Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

With a dear health care provider (DHCP) letter, dated June 10, 2016, Teva Pharmaceuticals temporarily suspended the sale, marketing and distribution of ZECUITY® (Sumatriptan Iontophoretic Transdermal System) due to post-marketing reports of application site reactions described as “burn” and/or “scar” in patients treated with ZECUITY®. The first and only FDA-approved migraine patch’s September 2015 release, indicated for the acute treatment of migraine headaches with or without aura had represented what was thought to be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea (MRN). Accordingly, a beginning-to-end study was launched in the interest of preventing reoccurrence, analyzing root causes and providing corrective tools and solutions. The science of iontophoretic delivery systems, the technology of transdermal route of administrations, and methods of adverse event reporting and postmarketing surveillance were scrutinized.

Biography

Sara Louise Joe is the President of There’s a Pharmacist in the House, LLC, an independent Pharmacist Consultant coalition engaged in developing research, educational and clinical strategies and initiatives for healthcare providers and consumers. She has over 25 years of experience as a Pharmacist in retail, hospital and pharmacy informatics practice. She has earned her BS in Pharmacy from Temple University in Philadelphia, PA, USA and her Doctorate of Pharmacy from Broadmore University in Stamford, Ontario, Canada. She has previously been an Adjunct Professor of Pharmacology at South University-Virginia Beach, VA, USA and was awarded CVS Pharmacist of The Year in her region in 1992 and 1993. She is a 2016-17 APhA delegate for the Academy of Pharmacy Practice and Management (APhA-APPM) delegation and an active Member of the APhA Medication Therapy Management Special Interest Group Committee.

Email: sara.joe@pharmacistinthehouse.com