faster than normal and irregularly spaced.11

             

            PATHOGENESIS

            In a normal heart, electrical impulses travel in a coordinated way through the heart’s pacemaker, the SA node, through the atrial tissue, and to the AV node.13 The AV node slows the impulse before it travels to and depolarizes the ventricles.14 When the SA node in a normal heart initiates a depolarization wave, it spreads across the atria from top to bottom. Once the cells depolarize, it cannot depolarize again for a while, and this is called the effective refractory period. Immediately after the refractory period, the tissue is in a vulnerable period because the electrical charge of the cells is normalized but the amount of sodium in the cell is too high and the potassium inside the cell is too low. If another depolarization stimuli hits tissue in the vulnerable period, fibrillation occurs. However, this is rare in normal hearts because it is impossible for the wave of depolarization to circle behind the effective refractory tissue to hit other tissue in the vulnerable period. However, when there is a mixing of electrically active and inactive cells together, the single wave of depolarization becomes fractionated into multiple wavelets in three-dimensional space and one of the wavelets can emerge and hit tissue in the vulnerable period.

             

            AFib originates in the pulmonary vein-atrial border 95% of the time because the pulmonary vein contains electrically active atrial cells and inactive pulmonary vein cells that are intermingled.12 However, in people with longstanding AFib, the stress kills atrial cells, which are replaced by electrically inactive connective tissue, and the anatomic milieu is created to have AFib generated in the body of the atria itself. Patients with AFib may present to healthcare providers with or without symptoms.1 Patients may experience chest pain, palpitations, a fast heart rate, shortness of breath, nausea, dizziness, sweating, or general fatigue when they have symptoms.1 The ventricular rate for a patient with AFib is 110 to 140 beats per minute (BPM).1

             

            When AFib occurs, the heart can usually quickly abolish it on its own but as periods of AFib continue to occur, subsequent AFib episodes last longer and longer until eventually AFib just continues.

             

            Providers classify AFib into five types1:

            • Paroxysmal AFib will revert to normal sinus rhythm in less than seven days with no antiarrhythmic medication or electrical cardioversion.
            • Persistent AFib occurs and then persists, requiring intervention with antiarrhythmic medication or electrical cardioversion.
            • Long-standing persistent AFib exists for longer than 12 months, either due to failure to attempt cardioversion or failure of cardioversion.
            • Permanent AFib is unresponsive to antiarrhythmic medication or electrical cardioversion and continues for the rest of the patient’s life.
            • Non-valvular occurs without rheumatic mitral valve disease, mitral valve repair, or prosthetic heart valves.

             

            AFib can be viewed on an electrocardiogram (ECG), which will show an “irregularly irregular” pattern with no discernable P-waves and irregular RR spacing during rest (see SIDEBAR).1 Failure to detect paroxysmal AFib on an ECG doesn’t preclude having the arrhythmia because normal sinus rhythm can intersperse between the arrhythmic episodes. In that case, a patient may wear a Holter monitor (a small portable ECG machine) continuously for a few days or a patch monitor with 30-day readouts to detect the arrhythmia.10,15

             

            SIDEBAR: ECG Interpretation 10116,17

            An ECG is a visual representation of the heart's electrical activity. For a 12 lead ECG, six electrodes are placed on the chest and four on the limbs before connecting them to an ECG machine, which produces a readout. A normal ECG consists of a small P-wave, a large and narrow QRS complex, and a T-wave. The P-wave is a small, positive, smooth wave that reflects atrial depolarization, which precedes contraction of the atria. The QRS complex represents depolarization of the ventricles which precedes ventricular contraction. The T-wave follows the QRS complex and reflects rapid repolarization.17 Abnormal results from an ECG are a sign of potential heart problems like arrhythmias, ischemia or infarction, or even ventricular hypertrophy.

             

            TREATMENT OF AFIB

            The goals for treating AFib include reducing symptoms, preventing clots, and reducing the risk of heart failure and other cardiac complications.10 According to the 2023 American Heart Association/American College of Cardiology/American College of Chest Physicians/Heart Rhythm Society (multi-society) guidelines, patient-specific factors direct the choice of antiarrhythmic agent.2 Among those factors is heart failure, cardiovascular disease, or other health conditions. Treatment also varies based on where providers discovered the AFib: in the inpatient or outpatient setting.2

             

            PHARMACOLOGIC AGENTS

            The multi-society guidelines divide the agents for treating AFib into rate control and rhythm control medications.2 Rate control agents control the ventricular rate when patients are in AFib for better symptom management.18 Rhythm control medications restore and maintain normal sinus rhythm.10

             

            PAUSE AND PONDER: What medications treat AFib symptoms most effectively?

             

            Providers may choose from a wide range of medications, with the treatment choice often determined by the patient’s clinical picture and the setting in which the AFib occurs.

             

            RATE CONTROL MEDICATIONS

            Rate control medications slow the impulses through the AV node, reducing the rate of contraction of the ventricles.18 While the number of ventricular contractions per minute decrease (allowing for better ventricular filling with blood during diastole), the RR spacing remains irregular. This irregularity coupled with the loss of atrial contraction in AFib reduces the cardiac output versus normal sinus rhythm. The goal is better symptom control with limited adverse effects. (See Table 1.)10

             

            Table 1. Rate Control Medications in AFib

            Class Drugs Notes
            Beta-blockers Atenolol

            Bisoprolol

            Carvedilol

            Metoprolol

            Nadolol

            Pindolol

            Propranolol

             

             

             

             

             

            l

            Metoprolol succinate (the XL form) and tartrate (the immediate release form), as well as bisoprolol are beta-1 selective; metoprolol succinate, bisoprolol, and carvedilol are preferred choices for patients with heart failure.
            Nondihydropyridine calcium channel blockers DilTIAZem

            Verapamil

            Dihydropyridine CCBs do not block the AV node.
            Cardiac glycosides Digoxin Not as effective as beta-blockers or non-DHP CCBs during exercise or stress and has a narrow therapeutic index; may use in combination with other rate control agents.
            Class III antiarrhythmic Amiodarone Has antiadrenergic effects similar to beta-blockers and non-DHP CCBs; many drug interactions and adverse effects; good choice in patients with heart failure.
            ABBREVIATIONS: CCBs = calcium channel blockers; DHP = dihydropyridine

             

            Beta-Blockers

            Beta-blockers inhibit the activity of the beta-1 adrenoceptor at the AV node, slowing conduction (negative dromotropic effect).18 Providers may choose from various options, including atenolol, bisoprolol, carvedilol, metoprolol (succinate and tartrate), and propranolol. Atenolol, bisoprolol, and metoprolol are the cardioselective beta-blockers, which means they less potently block the beta-2 adrenoceptors in the lungs.19 While all beta-blockers can cause drops in the Forced Expiratory Volume in 1-second (FEV-1) in asthmatic patients, the cardioselective agents do so to a lesser extent. Their effects are readily reversed with standard dosing of inhaled beta-2 agonists. All beta-blockers control the ventricular rate, and the multi-society guidelines consider them first-line therapy.2

             

            Non-Dihydropyridine Calcium Channel Blockers

            The multi-society guidelines also list non-dihydropyridine calcium channel blockers dilTIAZem and verapamil as first-line for treating AFib.2 They block the L-type calcium channel to produce their negative dromotropic effects and like the beta-blockers have negative chronotropic and inotropic effects, meaning they slow the SA nodal firing rate and decrease the force of muscle contraction, respectively.18 They provide reasonable rate control and improve AFib-related symptoms compared to beta-blockers.2 The multi-society guidelines note that dilTIAZem and verapamil are contraindicated in patients with pre-existing heart failure.18 However, if the signs and symptoms of heart failure are solely due to the AFib and no other underlying diseases, verapamil and dilTIAZem can be used.

             

            The Institute for Safe Medication Practices lists the generic name dilTIAZem on the look-alike sound-alike list due to the potential for confusion with diazePAM.20 The organization recommends the use of TALLman lettering to distinguish the two drugs.20

             

            Digoxin

            Digoxin provides a negative dromotropic and chronotropic effects but does not provide a negative inotropic effect. The inotropic effect can be neutral at serum concentration below 1.2 nanograms/mL but can be positive at higher concentrations.18 Since digoxin slows AV nodal conduction through enhancing the parasympathetic nervous system, it does not work as well in times of higher sympathetic outflow like exercise or stress. The multi-society guidelines indicate providers may use digoxin with other rate control medications because it will not augment the negative inotropic effects of beta-blockers or non-dihydropyridine calcium channel blockers.2 The guidelines also recommend digoxin in patients who do not tolerate or have an inadequate response from other rate control agents.2,18 It is a narrow therapeutic index medication, with the recommended serum digoxin level for AFib being <1.2 nanograms/mL.2 Providers should use digoxin cautiously with verapamil, since verapamil is a P-glycoprotein inhibitor and the combination may therefore increase digoxin levels (see SIDEBAR).18 However, digoxin may be a good initial choice for acute rate control in heart failure patients with AFib since the negative dromotropic effects of beta-blockers and nondihydropyridine calcium channel blockers could induce decompensated heart failure.2 If patients start with low dose beta-blockers and digoxin in heart failure patients, as the beta-blocker dose is increased to therapeutic levels (doubled every two weeks until therapeutic doses are achieved) the digoxin level can be reduced.  

             

            SIDEBAR: DIGOXIN IN AFIB: FRIEND OR FOE?

            Digoxin is the oldest medication used today in AFib, with records of its use as early as 1250 AD.21 Dr. William Withering first described its good and bad effects in 1785.22 Providers still prescribe it today; however, its use has decreased in the 21st century.23 In AFib, the multi-society guidelines recommend it as a rate control agent.2 The guidelines suggest using it with either beta-blockers or non-dihydropyridine calcium channel blockers or as a standalone medication if the other rate control options are not tolerated.2

             

            Digoxin has a wide variety of adverse effects triggered by toxicity. These include arrhythmias, GI symptoms like anorexia, fatigue, and nausea, and central nervous system issues like mental status changes and visual disturbances.24 Elevated drug levels cause the most toxic effects, often triggered by drug interactions. Other antiarrhythmics like amiodarone, dronedarone, flecainide, non-dihydropyridine calcium channel blockers, propafenone, and quinidine may block P-glycoprotein and increase digoxin blood levels as a result.25,26 Antibiotics like macrolides and tetracyclines may have similar effects.25

             

            According to reports, toxicity occurs in about 13 to 25 percent of digoxin patients.25 It happens more often with blood levels greater than 2.0 nanograms/milliliter.25 While providers may stop digoxin and provide supportive therapy in milder cases, severe cases require digoxin-specific antibody fragments (digoxin-fab).22 Derived from sheep, digoxin-fab is an intravenous medication that works in 30 to 45 minutes to reverse digoxin toxicity.27 According to reports, providers use it in about 20% of cases of digoxin toxicity.28

             

            Other Rate Control Options

            The multi-society guidelines recommend amiodarone, dronedarone, and sotalol for rate control, but only in extreme circumstances. Providers sometimes order amiodarone as a last resort in a hospital setting. Still, it should be used sparingly due to its many drug interactions and adverse effect profile.2 Dronedarone has a chemical structure similar to amiodarone, except that it does not contain iodine, making it safer.10 However, the guidelines do not recommend its use in patients with heart failure or permanent AFib due to the risk of death.2,18 Sotalol is both a beta-blocker and a potassium-channel blocker that also exerts rhythm control properties.18 While it is a negative dromotropic agent, it can also prolong the QTc interval on the ECG, which may lead to a life-threatening arrhythmia called Torsade de Pointes.18

             

            In Torsade de Pointes, the ventricles beat in a fast, irregular manner.29 Torsade de Pointes means “twisting of the points” in French. It refers to a characteristic twisting pattern of QRS complexes around the ECG baseline.29 QRS complexes are specific waves or deflections on the ECG, representing electrical activation of the ventricles.14 Symptoms of Torsade de Pointes may include dizziness, fainting, or palpitations, or it may not present with symptoms.29 The syndrome can be short-lived and self-limiting or life-threatening.29

             

            RHYTHM CONTROL MEDICATIONS

            The Vaughan Williams classification system divides commonly prescribed rhythm control agents into two classes.10 Miles Vaughan Williams, a British pharmacologist and fellow at Hertford College in Oxford, created the classification system in 1970.30 Medications in Class Ic block sodium channels in the heart.10 Class III medications alter potassium channels.10 (see Table 2.)

             

            Table 2. Rhythm Control Medications in AFib

            Agent Vaughan Williams

            Class

            Dose Notes
            Flecainide 1c 50-150 mg po q12h Not indicated in patients with structural heart disease* (may cause arrhythmias); pill-in-pocket dose: 300 mg
            Propafenone 1c 150-300 mg po q8h or 225-425 mg SR po q12h Weak calcium channel blocking and beta-blocking properties; not for use in patients with structural heart disease;* pill-in-pocket dose: 600 mg
            Amiodarone III 400-800 mg po daily for 3-4 weeks, then 100-400 mg daily Also has rate control action; toxicity and drug interactions a concern; IV dosing: 5-7 mg/kg up to 1500 mg every 24 hours
            Sotalol III 80-240 mg po q12h Also has beta-blocking action useful for rate control; requires dosing based on kidney function; potential for life-threatening arrhythmias
            Dofetilide III 125-500 mg po BID Strict dosing based on renal function, body size and age; started with patient in hospital on telemetry for 3 days
            Dronedarone III 400 mg po BID Contraindicated in patients with permanent AFib or decompensated heart failure
            ABBREVIATIONS: AFib = atrial fibrillation; BID = twice daily; IV = intravenous; SR = sustained release

            *Denotes heart failure, post-myocardial infarction, or left ventricular hypertrophy.

             

            Flecainide

            Flecainide, a Class 1c agent, is effective in treating paroxysmal AFib in patients without heart disease.10 However, it can trigger other arrhythmias; the multi-society guidelines recommend ECG monitoring at initiation and dose changes.2 Providers should avoid flecainide in patients with structural heart disease or enlarged left ventricles.10 Given twice daily for chronic use, it also may serve as a “pill-in-pocket” option at a larger, loading dose to convert an AFib episode to normal sinus rhythm.10

             

            Providers sometimes give patients “pill-in-pocket” prescriptions, which may be taken at the time of an acute AFib episode to return the heart rate to normal sinus rhythm.2 Typically, the approach is first tested under the supervision of a provider before the prescription is written for the patient. Providers instruct the patient to carry the dose with them and take it if and when symptoms occur.2

             

            Propafenone

            Providers use propafenone, another Class 1c agent, in paroxysmal and sustained AFib.10 It blocks sodium channels and has weak calcium channel-blocking and beta-blocking properties.10 Like flecainide, it can cause arrhythmias, and the multi-society guidelines recommend ECG monitoring at initiation, dosing changes, and periodically during treatment.2 Providers prescribe propafenone every 8 to 12 hours as a chronic medication. They may prescribe larger doses in a “pill-in-pocket” approach to convert recent-onset AFib to normal sinus rhythm.10

             

            Dofetilide

            Dofetilide is a Class III agent that blocks IKr, a key potassium channel in the heart.10 It limits the maximum frequency of electrical impulses without slowing conduction through the AV node.10 It can cause dangerous arrhythmias, including Torsade de Pointes.2 As a result, the multi-society guidelines recommend providers place patients under observation with ECG monitoring for three days when starting this medication.2 The initial period requires a hospitalization that lasts at least 12 hours after the patient converts to normal sinus rhythm.2 The guidelines indicate providers should monitor potassium and magnesium blood levels due to the risk of arrhythmia.2 Providers must dose dofetilide based on kidney function.10

             

            Sotalol

            Sotalol, another Class III antiarrhythmic, is a beta-1 and beta-2 blocker.10 It prolongs the length of electrical impulses to control heart rhythm.10 Like dofetilide, it can cause dangerous arrhythmias, including Torsade de Pointes.2 The multi-society guidelines recommend three days of inpatient ECG monitoring for patients who start sotalol. The guidelines also suggest regular monitoring of potassium and magnesium levels.2 Providers must dose sotalol based on renal function.10

             

            Amiodarone

            While amiodarone is more effective at preventing recurrent AFib episodes than sotalol, dotetilide, and dronedarone, the multi-society guidelines recommend these other options preferably for most patients, although it is a first line option (along with dofetilide) in heart failure.2 Amiodarone is a Class III drug that blocks both IKr and IKs potassium channels and exhibits rate control properties.10 It blocks sodium and calcium channels and displays antiadrenergic properties as well.10 The multi-society guidelines note that amiodarone has a long list of adverse effects and drug interactions, making it a poor choice for chronic therapy.2 The adverse effects include thyroid disorders (see SIDEBAR), lung toxicity, liver toxicity, photosensitivity, blue-green skin discoloration, corneal microdeposits, peripheral neuropathy, and the potential for Torsade de Pointes.16 However, the balance of IKr and IKs potassium channel blockade means it is less likely to cause Torsade de Pointes than Class III antiarrhythmics like dofetilide and sotalol.2 Amiodarone (like dronedarone) blocks many CYP P450 isoenzymes and P-glycoprotein. Notable drug interactions include atorvastatin, calcium-channel blockers, beta-blockers, digoxin, fluoroquinolone and macrolide antibiotics, phenytoin, simvastatin, and warfarin.35

             

            SIDEBAR: THE TROUBLESOME ‘I’ IN AMIODARONE

            The antiarrhythmic amiodarone comprises 37% iodine (element ‘I’ on the periodic chart) by weight.31 The iodine content and the molecule's shape can cause problems for patients prone to thyroid disorders.31 Depending on the patient’s susceptibility, amiodarone may cause low thyroid, called hypothyroidism, or a high thyroid condition, called thyrotoxicosis.31

             

            Each 200 mg of amiodarone contains 75 mg of iodine, with 7 mg of free iodine released when enzymes process the medicine.31 The free iodine is much more than the recommended daily requirement of 0.15-0.3 mg, which leads to iodine overload.31

             

            Iodine is critical in creating and processing thyroid hormones T3 and T4. Excess iodine in patients may lead to an overproduction of thyroid hormone, especially in the short to moderate term. Thyrotoxicosis may also occur due to direct damage to the thyroid, which is called thyroiditis.33 The consequences of thyrotoxicosis may be severe, including arrhythmias.33 Treatment of thyrotoxicosis depends on its subtype but may include methimazole, prednisone, or propylthiouracil.31,34

             

            With longer term use of amiodarone, the thyroid produces similar or slightly higher levels of T4 hormone but this T4 is shunted to reverse T3 (rT3) which is biologically inactive, instead of to T3 which is more potent than T4. It is this reduction in T3 that drives signs and symptoms of hypothyroidism in susceptible patients.31 The treatment of hypothyroidism is the use of levothyroxine, following guidelines for its use in low thyroid conditions.33 In cases in which providers stop amiodarone, thyroid function may return to normal.31

             

            Dronedarone

            Like amiodarone, dronedarone is a Class III antiarrhythmic that blocks sodium and calcium channels and features beta-blocking properties.10 It resembles amiodarone in chemical structure but lacks iodine. The absence of iodine makes it safer, removing or reducing thyroid, lung, and liver effects.10 Dronedarone has shown modest benefits for patients with non-permanent AFib.10 It is contraindicated in permanent AFib or New York Heart Association Class III to IV heart failure.2,10,18

             

            CONSIDERATIONS IN CHOICE OF RATE OR RHYTHM CONTROL

            Prescribers sometimes face difficult choices between rate control or rhythm control. Many factors affect the decision, including the patient’s clinical picture. How old is the patient? How severe are the symptoms? Does the patient have heart disease?

             

            PAUSE AND PONDER: In what situations would prescribers use rate and rhythm control?

             

            The goals of rate control include treating symptoms, preserving heart function, and improving quality of life.18 Providers prefer this strategy in older patients (age greater than 80 years) with no or mild symptoms.18 Rate control also may be the only option if rhythm control fails or the risks of it outweigh the benefits.18 Finally, rate control is more cost-effective due to the medications' wide availability and low cost.36

             

            However, the correct degree of rate control has been debated. Previous sources have recommended a goal ventricular rate of less than 80 bpm at rest in symptomatic patients, but newer recommendations suggest a more lenient approach of less than 110 bpm.2 A recent study showed no difference in outcomes with the more lenient strategy, which the multi-society guidelines currently favor.2,37 As a general rule, all AFib patients should have a ventricular rate less than 110 bpm; those who can tolerate lower heart rates should get the opportunity to see if this reduces their hemodynamic symptoms during AFib. Once a patient’s ventricular rate is below 80 bpm though, further heart rate reductions are unlikely to provide additional value and they should consider a rhythm control strategy.

             

            Rhythm control is preferred in most cases, even though it hasn’t shown an advantage over rate control in risk of death.1,10 It prevents stroke and improves quality of life but might increase the risk of hospitalization, especially due to ventricular arrhythmias such as Torsade de Pointes.38,39 Rhythm control is also the best option in patients with a recent diagnosis and in the case of AFib combined with heart failure.2 It reduces symptoms and slows disease progress from paroxysmal AFib to more sustained forms of the arrhythmia.2 Remember that rhythm control medication is overlaid upon rate control medication, one does not replace the other.

             

            ANTICOAGULANTS

            To reduce the risk of stroke in patients with AFib, the multi-society guidelines recommend the use of anticoagulation in select cases.2 Determining the need for anticoagulation involves a risk assessment using a scoring system – the CHA2D2-Vasc (see Table 3).2 In men, a score of 0 indicates low risk, 1 low-moderate risk, and 2 or more is moderate-high risk.1 In women, a score of 0 or 1 is low risk, a score of 2 is low-moderate risk, and a score of 3 or more is moderate-high risk.2 Providers should start anticoagulation in patients with moderate-high risk and consider it in patients with low-moderate risk.1 When uncertain about whether the benefits of anticoagulation are greater than the risk of bleeding, providers may use the HAS-BLED scoring system; however, the multi-society guidelines indicate it should not replace clinical judgment.2 HAS-BLED considers age, renal and kidney function, stroke history, and other factors to determine the risk of bleeding events with anticoagulation.40

             

            Table 3. CHA2DS2-VASc Scoring Considerations

            Condition Score
            Congestive Heart Failure 1
            Hypertension 1
            Age > 75 2
            Diabetes 1
            Stroke/TIA 2
            Vascular Disease 1
            Age 65-74 1
            Sex category (female sex) 1

             

            Providers prescribe direct oral anticoagulants (DOACs) and warfarin for anticoagulation (see Table 4).1,2 In patients with AFib and no signs of stroke, providers should start anticoagulation immediately.2 The standard for patients with a transient ischemic attack or stroke is the “1-3-6-12” rule. Providers should start anticoagulation in 1 day after a transient ischemic attack and 3, 6, and 12 days after mild, moderate, or severe strokes, respectively.41 This is because there is an increased risk of cerebral bleeding after a stroke for a short period of time and anticoagulation would exacerbate it.

             

            Table 4. Anticoagulants

            Class Agents Dosing Notes
            Vitamin K antagonists Warfarin Dependent on INR Frequent monitoring and dosing changes; drug and food interactions; required anticoagulant if patient has mitral stenosis or mechanical valves
            Direct oral anticoagulants (DOACs) Apixaban 5 mg po BID Renal dosing: 2.5 mg po BID in patients with > 2 of the following: age > 80 yr, body weight < 60 kg, creatinine level > 1.5 mg/dl
            Dabigatran 150 mg po BID Renal dosing: 75 mg po BID in patients with CrCl of 15-30 mL/min
            Edoxaban 60 mg po daily Renal dosing: 30 mg po daily in patients with CrCl of 15-50 mL/min
            Rivaroxaban 20 mg po daily Take with food; renal dosing: 15 mg po daily in patients with CrCl of 15-50 mL/min
            ABBREVIATIONS: BID = twice daily; CrCl = creatinine clearance; DOACs = direct oral anticoagulants; INR = international normalized ratio

             

            DOACs

            In most cases, providers prescribe DOACs, including apixaban, dabigatran, edoxaban, and rivaroxaban.2 Studies show that each is equal to, if not superior to, warfarin in preventing stroke and has less bleeding.2 DOACs have fewer drug and food adverse effects, cost more than warfarin, but do not have INR laboratory costs. Dabigatran binds to thrombin (Factor IIa) in the coagulation cascade, and prevents it from activating coagulation factors.42 Apixaban, edoxaban, and rivaroxaban are Factor Xa inhibitors and prevent the cleavage of prothrombin to thrombin.43-45

             

            Warfarin

            Warfarin is a Vitamin K antagonist.2 Researchers believe it competitively inhibits the vitamin K epoxide reductase complex 1 (VKORC1), which is important for activating Vitamin K in the body.46 Without active Vitamin K, Factors VII, IX, X, and II cannot be activated. Warfarin has long been a standard of anticoagulant therapy, although its many drug and food interactions and the need for regular monitoring make its use challenging for clinicians and patients alike.2 However, providers still use warfarin for the treatment of AFib in patients with mechanical heart valves or mitral stenosis.2 The goal international normalized ratio (INR) for AFib is 2.0 to 3.0 in most cases, except in the presence of certain mechanical heart valves where the INR is 2.5 to 3.5.10

             

            CONSIDERATIONS IN THE SELECTION OF ANTICOAGULANTS

            The choice of anticoagulant depends on several factors. Despite their high costs, the multi-society guidelines consider DOACs first-line therapy due to their advantages over warfarin.2 Compared to warfarin, DOACs have lower bleeding risks, fewer drug and food interactions, no dietary restrictions, and require less therapeutic monitoring.2 Providers must adjust DOACs based on renal function.2 However, warfarin is the only anticoagulant indicated for patients with mitral stenosis or mechanical heart valves.2 Multi-society guidelines do not recommend antiplatelet drugs such as aspirin or P2Y12 inhibitors as a substitute for anticoagulants in treating AFib.2

            In patients with both AFib and coronary artery disease, the use of an oral anticoagulant can be used alone to treat both. If the patient requires dual antiplatelet therapy (DAPT), after an acute coronary syndrome or the use of a drug eluting stent, but also has AFib, there is a new recommendation. Instead of 6-12 months of DAPT plus an anticoagulant, they recommend a single month of triple therapy, and then 5 months of the P2Y12 inhibitor + oral anticoagulant followed by the oral anticoagulant alone.

             

            PAUSE AND PONDER: What are the recommendations for reversing anticoagulation with warfarin and DOACs?

             

            Providers must also consider reversal of anticoagulation in the case of bleeding. Removal of the offending drug works in some cases, but providers have options in life-threatening instances. They may reverse warfarin by administering Vitamin K and 4-factor proprotein complex concentrate (PCC) in an acute setting.2 Reversal of DOACs occurs in only 2% to 4% of cases.2 Providers reverse dabigatran using idarucizumab.2 Andexanet-α reverses apixaban, edoxaban, and rivaroxaban.2 Providers administer PCC, idarucizumab, and andexanet-α intravenously.

             

            NONPHARMACOLOGIC INTERVENTIONS

            Electrical Cardioversion

            Providers may attempt electrical cardioversion in emergencies or when medications fail to treat AFib adequately.2 The procedure is completed in an outpatient facility. Providers place electrode pads on the patient’s chest and back and connect them to a cardioversion machine.47 The patient receives anesthesia, and providers administer a high-voltage shock. The shock resets the heart to its normal sinus rhythm. Providers monitor patients for several hours and then patients may go home if they experience no complications.47

            The multi-society guidelines recommend anticoagulation therapy three weeks before and four weeks after electrical cardioversion if AFib has been present for more than 48 hours (or an unknown period).2 The anticoagulant reduces the risk that a clot may be formed during or after the procedure that can be dislodged and cause medical problems.48 Even after the AFib is shocked to normal sinus rhythm, it takes a few weeks for the atria to fully start contracting normally again.

             

            Catheter Ablation

            Catheter ablation involves the insertion of small tubes directed through the veins to the heart. The ends of the tubes contain electrodes that damage the diseased heart tissue that is causing abnormal electrical pulses.49 Heat (radiofrequency ablation) or cold (cryoablation) from the electrodes destroy the tissue.50 As a result, ectopic foci or re-entry circuits are eliminated, and normal electrical conduction resumes. Young, healthy patients are good candidates for catheter ablation and the procedure is much more effective in patients with paroxysmal AFib.10 The multi-society guidelines recommend catheter abation when antiarrhythmic therapy is ineffective, not tolerated, or non-preferred.2 Catheter ablation can be curative of AFib in 70% of cases but may take as many as three attempts to fully resolve the arrhythmia.10 Providers should continue anticoagulation during and after the procedure unless it is clear that the procedure was curative months down the line.2

             

            Watchman LAA Device and AtriClip

            In patients who require anticoagulation, but the risk of bleeding outpaces the potential benefits, there are devices that occlude the left atrial appendage (LAA, the pouch on the left atria where most of the clots form in AFib). The Watchman LAA device is placed inside the atria and then opens like an umbrella to block off the LAA. The AtriClip is a clamp that is applied to close off the LAA from the outside of the heart during open heart surgery. In this case, the clots still form in the LAA but cannot get out in the circulation. If a patient is having nonadherence to oral anticoagulation due to bleeding, this is a potential option that a pharmacist could recommend a patient discuss with their cardiologist.

             

            TREATMENT IN THE ACUTE SETTING

            Providers in an acute setting order beta-blockers or non-dihydropyridine calcium channel blockers as the first-line treatment.2 If ineffective, digoxin is the next choice. Amiodarone is also an option, but only if the previous treatments fail. Providers should not use dilTIAZem and verapamil in patients with poor left ventricular function or heart failure.2

             

            Providers may attempt electrical or pharmacologic cardioversion in the acute setting, especially in unstable patients.2 Providers use one of three intravenous medications in pharmacologic conversion. The multi-society guidelines recommend ordering ibutilide if patients do not have reduced ventricular function or risk for Torsade de Pointes.2 Ibutilide is a Class III antiarrhythmic available only in an intravenous form that quickly restores normal sinus rhythm.10 Providers may also order amiodarone; however, converting to sinus rhythm takes longer than other antiarrhythmics (8 to 12 hours).2 The multi-society guidelines suggest procainamide as another option.2 It is a Class 1a antiarrhythmic that quickly restores normal sinus rhythm; however, the multi-society guidelines discourage its long-term use due to its many adverse effects.2,10 Procainamide may cause low blood pressure, nausea, vomiting, and a Lupus-like syndrome.10 Providers should avoid using it in patients with heart failure, and it can prolong the QTc interval, potentially leading to Torsade de Pointes.10

             

            LIFESTYLE MODIFICATIONS

            The multi-society guidelines recommend lifestyle modifications for patients with factors that may influence the disease course.2 Providers should recommend weight loss in overweight and obese patients and moderate to vigorous exercise for all AFib patients. The guidelines also recommend screening for sleep apnea with appropriate treatment if it is found. Finally, providers should counsel patients to reduce or eliminate alcohol and tobacco use.2

             

            AFIB AND HEART FAILURE

            Several factors complicate the management of AFib in the presence of heart failure.2 Providers should consider the degree of left ventricular dysfunction, which determines the type of heart failure and limits the choice of antiarrhythmic.2,51

             

            The multi-society guidelines recommend rhythm control over rate control in AFib with heart failure.2 However, the multi-society guidelines recommend against certain rhythm control agents—namely, flecainide, dronedarone, and propafenone—in patients with heart failure.2 Digoxin may be an appropriate choice for rate control, as it has a role in treating both diseases while non-dihydropyridine calcium channel blockers should not be used.2 Beta-blockers can be used, and actually provide enhanced survival in heart failure patients, but need to be started with low doses and then slowly titrated up to therapeutic doses.

             

            Besides treating AFib, an evaluation of the patient should reveal whether their profile meets guideline-directed medical therapy for heart failure.2 In the case of heart failure with reduced ejection fraction, this includes one of three approved beta-blockers: bisoprolol, metoprolol, or carvedilol.51 It also includes mineralocorticoid antagonists like spironolactone, a sodium-glucose cotransporter-2 inhibitor, and either an angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or sacubitril/valsartan.51

             

            DIGITAL HEALTH AND AFIB

            Smartphones, smartwatches, and handheld devices show promise for uncovering asymptomatic AFib.52 In approximately one-quarter of patients with asymptomatic disease, providers do not discover AFib until patients suffer a stroke.53 In recent years, smart devices have provided a solution – ECG monitors. The devices use a technology called photoplethysmography (PPG) sensor technology.52 Reflected light from the device measures changes in blood flow from the irregular heart rate.52

             

            Specific versions of the Apple Watch, the Garmin Venu, and the Samsung Galaxy all use PPG technology to look for irregular heart rhythms.52 Fitbit also has PPG capabilities in its Charge and Sense models.52 A meta-analysis showed that smartphones detect AFib with a sensitivity of 94% and a specificity of 96%.54 Sensitivity means that if a patient is having AFib, the device will detect it 94% of the time. Specificity means that in 4% of cases, when AFib is found, it is due to something other than AFib. PPG technology is equally as effective at detecting AFib as a single-lead ECG.54 Another meta-analysis confirmed that smartwatches were not inferior to medical-grade devices.55

             

            Some limitations of using smart devices in ECG monitoring include the potential for false positives, disparities in access, and the possibility patients will overload providers with consumer data. ECG monitors may incorrectly indicate positives, especially for young, healthy patients.53 AFib patients older than 65 with a low educational and socioeconomic status often do not own smart devices.56 Experts also worry about the possibility of consumer data overwhelming the overworked healthcare system.52

             

            Investigators are examining the possibility that mobile ECG monitoring can reduce stroke risk?52. A large initial trial of 75-year-old patients using a Zenicor-ECG device twice daily for two weeks revealed a small but significant reduction in endpoints, which included strokes, at five-year follow-up.57

             

            Application stores feature digital apps to help manage AFib.58 The apps allow patients to record appointments, feelings, symptoms, and questions for their doctors, among other things. App quality varies, and providers should advise patients to check ratings and reviews and provide recommendations.58

             

            PHARMACY TEAM IMPACT ON AFIB MANAGEMENT

            Nearly 90% of Americans live within five miles of a community pharmacy.59 That fact makes pharmacists one of the most accessible healthcare providers.60 Pharmacists and technicians can leverage their familiarity with their customers in several ways.

             

            For pharmacists, managing and monitoring anticoagulation is the most obvious intervention that can improve outcomes. Providers and administrators often ask pharmacists to dose INRs for warfarin patients in clinics, hospitals, and outpatient settings. Pharmacists may monitor for bleeding complications, both with warfarin and DOACs.

             

            Pharmacist medication review activities may catch meaningful drug-drug and drug-food interactions in AFib patients. Pharmacists can also monitor for the toxic effects of medications like digoxin and amiodarone and report any observations to providers. Even common agents like beta-blockers and calcium channel blockers may cause troublesome interactions in patients with complicated clinical pictures. Pharmacists may catch these problems and intervene with the prescriber.

             

            Pharmacists can collaborate with pharmacy technicians to improve patient adherence to medications. While technicians may coordinate the adherence programs, pharmacists counsel patients on the importance of following providers’ medication orders and communicate nonadherence to the prescriber.

             

            Pharmacists also may counsel patients on lifestyle modifications. If a pharmacy has a smoking cessation program, for example, the pharmacist may refer AFib patients to it. The pharmacist may also counsel on the need for weight loss or exercise and help the patient set goals.

             

            Finally, the advent of portable ECG monitors allows pharmacists to set up screening programs for asymptomatic or suspected AFib. The AliveCor KardiaMobile is a single-lead ECG that connects through a smartphone. Pharmacists may use it to collect ECGs and triage patients. A cardiologist then confirms any positive result and refers the patient for treatment.61

             

            Pharmacy technicians may also help manage AFib. Technicians often coordinate medication adherence programs, such as automated refill reminders, medication synchronization, and compliance packaging. Pharmacy technicians can then inform the pharmacist of cases of nonadherence.

             

            Technicians may also coordinate filling pill-in-pocket prescriptions for medications like flecainide or propafenone. They can also use TALLman lettering for sound-alike look-alike medications and place dosing labels on shelving for narrow therapeutic index medications like warfarin or digoxin.20

             

            Finally, technicians can inform pharmacists when AFib patients try to purchase inappropriate over-the-counter or herbal medications. Decongestants like pseudoephedrine can increase heart rate, and herbals like St. John's wort and hawthorn can interact with antiarrhythmics.62,63 Medications like non-steroidal anti-inflammatory medications, aspirin, and herbals like vitamin E supplements, ginseng, and ginkgo biloba may interfere with anticoagulation.62,631

             

            Finally, pharmacies can foster knowledge and understanding of the disease by hosting community events in coordination with local healthcare providers. For example, a pharmacy could hold an event during AFib awareness month in September. Pharmacy staff could invite representatives from local clinics and cardiologists’ offices.

             

            CONCLUSION

            AFib is the most common type of heart rhythm disorder or arrhythmia, and its incidence and prevalence continue to grow as the population ages. Goals for AFib patients include prevention of stroke, control of heart failure symptoms, and improvement in quality of life. Rate and rhythm control antiarrhythmics can treat AFib. The rate control strategies help with symptoms by controlling the ventricular rate. Rhythm control medications restore the normal sinus rhythm, but providers must carefully choose and monitor them due to their side effects and contraindications. Providers prefer rhythm control agents in many patients due to their ability to reduce the risk of stroke and improve quality of life. Anticoagulation is indicated in cases of higher stroke risk; providers should choose DOACs over warfarin in most cases, except for patients with mitral stenosis or mechanical heart valves.

             

            Beta-blockers and calcium channel blockers are the first choices in the acute setting, followed by digoxin. Providers have limited options in both rate and rhythm control in patients with heart failure. Beta-blockers, digoxin, dofetilide, sotalol, and amiodarone provide options. Pharmacists can play essential roles in managing and monitoring anticoagulation, performing drug use reviews and adherence monitoring, and screening patients for asymptomatic cases. Pharmacy technicians can aid pharmacists by coordinating adherence mechanisms, filling pill-in-pocket refills, and notifying the pharmacist of patients' improper OTC or herbal selections.

             

            Now let’s return to our patient case. Dan’s uncontrolled AFib requires a quick call to his cardiologist, who suggests he go to a local emergency room for examination. The pharmacy staff offers to put his apixaban, flecainide, and other medications on a medication synchronization program with refill reminders. They also suggest that he invest in a digital device that monitors ECG. He promises to go straight to the emergency room.

            Pharmacist Post Test (for viewing only)

            Pharmacist Post-Test
            After completing this education activity, pharmacists will be able to
            1. Explain the definition, clinical presentation, and types of atrial fibrillation
            2. Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
            3. Describe the role of anticoagulation in atrial fibrillation management
            4. Identify interventions that could improve outcomes in atrial fibrillation patients

            1. What symptoms do patients experience from the heart's abnormal or irregular electrical activity that is seen in atrial fibrillation?
            A. slow heart rate
            B. fast heart rate
            C. fewer clots

            2. What is the type of atrial fibrillation that recurs and persists, requiring intervention with medications or procedures?
            A. persistent
            B. paroxysmal
            C. permanent

            3. Beta-blockers and non-dihydropyridine calcium channel blockers like dilTIAZem and verapamil are first-line rate control medications for atrial fibrillation. If they fail or are contraindicated, what is the next best choice for rate control?
            A. digoxin
            B. flecainide
            C. amlodipine

            4. Which Class III antiarrhythmic blocks a key potassium channel and requires 3 days of observation with ECG monitoring when it is started?
            A. flecainide
            B. propafenone
            C. dofetilide

            5. What Class III antiarrhythmic is considered a last resort despite its rate and rhythm-control properties due to its drug interactions and adverse effects, including triggering thyroid disease?
            A. metoprolol succinate
            B. dronedarone
            C. amiodarone

            6. What does the CHA2D2-VASc scoring system measure?
            A. Risk of heart failure with atrial fibrillation
            B. Proper starting dose of warfarin
            C. Risk of stroke in atrial fibrillation

            7. You are a pharmacist dosing and monitoring warfarin in an anticoagulation clinic. Alfred Pennington arrives for his international normalized ratio (INR) test and warfarin dosing adjustment. You notice that he has atrial fibrillation, but he does not have mitral stenosis or mechanical heart valves. What is the next step?
            A. Contact his provider and suggest switching to a DOAC like apixaban
            B. Do nothing special; check his INR and change the dose if necessary
            C. Counsel Alfred on the drug and food interactions with warfarin without calling his provider

            8. Which of the following is an advantage of direct oral anticoagulants over warfarin in atrial fibrillation patients?
            A. fewer drug and food interactions
            B. lower cost
            C. more therapeutic monitoring

            9. Which medication quickly restores normal sinus rhythm during a pharmacological cardioversion in the acute setting?
            A. Digoxin
            B. Ibutilide
            C. Verapamil

            10. Judy James is in the pharmacy to pick up her prescription for Verapamil when she asks for the pharmacist. She states that she has been feeling nauseated (nauseous?) and fatigued lately and that her vision “isn’t right.” You check her profile and note that she is an atrial fibrillation patient who is also on digoxin. What do you do next?
            A. You tell her to discontinue the digoxin as it may be causing an interaction with the verapamil.
            B. Since you suspect digoxin toxicity, you call Judy’s provider and suggest that they do a digoxin level test (?)
            C. You tell Judy that these are normal side effects of her medications and that she shouldn’t worry about them

            Pharmacy Technician Post Test (for viewing only)

            Pharmacy Technician Post-Test
            After completing this education activity, pharmacy technicians will be able to
            1. Explain the definition, clinical presentation, and types of atrial fibrillation
            2. Discuss pharmacological and non-pharmacological treatment options for atrial fibrillation
            3. Describe the role of anticoagulation in atrial fibrillation management
            4. Identify programs designed to promote medication adherence in patients with atrial fibrillation
            1. What symptoms do patients experience from the heart's abnormal or irregular electrical activity that is seen in atrial fibrillation?
            A. slow heart rate
            B. fast heart rate
            C. fewer clots

            2. What is the type of atrial fibrillation that recurs and persists, requiring intervention with medications or procedures?
            A. persistent
            B. paroxysmal
            C. permanent

            3. Beta-blockers and non-dihydropyridine calcium channel blockers like dilTIAZem and verapamil are first-line rate control medications for atrial fibrillation. If they fail or are contraindicated, what is the next best choice for rate control?
            A. digoxin
            B. flecainide
            C. amlodipine

            4. Which Class III antiarrhythmic blocks a key potassium channel and requires 3 days of observation with ECG monitoring when it is started?
            A. flecainide
            B. propafenone
            C. dofetilide

            5. What Class III antiarrhythmic is considered a last resort due to its drug interactions and adverse effects, including triggering thyroid disease?
            A. metoprolol succinate
            B. dronedarone
            C. amiodarone

            6. What does the CHA2D2-VASc scoring system measure?
            A. Risk of heart failure with atrial fibrillation
            B. Proper starting dose of warfarin
            C. Risk of stroke in atrial fibrillation

            7. Wayne Peters comes to the pharmacy counter to pick up his prescription for apixaban. You know that Wayne has had problems with atrial fibrillation in the past, and the pharmacist has told you that apixaban reduces his risk of stroke. Wayne mentions that he occasionally forgets to take the second dose of apixaban. What can you suggest to help him remember?
            A. Ask his wife to remind him to take his second daily dose
            B. Suggest he enroll in the pharmacy’s compliance packaging system
            C. Tell him to set a reminder on his phone

            8. Which of the following is an advantage of direct oral anticoagulants over warfarin in atrial fibrillation patients?
            A. fewer drug and food interactions
            B. lower cost
            C. more therapeutic monitoring
            9. Which medication quickly restores normal sinus rhythm during a pharmacological cardioversion in the acute setting?
            A. Digoxin
            B. Ibutilide
            C. Verapamil

            10. You are coordinating the week’s medication synchronization patients, and you notice that John Denner’s dofetilide is not synced with his other medications. The pharmacist has told you he has both atrial fibrillation and heart failure. The pharmacist said the dofetilide controls his heart rhythm and prevents his heart failure from worsening. What is the next step?
            A. Coordinate with the pharmacist on next steps to determine if he should be taking the medication
            B. Assume he should be on the dofetilide and sync with his other medications
            C. Assume the medication has been discontinued and don’t include it in the sync

            References

            Full List of References

            REFERENCES

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              18. Alobaida M, Alrumayh A. Rate control strategies for atrial fibrillation. Ann Med. 2021;53(1):682-692. doi:10.1080/07853890.2021.1930137
              19. Tucker WD, Sankar P, Theetha Kariyanna P. Selective Beta-1 Blockers. In: StatPearls. Treasure Island (FL): StatPearls Publishing; January 30, 2023.
              20. FDA and ISMP Lists of Look-Alike Drug Names with Recommended Tall Man Letters. Institute for Safe Medication Practices. Accessed 9/12/24. https://www.ismp.org/sites/default/files/attachments/2017-11/tallmanletters.pdf
              21. Khandelwal R, Vagha JD, Meshram RJ, Patel A. A Comprehensive Review on Unveiling the Journey of Digoxin: Past, Present, and Future Perspectives. Cureus. 2024;16(3):e56755. Published 2024 Mar 23. doi:10.7759/cureus.56755
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              24. Beller GA, Smith TW, Abelmann WH, Haber E, Hood WB Jr. Digitalis intoxication. A prospective clinical study with serum level correlations. N Engl J Med. 1971;284(18):989-997. doi:10.1056/NEJM197105062841801
              25. Smith TW, Antman EM, Friedman PL, Blatt CM, Marsh JD. Digitalis glycosides: mechanisms and manifestations of toxicity. Part I. Prog Cardiovasc Dis. 1984;26(5):413-458. doi:10.1016/0033-0620(84)90012-4
              26. Fromm MF, Kim RB, Stein CM, Wilkinson GR, Roden DM. Inhibition of P-glycoprotein-mediated drug transport: A unifying mechanism to explain the interaction between digoxin and quinidine [seecomments]. Circulation. 1999;99(4):552-557. doi:10.1161/01.cir.99.4.552
              27. Chan BS, Buckley NA. Digoxin-specific antibody fragments in the treatment of digoxin toxicity. Clin Toxicol (Phila). 2014;52(8):824-836. doi:10.3109/15563650.2014.943907
              28. Hauptman PJ, Blume SW, Lewis EF, Ward S. Digoxin Toxicity and Use of Digoxin Immune Fab: Insights From a National Hospital Database. JACC Heart Fail. 2016;4(5):357-364. doi:10.1016/j.jchf.2016.01.011
              29. Cohagan B, Brandis D. Torsade de Pointes. In: StatPearls. Treasure Island (FL): StatPearls Publishing; August 8, 2023.
              30. Edward Miles Vaughan Williams. Royal College of Physicians. Accesssed 9/12/2024. https://history.rcplondon.ac.uk/inspiring-physicians/edward-miles-vaughan-williams
              31. Ylli D, Wartofsky L, Burman KD. Evaluation and Treatment of Amiodarone-Induced Thyroid Disorders. J Clin Endocrinol Metab. 2021;106(1):226-236. doi:10.1210/clinem/dgaa686
              32. Cohen-Lehman J, Dahl P, Danzi S, Klein I. Effects of amiodarone therapy on thyroid function. Nat Rev Endocrinol. 2010;6(1):34-41. doi:10.1038/nrendo.2009.225
              33. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028
              34. Bogazzi F, Tomisti L, Rossi G, et al. Glucocorticoids are preferable to thionamides as first-line treatment for amiodarone-induced thyrotoxicosis due to destructive thyroiditis: a matched retrospective cohort study. J Clin Endocrinol Metab. 2009;94(10):3757-3762. doi:10.1210/jc.2009-0940
              35. Cordarone. Prescribing Information. Pfzier Wyeth Pharmaceuticals Inc. Accessed 9/11/2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf
              36. Perez A, Touchette DR, DiDomenico RJ, Stamos TD, Walton SM. Comparison of rate control versus rhythm control for management of atrial fibrillation in patients with coexisting heart failure: a cost-effectiveness analysis. Pharmacotherapy. 2011;31(6):552-565. doi:10.1592/phco.31.6.552
              37. Smit MD, Crijns HJ, Tijssen JG, et al. Effect of lenient versus strict rate control on cardiac remodeling in patients with atrial fibrillation data of the RACE II (RAte Control Efficacy in permanent atrial fibrillation II) study. J Am Coll Cardiol. 2011;58(9):942-949. doi:10.1016/j.jacc.2011.04.030
              38. Tsadok MA, Jackevicius CA, Essebag V, et al. Rhythm versus rate control therapy and subsequent stroke or transient ischemic attack in patients with atrial fibrillation. Circulation. 2012;126(23):2680-2687. doi:10.1161/CIRCULATIONAHA.112.092494
              39. Ha AC, Breithardt G, Camm AJ, et al. Health-related quality of life in patients with atrial fibrillation treated with rhythm control versus rate control: insights from a prospective international registry (Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation: RECORD-AF). Circ Cardiovasc Qual Outcomes. 2014;7(6):896-904. doi:10.1161/HCQ.0000000000000011
              40. Gorman EW, Perkel D, Dennis D, Yates J, Heidel RE, Wortham D. Validation Of The HAS-BLED Tool In Atrial Fibrillation Patients Receiving Rivaroxaban. J Atr Fibrillation. 2016;9(2):1461. Published 2016 Aug 31. doi:10.4022/jafib.1461
              41. Fischer U, Koga M, Strbian D, et al. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. 2023;388(26):2411-2421. doi:10.1056/NEJMoa2303048
              42. Pradaxa. Prescribing Information. Boehringer-Ingelheim Pharmaceuticals Inc. Accessed 9/10/2024. https://content.boehringer-ingelheim.com/DAM/c669f898-0c4e-45a2-ba55-af1e011fdf63/pradaxa%20capsules-us-pi.pdf
              43. Eliquis. Prescribing Information. Bristol-Myers Squibb. Accessed 9/10/2024. https://packageinserts.bms.com/pi/pi_eliquis.pdf
              44. Savaysa. Prescribing Information. Daiichi Sankyo, Inc. Accessed 9/10/2024. https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Savaysa&inline=true
              45. Xarelto. Prescribing Information. Janssen Pharmaceuticals, Inc. Accessed 9/10/2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-informatio.RELTO-pi.pdf
              46. Coumadin. Prescribing Information. Bristol-Myers Squibb. Accessed 9/10/2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf
              47. Electrical Cardioversion. John Hopkins Medicine. Accessed 9/11/2024. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/electrical-cardioversion
              48. Lucà F, Giubilato S, Di Fusco SA, et al. Anticoagulation in Atrial Fibrillation Cardioversion: What Is Crucial to Take into Account. J Clin Med. 2021;10(15):3212. Published 2021 Jul 21. doi:10.3390/jcm10153212
              49. Ghzally Y, Ahmed I, Gerasimon G. Catheter Ablation. In: StatPearls. Treasure Island (FL): StatPearls Publishing; July 30, 2023.
              50. Catheter Ablation. Cleveland Clinic. Accessed 9/12/2024. https://my.clevelandclinic.org/health/treatments/16851-catheter-ablation
              51. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2022 May 3;145(18):e1033. doi: 10.1161/CIR.0000000000001073] [published correction appears in Circulation. 2022 Sep 27;146(13):e185. doi: 10.1161/CIR.0000000000001097] [published correction appears in Circulation. 2023 Apr 4;147(14):e674. doi: 10.1161/CIR.0000000000001142]. Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063
              52. Mohamoud A, Jensen J, Buda KG. Consumer-grade wearable cardiac monitors: What they do well, and what needs work. Cleve Clin J Med. 2024;91(1):23-29. Published 2024 Jan 2. doi:10.3949/ccjm.91a.23030
              53. Jaakkola J, Mustonen P, Kiviniemi T, et al. Stroke as the First Manifestation of Atrial Fibrillation. PLoS One. 2016;11(12):e0168010. Published 2016 Dec 9. doi:10.1371/journal.pone.0168010
              54. Prasitlumkum N, Cheungpasitporn W, Chokesuwattanaskul A, et al. Diagnostic accuracy of smart gadgets/wearable devices in detecting atrial fibrillation: A systematic review and meta-analysis. Arch Cardiovasc Dis. 2021;114(1):4-16. doi:10.1016/j.acvd.2020.05.015
              55. Elbey MA, Young D, Kanuri SH, et al. Diagnostic Utility of Smartwatch Technology for Atrial Fibrillation Detection - A Systematic Analysis. J Atr Fibrillation. 2021;13(6):20200446. Published 2021 Apr 30. doi:10.4022/jafib.20200446
              56. Dhingra LS, Aminorroaya A, Oikonomou EK, et al. Use of Wearable Devices in Individuals With or at Risk for Cardiovascular Disease in the US, 2019 to 2020. JAMA Netw Open. 2023;6(6):e2316634. Published 2023 Jun 1. doi:10.1001/jamanetworkopen.2023.16634
              57. Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M. Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial. Lancet. 2021;398(10310):1498-1506. doi:10.1016/S0140-6736(21)01637-8
              58. Turchioe MR, Jimenez V, Isaac S, Alshalabi M, Slotwiner D, Creber RM. Review of mobile applications for the detection and management of atrial fibrillation [published correction appears in Heart Rhythm O2. 2021 Feb 19;2(1):111-112. doi: 10.1016/j.hroo.2020.12.001]. Heart Rhythm O2. 2020;1(1):35-43. doi:10.1016/j.hroo.2020.02.005
              59. National Association of Chain Drug Stores. Re: Health Care Workshop, Project No. P131207. Accessed 10/3/2024. https://www.nacds.org/ceo/2014/0508/supplemental_comments.pdf
              60. Kelling, Sarah K. Exploring Accessibility of Community Pharmacy Services. Innov. Pharm. 2015;6(3):1-4. doi:10.24926/iip.v6i3.392
              61. Ritchie LA, Penson PE, Akpan A, Lip GYH, Lane DA. Integrated Care for Atrial Fibrillation Management: The Role of the Pharmacist. Am J Med. 2022;135(12):1410-1426. doi:10.1016/j.amjmed.2022.07.014
              62. 6 Drugs to Avoid if You Have Atrial Fibrillation. My Heart Disease Team. Accessed 9/12/2024. https://www.myheartdiseaseteam.com/resources/drugs-to-avoid-if-you-have-atrial-fibrillation
              63. What supplements should you not take with Afib. Medical News Today. Accessed 9/12/2024. https://www.medicalnewstoday.com/articles/supplements-to-avoid-with-afib

               

               

               

               

              Hemorrhoids: A Sensitive Subject

              Learning Objectives

                After completing this application-based continuing education activity, pharmacists will be able to
              1. DISCUSS the diverse types of hemorrhoids and the grading system of hemorrhoid severity
              2. RECALL chronic and acute medical conditions and disease states that may contribute to the frequency and severity of hemorrhoids
              3. DESCRIBE pharmacotherapy and procedures available for the treatment of hemorrhoidal disease
              4. ANALYZE a patient's need for referral to a medical professional or self-care based on patient interview
              After completing this application-based continuing education activity, pharmacy technicians will be able to:
              1. DESCRIBE the diverse types of hemorrhoids and the associated signs and symptoms
              2.RECALL available over the counter and prescription treatment options
              3.DISCUSS lifestyle modifications, dietary changes, and self-care options to relieve symptoms and reduce occurrences of hemorrhoids
              4. EMPLOY interview techniques to assess a patient's need for referral to a health care professional for evaluation

              Male pharmacist counseling an elderly female patient on a medication.

              Release Date:

              Release Date:  December 15, 2024

              Expiration Date: December 15, 2027

              Course Fee

              Pharmacist $7

              Pharmacy Technician $4

              There is no funding for this CPE activity.

              ACPE UANs

              Pharmacist: 0009-0000-24-052-H01-P

              Pharmacy Technician: 0009-0000-24-052-H01-T

              Session Codes

              Pharmacist:  24YC52-HLK20

              Pharmacy Technician:  24YC52-KLH18

              Accreditation Hours

              2.0 hours of CE

              Accreditation Statements

              The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-24-052-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

               

              Disclosure of Discussions of Off-label and Investigational Drug Use

              The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

              Faculty

              Catherine Koivisto, RPh
              Wal-Mart Pharmacy
              Woodstock, CT


               

              Faculty Disclosure

              In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

              Dr. Koivisto has no financial relationships with ineligible companies.

              ABSTRACT

              Hemorrhoids are completely natural anatomical structures that aid in the process of defecation. Hemorrhoidal disease results when hemorrhoids bleed or become swollen and prolapsed, leading to irritation and discomfort. Hemorrhoidal disease affects millions of people across the globe. Lifestyle changes and dietary modifications are often sufficient to resolve less severe cases. Over-the-counter treatment options provide moderate relief. More serious cases may require in-office or surgical procedures for removal. Certain acute and chronic medical conditions may contribute to the occurrence of hemorrhoidal disease. Situations exist in which symptoms of hemorrhoidal disease may mask underlying disease states leading to misdiagnosis and life-threatening complications. Patients may be reluctant to seek advice due to the sensitive nature of the topic. When patients do seek help, the pharmacy team can remind them that it is quite a common issue that should be addressed.

              CONTENT

              Content

              INTRODUCTION

              Hemorrhoids are often the “butt” of a joke. Some people also use the term “hemorrhoid” in a derogatory fashion to describe someone or something that is a “pain in the butt.” While amusing in this sense, hemorrhoids are no laughing matter. Hemorrhoids have plagued millions of adults from all levels of society and have been a documented complaint throughout the history of medicine. Fortunately, hemorrhoids are typically mild and manageable and may resolve without intervention.

              With access to medication profiles, community pharmacists often have insight into a patients’ overall health and wellness. This gives them the unique advantage of knowing what disease states patients may have, and current medications that may put patients at a higher risk for hemorrhoidal disease. When patients seek advice on their first experience with hemorrhoids or express frustration over a recurring struggle with hemorrhoids, pharmacists need sufficient background knowledge to make an appropriate recommendation. Pharmacists should make the decision to suggest self-care or over-the-counter (OTC) treatment as opposed to referral to a physician based on information provided by the patient. Patients may be hesitant to discuss such a delicate topic. Pharmacists should be compassionate, discreet, and respectful when counseling. Emphasizing the incredibly widespread occurrence of hemorrhoids will help reduce any anxiety associated with addressing the issue. Patients may first approach technicians asking for guidance with products the pharmacy has available. Technicians need to be able to assist in locating products or referring to the pharmacist for recommendations.

              Hemorrhoids affect a staggering number of people. Approximately 10 million people report the presence of hemorrhoids annually. That is roughly 4.4% of the population.1 An exact number is difficult to determine, as patients often do not report the issue or seek medical care unless they are symptomatic.2 Hemorrhoids primarily affect adults between the ages of 45 to 65 years. When considering healthy adults, the incidence between sexes is similar.1 It is rare for hemorrhoids to occur in patients younger than the age of 20. Hemorrhoids occur more often in White people than in Black people. Socioeconomic status also impacts the likelihood of hemorrhoids with those of a higher socioeconomic status having a higher incidence.3 This may explain the higher prevalence of hemorrhoids in developed countries compared to developing countries. Some researchers speculate that cultural differences in toilet habits in developing countries play a part in the reduced frequency.4

              ANATOMY AND PATHOLOGY

              Hemorrhoids occur naturally. They provide a cushion which, along with the internal anal sphincter, aids in defecation. The dentate line is an anatomical structure that separates the rectum and the anus. Internal hemorrhoids develop above the dentate line. Internal hemorrhoids can swell, then prolapse and appear below the dentate line. When this occurs, they are now considered external hemorrhoids. The hemorrhoidal plexus is a group of blood vessels that provides the blood supply. The hemorrhoidal plexus is also classified as external or internal depending on its physical relation to the dentate line.5

              Hemorrhoids are typically asymptomatic, but hemorrhoidal disease is the condition that arises when hemorrhoids become symptomatic. Hemorrhoidal disease results from enlarged and displaced hemorrhoids, which are a consequence of weakened supportive connective tissue.6 If the connective tissue becomes compromised, it can cause prolapse of the hemorrhoidal tissue. The most reported initial symptom is bright red blood in the stool. Patients also complain of itching and fecal soiling (involuntary or voluntary passing of stool into inappropriate places).7

              Risk factors that play a part in connective tissue weakening include constipation, sedentary lifestyle, dietary choices, certain acute and chronic medical conditions, toilet habits, and family history. Constipation is the most discussed risk factor for hemorrhoidal disease. Constipation typically leads to straining during defecation and longer amounts of time spent on the toilet. In addition to reading, the modern-day habit of scrolling on cell phones while on the toilet compounds the issue.8,9

              Hemorrhoidal disease involves the pathological progression of hemorrhoids to a potentially serious situation where rectal bleeding occurs, and pain and irritation develop. Whether in conjunction with a chronic disease or because of an acute condition, hemorrhoidal disease can significantly impact a patient's quality of life. Treatment options range from simple to complex and sometimes even outright bizarre. In some instances, hemorrhoids may not respond to conservative measures. In-office procedures and surgical options are available for more critical cases. Practitioners elect the appropriate procedure based on hemorrhoid classification and patient eligibility depending on the presence or absence of contraindications.

              PAUSE AND PONDER: What characteristics differentiate the types of hemorrhoids?

              Hemorrhoids Can Be Internal or External

              Internal hemorrhoids (i.e., those that develop proximal to the dentate line) are typically not painful and rarely clot or thrombose (a clot that reduces but does not obstruct blood flow).10 Bleeding is the primary sign that internal hemorrhoids exist and most often occurs with defecation.1 Internal and external hemorrhoids also differ symptomatically. Patients tend to self-report external hemorrhoids more often than internal hemorrhoids because of the general discomfort they experience. Somatic nerves, which supply the perianal skin, innervate external hemorrhoids resulting in pain.1

              The Goligher system, first proposed in 1980, further classifies and categorizes internal hemorrhoids based on severity and degree of prolapse.11 Table 1 describes four grades of internal hemorrhoids based on this classification.12

              TABLE 1. The Goligher system12
              GRADE Description
              1 Bleeding, non-prolapsed
              2 Prolapse on straining, but reduce spontaneously
              3 Prolapse, requires manual reduction
              4 Irreducibly prolapsing

               

              The Goligher system, while widely used, may be outdated and has its limitations. It does not consider the patient’s level of discomfort or related symptoms such as pain, itching, and soiling. The Goligher system also fails to account for other physical characteristics of the hemorrhoids, such as if they are isolated or circumferential (located around the anus). Providers should include these factors as part of the decision-making process when selecting treatment or determining if surgical intervention is necessary.13

              The first and second stages typically necessitate medical treatment or in-office procedures, and the third and fourth stages often require conventional surgery. Personal, subjective matters are not part of the Goligher classification process. Given these inadequacies, subject matter experts have attempted to revamp the classification process to be more inclusive so that patient-specific criteria determines the treatment plan.11

              Another classification system known as “BPRST” evaluates five characteristics: Bleeding, Prolapse, Reduction, Skin tags, and Thrombosis. 11

              • Bleeding: assigned a 0 or 1 depending on the presence or absence of bleeding (e.g, B0 or B1)
              • Prolapse: assigned a 0, 1, 2, etc. depending on the presence of prolapse and the number of piles affected. P0, P1, etc.
              • Reduction: assigned a 0, 1, 2 according to reducibility. 0 for spontaneous, 1 for manual, 2 for irreducible.
              • Skin Tags: assigned 0 or 1 for existence of symptomatic skin tags.
              • Thrombosis: assigned 0 for absence of thrombosis and 1 for acute thrombosis.

              The assessing clinician determines the presence or absence of these characteristics and quantifies them when appropriate. The BPRST classification system places patients into one of three clinical stages based on those physical findings. The clinical stage the patient is in determines recommended treatment options.

              “A/CTC” or Anatomical/Clinical-Therapeutic Classification aims to find a correlation between anatomical features, symptoms, existing disease states, contraindications, and specific treatment or surgery. This process cross-references patient characteristics against the indications for each procedure to find the best procedure for each patient, ensuring a successful outcome. This method also reduces the chances of recurrence and complications by matching patients to the most appropriate procedures based on individual situations rather than by a single feature.14

              In addition to lifestyle factors, certain acute and chronic medical conditions can also elevate a person’s risk of hemorrhoidal disease. One of the most problematic acute conditions is pregnancy. Hemorrhoids occur frequently during pregnancy, becoming more common during the third trimester. This is because increased intra-abdominal pressure occurs with enlargement of the uterus resulting in increased vascular engorgement (increased fluid in the uterus that causes tissues to swell or stretch). As the fetus grows and develops, the uterus also grows resulting in added weight increasing the pressure. This causes engorgement of the blood vessels. Frequently, hemorrhoids continue into the post-partum period, as the straining and pushing during labor and delivery further aggravates existing hemorrhoids.15

              Chronic medical conditions can also make patients more vulnerable to hemorrhoidal disease. Typically, chronic conditions that result in hemorrhoidal disease are those that increase frequency of either constipation or incontinence (inability to control defecation), like Crohn’s disease or ulcerative colitis.16 Additionally, a condition called neurogenic bowel dysfunction can occur in patients suffering from Parkinson’s disease or multiple sclerosis and those with spinal cord injuries. Neurogenic bowel dysfunction results in constipation and fecal incontinence. Parkinsons patients may experience this bowel dysfunction before the onset of neurological symptoms.17

              PAUSE AND PONDER: What situations or consequences may arise when symptoms are assumed to be hemorrhoids?

              Medical Conditions Masquerading as Hemorrhoids

              Hemorrhoids are such a common issue that the possibility exists for underlying serious issues being overlooked or misdiagnosed. Misdiagnosis can have life threatening consequences. Hemorrhoids can mask symptoms of colon cancer causing a delay in or complete failure to make a diagnosis.18 When a family history of colon cancer exists or in the presence of problematic symptoms such as pain, tenderness, dark red blood, or anemia, experts recommend a colonoscopy to rule out colorectal cancer.10 For example, a case study describes a patient who presented with rectal bleeding and pain during defecation and was sadly misdiagnosed and treated for prolapsed hemorrhoids when the correct diagnosis was anal canal melanoma, an extremely rare cancer.19

              Crohn’s disease—a chronic inflammatory bowel disease affecting digestive tract—presents with signs and symptoms that can be confused with hemorrhoids.20 Crohn’s disease can affect different areas of the gastrointestinal tract resulting in differences in presentation. Symptoms may include chronic constipation and diarrhea, both of which can contribute to the occurrence of hemorrhoids. Along with constipation and diarrhea, skin tags (small, benign skin growths that are not harmful but may be removed for cosmetic or irritation reasons) are also commonly associated with Crohn’s disease. The appearance of skin tags can be confused with hemorrhoids. Clinical signs of skin tags can include rectal bleeding that occurs with defecation and spotting of blood that occurs with straining, which are also symptoms of hemorrhoidal disease.20

              Patients with cirrhosis of the liver (scarring and dysfunction from chronic damage) can suffer from a correlating condition called portal hypertension (elevated blood pressure in the veins that drain blood from the stomach, intestines, pancreas, and spleen into the liver). Portal hypertension can lead to anorectal varices. Anorectal varices can bleed, thereby mimicking bleeding from hemorrhoids. It is important to ensure that the cause of bleeding is determined to be hemorrhoids as opposed to anorectal varices so that an underlying condition such as cirrhosis is not overlooked.9

              Less commonly reported anorectal issues misdiagnosed as hemorrhoids include21

              • anal fissure: a tear in the lining of the anus that can cause pain and bleeding during bowel movements
              • rectal prolapse: a condition where the rectum protrudes through the anus
              • anorectal abscess: pus filled mass in the anorectal area caused by infection
              • perianal necrotizing fasciitis: bacterial infection that destroys soft tissue
              • proctitis: inflammation in the rectum. Unprotected anal receptive intercourse can result in sexually transmitted proctitis. Symptoms of sexually transmitted proctitis include anal pain and discharge resembling hemorrhoidal symptoms.

              CONSERVATIVE HEMORRHOID MANAGEMENT

              Pharmacologic Treatment

              For patients who seek medical advice for hemorrhoids, multiple options are available for treatment.22 Depending on hemorrhoid severity or grade, the choices differ. Upon recognizing a benign case of hemorrhoids, the clinician and the patient may decide against any treatment at all using shared decision-making. Patients who are bothered by irritation and swelling can use at-home care or OTC preparations. OTC preparations typically consist of a combination of topical steroids to help with inflammation, anesthetics or numbing agents, vasoconstrictors to reduce blood flow, astringents, analgesics for pain, an antipruritic to help with itch, protectants to prevent further irritation, and a keratolytic to dissolve flaky or scaly skin.22

              In the community pharmacy, hemorrhoidal treatments are most often located with products used to treat mild gastrointestinal issues. One size does not fit all when it comes to hemorrhoidal treatment: individual patient factors impact product selection. Prescription strength products are also available but typically contain a similar combination of ingredients as the OTC options. (See Table 2.)

              Table 2. Active Ingredients of Hemorrhoidal Treatments22

              Ingredient(s) Class Routes of Administration RX and/

              or OTC

              Comments
              Phenylephrine Vasoconstrictor Suppository

              Ointment

              Gel

              OTC Caution use in patients with BPH, CVD, HTN, thyroid disease
              Benzocaine

              Dibucaine

              Lidocaine

              Pramoxine

              Anesthetics

               

              Cream

              Ointment

              Gel

              RX and OTC Possibility of allergic reactions; may mask pain related to more serious condition; often used in combination products.
              Calamine

              Witch Hazel

              Zinc oxide

              Astringents Wipe

              Suppository

              Cream

              Ointment

              OTC Witch hazel for external use only; can cause dryness
              Hydrocortisone Corticosteroid Cream

              Ointment

              Suppository

              Foam

              RX and OTC The only corticosteroid approved for use; available in RX strength suppository and in combination with pramoxine as RX foam
              Cocoa butter

              Glycerin

              Lanolin

              Mineral oil

              Protectants Cream

              Suppository

              Ointment

              OTC Primarily only in combination products

              ABBREVIATIONS: BPH: benign prostatic hyperplasia, CVD: Cardiovascular disease, HTN: Hypertension

               

              While topical treatments, lifestyle changes, and surgical or office-based procedures are the standard of care, oral therapy also has a place in the treatment of internal hemorrhoids. The primary class of oral therapy is phlebotonics. Phlebotonics contain plant-based ingredients called flavonoids. Researchers theorize they improve vascular tone, reduce inflammation and edema, and enhance lymphatic drainage.23

              Micronized purified flavonoid fraction (MPFF) is an example of an available phlebotonic. It is an oral supplement used in the management of hemorrhoidal disease to effectively relieve acute symptoms including pain, itching, and bleeding.12 MPFF can also be used to help with bleeding, swelling and discharge following hemorrhoidectomy. MPFF contains the flavonoids diosmin and hesperidin. The optimal dose of this product is unclear, but doses range from 1000 mg per day in divided doses for a short duration (3 months) to 1000 mg three times daily for acute hemorrhoid flares, gradually tapering to 1000 mg twice daily. Diosmin should not be used in children or in pregnant women due to the lack of data supporting the safety of use in these populations.24 MPFF can be found in OTC supplements in lower concentrations. These supplements claim to be beneficial for hemorrhoids and vein health. A search of “MPFF” at online retailers reveals a multitude of supplements with varying concentrations of MPFF.

              Calcium dobesilate, which is typically used for chronic venous insufficiency and diabetic retinopathy, has shown some efficacy in reducing inflammation and bleeding in acute incidents of hemorrhoidal disease.12 Calcium dobesilate with fiber supplementation reduces inflammation of hemorrhoids.25 Although not available in the United States, calcium dobesilate is a synthetic compound available in many other countries.26

              Non-Pharmacologic Treatment and Prevention

              At-home care is a good option for occasional hemorrhoid flare-ups. For patients who deal with hemorrhoids chronically, prevention is key. Simple lifestyle changes can often have a significant impact on hemorrhoid recurrence and frequency. Addressing any existing primary risk factors is the best place to start. The most common recommendations include increasing hydration, increasing fiber intake, and reducing strain while defecating.10

              Constipation leads to straining and more time spent on the toilet. Fiber intake and hydration are essential in preventing constipation. Dietary fiber is severely lacking in the modern American diet. Current guidelines recommend 25 to 40 grams of fiber per day, but most Americans average an intake of less than half that amount.27 Fiber supplementation reduces the risk of bleeding by as much as 50%.10 Increasing hydration is also essential to improving bowel consistency and maintaining soft stools.

              Individuals affected by hemorrhoids should also limit alcohol and caffeine consumption due to their dehydrating characteristics. Spicy foods may be problematic for some patients, but a direct correlation has not been found.12,28

              Research also implicates sedentary lifestyle as a contributor to the risk of hemorrhoidal disease. In addition to improving overall health, physical activity also reduces the risks of obesity and constipation. Patients who are overweight or obese are more likely to develop hemorrhoids and hemorrhoidal disease and would benefit from aerobic exercise such as walking or swimming. The choice of activity should not put further pressure on the anal veins. Therefore, activities that involve heavy lifting should be avoided.29 Table 3 summarizes the “dos and don’ts” of conservative hemorrhoid management.

              Table 3. Dos and Don’ts of Hemorrhoidal Disease27,29,30

                               Do               Don’t
              • Increase aerobic exercise
              • Increase hydration
              • Increase fiber intake
              • Mimic the squatting position when on the toilet
              • Use soft toilet paper
              • Use salt or sitz baths for good hygiene
              • Use ice packs or cold compresses
              • Wear cotton underwear

               

               

              • Use donut cushions
              • Spend long periods of time on the toilet reading, scrolling on phone, etc.
              • Use laxatives chronically (can lead to constipation)
              • Conduct activities that can worsen pressure in anal veins (e.g., horseback riding, cycling, heavy lifting, rowing)
              • Use topical steroids for long periods of time (can cause thinning of perianal skin and dermatitis)
              • Use harsh cleansing wipes

               

               

              IN-OFFICE AND SURGICAL PROCEDURES

              Surgeries and less complex procedures performed in the practitioner’s office are available for those patients who fail conservative therapies. Out of the population of patients seeking treatment for hemorrhoids, roughly 10% will require surgical intervention.31 The severity or grade of the internal hemorrhoid, the patient’s degree of discomfort, and individual patient characteristics such as correlating disease states or risk factors determine the choice of procedure. Diet and lifestyle changes should be recommended to all patients and may be sufficient to resolve symptoms in patients with grade 1 hemorrhoids. Minimally invasive treatment options are available for patients with persistent symptoms in grade 2 hemorrhoids. Those patients with grades 3 or 4 appear to benefit most from surgical procedures. Surgery continues to be the standard treatment for these patients.32 The procedures differ significantly in recovery time required, possibility of recurrence, and degree of pain.2,33

              External hemorrhoidal thrombosis is approached differently and can cause extreme pain. Conservative measures are similar to those recommended for internal hemorrhoids and include sitz baths, increased dietary fiber, analgesics, and increased fluid intake.34 Surgical treatment—either drainage or excision—is the best recommendation when severe pain is present and conservative methods are unsuccessful. Recurrence is frequent following excision of external hemorrhoidal thrombosis but patients typically experience a higher incidence of pain following the procedure.34 The following procedures are indicated for internal hemorrhoids.

              In-Office Procedures

              Rubber band ligation is an option for hemorrhoids grades 1 through 3 and is often the first choice when patients seek medical intervention for hemorrhoids. One advantage of rubber band ligation is that it can be performed in the practitioner’s office. As the name implies, it involves putting a small rubber band around a hemorrhoid to cut off its blood supply. This results in fibrosis and eventually (after about a week), the hemorrhoid dries, hardens, and falls off. Post procedure complications include bleeding and pain that can be severe lasting for a couple of days. Bleeding can be problematic for patients on antithrombotic medication (blood thinners), and pelvic sepsis (infection) is a rare complication. Recurrence rates range from 6.6% to 18%, however long-term efficacy is superior to sclerotherapy and infrared coagulation.35

              Injection sclerotherapy is performed in outpatient clinics with local anesthesia. It is generally used for grades 2 through 4 of internal hemorrhoids.32 The procedure involves injecting a sclerosant—a substance that causes blood vessels to shrink, often aluminum potassium sulfate and tannic acid—into the connective tissue layer around the pedicle (root) of the hemorrhoid. The sclerosant causes local inflammation which results in reduced blood flow to the hemorrhoid. An advantage of injection sclerotherapy is that it is associated with fewer complications and less pain than rubber band ligation. Unfortunately, it also has a lower success rate. Recurrence rates are high, but due to the safety profile and general ease of the procedure, it can be repeated if necessary.10,36

              Infrared coagulation is an in-office, endoscopic procedure primarily indicated for lower grade symptomatic internal hemorrhoids. The practitioner directs a probe of infrared light at a predetermined depth targeting individual hemorrhoids. The light is converted to heat, which causes tissue destruction, inflammation, and eventually fibrosis.37 In addition, the pressure applied by the probe itself reduces blood flow to the area and helps to bring vessels closer to the surface. This small amount of energy contributes to the desired coagulation (clotting).38 Infrared coagulation is as effective as rubber band ligation in the short term but carries a higher incidence of recurrence due to the minimal tissue destruction. Despite increased recurrence rates, patients tend to prefer infrared coagulation given its lower incidence of post procedure pain and shorter recovery time. Infrared coagulation also has minimal complications, with bleeding, ulceration, and dermatitis being the most reported.32

              Surgical Options

              Conventional hemorrhoidectomy is the surgical removal of prolapsed hemorrhoids and can be characterized as “open” or “closed.” Open hemorrhoidectomy is referred to as the Milligan-Morgan method. This method involves surgical excision of the hemorrhoid from the underlying anal sphincter. The surgeon stops blood supply to the hemorrhoid by tying off the blood vessel at its root. Upon completing this procedure, the wound remains open, giving the procedure its name. Providers can use various instruments for this procedure, including scissors, a scalpel, linear staples, a laser, radiofrequency, and electrocautery.39 One device does not appear to have an advantage over any another.31

              Closed hemorrhoidectomy is called Ferguson hemorrhoidectomy. Procedurally, this method is similar to the open procedure. The primary difference, as the name would imply, is that following the closed hemorrhoidectomy, the surgeon closes the wound, typically with an absorbable suture.31,39 Pain is a concern, naturally, for patients faced with the prospect of hemorrhoidal surgery. Changes in the device used to perform the excision in closed hemorrhoidectomy has reduced post-operative pain, but it continues to be an issue. This is in addition to prolonged wound healing and a longer time to return to normal activities.13 Both methods come with their share of complications. The most problematic are urinary retention, bleeding, anal stenosis (narrowing), infection, and incontinence.31 Sepsis is rare but possible and can be life-threatening.39

              Stapled hemorrhoidopexy is a surgical procedure also referred to as the Longo Procedure or procedure for prolapse and hemorrhoids (PPH). It is indicated for patients with second stage hemorrhoids who are unresponsive to non-surgical methods and patients with third and fourth stage hemorrhoids.31 This procedure repositions rather than removes hemorrhoidal tissue. Loose mucosal tissue which is involved in the prolapse of the hemorrhoids is removed. A circular stapler then excises the mucosa above the dentate line in a circumferential ring.13 The stapling results in an anastomosis, or connection, of mucosa to mucosa, causing the hemorrhoidal tissue to be lifted back into place.2 This connection interrupts the arteries supplying the blood flow thereby reducing engorgement (swelling). 39,40 Because the incision occurs above the dentate line, the patient does not have an external surgical wound or trauma to the anal mucosa or anoderm (skin-like tissue that lines the lower part of the anal canal).39 An advantage of stapled hemorrhoidopexy is reduced post-operative pain because the excision is performed where there are very few sensitive receptors.39 Overall recovery time and time to return to normal activities are also shorter than with conventional hemorrhoidectomy. One downside to the procedure is a greater incidence of recurrence and prolapse.31 Complications from stapled hemorrhoidopexy are like those of conventional hemorrhoidectomy and include bleeding, urinary retention, incontinence, anal stenosis, and, rarely, sepsis.39

              Hemorrhoidal artery ligation is also referred to as hemorrhoidal dearterialization. In hemorrhoidal disease, arterial blood flow increases, so hemorrhoidal artery ligation involves reducing blood supply to the hemorrhoidal plexus. It is indicated for hemorrhoids of grades 2, 3, and 4. It is minimally invasive and is commonly performed as a day surgery.41 The surgeon uses a proctoscope (a medical instrument used to examine the inside of the rectum and anus) with a Doppler transducer (a medical device that uses sound waves to detect and measure blood flow in blood vessels) that helps locate the arterial pulse.42 Upon locating the pulse, the practitioner performs ligation either by suture or laser. Ligation of the supplying artery results in hemorrhoidal plexus shrinkage and symptom relief.41 The benefits of hemorrhoidal artery ligation compared to conventional hemorrhoidectomy are significantly reduced post-op pain and fewer complications. The procedure does not alter anal anatomy, and the absence of any wounds reduces infection risk and results in rapid recovery and return to normal activities. One disadvantage may be a greater incidence of recurrence, particularly for patients with grade 4 hemorrhoids.42 Recurrence rates average less than 3% of patients presenting with bleeding at one year follow-up.43

               

              Dealing With Post-Op Pain

              Pain following hemorrhoidectomy is common regardless of which procedure a patient undergoes. The incidence of moderate to severe pain following conventional surgical procedures may be as high as 65%.44 The degree of pain experienced can range from mild to intractable (not easily controlled). Rectal hyperactivity, spasm, and compression or stimulation of nerve endings are possible outcomes of surgery and are likely the origins of pain.45 Infection, edema, and sensitivity of the surgical wound also contribute to post-op pain.46 The level of pain experienced can also be impacted by procedure type, anesthesia administered, and interventions performed during the procedure. Due to the different sources of pain, several options are available for pain management and a multimodal approach to treating pain is recommended.47 These treatments can be topical, oral, injectable, or in suppository form.

              Injections of products such as botulinum toxin, methylene blue, and ketorolac intraoperatively have shown modest effectiveness in reducing pain even several days post-op.44 Botulinum toxin works by loosening the tonicity of the internal anal sphincter resulting in reduction of pain and easier defecation.48 A small sample of patients with intractable pain were given an injection of a combination of ropivacaine and triamcinolone (anesthetic and steroid) at the painful site and reported no recurrence of pain at a six-month follow-up.45

              Topicals to treat post-op pain include a range of drug classes. Calcium channel blockers (diltiazem or nifedipine), applied topically, reduce pain and decrease spasm in the internal anal sphincter. These are not commercially available and would require pharmaceutical compounding.2,39 Anesthetics such as 2.5% lidocaine/2.5% prilocaine cream reduce pain when applied in the anal canal or the surrounding perianal skin. Sucralfate—a commonly used gastrointestinal medication—when compounded and applied as a 10% ointment, promotes mucosal healing and provides a protective barrier. The non-steroidal anti-inflammatory drug (NSAID) diclofenac can be compounded into a suppository and used for pain relief in the first day following hemorrhoidectomy. The muscle relaxer baclofen in a 5% cream form provides pain relief when applied immediately following surgery. Additionally, patients can use metronidazole topically or orally following surgery, as it exhibits antioxidant properties and helps to prevent infection at the surgical site.44

              Preferred oral pain medications include non-narcotic analgesics that target peripheral and central pain sensitization and include NSAIDs, corticosteroids, acetylsalicylic acid, ketamine, acetaminophen, and anticonvulsants such as gabapentin. Targeting pain through multiple mechanisms provides better pain control and reduces opioid use.47

              PAUSE AND PONDER: Which patients would be a special concern when determining hemorrhoid treatment?

              ADDITIONAL CONSIDERATIONS IN HEMORRHOID MANAGEMENT

              Comorbidities and Treatment Decisions

              When treating hemorrhoidal disease, the treatment team must consider each patient’s characteristics individually. For example, the team must evaluate any comorbidities when deciding on appropriate therapy. Comorbidities that can impact treatment choice include immunocompromise, pregnancy, anticoagulant use, Crohn’s disease, and portal hypertension.9

              Hemorrhoids are an extremely common complaint among pregnant women. Typically, hemorrhoids will resolve after giving birth, but most women will seek methods to relieve the discomfort without complications or risk of harm to the fetus during pregnancy. The first line recommendation aligns with recommendations for most patients with hemorrhoids and includes dietary modifications to reduce constipation. Kegel exercises and lying on the left-side seem to provide modest benefits. Topical treatments lack evidence of efficacy and safety and are not recommended for use during pregnancy.49

              Immunocompromised patients are also a special concern. Clinicians must account for symptom severity and always consider conservative methods first. If procedural or surgical intervention is necessary, the increased risk of sepsis and poor wound healing puts immunocompromised patients at a disadvantage. These patients should receive prophylactic antibiotics before any procedure and stop immunosuppressive agents when feasible.9,49

              Clinicians should also manage patients on anticoagulant therapy (e.g., warfarin) conservatively when possible, as increased risk of bleeding limits procedural options. If symptoms are severe and procedural intervention is necessary, injection sclerotherapy is preferred due to its lower bleeding risk. Patients should discontinue anticoagulants one week prior to the procedure.9

              Patients with portal hypertension often suffer from coagulopathy (impaired ability of the blood to clot). As in patients on anticoagulants, bleeding risk is elevated in those with portal hypertension. Similarly, the treatment team should try conservative methods first. If procedural or surgical intervention is necessary, again, sclerotherapy is the preferred procedure due to the lower bleeding risk.9

              Crohn’s patients should try conservative measures first. When developing a treatment plan, management of the underlying disease should be the primary concern.9

              PAUSE AND PONDER: What are some red flags when a patient presents with hemorrhoidal concerns?

              Interactions At the Pharmacy Level

              In the community pharmacy setting, technicians may be the first to encounter patients with hemorrhoids. It is essential that technicians are familiar with products available in the pharmacy, their ingredients, and their locations on shelves. While technicians cannot recommend a particular treatment, they can assist patients in locating desired items and directing them to generic versions if cost is an issue. Technicians can also refer patients to the pharmacist for more information if necessary.

              Interviewing patients enables pharmacists to make good recommendations. A good starting point is to determine patients’ prior history of hemorrhoidal disease and experience treating hemorrhoids. It is also imperative that pharmacists differentiate between hemorrhoidal symptoms and symptoms that may indicate an anorectal disorder that should receive immediate medical attention. Use open-ended questions to determine what other symptoms the patient is experiencing, how long have symptoms been present, and at what level of severity.

              For those patients experiencing rectal bleeding for the first time, referral to a medical professional is always the preferred recommendation. Rectal bleeding attributed to hemorrhoids often results in a completely different diagnosis upon examination.6 Swelling, discharge, fever, and chills are also red flag symptoms. These could potentially be an anal abscess, which can lead to sepsis and even death if not addressed. Persistent drainage and stool seepage are also red flags. These may indicate anal fistula (an area of infection between the skin and the anus), which requires surgical correction. Additional red flags include severe pain and burning with defecation indicating a possible anal fissure, or changes in bowel habits along with anal mass, pain, and discharge which are symptoms of anal neoplasms. While rare, anal neoplasms often have a poor prognosis.22

              Pharmacists may be able to determine through thorough interview if lifestyle is a factor. Does the patient lead a sedentary lifestyle? Do they have a family history of colon cancer? Do they have Crohn’s disease? Has the patient recently experienced weight loss or loss of appetite? Is there bleeding with defecation and, if so, is it bright red or dark?19 Hemorrhoidal blood is arterial and is therefore bright red in appearance. Darker blood could indicate a source of bleeding other than hemorrhoids.10 The patient’s age is also an important consideration. Patients older than 50 years who experience symptoms for the first time would be good candidates for colon cancer screening.50 A consultation with a primary care provider regarding a colonoscopy may be recommended. Due to the low incidence of hemorrhoids in children and adolescents, any rectal bleeding or hemorrhoidal symptoms would warrant medical attention.

              When counseling patients on the use of OTC hemorrhoidal treatment, it is important to ask open-ended questions and gather as much information as possible. For example:

              • “What other medical conditions do you have?” (Pregnancy, hypertension and depression are concerns.)
              • “What specific symptoms are you hoping to treat?”
              • “What route of administration would you prefer?”

              Medication allergies can be a concern, particularly with products containing anesthetics. It is important to ensure that patients understand how to use selected medications and that they can administer it themselves or have a trusted caregiver to help. For example, does the patient have the dexterity to unwrap and insert a suppository? Pharmacists should be comfortable answering questions regarding the application of rectal creams and ointments.

              It is also essential to be understanding and sympathetic to financial limitations. Generic equivalents are available for many of the most used products. In addition, due to the similarity between prescription and OTC products, many prescription hemorrhoidal treatments are non-formulary preferred and may be cost prohibitive.

              Importantly, patients may approach pharmacists asking, “An internet search said I can use ‘XYZ’ for hemorrhoids, is this true?” There are many seemingly outlandish therapies found on the internet. It is helpful to be familiar with these options as well. See SIDEBAR for the most common non-traditional therapies.

               

              SIDEBAR: Non-Traditional Therapies51-55

              • Aloe Vera: applied topically to soothe irritation
              • Black Seed: extract taken orally as a supplement to reduce inflammation
              • Chamomile: extract, applied topically as an ointment to reduce pain and itching
              • Coconut: applied topically as an oil to soothe irritation
              • Granulated Sugar: applied directly to swollen hemorrhoids to reduce prolapse
              • Leeches: attaches directly to hemorrhoid for intermittent periods of time, reduces engorgement
              • Quercus (Persian Oak): extract taken orally as supplement to reduce inflammation
              • Rosehips: applied topically to relieve pain and burning
              • Turmeric: extract taken orally as supplement to reduce inflammation

               

              CONCLUSION

              Historians have described and recorded hemorrhoids as a medical condition and a nuisance since 37 AD.30 Since that time, millions of people have sought treatment for hemorrhoidal disease and countless practitioners have attempted to provide relief from the pain and discomfort. Patients who routinely suffer from hemorrhoids probably feel like they have been dealing with it since 37 AD and they have been battling them alone. Conservative measures, whether medicinal or non-traditional, continue to be effective in improving symptoms and quality of life and are still the first line of defense. Fortunately, non-invasive and surgical procedures are available for non-responsive and severe cases of hemorrhoidal disease. Individual patient characteristics impact treatment choice. Community pharmacists’ and technicians’ accessibility often makes them the first medical professionals that patients consult for information regarding hemorrhoid treatment. It is essential to understand how overall health, lifestyle habits, risk factors, and medication profiles determine resulting recommendations. Being sensitive to the patient’s situation and treating them with respect and professionalism is key to ensuring they receive the proper care and attention. Hemorrhoids are a sensitive subject, and patients may have difficulty discussing it and asking the right questions. Hemorrhoids have been a pain in the butt for centuries. With today’s knowledge and treatment options, pharmacists and technicians can help patients sit a little more comfortably for years to come.

               

               

               

               

               

              Pharmacist Post Test (for viewing only)

              After completing this continuing education activity, pharmacists will be able to
              1. DISCUSS the diverse types of hemorrhoids and the grading system of hemorrhoid severity
              2. RECALL chronic and acute medical conditions and disease states that may contribute to the frequency and severity of hemorrhoids
              3. DESCRIBE pharmacotherapy and procedures available for the treatment of hemorrhoidal disease
              4. ANALYZE a patient’s need for referral to a medical professional or self-care based on patient interview

              1. Which characteristic(s) does the Goligher system use to grade internal hemorrhoids?
              A. Patients’ reported level of pain
              B. Whether hemorrhoids are isolated or circumferential
              C. Severity and degree of prolapse

              2. Which chronic disease often causes rectal bleeding, swelling, and skin tags, sometimes resulting in a misdiagnosis of hemorrhoids?
              A. Ulcerative colitis
              B. Gastroesophageal reflux disease
              C. Crohn’s disease

              3. Which of the following patients would be the MOST likely to suffer from an acute flare-up of hemorrhoids?
              A. A 6-year-old with attention-deficit/hyperactivity disorder
              B. A 32-year-old in her third trimester of pregnancy
              C. A 22-year-old recently diagnosed with diabetes

              4. Which of the following chronic medical conditions would put a patient at an increased risk of hemorrhoids?
              A. Fibromyalgia
              B. Chronic obstructive pulmonary disease
              C. Parkinson’s disease

              5. When comparing internal and external hemorrhoids, which of the following statements is TRUE?
              A. Internal hemorrhoids frequently thrombose and cause significant pain
              B. Somatic nerves innervate external hemorrhoids resulting in significant pain
              C. External hemorrhoids originate proximal to the dentate line

              6. A 62-year-old presents with Grade 4 hemorrhoids. He has increased his physical activity by walking daily. He also drinks plenty of water and avoids alcohol. Self-care options are no longer helping. His medication profile includes insulin glargine, levothyroxine, and warfarin. Which of the available procedures would be the MOST appropriate for this patient?
              A. Stapled hemorrhoidopexy
              B. Rubber band ligation
              C. Injection sclerotherapy

              7. A 55-year-old gentleman approaches the pharmacy counter carrying a box of witch hazel wipes and an inflatable donut cushion. He states that he recently changed jobs and is now a delivery driver for a furniture company. He recently saw blood on the toilet tissue and suspects he has a hemorrhoid. He has never experienced this before and wants to know what you would recommend. The pharmacy is quite busy. What is the best way to help this patient?
              A. Answer quickly that he has chosen some good products to try and tell him he should feel better in a few days
              B. Recommend he change jobs because the hemorrhoids will not resolve if his circumstances do not change
              C. Recommend seeing a medical professional for confirmation of hemorrhoids and colon cancer screening

              8. Which group of procedures treats hemorrhoidal disease by reducing blood flow to the hemorrhoid resulting in eventual fibrosis?
              A. Hemorrhoidal artery ligation, stapled hemorrhoidopexy, and closed hemorrhoidetomy
              B. Rubber band ligation, hemorrhoidal artery ligation, and injection sclerotherapy
              C. Injection sclerotherapy, rubber band ligation, and open hemorrhoidectomy

              9. Optimal Post-Op Pain control is best achieved through which method?
              A. Primarily though short-acting opioids only
              B. Over-the-counter analgesics and ice packs
              C. Multiple medications that target pain differently

              10. A long-time customer of your pharmacy pulls you aside and confesses that he is tired of dealing with his hemorrhoids. You are very familiar with his overall health and medication history. You recall dispensing a colonoscopy prep kit to him just a few weeks ago. He states that the colonoscopy did not show anything alarming, and he doesn’t want to keep bugging his doctor. How can you help this patient?
              A. Tell him to try taking a vegetable laxative daily and increase his caffeine intake
              B. Remind him that prevention is key and focus on his diet and lifestyle
              C. Knowing he can take a joke, you ask him if he’s ever tried leeches

              Pharmacy Technician Post Test (for viewing only)

              After completing this continuing education activity, pharmacy technicians will be able to
              1. DESCRIBE the diverse types of hemorrhoids and the associated signs and symptoms
              2. RECALL available over the counter and prescription treatment options
              3. DISCUSS lifestyle modifications, dietary changes, and self-care options to relieve symptoms and reduce occurrences of hemorrhoids
              4. EMPLOY interview techniques to assess a patient's need for referral to a health care professional for evaluation

              1. Which of the following hemorrhoidal treatments requires a prescription?
              A. Cocoa butter cream
              B. Witch hazel 20% pads
              C. Hydrocortisone 25 mg suppositories

              2. Which of the following is a recommended lifestyle change to reduce occurrence of hemorrhoids?
              A. Increasing weight bearing exercise
              B. Increasing fluid intake
              C. Increasing time spent on the toilet

              3. Which of the following is a vasoconstrictor commonly found in hemorrhoidal treatments?
              A. Phenylephrine
              B. Benzocaine
              C. Hydrocortisone

              4. A patient complains of recent episodes of bright red blood on toilet tissue without pain. What type of hemorrhoid is she most likely experiencing?
              A. External thrombosed
              B. Internal grade 1
              C. Internal grade 4

              5. A regular customer comes to your pharmacy to pick up a medication refill for her 6-year-old daughter. While at checkout, she asks where the children’s laxatives are located. She mentions that her daughter recently came out of the bathroom crying with alarm because her “butt was bleeding.” What would be the best next step to help this panicked parent?
              A. Point her in the direction of the glycerin suppositories and stool softeners and wish her good luck
              B. Remind her that little girls can be dramatic and it is most likely simple constipation
              C. Cautiously state that the situation sounds concerning due to her daughter’s young age and recommend she speak to the pharmacist

              6. Which of the following statements is TRUE when comparing internal and external hemorrhoids?
              A. Internal hemorrhoids frequently thrombose and cause significant pain
              B. External hemorrhoids originate proximal to the dentate line
              C. Somatic nerves innervate external hemorrhoids resulting in pain

              7. Increasing fiber is a standard recommendation for reducing constipation and therefore reducing frequency of hemorrhoids. Current guidelines recommend what amount of fiber intake per day?
              A. 5 to 10 grams
              B. 25 to 40 grams
              C. 25 to 40 milligrams

              8. A 55-year-old gentleman with obesity approaches the pharmacy counter. With an agonized look on his face, he explains that he is experiencing consistent pain in the rectal area whether or not he is on the toilet. He explains that he is a long-distance trucker and has had to take time off from his route due to the pain. He asks where the donut cushions are located. How should you respond to his question?
              A. Direct him to the pharmacist for further consultation
              B. Point him to the aisle with the inflatable donut cushions
              C. Suggest a different line of work

              9. A pregnant patient in her third trimester is extremely frustrated by her battle with hemorrhoids. She states that she prefers to avoid any medicinal treatments. Which of the following choices is the MOST appropriate response?
              A. “The pharmacist can recommend an over-the-counter herbal product to relieve your pain.”
              B. “There are no options to treat hemorrhoids without medication; you’ll need to see your obstetrician.”
              C. “Increasing fiber and fluid intake are your best options; the pharmacist can recommend a fiber supplement.”

              10. What technological advancement has resulted in a significant negative change in toilet habits, resulting in increasing incidence of hemorrhoids?
              A. Cell phone use while on the toilet
              B. Uber and Lyft ride sharing services
              C. Increased fiber intake leading to increased diarrhea

              References

              Full List of References

              REFERENCES

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              2. Mott T, Latimer K, Edwards C. Hemorrhoids: Diagnosis and Treatment Options. Am Fam Physician. 2018;97(3):172-179.
              3. Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation: An epidemiologic study. Gastroenterology.1990;98(2):380-386. doi:10.1016/0016-5085(90)90828-O
              4. Gardner IH, Siddharthan RV, Tsikitis VL. Benign anorectal disease: hemorrhoids, fissures, and fistulas. Ann Gastroenterol. 2020;33(1):9-18. doi:10.20524/aog.2019.0438
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              11. Sobrado Júnior CW, Obregon CA, E Sousa Júnior AHDS, Sobrado LF, Nahas SC, Cecconello I. A New Classification for Hemorrhoidal Disease: The Creation of the "BPRST" Staging and Its Application in Clinical Practice. Ann Coloproctol. 2020;36(4):249-255. doi:10.3393/ac.2020.02.06
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