COMPLETE SCHOOL PROJECT TOPICS & MATERIALS :
CHAPTERS: Chapter 1-5
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CHAPTER ONE
1.1 INTRODUCTION
In Nigerian today, there is an influx into the market, of fake machine parts, fake motor spare parts, fake chemicals, fake adulterated food items, amongst many others. It may appear that almost every existing product has a fake counterpart. According to Mba (2005:176) the era 19852004 in Nigeria has heralded the regime of faking and quackery, counterfeit drugs, quack doctors, illegal chemist shops and hospitals. Ohuabunwa (2002:42) maintained that drugs are no exception. In fact, the menace of drugs became prevalent in the last decade and the present situation is alarming.
Empirical observations have shown that there may be more fake than genuine drugs in circulation. Osibo (1998:81) stated that, a disturbing aspect of the counterfeit drugs menace is that the effects of consuming such drugs go unnoticed most of the time except in such cases where it results in mass death. Although, there are generally no reliable data on the mortality or morbidity arising from the consumption of counterfeit drugs in Nigeria, the sales of such drugs prevail uninspectedly (Dora, 2006:14).
The trend in the last decade prompted the public and particularly the professional bodies, notably the pharmaceutical society of Nigeria, to pressure the government to taking 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 a license of registration. The decree also created penalties for the breach of the provisions of the decree and a taskforce was established in each state of the federation, charged with the responsibility of seizing any drug or poison illegally displayed in unlicensed or unregistered premises. Moreso, the shortcomings in the decree led to its being repealed by decree No. 21 of 1989 and subsequent amendments.
Finally, drugs play pivotal role at all levels of healthcare. They are useful for maintenance of health, diagnosis, prevention, treatment, or mitigation of diseases/disorders. However, due to immense benefits derived from drugs and their global usage, some unscrupulous persons see them as a means of making fast money, thus, they indulge in producing and circulating fake/counterfeit drugs.
1.2 STATEMENT OF PROBLEMS
There are problems in many developing countries where manpower shortage has led to people with no training in pharmacy being employed in the procurement, storage and distribution of drugs.
As quoted Muoneke (2003:2) in one of his journals, the ratio of pharmacists to the population is relatively high in Urban Areas but extremely low in Rural Areas. This lack of personnel causes serious problems in the correct usage of drugs, especially where quacks are involved in drug distribution and marketing.
In most cases, the drugs are improperly stored, which could result in the degradation of drugs with resultant reduction in their shelf life.
Moreover, patent medicine dealers could not differentiate between the terms “cool”, “cold”, and “Room temperature”. This suggests they do not know the proper storage conditions required for various classes of drugs.
They do not seem to know fine distinction between drugs, foods and cosmetics products. The rampant stocking and sale of prescription drugs by patent medicine dealers is due to the weakness in the implementation of drug regulatory laws.
There are companies in Asia and Eastern Europe that are Mass-producing highly diluted drugs and are marketing them in Nigeria. Such has no indicated labels of actual content. And some Nigerian Merchants arrange with such companies to increase the quantity and reduce the quality to make easy profit.
Some traders buy empty cases with labels which are later filled up with chalk powder or coloured liquid concoctions in the squalor of the slums in Nigeria particularly, and are supplied to Hospitals or sold in pharmacy stores all over the country.
Another problem that is worth mentioning is the widespread use of herbal medicines and synthetic drugs which can have serious clinical consequence.
Generally, other problems which are pervasive in marketing ethical drugs in Nigeria include:-
- Corruption and conflict of interest among drug counterfeiters, drug regulators and drug marketers.
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Insecure and unfriendly environment.
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Discriminatory regulation by exporting countries.
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Lack of or inadequate legislation.
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Chaotic drug distribution system.
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Most Nigerians indulge in irrational self medication.
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Some Nigerian Hospitals/Clinics source drugs from incredible sources.
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Ignorance and laziness of some patients and doctors to examine drug packages for expiry date, spelling errors and other lapses before purchasing them.
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Drug availability in the public and private health care delivery system in Nigeria is in a poor state.
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Inadequate funding of hospital pharmacies and the “out of stock syndrome”.
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The major problem of marketing ethical drugs in Nigeria is the alarming presence of fake/counterfeit drugs which have been identified in various forms by NAFDAC.
1.3 OBJECTIVES OF THE STUDY
This study aims at
- Determining the extent of the problems militating against marketing ethical drugs, and the level of dominance by fake drugs in Nigerian market.
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Ascertaining the number of registered and certified drug marketers.
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Assessing and communicating risks and benefits of drugs in the market.
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Educating and informing the patients, doctors and pharmacists and drug manufacturers and marketers.
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Evaluating the practices of patent medicine dealers.
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Determining the best solution on how to redress the problems associated with the marketing ethical drugs and improper drug usage.
1.4 RESEARCH QUESTIONS
• Are the laws governing fake drugs adequate to curb, counterfeit and menace of drug faking?
• In which form do fake drugs come, especially in Nigeria?
• What are the actual problems of marketing prescription – only drugs?
• What are the underlying causes for the availability of fake drugs in Nigeria?
1.5 THE HYPOTHESIS OF THE STUDY
- Prescription – only drugs are not best marketed in
Nigeria.
- Distribution of counterfeit drugs does not make marketing of ethical drugs impossible.
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There is no significant effect on the division of labour in the marketing of ethical drugs.
1.6 LIMITATION OF THE STUDY
This project is limited to some factors such as the study of some problems of marketing Ethical Drugs in Nigeria but with a special emphasis on Enugu Urban; the drug manufacturers; drug importers; drug sales agents, patent medicine dealers, chemists, pharmacists, etc. Other factors are limited times and insufficient fund, respondent’s reluctance, illiteracy and hostility.
1.7 SIGNIFICANCE OF THE STUDY
This study is significant to all Nigerian’s health, especially, the inhabitants of Enugu Urban; because the people’s right to health include right to a reliable standard health care and assurance that drugs received are not only genuine but safe, effective and affordable. It is the responsibility of the government to protect its citizens from the clutches of unscrupulous members of the society. The approach is very simple with emphasis on technical depth of what individuals require for easy understanding. The medical professionals, pharmacists chemists with operation license, doctors and authorized medicine vendors, lecturers in the same field, academic researchers and students of tertiary Institutions should find it exceptionally useful for meeting and solving critical problems and challenges in the fields of medicine, pharmacy and drug administration and control.
1.8 DEFINITION OF TERMS
1.8.1 Adverse Drug Reaction
According to WHO, “ADR” is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease; or for the modification of physiological function. Here, a patient experiences an unwanted and/or harmful (noxious) reaction following drug therapy. An ADR is essentially a “bad” reaction suffered by the patient and differs from “side effect” which is essentially and unexpected therapeutic response that is related to the pharmacological properties of the drug and may be “good” or “bad”.
1.8.2 Unexpected Adverse Reaction
This is an adverse reaction, the nature or severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug
1.8.3 Adverse Event
Any untoward medical occurrence that may be present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment. An unwanted event occurs during or after the use of a drug. The term “adverse event” is a broad one encompassing “adverse drug reaction”, caused by the drug; and other unwanted reactions, the time of occurrence of which may be related to the use of the drug but are not caused by the drug.
1.8.4 Serious Adverse Experience
Is any untoward medical occurrence that at any dose:- – Results in death.
- Is life-threatening.
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Requires patient hospitalization or prolongation of existing hospitalization.
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Results in persistent or significant disability or incapacity.
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Causes a congenital anomaly or birth defect.
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Requires an intervention to prevent permanent impairment or damage.
1.8.5 Side Effect
Is any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug. Such effects may or may not be beneficial. Side effects are related to the known properties of the drug and can often be predicted. It must be stressed that in pharmacovigilance NAFDAC is interested in all drug related reactions – this includes both side effects and suspected adverse drug reactions.
1.8.6 Adverse Drug Reaction Case Report
A case report in pharmacovigilance is notification relating to a patient with an adverse medical event or laboratory test abnormally suspected to be induced by a medicine.
1.8.7 Signal
A signal refers to “Reported information on a possible causal relationship between an adverse event and a drug; the relationship being known or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
1.8.8 Pharmacovigilance
This is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problems.
1.8.9 Ethical Drugs
These are drugs only prescribed by the authorized physicians, pharmacists, chemists and doctors, including any medical professional for treatment of adverse medical cases (ADRC).
1.8.10 Over-The-Counter Drugs
Simply known as OTC, are drugs not necessarily prescribed by doctors which are bought and sold over the counter. In other word they are self medication drugs.