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Understanding counterfeit drugs and its impact on Pharmacovigilance


Drugs play a crucial role in the healthcare ecosystem. A drug should be safe, effective when used judiciously in order to get the desired outcome. In order to live a long and healthy life, along with good diet and healthy routine; taking medicine also plays a vital role. As consumer is well aware of drug information and rights, quality of medicine becomes very important to them. Due to enormous benefits associated with drugs and their usage, there lies a great scope of producing and marketing counterfeit drugs.

According to World Health Organization (WHO), a counterfeit drug is defined as “a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source”. A counterfeit medication is manufactured and sold with the dishonest objective of making fast money. It may contain inappropriate or no quantities of active ingredients thus affecting its authenticity and effectiveness, and or may be supplied with inaccurate or fake packaging and labelling. These drugs are past their shelf-life but being sold with a modified date of expiry or manufacturing causing zero benefit thereby leading to critical health issues or even death.

The history of counterfeiting goes back several centuries and the problem has been growing ever since. World health organisation (WHO) has played a key role in checking and eradication of counterfeit drugs.  In 2006, the International Medical Products Anti-Counterfeiting Taskforce has been established by the WHO, and it has since become the principal voice for the organisation's efforts to tackle spurious drugs. Most of the counterfeit drugs are produced from under-developed and developing countries due to absence of adequate regulation and a limited enforcement capability. Further due to high cost and paucity of medications, consumers are forced to look for the economical substitutes. With time, counterfeit medications has now paved in-roads into global supply chain with developed nations also getting impacted. 

One of the paramount risks linked to fake drugs is the development of resistance. Antibiotics are the most adulterated forming major share in spurious drug market. In order to check counterfeit drug menace, regulatory agencies, pharmaceutical companies, pharmacist and consumer will have to play their roles adequately.  With developed nations implementing electronic tracing that is compatible at the packaging level to identify and track specific prescription medications; developing nations are coming up with a unique identification number and bar coding that incorporates all product information for quick data retrieval at each stage of the supply chain. Pharmaceutical companies could further focus on raising awareness amongst the pharmacists, doctors, and the end consumers along with maintaining integrity of their drug supply chain. Pharmaceutical companies should keep monitoring the sanctity of the supply chain to protect the products at manufacturing sites, warehouses, during shipment, and at the end consumer. Pharmacists can also purchase from a trustworthy drug supplier source approved by the respective drug regulatory agencies. They can further keep records of products to monitor the tracking of medicine, if required. Lastly, consumer can contribute by buying medicines from trusted pharmacies. They must immediately contact the pharmacist or doctors if any discrepancy is noted in the appearance, taste, or effect of the consumed drug.

For Pharmacovigilance data, most of the pharma companies are relying on various sources like hospitals, patients, physicians, patient support program etc. Lack of efficacy is one of the most common adverse events reported by companies and one of the reasons is attributed to consumption of counterfeit drugs. In order to track correct information while reporting lack of efficacy, adequate facilities have to be provided to the patient (like toll free no, email address etc) while reporting a complaint against a company drug. Collecting samples of the company drug from the patient once a product complaint was filed due to lack of effect will let the drug manufacturer positive about issue related to manufacturing or supply chain issue or because of counterfeited drug. Penalties can be imposed along with stricter punishment including imprisonment in order to curb this menace. Hence, continuous efforts should be made in retrieving methods so that accurate data can be recorded in Pharmacovigilance.

Counterfeit drugs have emerged to be one of the major concerns at global level. From using holograms with further adding security features to assigning a unique identification number to track the product during entire supply chain, pharma companies are spending huge amount of money on technology to take care of their top blockbuster drugs. Different countries have different laws to discourage counterfeiting. Respective governments can play a crucial role in providing financial budgets to the health agencies to support active drug surveillance. Further from Pharmacovigilance aspect, procuring data regularly by encouraging pharmacy and consumer to report information when drug is not proven to be effective will help drug manufacturer save their drugs by reporting accurate information to agencies. To effectively manage danger posed due to counterfeit drugs, collaboration at global level including nations, pharmaceutical companies and regulatory bodies will be the game-changer.

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