The product is an important treatment option for diabetes patients who lack insurance or have inadequate coverage to afford the high cost of prescription treatment options. Nonprescription insulins are the only injectable human drugs that can be sold without a prescription under federal law, and advocacy groups such as the American Diabetes Association support their continued availability, according to a recent blog post from the National Association of Boards of Pharmacy (NABP).
Gregg Jones, RPh, NABP compliance senior manager, points out that, while the nonprescription insulin isn’t displayed as an OTC product, it can be legally sold upon request, which makes the pharmacists “an important frontline resource for diabetics.”
Some of the insulin was grandfathered in because the products were on the market before the enactment of the Federal Food, Drug, and Cosmetic Act in 1938. In other cases, in an effort to make nonprescription insulin more accessible to patients, one of the top manufacturers of insulin began working with community pharmacy chains, Jones explains.
A feature of those partnerships is that the manufacturer produces a line of insulin products exclusively for the chain, and the drug’s retail price for patients is often below the wholesale price of other insulin products sold to pharmacies.
Here’s where the downside comes in.
“Criminals posing as patients purchase this insulin at the retail pharmacies, collect it in large quantities, and resell it into the wholesale market,” Jones writes. “Wholesalers purchase this ‘diverted’ insulin and resell it to retail pharmacies and, in some cases, to other wholesalers. This deliberate scheme to subvert the regulated supply chain is exposing patients to the high risk of receiving an adulterated drug in the form of subpotent insulin.”
One state, Georgia, has enacted a law criminalizing the resale of nonprescription insulin obtained through an OTC sale. Under the law, that insulin is considered adulterated and, therefore, illegal.
Jones describes how NABP became aware of the scheme when inspecting a pharmacy that reported how insulin purchased by its facility was collected from several of the chain’s pharmacies over a single weekend. The pharmacy group found out that the scheme involved an organization which then sold the purchased insulin to a wholesale distributor, which then sold it to a mail-order pharmacy.
“Upon further investigation, we discovered that this is the typical pathway in which diverted insulin is resold into the marketplace,” Jones writes.
He warns that patients are put at risk by this type of distribution, adding that they are “receiving and injecting potentially adulterated insulin that is very likely subpotent.” It is unclear how the product is stored and handled in that type of transaction.
The blog advises that pharmacists should “maintain your awareness of these types of schemes and verify the source of insulin for retail pharmacies and drug wholesale distributors before purchasing. Pharmacies that turn a blind eye to the purchase and sale of insulin that is clearly labeled as being exclusively for sale by a specific pharmacy cannot claim ignorance of the source of the diverted insulin.”
Jones also recommends that pharmacists talk to patients about the importance of purchasing insulin and other medications from an accredited pharmacy.
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