Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them.
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently..
The challenge in preventing counterfeit drugs from infiltrating the supply chain is to make it airtight, and the verification methods sound, so fakes can be identified easily. However, the gains from counterfeiting are so attractive, and the punishments often so light, that many criminals, including those trafficking illegal drugs, continue to devise new and more elaborate schemes to peddle their fake or stolen products.
The dangers these products represent are many. Counterfeiters will replace effective active ingredients with inert ingredients like chalk or cornstarch and manufacture their fake products in humid, unsanitary buildings, blending them in washing machines or cement mixers. Vendors often offer their fake meds in open-air markets in the tropics, likely without storing them under the temperature conditions required for a drug to be stable. The most sophisticated counterfeiters may add an insignificant layer of active ingredient to avoid detection. The results can be deadly, particularly in lower-income nations and especially to children. The most egregious examples of counterfeiting include opioid, erectile dysfunction and antimalarial drugs. Counterfeiters count on the fact that these patients are already ill to quell suspicions about the integrity of their fake drugs. To escape detection, more care is given to the appearance of the packaging of these fakes than to the quality of the products themselves. For products that were once in the legitimate supply chain but that have been diverted, it is possible that the products have been degraded either by being past their expiration date or stored in inappropriate conditions.
Aside from the dangers to the patient, fake medications also have a detrimental effect on a product’s reputation and on its sales. Counterfeit or diverted product can be resold at a lower cost than legitimate product, competing directly with it. Illnesses or deaths caused by a fake product that is represented as legitimate could bring a company significant damage to its reputation.
The battle against counterfeit and diverted medications is a difficult one. Supply chains of counterfeit medications are deliberately made complicated to avoid detection. Regulatory agencies in many countries are seriously understaffed to combat the many actors in the counterfeit market, lack effective tools to detect counterfeit drugs, and in some cases may even run into opposition due to political motives by the authorities.
Following our review of the problem, we will discuss the strategies that have been employed successfully worldwide to control the flow of counterfeit medications and other threats to the Pharma supply chain. Electronic methods to verify authenticity of your product, besides being required by law, are your first defense against counterfeiting. New methods that increase the supply chain visibility can be added to these for even better results. There are best practices to be learned from the industry, law enforcement, government agencies, international organizations, and industry organizations to combat this serious problem.
It is hard enough to detect errors in the entire process of manufacturing and distributing one’s own pharmaceutical products, but Pharma companies must also address the challenge of counterfeit medications that at best are ineffective and at worst are deadly. Legitimate drugs can be diverted, or fake drugs can be created completely parallel with and invisible to your own supply chain, with their own distribution networks deliberately made complex to disguise them. Looking at the problem in its entirety can be overwhelming and frightening to pharma professionals and especially to consumers, who trust companies to provide them with safe and effective medications. Typical headlines illustrating the trend include: “Maryland Man Charged With Manufacturing And Selling Fake Xanax Since 2013,” “Fake paracetamol (aka Tylenol or acetaminophen) in Philippines,” “Police Seize Hundreds Of Thousands Of Fake Pills In South Carolina And Two Presses,”“The Motorcycle Gang Behind Philly's Biggest Pill Mill,” and on and on. The culprits could be your neighbors or a criminal entity operating halfway around the world. This trend is likely to increase because those involved in counterfeiting drugs are many, and laws have not caught up to the gravity of the problem.
Adding to the counterfeit issue is the problem of drugs that are diverted from the supply chain. Diversion can occur from the company’s warehouse to the hospital immediately before a dose is administered to a patient, highlighting the challenges of identifying exactly where a drug is compromised.
There are many best practices that can be implemented right now. Some do not carry a hefty price tag and depend on where your company sees vulnerabilities. Learn about these in this webinar.
Working with regulatory agencies, industry organizations, international agencies such as the WHO, and law enforcement (e.g., Interpol) to identify and combat fakes
Incorporating design elements into your packaging to make counterfeiting more difficult
Using verification methods at different points in the supply chain to ensure the integrity of your product
Taking advantage of new technologies
Review of learning objectives
The pharmaceutical industry, particularly those employees in the Supply Chain, including:
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations.
He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.