A FRAMEWORK FOR CONDUCTING
INITIAL MEDICATION ADHERENCE
RESEARCH
An ISPOR Workshop by the Medication Adherence Good Research Practices Working
Group of the Medication Adherence and Persistence Special Interest Group
Medication Adherence Good Research Practices Working Group
Co-Chairs: David Hutchins, MHSA, MBA
Executive Advisor, Pharmacy Networks, CVS Caremark (Scottsdale, AZ, USA)
Andrew M. Peterson, PharmD, PhD
Dean, Mayes College of Healthcare Business and Policy, University of the Sciences (Philadelphia, PA, USA)
Leadership Group:
Maria Malmenäs, MSc - Director, Health Economic Modeling Unit, HERON (Stockholm, Sweden)
Elizabeth Manias, RN, BPharm, MPharm, PhD - Deakin University, School of Nursing and Midwifery, Victoria; Adjunct Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, the University of Melbourne (Melbourne, Australia)
Craig S. Roberts, PharmD, MBASenior Director, Global Health & Value, Pfizer Inc (Collegeville, PA, USA)
Allison F. Williams, RN, PhD - School of Nursing and Midwifery, Monash University (Victoria, Australia)
WORKSHOP Presenters
Andrew M. Peterson David Hutchins – Discussion Leader
Craig S. Roberts John E. Zeber
PURPOSE of WORKSHOP:
To provide guidance on measuring initial medication adherence (IMA), including developing standard nomenclature and key components of quality IMA research
Encourage discussion among a diverse audience of investigators, health system practitioners, patients and policy makers
John E. Zeber
Central Texas VA; Scott & White Healthcare; Texas A&M Health Science Center
Initial Medication Adherence –
Study Background
Our first project* delved into complex IMA arena Observed complexity of topic, definitions
overlap, problematic study design issues Recognized need to summarize current IMA research, benefits and limitations
Focused on factors associated with poor IMA
Background (continued)
Systematic literature review through 2012: Medline, PsychInfo, CINAHL, others
Started with 865 articles … 63 read in full; 24 were eligible (moderate quality at best) Variety of terms for very first Rx
Numerous study design approaches with inconsistent abstract, key words, methods Most examined patient factors; some covered role of system and providers
Background (continued)
Key factors => medication class (16), patient characteristics (14), physical comorbidities (14), co-payments (11), health beliefs (6) Strongest predictors = RX cost (ORs up to 7.3), specific drug, illness severity, SES, lack of discharge counseling
Similar factors influence IMA as for longer-term adherence, but …
Discussion led into need for more standardized Methodological approach, i.e., this study!
David Hutchins
CVS Caremark
Overview of Current
Methodological Study
Background: Second Project
Second working subgroup Purpose: meta-analysis
Findings: similar to those in our first project
Current project
Provide guidance to and encourage more studies Summarize current body of research
different methods
Cramer Taxonomy
Cramer JA, Roy A, Burrell A, et al. Medication compliance and persistence: terminology and definitions. Value in Health. Jan-Feb 2008;11(1):44-47
Vrijens Taxonomy
Vrijens B, De Geest S, Hughes DA, et al. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. May 2012;73(5):691-705
Taxonomies
Initial Medication Adherence (IMA)
• Initial medication adherence is when a patient presents and receives a medication prescription for the treatment of a disease for the first time
• Nonadherence encompasses both
Taxonomy Challenge:
AUDIENCE INTERACTION #1
Break into groups (~10”)
Discuss Pros and Cons of “Initial Medication Adherence” (IMA) Re-gather and report
Summarize ideas
Initial Medication Adherence (IMA)
• Initial medication adherence is when a patient presents and receives a medication prescription for the treatment of a disease for the first time
• Nonadherence encompasses both
State of Current IMA Research
Andrew M. Peterson
University of the Sciences
Data Sources for IMA
Surveys of Patients Prescribers Pharmacists Databases Pharmacy Hospital/Clinic Prescriber Office Prescription Tracking Manual
Perspectives
• Provider Perspective • 13 studies • Patient Perspective • 3 studies • Pharmacist Perspective • 6 studies • System Perspective • 17 studiesIMA Process
Framework for Analysis of IMA
Two key events required for an IMA
Prescribing Event Dispensing Event
Parameters involved in an IMA
Core: must be provided to calculate a valid IMA measurement
Supplemental: refine accuracy of IMA measurement
Ancillary: influence IMA measurement
Defining IMA Study Parameters
• Must be provided for valid IMA measurement • Examples: clear prescribing and dispensing
information, specified time window for adherence, etc.
Core
• Refine accuracy of IMA measurement • Examples: Consideration of substitution at the
pharmacy, addressing potential out-of-network fulfillment, etc.
Supplemental
• Influence IMA measurement
• Examples: consider influence of behavioral factors, pharmacy characteristics, prescriber characteristics on adherence outcome.
Ancillary
Core parameters
Study parameters that must be defined and described for IMA research
Parameters include:
Identification and scope of prescribing events Identification and scope of dispensing events Means by which prescription may be
transmitted from prescriber to dispensing Defined time window after which qualifies as non-adherent
Supplemental parameters
Parameters that may impact the validity of IMA measurement
Impact may depend on data source, characteristics of medication
Considerations include:
Process to ensure initial prescription is a new prescription (e.g. 360 days history)
Address potential for substitution (Therapeutic substitution, OTC self-care)
Address potential for out-of-network prescribing/dispensing (outside network pharmacy, cash payment) Potential for alternate instructions to patient (e.g., ‘fill if not feeling better in 3 days’)
Considerations regarding censoring (e.g. hospitalization or death of patient)
Ancillary parameters
Study parameters that help understand attributes that influence IMA
Parameters include:
Patient factors: age, sex, race, health beliefs, income, comorbidities, support network, stated reasons for adherence/non-adherence Non-patient factors: health system
characteristics, covered benefits, provider and pharmacy characteristics
AUDIENCE INTERACTION #2
:
Study parameters
Consider the three classifications of parameters
(core, supplemental, ancillary)
What study parameters may go in each category? What considerations should researchers have when addressing these parameters?
Is there a fourth category of study parameters that is relevant to initial medication adherence?
Recommendations for
Conducting Solid IMA Research
Based upon our initial systematic review and the current deeper exploration into
Methodological issues, we have developed the following set of recommendations for conducting solid IMA research:
Hutchins D, Zeber JE, Peterson AM, Roberts CS et al. Initial Medication Adherence: A Review and Analysis of Methodology: A report by the ISPOR Medication Adherence Good Research Practices Working Group [manuscript to be submitted soon to Value in Health]
IMA Research Recommendations
I. Use the term “initial medication
adherence”
II. State and define the specific perspective
taken (e.g., patient vs. system)
III. Delineate the core, supplemental, and
ancillary parameters that will be covered General:
Recommendations (continued)
IV. Provide sufficient details on the prescribing event and the procedures for determining a new therapeutic class/initial Rx
V. Specify the timeframe between the
prescribing and dispensing event and justify selection
Recommendations (continued)
Supplemental:
VI. Address perspective bias by ensuring the
comprehensiveness of information sources
VII. Address substitution bias regardless of the source
Recommendations (continued)
Ancillary:
VIII. Include patient characteristics information
Wrap-up and Final Issues
Summary
Final Audience Input, Questions, or Concerns
Recommended next steps and future research directions
Contact Information
David Hutchins, MHSA, MBA Senior Advisor, Pharmacy Networks CVS Caremark - Scottsdale, AZ [email protected]
** The Working Group expresses our thanks and appreciation to Theresa Tesoro ([email protected]) for coordinating all of our activities, and to the two rounds of internal ISPOR
reviewers for their recent comments on the manuscript draft summarizing this study.
