Medication Safety in the Operating Room: Using the Operating Room Medication Safety Checklist CPSI Safe Surgery Saves Lives Workshop Montréal, QC 29Mar2011 Julie Greenall, RPh, BScPhm, MHSc, FISMPC Institute for Safe Medication Practices Canada 2011
ISMP Canada ISMP Canada is an independent not-forprofit organization dedicated to reducing preventable harm from medications. Our goal is the creation of safe and reliable systems for managing medications in all environments. www.ismp-canada.org
OR Medication Safety Checklist Developed by ISMP Canada in collaboration with: Canadian Anesthesiologists Society Operating Room Nurses Association of Canada Institute for Safe Medication Practices (US)
Why develop a medication safety checklist for the OR? OR is a unique environment Frequent use of high-alert medications Sterile field requirements add complexity Error reports and stakeholder feedback identified need for an OR-specific resource focused on medication management Complementary to the WHO Surgical Safety Checklist
High Alert Medications High-alert medications are drugs that bear a heightened risk of causing significant harm when they are used in error. ISMP s List of High-Alert Medications. Available from: http://www.ismp.org/tools/highalertmedications.pdf
Examples of High Alert Medications Anticoagulants Cancer chemotherapy Concentrated electrolytes Hypoglycemic agents Inotropic agents Neuromuscular blocking agents Opioids
OR Medication Safety Checklist Developed as part of the Ontario Medication Safety Support Service (MSSS) initiative which is funded by the Ontario Ministry of Health and Long-term Care Follows development of other resource kits for high-alert medications: Potassium Chloride, Opioids, Heparin
Health Care Reality Cognitive overload Workloads Multitasking Interruptions Miscommunication
Errors? Physicians, nurses, pharmacists and other providers are expected to function perfectly 100% of the time But... We work in an imperfect system
Swiss Cheese Model James Reason, 1991 Barriers & Safeguards against Errors Multiple Demands on Attention Poor Lighting Poorly Designed Storage Facility Patient receives wrong drug Inadequate Training and Skills Mix Poorly Designed Order Forms Poorly Designed Drug Packaging Latent Failures
Purpose of the Checklist Promotes distinguishing characteristics of safe medication management Facilitates assessment of potential vulnerabilities Identifies opportunities for improvement Provides a baseline so that improvement efforts can be monitored over time
OR Checklist Framework: 10 Key Elements Patient Information Drug Information Communication of Medication Orders and Other Drug Information Medication Labelling, Packaging, and Nomenclature Medication Standardization, Storage, and Distribution Medication Delivery Device Acquisition, Use, and Monitoring Environmental Factors Practitioner Education Patient Education Quality Processes and Risk Management
Context Individual hospital scores are not necessarily a reflection of performance, but risk associated with the business of health care High scores do not mean you will never have an error but do mean risk is decreased
Process Establish a multidisciplinary team. Estimated time commitment is 2-3 hours Achieve consensus on level of implementation for each representative self-assessment characteristic
Web-based Comparative Program On-line access allows comparison to: Previous in-house surveys Total aggregate Select fields Province Hospital type, bed size, service type, etc
Participation and Results to Date
Results Areas of Strength Top 5 (Highest scores) Item 1.5 Standardized and highly visible prompts are used for all patients with a known medication allergy. Item 1.8 Practitioners use 2 unique identifiers to confirm the patient s identity after the patient arrives in the OR (100%) Item 4.8 Labels for IV infusions are available in all medication preparation areas in the OR and have sufficient space to add drug name, concentration or dose, route, date and time prepared. Item 6.3 Infusion devices are used for continuous infusions of high-alert medications. Item 7.3 lighting in the OR and procedure area is adequate to allow labels and other important drug information to be easily read wherever medications are prepared and administered (100%).
Results Opportunities for Improvement Top 5 (lowest scores) Item 2.10 A pharmacist is assigned to provide clinical pharmacy services in perioperative areas. Item 5.6 The pharmacy prepares specialty solutions containing high-alert medications that are not commercially available, including those used for irrigation (e.g., solutions containing epinephrine). Item 5.12 Distinct labelling and bold warnings are used in all places where neuromuscular blocking agents are stored, including anesthesia medication trays and refrigerators.
Results Opportunities for Improvement (cont d) Item 5.15 Medications on trays are segregated by pharmacologic class to help prevent selection errors due to similar appearance (e.g., ephedrine and naloxone ampoules). Item 5.17 Medications for sub-specialty practice (e.g., cardiovascular anesthesia, neuroanesthesia) are stored on separate supplemental trays or in a manner that does not alter the standard storage design.
Context ISMP Canada is not a standard-setting organization The self-assessment characteristics in the MSSA are not purported to represent a minimum standard of practice Some of the self-assessment criteria represent innovative practices and system enhancements that are not widely implemented
When to Reassess Suggest reassessment on a regular basis e.g. every 1-2 years To track progress To maintain safety focus
Feedback from the Ontario Pilot 89% of respondents reported that they planned to continue using the Checklist as part of their operating room quality improvement process 67% reported they were planning or in the process of implementing changes as a result of their Checklist finding 44% indicated that they had fully implemented changes as a result of completing the Checklist
Concentrated Epinephrine - International Incidents Available from: http://www.ismp.org/newsletters/acutecare/articles/1996 1204.asp The American Academy of Otolaryngology - Head and Neck Surgery Nearly 70% of respondents to a survey of members were concerned about a potential mix-up in the administration of concentrated epinephrine during surgery. Shah RK, Hoy E, Roberson DW. Errors with concentrated epinephrine in otolaryngology. The Laryngoscope. Nov 2008;118: 1928-1930) An otherwise healthy adult male sustained a bicycle accident resulting in a nasal fracture...rather than lidocaine with epinephrine, the surgeon injected 4 ml of 1:1000 epinephrine...despite several hours of aggressive measures to stabilize the patient s condition, the patient expired.
A physician s story
Concentrated Epinephrine Canadian Incidents ISMP Canada Safety Bulletins available from: www.ismp-canada.org/ismpcsafetybulletins.htm
To view the alert or the video from the Food and Drug Administration, visit ISMP Canada website: http://www.ismp-canada.org/index.htm
Management of Concentrated Epinephrine (Additions to Version 2) 5.29 Multi-dose vials of epinephrine 1 mg/ml for injection (e.g., 30 ml vials) are not stored in, or provided to, the OR. 5.30 Epinephrine 1 mg/ml for topical use is supplied in a manufacturer s pour-bottle format. Additional precautionary measures are implemented to deal with back orders (e.g., having pharmacy prepare the epinephrine in a distinct, ready-to-use, pour-bottle format or in a topical syringe). 5.31 Medications intended for topical use, such as epinephrine, are not placed into a parenteral syringe (to avoid the risk of a substitution error or inadvertent injection). 5.32 Medications intended for injection by the surgeon (e.g., local anesthetic for infiltration of the surgical site) are not placed into an open container. 5.33 Local anesthetics for infiltration of the surgical site are kept in their original vials until needed. When such a medication is required, it is withdrawn into a syringe (and labelled) immediately before use so that the surgeon can participate in a reliable verification process using the manufacturer s product and the syringe label.
Key learning related to incidents with products intended for topical use Always label all syringes and containers Place all injectable medications into a syringe Place all topical medications into a bowl Ensure that the word TOPICAL appears on the label of any container used to hold a solution intended for topical application
Additional Activities A Failure Mode and Effects Analysis (FMEA) has been conducted in collaboration with a hospital and human factors engineer to identify system safeguards Discussions with manufacturers are in progress regarding enhanced labeling and packaging
We encourage you to report medication incidents Practitioner Reporting https://www.ismp-canada.org/err_report.htm Consumer Reporting www.safemedicationuse.ca/
Julie Greenall: jgreenall@ismp-canada.org OperatingRoomChecklist@ismpcanada.org ISMP Canada: 416-733-3131; 1-866-544-7672 (1-866-54-ISMPC)