Managing the logistics of pharmaceutical recalls is challenging as reaction time is often limited when alerts are received and that loss of valuable time can directly compromise patient safety if recalled products are not quickly and comprehensively removed from the medication distribution system. Methodist Healthcare System’s HCA San Antonio Division consists of seven hospitals comprising over 2000 licensed beds. As one can imagine, receiving, and manually disseminating and processing recalls effectively throughout seven separate hospitals can be a daunting task.
The responsibility for medication recalls is held by each individual pharmacy department, but action and resolution reports are reviewed by the Methodist Healthcare System’s San Antonio Division department of pharmacy. For any institutional pharmacy operation, such responsibility entails more than just processing information; rather it requires a concerted effort from several practitioners and committees (including the pharmacy & therapeutics and ethics & compliance committees) in order to protect patients. To this end, standardized documentation protocols are an integral portion of managing medication recalls.
In the past, medication recall processes relied on manufacturer notifications delivered either by postal mail or email, or even via word of mouth, and rarely did such notifications arrive in a consistent or expeditious manner; it was not uncommon for recall notifications to be received months after a recall was actually issued by a manufacturer. For pharmacy directors, such delays can be maddening and often pose very serious potential for harm to patients being treated with recalled medications. Unfortunately, delays were just the beginning of the headaches caused by recalls. Documenting these events was a labor-intensive, manual process and creating the necessary medication recall reports covering all facilities in our division required multiple personnel to coordinate each month in order to finalize a collective report. These challenges led us to seek out an automated solution that could consolidate many of the actions required by drug recalls. Accordingly, we signed with EXP Pharmaceutical Services in May of this year and went live using RASMAS in June.
Automate Recall Management
RASMAS is a Web-based program that collects medication recall notices from several sources. The notices are reviewed and placed in a standardized format, and then are sent out immediately to program subscribers. The program enables a single facility or multi-hospital system to organize a hierarchal structure to manage the alerts. At the administrative level, the pharmacy director (or designee) oversees the setup and maintenance of the program, and has the ability to run both canned and/or ad hoc reports in presentation-ready PDF format, or in an Excel spreadsheet for customization. In the even of an audit, any authorized designee can search for specific alerts in the system and see what actions were taken and who was responsible.
The pharmacy manager also has the ability to assign and manage roles within the organizational structure to best make use of time and resources. Directly beneath the manager, a coordinator should be assigned to initially receive the alerts. That staff member serves as the point contact for all email notifications. The coordinator can then either assign the alert to a designated responder, or can address and close the alert directly. The program does accommodate back-up coordinators in the event the primary contact is not available.
At each hospital in our system, the pharmacies are arranged such that medication products are stored in specific sections by types (eg, injectables, topicals, etc). From there, products that are alerted for recall can be easily located by going to that section and removing whatever stock remains. As for medications stored on the nursing units in ADCs, we have a central console where we can run reports by product that will verify the locations of ADCs housing that product as well as the amount in each ADC.
The entire process is documented within the system, and all relevant data is easily retrievable at any time via the Web. RASMAS teamed up with EXP to prepare any quarantined product for shipping. Within the program, we can create the return labels and an inventory list of the product or products being returned, all of which are shipped to EXP for processing of credits.
Program Results and Future Plans
In all of 2010, our pharmacy documented a total of 68 medication recalls that required our attention (ie, products had to be recalled and quarantined from shelves). In the three months we have been using the RASMAS service, we have already documented the same number of medication recalls. While this may be due in part to an increased number of recalls, it more likely is due to faster, more comprehensive notification of recalls in general. In that same three month time period, the pharmacy group received over 2500 recall alerts. Of these, 68 were actionable at our facilities and we were able to successfully remove all products related to those recalls.
As with any tedious operation, the best way for recall management to run is behind the scenes. Much like temperature monitoring or waste management, managing recalls in a timely and efficient manner may not seem exciting, but it is vital to proper drug storage and distribution, and so ultimately to regulatory compliance and patient safety. Due to the success we’ve had with this program, Methodist Healthcare System is looking into extending it to include recalls for areas such as supplies and equipment in addition to the pharmacy component it is currently managing.
Florante Roxas, PharmD, is the division director of pharmacy for HCA Pharmacy Services San Antonio Division in San Antonio, Texas.
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