Responding to Recalls Strategic steps to take to ensure patient safety BY SHELDON S. SONES

The retention and possible unknowing use of drugs that have been recalled by the manufacturer and/or the Food and Drug Admin-

istration (FDA) represents a significant breach in safe medication manage- ment. Further, in our experience, sur- vey teams correctly probe the process and timeliness by which recalled drugs are quarantined in health care facilities of all categories. Violative products, or those that interfere with the reasonable expecta- tions of all of the stakeholders, have to be handled swiftly, and that han- dling needs to be well documented. This process starts with adequate com- munication from vendors and manu- facturers. Whether we are concerned with recalled drugs, or other products within our facilities, mechanisms have to be established to ensure successful removal of these products, while at the same time ensuring a continuum of replacement or substantially equal therapeutic or equipment options. This advice cannot be over-emphasized as some recalls—referred to as “Class 1”—indicate a reasonable probabil- ity that exposure or use could lead to serious adverse health consequences or death. In our facilities, we have spent con-

siderable time ensuring that a policy and procedure that works to meet these elements of performance is approved and followed (see box on page 9).

Ideas That Work Prompt Notification Clearly, facilities must be informed promptly about drug or equipment recalls. A good strategy to ensure that your suppliers are clear on your facil-


Violative products, or those that interfere with the reasonable expectations of all of the stakeholders, have to be handled swiftly, and that handling needs to be well documented.”

— Sheldon Sones, Connecticut Patient Safety Organization

ity’s expectations is to secure a let- ter of commitment, particularly from your drug wholesalers or manufactur- ers, that validates that these vendors have received your policy and proce- dure and agree to partner with you by assuming responsibility for these piv- otal communications.

Understanding the Jeopardy of Transferring Drugs Between Facilities What appears to be a chronic, rather than isolated act, related to the deficits of the supply chain is the significant surge of “drug shortages.” Key drugs routinely become suddenly unavail- able. While several solutions have to

be explored, one option is not with- out some jeopardy: transferring drugs from one facility to another. Pursuing this option might set the stage for a serious negative event. Consider this very possible scenario that could have potentially serious con- sequences for your facility’s patients. Let’s say that a facility exhausts its supply of a key anesthetic agent, and another facility transfers part of its supply to the facility that has encoun- tered the shortage. If the particular lot number of that transferred drug supply is involved in a serious recall, the facil- ity that would be advised of that recall would be the facility that no longer has that lot number on hand. The facility that does, however, would not neces- sarily be advised of the recall since the notice would not find its way directly to the facility that received it.

Ensuring that Recalled Products Are Sequestered A facility would be taking one step forward and two back if the products it clearly identifies for recall are not ade- quately and safely retained in a manner that prevents unintended use while the facility awaits further direction from the recall initiator. When these situa- tions arise, clear marking and storage in a non-contiguous manner to unaf- fected products are elementary princi- ples that need to be followed to protect patient safety.

Documentation We suggest that facilities use a “prod- uct recall binder” that documents the review of all recalled materials within the facility, as well as the disposition of the products. If no recalled products are at hand, a dated notation “none on hand” is appropriate.

The advice and opinions expressed in this article are those of the author’s and do not represent official Ambulatory Surgery Center Association policy or opinion.

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