ABSTRACT
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.
CHAPTER ONE
Introduction
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
counterfeiting.
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 (Charatan, 2001).
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
Corruption
Lack
of law enforcement
High
cost of drugs; others are
Inadequate
laws
Lack
of and ineffective enforcement of existing laws
Non-
health professionals i drug business
Loose
control systems
Greed
Ignorance
Awareness
These
factors were found to enhance or hinder fake products especially drugs
availability in Nigeria depending on whether they are positive or negative.
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Item Type: Project Material | Size: 110 pages | Chapters: 1-5
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