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The future will be better tomorrow. - Dan Quayle

Clozapine REMS

Let’s hope that Mr. Quayle was/will be correct! The past few weeks have been challenging for many of our members who have been dealing with the new Clozapine REMS Program. Many have dealt with hours on hold, frustrations in certifying, errors, and uncertainties about how to proceed. I am proud of CPNP’s efforts in addressing the clozapine REMS. We started out attempting to provide guidance though our FAQs which ClozapineREMS has recently updated for us based on their responses on some of the issues. As members used our list serve to report problems, we reached out to both the FDA and the Clozapine REMS Program to summarize the issues, express the frustration of our members, recommend actions and suggest changes. The FDA noted that they had received more feedback from CPNP than from any other source. In some cases, it appears our suggestions were accepted. We have also been discussing these same concerns with the American Psychiatric Association and the American Association of Community Psychiatry. CPNP will continue to communicate your concerns and ideas through the communication pathways that we have opened. Hopefully, things will be better tomorrow.

CPNP’s clozapine efforts have been spearheaded by two members associated with the University of Maryland system who have gone “above and beyond” in our effort to keep you informed. Nicki Letvin has spent hours on the phone with Clozapine REMS establishing relationships with supervisors, asking the questions we document in our FAQ, and participating in our communications with the FDA. Marie Mackowick has assisted Nicki, helped with our responses and also contributed to conversations with the FDA. Thank you both!

In all the concern over the REMS process, we can’t ignore the “better” in the FDA’s new approach to clozapine – the new ANC parameters. Patients who have occasional low ANCs will no longer have to interrupt treatment; patients with benign ethnic neutropenia will be able to receive clozapine; “rechallenges” will be permitted for patients for whom the benefits outweigh the risks.

CPNP 2016

As long as we are speaking of the future, I hope you are including a trip to Colorado Springs for our 2016 Annual Meeting in your future. As noted in the numerous articles in this edition of CPNP Perspectives, CPNP 2016 will be offering a range of cutting-edge, quality programming along with numerous networking opportunities. Mark April 17-20, 2016 in your calendars for the premier meeting “Where Pharmacy and Psychiatry Meet.”

Recognizing Award Recipients and New CPNP Board Members

It’s also that time of year time to honor our future leaders and those who have served us in the past. Congratulations to Drs. Sally Guthrie and Glen Stimmel as the recipients of the Saklad Memorial Award and the Foundation’s Career Achievement Award, respectively! These two long-time members have made numerous and outstanding contributions to CPNP, psychiatric pharmacy and to future practitioners. It is a privilege to recognize their achievements through these awards.  

I also want to thank the Nominations Committee chaired by Past President Steve Burghart and those who agreed to be candidates for 2016-2018 Board positions. The slate of candidates was outstanding and we are fortunate to have had such a talented pool willing to volunteer.  Congratulations to our new Board members Drs. Cates, Kelly, and Nelson. I look forward to working with you in the near future. You can read more about these newly elected board members in this edition of CPNP Perspectives.

President-Elect: Deanna Kelly, PharmD, BCPP, Professor, University of Maryland, Baltimore, MD

Secretary: Leigh Anne Nelson, PharmD, BCPP, Associate Professor, University of Missouri-Kansas

Member-At-Large: Marshall Cates, PharmD, BCPP, FASHP, Professor of Pharmacy Practice, Samford University McWhorter School of Pharmacy, Birmingham, AL

Here’s to looking forward!

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