QIA can take many forms depending on the roles you do and the nature of your practice but they must be robust, systematic and relevant to your work. You should participate in Activities that are your own work or responsibility and where the work has been part of a team effort your role must be clearly explained. GMC examples of QIA from the updated key document Guidance on supporting information for appraisal and revalidation (2018) include:
- Review of your performance against local, regional or national benchmarking data where this is robust, attributable and validated. This could include morbidity and mortality statistics or complication rates.
- Clinical audit. This must be evidence of effective participation in clinical audit or an equivalent quality improvement exercise that measures the care with which you have been directly involved.
- Case review or discussion. A documented account of interesting or challenging cases that you have discussed with a peer, another specialist or within a multidisciplinary team.
- Learning event analysis.
- Audit and monitoring of the effectiveness of a teaching programme.
- Evaluating the impact and effectiveness of a piece of health policy or management practice.
Many doctors revalidating through the Faculty undertake clinical work and so the above GMC examples will be self-explanatory in relation to that part of their scope of work. However most pharmaceutical physicians also or entirely work in a non-clinical setting. The GMC requirements are the same and there are a large number of opportunities for relevant QIA. The key is to take the principles underpinning QIA and apply them to your work, which is something all doctors can do regardless of the nature of their practice. Below are some real life examples that when appropriately evidenced with reflection, learnings, changes in practice and re-evaluation would meet GMC requirements.
- Audit – It may be difficult for MHRA and FDA audits to be used as any individual doctor may not play a sufficient role especially in a large company but they can be appropriate, for example, in a smaller company and where the doctor is responsible for the medical department. There are however many other opportunities for audits of a doctor’s own or their department’s work. Examples are PMCPA audits, financial and expenses audits for doctors running their own company or CEO of a company. Also audits of informed consent procedure, departmental honorarium/grants, medical information letters, code of practice issues, regulatory submissions and reviews, ethical committee submissions, NICE submissions, safety monitoring. There are a wide range of outcomes that could be subject to an audit.
- Case Reviews – these are the most common QIA, but what is important is the writing up of what the doctor would do differently and better next time. The opportunities for case reviews where a doctor’s work has been subject to critique by peers or seniors is endless and examples include;
- healthy volunteer initial dosing
- loss to follow up in clinical studies (identified problems, analysed causes and developed an immediate and also longer-term solution with principles to guide future decision making)
- review of work by scientific advisory board (e.g. tox /ADR review)
- significant ADR(s) in a study or post marketing
- promotional copy that was subject to inter-company correspondence
- promotional copy that had significant alterations before use
- successful and unsuccessful regulatory submissions (eg IND applications, protocol variations, ethics committee submissions)
- mock resuscitation exercise
- patient materials reviewed by patient panels
- review of promotional material processes
- protocol reviewed by internal or external review committee
- named patient programme where there had been a significant event
- approach to managing a personal health matter which impacted on professional work
- case review of training delivered with changes made in light of delegate feedback
- case review of managing a direct report with a performance problem
- Health Policy, Management Practice – this could be an SOP that the doctor has written or updates for a particular reason and it would include what was done and why, the intended impact, how that will be monitored and, either for that appraisal or as a carry forward in the PDP, the evaluation of the outcome of the SOP to determine whether it has achieved its objectives.
There are many other examples can be considered as a critique of one’s own work which if followed by a demonstrable change in practice where indicated would meet the requirements, for examples submitting a manuscript for peer review, the comments, the changes and the learnings for next time, with appropriate documentation – as with any QIA. Acting as a peer reviewer would be CPD as it is not a critique of one’s own work but the work of another.