“… packaging innovations could make it easier to track the number of doses that have been taken … other options could work to improve storage and encourage prompt disposal to reduce the available supply and reduce the risk for third-party access… (the) FDA is committed to exploring our existing authorities to find new and impactful ways of regulating packaging, storage, and disposal options to improve safety.”

Statement from Scott Gottlieb, M.D.
Commissioner of Food and Drug Administration
October 30, 2017
Statement on New strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal

Most of the roughly 200 million opioid prescriptions dispensed in the United States each year are not finished by the patient for whom they are intended. No one knows how many unused opioid pills lie forgotten in American medicine cabinets and sock drawers, but it’s surely in the billions. This enormous reservoir of excess pills may be raided by addicted individuals (e.g., houseguests, holiday party attendees) or become the gateway to experiments in drug use or dealing by curious teenage children.

“One idea for preventing leftover opioids from fueling opioid abuse”

Keith Humphreys, PhD
Stanford University
Esther Ting Memorial Professor
Professor and Section Director for Mental Health Policy in the Department of Psychiatry and Behavioral Sciences

Washington Post, December 5, 2017

Prescription drug monitoring programs (PDMPs) continue to be among the most promising state-level interventions to improve opioid prescribing, inform clinical practice, and protect patients at risk. Although findings are mixed, evaluations of PDMPs have illustrated changes in prescribing behaviors, use of multiple providers by patients, and decreased substance abuse treatment admissions. States have implemented a range of ways to make PDMPs easier to use and access, and these changes have significant potential for ensuring that the utility and promise of PDMPs are realized.

Centers for Disease Control

Medication nonadherence is a leading cause of inadequate hypertension management leading to CVD, stroke, and chronic kidney disease. Approximately 50% of patients with CVD have suboptimal adherence to their prescribed medications, with deleterious effects on morbidity, mortality, and healthcare costs.

Enhancing adherence is potentially an effective and efficient means of improving US health outcomes and addressing health disparities.

Disparities in hypertension and cardiovascular disease in blacks: The critical role of medication adherence.

The Journal of Clinical Hypertension
August 2017
Keith C Ferdinand, MD, et. al

In a 2014 study involving 3000+/- treatment seeking heroin addicts, 75 percent reported that their addiction started with introduction to opioids through prescription drugs.

The Changing Face of Heroin Use in the United States: A Retrospective Analysis of the Past 50 Years
JAMA Psychiatry. 2014;71(7):821-826. doi:10.1001/jamapsychiatry.2014.366

(T)he kinds of actions we must consider (will) be far more intrusive than the steps we might have taken a decade ago…This includes the use of packaging innovations to improve storage and disposal and measure adherence. All this work has as a goal preventing misuse.

Other packaging innovations could make it easier to track the number of doses that have been taken. Still other options could work to improve storage and encourage prompt disposal to reduce the available supply and reduce the risk for third-party access.

There are also technologies that could allow providers, pharmacists or family members to monitor patient use of prescription opioids.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drug Administration
Workshop on Packaging, Storage, and Disposal Options to Enhance Opioid Safety — Exploring the Path Forward
Silver Spring, MD
Dec. 11, 2017