Prescribing Safety Alerts

Dr Ian McNicollClinical Analyst - SCIMP, Ocean Informatics

Dr Brian McKinstryDept of General Practice, University of Edinburgh and CSO Fellow

“Geez peace! “Pray keep the noise down, there’s a good chap!”

• 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 over-ride 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 bleeding

READ Trigger:Menorrhagia

Contraindications for DIAZEPAM:

Porphyria

READ Trigger:Gout

Precautions for DIAZEPAM:

Cardiorespiratory insufficiency, Renal impairment. Reduce Dose

Prescriber Warnings for DIAZEPAM:

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