A risk-based approach to sanitary and hygienic measures for improving compounding performance in pharmacies

BAKGRAUND: Risk management and effective sanitary and anti-epidemic measures are crucial for improving the efficiency of pharmaceutical compounding. Most pharmacies lack a comprehensive and well-defined algorithm for developing sanitary and anti-epidemic requirements or sanitary and hygienic measures in their standard operating procedures or other local policies.

AIM: This work aimed to provide a risk-based, research- and practice-oriented approach to developing standard operating procedures and local regulations to improve sanitary and hygienic measures in pharmacies, including those with the right to aseptic pharmaceutical compounding. The work also aimed to propose an algorithm for implementing these measures into routine practice.

METHODS: The work was based on laws and regulations on drug circulation and pharmaceutical activities, research into drug provision and sanitary and anti-epidemic measures in pharmacies, as well as other scientific publications and reference materials on the subject. Latent semantic, historical, structural logical, and content analyses were used.

RESULTS: Due to the lack of clear requirements for the implementation of sanitary and hygienic measures, the following risks have been identified: reduced quality and safety of pharmaceutical products; contamination of pharmacy facilities (e.g., process equipment) with various agents, including microorganisms. The fundamental principles of sanitary, hygienic, and anti-epidemic measures in pharmacies were justified. The key sanitary requirements for pharmacies were specified, including interior finishing, ventilation, and lighting, as well as receipt, storage, and transportation of purified water and water for injection. Specific sanitary and anti-epidemic measures were defined for pharmaceutical compounding, including aseptic compounding. A recommended schedule for junior pharmacy staff during sanitary and hygienic measures was provided.

CONCLUSION: Pharmacies should make the development and implementation of standard operating procedures and local regulations a priority to improve their sanitary and hygienic practices. This will significantly improve the effectiveness of pharmaceutical compounding. A risk-based approach to sanitary and hygienic measures in pharmacies is essential for ensuring the high quality and safety of compounded drug products. Any deviations in this approach can have a detrimental impact on public health.