The Project File Details
The study was on the attitude of the workers in Anambra Central Senatorial Zone (ACSZ) towards fake products. It examined the attitude of ACSZ workers towards the information created by NAFDAC, the attitude of ACSZ workers towards the purchase of fake drugs, the attitude of ACSZ workers towards the patronage of NAFDAC approved products and the attitude of ACSZ workers towards the services provided by NAFDAC. The descriptive survey research was the design adopted. Four research questions and four hypothesis were formulated to guide the study. A self–constructed questionnaire of the four – point rating scale type was used the four null hypothese were formulated and tested at 0.05 probability level using chi–square. The study revealed that 240 (70%) of the respondents strongly agreed that genuine products are expensive, 158 (48%) strongly disagreed that it is easy to differentiate between genuine from fake products, for lack of and ineffective enforcement of existing laws, there is significance difference between high cost of genuine products and fake products. The statistical test employed revealed that price, chaotic production and distribution of fake drugs; lack of and ineffective enforcement of existing laws, awareness affect fake drugs negatively. However, more than half of the respondents 240 (75%) strongly agreed that genuine products are expensive. The findings revealed that there is chaotic production and distribution of fake drugs in ACSZ.
COVER PAGE I – APPROVAL PAGE II
– CERTIFICATION PAGE III
– DEDICATION PAGE IV
– ACKNOWLEDGEMENTS V
– ABSTRACT VI
– TABLE OF CONTENTS VII
– LIST OF TABLES VIII
– Background of the Study 1-7
– Statement of the Problem 8-9
– Purpose of the Study 9-10
– Significance of the Study 10
– Scope of the Study 10
– Research Questions 10-11
– Hypotheses 11
Review of Related Literature
– Conceptual Framework 12-39
– Theoretical Framework 39-41
– Empirical Studies Related to NAFDAC Regulated and Fake Products 41-54
– Summary of Literature Reviewed 54-57
– Research Design 57-58
– Area of the Study 58-59
– Population of the Study 59
– Sample and Sampling Technique 60-61
– Instrument for Data Collection 61
– Validity of the Instrument 62
– Reliability of the Instrument 62
– Method of Data Collection 62
– Method of Data Analysis 63
Presentation and Analysis of Data
– Summary of Major Findings 72
Discussion, Conclusion and Recommendations
– Discussion of Findings 105
– Conclusion of the Findings 108
– Recommendations 108
– Limitations of the Study 109
– Suggestion for further research 110
Background of the Study
National Agency for Food, Drugs Administration and Control (NAFDAC,
1992) posited that the importance of food and drugs to man and animal are very
obvious. They need food in-order to grow and sustain life and because of the inhe-
rent disposition to illnesses, the organs of the body may not always function
properly. Such body dysfunction may be due to infection arising from the intake of
contaminated products it may also result from the effect of corrosive or poisonous
chemical on the body or due to breakdown following exhaustive work or
degeneration of the body organs. These situations of ill-health provide the
compelling need for drug in order to modify the functioning of the body and
restore it to normalcy. To be acceptable, the drug must not be deleterious to the
body but should rather produce a positive effect, which leads to restoration of
normal life. Furthermore cosmetics should have no harmful effect to the body to
which they are applied.
The production of fake and substandard products especially drugs is a vast
and underreported problem, particularly in poor countries. It is an important cause
of unnecessary morbidity, mortality and loss of public confidence in medicines and
health care. The prevalence of counterfeit drugs appears to be on the raise and has
not been opposed by close cooperation between companies, governments, or
international organizations concerned with trade, health, customs and exercise, and
Fake products are products whose composition and ingredients do not meet
the correct scientific specifications and which are consequently ineffective and
often dangerous to patients (WHO, 2003). WHO continued that it is one which is
deliberately and fraudulently mislabeled with respect to identity, composition, and
or source. It also includes those tampered with, adulterated, diluted, repackaged, or
relabeled so as to misrepresent the dosage, origin, or expiration date, as well as
those cheaply produced in order to make unlawful profits.
According to WHO (2003) the above products may occur as a result of
negligence, human-error, insufficient human and financial resources or
counterfeiting. NAFDAC (2003) stated that over 150 children died in 1989 as a
result of a formulation error in a drug. The problem of fake drugs was so severe
that neighboring countries such as Ghana and Sierra Leone officially banned the
sale of drugs made in Nigeria (Rudol, 2004).
Morris (2002) stated that issue of counterfeit drugs ‘’is a serious problem
that drugs are hawked even in commercial buses”. All these problems affected
Nigeria as a whole but the structure of NAFDAC is said to have put some of the
problems under control. WHO (2005) reported that globally, counterfeit drug
commerce will grow 13% annually through 2010. That means counterfeit drug
sales will grow at nearly twice the rate of legitimate pharmaceutical commerce. In
2010 this illegal business will generate $75 billion in revenues – a $92 increase
from 2005. The profits are high and the risk is high; that is a deadly combination.
A large proportion of the world’s counterfeit medicines originates in Asia
and ends in the US and European Union (EU). In the EU, between 1998 and 2004
there has been a 100% increase in seizures of counterfeit prescription drugs. China
particularly is a production center. In 2001, it was reported that Chinese
Authorities closed 1,300 factories while investigating 48,000 cases of counterfeit
drugs worth $57 million. The State Food and Drug Administration (SFDA) of
China announced that from January – November 2005, it banned 114,000
unlicensed drug manufactures, destroyed 461 illegal pharmaceutical factories. It is
estimated that in China “between” 200,000 to 300,000 people die each year due to
counterfeit or substandard medicine; which are reported cases. The true number of
cases is likely to be far higher (Lisa, 2007).
On April 29, 2006 the Chinese Department of Health announced that fake
medicines purporting lower blood sugar resulted in the least three blood-poisoning
cases in 2005. Patients have received fake medicines with illegal chemicals. In
2004, Chinese authority arrested 22 manufactures of grossly substandard infant
milk powder and closed three factories after the death of over 50 infants (Lisa,
2007). In 2005 December, United States (US) custom agents intercepted
more than 50 ships of counterfeit Tamifliu, the antiviral drug being stockpiled in
anticipation of bird flu pandemic. The fake drugs had none of Tamiflu’s active
ingredients. Jeffrey, Director of the Commerce Department’s office of Health and
Consumer Goods, announced that the US government is working on stopping the
illicit flow of
Active Pharmaceutical Ingredient (API), which can be used in counterfeit
medicines (Burns, 2006). A 2003 report produced by Michele Forezley of the
International Intellectual Property Institute (11PI) at the request of PTO compiled
data from numerous sources found reports that more than 1,000 hospital
admissions resulted from counterfeit insulin in Russia.
Since early 2005, health regulatory officials in Leizou have seized 308 types
of fake and substandard medicines and medical devices. Taiwan’s Criminal
Investigation Bureau (TCIB) announced recently that roughly $ 9 million worth of
counterfeit drugs was seized in Taipei. The products were China originated and
includes among others are cold treatment, gastrointestinal medicines, sedatives,
anti-obesity and erectile dysfunction drugs, and unknown pills (Bryce, 2005).
During a recent Food and Drug Administration (FDA) blitz operation at airports in
New York City and Miami, over 25 different controlled substances were
counterfeit and of Chinese origin. The EU council of ministers recently approved a
plan issued by the European commission to improve customs coordination against
counterfeit goods. Currently, 70% of seizures of counterfeit are from China
In Haiti, Nigeria, Bangladesh, India, and Argentina, more than 500 patients,
predominantly children are known to have died from the use of the toxin
diethyleneglycol in the manufacture of fake paracetamol syrup (WHO, 2003). The
recent discovery of counterfeit antiretrovirals (stavudine-lamivudine-nevirapine
and lamivudine- zidovudine) in Central Africa raises the prospect of a disastrous
setback in the treatment of AIDS in sub-Saharan Africa, unless vigorous action is
taken now (Burns, 2006). The effects on patients of counterfeit medicines are
difficult to detect and quantify; and are mostly hidden in public health statistics.
The estimate of 192,000 patients killed by fake drugs in China in 2001 gives an
indication of the scale of human suffering (Dondorp et al, 2004). It has been
estimated that up to 15% of all sold drugs are fake, and in parts of Africa and Asia
this figure exceeds 50% (Cockburn ,1984 WHO, 1998 & Newton, 2002).
In a study conducted in South-East Asia in 2001, it was reported that 38% of
104 antimalarial drugs on sale in pharmacies did not contain any active ingredients
and had resulted in a number of preventable deaths. The consumption of
paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in
antifreeze) lead to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998.
In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarial
prepared with sulphadoxine-pyrimethamine (an older, less effective antimalaria),
which were sold as Artusenate (WHO, 2003). WHO (2003) reported that regular
use of substandard or counterfeit medicines leads to therapeutic failure or drug
resistance; in many cases it can lead to death. In April 1999, reports of 771 cases of
substandard medicines had been entered into the WHO database on counterfeits,
77% of which were from developing countries. Data analysis showed that in 60%
of the 325 cases, an active ingredient was missing from the product. WHO survey
of counterfeit medicine reports from 20 countries between January 1999 and
October 2000 found that 60% of counterfeit medicine cases occurred in poor
countries and 40% in industrialized countries.
The USFDA estimates that counterfeits make up more than 10% of the
global medicines market and are present in both industrialized and developing
countries. It is estimated that up to 25% of the medicines consumed in poor
countries are counterfeit or substandard (WHO, 2003). The Centre for Medicine in
the Public Interest (USA) estimates that scale in counterfeit pharmaceuticals will
reach US $ 75 billion in 2010. In 2000, the health ministry in Russia reported that
56 drugs were counterfeit. The next year (2001), approximately 3.6% of all
pharmaceuticals in Russia were found to be fakes (Schofield, 2001). WHO
estimates that counterfeit drugs account for approximately 5-8% of the total
worldwide trade in pharmaceuticals (Charatan, 2001). The USFDA reported that in
spite of stringent controls, the number of cases of counterfeit drugs had increase in
2001 compared to the number of cases 5 years earlier (Wechsler, 2003).
The US has seen the first court case brought against two drug companies for
allegedly failing to act to protect customers over a fake drug discovery. In 2002, a
Kansas City pharmacist was jailed for diluting the anticancer drugs Gemzar
(gemcitabline) and Taxol (paclitaxel). The victims and dead patients’ families sued
the drug companies, Eli Lilly and Myers Squibb, for not taking steps to stop him.
The companies argued that they had no duty to protect the plaintiffs from the
pharmacist’s criminal acts, but a newspaper reported that Eli Lilly and Myers
Squibb settled out of court, apparently for US $72 million (Morris, 2002 &
Margolies, 2003). Mashelkar Committee (2003) and Aluko (2000) in their survey
on the reasons adduced for availability of counterfeit drugs in Nigeria identified
the following indices:
Inadequacies in drug testing
Severe shortage of regulatory inspectors
Lack of law enforcement
High cost of drugs; others are
Lack of and ineffective enforcement of existing laws
Non- health professionals i drug business
Loose control systems
These factors were found to enhance or hinder fake products especially drugs
availability in Nigeria depending on whether they are positive or negative.
Statement of the Problem
In Nigeria, drug related reportage is a common feature of the press (Udoh,
2005 & Udoma, 2006). This coverage focuses on the manufacture or the
importation of adulterated, fake or substandard products whose use or intake is
considered injurious to health. This phenomenon had, for years, threatened to
undermine government’s efforts, aimed at quantitative health delivery to the
generality of the population (Okoli, 2007 & Oditta, 2007). To regulate the
manufacture and importation of products, Nigerian government had established
NAFDAC with virtually all the newspapers and magazines carrying screaming
banner headlines (Olaniyi, 2006). While government and private radio and TV
stations report them as major news items, which have waged relentless war on
unscrupulous manufactures and importers (Nwoji, 2006).
In 2001, NAFDAC study showed that 68% of drugs in circulation were
unauthorized. The era 1985 – 2000 in Nigeria, has heralded the regime of faking
and quackery, counterfeit drugs, quack doctors, illegal chemist shops and hospitals,
drugs are no exception. (Ohuabunwa, 2002). Nigeria recently threatened to ban the
import of all drugs from India, a major supplier, because of the high prevalence of
counterfeits amongst the imports (Raufu, 2003). In Nigeria particularly since the
mid 1980’s shortages of drugs and other technologies have become pervasive
threats to the medical care system (Ohuabunwa, 2002).
During the meningitis epidemic in Niger in 1995, over 50,000 people were
inoculated with fake vaccines, received as a gift from a country, which thought
they were safe. The exercise resulted in 2,500 deaths. Out of the one million deaths
that occur from malaria annually, as many as 200,000 would be avoidable if the
medicines available were effective, of good quality and used correctly (Silverman,
Lydecker and Lee et al, 1990). Trade in these medicines is more prevalent in
countries with weak drug regulation control and enforcement, scarcity and/ or
erratic supply of basic medicine
The study sought to determine the reasons for fake products by workers in ACSZ,
and whether those indices of expensive drugs, ineffective laws, corruption, and
others already identified by previous studies leads to increase or decrease in fake
Purpose of the Study
The broad objective of the study was to determine the factors leading to fake
and substandard products in ACSZ. Specifically, the study determined whether:
1. To determine the attitude of ACSZ workers towards the information
provided by NAFDAC.
2. To investigate the attitude of ACSZ workers towards the purchase of fake
3. To ascertain the attitude of ACSZ workers towards the patronage of
NAFDAC approved products.
4. To determine the attitude of ACSZ workers towards the services
provided by NAFDAC.
Significance of the Study
The study would help to disclose some of the factors leading to fake and
substandard products. It would highlight ways of combating fake products in
ACSZ, Nigeria and the world at large.
It would reveal the need for manufacturers to know the benefits of
eradicating fake products. It could also show the need for consumers to be
educated and be able to differentiate between fake and original products.
The result would also help in reducing if not totally stopping the rate at
which consumers’ die, as well as treatment failure after consuming fake products.
Scope of the Study
The study was delimited to workers in Anambra Central Senatorial Zone.
The civil servants in the seven (7) Local Governments of the zone, in Anambra
state. It was also delimited to such variables as information created by
NAFDAC,purchase of fake drugs , patronage of NAFDAC approved products and
services provided by NAFDAC.
The following seven research questions guided the study:
1. What is the attitude of ACSZ workers towards the information created by
2. What is the attitude of ACSZ workers towards the purchase of fake
3. What is the attitude of ACSZ workers towards the patronage of
NAFDAC approved products?
4. What is the attitude of the workers of ACSZ towards the services
provided by NAFDAC?
The following four null hypotheses were tested at 0.05 level of significance.
1. There is no significance difference between the information crated by
NAFDAC and ACSZ workers.
2. There is no significance difference between attitude of ACSZ workers and
purchase of fake drugs.
3. There is no significance difference between ACSZ workers’ patronage and
NAFDAC approved products.
4. There is no significance difference between attitude of ACSZ workers and
services provided by NAFDAC.