Capacity Building

Provide comprehensive guidance and support for site pharmacists to build their capacity to implement research.

The traditional pharmacist’s role in a community or hospital setting is often restricted to dispensing medications; however, there is a shift towards clinical pharmacy, where pharmacists play a more active role in direct patient care and medication therapy management. This particularly becomes the case in a clinical trial, where pharmacists need to not only have experience with dispensing medications and providing clinical pharmacy services but also in understanding concepts of research and clinical trial management. Yet the lack of clinical research experience at many of the sites meant that the site pharmacists and trial administrators lacked understanding of the breadth of responsibilities and expectations placed on the site pharmacists. It is therefore important that capacity building support is provided for site pharmacists. Given the diversity of site pharmacists and their varying levels of experience, creating a detailed step-by-step guide outlining the roles and responsibilities of the pharmacist would have been extremely beneficial at the start of the trial.

Sponsor pharmacists strengthened capacity of site pharmacists through numerous methods. For example, to strengthen their capacity and ensure site pharmacists could meet the needs of the trial, we provided supportive supervision to STREAM sites through onsite visits and regular communication to ensure the Pharmacy Plan and trial protocol were adhered to. The collection of monthly stock reports, and regular CRO visits to site pharmacies in Stage 2 also ensured that pharmacy staff were adept and prepared for regulatory inspections. Sponsor pharmacists also instituted continuing education activities by providing monthly scientific articles with topics ranging from pharmacist roles within global health to advances in MDR-TB treatment. We also developed a GCP course, available online, specifically geared toward pharmacy practice to make sure site pharmacists were educated on the biomedical ethics within clinical trials of investigational drugs. The benefits of these capacity building activities were seen in more efficient and reliable supply chain management and pharmacy operations.

Vital Strategies Sponsor pharmacists provided us monthly Pharmacy Continuing Education resources. These resources were very useful for my professional development. I even shared them with my colleagues.

STREAM Pharmacist, Stage 2 Site

Recommended best practices

Build the capacity of site pharmacists in implementing research through the following measures:

  • Create a comprehensive pharmacy guide that provides concrete steps each pharmacy staff member must undertake to succeed in the role, including supply chain management, pharmacy operations, data collection, and reporting

  • Create electronic training materials which cover important topics, including GCP and common medication and dispensing errors, for pharmacy staff

  • Incorporate online refresher training to ensure staff are abreast of any trial developments that impact pharmacy operations

  • Create audit and inspection readiness training for pharmacy staff to ensure they are prepared for any drug regulatory body or sponsor audit

  • In addition to onsite monitoring, consider remote monitoring options to ensure adequate oversight

  • SOPs should be agreed upon and provided to outline roles and responsibilities for trial pharmacists

  • Provide access to professional and local pharmacy training to increase staff knowledge and skills and promote continuous learning