April 6, 2020
National Center for Health Research’s Public Comments on The Food and Drug Administration’s Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations
We are glad to have the opportunity to express our views on the proposed collection of information on Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
We support FDA’s decision to conduct a comprehensive evaluation of opioid prescribers’ knowledge, attitudes, perceptions, experiences and behaviors related to Abuse Deterrent Formulations (ADF) and agree with the FDA that new language is needed to better describe and explain ADF.
There is clear evidence that the term ADF has been widely misunderstood by patients and their families and also by health care providers. Most notably, the term “abuse-deterrent” is often misunderstood to mean that these drugs are less addictive than others. Since the proposed study is planning to study the understanding of the terms addiction, abuse, and abuse-deterrent and explore alternative language to “abuse-deterrent,” we strongly encourage testing the impact of terminology that more accurately describes the product’s abuse-deterrent properties. For example, if a pill is formulated to be difficult to crush, it should be labeled “crush-resistant.” The evidence already seems clear that the term “abuse-deterrent” is widely misunderstood. In fact, it may be that the term does more harm than good, because rather than resulting in safer prescribing practices, it may result in overprescribing opioids that are more addictive than the prescriber or the patient realizes. We strongly urge that the research should focus on the self-explanatory, accurate terms that the FDA should use to provide clear and specific descriptions of what the drug does and does not prevent or deter.
We support FDA’s efforts to ensure the diversity of the sample populations for the three proposed studies. It is important to study health care providers with varying opioid prescribing levels, and years and locations of practice. We particularly commend the efforts to additionally account for diverse ages, ethnicities, and gender of the health care providers, as all of these factors can affect knowledge, attitudes, and the patients they serve.
The proposed study plans to include a wide range of health care providers, including primary care providers; specialists from various fields such as rheumatology, neurology, anesthesiology, pain management, emergency medicine, surgery, orthopedics, and physical medicine and rehabilitation; nurse practitioners; physician assistants; as well as dispensers/pharmacists. However, there is clear evidence that dentists, periodontists, and oral surgeons should also be included, since research has shown that they often overprescribe opioids. 
As noted at a recent FDA Advisory Committee meeting on opioids, the most common abuse of opioids is simply by swallowing too many pills. Crushing, snorting, and injecting are less common. Opioids that are crush-resistant or otherwise considered to have abuse-deterrent properties are abused extensively once they are on the market. This was, for example, the case with the reformulated Opana ER, that the FDA subsequently decided should be taken off the market. It is therefore essential that this proposed study also explores providers’ knowledge of how these drugs are used and abused once they are on the market.
The National Center for Health Research can be reached at firstname.lastname@example.org or at (202) 223-4000.
 Suda, K.J., Durkin, M.J., Calip, G.S., Gellad, W.F., Kim, H., Lockhart, P.B., Rowan, S.A. & Thornhill, M.H., (2019). Comparison of opioid prescribing by dentists in the United States and England. JAMA network open, 2(5), pp.e194303-e194303. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2734067