Evaluation of extemporaneous compounding in tetriary hospital pharmacy in the Polokwane Municipality : a pilot study.

Abstract

Background: Some medicines are available in doses that are not suitable for a specific population group and therefore manipulation of the existing medication is undertaken in order to obtain the required concentration of that medication. The groups affected by this include paediatrics, adults who are unable to swallow (such as, geriatric patients); those who are fed using naso-gastric tubes; and the terminally ill. Studies on the practices, frequency and extent of extemporaneous compounding have been undertaken in other countries such as New Zealand, Australia, United Kingdom, United States of America, the Netherlands and Mexico. No published data currently exists for South Africa. Extemporaneous compounding studies are essential for improving the care of patients particularly in South Africa with its complex and unique challenges. Aim: The aim of this pilot study was to explore the extemporaneous compounding practices in a South African public sector setting. Methods: This was a pilot study using a cross-sectional descriptive design. Purposive sampling was used to sample both the hospitals and the pharmacists. A self-administered close-ended and open-ended questionnaire was designed to collect information from willing pharmacists for exploring the compounding practice processes. All the batch records from April 2008 to March 2009 were purposively sampled for frequency and extent of compounding to obtain information on dosage form, medicine classification and route of administration. The descriptive analysis was done using Statistics Package for Social Sciences (SPSS Version 20, 2011). Results: Fifty-nine questionnaires were distributed to tertiary hospital pharmacy personnel, of which 25 were returned (a 42.37% response rate). The main findings were that almost all of the pharmacists (96%) reported receiving compounding skills training and 60% of the respondents confirmed that the expiry date was personally developed. There was no proof of records being kept on the regular calibration of electronic weighing balances (76%) and maintenance (72%) despite the fact that documentation for compounding comprising of manufacturing batch records (80%), as well as compounding formula and procedures (72%) are mostly kept. The maintenance of electronic weighing balances was in the most instances, not carried out (64%). A logbook of all compounded medicines was commonly not kept (64%). A key finding was that there was limited training in aseptic technique (3%), which, if not applied correctly, could result in contamination of compounded products. About 691 batch records were reviewed for the study period. The most compounded medicines were dermatologicals (46.60%), with, creams and ointments totalling 33.0% and 13.60%, respectively. The most compounded product was Betamethasone cream (27.9%) . Conclusion: The findings suggest that there seem to be insufficient skills within the tertiary hospital pharmacy staff for small scale compounding. Documentation on equipment calibration and maintenance was not available in most cases. The findings of this pilot study highlight the need for further such studies across South Africa to identify and improve extemporaneous compounding training and practice in the country.