Operation of an allergen-extract pharmacy.
The quality control (QC) and quality assurance (QA) systems for a military allergen-extract pharmacy are described. The United States Army Allergen Extract Laboratory (USAAEL) provides diagnostic and therapeutic allergen-extract materials to military personnel throughout the world. More than 40,000 individualized prescriptions are compounded annually. The staff is composed of one pharmacist, 16 medical technicians, and four clerical, two inventory, and three supervisory personnel. Each prescription takes about one man-hour to prepare. The technicians are trained in aseptic technique, allergen-extract compounding, and the diagnosis and treatment of allergies during an eight-week program. Following a physician-allergist's evaluation of a patient, a prescription is written with a formula itemizing the specific allergen components, their relative concentrations, and a treatment schedule. Patient profile cards are kept on every patient. A complete record of patient, prescriber, demographic data, allergen formula, treatment schedule, lots, and initials of personnel responsible at each step allow a thorough assessment for QC and QA. The identity and volume of each allergen in every prescription are checked twice. A multitiered QC system is used to identify problems and errors. A QA and QC assessment was conducted on more than 18,000 prescriptions received during a six-month period. More than 99% of all known errors were discovered before the prescriptions were dispensed. Allergen-extract prescriptions must be accurate, precise, and reproducible to be effective and to avoid adverse reactions. Pharmacists can play a vital role in ensuring the optimal quality of diagnostic and therapeutic allergen extracts.
D000485:Allergens / Q000627:therapeutic use*; D004339:Drug Compounding; D006801:Humans; D008887:Military Medicine; D010594:Pharmacies / Q000458:organization & administration* / Q000592:standards; D011785:Quality Assurance, Health Care; D011786:Quality Control; D014481:United States
D000485:Allergens