Spontaneous Reporting in Pharmacovigilance: Strengths, Weaknesses and Recent Methods of Analysis

Volume 1, Jan 2012

Rachna Kasliwal; Berkshire, UK

Use of medicines in real-life clinical setting is very different to the controlled clinical trial environment in which drugs are tested prior to marketing. As not all adverse effects of a drug may be identified from pre-marketing clinical trials, the continuous safety monitoring of drugs is essential to ensure a favourable benefit-risk profile of the drug. The spontaneous reporting system is a method whereby healthcare professionals (HCPs) report suspected adverse drug reactions (ADRs) to drug regulatory bodies or pharmaceutical companies. It is a widely employed and effective method of collecting information on suspected ADRs. It helps to detect previously unknown effects of a drug and provides information from real-life clinical practice, throughout the life of the drug. In spite of its limitations such as under-reporting, spontaneous reporting forms the backbone of a Pharmacovigilance system. As the spontaneous reporting system is a passive method that relies on HCPs to report suspected ADRs, HCPs can contribute immensely in enhancing knowledge about the safety profile of a drug. More recently a number of different statistical tools have been developed to discern meaningful drug safety signals from the background ‘noise’ within large databases comprising of spontaneous reports. These tools have to be used cautiously and in conjunction with other methods of causality assessment.