Center for Improvement in Healthcare Quality Newsletter
December 2021

CIHQ-ARS Blog

Safety Rules when Admixing Medications Outside the Pharmacy

By: Gina Miller
I can remember pulling a variety of medications from the storage area and mixing one - or more of them into IV bags for intermittent or even continuous infusion. Remember banana bags? We used to mix those in the emergency department. When I started practicing as a nurse, this was a rather common practice. As the years passed, it became more and more infrequent – medications for infusion came pre-mixed by pharmacy or stocked in a ready-to-use formulation; even medications for injection or oral use came premixed in a syringe ready for administration.
While compounding and admixing outside the pharmacy may be less prevalent these days, it still occurs in both large and small organizations. In a survey completed by the Institutes for Safe Medication Practices (ISMP), nearly 30% of those surveyed (nurses and APRNs, anesthesia providers, & physicians) stated they often or always compound medications for administration or infusion. Most cited medications included insulin, vasopressors, and lifesaving drugs during resuscitation. Further, half of respondents reported learning how to perform sterile, injectable medication and/or infusion preparation and admixture tasks only during their professional training program.
Both the United States Pharmacopeia (USP) and American Society for Health-System Pharmacists (ASHP) strongly recommend that any compounding, which includes both mixing in a syringe (e.g., Ceftriaxone IM injection) or compounding a bag (e.g., Cardizem infusion) that occurs outside of the ISO controlled environment in the pharmacy should be reserved for emergent use or situations where a delay in patient care could cause a risk to the patient. Examples would be during cardiopulmonary resuscitation, during diagnostic procedures with short-stability medications that must be prepared immediately before administration, or outside health care facilities (e.g., in home infusion or emergency care at an accident site). Staff who prepare infusions or admix medications should have documented competencies in their file to assure safe practice. What will surveyors be looking for when it comes to safe preparation?

Safe Preparation Outside of the Pharmacy

  • Hand hygiene according to CDC guidelines
  • Separate, clean, uncluttered area used for preparation
  • Low-risk compounding only – which means a total of three sterile, non-hazardous products (one is the IV fluid bag or vial to which you are adding the medications) with no more than two entries into a single product. Make sure you have a large enough syringe to withdraw the entire product and add to the IV mini-bag with a single puncture.
  • The preparation is labeled with the patient identification, name and amount of all ingredients, name or initials of preparer, and the exact one hour beyond use date and time.
  • The infusion is then hung within one-hour of the time you started the preparation.
  • There should be documentation of competency for any staff who compound outside the pharmacy including use of aseptic technique, labeling, and beyond-use dating.
Other safe practices to remember:
  • Ampuls or single-dose vials may not be saved and reused to withdraw into a syringe or mix another bag for infusion later. Multi-dose vials have a beyond use date (BUD) of 28 days or as defined by the manufacturer. If kept and accessed in a controlled environment (medication area, nurses’ station), they may be used on multiple patients. If they enter a treatment area, they are dedicated to that single patient.
  • Withdrawing from glass ampuls requires a filter needle.
  • You may not prepare ahead multiple bags for use during the shift – each bag must be prepared just prior to administration.
  • Any bag that is prepared and not initiated within the one-hour BUD must be discarded.

What About Point-of-Care Activiated Devices?

Products such as Add-Vantage, ADD-Ease, Add-A-Vial, Point of Care plus systems which have a physical barrier between two products and are activated just prior to administration have special rules. When assembled by pharmacy in a controlled ISO 5 environment, the BUD varies by manufacturer and is generally 15-60 days after assembly. When the products are assembled by staff at the bedside or outside of the controlled ISO environment in pharmacy, they are considered immediate use and should be activated and initiated within one-hour of assembly. The manufacturer’s instructions for use should be followed for appropriate timeframes.

References

American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014; 71:145–66.
Institute for Safe Medication Practices. (2020). ISMP Survey provides insights into preparation and admixing outside the pharmacy. Available from ismp.org
United States Pharmacopeia. (2012). USP-NF General Chapter . Pharmaceutical Compounding – Sterile Preparations. Available from usp.org
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