Care – Medication Adverse Events

Service: Risk Management
Subject: Care
Setting: Medications
Type: Risk Profiles

Medication adverse events may occur in any healthcare setting and may result in significant harm to patients.  Medication adverse events may be a result of human error (e.g., knowledge deficit, lack of compliance with safety protocols), ineffective processes, physical environment.

This document contains information entered by HIROC subscriber healthcare organizations (acute and non-acute) in the Risk Register application to help you in your assessment of this risk.

Ranking / Ratings

  • Likelihood – average score 2.84
  • Impact – average score 3.63

The Risk Register allows for risks to be assessed on a five-point likelihood and impact scale, with five being the highest

Key Controls / Mitigation Strategies

  • Key policies/procedures/processes 
    • Safe medication practices and incident review committees
    • 8-rights of medication administration 
    • Point-of-care patient identification and verification (i.e. scanning patient armbands – barcodes)
    • Allergy documentation and alerts in medical record, pharmacy system, and patient armband
    • Independent double checks 
    • High-alert medication identification/list
    • Elimination of concentrated potassium solutions in clinical areas
    • ‘Do Not Use’ abbreviation list
    • Medication reconciliation (admission, transfer, discharge)
    • Best Patient Medication History (BPMH)
    • Management of patient’s own medication (including storage separate from Pharmacy dispensed medications)
    • Standardized order sets and processes to develop and review
    • Pharmacy review and oversight of prescribing (i.e. dose/concentration/contraindications)
    • Pharmacy identification and notification to prescriber of need for therapeutic drug monitoring
    • Alignment of paper orders and electronic orders
    • Formulary review
    • Look alike and sound alike medications
    • Storage locations of drugs used for topical and injectable use
    • Limit concentrations of hydromorphone in clinical areas 
    • Standardized IV solutions
    • Pre-mixed IV solutions; pre-filled syringes
    • Standardized medication labeling
    • Safe storage of medications
    • Management of narcotics and controlled substances
    • Management of neuromuscular blocking agents
      • Specialized labeling for neuromuscular blocking agents
      • Access to airway and resuscitation equipment and resources when using neuromuscular blocking agents
    • Management of cytotoxic and non-cytotoxic hazardous drugs
      • Limit location where chemotherapy agents can be administered
      • Compounding worksheets outlining PPE requirements (pharmacy-specific)
      • Make available Intravenous (IV) monographs outlining handling requirements
      • Auxiliary labels indicating cytotoxic status
      • Medical order clear identification of route for administration of chemotherapy
      • Dispensing of medication that avoids any direct handling outside of the pharmacy 
      • Limit administration of intrathecal chemotherapy to hematologists
        • Limit where intrathecal chemotherapy can be administered
  • Equipment and technology
    • Smart pump technology
      • Patient Profile Capability Error Messaging
      • Maintenance of Smart Pump Drug Libraries
    • Closed-loop medication management systems (including bar code packaging)
    • Preventative maintenance program for all IV pumps
    • Dedicated vaccine  refrigerator  with temperature monitoring log
    • Medication dispensing systems (with automated storage and retrieval)
    • Automated warning on Omnicell for high alert/high concentration medications
    • Hazardous medications secure storage containers 
    • Optimize usage of electronic solutions intended to improve medication safety
      • Computerized Physician Order Entry (CPOE)
      • Electronic medical record (EMR) allergy alerts
    • Proactive monitoring of drug shortages, alerts and recalls
  • Education/Training/Resources
    • Nursing orientation/annual medication safety education/in-services
      • Medication safety, knowledge and testing 
      • Drug calculation knowledge and testing 
      • IV smart pump knowledge and training yearly
      • High alert medication knowledge and testing 
      • Oxytocin knowledge and testing 
      • Patient controlled analgesia (PCA) pain management knowledge and testing
      • Independent double check for high-risk medication knowledge and testing
      • eFormulary knowledge and testing
      • Comprehensive skills training related to intravenous (IV) fluid therapy including early detection of IV infiltration and management of
    • Drug-related information resources available and accessible
    • Hard copy drug formulary available for downtime procedures
    • eFormulary on organization website and mobile applications
    • IV drug monograph instructions available and accessible 
    • Up to date listing of all cytotoxic/biologic agents in formulary
      • Management of
      • Safe handling and disposal of
    • Pharmacist on-call afterhours and on-site weekend coverage
    • Pharmacy order entry staff are regulated health care providers 
    • Pharmacy technicians with specialized knowledge for sterile compounding
    • Aseptic technique training for staff in compounding room
    • Code Brown/management of hazardous cytotoxic medication spills education
    • College of Pharmacy – standards of practice (i.e. Schedule II and III drugs)
    • College of Nurses – medication practice standards
    • College of Physicians and Surgeons – medication management 
    • Accreditation Canada – medication management and prevention of adverse medication events 

Monitoring / Indicators

  • Medication incident reports/reviews/trends (including near misses)
  • Monitor mandatory reporting of adverse drug events
  • Monitor maintenance of shortage lists
  • Narcotic utilization and losses 
  • Hazardous drug spills and safety incidents to occupational health and risk department
  • Reviews of incidents and current processes 
  • Independent double check/high alert medications audits
  • IV solution concentration and volumes audits
  • Electronic medication management audits
  • Education logs
  • Audits to assess compliance with policies and processes e.g. narcotic count process and records
  • Documentation audits
  • Computerized Physician Order Entry (CPOE) audits
  • Number of patient complaints related to IV insertion, drug errors
  • Surveillance cameras in medication rooms where narcotics are dispensed
  • Smart pump errors investigations
    • Review of smart pump logs
  • Reports to MAC, Quality and other Governance committees
Date last reviewed:
This is a resource for quality assurance and risk management purposes only, and is not intended to provide or replace legal or medical advice or reflect standards of care and/or standards of practice of a regulatory body. The information contained in this resource was deemed accurate at the time of publication, however, practices may change without notice.