The pharmacovigilance processes

The basic component of Pharmacovigilance processes is summarized below.

Data generation;

Data generation is the first stage in pharmacovigilance in which data is sourced from spontaneous reporting or mandatory reporting

1-Spontaneous reporting.

 The most common form of adverse drug reaction reporting. Healthcare professionals identify and report any suspected adverse drug reaction to their national pharmacovigilance centers or the manufacturers.

2-Mandatory reporting.

Manufacturers are required to submit reports they received from healthcare providers and from the surveys (Post-marketing surveillance) they made to the national authority in the form of a PSUR (Periodic Safety Update Report) which is a regulatory document prepared by the Marketing Authorisation Holder & submitted to the national regulatory agency (FDA in the USA) (NAFDAC in Nigeria).

Worldwide post-authorisation safety experience includes information gathered on all ADRs collected irrespective of the reporting country and includes scientific evaluation of the risk-benefit balance.

Case Evaluation And Reporting.

Product manufacturers are required to evaluate each case for seriousness, expectedness, and causality. Manufacturers can also contact the patient or other healthcare professionals to get additional information. After analyzing available information, manufacturers may determine if the case is urgently reportable to the regulatory authorities. Manufacturers are also required to maintain information on all reports of adverse events irrespective of their seriousness, expectedness, or causality.

Aggregate data analysis.

Various types of a report may indicate some level of association between the suspected medicinal product and the event occurred. However, confirming a causal relationship between adverse the drug and adverse event requires careful analysis of all the collected data to properly ascertain the causal relationship. Uppsala Monitoring Center UMC (The World Health Organization center for pharmacovigilance and drug monitoring) is responsible for receiving the worldwide report and maintain the record of the received cases in their database (Vigibase).

Safety data dissemination

UMCcenter maintains the publications of new potential safety signals identified. The information may contain warning letters to various nationals regulatory agencies about the safety of the particular drug. National regulatory centers are required also to disseminate such information to health care professionals about the safety issues and take actions such as drug withdrawal and license cancellation when necessary.


A. Mukhtar BPharm, MSc. (In view).

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