Medication Safety in Ambulatory Care Thursday, February 15, 2007 12:00 – 1:00 p.m. Eastern Time

1. Medication Safety in Ambulatory CareThursday, February 15, 200712:00 – 1:00 p.m. Eastern Time

2. Moderator: Karen Frush, MD, FAAP Chief Patient Safety Officer Duke University Health System Durham, North Carolina

3. This activity was funded through an educational grant from the Physicians’ Foundation for Health Systems Excellence.

4. Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities Grid The AAP CME program aims to develop, maintain, and increase the competency, skills, and professional performance of pediatric healthcare professionals by providing high quality, relevant, accessible and cost-effective educational experiences. The AAP CME program provides activities to meet the participants’ identified education needs and to support their lifelong learning towards a goal of improving care for children and families (AAP CME Program Mission Statement, August 2004). The AAP recognizes that there are a variety of financial relationships between individuals and commercial interests that require review to identify possible conflicts of interest in a CME activity. The “AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities” is designed to ensure quality, objective, balanced, and scientifically rigorous AAP CME activities by identifying and resolving all potential conflicts of interest prior to the confirmation of service of those in a position to influence and/or control CME content. The AAP has taken steps to resolve any potential conflicts of interest. All AAP CME activities will strictly adhere to the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. In accordance with these Standards, the following decisions will be made free of the control of a commercial interest: identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the CME activity. The purpose of this policy is to ensure all potential conflicts of interest are identified and mechanisms to resolve them prior to the CME activity are implemented in ways that are consistent with the public good. The AAP is committed to providing learners with commercially unbiased CME activities.

5. DISCLOSURES

6. DISCLOSURES

7. DISCLOSURES

8. CME CREDIT The American Academy of Pediatrics (AAP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAP designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity is acceptable for up to 1.0 AAP credit. This credit can be applied toward the AAP CME/CPD Award available to Fellows and Candidate Fellows of the American Academy of Pediatrics.

9. OTHER CREDIT This webinar is approved by the National Association of Pediatric Nurse Practitioners (NAPNAP) for 1.2 NAPNAP contact hours of which 1.0 contain pharmacology (Rx) content. The AAP is designated as Agency #17. Upon completion of the program, each participant desiring NAPNAP contact hours should send a completed certificate of attendance, along with the required recording fee ($10 for NAPNAP members, $15 for nonmembers), to the NAPNAP National Office at 20 Brace Road, Suite 200, Cherry Hill, NJ 08034-2633. The American Academy of Physician Assistants accepts AMA PRA Category 1 Credit(s)TM from organizations accredited by the ACCME .

10. Heather McPhillips, MD, MPH, FAAP Assistant Professor and Associate Residency Director Dept. of Pediatrics, University of Washington Children’s Hospital and Regional Medical Center Seattle, Washington

11. Medication Safety in Ambulatory Pediatrics Heather McPhillips, MD, MPH University of Washington, Department of Pediatrics Funding Source: Agency for Healthcare Quality and Research Collaborators: Robert Davis, Christopher Stille, Marlene Miller, Rainu Kaushal, Dave Smith, John Pearson, John Stull, Susan Andrade, Jerry Gurwitz & The HMO Research Network CERT

12. Objectives • Epidemiology of medication errors in ambulatory care • What do we know about medication errors in children specifically in the outpatient setting? • Known risk factors for medication errors • What are barriers to error-free prescribing to children? • Which children are at highest risk for errors? • Strategies to reduce or eliminate medication errors in ambulatory settings • What is known and where does future work need to focus?

13. Medication Safety in Children • Children are seen by physicians often and receive medication in up to 60% of these visits. • Medication errors are common and can occur at any step in the process • Prescribing errors (dose, drug, allergy) • Dispensing errors (formulation, instructions) • Administration errors (dose, timing, others)

14. Objective #1 • Epidemiology of medication errors in ambulatory care • What do we know about medication errors in children specifically in the outpatient setting? • Known risk factors for medication errors • What are barriers to error-free prescribing to children? • Which children are at highest risk for errors? • Strategies to reduce or eliminate medication errors in ambulatory settings • What is known and where does future work need to focus?

15. Medication Errors in the ED Kozer et al (Pediatrics, 2002) • Retrospective review of medication errors in charts during 12 randomly selected days in emergency department • Prescribing errors in 10% of charts • Only counted errors 20% or more outside of dosing range • Analgesics, antibiotics, antihistamines, asthma drugs most likely involved • Highest risk in trainees at beginning of year and seriously ill patients

16. Sedation Errors Cote et al (Pediatrics, 2000) • Examined 95 adverse sedation events (ASEs) • 2/3 resulted in death or permanent injury • Sedation for dental procedures accounted for 32 ASEs • Medication overdoses, multiple sedatives, improper administration and inadequate monitoring contributed to serious errors • Nearly ½ ASEs occurred outside the hospital setting (home, dental office, clinic, car)

17. Administration Errors • Errors in administration of medications to children by their caregivers are common • As few as 30% of parents correctly administer proper dose of acetaminophen to their child • Even when parents provided with correct dosing information and child’s weight, correct dose given 40% of the time • Frush et al (Archives of Pediatrics, 2004): Significantly less error associated with simplified color-coded information sheet and color-coded dosing syringe • 50% conventional vs 92% color-coded given correct dose

18. Outpatient Chemotherapy for ALL Taylor et al (Cancer, 2006) • Reviewed chemotherapy at clinic visit over two-month period for 69 patients prescribed 172 drugs • Identified 17 medication errors in 13 children (19%) • Administration errors were most common, followed by prescribing errors

19. Potential Ambulatory Dosing Errors McPhillips et al (Journal of Pediatrics, 2005) • Examined potential dosing errors in new outpatient prescriptions for 22 common medications at 3 HMOs • Potential dosing errors occurred in 280 of 1,933 (15%) of prescriptions • 8% potentially overdosed • 7% potentially underdosed

20. Dosing Variation Mg/Kg/Day(Children < 35kg, N = 1,050 Dispensings) McPhillips et al, Journal of Pediatrics, 2005

21. Objective #2 • Epidemiology of medication errors in ambulatory care • What do we know about medication errors in children specifically in the outpatient setting? • Known risk factors for medication errors • What are barriers to error-free prescribing to children? • Which children are at highest risk for errors? • Strategies to reduce or eliminate medication errors in ambulatory settings • What is known and where does future work need to focus?

22. Challenges in Pediatric Prescribing 1. Pediatric prescribing is complex 2. Off-label medication use is common 3. Lack of standardization of recommended doses 4. Lack of guidelines regarding use of adult dosing regimens

23. Prescribing is Complex • An accurate weight must be obtained and correctly transcribed (pounds or kilograms) • In the course of a brief visit, the prescriber then must: • convert pounds to kilograms • make rapid weight-based calculations to determine daily dose • divide daily dose into multiple doses to obtain the appropriate frequency for the medication • choose the correct preparation and concentration (liquid, chewables, tablets) of the medicine • Determine the amount of liquid/tablet to be taken for individual dose

24. Prescribing is Complex (3) Communication with the parent or caregiver often will occur without the medication present (4) The prescription must be legible and correctly interpreted by the pharmacist (5) The pharmacist must dispense the appropriate medication in its appropriate formulation labeled with the appropriate dose and frequency.

25. Off-label Prescribing is Common • Top 100 drugs dispensed to 2 million HMO members (HMO Research Network CERT) • 40 have no labeling for children • 32 have some labeling restrictions • Study examining prevalence of off-label use (1999-2001) • 13% of children <17 years dispensed off-label medication • 25% of children <2 years dispensed off-label medication • Off-label medications increase risk of Adverse Drug Events (ADEs) • Less information available about appropriate doses—less standardization

26. Recommended Doses Can Differ

27. No Clear Rules about Adult Dosing • No standard for when to switch from weight-based dosing (pediatric) to daily dosing (adult) • Some medications provide both weight-based and age-based dosing (how do you choose?) • Difficult to determine potential errors • Unclear if clinically relevant

28. For example: amoxicillin 6 year-old 40kg male with otitis failed conservative therapy Dr. Smart would like to treat with 90 mg/kg/day divided bid Appropriate pediatric dose: 3600 mg/day (1800mg bid) Appropriate adult dose: 2000 mg/day (1000 bid) Potential overdose?? Potential underdose??

29. Risky Situations

30. Medications Prone to Error(N = 2,028 Dispensings) McPhillips et al, Journal of Pediatrics, 2005

31. Children at Risk for Potential OD *Adjusted for HMO, class of drug McPhillips et al, Journal of Pediatrics, 2005

32. Objective #3 • Epidemiology of medication errors in ambulatory care • What do we know about medication errors in children specifically in the outpatient setting? • Known risk factors for medication errors • What are barriers to error-free prescribing to children? • Which children are at highest risk for errors? • Strategies to reduce or eliminate medication errors in ambulatory settings • What is known and where does future work need to focus?

33. Computerized Prescribing for Children: Will it reduce error? • CPOE may prevent substantial errors in children in inpatient settings (ICU), but most systems are currently home-grown • Little is known about effectiveness in ambulatory settings • Few commercial systems have “standard” pediatric decision support

34. Can CPOE Prevent Errors? McPhillips et al, Journal of Pediatrics, 2005

35. Conclusions • Medication errors are common in ambulatory pediatrics and dispensing and prescribing errors are most common. • Higher risk prescribing situations include • young children • children who have not been seen in clinic • multiple medications at one time • “prn” medications (analgesics, asthma meds) • CPOE without decision support may not reduce medication dosing errors in children.

36. Implications/Future Studies • Electronic prescribing is a potentially successful strategy but NOT without pediatric decision support • Evidence in inpatient settings that CPOE reduces medication dosing errors • Complexity of pediatric prescribing leads to complexity in designing electronic systems • Simplified dosing regimens and standardization of medication doses is needed

37. References Kozer E, Scolnik D, Macpherson A, Keays T, Shi K, Luk T, Koren G. Variables associated with medication errors in pediatric emergency medicine. Pediatrics. 2002 Oct;110(4):737-42. Kozer E, Scolnik D, MacPherson A, Rauchwerger D, Koren G. Using a preprinted order sheet to reduce prescription errors in a pediatric emergency department: a randomized, controlled trial. Pediatrics. 2005 Dec;116(6):1299-302. Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44. Li SF, Lacher B, Crain EF. Acetaminophen and ibuprofen dosing by parents. Pediatr Emerg Care. 2000 Dec;16(6):394-7.

38. References Simon HK, Weinkle DA. Over-the-counter medications. Do parents give what they intend to give? Arch Pediatr Adolesc Med. 1997 Jul;151(7):654-6. Frush KS, Luo X, Hutchinson P, Higgins JN. Evaluation of a method to reduce over-the-counter medication dosing error. Arch Pediatr Adolesc Med. 2004 Jul;158(7):620-4. Taylor JA, Winter L, Geyer LJ, Hawkins DS. Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia. Cancer. 2006 Sep 15;107(6):1400-1406.

39. References McPhillips HA, Stille CJ, Smith D, Hecht J, Pearson J, Stull J, Debellis K, Andrade S, Miller M, Kaushal R, Gurwitz J, Davis RL. Potential medication dosing errors in outpatient pediatrics. J Pediatr. 2005 Dec;147(6):761-7. Gandhi TK, Weingart SN, Seger AC, Borus J, Burdick E, Poon EG, Leape LL, Bates DW. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med. 2005 Sep;20(9):837-41.

40. Karen P. Zimmer, MD, MPH, FAAP Assistant Professor Johns Hopkins University Baltimore, Maryland

41. Epidemiology and Intervention for Pediatric Ambulatory Medication Errors Karen P. Zimmer, MD, MPH Marlene R. Miller, MD, MSc February 15, 2007 Safer Health Care for Kids Webinar “Medication Safety in Ambulatory Care”

42. Goals Background Epidemiology Example: Analysis of a National Voluntary Database (MEDMARX Database) Suggestions for Addressing Medication Errors Process Improvement Example: Narcotic Prescription Writer

43. Background on Medication Errors Most common adverse event IOM, 2000; Bates 1995 Most error prone step is prescribing Lesar TS, 2002; Errors DB, 1999 Most errors occur as a result of both individual and system failures Leape LL et al. 1995; Reason J, 2000 Competent staff make mistakes

44. National Reporting System: United States Pharmacopeia MEDMARX United States Pharmacopeia (USP) A practitioner-based organization that sets standards for identity, strength, quality, purity, packaging, labeling, and storage of therapeutic products. MEDMARX Database National, voluntary, internet-accessible error reporting system Consists of 616 subscribing hospitals since January, 2005 All are US hospitals All 50 states are represented

45. Study on Epidemiology Objective: To characterize and understand medication errors in the outpatient clinic settings What types of medication errors occur? Where in the process do errors occur? What harm occurs?

46. MEDMARX Error reporting System Standardized Provides information on prescriptions as well as medications in all types of ambulatory clinics Error timing Unit location Phase of care in which error occurred Error category Cause of error Medication Involved

47. MEDMARX Analysis Inclusion Criteria Queried database for all error reports from 2003 and 2004 Involving patients < 19 years of age In all outpatient clinics (general and specialty clinics) Error category limited to harm scores of Category C-I (medical errors that reached the patient).

48. Results: All Errors Medication error reports (N=566) Involved 636 products (medications) Number of participating institutions 154 (2003) and 162 (2004) Clinic-Type Distribution General Community Hospital Affiliate (52%) Stand alone Outpatient Clinic (28%) University Hospital Affiliate (11%) Age distribution Greatest for ages 1-3 (25.1%) and 12-18 (24.7%)

49. Results: All Errors Harm Score Over 2/3 of errors reached the patient but did not cause harm (Category C) 4% harmed the patient (Category E-I) Family/Patient discovered medication errors almost 20% of the time.

50. Results: All Errors • Error Node • Definition: the phase of the medication process where the error occurs • Administering (42%) • Prescribing phases (41%) • Dispensing (12%) • Transcribing/Documenting (4%) • Monitoring (1%)