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P05 Experience of improving governance and validity of an electronic drug guide
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  1. Melody Chan,
  2. Jennifer Weddell
  1. Southampton Children’s Hospital

Abstract

Background The neonatal network transport drug guide was due for review as per usual governance process and as part of the Get It Right First Time (GIRFT) neonatology report.1 Transport drug guides are used to provide information for Special Care Units (SCUs)/Local Neonatal Units (LNU) on preparation of unfamiliar drugs to enable safe transfer of patients to the tertiary centres. The existing guide used an Excel spreadsheet, entry of a patient’s weight and gestational age returns doses and dilutions to aid prescribing and administration. The Medicines and Healthcare products Regulatory Agency (MHRA) recommends that all medical devices should be registered,2 so advice on digital compliance was required. As part of the planned review, a comprehensive validation process was required to improve governance around the drug guide.

Aim To improve patient safety associated with use of the neonatal network drug guide by updating drug doses, improving usability, and enhancing governance compliance.

Method Guidance was sought from the host site Trust’s Medical Devices Safety Steering Group. Formulas within the drug guide were made visible and verifiable by the user, and all logical functions (e.g., ‘if’ functions) within the spreadsheet were removed. Protection against data entry, except in allocated fields, was enhanced. Drug doses were verified against the local neonatal formulary, national guidelines, and other resources. The drug guide was subjected to a stringent validation process including user acceptance testing by a range of healthcare professionals using different internet browsers and versions of Excel. A change control process was implemented to track and trace future changes to the drug guide.

Results A validated drug guide with associated quality management and change control structure akin to the recommendation of the MHRA and GIRFT report was submitted to the Trust’s governance process. The guide was approved as an interim solution prior to development of a MHRA certified drug calculator. The drug guide was placed on the Trust and Network risk registers to highlight that the interim solution is not a drug calculator and should be used as an aide, with staff completing drug checks as per local medicines administration policy.

Conclusions MHRA guidance on medical devices is designed to improve patients’ safety. However, these recent regulations can be seen as a challenge for the continuation or development of well-intentioned medication safety projects. Nevertheless, it should be considered critical that drug guides are technically simple and have undertaken a thorough and robust validation process. The drug guide is a validated interim solution that supports safe patient management. Positive verbal feedback from LNUs/SCUs has been obtained and formal feedback will be sought when the drug guide has been in circulation for a longer period. Incident reports will be monitored for errors alongside any near misses related to the drug guide. The team is working with relevant local experts to create a medical device that could be certified within MHRA guidance by the end of 2024.

References

  1. Adams E, Harvey K, Sweeting, M. Neonatology GIRFT Programme National Specialty Report. Get It Right First Time, 2022. https://gettingitrightfirsttime.co.uk/girft-reports/

  2. MHRA. Guidance: Medical devices: software applications (apps) Appendix 2- Clinical calculators, 2023 https://assets.publishing.service.gov.uk/media/64a7d23c7a4c230013bba33e/Appendix_2_-_clinical_calculators.pdf

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