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ABC and the National Forum Tackle Complex
Issues in Overcoming Nonadherence

The Enhanced Adherence Strategic Initiative (EASi) was founded as a collaboration between multiple ABC members and their colleagues and as a consequence of a mandate from the CDC’s Million Hearts Campaign to “think out of the box” regarding drug development. The “box” represented bringing safe and effective drugs to the market. “Out of the box,” then, became defined as enhancing medication adherence once the drug was on the market. The EASi board, under the guidance of Dr. Fortunato Fred Senatore, Medical Officer, U.S. Food and Drug Administration, investigated the root causes of medication non-adherence, which included socio-economic issues, education, trust, ease of drug administration, therapeutic index, and racial/ethnic disparities. The board also explored potential action items and their effect on adherence. This included adherence monitoring methodologies, patient incentives, and greater patient engagement with health care providers, especially at the community level.

Dr. Keith C. Ferdinand, ABC Access to Care Initiative Chair and a leading member of the EASI coalition notes, "Despite excellent present-day pharmacotherapy and devices for treatment, adequate control of CVD morbidity and mortality will not be successful unless issues of access and adherence are addressed."

The public health work and peer-reviewed publications are ongoing and are designed to look into the year 2020 and beyond. Based on an evolving regulatory environment that recognizes the need to enhance medication adherence, the FDA conducted a public workshop meeting in D.C. on December 10, 2019. Members of the EASi board served on various panels. The goal of the public meeting was to examine the impact of potential regulatory actions to improve medication adherence and secure adherence claims. This workshop included novel trial designs aimed at real-world data acquisition, as well as sharply focusing on racial/ethnic disparities.

“Issues related to medication adherence — access, education, patient engagement, and treatment disparities — continue to plague advances in developing safe and efficacious drugs to reduce morbidity and mortality in cardiovascular disease,” said Dr. Senatore. “These issues need to be addressed at multiple levels of the health care paradigm, including the development of regulatory policies to address and improve medication adherence.”

The EASi board remains committed to its efforts in supporting enhanced medication adherence and attenuating, to the point of removing, racial/ethnic disparities still in effect today. This initiative will continue to be in conjunction with the ABC and the National Forum for Heart Disease and Stroke Prevention. In 2020-2021, the Value & Access Committee of the National Forum will advocate policy changes that will allow interventions proven to improve adherence to be implemented in more states.

The following publications emanating from EASi board members support EASi’s work and provide examples of the board’s thinking as well as future directions for the initiative.

Contemporary Concepts in Access to Health Care: Identification and Elimination of Disparities in Care of Minority Patients
Co-authored by Fortunato Fred Senatore (and Samar A.Nasser)
Medication adherence has been recognized as a significant determinant of CV health and the lack of adherence is intertwined with societal factors that impact racial/ethnic disparities. From the emerging evidence, a strategic approach to improve outcomes in CVD and attenuate healthcare and outcome disparities is to address adequate medication access, improve education, and increase consistent medication adherence.
Review Paper: Disparities in Hypertension and Cardiovascular Disease in African Americans: The Critical Role of Medication Adherence
Co-authored by lead author Keith C. Ferdinand MD, Helene D. Clayton-Jeter OD, Dennis R. Cryer MD and Fortunato Fred Senatore MD, PhD (with Kapil Yadav MD, Samar A. Nasser PhD, MPH, PA-C and John Lewin MD)
One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. This review describes the relationship between disparities and medication adherence, which likely plays a role in persistent disparities in cardiovascular morbidity and mortality.
Standardized Classification and Framework for Reporting and Interpreting Medication Non-Adherence in Clinical Trials
Co-authored by Fortunato F. Senatore (and Robert M. Califf)
Valgimigli and colleagues propose, in this issue of the European Heart Journal, a Nonadherence Academic Research Consortium (NARC) classification scheme designed to enhance the accuracy of the efficacy assessment in clinical trials, provide a consistent approach to measuring non-adherence, and reliably estimate effectiveness in clinical practice after approval. (This editorial refers to ‘Standardized classification and framework for reporting, interpreting, and analyzing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC)’†, by M. Valgimigli et al., on page 2070.)
Reply to Directly Observed Therapy: A Possible Tool to Tackle Medication Nonadherence in the CVD Epidemic
Co-authored by Keith C. Ferdinand MD and Fortunato Fred Senatore MD, PhD (with Samar A. Nasser PhD, MPH, PA-C)
Dr. Keith C. Ferdnand et al reply with a 4-point response to Drs. Kenechukwu Mezue and Janani Rangaswami’s recommendation to use directly observed therapy (DOT) as a tool to reduce medication nonadherence for cardiovascular disease (CVD) in high-risk populations.
Improving Medication Adherence in Cardiometabolic Disease-Practical and Regulatory Implications, State-of-the-Art Review
Co-authored by lead author Keith C. Ferdinand MD, Fortunato Fred Senatore MD, PhD, Helene Clayton-Jeter OD, and Dennis R.Cryer MD (with John C. Lewin MD, Samar A. Nasser PhD, MPH, PA-C, Mona Fiuzat PharmD, and Robert M. Califf MD)
This paper summarizes the scope of CVD nonadherence, describes key U.S. Food and Drug Administration initiatives, and identifies potential targets for improvement. The authors describe key adherence factors, methods, and technological applications for simplifying regimens and enhancing adherence, and 4 areas where additional collaborative research and implementation involving the regulatory system and clinical community could substantially reduce nonadherence.

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