What are the competency requirements for clinical pharmacist verification of systemic anti-cancer therapy (SACT) prescribed within a clinical trial? A consensus study

Abstract

Background Since 2005 it has been a legal requirement in Scotland to have a suitably trained pharmacist verify SACT prescriptions. Published information for verification of SACT does not currently cover SACT prescribed within a clinical trial and the additional knowledge this requires. This poses the question of how pharmacists are deemed suitably trained to competently verify SACT prescribed within a clinical trial to ensure patient safety and service efficiency. Aim To determine and gain consensus on the competency requirements for clinical pharmacist verification of SACT prescribed within a clinical trial. Method A two stage process was adopted. Firstly, a Nominal Group Technique (NGT) was conducted with a multi-disciplinary expert panel (n = 7) from National Health Service (NHS) Lothian, part of the South East Scotland Cancer Network (SCAN). Secondly, a national survey was distributed to expert cancer care pharmacists with experience in clinical trial verification across NHS Scotland (n = 86). Results Of the 28 competencies proposed, 100% achieved consensus and were deemed important by the expert panel during the NGT. From the national survey, 26 (92.9%) of the competencies achieved national agreement and were considered transferable across Scotland. The final national competencies were split into four categories: general trial background (n = 13); calculations, laboratory results and toxicity assessments (n = 7); administration details (n = 3); prescription and patient details (n = 3). Based on the themes identified during the NGT the final national competencies were further split into two suggested complexity levels; Level 1 (core) and Level 2 (advanced). Conclusion The competency requirements for clinical pharmacist verification of SACT prescribed within a clinical trial were defined for national use across Scotland. The competencies were split into four categories and two complexity levels. Further work will be required to identify training requirements, develop a training programme to support these and to determine how these competencies should be assessed. In addition, further work could be undertaken to develop a United Kingdom wide competency framework based on the results of this study.