Protecting the Integrity of the Supply Chain

The National Association of Boards of Pharmacy (NABP) released a white paper in August 2013 titled “Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply.” The intent of this piece is to address the problem of counterfeit drugs, foreign unapproved drugs, and drugs diverted from the supply chain.

There have been a number of recent instances in which interruptions in the supply chain led to potential use of counterfeit drugs by patients. One such incident involved clinics purchasing counterfeit Avastin. Among the reasons why one would purchase a fake drug, a major one is money. If a physician or pharmacy is able to buy a drug at a lower price while getting reimbursed at a normal level, they can pocket the difference. If everything looks proper, what could be wrong? In the Avastin case, the medications were issued by a supposedly licensed wholesale drug distributor, but they had been received from foreign sources and were counterfeit. While using a medication with this sort of background might seem appropriate on first review, further deliberation should show the inherent risks. In the case of the counterfeit Avastin, not only did the patients who received the drug get substandard treatment for cancer, but one physician who allowed these purchases to go forward received criminal punishment.

Purchasing medications outside of regular and normal paths can have dangerous consequences for the patients we serve. Almost all hospitals are confronted with wholesalers or other entities who offer to provide medications that are in shortage. Some hospitals or physicians have pressured pharmacists to purchase these drugs, even when the drugs’ integrity is questionable or the seller is unfamiliar. As pharmacists, we need to stand up to the pressure and resist purchasing medications when we cannot guarantee that they are genuine and unadulterated.

There is a recent but similar example in which hospital pharmacists did not do their due diligence regarding purchasing compounded medications. Rather than inspecting the compounding pharmacy, researching it with the state board of pharmacy or with the FDA, saying no to physicians who were demanding the purchase of certain high-risk compounded medications, or developing the expertise internally to prepare certain medications, hospitals and physician offices chose to purchase them from the New England Compounding Center and other similar compounding pharmacies. It is easy to observe the wrongheadedness of these decisions in hindsight, but very few questioned them at the time.

Similar problems can occur when an organization purchases medications outside of the normal supply chain. Doing so exposes patients to medications that may be counterfeit or mislabeled. This sort of purchase might seem okay at the time, but it isn’t worth the risk.

Here are a few recommendations for hospitals and others involved in purchasing medications:

• Do not purchase medications from the gray market—and in particular beware of distributors that are able to acquire medications on shortage when others cannot.
• Have checks and balances in the ordering process—and make sure those involved have training in this area. Also, having well-developed policies and procedures that minimize avoidance of critical safety checks when unique situations arise helps to ensure the safety of medications purchased.
• Do not use a wholesaler who buys medications from another wholesaler. If medications are not purchased directly from the manufacturer, the medications’ potency and quality of storage conditions are automatically questionable. Primary wholesalers should be able to state with certainty that they do not acquire medications from a secondary distributor.
• Push for electronic pedigrees. This has been discussed for many years, and numerous explanations have been proposed for why it cannot occur. If end users such as hospital pharmacists were to join together and agree that this is a fundamental requirement for doing business, adoption and implementation would occur much more quickly because there would be a purchasing advantage for those organizations able to do it first.
• Require all state boards of pharmacy to mandate the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program. This would implement a standard accreditation process for all wholesalers, regardless of their location.

While some might argue that these recommendations cannot be implemented, I would counter that they are critically needed.

If you want to understand the risks for abuses in the drug supply chain as it currently operates, I highly encourage you to read Dangerous Doses by Katherine Eban, which provides an excellent overview on the subject. I was surprised to learn how fragile the whole supply chain is, the backgrounds of some of the people involved in it, and how pharmacists can help monitor it. Our patients deserve no less.

Have you also had an experience with maintaining the integrity of the supply chain? I would appreciate learning about it.