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Multi-dose vial management The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have developed recommendations and guidelines administration rather than multi-dose vials due to the risk of cross contamination and the potential to administer too high of a dose to patients.6 regarding best practices for infection control. These recommendations and guidelines stress the Multi-dose vial use summary recommendations importance of single-dose or single-use vials for from CDC and WHO parenteral administration of medications. Several Avoid or strictly limit the use of multi-dose vials. Use single-dose, preservative-free medications for a studies reviewed by these two organizations reported that multi-dose vials were identified as a potential source of infection, despite the presence of preservatives to reduce bacterial survival.1,2 The single patient only. contents have been drawn up into a syringe and studies also found that multi-dose vial handling and poor technique by healthcare workers were contributing factors to the incidence of hospital Discard single-use vials and ampules after the discard the syringe after use on a single patient. If multi-dose vials must be used, aseptic technique must be strictly adhered to: acquired infections.1,2 The Joint Commission has established National Patient - Avoid touch contamination. - Cleanse the vial diaphragm or septum with 70% alcohol before inserting an access device (needle Safety Goals (NPSGs) in conjunction with the Standards or other). for Hospital Accreditation Program. There are two 2012 - NPSGs that apply to multi-dose vial use. Goal 3 is “Use devices and discard them after each use. Medications Safely” and Goal 7 is “Prevent Infections.” Consider a syringe or needle/cannula The Joint Commission Medication Management Standard contaminated once it has been used to enter or 3.01 in combination with NPSGs 3 and 7 require connect to a patient’s intravenous infusion bag processes, policies and monitoring of practices that or administration set. promote safe patient care. The American Society of Anesthesiologists (ASA) Recommendations for Infection Control for the Practice of Anesthesiology has identified that there is potential risk of infection with the use of multi-dose vials, - higher volume of critically ill patients, there are more opportunities for breaks in aseptic technique. Therefore, Documentation on the multi-dose vial label should include the revised expiration date (or “beyond use” date, which is 28 days after opening) and the initials of the person who opened the vial. Refrigerate any opened and properly labeled medication as recommended by the manufacturer. Discard opened multi-dose vials 28 days after opening. If the manufacturer’s original expiration the trend is to use single dose vials or to discard multi- date is shorter than the revised expiration date, dose vials after use on a single patient. The Association of periOperative Registered Nurses Discard multi-dose vials if there is any suspected visible contamination. maintained or opened vials are not properly managed areas such as the operating room (OR), where there is a Do not leave access device in diaphragm or septum. especially when aseptic technique has not been and labeled.3 The recommendations suggest that in Use only sterile, single-use syringes and access then the shorter date must be used. Currently, vaccines are exempt from this (AORN) 2012 edition of Perioperative Standards and requirement and are to be discarded per the Recommendations for medication safety now includes manufacturer’s expiration date, provided they are recommendations for collaborating with pharmacy to stored and handled according to manufacturer’s procure and store single dose vials for medication guidelines. Setup for multi-dose vials Due to medication supply shortages pharmacies may have to supply medications in the multi-dose or multiuse form to meet patient care needs. The hospital charge master and patient billing system must support the multi-dose medication vial process to assure compliance with government and third-party payer regulations. Coordinating multi-dose medication practice with hospital financial systems and policies will help assure successful billing audits and avoid disputes as well as potential fines for patient billing inaccuracies. The Pyxis® system formulary and the hospital billing system need to be setup to dispense and bill for each milligram or milliliter of medication used from a multidose vial. Once the setup for both is complete, thorough testing of the process from dispensing via the Pyxis® Examples of formulary setup Generic Brand Strength Strength unit Volume Volume unit Dosage form Generic Brand Strength Strength unit Volume Volume unit Dosage form neostigmine 1:1000 (10 mL vial) Prostigmin 1:1000 (10 mL vial) <blank> <blank> 10 mL mL etomidate 2 mg/1 mL (20 mL vial) Amidate 2 mg/1 mL 40 mg 20 mL mg Generic Brand Strength Strength unit Volume Volume unit Dosage form labetalol HCL 5 mg/1 mL (20 mL vial) Trandate 5 mg/1 mL 100 mg 20 mL mg Anesthesia System or Pyxis MedStation® system to the usage messages sent to and received by the hospital billing system must occur to validate consistently accurate patient charges. Loading In the examples listed, the dosage form is the key element in setting up the formulary correctly. The dosage form drives the dispensing, refilling and patient charging. The minimum and maximum par levels should be established in multiples of the dosage form that The vials should be loaded in the Pyxis system with a equal a whole vial to facilitate replenishment. Including quantity based on the dosage form. In the example the size of the vial and the milligrams per milliliter below, the minimum par level is 400 mg and a maximum par level is 600mg. Example: Labetalol 5mg/mL, 20 mL vial (100 mg/vial) Desired Min = 4 vials Desired Max = 6 vials Refilling For the Labetalol example, refilling is done in amounts of 100 mg rounded down to the nearest whole unit or vial. For example, if the refill report indicated that 425 mg of Labetalol was needed to refill the device, then 400 mg or 4 vials should be refilled. (mg/mL) in the generic medication description are helpful in facilitating accurate picking and refilling for the Pyxis system. Dispensing When dispensing for a patient, the user should enter the total amount of milligrams or milliliters needed for the dose. In the Labetalol example, if a dose of 20mg is needed, the quantity of 20 will need to be accounted for because the dosage form is 1mg. Testing If the Pyxis Anesthesia system My Items and/or Transfer to Patient features are being considered for use, thorough testing of the entire process must be completed to ensure billing accuracy. The hospital pharmacy and financial systems must be able to receive the desired billing and credit quantities from the Pyxis Training product interface. The testing should include end users Include training on the handling of multi-dose vials in such as anesthesia providers and nurses working implementation training as well as ongoing new user through their processes. End users should test all of the training for the Pyxis Anesthesia System. Anesthesia process steps from dispensing to the transfer of multi- providers and other clinical end users require training dose vial quantities via the Pyxis Anesthesia system with on dispensing, wasting and returning. Pharmacy staff the My Items and/or Transfer to Patient features requires training on loading, refilling, unloading and activated. supporting clinical end users on multi-dose vial process questions. Policy and procedure Clearly outline the processes for the management of multi-dose vials for pharmacy, anesthesia providers and other applicable clinical end users in the Pyxis system policy and procedure. The defined processes for replenishment and dispensing should be part of user training. Include all dispensing scenarios: individual patient and transfer processes for the My Items and Transfer to Patient features, if applicable. . Sources 1 Bulletin of the World Health Organization 2003; 81:491-500. 2 Centers for Disease Control and Prevention (CDC): Preventing Transmission of Infectious Agents in Healthcare Settings 2007, Recommendation IV.H. Safe Injection Practices. 3 American Society of Anesthesiologists: Recommendations for Infection Control for the Practice of Anesthesiology, second edition, 1999. 4 The Joint Commission: “Standards FAQ Details” on Multi-dose vials (July 20, 2010). 5 Centers for Disease Control and Prevention (CDC): Safe Injection Practices to Prevent Transmission of Infections to Patients, May 21, 2010. 6 ISMP Medication Safety Alert-Acute Care Newsletter January 26, 2012. © 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis, Pyxis MedStation system, and Pyxis Anesthesia system are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners. 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