Med Safety in Anesthesia Class (3 per) PDF

12/14/23 Medication Administration Safety in Anesthesia Kelly Elmore DNP, APRN-CRNA Mary Baldwin University Advanced Pharmacology for Anesthesiology Practice I Spring Semester 1 U.S. Federal Drug Regulation 1938 Food, Drug, and Cosmetic Act (FDCA) Est...

12/14/23 Medication Administration Safety in Anesthesia Kelly Elmore DNP, APRN-CRNA Mary Baldwin University Advanced Pharmacology for Anesthesiology Practice I Spring Semester 1 U.S. Federal Drug Regulation 1938 Food, Drug, and Cosmetic Act (FDCA) Established FDA New Drug Application (NDA) 1962 Kefauver-Harris Amendment FDA power extension Requirement of “substantial evidence” of safety, effectiveness 2 U.S. Federal Drug Regulation Manufacturer standards Physiological risks Public health safeguards Federal regulations Drug labeling Rx drug distribution Innovations & patents 3 1  12/14/23 U.S. Federal Drug Regulation 1984 Dietary Supplement Health and Education Act (DSHEA) Dietary supplements Regulation similar to foods ”Qualified” health or disease claim allowed Biologics From living organisms to treat human diseases/conditions Must demonstrate similar outcomes with no additional risk 4 Definition of “Drug” “Any article designed to treat illness or alter the structure or function of the human body” (FDCA) A device may be classified as a drug depending on intended use Supplements may be classified as drug if they contain medications U.S. Pharmacopeia (USP) = official compendia Establishes regulations 5 Clinician Responsibilities Report: Significant abnormalities Prospective or existing product use faults Quality issues (pharmaceuticals, biologics, devices, dietary items, cosmetics) Report is not a legal claim or admission that adverse event or error occurred 6 2  12/14/23 7 8 Safety First! 2000 Institute of Medicine - improve patient safety, standards of care, learn from errors $ 2B annually on adverse drug events (ADEs) Anesthesia care Prescribe, select, order Dispense, prepare, label Administer, monitor, assess/re-assess Document Rare safety check, secondary verification Vigilance! 9 3  12/14/23 Medication Errors Common medications ○ Opioids, sedatives, antibiotics, vasoactive meds, muscle relaxants Risk factors ○ Absence of, improper _________________________________________________ ○ Poor implementation of prevention strategies ○ Long procedures Incidence ○ 4-11% ○ Lit review: 1 of 130-300 surgeries, ~79% preventable ○ Limited due to challenges of voluntary, self-reporting 10 Types of Errors - Intravenous Medications Prospective, observational & retrospective studies: ________________________________________________________** ○ Calculation errors (peds*), concentration or infusion rate errors ○ Repetition (extra dose) ○ Omission/failure to act (missed dose) Substitution ○ Syringe/ampule swap* ○ Wrong route Labelling errors Administering despite known allergy/intolerance Failure to flush a line after a drug 11 Prospective, observational study Six hospitals, pediatric surgery & anesthesia, nurse anesthetists 248 drug dilution samples prepared according to hospital protocol ○ Epinephrine, atropine, sufentanil, atracurium, cisatracurium Analyzed via liquid chromatography Greatest deviation from target - _____________________________________________________ ○ 70% of samples, > 10% of target ○ 23% of samples, > 30% of target Difficult to identify and include in ADE studies Risk serious and undiagnosed events 12 4  12/14/23 Closed Claim Examples Case #1 Cataract procedure under MAC Morbidly obese pt with multiple co-morbidities including OSA Midazolam, fentanyl, general anesthetic induction dose of propofol Apnea → unsuccessful mask ventilation & intubation → cardiac arrest LMA placement and ACLS → ICU → D/C home Claim: inappropriate administration medications 13 Closed Claim Examples Case #2 Facial surgery under MAC High oxygen flow rate through nasal cannula Electrocautery used during procedure → surgical fire Claim: inappropriate anesthesia planning 14 Strategies for Prevention Two RCTs Barcode scan, computerized read-back of med names, standardized cart organization Decrease in ADEs 11% to 9% (11% to 6% in simulation) Standardization Labels (name, strength, amount, diluent, expiration date/time within 24 hrs) Tallman lettering Color-coding (blue, red, yellow, orange, violet, green) Standardized concentrations Storage, med trays 15 5  12/14/23 Strategies for Prevention Technology “Smart” infusion pumps (w/medication library) Barcode-assisted Software tracking of controlled substances Unique connections for devices at various routes (eg, enteral feeding tube vs regional anesthesia system) 16 Strategies for Prevention Pharmacy Prefilled syringes Premixed solutions Avoid multiuse vials Avoid look-alike meds Pharmacist as clinical consultant 17 Recommendations Error detection (self-report, mandatory incident report, chart review/computer surveillance, etc.) Medication reconciliation ○ Verify medications as appropriate to plan of care ○ Review prescribed home medications, inpatient medications, allergies/intolerances ○ Ensure proper and correct documentation 18 6  12/14/23 Recommendations Utilize standardization, technology, and pharmacy strategies Provide thorough, standardized handoff between providers ○ Preoperative, postoperative staff ○ Anesthesia care team members, surgeon, OR staff as needed ○ Reconcile continuous infusions, controlled medications, needed medications prior to care handoff _______________________, distraction reduction during care 19 20 21 7  12/14/23 22 23 END! 24 8  12/14/23 References Brown, L. B. (2014). Medication administration in the operating room: New standards and recommendations. AANA Journal, 82(6):465-469 Nanji, K. (2023). Prevention of perioperative medication errors. https://www.uptodate.com/contents/prevention-of-perioperative-medication- errors/print?csi=6aef20b3-4ebc-4187-8f0e-c5c68f331201&source=contentShare#H3263160345 Kremer, M. J., et al. (2019). Preventable closed claims in the AANA foundation closed malpractice claims database. AANA Journal, 87(6):468-476 Wahr, J. A. et al. (2017). Medication safety in the operating room: Literature and expert-based recommendations. British Journal of Anaesthesia, 118(1):32-43. doi:10.1093/bja/aew379 Welte, J. F., et al. (2017). Medication errors in paediatric anaesthesia: The hidden part of the iceberg. British Journal of Anaesthesia, 118(5):797-809 Nahian, A., & Wadhwa, R. (2023, June 5). Federal regulation of medication production. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK572098/ 25 9