CERTs.Announcement.Archive.2004

Reprinted from the International Society for Pharmacoepidemiology's Scribe, 4th Quarter 2005, Volume 8, Number 4, www.pharmacoepi.org.

Arizona Center for Education and Research on Therapeutics (Az CERT)
By Raymond L. Woosley, MD, PhD, Dan Malone, PhD and Mary Brown, PhD

The University of Arizona CERT (originally founded at Georgetown University, Washington, DC) is a collaborative effort of faculty from the colleges of Medicine, Pharmacy, Nursing, Public Health and Social and Behavioral Sciences. The Az CERT's mission is to improve therapeutic outcomes and reduce adverse events caused by drug interactions, especially those affecting women. This is being accomplished through basic laboratory research, clinical research, and a broad range of educational programs for healthcare professionals and the public. The Az CERT has three Core programs with overlapping participation by the faculty: The Education Core, the Pharmaceutical Outcomes Core and the Pharmacodynamics Core.

The Educational Programs of the Az CERT have, for the most part, focused on prescribing healthcare providers and the public.

A Clinical Pharmacology Educational Module was developed based on a needs survey sent to all third-year medicine clerkship directors and all medicine residency program directors in the United States and Canada. The module was developed in collaboration with the Center for Drug Evaluation and Research at the Food and Drug Administration and is available on www.azcert.org and www.fda.gov/cder/drug/drugreactions. The lecture guide has been downloaded by over 10,000 web visitors.

A fourth year medical school course was developed at Georgetown University that continues today. This course is case-based and uses discussion groups, role-playing, one-on-one exercises with faculty to critically analyze the evidence behind therapeutic decisions in case management. The learning objectives of the course include how to prescribe rationally for special populations and to avoid drug interactions. Students learn to recognize the sources of bias that are in the medical literature, in the marketing efforts of the pharmaceutical industry and formularies.

In January 2004, the Education Core launched an interactive module on the Az CERT Web site designed to educate consumers about potential interactions between over-the-counter (OTC) drugs and prescribed medications. The Over-the-Counter Medicine Interaction Cabinet uses Flash video technology to allow consumers to "open" a virtual medicine cabinet on the Az CERT homepage, www.arizonacert.org. This Web site has had over 11,000 visits in the last year.

To address the need for a trustworthy, independent, user-friendly and reliable source of medication information for consumers, the Education Core has developed a consumer-targeted medication Webliography, or annotated list of Web sites that have met specific evaluation criteria. The Webliography will be available on the Az CERT Web site in Fall 2005.

The Pharmaceutical Outcomes Core is investigating practice-based factors associated with prescribing outcomes. As part of this effort, the Education Core is developing a web-based interactive causal diagram showing causal pathways of factors that contribute to ADEs in community settings, from the perspectives of primary care patients and providers. The aim of this project is to obtain patient and provider perspectives on factors that contribute to adverse drug events in primary care settings and to diagram logical relationships among these factors.

The overall goal of the Pharmaceutical Outcomes Core (POC) is to evaluate the existence of adverse drug interactions (ADIs) within the context of usual medical and pharmacy practice, and to investigate methods to reduce the incidence of ADIs and improve patient safety. Several studies evaluate the structure, process, and outcomes associated with drug interactions. Each of these projects seeks to evaluate the structure, attitudes or process that may be contributing to ADIs.

An analysis of pharmacy managers' perceptions of drug-drug interaction alerts found that they were generally positive and they perceived that physicians were receptive to being contacted about ADIs. However, they were not completely confident that their computer systems provided them with meaningful drug-drug interaction alerts.

The Az CERT is examining the role of computerized physician order entry, and prescriber characteristics on the occurrence of ADI. Investigators are also examining the effect of therapeutic detailing of primary care physicians on the occurrence of ADIs.

Since 2001, the Az CERT has maintained the QTdrugs.org Web site and The International Registry for Drug-Induced Arrhythmias. The Web site is a source for information about new or existing marketed drugs that have risk of prolonged QT interval and/or torsades de pointes (TdP). Last year, 65,000 visits were made to the entry site for the drug lists. Twenty thousand visits were made to the printable drug page lists. An example of the importance of the information received through this Web site is the report received that methadone appeared to be associated with prolonged QT and TdP. Since that notification, the Az CERT has demonstrated the ability of methadone to block the cardiac HERG potassium ion channel and prolong the QT interval. The risk factors associated with TdP have also been identified and in February of 2004, the FDA required a black box warning be added to the labeling of IV methadone. Methadone treatment centers are now incorporating guidelines for addressing this potentially dangerous adverse effect of the drug.

The Az CERT is collaborating with a large chain of pharmacies in Arizona to establish an active surveillance system for comparison of the rates of adverse events associated with drugs. The validated self-reporting system developed by Dr. Seymour Fisher in Galveston, Texas will be the model for this program. The Az CERT will also examine the potential of the system to conduct assessment of the comparative effectiveness of therapies.

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