Even when companies have a robust recall plan in place, preparing for a soon-to-be-announced recall is a stressful event. Companies must act quickly in order to satisfy regulatory mandates and mitigate risk. Here are four steps pharmaceutical companies should take to get ready for a recall:
This is often one of the largest pain points for pharmaceutical companies in particular. Even when the recall reaches the patient level, the medication may be stocked at hospitals, clinics, and pharmacies. Each must be notified directly, and if facilities have changed locations or the main point of contact has changed, it may delay the notification and, ultimately, the removal of the affected product. In some cases, multiple systems may have conflicting information, so it is crucial to cross check data or reach out to a trusted recall management partner to assist with getting the notification into the right hands.
It is also important to keep in mind that some patients may avoid calling a designated recall hotline and turn to the pharmacy or physician they are familiar with instead. Ensuring consignees are informed of the situation and ready to answer their questions can help reduce patient fear and confusion.
During a pharmaceutical recall, replacement and reimbursement are the typical recall remedy options. In cases where 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 reimbursement is the best option, companies must be ready to manage the complex process of determining the appropriate amount based on insurance coverage of the medication. Even when the patient did not pay out of pocket for a recalled product, companies that are concerned about consumer loyalty and reputation may want to offer some remedy to ensure those patients feel their issue was taken seriously. Experienced recall management partners can help determine the risk and suggest possible solutions.
When a patient-level pharmaceutical recall involves a serious risk, those affected will often be understandably concerned and even panicked. When the recall is widely covered in the media, it makes large call volumes much more likely. Long wait times will only add to the distress, so it is crucial that companies have sufficient agents on hand.
Effective response management isn’t only about the number of agents on hand. A serious hazard also demands that agents have adequate sensitivity training. In addition, the privacy concerns involved with a sensitive recall mean it is often necessary to establish a separate, controlled area designated for capturing medical information.
Of course, companies with a recall plan that is flimsy or no longer applicable will have a more difficult time getting ready for an upcoming recall. And those with no plan at all are way behind the curve. In those cases, it is especially vital to reach out for help. The good news is that experienced recall management companies have been through that situation before and can work quickly to get the recall up and running.
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https://t.co/9w9LYiTMne Interesting article from RAPS: Sentinel: FDA Outlines Five-Year Roadmap https://t.co/81gCn7dtlj
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