Development and outcomes of a pilot risk assessment process and expert panel for medicines procured in an NHS Acute Trust
Authors: Lewis C , Weerasooriya D , Cheng C 
Published: November 2023

Abstract

Introduction
The risk assessment process for new medicines procured into NHS Acute Trusts varies between organisations. National guidance identifying categories of medicines requiring risk assessment is lacking. A UK Medicines Information (UKMi) developed risk assessment tool1 was fully completed for all new medicines procured at the Trust without exception, consuming significant clinical pharmacist resource. Completed risk assessments received review and approval by the specialty Principal Pharmacist only. Wider input from the Medication Safety team was sought if identified as required by the pharmacist completing or reviewing the tool.

Aim
To pilot a rationalised risk assessment process for newly procured medicines and measure the effect of implementation on clinical pharmacist workload and satisfaction, identification of risks and mitigations.

Methods
The rationalised risk assessment process was informed by a working group encompassing formulary, governance, medication safety and clinical service leads. The UKMi risk assessment tool was adapted and National Patient Safety Agency (NPSA) parenteral medicine risk assessment2 incorporated. A flowsheet triaging medicines requiring risk assessment was agreed. This included; unlicensed medicines, off-label use, parenteral medicines with an NPSA score over 2, controlled drugs, changes to concentration/excipients, known safety concerns e.g. due to national alerts, and any other medicine deemed high risk such as anticoagulants, cytotoxics, insulins and intrathecals. A New Drug Panel (NDP) was established, comprising a broad range of senior pharmacy leaders including the chief pharmacist. The NDP convened 6 weekly to agree the process, review risk assessments and propose additional mitigations. The process was piloted for 6 months (November 2021-May 2022). During the pilot, the number of new medicines procured and number of completed risk assessments were measured, alongside outcomes of NDP review. At the end of the pilot, users were invited to provide feedback directly via email and this was collated. Ethical approval was not required for this service evaluation.

Results
During the pilot, 248 requests to add medicines to the pharmacy dispensing system were made; 124 (50%) were new medicines to the Trust. 55/124 (44%) were triaged requiring risk assessment.
The NDP met 4 times; 45/55 completed risk assessments were reviewed, 4 of which were considered via email due to urgency. The remaining 10 were scheduled for review at the next meeting. A total of 14 additional mitigations were advised and actioned for 12/41 (29%) new drugs reviewed, the remaining risk assessments were approved without further mitigations. Four pharmacists provided feedback and 100% was positive. The modified risk assessment was preferred due to ease of completion and improved clarity.

Discussion/Conclusion
A modified risk assessment process was piloted successfully; the number of required risk assessments halved releasing clinical pharmacist time and improving satisfaction with the process. Risk of patient harm was reduced through establishment of an expert NDP who identified a number of additional risk mitigations. No issues were identified from the medicines which were triaged out of the risk assessment process, though these would only be identified retrospectively. Limitations included that user feedback could have been collated more robustly, e.g., to provide more specific responses.

References
1. UKMi. Tool for assessing the in-use patient safety characteristics of medicines and medicinal products, Specialist Pharmacy Service. 2016. Available from: https://www.sps.nhs.uk/wp-content/uploads/2016/03/Product-risk-assessment-tool-abbreviatedversion.pdf [Accessed 10th May 2023].
2. National Patient Safety Agency. Risk assessment tool for the preparation and administration of injectable medicines in clinical areas. 2007. Available from: https://webarchive.nationalarchives.gov.uk/ukgwa/20180501163752/http:/www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=59812&p=3 [Accessed 10th May 2023].