Adherence to Medications: A Consensus on Taxonomy B. Vrijens, S. De Geest, D. Hughes, P. Kardas, J. Demonceau, T. Ruppar, F. Dobbels, E. Fargher, V. Morrison, M. Matyjaszczyk, P. Lewek, C. Mshelia, W. Clyne, J. Urquhart, for the European Union Project Team, ‘ABC’ (www. abcproject. eu). 6 th International Conference on HIV Treatment and Prevention Adherence Miami Beach, Florida, May 22 -24, 2011
7 th Framework Programme: www. ABCproject. eu AIM: To produce evidencebased policy recommendations for European policymakers for improved patient adherence and subsequent better use of medication, in order to obtain safer, more effective and cost-effective use of medicines in Europe. Objective 1 European consensus on terminology used in the field of deviations from assigned treatment and relevant taxonomy Objective 2 segments Identification and classification of the determinants of noncompliance with short-term and long-term treatment for different clinical sectors, health care settings and population segments Objective 7 Preparation of policy recommendation for promoting patient compliance in European healthcare Objective 6 Objective 3 Assessment of the costeffectiveness of interventions that promote compliance Development of a conceptual framework for the determinants of noncompliance Objective 5 Identification and assessment of complianceenhancing interventions Duration: Jan 2009 - Dec 2011 Budget: ~3’ 000 € Objective 4 Exploring the current practices of compliance management by healthcare professionals and the pharmaceutical industry
39’ 186 hits in Medline on « Patient Compliance » Definition Authors - Year Compliance is the extent to which the patient's behavior (in terms of taking medications, following diets or executing other lifestyle changes) coincides with the clinical prescription. Sackett DL, Haynes BR; 1976 Compliance is the extent to which the patient's behavior coincides with the clinical prescription, regardless of how the latter was generated. Sackett DL, Haynes BR; 1976 Compliance is the extent to which a person’s behaviour (in terms of taking medication: following diets, or executing other lifestyle changes) coincides with medical or health advice Haynes R. B. , Taylor D. W. and Sackett D. L. ; 1979 Compliance is the extent to which an individual chooses behaviours that coincide with a clinical prescription, the regimen must be consensual, that is, achieved through negotiations between the health professional and the patient. Dracup K. A. , Meleis, A. I. ; 1982 Adherence is the degree to which a patient follows the instructions, proscriptions, and prescriptions of his or her doctor Meichenbaum, D. , Turk D. C. ; 1987 Adherence is the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes - corresponds with agreed recommendations from a health care provider World Health Organization; 2003 Adherence is the extent to which a patient participates in a treatment regimen after he or she Balkrishnan R. ; 2005 agrees to that regimen
Objectives of WP 1 European consensus on taxonomy/terminology used in the field of deviations from recommended treatment ü To conduct a systematic review to identify across different fields of expertise – clinicians, statisticians, pharmacologists, health economists, patients, etc - the terminology commonly used to describe deviations from assigned treatment in ambulatory patients ü To compare formally the different taxonomic approaches, to support quantitative assessment of drug exposure and allow for benchmarking of treatment-enhancing strategies ü To take a system-wide view of the process of ambulatory pharmacotherapy ü To forge a consensus for a rigorous taxonomy that will support and inform the remaining tasks of the ABC project ü To communicate and defend the consensus taxonomy across European countries and abroad 4
Systematic review resulted in 142 selected papers Main terms used to describe deviations from assigned treatment 5
Time sequence of terminology introduction First recorded incident of human noncompliance… occured when Eve ate the apple in the Garden of Eden… Hippocrates : « [The physician] should keep aware of the fact that patients often lie when they state that they have taken certain medicines R. Koch stipulated that patients with TB were « vicious consumptives’, ‘careless’ and/or ‘irresponsible’ 1882 Ca 460 BC – ca. 370 BC Mc Master Sackett workshop/sy introduced the mposium on term « compliance » Compliance The term with into medicine « Pharmionics » therapeutic is introduced by J. regimens Urquhart Mc Master workshop/sym -posium on Compliance with therapeutic regimens 1974 1975 1977 1976 1987 « Compliance » becomes a Me. SH term ? Leventhal has suggested that the conceptual shift Concordance is from compliance to introduced by a joint adherence represents an working group of the WHO definition on important step moving adherence AHA, behavioral Royal Pharmaceutical away from roles process influenced Society of Great emphasising obedience to by the Britain instructions (Myers environement 1998)… 1991 1993 « Treatment refusal » becomes a Me. SH term 1995 1997 2003 Intentional vs unintentional adherence (report NCCSDO=National Co-ordinating Centre for NHS and Delivery Organisation R&D ) 2005 … 2008 - 2009 « Medication Therapy Management » « Medication adherence » become Me. SH terms 6
Time sequence of terminology introduction First recorded incident of human noncompliance… occured when Eve ate the apple in the Garden of Eden… Hippocrates : « [The physician] should keep aware of the fact that patients often lie when they state that they have taken certain medicines R. Koch stipulated Mc Master Sackett Biomedical perspecive that patients with workshop/sym introduced the TB were « vicious posium on term consumptives’, Compliance « compliance » « Pharmacometric » ‘careless’ with into medicine and/or ‘irresponsible’ 1882 Ca 460 BC – ca. 370 BC therapeutic regimens 1974 1975 1976 Mc Master workshop/sy mposium on Compliance The term with « Pharmionics » therapeutic is introduced by J. regimens Urquhart 1977 1987 « Compliance » becomes a Me. SH term ? Leventhal has suggested that the conceptual shift Concordance is from compliance to introduced by a joined adherence represents an working group of the WHO defintion on important step moving adherence AHA behavioral Royal Pharmaceutical away from roles process influenced Society of Great emphasising obedience to by the Britain instructions (Myers environement 1998)… Intentional vs unintentional adherence (report NCCSDO=National Co-ordinating Centre for NHS Service and Delivery Organisation R&D ) Psychological/Ecological perspective « Behaviour » 1991 1993 « Treatment refusal » becomes a Me. SH term 1995 1997 2003 2005 … 2008 - 2009 « Medicatrion Therapy Management » « Medication adherence » become Me. SH terms 7
Multiple orthogonalities Conceptual definitions Individual view Cross-sectional approach Psychological/ Ecological (behaviour) perspective Biomedical (Pharmacometric) perspective Longitudinal approach Herd view Operational definitions
Description of work from JAN ’ 09 until May‘ 11 • JAN-JUN ‘ 09 : Systematic review of the literature • JUN ‘ 09 : ABC internal consensus meeting, Aberdeen, UK • JUN-AUG ‘ 09 : Internal discussions & experts’ advice • SEP ‘ 09 : European consensus meeting – ESPACOMP ’ 09, Bangor, UK • SEP-DEC ‘ 09 : Wiki interactive web-platform – experts’ discussions • DEC ‘ 09 : First draft submission to EU • JAN ‘ 10: ABC internal consensus meeting, Sion, CH • JAN-JUN ‘ 10: Internal discussions – presentation of the taxonomy at international meetings and experts’ discussions • JUN’ 10: ABC internal consensus meeting, Leuven, BE • SEP’ 10: Final consensus meeting – ESPACOMP ’ 10, Lodz, Poland • May’ 11: Publication in peer reviewed journal
New conceptual foundation and transparent taxonomy: 3 elements
1. Adherence to medications: the process by which patients take their medications as prescribed. It is composed of 3 parts: Initiation occurs when the patient takes the first dose of a prescribed medication. Discontinuation occurs when the patient stops taking the prescribed medication. Execution is the extent to which a patient’s actual dosing history corresponds to the prescribed dosing regimen, from initiation until discontinuation of dosing. Persistence is the length of time between initiation and discontinuation of dosing. Adherence to medications Persistence Non-persistence Execution Initiation First prescription First dose Discontinuation Last dose End of prescribing time
Examples of types of adherence to medications Patient with late initiation but good execution Patient with suboptimal execution Patient with excellent execution but short persistence (early discontinuation) www. iadherence. org (HIV)
2. Management of adherence: the process of monitoring and supporting patients’ adherence to medications by health-care systems, providers, patients, and their social networks. The objective of medication management is to achieve the best use, by patients, of appropriately prescribed medicines, in order to maximize the potential for benefit and minimize the risk of harm. Health-care/Prescribing Policy Community & Institutions Management of adherence Providers & Prescribers Adherence to medications Family & Carers Persistence Non-persistence Patient Execution Initiation First prescription First dose Discontinuation Last dose End of prescribing
3. Adherence-related sciences include disciplines that seek understanding of the causes or consequences of differences between the prescribed (i. e. intended) and actual exposures to medicines. The complexity of this field, as well as its richness, results from the fact that it operates across the boundaries between many disciplines, including but not limited to: medicine, pharmacy, nursing, behavioural science, sociology, pharmacometrics, biostatistics, and health economics. Adherence-related Sciences Adherence to Medications Initiation-Execution-Discontinuation Management of Adherence
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