Jp. Santell et Rf. Kamalich, NATIONAL SURVEY OF QUALITY ASSURANCE ACTIVITIES FOR PHARMACY-PREPAREDSTERILE PRODUCTS IN HOSPITALS AND HOME INFUSION FACILITIES 1995, American journal of health-system pharmacy, 53(21), 1996, pp. 2591-2605
The results of a survey of hospital pharmacy and home infusion facilit
y activities for quality assurance in the preparation of sterile drug
products are reported, and the hospital results are compared with thos
e of a 1991 ASHP survey.A questionnaire was mailed in May and June 199
5 to 778 hospital pharmacy directors and 203 home infusion pharmacy di
rectors. Usable questionnaires were returned by 547 hospitals and 111
home infusion facilities, for an overall response rate of 67%. The per
centages of hospitals with pharmacists involved in extemporaneous (70%
) and batch (28%) preparation of sterile drug products have decreased
since 1991, while the percentage with technicians who are not limited
as to the types of sterile products they may prepare has increased. So
me 16% of all sterile products compounded in hospitals were prepared b
y nonpharmacy personnel. Few respondents contracted with outside sourc
es for compounding of sterile products. A need for educational program
s on aseptic technique was identified by 83% of hospitals, and 84% of
home infusion facilities indicated a need for education on environment
al monitoring. Three fourths of respondents used the ASHP Technical As
sistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile P
roducts in developing their policies and procedures. Significant impro
vements in orientation and training techniques have occurred since 199
1. Use of a laminar-airflow hood in a limited-access room has increase
d. The aspects of sterile product compounding most often modified sinc
e 1991 were, for hospitals, personnel training and evaluation (74%), f
acilities and equipment (48%), and garb policies (36%); for home infus
ion facilities, personnel training and evaluation (76%), facilities an
d equipment and garb policies (both 69%), and end-product testing and
evaluation (66%). There have been advances in quality assurance proced
ures related to pharmacy-prepared sterile products, but opportunities
for improvement remain.