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Prescribing Safety Alerts “Pray keep the noise down, there’s a good chap!” “Geez peace! Dr Ian McNicoll Clinical Analyst - SCIMP, Ocean Informatics Dr Brian McKinstry Dept of General Practice, University of Edinburgh and CSO Fellow • • • • • Importance of prescribing safety Background to SEF Implementation of SEF Lessons learned Current challenges in medication related clinical decision support • Future developments Why Prescribing Safety • Medication related adverse events are a major cause of death and injury. • It has been estimated that around 6.2% of hospital admissions and 5700 deaths per year in the UK are due to adverse drug events. • Systematic reviews in the area have confirmed the central role that information technology has in the reduction of prescribing errors Patient Safety Agency Study • Two round Delphi approach to reach agreement on the most important safety features of general practice computer systems • Panel judged 32 of these statements to be important, and these were then used to develop scenarios • Drug-condition, drug-drug, drug-age, drug-lab result Prescribing scenarios tested • • • • • • Aspirin prescribed for a child of eight years Methotrexate prescribed in pregnancy Penicillin prescribed in a patient with penicillin allergy Oxytetracycline prescribed in with renal impairment Enalapril prescribed in patient with renal impairment Microgynon 30 (a combined oral contraceptive pill) prescribed in a patient with a past history of DVT • Oxytetracycline prescribed in a patient with a serum creatinine of 160 mmol/l • Propranolol prescribed in a patient with CCF Results • None of the systems met all the criteria. • They varied in the warnings they gave • All suppliers felt the problems could be rectified • How could this be encouraged The solution:Scottish Enhanced Functionality • Minimum standards for prescribing safety • No SEF revalidation means … No reimbursement for GP system • No extra funding to vendors to help with SEF costs • Must be used judiciously Speak softly but carry a big stick (Theodore Roosevelt) SEF Prescribing Safety 2006 • Based on NPSA paper aimed to include – – – – – – – Drug-drug interaction alerts Allergy warnings Contraindication warnings due to pregnancy Drug-disease contra-indication alerts Inappropriate dosage warnings Duplicate therapy warnings Similarly named drug alerts. • Awareness that many systems already had implemented these warnings SEF Prescribing Safety • A minimum of one click would be required to override every type of alert. • Where potentially more serious alerts are raised, the supplier should ensure that it is not possible to continue prescribing without requiring the clinician to verify they wish to override by a second prompt • The underlying reason for each alert had to be highly accessible. • The supplier should ensure that ALL alert overrides are registered on the system for medico-legal purposes. SEF Prescribing Safety • Complete block • Methotrexate less than weekly • Similar drug name warning • Penicillamine <-> Penicillin • High level alerts – 2 action override No blanket override • Allergies • Level 3-4 drug-drug interactions SEF Prescribing Safety Overrides • For the lower levels of alert (e.g. Multilex Grades 1 and 2 equivalent), overrides might be on an individual alert basis or through the end-user switching off this level of alert in the system. • For more serious alerts (e.g. Multilex grade 3 and 4 equivalents), the supplier should ensure that it is not possible for the end user to switch off the alert system. • If the user has switched off these lower levels of alert the suppliers must still ensure that the system records the fact that the alert system was switched off when the prescription was issued. SEF Prescribing Safety - Development • Testing – Test scripts – testing by commercial 3rd party • Minimum standards • User Group “sign off” • Vendor Beta testing • Few grumbles about over-alerting but... June 2008 – SEF Rollout • Unacceptable levels of over-alerting – Drug –doubling alerts – Drug – condition checking • Clumsy ‘double-click ‘override mechanism SEF Response • Immediate dialogue with User Group reps via SCIMP • Immediate discussion with vendors inc. drug safety database suppliers • Sample SEF override logs from users Contraindications for CERAZETTE: Undiagnosed gynaecological Precautions bleedingfor DIAZEPAM: Cardiorespiratory READ Trigger: insufficiency, Renal impairment. Reduce Dose Menorrhagia Contraindications for DIAZEPAM: Porphyria Prescriber Warnings for DIAZEPAM: READ Trigger: Gout Monitor patients with marked personality disorder (trigger anxiety) Diagnosis • Misunderstandings about Blanket overrides – Some vendors did not allow overrides on lower alert levels (not SEF requirement) • Condition checking / Drug doubling • Issues around age-related alerts – Aimed at children – Many non-specific alerts in elderly • Condition checking misfiring in some systems – Over-inclusive matching • BPH == Erectile dysfunction • Vendors not using most up to date versions Lessons Learned • The Supply Chain – Involve ALL stakeholders early – Use vendor, safety product provider expertise • End to end testing important • Standard Requirements documentation inadequate • Agile, Collaborative approach w vendors Formal Clinical Safety review • Standard Beta testing insufficient – Standard script led testing insufficient • Experienced informaticians/users – Hands-on evaluation – Time and funding • GP2GP Clinical Safety testing Positives? • First attempt to define national prescribing safety standards? – Most of the recommendations were reasonable – Override logs will prove a valuable research resource to improve alert accuracy – Highlighted the issues, state of the art prescribing safety. – Excellent cooperation from all involved