Practices of pharmacies that compound extemporaneous formulations

Abstract

A survey was conducted to characterize the standard of practice for extemporaneous pharmaceutical compounding within community and institutional pharmacies. Extemporaneous compounding practices vary among pharmacies. Because of this, the survey inquired specifically about a single pharmaceutical product (caffeine citrate 20 mg/mL) to minimize variability among respondents. Survey questions were written to identify compounding practice variations with (1) policies and procedures, (2) process validation, (3) personnel education, training, and evaluation, (4) expiration dating, (5) storage and handling of compounded prescriptions within the pharmacy, (6) labeling, (7) facilities and equipment, (8) end-product evaluation, (9) handling of sterile products outside of the pharmacy, (10) aseptic technique and product preparation, and (11) documentation. A total of 522 surveys were mailed; 117 completed surveys were returned and included in the analyses. Over half of the pharmacies surveyed were large institutional pharmacies with daily prescriptions exceeding 300. Almost 71% of pharmacies reported having policies and procedures for compounding and providing compounding training for staff. Almost one third of the pharmacies that responded did not have compounding policies and procedures and did not provide staff training. For those pharmacies that provided training, the methods used were diverse (e.g., lectures and videotapes, external certificate programs). Formulations used to compound caffeine appeared to be diverse as evidenced by the varied addition of inactive ingredients. A survey of compounding pharmacies found variability in overall compounding practices and training and in practices specifically related to compounding preparations of caffeine citrate.