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Error Reduction Strategies for High-Alert Medications Kelly Besco, Pharm.D., FISMP, CPPS Medication Safety Officer | OhioHealth Pharmacy Services Conflict of Interest Disclosure Kelly Besco declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 2 Objectives • Describe troublesome process designs that often impact the safe use of high alert medications. • Identify three key safety principles to use in medication error prevention. • Differentiate between high leverage and low leverage error reduction strategies. 3 Principles of Safe Use of Medications • Three principles to promote the safe use of medications 1) Reduce or eliminate the possibility of error 2) Make errors visible 3) Minimize the consequence of error 4 Reduce of Eliminate Possibility of Error • Limit the number and variety of medications available for use. • Examples: – Isolate storage of medications to Pharmacy – Ban on OTC sale of pseudoephedrine, which is used to make methamphetamine 5 Make Errors Visible • Making errors visible can prevent patient harm from occurring. 6 Minimize Consequences of Error • Practices can be changed to reduce effect of errors that occur. • Closer monitoring can improve early detection of errors and prompt remedial action. 7 Error Reduction Strategies 8 Rank Order of Error-Reduction Strategies Strategy – Fail-safes and Constraints – Forcing Functions – Automation and computerization -----------------------------------– Standardization – Redundancies – Reminders and checklists ------------------------------------– Rules and policies – Education and information – Suggestions to “be more vigilant” Power (Leverage) Car won’t start if alcohol is detected on breath Reminder signs and checkpoints Rule/Law: It’s illegal to drive over the allowable alcohol limit – High – Medium – Low Fail-safes Feature which, in the event of failure, responds in a way that will cause no harm or at least a minimum of harm. It is automatically activated in the event of failure. Fail-safes Bubble detector: A safety device that detects air bubbles in the tubing, indicating that air was drawn into the line and a decreased delivery of the ingredient could result. 11 Constraints The state of being checked, restricted, or compelled to avoid or perform some action. Forcing Functions • Aspect of a design that prevents the user from taking an action without consciously considering information relevant to that action. 15 Standardize and Simplify • Standardization reduces reliance on human memory and vigilance. • Simplification of processes reduces load on memory, planning and problem solving. • Standardization and simplification reduce variation and complexity. 16 Available Heparin Vial Concentrations • 10 units/mL • 100 units/mL – 1 mL vial – 10 mL vial • 1,000 units/mL – – – – 1 mL vial 2 mL vial 10 mL vial 30 mL vial • 5,000 units/mL – 1 mL vial – 10 mL vial • 10,000 units/mL – – – – 1 mL vial 4 mL vial 5 mL vial 10 mL vial • 20,000 units/mL – 1 mL vial – 5 mL vial • Order stated “Cytoxan 4 g/m2 days 1-4 (over 4 days) • Given as 4 g/m2 EACH DAY for four days Benefits of Standardized Work Before implementing daily goals sheet: Less than 10% nurses and residents understood goals for care for the day After implementing daily goals sheet: Greater than 95% of nurses and residents understood the goals for care for the day ICU LOS decreased from a mean of 2.2 days to 1.1 Simplify 21 Differentiation • Need to draw attention to differences between lookalike products. • Strategies: 1) Remove one of the look-alike medications from use 2) Purchase one of the products from a different manufacturer 3) Use auxiliary warning labels 4) Barcode scanning 22 Reminders • Examples: – Warning labels – Computerized warnings – Visual aids 24 Redundancies • A system of redundancies in which one person independently checks the work of another individual is essential to embed in processes involving high-risk medications and populations (e.g., pediatrics). 25 Case Study: Concentrated U-500 Insulin 26 Concentrated U-500 Insulin: Common Errors • Dose Translation— – Incorrect doses translated when dose written as corresponding units on U-100 insulin syringe. • Many “good catches” made by hospital with established Pharmacist verification protocol. • Omissions— – Protocol was to use patient’s own supply resulting in missed doses until medication brought in by patient’s family. • Patient Administration Events— – Patient administered own supply without physician order. U-500 Insulin Safe Use Protocol • Standardized order set • Endocrinology consult • Pharmacist double check • Patient Interview Prescribing Administration • Nursing education • Patient specific doses Transcribing Storage/ Dispensing • Separate storage • Dispense in tuberculin syringe • Product double check Safe Use Protocol– Prescribing Safe Use Protocol– Prescribing Safe Use Protocol– Prescribing Safe Use Protocol– Prescribing Safe Use Protocol– Prescribing • Additional Ordering Parameters— – If an order is NOT completed on the order set, the reviewing Pharmacist contacts the prescriber. – Pharmacists may complete the order as a telephone order if desired by the prescriber. Safe Use Protocol– Transcribing • As an additional layer of safety, a process was approved for Pharmacists to interview the patient to verify their home dose of U-500 insulin. • A kit was developed for use during the interview. • The kit features a U-100 and Tuberculin syringe as well as an interview checklist. • Orders are not transcribed by the Pharmacist until the interview is conducted. Safe Use Protocol– Transcribing • During interview patient is asked which syringe they use to administer their insulin and demonstrate using the identified syringe, the dose they draw up into the syringe. • A progress note is completed by the Pharmacist once the verification is completed. • A standardized template was developed for the progress note. • Pharmacist additionally updates electronic medication reconciliation list with home dose and notes the equivalent dose on a U-100 syringe. Safe Use Protocol– Transcribing • Order Entry— – U-500 process checklist available to pharmacists – Link in pop-up box in Pharmacy information system. – Computer entry listing designed to reduce risk of incorrect selection. – Default route to subcutaneous in computer system. – Independent double check required to verify accuracy. Safe Use Protocol– Storage/Dispensing • Storage— – U-500 vials are separated from other types of insulin in the Pharmacy. • Vials are NOT stored in patient care areas. – Stored in red “high alert” medication bins. – Auxiliary labeled— “high potency” Safe Use Protocol– Storage/Dispensing • Dispensing— – Pharmacy dispenses individual doses to the units • Tuberculin syringes • Each dose labeled will “high potency” auxiliary sticker • Each syringe requires a two Pharmacist double check prior to dispensing. Safe Use Protocol– Administration • Since orders for U-500 insulin are rare, a Nursing Education sheet is sent with each dispensed syringe to remind Nursing staff of required safe practices. Validate Effectiveness! • Review was completed of patients that received U500 insulin over a 6 month period. – 22 patients included in the review. • Results of the review showed that overall, we are doing a GREAT job in following our safety protocol. – Example: The Humulin Regular U-500 Insulin Order Set was completed in 100% of patients! • There was 1 opportunity identified from the review related to completion of the Pharmacist Progress Note subsequent to the patient interview. Opportunities • Completion of Progress Note— – Pharmacist feedback was that the initial template provided for the progress note was too long and detailed; therefore, it was not being used 100% of the time. – SOLUTION: A streamlined/shorter version of the progress note template was developed. Process Improvement Revised Progress Note Template— PHARMACOTHERAPY NOTE: INSULIN U-500 VERIFICATION Pharmacist has evaluated patient’s home dose of insulin U-500 during an interview with the patient and/or caregiver and: ___ Verified dose has been correctly ordered OR ___ Physician has been contacted to correct order Please call with any questions. Pharmacist Name: Contact Number: Rank Order of Error-Reduction Strategies Strategy – Fail-safes and Constraints – Forcing Functions – Automation and computerization -----------------------------------– Standardization – Redundancies – Reminders and checklists ------------------------------------– Rules and policies – Education and information – Suggestions to “be more vigilant” Power (Leverage) – High – Medium – Low Risk Management Plan Design 45 Risk Control • Error prevention strategies are not mutually exclusive. • The fastest and easiest solution may not always be the best . . . may introduce new sources of error. • People cannot be expected to compensate for weak systems • Do not rely on education alone! 46 Prioritize Risk-Control Efforts • High impact (for severity) – Effect which has the greatest potential to cause harm • Actionable • Streamlines and simplifies, does not add complexity 47 48