ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products

Patient morbidity and mortality have resulted from incorrectly prepared or contaminated pharmacy-prepared products. 1–7 Pharmacists seldom know that inaccurate or contaminated products are dispensed when pharmacy quality monitors are inadequate. 8–10 In contemporary health care organizations, more patients are receiving compounded sterile products that are stored for extended periods before use (allowing the growth of a pathological bioload of microorganisms 11), more patients are seriously ill, and more patients are immunocompromised than ever before. These ASHP guidelines are intended to help pharmacists and pharmacy technicians prepare sterile products of high quality. a The pharmacist is responsible for compounding and dispensing sterile products of correct ingredient identity, purity (freedom from physical contaminants, such as precipitates, 12 and chemical contaminants), strength (including stability 13 and compatibility), and sterility and for dispensing them in appropriate containers, labeled accurately and appropriately for the end user. Other professional organizations have published useful guidelines on compounding and dispensing sterile products. The United States Pharmacopeia (USP) publishes the official compendium The United States Pharmacopeia and The National Formulary (USP) and its supplements, all of which may have legal implications for pharmacists. 14,15 The reader would especially benefit from studying the USP general information chapter on sterile drug products for home use, 13 which is referred to often in this ASHP guideline. The National Association of Boards of Pharmacy (NABP) has published less detailed model regulations for use by state boards of pharmacy. 16,17 The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) recently published a special report on safe practices for parenteral nutrition formulations. 18 Other governmental and accreditation sources are more general. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) publishes at least four sets of standards that mention pharmacy compounding. The hospital accreditation standards simply state that the organization adheres to laws, professional licensure, and practice standards governing the safe operation of pharmaceutical services. 19 The JCAHO home care standards require that medications be safely prepared, including " using appropriate techniques for preparing sterile and nonsterile medications and products. " For example, the home care standards state that " appropriate quality-control techniques are used to check for preparation accuracy and absence of microbial contamination. Techniques for preparing sterile products follow guidelines established by the American Society of Health-System Pharmacists. " 20 The JCAHO standards for long-term-care pharmacies list important conditions for product preparation, such as separate areas for sterile product preparation, use of a …