Enrica Menditto, PhDEnrica Menditto, PhDCIRFF, Department of Pharmacy, University Federico IICIRFF, Department of Pharmacy, University Federico II

Enrica Menditto, PhDEnrica Menditto, PhDCIRFF, Department of Pharmacy, University Federico IICIRFF, Department of Pharmacy, University Federico II

Naples, April 19 2013

Action A1Action A1Prescription and adherence Prescription and adherence

to treatment’to treatment’

AHA Strategic Implementation Plan: The PillarsAHA Strategic Implementation Plan: The Pillars

• AIFA Consortium AIFA Consortium CoordinatorCoordinator• Andalusian Regional Ministry of Health and Social Welfare Andalusian Regional Ministry of Health and Social Welfare • Aston University UKAston University UK• APSS, (Regional Health Provider Trento Province) APSS, (Regional Health Provider Trento Province) • CIRFF, University of NaplesCIRFF, University of Naples• Department of Health and ConsumerAffairs of the Basque GovernmentDepartment of Health and ConsumerAffairs of the Basque Government• Department of Health, Social Services and Public Safety Northern Ireland Department of Health, Social Services and Public Safety Northern Ireland • Education, Health and Society Foundation MurciaEducation, Health and Society Foundation Murcia• General Council of pharmacists SpainGeneral Council of pharmacists Spain• GIRP European Association of Pharmaceutical Fullline Wholesalers, Brussels, BelgiumGIRP European Association of Pharmaceutical Fullline Wholesalers, Brussels, Belgium• GSKGSK• Healthy Ageing Network Northern Netherlands (HANNN) Healthy Ageing Network Northern Netherlands (HANNN) • Hospital de Getafe SpainHospital de Getafe Spain• LST Universidad Politecnica Madrid Spain LST Universidad Politecnica Madrid Spain CoordinatorCoordinator• Medical university of WarsawMedical university of Warsaw• Merck SeronoMerck Serono• NHS Scotland NHS Scotland CoordinatorCoordinator• University CoimbraUniversity Coimbra• ParkinsonNet (Radboud University Nijmegen Medical Centre)ParkinsonNet (Radboud University Nijmegen Medical Centre)• Perugia UniversityPerugia University• UCC Cork IrelandUCC Cork Ireland• University Coimbra PortugalUniversity Coimbra Portugal• Veneto Region ItalyVeneto Region Italy

Partners –members of Action Group A1Partners –members of Action Group A1

A1 Action Plan: General ObjectivesA1 Action Plan: General Objectives

• ACTIONSOBJECTIVES

• Decision Support Tools• Dispensing & Prescribing• Interventions• Monitoring

1 – Improve Patient 1 – Improve Patient Adherence to Care PlansAdherence to Care Plans

• Counseling & Education• Online services• Social networks

2 – Empower Patients 2 – Empower Patients and care giversand care givers

• Electronic prescription• Best-practices• Service models• Training

3 – Deliver 3 – Deliver improvements in the improvements in the health care systemshealth care systems

• Evidence• Guidelines

4 - Research and 4 - Research and methodologymethodology

• Data repositories• Networking

5 – Fostering 5 – Fostering CommunicationCommunication

Action Plan and CIRFF Commitment ObjectivesAction Plan and CIRFF Commitment Objectives

Action PlanAction PlanGeneral ObjectivesGeneral Objectives

4. Research4. Research and and methodology on methodology on adherenceadherence

5. Foster 5. Foster communication communication between different between different partners/actors in the partners/actors in the healing and caring healing and caring process to improve process to improve adherence foster adherence foster communicationcommunication

1. Improve patient 1. Improve patient adherence to care adherence to care plans, including plans, including medication and medication and healthy habits healthy habits

CIRFFCIRFFCommitment ObjectivesCommitment Objectives

Develop a model to evaluate adherence on Develop a model to evaluate adherence on large population databaseslarge population databases, especially focusing , especially focusing on:on:• Correlation between poor adherence and Correlation between poor adherence and negative clinical outcomesnegative clinical outcomes• Optimal Optimal Proportion of Days Covered (PDC) Proportion of Days Covered (PDC) threshold to assess adherence levelsthreshold to assess adherence levels• Predictive factors of discontinuationPredictive factors of discontinuation• Cost-effectiveness of enhancing adherence Cost-effectiveness of enhancing adherence levelslevels

Develop a remote monitoring Develop a remote monitoring system system of adherence levels of adherence levels based based on prescription refill dataon prescription refill data in in patients affected by chronic patients affected by chronic diseasesdiseases

Develop a web-based platform to Develop a web-based platform to report report and deliver information and deliver information about adherenceabout adherence

State of PlayState of Play

In timeframe Nov2012-In timeframe Nov2012-Jan2013; Feb-Jun2013; Jul-Jan2013; Feb-Jun2013; Jul-Dec. We have collected data Dec. We have collected data from regional Health Agency from regional Health Agency and created a population and created a population database ready to be used. database ready to be used. We are currently defining We are currently defining cohorts of study, focusing on cohorts of study, focusing on osteoporosis, diabetes, CHF, osteoporosis, diabetes, CHF, hypertension.hypertension.

Consultation ongoing Consultation ongoing with partners.with partners.

Gathering platform Gathering platform design proposalsdesign proposals

CIRFFCIRFFCommitment PartnersCommitment Partners•CIRFF, Department of CIRFF, Department of Pharmacy, Federico II UninaPharmacy, Federico II Unina

• Lara NataleLara NataleCampania Region Health Campania Region Health Care AuthorityCare Authority

•Maddalena IllarioMaddalena IllarioAdelaide Ipppolito Adelaide Ipppolito Federico II University Federico II University Hospital R&D UnitHospital R&D Unit

• Carolina Di Somma Carolina Di Somma Department ofDepartment ofClinical and Molecular Clinical and Molecular Endocrinology Endocrinology Federico II UninaFederico II Unina

• Guido IaccarinoGuido IaccarinoDepartment of Medicine Department of Medicine and Surgery, University and Surgery, University Hospital Salerno.Hospital Salerno.

Chronic Disease and polytherapyChronic Disease and polytherapy

Age groupAge group% of Population% of Populationwith with chronic chronic conditionsconditions

% of Pharmaceutical Expenditure

All agesAll ages 27. %27. % 83.1 %83.1 %

Elderly (65 + y)Elderly (65 + y) 81.9 %81.9 % 94.6 %94.6 %

Source : Source : Own Own elaborationelaboration based on based on CIRFF CIRFF datadata..

Rationale for prescription and Rationale for prescription and adherence action at regional leveladherence action at regional level

Poor adherence: relevancePoor adherence: relevance

Time to Discontinuation* of Chronic Therapy Classes Time to Discontinuation* of Chronic Therapy Classes

Source : Source : Own Own elaborationelaboration based on based on CIRFF CIRFF datadata..

* 30 days gap allowed* 30 days gap allowed

The Opportunity: The Opportunity: Adherence improves health and reduces costs Adherence improves health and reduces costs

Sorce: Sokol et al. 2005Sorce: Sokol et al. 2005

Tools : administrative databasesTools : administrative databasesobservational modelobservational model

Population databasePopulation database

PrescriptionPrescription

Resources utilizationResources utilization

CostsCosts EffectivenessEffectiveness

PharmacoepidemiologyPharmacoepidemiologyDrug utilizationDrug utilization

PharmacoeconomicsPharmacoeconomics

Our experiencesOur experiences

-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 de Portu S, Cammarota S, Menditto E, Mantovani LG. Valutazione economica dello studio AVERTeconomica dello studio AVERT Farmeconomia e percorsi terapeutici Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 31-352007; 8 (Suppl 2): 31-35

The use of administrative databases to monitor adherence The use of administrative databases to monitor adherence

allows to detect in real-life scenario: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

Our Action : Adherence Monitoring System (AMS)Our Action : Adherence Monitoring System (AMS)

Patients RegistryPatients Registry

• Patient encrypted CodePatient encrypted Code• Birth dateBirth date• GenderGender• Withdrawal dateWithdrawal date

Pharmaceutical RecordsPharmaceutical Records

• Patient encrypted CodePatient encrypted Code• Drug AIC codeDrug AIC code• Drug ATC codeDrug ATC code• Prescription datePrescription date• Dispensation dateDispensation date• Amount of boxes Amount of boxes

Hospital Discharge RecordsHospital Discharge Records

• Patient encrypted CodePatient encrypted Code•Hospitalization dateHospitalization date•Discharge dateDischarge date• Admission typeAdmission type• Discharge typeDischarge type• DRGDRG• Main diagnosisMain diagnosis• Concomitant diagnosisConcomitant diagnosis

Data Banks and Information SystemsData Banks and Information Systems

Patient encrypted Code–details – Pharmaceutical prescriptions – Hospitalizations

Adherence Monitoring SystemAdherence Monitoring System

DB

ReportingReporting

Expected resultsExpected results

• Improving quality of care for patients Improving quality of care for patients

• Drug comsumption razionalizationDrug comsumption razionalization

• Improving knowledge about adherence issuesImproving knowledge about adherence issues

• Improving interaction among patients, physicians and Improving interaction among patients, physicians and pharmacistspharmacists

““Drugs don't work in patients who Drugs don't work in patients who don't take them.”don't take them.”

——C. Everett Koop, MDC. Everett Koop, MD

Enrica MendittoNaples, April 19 2013