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

Trial Summary

What is the purpose of this trial?

The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.

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 data supports the effectiveness of the treatment for disposing leftover painkillers after surgery?

Research shows that using drug disposal kits or bags significantly increases the rates of disposing unused opioids after surgery, compared to not using any intervention. ^{1 2 3 4 5}

Is it safe to use drug disposal methods like pouches or mail-back envelopes for leftover painkillers?

The studies focus on the effectiveness and preference of drug disposal methods, but they do not provide specific safety data for humans. However, these methods are generally considered safe as they aim to prevent misuse and accidental ingestion of leftover medications. ^{1 2 3 4 6}

How does the treatment for disposing leftover painkillers after surgery differ from other treatments?

This treatment involves using a carbon-based home medication disposal pouch, which is unique because it provides a simple and effective way to safely dispose of unused opioids at home, reducing the risk of misuse. Unlike other methods that may require more effort or cost, this pouch can be used easily by patients themselves, increasing the likelihood of proper disposal. ^{2 3 4 5 6}

Research Team

Mark Bicket, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

I expect to use opioid painkillers after my planned surgery.

Opioid-naive

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using an Environmentally Friendly Disposal Bag to Discard Leftover Opioids After Gynecologic Surgery. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Opioid Disposal in Patients Undergoing Total Joint Replacement Utilizing a Carbon-Based Home Medication Disposal Pouch. [2021]

3. United States 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. [2023]

4. Netherlands 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Postoperative Disposal of Unused Opioids: A Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mail-Back Envelopes for Retrieval of Opioids After Pediatric Surgery. [2021]