LAW: “An Apple A Day Keeps COVID Away” Legal Issues in Suppressing Health Misinformation

After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

o DISCUSS the characteristics of health misinformation and its effect on public health

o CHARACTERIZE the role of the states in disciplinary actions for misinformation

o DESCRIBE the legal issues that emerge when state authorities try to control the flow of information.

o CONTRAST different approaches taken by states in addressing the dissemination of healthcare information

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.

Health misinformation is an age-old problem that has become more visible due to the influence of social media and the COVID pandemic. Various governmental and professional bodies have sought to temper the influence of misinformation from health care professionals but have encountered logistical and constitutional barriers. State licensing boards exist to regulate the professions and are the most appropriate body to exert influence. However, state boards are government entities and have faced First Amendment limitations. Lawsuits from individual prescribers as well as opposition from legislative bodies in some states have hampered the ability of boards to act. Recently, the FDA has also been sued for its messaging with potentially far-reaching consequences. These events will be reviewed in this activity.

“I believe that misinformation is now our leading cause of death... People are distracted and misled by the medical information Tower of Babel.”¹ Dr. Robert Califf, Commissioner, Food and Drug Administration.

INTRODUCTION

The world faced a deadly infection running rampant. Some health experts believed that a vaccine could confer protection against the infection, but this view was met with skepticism and distrust. Misinformation spread within and beyond the scientific community and debates about the inoculation’s safety and efficacy emerged on many fronts. Physicians observed infections in some vaccinated individuals and opponents began speaking publicly about their distrust of the vaccine. The use of an animal source for the vaccine contributed to the belief that miniature cow heads could grow from sites of vaccination. Vaccine hesitancy and fear grew among the public.²

While this may sound like recent events, it describes the atmosphere surrounding the development of a vaccine for smallpox in 1796.² Many years later, the increasing popularity of television [like social media today] exaggerated fears of smallpox vaccination by broadcasting both descriptions and visual footage of the rare instances in which the smallpox vaccine produced severe adverse effects.² This messaging skewed perceptions about the vaccine’s risk/benefit profile and further eroded trust in the scientific community. Overall, these misperceptions delayed the worldwide eradication of smallpox by more than 200 years.²

This narrative illustrates that misinformation is not a recent phenomenon. Examples can be cited going back thousands of years.³ More significantly, it demonstrates misinformation’s destructive consequences. Recently, misinformation rose to unprecedented prominence with the COVID-19 pandemic, with the Director of the International Fact Checking Network calling COVID-19 “the biggest challenge fact-checkers have ever faced.”⁴

Health misinformation can be harmful. U.S. Surgeon General Dr. Vivek Murthy has stated, “Misinformation takes away our freedom to make informed decisions about our health and the health of our loved ones. Simply put, health misinformation has cost us lives.”⁵

Health misinformation can influence political, economic, and social well-being. People can become confused and anxious when faced with contradictory information, and this is especially dangerous during a public health crisis.^5,6 It can expose patients to wasteful and harmful products and procedures, delay treatment with a more scientifically based therapy, and divide families and communities.⁶

Pharmacists, of course, also have a role during a healthcare crisis and can be either another source of misinformation or a resource to clarify and refute poor advice. This continuing education activity will examine some recent efforts by governmental and non-governmental organizations to limit information that is contrary to mainstream medical advice and the sanctioning (or lack thereof) of healthcare providers for encouraging such therapies. Various approaches by governmental agencies to deal with conflicting information have raised legal issues when trying to restrict the free flow of information.

Disclaimer: Please note that the examples referred to in this lesson were chosen based upon their high-profile and impact and should not be interpreted as representing any political commentary, agenda, or endorsement by the author or publisher. It is acknowledged that “misinformation” is hard to characterize, and a consensus can shift as more data are developed. One should also not infer that the examples represent a deliberate intent to deceive by their sponsors.

PAUSE AND PONDER: What should be the role for pharmacists and pharmacy technicians in mitigating the impact of misinformation?

MISINFORMATION

Misinformation is frequently used as a catch-all term for related concepts such as disinformation, ignorance, rumor, and conspiracy theories, often resulting in different interpretations and imprecise definitions.⁷Misinformation is often distinguished from disinformation on the basis of intent. In this context, misinformation is used to describe information that is unintentionally erroneous (e.g., mistakenly repeated or due to ignorance) while disinformation is information that is deliberately intended to mislead or deceive (e.g., malicious, fraudulent, or for propaganda).⁷

Health misinformation has been defined as information that is false, inaccurate, or misleading according to the best available evidence at the time (emphasis added).⁵ This definition recognizes that the accuracy and recognition of information can change as new data or experiences emerge. Although not health related, one needs to look no further than the writings of Galileo to find an example of information that was once condemned and humiliated. Formerly branded a heretic for claiming that the earth rotated around the sun, Galileo’s ideas later became the fundamental basis for astronomy and space travel.⁸

Public health recommendations changed rapidly during the progression of the COVID pandemic and resulted in confusion among the public and distrust of public health agencies. A recent survey found that 60% of adults in the U.S. say they have felt confused as a result of changes to public health officials’ recommendations on how to slow the spread of the coronavirus.⁹ In addition to confusing patients, negative consequences of health misinformation include misallocation of health resources, fraud, increased reliance on unreliable cures, a negative impact on mental health, and an increased hesitancy to seek medical care.

CAN MISINFORMATION BE REGULATED?

If misinformation is a dangerous phenomenon, as many have suggested, can anything be done to control its flow? During COVID, officials from the federal government, many states, and healthcare and professional organizations promulgated regulations and policies aimed at limiting or promoting health information as will be described below. Some of these approaches have threatened to impose sanctions against practitioners who have disseminated erroneous or misleading information.

However, the suppression of information can face constitutional challenges.¹² Healthcare professionals, like all Americans, have a right to speech that is free of government restrictions even if the content is false.¹³

Justice Thurgood Marshall wrote in a Supreme Court decision in 1972, “…the First Amendment means that government has no power to restrict expression because of its message, its ideas, its subject matter, or its content.”¹⁴ The rights enumerated in the First Amendment protect individual against government infringement on their expression, but do not protect them from other individuals, businesses, or private organizations.¹⁵ Healthcare professionals can be disciplined by professional licensing boards and health departments for certain actions, but these organizations are governmental bodies (termed state actors in constitutional law) and they, along with public hospitals and universities, are prohibited from infringing on free speech.¹⁵

A content-based restriction “discriminates against speech based on the substance of what it communicates” and receives the greatest protection from any government-imposed restrictions.¹⁶ Content-based restrictions are presumptively unconstitutional and can only be applied if the state shows that the prohibition is the least restrictive means of achieving a compelling state interest such as the protection of public health and safety.¹⁶ (Compelling means essential or necessary rather than a matter of choice, preference, or discretion.¹⁶) The Supreme Court recognizes that certain narrow categories of expression, such as obscenity, child pornography, true threats, and incitement to imminent lawless action, can be barred because of their harmful content.¹⁶ Learners who are interested in learning more about how the courts scrutinize speech can find excellent information here: https://crsreports.congress.gov/product/pdf/R/R47986

Commercial speech, on the other hand, does not receive as much protection as content speech. Commercial speech applies when there is some form of transaction and includes commercial advertising and solicitations.^12,16 Historically, commercial speech did not receive any First Amendment protection, but an important 1976 Supreme Court decision involving pharmacies extended protection to commercial speech.¹⁶ The case, Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, challenged a state law that made it illegal for pharmacies to advertise drug prices. The Court reasoned that the First Amendment not only granted the speaker the right to speak, it also granted the listener the right to receive information. Commercial speech receives some protection because it serves the important societal interests of providing information to consumers and promoting the economic interests of the speaker.¹² In the case cited, consumers had a right to receive lawful information about drug prices.¹⁶ This narrow exception to free speech could apply in cases where a healthcare practitioner monetizes health misinformation.¹²

Commercial speech can be restricted if it is false, misleading, or proposes an illegal transaction since consumers must be able to make informed decisions.¹² Unlike political speech, where it may be difficult to ascertain what is truthful, courts recognize that commercial advertising is more objective and more readily subject to determination of its truthfulness.¹⁶

Courts have also traditionally recognized a third form of speech, professional speech, which is “uttered in the course of professional practice” as distinct from “speech . . . uttered by a professional.”¹⁷ This form of speech could also be restricted. Some courts have ruled that healthcare practitioners are entitled to less stringent First Amendment protection when providing professional advice to individual patients than when speaking to a larger audience about public issues.¹³

However, a 2018 Supreme Court decision overturned the prior recognition of professional speech as a separate category that would receive lesser First Amendment protection.¹² The Court’s decision stated that “speech is not unprotected merely because it is uttered by 'professionals.’” Consequently, speech expressed by professionals receives complete protection unless it falls under the commercial exception.

There are also practical concerns that sanctioning health professionals for questioning accepted medical standards when they feel they are inaccurate or misguided may stifle advances in practice.¹³ This is especially troublesome during a public health crisis when guidance from public health officials evolves as circumstances and knowledge unfold. The many examples of shifting public health recommendations during the COVID pandemic underscore this concern.¹⁸ Generally, healthcare providers have greater latitude when speaking on medical matters to the general public, such as on social media, than they do when providing medical advice to a specific patient.¹⁹

While constitutional protection is available to healthcare providers when sharing their view on medical matters, other legal situations can impact speech.¹⁹ An employment contract can restrict how much leeway a healthcare provider has, and tort law (malpractice claims) may provide penalties for improper medical advice, especially in the context of informed consent.^15,19

DISCIPLINING HEALTHCARE PROVIDERS FOR MISINFORMATION

Professional licensing boards provide oversight to ensure that rules governing the profession are followed.¹³ The structure and authority of medical and pharmacy boards vary from state to state.¹³ Each state has Practice Acts that prohibit licensed healthcare practitioners from engaging in “unprofessional conduct,” although the definition of unprofessional conduct may vary from state to state. Unprofessional conduct is the most common reason for disciplinary action against healthcare personnel.¹³ States have applied standards of professional conduct when trying to sanction healthcare personnel for misinformation (see below).

It should be apparent that when attempting to sanction a healthcare provider for misinformation, state regulatory agencies must walk a fine line. During COVID, a number of healthcare organizations endorsed revocation of the licenses and certifications of physicians who disseminated harmful health misinformation such as rejection of widely accepted preventive measures and endorsement of unproven treatments. The organizations included the Federation of State Medical Boards (FSMB) and professional certification boards such as the American Boards of Family Medicine (ABFM), Internal Medicine (ABIM), and Pediatrics (ABP).¹³

The FSMB took note of the “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other healthcare professionals on social media platforms, online and in the media” and issued a warning to physicians that that they risk suspension or revocation of their medical licenses by state medical boards if they generate and spread COVID-19 vaccine misinformation or disinformation.²⁰

The FSMB commented, “Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded and consensus-driven for the betterment of public health.” Although the statement focused on vaccination, it could apply to all health information and spreading inaccurate information undermines that responsibility and “threatens to further erode public trust in the medical profession and puts all patients at risk.”²⁰ Of course, the same comments would apply to pharmacists and other health professionals.

State medical boards have traditionally brought disciplinary actions against physicians for making false or misleading statements in situations such as serving as an expert witness in malpractice cases.²¹ Some state laws explicitly authorize disciplinary action against physicians who make false, deceptive, or misleading statements to the public. In most cases, these statutes apply to statements made in connection with advertising, especially when solicitating patients. (See distinction between content-based and commercial speech above.) However, some are worded broadly enough to cover other forms of misrepresentation.^13,21For example, Minnesota authorizes disciplinary action against physicians who engage in “conduct likely to deceive or defraud the public.”²¹

It is not clear how often healthcare professionals are sanctioned for spreading misinformation, but it appears to be infrequent.²² The president of the FSMB has pointed out that medical license renewals are designed to be simple for applicants and it is usually an automatic procedural step. He added that medical boards do not have the capacity to review the large number of renewals that occur each year.²²

The license suspension process is long and slow with procedural barriers. Investigations will ordinarily begin only in response to a complaint, rather than being initiated by the board itself.²³ Licensing boards are primarily concerned with medical malpractice, patient abuse, and illegal activity, so misinformation takes a relatively low priority.²³ Moreover, both non-renewals and suspensions require due process.²² In addition, it can be difficult to evaluate whether a comment is outside the range of scientific and medical consensus and boards are reluctant to take action on a “fringe” opinion.²³ Investigations can take months or years to complete and many proceedings are conducted in private.²⁴ In many states the legal framework for discipline, which was developed in the 20^th century, may narrowly apply to actions or speech related directly to patients under the physician’s care and not to broader circumstances like social media.²⁵ Moreover, boards face daunting legal and policy obstacles if they try to take action (see below).^25,26 Political opposition from legislators in some states can also impede a board’s actions (see below).²⁵

The arguments for disciplinary proceedings by licensing boards usually emphasize the potential harm to public health.¹³ However, this may be insufficient to achieve constitutionality in most cases where it would be necessary to apply the “least restrictive means” test mentioned above.¹³A state can instead mitigate the harm by disseminating factually accurate messages, especially in instances where the commercial speech exception would not apply.¹³

PAUSE AND PONDER: Is a state licensing board the best party to try to dissuade healthcare practitioners from issuing information of questionable validity?

Professional credentialing boards (private organizations providing certification) can also take steps to minimize misinformation. For example, consider a pharmacist who works in a large health system and has a specialized position running a hypertension clinic; she has been credentialed to prescribe medication and adjust dosing. The terms of her credentialing may restrict the type and quality of the information she can provide to patients and the credentialing board can retract her credentials if she begins to tell patients that ACE inhibitors are terrible antihypertensives. A joint statement from the ABFM, ABIM, and ABP declared that providing misinformation about the COVID-19 vaccine contradicts physicians' ethical and professional responsibilities and warned physicians that such conduct may prompt a Board to take action that could put their certification at risk.²⁸ (Credentialing boards as non-state actors have more latitude to impose penalties.)

STATE ACTIONS AND PUSHBACK

Concerns over misinformation during the pandemic prompted various health related organizations to take steps. Boards in at least a dozen states have issued sanctions against physicians for spreading dubious information.²⁴

While private professional organizations can impose loss of credentialing, state licensing boards can levy more serious sanctions such as loss of licensure or fines. Recent Board actions have generated a number of legal skirmishes. In addition to state regulatory bodies like licensing boards, state legislatures have acted directly to address misinformation. Different states have taken different – even opposite – approaches to this issue.

California

In 2022, the California legislature passed a bill stating that “the dissemination of misinformation or disinformation related to COVID-19 by physicians and surgeons constitutes unprofessional conduct.”²⁸ The types of false or misleading information that could lead to disciplinary action include communication about the nature and risks of the COVID-19 virus; its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines. False statements regarding prevention and treatment “would presumably include the promotion of treatments and therapies that have no proven effectiveness against the virus.” The bill’s proponents expressed the view that “providing patients with accurate, science-based information on the pandemic and COVID-19 vaccinations is imperative to protecting public health.” They also said that the bill was necessary because “licensed physicians ... possess a high degree of public trust and therefore must be held accountable for the information they spread.”²⁸ By passing this legislation, the law continues, “California will show its unwavering support for a scientifically informed populous to protect ourselves from COVID-19.”²⁸

PAUSE AND PONDER: Should laws such as those discussed above include other healthcare professionals, such as pharmacists, instead of focusing only on physicians?

Under the statute, the misinformation or disinformation must be conveyed “[by] the licensee to a patient under the licensee's care in the form of treatment or advice.”²⁸ It excludes speech outside of a direct physician-relationship such as social media postings.²⁹ California Governor Newsom also indicated that he is “confident that discussing emerging ideas or treatments including the subsequent risks and benefits does not constitute misinformation or disinformation under this bill's criteria."²⁹

The bill’s original intent was an effort to grant California’s Medical Board the power to discipline providers who were found to have conveyed misinformation about COVID vaccines and treatments. The proposed bill included statements they might make on social media or in other public forums such as public protests. It was narrowed, however, to apply only to conversations between a provider and a patient in clinical settings when the practitioner made statements that were "contradicted by contemporary scientific consensus contrary to the standard of care."³⁰ Opponents said the statute was overly broad and that information considered scientific consensus about the rapidly-mutating virus could change daily.³⁰ They also argued that providers had the right to express their opinions in clinical settings.³⁰

Two different lawsuits were filed seeking an injunction against enforcing the law and the judges hearing the cases reached different conclusions.³¹ In one case, the judge declined to grant the injunction.³¹

In the other, filed in a different California judicial district, a group of physicians licensed in California were joined by organizations representing the interests of doctors and patients. They sued the State alleging that the above statute was in breach of their First and Fourteenth Amendments rights (i.e., free speech and equal protection rights).³² The physicians had provided advice and treatments contrary to public health recommendations (universal masking or vaccines) and intended to continue to do so, claiming it was consistent with the standard of care.^32,33 They also claimed that the law’s definition of misinformation as false information that is “contradicted by contemporary scientific consensus” would suppress the ability of physicians to advise patients about the pros and cons of alternative COVID-19 treatment and practices.^32,33

The court in this case granted a temporary injunction, ruling that the law’s definitions of misinformation and the uncertainty about its enforcement were “unconstitutionally vague”³² The Court noted that a phrase defining the unlawful conduct, as contradicting “contemporary scientific consensus,” lacked any established meaning within the medical community and was not clarified further in the statute.³² They went on to say that it “fails to provide sufficiently objective standards to focus the statute’s reach.” The judge found this particularly problematic in the context of the pandemic since scientific understanding of the virus had repeatedly changed, negating a true consensus.³²

He went on to say that the law leaves many questions unanswered, such as who determines whether a consensus exists? Moreover, the judge ruled that the term “scientific consensus” is so ill-defined that the physicians would be “unable to determine if their intended conduct contradicts the scientific consensus, and accordingly ‘what is prohibited by the law.’”

The conflicting decisions necessitated a resolution (since the law could not be simultaneously upheld and enjoined). The first case was appealed, but the state repealed the law before the court could rule.³⁴ Following the court’s decision granting the injunction, the state rescinded the law about a year after it was signed.^30,31

Missouri

Missouri also enacted statutes dealing with the dissemination of COVID-related health information, but their approach was quite different from California. A law passed in 2022 prohibits the state boards overseeing medicine and pharmacy from disciplining a registered practitioner for “lawfully” prescribing or dispensing ivermectin or hydroxychloroquine for human use.³⁵ In other words, the prescribing or promotion of these drugs could not be used as a basis for establishing unprofessional conduct and sanctioning a healthcare practitioner.

A second part of the law prohibits pharmacists from contacting the prescribing a physician or the patient to dispute the efficacy of ivermectin or hydroxychloroquine unless the physician or patient inquires of the pharmacist about the drug’s efficacy.³⁵ In other words, a pharmacist would be prohibited from expressing legitimate concern about questionable treatments.³⁶ (The Missouri Pharmacy Association issued a clarification that pharmacies are not required to dispense nor stock the drugs, nor does it prevent a pharmacist from counseling a patient who should not take these drugs due to certain health conditions or interactions.³⁶)

A sponsor of the bill indicated that these actions were necessary because “certain pharmacists wanted to begin acting like physicians and denying the filling of the prescriptions. This re-establishes the professional equilibrium between doctors and pharmacists.”³⁷ No doubt most pharmacists are grateful that the equilibrium has been reestablished.

A pharmacist also challenged this law on First Amendment grounds. The pharmacist’s suit alleged that “all pharmacists in Missouri, now face the impossible—and constitutionally impermissible—conundrum of deciding whether to endanger their livelihood when choosing whether to speak in a manner that is both vital to their professional duties to patients and protected by the First Amendment.”³⁸ The pharmacist believed that it is a matter of legitimate professional ethics to contact a patient or prescriber to dispute a medication’s efficacy.

The court granted an injunction against implementation of the new law stating that the relevant section quoted above “infringes the free speech rights of Plaintiff and other Missouri-licensed pharmacists by threatening to impose liability based on the viewpoint of their speech.”³⁸The court pointed out that the regulation “does not prohibit pharmacists from initiating contact to tout, endorse, or acclaim the drugs, thus it is taking sides in a politically charged debate about the drugs efficacy."³⁸ In other words, it was a content-based restriction of speech (see above) and therefore was an impermissible infringement of the First Amendment.

The Board replied that the statute was constitutional because it regulated conduct and not speech.³⁸ Unpersuaded by this argument, the court noted that the statute does not prohibit initiating contact with patients or prescribers which would be a permissible regulation of conduct. Instead, it prohibits contact only if the pharmacist wishes to "dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use.” The court also said that this interpretation is “consistent with the legislature's apparent purpose in enacting (the law): to insulate ivermectin or hydroxychloroquine from criticism.”³⁸

Elsewhere Around the U.S.

In other states, attempts by medical boards to restrict dissemination of health information that deviates from mainstream medicine have faced backlash from state legislatures. Dozens of state legislatures (e.g., North Dakota) have introduced or passed measures that would prevent a regulatory agency from punishing medical providers who promote COVID-19 misinformation or unproven treatments.^15,39

A particularly contentious dispute arose in Tennessee between the state licensing board and the state legislature. The Board of Medical Examiners unanimously declared that physicians spreading false information about COVID would put their license in jeopardy and the board posted the new policy on its website.⁴⁰ Soon afterwards, state legislators charged that the board had overstepped its authority and demanded that the statement be deleted from the state’s website. The state threatened to disband the board.^39,40

Many of the same Tennessee legislators had previously threatened to defund the Health Department when it promoted COVID vaccines to teens and introduced a bill that would have prevented the board from disciplining physicians for administering any treatment for COVID-19, even if it is not recommended by the Department of Health nor the FDA.³⁹ Another proposed bill would have prevented pharmacists from interfering with prescriptions to treat COVID.

Despite the threats, the Tennessee board voted to retain the misinformation policy with a tweaking of the definition of misinformation.⁴¹

A similar situation arose in Washington state. Four physicians threatened with disciplinary action by the state Medical Commission for misinformation challenged the commission's policy statement. They claimed that the commission did not follow their standard procedures in implementing the policy and that the position statement infringed their constitutional right to free speech.⁴² The physicians faced charges over their alleged care for COVID patients with unproven treatments and "false and misleading" statements regarding the pandemic and vaccination. The physicians maintained that the distinction between them and “other medical professional[s] who were not investigated and charged under the Statement is that plaintiffs dissented politically, scientifically and medically from health officials on various matters related to COVID.”⁴³ The physicians were charged with negligent care; one physician allegedly “failed to discuss alternative treatments” (monoclonal antibodies) with an elderly, unvaccinated patient with a COVID-19 infection who later died.⁴³

FDA Lawsuit

On a broader scale, the controversy over misinformation has even touched the FDA. In 2024, a lawsuit was brought against the FDA’s messaging with potentially very significant consequences. Three physicians in Texas who prescribed ivermectin to thousands of their patients for COVID initiated the suit.⁴⁴ They objected to the FDA’s public advisory and social media posts (“You are not a horse,” a post that is no longer available) warning patients not to use the drug. (See image here: https://www.pharmamanufacturing.com/compliance/regulatory-guidance/news/11291402/you-are-not-a-cow-fda-warns-public).⁴⁵ The physicians claimed that the messages exceeded the FDA’s authority and encroached on the practice of medicine.⁴⁴ The physicians alleged that the posts interfered with their “ability to exercise professional medical judgment in practicing medicine” and harmed their reputations.

The FDA claimed sovereign immunity (a legal doctrine that the government cannot be sued without its consent) in its defense.⁴⁶

The District Court (first level) judge hearing the case dismissed it, ruling that sovereign immunity protects the FDA.⁴⁶ The court also noted that Congress charged the FDA “with protecting public health and ensuring that regulated medical products are safe and effective” and that “FDA has the authority, generally, to make public statements in-line with these purposes.”⁴⁶

The physicians appealed, and the appellate judge reversed the decision, finding, often in very colorful language, that the FDA did exceed its legal authority.⁴⁶ The judge stated that no legal basis allows the FDA to issue recommendations or give medical advice. He wrote that the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”⁴⁶

The FDA argued that it has the authority to communicate information to the public and that the posts are purely informational and not imperative. The court, however, disagreed, finding that the posts contained syntax that directed patients to take action such as “Stop it with the #ivermectin.”⁴⁶The court also chided the FDA for failing to mention that there is also a human version of ivermectin which was being used off-label to treat the coronavirus.⁴⁶

The FDA responded to the decision by agreeing to retire the consumer update entitled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19" and to delete various related social media posts.⁴⁷ The FDA issued a statement stating that "the agency has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old" and that it “stands by its authority to communicate with the public regarding the products it regulates."⁴⁷ Furthermore, the agency indicated that it “has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19” and reiterated that it “has not authorized or approved ivermectin for use in preventing or treating COVID-19."⁴⁷

While this might appear to be a minor dispute involving the agency and aggrieved prescribers, there are fears that it could have far-reaching implications. There is a concern that the FDA, and possibly other consumer-related regulatory agencies, may need to reevaluate all their communications to the public to ensure that they comply with the decision.⁴⁸ This would obviously limit the agency’s role as a public health educator. It could also disrupt the FDA’s ability to limit a manufacturer’s promotion of off label drug use.⁴⁸ In addition, the physicians’ claim that they suffered harm as a result of the FDA’s actions could lead to more claims against regulatory agencies for damages.⁴⁸ On the other hand, there is a consideration that the ruling could be challenged since it may be at odds with the constitutional principle of government speech in which the government can itself be a speaker and is not required to be neutral when expressing an opinion.⁴⁸

PAUSE AND PONDER: What should the FDA’s role be in discouraging misinformation?

SUMMARY AND FINAL COMMENTS

Misinformation about health matters became more troublesome during the COVID pandemic, raising concerns that this has had negative consequences for society and public health. Many professional and governmental organizations have expressed apprehension about the influence of health misinformation and have sought to limit its spread by sanctioning healthcare professionals. This has been met with legal challenges by the affected healthcare providers centering around First Amendment protection of speech. At the same time, legislators in many states have tried to suppress these efforts and limit the ability of licensing boards to discipline healthcare providers for their promotion of remedies outside of mainstream medicine. Some legislative efforts have also tried to restrict the ability of healthcare providers, including pharmacists, to express concerns about unproven treatments. Recently, messaging by the FDA has also been challenged with potentially far-reaching consequences. It is important for pharmacists to be aware of the positions taken by governmental agencies and legislators in their state and to respond accordingly.

“An Apple A Day Keeps COVID Away”: Legal Issues in Suppressing Health Misinformation
Post-Test
Learning Objectives
After completing this activity, participants should be better able to

o DISCUSS the characteristics of health misinformation and its effect on public health
o CHARACTERIZE the role of the states in disciplinary actions for misinformation
o DESCRIBE the legal issues that emerge when state authorities try to control the flow of information.
o CONTRAST different approaches taken by states in addressing the dissemination of healthcare information

1. What did the U.S. Surgeon General’s statement about misinformation issued during the COVID pandemic say?
A. Health misinformation has been deadly in the U.S.
B. Government guidelines are a “best guess” only
C. All physicians must follow prevailing standards of care.

2. What is the position of the Federation of State Medical Boards (FSMB) on health information?
A. Physicians need to be able to use unauthorized treatments in a pandemic without fear of reprisal.
B. It is not the role of state medical boards to monitor health care workers for providing information.
C. Physicians risk suspension or revocation of their medical licenses if they disseminate misinformation.

3. Which of the following situations would be least likely to receive First Amendment protection?
A. A pharmacist touts the benefits of an unproven treatment for COVID during a counseling session.
B. A pharmacist promotes the sale of an unproven treatment though advertising in the pharmacy.
C. A pharmacist endorses the use of an unproven remedy on their social media page.

4. A law was passed in California which would sanction physicians for the dissemination of misinformation or disinformation. Which of the following is a component of the law?
A. The law would apply strictly to information posted on social media platforms.
B. Misinformation in the law is considered to be a form of unprofessional conduct.
C. The law provided extensive guidance on types of statements that would be included in the definition.

5. Missouri passed a bill dealing with information on ivermectin. What did the bill entail?
A. Prescribers could be sanctioned for prescribing ivermectin or recommending use of veterinary formulations.
B. Pharmacists were prohibited from questioning the use of ivermectin for COVID in discussions with prescribers or patients.
C. Prescriptions for ivermectin required a diagnostic code that pharmacists were expected to acknowledge before dispensing.

6. Both the California and Missouri laws were challenged in court and overturned. What was the basis for the decision in both cases?
A. They violated the First Amendment.
B. They violated health care practitioners’ due process rights.
C. They violated the State medical/pharmacy practice act.

7. A pharmacist is called into his employer’s HQ where he is asked to take down his social media post where he espouses support for a dubious treatment while dressed in his pharmacy jacket with the company’s logo. He refuses, stating it violates his First Amendment rights. What is the most likely resolution?
A. The pharmacist will prevail because there is no commercial transaction involved.
B. The company will prevail because private employers face fewer restrictions than government actors.
C. The pharmacist will prevail because the employer cannot tell him what he can do during his personal time.

8. The Tennessee state Board of Medical examiners issued a statement that physicians spreading false information about COVID would put their license in jeopardy. What did the state’s legislature do in response?
A. They overwhelmingly endorsed this position.
B. They enacted a law to include other areas beyond COVID.
C. They threatened to disband the board.

9. Physicians sued the FDA for its messaging about ivermectin during the COVID pandemic. What was the basis of the lawsuit?
A. The FDA was interfering with the physician-patient relationship.
B. The FDA has no authority to warn prescribers not to prescribe ivermectin for COVID.
C. The FDA was trying to prohibit off-label prescribing of ivermectin.

10. What did the FDA do in response to the lawsuit?
A. They posted a rebuttal from the physicians involved in the lawsuit.
B. They published an altered version notifying patients that ivermectin is approved for
use in humans.
C. They took down the public service message.

References

REFERENCES

Ollstein AM. FDA Commissioner Califf Sounds the Alarm on Health Misinformation. Association of Health Care Journalists. April 30, 2022. Accessed August 23, 2024.

https://healthjournalism.org/blog/2022/04/fda-commissioner-califf-sounds-the-alarm-on-health-misinformation-at-ahcj/

Jin SL, Kolis J, Parker J, et al. Social histories of public health misinformation and infodemics: case studies of four pandemics. Lancet Infect Dis. 2024:S1473-3099(24)00105-1. doi: 10.1016/S1473-3099(24)00105-1. 3. Ashby J. The Effects of Medical Misinformation on the American Public. Ballard Brief. Winter 2024. Accessed August 23, 2024.

https://scholarsarchive.byu.edu/cgi/viewcontent.cgi?article=1123&context=ballardbrief

Krishnatray P, Bisht SS. Misinformation, the Pandemic, and Mass Media: The India Story. In: Global Journalism in Comparative Perspective: Case Studies. edited by Dhiman Chattopadhyay. Taylor & Francis 2024. ISBN 1003848079 97810003848073

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Murthy V. Confronting Health Misinformation: The U.S. Surgeon General’s Advisory on Building a Healthy Information Environment. U.S. Department of Health & Human Services. March 7, 2022. Accessed August 23, 2024.

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Caulfield T. Misinformation, Alternative Medicine and the Coronavirus. Policy Options. March 12, 2020. Accessed August 23, 2024.

https://policyoptions.irpp.org/magazines/march-2020/misinformation-alternative-medicine-and-the-coronavirus/

Cacciatore MA. Misinformation and Public Opinion of Science and Health: Approaches, Findings, and Future Directions. Proc Natl Acad Sci U S A. 2021;118(15):e1912437117. doi: 10.1073/pnas.1912437117.
Markel H. How Galileo’s Groundbreaking Works Got Banned. PBS News. February 15, 2022. Accessed August 23, 2024.

https://www.pbs.org/newshour/science/how-galileos-groundbreaking-works-got-banned

Tyson A, Funk C. Increasing Public Criticism, Confusion Over COVID-19 Response in U.S. Pew Research Center. February 9, 2022. Accessed August 23, 2024.

https://www.pewresearch.org/science/2022/02/09/increasing-public-criticism-confusion-over-covid-19-response-in-u-s/

Keslar L. The Rise of Fake medical News. Proto. Mass General Hospital. June 18, 2018. Accessed August 23, 2024. https://protomag.com/policy/rise-fake-medical-news/
Borges do Nascimento IJ, Pizarro AB, Almeida JM, et al. Infodemics and Health Misinformation: A Systematic Review of Reviews. Bull World Health Organ. 2022;100(9):544-561. doi: 10.2471/BLT.21.287654.
Cullen E. An Apple a Day Keeps the Doctor Away: COVID-19 Misinformation by Medical Professionals May Be Protected by the First Amendment. Syracuse L. Rev. 2023;73:241-272.
Yang YT, Schaffer DeRoo S. Disciplining Physicians Who Spread Medical Misinformation. J Public Hlth Management Pract. 28(6):p 595-598, November/December 2022. Accessed August 23, 2024. DOI: 10.1097/PHH.0000000000001616
Police Department of Chicago v Mosley. 408 U.S. 92 (1972).
Sage WM, Yang YT. Reducing “COVID-19 Misinformation” While Preserving Free Speech. JAMA. 2022;327(15):1443–1444. doi:10.1001/jama.2022.4231
Hudson DL, Jr. Content Based. Middle Tennessee State University Free Speech Center. Updated July 2, 2024. Accessed August 23, 2024.

https://firstamendment.mtsu.edu/article/content-based/

Halberstam D. Commercial Speech, Professional Speech, and the Constitutional Status of Social Institutions. U Pa L Rev. 1999;147:771-843.
Cummins R. Think the Rules on COVID-19 Keep Changing? Here's Why. Consult. December 7, 2020. Accessed August 23, 2024.

https://www.umc.edu/news/News_Articles/2020/12/COVID-19-Evolving-Information.html

Weiner S. Is Spreading Medical Misinformation A Physician’s Free Speech Right? It’s Complicated. AAMC News. December 26, 2023. Accessed August 23, 2024.

https://www.aamc.org/news/spreading-medical-misinformation-physician-s-free-speech-right-it-s-complicated

Federation of State Medical Boards. FSMB: Spreading Covid-19 Vaccine Misinformation May Put Medical License at Risk. Federation of State Medical Boards. July 29, 2021. Accessed August 23, 2024. https://www.fsmb.org/advocacy/news-releases/fsmb-spreading-covid-19-vaccine-misinformation-may-put-medical-license-at-risk/.
Coleman CH. Physicians Who Disseminate Medical Misinformation: Testing the Constitutional Limits of Professional Disciplinary Action. First Amend. L. Rev. 2022;20:113-146.
Brumfiel G. This Doctor Spread False Information About COVID. She Still Kept Her Medical License. NPR. September 14, 2021. ccessed August 23, 2024.

https://www.npr.org/sections/health-shots/2021/09/14/1035915598/doctors-covid-misinformation-medical-license

Knight V. Will Doctors Who Are Spreading COVID-19 Misinformation Ever Face Penalty? Time. September 20, 2021. Accessed August 23, 2024.

https://time.com/6099700/covid-doctors-misinformation/

Hollingsworth H. Pressure Builds for Medical Boards to Punish Doctors Peddling False COVID-19 Claims. Mercury News. December 16, 2021. Accessed August 23, 2024.

https://www.mercurynews.com/2021/12/16/pressure-builds-against-doctors-peddling-false-virus-claim

Tahir D. Medical Boards Get Pushback as They Try To Punish Doctors For Covid Misinformation. Politico. February 1, 2022. Accessed August 23, 2024.

https://www.politico.com/news/2022/02/01/covid-misinfo-docs-vaccines-00003383

Kim OJ. Limitations of Medical Licensing: The Role of State Boards of Medicine in Regulating Medical Misinformation. Northeastern U. L. Rev. 2024;16:227-262.
American Board of Internal Medicine. Standing Up for the Profession, Protecting the Public: Why ABIM Is Combatting Medical Misinformation. May 18, 2022. Accessed August 23, 2024.

https://blog.abim.org/standing-up-for-the-profession-and-public-why-abim-is-combatting-medical-misinformation/.

California AB-2098. Physicians and Surgeons: Unprofessional Conduct. September 30, 2022. Accessed August 23, 2024.

https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220AB2098

Clark C. California Bill Barring Docs from Telling COVID Lies Signed into Law. MedPage Today. October 1, 2022. Accessed August 23, 2024.

https://www.medpagetoday.com/special-reports/exclusives/101008?xid=nl_medpageexclusive_2022-10-03&eun=g1359385d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MPTExclusives_100322&utm_term=NL_Gen_Int_Medpage_Exclusives_Active

Clark C. California Misinfo Law is Dead. MedPage Today. October 3, 2023. Accessed August 23, 2024.

https://www.medpagetoday.com/special-reports/features/106603

Sullum J. California Quietly Repeals Restrictions on Doctors' COVID-19 Advice. Reason. October 11, 2023. Accessed August 23, 2024.

https://reason.com/2023/10/11/california-quietly-repeals-restrictions-on-doctors-covid-19-advice/

Hoeg v. Newsom, 2:22-cv-01980 WBS AC (E.D. Cal. 2023). Accessed August 23, 2024.

https://caselaw.findlaw.com/court/us-dis-crt-e-d-cal/2185986.html

Myers SL. A Federal Court Blocks California’s New Medical Misinformation Law. NY Times. January 26, 2023. Accessed August 23, 2024.

https://www.nytimes.com/2023/01/26/technology/federal-court-blocks-california-medical-misinformation-law.html

McDonald v Lawson. US Court of Appeals, Ninth Circuit. Docket No: No. 22-56220, No. 23-55069. Decided: February 29, 2024. Accessed August 23, 2024.

https://caselaw.findlaw.com/court/us-9th-circuit/115884306.html

General Assembly of the state of Missouri. House Bill 2149. 101^st General Assembly. 2022. Accessed August 23, 2024.

https://documents.house.mo.gov/billtracking/bills221/hlrbillspdf/4028H.06T.pdf

Latner AW. Missouri Law Prevents Pharmacists from Disputing Ivermectin Efficacy with Physicians. Pharmacy Learning Network. July 5, 2022. Accessed August 23, 2024.

https://www.hmpgloballearningnetwork.com/site/pln/commentary/missouri-law-prevents-pharmacists-disputing-ivermectin-efficacy-physicians

Weinberg T. Missouri Governor Signs Law Shielding Doctors Prescribing Ivermectin, Hydroxychloroquine. Missouri Independent. June 7, 2022. Accessed August 23, 2024.

https://missouriindependent.com/briefs/missouri-governor-signs-law-shielding-doctors-prescribing-ivermectin-hydroxychloroquine/

Stock v. Gray, 2:22-CV-04104-DGK (W.D. Mo. Mar. 22, 2023). Accessed August 23, 2024. https://hlli.org/mo-board-of-pharmacy/
Ollove M. States Weigh Shielding Doctors’ COVID Misinformation, Unproven Remedies. Stateline. April 6, 2022. Accessed August 23, 2024. https://stateline.org/2022/04/06/states-weigh-shielding-doctors-covid-misinformation-unproven-remedies/
Farmer B. Medical Boards Pressured to Let It Slide When Doctors Spread Covid Misinformation. KFF Health News. February 15, 2022. Accessed August 23, 2024.

https://kffhealthnews.org/news/article/medical-boards-pressured-to-let-it-slide-when-doctors-spread-covid-misinformation/

Farmer, B. Tennessee’s Medical Board Sticks with COVID Misinformation Policy Over Objection of GOP Leaders. WPLN News. January 26, 2022. Accessed August 23, 2024.

https://wpln.org/post/tennessees-medical-board-sticks-with-covid-misinformation-policy-over-objection-of-gop-leaders/

42. Dyer O. Covid-19: US doctors sue regulator for charging them with spreading misinformation in pandemic. BMJ. 2023;382:1991.

Henderson J. Doctors Facing Discipline for COVID Misinfo Sue State Medical Board. MedPage Today. August 9, 2023. Accessed August 23, 2024.

https://www.medpagetoday.com/special-reports/features/105819

Langford C. Fifth Circuit Sides with Ivermectin-Prescribing Doctors in their Quarrel with the FDA. Courthouse News. September 1, 2023. Accessed August 23, 2024.

https://www.courthousenews.com/fifth-circuit-sides-with-ivermectin-prescribing-doctors-in-their-quarrel-with-the-fda/

Rutherford F, The FDA Deleted Its Viral Ivermectin Tweets. Now There’s Even More Misinformation. Bloomberg News. April 16, 2024. Accessed August 23, 2024.

https://www.bloomberg.com/news/newsletters/2024-04-16/fda-deletes-viral-ivermectin-not-a-horse-tweet-opens-door-for-misinformation

Apter v. U.S. Dep't of Health & Human Servs., 644 F. Supp. 3d 361 (S.D. Tex. 2022). Accessed August 23, 2024.

https://law.justia.com/cases/federal/appellate-courts/ca5/22-40802/22-40802-2023-09-01.html

Bond P. FDA Settles Lawsuit over Ivermectin Social Media Posts. Newsweek. March 22, 2024. Accessed August 23, 2024.

https://www.newsweek.com/fda-settles-lawsuit-over-ivermectin-social-media-posts-1882562

Watson T, Robertson C. Silencing the FDA’s Voice – Drug Information on Trial. NEJM. 2023;389:2312-2314.

State of Connecticut Naloxone Training Program-RECORDED WEBINAR

****IMPORTANT UPDATE****

Update August 2024: Naloxone Availability

Note that, despite their mention in this activity, intramuscular (IM) naloxone autoinjectors are no longer commercially available in the United States (U.S.). Prefilled syringes, however, remain available for IM administration of naloxone.

Additionally, since the original release of this continuing education activity, the U.S. Food and Drug Administration (FDA) approved naloxone for nonprescription marketing. It’s important to know that the prescription to over the counter (OTC) switch does not automatically apply to all forms of naloxone. Each manufacturer of existing naloxone products must individually apply for redesignation to OTC status. Visit Drugs@FDA: FDA-Approved Drugs to check the up-to-date status of any naloxone product before dispensing.

The FDA deemed naloxone nasal spray safe enough for OTC use, but that doesn’t preclude the need to counsel individuals on its safe and appropriate use. Pharmacists should counsel all patients buying OTC naloxone nasal spray about signs of an opioid overdose, how to administer naloxone, and other important clinical pearls.

We encourage all individuals completing this certificate to review our activity An Over-The-Counter Lifesaver: Increased Intranasal Naloxone Accessibility for more information on this topic.

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

• Identify the risk factors for and clinical presentation of a person with an opioid overdose

• Discuss naloxone use as an opioid antagonist

• Describe naloxone prescribing and dispensing instructions for intranasal and intramuscular dosage forms

• Discuss how to administer intranasal and intramuscular naloxone

• Review current CT state laws regarding naloxone access

• Discuss proper counseling points and technique

• Discuss the referral of patients and caregivers to support programs, 211, and physicians specializing in addiction services

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 2.0 CE Hours (or 0.2 CEUs) for completing the activity ACPE UAN 0009-9999-24-040-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.

Pharmacist Post-test

1) Opioid overdose only occurs in low socio-economic groups? T/F

2) Which of the following is not a risk factor for Opioid Overdose?
a. History of opioid addiction (especially after abstinence)
b. Daily opioid doses less than 100mg of morphine equivalents
c. Comorbid mental illness
d. Concurrent use of benzodiazepines or alcohol

3) Which of the following is not a clinical presentation with an opioid overdose?
a. Slow breathing or respiratory arrest
b. Blue fingernails and lips
c. Dilated pupils
d. Vomiting or making gurgling noises

4) Naloxone is expensive and hard to administer? T/F

5) Naloxone should be used when
a. Breathing status is normal or fast
b. Breathing status is slow
c. Not breathing or gasping
d. B and C

6) Naloxone is an opioid receptor antagonist at the mu, kappa and sigma receptors? T/F

7) Which of the following is TRUE when using intranasal naloxone?
a. Person needs to be breathing to use
b. Does not need to be assembled
c. Need to tilt person’s head backwards to prevent the medication from running out of the nose
d. The recipient will experience pain when it is given

8) Which of the following is FALSE when using intramuscular naloxone?
a. Can be administered into thigh or another large muscle
b. Can administer a second dose after 2-5 minutes
c. Wait 2 to 5 minutes before administering a second dose
d. Inject half the contents of the syringe, then wait 2 minutes and repeat

9) After receiving Naloxone, the patient never requires medical attention? T/F

10) Naloxone has duration of action of 20-90 minutes; therefore, the person can go back into overdose if long acting opioids were ingested? T/F

11) A pharmacist who is licensed and registered in the State of Connecticut, and who has been trained and certified regarding the proper prescribing of naloxone, may prescribe an opioid antagonist to which of the following people:
a. The drug addicted patient.
b. The drug addict’s mother or father.
c. A friend of the drug addicted person.
d. Any person who is concerned about the drug addicted person.
e. All of the above answers are correct.

12) When prescribing an opioid antagonist, the pharmacist:
a. May delegate a pharmacy technician to provide training regarding the administration of the opioid antagonist to the person to whom the opioid antagonist is dispensed as long as the pharmacy technician is under the direct supervision of the pharmacist and has been properly trained by the pharmacist.
b. Must show a video depicting the proper administration of the medication to the person to whom the opioid antagonist is dispensed and obtain a signature of the person to whom the opioid antagonist is dispensed to.
c. Must personally provide appropriate training regarding the administration of the opioid antagonist to the person to whom the medication is dispensed and maintain a record of such dispensing.
d. Is under no obligation to provide training regarding the administration of an opioid antagonist to the person to whom it is being dispensed although it is recommended that the pharmacist provide such training to avoid potential law suits.
e. Must first obtain permission from the patient’s doctor or practitioner prior to prescribing an opioid antagonist.

13) A pharmacist may only prescribe an opioid antagonist if the pharmacist has been trained and certified by a program approved by the Connecticut Medical Society and Department of Public Health.

True False

HIV, Baby, and Me: Preventing Perinatal Transmission of HIV-RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-9999-24-024-H02-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.

1. A 24-year-old female living with HIV is interested in having children and is concerned about perinatal transmission. Her HIV viral load is currently undetectable by adherence to antiretroviral therapy (ART). Is it possible for HIV mothers to breastfeed their babies, assuming the babies do not contract HIV during childbirth?

A. Yes, as long as the mother’s viral load is undetectable at <50 copies/mL
B. Yes, as long as the mother’s viral load is undetectable at <200 copies/mL
C. No, the baby can still contract HIV even if the mother’s viral load is undetectable at <200 copies/mL

2. Maria, a 29-year-old woman living with HIV has been on a stable ART regimen for the past two years. During her recent check-up, she reported experiencing significant nausea and fatigue from her medication. She is currently in her first trimester of pregnancy and is considering stopping her ART due to these side effects. What should be the primary course of action for Maria's healthcare provider to ensure both her health and the health of her unborn child?

A. Encourage Maria to discontinue her ART temporarily while she consults with a nutritionist to address her side effects, assuming that her HIV will remain under control during this period.
B. Assess and manage Maria's current side effects and explore alternative ART options or supportive treatments that can alleviate her symptoms, ensure continued viral suppression, and minimize risks to her pregnancy.
C. Reassure Maria that side effects are temporary and advise her to continue with the current ART regimen without making any changes, regardless of her concerns or symptoms.

3. Samantha, a 30-year-old woman, is newly diagnosed with HIV and is currently in her first trimester of pregnancy. She has not started any ART and refused to take any medication. A couple of weeks later, after listening to the pharmacist's consultation, Samantha is now concerned about choosing a regimen that will be both effective and safe for her and her unborn child. Which of the following ART regimens would be the most appropriate initial choice for Samantha based on current guidelines and safety considerations?

A. Tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) + abacarvir
B. Abacavir + lamivudine
C. Tenofovir disoproxil fumarate (TDF) + lamivudine + dolutegravir

4. Emily, a 34-year-old woman living with HIV, is pregnant and is currently adherent to ART. During her recent check-up, her healthcare provider confirmed that her HIV viral load is undetectable. However, she is still worried about the possibility of HIV transmission to her baby during pregnancy phases and wants to understand the implications of her undetectable viral load for her baby’s health. Which of the following statements accurately reflects the risk of HIV transmission to her baby during pregnancy, childbirth, and breastfeeding?

A. With an undetectable viral load, Emily is at a high risk of transmitting HIV to the baby during her pregnancy phases because it’s hard to know if her condition is under control.
B. There is no risk of HIV transmission to the baby during pregnancy, childbirth, or breastfeeding, provided that ART is consistently taken and the viral load remains undetectable.
C. Emily can transmit HIV to her baby during pregnancy, but the risk is low if her viral load remains undetectable throughout her pregnancy.

5. A 23-month-old boy living with HIV is starting a new regimen next month. The new regimen is an INSTI-based regimen with the anchor drug being dolutegravir plus FTC/TAF in FDC (Descovy). What verification(s) is/are required before filling this order?

A. Mother’s viral load is <50 copies/mL
B. Patient’s viral load is between 50 to 200 copies/mL
C. Weight + Route of administration

6. What is the key difference between opt-in and opt-out HIV screening?

A. Specificity
B. Stages of infection
C. The assumption of Consent-longest…can we just say “consent”?

7. A postpartum patient with HIV is in her 6-week follow-up visit. She is adhering well to her ART but expresses concern about her contraceptive options and the feeding of her newborn. Which of the following recommendations is the best course of action for her situation?

A. Recommend that she exclusively uses barrier methods for contraception to avoid any potential interaction with her ART.
B. Inform her that donor human milk is a safe option for her baby, provided it is obtained from a reputable milk bank and properly pasteurized.
C. Suggest that she avoid all forms of hormonal contraception due to potential drug interactions with her ART regimen.

Understanding Treatment Approaches for Autism Spectrum Disorder

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

DESCRIBE autism spectrum disorder (ASD) and its manifestations

LIST medications used to manage symptoms of ASD

APPLY techniques to improve care in the pharmacy for patients with ASD and their caretakers

After completing this application-based continuing education activity, pharmacy technicians will be able to

DESCRIBE autism spectrum disorder (ASD) and its manifestations

LIST medications used to manage symptoms of ASD

RECOGNIZE situations in which they can help patients with ASD and their caretakers appropriately

Our understanding of "autism" has evolved from the early 1900s when it was originally described as childhood schizophrenia. Although classified as an independent condition in the DSM-III in 1980, the DSM-V consolidated autistic disorder, Asperger syndrome, pervasive developmental disorder—not otherwise specified, and childhood disintegrative disorder into the term known as autism spectrum disorder (ASD). This has left many healthcare providers confused about the diagnosis and its treatment. Pharmacists and pharmacy technicians need tools so that they will be able to communicate with and help people who have ASD. In addition, they need to have science- based information about the treatments used in ASD, and the indications for which they are employed. It also introduces and expands upon the terms neurotypical and neurodiverse.

INTRODUCTION

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent challenges in social interaction and communication, and restricted, repetitive patterns of behavior, interests, or activities. “Autism” has evolved from the early 1900s, when it was originally described as childhood schizophrenia in the first and second editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM).¹Autism was classified as an independent condition in the DSM-III in 1980. The DSM-IV in 1994 was the first to recognize autism as a spectrum with various distinct diagnoses. In 2013, the DSM-V consolidated autistic disorder, Asperger syndrome, pervasive developmental disorder-not otherwise specified, and childhood disintegrative disorder into the term known as autism spectrum disorder.²

The change in terminology has left many healthcare providers unsure about how to talk with and about people who have ASD. Researchers from the United Kingdom surveyed 654 English-speaking adults with ASD around the world to determine their preferences.³ Regardless of country, participants tended to favor the terms autism, autistic person, is autistic, neurological/brain difference, differences, challenges, difficulties, neurotypical people, and neurotypicals. Thus, the researchers were unable to find a universally accepted vernacular to talk about autism.³ Perhaps the best way to determine how to describe a patient with ASD is to ask how they themselves prefer to discuss their condition.

The term neurotypical is closely related to the term neurodiverse, and the SIDEBAR describes this relatively new term.

SIDEBAR: Neurodiversity^4-7

Medical insight and social changes in the perception of developmental disorders and neurodevelopmental trajectories, including the autism spectrum, have led to a changing vocabulary and a deeper appreciation of what is “normal.” Increasingly, we understand that human development is neurodiverse, meaning all individuals develop and behave differently. The concept of neurodiversity promotes the idea that people who have neurological limitations also have strengths, and that accommodating their differences as early in life as possible can be beneficial to the individual and to society at large. This is an empathetic, humanistic, tolerant approach.

It's now clear that people with ASD are often skilled in working with systems and finding patterns in complex data or material. This makes them good candidates to work in technology and manufacturing if an employer can accommodate an individual’s needs (e.g., quiet or dimly lit spaces, private or uncrowded work areas). People with dyslexia are often better than others at identifying peripheral or diffuse visual information or processing blurry visual scenes, making them excellent candidates for jobs that engage three-dimensional thinking (e.g., computer graphics, engineering, genetics, or molecular biology). Similarly, people with Williams syndrome (a rare genetic condition that affects physical features, development, and cardiovascular health), Down syndrome, and Prader-Willi syndrome (a rare genetic disorder causing weak muscles, poor feeding, and slow development in infants followed by constant hunger in childhood), tend to be more musical, more friendly, and more nurturing than others, respectively. Researchers have also connected specific strengths to other neurologic and intellectual disability diagnoses.

The origin of these strengths and limitations is probably linked to evolutionary adaptation. Being able to focus on patterns and systems, as seen in ASD, likely helped early humans in hunting and gathering societies. They were able to respond quickly to environmental stimuli and move in an appropriate direction when they identified potential prey. A famous quote comes from the autism activist Temple Grandin, who has autism. She has said, “Some guy with high functioning Asperger's developed the first stone spear; it wasn't developed by the social ones yakking around the campfire.”

The bottom line is that appreciating and respecting neurodiversity is kind and reasonable. Another quote from Temple Grandin explains it well: “Nature is cruel, but we don't have to be.”

Prevalence rates of ASD are reported to be approximately 1% worldwide (i.e., affecting 1 in 100 people), with comparable figures observed in samples of children and adults.⁸ Prevalence estimates have increased over time and vary greatly within and across socioeconomic and demographic groups. ASD is diagnosed four times more often in males than females.²

PAUSE AND PONDER: How many symptoms of autism spectrum disorder can you list before you continue reading?

Diagnosing ASD

According to the DSM-V, diagnosis of ASD requires persistent deficits in all three areas of social communication and interaction, in addition to at least two of four types of restricted, repetitive behaviors. Table 1 lists ASD’s core characteristics and symptoms.

Table 1. Symptoms of ASD²

Social Communication Deficits

Restricted/Repetitive Behaviors

1) Deficits in social-emotional reciprocity

· Reduced sharing of interests

· Struggles with emotional recognition

2) Deficits in non-verbal communication

· Aversion to eye contact

· Abnormal body language/facial expressions

3) Deficits in developing, maintaining, and understanding relationships

· Scripted speech/taking language literally

· Difficulty in sharing imaginative play

· Difficulty making friends

· Absence of interest in peers

1) Stereotyped or repetitive motor movements, use of objects, or speech

· Arranging objects meticulously

· Echolalia (meaningless word repetition)

· Stereotypical movements like hand-flapping

2) Hypo- or hyper-reactivity to sensory input or unusual interest in sensory input

· Apparent indifference to pain/temperature

· Adverse response to sounds or textures

· Excessive smelling/touching of objects

· Visual fascination with lights or movement

3) Highly restricted, fixated interests that are abnormal in intensity or focus

· Expecting others to share their interests

· Strong attachment to unusual objects

4) Insistence on sameness, inflexibility in routines, or ritualized patterns of behavior

· Discomfort with change

Symptoms must be present in early development, cause clinically significant impairment in functioning, and cannot be attributable to intellectual disability or developmental delay. Since ASD is a spectrum, symptoms, severity, and treatment response vary widely among children and adults. Severity is categorized into three levels, described in Table 2.²

Table 2. Level of Severity of ASD²

Severity	Social Communication	Restricted/Repetitive Behaviors
Level 1 Requiring support	Noticeable impairments in social communication without support, difficulty initiating social interactions and exhibiting atypical or unsuccessful responses to social cues, possible decreased interest in social interactions Example: Able to speak full sentences, engages in communications, but social conversation attempts are odd/unsuccessful	Rigid behavior significantly disrupts functioning in various contexts, challenges transitioning between activities, difficulty with organization and planning
Level 2 Requiring substantial support	Marked deficits in verbal/nonverbal social communication skills, social impairments apparent even with support, limited initiation of social interactions, reduced/abnormal responses to social approaches from others Example: Speaks simple sentences, interaction limited to narrow special interests, odd nonverbal communication	Difficulty coping with change and showing obvious restricted/repetitive behaviors that interfere with functioning in multiple contexts, distress/difficulty switching focus
Level 3 Requiring very substantial support	Severe deficits in verbal/nonverbal social communication skills, severe impairments in functioning, very limited initiation of social interactions, minimal response to social cues from others Example: Few words of intelligible speech, rarely initiates interaction, makes unusual approaches to meet needs only and responds to only very direct social approaches	Inflexibility of behavior, extreme difficulty coping with change, restricted/repetitive behaviors significantly interfere with functioning in all contexts, great distress/difficulty changing focus or action

Prognosis

One concern for many people with ASD and their caregivers is long-term prognosis. A recent systematic review looked at data from 16 small studies (two randomized, 14 non-randomized).⁹ Only three of the included studies enrolled more than 100 participants, limiting the ability to draw conclusions, but researchers found that early intervention improved children’s prognosis considerably.

Children who received intervention before 2 years of age were more likely to improve their cognition, social skills, and stereotyped behaviors than others. They needed less monitoring at school and were better able to function and integrate socially. These researchers noted that healthcare providers often fail to offer early intervention for four reasons⁹:

Many healthcare providers are unfamiliar with the necessary screening, diagnosis, and intervention tools for ASD
Early intervention involves many different strategies and is costly
Involving parents in early intervention programs is difficult
It’s difficult to recognize ASD’s signs in toddlers younger than 2 years

ASD CASE PRESENTATION

John, a 10-year-old boy with ASD, enters the community pharmacy with his mother to pick up his prescription for aripiprazole 10 mg tablets. His agitation due to the bright lights and loud chatter from other customers becomes immediately apparent to the pharmacy team. They notice several visible signs and hear auditory cues that indicate his discomfort and distress in the environment. John's body tenses up, with rigid posture and fidgety movements, and his hands are clenched tightly as he paces and rocks back and forth. His facial expressions—furrowed brows and widened eyes—convey distress, and his vocalizations include whimpers and "I don't like it here." Additionally, John exhibits repetitive behaviors such as hand-flapping and tapping his mother. He attempts to retreat from the situation by seeking refuge behind his mother. Understanding his sensitivity to sensory input, the pharmacy team must respond with patience, empathy, and sensitivity to ensure John feels supported and safe during his visit. In addition, John’s mother will appreciate empathy and accommodation.

Strategies for Support

Pharmacists can employ their medication expertise to help the healthcare team, families, and patients improve ASD management. As John’s description indicates, patients with ASD are often sensitive to sensory input like noise, light, and crowded environments.¹⁰Pharmacists should recognize how a pharmacy setup can affect patients, potentially hindering communication. Offering to move to a quiet, dimly lit, private space (e.g., the consultation or vaccination area) for counseling helps accommodate sensory sensitivities.

When communicating with patients with ASD, pharmacists should consider the patient's level of autonomy and assess the need to interact primarily with the patient or the caregiver. Communication strategies can include using simplified language, direct communication, and patients' names to engage them and aid comprehension. Providing training to pharmacy staff on ASD can help pharmacists and technicians to serve these patients better.¹⁰

Putting Strategies in Action

The pharmacist, Keith, addresses John by name, acknowledges his discomfort, and minimizes distractions to create a more calming environment to put John at ease. For example, “Hello, John. I’m your pharmacist, and my name is Keith. It’s noisy out here. Would you like to move to a quieter room?” A technician familiar with the patient can also make this suggestion as soon as the patient arrives.

Keith also involves caregivers in the discussion, ensures they understand the medication instructions, and addresses any concerns they may have. He also reassures them of his availability for further assistance by saying, “I’m glad we talked about your medications today. If you have questions, you can stop in or call. I’m generally here Tuesday through Saturday, and my coworker Suzanne covers when I’m not here.”

By implementing these strategies, community pharmacists and technicians can improve the patient care experience for individuals with ASD.¹⁰

ASD TREATMENT

ASD is complex, and treatment often involves a multidisciplinary approach targeting various symptoms and challenges.¹¹ Although there is no outright “cure,” effective interventions may enhance functioning of children and adults with ASD. Pillars of treatment include behavioral therapies, speech and language therapy, occupational therapy, educational support, and sometimes medication management.

Behavioral therapy (e.g., applied behavioral analysis) involves creating a structured behavioral plan to improve adaptive skills and reduce inappropriate behaviors by studying affected individuals' functional difficulties systematically. Speech and language therapy is an integral part of ASD treatment for many children. Speech therapy targets difficulty with social communication and language development, which are some of ASD's core symptoms. Language therapy may employ visual supports like picture cards, augmentative and alternative communication devices, and teaching sign language (e.g., American Sign Language). Occupational therapy focuses on enhancing individuals' ability to participate in everyday activities and improve their quality of life. It typically addresses sensory processing issues, motor skill development, self-care skills, social interaction, and coping strategies, aiming to promote independence and function in various environments.¹¹

ASD treatment involves a multidisciplinary care team comprising professionals such as specialists, psychologists, pediatricians, paraprofessionals, and educators; ideally, team members collaborate to address individuals’ diverse needs and provide comprehensive support and intervention.¹¹

ASD Treatment Guidelines

Several treatment guidelines are available for ASD. The United Kingdom’s National Institute for Health and Care Excellence (NICE) has published ASD guidelines for both children under 19 years old and adults.^12,13 The Canadian Pharmacists Journal published ASD practice guidelines specifically for pharmacists. The latter guideline outlines strategies for effective communication and discusses how the community pharmacy team can create a welcoming environment for people with autism and their caregivers.¹⁰

Community pharmacists and technicians often encounter patients with diverse needs, including those with ASD. To provide optimal care, it's crucial to understand patients’ unique challenges and tailor services accordingly. Let's look at a case that highlights the importance of accommodating a patient with ASD in the pharmacy setting.

Pharmacologic Interventions

Pharmacotherapy for ASD primarily focuses on managing symptoms rather than directly targeting core features.⁸However, many challenges exist in this area, including limited efficacy and evidence, adverse effects, individual variability, lack of targeted therapies, and long-term monitoring. Prescribers should consider that children with ASD often have heightened sensitivity to medication and are more prone to adverse reactions compared to neurotypical children. It is advisable to initiate pharmacologic treatment at lower doses and increase gradually based on response and tolerability. It's crucial to gather objective symptom measures from various sources both before and after intervention to assess treatment response accurately across different settings.⁸

Another major hurdle lies in addressing co-occurring disorders that often accompany ASD, such as attention-deficit/hyperactivity disorder (ADHD), anxiety, epilepsy, sleep disorders, and more. These additional conditions complicate treatment approaches, requiring tailored interventions to address unique needs. Very limited evidence supports the effectiveness of many medications used to manage ASD symptoms.¹⁴

The lack of medications specifically targeting core ASD symptoms and the limited efficacy data for various medications present barriers to identifying effective treatment strategies. Addressing these challenges requires a comprehensive approach that integrates pharmacologic interventions with behavioral, educational, and supportive therapies personalized to the individual's specific needs and circumstances. Additionally, ongoing research is crucial to advance our understanding of ASD and to develop more effective and targeted pharmacological treatments in the future.¹⁴

Most medications for ASD are used off-label and few United States Food and Drug Administration (FDA)-approved drugs are available for specific symptom management. Medications used may include atypical antipsychotics, stimulants, serotonergic drugs, alpha-2 adrenergic antagonists, anticonvulsants, and many others.¹⁴

Atypical Antipsychotics

Prescribers often use atypical antipsychotics for irritability associated with ASD. Currently, the FDA has approved only two medications for treatment of irritability associated with ASD: risperidone and aripiprazole.^15,16 Both are atypical (second generation) antipsychotics and exert effects through dopamine, 5-HT (serotonin), alpha-adrenergic, and histaminergic receptors in the brain.

Clinical trials have demonstrated effectiveness of these drugs in reducing irritability and, to a lesser extent, repetitive behaviors. They share similar safety profiles, with common adverse effects including fatigue, increased appetite, gastrointestinal symptoms, hyperprolactinemia, weight gain, and sedation. Less common adverse effects include restlessness and akathisia (inability to remain still). Serious adverse effects such as dyslipidemia, hyperglycemia, metabolic syndrome, and extrapyramidal symptoms (e.g., involuntary movements, muscle stiffness, tremors) or drug-induced movement disorders have also been reported, necessitating close clinical and laboratory monitoring.¹⁴

Risperidone is FDA-approved for treatment of ASD-associated irritability in children and adolescents aged 5 to 16 years.¹⁵ Studies have demonstrated that risperidone may effectively improve core symptoms of ASD, including communication, social interaction, and repetitive behaviors. Non-core symptoms such as aggression, tantrums, and self-injurious behaviors also improved based on various behavioral rating scales. Risperidone is generally well-tolerated and safe, with the most common adverse effect being mild, self-limiting weight gain. In one small study of 97 children treated with risperidone over a 6-month period, participants gained an average of 5.4 kg over 24 weeks. At baseline, 59 of the 97 children (60.8%) had normal weight status. By week 24, only 25 of the remaining 85 children (29.4%) maintained normal weights.¹⁷In adults with ASD, adverse cognitive effects have not been observed in patients treated with risperidone for other psychiatric disorders. However, further exploration is needed regarding the efficacy of risperidone in adults with ASD.¹⁸

Aripiprazole is FDA-approved for treatment of ASD-associated irritability in pediatric patients 6 to 17 years old.¹⁶ Short-term studies have shown that aripiprazole can improve irritability, hyperactivity, and repetitive behaviors in children and adolescents with ASD compared to placebo. However, researchers have not observed improvement in lethargy or withdrawal symptoms. Aripiprazole use was associated with higher rates of movement disorders such as tremors and muscle rigidity. While aripiprazole may offer benefits, weight gain and neurological adverse effects like involuntary movements can limit its use. Regular monitoring of symptoms and adverse effects is recommended, and further research is needed to evaluate the long-term safety and effectiveness of aripiprazole in treating ASD.¹⁹

Other atypical antipsychotics occasionally used off-label for ASD include olanzapine, quetiapine, and ziprasidone. Providers generally avoid first generation antipsychotics due to the higher risk of movement-related adverse effects.¹⁴

Revisiting John’s Case

John's ASD is graded at Level 2—needing substantial support. He requires a range of support services tailored to his individual needs to thrive. For instance, John may benefit from behavioral interventions aimed at addressing his irritability and other behavioral challenges associated with his autism. These interventions could include strategies to manage his sensory sensitivities, develop coping skills, and enhance social communication. Additionally, providing John with structured routines and visual supports, such as clear schedules and visual cues, can help him navigate daily activities more effectively and reduce anxiety. Given his sensitivity to sensory stimuli, providing sensory accommodations like a quiet space or sensory tools (e.g., noise-canceling headphones) can aid in regulating his sensory experiences and minimizing agitation.

Moreover, John's prescription for aripiprazole indicates the need for medication management to address his irritability. Keeping in mind that John is 10 years old and in a period of rapid growth, it's crucial for the pharmacy team to monitor his height and weight regularly. The pharmacy team must inquire about any recent changes in his behavior or symptoms. The reason: the two atypical antipsychotics approved for irritability have similarities and differences that are critical to recognize, and with weight changes, the dose may require adjustments. The pharmacy team can support John's family, particularly his mother, with referral to resources such as parent training programs and support groups that can help them navigate the challenges associated with caring for a child with ASD. John can receive the assistance he needs to thrive and lead a fulfilling life with these comprehensive supports in place.

PAUSE AND PONDER: How many children with ASD receive care from your pharmacy? What behaviors do you see and hear?

Stimulants

Clinicians often prescribe stimulants to manage hyperactivity and inattention in ASD and co-existing ADHD. Two main classes of stimulants are commonly used in ADHD: amphetamines and methylphenidate derivatives.¹⁴ Prior to initiating stimulant therapy, clinicians must evaluate patients' medical and family histories and conduct a comprehensive physical exam focused on cardiovascular health. Ongoing monitoring for common adverse effects, such as appetite changes and sleep disturbances, is imperative, and it is essential to assess adolescent patients for risk of substance use or misuse before treatment initiation.

Amphetamine formulations include amphetamine-dextroamphetamine, dextroamphetamine, amphetamine sulfate, amphetamine, and lisdexamfetamine. Research suggests that amphetamines tend to be slightly more effective in reducing ADHD symptoms than methylphenidate, but they are also less tolerable. In a systematic review of data from more than 10,000 neurotypical individuals (i.e., children, adolescents, and adults without ASD), researchers found that amphetamines were more efficacious in reducing ADHD symptoms, although they were less well-tolerated than both placebo and methylphenidate in children and adolescents.²⁰

Methylphenidate products come in various formulations including immediate- and extended-release tablets or capsules, a transdermal patch, an extended-release liquid, and orally disintegrating tablets. Short-term treatment with methylphenidate has shown some benefit in improving hyperactivity, inattention, and other ADHD symptoms in children with ASD, but studies are small. The largest has enrolled just 66 children.²¹ Nonetheless, no evidence showed improvement in core ASD symptoms or social interaction. Additionally, while some children with ASD responded positively to methylphenidate, a significant number experienced adverse effects such as irritability, repetitive behaviors, insomnia, and reduced appetite.¹⁴

Alpha-2 Adrenergic Agonists

Alpha-2 adrenergic agonists—including guanfacine and clonidine—are commonly used in ADHD management for younger children. Evidence exists regarding the off-label use of alpha-2 adrenergic agonists in alleviating some symptoms of ASD, so some providers use them off label for this condition. Clinicians commonly prescribe these for children younger than 5 years old with ADHD or hyperarousal (intense, rapid, and often overwhelming emotional responses). These medications are also useful in cases when patients have poor responses to stimulants or selective norepinephrine reuptake inhibitors (e.g., atomoxetine) or when patients have significant co-occurring conditions like sleep issues that preclude stimulant use.

Research on the use of alpha-2-adrenergic agonists in ASD is limited to a few small studies.¹⁴ Guanfacine has been shown to be safe and effective in managing hyperactivity and impulsiveness in children with ASD. Common adverse effects of guanfacine include sedation, constipation, irritability, and aggression, but they are generally better tolerated than stimulant medications.¹⁴

PAUSE AND PONDER: What kinds of questions should you ask caregivers when they present a new prescription for a patient with ASD? What information do they need to know (but might not think about)?

Other Medications with Limited Supporting Data

Several medications have been explored with limited evidence in ASD management. These include various serotonergic medications (selective norepinephrine receptor inhibitors [SNRIs] and selective serotonin reuptake inhibitors [SSRIs]), anticonvulsants, gabapentin, and trazodone.

Researchers have looked at SNRIs and SSRIs to treat difficult behaviors in ASD. Venlafaxine has been proven beneficial as an adjunct treatment for self-injurious behaviors, aggression, and ADHD symptoms in children and adults with ASD, particularly when administered at doses lower than those typically used for depression.²² Conversely, duloxetine (also an SNRI) did not demonstrate any additional advantages in addressing comorbid symptoms and behaviors associated with ASD when compared to alternative antidepressants.²²

SSRIs can be helpful in patients with comorbid anxiety, which is very common with ASD. However, clinical trials assessing the SSRIs citalopram and fluoxetine found them to have low tolerability and limited effectiveness in addressing repetitive behaviors.²³

Anticonvulsants, also known as antiepileptic drugs, are sometimes used off-label in the treatment of certain ASD symptoms. While these medications are primarily indicated for seizure management, they may also be prescribed to address co-occurring conditions such as epilepsy, aggression, irritability, and repetitive behaviors in individuals with ASD. Examples of anticonvulsants studied or used in ASD treatment include valproic acid (valproate), lamotrigine, levetiracetam, and topiramate.¹⁴ However, the evidence supporting anticonvulsants' efficacy in treating ASD symptoms remains limited, and healthcare professionals should consider the use of these drugs carefully and monitor closely for potential adverse effects and individual variability in response.¹⁴

Limited research suggests that carbamazepine, oxcarbazepine, levetiracetam, and topiramate may exacerbate hyperactivity, mood disturbances, psychotic symptoms, and other psychiatric or behavioral issues in individuals with ASD.²⁴ These effects appear most common with levetiracetam. Evidence is inconclusive on the role of anticonvulsants in ASD in the absence of epilepsy, but there always remains potential for specific cases. Further research is needed to better understand the safety and effectiveness of anticonvulsants in ASD treatment and to identify subgroups of individuals who may benefit most from this approach.

Off-label use of gabapentin and trazodone for ASD presents significant patient safety concerns. Despite lacking FDA approval for this indication, these drugs are increasingly prescribed, leading to adverse drug reactions.²⁵ Gabapentin is often used off-label to address anxiety and occasionally behavioral problems. Gabapentin can also cause central nervous system depression. Its use in ASD is poorly studied, with one study that enrolled just 23 children (mean age 7.2) with various neurologic diagnoses finding that 78% of children had improved sleep at doses of 5 mg/kg 30 to 40 minutes before bedtime.²⁶ However, further research is required to substantiate these findings.²⁶

Very limited evidence supports using trazodone to manage irritability, but many individuals with ASD still use it, as sleep disturbances are very common. Safety considerations exist, as trazodone poses risks of overdose-related complications, including arrhythmias, respiratory arrest, coma, and the rare but serious condition of priapism. Overprescribing of these medications is increasing and not backed by evidence, especially in ASD. Cautious prescribing practices and thorough patient education are needed to ensure the safety and well-being of individuals with ASD using gabapentin and trazodone.

As mentioned, sleep problems are common in children with ASD. In fact, between 40% and 80% of children with ASD develop them.²⁷ For many children, insomnia is the problem, but other children develop parasomnias (e.g., sleep talking, sleepwalking, sleep terrors), or circadian rhythm sleep-wake disorders. Prescribers have various options available to treat insomnia, but in autism, the largest body of work describes the use of melatonin to improve sleep onset and maintenance. Research suggests using lowest doses (1 to 2 mg) and titrating upward gradually.^28,29

John Develops Insomnia

Once again, John and his mother visit the pharmacy to fill a prescription. His mom says that although they have a very structured schedule and John's regular bedtime is 9:00 PM, John has difficulty falling asleep and is often awake and moving around in his room for long periods of time. His mom says, “Recently, it feels like he's awake all night long and his symptoms are worse when he doesn't get enough sleep. It's a vicious cycle.” She looks exhausted; a key issue when children with ASD develop sleep disorders is that the entire family often loses sleep.

Mom also reports that her primary care provider has counseled her on ways to help John get to sleep, including discouraging behaviors that interrupt sleep, using positive reinforcement when John is actively trying to sleep, and employing relaxation techniques. She says that she moved his bedtime to 11:00 PM and he has been a little bit sleepier. Her plan is to move John’s bedtime 15 minutes earlier each week. Regardless, John and his entire family still need additional help with this issue. John’s mother indicates that the prescriber told her to speak with the pharmacist so she can find the most reliable melatonin product. That’s a prudent recommendation, since many supplements are mislabeled or unreliable.²⁸

PHARMACY IMPLICATIONS

Pharmacists, pharmacy technicians, and the community pharmacy setting serve as essential components of healthcare for patients with ASD and their families. The pharmacy team can address concerns, provide encouragement, and ensure parents and caregivers feel equipped to manage medication administration effectively. Pharmacists can provide counseling and technicians can offer support to help caregivers confidently manage medication regimens for patients with ASD, ensuring better adherence and improved healthcare outcomes. Table 3 lists important reminders for the pharmacy team.

Table 3. Best Interventions for Children with ASD at the Pharmacy^10,30,31

Anticipate that you will provide care for patients with ASD and identify a calm area where you can council without noise or distraction
Accept that some parents do not want to take any more time in a store (pharmacy or not) than they must, and try to accommodate them
At every visit, ask if anything has changed since the last visit and record an updated height and weight (especially if the patient is on a medication dosed by weight)
If parents struggle with administering medications to children with ASD
- Provide tailored support and education, offer clear and concise medication instructions using visual aids and use simplified language
- Recommend dosage forms like liquids or chewable tablets to ease administration challenges
- Offer customized packaging options such as unit-dose blister packs or pre-filled syringes proactively to simplify dosing and organization
- Help parents and caregivers create visual medication schedules or reward systems to reduce anxiety during medication administration
Encourage parents and caregivers to keep a diary of symptoms so they can monitor the patient’s response to newly prescribed medications
Remember that stimulants, gabapentin, and trazodone have been linked to abuse and all families need to be reminded to store these drugs securely
- In some states, gabapentin is a controlled substance

Pharmacists are a valuable drug information resource and adept at assessing existing evidence to help patients with ASD and their families make well-informed decisions. Pharmacy involvement is invaluable in providing optimal care and support for this patient population.

The Future of Treating ASD

The future of pharmacologic treatment for ASD holds promise but also faces significant challenges. Continued research into ASD's underlying neurobiologic mechanisms may lead to the development of more targeted interventions tailored to address specific symptoms and subtypes of the disorder. Additionally, advancements in genetic testing and biomarker identification could enable personalized treatment approaches, optimizing efficacy while minimizing adverse effects.

Large-scale clinical trials and collaborative research efforts to evaluate treatment effectiveness comprehensively are needed. Ultimately, the future of medication therapy for ASD will depend on the ability to integrate advancements with a nuanced understanding of individual differences and needs of patients with ASD.¹⁴

CONCLUSION

While progress has been made in understanding and treating ASD, significant challenges remain. A comprehensive approach combining behavioral interventions, therapies, and pharmacotherapy tailored to individual needs is essential for improving outcomes in individuals with ASD. Continued research efforts are necessary to develop more effective and evidence-based treatments for this complex disorder. Temple Grandin explains it well: “A treatment method or an educational method that will work for one child may not work for another child. The one common denominator for all of the young children is that early intervention does work, and it seems to improve the prognosis.”

UNDERSTANDING TREATMENT APPROACHES FOR AUTISM SPECTRUM DISORDER

Pharmacist Post Test

After completing this continuing education activity, pharmacists will be able to
• DESCRIBE autism spectrum disorder (ASD) and its manifestations
• LIST medications used to manage symptoms of ASD
• APPLY techniques to improve care in the pharmacy for patients with ASD and their caretakers

1. Which of the following is TRUE about autism spectrum disorder?
A. It affects 10% of children worldwide
B. It affects four times as many males than females
C. Prevalence has decreased over the past decade

2. Which of the following symptom lists BEST represents autism spectrum disorder?
A. Avoiding eye contact, sensitivity to loud noises, disinterest in peers or making friends
B. Strong attachment to unusual objects, sensitivity to cold temperatures, discomfort with change
C. Hand flapping, excessive smelling of objects, increased sharing of imaginative play

3. Which job would an individual with ASD be expected to excel at?
A. A professional musician
B. A manufacturing job in a busy warehouse
C. An accounting job at a quiet firm

4. Which of the following is TRUE about sleep disorders in patients with ASD?
A. They are relatively uncommon, affecting about 20% of patients with ASD
B. They are best treated with non-pharmacologic techniques with or without melatonin
C. Patients with ASD typically only develop parasomnias like sleepwalking or sleep talking

5. Which of the following is FDA-approved to treat ASD-associated irritability in a 5-year-old?
A. Quetiapine
B. Aripiprazole
C. Risperidone

6. Which of the following is TRUE about aripiprazole for ASD?
A. It’s used off-label to treat ASD-associated insomnia
B. It can improve repetitive behaviors seen in ASD
C. It’s known to cause decreased appetite and weight loss

7. Which of the following co-occurring conditions in a patient with ASD could benefit from the use of dextroamphetamine?
A. Attention-deficit/hyperactivity disorder
B. Sleep disturbances (e.g., insomnia)
C. Self-injurious behaviors and aggression

8. Which of the following is gabapentin used off-label to treat in ASD?
A. Insomnia
B. Anxiety
C. Epilepsy

9. George is a 3-year-old boy who comes to the pharmacy with his mom. George’s mom asks your help picking out a melatonin supplement for her son who is having trouble sleeping at night. She explains that his pediatrician recommended getting him evaluated for ASD based on other symptoms he is exhibiting, but she thinks this isn’t necessary. She says “he’s just a toddler who can’t sleep because he’s too excited, we’ll try the melatonin first.” Which of the following is the BEST response?
A. Advocate to have George evaluated soon, rather than waiting, as outcomes are better for patients who are diagnosed and treated earlier
B. Let her know she’s right to delay evaluation because providers typically can’t diagnose ASD before 8 years of age
C. Offer to contact George’s pediatrician to see if she is willing to prescribe trazodone, as it works better for patients with ASD-associated insomnia

10. Amelia is a 12-year-old patient with diagnosed ASD who comes to the pharmacy with her mom to pick up her prescription for aripiprazole. You are understaffed due to a call out and the only technician is assisting someone in the drive thru while you are on hold with an insurance company. Amelia and her mom are third in line at pick-up, and you notice Amelia is pacing back and forth, shielding her eyes from the fluorescent lights, and tugging her mom’s arm asking to leave. Which of the following is the BEST course of action?
A. Toss Amelia’s mom your noise-cancelling headphones and a pair of sunglasses and tell her you will be with her as soon as you can
B. Make a note to contact Amelia’s provider and let them know that her aripiprazole dose should be increased
C. Offer to let Amelia and her mom wait in your vaccination area with the lights off until you or the technician can help her

UNDERSTANDING TREATMENT APPROACHES FOR AUTISM SPECTRUM DISORDER

Pharmacy Technician Post-test

After completing this continuing education activity, pharmacy technician will be able to
• DESCRIBE autism spectrum disorder (ASD) and its manifestations
• LIST medications used to manage symptoms of ASD
• RECOGNIZE situations in which they can help patients with ASD and their caretakers appropriately

3. Which job would an individual with ASD be expected to excel at?
A. A professional musician
B. A manufacturing job in a busy warehouse
C. An accounting job at a quiet firm

5. Which of the following is FDA-approved to treat ASD-associated irritability in a 5-year-old?
A. Quetiapine
B. Aripiprazole
C. Risperidone

8. Which of the following is gabapentin used off-label to treat in ASD?
A. Insomnia
B. Anxiety
C. Epilepsy

9. Which of the following strategies helps patients with ASD feel more comfortable coming to the pharmacy?
A. Greet them by name upon arrival
B. Avoid talking to them directly
C. Conduct transactions as slowly as possible

10. Amelia is a 12-year-old patient with diagnosed ASD who comes to the pharmacy with her mom to pick up her prescription for aripiprazole. You are understaffed due to a call out and you are the only technician working today. You are assisting someone in the drive thru while the pharmacist is on hold with an insurance company. Amelia and her mom are third in line at pick-up, and you notice Amelia is pacing back and forth, shielding her eyes from the fluorescent lights, and tugging her mom’s arm asking to leave. Which of the following is the BEST course of action?
A. Toss Amelia’s mom your noise-cancelling headphones and a pair of sunglasses and tell her you will be with her as soon as you can
B. Make a note to tell the pharmacist to contact Amelia’s provider and let them know that her aripiprazole dose should be increased
C. Offer to let Amelia and her mom wait in your vaccination area with the lights off until you or the pharmacist can help her

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19. Hirsch LE, Pringsheim T. Aripiprazole for autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2016;2016(6):CD009043. doi:10.1002/14651858.CD009043.pub3
20. Cortese S, Adamo N, Del Giovane C, et al. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018;5(9):727-738. doi:10.1016/S2215-0366(18)30269-4
21. Posey DJ, Aman MG, McCracken JT, et al. Positive effects of methylphenidate on inattention and hyperactivity in pervasive developmental disorders: an analysis of secondary measures. Biol Psychiatry. 2007;61(4):538-544. doi:10.1016/j.biopsych.2006.09.028
22. Nanjappa MS, Voyiaziakis E, Pradhan B, Mannekote Thippaiah S. Use of selective serotonin and norepinephrine reuptake inhibitors (SNRIs) in the treatment of autism spectrum disorder (ASD), comorbid psychiatric disorders and ASD-associated symptoms: a clinical review. CNS Spectr. 2022;27(3):290-297. doi:10.1017/S109285292000214X
23. Hellings J. Pharmacotherapy in autism spectrum disorders, including promising older drugs warranting trials. World J Psychiatry. 2023;13(6):262-277. doi:10.5498/wjp.v13.i6.262
24. Chen B, Choi H, Hirsch LJ, et al. Psychiatric and behavioral side effects of antiepileptic drugs in adults with epilepsy. Epilepsy Behav. 2017;76:24-31. doi:10.1016/j.yebeh.2017.08.039
25. Lenzer J. Pfizer pleads guilty, but drug sales continue to soar. BMJ. 2004;328(7450):1217. doi:10.1136/bmj.328.7450.1217
26. Mammarella V, Orecchio S, Cameli N, et al. Using pharmacotherapy to address sleep disturbances in autism spectrum disorders. Expert Rev Neurother. 2023;23(12):1261-1276. doi:10.1080/14737175.2023.2267761
27. Sidhu N, Wong Z, Bennett AE, Souders MC. Sleep Problems in Autism Spectrum Disorder. Pediatr Clin North Am. 2024;71(2):253-268. doi:10.1016/j.pcl.2024.01.006
28. Souders MC, Taylor BJ, Zavodny Jackson S. Sleep Problems in Autism Spectrum Disorder. In: White SW, Maddox BB, Mazefsky CA, eds. The Oxford Handbook of Autism and Co-Occurring Psychiatric Conditions. Oxford University Press; 2020: 258-283. Accessed May 10, 2024. https://academic.oup.com/edited-volume/28150/chapter-abstract/212932907
29. Williams Buckley A, Hirtz D, Oskoui M, et al. Practice guideline: Treatment for insomnia and disrupted sleep behavior in children and adolescents with autism spectrum disorder: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2020;94(9):392-404. doi:10.1212/WNL.0000000000009033
30. Kurtz SP, Buttram ME, Margolin ZR, Wogenstahl K. The diversion of nonscheduled psychoactive prescription medications in the United States, 2002 to 2017. Pharmacoepidemiol Drug Saf. 2019;28(5):700-706. doi:10.1002/pds.4771
31. Anderson LA. Is gabapentin a controlled substance/narcotic? Drugs.com. Updated December 5, 2022. Accessed April 5, 2024. https://www.drugs.com/medical-answers/gabapentin-narcotic-controlled-substance-3555993/

Demystifying the Medicare Prescription Payment Plan

After completing this application-based continuing education activity, pharmacists and technicians will be able to

Describe the benefits and features of the Medicare Prescription Payment Plan
Outline the responsibilities of Part D Sponsors and dispensing pharmacies under the Medicare Prescription Payment Plan
Discuss the characteristics of beneficiaries most likely to benefit from participating in the Medicare Prescription Payment Plan
Explain the resources available for Medicare Beneficiaries to learn more about the Medicare Prescription Payment Plan

More than 1.4 million Americans paid drug costs of $2000 or more in 2020. Starting January 1, 2025, the M3P allows Medicare Part D members the option to pay for their Part D medications through a monthly invoice while paying nothing at the pharmacy counter. This change has operational and financial impacts for many areas of pharmacy. M3P claims processing requires coordination between Plans, PBMs, and dispensing pharmacies. Pharmacists and pharmacy technicians can help their patients benefit from the M3P by educating themselves and their patients about the program.

INTRODUCTION & BACKGROUND

The Inflation Reduction Act (IRA) of 2022 is a large piece of legislation that included a wide range of provisions, including clean energy, tax revenues, and healthcare costs. The Medicare Part D changes contained in the IRA aim to make prescription drugs more affordable for Medicare beneficiaries.¹

One of the Medicare Part D changes included in the IRA is the Medicare Prescription Payment Plan (M3P). Starting January 1, 2025, the M3P allows Medicare Part D members the option to pay for their Part D medications through a monthly invoice while paying nothing at the pharmacy counter.² This change has operational and financial impacts for many areas of pharmacy, including dispensing pharmacies, Medicare Part D Plans (Plans), and Pharmacy Benefit Managers (PBMs).

Overview of the Medicare Prescription Payment Plan

The Kaiser Family Foundation estimated that more than 1.4 million Americans paid drug costs of $2000 or more in 2020.³ While the IRA contains other provisions designed to lower prescription drug costs, the M3P does not change the amount that patients pay for their medications. Instead, the M3P (originally called “copay smoothing”) helps Medicare beneficiaries afford their prescriptions by “smoothing” the costs over monthly invoices instead of paying the full amount to their pharmacy. The IRA requires Plans to make the M3P available to any member who has out-of-pocket costs for Part D medications, regardless of their income or out-of-pocket amount. The M3P also requires Plans to⁴

Educate members about the availability of the M3P
Notify dispensing pharmacies when members are likely to benefit from participating in the M3P
Reflect $0 member payment for approved M3P claims
Allow multiple methods for members to opt-in to the M3P
Issue monthly M3P invoices to participating members
Include all prescriptions covered under Medicare Part D in the M3P
Pay the dispensing pharmacy for the member’s portion of the drug cost

Figure 1 illustrates the basic process for patients who choose to participate in M3P.

The Centers for Medicare & Medicaid Services (CMS) requires Plans to educate members about the availability of M3P through a variety of channels. Plans must include general M3P information on their websites, when issuing new member identification, and with annual plan document mailings. Plans and dispensing pharmacies must also provide M3P information to targeted members who are likely to benefit from participating in the program. CMS has determined that members with out-of-pocket costs of at least $2000 in the first three quarters of the year or $600 for a single prescription are the most likely to benefit from using the M3P.⁵

M3P claims processing starts January 1, 2025, and requires coordination between Plans, PBMs, and dispensing pharmacies. For members not participating in the M3P, Plans, through their PBMs, must indicate that the patient is likely to benefit from the M3P on approved Part D prescription claims with patient costs that are $600 or more. Receipt of this information from the claim requires the dispensing pharmacy to provide educational materials about the M3P to the patient. While CMS requires pharmacies to distribute M3P information to patients in response to claims messaging, CMS does not require them to provide additional counseling about the program. Pharmacists and pharmacy technicians may, however, choose to educate themselves and their patients about the M3P to provide an elevated patient experience.⁵

PAUSE AND PONDER: What quick talking points can you provide to your patients to help them understand the M3P?

Approved Part D claims for patients who have opted into the program will include instructions for the dispensing pharmacy to send a secondary M3P claim. The secondary M3P claim must use a different Bank Identification Number/Processor Control Number (which pharmacy staff usually refer to as BIN/PCN) combination than the corresponding primary Part D claim. The National Council for Prescription Drug Programs (NCPDP) creates and maintains the standardized format for prescription claims transmission. NCPDP is adding specific transmission codes for PBMs to transmit M3P information to dispensing pharmacies.⁴ Table 1 describes the types of M3P claims processing information that dispensing pharmacies should expect starting January 1, 2025. Pharmacists and technicians should consult their employer’s training materials for specific instructions on providing patients with information about the M3P, using NCPDP M3P transmission codes, and submitting secondary M3P claims.

Table 1. Anticipated M3P Claims Messaging Information

Patient Status	Claim Type	Message Type
Not participating in M3P	Approved Part D Claims with ≥ $600 patient cost	The member is likely to benefit from participating in the M3P; the pharmacy should provide M3P educational information.
Not participating in M3P	Secondary M3P Claims (if sent accidentally)	The member is not participating in the M3P program; the pharmacy should collect the member’s cost share based on the Part D claim.
Participating in M3P	Approved Part D Claims	The member is participating in the M3P; the pharmacy should send a secondary M3P claim.
Participating in M3P	Secondary M3P Claims	The corresponding Part D claim is not found. Transmission may have failed or the Part D claim has been reversed; the pharmacy should reprocess the Part D claim and then re-send the secondary M3P claim.
Participating in M3P	Secondary M3P Claims	The drug is not covered by Part D and therefore not eligible for M3P; the pharmacy should collect the member’s cost share based on the Part D claim.

Members can start signing up for the M3P as early as October 15, 2024, which is the beginning of open enrollment for 2025 Medicare Part D coverage. They can also sign up any time after their 2025 Part D coverage starts. CMS requires Plans to accept M3P participation requests by mail, telephone, or through a website application.⁴ CMS does not currently require dispensing pharmacies to process M3P election requests, and pharmacists and pharmacy technicians should direct patients to their Plan to sign up for the M3P.

Once a member opts into the program, their Plan will issue a monthly M3P invoice for all Part D prescription costs including the deductible and copay/coinsurance amounts. CMS requires Plans to issue M3P invoices separately from monthly premium invoices.⁴

Plans can remove members from M3P participation for failure to pay M3P invoices after a 2-month grace period but cannot disenroll members from Part D coverage for failure to pay M3P invoices. Members who are removed from M3P participation for falling behind on M3P payments can restore their M3P participation by paying their past-due M3P balance in full.⁴ Plans may disenroll members from Part D coverage for failure to pay monthly premium invoices after a 2-month grace period, even if their M3P invoices are paid in full.⁶ Pharmacists and pharmacy technicians can help M3P patients stay current with their payments by reminding them to pay both M3P and monthly Part D premium invoices. The SIDEBAR explains common terms.

SIDEBAR: Part D Patient Costs Defined

Monthly Premium: a monthly payment that maintains enrollment in the Plan; not impacted by deductible, copay, or coinsurance amounts

Annual Deductible: a yearly dollar amount the patient pays before their Plan starts to contribute to prescription costs

Copayment (or Copay): a specific, pre-determined dollar amount the patient pays for each prescription after satisfying the deductible

Coinsurance: an alternative to a copay, the percentage of the total cost the patient pays for each prescription after satisfying the deductible

Distribution of M3P responsibilities

CMS develops guidance and member-facing documents that Plans and PBMs use when building operational processes. For the M3P, CMS is providing Plans with⁵

Detailed guidance documents that provide M3P requirements and invoice calculation instructions
Content for plan mailings including the Annual Notice of Change, Evidence of Coverage, and Explanation of Benefits
A fact sheet with educational language for Plan websites and printed materials
An election request form
Letters to notify members of M3P election, failure to pay, and termination from the program
A targeted letter for members who are likely to benefit from participating in the M3P

CMS is also adding M3P information to the resources and educational materials that they provide directly to Medicare beneficiaries, including the annual Medicare & You Handbook, Medicare.gov, and Medicare Plan Finder.⁵

CMS assigns most of the responsibility for the M3P to Plans and holds Plans accountable for meeting all program requirements. Plans are responsible for delivering all aspects of the M3P but must rely on PBMs, vendors, and dispensing pharmacies for certain requirements. Table 2 provides an overview of the main activities that Plans must implement for M3P.^4,5

Table 2. Plan M3P Responsibilities^{4, 5}

Activity	Requirements
Member education	· General information during open enrollment, with annual plan mailings, and on their website · Targeted information prior to and during the plan year for members who are likely to benefit from the M3P
M3P participation processing	· Mail, telephone, and web-based options · Accept M3P elections during open enrollment, before the start of the plan year · Activate completed M3P elections received during the plan year within 24 hours · Outreach to gather missing information from incomplete M3P election requests · Communication to PBM for claims processing
M3P claims processing	· Coordination and oversight of their PBM for o Claims notification to pharmacies for members who are likely to benefit from M3P o Processing information and $0 copay/coinsurance for M3P participants o Payment to the dispensing pharmacy for the member’s portion of the drug cost
M3P Invoices and Payment Collections	· Monthly invoices based on CMS-required calculations · 60-day grace period, then removal from M3P for failure to pay
Other	· Customer service · Pharmacy and provider education · Data and reporting · Oversight of dispensing pharmacies

While Plans hold the most responsibility for M3P, dispensing pharmacies play a large part in the program’s success. CMS requires all pharmacies who accept Part D prescription drug coverage to participate in the M3P. Pharmacists and pharmacy technicians must act on M3P claim information to distribute M3P materials to members and process M3P claims.Pharmacies may need to adjust their claim reversals and reprocessing procedures to ensure that both the primary Part D and the secondary M3P claims are included. For example, if a patient decides to fill a prescription for less than the original quantity, the pharmacy would need to first reverse both the Part D and M3P claims and then resubmit both claims with the new quantity. CMS also requires pharmacies to re-process claims for members who sign up for M3P after filling but before picking up their prescriptions.^4,5

To benefit from the M3P, Medicare beneficiaries are responsible for reviewing the educational materials provided by CMS, their Plan, and their pharmacy. They also have the opportunity to use the tools provided by their Plan to determine if they would benefit from participating in the M3P. After signing up, members are obligated to pay their M3P invoices on a monthly basis to avoid being removed from the program. Members who sign up for the M3P may decide later to drop out of the program but are still responsible for paying invoices incurred during their M3P participation.^4,5

Monthly invoice calculations and members most likely to benefit from participating in the M3P

The monthly invoice calculations required by CMS are complex and typically do not result in equal monthly installments. Members can sign up for the M3P at any time during the year, and the monthly invoice calculation for their first month in the program is different from the invoice calculations for later months. Invoice amounts also vary based on when the member signs up for the M3P and prescriptions purchased at the pharmacy before they entered the program. CMS protects members who participate in the M3P by prohibiting Plans from adding service/late fees or charging interest on M3P balances.⁴

PAUSE AND PONDER: What can you tell a patient who asks how the M3P is different than using a credit card to pay for his prescriptions?

CMS holds Plans responsible for accurately calculating M3P invoice amounts and answering member questions. Dispensing pharmacies are not required to explain invoice details but may benefit from understanding why not all patients will benefit from participating in the M3P.⁴

Figures 2 and 3 provide examples of pharmacy copay/coinsurance amounts compared to M3P invoice amounts for members who sign up for M3P in January. Both example members have the same out-of-pocket prescription costs for the year. The member in Figure 2 is more likely to benefit financially from the M3P because the monthly M3P invoice amount is never higher than what they would have paid at the pharmacy counter. In general, the higher the member’s out-of-pocket prescription costs the earlier in the year, the more likely the member will benefit financially from using the M3P.⁴

All Part D members are entitled to sign up for the M3P, regardless of their drug costs or M3P invoice amounts. Members who do not benefit financially from the M3P, such as the member illustrated in Figure 3, may have personal reasons for signing up for the program. For example, patients who rely on caretakers to pick up their prescriptions from the pharmacy may prefer the convenience of having no cost at the pharmacy counter. Patients may also pay more than their MP3 invoice amounts earlier in the year to reduce invoice amounts later in the year as long as they do not pay more than their total year-to-date copay/coinsurance amounts.⁴

Alternatively, patients may have non-financial reasons for not signing up for the M3P. They may not want to receive another monthly bill or may feel that paying for their prescriptions at the pharmacy provides better visibility into their drug costs. Even patients who would benefit financially from using the M3P may be put off by the uneven monthly M3P payment amounts. Patients who sign up for the M3P have the option to leave at any time if they feel they are not benefiting from the program.

PAUSE AND PONDER: What other non-financial situations may members face where they could benefit from the M3P?

M3P Resources

CMS has a number of resources available for anyone looking for more information about the M3P. They provide access to detailed M3P guidance, technical, and related information at https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements/medicare-prescription-payment-plan

CMS also provides an annual handbook entitled “Medicare and You” designed to educate members about all aspects of Medicare. When the 2025 version of “Medicare and You” is released by CMS in late 2024, it will include educational information about the M3P.⁵ The “Medicare and You” handbook is available at https://www.medicare.gov/medicare-and-you.

At the time of this publication, CMS is still developing additional resources, but expects information about the M3P to be available at www.medicare.gov.⁵

CMS requires Plans to provide information about the M3P on their websites before October 15, 2024. While the general M3P information included on Plan websites will likely be similar to the information provided by CMS, it will also include Plan-specific instructions and contact information.⁵

SUMMARY AND CONCLUSION

The M3P provides flexibility for Medicare beneficiaries who prefer to receive a monthly invoice instead of paying for their prescriptions at the pharmacy counter. The program requires complex operational changes for Plans, PBMs, and dispensing pharmacies.

CMS holds Plans responsible for the overall administration of the M3P, but PBMs and dispensing pharmacies have important responsibilities. Pharmacists and pharmacy technicians can help their patients benefit from the M3P by educating themselves and their patients about the program.

Good:

Be familiar with your pharmacy’s procedures for processing M3P claims
Provide M3P information to patients when prompted by your pharmacy’s dispensing system
Refer patients to their Plan for additional information about the M3P

Better:

Discuss the overall benefits of the M3P
Answer patient questions about how the M3P works
Describe the characteristics of patients most likely to benefit from using the M3P

Best:

BE COMMUNITY CHAMPIONS! Stay abreast of upcoming changes and take the time to comment on proposed revisions to Medicare
Assist patients with decisions about M3P participation
Consider appointing one staff member to be your “M3P Expert” who deals with complex patient questions

Demystifying the Medicare Prescription Payment Plan
Educational Objectives for Pharmacists and Pharmacy Technicians:
1. Describe the benefits and features of the Medicare Prescription Payment Plan
2. Outline the responsibilities of Part D Sponsors and dispensing pharmacies under the Medicare Prescription Payment Plan
3. Discuss the characteristics of beneficiaries most likely to benefit from participating in the Medicare Prescription Payment Plan
4. Explain the resources available for Medicare Beneficiaries to learn more about the Medicare Prescription Payment Plan.

1. What can you tell patients who ask about the Medicare Prescription Payment Plan?
a. It will lower prescription drug costs for millions of Americans
b. It creates an option to pay for Part D prescriptions through a monthly invoice
c. The government will make this program available on January 1, 2026

2. What can members who participate in the Medicare Prescription Payment Plan expect?
a. They will pay $0 at the pharmacy for their Part D prescriptions
b. They must meet strict minimum income requirements
c. They will receive monthly invoices from their pharmacy

3. Which of the following is an M3P responsibility for dispensing pharmacies?
a. Provide counseling about the program
b. Distribute materials in response to claims messaging
c. Identify patients who are likely to benefit from the program

4. If a member fails to pay M3P invoices, what could happen?
a. They could be required to change pharmacies
b. They could be denied prescription drug coverage
c. They could be removed from the M3P program

5. Which of the following is a Medicare Part D Plan responsibility?
a. Processing M3P participation requests
b. Allowing a 90-day grace period for failure to pay M3P invoices
c. Developing guidance and member-facing documents

6. Which Medicare beneficiaries are most likely to benefit financially from using the M3P?
a. People who have high drug costs early in the year
b. People who have low drug costs throughout the year
c. People who have high drug costs late in the year

7. What advice can you offer to patients who do not benefit financially from the M3P?
a. They are not permitted to use the program
b. They must remain in the program until the end of the plan year
c. They may choose to join the program for non-financial reasons

8. Which of the following may patients consider a disadvantage to using the M3P, even for patients who may benefit financially from the program?
a. Invoice amounts that are not the same every month
b. Being required to change pharmacies to participate
c. Risk of losing their prescription coverage if they cannot pay their M3P invoices

9. Where can beneficiaries learn more about the M3P?
a. The 2024 “Medicare and You” Handbook
b. From their Plan Formulary
c. CMS and Plan websites

10. When will Medicare Part D Plans have M3P details available on their websites and start accepting M3P member elections?
a. After patients meet their annual deductible
b. No later than October 15, 2024
c. After January 1, 2025

References

Centers for Medicare & Medicaid Services. The Inflation Reduction Act Lowers Health Care Costs for Millions of Americans. Accessed April 27, 2024. https://www.cms.gov/priorities/legislation/inflation-reduction-act-and-medicare/lowers-health-care-costs-millions-americans

Centers for Medicare & Medicaid Services. Fact Sheet: Medicare Prescription Payment Plan. Accessed April 27, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-fact-sheet.pdf

Kaiser Family Foundation. Explaining the Prescription Drug Provisions in the Inflation Reduction Act. Accessed July 1, 2024. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/
Centers for Medicare & Medicaid Services. Medicare Prescription Payment Plan: Final Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments. Accessed April 27, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-final-part-one-guidance.pdf

Centers for Medicare & Medicaid Services. Medicare Prescription Payment Plan: Final Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Solicitation of Comments. Accessed July 17, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-final-part-two-guidance.pdf

Centers for Medicare & Medicaid Services. What Happens When a Plan Member Doesn’t Pay Their Medicare Plan Premiums? Accessed April 28, 2024. https://www.cms.gov/outreach-and-education/outreach/partnerships/downloads/11338-p.pdf

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

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

· Describe type 2 diabetes diagnostic criteria and glycemic targets

· Identify the components of diabetes self-management education and support

· Recognize the importance of an individualized treatment program

· List treatment recommendations for type 2 diabetes in the setting of common comorbidities

After completing this application-based continuing education activity, pharmacy technicians will be able to

· Describe type 2 diabetes diagnostic criteria and glycemic targets

· Identify the components of diabetes self-management education and support

· Recognize the importance of an individualized treatment program

· List common comorbidities in type 2 diabetes

The diabetes epidemic is growing globally. Knowledge of current standards of care is essential for healthcare professionals. Understanding the importance of lifestyle recommendations and current pharmacologic therapies based on comorbidities is integral to improving diabetic patient outcomes. This continuing education activity follows a format similar to the Standards of Medical Care in Diabetes, focusing on the non-pregnant adult with T2DM. The current standards stress the importance of assessing each patient as an individual and emphasize a team care approach with patient involvement in monitoring diet, weight, physical exercise, and glycemic targets. This continuing education activity reviews the treatment of comorbid conditions, including obesity, hyperlipidemia, hypertension, heart disease, and chronic kidney disease, in addition to glycemic care. Using glucose-lowering therapy that decreases weight and slows cardiovascular disease progression is the new standard of care. Current medication therapy highlights incorporation of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 agonists into therapeutic treatment plans.

INTRODUCTION

Many years ago, I dined with a large man who looked as if he had lost a substantial amount of weight. He ordered meat and vegetables and explained to me that he had eliminated most carbohydrates from his diet. As a result of dietary changes, he was able to discontinue his diabetes medication. As a pharmacist, this concept of treating a disease with lifestyle changes, rather than medication, left a profound impact.

Globally, diabetes mellites is the ninth major cause of death. This epidemic has quadrupled in the past 30 years, affecting about one in 11 adults.¹ Type 2 diabetes mellitus (T2DM) accounts for approximately 90% of diabetes mellitus diagnoses.¹ Traditionally, treatment goals focused on hemoglobin A1C (HbA1c) and blood glucose levels to treat T2DM. However, the incidence of diabetes and diabetic complications continues to rise despite the many hypoglycemic medications on the market.^2,3 Many older hypoglycemics can lead to weight gain, conflicting with the treatment goal of decreasing body mass.⁴ Optimizing diet, nutrition, and physical exercise are important treatment components, but patients may find this challenging. The healthcare team can supply the necessary support to optimize therapy. If lifestyle modifications and traditional treatments are ineffective, newer T2DM medications offer novel treatment approaches that potentially improve overall patient outcomes.

Prevalence and Risk Factors

The global adult prevalence of diabetes is significant and varies by several factors⁵:

Overall, approximately 6.1%
Males 6.5%
Females 5.8%
Older adults between the ages of 65 and 95 years, over 20%
Adults in their late 70’s (75 to 79 years) 24.4%.

In 76.5% of those with T2DM, research found risk factors were present, with high body mass index (BMI) being the primary risk factor for T2DM worldwide. Other risk factors included dietary risks, environmental or occupational risks, tobacco use, low physical activity, and alcohol use.⁵

According to the Centers for Disease Control and Prevention (CDC) National Diabetes Statistics Report (2023), in the United States in 2019, 8.7% of the population had diagnosed diabetes. Its prevalence also varied by ethnicity⁶:

Native Americans and Alaska Natives 14.5%
Non-Hispanic blacks 12.1%
Hispanics 11.8%
Non-Hispanic Asians 9.5%
Non-Hispanic whites 7.4%.

People with less than a high school education were more likely to have diabetes (13.4%) than those with a high school education (9.2%) and those with more than a high school education (7.1%). Below the federal poverty level, the prevalence was 13.7% for men and 14.4% for women. The percentages vary depending on the affected individuals’ eating and exercise habits, age, ethnicity, culture, location, education level, and economic status.⁶

Diagnosis

According to the American Diabetes Association (ADA) Professional Practice Committee Classification and Diagnosis of Diabetes, clinicians diagnose T2DM according to one of the following criteria⁷:

A fasting plasma glucose level of 126 mg/dL (7 mmol/L) or higher
A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-gram oral glucose tolerance test
A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
A HbA1c level of 6.5% (48 mmol/mol) or higher.

Glycemic Goals

Clinicians in all walks of practice use guidelines to monitor glycemic status in patients with diabetes. Assessing glycemic status at least two times annually in patients who have stable glycemic control is sufficient. Assessment of glycemic status involves one or more of the following⁸:

Monitoring HbA1c status
Employing a continuous glucose monitoring device with time in range monitoring
Using a device containing a glucose management indicator.

The ADA recommends quarterly HbA1c monitoring for those with less stable glycemic control.^8,9 The HbA1c goal for most nonpregnant adults is 7% if the patient experiences no significant hypoglycemia. If the patient uses ambulatory glucose management, a target goal of 6.5% may be suitable. Less stringent HbA1c goals of up to 8% may be appropriate for patients with limited life expectancy or if treatment harm outweighs its benefits. When patients experience unexplained hypoglycemia, providing prompt hypoglycemia avoidance education or raising the glycemic targets are essential interventions, especially in patients with low cognition or declining cognition.⁹

COMMON COMORBIDITIES

Frequently, patients with T2DM have comorbidities. A review study analyzed patients with T2DM at varying times from diagnosis to identify the dominant multimorbidity cluster types. The study found that three condition clusters appeared consistently^10-13:

Cardiometabolic precursor conditions are common at diagnosis of T2DM
- Disorders of lipid metabolism (hyperlipidemia)
- Obesity
- Hypertension

Vascular conditions are usually associated with later stage T2DM
- Coronary artery disease (which can lead to heart failure)
- Chronic kidney disease
- Peripheral vascular disease (including peripheral arterial disease)
- Stroke (a manifestation of cerebrovascular disease)
- Atrial fibrillation

Mental health conditions occur regardless of diabetes duration
- Depression (the second most common condition in females after hypertension)
- Severe mental illness

DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT

Diabetes Self-Management Education and Support (DSMES) is an essential component of diabetes treatment. Support from the healthcare professional team augments patients’ necessary knowledge and skills. The four critical times to evaluate the need for DSMES are¹⁴:

at diagnosis
annually and/or when not meeting treatment targets
when compelling factors develop
when transitions in life or care occur.

Collaboration between patients and the healthcare team provides patient-centered DSMES. Thorough DSMES includes counselling on nutrition, physical activity, and psychosocial issues. Digital coaching and self-management interventions can be the means to deliver education and support.¹⁴

Diabetes self-management training (DSMT) is the reimbursable component of DSMES. A health care professional who is a certified Diabetes Care and Education Specialist (CDCES) —generally a dietitian, nurse or pharmacist— administers the DSMT. DSMT covers blood glucose monitoring, physical activity, healthy eating, medication, coping, problem solving.¹⁵

PAUSE AND PONDER: What lifestyle behaviors are fueling the diabetes epidemic?

Nutritional Therapy

Compelling evidence supports nutrition therapy’s efficacy and cost-effectiveness as a component of the medical management of T2DM.¹⁶According to the CDC, a registered dietitian or nutritional professional provides medical nutrition therapy (MNT). MNT focuses solely on diet. Education should encompass in-depth, individualized nutritional assessment and follow-up with repeated reinforcement to aid with behavior change.¹⁷ MNT encourages a diet rich in non-starchy vegetables, whole foods, and limited added sugars and refined grains. Increasing dietary fiber intake is beneficial, as diets high in fiber may lower HbA1c moderately. Minimizing carbohydrate intake improves glycemia. Diets higher in unsaturated fats than carbohydrates improve glycemia, triglycerides, HDL-C, and LDL-C in patients with cardiovascular disease and kidney disease.¹⁶

Caloric goals with an overall energy deficit (calories in are less than calories expected) promoting 5% weight loss have shown clinical benefit in reducing HbA1C. The goal for optimal outcomes in T2DM is to reduce body weight by 15%.¹⁶Dietary intervention can lead to disease remission, defined as sustained HbA1c levels below 6.5% for three months. Those diagnosed with type 2 diabetes for four years or fewer are more likely to achieve remission through diet. However, interventions accompanied by other lifestyle changes can be more effective than diet alone.¹⁸

Physical Activity

The World Health Organization (WHO) recommends adults engage in at least 150 to 300 minutes of moderate-intensity or 75 to 150 minutes of vigorous-intensity physical activity, or a combination of both, per week. Additionally, the WHO recommends reducing sedentary behaviors across all age groups and abilities.¹⁹

According to the CDC, moderate-intensity physical activity includes brisk walking, light yard work, light snow shoveling, biking, or playing with children. Ideally, patients’ heart rates will be 64% to 76% of their maximum. (To calculate actual beats per minute, patients subtract their age from 220, then multiply by 0.64 for the lower limit and by 0.76 for the upper limit.) Vigorous-intensity (high-intensity) exercise is jogging, swimming, rollerblading, cross country skiing, competitive sports, or jumping rope. Ideally, patients’ heart rate will be 77% to 93% of their maximum heart rate. (Calculation of the beats per minute is the same as above using 0.77 and 0.93 as the multipliers.)²⁰

Physical exercise has a positive effect on glycemic control. One study compared baseline glycemic levels with those measured after 30 minutes of moderate exercise before breakfast for three consecutive days. The study found that blood glucose levels were less variable throughout the day after morning exercise.²¹In patients with impaired fasting glucose, progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.²² High intensity exercise improves HbA1c more than moderate- or mild-intensity exercise.²³

Researchers conducted an 8-year study of 30 patients with T2DM in which participants engaged in three 90-minute sessions of aerobic exercise per week. The exercise program included a 15-minute warm up and cool down period. During the aerobic period, participants’ exercise intensity gradual increased from 50% to 80% maximum heart rate. Study participants had significantly reduced HbA1c and BMI. Participants also had significantly improved oxygen utilization. The researchers reported a HbA1c significant decrease of 1.39% among the experiment group.²⁴

Physical activity may be the most underutilized tool in T2DM management. Physical activity improves cardiorespiratory fitness, reduces insulin resistance and insulin levels, improves lipid profiles, reduces visceral adipose tissue, and lowers blood pressure, decreasing cardiovascular risk.²⁵ Due to exercise’s overwhelming benefit, developing a structured exercise plan for patients diagnosed with T2DM is a key responsibility for healthcare teams. Ideally, the healthcare care team would include an exercise physiologist.²⁵

PAUSE AND PONDER: What self-care behaviors contribute to effective T2DM self-management?

Psychosocial Support

Up to 19% of patients with diabetes experience mental health symptoms. Depression is common, especially in women. Early detection and treatment of mental health comorbidities can reduce their impact on health outcomes. Mortality risk is higher in patients with mental health comorbidities, especially in those with substance use disorder and schizophrenia. Mental health comorbidities also increase the likelihood of all-cause hospitalization.²⁶

Experts agree that collaborative patient-centered approaches to psychosocial care are best; such approaches include assessing patients for depression, anxiety, disordered eating, and cognitive capacities. Psychosocial screening and follow-up may include attitudes about diabetes, expectations for medical management, and outcomes.⁸

The Association of Diabetes Care and Education Specialists has identified seven self-care behaviors that contribute to effective self-management of diabetes and related conditions through improved behavior²⁷:

being active
healthy coping
healthy eating
monitoring
problem solving
reducing risk
taking medication

Well-educated patients can contribute to their diabetes management with self-care behaviors. Monitoring health metrics like blood glucose, blood pressure, physical activity, diet, weight, medication adherence, mood, and sleep empower diabetes patients and improve outcomes.²⁷Higher medication adherence, as would be expected, is associated with improved glycemic control, fewer emergency department visits, decreased hospitalizations, and lower medical costs.²⁸Patients sharing data with the healthcare team can fuel discussion to find solutions, reduce risk, and improve personalized therapy plans.²⁷

PHARMACOLOGIC THERAPY

First line therapy for T2DM depends on comorbidities, patient-centered treatment factors, and management needs. It frequently includes metformin and comprehensive lifestyle modification. If the patient has atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and/or chronic kidney disease (CKD) then appropriate initial medical therapy may include glucagon-like peptide 1 (GLP-1) receptor agonists and sodium-glucose cotransporter 2 (SGLT-2) inhibitors with or without metformin. Prescribers may continue metformin upon initiation of insulin therapy for ongoing glycemic and metabolic benefits.⁸

Metformin

Apothecaries have used metformin medicinally for centuries. It is a guanidine derivative found in Galega officinalis, a plant called goat’s rue. Metformin was isolated and introduced in Europe in the 1950s and the United States in the 1990s.²⁹ Metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin does not cause hypoglycemia and patients generally tolerate it well. The most common adverse effect is diarrhea, resulting in 6% of patients discontinuing therapy. Other common adverse effects include nausea/vomiting, flatulence, asthenia, indigestion, and abdominal discomfort. Precautions include the potential for lactic acidosis, especially in patients with the following risk factors³⁰:

Renal impairment
Hepatic impairment
Heart failure
Hypoxic states
Excessive alcohol intake
Radioactive dye studies
Restricted food and fluid intake

Metformin may interfere with vitamin B₁₂ absorption. Approximately 7% of patients become deficient. Supplementation with vitamin B₁₂ is appropriate if deficits develop.³⁰

Metformin can reduce HbA1c by 1.8% and lower the amount of insulin required to achieve glycemic targets by 19%.³¹ Initial dosing is 500 mg twice daily, or 850 mg daily, increasing as tolerated by 500 mg weekly to a maintenance dose of 1000 mg twice daily in patients with normal renal function. The maximum recommended dose is 2,550 mg per day. Monitoring fasting plasma glucose during initiation and dose titration aids in determining therapeutic response. Maintenance measurement of HbA1c levels should occur every three months.³⁰Renal function is an important factor in metformin use. The recommended eGFR threshold for initiation of metformin is 45 mL/min. If, during therapy, the eGFR falls below 45 mL/min, the team need to assess the benefit of continued therapy. Use is contraindicated in patients with an eGFR below 30 mL/min.³⁰

INSULIN THERAPY

ADA Standards of Care recommend early introduction of insulin if clinicians see evidence of ongoing weight loss, symptoms of hyperglycemia, HbA1c levels exceeding 10%, or blood glucose levels of 300 mg/dL or higher. The potential for over-basalization (titration of basal insulin beyond an appropriate dose in an attempt to achieve glycemic targets) exists with insulin therapy. Signs of over-basalization may include a basal dose exceeding 0.5 units/kg/day, high bedtime-morning or post-prandial glucose differential, hypoglycemia, and high glycemic variability.⁸

When caring for hospitalized patients with diabetes, basal insulin or a basal plus bolus correction insulin is the preferred treatment for noncritically ill patients with poor oral intake. The standards prefer an insulin regimen with basal, prandial, and correctional components in patients with good nutritional intake. In many hospital settings, the basal and prandial doses are weight-based, and a correctional scale is added to scheduled mealtime doses to correct for pre-meal hyperglycemia.

It’s critical to initiate insulin therapy for persistent hyperglycemia at a threshold of 180 mg/dL or more, confirmed on two occasions. After initiating insulin, the current Standards of Care recommend a target glucose range of 140 to 180 mg/dL for most patients. More stringent goals, such as 110 to 140 mg/dL, may be appropriate for select patients if they do not exhibit significant hypoglycemia. The ADA defines hyperglycemia as blood glucose levels over 140 mg/dL in the hospital, and hypoglycemia as blood glucose below 70 mg/dL. Monitoring glucose every four to six hours or every two hours for an insulin infusion is best. Each hospital or hospital system should implement hypoglycemic management protocols.⁸

TREATMENT RECOMMENDATIONS IN COMMON COMORBIDITIES

Obesity

High BMI is the primary risk factor for T2DM.⁵Diabetes was the second leading cause of BMI-related deaths in 2015 globally.³² The DIRECT trial showed a T2DM remission rate of 36% after 24 months in patients receiving structured support for initial weight loss and weight loss maintenance.³³The 2022 ADA Standards of Medical Care in Diabetes categorize obesity treatment options based on BMI⁸:

Nonpharmacologic strategies may be sufficient for those with BMI 25 to 26.9
Providers should consider adding pharmacotherapy for those with a BMI of 27 to 29.9
For those with a BMI exceeding 30 (or for Asian Americans with BMI 27.5 and over), patients and their treatment teams might consider metabolic surgery

The Standards of Care in Diabetes stress a minimum of 5% weight loss for most people with T2DM. It is important to include counseling with two to three monthly sessions focusing on dietary changes, physical activity, and behavioral strategies to achieve a 500 to 750 kcal/day energy deficit. Person-centered, nonjudgmental language, specifically “person with obesity” rather than “obese person,” fosters collaboration between patients and providers. Consideration of the medication’s effect on weight gain is important.⁸ Metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors, and amylin mimetics promote weight loss.³⁴

As of November 2023, three FDA-approved obesity medications also have FDA approval for treating T2DM. These are the GLP-1 agonists liraglutide, semaglutide, and tirzepatide.^35,36Dosages are as follows^37-39:

Liraglutide (Saxenda) has an initial dose of 0.6 mg/day with a maintenance dose of 3 mg/day
Semaglutide (Wegovy) has an initial dose of 0.25 mg/week with a maintenance dose of 2.4 mg/week
Tirzepatide (Zepbound) has an initial dose of 2.5 mg/week with a maintenance dose of 5 to 15 mg/week

The FDA has approved these medications for weight loss in patients with a BMI of 30 or above or BMI of 27 or above with a comorbidity including hypertension, T2DM, or dyslipidemia.^37-39 These drugs lower glucose by stimulating insulin secretion from pancreatic islets in response to oral glucose load, like the natural hormone incretin. They delay gastric emptying, suppress appetite, increase satiety, decrease inappropriate glucagon secretion, and promote beta cell proliferation.^40,41

Clinical data for the GLP-1 medications in weight loss is impressive. The SCALE trial has shown that the absolute weight loss with liraglutide 3 mg daily in patients with T2DM is 5.6 kg (12.3 lbs) over 56 weeks.⁴²The absolute weight loss associated with semaglutide 2.4 mg weekly in obese patients or overweight patients with at least one risk factor is 12.7 kg (28 lbs) over 68 weeks.⁴³Diabetic patients treated with tirzepatide 5, 10 or 15 mg weekly for 72 weeks lost an average of 12% body weight compared to placebo.³⁹ These medications contain warnings and precautions for thyroid C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia with some T2DM medications, kidney injury, hypersensitivity reactions, and suicidal ideation.^37-39 The labeling for semaglutide and tirzepatide carries a precaution for diabetic retinopathy.^38,39 A precaution for heart rate increase is included in the labeling for liraglutide and semaglutide.^37,38 Most patients find these drugs have overwhelming benefits with primarily gastrointestinal adverse effects.^36-38

Providers may consider metabolic surgery for T2DM treatment in adults with a BMI of 30 and over (or for Asian Americans with a BMI of 27.5 and greater). Metabolic surgery refers to surgical organ modification; bariatric surgery, for example, is metabolic surgery for treatment of obesity (commonly known as a gastric bypass). A high-volume surgical center with experienced multidisciplinary teams knowledgeable about obesity management, diabetes, and gastrointestinal surgery is the best choice. Access to long-term medical, nutritional, and behavioral support after the procedure optimizes recovery. Patients may benefit from continuous glucose monitoring as an important adjunct, especially for those with episodes of hypoglycemia. After surgery, the clinical team should provide patient support, including mental health services.⁴⁴

Bariatric surgery is an effective treatment option in T2DM patients with obesity. In a recent study, after a median follow-up of 19 months post-surgery, 68 of 105 obese patients achieved diabetes remission. Study participants had a median BMI of 42.4 and a diagnosis of T2DM before the procedure. Patients taking multiple glucose-lowering medications or dependent on insulin or SGLT2 inhibitors were less likely to undergo complete remission. A longer duration of T2DM pre-operatively was a negative predictor of remission.⁴⁵

PAUSE AND PONDER: Which classes of diabetes medications are best for patients with ASCVD?

Cardiovascular Disease

All diabetic patients require yearly assessment of HF and ASCVD (coronary artery disease, cerebrovascular disease, or peripheral arterial disease). Hypertension, dyslipidemia, and diabetes are risk factors for ASCVD. Controlling cardiovascular risk factors can prevent or slow ASCVD in people with diabetes.⁴⁶

Prescribers should consider the presence of coronary artery disease in patients exhibiting atypical cardiac symptoms, signs of vascular disease, or electrocardiogram abnormalities. Atypical cardiac symptoms include unexplained dyspnea or chest discomfort. Carotid artery stenosis, transient ischemic attack, stroke, and peripheral arterial disease are indicators of ASCVD.⁴⁶

In T2DM patients with established ASCVD or kidney disease, current ADA Standards of Medical Care suggest an SGLT-2 inhibitor or GLP-1 receptor agonist with demonstrated cardiovascular disease benefit (see Table 1 and Table 2). A quick review of FDA indications and landmark trials ensures the correct medication and dose have been chosen as newer agents continue to emerge with indications that may encompass weight loss and treatment of T2DM. To reduce the risk of adverse cardiovascular and kidney events, patients with T2DM and established ASCVD may benefit from combined therapy with an SGLT-2 inhibitor and a GLP-1 receptor agonist with demonstrated cardiovascular benefit.⁴⁶

Table 1. Landmark Trials for SGLT-2 Inhibitors Evaluating T2DM with Cardiovascular Disease^47-50

Trial	Drug	Outcome
EMPA-REG OUTCOME	Empagliflozin 10-25 mg daily	Reduction in major adverse cardiovascular events; Reduction in hospitalization for heart failure
CANVAS	Canagliflozin 300 mg daily goal	Reduction in major adverse cardiovascular events; Reduced hospitalization for heart failure and cardiovascular death
DECLARE-TIMI 58	Dapagliflozin 10 mg daily	Reduction in heart failure-related death and hospitalization; Reduction in renal events

The SGLT-2 inhibitors’ primary mechanism of action is reduction of renal tubular glucose reabsorption at the proximal tubule resulting in glucosuria.⁵¹ The SGLT-2 inhibitors’ glucose-lowering efficacy decreases with increasing renal impairment.⁵² Most patients tolerate these medications well, with mild adverse effects. The proposed cardiovascular benefits include improved, blood pressure reduction, inflammation reduction, diuresis, inhibition of nervous system, and prevention of cardiac remodeling (physical changes to heart).⁴⁷ Their adverse effects include genitourinary infections, intravascular volume depletion, increased risk of diabetic ketoacidosis, and potentially an increased risk of lower limb amputations.⁵² Prescribers need to hold SGLT-2 inhibitors during acute illness (hospitalization), when fluid intake is inadequate, or if acute kidney injury occurs.⁴⁷

Pancreatic hormones and incretin hormones regulate glycemic homeostasis. GLP-1 is an incretin hormone that increases pancreatic insulin release and decreases glucagon release.⁴¹ The GLP-1 receptors are located in the renal proximal convoluted tubular cells and preglomerular vascular smooth muscle cells in the kidneys.⁵³ The GLP-1 receptor agonists lower HbA1c, weight, and blood pressure.⁵⁴

GLP-1 receptor agonists promote natriuresis (increased sodium in the urine), lowering blood pressure.⁵⁵ GLP-1 receptor agonists also reduce reactive oxygen production, thereby reducing platelet activation, macrophages, and monocytes in the vascular wall. Stabilization of the endothelial cells occurs with less plaque hemorrhage and rupture.⁵⁶ Overall, GLP-1 enhancement results in a slower progression of atherosclerosis.⁵⁷

Table 2. Landmark Trials for GLP-1 Agonists: Evaluating T2DM with Cardiovascular Disease^57-60

Trial	Drug	Outcome
REWIND	Dulaglutide 1.5 mg once a week	Reductions in major adverse cardiovascular events
SUSTAIN-6	Semaglutide 0.5 or 1 mg once a week	Relative risk reduction in major adverse cardiovascular events
LEADER	Liraglutide 1.8 mg (or max dose tolerated) daily	Relative risk reduction in major adverse cardiac events and cardiovascular death

In T2DM patients with a history of ASCVD, aspirin 75 mg to 162 mg daily is a secondary prevention strategy. In patients with documented aspirin allergies, clopidogrel 75 mg daily is an alternative. Patients with stable coronary and or peripheral artery disease and a low bleeding risk should take dual antiplatelet therapy for at least one year following acute coronary syndrome. Aspirin and low dose rivaroxaban can prevent major adverse limb and cardiovascular events.⁶¹

Hypertension

Hypertension exacerbates cardiovascular disease, which is the major cause of morbidity and mortality in diabetes.⁶² In 2023, the ADA updated the hypertension criteria. According to the 2023 Standards of Care in Diabetes recommendations, patients are hypertensive if they exhibit a sustained blood pressure of 130/80 mm Hg or more, or a single level of 180/110 or more. The target goal is 130/80 mm Hg or less. Blood pressure targets below 120/80 mmHg are associated with hypotensive adverse events (such as falls). Patients with diabetes who are hypertensive should monitor their blood pressure at home. Patients with blood pressures exceeding 120/80 should implement lifestyle interventions including diet changes and weight loss, reduced sodium and increased potassium intake, moderation of alcohol, and increased physical activity.⁶¹ Treatment of hypertension reduces cardiovascular events and microvascular complications.^63,64

In patients with persistently elevated blood pressure, pharmacologic therapy in addition to lifestyle modifications improves outcomes. First-line pharmacologic therapy includes use of an angiotensin-converting enzyme inhibitor (ACEi), or an angiotensin receptor blocker (ARB). Clinical trials assessing these drugs demonstrate a reduction of cardiovascular events in T2DM patients with coronary artery disease. Prescribers should maximize doses for patients with a urine-to-creatinine ratio greater than 30 mg/g creatinine, as this is a sign of kidney damage. If the patient does not tolerate one drug class, the prescriber may switch to the other; however, the prescriber should not use them together. Annual monitoring of glomerular filtration rate (GFR) and serum potassium are needed.⁶¹

Prescribers should start their patients on two medications if they have a confirmed office blood pressure of 160/100 mm Hg or more.⁶¹ Common therapies include thiazide-like diuretics and dihydropyridine calcium channel blocker.⁶⁵ Patients on triple antihypertensive therapy including a diuretic with unmet blood pressure goals may require a mineralocorticoid receptor antagonist, such as spironolactone.⁶⁶ Adding a mineralocorticoid receptor antagonist may increase the risk of hyperkalemia. Regular monitoring of serum creatinine and potassium is prudent.⁴⁶

In the absence of albuminuria, ACEi and ARBs may not provide superior cardio-protection over thiazide-like diuretics or dihydropyridine calcium channel blockers.⁶⁷ Patients who have had a prior myocardial infarction, active angina, or HF with reduced ejection fraction (HFrEF) should be treated with a beta blocker. However, beta blockers do not reduce mortality when used as antihypertensives in the absence of these conditions.^54,68

Hyperlipidemia

Reduction of lipids and cholesterol is important because hyperlipidemia is a risk factor and common comorbidity for T2DM. Lifestyle modification focusing on weight loss is the first step of lipid management. Trained nutritionists can educate patients to eat a diet low in saturated fat and trans-fat. The goal is a diet that increases dietary n-3 fatty acids, viscous fiber, and plant stanols/sterols. Physical activity also helps improve lipid profiles. The importance of lifestyle therapy and glycemic optimization for triglycerides of 150 mg/dL or greater, and/or HDL equal to or less than 40 mg/dL for men and 50 mg/dL for women, cannot be understated. Lipid profiles at the time of diabetes diagnosis, at initiation of statin therapy or dose change, and annually thereafter are useful to monitor disease progression.⁶¹

Statin therapy has documented beneficial outcomes in patients with ASCVD.^69,70 The intensity of dosing is outlined below (see Table 3)⁶¹:

Patients with diabetes aged 40 to 75 without ASCVD should begin moderate-intensity statin therapy in addition to lifestyle therapy.
Patients with diabetes aged 40 to 75 years and multiple ASCVD risk factors should take high intensity statin therapy to reduce LDL cholesterol by at least 50% of baseline for an LDL target of less than 70 mg/dL.
Patients with diabetes and ASCVD should take high-intensity statin therapy. Prescribers may add ezetimibe or a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, such as alirocumab or evolocumab, to achieve a goal of LDL below 55 mg/dL and an LDL reduction of 50% or more.

Table 3. Once daily: High-intensity and Moderate-intensity Statin Therapy⁶¹

Moderate-intensity statin therapy	High-intensity statin therapy
Atorvastatin 10–20 mg	Atorvastatin 40–80 mg
Rosuvastatin 5–10 mg	Rosuvastatin 20–40 mg
Simvastatin 20–40 mg
Pravastatin 40–80 mg
Lovastatin 40 mg
Fluvastatin (extended release) 80 mg
Pitavastatin 1–4 mg

Heart Failure

HF is a major cause of morbidity and mortality from cardiovascular disease. Recent studies indicate that people with diabetes have twice the risk of hospitalization due to HF compared to those without, after adjusting for age and sex.^71,72 Patients with established T2DM have a 33% greater risk of hospitalization for HF.⁷¹

HF is staged as A to D. Stage A HF indicates risk for developing HF. All patients with established diabetes are in the stage A category and at heightened risk for progression to later stages of HF. Stage B HF is asymptomatic with structural heart disease, abnormal cardiac function, or elevated cardiac biomarkers. Prescribers should monitor biomarkers, natriuretic peptide (BNP), or high sensitivity cardiac troponin yearly to detect subclinical HF in individuals with diabetes. Monitoring helps identify those in stage A or B HF who are at the highest risk of progressing to symptomatic HF. Useful cutoff values for these indicators are a BNP of 50 pg/mL and a NT-proBNP of 125 pg/mL.⁷³

Individuals considered to be at stages C and D have had or are experiencing symptomatic HF. Common symptoms are exertional dyspnea (shortness of breath), fatigue and edema that reflect fluid retention, congestion, and low cardiac output. Laboratory evaluations for patients with HF include natriuretic peptide, complete blood count, urinalysis, serum electrolytes, blood urea nitrogen, serum creatinine, glucose, fasting lipid profile, liver function, and thyroid stimulating hormone. Additionally, prescribers should order a chest x-ray and 12 lead electrocardiogram.⁷³

In stage A or B HF patients with diabetes and hypertension, medical therapy includes an ACEi or ARB. Clinical trials have found that treatment with a thiazide-type diuretic or an ACEi is more effective than treatment with a calcium channel blocker in preventing progression to symptomatic HF. Patients with diabetes and diabetic kidney disease (DKD) without symptomatic HF may benefit from finerenone, a nonsteroidal mineralocorticoid receptor antagonist.⁷³

Standards of Care recommendations for those with HFrEF and diabetes include an angiotensin receptor/neprilysin inhibitor (ARNI) or ACEi or ARB, beta blockers, mineralocorticoid receptor antagonist, and SGLT-2 inhibitor. In individuals with diabetes and HFrEF, including an ARNI (sacubitril/valsartan) instead of ACEi or ARBs is prudent. It is reasonable to consider treatment with spironolactone among individuals with heart failure with preserved ejection fraction (HFpEF) as well. Clinical trials have shown that treatment with an SGLT-2 inhibitor reduces HF hospitalizations.⁷²Individuals with high cardiovascular risk, including those with stage B HF and those with symptomatic HF, should take an SGLT-2 inhibitor. Prescribers may consider statins based on age and background risk factors. Treatment for patients requiring additional glycemic control may include a GLP-1 agonist, metformin, or both, or insulin. Current Standards of Care do not recommend the use of dipeptidyl peptidase-4 (DPP) inhibitors or thiazolidinediones in T2DM patients with stage B, C or D HF.⁷³

In addition to drug therapy, participation in cardiac rehabilitation is associated with improved patient outcomes. Cardiac rehabilitation involves exercise training, education, and emotional support. Key counseling points for patient with diabetes and HF are to minimize alcohol intake and avoid smoking. Weight loss improves cardiometabolic risk factors. Metabolic surgery can improve risk factors for HF in obese patients.⁷³

Chronic Kidney Disease

Diabetes is the leading cause of kidney disease in the developed world.⁷⁴ The presence of CKD markedly increases cardiovascular risk and health care costs.⁷⁵ Practitioners diagnose CKD primarily by sustained elevation of urinary albumin excretion and low estimated glomerular filtration rate (eGFR).⁷⁶

Recommendations include yearly assessment of eGFR and urinary albumin in all T2DM patients. In patients with established DKD, monitoring up to four times yearly may be necessary.⁷⁶ Consistent eGFR values less than 60 mL/min, in conjunction with a urinary albumin value over 30 mg/g creatinine defines an abnormal eGFR.⁷⁷ The definition of stage 1 and 2 CKD is high albuminuria with eGFR 60 mL/min or above. CKD stages 3-5 have progressively lower eGFR ranges.⁷⁸ At any eGFR, the degree of albuminuria is associated with risk of cardiovascular disease, CVD progression, and mortality.⁷⁵

Current ADA Standards of Care emphasize optimization of blood pressure and blood glucose to reduce the risk of and slow CKD progression.⁷⁶ ACEi or ARBs are the preferred first-line agents for blood pressure treatment in T2DM patients with hypertension and decreased eGFR.^79,80 The healthcare team needs to continue renin-angiotensin system blockade for increases in serum creatinine of 30% or less in the absence of volume depletion. In addition, it needs to monitor serum potassium levels when patients take ACE inhibitors, ARBs, or diuretics.⁷⁶

Recent trials show SGLT-2 inhibitor therapy reduces CKD progression and cardiovascular events in patients with CKD, T2DM, and an eGFR of 20 mL/min/1.73m² or greater.⁷⁶ SGLT-2 inhibitors reduce renal tubular glucose reabsorption, weight, systemic blood pressure, intraglomerular pressure, albuminuria, and slow GFR loss through mechanisms that are independent of glycemia.⁸¹ To minimize cardiovascular events, addition of a glucagon-like peptide 1 agonist may help, or a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) if eGFR is 20 mL/min/1.73m². For patients with urinary albumin of 300 mg/g or greater, reduction of at least 30% slows CKD progression.⁷⁶ Suggested daily protein intake in CKD stage 3 (non-dialysis) patients is 0.8 g/kg body weight per day. Higher levels of protein have been associated with increased albuminuria and more rapid kidney function loss.⁸² If the eGFR falls below 30, a nephrologist referral is needed.⁷⁶

Tables 4 and 5 list recent trials that support current ADA Standards of Care regarding treatment of diabetes in the presence of CKD.⁷⁶ In the CREDENCE trial, canagliflozin therapy reduced the development of ESRD by 32% in patients with CKD.⁸³ The DAPA-CKD trial studied dapagliflozin in CKD. Two thirds of the patients had a diabetes comorbidity. There was significant benefit for a decline in eGFR, ESRD or death from cardiovascular or renal causes.⁸⁴ The FIDELIO-DKD trial studied the nonsteroidal mineralocorticoid receptor antagonist, finerenone. The trial identified a significant reduction in DKD progression and cardiovascular events in people with advanced kidney disease. Participants took finerenone 10 to 20 mg daily. Evaluation after a mean of 3.4 years demonstrated a 23% reduction in the composite kidney outcome consisting of sustained decrease in eGFR of at least 57%.⁸⁵

Table 4. Landmark Trials for SGLT-2 inhibitors in renal disease^47,83,84,86

Trial	Drug	Outcome
CREDENCE	Canagliflozin 100 mg daily	Cardiovascular and renal protection
DAPA-CKD	Dapagliflozin 10 mg daily	Reduction of eGFR decline; Reduction of ESRD; Reduction of renal mortality
EMPA-KIDNEY	Empagliflozin 10 mg daily	Reduced progression of kidney disease; Reduced cardiovascular death

Table 5. Landmark Trials for GLP-1 Receptor Agonists in T2DM and Renal Disease^57,58,87,88

Trial	Drug	Outcome
AWARD-7	Dulaglutide 0.75 -1.5 mg once a week	Slower decline in eGFR. No change in urine albumin-creatine ratio
LEADER	Liraglutide 1.8 mg (or max dose tolerated) daily	Reduced the development and progression of diabetic kidney disease
REWIND (analysis)	Dulaglutide 1.5 mg once a week	Relative risk reduction in composite renal outcome

CONCLUSION

T2DM is indeed a growing epidemic fueled by an unhealthy diet and a sedentary lifestyle.¹ A prescription is only a partial answer to a multifactorial problem. This is why the ADA Standards of Care for diabetes incorporate a multidisciplinary approach focusing on individuals, their current disease states, and preventive measures for disease progression. Recommendations emphasize the importance of self-management, education, and support. Nutritional therapy, physical activity, and psychological support are key elements. Effective weight management is a powerful tool for managing or even reversing T2DM. Current therapy recommendations also incorporate the use of cardiovascular protective medications with demonstrated efficacy for ASCVD.⁸

Due to the high prevalence of comorbid conditions associated with T2DM, it is fortunate that the SGLT-2 inhibitors and GLP-1 receptor agonists are a resource for patients with T2DM comorbidities. These agents improve cardiovascular function and are compatible with guideline-based preventive recommendations for blood pressure, lipids, glycemia, and antiplatelet therapy.^51,89 Diabetes treatment has entered a new era of understanding. The overwhelming data favors addressing the whole patient including lifestyle, education, weight loss options, and cardiovascular related comorbidities. The new ADA Standards of Medical Care provide clinicians with the knowledge and tools to treat the growing diabetic epidemic.

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

Post-test Questions for Pharmacists

Learning Objectives (pharmacists)
● Describe type 2 diabetes diagnostic criteria and glycemic targets
● Identify the components of diabetes self-management education and support
● Recognize the importance of an individualized treatment program
● List treatment recommendations for diabetes type 2 in the setting of common comorbidities

1. Which of the following is TRUE about the incidence of the global diabetes epidemic?
a. The incidence has quadrupled in the past three decades with a current estimate of about 1 in 11 adults affected worldwide
b. The incidence has doubled in the past four decades with a current estimate of about 1 in 15 adults affected worldwide
c. The incidence has tripled in the past decade with a current estimate of about 1 in 8 adults affected worldwide

2. Which group of people is LEAST LIKELY to be diagnosed with diabetes in the US?
a. Those below the federal poverty level
b. Native Americans and Alaska natives
c. Non-Hispanic whites with college degrees

3. According to ADA Standards of Medical Care in Diabetes, pharmacologic therapy options for patients with HFrEF and diabetes may include all of the following drug classes EXCEPT?
a. ARNI
b. SGLT2 inhibitor
c. DPP-4 inhibitors

4. What is the focus of DSMES?
a. Nutrition, relaxation, and psychosocial issues
b. Nutrition, physical activity, and psychosocial issues
c. Physical therapy, psychotherapy, and natural dietary supplements

5. Which of the following statements about diet is TRUE?
a. Diet as a primary intervention for T2DM can achieve remission, defined as sustained HbA1c levels under 6.5% for 3 months
b. Diets low in fats and higher in carbohydrates are recommended for those with T2DM due to the risk of cardiovascular disease
c. Sustaining calorie intake and monitoring blood glucose levels is often the best course of action for those recently diagnosed with T2DM

6. Which statement is true regarding physical activity and diabetes?
a. The World Health Organization guidelines state that those with diabetes should exercise less than 75 minutes per week.
b. Aerobic exercise before breakfast increases blood glucose levels.
c. In patients with impaired fasting glucose progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.

7. Which of the following self-care behaviors is an effective self-management tool for diabetes?

a. Healthy coping, healthy eating, being active, taking medication, monitoring, reducing risk, and problem solving
b. Healthy coping, healthy eating, resting, taking medication, monitoring, reducing risk, and spending time with family
c. Healthy coping, healthy eating, being active, taking medication, monitoring, reducing risk, and allowing your doctor to decide the best way for you to manage your diabetes independently

8. Which statement best defines the current ADA Standards of Medical Care in Diabetes recommendations?
a. All diabetic patients should follow a step-up drug therapy algorithm developed by the American Diabetes Association to meet glycemic targets.
b. Regardless of comorbidities, initial treatment of T2DM should include hypoglycemic agents such as sulfonylureas supplemented by insulin, if needed, to achieve a HgA1c of 7% or lower
c. First line therapy for T2DM depends on comorbidities, patient centered treatment factors and management needs.

9. Under what circumstances should initial treatment include insulin?
a. If there is ongoing weight loss, symptomatic hyperglycemia, A1C levels over 10%
b. If there is fluid overload, symptomatic hypoglycemia or A1C levels over 8%
c. If the patient has chronic kidney disease, heart failure or chronic obesity

10. For a patient with diabetes whose eGFR > 20, which comorbidity would benefit most from a medication regimen containing an ACEi, SGLT2 inhibitor, and a GLP-1 agonist or a nsMRA?

a. Chronic kidney disease
b. Hypertension
c. Hyperlipidemia

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

Post-test Questions for Pharmacy Technicians

Learning Objectives (technicians)
● Describe type 2 diabetes diagnostic criteria and glycemic targets
● Identify the components of diabetes self-management education and support
● Recognize the importance of an individualized treatment program
● List common comorbidities in type 2 diabetes

3. Which laboratory data would lead to a positive diagnosis of diabetes?
a. A hemoglobin A1c level of 6.0%
b. A 2-hour plasma glucose level of 200 mg/dL or higher during a 75 gram oral glucose tolerance test
c. A fasting plasma glucose level of 120 or higher

6. Which statement is true regarding physical activity and diabetes?
a. The World Health Organization guidelines state that those with diabetes should exercise less than 75 minutes per week.
b. Aerobic exercise before breakfast has increases blood glucose levels.
c. In patients with impaired fasting glucose progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.

7. Which of the following self-care behaviors is an effective self-management tool for diabetes?

8. According to the new 2023 ADA Standards of Medical Care in Diabetes, patients are hypertensive if they exhibit a sustained blood pressure above which level?
a. 140/90 or more
b. 130/80 or more
c. 120/80 or more

9. Which of the following lists accurately describes the most common comorbidities in type 2 diabetes?

a. Cardiometabolic, vascular, and mental health conditions
b. Cardiometabolic, vascular, and dermatologic conditions
c. Cardiac, gastrointestinal, and mental health conditions

10. How much more is risk of heart failure hospitalization in people who have type 2 diabetes?

a. 33%
b. 50%
c. 77%

References

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Law: People are not Cows and Off-label Prescribing is Utterly Different – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-018-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.

1. Off label drug uses generally do not become on-label uses. What is a primary reason for this?
A. There is a financial disincentive to manufacturers.
B. The FDA has no easy mechanism to accomplish this.
C. Manufacturers want to emphasize their drug’s primary.

2. You have a sick cow. Which of the following is correct about the type of drug that can be used for treatment?
A. Any drug approved by the FDA for human use.
B. A drug approved for use in chickens if there is no comparable drug approved for cows.
C. A drug that can be compounded by a pharmacist and added to the cow's feed.

3. What category of drugs has the highest rate of off-label use? (Prior to the pandemic.)
A. Anti-seizure drugs
B. Anti-depressants
C. Antibiotics
4. Why does the FDA take a hands-off approach to off-label use?
A. The FDA is not permitted to prevent manufacturers from touting an unapproved use once a drug has been approved.
B. The FDA does not regulate the practice of medicine.
C. The FDA can only act after it receives information of unintended consequences from off-label use.

5. When may a pharmacist recommend an OTC human drug for an animal?
A. Under any circumstances so long as it is not a food animal.
B. When there is no comparable veterinary product available.
C. A pharmacist may not recommend a human OTC drug for use in an animal.

6. Which of the following is a notable risk associated with illicit use of xylazine?
A. Naloxone-resistant overdose
B. Whole body rash and desquamation
C. Respiratory depression

7. The FDA was sued for publishing a warning about the off-label use of ivermectin for COVID. What was the basis of the lawsuit?
A. The FDA cannot prevent physicians from prescribing a drug off-label and need not issue warnings.
B. The FDA's warning on ivermectin was erroneous and used misplaced humor to try to sway opinions.
C. In publishing warning overstepped the FDA’s authority and interfered with the doctor-patient relationship.

The Human-Animal Bond: How Close Is Too Close? – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-021-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.

The Human-Animal Bond: How Close is Too Close?

Recognize and describe different zoonotic diseases: Rabies, Lyme Disease, Ringworm (Dermatophytosis), Leptospirosis, Giardia, and Toxoplasmosis
Describe method of transmission of each disease
List the treatment of each disease (if possible)
Indicate the species of animal that can harbor the disease
Describe how to prevent the disease

1. At what age is the earliest a dog or cat can receive the rabies vaccination?
A. 8 weeks
B. 6 months
C. 12 weeks

2. What is the symptom of Lyme Disease in dogs that owners tend to notice first?
A. Shifting lameness
B. Vomiting
C. Increased thirst and urination (PUPD)

3. What is the best way to prevent most zoonotic infections?
A. Avoid wildlife
B. Use essential oils
C. Wash your hands

4. What antibiotic do veterinarians use most often to treat Spirochete bacterial infections?
A. Doxycycline
B. Clindamycin
C. Amoxicillin-clavulanic Acid

5. How are most zoonotic intestinal parasites are spread?
A. Aerosolized
B. Infection through break in the skin
C. Fecal-oral

6. What zoonotic disease causes an itchy, circular red lesion on the skin?
A. Lyme disease
B. Ringworm
C. Leptospirosis

7. What species most commonly carries toxoplasma?
A . Cats
B. Dogs
C. Ferrets

Compounding: Go Hog Wild: Creative (and Informed) Veterinary Compounding – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-019-H07-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.

1. Farmer Brown's large Maine Coon cat needs fluoxetine. Considering size, anatomy, and skin absorption, which animal would require a similar dose of fluoxetine transdermal gel?
A . A small terrier dog
B. A medium sized sphinx (hairless) cat
C. A large barn owl

2. Meow-Meow is a domestic American cat. She weighs 6.3 pounds, although she needs to gain at least 3 pounds. She needs medication for her heart condition, and the veterinarian wants to prescribe lisinopril 0.25 mg/kg once daily. YIKES! You calculate that Meow-Meow weighs 2.9 kg and needs a dose of 0.725 mg of lisinopril. Can you compound this dose?
A. No, the veterinarian needs to find a different medication
B. Yes, but it would be easier to give 1.5 mg every other day
C. Yes, because a commercial product is unavailable in this strength

3. Your 30-pound hound, Bosco, is begging to eat the food you left on your plate after dinner. In keeping with your house rule never to feed the dog from the table, you take your plate to the sink and get Bosco’s bowl. Which of the following things should you throw in the trash rather than feed to Bosco?
A. The piece of grilled, boned ribeye steak
B. The grapes and raisins on the salad
C. The plain baked potato with yogurt

4. Your client, Venice Marriot, needs to have a medication compounded for her teacup chihuahua Tokyo. She indicates that she and Tokyo prefer medications that are pink. After discussing the pros and cons of compounding with color, which food coloring should you use to make a pink oral solution?
A. Natural beet extract
B. FD&C Red No. 3
C. Neither

5. Which of these basic oral paste formulas would be best to use for Farmer Brown’s cat?
Ingredient Formula 1 Formula 2 Formula 3
Polyethylene glycol 300 65 grams 25 grams
Polyethylene glycol 3350 35 grams 25 grams 25 grams
Propylene glycol 50 grams 25 grams
Molasses (for horses) 50 grams

A. Formula 1
B. Formula 2
C. Formula 3

6. Which flavoring would be best suited for a picky Emperor penguin at Mystic Aquarium?
A. Orange or mango flavoring
B. Sardine or tuna flavors
C. Beef or liver flavoring

7. What Is the BEST way to improve pharmacy personnel’s knowledge of veterinary medications?
A. Pharmacies can be sure to have a veterinary drug handbook at the pharmacy and that the computer system flags veterinary precautions.
B. Pharmacists can complete a continuing education activity on veterinary pharmacy and require all other staff members to take it also.
C. Pharmacy owners and systems can take out extra liability insurance and pray that nothing happens to any animal that receives a prescription from their pharmacies.

Animal Models of Disease: Barking up the Right Tree – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-022-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.

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist & Pharmacy Technician Post Test (for viewing only)

References

Full List of References

42. Dyer O. Covid-19: US doctors sue regulator for charging them with spreading misinformation in pandemic. BMJ. 2023;382:1991.

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist Post Test (for viewing only)

Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Overview of the Medicare Prescription Payment Plan

Figure 1 illustrates the basic process for patients who choose to participate in M3P.

Table 1. Anticipated M3P Claims Messaging Information

Distribution of M3P responsibilities

Table 2. Plan M3P Responsibilities4, 5

Monthly invoice calculations and members most likely to benefit from participating in the M3P

M3P Resources

SUMMARY AND CONCLUSION

Pharmacist & Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist Post Test (for viewing only)

Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Table 2. Plan M3P Responsibilities^{4, 5}