Consignee identification and notification are among the first steps pharmaceutical companies need to take when they experience a recall. They can also be some of the biggest challenges.
When physicians, pharmacists, and other healthcare professionals change office locations or transfer to other employers, available data can become outdated. It is important to identify gaps and obtain up-to-date contact information to ensure notifications are being sent to the correct professionals.
In addition to ensuring contact lists are in order, notifications must meet Food and Drug Administration (FDA) guidelines and be carefully crafted for maximum impact. They should clearly state what the issue is and include easy-to-follow instructions for returning the recalled product. In addition, companies should make it as easy as possible for consignees to follow through. Medical professionals often don’t have the time or inclination to decipher and respond to any complex calls to action. Including a simple reply form can help encourage them to take the necessary steps.
An experienced recall management partner can help provide guidance on FDA requirements and on specific language that is most effective in getting consignee response, making recall execution as smooth as possible. Once all notifications have been delivered, it is crucial to perform effectiveness checks. These help ensure recalled product has been removed and returned as directed. Whether performed by mail, through outbound calls, or on-site through a retrieval service, they help complete and verify data needed for regulatory reporting.
When notifications have been exhausted and affected product remains on the market, a field force can be deployed to retrieve it directly from wholesalers and medical professionals. But by sending the right notifications the first time around, this step can often be minimized – saving both time and money.
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The FDA has announced a new Toolkit to combat counterfeits and other substandard medical products.… https://t.co/ifpjNuidD8
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