Maintaining and Enhancing the Value of Spontaneous Reporting Programmes

• DOI: 10.1007/bf03256849
• Publication Date: 2012-08-23T13:28:16Z
• Authors: Kathlyn J. Ronaldson
• Keywords: Drug reaction; Adverse drug reaction

Recent drug safety issues, such as myocardial infarction with rofecoxib, illustrate the limitations of spontaneous reporting programmes (SRPs) and have led to regulatory changes requiring drug manufacturers to conduct active safety investigations after the marketing of a drug. Technological advances mean that large health management databases can be used to explore adverse drug reactions (ADRs), but at present there is no proven cost-effective method that could fulfill the functions of SRPs. One of the regulatory specifications for risk management plans for drugs is the investigation of risk factors for ADRs. The value of SRPs could be greatly enhanced if they were a widely recognized source of cases for pharmacoepidemiological studies to investigate risk factors for adverse reactions, including predisposing genetic polymorphisms. This use of the cases is in keeping with the purpose for reporting adverse reactions, specifically, to improve understanding of adverse reactions, giving justification for use of identifiable patient information. Such studies have the potential to enable drugs to be used with a reduced risk of ADRs, particularly serious reactions.