Learning Objectives. Collaborative Medication Management (MTM) Programs: Successful Outcomes. Collaborative Drug Therapy Management (CDMT)

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1 Learning Objectives Collaborative Medication Management (MTM) Programs: Successful Outcomes Robert J. Lipsy, PharmD, FASHP, BCPS Managed Care Clinical Specialist Forest Research Institute Upon completion of this CPE activity, the participant should be able to: Determine which types of patient care settings have been most successful in implementing collaborative MTM programs Describe the common outcome measures used to determine the success of MTM programs Recognize the critical components of an MTM program Collaborative Drug Therapy Management (CDMT) A team approach to healthcare delivery with written guidelines or protocols authorize the pharmacist to initiate, modify, or continue drug therapy Maximizes the expertise of pharmacists and physicians Increases the likelihood that drug therapy problems will be averted Achieve better patient results Prevents complications Saves lives Avoids unnecessary costs Collaborative Drug Therapy Management (CDMT) International Pharmaceutical Federation statement 2010 Clinical pharmacists collaborating with other healthcare professionals to care for patients, carers, and the public Levels 1 (minimal contact) to 5 (ability to start or modify therapy All countries should train pharmacists for level 5 Allicance for Pharmaceutical Care Thompson, CA. Am J Health-Syst Pharm. 2010;67: Collaborative Drug Therapy Management Then and Now 1960s: Indian Health Service 1973: IHS Pharmacy Practitioner Program 1977: California Pilot Programs 1979: Washington state allows CDTM 1981: California allows inpatient and acute care CDTM 1983: California pharmacists can initiate therapy 1995: Veterans Administration allows site specific 1997: 14 states 2003: 38 states, USPHS, armed forces, VA, HIS, 50% of hospitals 2008: 45 states AMCP: Defining Features of Effective MTMPs Patient-centered approaches addressing the individual's environmental, social, and medical status Team-based, multidisciplinary approaches Open lines of communication between the patient and the health care team, with pharmacists overseeing MTM services Approaches that consider population and individual patient perspectives Flexibility and scalability of MTM services for diverse applications Reliance on evidence-based medicine for developing MTM services Active promotion of MTM services Academy of Managed Care Pharmacy. J Manag Care Pharm. 2008;14(1 Suppl B):S2-S44.

2 2010 MTMPs Must... MTMP Core Elements Service Model 7. Offer interventions for both patients and prescribers 8. Offer the patient an annual, interactive, personalized, and comprehensive medication review (CMR) as well as quarterly targeted reviews; CMR may include OTC s, herbals, and dietary supplements 9. Measure and report the number of: CMRs Targeted reviews Prescriber interventions Centers for Medicare and Medicaid Services Call Letter formedicare Advantage Organizations. Accessed 1/27/2010. The American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model Version Accessed 1/26/2010. MTM and CDTM What s in a Name? The patient asks you Can I take my lovastatin at night? I can t remember to take it in the morning. You answer that would be fine. You call the physician and say Didn t you mean warfarin 5 mg daily and not 50 mg daily? He responds Thank you very much for catching that. The nurse asks you if 25 days of oral vancomycin for Ms. Jones is enough to treat her systemic Staph. infection. She seems to not be getting better. After a brief consultation with the prescriber, a different medication is prescribed. Attitudes Toward MTMPs Among Community Pharmacists Familiar or very familiar with Medicare-defined MTMP % of Contracted Pharmacists % of Noncontracted Pharmacists Feel qualified to provide MTM services Strongly agree that an annual medication review would benefit patient outcomes Feel a pharmacist should be the primary provider of MTM services Agree that they are qualified to provide MTM services Agree that MTM functions are an important part of the pharmacist s role Agree that patients receive adequate information about chronic diseases MacIntosh C, et al. J Am Pharm Assoc. 2009;49(1): More Attitudes Toward MTMPs Among Community Pharmacists Pharmacists Perceived Challenges in Developing and Implementing MTMPs Survey Item Agree that sufficient time is available to maximize patient outcomes Agree that pharmacists struggle with setting aside time for one-on-one patient meetings Agree that patients would find MTM services valuable Agree that a pharmacist monitoring medications will improve patient outcomes Plan to participate in Community Care Rx MTM in subsequent year MacIntosh C, et al. J Am Pharm Assoc. 2009;49(1): % of Contracted Pharmacists % of Noncontracted Pharmacists Health plans have different specifications of MTM services Lack of time Uncertainty of terms of reimbursement Lack of staffing Problems due to Part D Lack of information on requirements of MTM services Lack of physician support Physical space limitations Too many options for communication/documentation/billing Lack of knowledge in developing MTM programs Negative patient attitudes Cost of implementation of MTM programs Lack of pharmacist experience Lack of pharmacist willingness Inability to make unilateral decisions eg, due to corporate Total number of survey respondents: 143 Number of Respondents Law AV, et al. Res Social Adm Pharm. 2009;5(4):

3 60% MTMP Pharmacists Time Spent on Medication Review and Reconciliation Time Spent with Physician/Staff 60% Time Spent with Patient/Family Patient Perceptions of MTM Benefits 50% 40% % 40% Improving your overall health 3 Improving your medication use % 30% Improving relationship with your 1 3 pharmacist % 20% 10% 10% Improving communication with your pharmacist % 0% > > 90 Minutes Minutes Investigation Time: average of 45 minutes Pindolia VK, et al. Ann Pharmacother. 2009;43: Data reflect time spent per patient-case No response Not important Somewhat important Very important Truong HA, et al. J Am Pharm Assoc. 2009; 49(3): Number of Respondents n = 81 General Patient Perceptions of MTM Core Elements Has your pharmacist ever recommended that you visit other health care providers? Has your pharmacist ever provided you with advice or recommendations? Have you ever received a medication action plan? Have you ever received a personal medical record? Have you ever had a medication therapy review? Have you ever heard about MTM services? No Truong HA, et al. J Am Pharm Assoc. 2009; 49(3): Number of Respondents n = 81 Physician Attitudes Toward Pharmacist Provided MTM Mean Level of Comfort Range of 1-5 Strongly Disagree to Strongly Agree Service Mean General Drug Education 4.32 Smoking Cessation 3.91 Anticoagulation 3.09 Diabetes 3.26 Therapeutic Drug Monitoring 3.22 Osteoporosis 3.18 Immunization 2.92 Dyslipidemia 3.02 Asthma 2.94 Medicare Part D 4.10 Alkhateeb FM et al. J AM Pharm Assoc. 2009;49: Physician Attitudes Toward Pharmacist Provided MTM Level of Agreement of Expectations of Pharmacists Responsibilities Likert Scale 1 Strongly Disagree to 5 Strongly Agree Assist physician in designing drug treatment plans 2.69 Educate patients on safe and effective use 4.36 Monitor response to therapy and alert if DRP present 3.40 Knowing indication for which each drug is prescribed 3.53 Insuring refills are on time 4.03 Suggesting use of non-rx medications to patients 2.94 Suggesting use of Rx medications to patients 2.20 Suggesting use of Rx medications to physicians 2.92 Catching and preventing prescription errors 4.59 Physician Attitudes Toward Pharmacist- Provided MTM Services Survey Item Support collaborative agreement with pharmacists % of Responses by Likert-Scale Answer SD D N A SA Pharmacist should provide MTM services Nurse should provide MTM Services SD, strongly disagree; D, disagree; N, neutral; A, agree; SA, strongly agree Alkhateeb FM et al. Pharm World Sci. 2009;31: Alkhateeb FM et al. Pharm World Sci. 2009;31:

4 Successful Pharmacist Interventions Documentation of therapeutic outcomes and safety N = 56,573 citations of RPh as a team member N = 298 met criteria for inclusion in review Clinical = 224, Humanistic = 120, Safety = 73, Multiple = % were outpatient and 48.3 reported Level 1 outcomes Level 1: clinical or QOL, Level 2: surrogate endpoints, Level 3: knowledge, Level 4: patient satisfaction or avoidance of potential ADRs Successful Pharmacist Interventions Study results were judged as Favorable, Not favorable, Mixed, or Unclear Outcomes Measured Percent of Favorable Studies Mortality 72.2 Hospital admissions 51.4 Length of stay 59.4 Emergency room use 52.0 Improved medication use 66.7 Fasting blood glucose 81.8 Body mass index 62.5 INR / PT 85.0 Lipids 81.5 A1C 88.9 Blood pressure 84.7 Adverse drug reactions 78.6 Medications 81.8 Chisholm-Burns, MA, et al. Med Care. 2010;48: Outcomes of MTM Pharmacists Recommendations to Health Care Providers 7-Year Analysis of Pharmacist-Provided MTMPs Total number of recommendations 692 Number of recommendations accepted by providers 425 (61.4%) Total number of recommendations related to drug therapy problems 578 (83.5%) Number of recommendations related to drug therapy problems accepted by providers Median time to acceptance of clinical recommendations 348 (60.2%) 13.5 days Total number of formulary recommendations 114 (16.4%) Number of formulary recommendations accepted by providers 77 (67.5%) Average monthly cost savings per accepted formulary recommendation for the health plan Average monthly cost savings per accepted formulary recommendation for the patient $13.59 $13.85 Study Objectives Participants Methods and Primary Outcomes Describe changes in primary types of MTM services provided by community pharmacies from 2000 through 2006 Quantify potential MTM-related cost savings Convenience sample of 50 MTMPs administered by Outcomes Pharmaceutical Healthcare From 76,148 MTM claims (23,798 patients), data were analyzed for patient demographics, information about medications, MTM services provided, and pharmacy payments DeName B, et al. J Am Pharm Assoc. 2008;48(6): Doucette WR. Clin Ther.2005;27(7): Barnett MJ, et al. J Manag Care Pharm. 2009;15(1): lg2 7-Year MTMP Analysis: Primary Reasons for MTM Intervention lg1 7-Year MTMP Analysis: Patient Characteristics and Drug Categories Analysis Year 2000 Year 2006 P value New or changed prescription drug therapy <0.001 OTC therapy <0.001 Suboptimal drug selection <0.001 Insufficient dose or duration <0.001 Adverse drug reaction <0.001 Drug interaction <0.001 Excessive dose or duration <0.001 Overuse of drug Underuse of drug <0.001 Administration technique <0.001 Analysis Year 2000 Year 2006 P value Patients mean age (years) <0.001 % males <0.001 Average number of claims per patient Antimicrobial drugs <0.001 Cardiovascular system drugs <0.001 Central nervous system drugs <0.001 Penicillin antibiotics <0.001 Narcotic analgesics <0.001 Macrolide antibiotics <0.001 Statins and other lipid-lowering agents <0.001 Cost-efficiency management <0.001 Data for medications are expressed as percentages of all MTM claims Data are percentages of all MTM claims Barnett MJ, et al. J Manag Care Pharm. 2009;15(1): Barnett MJ, et al. J Manag Care Pharm. 2009;15(1):18-31.

5 Slide 23 lg2 Please make a bar graph (see my previous comment) lgreene, 3/5/2010 Slide 24 lg1 Production: please make this a bar (horizontal) graph with different color fills for the two years. We can get rid of the P values. Instead, just include a statement below the graph saying Percentages for 2000 and 2006 were significantly different for all analyses (p < 0.001) except "Average number of claims per patient" If this comment doesn't make sense, I can explain how I'm thinking the graph should be designed. lgreene, 3/5/2010

6 lg3 7-Year MTMP Analysis: Action or Intervention lg4 7-Year MTMP Analysis: Intervention Results Analysis Year 2000 Year 2006 P value Comprehensive medication review <0.001 Prescriber consultation <0.001 Analysis Year 2000 Year 2006 P value Therapeutic success <0.001 Therapeutic failure <0.001 Initiated new therapy <0.001 Discontinued therapy <0.001 Patient consultation <0.001 Changed drug <0.001 Decreased dose/duration <0.001 Patient education or monitoring <0.001 Patient compliance consultation <0.001 Altered compliance <0.001 Patient refusal <0.001 Prescriber refusal <0.001 Initiation of cost-effective therapy <0.001 Data are percentages of all MTM claims Data are percentages of all MTM claims Barnett MJ, et al. J Manag Care Pharm. 2009;15(1): Barnett MJ, et al. J Manag Care Pharm. 2009;15(1): Examples of State MTM Programs Examples of State MTM Programs State Type Description and Notes California Medicaid HIV/AIDS for Medi-Cal (reported cut in 2010) Colorado Medicaid Program expanded statewide in 2008 Florida Medicaid Program operational Georgia Institutional patients Iowa Medicaid Outpatient pharmacies Collaboration of hospital pharmacists and medical staff in the institutional setting (Enacted in 2010) Minnesota Medicaid MTM services for low-income patients with complex medical and drug-related needs Mississippi Medicaid First state to offer MTM in Medicaid pays $20 for initial visits, maximum 12-visit annual cap Missouri Medicaid Started in 2008 focusing on diabetes and asthma education. Will expand to COPD, CVD, depression, GI, migraine, osteoporosis. Initial 15 min, new patient $50 Montana Medicaid MTM program reported as operational New Mexico Medicaid MTM program reported as operational State Type Description and Notes New York Medicaid Pilot program 2010 Bronx, NY North Carolina Medicaid and State employee plan Forced Risk Management Program (FORM) limits eight Rx per month unless enrolled in FORM ChecKmeds program available to all 650,000 Medicare Part D patients Ohio Medicaid MTM program reported as operational Oregon Utah Medicaid No details MTM pharmacists must enroll as a professional provider. Must be on referral from a physician, licensed provided, or a prepaid healthplan Vermont Medicaid MTM program reported as operational Virginia Medicaid MTM program reported as operational Washington State public employees Wisconsin Medicaid Public employee pilot Washington State Health Care Authority administers to public employees enrolled in the Uniform Medical Plan and the Aetna Public Employees Plan of Washington Wyoming Medicaid MTM program reported as operational Various State Results Minnesota Experience State Program Results New York Diabetes A1c 8.5% 7.4% Total medical costs $2,500/ pt/ yr Missouri All patients $6,804/pt/yr $2.4 million/yr Wyoming PharmAssist all patients $1,200/pt/yr North Carolina Pilot 88 patients with at least 12 Rx $107/pt/yr Mississippi DUR Lipids and Asthma $1,324/pt/hr including hospitalizations Enacted in 2005 Patients averaged six medical conditions and 14 drugs each Average of 3.1 drug-related problems resolved per patient Reimbursement First time face to face up to 15 minutes = $54 Repeat visit = $34 Additional 15 minutes = $24 Pharmacist reimbursement mean $92.50 per visit based on complexity of care Issets BJ, et al. J Am Pharm Assoc. 2008;48(2):

7 Slide 25 lg3 Please make a bar graph lgreene, 3/5/2010 Slide 26 lg4 Please make a bar graph lgreene, 3/5/2010

8 Clinical and Economic Outcomes of MTM Services: The Minnesota Experience Outcomes from DiabetesCARE Number of drug therapy problems resolved 637 Increase in percentage of patients therapy goals achieved 76% to 90% Variable n Baseline Mean 1-year Mean Mean Difference A1C a LDL-C (mg/dl) a Improvement in HEDIS measures in the intervention group versus control group for hypertension management Improvement in HEDIS measures in the intervention group versus control group for cholesterol management Decrease in total health expenditures per person in intervention group Ratio of reduction in total annual health expenditures to cost of providing MTM services HEDIS, The Healthcare Effectiveness Data and Information Set Issets BJ, et al. J Am Pharm Assoc.2008;48(2): % vs 59% 52% vs 30% $11, 965 to $8,197 >12:1 HDL-C (mg/dl) a Triglycerides (mg/dl) a Total cholesterol (mg/dl) a SBP (mm Hg) DBP (mm Hg) Weight (kg) BMI (kg/m 2 ) A1C, glycosylated hemoglobin; DBP, diastolic blood pressure; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure Nvaries due to missing data because measurements were not taken at 1-year follow-up a P 0.05 (paired t test) Johnson CL, et al. J Am Pharm Assoc. 2008;48: MTMP Impact on LDL-Cholesterol and Costs in Patients with Diabetes Variable MTM Opt-Outs/ Nonparticipants (n = 56) MTM Participants (n = 255) CDC-Only Controls (n = 2,114) Age P Value LDL-C value (mg/dl) <0.001 LDL-C < 100 mg/dl (% achieved) No < year Difference in Medicare Part D Costs (PMPM $) 1-year Difference in Medicare Part D Copayments (PMPM $) CDC, comprehensive diabetes care Fox D, et al. J Am Pharm Assoc. 2009;49: NA NA 0.62 Iowa Medicaid Pharmaceutical Care Management Initial assessment $75, follow-up $40, preventative follow-up $25 31% of 3,037 eligible patients met with pharmacists 2.6 medication-related problems per patient 52% of interactions recommended starting a new medication 31% recommended discontinuing a medication AJHP. 2003:60(1): Iowa Medicaid Pharmaceutical Care Management Patients with 4 medications and 1 hospital visit in previous 2 years N = 150, average # of meds 9.3, average # of medical conditions drug-related problems Adherence 26% Needs new tx 22% Wrong drug 13.2% Drug not needed 12.9% Adverse reaction 11.1% Low dose 9.7% High dose 5.3% Recommendations accepted 47.4% AJHP. 2003;60(1): Drug-Related Problems among Home-Based MTMP Patients Potential Drug-Related Problem (DRP) Patients Who Opted In (n = 459) a Patients Who Opted Out (n = 123) b Dose adjustment Cost Drug-disease interaction Drug-drug interaction Drugs to avoid in the elderly Duplication of therapy Monitoring gaps Multiple prescribers Nonadherence Therapeutic gap Data refect percentages of patients experiencing DRPs a DRP identified during MTM intervention; b DRPs among patients who died, had an ED visit, and/or an inpatient hospitalization during the 180-day follow-up period; identified during a mock MTM intervention. Welsh EK, et al. Ann Pharmacother. 2009;43(4):

9 Outcomes for Home-Based MTMP Patients Overview of Research on Drug Management Programs: Endpoints of 76 Studies Characteristic Baseline Data Patients Who Opted In (n = 459) Patients Who Opted Out (n = 336) P Value Age Chronic disease score Medication costs Outcomes in the 6-month period following MTM Number of Studies % of patients who died % of patients hospitalized % increase in medication cost Plan Adherence or Likelihood of Pt Clinical/Physiologic Rx Switching Workload for Rx Cost Continuation Receiving Tx Outcomes Provider Patient Out-of- Prescription Medical Resource Patient Guideline Pocket Cost Utilization Utilization Satisfaction Adherence Study Endpoints Welsh EK, et al. Ann Pharmacother. 2009;43(4): Holtorf AP, et al. BMC Health Serv Res. 2009;9:38 doi: / MTM in The Primary Care Medical Home Citation Disease / Criteria Am J Health- Syst-Pharm. 2004;61: Arch Intern Med. 2009;168: Am J Manag Care. 2205;4: Pharmacothe rapy. 2003;22: Ann Pharmacothe rapy. 1966;30: Depression with new med N Outcome Measurement 74 Adherence and symptom improvement CDTM Outcome Met Good Study Criteria Hypertension 402 Percent at goal BP N Higher percentage at goal Diabetes 65 A1c at 6 months Y Improved A1c Depression with new med 125 Adherence, symptoms, patient satisfaction Y Y No difference Intervention not distinct from control Not powered or blinded No difference Not powered or blinded Diabetes 39 A1c at 4 months Y Improved No power MTM in The Primary Care Medical Home Citation Disease / Criteria Am J Manag Care. 2009;15: JAMA. 2004;292: Am J Med. 2005;118: CMAJ. 2003;169: Fam Pract. 2007;24: N Outcome Measurement CDTM Outcome Met Good Study Criteria CAD 421 Goal lipids and BP N No difference Diabetes 217 A1c and BP at 0, 6, 12 mo Diabetes 217 A1c, BO, ASA use, lipids at 0, 6, 12 mo 65 yo 5 meds and 1 chronic condition 889 Cost of drugs, # of drugs, cost of all care, QOL all at 5 mo CAD 1493 % appropriate use of 2 nd preventative meds, health-related QOL, cost of care, pt satisfaction Y Y Y Both measures improved A1c, BP, ASA use improved. Lipids, no difference No differences No diff in 2 nd meds or QOL. Costs increased as did pt satisfaction Successful MTM / CDTM Programs Reference Fera T. JAPhA.2008;48: Rochester CD, et al. Am J Health- Systm Pharm 2010;67:42-48 Coast-Senior EA. Pharmacother. 1998;32: Fox D, et al. JAPhA. 2009;49: Fick, DM. Arch Intern Med. 2003;163: Chrischilles EA, et al. JAPhA.2004;44(3): Disease/ Condition Diabetes Diabetes Intervention Measures Community pharmacists face to face VAHCS clinic face to face A1c, LDL-C BP, Flu shots, foot exams CDTM Y / N N Outcomes All improved Weight and BMI did not A1c Y Mean A1c 11.6% 8.6% Diabetes VAHSC clinic A1c Y Mean A1c declined 2.2% Diabetes Beers list medications Medication appropriate index score Medicaid health plan Physician mailings Physician education LDL-c N 83.2% at goal vs. 69% Prescriptions for high risk drugs Index score change N N Decline of 15% Improved score from 8.3 to 9.4 Type 2 Diabetes N = 199, 10 month study period Outcome Measures CDTM in Diabetes Pre Post Total cholesterol mg/dl Triglycerides mg/dl HDL-C mg/dl LDL-C mg/dl Blood glucose mg/dl A1c % SBP mmhg DBP mmhg Weight lbs BMI kg/m % at goal A1c 6 41 Leal S et al. Diabetes Care. 2004;27(12):

10 Key Elements of Success Patient selection Disease vs. multiple medications Goals Specific target goals Integration Pharmacists, physicians, nurses, patients and care givers Location Integrated health-delivery systems Access to pharmacy and medical data Stable academic environment Method of Delivery Multidimensional Face-to-face Phone Mailings Timely communication Routine follow-up