EXCLUSIVE INTERVIEW: We are working to review the Phamacovigilance policy – NAFDAC DG
Prof. Mojisola Adeyeye is the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC). She spoke with IMPACT NEWS on effort to improve reporting of Adverse Drug Reaction (ADR) in the country. Excerpts,
Since the introduction of Adverse Drug Reaction reporting, what has been its impact in the healthcare system?
Essentially Nigeria became a member of the WHO Drug Safety Monitoring on 9th September 2004. This provided opportunity for Nigeria to detect, document adverse effects associated with medicine within Nigeria, enter it into the global database and make it possible also for Nigeria as a country through the National Phamacovigilance Centre to view and assess what is happening in other countries of the world.
Some of the benefits are that issues that happen in other countries, NAFDAC is informed and we would be able to take appropriate measures so that our own people in the country will not experience such. Using that, we were able to detect some hazard associated with the use of Analgin. One of the issues that arises was that some children in Delta State were administered Analgin and their skin peeled off to the extent that one of them died. Technically we refer to the effect as toxic epidemalnecrolysis. It is one of the harmful effect of Analgin. As a result of that Nigeria was able to take necessary steps and the use of Analgin was stopped in Nigeria.
The other thing is that since we became a member of the WHO Drug Safety Monitoring, Nigeria was able to build capacity of some healthcare providers in health facilities and who have been able to get reports which we now report in the global database. We also participate in capacity building programmes and we have been able to go into collaboration with some research institutes like Institute of Human Virology in Nigeria, to carry out some research work and publish in International journal.
What has been done to translate this effort to healthcare centres in the states?
Recently, we just visited one state each in the six geopolitical zones. I visited Sokoto state with one of my team and others. We were able to visit some health facilities to carry out assessment of their level of preparedness for detection and reporting of Adverse Drug Reaction. We were able to do this with the support of Medical Services for Health. We discovered that some institutions have capacities while other do not. The good thing in building capacity is that if you are able to detect the hazard measures are put in place so that other people are not subjected to that hardship.
We have seen situation where ADR resulted into hospitalization of the patient beyond the normal time it is supposed to be. Some are so severe and so serious that the person has some deformities or it might result in death. So with the experience some health facilities have had, they were able to put in place measures to treat patients experiencing ADR to make sure that it does not happen again.
With ADR, it is not that the drug is bad, but because of the genetic composition of individuals, the body of some individuals will not tolerate that medicine and they will react to it. For instance there are some medicine used in treating malaria, because of the sulfur components some individuals react to it in such a way that their skin can peel off. When such situations arises, it is detected, documented and the patient is well informed that he or she have to notice the medicine and any time he goes to another health facility, he should inform them that there are some medicine he reacts to in such a way that it should not be given to him because if the drug is administered the second time the reaction might be worse.
With this some of the healthcare professionals were able to interact with the patients and we’re able to avoid some of these unnecessary hardship. Also, there are some that are very toxic and the heart can react to it, like some of the drugs they use in treating TB. These are documented and they are reflected in the document I mean the inside leaflets of the medicine. What we always advocate is that individuals given this medicine or healthcare provider giving this medicine to patients should be able to counsel the patient that these are what you are supposed to expect and if you experienced it, contact me do that it can be documented.
What is the difference between ADR and side effects?
In the case of side effect experienced it is part of the action of the chemical that made up that medicine. But that effect is not effect that is desirable, but in the case of ADR, the reaction that is experienced is unwanted reaction, and that reaction occurred when the drug is taken on normal doses and it is not part of the phamacological properties of that medicine. That is why I said one person can react, the other will not react. The ADR occurred and a result of the genetic composition of that person that doesn’t tolerate the drug. That is why they call it unwanted reaction. Sometimes it can be so serious that the person can become unconscious.
What challenges do the National Phamacovigilance Centre experience with the reporting of ADR?
The patients should be able to report some of these things but what we have in most cases where we have low reporting is that the culture of reporting is not in the people. Also the health system is not so strong as expected to detect some of these ADRs. In most countries where they were able to address the challenge, the health system is strong enough and the healthcare providers are very enthusiastic to report some of these ADRs.
Knowing that we have these challenges we have been able to engage in advocacy visit to some policy makers, healthcare providers and it has started improving the status of our reporting. The standard is that every country should be able to report 200 per million. In Nigeria where we have about 200 million population, we are expected to report like 4000 .Even advance countries cannot meet this target, the reason is because there is a challenge in reporting ADR from the patient because some patients believe whatever they feel is their confidential information.
Also, the relationship between some healthcare providers and patients is not strong enough to make the patient relate ADR to the healthcare provider.
Another thing that is always a barrier is that the patients themselves are encouraged to report their experiences when they take a drug but they don’t read the leaflet inside the drug to know that what they experience is not part of what they are expected to experience. What we have been able to do is that we try as much as possible to come up with a system, we call it Phamacovigilance Rapid Alert System for Consumer Reporting.
When they take a medicine and they experience something that is unusual they have a code 20543. when they text the name of the medicine to this code and the kind of reaction, we get it inform of email and their phone number but the challenge we have is that most of the time, the quality of the report is not very good. Not very good in the sense that somebody sends you a report and you ask him what is the name of the medicine and he tells you he has forgotten. There are the areas we are also trying to enlighten the patients in such a way that they will be able to give us adequate information.
What plans do you have to mitigate these challenges?
We have also decided that we have a phamacovigilance policy that spelt out the various responsibilities of stakeholders. This policy was developed and presented to the public in 2012. We observed that there are some defects in this policy. It is stated in the policy that government at all levels should promote phamacovigilance, but how do you promote it? We are reviewing the policy with the support of Medical Services for Health.
In the review we are putting it in place for effective implementation and it is stated that government at all levels should promote the establishment of phamacovigilance units in health facilities. We believe that if there is a unit there is going to be financial allocation to that unit, there is going to be an officer in that unit, and that officer will be trained to promote phamacovigilance and strengthen ADR within that health system. But what we see presently, we have seen situation where there is no unit, sometimes the desk officer in charge once he is transferred that is the end. And it affects the report. Also there is no budgetary allocation. We are believing that if we are able to review and finalize it there will be improvement in the reporting culture.
We are also appealing to the healthcare providers that the reporting of ADR is a professional responsibility and ethical responsibility.
Having said all these, the phamacovigilance activities is capital intensive because the laboratory assessment that is carried out has to be accurate for you to be able to conclude that the drug was the one that cause this effect. Also, the patient should be given accurate and correct drug. All these areas is what we are appealling to government to strengthen the health system. When the healthcare system is strengthened you have a proper way of getting drugs, proper laboratory assessment, proper diagnosis so that the right medicine is given to the right patient in the right amount. You will discovered that incidences of abuses and misuse of medicine will reduce.
Considering the level of Literacy in the country what is being done to improve ADR reporting amongst those that are less literate?
What we have done is to do public enlightenment and pay advocacy visit to religious and traditional leaders. These are the people that live within the community. Literacy is important in ADR but the most important thing is that you should have the willingness to report. When you contact a healthcare provider, there are trained in such a way that they know what to report.
Literacy is very important but the challenge we have in the health system is not only being able to read and write, you should be able to understand, interact and build confidence and relate with your healthcare provider. There should be the willingness to report.
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