Report adverse drugs reactions, NAFDAC urges Nigerians

Drugs used to illustrate the story.
Drugs used to illustrate the story.

The National Agency for Food and Drugs Administration and Control, NAFDAC, has called on Nigerians to take reports of adverse drugs reactions more seriously.

The agency gave the advice through its acting Director-General, Yetunde Oni, at a media chat on pharmacovigilance and malaria held in Abuja on Tuesday.

The advice was against the backdrop of a revelation that Nigerians report only a fraction of cases of adverse drugs reactions they experience.

“Due to the inherent nature of medicines, no medicine, no matter how skilfully produced to meet specified quality standards, properly distributed and stored, rationally prescribed and used is 100 per cent safe.

“Medicines are double-edged swords that can have tremendous benefits or untoward effects on our health,” Mrs. Oni, who was represented by the agency’s director of planning research statistics, Samson Adebayo, said.

“However, by continuously monitoring all medicines, it is possible to detect those causing unwanted ADRs, understand why they cause ADRs and prevent them from further causing harm to users.

“This can only be done effectively if health care providers detect and report all suspected ADRs and other medicine related problems”, she said.

The programme, which was organised by NAFDAC in collaboration with National Malaria Elimination Programme, aims to create awareness on the importance of reporting any reaction caused by the use of medicines.

The National Pharmacovigilance Programme, which was officially launched in September 2004, aims to enhance patient care and safety in relation to the use of medicines; and to support public health programmes by providing reliable and balanced information to assess the risk-benefit profile of medicines.

Decrying the rate at which Nigerians have responded to the Adverse Drugs Reactions report, Mrs. Oni said “Each participating country is expected to have a reporting rate of 200 individual case safety reports, ICSRs, per one million inhabitants per year.


“This means that Nigeria with a population of over 140 million people is expected to generate about 28,000 ICSRs per year.

“This is a far cry from the reality. As at December, the National adverse drug reaction database had received 2361 reports for 2016.

“The numbers for the last three years are 1385, 988 and 2162 for 2015, 2014 and 2013 respectively.

“These figures indicate that there are many adverse drug reactions that are not reported by health care providers and patients”, she said.

“There is a need for people to take Adverse Drug Reactions reporting as a provisional responsibility and the patients should be able to come forward and report”, the acting director, pharmacovigilance /post marketing surveillance, Ibrahim Ali, said.

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“Because if they don’t report, we cannot document.

“We have been able to improve because we felt there was need to collaborate with some organizations like Institute of Human Virology, National Malaria Elimination Programme, National Agency for the Control of AIDS, and others, the reporting is progressing,” he added.

Going forward, he said NAFDAC has concluded plans to partner healthcare institutions, the academia and other relevant stakeholders for effective monitoring of medicines and their usage.


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