The National Agency for Food and Drug Administration and Control (NAFDAC) has mandated the pharmaceutical industry in Nigeria to establish Pharmacovigilance (PV) surveillance department as the agency is set for full implementation of PV across the country.
At the PV inspection interactive session with pharmaceutical stakeholders in Lagos on Friday, Director General of NAFDAC, Prof. Mojisola Adeyeye disclosed the preparedness of the nation to begin malaria vaccine clinical trial in its resolve to exterminate the scourge of the disease in Nigeria.
The NAFDAC boss further explained that the pharmaceutical industry must put structures in place to ensure adequate monitoring of their products throughout the supply chain, adding that they must have strategies, goals, and clear objectives that will ensure the safe use of their products.
In a statement on Sunday, NAFDAC Resident Media Consultant, Mr. Sayo Akintola said the DG pointed out that the Marketing Authorisation Holders (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 Adverse Drug Reactions/Adverse Events Following Immunisation (ADRs/AEFIs) to the agency. According to Adeyeye, the sustained safety of medical products in Nigeria lies on a vast array of stakeholders and it has become imperative to continually improve on the PV processes for safety monitoring in the country.
She also noted that the various public health programmes involved in the importation of medical products for use in their respective programmes are regarded as MAHs for their products and she therefore encouraged them to establish and identify key personnel that would coordinate the activities of pharmacovigilance within their programmes.
She however said that the six pharmacovigilance centres established across the six geopolitical zones of the country would be strengthened 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 the centres that had been approved should also be involved, vowing to take charge of strengthening them personally.
The DG explained that community pharmacists are strategic in the call because they reach the populace more than any other sector with impressive records. She noted that since community pharmacists are also involved with immunization delivery services, it has become imperative that their PV system should be inspected to ensure compliance with PV regulations and guidelines.
Going down the memory lane, Adeyeye said that, since its inception, NAFDAC had engaged in some level of activities towards ensuring the safe use of medical products in-country. She said that, in recent times, PV has 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 further said that the AU-3S also provided platform for capacity building of the agency’s staff on various aspects of PV, noting that that greatly contributed towards NAFDAC’s attainment of Maturity Level 3 (ML3) under the global benchmarking system of the World Health Organisation (WHO). ‘’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 said that PV inspections of MAHs is a key aspect of PV, 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 further said that that entailed that all MAHs must have a well-established PV 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 PV in NAFDAC when she got to the agency in 2017 prompting her resolve to change the tide. She lamented that PV did badly when NAFDAC had its WHO Global Benchmarking first visit in 2019.
She said Prof. Isa Odidi from the University of Benin, who is the father of PV 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”, she recalled.
‘’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 are 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’’, Adeyeye further said.
She disclosed that, following the dismal outcome of the WHO first Benchmarking visit, she and Pharmacist Ali started talking with Gates Foundation, represented by Ms. RajLong at a conference in Abuja, stressing that that was the push to the improvement that had taken place.
According to Adeyeye, the goal of AU-3S is to have an African vigilance database that can interact, that can be shared with WHO vigibase, saying, ‘we started building the pillars around pharmacovigilance at that point”.
She disclosed that AU-3S is made up of five African regulatory agencies – Ghana, Nigeria, South Africa, Ethiopia and Kenya – adding “that was when we started seeing changes in the pharmacovigilance in NAFDAC”.
She said the agency got the digital tool – the Med Safety App – launched in November 2021 to aid reporting, adding that that instantly revolutionised what the agency is doing. She said the ADR/AEFI reporting of PV improved 10 to 15 times because of the use of the digital tool.
‘’During the pandemic, we were meeting every two weeks with AU-3s, 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”.
As pharmacists, she urged the stakeholders to think of the science that can lead to side effects, serious side effects and signals.
The National President of Community Pharmacists Association of Nigeria, Pharm. Wale Oladigbolu 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”.
Describing drugs as very potent chemicals, Oladigbolu noted that, if sent on an errand to go and cure, it could cause a damage in the process, stressing that “we want to aggregate the number of damages they have 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’’.
