Analysis of the Risks Associated with the Functions of a Pharmacy Cleaner in Pharmaceutical Compounding

Abstract

INTRODUCTION. Pharmacy compounding involves certain risks that are directly related to the process of extemporaneous preparation and the actions of its participants. However, the role of pharmacy cleaners, whose actions can influence the quality of compounded medicinal products, has not been studied yet.AIM. This study aimed to analyse the risks to the quality of compounded medicinal products associated with the functions of a pharmacy cleaner in pharmaceutical compounding of non-sterile dosage forms.MATERIALS AND METHODS. The study used failure modes and effects analysis (FMEA) in accordance with the relevant Russian State Standard, as well as open brainstorming discussion. The study examined the functions of a pharmacy cleaner in pharmaceutical compounding of non-sterile dosage forms. The results were assessed by statistically processing the study data and assigning each potential failure mode a certain category.RESULTS. The risk analysis identified 45 potential failure modes for the functions of a pharmacy cleaner. Of these, 12 failure modes (26.7%) had a high level of criticality, 14 failure modes (31.1%) had a medium level of criticality, and 19 failure modes (42.2%) had a low level of criticality. Not all potential failure modes had valid documented regulatory provisions for the risk assessment and the development of prevention-type controls.CONCLUSIONS. The analysis of the functions of a pharmacy cleaner highlighted the potential risks to the quality of extemporaneous medicinal products prepared by compounding pharmacies. The study identified a lack of valid regulatory documentation. The authors suggested using the study results to amend the regulatory documents and standard operating procedures (SOPs) guiding the work of a pharmacy cleaner, to develop illustrative educational materials, and to conduct on-the-job training for pharmacy staff.

Keywords

• compounding pharmacies
• risk assessment methods
• failure modes and effects analysis
• fmea
• pharmacy cleaner
• pharmaceutical compounding
• compounded medicinal products
• extemporaneous medicinal products
• regulatory documentation
• standard operating procedure
• sop