This study seeks to determine the prevalence of counterfeit drugs in community pharmacies, patent medicine vendor drug distribution outlets and drug consumers in Cross River State. A cross- sectional descriptive study design will be applied in this research and data will be collected from important drugs randomly selected from community pharmacies and patent medicine drug distribution outlet and the level of knowledge of the public health implication of counterfeit drugs will be collected from pharmacist and patent medicine vendors using structured questionnaires. The structured questionnaire will be pretested prior to the survey in a set up similar to and outside the study area to test for validity and reliability of instrument. Data for this study will be entered, coded, cleaned and analyzed using Statistical Package for the Social Sciences (SPSS) version 22.0. Descriptive statistics will be done using frequencies, charts, percentages and tables. Bivariate analysis and Multivariate analysis (using logistic regression) will be used to assess effects of selected variables on the prevalence of counterfeit drugs, P- value of less than 0.05% will be considered as statistically significant and statistical tests such as odds ratio, chi-square and 95% confidence interval will also be used to analyze the data as applicable. Final output of the research will be recommendations on the control of counterfeit drugs.
The objectives of this study are to:
• assess the prevalence of the distribution of counterfeit drugs in community pharmacies and patent medicine vendors in Calabar metropolis
• compare the proportion of distribution of counterfeit drugs in community pharmacies and patent medicine vendors in Calabar metropolis
• compare the proportion of distribution of counterfeit drugs in urban and rural setting
• identify factors influencing the distribution of counterfeit drugs among community pharmacies and patent medicine vendors in Calabar metropolis
• determine the level of knowledge of community pharmacist, patent medicine vendors and consumers on the public health implications of counterfeit drugs
Identification / defining research problem
The availability of counterfeit drugs in the market presents a serious public health problem, particularly in developing countries such as Nigeria, and may have a significant impact on the national disease and economic burden. Current estimate suggests that 10% of prescription drugs sold worldwide are counterfeits, fake or contaminated, and in parts of Africa and Asia, the figures exceed 50% (Newton, Lee, Goodman, Fernández, Yeung, Phanouvong, Kaur, Amin, Whitty, Kokwao, Lindegardh, Lukulay, White, Day, Green, 2009).
Counterfeit medicines are widespread and represent a threat to public health which can lead to healthcare failures, such as resistance to antibiotics and the spread of disease within a community, as well as loss of life. Research has also shown that poor-quality medicines can reach the market through deliberate fraudulent practices by those that want to get rich overnight. There is low awareness of the problem of counterfeit medicine; a problem that could lead to public-health crisis (Charles, 2010). Knowledge, attitude and practice regarding counterfeit drugs are often undermine and given less concern in the area of research.
Measuring the magnitude of the phenomenon of counterfeit drugs turns out to be extremely complicated, particularly due to various reasons that have to do with the disposable means to detect the trafficking routes, the number and the identity of those involved in the production and distribution processes, and the difficulty in systematizing and coordinating the information from the various stakeholders in charge of keeping, collecting and analyzing data (Charles, 2010).
Available statistics have tried to propose figures on the exact percentage of counterfeit medicines within the worldwide pharmaceutical market. Their estimations reflect both the magnitude and the volatility of the problem: percentages of counterfeit medicines in different national pharmaceutical markets vary from as 1 percent to as high as 50 percent. In general, higher percentages refer to less developed countries and economies in transition whereas lower percentages refer to the developed countries. Therefore, it is essential to take into account geographical, economic, legal and social criteria in order to interpret these percentages (Newton, et al, 2009).
Research has shown that counterfeit medicines is less spread in more developed countries due to a combination of enhanced legislation, stronger institutions and a more efficient regulatory control. According to the WHO, developed countries such USA, Australia, Canada, Japan, New Zealand and those within the European Union (EU) have a very low proportion of counterfeit medicines no more than one per cent of market value (WHO, 2012).
However, the fact that a considerable amount of counterfeit drugs cases are declared on an annual basis by developed countries proves that this problem still affects both developed and developing countries. Case studies can illuminate what statistics cannot.
Nevertheless, the situation is more dramatic in less developed countries due to fragile economies, widespread poverty, lack of regulation, difficulties in controlling the system, as well as the difficulties in furthering and enforcing strong legislative measures. WHO has estimate shows that counterfeit medicines would represent approximately ten percent of the entire amount of medicines worldwide (WHO, 2012). Pfizer estimates that counterfeit Viagra alone causes a loss of 2 billion USD in sales. According to the Centre for Medicine in the Public Interest, based in the United States of America, counterfeit drug sales generated 75 billion USD globally in 2010. However, and according to other estimates, these rates increased to 20 per cent as there is a growing problem of drugs that look alike in most market. The situation seems to be even worse in some African countries.
However, there are currently little published work on the prevalence of counterfeit drugs in Nigeria including Knowledge, Attitude practice and no available research work in the study area. Thus the following questions need to be answered:
• What is the proportion of distribution of counterfeit drugs in community pharmacies and patent medicine vendors in Calabar metropolis
• What is the proportion of distribution of counterfeit drugs in urban and rural setting
• What are the factors affecting the distribution of counterfeit drugs among community pharmacies and patent medicine vendors in Calabar metropolis
• What is the level of knowledge of community pharmacist, patent medicine vendors and consumers on the public health implication of counterfeit drugs
1. There is no significance differences in the prevalence of counterfeit drugs in community pharmacies and patent medicine vendor drug distribution outlets in Calabar metropolis
2. Socio-demographic factors such as age, educational qualification and years of experience has no effect on the proportion of counterfeit drugs in Calabar metropolis
According to World Health Organization (2010) defined counterfeit drugs as drugs that have been deliberately or not well labeled with respect to identity and or source which makes it difficult to track the manufacturer of such drugs (WHO, 2011). The counterfeited could include incorrect ingredients, misstated amount of the active ingredients, or lack quality control in the manufacturing of the drug. According to NAFDAC in its definition of Counterfeit drugs included preparations without active ingredients, preparations that are toxic, expired drugs that are relabeled, drugs issued without complete manufacturing information and drugs that are not registered with the National Agency for Food and Drug Administration and Control (NAFDAC). Looking at the above definition, it can be deducted that counterfeit drugs are drugs that are adulterated, inappropriate, and illegal and poses a threat to human health.
The latest attempts at the international level to better specify the definition of counterfeit medicines showed how complex the problem is in reality. This is what happened for example when in 2008 the International Medical Products Anti-Counterfeiting Task-force (IMPACT) tried to redefine counterfeit medicines. At the end the proposed definition, was not officially endorsed at an international level, lengthily yet precisely explained what counterfeiting was and was not, stressing the differences between Intellectual Property Rights (IPRs) related issues and public health protection (Charles, 2010).
The term counterfeit drugs describe a drug with a false representation of its identity and or source (3) and this is also applicable to the drug container or other packaging or labeling information. Counterfeits may include drugs with correct ingredients or wrong ingredients/components, some without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Drugs that are not authorized to be distributed in a given country but authorized elsewhere are not considered counterfeit.
In reality the fight against counterfeit medicines goes well beyond the mere protection of IPRs and is a struggle aimed at protecting patients and public health while fighting organized criminals profiting from this crime. For this reason, its use was sometimes avoided or well specified in the new regulations proposed at the international level and aimed at protecting public health.
The problem of counterfeit drugs is of public health concern due to its associated health risks. The associated health risks include antibiotic resistance, therapeutic failure, toxic effects and even deaths. (Akunyili, 2005).
Counterfeit antibiotics with low doses of active ingredients are potentially more dangerous than counterfeited drugs containing no active ingredient at all and this may result to negative effect of drug resistance that may affect the entire community. Antibiotic resistance caused by drug counterfeiting might have contributed significantly to the inability to eradicate or control important infections such as malaria and tuberculosis in developing countries. Resistance to chloroquine and sulfadoxine-pyrimethamine is already common (Meremikwu, 2007). The recent emergence of counterfeits of Artemisinin derivatives (Newton et al, 2006) and antiretroviral drugs (Ahmad, 2004) in some countries of South-East Asia and Africa is an important development which is potentially disastrous because alternative drugs are either inaccessible or unaffordable.
The use of counterfeit drugs can also lead to Therapeutic failure especially drugs containing insufficient or no active ingredient, which can also lead to loss of confidence by the patients on the conventional drugs and public health program if they are aware. An estimated 700,000 deaths annually are caused by fake antimalarials and tuberculous agents, suggesting that the total annual mortality due to the menace will definitely be much higher (Harriset al., 2009). Various instances where fake drugs resulted in deaths due to failure to treat life-threatening conditions have been reported in the literature. In 2001 about 192,000 people were reported to have died in China as a result of fake drugs. Also about 2500 people died in Niger following the administration of counterfeits of meningococcal-vaccines (containing no active ingredient) to some 60,000 people during the 1995 meningitis epidemic (Cockburn 2005).
Research has shown the incidence of Acute renal failure due to poisoning from diethylene glycol packaged as a cough syrup which resulted in hundreds of deaths in Haiti, Bangladesh, Nigeria, India and Argentina which are examples of the potentially fatal effects of counterfeit drugs containing a toxic ingredient in place of the original active ingredient (WHO, 1995). Also as recent as 2008, deaths in the US have been attributed to the use of adulterated heparin from China (Harris et al., 2009).
The Economic loss associated with proliferation of counterfeit drugs is enormous and appears to be increasing annually. According to the WHO, about 32 billion US dollars were lost to drug counterfeiting business in 2004 (WHO, 2006). This increased to 40 billion US dollars in 2006 and is projected to reach 75 billion US dollars in 2010 (WHO, 2006; Bate and Boateng, 2007). Many pharmaceutical companies are deprived of their rightful profits due to the unjust competition from this brutal crime and have even resulted in the collapse of some of the companies (Akunyili, 2005).
Drug counterfeiting business thrives better in a place where the drugs are relatively scarce of the prices are high. According to the WHO, an estimated 2 billion people globally have limited access to essential drugs (WHO, 2004) which is attributed to poverty, high cost of drugs, inadequate health facilities and corruption (Cohen et al., 2007).
Unlike in more developed nations where little or no tariffs are collected from pharmaceutical products (Harris et al., 2009), high taxes and tariffs are usually collected from genuine medicines in less developed countries, leading to eventual increase in drug prices, decrease in incentive to adequate supply of drugs and consequent scarcity of the drugs that may be exploited by the counterfeiters (Morris and Stevens, 2006) since, most of the patients in those countries pay for the drugs from their own pockets.
Although, drug counterfeiting is as dangerous and as lucrative as the narcotic business, its penalty tends to be less severe. Therefore, it is not surprising that criminal gangs previously known to be involved in the narcotic trade usually switch to drug counterfeiting because they find it quite appealing and less risky. There are also some reports of individuals being singly involved in this offense as in the case of a US pharmacist convicted of diluting patients’ injections (Reggi, 2007). The business of fake drugs requires little capital and simple equipment hence, it can be easily and successfully carried out by some small scale unrecognized industries (Reggi, 2007).
Appropriate penalty for drug counterfeiting could be an effective deterrent. Unfortunately, the penalty for manufacturing or distributing counterfeit drugs is very lenient in many developing countries. For instance, in Nigeria such an offense is usually punished by imprisonment for periods ranging between 3 months to 5 years or alternatively a fine of 70-3600 US dollars (Akunyili, 2007). Similarly, in South American countries, the penalty for such a crime is just six months in jail or a fine (Bate and Boateng, 2007). Such a weak and incongruous penalty is incapable of making any great impact in preventing this lucrative crime.
Unlike developed nations with clear and strongly enforced laws on civil liability against suppliers or manufactures whose product causes harm to consumers, most of the poor countries afflicted with the problem of drug counterfeiting have laws in which civil liabilities are either not clearly defined or inadequately enforced. For example, in the US it is not uncommon for victims of fake drugs to seek compensation in the order of millions of dollars from the culprits of the crime. On the other hand, although, the punishment for the supply and manufacture of fake drugs in India and China is very severe (death penalty), inadequate and inefficient civil liability laws is a huge roadblock to successful combat of drug counterfeiting in the two nations (Harris et al., 2009).
Further findings have shown that developing countries are not merely the victims of the problem but also serve as the sources of counterfeit drugs with India and China being the biggest culprits globally (Bate and Boateng, 2007). One statistics by the European Commission described India as the source of 75% of fake drugs and according to one report, most of the fake drugs in Nigerian markets originate from India (Raufu, 2003).
Drug counterfeiting business may also be encouraged by the different standards set by the exporting countries regarding the drugs for public use and those for exports with the standard of the latter being less stringent than the former. One expert suggested that abolishing such a double standard could help to a large extent in combating the crime (Reidenberg and Conner, 2001). This factor is particularly important in countries like Nigeria whose indigenous pharmaceutical industries can only cater for 40% of the demand of its teeming population (Akunyili, 2007). Despite the effort of NAFDAC in fighting counterfeit drugs in Nigeria, gap still exist in the availability of published research in the study area.
The study will be carried out in Cross River State, Nigeria. Cross River State is one of the 36 political administrative states in the Federal Republic of Nigeria. It comprises of three Senatorial districts each of which is made up of 5-7 Local Government Areas (LGAs). Calabar is the capital of Cross River State. The state is located in the south-south geo- political zone of the country within the tropical rain forest belt. The State has an annual rainfall of over 3500 millimetres. The state capital has one tertiary hospital, the University of Calabar Teaching Hospital, a Neuropsychiatric hospital, two General hospitals, many primary health centres, registered maternity homes, registered private hospitals, registered clinics, registered Pharmacies, patent medicine shops. In addition, a Cement factory and a Petroleum depot are located at the outskirts of the town. The major occupations of the people are trading, farming, fishing and civil service. The state shares boundaries with Akwa Ibom,, Abia, Ebonyi and Benue State. The state is made up of 1,47,1967 males and 1,421,021 females. Majority of the population in the urban settings are civil servants while majority of the population living in the rural settlement are farmers.
The researcher intends to carry out a cross sectional descriptive study by searching literature, collecting drug samples from selected community pharmacies, patent medicine vendors and drug consumers and interviewing the subjects. The choice of the research design is because of it flexibility and adaptability to change. This design also requires strong focus and concern to create observational skills, capable of getting precise and accurate data and to be competent to interpret different situation effectively. Quantitative research strategy will be used in the design, collection and analysis of data.
Community pharmacies and patent medicine vendor’s outlets will be selected using a simple random sampling technique. 10 registered Community pharmacies and patent medicine vendor’s outlets each will be selected in both LGAs using the collected list from the state ministry of health as sampling frame. The first phase will include, mapping, enumeration of Community pharmacies and patent medicine vendor outlets while Numbers will be assigned to each Community pharmacies and patent medicine vendors outlets, folded and put in a polythene bag and then 10 persons will be blind folded to pick from the bag without replacement. The first 10 Community pharmacies and patent medicine vendor outlets selected will be included in the research. Medications to be included in this research will be selected based on high therapeutic importance and utilization based on discussion with local pharmacist experts
For the community based sampling for drug consumers, the following multi-stage techniques will be used:
Phase I: Simple random sampling technique will be employed to select three wards from each setting (rural and urban) using the lottery method. Numbers will be assigned to each ward, folded and put in a polythene bag and then six persons will blind folded to pick from the bag without replacement. The first six wards selected will be included in the research
Phase II: In each selected ward, simple random sampling technique will be employed to select 4 settlements using the lottery method. Numbers will assign to each settlement folded and put in a basket. It will then be vigorously mixed. The first 4 settlements picked will be recruited into the study (i.e.6 wards x 4 settlements = 24 settlements).
Phase III: In each selected settlement, at the entrance, a pen will be spin and the direction of the mouth of the pen will determined the first household to be selected and thereafter systematic sampling procedure will be employed in subsequent selection of eligible households
Four research assistants (2 males and 2 females) who are fluent in the local language and English will be recruited for data collection and will be trained on field exercise and how to handle ethical issues. Those field assistant will present themselves as local buyers and follow the research protocol for obtaining drug samples based on the recommended sampling techniques. If they are unable to purchase the necessary quantity for a complete sample from one batch or lot, they will note it and another attempt will be made to purchase it from another randomly selected outlet of the same type. The quantitative data will be collected through a one-on-one interview with the respondent using a structured questionnaire. The structured questionnaire will be pretested prior to the survey in a set up similar to and outside the study area to ensure questions are clear and well understood by the respondents and data collectors.
Data obtained from the study will be entered, coded, cleaned and analyzed using Statistical Package for the Social Sciences (SPSS) version 22.0. Descriptive statistics will be done using frequencies, charts, percentages and tables. Bivariate analysis and Multivariate analysis (using logistic regression) will be used to access effects of selected variables on institutional delivery services utilization. P- Value of less than 0.05% will be considered as statistically significant and statistical tests such as odds ratio, chi-square and 95% confidence interval will also be used to analyze the data as applicable.
S/N TASK/ACTIVITIES TO BE PERFORMED TIME LINE PERSONNEL RESPONSIBLE FOR TASK
1. Final research proposal 1 week Research team
2. Preliminary visits to area of study 1 week Research team
3. Clearance and permit from communities and local authorities 4 weeks Research team
4. Recruitment of field staff/community mapping 1 week Research team/ field staff
5. Training of field assistant 1 week Research team
6. Pretesting of instruments for collection of data (questionnaire) 4weeks Research team
7. Finalize data collection tools 1 week Research team
8. Collation and analysis of data 4 weeks Research team
9. Report writing and presentation of findings 3 weeks Research team
Total weeks = 20weeks (4 months)
This research will provide data on the prevalence of counterfeit drugs in Urban and rural settings and make recommendations on public health approach to addressing the current challenge.
Societal and scientific relevance
The output from this research will serve as evidence to inform the scientific community and relevant government agency on the proportion of counterfeit drugs in the study area, this will help inform policy guidelines and safeguard against counterfeit drugs. This study will also improve public health practice in terms of improving health education and identify the most at risk population of counterfeit drugs for intervention.
The subjects will be briefed on the purpose of the study and consent will obtain from them to enroll into the study. Any subject who decline assent will be excluded from the study. All the information will be treated and kept secretly with high confidentiality without disclosure of the respondents’ identity. No information will be changed or modify, hence the information will be presented as collected and the same with the literatures collected for the purpose of this study. Furthermore the researcher will avoid using any equipment or technique that will have possible harm or against the interest of the participants. Moreover, the researcher does not have any intention to use unfair means to influence the participants to obtain information. The drugs and questionnaire will be anonymous and the researcher will maintain a high level of confidentiality when treating the information collected.