Law: Psychedelic Drugs for Mental Health Disorders: Clinical and Legal Issues

Learning Objectives

· Describe the important features of post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) with commonly employed non-pharmacologic and pharmacologic treatments

· Identify the pharmacologic features of MDMA and psilocybin and clinical trial results when applied to patients with mental health disorders

· Describe legal barriers to using psychedelics in patients with mental health disorders and ways to circumvent them at a national or state level

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 0009-0000-22-017-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.

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.

Herbal/Drug Interactions in Cancer Care

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 0009-0000-22-018-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.

1. How does the medical community usually define complementary medicine?
A. Medicine used with standard treatment but not considered standard treatment by itself
B. Medicine used instead of standard medical treatment
C. Medicine at no cost –it’s complementary!

2. Which aspect of pharmacokinetics is St. John’s Wort known to alter in patients who are taking imatinib?
A. Absorption–by affecting gastric pH
B. Metabolism–by increasing drug clearance
C. Distribution–by competing with albumin binding sites

3. With respect to the gastrointestinal tract, how do orally administered herbs interact with prescription medication for cancer?
A. They may alter motility, gastric pH, and P-gycoprotein transport
B. They may alter motility, gastric pH, and CYP enzyme activity
C. They may alter the peritoneal space, sodium levels, and P-GP transport

4. Which of the following complementary medications used for hot flashes MAY be a problem in a woman taking tamoxifen?
A. St. John’s wort
B. Echinacea
C. Black cohash

5. Which of the following references contains monographs, an adverse effects checker and a tool to check interactions with hormone sensitive diseases such as breast cancer.?
A. Sloan Kettering Cancer Center’s About Herbs database
B. Natural Medicines Comprehensive Database
C. NIH’s Herbs at a Glance fact sheet

Addiction Pharmacology and Ibogaine

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 0009-0000-22-019-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.

1. Which of the following is TRUE of ibogaine?
A. It was synthesized by researchers in Japan during the early 1900s
B. It is a naturally occurring alkaloid derived from Tabernanthe iboga
C. It is extracted from the iboga root that is native to South America

2. Which of the following is TRUE regarding the pharmacology of ibogaine?
A. It has a long-acting metabolite called noribogaine
B. Its pharmacokinetic profile is remarkably simple
C. It binds exclusively to the opioid receptor

3. In which condition would ibogaine be contraindicated?
A. Allergic rhinitis
B. Pancreatic cancer
C. Prolonged baseline QTc interval

4. Which of the following is a pharmacologic effect of ibogaine supported by observational research?
A. Detoxification of heroin use disorder
B. Detoxification of alcohol use disorder
C. Detoxification of SSRI overdose

5. Which adverse effect has been reported with ibogaine use?
A. Serotonin toxicity
B. Neuroleptic malignant syndrome
C. Ventricular arrythmias

Law: Psychedelic Drugs: Can They Make the “Trip” to the Pharmacy Shelf?-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.

Schwarting Webinar 2023 Post-Test

1. Review the development of the knowledge of the effects of psychedelic drugs and their potential use in psychiatry, with an emphasis on psilocybin.
2. Characterize the traditional legal classification of psychedelic drugs and modern reconsideration of their legal status.
3. Describe efforts at the state level to expand the medical use of psychedelic drugs.

The tryptamine class of psychedelic drugs (e.g., LSD, psilocybin) produce their psychedelic/therapeutic effects by acting as agonists of a neurotransmitter in the CNS. What is the relevant neurotransmitter system?

Serotonin
Dopamine
Glutamate

The FDA granted “breakthrough therapy” designation to psilocybin for treatment of a specific condition. What condition is it?

Schizophrenia
Treatment resistant depression
Post traumatic stress disorder

Which feature distinguishes a C-I drug from other controlled substances?

High potential for abuse, especially among hi-riskpopulations
Lack of accepted safety for use under medical supervision
No currently accepted medical use in treatment in the United States

Which state was the first to approve the use of psilocybin for medical use?

California
Oregon
Maryland

A patient considering psilocybin treatment for a psychiatric disorder asks you for advice; he is specifically interested in disadvantages of this type of therapy. What do you tell him?

Use of psychedelic therapy is time-and resource-intensive
Requires multiple treatments with a slow onset of activity
There is a high risk of autonomic side effects and addiction

In the state where medical use of psilocybin was first approved, which of the following statements describes its availability?

Psilocybin can be purchased at retail outlets including pharmacies
Psilocybin is available from any therapist throughout the state
Psilocybin is only available in state licensed clinics

Law: Off-Label Drug Use and The Pharmacist’s Role

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

Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-21-055-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. How do federal and state law compare?
A. Most states use a model that mimics federal system
B. State law trumps any federal law in explicit conflict
C. The law that affords the fewest rights always prevails

2. An employee believes she has a discrimination case against her employer. She does her research and learns she is unlikely to win. What type of discrimination has she alleged?
A. Retaliation
B. Color
C. Race

3. Why is the OSHA “look-back” period important once a pharmacy is cited for a violation?
A. Repeat citations for the same violation during the next five years can cost up to $70,000 each
B. OSHA can fine employers if employees allege violations in previous five years without proof
C. Should an employee death or injury occur within five years, OSHA will shutter the business.

4. Which of the following questions can reduce risk and increase employee satisfaction in your workplace when an employee files a complaint or grievance?
A. Did you complain about this at your last job?
B. What exactly is your problem?
C. What relief are you seeking?

5. What can an employer use as an affirmative defense if an employee files a discrimination complaint?
A. Demonstrate the plaintiff’s performance was better than other employees’
B. Provide detailed records of complaint filed by clients/patients/customers
C. Show documentation that the plaintiff was an acceptable team player

From the Mouths of Snakes: ACE Inhibitors

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 0009-0000-22-020-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.

1. How do ACE inhibitors work?
A. They convert angiotensin I to angiotensin II
B. They convert renin to angiotensin II
C. They convert Angiotensin II to angiotensin I

2. Before ACE inhibitors were marketed, what drugs were the mainstay of treatment for hypertension?
A. Injectable diuretics, especially furosemide
B. Oral diuretics, and especially chlorthalidone
C. Surgical interventions

3. Which of the following are FDA-approved uses for many ACE inhibitors?
A. Heart failure, hypertensive emergencies, MI and/or stroke prophylaxis
B. Heart Failure, hypertensive emergencies, MI and pancreatic cancer
C. Heart Failure, hypertensive emergencies, MI and sarcopenia

4. Which of the following indications are under investigation for ACE inhibitors?
A. Hepatic necrosis, oligospermia, and sarcopenia
B. Raynaud’s syndrome, sarcopenia, and oligospermia
C. Oligospermia, Raynaud’s syndrome, and sarcopenia.

5. In most conditions in which ACE inhibitors are being investigated but are not yet approved, what is the value of these drugs?
A. We have no treatments for many of these conditions, so ACE inhibitors would be valuable first-line options for people who are suffering
B. Many of these conditions have preferred treatments, ACE inhibitors may be valuable second- or third-line options for refractory cases
C. Many of these conditions have preferred treatments, but ACE inhibitors would replace the first-line treatments with fewer side effect

Vitamin K Antagonist Pharmacology, Pharmacotherapy and Pharmacogenomics

UConn has developed web-based continuing pharmacy education activities to enhance the practice of pharmacists and assist pharmacists in making sound clinical decisions to affect the outcome of anticoagulation therapy for the patients they serve. There are a total of 12 hours of CPE credit available. Successful completion of these 12 hours (13 activities) or equivalent training will prepare the pharmacist for the Anticoagulation Traineeship, which described below in the Additional Information Box.

The activities below are available separately for $17/hr or as a bundle price of $140 for all 13 activities (12 hours). These are the pre-requisites for the anticoagulation traineeship. Any pharmacist who wishes to increase their knowledge of anticoagulation may take any of the programs below.

When you are ready to submit quiz answers, go to the Blue "Take Test/Evaluation" Button.

If desired, “bundle” pricing can be obtained by registering for the activities in groups. It consists of thirteen anticoagulation activities in our online selection.

You may register for individual topics at $17/CE Credit Hour, or for the Entire Anticoagulation Pre-requisite Series.

Pharmacist General Registration for 13 Anticoagulation Pre-requisite activities-(12 hours of CE) $140.00

In order to attend the 2-day Anticoagulation Traineeship, you must complete all of the Pre-requisite Series or the equivalent.

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

The University of Connecticut School of Pharmacy and The UConn Health Center Outpatient Anticoagulation Clinic have developed 2-day practice-based ACPE certificate continuing education activity for registered pharmacists and nurses who are interested in the clinical management of patients on anticoagulant therapy and/or who are looking to expand their practice to involve patient management of outpatient anticoagulation therapy. This traineeship will provide you with both the clinical and administrative aspects of a pharmacist-managed outpatient anticoagulation clinic. The activity features ample time to individualize your learning experience. A “Certificate of Completion” will be awarded upon successful completion of the traineeship.

More Information About Traineeship

1. Which of the following is NOT a catalyst for the coagulation cascade?
a. Tissue Factor
b. Collagen
c. Negatively charged phospholipid surfaces
d. Positively charged phospholipid surfaces

2. The following is true regarding VKOR, except:
a. It is an enzyme
b. It is the target of warfarin’s mechanism of action
c. It binds to negatively charged phospholipids in the presence of calcium
d. It recycles vitamin K epoxide to active vitamin KH2

3. Which if the following is not a contraindication for warfarin therapy?
a. Pregnancy
b. Major surgery or trauma
c. Active bleeding
d. Spinal puncture
e. Asymptomatic PE

4. DE is a 60 year old male being referred to your anticoagulation clinic with a diagnosis of new onset atrial fibrillation. DE’s past medical history is significant for hypertension, hypercholesterolemia, rheumatoid arthritis, and type 2 diabetes mellitus. Based on the CHEST guidelines, what duration of warfarin therapy do you recommend for DE? Why?
a. 3 months to indefinite, CHADS score of 2
b. Indefinite, CHADS score of 4
c. Indefinite, CHADS score of 2
d. Aspirin therapy preferred over warfarin in this patient
e. None of the above

5. ML is a 65 year old female being referred to your anticoagulation clinic with a s/w new mechanical heart valve in the mitral position. What duration of warfarin therapy and INR goal do you recommend for ML?
a. 2-3; Indefinite therapy
b. 2-3; 3-6 months
c. 2.5-3.5; Indefinite therapy
d. 2.5-3.5; 3-6 months
e. 1.5-2; Indefinite therapy
f. Warfarin is not recommended

6. AL is a 48 year old female who is on warfarin therapy with an indication of mechanical heart valve in the aortic position. Her INR goal is 2-3. Today AL’s INR returned at 1.6. She reports no pertinent findings. The patient take 7.5 mg on Monday and 5 mg on all other days.
a. What are your next steps for this patient?
b. No Change. Continue current warfarin dosing.
c. Instruct the patient to take warfarin 5 mg daily
d. Instruct the patient to take warfarin 7.5 mg on M/F and 5 mg on all other days
e. Instruct the patient to take warfarin 10 mg daily
f. Contact the clinician. The patient’s INR goal is incorrect

7. When considering warfarin dosage adjustments, which of the following patient specific factors is important to consider?
a. Dietary vitamin K intake
b. Upcoming dental procedure
c. Newly started amiodarone
d. History of patient non-adherence
e. All of the above

Direct Oral Anticoagulants and Factor IIa and Xa Inhibitors

When you are ready to submit quiz answers, go to the Blue "Take Test/Evaluation" Button.

If desired, “bundle” pricing can be obtained by registering for the activities in groups. It consists of thirteen anticoagulation activities in our online selection.

You may register for individual topics at $17/CE Credit Hour, or for the Entire Anticoagulation Pre-requisite Series.

Pharmacist General Registration for 13 Anticoagulation Pre-requisite activities-(12 hours of CE) $140.00

In order to attend the 2-day Anticoagulation Traineeship, you must complete all of the Pre-requisite Series or the equivalent.

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

More Information About Traineeship

1. The newer oral anticoagulants work by:

Indirectly inhibiting factor VIII
Directly inhibiting factor IIa or Xa
Causing the breakdown of fibrin
Decreasing the production of factor II

2. p-Glycoprotein inhibition leads to

Increased substrate serum levels
Decreased substrate serum levels
Increased metabolism of substrate
No effect

3. Which agent was shown to be superior to warfarin in both safety and efficacy in atrial fibrillation

Dabigatran
Rivaroxaban
Apixaban
None of the above

4. There is no evidence to suggest that pharmacists can impact the care of patients receiving the new oral agents.

True
False

5. For the treatment of an acute venous thromboembolism, initial parenteral anticoagulants are not needed for therapy with:

Dabigatran or Rivaroxaban
Rivaroxaban or Apixaban
Apixaban or Edoxaban
A parenteral anticoagulant is always needed for at least the first week.

6. This drug should not be placed in a pill box

Dabigatran
Rivaroxaban
Apixaban
Edoxaban

7. What type of patient would be considered a good candidate to for DOAC therapy?

Documented warfarin allergy
History of poor INR control on warfarin despite good compliance
Considerable barriers to routine monitoring, such as physical or transportation issues
Document and confirmed warfarin failure such as an ischemic stroke while consistently therapeutic on warfarin
All of the above

8. To switch a patient from subcutaneously LMWH to a DOAC, you would recommend to discontinue the LMWH and then…

begin the new agent 3 days later if the patient has normal renal function
begin the new agent when the patient’s PTT and INR are sub-therapeutic
bridge with LMWH and the DOAC for 24 hours
begin the new agent when the next dose of LMWH would be due

9. Which of the following DOACs’ bioavailability substantially increases when it is taken with food (largest meal of the day)?

Edoxaban
Rivaroxaban
Dabigatran
Apixaban

10. Prior to initiating a DOAC, the patient should be evaluated for which the following?

Renal Clearance
Appropriate and approved indication for the specific DOAC agent
Review of patient medication profile to check for potentially significant drug-drug interactions
Adequate insurance coverage or prescription assistance before starting the DOAC agent
All of the above

Laboratory Monitoring of Anticoagulation

When you are ready to submit quiz answers, go to the Blue "Take Test/Evaluation" Button.

At the end of this knowledge-based continuing education activity, the learner will be able to:

Explain the role of common laboratory tests used in monitoring of anticoagulation therapy.
Identify an alternative to INR monitoring for warfarin therapy.
Identify the clinical situations requiring Activated whole blood Clotting Time (ACT) and Anti-factor Xa activity monitoring for unfractionated heparin.
Discuss the technical differences between point of care testing and laboratory testing and the influence on patient care.

If desired, “bundle” pricing can be obtained by registering for the activities in groups. It consists of thirteen anticoagulation activities in our online selection.

You may register for individual topics at $17/CE Credit Hour, or for the Entire Anticoagulation Pre-requisite Series.

Pharmacist General Registration for 13 Anticoagulation Pre-requisite activities-(12 hours of CE) $140.00

In order to attend the 2-day Anticoagulation Traineeship, you must complete all of the Pre-requisite Series or the equivalent.

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

More Information About Traineeship

1. The Prothrombin time is prolonged in patients:

Receiving warfarin
With significant liver disease
on a typical dose of enoxaparin
both A and B

2. A patient receiving warfarin may also be monitored by checking the activity level of:

Anti-factor Xa
Factor II
D-dimer
fibrinogen

3. Useful tests to screen for a coagulation disorder in a bleeding patient include

aPTT and PT
TT and PT
D-dimer and aPTT
ACT and aPTT

4. The activity of heparin can be monitored with

aPTT
Anti factor-Xa
ACT
all of the above

5. Anti-factor Xa test is

test of clotting time
functional test of enzymatic activity

6. Very high doses of unfractionated heparin are best measured with

TT
ACT
aPTT
PT

7. This test measures the last step in the coagulation cascade, the conversion from fibrinogen to thrombin:

TT
ACT
aPTT
PT

8. If the patient’s PT is 39, the control PT is 13, and the sensitivity of the reagent is 1, what is the INR

more info is needed
2.0
3.0
1.0

9. Antiphospholipid Antibody Syndrome:

Is a clinical condition predisposing patients to hemorrhagic complications
May interfere with PT/INR testing leading to a false prolongation
Predisposes the patient to a pro-thrombotic state and may falsely shorten the PT test
Can easily be corrected for by the lab through analytical methods.

10. Argatroban use is not expected to significantly affect the monitoring of warfarin.

True
False

Risk Management in Anticoagulation

When you are ready to submit quiz answers, go to the Blue "Take Test/Evaluation" Button.

If desired, “bundle” pricing can be obtained by registering for the activities in groups. It consists of thirteen anticoagulation activities in our online selection.

You may register for individual topics at $17/CE Credit Hour, or for the Entire Anticoagulation Pre-requisite Series.

Pharmacist General Registration for 13 Anticoagulation Pre-requisite activities-(12 hours of CE) $140.00

In order to attend the 2-day Anticoagulation Traineeship, you must complete all of the Pre-requisite Series or the equivalent.

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

More Information About Traineeship

1. High quality risk management programs protect…

The patient
The provider
The institution
All of the above

2. The three most important ways to reduce risk are:

Education, providing a quality service, and complete documentation
Physician involvement, light workload, and malpractice insurance
Commercial management software, education, and malpractice insurance
Providing a quality service, good customer service, and malpractice insurance

3. Application, analysis and synthesis of new knowledge can best be taught through:

Lecture
Reading
Case presentation and practice-based learning
Observation

4. A high quality protocol will include:

Rigid dosing guidelines
Process for medication refill requests
Critical value cut-offs
All of the above
A B and C

5. It is important to document all patient interaction:

True
False

6. Documentation must be recorded by using:

Commercial software
A quality home-grown system
A paper record
A or B
Any medium as long as it’s complete and retrievable

7. Limiting risk through risk sharing can be accomplished by

Physician oversight
Patient education
Both A and B
Risk cannot be shared between involved parties

8. Adhering to institutionally approved clinic policies helps to minimize the risk of the individual practitioner

True
False

9. Quality improvement activities:

Increase risk
Decrease risk
Have no effect on risk

10. When a pharmacist’s recommendations are reviewed and approved by a physician:

The physician assumes all the risk
The pharmacist still carries risk
The pharmacist does not need to document
The pharmacist can only bill for the lab test

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

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

About this Course

Target Audience

Pharmacist Learning Objectives

Bundle Options

Additional Information

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

Accreditation Statement

Grant Funding

Requirements for Successful Completion

Faculty

Faculty Disclosure

Disclaimer

Program Content

Program Handouts

Post Test Evaluation

View Questions for Vitamin K Antagonist Questions

Additional Courses Available for Anticoagulation

About this Course

Target Audience

Pharmacist Learning Objectives

Bundle Options

Additional Information

Anticoagulation Traineeship at the University of Connecticut Health Center, Farmington, CT

Accreditation Statement

Grant Funding