The counterfeit drug epidemic is one of the greatest global health threats present today. The World Health Organization (WHO) estimates that the selling of counterfeit drugs is worth $83 billion dollars each year, and 1 in 10 medical products circulating in developing countries are substandard or fake. Additionally, there is growing evidence that this problem is only becoming more prevalent. People with chronic pain need daily drugs, but the industries that make and distribute them are highly regulated. This epidemic exists because it’s outside those industries, and because people need these drugs daily. The issue strikes at the heart of the pharmaceutical and medical industries. Not only do counterfeit drugs erode public trust, but they also cause preventable deaths. For example, the consumption of counterfeit antibiotics leads to approximately 72,430 and 169,271 children dying of pneumonia each year.1
In the future, everyone will be directly or indirectly affected by counterfeit drugs. It is an unavoidable consequence of supply and demand due to supply chain issues and a growing market for less expensive drug products. There are multiple ways that these consequences are felt. Direct impact will have the most acute effects, as lifesaving or life enhancement drugs taken directly by a patient. These drug products are considered adulterated and will either have decreased efficacy or will be misbranded completely. In most cases, the fraudulent drugs have weaker amounts of active pharmaceutical ingredients (API), or none at all. In some cases, they have been found to contain the following dangerous and potentially lethal substances: highway paint, rat poison, floor wax, brick dust, boric acid, paint thinner, sheetrock, and antifreeze. Indirect impact will be more widespread and will have longer lasting impacts. These include antibiotic resistance, and the resurgence of infectious diseases such as malaria and tuberculosis.
Drugs most often counterfeited include high demand, expensive medicines. These include various chemotherapeutic drugs, antibiotics, vaccines, erectile dysfunction drugs, weight loss aids, hormones, analgesics, steroids, antihistamines, antivirals, and anti-anxiety drugs.
The diversity of counterfeit drugs and the scope of the counterfeit drug market is broad. Production and consumption of these drugs extends to every country on the globe.
As the above graphic shows, the extent of the problem varies between regions and individual countries and depends on temporary supplies. The WHO estimates that in some areas in Africa, Asia, and South America, more than 30 percent of medicines in circulation are counterfeit. In some countries of Eastern Europe, the proportion of counterfeit medicines can be more than 20 percent. In Europe and in the USA, as well as in other developed countries, less than one percent of the medications sold are counterfeits. Despite this, the trend shows that counterfeits in our globalized world are no longer just a problem of developing countries. When traveling, patients often purchase their medicines abroad. Typical market structures and trading routes have been liberalized, allowing vendors to sell medicines at lower prices. And finally, the internet has made sales and trade of various drugs simpler and more global.2
Now that the scope and significance of the counterfeit drug problem has been established, how do pharmaceutical companies move forward? One of the best tools that pharmaceutical companies must combat this epidemic with is a robust Computer System Validation (CSV) program. CSV is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems is necessary to ensure accuracy, reliability, consistent intended performance,and the ability to discern invalid or altered records. It is a critical requirement for electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EU Annex 11, Section 4.3
CSV is a regulatory requirement for a reason, because in many instances, it can be lifesaving. For example, detecting medication defects can prevent unfortunate side effects and avoid significant damage a drug consumer would have otherwise received. If these systems are going to meet GxP and regulatory requirements, there needs to be a plan for documentation, implementation, and post-implementation strategies. The impact of this will directly and indirectly affect SQuIPP (Safety, Quality, Identity, Potency, and Purity).
Establishing a robust CSV program will help ensure product quality and patient safety. More importantly, it is a key mechanism in the main fight against counterfeit drugs. Serialization requirements aim to provide patients with products that are kept secure throughout their distribution life cycles, and have begun to foster a culture of strengthening existing relationships. A data exchange network enables data sharing across the pharmaceutical supply chain that supports each transactional event, from manufacturing to dispensing to the patient. As a result, serialization processes capture vital digital data along the various points in the supply chain, resulting in greater insights and improved execution.
Over the last several years, all markets have implemented their serialization requirements. Every salable unit of prescription medicine is identified with a unique serial number associated with the batch. Over the next decade, most of these markets would have added requirements that mandate exchange of the serialization data throughout the supply chain. Examples of ongoing regulations include U.S. Drug Supply Chain Security Act (DSCSA) 2023 unit-level traceability requirements and legislation in Saudi Arabia, Russia, China, and Brazil. Refer to the global map for more information on markets requiring traceability in addition to serialization now or in the future.4
With increased awareness and the promotion of global health, the growing threat of counterfeit medications may begin to decline. As more countries continue to implement serialization requirements for their drug products, CSV will continue to be a focal point for the pharmaceutical industry. Implementing a rigorous CSV program and ongoing expansion of serialization is paramount in the fight against counterfeit drugs and patient safety across the globe.
Reference:
1.Fake medicines. INTERPOL. Accessed October 26,2021. 2.https://www.bayer.com/en/health/background-information-on-counterfeit-drugs 3.http://www.ofnisystems.com/services/validation/computer-systems/ 4.https://www.pharmaceuticalonline.com/doc/next-steps-for-serialization-in-the-pharma-supply-chain-0001
