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Inappropriate Use of Pharmacy Bulk Packages of IV Contrast Media Increases the Risk of Infections
Some clinical staff members have been using pharmacy bulk packages (PBP) of contrast media as multiple-dose containers and administering doses from the same container to multiple patients throughout the day in the radiology department, cardiac catheterization lab, or cardiac surgery locations. Staff members may believe the PBP of contrast media is a multiple-dose container because some manufacturers refer to it as a “multipack” (e.g., Isovue Multipack, Prohance Multipack). However, we are unaware of any IV contrast media that is packaged in a multiple-dose container in the traditional sense. PBPs of contrast media do not contain the preservatives found in most multiple-dose containers of medications that normally help to prevent contamination and the spread of infection.
The U.S. Pharmacopeia (USP) provides a detailed definition of a PBP, which includes but is not limited to the following crucial parameters:
The Food and Drug Administration (FDA) considers an aseptic area to be a suitable work area for using PBPs. The FDA defines an aseptic area as having engineering controls such as HEPA-filtered laminar air flow that meets the guidelines of International Standards Organization (ISO) Class 5, appropriate cleaning and disinfection procedures, and periodic microbiological monitoring of the area.3 The FDA does not regard PBPs as appropriate for use in a radiology suite unless the suite meets the criteria for a suitable work area as noted above. More information pertaining to a suitable work environment can be found in USP General Chapter 797.4
Accordingly, package labeling for PBPs of IV contrast media recommends transfer of the contents in a suitable work area as defined above, penetration of the closure only one time, and immediate transfer of the contents using a suitable transfer device. However, the labeling suggests that if the content transfer cannot be accomplished immediately, it can be completed within a maximum of four to 10 hours (depending on the specific product) from initial closure entry as long as the PBP container is not removed from the aseptic area during the entire four- to 10-hour period.
Confusion regarding the proper transfer of IV contrast media from PBPs has been perpetuated by the labeling of some radiographic contrast injectors on the market that describe use with PBPs, which is inconsistent with the PBP labeling. The FDA is aware of these labeling issues and is in the process of resolving the inconsistencies in the device and drug labeling.
Another confounding factor is that some staff members erroneously believe that use of a sterile transfer set, as outlined in point 2 of the USP definition of a PBP, is all that is required to meet the standards of a “suitable work area.” In these cases, hospital staff members hang a PBP of IV contrast media with a sterile transfer set attached for the entire day in a radiology suite or other unsuitable environment. Staff members then withdraw multiple, individual patient doses from the PBP with a power injector (or by hand in cardiac catheterization and surgery units) by entering the container over and over again. Such practices, which are inconsistent with FDA requirements for the proper use of PBPs, the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals, the CDC Injection Safety Guidelines, and the Joint Commission standards, expose patients to the risk of developing a potentially life-threatening infection.
In fact, serious and fatal infections from misuse of single-use vials of contrast media were reported in the July 13, 2012, issue of Morbidity and Mortality Weekly Report.5 According to the CDC, three patients in an Arizona pain management clinic who received contrast media injections from the same container during radiological imaging were admitted to the hospital for severe methicillin-resistant Staphylococcus aureus (MRSA) infections, including mediastinitis, bacterial meningitis, epidural abscess, and sepsis. Hospitalization ranged from nine to 41 days, with additional long-term care required for one patient. A fourth patient who received contrast from the same vial was found deceased at home. The cause of death was reported as a multiple-drug overdose; however, an invasive MRSA infection from cross-contamination of the contrast media could not be ruled out. In addition to identifying improper reuse of contrast media containers intended for single use, officials noted that health care staff members failed to wear face masks during the spinal injection procedures.
Pharmacy oversight. The pharmacy department should oversee the purchase, distribution, storage, and use of IV contrast media in all inpatient and outpatient clinical areas of the health care organization. Regular pharmacy monitoring of the storage and use of these products should become routine. Pharmacists should periodically attend departmental staff meetings for units where contrast media is used to discuss the safe use of IV contrast media, including the inappropriate handling of PBPs in such areas.
Single-dose vials and syringes. In patient-care units such as radiology, cardiac catheterization labs, and operating rooms, staff members should draw doses of IV contrast media from single-dose vials or use prefilled single-use syringes from the pharmacy or as available from most manufacturers. Any medication remaining in the vials or syringes should be discarded immediately.
Proper use of PBPs. The contents of PBPs of IV contrast media (or PBPs of any medication) should only be transferred to single-dose containers or syringes in the pharmacy under a laminar flow hood or other suitable ISO Class 5 environment according to USP 797. If the dose of contrast media in a single-use vial is insufficient for one patient, a PBP could be used for a single aseptic transfer to a sterile container or syringe for one patient only. The PBP should be treated as a single-use vial—the transfer set should be disconnected and any remaining drug in the PBP should be discarded immediately after the initial removal of the patient’s individual dose.
- Centers for Disease Control and Prevention. Protect patients against preventable harm from improper use of single-dose/single-use vials. May
22012;Available at www.cdc.gov/injectionsafety/CDC-position-SingleUseVial.html. Accessed March 20, 2015.
- Institute for Safe Medication Practices. Perilous infection control practices with needles, syringes, and vials suggest stepped-up monitoring is needed. ISMP Medication Safety Alert! December
22010;Available at: www.ismp.org/Newsletters/acutecare/articles/20101202.asp. Accessed March 20, 2015.
- Food and Drug Administration. Guidance for industry: sterile drug products produced by aseptic processing—current good manufacturing practice. September 2004;Available at: https://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf. Accessed March 20, 2015.
- Chapter 797: Pharmaceutical Compounding—Sterile Preparations. USP Compounding Compendium Rockville, Maryland: U.S. Pharmacopeial Convention. 2015;43–87.
- Centers for Disease Control and Prevention. Invasive
Staphylococcus aureusinfections associated with pain injections and reuse of single-dose vials—Arizona and Delaware, 2012. MMWR 2012;61;(27):501–504.