|Year : 2017 | Volume
| Issue : 2 | Page : 137-142
Fake drugs: A survey of healthcare providers in Lagos State, Nigeria
Arinola E Joda1, Casmir Amadi2, Olufemi I Adebayo3, Yakub I Maji3, Chisom Uchem3, Helen Olih3
1 Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, Idiaraba Campus, Lagos, Nigeria
2 Department of Medicine, College of Medicine, University of Lagos, Idiaraba, Lagos, Nigeria
3 Pharmaceutical Society of Nigeria, 36 Faramobi Ajike Street, Anthony Village, Ikeja, Lagos, Nigeria
|Date of Web Publication||5-Oct-2017|
Arinola E Joda
Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, Idiaraba Campus, Idiaraba, Lagos
Source of Support: None, Conflict of Interest: None
Background: Faking and counterfeiting occurs throughout the world with claims that it is more common in some developing countries with weak regulatory programs. It is estimated that more than 10% of drugs worldwide are counterfeit, with up to 50% in some countries. Heightening vigilance and awareness of counterfeiting is one measure for combating faking. Rationale: The aim of this study was to document perceptions of various healthcare providers regarding the problem of drugs faking/counterfeiting including perceived levels, affected drugs, implications, and measures to control; thus, this study aims to provide empirical data on the perception of healthcare providers regarding counterfeit drugs and their effect on public health/safety. Materials and Methods: Ethical approval was obtained and pretested questionnaires were administered to consenting healthcare providers in six local government areas in Lagos. The collected data was sorted and entered into Microsoft Excel, following which analysis was carried out. Results are presented as tables and charts. Results: Respondents believed that the problem of fake/counterfeit drugs is common with a modal faking range of 41–50% of drugs in the country. Anti-infectives, anti-malarials, and analgesics were reported to be the most implicated drugs. Many believed that faking/counterfeiting of drugs can be surmounted by the promulgation and enforcement of appropriate legislation and closure of open drug markets. Conclusions: It can be concluded that respondents are aware of the challenges posed by counterfeit drugs and if empowered can serve as a tool in its eradication. It is recommended that appropriate modalities to review the existing laws and close open drug markets be put in place.
Keywords: Community pharmacists, counterfeit drugs, fake drugs, PPMVL, private physician
|How to cite this article:|
Joda AE, Amadi C, Adebayo OI, Maji YI, Uchem C, Olih H. Fake drugs: A survey of healthcare providers in Lagos State, Nigeria. Niger J Basic Clin Sci 2017;14:137-42
|How to cite this URL:|
Joda AE, Amadi C, Adebayo OI, Maji YI, Uchem C, Olih H. Fake drugs: A survey of healthcare providers in Lagos State, Nigeria. Niger J Basic Clin Sci [serial online] 2017 [cited 2019 Jul 19];14:137-42. Available from: http://www.njbcs.net/text.asp?2017/14/2/137/216051
| Introduction|| |
Drugs offer a simple, cost-effective solution to many health problems provided they are available, affordable, and properly used., Drugs are essential for the provision of both curative and preventive health care. The private sector provides most of the health care delivery in Nigeria.,, Patients or end users obtain drugs from hospital pharmacies (public or private) or retail outlets (pharmacies or patent medicine shops, illegal vendors, and hawkers). The reality is a chaotic drug distribution network handled by both professionals and nonprofessionals comprising both registered and unregistered premises.,,
Fake and counterfeit drugs are defined differently in different countries. The definitions used in the various World Health Organization (WHO) Member States show that the problem of counterfeit drugs varies from country to country., Counterfeiting occurs globally, although there are claims that it is more common in developing countries with weak regulatory systems.,,,,,, In developing countries, the most disturbing issue is the common availability of counterfeit drugs for the treatment of life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS.,, Use of counterfeit drugs can result in treatment failure, harm, or even death. Public confidence in healthcare delivery systems may be eroded following the use and/or detection of counterfeit drugs.,,, Counterfeiting is difficult to detect, investigate, quantify, or stop.,, Factors facilitating the occurrence of counterfeit drugs include weak penal sanctions and weak or absent national drug regulatory authorities, among others., Heightening vigilance and awareness of counterfeiting among healthcare providers is one of the measures to combat counterfeiting.
The aim of this study is to document the perceptions of various healthcare providers regarding the problem of fake and counterfeit drugs in Nigeria, thus providing empirical data for policy decisions.
| Materials and Methods|| |
The study setting was the healthcare landscape in Lagos, Nigeria to provide the National outlook. Lagos state serves as home to majority of the healthcare providers and healthcare premises in the country and hence was chosen as the study site. The state was divided into three broad groups based on the density of residents. Two locations were selected under each category, i.e., high density areas (Agege and Ikorodu), medium density areas (Ikeja and Surulere), and low density areas (Apapa and Eti-Osa). The healthcare practitioners surveyed were community pharmacists (C.PHARM), private physicians (PR. PHYS), and patent and proprietary medicines vendors license holders. The survey instrument was a pretested self-administered questionnaire. Six researchers were recruited, trained, and sent to the field in February 2014. For each Local Government Area (LGA), 30 community pharmacies, 30 private hospitals, and 30 PPMVL premises were surveyed giving a total of 540 healthcare workers. In some cases, repeat administration was necessary before filled questionnaire was finally received.
Ethical approval for the study was obtained from the Association of General and Private Medical Practitioners of Nigeria (AGPMPN). Verbal consent was obtained from each healthcare provider before questionnaires were administered. The collected data was sorted, collated, and entered into Microsoft Excel 2007 by Microsoft Company, Redmond, USA. Analysis was done using EPI Info Version 6 (EPI-6 Info) statistical software (Dean et al., 2002), Statistical Package for Social Sciences (SPSS) version 17.0 and Microsoft Excel 2007. Research questions were tested with Chi-square distribution to determine any association using relevant critical values and degrees of freedom (95% confidence interval). Results were deemed to be significant when P < 0.05 or when the calculated Chi-square (χ2) was smaller than the critical value for the degrees of freedom.
| Results|| |
A total of 541 questionnaires were received among the questionnaires administered to the healthcare providers, giving a 100.2% response rate. Reliability analysis gave Cronbach's alpha value of 0.635 for the variables included in the survey.
The mean of years of experience possessed by the HCPs was 7.2 years whereas the mean number of years in the current job was 5.8 years. The minimum and maximum years were 0 and 38 years and 0 and 32 years for each classification, respectively.
The results reveal that most of the respondents were Christian married males within the age range of 31 to 40 years. In most of the facilities, the person in charge of the dispensary was either a fulltime staff or the owner. The result for the different areas, gender, and religion of the respondents were significantly different among the various healthcare professionals surveyed [Table 1].
Perception about faking
Approximately 11% of the respondents said they did not know if faking was common. However, an overwhelming 79% believed that it is common [Table 2].
[Table 3] presents the respondents' perception of the extent of faking. The modal faking range is 41–50%, and using sum-product statistical function, the mean value for level of faking was calculated to be 49% [Table 3].
[Table 4] shows that the respondents' levels of agreement with various statements about faking and counterfeiting arranged in order of agreement from strongly disagree to strongly agree. The respondents strongly disagreed that no faked herbal products exist and they disagreed that faking is due to corrupt practices of healthcare professionals. They strongly agreed that the high level of faking is because there is a lack of appropriate laws and that shutting down open drug markets will drastically reduce the incidence of faking [Table 4].
The result shows the respondents perception of the most implicated drug class and it reveals that anti-infectives, anti-malarials, and analgesics were the most commonly faked drug class in the respondents' opinion [Figure 1].
|Figure 1: Respondents Perception of Most Implicated Class by Counterfeiters. Key: Antimal=antimalarial; Anthel=anthelmintic; Antiinf=anti-infective/antibiotic; Anal=analgesic; Antihyp=antihypertensive; Antidia =antidiabetic|
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Containing and combating faking
[Figure 2] shows that most of the respondents believed that the counterfeiting of drugs can be contained using a mix of legal tactics, monitoring, and closure of open drug markets in the state [Figure 2].
|Figure 2: Respondents Proposed Strategies to Contain Fake Drugs Problem in Nigeria (% Pooled Result). Key: Inc. = Increase; Prof. Professionals; Trail = Audit Trail|
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Similarly, respondents believed that, to combat the problem of faking promulgating appropriate laws and enforcing them, monitoring products in the market, and use of the anti-faking devices of NAFDAC will help [Figure 3].
|Figure 3: Respondents Suggestions on Combating Fake and Counterfeit Drugs in the Country (% pooled responses)|
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| Discussion|| |
This study aimed to document the perceptions of various healthcare providers regarding the problem of fake and counterfeit drugs. The results show that most of the healthcare providers believed that there is a high level of fake and counterfeited products in circulation in the country, as documented in a previous study. The result obtained shows that the class of drugs the healthcare providers feel are the most faked are anti-infectives (including antibiotics), anti-malarials, and analgesics. In 2004, the US FDA issued a report entitled “Combating Counterfeit Drugs: A Report of the Food and Drug Administration.” This report identified six critical measures to combat fake drugs. These include securing the actual drug product and its packaging, securing the movement of the product through drug distribution chain, enhancing regulatory oversight and enforcement, increasing penalties for counterfeiters, heightening vigilance and awareness of counterfeit drugs, and increasing international collaboration. Thus, there is an urgent need for regulatory bodies to tackle the issue of fake and counterfeiting using legal means and monitoring to improve the nations' drug use scenario.
Level of fake and counterfeit drugs in circulation
Majority of the respondents (80%) believed that the problem of faking and counterfeiting is common in the country. A previous study  showed that respondents believed that the problem of counterfeit drugs in the country was common and could undermine the healthcare delivery efforts of the government. It has been reported that the actual prevalence of counterfeit drugs is difficult to determine partly because most WHO member nations fail to report instances of drug counterfeiting., A study carried out in 2011 showed that WHO estimates that approximately 10% of drugs circulating worldwide and 25% in less developed countries are fake. It also states that Africa and some parts of Asia are the most affected regions followed by Latin America. However, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) cautioned against using the off-quoted estimate of 10% of the global supply being counterfeit, and suggested that “many developing countries of Africa, parts of Asia, and parts of Latin America have areas where >30% of the drugs on sale can be counterfeit.” Other developing markets, however, have <10%. In another study, it was estimated that up to 15% of all sold drugs are fake, and in parts of Africa and Asia this figure is greater than 50%. The healthcare providers surveyed have reported an estimated mean value of 49% of fake/counterfeit drugs in the market. A previous study stated that “Counterfeit drugs constitute between 40 and 50 per cent of total supply in Nigeria and Pakistan,” which is similar to the proportion obtained in this study. Counterfeiting is primarily motivated by its potentially huge profits.,, Counterfeiters usually work in unauthorized settings, within the international networks and with the intention of hiding their identity; thus, law enforcement measures taken by national and regional regulatory procedures cannot be effective if undertaken in isolation.,
Types/Classes of drugs usually faked
Literature shows that almost all kinds of drugs are being faked/counterfeited,, and that the type of drugs most commonly affected in poor/developing countries are antibiotics., Another study shows that according to WHO, drugs commonly counterfeited include antibiotics, anti-malarials, hormones, and steroids. Increasingly, anticancer and antiviral drugs are also faked. This survey shows that the class of drugs the healthcare providers feel are the most faked are anti-infectives (including antibiotics), anti-malarials, and analgesics. A previous survey in Nigeria shows that more than half of the fake drugs seized by NAFDAC consists of anti-bacterials. Literature also shows that counterfeits of anti-malarial drugs are widespread in developing countries, particularly southeast Asia and Africa.,,,
Healthcare providers's suggestions on containing and combating fake and counterfeit drugs in circulation
The healthcare providers strongly believe that faking is due to the corrupt practices of businessmen. Indeed, drug counterfeiting is a grievous crime which is equivalent to murder ,, because people that use counterfeit drugs have been known to die either from the worsening of their condition or other toxic effects of the content or both. The punishment should therefore be equal to the offence for it to serve as an effective deterrent to the perpetrators of the crime. The Routine Activity Theory of Crime Prevention states that “A crime occurs when a suitable target and a potential offender meet at a suitable time and place lacking capable guardianship.” According to this theory, drug counterfeiting business thrives better where drugs are relatively scarce or the prices are high.
This study documents that the healthcare providers strongly believe that provision of adequate laws and enforcement of same will curb faking and counterfeiting of drugs in the country. This opinion is supported by the literature.,,, Chika et al., stated that “long term strategies for battling drug counterfeiting include provision as well as enforcement of clear and adequate civil laws that will compensate and protect the right of affected individuals.” He further stated that “without such enforcement, state laws will not serve as enough deterrent to combat a crime as lucrative as drug counterfeiting.” A previous study in Nigeria revealed that the two main reasons adduced for the high prevalence of faking are ineffective enforcement of laws and greed. Thus, the position of the respondents in this survey on enforcement of laws agrees with this position. Although literature posits that healthcare providers such as pharmacists, physicians, and nurses are well positioned to help governments in the fight against counterfeit drugs, this survey shows that the respondents believe that the legal option, monitoring/audit trailing, and closure of open markets are the most effective solutions to the problem of counterfeits in the country. However, Rozendaal, stated that “Stronger regulation of the private or informal sector in poor areas with weak government structures will be counter-productive if not complemented by other measures such as information campaigns aimed at protecting consumers and measures to improve availability of quality-assured drugs.” The National Agency for Food and Drug Administration and Control (NAFDAC) and the Pharmacists' Council of Nigeria (PCN) are the national regulatory authorities responsible for the regulation of the Nigerian pharmaceutical sector. NAFDAC has the mandate to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs; whereas PCN regulates and controls the practice of pharmacy in all its ramifications. This includes the issuance of licenses for professional practice and pharmaceutical premises, as well as development of curriculum for training of professionals. PCN also regulates and issues licenses to patent medicine vendors (PMVs) who are authorized to sell over-the-counter drugs., The important contribution corruption makes to the counterfeiting problem in developing countries including Nigeria cannot be overlooked. Some of the respondents in this study believe that increasing awareness and dealing with corruption are necessary to both contain and combat faking and counterfeiting. Different previous studies also support this point including WHO documents., Literature also documents that international collaborations and information sharing from drug companies are strategies that work., A case is also made by a few of the respondents for the regulation of prices of drugs. Literature documents that “When prices of drugs are high and price differentials between identical products exist there is a greater incentive for the consumer to seek drugs outside the normal supply system.”,,,
| Conclusion and Recommendations|| |
It can be concluded that most of the healthcare providers surveyed believe that the problem of fake and counterfeiting of drugs is high in the country. The result also shows that these care providers believe that the problem is surmountable.
It is recommended that the appropriate authorities, NAFDAC, PCN, and Federal Ministry of Health set in motion modalities to review the existing laws as it relates to faking and counterfeiting to ensure that offenders are punished appropriately to serve as a deterrent to them and that others that may want to follow them. Public enlightenment campaigns should be mounted to help people identify fake/counterfeit drugs and warn on the ills of counterfeiting. A task force should also be constituted to see to the systematic closure/dismantling of open drug markets in the state and elsewhere. The need for all healthcare personnel to be involved cannot be overemphasized. By their expertise, they should have a high index of suspicion of the possibility of counterfeiting, educate themselves and their patients on how to recognize fake drugs and disseminate information widely about any identified fake drugs. From the results of this study, it is clear that many healthcare providers are aware of the challenges posed by counterfeit drugs, and if adequately empowered will serve as a tool in its eradication.
Financial support and sponsorship
This project was sponsored by the Pharmaceutical Society of Nigeria (PSN).
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]