Anticounterfeiting Strategies of Local Drug Manufacturers in Lagos, Nigeria
Paper Title: Anticounterfeiting Strategies of Local Drug Manufacturers in Lagos, Nigeria: Drug Safety and Implications for Public Health
Authors: Samson Fatokun and Olufunsho Awodele
Publication: Journal of Population Therapeutics and Clinical Pharmacology
Volume and Issue: Volume 24, Issue 3
Pages: 99–120
Publication Date: December 4, 2017
DOI: 10.22374/1710-6222.24.3.7
Research Type: Original Research
About the Paper
Counterfeit and poor-quality medicines pose serious risks to public health in Nigeria. They may cause treatment failure, injury, disability, death, loss of confidence in the healthcare system, and significant financial losses.
This paper examines the anticounterfeiting strategies used by local pharmaceutical manufacturers in Lagos State. It also considers the types of medicines most vulnerable to counterfeiting and evaluates selected drug samples using the TruScan device deployed by the National Agency for Food and Drug Administration and Control.
The study was written by Samson Fatokun of NAFDAC and Olufunsho Awodele of the Department of Pharmacology, Therapeutics and Toxicology, College of Medicine, University of Lagos.
Objectives of the Study
The study sought to:
- identify the anticounterfeiting strategies adopted by local drug manufacturers in Lagos;
- determine the classes of medicines considered most vulnerable to counterfeiting;
- examine the use of overt and covert product-protection technologies;
- identify barriers affecting manufacturers’ anticounterfeiting efforts; and
- test selected antimalarial and antibiotic samples using TruScan spot-check analysis.
Research Method
The research was conducted in two phases.
The first phase used a descriptive, cross-sectional questionnaire to collect information from managers and pharmacists working for local pharmaceutical manufacturers in Lagos. A total of 175 questionnaires were distributed, and 162 completed questionnaires were returned and analyzed.
The second phase involved samples from the two classes of medicines identified as having the highest potential for counterfeiting: antimalarials and antibiotics. Samples were obtained from manufacturers and the open drug market in Idumota, Lagos, and examined using the TruScan device.
Key Findings
The study found that 95.7 percent of respondents had encountered a counterfeit version of one of their companies’ products.
Open drug markets and patent medicine stores were identified as the places where counterfeit medicines were most likely to be found or purchased.
Respondents identified antimalarials and antibiotics as the medicine classes with the greatest potential for counterfeiting.
The most widely reported overt anticounterfeiting technologies were:
- sequential batch numbering — 61.1 percent;
- tamper-proof devices — 33 percent;
- mobile product authentication — 29 percent;
- holograms — 28.4 percent;
- on-product markings — 23.5 percent; and
- security graphics — 22.8 percent.
Among covert technologies, bar codes were the most commonly reported, at 29 percent, followed by serialization at 18.5 percent and embedded images at 17.9 percent.
The study also found that the sampled products relied mainly on visible or overt anticounterfeiting features. None of the antimalarial or antibiotic samples examined carried covert anticounterfeiting technologies.
TruScan Results
For locally manufactured antimalarials:
- 83.3 percent of samples obtained from manufacturing facilities passed the TruScan spot checks; and
- 77.8 percent of the available open-market samples passed.
For antibiotics:
- 50 percent of samples obtained from manufacturing facilities passed the TruScan spot checks; and
- all four available open-market samples passed.
Some samples could not be fully assessed because the TruScan device did not have an internal reference for those products or because corresponding open-market samples were unavailable.
The researchers found no statistically significant difference between the antimalarial and antibiotic samples obtained from the manufacturing sources and those obtained from the open market.
Barriers to Anticounterfeiting Efforts
The leading barriers identified by respondents were:
- widespread informal drug markets — 63.6 percent;
- weak or inadequate penalties for counterfeiters — 56.8 percent;
- chaotic drug distribution channels — 56.2 percent;
- weak regulations — 50 percent;
- inadequate training — 32.7 percent;
- financial constraints — 31.5 percent;
- limited human resources — 25.3 percent; and
- inadequate management support — 22.8 percent.
Conclusions and Recommendations
The authors concluded that local pharmaceutical manufacturers had made progress in protecting their products, particularly through sequential batch numbering, security graphics, on-product markings, and tamper-resistant packaging.
However, relying mainly on visible security features may not provide sufficient protection against sophisticated counterfeiters. The paper recommends using a combination of overt and covert anticounterfeiting technologies.
The authors also recommend:
- stronger information sharing and collaboration among manufacturers, regulators, distributors, healthcare professionals, and other stakeholders;
- a review of relevant laws and regulations to strengthen the anticounterfeiting features used on locally manufactured medicines;
- greater use of multilevel product-authentication and brand-protection technologies; and
- expansion of the TruScan internal-reference database so that more locally manufactured medicines can be examined through spot-check analysis.
Citation
Fatokun, S., and Awodele, O. “Anticounterfeiting Strategies of Local Drug Manufacturers in Lagos, Nigeria: Drug Safety and Implications for Public Health.” Journal of Population Therapeutics and Clinical Pharmacology, Vol. 24, No. 3, 2017, pp. 99–120. DOI: 10.22374/1710-6222.24.3.7.