NAFDAC, USP to develop roadmap for post-market surveillance

The United State Pharmacopeia (USP) has assisted the Nigerian Agency for Food and Drug Administrative Commission (NAFDAC) to develop a road map toward strengthening Post Marketing Surveillance (PMS) in the country.

The Country Director USP, Chimezie Anyakora during a two-day workshop on Post Marketing Surveillance organized by USP in conjunction with NAFDAC, said it was part of their effort to help the agency develop strategy to move from Pre-market testing to post-market testing of drugs.

He noted that given the high incidence of fake drugs globally, it has become expedient for NAFDAC to intensify drug monitoring and testing so that they can sanction people producing fake drugs and change the face of clinical trials in the country.

Anyakora noted that Post Marketing surveillance has become a global trend and NAFDAC has keyed into this adding that United State Administration for International Development (USAID) has provided all the needed expertise and resources the country would need towards strengthening its post drug testing.

The Acting Director General of NAFDAC, Mrs. Yetunde Oni in her remarks explained Post Marketing surveillance to mean the practice of monitoring the safety and quality of medicines or medical devices after it has been granted marketing authorization.

She said: “It is an important part of the science of pharmaco-vigilance. Medicine and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose.

Stressing the importance of PMS, Oni stated that it was critical due to limitation of phase three clinical trials where limited numbers of patients are used to monitor medicine use over a short period of time and some certain groups such as pregnant women, children and the elderly who use the product when granted approval are often not included in such trials.

She added that PMS was also important because some certain rare adverse events, which were not discovered during the clinical trials, would be identified once the products are widely used and monitored during post marketing surveillance.

The DG stated that the workshop was organized to identify gaps and provide ways to strengthen PMS system in the country, adding that the workshop would help fashion out road map towards improving PMS in the country.