D’Amore Mental Health —

Jane from D’Amore Mental Health contacted me and asked if I would include their organization on my resources page. With May being Mental Health Awareness Month, I can’t think of a better time to add a new Mental Health resource. Photo by RODNAE Productions on Pexels.com Child Abuse and Childhood trauma can impact a person […]

D’Amore Mental Health —

I’m Not a Doctor, But I Play One in DC —

Pain Week is a publication specifically for Pain Doctors, one I haven’t heard of before. This mini article and Podcast shine a light on a topic those who suffer from chronic pain already know. Pain medication is not being prescribed when needed and specialized pain care is dwelling. This Podcast is very interesting, we now […]

I’m Not a Doctor, But I Play One in DC —

Let’s Talk About Addiction — Looking For The Light

If you suffer from chronic pain chances are you’ve taken addictive pain medication or at least talked to your doctor about finding pain relief. With limited alternatives for those looking for consistent pain relief, many are faced with the tough decision to take addictive medications. If you read about drug addiction, you’ll often run across […]

Let’s Talk About Addiction — Looking For The Light

FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

The New England Journal of Medicine

Barbara R. Cohen, M.P.A, Karen M. Mahoney, M.D., Elande Baro, Ph.D., Claudia Squire, M.S., Melissa Beck, B.A., Sara Travis, B.S., Amanda Pike-McCrudden, M.A., Rima Izem, Ph.D., and Janet Woodcock, M.D.

Abstract

BACKGROUND

The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use.

METHODS

In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval.

RESULTS

The results for performance on six primary end points met or exceeded thresholds, including the steps “Check for a suspected overdose” (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and “Give the first dose” (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of “Call 911 immediately,” but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of “Check, give, and call 911 immediately” (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9).

CONCLUSIONS

Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.

Timely administration of naloxone can save lives in the event of opioid overdose. Thus, emergency treatment provided by persons who may be at the scene of an overdose plays a crucial role in addressing the ongoing global opioid crisis. World Health Organization guidelines1 recommend that all persons who are likely to witness an overdose — not only medical professionals but also people who use drugs and their family and friends — have access to naloxone. However, jurisdictional policies related to the availability of naloxone vary across the world, and all too frequently legal and regulatory barriers limit access.2 In the United States, all 50 states and the District of Columbia have enacted policies to expand access to naloxone, in many instances providing for standing orders and third-party prescribing. Such expanded access allows naloxone to be prescribed both to people who may themselves be at risk for overdose and to people who are in a position to administer naloxone to others. However, both pharmacists and consumers are often either unaware of these options or are aware but associate opioid use and naloxone with stigma, which creates a barrier to purchase.3 Consequently, many health care professionals and policy makers have called for the availability of over-the-counter naloxone in the United States, which would facilitate direct purchase of the product from the store shelf by anyone, eliminating the gatekeeper.

The regulatory challenge for any industry sponsor seeking approval of an over-the-counter drug product in the United States is to provide evidence through consumer studies that consumers can safely and effectively use the product without guidance from medical professionals. Currently, the over-the-counter drug facts label is the primary means through which instructions for safe and effective use are conveyed to consumers. Potential industry sponsors have previously stated that the requirements for developing a label for over-the-counter naloxone and for assessing the effectiveness of the label through comprehension studies present barriers to bringing naloxone to the over-the-counter market. Our aim was to determine whether the Food and Drug Administration (FDA) could create and test a model label that could be assessed as adequately facilitating appropriate use of naloxone.

As a foundation for the model label, the FDA used the prescribing information for the two prescription products that had been approved for community use as of 2016: Evzio, a prefilled autoinjector, and Narcan, a nasal spray. FDA clinicians, in consultation with experts on the treatment of addiction, distilled the prescribing information for naloxone (which consists of more than 6300 words contained in 18 pages) into what were deemed to be critical elements in instructions for emergency use, limiting the text to the amount that would fit into the format for drug facts labels. The communication experts at the FDA further enhanced label usability by adding white space and boldface type, by “chunking” the information (i.e., breaking up information into small units, or chunks, that make it easier to notice), and by incorporating adjacent pictograms to clarify the stepwise directions for use.4 FDA social scientists, statisticians, and clinicians designed a label-comprehension study that incorporated best practices from the FDA’s Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products.5

The research began with a qualitative phase in which the pictograms and language in the label were iteratively revised on the basis of information obtained during in-depth, sequential, one-on-one interviews with 36 participants. This phase was followed by a pilot label-comprehension study involving another 36 participants. These preliminary phases enabled us to craft our label, refine study questions, and determine the sample size for the pivotal study, which is the focus of this article.

To read the entire article please click here: https://www.nejm.org/doi/full/10.1056/NEJMsa1912403?query=psychiatry