Expert Seeks Stronger Drug Safety Monitoring to Protect Patients
By Ojoma Akor
A public health expert has called for stronger pharmacovigilance in Nigeria, warning that inadequate monitoring and reporting of adverse reactions to medicines and vaccines could undermine patient safety.
Speaking in an interview with Health and Science Africa, Program Manager and Pharmacy Lead at the Institute of Human Virology Nigeria (IHVN), Dr. Istifanus Sako Usman urged healthcare providers to monitor the effects of medicines on patients more closely and promptly report suspected adverse drug reactions to the relevant authorities.
Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse effects or other medicine-related problems after drugs and vaccines are introduced for use.
Dr. Usman said effective monitoring is particularly important because many medicines used in Nigeria, including those deployed in public health programs, are imported or donated by foreign countries. “Most of these drugs, especially drugs that are used for public health programs, are imported; they are brought or donated by other countries,” he said.
According to him, although medicines undergo clinical trials before approval for human use, many of those trials are conducted outside Nigeria. They may not fully capture how the medicines will affect people in different populations and environments. He said this made it necessary for Nigeria to continue monitoring medicines after they were introduced into the country.
He said, “When they do these clinical trials, and then they certify that the medicine is good for human consumption, it is now brought into our own climate where the clinical trial was not done,” he said, adding that “for this reason, we need to observe and see the effect of these drugs on our own people. That is pharmacovigilance. We cannot just observe and leave these cases; we need to treat them too.”
ADR cases ‘grossly underreported’
Dr. Usman expressed concern that adverse drug reactions (ADR) are significantly underreported in Nigeria, saying studies have consistently highlighted gaps in the country’s pharmacovigilance system. “So many studies have shown that adverse drug reactions are underreported in our country,” he said.
He said healthcare professionals have a critical role in closing the reporting gap because they are often the first to identify unusual or harmful reactions to medicines. “Healthcare providers need to improve on this because it is only when they are vigilant that they will be able to spot these adverse drug reactions and report them appropriately,” he said.
Dr. Usman explained that reports of suspected adverse reactions are submitted to the National Pharmacovigilance Center of the National Agency for Food and Drug Administration and Control (NAFDAC), contributing to the international medicine-safety monitoring system.
He said information gathered from different countries helps the World Health Organization assess medicine safety and inform decisions on medicines.
“WHO takes decisions on medications based on the reports received from different countries,” he said. “So, if a country is not reporting, they are not doing their population any good at all.”
IHVN intervention increases reporting
Dr. Usman said the Institute of Human Virology Nigeria (IHVN) has contributed to improving pharmacovigilance in the country by training healthcare professionals and establishing pharmacovigilance committees in several secondary and tertiary health facilities it supports.
He recalled that IHVN secured a grant in 2015 that enabled it to train more than 300 healthcare professionals from the 36 states and the Federal Capital Territory.
Those trained included medical doctors, pharmacists, nurses and laboratory scientists, who underwent a two-week pharmacovigilance and adverse drug reaction reporting program in Abuja.
Dr. Usman said the intervention led to a substantial increase in reports submitted to the National Pharmacovigilance Center. According to him, within 12 months of the training, the number of reports the center received rose to more than 10 times the total recorded between 2004 and 2015.
He said IHVN further strengthened its work in the area in 2018 when it secured a four-year European Union grant, in collaboration with the University of Benin and NAFDAC, under the Pharmacovigilance Africa (PAVIA) program. The program, he said, was designed to strengthen pharmacovigilance systems in Nigeria, Ethiopia, Tanzania and the Kingdom of Eswatini.
Dr. Usman stressed the need for sustained investment in drug-safety monitoring, saying stronger pharmacovigilance would help Nigeria detect adverse reactions earlier, protect patients, and contribute vital safety information to the global health system.
