Drug Recalls: Industry struggles with recall procedures


Recallability of medical products is a hot topic in today’s healthcare world.  I am registered with many different services that alert their subscribers when a manufacturer has issued a recall on a product or device.  It is a rare event when my email inbox does not have news of another recalled drug or medical product.  The ultimate responsibility of a facility, where healthcare is administered, is to be able to notify patients if a recall affects them.  This has never been more true than with the recent recall from the NECC.  Many facilities have had to call hundreds of patients simply because they had NECC product on the shelf even though many of those patients had not received a dose of a drug from one of the contaminated lots.  Tracking down every single patient is a nightmare.   The process is inefficient and cumbersome.  Patients become alarmed and frightened and your relationship with them is forever tarnished – in many cases for no reason. 

Because of the NECC tragedy, there are several different types of legislation being introduced to Congress.  Many state boards of pharmacy are reinterpreting their laws to include statements that prescriptions for individual patients must be issued in order to receive a compounded product into the facility.  This creates many logistical issues at the user level due to the complexities involved with day to day surgery planning.  For instance, if a prescription is required for every patient that receives a compounded product, how do you handle the “add on” case?  Do they have to wait until a prescription is issued, filled, and delivered back to the facility?  Or, what happens when a patient who was issued a prescription for a compounded product has to cancel their case?  Does the product become unusable because it has a patient name on it and cannot be used for another patient?  What about compounded multiple dose vials? 

Perhaps a different system could be used that would work better in the event of a recall.  Some facilities are using log sheets that contain the name, strength, lot number and beyond use date of the compound.  When that product is administered to a patient, the patient’s name is listed on the log sheet.  In the case of a recall, every patient who received a recalled lot of product could be identified quickly and called immediately.  It seems to me that this is the ultimate patient safety net…which is the goal, correct?

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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