Opioid Use Clinical Trial
Official title:
Keeping Your Children and Home Safe Through Return and Disposal of Unused Opioids
The opioid epidemic in the United States has become a clear health and safety concern for our children and families. Opioids given to our patients for the treatment of pain that go unused after the immediate post operative period pose a major hazard when left in the home unattended. Opioids can be accidentally ingested by small children or deliberately ingested by pre-teens and adolescents leading to major morbidity and or death. Additionally, studies have shown that many people addicted to opioids/narcotics have become so due to ingestion of medically prescribed drugs. Finally, there has been an increase number of home robberies specifically with the intent to steal prescription drugs. Removal of unused medication from the home is an important public safety concern to protect our patients, families and friends. The Sharps Co (R), offers a product called Takeaway Medication Recovery System. This product allows individuals to put unused opioids in a pre-paid envelope which is returned to the company through the postal system and properly incinerated. This provides safe disposal in accordance with the Environmental Protection Agency (EPA) to protect the water table from contamination by drugs disposed of my other means. This system through the Sharps Co would allow for de-identified tracking of returned drugs.
Participants identified by the PI and participating research staff/coordinators that will
receive opioids following discharge will be approached. The participant information sheet
will be provided to the parents/legal guardian and explained. The consenting study
coordinator will review the potential risks of opioids as described in the information sheet.
A brief demonstration of the TakeAway envelope will be provided. The participants will be
instructed that there is absolutely no cost to them or their family and that the envelope is
pre-paid and that all returned or unreturned contents are strictly confidential. A few brief
demographic questions will be asked and are completely optional. The participant will be
asked for an email and contacted 15 days and 30 days following the procedure. The email will
strictly be a reminder to return all un-used medication using the provided envelope Or an
optional response reporting nothing to return. If participants do not have an email or do not
wish to be contacted, they may still enroll in the study. The entire peri-operative period
will progress in the usual manner.
Each envelope has a serial number that will be recorded during enrollment - the company
provides access to ascertain exactly how many pills are returned. This access is strictly
provided to the PI. The company will have no patient information and therefore only the PI
will be able to track the serial number to the patient. The PI and research staff will record
the number of pills prescribed to the patient to allow the research team to calculate the
percentage of pills returned.
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