A Secure Drug Supply Chain is the Best Anti-Counterfeiting Technology We Have

By: Shabbir J. Safdar, Executive Director, The Partnership for Safe Medicines

There are several technologies that have been developed to identify and weed out counterfeit medicines, from serialization to edible security tags on individual pills, but no anti-counterfeiting technology can take the place of a secure, and well-enforced medication supply chain.

Serialization, a central part of our Track & Trace system, provides unique identifying tags on individual packages of medication at the point of manufacture. It is an effective means of quickly spotting fake medicine. However, if you allow members into your supply chain that aren’t effectively regulated, or that are sloppy, it will not prevent patient harm. Though it will make it easier to find the problem after the fact in a follow up investigation by checking the serial numbers against numbers from the manufacturer.

One of PSM’s board members is fond of saying that no technology can protect you when someone is intent on trading your safety to make a dollar. Missing holograms can be ignored, serialized product can be mixed or repackaged with non-serialized product, and other means of making more money and endangering the patient. Serialization will always find the problem after the fact, but our safety goal is higher: we want to prevent such products from ever reaching patients in the first place.

Edible tags, such as the one’s being developed at Purdue University can make identifying genuine pills easier, but again, vigilance on the part of supply chain members is key to their success. A patient may be very interested indeed to find out if their prescribed medication is genuine but if their doctor does not bother to check, the security of edible tags is pointless.

Patients seldom see the packaging of injectable medications such as Avastin, used in cancer treatment; Prolia and Aclasta, used to treat osteoporosis; and Botox, used in treatments ranging from cosmetic to dental and ocular. Every one of these injectable treatments has been counterfeited and successfully sold in the United States, because no one bothered to the genuineness of the medication by examining the packages or checking lot and serial numbers or they had a financial incentive not to. In the case of counterfeit Avastin, U.S. authorities only discovered that American doctors were treating their patients with it when the United Kingdom’s MHRA alerted the FDA in 2012 to warn them that a fake version was in circulation.

If members of the secure supply chain do not carefully examine medication packaging and pills to verify that they genuine using anti-counterfeiting technology, drug counterfeiters can easily fool them with similar packaging and identical-looking pills and vials. The visual spotting of a fake by its label, box, or pill shape and color is imperfect, at best.

Lastly, there has been a lot of press about using blockchain technology to keep counterfeit drugs out of the supply chain. Manufacturers can use technological tracking of their products throughout the supply chain, but if any member of the supply chain ignores digital footprints for medication or fails to recognize their lack, blockchain falls apart and does nothing to protect patients. The best technology to protect patients from counterfeit medication is strong regulation, a secure supply chain, and clear consequences for manufacturers, wholesalers, distributors, and medical professionals who ignore or sidestep the supply chain. In every case where counterfeit medicine has reached patients, bad actors consciously breaking the supply chain put fake drugs in the hands of doctors, clinics, and pharmacies..

References:

• Lilly Serialization: https://www.lilly.com/products/anti-counterfeiting/serialization
• TC Medical: https://www.safemedicines.org/2015/05/canada-based-company-that-acted-as-drop-shipper-pays-33-million-fine-in-misbranded-drug-smuggling-case.html
• Securing Industry edible tags: https://www.securingindustry.com/pharmaceuticals/purdue-scientists-detail-edible-security-tags-for-medicines/s40/a11237/#.XjryFC2ZO9
• Black Market Cancer: https://www.safemedicines.org/2018/08/imported-black-market-cancer-meds.html
• Black Market Osteoporosis: https://www.safemedicines.org/2013/01/the-us-food-and-drug-administrationfda-has-issued-warning-letters-to-20-us-doctors-that-they.html
• Black Market Botox: https://www.safemedicines.org/2014/10/black-market-injectable-cosmetic-treatments-a-nationwide-problem-10-22-14.html
• PSM Fake Avastin: https://www.safemedicines.org/2012/02/mhra-fda-cooperation-rousts-counterfeit-cancer-drugs.html
• Reuters Blockchain: https://www.insurancejournal.com/news/national/2020/02/21/559057.htm

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.