PC1 – Risk assessment: choose your battles wisely

Link to EAHP Statements
Section 3 – Production and Compounding: Statements – 3.3, 3.5
Section 5 – Patient Safety and Quality Assurance: Statements – 5.6

Abstract
The preparation of medicinal products in pharmacies is governed by strict regulatory frameworks, particularly those outlined in Good Manufacturing Practice (GMP) as defined in Eudralex Volume 4. These guidelines are designed to ensure the quality, safety, and efficacy of compounded medications. While adherence to these standards is essential, they also provide opportunities to implement risk-based approaches in specific areas. This flexibility allows pharmacies to adapt measures and processes based on the level of risk involved, enabling a more targeted and efficient allocation of resources.
A risk-based approach offers numerous benefits, including the ability to prioritize activities that have the greatest impact on product quality and patient safety. By focusing efforts on critical risks, pharmacies can streamline their workflows, reduce unnecessary steps, and enhance operational efficiency. Additionally, this approach fosters innovation by encouraging the development of tailored solutions that meet regulatory requirements while addressing the needs for individual preparations. However, challenges remain, such as the potential lack of sufficient or reliable data to conduct a robust risk assessment. Furthermore, ensuring thorough documentation and traceability of risk-based decisions is crucial to maintaining compliance with regulatory expectations and withstanding inspections or audits.
This session will explore both the advantages and limitations of risk-based decision-making in pharmaceutical compounding. Practical examples will illustrate how pharmacists can apply these principles effectively in their daily practice to achieve a balance between compliance, efficiency, and safety. Participants will gain a deeper understanding of how to use risk assessment tools to enhance their processes while maintaining the necessary high-quality standards in the pharmacy’s manufacturing unit.

Learning objectives
After the session, the participant should be able to:
– Identify how a risk-based approach can be applied to pharmaceutical compounding, including relevant regulatory frameworks.
– Discuss the potential benefits, challenges, and limitations of implementing risk-based strategies.
– Analyse practical examples to apply risk assessment methods in improving efficiency and maintaining high-quality standards in pharmacy practice.

Educational need addressed
With increasing regulatory demands, hospital pharmacists need to know the advantages and opportunities of a risk-based approach for the preparation of medicines in the pharmacy setting. Hospital pharmacists should apply risk assessment strategies to focus on the critical aspects of their manufacturing processes, thereby improving the efficiency while ensuring the quality of the product.

Keywords
Drug Manufacturing, Compounding, Good Manufacturing Practice, extemporaneous preparation, Risk Management.