INTRODUCTION
CHAPTER ONE
- BACKGROUND OF THE STUDY
In, today’s world, computer has permeated every part of life with its benefits. With this information processing which is the life wire of any organization is not left out in the scheme of computerization of Drug verification. Drugs are chemical substances that are administered to patients for curative purposes; it can also be called medicine because it is the essential part of people care. In recent years, rapid growth in fake drugs incident has claimed a lot of lives in Nigeria which led to the establishment of National Agency for Food and Drug Administration and Control (NAFDAC). NAFDAC is a Nigerian government agency and they are responsible for controlling and regulating the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and prepackaged water. Its creation was inspired by a 1988 World Health Assembly resolution requesting countries to “help in combating the global health threat posed by counterfeit pharmaceuticals, and amidst growing concerns about the growing problem of fake and poorly regulated drugs in Nigeria” [Olike, 2018]. In 1989, over 150 children died due to error in a drug formulation. Consequent upon these problems, the Federal Government of Nigeria established NAFDAC to help create a fake-drug free environment in the country. NAFDAC’s effort in this direction and in pursuance of the nation’s vision for its establishment has been commendable, but researchers still wonder why there remain many unanswered questions: “why does Nigeria still have in existence open drug markets? Why do Nigerians in Drug business breech the stipulated drug laws and get away with it, and continue with their business, committing mass murder and smiling to their banks? How long are we to fight the battle of fake drug even with the threats on the lives of those who fight to preserve the health of the nation?” (Ogar, 2015).
Accurate definitions of poor quality medicines are essential. The World Health Organization (WHO) uses the umbrella term, “Substandard/ Spurious/ Falsely-labelled/ Falsified/ Counterfeit medical products” (SSFFC (World Health Organization, 2016), sometimes shortened to SFFC), though there is no universally agreed definition for this. Previously, WHO defined “counterfeit” medicines as being, “deliberately and fraudulently mislabelled with respect to identity and/or source” (World Health Organization, 2016). However, it has been argued that the causes and solutions of the constituent problems in the SSFFC grouping are different (Newton et al., 2011; Attaran et al., 2012); in particular, “counterfeit” should not be conflated with falsified and substandard, as this may shift focus away from public health issues and more towards intellectual property (IP) concerns (Newton et al., 2011). We use the term ‘unregistered generic’ to refer to safe and effective medication manufactured without proper IP law authorisation. This is a legal and economic problem but does not pose a direct threat to public health, and is not a major focus in this review. In contrast, ‘substandard’ drugs are, “genuine medicines produced by manufacturers authorised by the National Medicines Regulatory Authority (NMRA) which do not meet quality specifications set for them by National standards” (World Health Organization, 2016). ‘Degraded’ medicines were of adequate quality when they left the factory but have subsequently degraded, for example through inadequate storage or transport conditions (Newton et al., 2009). We use ‘falsified’ to refer to medicines that have been fraudulently produced and distributed, and which do not meet the quality specifications for that drug – these are the primary focus of this review. Lastly, we use the term ‘poor quality’ to refer collectively to falsified, substandard, and degraded medicines, which all pose serious threats to public health.
Poor quality medicines directly harm patients by denying them access to potentially life-saving active pharmaceutical ingredients (API), or exposing them to toxins. It was recently estimated that 122,350 deaths in children under five years old in Sub-Saharan Africa were attributable to poor quality antimalarials in 2013 (Renschler et al., 2015), representing 3.75% of all under-five child deaths in the region. Poor quality medicines also have pernicious consequences for communities and healthcare systems (Newton et al., 2006, 2010; Mackey and Liang, 2011; Karunamoorthi, 2014), causing lack of faith in healthcare amongst local people and providing a source of funding for organised crime networks. Of broadest consequence is the potential to promote antimicrobial resistance (AMR), now recognised as a major threat to global public health (Pisani, 2015). If poor quality medicines contain less than the intended API, pathogens can become exposed to drug concentrations in the ‘mutation selection window’ – high enough to exert a selection pressure but too low to kill all of the pathogens (Abdul-Aziz et al., 2015).
The high occurrence of fake drugs in Nigeria is as a result of the arbitrary ways by which importation licenses on drugs were issued to people by then politicians and military leaders in the 80’s, without considering the eventual implications their actions could bring on the health of the public. As the drug market boomed and competition for market share increased, some of the beneficiaries of drug importation licenses looked at the option of importing fake products in order to have a favorable margin over their competitors. “In Nigeria today, it is common knowledge that drugs are treated as general merchandise, which can be obtained easily from open markets, moving vehicles, faceless medicine stores, ferries, and even in the provision stores. This is because the drug distribution business has been left in the hands of non-professionals who just want to make profit at the expense of the consuming public. Poor people are faced with a confusing myriad of health providers and drug sellers” (Olike, 2018).
- STATEMENT OF THE PROBLEM
Drug Faking is a worldwide health problem as the effects can be felt by both the manufacturing country of such drugs and the recipient countries. Olike, (2018) noted that “National measures for combating of fake drugs in country might be insufficient because of the advanced sophistications of those who manufacture and sell them” (Olike, 2018). Furthermore, Beverley Glass asserted that “product counterfeiting is increasing worldwide, both in terms of the volume, level of sophistication, and in the number the countries affected, both in the developed and developing world” (Glass, 2014). Till date, Nigeria is not excluded in the challenges of fake drugs. Some people still prefer to undertake self-medication when they are ill, and often times the drugs are purchased from unlicensed drug vendors, whose drug quality is not certain. Moreover, fake drugs proved the main factor in contributing to high rate of deaths. “Over 150 children died in 1989 as a result of a formulation error in a drug. Such problems led to the establishment of NAFDAC, which would help create a fake-drug-free environment. The reason was to ensure effective registration of good quality drugs that are inexpensive in Nigeria. In April 2001, Professor Dora Akunyili the Director General of NAFDAC worked hard in combating the problems of sale of fake drugs” (Olike, 2018). Dora Akunyili’s comment on the menace of drugs faking and its negative impact on the Nigeria was captured properly by Olusegun, (2013), “the problems of Fake drugs have embarrassed our healthcare providers and denied the confidence of the public on the nation’s healthcare delivery system. The result of fake drug proliferation has led to treatment failures, organ dysfunction or damage, worsening of chronic disease conditions and the death of many Nigerians. The situation became so bad that even when patients were treated with genuine drugs, there is no response due to resistance caused by previous intake of fake drug” (Akinyandenu, 2013).
Fake drugs comes in variant forms and styles as observed by Agbaraji (2012), “A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (e.g., absorption by the body), may be supplied with inaccurate or fake packaging and labeling, or may contain ingredients that are not on the label (which may or may not be harmful). Medicines which are deliberately mislabeled to deceive consumers including genuine generic drugs but mislabeled are otherwise counterfeit. Counterfeit drugs are related to pharmacy fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimize the impact of counterfeit drugs” (Emmanuel, 2012).
It is therefore in the light of the above and the gaps in the existing literature that the study intends to investigate the relationship between regulatory agencies and drug verification authentication system.
- AIM AND OBJECTIVES
The aim of the study will be to investigate the relationship between regulatory agencies and drug verification authentication system.
Specifically, the study seeks to:
- Examine the role effect of NAFDAC in drugs verification and authentication system
- Ascertain the variant forms and styles of fake drugs
- Examine the challenges of drugs products verification and authentication system by NAFDAC
- Find out ways of implementing and maintaining effective drugs verification and authentication system
- RESEARCH QUESTIONS
Arising from the research objectives, the following research questions will be critically addressed in the study:
- What is the role effect of NAFDAC in drugs verification and authentication system?
- What are the variant forms and styles of fake drugs?
- What are the challenges of drugs products verification and authentication system by NAFDAC?
- What are the ways of implementing and maintaining effective drugs verification and authentication system?
- RESEARCH HYPOTHESIS
H0 there is no significant relationship between regulatory agencies and drug verification authentication system
H1 there is significant relationship between regulatory agencies and drug verification authentication system
- SIGNIFICANCE OF THE STUDY
The study is very important because it has to do with drugs verification and authentication system. Human health is as important as human life.
The findings will reveal the existing relationship between regulatory agencies and drug verification authentication system. It will show important is the role of regulatory agencies like NAFDAC in the verification and authentication of drugs.
Through the findings of the study; both the public and the regulatory agencies will know the mystery of variant forms and styles of fake drugs and consequently, the ways of implementing and maintaining effective drugs verification and authentication system.
- SCOPE OF THE STUDY
The study is on design and implementation of drugs products verification and authentication system.
The study is limited to the role effect of NAFDAC in drugs verification and authentication system; the variant forms and styles of fake drugs; the challenges of drugs products verification and authentication system by NAFDAC; the ways of implementing and maintaining effective drugs verification and authentication system.
- LIMITATION OF THE STUDY
TIME CONSTRAINTS: One the challenges experienced by the researcher is the issue of time; the research will simultaneously engage in departmental activities like seminars and attendance to lectures. But the researcher was able to meet up with the deadline for the submission of the project.
FINANCIAL CONSTRAINTS: Every research work needs funding; however lack of adequate funds might affect the speed of the researcher in getting materials for completion of the project.
DEFINITION OF TERMS
Drug: It is referred to as a medicine or chemical substances that are administered to Patients for curative measures.
Database design: The process of creating a design that will support emprise mission statement and mission required database e system.
Management information system: collection of people, database, and devices produced to use in providing routine information to manager and decision makers of the organization.
Software: These are program for computer which allows certain specific task to be accomplished e.g. word process etc.
Hardware: Computer equipment used to perform input processing and system output activates.
Verification and authentication system
In computer science, verifying a user's identity is often required to allow access to confidential data or systems. Authentication can be considered to be of three types: The first type of authentication is accepting proof of identity given by a credible person who has first-hand evidence that the identity is genuine.
