Action A1 Prescription and adherence to treatment’ Enrica Menditto, PhD CIRFF, Department of Pharmacy, University Federico II Naples, April 19 2013 1

AHA Strategic Implementation Plan: The Pillars

Action Group A1 Partners The partners involved in the action come from several countries and the Italian stakeholders represent the 15%. AIFA, Italian Medicines Agency represents one of the coordinator of the Action

Partners –members of Action Group A1 AIFA Consortium Coordinator Andalusian Regional Ministry of Health and Social Welfare Aston University UK APSS, (Regional Health Provider Trento Province) CIRFF, University of Naples Department of Health and ConsumerAffairs of the Basque Government Department of Health, Social Services and Public Safety Northern Ireland Education, Health and Society Foundation Murcia General Council of pharmacists Spain GIRP European Association of Pharmaceutical Fullline Wholesalers, Brussels, Belgium GSK Healthy Ageing Network Northern Netherlands (HANNN) Hospital de Getafe Spain LST Universidad Politecnica Madrid Spain Coordinator Medical university of Warsaw Merck Serono NHS Scotland Coordinator University Coimbra ParkinsonNet (Radboud University Nijmegen Medical Centre) Perugia University UCC Cork Ireland University Coimbra Portugal Veneto Region Italy

A1 Action Plan: General Objectives ACTIONS OBJECTIVES Decision Support Tools Dispensing & Prescribing Interventions Monitoring 1 – Improve Patient Adherence to Care Plans Counseling & Education Online services Social networks 2 – Empower Patients and care givers Electronic prescription Best-practices Service models Training 3 – Deliver improvements in the health care systems Evidence Guidelines 4 - Research and methodology Data repositories Networking 5 – Fostering Communication

Commitment Objectives Action Plan and CIRFF Commitment Objectives Action Plan General Objectives 4. Research and methodology on adherence 5. Foster communication between different partners/actors in the healing and caring process to improve adherence foster communication 1. Improve patient adherence to care plans, including medication and healthy habits CIRFF Commitment Objectives Develop a model to evaluate adherence on large population databases, especially focusing on: Correlation between poor adherence and negative clinical outcomes Optimal Proportion of Days Covered (PDC) threshold to assess adherence levels Predictive factors of discontinuation Cost-effectiveness of enhancing adherence levels Develop a remote monitoring system of adherence levels based on prescription refill data in patients affected by chronic diseases Develop a web-based platform to report and deliver information about adherence State of Play In timeframe Nov2012-Jan2013; Feb-Jun2013; Jul-Dec. We have collected data from regional Health Agency and created a population database ready to be used. We are currently defining cohorts of study, focusing on osteoporosis, diabetes, CHF, hypertension. Consultation ongoing with partners. Gathering platform design proposals CIRFF Commitment Partners CIRFF, Department of Pharmacy, Federico II Unina Lara Natale Campania Region Health Care Authority Maddalena Illario Adelaide Ipppolito Federico II University Hospital R&D Unit Carolina Di Somma Department of Clinical and Molecular Endocrinology Federico II Unina Guido Iaccarino Department of Medicine and Surgery, University Hospital Salerno.

% of Pharmaceutical Expenditures Rationale for prescription and adherence action at regional level Campania Region: Outpatient Pharmaceutical Comsumption Age group % of Population % of Pharmaceutical Expenditures DDD/1000 inh, die All ages 100 Children (0-17 y) 16.5 3.3 2.0 Non elderly adults (18-64 y) 67.5 46.5 44.6 Elderly (65 + y) 16.0 50.2 53.4 Source: CIRFF report Campania Region 2011

with chronic conditions % of Pharmaceutical Expenditure Rationale for prescription and adherence action at regional level Age group % of Population with chronic conditions % of Pharmaceutical Expenditure All ages 27. % 83.1 % Elderly (65 + y) 81.9 % 94.6 % Chronic Disease and polytherapy Source : Own elaboration based on CIRFF data.

Poor adherence: relevance Time to Discontinuation* of Chronic Therapy Classes * 30 days gap allowed Source : Own elaboration based on CIRFF data.

Adherence improves health and reduces costs The Opportunity: Adherence improves health and reduces costs Sorce: Sokol et al. 2005

Pharmacoepidemiology Resources utilization Tools : administrative databases observational model Prescription Pharmacoepidemiology Drug utilization Population database Resources utilization Costs Effectiveness Pharmacoeconomics

Our experiences - Antiosteoporosic drugs Antihypertensive therapy The pharmacoeconomic impact of amlodipine use on coronary artery disease. de portu S, Menditto E, Scalone L, Bustacchini S, Cricelli C, Montovani LG. Pharmacological research 54 (2006) 158-163 Pharmacoeconomic consequences of amlodipine besylate therapy in patients indergoing PTCA. Rossetti F, De portu S, Menditto E, Scalone L, Bustacchini S, Cricelli C, Montovani LG. Pharmacological Research 53 (2006) 197-201 - Cost-effectiveness analysis of bisoprolol treatment for heart failure. Di Stasi F, Scalone L, De Portu S, Menditto E, Mantovani LG. Ital Heart J. 2005 Dec;6(12):950-5 Lipid lowering therapy Cammarota s, de Portu S, Riegler S, Citarella A, Menditto E, Mantovani LG. Predictors of non-persistence on statin treatments in Italy: A retrospective Citarella A, Mantovani LG, Cammarota S, Menditto E, Riegler S, de Portu S. Pharmacoeconomic consequences of losartan therapy in patients undergoing Diabetes End-Stage Renal Disease. Value in Health 2009; Vol.12 (n. 7): A406. Therapy for diabetes The burden of hospitalization related to diabetes mellitus: a population-based study. De Berardis G, D'Ettorre A, Graziano G, Lucisano G, Pellegrini F, Cammarota S, Citarella A, Germinario CA, Lepore V, Menditto E, Nicolosi A, Vitullo F, Nicolucci A; DADA (Diabetes Administrative Data Analysis) Study Group. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):605-12. - Antiosteoporosic drugs Casula M, Filippi A, Flacco E, Gambera M, Manzoli L, Menditto E, Orlando V, Piccinelli R, Tragni E, Catapano A. Assessment and potential determinats of compliance and persistence to anti-osteoporosis therapy in Italy. . Iolascon g, Capaldo A, Orlando V, Menditto E. Persistence at one year of anti-osteoporotic drugs in southern italy: Analysis of administrative databases Clinical Cases 2013 in press Miscellaneous on drug therapy Proton pump inhibitors prescribing following the introduction of generic drugs. Cammarota S, Bruzzese D, Sarnelli G, Citarella A, Menditto E, Riegler S, Savino IG, Vozzella L, Piccinocchi G, Napoli L, Arpino G, Cuomo R. Eur J Clin Invest. 2012 Oct;42(10):1068-78. P Comella, L Franco, R Casaretti, S de Portu, E Menditto. Emerging role of capecitabine in gastric cancer. Pharmacotherapy 2009;29(3):318-30. Pharmaco-economic consequences of losartan therapy in patients undergoing diabetic end stage renal disease in EU and USA. de Portu S, Citarella A, Cammarota S, Menditto E, Mantovani LG.Clin Exp Hypertens. 2011;33(3):174-8. Menditto E, Citarella A, Cammarota S, de Portu S, S.Mantovani L G, Riegler S. Prevalence, incidence and persistence of antidepressant drug prescribing in the Italian general population: retrospective database analysis, 2005-2007. Value in Health 2009; Vol.12 (n. 7): A353. Miscellaneous on methods Menditto E,  Citarella A, Cammarota S, Sabatella C,  Riegler S. L’utilizzo dei database amministrativi per la ricerca di base e la programmazione sanitaria: l’esperienza dell’ASL Salerno 2. GIFF 2009; 2 (1) : 24-29. Menditto E, Citarella A. Valutazione economica dello studio IDEAL. Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 23-26 de Portu S, Menditto E, Mantovani LG. Valutazione economica dello studio CARDS, aggiornamenti. Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 36-40 de Portu S, Cammarota S, Menditto E, Mantovani LG. Valutazione economica dello studio AVERT Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 31-35

Measuring adherence Pharmacoepidemiology and drug safety, 2006

Our Action : Adherence Monitoring System (AMS) The use of administrative databases to monitor adherence allows to detect in real-life scenario: - drug exposure in a population over time levels of adherence to medication predictive factors of discontinuation- establish risk definitions to tailor interventions correlation between poor adherence and negative clinical outcomes cost-effectiveness of enhancing adherence levels

Pharmaceutical Records Hospital Discharge Records Data Banks and Information Systems Patients Registry Patient encrypted Code Birth date Gender Withdrawal date Pharmaceutical Records Patient encrypted Code Drug AIC code Drug ATC code Prescription date Dispensation date Amount of boxes Hospital Discharge Records Patient encrypted Code Hospitalization date Discharge date Admission type Discharge type DRG Main diagnosis Concomitant diagnosis Data Set CIRFF Patient encrypted Code–details – Pharmaceutical prescriptions – Hospitalizations

Adherence Monitoring System ALERTT DB Reporting

Expected results Improving quality of care for patients Drug comsumption razionalization Improving knowledge about adherence issues Improving interaction among patients, physicians and pharmacists

“Drugs don't work in patients who don't take them.” —C. Everett Koop, MD Naples, April 19 2013 Enrica Menditto