Pharmacist Yohanna Kambai Avong is the Principal Investigator and Senior Consultant of Pharmacovigilance Africa (PAVIA) project of the Institute of Human Virology Nigeria (IHVN). In this interview, he spoke about the adverse drug reactions reporting system in Nigeria, importance of pharmacovigilance (monitoring the safety of medicines and actions to reduce risks and increase the benefits of medicines) for effective healthcare delivery in the country, and achievements of the PAVIA project among others.
What are adverse drug reactions, and what should people do when they experience them?
Medications are good but there’s no medication that is totally free from adverse reactions. Every medicine has an inherent capacity to cause harm. However, the level of harm differs from mild, to moderate and severe.
This means we should not abuse drugs – when you abuse drugs, drugs will abuse you. In fact, with drug abuse, you can move from adverse drug reactions to drug toxicity. Toxicity can lead to instant death. Another angle to this is the impact of fake drugs. Some people use fake drugs because they are cheap; but don’t risk it.
When we take medications, we should be observant of unwanted, harmful responses from our bodies. We call such responses an ‘adverse event’ when we have sufficient proof to establish that it is the medication that is causing the problem. When you go to the hospital and it is proven, it is called an adverse drug reaction. What is important is that as soon as you notice these unusual occurrences, you should go to the hospital.
Adverse drug reactions can kill. Let me give you an example; in 1998 in the United States, adverse drug reactions alone were found to kill more people than HIV/AIDS, pneumonia, and some heart conditions. Report it when it is mild – don’t suppress it. An example of this is when in reaction to Stavudine, a medication that was used for HIV/AIDS, some individuals had mild abdominal pain and suppressed it till they developed pancreatitis.
When you report these events, your health care provider reports to the National Agency for Food and Drug Administration and Control (NAFDAC). NAFDAC studies and compiles these reports which eventually are sent to the World Health Organisation (WHO).
WHO monitors adverse events globally. Every person that is involved in treating patients has a responsibility to monitor adverse side events and not just give the medication. What we did in IHVN is increase the monitoring and reporting; we distributed information, education, and communication materials to serve as reference materials for healthcare workers.
What is your advice to the public, health workers, and other stakeholders concerning adverse events?
In monitoring side effects, healthcare workers should remember that some individuals, especially men, find it difficult to talk about the adverse events that they experience – it may be that tendency of wanting to be in control. This means that health care providers should not relent in asking questions about how a patient’s treatment is going. Investigate and encourage patients to speak about likely side effects.
The new pharmacovigilance policy spells out that the management of adverse reactions is still the ethical responsibility of healthcare workers. It is from reports from health workers nationally to NAFDAC and then at the global level that NAFDAC is guided in deciding about drugs that are safe for the public.
Can you briefly tell us about the Pharmacovigilance Africa (PAVIA) project?
I was the principal investigator of the PAVIA project when I was in IHVN and became a senior consultant on the project when I left. We have been implementing this project from 2018 up to this year. The project was extended to 2023 because of COVID-19. The project was implemented by 13 organisations, some from Africa and Europe, with the coordinating office in the Amsterdam Institute for Global Health and Development (AIGHD).
The countries in Africa whose pharmacovigilance systems were strengthened by the project are Nigeria, Ethiopia, Tanzania, and the Kingdom of Eswatini (formerly Swaziland). These were the countries the programme was designed to strengthen.
What inspired the project, and how is it related to the safety of medicines especially in Nigeria?
Pharmacovigilance, as the name implies, is concerned with vigilance and vigilance is in relation to the safety of medications.
The goal is to prevent medicines from harming people while on treatment. In sub-Saharan Africa, especially the four PAVIA-supported countries that we have mentioned, there is a large population of people living with HIV as well as TB and being treated with different medications that are potentially harmful.
Sometimes, there is a switch between old medications and new ones. For the new medications, we need to get information about possible harmful effects by monitoring their use. The concern for the safety of the thousands of people using the medications inspired the project.
Strong pharmacovigilance systems help to keep people on life-saving treatment while monitoring the medications. With a strong system, we can easily identify individuals experiencing harmful side effects and take regulatory measures for the safety of the public.
What were the key achievements of PAVIA during the 48 months it was implemented?
One of the greatest achievements that we made was that we revised the national policy. We now have a modern national pharmacovigilance policy that has been distributed all over the country.
Secondly, we introduced a new method of training which is online and designed to train many people in a short period. This is the blended learning method. An estimated number of 10,000 people were trained in five years. We have increased the workforce within the country in pharmacovigilance.
We have also created awareness about adverse drug reaction reporting – the legislature was involved to see the importance of this to the country. Some of the achievements that we have made in terms of impact are difficult to measure within a very short time of intervention. However, it is notable to mention that reporting of adverse drug reactions has increased.
What is your call to action for Nigeria in respect to pharmacovigilance?
I must thank the Government of Nigeria for its efforts in pharmacovigilance – Nigeria is one of the countries doing well in that area. If you are doing well, there is a need to do more. It means they can strengthen NAFDAC to carry out its duties. They can do this through continuous funding for the pharmacovigilance policy to be widely distributed.
Secondly, the PAVIA project made some findings that NAFDAC should follow up on such as the PAVIA triangle of bringing stakeholders together. The stakeholders here include the national coordinating bodies for the treatment programmes, for example, the National Tuberculosis and Leprosy Training Programme, the National Agency for the Control of AIDS (NACA), the National AIDS STI Control Programme and National Malaria Elimination Programme (NMEP).
The focus is on medications for HIV, tuberculosis, and malaria because thousands of people are taking medications to treat these diseases. Medical research institutes and universities as well as non-governmental organizations are also stakeholders to be brought together by NAFDAC.
The blended learning method that PAVIA utilized is also one we should continue. Currently, the University of Benin has the right to host this platform. IHVN is working with them to see that many Nigerians are trained through this online platform – this still must be supported financially and otherwise. My hope is that we’ll even go beyond training healthcare providers to training patients on how to report adverse drug events.
In fact, that is the area of my specialisation in the doctorate programme – electronic pharmacovigilance for people to report adverse events from wherever they are. For now, let us start with reporting by healthcare workers and getting them trained. If we sustain efforts in this area, we’ll make progress like the developed countries in ensuring the safety of our people.
Government spending on medications is lopsided if pharmacovigilance is not taken seriously. Deliberate investment is to be made in this area so that we don’t develop more illnesses while trying to fight diseases.
NAFDAC is already using a new tool for reporting adverse drug reactions which was launched in November 2020. With the tool, Nigeria has reported more adverse reactions than any other country in Africa. We have even gone ahead in reporting adverse events from vaccines. However, we need to move beyond making sure reporting is done in tertiary hospitals to secondary hospitals and primary health centres in rural communities.