Advancing the Use of Ethics in Community-Based Commercial Drug Formulary Decision-Making: A Critical Analysis Focused on Pharmacy Benefits Coverage Provided by Large Employers in the U.S. Healthcare System

This thesis answers the two-part question: (1) What are the perspectives of the core decision-makers (employer benefit design decision-makers, managed care P&T committee members) and affected end-users (community practicing physicians, community retail pharmacists, employees (insured members)) as it relates to community-based commercial drug formulary decision-making?, and (2) What are the ethical implications of these identified perspectives? The research focused on large employers in the U.S. healthcare system providing pharmacy benefits coverage to their employees. Despite the extensive use of formularies by managed care in the U.S., there is a lack of research on this topic specific to the perspectives of the stakeholders included in this thesis and the implications of their perspectives as it relates to normative ethical theories of utilitarianism, deontology, virtue ethics and principles of biomedical ethics, namely autonomy, beneficence, maleficence and justice. The PhD Researcher conducted 1:1 blinded interviews with 10 study participants from each stakeholder group included in this thesis (n=40) with the exception of the employees (insured members) who participated in one of two focus groups (n=5; n=6). Research methods associated with Grounded Theory were applied to the interview and focus group transcripts to develop initial codes, focused codes and categories. A literature review was completed on relevant ethical theories and principles as well as the U.S. healthcare system. Based on findings of the research completed, ethics is not considered in community-based commercial drug formulary decision-making and implementation. Four categories emerged from analysis of the research: (1) Access to Rx Medications is impacted by the Financials, (2) Drug Formularies are a Means to an End, (3) Informed Decision-making is Essential to Understanding Implications of Choice, and (4) Population vs Patient-level Care is not Necessarily Reconcilable. A three-step approach is proposed to integrate ethics into the commercial drug formulary decision-making process.