Disposal Methods for Leftover Painkillers After Surgery

(MEDSAFE Trial)

Overseen By Heather Lipkovitch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Opioids

Disqualifiers: Inability to receive email, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how people dispose of leftover prescription painkillers after surgery. It compares two methods: using an in-home drug disposal pouch or sending them back in a mail-in prepaid envelope. The goal is to determine which method is more effective. Individuals who have never used opioids (strong prescription painkillers) and will receive them for post-surgery pain may be suitable candidates. As an unphased trial, this study allows participants to contribute to safer pain management practices.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these disposal methods are safe for leftover painkillers?

Research shows that both in-home drug disposal pouches and mail-in prepaid envelopes are designed to be safe.

The in-home drug disposal pouch, such as the Deterra system, uses safe materials to deactivate drugs. Studies indicate that the pouch's activated carbon prevents drug misuse and does not release harmful chemicals, making it safe for use around children and pets and environmentally friendly.

The mail-in prepaid envelope, required by the FDA for disposing of opioids, provides a reliable method. These envelopes securely handle various controlled substances, offering a safe way to dispose of drugs without needing to visit a drop-off site, thus ensuring convenience and security for users.

Both methods have proven to be safe and effective for disposing of leftover medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for disposing of leftover painkillers after surgery. Unlike traditional disposal methods, which might involve returning medications to pharmacies or flushing them, the in-home drug disposal pouch allows patients to safely neutralize medications right at home. Similarly, the mail-in prepaid envelope provides a convenient way for patients to send unused medications for proper disposal without leaving their homes. These methods aim to reduce the risk of misuse or environmental harm, offering a safer and more accessible solution for managing leftover painkillers.

What evidence suggests that these disposal methods are effective for leftover painkillers?

This trial will compare two methods for disposing of leftover painkillers after surgery: in-home drug disposal pouches and mail-in prepaid envelopes. Research has shown that using drug disposal pouches at home can reduce leftover opioids. One study found that patients using Deterra® Pouches safely disposed of their medications at twice the rate of those who did not use them. Additionally, these pouches deactivate 98.1% of leftover prescription drugs.

For mail-in prepaid envelopes, studies indicate they offer a convenient way to return unused medications. Providing these envelopes, along with information on safe disposal, helps prevent the misuse of leftover opioids. Overall, both methods show promise for improving the safe disposal of unused opioids after surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Mark Bicket, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have not regularly used opioids before and expect to use opioid painkillers after elective outpatient surgery. Participants must be able to receive emails and phone calls for follow-up.

Inclusion Criteria

Opioid-naive

I expect to use opioid painkillers after my planned surgery.

Exclusion Criteria

I cannot receive emails or phone calls for follow-ups.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to either mail-in or in-home disposal methods for leftover prescription opioids after surgery

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for the use and satisfaction of the disposal method

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• In-home drug disposal pouch
• Mail-in prepaid envelope

Trial Overview

The study is testing two ways of getting rid of leftover prescription opioids: using a drug disposal pouch at home or sending them back through a prepaid mail envelope. The goal is to see which method works best after surgery.

How Is the Trial Designed?

Group I: In-home Active Control 1 Intervention

Group II: Mail-in Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Michigan Department of Health and Human Services

Collaborator

Trials

13

Recruited

10,900+

Published Research Related to This Trial

In a study of 221 adults who underwent same-day surgery, the use of medication disposal pouches led to a higher rate of opioid disposal (23.0%) compared to usual care (13.8%), indicating that providing disposal pouches can encourage safe disposal practices.

Despite the higher disposal rates in the pouch group, overall disposal of unused opioids remained low, suggesting that additional strategies may be needed to improve opioid disposal rates among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Medication Disposal Pouch versus Usual Care on Post Discharge Disposal of Unused Opioids: A Randomized Controlled Trial. Zito, A., Briskin, I., Bena, JF., et al.[2023]

Surplus opioid disposal rates after surgery are generally low, ranging from 4.9% to 87%, with non-intervention studies showing rates between 4.9% and 46.5%.

Using opioid disposal kits or bags significantly increases the rates of surplus opioid disposal, indicating that providing these tools could help mitigate the risks associated with unused opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Disposal of Unused Opioids: A Systematic Review. Lamplot, JD., Premkumar, A., James, EW., et al.[2022]

A study involving 1,006 participants found that the most important factors influencing consumer preference for at-home drug disposal products were cost, ease of access, and product design, with free disposal options being the most favored.

Pharmacy-based takeback programs were the preferred method for disposing of unused opioids, suggesting that providing disposal resources at no cost with prescriptions could enhance safe disposal practices and support the FDA's proposed REMS program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients prefer free drug disposal options delivered by pharmacists at the point of care: Results of a decision tree analysis of a national factorial vignette panel survey. Varisco, T., Patel, H., Saadi, RA., et al.[2023]

In a study of 200 patients undergoing gynecologic surgery, 41% had leftover opioid pills after their procedures, highlighting the need for effective disposal methods.

Providing patients with an environmentally friendly drug deactivation bag and education led to 73% of those with leftover pills safely discarding them, demonstrating the effectiveness of this approach in promoting safe opioid disposal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an Environmentally Friendly Disposal Bag to Discard Leftover Opioids After Gynecologic Surgery. Boitano, TKL., Norton, SB., Shrestha, KS., et al.[2023]

An educational program on opioid safety and disposal significantly increased the rate of disposal of unused opioids among patients undergoing joint replacement, with 74% of attendees disposing of their opioids compared to only 36% of non-attendees.

The study involved 104 patients and demonstrated that providing a disposal pouch along with a brief instructional session effectively encouraged safer opioid practices post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Disposal in Patients Undergoing Total Joint Replacement Utilizing a Carbon-Based Home Medication Disposal Pouch. Bobo, T., Fitzgerald, K., Wdowiarz, K.[2021]

In a feasibility study involving 331 pediatric patients prescribed opioids after outpatient surgery, 19.3% returned their unused medications using a provided mail-back envelope, effectively removing over 2000 mL of liquid opioids and nearly 3000 mg of oral morphine equivalents from homes.

The median return rate among those who participated was 58% of the prescribed amount, indicating that a simple and cost-free mail-back system can be an effective method for reducing the risk of accidental or deliberate opioid ingestion in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mail-Back Envelopes for Retrieval of Opioids After Pediatric Surgery. Adler, AC., Yamani, AN., Sutton, CD., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11491157/

Drug Deactivation Pouches for Primary Prevention of ...

A systematic review of surgical patients who had been prescribed opioids found that 67–92% of the patients reported having unused opioids; 42% to 71% of the ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1089947222000211

Effect of a Medication Disposal Pouch versus Usual Care ...

Although opioid medication disposal rates were higher in the medication disposal pouch group; overall rates of disposal of unused opioid medications were low.

3.

deterrasystem.com

deterrasystem.com/patients-double-safe-disposal-of-unused-opioids-when-provided-deterra-drug-disposal-bags/

Patients double safe disposal of unused opioids when ...

Providing patients with Deterra® Pouches doubled the percentage of those who safely deactivated and disposed of leftover opioids after surgery ...

4.

jabfm.org

jabfm.org/content/jabfp/early/2023/12/01/jabfm.2023.230227R1.full.pdf

Drug Deactivation Pouches for Primary Prevention of ...

Convenient, efficient, and environmentally safe mechanisms for disposal are needed to prevent the diversion of unused opioid analgesics.

5.

pharmacytimes.com

pharmacytimes.com/view/safe-drug-disposal-technology-now-available-online

Safe Drug Disposal Technology Now Available Online

In fact, the system has a 98.1% success rate at deactivating leftover prescription drugs such as opioids and transdermal patches, according to a study supported ...

6.

deterrasystem.com

deterrasystem.com/

Deterra® Drug Deactivation and Disposal System

Deterra is a pouch and/or container system that makes unwanted medications permanently unusable and safe to throw away. Using patented technology, it destroys ...

7.

deterrasystem.com

deterrasystem.com/faqs/

Deterra Frequently Asked Questions (FAQs) | Drug Disposal

When used properly, the activated carbon will retain the drugs, rendering the contents of the Deterra Drug Deactivation System inert, unavailable for misuse and ...

8.

amazon.com

amazon.com/Deterra-LP-Pack-Deactivation-Disposal/dp/B01N5SQPL9

Deterra-LP - Drug Deactivation and Medication Disposal ...

Safe To Use: Our drug deactivation pouch uses non-toxic ingredients that fully deactivate drugs preventing harmful chemicals from reaching children, pets, or ...

9.

cga.ct.gov

cga.ct.gov/2024/phdata/TMY/2024SB-00001-R000318-Sundby,%20Jason,%20CEO-Deterra%20System-Supports-TMY.PDF

DETERRA® DRUG DEACTIVATION & DISPOSAL SYSTEM

Drug substances did not get released from activated carbon when washed out with large volumes of water or 30% ethanol indicating minimal environmental effect.