By: Lunbao (Jerry) Huang, Pharm.D. Candidate c/o 2013

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Counterfeit prescription medications are becoming a great concern for us. They have increased worldwide costs and endangered our public safety. Activities related to counterfeit drugs cost our healthcare system an estimated $75 billion in 2010. Many patients were seriously injured and died due to counterfeit medications.

The FDA defines counterfeit medications as “…fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health….”

Ingredients found in counterfeit medications are dangerous due to two main factors (or reasons). The first factor is the active ingredient content. There could be an incorrect amount of active ingredient or often no active ingredient at all. Patients depend on prescription medications during emergencies and life-threatening situations, and lacking the correct amounts of active ingredients leads to under-treatment of the illness and causes further complications. For medications, such as antibiotics, an unexpected alteration in the dose could lead to bacterial resistance. The patient may then progress into a more severe state of infection.

The second factor is that these counterfeit medications contain inactive ingredients, such as calcium carbonate, flour, vitamins, talcum powder, fluoric acid, floor wax, or maple sugar. They could mix with dirty water, open air, excessive heat, insects, and other unsanitary conditions. To some patients, these medications may be innocuous. However, in those taking multiple medications for multiple medical conditions, counterfeit drugs can cause unexpected and undesirable drug-drug interactions, drug-food interactions, and drug-disease interactions.

Through news media, we have learned that counterfeit pharmaceuticals’ main manufacturing locations are in China and India, and they operate under non-GMP (Good Manufacturing Practices) conditions. These illicit drug labs or “street laboratories” are part of a network that utilizes multinational transportation methods (in air and on the road). Globalization brings in many imports from China and India, two countries known for having weak quality control systems. This enormous global network surpasses United States Postal Service’s jurisdiction or power to pursue after these package senders. It would also take a lot more physical and financial means to find the operators behind the organized crime networks.

In contrast, packages often arrive in United States from the United Kingdom. According to the U.S. Immigration and Customs Enforcement (ICE), companies like FedEx, UPS, USPS, and other express mail services, usually ship the final products into our country. Alas, it is more difficult for law enforcement agents to detect these packages, especially when compared to large container shipments (inspected by U.S. customs).

It would be easy to avoid counterfeit medications if we could simply tell the difference between the genuine and fake ones. However, it is more difficult than we imagined. First, counterfeit drugs appear so similar to genuine medications that it is often impossible to tell with the naked eye. Without pairing them up with the genuine products and put them next to each other, it is often impossible to tell the difference between the packaging and the labeling.

What can we do to fight against these counterfeits? Howard Zucker, a former Assistant Director General of the WHO and former head of IMPACT, addressed that the five main areas we need to focus on are technology, strong legislation, enforcement, unilateral regulatory standards, and public knowledge. Just by learning about this information, we already have taken steps to combat against counterfeit medications. The best way for pharmacies in the U.S. to avoid stocking counterfeit medications on their shelves is to avoid unreliable distributors. Unregulated online pharmacies sell most of the counterfeit medications. This is also how most of the counterfeit medications get into our country. One of the reasons why consumers visit these websites is because they often provide prescription drugs without any pharmacy license or prescriber authorization. This is illegal, at all times!

The second reason is that these medications have attractively cheap pricing that seem to hold onto consumers’ attention. Most of these websites often announce that they are in Canada. They create the image of reliable, safe, and inexpensive medication because Canada’s pharmaceuticals are “generally safe” and have “trustworthy quality controls” with “cheaper import pricings.” Unfortunately, the FDA does not approve counterfeit online pharmacy websites. From the price, seller’s policy, and regulations, one can infer that they do not belong to Canadian origins. However, pharmacists and physicians need to understand that not all online pharmacies are illegal. Legitimate online pharmacies are always safe for placing orders. The National Association of Boards of Pharmacy (NABP) with the VIPPS accreditation program validates all online pharmacies. As of January 12, 2012, there are 30 online pharmacies accredited by VIPPS. Pharmacists can verify whether a particular online pharmacy is legal by going to http://vipps.nabp.net.

Among some of the findings about counterfeit and stolen medications, the FDA received reports of adverse events. In summer of 2009, patients stated that their insulin was not controlling their sugar level. The FDA later used the lot numbers of the insulin products to discover that they were stolen products from months ago. Because of inappropriate handling and storage, the insulin products lost their activity months ago. Such crimes are no different from other crimes that risk public lives in exchange for money. It is a serious crime to sell fake, stolen, or expired medications, and the FDA is taking significant steps to fight against these issues.

In 2008, news about heparin contamination revealed that the medication had counterfeit active ingredients sourced from Changzhou SPL in China. This led to extensive recalls of the drug because of severe adverse events, injuries, and deaths. The FDA now calls for testing to detect over-sulfated chondroitin sulfate in all medications, especially heparin.

The best way to find drug adulterators is to realize their motives, and this reason is usually economical. If a drug ingredient is expensive, then criminals have the incentive to find cheaper alternative for these expensive ingredient. If a cheaper alternative yields a similar result as the original ingredient, then the incentive would sharply increase. The FDA found more than 1,000 active ingredients at risk for “economically-motivated adulteration.” The FDA will then put higher restrictions, as well as more specific testing and sampling of these products.

In addition, due to this global network of organized crime, the FDA is required to work with foreign regulatory authorities around the world, the World Health Organization, and other international organizations (such as forums on international pharmaceutical crime and pharmaceutical industries). We need this cooperation to prevent the importation of counterfeit pharmaceutical products. The FDA is training fellow regulators around the world. It would like to provide more scientific and technical expertise to maximize our security system for better detection, surveillance, and assessment on imported medications. We now have international posts with field inspectors to improve the safety of imported food and medical products.

As mentioned multiple times in this article, counterfeit medications are dangerous and life threatening. There is an enormous network of organized crime, and it has its way of effectively luring its buyers. The FDA and pharmaceutical companies are increasing security measures to prevent counterfeiting inside and outside our country. The best way to protect pharmacies and hospitals is to be aware of the issues, purchase pharmaceutical products from trusted retailers, and avoid unregulated online pharmacies. Medications within the United States are still safer compared to those purchased from outside the country. Experts like Howard Zucker encourage Americans traveling abroad to take their medications with them and avoid purchasing drugs abroad. As Zucker states, “try to keep your eyes open in developing countries.”

FUN FACT: Viagra is the world’s most counterfeited drug.

SOURCES:

1. U.S. Food and Drug Administration. Counterfeit Medicine. Website. Available online: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm. 2012 Jan. Accessed Jan 5, 2012.
2. National Association of Boards of Pharmacy® (NABP®). Find a VIPPS online pharmacy. Website. Available online: http://www.nabp.net/programs/accreditation/vipps/find-a-vipps-online-pharmacy/. 2012 Jan. Accessed Jan 10, 2012.
3. CNBC LLC. The Painful Costs of Counterfeit Prescription Drugs. Website. Available online: http://www.cnbc.com/id/44759614/The_Painful_Costs_of_Counterfeit_Prescription_Drugs. 2012 Jan. Accessed Jan 10, 2012.
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6. WHO. Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines. Website. Available online: http://www.who.int/mediacentre/factsheets/fs275/en/. 2010 Jan. Accessed Jan 14, 2012.
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8. Hamburg MA. Partnership for Safe Medicines Interchange 2010. Website. Available online: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/UCM235240.pdf. 2010 Oct. Accessed Jan 15, 2012.
9. 9. Bogdanich W. Heparin Find May Point to Chinese Counterfeiting. Website. Available online: http://www.nytimes.com/2008/03/20/health/20heparin.html. 2008 Mar 20. Accessed Jan 15, 2012.
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Published by Rho Chi Post