Postmarketing drug surveillance

Rodriguez EM, Staffa JA, Graham DJ. 2001. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol. Drug Saf. 10 407—410. 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Postmarketing surveillance is critical to ensuring the safety of medications because of the limitations of Phase 2 and 3 studies to identify rare, serious adverse events. Typically, these studies are too short and the study population is fairly healthy. Once a drug is marketed, the population of patients using the drug expands to include sicker patients, older patients, and other populations. 

Noah, B.A. and D.B. Brushwood, "Adverse Drug Reactions in Elderly Patients Alternative Approaches to Postmarket Surveillance," /. Hlth. Law, 33, 383-454 (2000). 

Center for Drug Evaluation and Research (CEDR) Postmarketing Surveillance Programs, www.fda.gov/cder/regulatory/applications/postmarketing/ surveillancepost.htm (accessed May 24, 2002). 

Populations, gene flow between, 55-56 Population structure, 55-56 Positional cloning, 35, 36 Positive drug response, 262 Positive predictive value (PPV), 169-171 Postmarketing surveillance, 94—95, 324-325... 

A case is a basic unit of drug safety surveillance. It is used to assure, to the greatest extent possible, the safety of approved drug products that are still in use. The basic unit of all postmarketing safety submissions is the adverse drug experience case , which is an individual adverse drug experience. 

Postmarketing Surveillance Studies. Any surveillance of safety of a drug after marketing is postmarketing surveillance (PMS) (now often referred to as a postauthorization safety study). In practice the distinction between Phase TV studies and PMS is blurred (e.g., German drug experience studies). 

Brewer, T. and Colditz, G.A. (1999). Postmarketing surveillance and adverse drug reactions Current perspectives and future needs. JAMA 281 824-829. 

The astute individual healthcare practitioner is the critical link in the postmarketing surveillance of medical products. One reporter can indeed make a difference in a newly approved drug s postmarketing phase. Only through the diligence of individual practitioners, such as pharmacists, can FDA hope to monitor the adverse events associated with newly marketed products and determine their safety for patient use. 

The FDA s postmarketing surveillance of drug safety in FY 2003 includes a new database on prescribed drug use (with patient idenhhes removed). The agency uses this database of marketed drugs to "make risk assessments and decisions about the most appropriate way to manage any new risk or new perspective on a previously known... 

Warden, W.M., Tsianco, M.C., Anavekar, S.N., and Davis, H.T., Postmarketing Surveillance of New Drugs II, Case Study, /. Clin. Pharm., April 1979. 

Other activities that fall within the area of postmarketing surveillance require input from, if not handling by, those responsible for clinical drug safety. These may include observational (non-interventional) studies, which may be retrospective or prospective, and other projects specifically designed to investigate a safety issue. 

Lawson DH. Postmarketing surveillance of drugs. Proc Roy Coll Phys Edinb 1990 20 129-42. 

Gex-Fabry, M., Balant-Gorgia, A.E., and Balant, L.P. (1997) Therapeutic drug monitoring databases for postmarketing surveillance of drug-drug interactions evaluation of a paired approach for psychotropic medication. Ther Drug Monit 19 1-10. 

Because premarket review can t catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program. 

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