By Abayomi O. Akinmutola
Drug counterfeiting is a significant public health threat and is rapidly increasing with dozens of new cases being reported throughout the world every day. A drug must obtain Market Authorization (MA) granted by competent authority before being marketed. This MA guarantees the product’s safety, quality and efficacy.
Counterfeit drugs do not meet these requirements and subsequently dangerous to an individual’s health. At best, drug counterfeiting is a form of terrorism against public health as well as an act of economic sabotage. In the etymological context, counterfeiting is fraudulent copy of another’s product without his consent. World Health Organization (WHO, 2011) defines counterfeit drug as a medicine deliberately and fraudulently mislabeled with respect to identity and/or source. This applies to both branded and generic products and It may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
In the Nigerian Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Decree, а fake drug is defined as any drug product that is not what it purports to be; Any drug or drug product so colored, coated, powdered or polished that the damage is concealed or which is made to appear to be better or of greater therapeutic value than it really is, which is not labeled in the prescribed manner.
The statutory definition further pertains to any drug or drug product which accompanying label or container bears any statement, design, or device which makes false claim for the drug or which is false or misleading; or abydock, Uyi rug or drug product whose container is so made, formed or filled as to be misleading; or Any drug product whose label does not bear adequate directions for use and such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of use.
The decree extends it to any drug product not registered by the recognized drug control or regulatory agency in accordance with the provisions of the Food, Drugs and Related Products (Registration) Decree 1999 as amended. A counterfeit drug therefore, is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness, bearing in mind that Public Health is the science and art of promoting health, preventing disease and prolonging life through the organized efforts of society (Acheson, 1988; WHO).
Counterfeit drug as plague to public health is a global threat known, developed nations not excluded, and it can occur to any pharmacological class and formulation type. Antibiotics and antimalarial are the two highest categories of suspected drugs reported to the WHO by far over this development. WHO/IMPACT estimates the level of prevalence of counterfeit drugs to be less than 1% (US, EU, Canada), 5 – 10% South East Asia), 10% (Russia), 10 to 20% (Latin America), 16% – 20% (India) and up to 50% (Africa).
Drug counterfeiting represented approximately 40 billion dollars in sales. This approximates almost 10 % of the world pharmaceutical market (WHO, 2016). According to the International Criminal Policing Association otherwise known as (Interpol), counterfeit drugs kills more than one million people every year. Statistics from NAFDAC (2012) revealed that Nigeria is the world’s largest market for counterfeit drugs among developing nations of the world.
This global threat is amplified by large profit potential from the counterfeit market, high cost of drugs, scarcity and/or erratic drug supply, infiltration of the supply chain, highly porous borders, weakness drug regulatory systems, weak enforcement and penal sanctions, corruption, lack of awareness among health professionals and the public, ineffective reporting culture and inefficient cooperation among stakeholders.
The evil of counterfeit drugs is worse than the scourge of malarial, HIV/AIDS and armed robbery put together. Regular use of counterfeit medicines can lead to therapeutic failure or drug resistance; economic losses; disability and discomfort; loss of confidence in medicines, healthcare providers and health systems; toxicities; diseases; in some cases it can lead to death.
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Timeline on critical impact on the society –
• 1995: In Niger Republic, the use of counterfeit meningitis vaccine resulted in the death of about 2500 persons.
• 1998: In Brazil, 200 cases of unwanted pregnancies resulted from the use of counterfeit oral contraceptives tablets.
• 2003: In Nigeria, 3 children died at a University Teaching Hospital during an open heart surgery as a result of the use of counterfeit adrenaline.
• 2004: In France, contact lenses containing Pseudomonas bacteria were detected by the regulatory authorities after receiving complaints from patients.
• 2009: In Nigeria, the consumption of a Paracetamol-based syrup prepared with diethylene glycol led to the death of 84 innocent children.
Some Analytical Methods used in Detecting Counterfeit Drugs include physical characterization like Weights, Measures and Hardness testing of drugs, Chromatographic techniques like TLC and Gas chromatography helps to assay the chemical composition of the product and in identifying chemical impurities or contaminants in products and NIR spectroscopic techniques to generate thousands of spectra which can be analyzed to first classify the counterfeit product then see if they are linked to a common source and finally identify the chemical components and quantify them.
Among trending innovations at checking this scourge, the broad classification involves overt or visible features, including use of Holograms, Product marking, Light sensitive colour change, and, Tilt view for some product packaging. This is similar to those images we see when we tilt our Drivers licenses, Certificates, Naira notes or even our ATM cards to check for marks of originality. Covert or hidden markers include use of Hidden Ghost images on product packaging and need special knowledge and techniques in identifying them. Also in vogue is the use of micro-encapsulated distinctive odor to uniquely identify the drugs.
There is Mobile Authentication Service (MAS) which addresses problem of counterfeiting by enabling users to verify product authenticity using a security label. At the point of purchase, customers scratch the label to reveal a unique code on the product which they validate via SMS; voice calls or website. This technology is common with most antibiotics, antimalarial and creams in Nigeria. We can mention Serialization/Track and trace technology, Radio Frequency Identity (RFID) tagging.
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Among key actions to address counterfeit drugs in Nigeria, prevention requires comprehensive legal frame work with stiffer sanctions for offenders, multi-stakeholder engagement (Judiciary, medical professionals, pharmaceutical companies, regulatory agencies, the media etc), continuous education and awareness of the general public by medical professionals (pharmacists, doctors, nurses, etc). Other preventive measures include maintaining adequate supply chain integrity and purchase of all drugs from registered pharmacies.
To detect counterfeited drugs, the public is advised to always use the MAS and carefully scratch the security label of all drugs purchased at the Pharmacy. There is need to encourage access to laboratories and screening technologies, high risk based inspection and surveillance by regulatory agencies, reporting systems by professionals and the general public to the appropriate regulatory agencies and adequate land, sea and air border control by government.
Among appropriate responses to confront this menace, it is vital to alert relevant authorities to recall all detected counterfeit drugs. There is urgency to strengthen regulatory agencies in Nigeria with the needed support and to fashion transparent legal process culminating in speedy dispensation of justice for victims against suspected offenders.
Conclusively, harmful implications of counterfeit drugs is a major challenge to the integrity of public health systems around the globe, and also a threat to our individual health and existence. There is no single solution to every problem, but a secure strategy will involve a mixture of stakeholders and technologies, often in combination.
But as long as counterfeiters target medicines for illegal profit, a product with no form of anti- counterfeit marker represents a significant potential risk to public health and safety. It is therefore important to make informed decisions when procuring any drug for consumption.
ABAYOMI O. AKINMUTOLA (Pharm. D) Clinical Pharmacist, wrote from Benin-City, Nigeria.
