Accessing data for quality improvement
Topics for data usage in quality improvement activities come from all aspects of pharmaceutical medicine and include:
- clinical trials
- drug safety
- medical services
- reports and publications
- standard operating procedures and audits
- assessments and outcomes
- recognition and awards.
The specialty improves practice by making available relevant and focused education and training programmes in drug development science (pharmaceutical medicine), including specialty training (PMST). As part of PMST, the training progression (ARCPs), outcomes (CCT and CESR) and the ongoing feedback on training (GMC Annual Trainee Survey) are all designed to improve practice. The FPM is the standard-setting body for the specialty and concerned with data and information to improve practice – for instance the Good Pharmaceutical Medicine Practice (GPMP) guidelines, launched in 2014.
As a regulated research-based specialty concerned with the discovery, development, evaluation, licensing and monitoring of medicines and the medical aspects of their marketing, pharmaceutical medicine is subjected to:
- regular audit and inspection of pharmacovigilance (medicines safety) (GVP)
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP).
These rigorous and legally-based inspections have an effect on the continuous improvement of standards of practice within the specialty, particularly in relation to the systems and processes in place in the R&D of medicines for risk-reduction, and to protect the safety and wellbeing of patients and research participants.
Much of the activity concerned with improving quality and standards of practice have counterparts or direct comparisons in clinical practice, for example:
- areas of clinical research conduct and of safety of medicines
- pharmacovigilance (detecting, recording and reporting drug adverse events and reactions and drug interactions)
- ethical practices in interacting with patients, including recruitment to clinical trials and informed consent.