NAFDAC advises pharmaceutical industries to set up inspection department

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Lagos, June 18, 2023 – The National Agency for Food and Drug Administration and Control (NAFDAC) has advised operators in the pharmaceutical industry in Nigeria to establish Pharmacovigilance Surveillance departments.

Prof. Mojisola Adeyeye, the Director General of NAFDAC, said this was important as NAFDAC would soon start full implementation of Pharmaceutical Vigilance (PV) across the country.

She gave the advice on Friday at the Pharmacovigilance Inspection interactive session with Pharma Stakeholders in Lagos.

Adeyeye said that this was also necessary in view of the preparedness of the nation to begin Malaria Vaccine Clinical trial in its resolve to exterminate malaria scourge in Nigeria.

She said the pharmaceutical industry must put structures in place to ensure adequate monitoring of their products throughout their supply chain. 

She also advised that they must have strategies, goals, and clear objectives that will ensure the safe use of their products.

In a statement by the NAFDAC Resident Media Consultant, Sayo Akintola, on Sunday, Adeyeye said that the MAHs, must as a matter of importance, train and further engage all relevant stakeholders along their supply chain on the need for pharmacovigilance and use of relevant reporting platforms for reporting ADRs/AEFIs to the Agency.

According to her, the sustained safety of medical products in Nigeria lies on a vast array of stakeholders and it has become imperative to continually improve on our pharmacovigilance processes for safety monitoring.

 She said the various public health programmes involved in the importation of medical products for use in their respective programmes were regarded as marketing authorization holders for their products.

The NAFDAC boss, therefore, urged the operators to establish and identify key personnel that would coordinate activities of pharmacovigilance within their programmes.

She said the six pharmacovigilance centers established across the six geopolitical zones of the country would be strengthened further to serve as convergence centres from the states to the Centre, but most importantly from the communities to the states to the Centres.

She said those centres that have been approved should also be involved to take charge of strengthening them personally.

Adeyeye said community pharmacists were strategic in this call because they reach the populace more than any other sector with impressive records.

She said since community pharmacists were also involved with immunization delivery services, it had become imperative that their pharmacovigilance system should be inspected to ensure compliance with PV regulations and guidelines.

Adeyeye said NAFDAC, since its inception, had engaged in some level of activities toward ensuring the safe use of medical products in-country.

She stated that in recent times, pharmacovigilance had been brought to the fore with the COVID-19 pandemic and the key role that the African Union smart safety surveillance (AU 3S) played in assuring safety of products used in the pandemic within the member countries including Nigeria.

The AU-3S programme, led by African Union Development Agency (AUDA-NEPAD), aims to create a sustainable continental safety monitoring system to improve the safety of priority medical products for patients across Africa. The AU3S coordinated surveillance system was piloted with the COVID 19 vaccines in the five member countries with the goal of future continent-wide safety surveillance of other medical products.

Adeyeye said the AU3S also provided platform for capacity building of our Staff on various aspects of Pharmacovigilance, noting that this had greatly contributed toward NAFDAC’s attainment of Maturity Level 3 (ML3) under the WHO global benchmarking system.

‘’This means that we are now a stable, well-functioning and integrated regulatory system’’.

Having achieved this feat, she said the Agency is now poised to delve into aspects of pharmacovigilance inspection which before now we had not ventured into.

She opined that Pharmacovigilance Inspections of Marketing Authorization Holders (MAHs) is a key aspect of Pharmacovigilance which cannot be ignored by any regulatory authority that has intent on ensuring patient safety with use of medical products and attaining higher levels of maturity in its regulatory processes.

She added that this entails that all MAHs must have a well-established pharmacovigilance system in place and most importantly, vigilance activities are being carried out in accordance with national regulations and guidelines.

Adeyeye recalled with pain the parlous state of Pharmacovigilance in NAFDAC when she got to the Agency in 2017 prompting her resolve to change the tide.

She lamented that Pharmacovigilance did very badly when NAFDAC had its WHO Global Benchmarking first visit in 2019.

She said Prof Isa from the University of Benin who is the father of Pharmacovigilance in Africa felt extremely bad with the outcome of WHO audit that year.

 ‘I invited him to the audit from WHO and he was disappointed because he goes around the world guarding people about pharmacovigilance’.

‘’I knew that the situation was very bad. But you cannot change something that is very bad overnight. We also went to Morocco and saw the pharmacovigilance centre.

“Our people are getting the short end of the stick because if the community pharmacist, the hospital pharmacist is not made aware of the importance of reporting, then our own population is getting the short end of the stick in the sense that whatever we are supposed to have gotten in terms of reporting we are not getting,’’ she said.

Adeyeye said that following the dismal outcome of the WHO first benchmarking visit, she and Pharmacist Ali started talking with Gates Foundation, represented by Ms. Raj Long at a conference in Abuja, stressing that she was the push to the improvement that had taken place.

She said the goal of AU3S was to have an African vigilance database that could interact and could be shared with WHO vigibase, adding that ‘’we started building the pillars around pharmacovigilance at that point’’.

Adeyeye said that AU3s was made up of five African regulatory agencies in Ghana, Nigeria, South Africa, Ethiopia, and Kenya.

She said NAFDAC got the digital tool, the Med Safety App, launched in November 2021 to aid reporting, adding that this instantly revolutionized what we were doing.

She said the ADR/AEFI reporting of pharmacovigilance had improved by 10 to 15 times because of the use of the digital tool.

‘’During the Pandemic we were meeting every two weeks with AU3s, reporting everything that was taking place in Nigeria.

“We also have the National Signal Detection Group that was meeting with other National Regulatory Agencies in their own different groups. 

“NAFDAC/ Nigeria led the reporting of AEFIs because of the change that can take place in a particular Directorate, she said.

Adeyeye advised stakeholders to think of the science that can lead to side effects, serious side effects and signals.

Wale Oladigbolu, the National President of Community Pharmacists Association of Nigeria (FPSN), commended NAFDAC for the initiative, stressing that ‘’although PV is not new, with this new approach we know that we will be dealing with the public in a very scientific manner to protect their health.”

Oladigbolu described drugs as very potent chemicals that could cause damage in the process of healing a patient.

‘’We want to aggregate the number of damages they have been caused over a period of time so that we can scientifically say that this drug is still delivering on promise, or this drug should be withdrawn,’’ he said. (GBN).

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