Focus on CFMC s Drug Safety Project

1. Focus on CFMC�s Drug Safety Project Christine LaRocca, M.D. CFMC Chief Medical Officer for Quality Performance 1

2. Introduction to CFMC: Our Role in Healthcare Quality Improvement in Colorado Risks, Adverse Effects, and Costs of Potentially Inappropriate Medications (PIMs) & Drug-Drug Interactions (DDIs) CFMC�s Drug Safety Project The Role of Healthcare Providers & Key Strategies for Reducing PIMs & DDIs to Improve Drug Safety Overview 2

3. The Colorado Foundation for Medical Care (CFMC), is the Medicare Quality Improvement Organization, or QIO, for Colorado QIOs are under contract with the Centers for Medicare & Medicaid Services (CMS) Single QIO contract per state, U.S. territory, and the District of Columbia (53 total) 3 Introduction to CFMC

4. Purpose of the QIO Program: To improve the efficiency, effectiveness, economy, and quality of services delivered to Medicare beneficiaries 4 Introduction to CFMC

5. QIOs are expected to achieve results, and are held accountable by CMS for the performance of the healthcare providers that they assist. QIOs operate under 3-year contract cycles (Statement of Work- SOW) 9th SOW began in August 2008 and ends July 31, 2011 Introduction to CFMC 5

6. Patient Safety/CFMC�s Focus on Drug Safety Drug Safety is part of CFMC�s Patient Safety work in the 9th SOW CFMC provides Quality Improvement (QI) assistance to decrease the rates of PIMs and DDIs prescribed 6

7. Elderly Americans consume 1/3 of all prescription medications, yet they make up less than 13% of the population1 Why so many prescription medications? Older people often have more diseases than the general population The more diseases, the more prescription medications The more medications prescribed, the higher the risk of inappropriate medication use Why Focus on �Drug Safety� 7

8. On average, how many medications is a newly admitted nursing home resident taking? 5 8 12 15 Balogun SA, Preston M, Evans, J. Potentially Inappropriate Medications in Nursing Homes: Sources and Correlates. The Internet Journal of Geriatrics and Gerontology 2.2 (2005) Did you know. . .? 8

9. �Medications that should generally be avoided in persons 65 years or older because they are either ineffective or they pose unnecessarily high risk for older persons and a safer alternative is available�; and �Medications that should not be used in older persons known to have specific medical conditions.�2 What is a Potentially Inappropriate Medication (PIM)? (Beers criteria) 9

10. Drug-drug interactions occur when 2 or more drugs react with one another This drug-drug interaction may cause an unexpected side effect 3 Example: A drug to help with sleep (a sedative) combined with a drug for allergies (an antihistamine) can slow reactions and cause confusion Definition of Drug-Drug Interaction (DDI) 10

11. Drug Safety: How Big is the Problem? Medication-related problems estimated to be responsible for 106,000 deaths and $85 billion in costs to healthcare system in year 20002 In 1998, it was noted that �fatal adverse drug reactions appear to be between the fourth and sixth leading cause of death�4 11

12. Gurwitz:11,12 If findings are applied to all U.S. nursing homes (NH): 24 -120 ADEs/year in the average nursing home (bed size 105) 350,000-1.9 million ADEs/year among the 1.6 million U.S. NH residents, 40�50 percent of which are preventable Of the 20,000�86,000 fatal or life-threatening ADEs, about 70�80 percent are preventable�13  Adverse Drug Events (ADEs): How Big is the Problem? 12

13. What percent of hospital admissions in the elderly may be linked to drug-related problems or drug toxic effects? 5% 10% 20% 30% Fick DM, Cooper JW , Wade WE, Waller JL, MacLean JR, Beers MH. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Results of a US Consensus Panel of Experts. Arch Intern Med 2003;163:2716-2724. Risks, Adverse Effects & Costs of PIMs and DDIs 13

14. Risk of Drug-Drug Interactions (DDI) 14

15. Common for Elderly in All Settings Willcox et al found 23.5% of community dwelling people > age 65 received at least one of 20 contraindicated drugs8 Rothberg et al found 49% of nearly 500,000 hospitalized elders received at least one PIM and 6% received 3 or more PIMs based on a modified Beers list9 Balogen et al found 32 % of newly admitted nursing home residents were prescribed at least one PIM10 15

16. Synopsis of Regulation F329, Unnecessary Drugs �The facility must assure that medication therapy (including antipsychotic agents) is based upon: An adequate indication for use; Use of the appropriate dose; Provision of behavioral interventions and gradual dose reduction for individuals receiving antipsychotics (unless clinically contraindicated) in an effort to reduce or discontinue the medication; (cont�d) 16

17. Synopsis of Regulation F329 (6 aspects continued) �Use for the appropriate duration; Adequate monitoring to determine whether therapeutic goals are being met and to detect the emergence or presence of adverse consequences; and Reduction of dose or discontinuation of the medication in the presence of adverse consequences, as indicated.� 17

18. Deficiencies/Statewide Data Incidence of F-Tag Citations in Colorado for the 12 month period ending February 11, 2010: 18

19. Convened Drug Safety Advisory Group of medical directors and consultant pharmacist from Colorado Medical Directors Association (CMDA) Recruited & selected identified provider group of nursing homes Selected categories of PIMs and DDIs relevant to F-329 Determined method and time frame for data collection Quality Improvement (QI) technical assistance 19 CFMC Drug Safety Project

20. CFMC�s Drug Safety Advisory Group Dr. A. Lee Anneberg Dr. Fred Feinsod Dr. Greg Gahm Dr. David Koets Dr. Karyn Leible Dr. Cari Levy Alan Miller, RPh, MS. CGP Dr. Pam Tyrrell 20

21. Categories Selected for PIMs Antihistamines/Anticholinergics Including urinary incontinence medications Proton Pump Inhibitors Metoclopramide Antipsychotics Conventional and atypical Anti-Anxiety/Sedatives/Hypnotics/ Tricyclics Including benzodiazepines 21

22. Rationale for SelectionAnticholinergics/Antihistamines Anticholinergics/antihistamines may impair memory and cognitive functioning; older people have increased susceptibility15,16 May cause adverse effects (dry mouth, urinary retention, constipation, dry eyes, confusion, dizziness, excessive sedation, and falls)15 22

23. Rationale for SelectionProton Pump Inhibitors (PPIs) PPIs may be routinely started during hospitalizations and continued without additional re-evaluation Long term PPI therapy has been linked to increased risk of hip fractures17 PPI use within preceding 8 weeks was associated with an increased risk of Clostridium difficile18 23

24. Rationale for SelectionAntipsychotics FDA Alert for Antipsychotics 6/16/2008 Conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis and are not indicated for the treatment of dementia-related psychosis.19 May cause neuroleptic malignant syndrome, parkinsonian events, tardive dyskinesia, orthostatic hypotension, cardiac conduction disturbances, reduced bone mineral density, sedation, and cognitive slowing21 24

25. Rationale for SelectionSedatives/Hypnotics/Anti-Anxiety Drugs Patients using sedative hypnotics (classified as Beers high-severity) were 22% more likely to suffer a fall or fracture than control subjects7 Significantly higher adjusted medical and total healthcare costs for those on sedative hypnotics compared to control group7 25

26. Rationale for SelectionBenzodiazepines Benzodiazepines demonstrate significant association with falls in the elderly22 Risk of hip fracture increased by 50% in one study23 For treatment of insomnia: Benzodiazepines provide no major advantage over placebo, and adverse effects include drowsiness, dizziness, lightheadedness, cognitive impairment24 26

27. Drug�Drug Interactions Selected Warfarin combined with aspirin or other anti-platelet medications Why? Potential for serious gastrointestinal bleeding Amiodarone combined with any other medication 27

28. Rationale for Selection of Amiodarone Combined with any Other Medication FDA Alert25 for Amiodarone May 2005 Amiodarone should only be used to treat adults with life-threatening recurrent ventricular arrhythmias when other treatments are ineffective or have not been tolerated Amiodarone may cause potentially fatal toxicities, including lung toxicity, liver injury, and worsened arrhythmia Multiple clinically significant drug-drug interactions26 One online source reports 647 drugs known to interact with amiodarone27

29. Data Collection Developed a data collection tool Chart/EMR abstraction on-site Resident information Category of PIM, specific medication DDI, precipitant and object medications Dosing (PRN, scheduled, administered, D/C date ) Attending physician Baseline 2nd quarter 2009 Interim data collections Re-measurement 2nd quarter 2010 29

30. Interventions Established communication and solicited input Elevated awareness and focused attention Collected, analyzed and returned individualized data Facilitated identification of patterns & priorities for action Included resident information for specific actions Stimulated review, analysis, & modification of current processes 30

31. On-site visits Interviews Sharing of data collection results Mapping of processes Workflow assessments Action planning/ goal setting Outreach to medical directors, physicians, pharmacists Interventions/ CFMC Technical Assistance included: 31

32. Educational presentations Bi-monthly webEx, educational programs & best practices sharing Distribution of educational materials Drug Safety Toolkit Currently, CFMC is continuing to promote increased awareness & interest in reducing PIMs & DDIs with statewide healthcare partners Interventions/ CFMC Technical Assistance included (cont): 32

33. Check out http://www.cfmc.org/hospital/hospital_drug-safety.htm for protocols, flowcharts, toolkits, alert cards, alert forms, journal articles, FDA Safety Information, Clinical Practice Guidelines, info for residents and families, and more CFMC Drug Safety Resource Toolkit 33

34. Successfully Decreased Selected PIMs & DDIs by >5% Activity in NHs included: Interdisciplinary team involvement, including the consultant pharmacist Reviewing and refining processes Planning and prioritizing activities, including reducing existing PIMs & DDIs and preventing new ones Chart reviews/evaluation of medication orders and practices Staff education and training Staff and prescriber outreach and communication 34

35. Identified the Following Improvement Opportunities: Ineffective medication reconciliation Lack of standard processes Prevalence of PRN (as needed) medications Communication challenges between prescribers and clinical staff The Role of Healthcare Providers & Key Strategies for Reducing PIMs & DDIs to Improve Drug Safety 35

36. Potential causes: Residents return to NH on new meds, some of which may have been inadvertently continued upon hospital discharge (PPIs, sedatives) NH staff time constraints: To review orders/contact physician/clarify med list Role of Healthcare Provider/Strategy: Foster improved collaboration & communication between hospital (discharge planners and hospitalists) and NH providers 1. Ineffective Medication Reconciliation 36

37. Potential causes: Competing priorities PIM and DDI educational/training needs Role of Healthcare Provider/Strategy: Review and revise processes with interdisciplinary team involvement, including the consultant pharmacist. CFMC Toolkit includes a Medication Simplification Protocol, Flowchart of processes for ongoing medication-reduction program20 and more  2. Lack of Standard Processes for Ongoing Medication Reduction 37

38. May result in the use of a PIM (example: using a sedative/hypnotic) rather than considering alternatives to medication Potential Causes: PIM/DDI educational & training needs Understaffing Role of Healthcare Provider/Strategy: Staff education and training about the risks of PIMs/DDIs. Training about potential alternative therapies. Assess staffing needs 3. Prevalence of PRN (as needed) Medications 38

39. Potential Causes: Poor information exchange Ineffective modes of communication Role of Healthcare Provider/Strategy: Interdisciplinary team involvement, including a physician champion. Evidence-based literature (see Toolkit) and feedback of data may be useful for changing prescribing patterns. Risk-benefit statements may be helpful. Communication training. Consider participation in TeamSTEPPs  4. Communication Challenges Between Prescribers and Clinical Staff 39

40. ASCP and AMDA believe:29 � The Beers list is a helpful general guide regarding potentially inappropriate medication use. . . for older adults, but it must be used in conjunction with a patient-centered care process. � Ultimately, decisions about medication prescribing must be clinically based and consider the patient's total clinical picture, including the entire medication regimen, history of medication use, comorbidities, functional status, and prognosis. Beers Criteria 40

41. ASCP and AMDA believe: Checklist approaches should not substitute for the necessary steps in the care process for appropriate prescribing. � The Beers list should be used as a general guide for assessing the potential inappropriateness of medications, not as an isolated justification for any recommendation, including discontinuation of a medication.29 American Medical Directors Association. AMDA and ASCP Joint Position Statement on the Beers List of Potentially Inappropriate Medications in Older Adults. Columbia, MD: American Medical Directors Association, 2004. http://www.ascp.com/resources/policy/upload/Sta04-ASCP-AMDA-Beers.pdf Beers Criteria (cont) 41

42.    What�s Next? CMS 10th SOW begins August 1st [content subject to change] Patient-centered care CFMC will support and convene a Reducing Adverse Drug Event (ADE) Learning and Action Network: We will partner with organizations currently participating in the Patient Safety and Clinical Pharmacy Services (PSPC) Collaborative http://www.hrsa.gov/patientsafety We will lead 5-10 multidisciplinary community teams Data monitoring, tracking and reporting for population of focus: High risk patients 42

43. For more information, contact CFMC: Dr. Christine LaRocca 303-695-3300 ext 3101 clarocca@cfmc.org Deanna Curry 303-695-3300 ext 3010 dcurry@cfmc.org 43

44. Bushardt RL, et al. Polypharmacy: Misleading, but Manageable. Clinical Interventions in Aging 2008;3(2):383-389. Fick DM, et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Results of a US Consensus Panel of Experts. Arch Intern Med 2003;163:2716-2724. Drug Interactions: What You Should Know. http://www.fda.gov/downloads/Drugs/ResourcesForYou/UCM163355.pdf Lazarou J, et al. Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-Analysis of Prospective Studies. JAMA 1998; 279: 1200-1205. Pham CB, et al. Minimizing Adverse Drug Events in Older Patients. Am Fam Physician 2007;76(12):1837-1844. Hamilton HJ, et al. Inappropriate Prescribing and Adverse Drug Events in Older People. BioMed Central Geriatrics 2009, 9:5. http://www.biomedcentral.com/1471-2318/9/5 References 44

45. 7. Stockl KM, et al. Clinical and Economic Outcomes Associated with Potentially Inappropriate Prescribing in the Elderly. American Journal of Managed Care. 2010;16(1):e1-e10. 8. Willcox SM, et al. Inappropriate Drug Prescribing for the Community-Dwelling Elderly. JAMA 1994; 272(4) 292-296 9. Rothberg MD, et al. Potentially Inappropriate Medication Use in Hospitalized Elders. Journal of Hospital Medicine 2008; 3(2): 91-102. 10. Balogun SA, et al. Potentially Inappropriate Medications in Nursing Homes: Sources and Correlates. The Internet Journal of Geriatrics and Gerontology 2.2 (2005) 11.Gurwitz JH, et al. Incidence and preventability of adverse drug events in nursing homes. The American Journal of Medicine 2000;109(2):87�94. 12. Gurwitz JH, et al. The incidence of adverse drug events in two large academic long-term care facilities. The American Journal of Medicine 2005;118(3):251�258. References 45

46. 13. Preventing Medication Errors. Quality Chasm Series. Aspden P, et al. Editors 2007 Institute of Medicine of the National Academies The National Academies Press Washington, DC pg 381. 14. Top Ten Dangerous Drug Interactions in Long-Term Care http://www.scoup.net/M3Project/topten/index.htm 15. Rudolph JL, et al. The Anticholinergic Risk Scale and Anticholinergic Adverse Effects in Older Persons, Arch Intern Med. 2008;168(5): 508-513. 16. Sheth HS, et al. Promethazine Adverse Events After Implementation of a Medication Shortage Interchange. The Annals of Pharmacotherapy 2005;39(2):255-261. 17. Yang YX, et al. Long-term Proton Pump Inhibitor Therapy and Risk of Hip Fracture. JAMA 2006;296, 24,2947-2953. 18. Cunningham R, et al. Proton Pump Inhibitors as a Risk Factor for Clostridium Difficile Diarrhoea. J Hosp Infect.2003; 54(3), 243-245. References 46

47. 19.Information for Healthcare Professionals: Conventional Antipsychotics http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm 20. Texas Department of Aging and Disability Services, Medication Regimen Simplification. http://qmweb.dads.state.tx.us/MedSim.asp and http://qmweb.dads.state.tx.us/MedSim2/process_program.pdf 21. Masand PS. Side Effects of Antipsychotics in the Elderly, J Clin Psychiatry 2000; 61Suppl 8:43-49, 50-51. 22. Woolcot JC, et al. Meta-Analysis of the Impact of 9 Medication Classes on Falls in the Elderly, Arch Intern Med 2009,169(21): 1952-1960. 23. Wang PS, et al. Hazardous Benzodiazepine Regimens in the Elderly: Effects of Half-Life, Dosage and Duration on Risk of Hip Fracture. American Journal of Psychiatry 2001;158(6): 892-98. References 47

48. 24. Holbrook AM, et al. Meta-analysis of Benzodiazepine Use in the Treatment of Insomnia. Canadian Medical Association Journal; 2000;162(2):225-33. 25. Information for Healthcare Professionals: Amiodarone (marketed as Cordarone). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084108.htm 26.Jenkins AT et al. Amiodarone Drug Interactions Consultant Live, 2006. 46 (14). http://www.consultantlive.com/display/article/10162/40174 27. Amiodarone Drug Interactions. Drugs.com: http://www.drugs.com/drug-interactions/amiodarone.html Accessed Feb 16, 2011. References 48

49. 28. Safe Medication Practices Workbook, MASSPRO, 2007 http://www.masspro.org/NH/docs/tools/SafeMedPrac06_8-07Upd.pdf 29. American Medical Directors Association. AMDA and ASCP Joint Position Statement on the Beers List of Potentially Inappropriate Medications in Older Adults. Columbia, MD: American Medical Directors Association, 2004. http://www.ascp.com/resources/policy/upload/Sta04-ASCP-AMDA-Beers.pdf References 49