Medication Adverse Events

Medication adverse events consist of both preventable medication incidents and adverse reactions (Agency for Healthcare Research and Quality, 2019). Medications are one of the most frequently cited sources of adverse events in all healthcare settings. Errors can occur at any or multiple points in the medication use process. Certain client populations such as neonatal and paediatric clients, frail elderly, or the critically ill are especially vulnerable to medication-related events. High-alert medications, defined as drugs that bear a heightened risk of causing significant client harm when used in error (such as insulin, opiates, chemotherapy agents), require heightened vigilance during ordering, transcribing, dispensing, administering, and monitoring (ISMP Canada, n.d.). In 2015, five of Canada’s “never events” were identified as pharmaceutical-related (Canadian Patient Safety Institute & Health Quality Ontario, 2015).

Expected Outcomes

Implement standardized, evidence-based strategies to enhance safe medication prescription, preparation, and administration.

Medication safety is a top organizational priority.

Implement formal strategies to provide ongoing and targeted education and training to staff and clients.

Definitions and Acronyms

• Client – includes all persons who receive healthcare and related services including patients, residents and persons in-care
• CT – computerized axial tomography
• EHR – electronic health record
• IV – intravenous
• Medical directives - an indirect order that gives authorization to a care provider or group of care providers (e.g., ED nurses) to implement the order (e.g., ED chest pain for adults) with a predefined patient population (e.g. ED patients presenting with symptoms suggestive of cardiac ischemia or cardiovascular symptoms such as discomfort jaw to umbilicus, upper limb discomfort without known injury, chest trauma…)
• Never events – “patient safety incidents that result in serious patient harm or death that are preventable using organizational checks and balances”, aka “never events” (defined as “patient safety incidents that result in serious patient harm or death that are preventable using organizational checks and balances” (Canadian Patient Safety Institute & Health Quality Ontario, 2015)
• OR – operating room
• POE – prescriber order entry

Common Claim Themes and Contributing Factors
 

Errors involving

• High alert medications.
• Antipsychotics.
• Vulnerable or clients with multiple co-morbidities specifically neonatal, paediatric, frail elderly, and critically ill clients.

Organizational

• Cumbersome or impractical medication policies / procedures.
• Assumption that medication administration and use of IV smart pumps is a core competency of all nurses (including travel and agency).
• Lack of processes to ensure requested laboratory tests are performed and results reviewed prior to medication administration (e.g., electrolytes).
• Laboratory calibration errors resulting in inaccurate results and inappropriate medication titration.
• Inexperienced staff ordering, preparing, or administering medications to unfamiliar client populations (e.g., neonates) or with unfamiliar medication concentrations.
• Work environments that:
  • Are not conducive or supportive of independent double checks (e.g., workload issues, tolerance for short-cuts);
  • Do not support or welcome escalation of unresolved care concerns or disagreements with the ordering or consulting practitioner.
• Interruptions during medication preparation and administration.
• Lack of standardization in placement of medications in automatic dispensing units.
• Informal workaround processes to access medications from automatic dispensing units.
• Lack of emergency preparedness protocols for unplanned EHR system downtime.

Judgement and Knowledge

• Re-ordering of medications without reassessment.
• Failure to re-order medication(s) post-surgery / post-procedures.
• Accepting or not questioning orders despite concerns about their clinical appropriateness.
• Incorrect programming of smart pumps.
• Failure to follow instructions on manufacturers’ printed labels.
• Failure to perform independent double checks for high-alert medications.
• Failure to recognize and act on lack of knowledge. 

Documentation

• Inconsistent documentation of client assessments / vital signs before and after administration.
• Failure to label syringes, vials, bowls, etc. for all topical and injectable medications in the OR.
• Illegible handwritten orders.
• Use of unapproved and dangerous abbreviations.

Communication

• Failure to escalate care concerns in a timely way, or at all.
• Failure to confirm and read back verbal orders during code situations.

Mitigation Strategies

Care Processes

• Adopt standardized, evidence-based opioid dosing and monitoring guidelines with a focus on (but not limited to) vulnerable and at risk clients such as neonatal, paediatric, critically ill, and frail elderly clients; ensure guidelines include initial and maximum dose recommendations (ISMP Canada, 2014) (ISMP Canada, 2014) (Dowell, Ragan, Jones, Baldwin, & Chou, 2022) (ISMP Canada, 2015) (ISMP Canada, 2012) (ISMP Canada, 2016). 
• Dispense high-alert medications in ready-to-use single doses, especially for neonatal and paediatric clients; consider pharmacy preparation and dispensing of all non-emergency high-alert parenteral doses for neonatal and paediatric clients where ordered (ISMP, 2017).
• Implement effective strategies to reduce distractions during medication preparation and administration.
• Adopt a carefully selected, limited list of medications requiring independent double checks (ISMP, 2019) (ISMP, 2017); support a culture that welcomes and encourages requests for independent double checks from all practitioners and disciplines.
• Adopt a standardized “Do Not Use” list for abbreviations, symbols, and dosage designations (ISMP Canada, 2018).
• Implement formal strategies to standardize concentrations of IV and oral liquid medications (Kimble, 2022) (Traynoe, 2016) (American Society of Health-System Pharmacists, n.d.).
• Adopt a standardized method for how medications are stocked, labelled, and placed in medication dispensing units (ISMP, 2022) (Health Canada, 2016).
• Implement a formal best practice plan for unplanned EHR system downtime (Miller, 2009) (Fahrenholz, Smith, Tucker, & Warner, 2009) (ISMP, 2022) (MGH Center for Disaster Medicine , 2018) (ECRI, 2017).

Safety Culture

• Implement formal strategies to develop and maintain a work environment which supports and expects:
  • Early response to suspected and actual clinical deterioration and medication incidents, including seeking assistance from peers and other resources (e.g., rapid response teams);
  • Assertive and respectful questioning and challenging of care decisions (in order to obtain clarity and / or to advance client safety concerns);
  • Zero tolerance of intra- and inter-disciplinary bullying and intimidation.
• Adopt a standardized, formalized, and program-specific chain of command (escalation) protocol for the rapid escalation of unresolved care concerns or disagreements related to concerns about questionable client conditions, orders, or care delivery (Canadian Medical Protective Association, 2021) (Canadian Patient Safety Institute, 2020) (Royal College of Nursing, 2020).

Communication    

• Adopt a standardized and structured communication framework for team (intra- and inter-disciplinary) including (but not limited to) communications with the prescriber.
• Implement evidence-based practice for the development of preprinted order sets (ISMP, 2010) (Wells & Loshak, 2019) and medical directives (College of Physicians and Surgeons of Ontario, 2021) (HIROC, 2018).
• Implement a standardized organization-wide mechanism to distribute and track responses to internal and external medication alerts and recalls (ECRI, 2018) (Magee, 2006).
• Employ the teach-back method with clients to confirm their understanding of medications and encourage them to ask questions; incorporate communication tools (e.g., ISMP Canada’s 5 Questions to Ask About Your Medications) to supplement discussion (ISMP Canada, 2016).

Equipment, Supplies and Technology 

• Ensure adequate and appropriate supplies for preparing / measuring paediatric doses less than 1 mL (e.g., T.B. syringes).
• Ensure oral syringes are kept stocked in client care areas for administration of oral liquid medications; do not use parenteral syringes to administer orally.
• Implement formal strategies to replace free flow IV systems with smart infusion pumps, especially for neonatal and paediatric clients.
• Adopt evidence-based / best practice for reducing errors associated with customizing and maintaining smart infusion pumps drug libraries (ISMP, 2022) (ISMP Canada, 2023) (ISMP, 2020).
• For smart infusion pumps, require all titration medication orders to include medication name, route, initial / starting rate, incremental units the rate can be increased or decreased, frequency of dose titrations, and maximum rate of infusion (ISMP, 2022).
• Work with vendors:
  • When creating parameters for customizing alerts, dosing, etc. and prohibit the cut and paste function from all EHR and POE systems;
  • To create forcing functions to ensure required information is entered before permitting order to be posted.

Team Training and Education

• Implement formal strategies to support and enhance the teams’ clinical knowledge, skills (technical and non-technical), and practical experience surrounding safe medication practices, use and programming of smart pumps, and computerized POE systems, including (but not limited to), scheduled interprofessional and cross-department skill drills and simulations.
• Ensure the team training and education strategies consider or involve: 
  • Knowledge, skills, and practical experience required for the given care setting (e.g., home, community health centre);
  • Unplanned EHR system downtime;
  • Unregulated care providers (where involved in medication preparation, administration, or monitoring), locums, travel, agency, contracted care providers in addition to regulated health professionals. 

Incident / Emergency Response

• Implement formal strategies to ensure medication syringes, bags, containers, vials, pumps, and documentation involved in medication-related events are retained / secured in anticipation of an analysis / review / investigation.
• Ensure post incident management processes include (but are not limited to) mandatory (e.g., Vanessa’s Law) and permissive (e.g., Canadian Medication Incident Reporting and Prevention System) reporting of medication-related adverse events (Health Canada, 2019).

Monitoring and Measurement

• Adopt a standardized, interdisciplinary, collaborative and evidence-based protocol for conducting quality of care reviews involving medication safety events resulting in client harm or death (Canadian Patient Safety Institute , 2012) (HIROC, 2015) (Machen, 2023); incorporate system thinking and human factors concepts into the review process.
• Adopt standardized quality indicators for safe medication dispensing, preparation, and administration (ISMP Canada, 2010) (Canadian Institute for Health Information, 2022) (Canadian Institute for Health Information, 2022) (Smeulers, et al., 2015) (Ontario College of Pharmacists, 2019).
• Incorporate learning from local, provincial, and national medication-related safety reviews and data into local protocols as well as staff and client education and training.

References

• Agency for Healthcare Research and Quality. (2019). Medication errors and adverse drug events. Retrieved from PSNet: https://psnet.ahrq.gov/primer/medication-errors-and-adverse-drug-events#:~:text=Background%20and%20Definitions&text=An%20adverse%20drug%20event%20(ADE,of%20exposure%20to%20a%20medication
• American Society of Health-System Pharmacists. (n.d.). Standardize 4 Safety. Retrieved from https://www.ashp.org/pharmacy-practice/standardize-4-safety-initiative
• Canadian Institute for Health Information. (2022). Hospital Harm Indicator General. Ottawa, ON: CIHI.
• Canadian Institute for Health Information. (2022). Potentially Inappropriate Medication Prescribed to Seniors. Retrieved from https://www.cihi.ca/en/indicators/potentially-inappropriate-medication-prescribed-to-seniors
• Canadian Medical Protective Association. (2021). Resolving conflict between healthcare providers. Retrieved from https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2021/resolving-conflict-between-healthcare-providers
• Canadian Patient Safety Institute . (2012). Canadian Incident Analysis Framework. 
• Canadian Patient Safety Institute & Health Quality Ontario. (2015). Never Events for Hospital Care in Canada. 
• Canadian Patient Safety Institute. (2020). The Safety Competencies: Enhancing Patient Safety Across the Health Professions. 2nd Edition. Edmonton, AL.
• College of Physicians and Surgeons of Ontario. (2021). Deligation of Controlled Acts. Retrieved from https://www.cpso.on.ca/Physicians/Policies-Guidance/Policies/Delegation-of-Controlled-Acts
• Dowell, D., Ragan, K. R., Jones, C. M., Baldwin, G., & Chou, R. (2022). CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Morbidity and Mortality Weekly Report, 71(No. RR-3), pp. 1-95. doi:10.15585/mmwr.rr7103a1
• ECRI. (2017). Self-Assessment Questionnaire Unplanned Downtime of Health Information Technology Systems. 
• ECRI. (2018). Medical device hazards and recall management. 
• Fahrenholz, C. G., Smith, L. J., Tucker, K., & Warner, D. (2009). Plan B. A practical approach to downtime planning in medical practices. Journal of AHIMA, 80(11), 34-38.
• Health Canada. (2016). Good Label and Package Practices Guide for Prescription Drugs. 
• Health Canada. (2019). Module 1: Overview of Vanessa’s Law and reporting requirements. Retrieved from Government of Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/education/module-1.html
• HIROC. (2015). Critical Incidents & Multi-Patient Events. Retrieved from https://www.hiroc.com/system/files/resource/files/2018-10/HIROC-Management-of-Critical-Incidents-April-2015.pdf
• HIROC. (2018). Medical Directives. Retrieved from https://www.hiroc.com/resources/risk-notes/medical-directives
• ISMP. (2010). ISMP Guidelines for Standard Order Sets. Retrieved from https://www.ismp.org/guidelines/standard-order-sets
• ISMP. (2017). ISMP Medication Safety Self Assessment for High-Alert Medications. 
• ISMP. (2019). Independent Double Checks: Worth the Effort if Used Judiciously and Properly. Retrieved from https://www.ismp.org/resources/independent-double-checks-worth-effort-if-used-judiciously-and-properly
• ISMP. (2020). ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps. Retrieved from Institute for Safe Medication Practices: https://www.ismp.org/node/972 
• ISMP. (2022). Adopt strategies to manage look-alike and/or sound-alike medication name mix-ups. ISMP Medication Safety Alert! Acute Care, 27(11), pp. 1-4.
• ISMP. (2022). Emergency preparedness: be ready for unanticipated EHR downtime. ISMP Medication Safety Alert! Acute Care, 27(17), pp. 1-5.
• ISMP. (2022). Safety considerations for challenges when using smart infusion pumps. ISMP Medication Safety Alert! Acute Care, 27(21), pp. 1-5.
• ISMP Canada. (2010). Medication Safety Support Service: Identification of Medication Safety Indicators for Public Reporting. 
• ISMP Canada. (2012). Opioid-Related Incident in a Long-Term Care Home. ISMP Canada Safety Bulletin, 12(12).
• ISMP Canada. (2014). Advancing Opioid Safety for Children in Hospitals. ISMP Canada Safety Bulletin, 14(3), pp. 1-6.
• ISMP Canada. (2014). Opioid-Related Deaths Associated with Medication Incidents: Findings of a Multi-Incident Analysis. Toronto, ON.
• ISMP Canada. (2015). Medication Incidents that Increase the Risk of Falls: A Multi-Incident Analysis. ISMP Canada Safety Bulletin, 15(12).
• ISMP Canada. (2016). 5 Questions to Ask About Your Medications. Retrieved from https://www.ismp-canada.org/download/MedRec/MedSafety_5_questions_to_ask_poster.pdf
• ISMP Canada. (2016). Safer Decisions Save Lives: Key Opioid Prescribing Messages for Community Practitioners. ISMP Canada Safety Bulletin, 16(8).
• ISMP Canada. (2018). Reaffirming the "Do Not Use: Dangerous Abbreviations, Symbols and Dose Designations" List. ISMP Canada Safety Bulletin, 18(4).
• ISMP Canada. (2023). “No Drug Selected” = Taking the Smart Out of Smart Pumps. ISMP Canada Safety Bulletin, 23(1), pp. 1-5.
• ISMP Canada. (n.d.). Definitions of Terms. Retrieved from https://www.ismp-canada.org/definitions.htm
• Kimble, C. (2022). Developing Standardized Concentrations, Overcoming Barriers. Pharmacy Times, 4(4), 16.
• Machen, S. (2023, 5). Thematic reviews of patient safety incidents as a tool for systems thinking: a quality improvement report. BMJ Open Quality, 12(2), e002020.
• Magee, A. (2006). Recall Management: Best Practice Basics. Biomedical Instrumentation & Technology.
• MGH Center for Disaster Medicine . (2018). Hospital Preparedness for Unplanned Information Technology Downtime Events: A Toolkit for Planning and Response. 
• Miller, A. S. (2009). Planning for Downtime. In D. Dumitru, The Pharmacy Informatics Primer (pp. 195-196). American Society of Health-System Pharmacists. doi:10.37573/9781585282753.012
• Ontario College of Pharmacists. (2019). Quality Indicators for Pharmacy. Retrieved from https://www.ocpinfo.com/about/key-initiatives/quality-indicators-for-pharmacy/
• Royal College of Nursing. (2020). Raising and escalating concerns. London, UK.
• Smeulers, M., Verweij, L., Maaskant, J. M., de Boer, M., Krediet, C. T., Nieveen van Dijkum, E. J., & Vermeulen, H. (2015). Quality indicators for safe medication preparation and administration: a systematic review. PloS one, 10(4), e0122695. doi:10.1371/journal.pone.0122695
• Traynoe, K. (2016). Medication Standardization Effort Aims to Improve Patient Safety. Retrieved from American Society of Health-System Pharmacists: https://www.ashp.org/news/2016/07/13/medication_standardization_effort_aims_to_improve_patient_safety
• Wells, C., & Loshak, H. (2019). Standardized Hospital Order Sets in Acute Care: A Review of Clinical Evidence, Cost-Effectiveness, and Guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health.