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PubMed1986

An evaluation of spontaneous adverse drug reaction monitoring systems.

The Food and Drug Administration maintains an adverse drug reaction reporting system. Physicians report suspected adverse reactions that occur while a patient is taking a drug; reporting is voluntary and spontaneous. Data from spontaneous adverse drug reaction reporting systems are designed to signal that rare, unsuspected adverse reactions exist as a result of using a specific drug. Problems arise when attempts are made to use such data for other purposes. Specifically, spontaneous adverse drug reaction data, such as those published by the Food and Drug Administration, are inappropriate for calculating actual adverse drug reaction rates for specific drugs or for making safety comparisons among drugs. This is because these data are subject to numerous biases that can be easily identified and described but not easily corrected. As a result, data from spontaneous adverse drug reaction reporting systems bear little relationship to the actual incidence of adverse drug reactions.

Adult↗
PubMed1985

A national monitoring system for congenital malformations in Israel.

In 1976 the Department of Maternal and Child Health in Israel established, at minimum cost, a national system for reporting of congenital malformations. The system is based on hospital reporting of all live births through a special form attached to the live birth certificate. Compliance of reporting has reached 80 to 90%. Data obtained are tabulated and circulated monthly. It was found that forms that were received later reported a relatively higher percentage of congenital anomalies.

Birth Certificates↗