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Making the Most of Spontaneous Adverse Drug Reaction Reporting
Author(s) -
Waller Patrick C.
Publication year - 2006
Publication title -
basic and clinical pharmacology and toxicology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.805
H-Index - 90
eISSN - 1742-7843
pISSN - 1742-7835
DOI - 10.1111/j.1742-7843.2006.pto_286.x
Subject(s) - medicine , drug , drug reaction , thalidomide , adverse effect , tragedy (event) , adverse drug reaction , health professionals , intensive care medicine , internet privacy , risk analysis (engineering) , business , medical emergency , pharmacology , psychiatry , computer science , health care , immunology , political science , multiple myeloma , law
The primary purpose of spontaneous adverse drug reaction reporting is to provide early warnings or “signals” of previously unrecognized drug toxicity. The method was developed in the 1960s in response to the thalidomide tragedy and is now well‐established throughout the developed world. Health professionals are the key original source of reports, the value of patient reporting is yet unclear. Electronic transmission of all reports is likely to become the norm within a few years. This is well‐advanced between pharmaceutical companies and regulatory authorities but still in its infancy for health professionals in many parts of the world. Considered globally, the process may be inefficient and movement towards centralization of databases with appropriate access controls is logical. Alternative methods for capturing clinical suspicions of adverse drug reactions should be investigated and could provide more systematic data. However much it can be improved, spontaneous adverse drug reaction reporting is unlikely to identify all important unrecognized drug safety hazards. Complementary approaches therefore still need to be identified and developed.