Government Moves To Strengthen Adverse Drug Reaction Reporting Through Phamacovigilance Policy Review
Samuel Oyejola and Samirah Abdu-Aguye
Adverse Drug Reactions (ADRs) are any unintended or potentially harmful effects that occur when an individual takes any type of medicine. They can range from relatively mild reactions like headaches or sleep disturbances to much more serious ones like skin reactions. These reactions can have many real world consequences including reduced productivity in individuals, increased length and cost of hospital stay for hospitalized patients or even death. It is estimated that ADRs occur in at least one out of every ten individuals who take medicine.
Collecting information about ADRs-a process known as Phamacovigilance, is the responsibility of drug regulatory bodies all over the world. Consequently-in 2012, the Nigerian Government launched the National Phamacovigilance Center (NPC) to mitigate incidents caused by ADRs on individuals within the country. This center is domiciled in the headquarters of the National Agency for Food and Drug Administration and Control (NAFDAC). In spite of the operationalization of this center for close to a decade now, many Nigerians still find it unnecessary to report their ADR experiences. A correspondent for Time Nigeria Magazine found out that various factors contributed to this apathy. Chief among these are the weak healthcare systems in the country, and strained relationships between patients and healthcare providers; resulting in unwillingness of patients to report their ADR experiences.
Durotolu Olutosin- a mother of two, told the correspondent that she was aware of ADR reporting, but found it unnecessary. She said she is unmotivated by the healthcare system in the country, especially the attitudes of healthcare providers towards patients. She claimed to detest all hospital processes; the queues, the unfriendly attitudes of nurses and the unending waiting to see a doctor. “There is nothing encouraging about the healthcare system in the country, why then should I send information about any ADR I experience to any government organization?”. When she had typhoid, her best alternative was a pharmacy in her neighborhood. The drugs were effective but she would throw up anytime she took a particular drug. She noticed this after three days, then stopped taking the drug and the vomiting ceased. “I am aware of the Phamacovigilance programme of the Federal Government. But while I was on my sickbed, what was on my mind was not reporting the adverse effects of the drug to that office,” she told the correspondent. “What was on my mind, was recovering from the illness.”
For Joseph Agoro, he was unaware of the National Phamacovigilance Center. Yet, when he was asked if he would report an ADR experience, he said it would be a waste of time. Some years back, when he had a Malaria episode that almost claimed his life, he was admitted to a hospital in Lagos state where he was prescribed some drugs. He noticed that one of the drugs made him weak anytime he used it, so he stopped taking it. “If there is any programme by the Federal Government like that (pharmacovigilance), I am unaware of it. In fact this is the first time I am hearing of any such thing. Yet- if I was aware, I don’t think I would go ahead to inform them of my experience with that drug, since I am not the first to have such an experience.” He agreed that the national pharmacovigilance programme was a good initiative, however he was doubtful about its impact on the health system within the country.
Amongst other mechanisms to report ADRs, the NPC introduced a text message based reporting system called PRASCOR to enable individuals engage in direct reporting of any suspected ADR. To report, patients are expected to send a toll-free text message to a short code, containing the name of the medicine they used and information about the ADR experienced. Despite this, some researchers recently reported that this system (PRASCOR) was not being fully utilized for ADR reporting by individuals within the country. For their research, they looked at all of the text messages received by the PRASCOR system over a five year period. They discovered that while a total of 3379 consumer complaints via text message were received, only around half of these complaints contained all of the information that was required for follow up (i.e. contained information about both a medicine and at least one suspected ADR). They also found out that after these text messages were followed up, they ended up generating only around 353 case reports (accounting for less than 5% of the over 9000 ADR case reports present in the NPC database over the same time period).
Nigeria became a member of the World Health Organization’s (WHO) drug safety monitoring programme in 2004. This provided an opportunity for the country to detect, document and record adverse effects associated with the use of medicines, and enter its’ records into the WHO global database. It also makes it possible for NPC officials within the country to view and assess what happens in other countries, so that they can take appropriate measures to forestall similar occurrences from happening here.
The WHO guidelines on ADR reporting recommend that member countries should submit 200 cases per one million individuals of their population annually. Our correspondent reports that Nigeria between 2016 and 2019 barely recorded over two thousand cases annually. “ADR reporting is increasing as we build the capacity of more healthcare providers. We were able to build capacity through support from the WHO and we are part of the Phamacovigilance Africa project. Our major constraint is funding, because we need money to build the capacity of healthcare providers, for advocacy and other activities.” Pharm. Ali Ibrahim, the Director of the Phamacovigilance and Postmarketing Surveillance Department of NAFDAC said.
In 2012, when the pharmacovigilance programme was first initiated, massive public advocacy and enlightenment were done to drive home the need to report any form of ADR to the authorities. However at the local level, ADR reporting may be challenging. The NAFDAC office in charge said it is working on overcoming these challenges. “When the office was set up, we embarked on vigorous campaigns to sensitize the public on the danger of ADRs to the populace, and up till now we still do that. It is very important to share ADR experiences with our office, to enable us know the effects of these drugs on the general public. That is what this office is all about,” he explained.
Pharm. Ibrahim also said a review of the national phamacovigilance policy to ensure that governments at all levels have phamacovigilance offices in their health ministries, and in all healthcare centers is in the offing. “We are reviewing the Phamacovigilance policy to ensure that governments at all levels promote the establishment of Phamacovigilance units in all healthcare centers across the country. We are also trying as much as possible to appeal to healthcare providers that ADR reporting is part of their professional and ethical responsibilities”
“The ADR reporting culture within our population is poor, and our health systems are often not able to detect ADRs. In addition, relationships between patients and their healthcare providers are often not cordial enough to encourage patients to report ADRs. Patients also don’t read the paper leaflets included in the packs of most of their medicines. We have been engaging in advocacy visits in order to change these tides.”
In conclusion, a review of the National phamacovigilance policy would improve the healthcare system, since phamacovigilance offices would be stationed in more healthcare centers across the country. It will also call for more commitment from governments at all levels to provide the funding needed for capacity building of relevant stakeholders.