Measuring the Impact of FDA Communication Alerts and Re-Alerts

Tuesday, February 16, 2016
2:00 p.m.-3:00 p.m.
FDA White Oak Campus, Silver Spring, MD Bldg. 2 Rm. 2031
Ann Anonsen
301 405 0285

G. Elliott Cook, PharmD, BCPS

Chief Pharmacist, Provider Resources, Inc.



Elliott is PRI’s Chief Pharmacist, and provides drug information support, clinical expertise, policy guidance and oversight to two of PRI’s national contracts within the Centers for Medicare and Medicaid Services (CMS), including Medicare’s Part D Coverage Gap Appeals Contract and Medicare’s Workers’ Compensation Review Contract.  Further, Dr. Cook has past experience providing sub-contractual support for the Prescription Drug Labeling Improvement and Enhancement Imitative (PDLI-EI) through the U.S. Food and Drug Administration (FDA). 



Dr. Cook received a Doctor of Pharmacy Degree (PharmD) from Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, completed an American Society of Health-System Pharmacists accredited Post-Graduate Year One (PGY1) Pharmacy Residency at Hillcrest Hospital – A Cleveland Clinic Hospital, and is currently in the process of attaining a Master of Science Degree from Georgetown University in Clinical and Translational Research with a concentration in Regulatory Science (an FDA funded program).  In addition, Dr. Cook is also certified by the Board of Pharmaceutical Specialties as a Board Certified Pharmacotherapy Specialist (BCPS), and licensed by the Pennsylvania State Board of Pharmacy and Ohio State Board of Pharmacy.  He is a member of many state and national pharmacy organizations, and recently completed a two year term for the Pennsylvania Pharmacists Association (PPA) Board where he was the Northwest Regional Director for PPA.




During Dr. Cook’s hospital and academic career, he has been instrumental in creating the Lake Erie College of Osteopathic Medicine (LECOM’s) Center for Drug Information and Research where he held an Assistant Professor in Pharmacy Practice Position. During his tenure at LECOM, Dr. Cook lectured and led various courses including Pharmacotherapeutics, Research Methods, Pharmacoepidemiology, Drug Information and Literature Review.  He has been a member of many Pharmacy and Therapeutics Committees producing drug reviews, medication usage evaluations, and cost-effectiveness strategies for hospitals and has various publications in high impact medical journals including the New England Journal of Medicine, British Medical Journal, JAMA Pediatrics and the Archives of Internal Medicine.  Of these publications, Dr. Cook and his Colleague published an important study around drug safety in the Archives of Internal Medicine entitled “Potential Safety Signals and their Significance”.  This study was commented within the journal by Drs. Gerald Dal Pan, Robert Temple, and Emily Woo at FDA and written about in the New York Times.  Dr. Cook and his colleagues also published a paper in JAMA Pediatrics on dietary supplements that was recognized in many news outlets including Forbes, Fox News, and many others.   




Beyond academic publishing in drug safety, Dr. Cook’s unique perspective on drug labeling and PRI’s further experience led to a subcontract at the FDA where he led a team of PharmDs and PhDs whom updated the science of prescription drug labels, commonly referred to as package inserts. Dr. Cook and his team provided literature review and research analysis via the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLI-EI) courtesy of the FDA.  His team was tasked to enhance and improve all sections of various drug labels such as adverse drug reactions, warnings and precautions, drug interactions, and indications and usage to improve the overall safety and efficacy of older drug products. 

Lecture Abstract


Research Objective: The U.S. Food and Drug Administration (FDA) uses electronic communication alerts to inform patients and providers of new drug safety information. This study analyzed large-scale clinical data from a multi-site electronic health record (EHR) system to assess the prescribing impact of two FDA communication alerts about concomitant usage of citalopram 40mg with omeprazole, as a drug-drug interaction may contribute to prolongation of QTc and lead to sudden death (Torsade de Pointes).




Study Design: A retrospective time-to-event database study was performed to assess the impact of FDA drug safety communication alerts on August 24, 2011, and March 28, 2012, about citalopram prescribing, within the Medstar Health Centricity outpatient EHR database. Concomitant usage of citalopram 40 mg and omeprazole (any dosage) was studied, assessed by plotting the number of subjects by day; at least one day of concomitant usage was considered a positive count. Subjects’ counts were averaged per day-per month and plotted over time using the National Cancer Institute’s Joinpoint Trend Analysis Software to assess statistically significant breaks in trends. Analysis of the cohort included subgrouping by age, point-of-care institution type, and prescriber type or specialty. Subjects’ ages were stratified by days of concomitant usage; ANOVA was utilized to detect statistical differences among facilities or provider types.




Population Studied: Medstar Health, a nonprofit healthcare organization of more than 120 entities in the Baltimore-Washington metropolitan area, provides care for more than one-half million people each year. Medstar Health’s cohort of citalopram 40 mg usage was assessed through the data mining application of Centricity in a time period from January 1, 2010, through April 12, 2015 (n=3,992). Subjects were included into the primary analysis if they received citalopram 40 mg and omeprazole (any dosage) concomitantly any time during the specified time period (n=520).


Principal Findings: The FDA drug safety communication alerts did not lower concomitant prescribing of citalopram 40 mg and omeprazole. There was a statistically significant change in trend approximately one month after the second alert, but it did not result in a trend large enough to decrease or minimize the upward momentum of usage. More than 1 in 8 subjects on citalopram 40 mg were taking omeprazole concomitantly within Medstar Health; more than 1 in 3 subjects were also on citalopram 40 mg and omeprazole who were >=60 years of age, which may further potentiate the risk of Torsade de Pointes or life-threatening hyponatremia.




Conclusion: Two FDA drug safety communication alerts intended to discourage the concomitant prescribing of citalopram 40 mg and omeprazole, a CYP2c19 inhibitor, did not produce a positive usage trend change within a large outpatient system.




Implications for Policy or Practice: The FDA should consider increasing the awareness of this drug interaction in the form of a black-box warning within the drug label of citalopram to improve and optimize prescribing, and to protect the public from inappropriate concomitant drug use. In addition, EHRs may need to include mandatory stops during prescribing or verification.




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