A Successful Global Drug Safety System: The Hoffmann-La Roche Experience
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Drug Information Journal. Vol. 33. pp. 1109-1 116. 1999 printed in the USA. All rights resewed.
A SUCCESSFUL GLOBAL DRUG SAFETY SYSTEM: THE HOFFMANN-LA ROCHE EXPERIENCE ALANL. BESS,MD Vice President, Pharma Development Safety, Hoffmann-La Roche, Nutley, New Jersey
While premarketing clinical trials detect the majority of drug-related adverse events (AEs), they are not capable of detecting all possible reactions. Through postmarketing surveillance activities, voluntary reports of adverse events are reported to pharmaceutical companies and the Food and Drug Administration (FDA) where they are analyzed for trends and signals. H o m n n - L a Roche has developed a truly global drug safety system, in which all local centers funnel adverse event reports to one global processing center where they are coded onto a single, centralized database. This organization draws cases from all exposedpatient populations worldwide and is able to develop corporate opinions on safety issues. In order to evaluate the customer impact of the new system, a survey was conducted of 1000 health care providers who had contacted the United States Roche Drug Safety Department during 1997. Survey results indicated overwhelming satisfaction with the Roche service, and also suggested that the presence and quality of such interactions can affect patient care and prescribing habits. Key Words: Postmarketing surveillance; Globalization; Drug safety; Adverse events;
Voluntary reporting system
INTRODUCTION TODAY’S MEDICAL PRACTITIONER has access to a vast array of pharmaceutical products, each of which has certain desirable pharmacologic actions. Unfortunately, the same compounds which produce tremendous health benefits are rarely free of unwanted side effects. The adverse events associated with the administration of a drug can range in seventy from simply bothersome to serious or even fatal.
Reprint address: A. L. Bess, MD, Pharma Development Safety, Hoffmann-La Roche, Inc.. 340 Kingsland Street, Nutley. NJ 07110.
For a pharmaceutical company, dealing with A E s has several ramifications. Ethically, the manufacturer has an obligation to thoroughly investigate the safety of its drug products. This is accomplished formally during premarketing clinical trials and continues through the collection of voluntary reports after the drug is marketed (postmarketing surveillance). AEs need to be understood as completely as possible in order to provide sufficient warning to patients, develop recommendations for management, and prevent the drugs use in patients who may be at particular risk. Legally, the company is required to update regulatory agencies about safety issues on a regular basis. For these reasons, pharmaceutical companies maintain depart-
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Alan L. Bess
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ments and resources committed specifically for the purpose of addressing safety issues. As the development and marketing of pharmaceutical products becomes more global in nature, it is only natural that postmarketing
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