O T H E R F E AT U R E S The Effects of Drug Shortages on Unsafe Injection Practices INTRODUCTION On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act of 2012. The US Food and Drug Administration (FDA) now has new authority to combat shortages of drugs in the United States and impose new requirements on manufacturers regarding early notification to FDA of potential short- ages or disruptions of supplies. The legislation also requires FDA to develop a list of drug shortages, including the reason for and duration of the shortages.1 Jeffrey Bomboy, RN, BS Patient Safety Liaison, Northeast Region National drug shortages have become a factor in safe injection practices in healthcare Pennsylvania Patient Safety Authority facilities. Due to the ongoing shortages of frequently used drugs, practitioners are find- ing ways to help ease the burden of not having enough of these critical frequently used medications. Unsafe practices, such as reuse of single-dose vials on multiple patients, are done with the notion that they reduce costs without an appreciation of the risks involved.2 As a patient safety liaison for the Pennsylvania Patient Safety Authority sharing information on current drug storages with my peers and facilities, some facili- ties have stated they are using single-dose vials for more than one patient in order to conserve resources and prevent waste. There are other rationalizations for the misuse of single-dose vials, including efficiency, time constraints, conservation of resources, avoidance of waste, and cost considerations.3 No matter what the rationalization is, the improper use of single-dose vials continues to result in infection outbreaks.4 This year, two outbreaks of invasive Staphylococcus aureus infections in Arizona and Delaware were associated with the reuse of single- dose vials.4 During the last five years, the Centers for Disease Control and Prevention (CDC) is aware of at least 19 outbreaks due to unsafe injection practices involving the use of single-dose or single-use medications for more than one patient.4 National drug shortage was a documented factor in the unsafe injection practices of an outbreak involving bupivacaine this year. To conserve resources, staff used each 30 mL vial of the anesthetic, as needed, for multiple patients until the vial contents were depleted. If the 30 mL vial was not used in a single day, the vial was not discarded but saved for use the following day.3 Vials intended for single use are labeled “single-use” or “single-dose” because these vials contain no preservatives or antimicrobials to prevent bacterial contamination. Because such contamination is not visible to the human eye, it must be assumed that once the stopper is penetrated or the ampule is broken, contamination occurs, posing a risk of infection to the patient who next receives contents withdrawn from the vial.3 Frequent drug shortages complicate this problem. In most cases, there are no warn- ings of upcoming drug shortages or how long the shortages may last. Approximately 280 drugs, almost all manufactured in the United States, remain in short supply because of factors such as a dwindling number of drug manufacturers, deteriorating conditions in factories, and low prices for generics leading to a lack of investment to upgrade plants.5 Propofol is another drug in particular that is on the list of drug short- ages. This drug is commonly used both in hospitals and ambulatory surgical facilities. Propofol is formulated in a lipid emulsion that supports rapid bacterial growth. There have been numerous outbreaks of bacterial and viral infections as a result of reuse of single-dose vials of propofol on multiple patients.2 CDC and the Centers for Medicare and Medicaid Services (CMS) have recently reiter- ated their stance on the use of single-dose vials.6,7 Both organizations state that the practice of using single-dose vials for more than one patient is unacceptable. There is one exception to this policy in that single-dose vials may be split into multiple doses Page 150 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority when utilizing US Pharmacopeia (USP) implementation of these recommenda- waste and avoid the misconception by chapter 797 guidelines. Strict adherence tions by many practitioners. Guidance clinical staff that there is enough medicine to these guidelines by qualified, trained on the issue of safe injection practices for more than one patient in the single- personnel, and under no less than Inter- and drug shortages can be found from dose vials. Another alternative would be to national Organization for Standardization various organizations, including CDC, use multidose vials when appropriate. (ISO) class 5 air quality conditions, is CMS, FDA, and the Authority (in articles mandatory. Proper labeling of these medi- published in June 2008 and June 20118,9). CONCLUSION cations is also required. Clinical units The Safe Injection Practices Coalition has Outbreaks of infection resulting from and operating rooms are not considered joined in a partnership with healthcare unsafe injection practices are both unac- adequate for this purpose. CMS states organizations led by CDC in the One and ceptable and preventable. Each time a that facilities that reuse single-dose vials Only Campaign to provide resources for healthcare professional does not adhere for more than one patient without adher- safe injection practices for the healthcare to safe injection practices, they endanger ing to USP chapter 797 standards must be community and patients. Information on the very patient who they set out to help. cited during regulatory survey.3 this campaign can be found at http:// Healthcare practitioners must not endan- Despite the availability of guidance on best www.OneandOnlycampaign.org.4 Clini- ger patients due to these shortages and practices from CDC and other groups, cians and purchasing staff should consider inappropriate workarounds. Single-dose there remains a lack of awareness and purchasing the smallest-size vials to prevent vials are only meant for one patient. NOTES 1. US Food and Drug Administration. 4. Centers for Disease Control and Preven- 7. Centers for Medicare and Medicaid Ser- Food and Drug Administration Safety tion (CDC). Injection safety [website]. vices. Safe use of single-dose/single-use and Innovation Act (FDASIA) [website]. [cited 2012 Sep 8]. Atlanta: CDC. http:// medications to prevent healthcare associ- [cited 2012 Sep 14]. Silver Spring (MD): www.cdc.gov/injectionsafety. ated infections [memorandum]. 2012 FDA. http://www.fda.gov/ 5. Devi S. US drug shortages could Jun 15. RegulatoryInformation/Legislation/ continue for years. Lancet 2012 Mar 8. Dangers associated with shared multi- FederalFoodDrugandCosmeticAct 17;379(9820):990-1. dose vials. Pa Patient Saf Advis [online] FDCAct/SignificantAmendmentstothe 6. Centers for Disease Control and Preven- 2008 Jun [cited 2012 Sep 8]. http:// FDCAct/FDASIA/ucm20027187.htm. tion. Protect patients against preventable patientsafetyauthority.org/Advisories/ 2. Pugliese G, Gosnell C, Bartley JM, et al. harm from improper use of single-dose/ AdvisoryLibrary/2008/jun5(2)/pages/ Injection practices among clinicians in single-use vials [official position statement 68.aspx. United States health care settings. Am J and messages online]. 2012 May 2 [cited 9. Prevent the occurrence of bloodborne Infect Control 2010 Dec;38(10):789-98. 2012 Sep 8]. http://www.cdc.gov/ disease transmission associated with 3. Stokowski LA. Single-use vials: safety, injectionsafety/cdcposition-singleusevial. unsafe injection practices. Pa Patient cost, and availability [online]. Medscape html. Saf Advis [online] 2011 Jun [cited 2012 Infect Dis 2012 Aug 2 [cited 2012 Sep 8]. http://patientsafetyauthority. August 2]. http://www.medscape.com/ org/Advisories/AdvisoryLibrary/2011/ viewarticle/768187. jun8(2)/pages/70.aspx. Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 151 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, No. 4—December 2012. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. 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