Manage risks better with pharmacovigilance signal detection

Pharmacovigilance primarily involves the study of adverse reactions to drugs

. Most drugs are tested on a few thousand patients before they are sold in the market. So, its as important to study the long-term effects of the drugs as it helps to assess the potency and side-effects of the drugs and manage risks associated with the product more effectively. One way in which the adverse effects of drugs are studied is through pharmacovigilance signal detection. WHO defines a pharmacovigilance signal as reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented previously. In laymans terms, when a patient experiences an adverse effect to some drug, she may show some symptoms. These are the signals. The role of pharmacovigilance is to record those signals and identify the causal factors behind the signals. Clinical tests are also conducted to assess the extent of the signals, to identify whether it is limited to a particular individual or extends to all drug users and to measure the duration of the signals, etc. Signal detection plays an important role in understanding adverse reaction to certain drugs. Its very important as it saves so many drug users from so much suffering and sometimes even pain. There have been cases where pharmacovigilance signal detection has resulted in withdrawal of drugs from the market. With new innovations in technology come new means of pharmacovigilance signal detection. Automated signal generation using pharmacovigilance systems has improved signal detection standards and has helped early detection and analysis of signals. Automated signal detection usually compares the reported safety profile of a drug with the existing database using statistical methods to detect early warning signs. This process saves a lot of time, man hours and money and also helps in managing product risks effectively.

Manage risks better with pharmacovigilance signal detection

By: Vikas Sah

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