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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.

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 products.  

    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  drug.  

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.

Research Questions

The following seven research questions guided the study:

1.                 What is the attitude of ACSZ workers towards the information created by

NAFDAC?

2.                 What is the attitude of ACSZ workers towards the purchase of fake drugs?

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?

Hypotheses 

       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. 


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