Minutes Drugs Safety Content Profile June 5, 2008

Drug Safety Content Profile

Minutes, 5 June 2008 Conference Call (1:00 - 1:30 PM CDT); Meeting ended early due to low attendance;

Attendees;

• Floyd Eisenberg (Siemens)
• Jason Colquitt (Greenway Medical Systems)
• Carolyn Dunaway-Shanks (Siemens
• Jan Orton (Intermountain Healthcare)
• Daemon Whittenburg (Greenway Medical Systems)

Discussion

• Recap of discussion 22 May 2008 Drug Safety Content Update

Profile Proposal

• Primary issues with creation of this profile include;
  • Identification of a trigger for identification of an adverse medication reaction
    • Jan Orton will review potential availability of triggers with her organization
    • Addtional sources for triggers:
      • Institute for Healthcare Improvement [(IHI) http://www.ihi.org/ihi/workspace/tools/trigger/ ADE Trigger Tools]
      • Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical methodology for measuring medication related harm, Qual Saf Health Care. 2003;12:194-200. - Lists 24 clinical triggers to identify potential adverse drug events.
        • T1: Diphenhydramine: Hypersensitivity reaction or drug effect
        • T2: Vitamin K: Over-anticoagulation with warfarin
        • T3: Flumazenil: Oversedation with benzodiazepine
        • T4: Droperidol: Nausea/emesis related to drug use
        • T5: Naloxone: Oversedation with narcotic
        • T6: Antidiarrheals: Adverse drug event
        • T7: Sodium polystyrene: Hyperkalemia related to renal impairment or drug effect
        • T8: PTT >100 seconds: Over-anticoagulation with heparin
        • T9: INR >6: Over-anticoagulation with warfarin
        • T10: WBC <3000 × 106/μl: Neutropenia related to drug or disease
        • T11: Serum glucose <50 mg/dl: Hypoglycemia related to insulin use
        • T12: Rising serum creatinine: Renal insufficiency related to drug use
        • T13: Clostridium difficile positive stool: Exposure to antibiotics
        • T14: Digoxin level >2 ng/ml: Toxic digoxin level
        • T15: Lidocaine level >5 ng/ml: Toxic lidocaine level
        • T16: Gentamicin or tobramycin levels peak >10 μg/ml,trough >2 μg/ml: Toxic levels of antibiotics
        • T17: Amikacin levels peak >30 μg/ml, trough >10 μg/ml: Toxic levels of antibiotics
        • T18: Vancomycin level >26 μg/ml: Toxic levels of antibiotics
        • T19: Theophylline level >20 μg/ml: Toxic levels of drug
        • T20: Oversedation, lethargy, falls: Related to overuse of medication
        • T21: Rash: Drug related/adverse drug event
        • T22: Abrupt medication stop: Adverse drug event
        • T23: Transfer to higher level of care: Adverse event
        • T24: Customized to individual institution: Adverse event
        • PTT=prothrombin time; INR=international normalized ratio; WBC=white blood cells
      • Resar RK, Rozich JK, Classen D. Methodology and rationale for the measurement of harm with trigger tools, Qual Saf Health Care. 2003;12:ii30-ii45.
      • Takata GS, Mason W, Taketomo C, Logsdon T and Sharek PJ. Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in US Children's Hospitals. Pediatrics 2008;121:927-935. Full Text of Article
  • Mapping of ICSR2 to CCD
• Determine readiness with respect to existing standards - requires more participation
• Next steps - Reschedule for follow up