This newsletter includes information about the recent problems with the clozapine REMS program that has led to confusion and for some patients, missing their clozapine treatment.
We also share practical tips for diagnosing and treating feeding and eating disorders, key points from a presentation on the management of behavioral and psychological symptoms and dementia, and our practical research summaries (Quick Takes).
The Problem of Clozapine REMS
- What is REMS?
- The acronym stands for Risk Evaluation and Mitigation Strategy, a drug safety program for certain medications with serious safety concerns. It promotes measures that support the safe use of medications to mitigate a specific risk.
- Why is clozapine in the REMS program?
- It was originally instituted in September 2015 due to the risk of severe neutropenia associated with clozapine treatment. You can learn more here.
- Who administers the program?
- The FDA dictates the requirements of the Clozapine REMS; however, the system is administered by the Clozapine Product Manufacturers Group (CPMG).
- How does the clozapine REMS program work?
- Prescribers, pharmacists, patients, and distributors need to enroll in the REMS registry before clozapine can be dispensed.
- Prescribers need to submit the ANC as described in the Monitoring Schedule of the Prescribing Information using the ANC Lab Reporting Form in order for the patient to receive the medication.
- What requirements were modified in November 2021?
- All prescribers, dispensing pharmacies, and distributors were needed to recertify and re-enroll in the new system.
- Patients needed to be re-enrolled by their prescribers.
- A monthly Patient Status Form (PSF) replaced the ANC Lab Reporting Form with more data to fulfill monthly.
- What have the consequences of modifying the requirements been?
- These changes have confused pharmacies, prescribers, and patients, causing some patients to discontinue treatment for a period.
- Also, prescribers have experienced increased administrative time navigating the REMS website, and pharmacies had problems with the enrollment process and delays in getting authorization for individual prescriptions.
- What has been the solution to this problem?
- The FDA has temporarily stopped enforcement of certain requirements to undergo thorough reviews.
- However, the APA and 6 other organizations have been advocating with the FDA and Congress to suspend the program. Many prescribers and advocacy groups believe the REMS requirements are unnecessary and could prevent broader access to clozapine. You can read more here.
If you have had problems prescribing or accessing clozapine since the REMS program changed in November of 2021, you can complete this survey from NAMI.
The Psychopharmacology of Feeding and Eating Disorders, With Timothy Brewerton, M.D.
In this interview, Dr. Timothy Brewerton presents diagnostic and management strategies for feeding and eating disorders. He also identifies the need for stigma reduction and pharmacologic and nonpharmacologic options for these disorders.
Interview highlights include the following:
- Eating disorders are often comorbid with depression, OCD, PTSD, alcohol and other substance use disorders, ADHD, personality disorders, and trauma-related disorders.
- SSRIs are not recommended for the management of low-weight anorexia nervosa due to the profound depletion of central serotonin levels.
- Among the psychotropics, olanzapine has the most evidence for the treatment of non-weight-restored anorexia nervosa. Initial dosing should be very low and up-titrated very slowly. Start children and adolescents at 0.625 mg and adults at 1.25 mg.
Learn more and earn 0.5 CME credits here.
Management of Behavioral and Psychological Symptoms of Dementia
In this video lecture, Dr. Lauren Gerlach addresses important concepts regarding behavioral and psychological symptoms of dementia, including a thorough description of the underlying factors that contribute to the development of these behaviors. In addition, she gives a complete explanation of the DICE approach and guides clinicians on pharmacologic measures.
Antipsychotics and Cholinesterase Inhibitors for BPSD
- Use the lowest effective dose of antipsychotics to treat BPSD.
- Attempt gradual dose reductions when possible.
- Antipsychotics are associated with other side effects in addition to the FDA box warning for increased mortality.
- Use antipsychotic medications with low D2 blockade in patients with LBD or PDD.
- Cholinesterase inhibitors and memantine show a statistically significant improvement in BPSD but limited clinical impact.
Learn more and earn 1.0 CME credit here.
Quick Takes: Informing Your Practice
Repetitive Transcranial Magnetic Stimulation for Smoking Cessation: A Pivotal Multicenter Double-Blind Randomized Controlled Trial
- Active transcranial magnetic stimulation is more effective for smoking cessation than a well-blinded sham stimulation.
- Although study designs are not identical, a meta-analysis of varenicline suggests higher medium-term abstinence rates than TMS. Learn more.
Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder
- Ketamine plus mindfulness psychotherapy was more effective for sustained abstinence from alcohol than placebo plus alcohol psychoeducation.
- Adverse effects were minimal, suggesting that current alcohol use is not a contraindication for the consideration of ketamine. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
Listen to Our Podcast: Psychopharm Updates
Don’t miss out on the latest updates in psychopharmacology! Each episode of our podcast showcases one of our products on a regular basis: Video lectures, Quick Takes, and Expert Consultations. We update our feed every 5 days.
References
- Clozapine REMS. What is the Clozapine REMS? https://www.newclozapinerems.com. Accessed April 26, 2022.
- U.S. Food and Drug Administration. (2021, December 2). FDA is temporarily exercising enforcement discretion. https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program
