Clozapine REMS Updates

Today, CPNP and its partner organizations sent a another communication to the FDA after receiving no further substantive information following up on the October 21 meeting with the FDA and the Clozapine Product Manufacturers Group (CPMG). We expressed the significant concern of our organizations and our respective members as the implementation date of November 15 grows near. The stakeholders additionally expressed our concern that no updates appear to be likely prior to the New Clozapine REMS going into effect. The stakeholders also shared your feedback as CPNP members that various parts of the new REMS are not working. We further informed the FDA of the difficulties that many of you are encountering getting answers from the new REMS as you try and plan for your patients.

We noted that the new REMS appears to be an untested system still under construction. We therefore requested that the FDA provide further information on these issues so that practitioners can understand what they are facing.  In the interest of patient safety, we again requested that the FDA consider postponing or suspending implementation of dispensing and reporting requirements of the new Clozapine REMS until these issues are resolved.

CPNP continues its outreach to FDA offering its assistance and partnership on the new Clozapine REMS. With no new information to share, CPNP recommends that psychiatric pharmacists and their organizations be prepared for the 11/15 implementation date. We will continue to keep you abreast of any action and feedback we receive from the FDA. A special thanks to Past Presidents Ray Love and Megan Ehret who continue to lead on this issue. 

For your information, the full communication appears below:

Colleagues:

Thank you for the response. Following up on the FDA listening session, the stakeholder groups and our members are growing increasingly concerned as the implementation of November 15 grows near. Based on the most recent email it does not seem we will receive updates prior to the New Clozapine REMS going into effect, which is a concern.

Regarding the following issues, we would like to raise:

1. At the meeting, CPMG discussed a 90-day transition period.  The stakeholders were accepting of a transition period, but noted the potential challenge of the single transition measure offered by CPMG.  
2. The difficulties that patients would face if hospital pharmacies were only able to dispense a seven-day supply of medication upon discharge. 
3. The need for the pharmacy classification system to change.
4. The stakeholders suggested suspending the RDA component of the REMS until implementation issues are resolved.  The stakeholders have stated that this is an obvious potential barrier to patients obtaining medication (unless pharmacies just ignore the new REMS).

We do acknowledge that the designee system has been partially resolved.  However, there are still difficulties with pharmacists serving as designees and prescribers serving as designees for other prescribers.

The stakeholders continue to receive reports that parts of the new REMS are not working.  Our members report difficulties getting answers to numerous questions posed to the REMS program as they try and plan for their patients.  It is obvious that the new REMS is an untested system still under construction.

We request that the FDA provide further information on these issues so that practitioners can understand what they are facing.  In the interest of patient safety, we again request that the FDA consider postponing or suspending implementation of dispensing and reporting requirements of the new Clozapine REMS until these issues are resolved.

As mentioned during the October 21st listening session, we would like to partner with you to help work through issues and share information with our members.