pharmacist in pharmacy, fda medication envelope

Last updated on June 29, 2022

A Persistent Problem

Though the number of prescription opioids dispensed in the U.S. has decreased since 2012, it is still a sizable number. Since 2012, an estimated 140.6 million prescriptions (approximately 8.7 billion tablets/capsules) has been dispensed from outpatient retail and mail-order pharmacies.1

  • In 2019, around 7 million Americans over 12 years old abused or misused prescription pain relievers like opioids, making them the most common class of prescription drugs used nonmedically in the U.S.2
  • Between 2010 and 2018, there were 48,000 accidental prescription opioid exposures among young children.3
  • Since 2020, prescription opioids were responsible for more than 16,000 deaths per year due to overdoses, higher than the rate seen at the peak of opioid dispensing in 2012.4
  • Nonmedical use of prescription opioids commonly leads to the use of illegal drugs like heroin and illegally manufactured fentanyl and fentanyl analogues.

Improper Storage/Disposal Provides an Easily Accessible Supply of Opioids for Nonmedical Use, Accidental Exposure, and Overdose

Many studies report that patients typically store unused opioids in unsecured places, creating dangerous opportunities for nonmedical use, accidental exposure, and overdose, which potentially lead to rising rates of opioid addiction. Most Americans gain their first exposure to nonmedical use of prescription pain relievers through friends and relatives, but many patients end up with unused opioids from their own prescription after acute or chronic pain treatment.

A large-scale literature review from 2017 reported that up to 92% of patients had leftover opioids after seven common surgeries.5 Another review, including studies published up to 2019, found up to 70% of opioids dispensed after surgery went unused.6 Chronic pain treatment can also lead to unused opioids due to the following:

  • Changes in the duration or dose
  • Their discontinuation
  • Death of the patient

FDA Focuses on Encouraging Appropriate Disposal

In 2018 Congress signed into law the SUPPORT Act (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act). The SUPPORT Act gave the FDA authorization to require safer opioid packaging and dispensing methods through a Risk Evaluation and Mitigation Strategy. In April of 2022, the FDA announced it is seeking public comment on a potential change to this strategy that would require drug manufacturers to provide free prepaid mailback envelopes for pharmacists to provide with every opioid dispensed in outpatient settings.

Increased Disposal via Education and In-Home Disposal Options

A recent review of studies examining opioid disposal practices found that fewer than 50% of patients disposed of their opioids.7 One study found that either patient education or providing a take-home disposal method increased the disposal rate by approximately 12%, but the combination of strategies increased the disposal rate by 19.5%.8 The actual or planned disposal rate increased to over 50% of the study populations if a disposal kit was provided.8,9,10,11

Though the disposal products in these studies were often not specified and were provided only after surgery, one can reasonably assume that disposal rates would also increase with mailback envelopes provided beyond just post-surgical management.

Mail-Back Envelopes in the Current Landscape of Opioid Disposal Options

There are several options for patients to dispose of opioids. The FDA currently recommends disposal options outside the home, including the use of collection kiosks (often in pharmacies) or attending take-back events. From their homes, patients can do the following:

  • Flush (only medications on the FDA’s “Flush List”)
  • Use in-home disposal products or techniques, like mixing with an unpalatable substance and disposing of it in the trash

These options are not all ideal, however. For example, bringing medications to a collection kiosk or event requires planning transportation and potentially uncomfortable exposures in the public or a law enforcement setting. In-home disposal options are generally undesirable due to user discomfort with mixing drugs with other substances and then disposing of them in the trash where the mixtures can potentially harm the environment.

By contrast, mailback envelopes:

  • Do not require patients to mix their medications with any substances
  • Can be mailed from their home
  • Include prepaid postage

Such envelopes are designed according to DEA and USPS regulations, both of which ensure the safe and secure transport to a location where they will be destroyed. Unlike home-based disposal, the DEA requires mailback envelopes to be destroyed in a manner that renders the medications non-retrievable, which is typically achieved through incineration (non-retrievable means the drug is permanently and irreversibly changed). As a result, the use of envelopes (and kiosks) helps prevent drugs like opioids from entering the water supply and landfills, unlike home-based methods.

Sharps Compliance offers the TakeAway Medication Recovery System envelopes for the commingled collection and disposal of patient dispensed controlled substances (Schedules II-V) and non-controlled medications. The envelopes are nondescript with unique tracking features and include prepaid return USPS postage for proper destruction that meets the DEA’s non-retrievable standard.

The FDA believes requiring drug manufacturers and pharmacists to provide a mailback envelope with every opioid dispensed would give patients and caregivers a convenient way to ensure homes and communities are safe from intentional and accidental opioid use.

Parties interested in voicing their support for the FDA’s proposed mailback envelope requirement, including patients, patient advocates, healthcare professionals, academics, researchers, the pharmaceutical industry, and other government entities and interested parties, have until June 21, 2022 to submit their public comments.

References

  1. National Prescription AuditTM. Data extracted January 14, 2022.
  2. S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration. ‘‘Key Substance Use and Mental Health Indicators in the United States: Results from the 2019 National Survey on Drug Use and Health.’’ HHS Publication No. PEP20–07–01–001, NSDUH Series H–55, Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration (2020). Available at: https://www.samhsa.gov/data/sites/default/files/reports/rpt29393/2019NSDUHFFRPDFWHTML/2019NSDUHFFR090120.htm.
  3. Wang, G.S., H. Olsen, G. Severtson, et al. ‘‘The Impact of the Prescription Opioid Epidemic on Young Children: Trends and Mortality.’’ Drug and Alcohol Dependence, Vol. 211 (June 2020): 107924. https://doi.org/10.1016/j.drugalcdep.2020.107924.
  4. Ahmad, F.B., L.M. Rossen, and P. Sutton. ‘‘Provisional Drug Overdose Death Counts.’’ National Center for Health Statistics (2021). https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed August 20, 2021.
  5. Bicket, M.C., J.J. Long, P.J. Pronovost, et al. ‘‘Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review.’’ JAMA Surgery, Vol. 152(11) (November 2017): 1066–1071. https://doi.org/10.1001/jamasurg.2017.0831
  6. Mallama, C.A., C. Greene, A.A. Alexandridis, et al. ‘‘Patient-Reported Opioid Analgesic Use After Discharge from Surgical Procedures: A Systematic Review.’’ Pain Medicine, Vol. 23(1) (January 2022): 22–29. https://doi.org/10.1093/pm/pnab244
  7. Kornegay, C. ‘‘Epidemiology Review: Consumer Opioid Disposal Literature Scan and Search Results.’’ AIMS 2021– 775. Uploaded to DARRTS April 29, 2021.
  8. Voepel-Lewis, T., F.A. Farley, J. Grant, et al. ‘‘Behavioral Intervention and Disposal of Leftover Opioids: A Randomized Trial.’’ Pediatrics, Vol. 145(1) (January 2020): e20191431. https://doi.org/10.1542/peds.2019-1431.
  9. Brummett, C.M., R. Steiger, M. Englesbe, et al. ‘‘Effect of an Activated Charcoal Bag on Disposal of Unused Opioids After an Outpatient Surgical Procedure: A Randomized Clinical Trial.’’ JAMA Surgery, Vol. 154(6) (March 2019): 558– 561. https://doi.org/10.1001/jamasurg.2019.0155.
  10. Stokes, S.M., R.Y. Kim, A. Jacobs, et al. ‘‘Home Disposal Kits for Leftover Opioid Medications After Surgery: Do They Work?’’ Journal of Surgical Research, Vol. 245 (January 2020): 396–402. https://doi.org/10.1016/j.jss.2019.07.034.
  11. Lawrence, A.E., A.J. Carsel, K.L. Leonhart, et al. ‘‘Effect of Drug Disposal Bag Provision on Proper Disposal of Unused Opioids by Families of Pediatric Surgical Patients: A Randomized Clinical Trial.’’ JAMA Pediatrics, Vol. 173(8) (June 2019): e191695. https://doi.org/

by Kathryn Kane-Neilson

Kathryn earned her Masters in Public Health with a concentration in Epidemiology from Texas A&M University and her Bachelor of Science from the University of Texas. She is certified in high-complexity testing by the ASCP and has been published in the journal Cancer Cytopathology. Her experience ranges from the clinical laboratory to compliance expertise in biohazardous waste management.

published in Medication DisposalTagged