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Methodologic Issues in Pharmacy-Based Post-Marketing Surveillance

The Medication Monitoring Programsm (MMP) is a research operation of the Upjohn Company Division of Medical Affairs established for the purpose of conducting studies of marketed medications under conditions of usual use. This report describes five pharmacy-based studies conducted through the MMP. The basic methodology is reviewed, some of the analyses are presented, and advantages and disadvantages are discussed. The author concludes that the pharmacy-based method is effective for monitoring drug use on an outpatient basis. It is possible to obtain information about use patterns, safety, and therapeutic benefit. However, no single method of post-marketing surveillance satisfies all requirements. Multiple complimentary methods are necessary for a comprehensive approach to post-marketing drug evaluation.