For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser The Challenges of Patient-level Pharmaceutical Recalls

The Challenges of Patient-level Pharmaceutical Recalls

When it comes to pharmaceutical recalls, those at the patient level are often very different from those that only affect hospitals, clinics, and other providers.

First, there is the challenge of effectively notifying patients. For prescription drugs, the manufacturer typically notifies pharmacies, who then contact patients. Over-the-counter (OTC) medications usually leave no way of contacting the consumer directly, although there are some exceptions, such as retailer loyalty programs. In either case, the media may report on the recall, depending on the scope and severity of the issue, but because recalls across industries have increased over the last several years, consumers often suffer recall fatigue and tune out the news. 

For those who do learn about the recall, it can be difficult to determine whether the medication they have on hand is affected. The amber bottles typically used for prescriptions usually don’t contain lot numbers on the label. Companies are forced to rely on date ranges, and that often forces manufacturers to increase the scope of the recall.

Another issue is managing remedies. In many cases, a replacement may be the best option, but when manufacturers are still addressing the issue that led to the recall, they may not be able to replace it with the exact same medication from their own company. In those cases, they may be forced to look for an alternative product – including from a competitor, if necessary.

If the company opts for reimbursement, the process is still much more complex than, say, a consumer product. That’s because pharmaceuticals are often partially or completely covered by insurance. Manufacturers must determine how they will determine the appropriate amount, keeping in mind that reimbursing only out-of-pocket expenses could come with risk. If patients didn’t incur any expenses and don’t receive any remedy, they may feel that the company didn’t take the issue seriously or make enough effort to correct the issue. When these questions arise, it is important to consult with experienced recall management partners to understand what the possible implications may be.

Patients will likely contact their pharmacy or physician with questions about what to do with the affected product, how to receive replacements or reimbursement, and other logistics, so it is crucial to ensure consignees understand the procedures and instructions involved. This will help minimize confusion and disinformation. Finally, if there are any added sensitivities involved, it is important to customize the response. Preparing for the unique challenges of a patient-level recall will help mitigate liability and the potential damage to customer loyalty. 

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