Showing posts with label FACA. Show all posts
Showing posts with label FACA. Show all posts

Tuesday, April 9, 2013

End-preparation Assessments and Tests for Compounded Sterile Preparations Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA


The fungal meningitis tragedy that occurred in the fall of 2012 and the closure of NECC and AmeriDose has raised serious quality and safety concerns for health systems about outsourcing sterile preparations. Outsourcing has become a necessity to obtain sterile products that are currently on backorder. Although there are evaluation tools through the International Academy of Compounding Pharmacists (IACP) and the American Society of Health-System Pharmacists (ASHP) to assist hospital pharmacy leadership in selecting a compounding pharmacy or FDA-registered manufacturer that provides customized compounded preparations, there is still not a 100% guarantee that the contractor is following all of theUnited States Pharmacopeia (USP) standards for sterile compounding.1Outsourcing sterile compounding can be very expensive and put a financial strain on a hospital pharmacy budget that is already tight. Pharmacy leadership in health systems are now considering the option of insourcing sterile compounding to reduce pharmacy expenses and control how these sterile preparations are compounded.
Many of the parenterals that are on manufacturer backorder, such as electrolytes used to prepare large volume parenterals, are relatively simple to compound. These commercial products are usually just the active ingredient dissolved in sterile water that is adjusted to a certain pH range and then sterilized by filtration and/or steam-autoclaved. It is also relatively easy to find information on the exact quantities of each ingredient through websites such as drugs.com, manufacturer package inserts, professional peer-reviewed journals, and credible compounding resources such as CompoundingToday.com. However, the key to preparing high-quality, safe, sterile preparations is end-preparation assessments and tests.
What are End-preparation Assessments and Tests?
The stated objective in the USP <797> chapter on sterile compounding is to provide and describe the conditions and practices required to safely compound sterile preparations in order to prevent harm and even death to patients receiving these medications. End-preparation assessments and tests ensure that the finished compounded sterile preparations (CSPs) are not contaminated with bacteria, fungus, endotoxins, particulate matter, or unintended chemicals. It also ensures that the patients will receive accurate doses and that the CSPs are compatible with the patients' body fluids, organs, and tissues. End-preparation assessments and tests are the final checks before a CSP should be dispensed and administered to a patient.

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