CPNP Continues Engagement on Clozapine REMS

Raymond C. Love, PharmD, BCPP, FASHP, CPNP President

Over the past 6 months, CPNP has led a response regarding the Clozapine REMS on behalf of its membership. We have successfully raised a number of issues of concern about the REMS Program and took the following actions:

1. Developed FAQs that were among the easiest to find resources available prior to the Clozapine REMS launch.
2. Obtained ongoing member input regarding concerns which were directly communicated to the FDA. These concerns included, but were not limited to pharmacists roles, wait times, implementation dates, handling of inpatients, HIPAA concerns, system screens, improperly imported data, transfer of patients, patient identifiers and notifications of overdue labs,
3. Worked with the American Psychiatric Association and American Association of Community Psychiatrists to share concerns of an interprofessional nature and help the FDA understand the potential impact of implementing the required portions of the REMS Program by the initial deadline of November. Subsequently, that date was pushed back indefinitely.

CPNP was recently invited to join the FDA Network of Experts which just this month involved CPNP assisting with the identification of experts to advise on specific aspects of clozapine administration. This invitation recognizes the fact that we have become a more visible resource within the FDA.

As you know, the REMS Program has made many significant changes based on our input, but we continue to hear concerns about:

1. inability of pharmacists to sufficiently access laboratory information;
2. prescriber information not being displayed for those are who are designees for multiple prescribers;
3. transferred patients continuing to appear on one's list of patients.

We remind you of the FDA’s message to us is that the medical needs of patients are a priority that should not be negatively impacted by the REMS program. We will continue to advocate for necessary changes to the Clozapine REMS Program addressing the issues above and additional issues as they arise. Please keep us apprised of the additional challenges that the REMS Programs presents by emailing info@cpnp.org or by communicating via the CPNP list at list@cpnp.org.