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NAFDAC And Counterfeit Drugs Administration

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Vigilance as a virtue or
    progressive  act  is applicable in every facet of human involvement .As a progressive tool,its implementation is widely and maximally crave for globally.Broadly examined,vigilance is equally embracive of practices like carefulness,being observant, mental alertness,consciousness to mention but a few.It is in recognition of the effectiveness of this psychological  tool that the  management of the National Agency For Food,Drug Administration and Control [NAFDAC] decided to embrace and wholly adopt  it as a tool to combat counterfeiting and faking of Pharmaceuticals.
 Drugs,be it  orthodox or indigenous,are products of wisdom,research and intensive scientific engagements which was necessitated by the urge and outright determination to save precious lives which before now were lost to  several ailments which could not be cured or prevented owing to lack of the requisite healing or curative  substances and know-how. Although the existence of herbs,medicinal plants and other such  materials is as old as the theological art of creation,the western scientific well-withal to explore,source,identify and modernise them for maximum public acceptance and utilization were yet to be acquired.
However,it was in view of the speedy loss of lives to varieties of diseases and sicknesses over the years,that prompted western Medical Scientists and Health Experts to selflessly,embark on human health salvaging expeditions. Expectedly,these dogged scientific efforts of our fearless heroes and heroines eventually yielded bountiful good health preserving,boosting and sustaining dividends which has today brought competence and confidence into healthcare services provision worldwide.Today, curative and preventive health care services are rendered and made readily available by stakeholders in the sector owing to the availability of professionally and competently refined pharmaceuticals suitable for this purpose. An intensively scientific undertaken drug production  involves research, identifying and sourcing ideal medicinal materials, experimentation to determine materials suitability,etc.
Notably, in the advanced nations where majority of our domestic pharmaceutical needs are sourced, they produce to suit their climatic, atmospheric  and weather conditions,diverse ethnic and racial differences , diversity in nutritional profiles etc prompting the decision to entrench a feedback  mechanism in Nigeria drug distribution,circulation and administration chain which is welcomed and above all,highly applaudable and dynamic . Aside great efforts severally made by government to guarantee unhindered availability and access to essential,safe and effective medicines, the Nigeria democratic leadership has courageously concretized an enduring pharmaceutical framework to unify and harmonise interactions, inputs and operations of stakeholders in the nation’s health sector so as to bring about a more effective, efficient and efficacious use of medicines nationwide. Expectedly,the National Agency For Food, Drug Administration and Control [NAFDAC], a regulator in the sector,is saddled with the responsibility of driving and successfully actualising the historic concept which entails promoting the act of vigilance in pharmaceutical products consumption and administration which is scientifically tagged; Pharmacovigilance.
In expressing its  determination to live up to expectation in this regard,the incumbent Dr Paul .B Orhii NAFDAC  leadership , evolved a dynamic and professionally seasoned arm to contend with the anticipated challenges.Accorded the appellation- Pharmacovigilance  unit/directorate, it is specifically saddled   with the identification of   non -efficacious outcome of drug application in  the treatment of ailments,abuse of medicines  as well as other negative consequencies.By this is meant that should a drug be administered on a patient for the  eradication or treatment of a particular ailment,the agency in this regard is out rightly interested in medication errors, its inability to cure  as well as  other negative developments that may have arisen from the usage of that product  as such information will help to rectify identified product  lapses,combat counterfeiting and faking,standardize healthcare delivery services etc.
However,since  NAFDAC performs basically a regulatory function while others are responsible for manufacturing,distribution and usage of Pharmaceutical products, it certainly requires the collaboration and support of players and stakeholders in the sector to achieve the desired success in this aspect of enhancing efficient,effective and quality healthcare provision. Consequently, Pharmacists, Doctors, Dentists, Medical Laboratory Scientists, Nurses, Herbal Medicine Practitioners, Patients, Importers, Distributors, Retailers, Pharmaceutical Products Marketing Authorization Holders etc, have been maximally saddled with the responsibility of ensuring the success of Pharmacovigilance activities in Nigeria by perceiving the act as above all, a professional and ethical engagement.
Interestingly, advocacy visits  are regularly  made by the Dr Paul B Orhii led NAFDAC management to relevant stakeholders in the sector to garner the needed support for the success of this healthcare boosting policy .In  most developed nations where large chunk of Pharmaceutical products are manufactured and turned into the global markets for global consumption and patronage,series of factors are critically considered. Specifically therefore, caution, care, observation and vigilance  are essential  virtues needed for the sustenance of a desirable cum internationally considerable and acceptable  healthcare sector. Globally, the act of vigilance in pharmaceuticals administration and application is a necessity for efficient healthcare delivery service thereby inferring that a feedback mechanism must be successfully entrenched in the sector to absolutely access product performance to determine effective curative and preventive capability .
However, it would not amount to an overstatement  to assert that Pharmaceutical  substances generally regarded as drugs are indeed an integral and outrigthly non negligible  aspect of ideal healthcare sustaining practices both in the domestic and global community. This apparently accounts for why it is being maximally accorded a seeming water tight security in an attempt to  avert  its contermination through counterfeiting, faking and illicit smuggling. Aside adoption of series of modernized technological and numerous dynamic fortificating measures for  ideal drug security,there is the need to ensure that its efficacy is adequately ascertained and sustained.Interestingly however,the onus of ensuring that pharmaceutical commodities are efficient,effective and efficacious  in healing is not merely the responsibility of producers and the regulatory authorities.The products dispensers and users equally have a very integral part to play in the sanitization of healthcare practice. Obviously, Doctors, Pharmacists, Nurses,etc and patients are indeed important players in an effective and efficient drug distribution and administration chain.As products administrators and consumers respectively, they are better placed to provide information on product efficacy or otherwise .
Incontestably,the nation’s dynamic regulator in this regard-NAFDAC, is outrightly conscious of the enormous benefits accruable from successfully harnessing this end users potentials for the purpose of attaining sanity in healthcare provision.This  entails collation of imputs, comments or information from both users and administrators of pharmaceutical products through the provision of reports [i.e negative ] about  reaction of  drugs used by patients for the treatment of ailments.It is also termed ‘adverse report’ to the agency-NAFDAC through specified channels. It is in an attempt to entrench the culture of vigilance in pharmaceuticals composition ,application and administration  that the National Agency For Food,Drug Administration and Control {NAFDAC] accommodates  a strategic and operationally unique  department referred to  as the Pharmacovigilance directorate  whose responsibility is to  receive, collate and channel to the respective authorities information effect of  medicinal products  administered  on ailing persons.
This is intended to guarantee  the presence of and  access to  safe cum essential pharmaceutical products nationwide. Interestingly,the diversity in  racial,ethnic and environmental status of foreign countries where majority of our drug imports  are sourced,influences consumers reaction to medicines. Entailing detection, understanding, assessment as well as prevention of  negative  implication of pharmaceautical substances ,pharmacovigilance is absolutely beneficial to  the provision of effective and efficient healthcare services.This scientific feedback mechanism requires stakeholders in the nation’s pharmaceautical sector to mandatorily furnish  NAFDAC with information on the performance of medicines administered on persons for curative or preventive purposes. Those on whose shoulders this responsibility falls include doctors, dentists, pharmacists, nurses, medical laboratory scientists,traditional herbal medicine practitioners, Patients, Hospitals, clinics,medical centers, research institutes, traditional/herbal medicinal institutions, importers, manufacturers, distributors, retailers, marketing authorization holders of pharmaceutical  products, traditional/herbal medicinal products etc.
In turn,the agency’s pharmacovigilance directorate is saddled with the coordination of pharmacovigilance  activities nationwide,establishment and maintainance  of a functional national database on adverse drug reactions and other medicine related problems,receive,document ,follow-up,analyse and evaluate individual case safety reports [ie ICSRs] for completeness, technical correctness and validity.It is also to acknowledge  ICSRs, feedback information,and dissemination to health professionals and the public as appropriate through the use of articles in journals, adverse drug reaction bulletins and or newsletters. It is also to conduct causality assessment of ICSRs in the national database and forward same to the World Health Organisation global drug safety database, periodically send out alert on medicine safety concerns as well as coordinate training and capacity building for Pharmacovigilance among others.Accordingly,the agency is discharging its responsibilities in this regard.
Interestingly,series of vigorous efforts have been made by NAFDAC under its incumbent leadership to accord this unique pharmaceutical policy a household status. Among such is the incessant convocation of  national stakeholders foras on Pharmacovigilance in a bid to evolve  sustainable platforms for stakeholders engagement.There is also the intensive sensitization of the general public and the healthcare providers to make them aware of their roles in the provision of adverse drug reaction information. Notably, the agency requires the support of all to excel in this noble , patriotic and dynamic effort since a tree they say,cannot make a forest.    
Ikhilae, is a Lagos based Public Affairs Analyst   

 

Martins Ikhilae

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