On NAFDAC’s vigilance and public safety
IN today’s Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) is unarguably the face of the quintessential state regulator. Its responsibility of driving, promoting and successfully perfecting the act of vigilance in the nation’s pharmaceutical products consumption and administration, an act widely known as pharmacovigilance, including the deployment of cutting edge technologies have caught the attention of the world.
The agency’s seamless regulation and control of the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals, packaged water and detergent across the length and breadth of the country have etched in the consciousness of Nigerians the image of a super-protective state institution.
The demands made on its statutory functions make NAFDAC ubiquitous, thus making it the unseen ‘watchful eye’ in the food and drugs chain. Why and how? Appropriate tests are conducted and compliance with standard specifications for the effective control of the quality of food, packaged water and the raw materials as well as their production processes in factories and other establishments are ensured by the agency.
It also undertakes appropriate investigations into production premises and raw materials for food and establishes relevant quality assurance systems, including certification of the production sites and the regulated products and pronounces on the quality and safety of food, packaged water and chemicals. Its role also extends to the inspection of imported food facilities to ascertain relevant quality assurance systems necessary for certification of such products.
As an omnibus state institution, NAFDAC’s emergence on the drug and food production and distribution chain in the country flows from the global drive to make the world safer by holistically addressing the issue of food safety and food-borne toxicants in the developing world of which Nigeria is a part. Before NAFDAC came into the scene, public ignorance, uncoordinated approach to food control, lack of technical expertise and adequately equipped laboratories in some cases, poor enforcement of legislations and regulatory limits, were very serious issues in the nation.
The agency has taken a step further to be on top of its statutory responsibilities by enabling the emergence of a Pharmacovigilance Directorate to solely address the non-efficacious outcome of drug application in the treatment of ailments, abuse of medicines as well as other negative consequences arising from use of drugs. The Directorate is saddled with the coordination of pharmacovigilance activities nationwide, establishment and maintenance of a functional national database on adverse drug reactions and other related problems; receive, document, follow up, analyse and evaluate individual case safety reports (ICSRs) for completeness, technical correctness and validity.
It is also to acknowledge ICSRs’ feedback information and dissemination to health professionals and the public through articles in journals, adverse drug-reaction bulletins and or newsletters. The directorate receives, collates and channels to the control room of the agency information on effects of medicinal products on the consumers persons. This is intended to guarantee the presence of and access to safe pharmaceutical products nationwide. It is also to conduct causality assessment of ICSRs in the national database and forward same to the World Health Organisation’s global drug safety database, periodically send out alert on medicine safety concerns as well as coordinate training and capacity building for pharmacovigilance among others. The data collected are processed into remedial measures.
The success of this Directorate is contingent on the support from stakeholders in the health sector, particularly pharmacists, doctors, dentists, medical laboratory scientists, nurses, herbal medicine practitioners, patients, importers, distributors, retailers, market authorization holders of pharmaceutical and herbal products etc, among others. Globally, vigilance in pharmaceuticals administration and application is a necessity for efficient healthcare delivery services. An integral part of vigilance is the feedback mechanism that helps to access product performance. Aside the adoption of series of cutting-edge technological products and numerous dynamic fortification measures for ideal drug security, there is the need to ensure that its efficacy is adequately ascertained and sustained.
The NAFDAC management, led by Dr. Paul B Orhii, is building bridges across the broad spectrum of the food and drug production and distribution chain through numerous advocacy visits. As he is doing this locally, he is equally paying necessary attention to the outside world where the largest chunk of pharmaceutical products is imported into the country. He is driving the agency through series of vigorous efforts to accord this unique pharmaceutical policy (pharmacovigilance) a household status.
Globally, it is generally known that contamination of food and feeds arising from naturally occurring toxicants, microbiological contaminants, chemical contaminants such as additives used above the permitted levels, pesticide and veterinary residues in food or as toxic components from food processing could have deleterious effects in humans and animals. Naturally occurring toxicants are of both plant and animal origin. Bacterial contamination, fungal toxins, pesticides and toxic metals are the food contaminants of major health concerns.
Bacterial food-borne diseases caused by species of salmonella, clostridium, campylobacter and Escherichia are some of the identified major health concerns in Nigeria contributing to the morbidity and mortality rates of the country. For example, fatal aflatoxin-poisoning outbreaks were reported in Nigeria and Kenya, among other African countries. The lack of or inadequate application of Good Agricultural Practices (GAP) and the abuse or misuse of agrochemicals by farmers and during storage have had serious health effects on the population.
Other unsafe common practices include the use of pesticides for fishing, inappropriate application of pesticides to store products such as beans and grains to prevent insect infestation, inappropriate application of chemicals to fruits such as bananas to ripen them or to vegetables such as carrots and cabbages to control insect infestation. Between March and June 2010 for instance, the world was jolted by lead poisoning incident in Zamfara State, which led to the death of certain number persons.
The development showed the poor attention given to toxic metals in food consumed in the country. Similarly, improper use of food additives such as artificial sweeteners, butylated hydroxyl anisole (BHA), nitrates, nitrites, food colours, etc could result in various ailments ranging from gastrointestinal disorders to carcinogenesis and death.
Some packaging materials with toxic degradable components that are no longer in use in developed countries are still being used in rural But these are challenges NAFDAC is combating to the admiration of Nigerians and indeed, the world. Its vigilance as a state regulator is getting better by the day, especially with the emergence of Pharmacovigilance Directorate.
The efficacy of the directorate could be boosted through an efficient feedback mechanism. This scientific feedback mechanism requires all stakeholders in the nation’s pharmaceutical sector to mandatorily furnish NAFDAC with the appropriate information on the performance of medicines administered nationwide. And so it behooves on pharmacists, doctors, dentists, medical laboratory scientists, nurses, herbal medicine practitioners, patients, importers, distributors, retailers, market authorization holders etc, to build the necessary synergies with NAFDAC to take drug control and administration in the country to the next level. • Ikhilae, a Lagos-based public affairs analyst, wrote via firstname.lastname@example.org
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