One of the ways that the U.S. Food and Drug Administration (FDA) has tried to address the opioid epidemic is by approving opioid analgesic products that are designed to be harder to manipulate and abuse. These so-called 'abuse-deterrent formulations' (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.
As the healthcare community works to improve its stewardship of opioid analgesics, many questions remain as to what role ADF opioids may play in this effort. What factors influence a practitioner’s decision to prescribe an ADF opioid versus a traditional formulation? How do state laws and health insurance coverage limit the use of ADF opioids? To what degree are traditional formulations being used in place of ADF opioids because of cost or other considerations?
ADF opioids represent an opportunity to deter the misuse and abuse of opioids. In the clinical setting, decisions by physicians and other practitioners directly impact who receives a prescription for an ADF opioid versus a traditional formulation. The identification of factors associated with ADF opioid prescribing is critical to inform clinical guidelines and policymaking.
We will send a survey to all licensed pharmacists who dispense opioids and all licensed physicians who prescribe opioids in the state of Kentucky. The survey will ask practitioners about their perception of the role ADFs play in the opioid epidemic, their experience dispensing/prescribing ADFs, and how communication with other practitioners, and health insurance coverage policies have affected their experience with ADFs.
The surveys will be deployed in Kentucky in fall 2019 and responses will be analyzed in 2020. In order to understand how perceptions regarding ADFs and their utilization in clinical practice may vary in different geographic areas, the survey will be deployed to pharmacists in additional states in 2021.
In navigating the complex landscape of pain management, providers, policymakers, and others continue to seek to identify effective solutions to address the opioid epidemic. The results of these surveys, to be made publicly available through publication, will assist practitioners in better understanding the perceived benefits and challenges associated with utilization of ADFs. Additionally, results will inform researchers of factors associated with ADF prescribing which may not have been taken into account in previous studies.
The study is being led by Trish Freeman at the University of Kentucky. The data are being collected by John Brown, and analyzed as a team. The study is funded by the United States Food and Drug Administration. A joint team of independent researchers at the University of Kentucky and University of North Carolina at Chapel Hill will analyze the survey results. This study has been registered with the University of Kentucky and FDA Institutional Review Boards. All studies at the Opioid Data Lab are conducted by independent researchers at the University of Kentucky and the University of North Carolina at Chapel Hill, and do not necessarily represent the views of funders or partners. We are grateful to generations of taxpayers in Kentucky and North Carolina for supporting public universities. We are also grateful to US taxpayers for safeguarding public health by supporting FDA and this research project.