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Managing Drug Recalls in the Compounding Environment
July 2012 : Drug Distribution - Vol. 9 No. 7 - Page #6

Of the 42 Class I recalls issued in 2011, only 14 required notification to the consumer or patient level; seven of these recalls were for injectable products that could have been used to prepare compounded sterile preparations (CSPs), yet in none of these cases did the recall notification direct the hospital to contact patients who may have received the recalled product.1 However, in certain situSations, patient contact is required2 and if the pharmacy has no method by which to identify specific product lot numbers used in the preparation of CSPs, attempts at such contact will not only be unwieldy, they will also affect many more patients than would realistically be necessary. Imagine the following scenario, which may seem all too familiar.

After arriving at the hospital in the morning, your pharmaceutical buyer informs you of a recall notice for vancomycin posted on your wholesaler’s Website, causing some concern. That afternoon an email comes in from the FDA describing an urgent, Class I recall of vancomycin 1000-mg vials, lot numbers A45FG12 through A45FG18, supplied by Manufacturer X, due to possible contamination with Listeria monocytogenes. The email states that these lot numbers are to be quarantined and any patients that received the drug from these lots must be contacted and informed. A quick check of carousels, the IV room, ADCs, satellite pharmacies, and off-site facilities reveals that lots A45FG16 and A45FG17 are stocked in a carousel and the IV room. After sequestering these lots, it is determined that no other lot numbers are in stock. Purchase records indicate a new shipment of 1000-mg vials of vancomycin was received the day before, but perhaps the recalled lots have not yet been dispensed. Panic sets in. Even if no more recalled lots can be found, what about last month’s administrations? The PIS report indicates that 450 patients had an order for vancomycin injection in the past two months, but how can it be determined whether the recalled lots were used to compound doses for any of these patients? After conferring with Risk Management, you are informed that your only recourse is to contact every patient that received vancomycin injection in the past two months. You decide to take an early retirement.

Real Obstacles and Potential Solutions
For most of us, early retirement is not an option, so for those pharmacists that remain bound to protecting patient safety, the type of recall described above poses myriad challenges. Among them are the following:

  1. Drug wholesalers often do not include manufacturer lot numbers in their purchase database and may be unable to tell a customer what lot numbers they have purchased. 
  2. Hospital pharmacies that do not enter product lot numbers into their inventory system or PIS databases are unable to tell if the recalled lots have been inventoried or dispensed from their pharmacy. 
  3. Hospital pharmacies generally do not record the NDC and lot number of ingredients used to prepare CSPs, and thus are unable to determine if any CSPs contained the recalled product.
  4. Without lot number tracking it would be impossible to determine which patients received the recalled lots. 

Potentially, drug wholesalers could incorporate lot number information into purchase records to enable tracking to the hospital level, but this would only tell the pharmacy manager if and when the affected lot number(s) were ever in inventory. If the lot number was embedded in the product bar code on the unit dose package it could be captured when the nurse scans the bar code on administration, if the nursing documentation system has that capability. This approach could link the product NDC and lot information to the patient and could be used to identify recipients of recalled lots (and to facilitate NDC-driven billing). However, this would not work for compounded doses, since there is no product-specific bar code on the patient label that the nurse scans at the bedside. Currently, the FDA does not require manufacturers to include lot number and expiration date on all product bar codes.3

Some states and regulatory bodies require lot number documentation for certain products, such as vaccines or blood products, but most medications are dispensed and administered with little or no tracking. This reality spurred the CDC to initiate a bar coding pilot project in 2011 to assess the utility of 2D bar codes in tracking certain vaccines. (Visit www.2dbarcodepilot.com for more information.)

Consider Active Preparation Monitoring
To be able to track recalled lot numbers to recipients of compounded doses, hospital pharmacies should consider technology designed to capture NDCs and lot numbers of drugs used to compound both sterile and non-sterile products. Several vendors sell bar code medication preparation (BCMP) systems (also referred to as IV workflow monitoring systems) as a means to prevent compounding errors, improve workflow, and reduce waste in the IV room. While lot number tracking is not a primary focus of these systems, they can be used to accomplish this goal. Of particular benefit, these systems require NDC bar code scanning and digital image capture of all ingredients during preparation. This information is archived and can be retrieved as necessary with lot numbers having been photographed, manually entered, or both (see Figure 1).



At Indiana University Health Bloomington Hospital (IUHB)—a nonprofit community hospital with 355 beds—automated technology is incorporated into all phases of the medication use process including ordering, compounding, dispensing, administration, and storage. Like every hospital, IUHB contends with hundreds of drug recalls each year, including dozens of Class I recalls.1 While, fortunately, relatively few of the total number of annual recalls extend to the patient notification level, many of those that do are Class I recalls of injectable products—certainly the most difficult to remedy once they have been administered (see Table 1). In order to address this significant concern and institute a more comprehensive management system for monitoring preparation and tracking the distribution of CSPs, IUHB installed a BCMP system in November of 2010. 

Click here to view a larger version of this Table


Capturing Medication Preparation
During the course of CSP preparation using a BCMP system, the attendant technician photographs the lot number and expiration date for all products used to make that CSP. For IV doses containing blood products, the technician will manually enter those numbers into the system. We include this extra step for blood products, including albumin, clotting factors, and immune globulin, due to the added concern for blood-borne diseases, such as HIV and hepatitis, as these are products pooled from many donors. This same technology can be adapted to capture lot numbers and expiration dates for nonsterile compounding as well. IUHB uses this BCMP system to document the NDCs, lot numbers, and expiration dates of three commonly used liquids that are not commercially available—vancomycin oral liquid, GI cocktail (lidocaine and aluminum-magnesium hydroxide) and Mary’s Mouthwash (diphenhydramine, nystatin, and hydrocortisone). Prior to implementing our BCMP system, a compounding log was written for these products on paper forms and stored in a binder (see Figure 2).



There Is No Perfect System
While photographing and capturing lot numbers is easy during the preparation stage, they can be cumbersome to search for, as there is a photograph of the lot number, but that number is not automatically deciphered by the system and added to the preparation record. In order to track back to a specific dose that was prepared with a specific lot number, users would need to review all doses containing a certain NDC over a specified period of time. On the other hand, manual entry of lot numbers during preparation facilitates fast database searching, but doing so increases dose preparation time (see Figure 3). Both methods—photographic capture and manual entry—have positive and negative aspects, but the bottom line is, both provide lot-tracking capability. Currently, approximately 11% of hospitals utilize BCMP to intercept compounding errors in the IV room and even fewer use the system to track lot numbers.4

Ultimately, this technology enables lot number documentation and tracking for sterile and nonsterile compounding; an invaluable service. However, solving the larger and more complex problem of tracking all doses will require industry-wide adoption of lot number-enriched bar codes on all unit dose packages. Suppliers of medication bar code scanning products also must develop systems capable of reading such enhanced bar codes, as well as enable searchable and storable information that can be readily retrieved.

References

  1. Drug Recalls. US Food and Drug Administration Web site. www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm Accessed June 21, 2012
  2. The Joint Commission. 2012 Accreditation Process Guide for Hospitals. Standard MM.05.01.17. EP 4. pp. 213-14 
  3. Council Recommendations. National Coordinating Council for Medication Error Reporting and Prevention Web site.www.nccmerp.org/council/council2007-06-05.html Accessed June 21, 2012
  4. State of Pharmacy Compounding. Pharm Purch Prod Supplement. April 2012.

Stephen Speth, MS, RPh, is the inpatient pharmacy manager at Indiana University Health Bloomington Hospital. He received his degrees from Butler University College of Pharmacy & Health Sciences and his primary practice focus is on medication safety initiatives.

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