It’s been almost three years since FDA announced plans to deploy its ground-breaking handheld counterfeit detection device (CD-3) in Ghana to aid in combating the insidious counterfeit and substandard malaria medicine problem in that region (see my previous posts on CD-3 here and here).
This noble effort showcases FDA’s ability to ease human suffering and save lives on a grand scale. It’s also heartening to see that FDA’s commitment to its core public health mission knows no boundaries. However, our nation’s pharmaceutical distribution supply chain continues to exhibit vulnerabilities, beckoning an urgent need for FDA to pursue a Ghana-style approach here at home. Unfortunately, the application of this amazing device to protect patients within our own borders appears to be languishing.
According to an April 2013 FDA report, CD-3 devices have been used since 2010 “in some U.S. ports and mail centers, where drugs entering the country after being bought over the Internet represent a major problem.” The time has clearly come for FDA to adopt a more comprehensive CD-3 strategy. The use of CD-3 to detect and deter supply chain threats involving counterfeit and diverted drugs must become a top agency priority.
It’s no secret that inadequate resources are severely crippling state efforts to ensure pharmacy and wholesale distributor integrity on drug distribution matters (something diverters are counterfeiters are no doubt well aware of). While many states have surely beefed up their inspection corps in the aftermath of the 2012 New England Compounding Center catastrophe, I suspect that Drug Supply Chain Security Act (DSCSA) compliance nonetheless remains a relatively low priority.
To address crucial oversight gaps that have long plagued our supply chain, FDA should consider providing state regulatory authorities and trading partners with access to CD-3 devices and training. For instance, suspect and illegitimate product determinations will likely increase exponentially once trading partners, newly equipped with these devices, gain the knowledge and ability they previously lacked to identify potentially diverted and counterfeit products in their possession.
The following scenarios demonstrate how CD-3 could be used by state board of pharmacy inspectors and trading partners to strengthen our supply chain:
Scenario 1 (Dispenser)
A dispenser uses CD-3 to scan multiple bottles of a product received from a secondary wholesale distributor that is often targeted by drug diverters because of its high sales price and identifies several bottles exhibiting what appear to be glue residues from previously applied patient labels. A subsequent suspect product investigation by the dispenser results in an illegitimate product determination when attempts to validate the transaction history and transaction information provided by the secondary wholesale distributor supplier are unsuccessful. The dispenser submits a corresponding illegitimate product notification to FDA and the supplier, triggering an FDA investigation into the supplier’s origin of the illegitimate product. The secondary wholesale distributor and several illicit suppliers are ultimately implicated for their roles in a massive drug diversion scheme.
Scenario 2 (Manufacturer)
After meeting with a physician who prescribes a large volume of a certain product that is often targeted by drug diverters because of its high sales price, the manufacturer’s sales representative visits a nearby pharmacy responsible for dispensing a majority of the products prescribed by the physician. The sales representative obtains the pharmacist’s consent to use CD-3 and several bottles of the product are found to be inconsistent with images taken by CD-3 of the authentic product, suggesting the bottles were previously dispensed to a patient. The manufacturer subsequently reports this incident to FDA after the dispenser refuses to make a suspect product determination. The dispenser ignores FDA’s verification request, triggering an FDA investigation that uncovers a massive drug diversion scheme implicating several physicians, wholesale distributors, and illicit suppliers, in addition to the dispenser.
Scenario 3 (State Board of Pharmacy Inspector)
A state board of pharmacy inspector conducting a periodic inspection of a pharmacy uses CD-3 to scan multiple capsules of a certain product that is often targeted by drug diverters because of its high sales price. Several capsules are identified which appear to be inconsistent with images taken by CD-3 of the authentic product, suggesting the capsules are potentially counterfeit. Samples of the suspect capsules are subsequently forwarded by the state board of pharmacy to FDA’s Forensic Chemistry Center which confirms the capsules are counterfeit and do not contain any of the active ingredient. An FDA investigation ensues after the dispenser fails to comply with the DSCSA’s verification requirements and it is determined the counterfeit product was purchased by the dispenser from an unlicensed supplier in a van. CD-3 devices are quickly deployed by teams of state and federal investigators and counterfeit versions of the same product are detected in several nearby pharmacies.
As the above scenarios illustrate, CD-3 has enormous potential to secure our nation’s pharmaceutical distribution supply chain, but the positive impact of this device will not be fully realized unless FDA adopts a more comprehensive CD-3 strategy. Relegating CD-3 to duty at international mail facilities where droves of drugs arrive on a daily basis from countries known to supply unapproved, misbranded, and counterfeit drugs to U.S. consumers is a fate that does not befit a device of this caliber. You don’t need a device like CD-3 to tell you that Viagra coming from China is likely going to be counterfeit! Protecting vulnerable patients from counterfeit and diverted drugs in our supply chain-now that’s a job worthy of CD-3.