ABSTRACT
Drug availability, distribution and control are majorly concern in health development as drugs constitute an important aspect of health development technology (Silverman, Lydecker and Lee, 1990). In Nigeria particularly since the mid 1980’s shortage of drugs and other technologies have become pervasive threats to the medical care system (Ohuabunwa, 2002), the major problem however seems to lie within the drug distribution and control channel. The sum total of the effect is the increase in the sale and distribution of counterfeit drugs, which have grave consequences for the health of the health of the people of Nigeria. The fore mentioned laws shows that the government has positively responded by legislation of forestall a chaotic drug distribution situation in Nigeria. But empirical data has shown that the situation is far from adequate.
TABLE OF CONTENT
Title page i
Certification ii
Approval iii
Dedication iv
Acknowledgement v
Abstract vi
Table of content vii
CHAPTER ONE
- Introduction 1
- Statement of problem 5
- Objectives of the study 5
- Scope of study 6
- Significant of study 6
- Assumption 7
- Definition of terms 7
CHAPTER TWO
- Review of Literature 8
CHAPTER THREE
- System Analysis and Design 12
- General Overview of the System 12
3.1.0 Organ gram 13
3.1.1 Information Flow Diagram 14
3.2 Methodology 15
3.2.1 Facts Finding Method 15
CHAPTER FOUR
- Design and System Implication 17
- Design Standards 17
- Output Specification and Design 18
- Input Specification And Design 19
- File Design 20
- Procedure Chart 24
- System Flowchart 25
- Implementation 26
4.7.1 Program Flowchart 26
4.7.2 Pseudo Code 28
- Coding 30
- System Requirements 30
4.9.1 Software Requirements 30
4.9.2 Hardware Requirements 30
4.9.3 Operational Requirements 31
4.9.4 Personnel Requirements 31
- Environmental 31
- Testing 32
- Cutover Process 32
- Documentation 32
CHAPTER FIVE
- Summary, Recommendation and Conclusion 34
- Summary 34
- Recommendation 34
- Conclusion 35
References 36
CHAPTER ONE
1.0 INTRODUCTION
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian Government Agency under the federal ministry of health that is responsible for regulatory and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drug, cosmetics, medical devices, chemicals and prepackaged water. The current Director General of NAFDAC Dr. Paul Orhii, holds a PHD in Medicine.
In Nigeria today, there is an influx into the market of fake machine parts, fake motor spare part, take chemicals, fake adulterated food items, amongst others. It may appear that almost every existing product has a fake counterpart. The era 1985-2000 in Nigeria has heralded the regime of faking and quackery, counterfeit drugs, quack doctors, illegal chemist shops ad hospitals. Drugs are no exception (Ohuabunwa, 2002). The menace of fake drug became prevalent in the last decade and the present situation is alarming in the West African Sub-region, including Nigeria. Empirical observations have shown that there may be more fake than genuine drug in circulation (Osibo, 1998).
A disturbing aspect of the counterfeit drug menace is that the effects of consuming such drugs go unnoticed most of the times except in such cases where it results in mass deaths. There are generally no reliable data on the mortality or morbidity arming from the consumption of counterfeit drugs in Nigeria. In 1947, 14 children were reported dead after being administered Chloroquine phosphate injections and in 1990, 1909 children died after being administered fake Paracetamol (Aluko, 1994). Usually such incidence stimulates governments into taking positive steps, principally arising from public outcry.
The trend in the last decade prompted the public and particularly the professional bodies notably pharmaceutical society of Nigeria, to pressure the government to take definite steps towards controlling the preponderance of fake drugs in Nigeria, the government responded by promulgating the counterfeit and fake drugs (miscellaneous provisions) decree No.21 of 1988. This decree prohibited the sale and distribution of counterfeit, adulterated, banned and fake drugs or poisons in open markets and without License of registration. It also created penalties for the breach of the responsibility of seizing any drug or poison illegally displayed unlicensed or unregistered premises. Shortcomings in the degree led to its being repealed by decree No.21 in 1989 and subsequent amendments.
The drug situation in Nigeria:
There is a large market for drugs in Nigeria. out of over 130 existing pharmaceutical manufacturers only 60 are in active manufacturing. This is despite the installed capacity of the industry to produce between 50% and 75% of the nation’s drug needs. Capacity utilization is below 30% and about 70% of the drugs are thus imported, (Okoli, 2002).
Drug availability in the public and private health care delivery system in Nigeria is a poor state. Various reasons have been adducted for this trend (Ertun, 1996). These include:
- Inadequate funding of hospitals pharmacies and the “out of stock syndrome”.
- Involvement of unqualified persons in the procurement and distribution of drugs.
- Inadequate storage facilities, transportation and distribution.
The adoption of an essential drugs program through the promulgation of decree 43 of 1989 on essential drug was a step taken to ensure the availability of drugs. Ordinarily, banded drug prescribing is still quite common in much public health institution, contrary to specification of the essential drug Act. (Govt. of Nigeria). This has partially eroded the expected gains of the essentials drugs program.
The drug distribution network in Nigeria is in a state of chaos because it consists of markets patent medicine stores, community pharmacist, private and public hospitals, wholesalers/importers and pharmaceutical manufacturers. It is a common scene in Nigeria to see petty traders who sell kola nuts, cigarette and oranges among other items, in market kiosk, motor parks and road sides hawking drugs that range from over the counter items to antibiotics (popularly called Capsules) (Adelusi Adeluyi, 2000). The medicines are usually left under the sun in such conditions that could facilitate the deterioration of the active ingredients. Patent medicine stores are owned by the holders of patent and proprietary medicine vendor’s licenses ordinarily, the patent medicine should be sold in their original packs. Over the counter (OTC) drugs are the only drugs authorized to be sold by vendors but they generally sell all types of drugs as determined by their financial capability. Considering the knowledge base of these vendors, whose minimum academic requirement to obtain a license is the First School-Leaving-Certificate.
Community pharmacies are statutorily registered with the pharmacist’s council of Nigeria. a superintending pharmacist, who is also registered and licensed overseas the pharmacy anytime it is opened for business with such pharmacies there should not be any serious problem of sale of fake drugs. Unfortunately however, there are many unregistered pharmacies thriving. And in such premises drugs are purchased from doubtful sources with its attendant danger to the health of the public (Erhun and Adeola, 1995).
1.1 STATEMENT OF THE PROBLEM
The major problem encountered in this study was the initial reluctance of regulatory bodies to divulge vital information that will reveal their level of performance.
- Adequacy of the laws governing the eradication of counterfeit drugs in Nigeria
- Why counterfeit drugs are common
- The performance of the state task forces
- Methods employed by the task forces in carrying out their duties and the major problem affecting performance.
- How seized goods are prevented from going back into the drug distribution chain
1.2 OBJECTIVES OF THE STUDY
The main objectives of this study are to examine the factors that have contributed to the preponderance of counterfeit drugs despite the existence of laws and regulatory agencies. Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water and chemicals which establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
To achieve these objectives, the following questions would be answered:
- What are the underlying causes for the availability of fake drugs in Nigeria?
- Are the laws governing counterfeit and fake drugs adequate to curb the menace of drug faking and counterfeit?
- To what extent have task forces been able to control the proliferation of counterfeit drugs in Nigeria?
1.3 SCOPE OF THE STUDY
This research work is limited only to the National agency for food and drug Administration and Control (NAFDAC) area office Enugu.
1.4 SIGNIFICANCE OF THE STUDY
This study is significant to people’s right to health which include the right to access a reliable standard of health care and assurance that drugs received are not only genuine but safe, effective and affordable. It is also the responsibility of government to protect its citizens from the clutches of unscrupulous members of the society. The Nigerian Government has designed various ways to do this, and it’s expected to equip the regulatory agencies with materials and man-power to effectively perform their duties. Very few studies if any have been undertaken to evaluate these measures put in place by government. The outcome of the task forces that have the main organ set-up to control this menace, the result of this investigation would be instructive to regulatory bodies in the third world.
1.5 ASSUMPTIONS OF THE STUDY
I assumed that the Federal Government of Nigeria should be actively involved in helping to control fake drugs in Nigeria.
1.6 DEFINITION OF TERMS
Information: this is a processed data, which provide and individual knowledge needful in decision making.
Data: it is a collection of raw facts, figured charts or symbols that represent ideas, objects or situation which need to processed to a given real meaning program
Design: is a creation of a plan or convention for the construction of an object or system as in architectural blueprints.
Drug: is a substance which may have medicinal, intoxicating, performance enhancing or other effects when taken or put into a human body or animal and is considered a food.
Investigation: it is simply a fact find and fact recording concerning a particular issue or event. It can be obtained through interview, observations and questions.
Evidence: material or information on which a conclusion or proof may be used.
Information technology: it is the technology which supports activities involving the creation, storage, manipulation and communication of information together with their related methods, management and application.
Surveillance: an operation carried out by operatives in a remote area in a city.
Operatives: officers of Federal investigation and intelligence.
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