A recent survey found that pharmaceutical recalls are among the types consumers consider most important – the ones most likely to catch their attention. With that kind of interest, it is vital for companies to execute recalls effectively and compliantly. And the key steps for managing pharmaceutical recalls are as complex as the regulations that govern them.
The first is to develop a recall plan that can facilitate quick action to locate the affected products and remove as many as possible from circulation – whether at the retailer, hospital and clinic, or consumer level. While every recall is different, a robust plan has broad applications. Ideally, this plan should be developed well before a major recall occurs so it can be tested through mock recalls.
The next step is consignee identification and notification. For recalls at the hospital or clinic level, this phase may seem straightforward, but contact information is often incomplete or outdated. Refining and updating the data can greatly improve recall effectiveness. Consumer-level recalls are even more challenging, especially for over-the-counter drugs that depend on mass communication.
Once notifications have been delivered, it is time to prepare for the response. Certain recalls, such as those that receive intense media coverage or involve highly sensitive diseases and conditions, often result in higher than normal response that demands additional call center capacity, specialized sensitivity training, and even medically trained personnel.
When affected products are returned, they should be processed and stored in a dedicated facility to ensure they are never co-mingled with nonaffected product and, for certain drugs in particular, to keep them safe and secure. Dedicated recall providers can provide established infrastructure and automated systems for processing and tracking, and then consolidating critical data for regulatory reporting.
After affected product is received, remedies must be distributed. In many cases, a replacement is considered 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, alternative products must be explored, even if they come from a competitor.
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 often feel that the company didn’t take the issue seriously or make enough effort to correct the issue.
Finally, the affected products must be properly disposed of. Regulators typically have very specific standards for this step as well, including witnessed and certified destruction. Again, this process can often be streamlined with the assistance of service providers accustomed to meeting such requirements.
If a pharmaceutical manufacturer determines one or more of these steps are too cumbersome to manage internally, it is important to remember that no two recall management companies are alike. Regulations, the media landscape, and even public scrutiny are constantly evolving, and it is important to work with a company that is committed to product recall management and continually looking for ways to improve and invest in new technology to keep up with these changing dynamics.
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Reporting Adverse Events: FDA Seeks Comments on Revisions to Submission Forms https://t.co/919JeroD4O by @RAPSorg https://t.co/L87wZe8ITD
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