Drug recalls have become increasingly commonplace in recent years. The FDA reported more than 1,742 recalls of prescription and over-the-counter drugs in 2009, skyrocketing from 426 recalls in 2008.1 The increasing prevalence of pharmaceutical recalls, in addition to other types of recalls affecting disparate areas of the hospital (such as those involving OR and laboratory products, medical supplies, and biomedical devices) requires facilities to adopt robust management programs to ensure these notifications are addressed appropriately and in a timely manner.
Children’s Mercy Hospital (CMH), located in Kansas City, Missouri, is the largest facility within Children’s Mercy Hospitals and Clinics. The health system has two main hospitals and five satellite facilities in the Kansas City metropolitan area. As a comprehensive pediatric hospital, CMH provides more than 40 pediatric specialty services, and is the region’s only level 1 pediatric trauma center.
In December 2009, CMH implemented a Web-based subscription service that provides comprehensive notification, distribution, and management of product alerts/recalls from numerous sources, including the Food and Drug Administration (FDA), Consumer Product Safety Commission, the US Medical Material Agency, and other subscriber submissions that require action on the part of CMH. This service was implemented hospital-wide to manage recalls of all types, including the most common category—drug recalls.
Scope of Recall Management Services
The Web-based service breaks down the various categories of recalls into domains: biologics, biomedical devices, blood, children’s consumer products, engineering and facilities, food, information systems, laboratory products, medical supplies, OR products, pharmaceuticals, radiology products, and tissue. The coordinator of pharmacy purchasing oversees all pharmaceutical alerts. Using the FDA classification system, every drug recall is designated as Class I, II, or III depending on the severity and possibility for patient harm (see TABLE 1). The service also provides drug bulletins, which are notifications that a drug recall may be imminent but has not yet occurred.
CMH experiences substantially more pharmaceutical recalls than any other domain (see FIGURE 1). As such, ensuring a robust process for managing pharmaceutical recalls is a significant priority. It is essential for pharmacy, as the champion of medication safety and use processes, to actively manage pharmaceutical recalls.
Previous Recall Management Process
Prior to the 2009 implementation of the Web-based recall subscription service, our hospital utilized an email-based recall procedure, without a centralized hub to manage all recalls affecting patients. Rather, when alerts were received from the FDA, manufacturers, or our wholesaler, we would investigate whether our inventory contained that lot number, and if so, the drug was segregated prior to being returned. We documented what areas had been checked for the product and what actions were taken as a result of the alert (eg, the affected lot numbers were sent back to the manufacturer). When our manufacturer sent us an alert, they required a faxed response indicating that we had received the alert and were taking appropriate action.
This piecemeal recall management approach introduced significant room for error. One challenge we encountered using the email-based system was the high probability that important notifications would be overlooked. Because there was no centralized service to prioritize the alerts, they were managed as they were received and saved in a subfolder in the email system. Once the affected lot number(s) were determined to be in inventory, the alerts were then forwarded to the appropriate staff for further evaluation. It was common to receive five or more alerts per day, and each alert was forwarded to 20 different people; consequently, more than 100 emails were oftentimes received in one day and had to be sorted into five different folders. Many of these emails required additional follow-up. Not only was this method error-prone, but it was extremely time-consuming, making it difficult to complete other required tasks. Clearly, an improved recall management plan was required.
A New Hospital-wide Alert Procedure
The new recall subscription service provides timely alerts to selected CMH staff members for evaluation and resolution. To ensure appropriate action is taken after an alert has been received through the service, CMH implemented a system utilizing staff alert coordinators and responders. Alert coordinators are responsible for triaging alerts within their designated domain, with back-up alternate coordinators designated in case of the main coordinator’s absence. At CMH, coordinators are managers, supervisors, or directors, while responders are leaders and designated frontline staff in various areas of the department (see FIGURE 2).
Specific Staff Responsibilities
Designated facility managers are responsible for implementing and supervising the recall service throughout CMH, as well as ensuring the overall success of the alert management program. They confirm user access is for authorized employees only. Facility managers notify physicians and risk management staff when a recall may have potential patient impact, monitor alert escalation activities and assist staff in recall management as needed, follow up with all notified staff members who have not complied with the recall, and act as the liaison between the service and the product manufacturer when necessary. In addition, the facility manager assists the department director and other hospital leaders by generating a quarterly report of all alert notification activities. These reports are then presented to the physical environmental safety committee and the medication management continual readiness team.
Alert coordinators hold alert-specific responsibility for one or more of the appointed domain areas. Coordinators review alerts, determine if their department is in possession of the listed product, assign alerts to alert responders, and close notifications after they have been responded to appropriately. Alert coordinators assist in identifying which recalls have potential impact on patients and thus require additional notification. When an alert coordinator is not the department director, the coordinator communicates directly with their director to determine the need for clinical alerts to providers, hospital administration, quality and safety, and risk management.
Designated alert responders are responsible for checking their assigned area of responsibility for the affected items and following instructions exactly as indicated by the assigning alert coordinator. If the recall is deemed life threatening (ie, Class I recall), all required actions must be completed within three days. The alert responder also must document in the system quantities by location and all actions taken in response to the alert.
Every product is assigned a domain by the subscription service; this, in turn, determines which alert coordinators will be notified. With each alert, there are specific details on the reason for the alert, a summary of the manufacturer’s instructions for actions to be taken, and links to additional information (eg, product lot numbers) for further direction on proper management. Coordinators receive an email notice from the service and determine whether the product exists in the CMH system; if it does, the coordinator notifies the alert responders to retrieve and segregate the product.
Alerts are often received directly from the manufacturer, distributor, or FDA via email, fax, or listserv, in addition to the subscription service. These recall notices must be reviewed and verified against the information provided by the subscription service. If no alert was received from the service, staff forwards the alert to the facility manager, hospital risk manager, and/or directly to the subscription service for inclusion. Depending on the urgency of the notification, CMH follows standard or urgent alert activity parameters (see TABLE 2).
If the product under recall is determined to be in use at CMH, action is taken to remove the product from the hospital distribution system and all patient care areas. The alert responders physically remove affected product from inventory and bring it back to the pharmacy buyer, where they are quarantined in a locked drawer until the alert is closed and the product is returned to the manufacturer or disposed of through a pharmaceutical reverse distribution service. When there is the possibility of patient harm, the clinical safety officers (CSOs) in the quality and safety department and the hospital risk manager are notified immediately. The risk manager and a CSO convene a group that includes hospital administration, department leaders, and alert coordinators to develop and implement an action plan for notification.
Documenting Actions Taken
After the recall has been addressed, it is critical to document the actions taken. This data becomes especially important in the event of an audit. The alert coordinator is responsible for documenting all recall responses. Examples of actions taken as a result of a recall may include:
Since the implementation of the recall management program, the FDA visited our hospital to perform a random check of our response to a recall, and were pleased with our recall and return policy. Because the Web-based service provides documentation of all recalls received and action taken, we were able to present a robust audit trail to the FDA.
Hospital administration recently commended the pharmacy department for its recall management process. Pharmacy receives significantly more alerts than any other area in the hospital, while simultaneously maintaining the lowest rate of delay status notices (ie, alerts for which a response is overdue). Maintaining close relationships with the pharmaceutical alert responders is an essential element of our successful recall process.
For more information on recall management, see the online-only Suggested Reading List at www.pppmag.com/recallreadinglist
Rachel Eckles, CPhT, is the coordinator of pharmacy purchasing at Children’s Mercy Hospital (CMH) in Kansas City, Missouri, and is responsible for overseeing the pharmacy recall program at the hospital.
The author would like to acknowledge Susan Feldman, BSPharm, RPh, CPHQ, clinical safety officer; Carol Kemper, RN, PhD, CPHQ, vice president, quality and safety; and Jeff Little, PharmD, MPH, assistant director of pharmacy, for their assistance with this article.