A Bad Outcome. Drugs don t work in patients who don t take them. Does Compliance Really Matter? Why Should I Care about This?

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1 Does Compliance Really Matter? Sunanda Kane MD, MSPH, FACG, FACP, AGAF Professor of Medicine Mayo Clinic Drugs don t work in patients who don t take them C. Everett Koop A Bad Outcome Why Should I Care about This? Ongoing Professional Practice Evaluation (OPPE) initiatives are being developed to include patient outcomes and adherence: Credentialing Board re-certification Career benchmarking 1

2 Goals National Quality Forum Report Improve medication adherence by creating standards to change the way healthcare professionals interact with patients Develop standard performance measures that could be implemented in patient care settings to improve adherence Recommendations Adherence needs to be evaluated as a vital sign, every time a patient is seen by a physician or nurse Ask the questions: Are you taking the medication, how are you taking it, and what is the dose? Adherence = What is Adherence? Compliance (medication consumption as instructed, % pills taken) Measured by the Medication Possession Ratio (MPR) + Persistence (duration of time during which medication is consumed, 1-discontinuation) Traynor K. Am J Health-Syst Pharm. 2005;62: Case examples of older adults' dosing of a 7-drug regimen Wolf, M. S. et al. Arch Intern Med 2011;171: Interval Empathy and Patient Outcomes Empathy is important for effective communication and education Associated with improved patient satisfaction and compliance with recommended treatment Patients who are satisfied with communication have improved understanding of their condition, less anxiety Copyright restrictions may apply." Stewart MA. Soc Sci Med 1984;19(2): Roter DL. Arch Intern Med 1995; 155(17):

3 Rapid Decline in Refills at 3 months % 90% 5-ASA Persistency: 12 months Percent of patients Sulfasalazine Pentasa Asacol Colazal % of Persistent Patients 80% 70% 60% 50% 40% 30% 20% Asacol (N=25,887) Colazal (N=4,557) Lialda (N=6,170) Pentasa 250mg (N=1,730) Pentasa 500mg (N=5,498) Months following treatment initiation 10% 0% Kane SV. Am J Gastroenterol 2006; 101(9):P1079 Kane S. Dig Dis Sci 2011; accepted. 100 Nonadherence to 5-ASA Therapy Clinical Impact Non-Adherence is Predictive of Higher Health Care Costs per Patient Percent patients remaining in remission Adherent Nonadherent * *P < Time (months) Parameter Estimate Chi-square P value Male gender Carlson Comorbidity Index < Age < MPR < Kane S, et al. Am J Med. 2003;114: Kane SV. Dig Dis Sci 2008;53(4):

4 Cost-Effectiveness of 5-ASA Maintenance in UC Non-Adherence to Infliximab Associated with Higher Health Care Costs Markov model over 2 years using 2.4 g/day maintenance Without maintenance, mean flares 1.92/person mean cost $3402 With maintenance, flares fell to 1.38 at a cost of $8810 flare prevented Maintenance increased discounted qualityadjusted life-years Yen E. Am J Gastro 2008; 103: Integrated Healthcare Information Services database which covers 25 million lives 647 pts with CD on infliximab identified 1-year non-adherence was 36% (< 7 infusions during first year) Kane SV. Adv Ther 2009; 26(10): Multivariate analysis identified non-adherence associated with higher risk of hospitalization Longer hospital stays Higher inpatient costs Higher outpatient costs Reductions in Health Care Costs with Adalimumb Maintenance Therapy 749 pts identified from Ingenix Impact database 83% adherence rate Adherent patients fewer hospitalizations, ED visits (16 vs 24%) CD related hospitalization 0.45 ( ) if adherent Lesser all cause and CD related medical costs ($2,152/pt/ yr) BID vs QID: Active Disease 227 mild-moderate active UC randomized to 2 packets bid:1 packet qid:2 tablets qid for 8 weeks Complete responders similar in all groups Non-inferiority of granules demonstrated No difference in efficacy, safety of bid vs qid granules Kane S. Gastroenterol 2010; S1275 [Abstract] Farup PG Inflamm Bowel Dis 2001;7(3):

5 BID vs TID: Active Disease 362 patients with mild-moderate UC randomized to micropellets vs tablets 1.5 g sachets vs. 500 mg tablets tid Micropellets showed non-inferiority to tablets for remission at 8 weeks Safety profiles similar Higher doses can be safely taken less frequently Summary Non-adherence is: Prevalent Clinically relevant Multi-factorial Easy to study, hard to fix Non-adherence will not improve without better interventions and education Raedler A. Aliment Pharmacol Ther 2004:20(11-12):