Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs _ ___________________________
DOCUMENTATION As noted, documentation is a necessary aspect of all patient care, but it is of particular importance when opioid prescribing is involved. All clinicians should maintain accurate, complete, and up-to-date medical records, including all written or tele- phoned prescription orders for opioid analgesics and other controlled substances, all written instructions to the patient for medication use, and the name, telephone number, and address of the patient’s pharmacy [1]. Good records demonstrate that a service was provided to the patient and that the service was medically necessary. Regardless of the treatment outcome, thorough medical records protect the prescriber.
There are no universal recommendations for the proper disposal of unused opioids, and patients are rarely advised of what to do with unused or expired medications [49]. Accord- ing to the FDA, most medications that are no longer necessary or have expired should be removed from their containers, mixed with undesirable substances (e.g., cat litter, used coffee grounds), and put into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in the trash [50]. Any personal information should be obscured or destroyed. The FDA recommends that certain medications, including oxycodone/acetaminophen (Percocet), oxycodone (OxyContin tablets), and transdermal fentanyl (Duragesic Transdermal System), be flushed down the toilet instead of thrown in the trash [31; 50]. The FDA provides a free toolkit of materials (e.g., social media images, fact sheets, posters) to raise awareness of the serious dangers of keeping unused opioid pain medicines in the home and with informa- tion about safe disposal of these medicines. The Remove the Risk Outreach toolkit is updated regularly and can be found at https://www.fda.gov/drugs/ensuring-safe-use-medicine/ safe-opioid-disposal-remove-risk-outreach-toolkit [31]. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifi- cally instructs doing so. The American College of Preventive Medicine has established best practices to avoid diversion of unused drugs and educate patients regarding drug disposal [49]: • Consider writing prescriptions in smaller amounts. • Educate patients about safe storing and disposal practices. • Give drug-specific information to patients about the temperature at which they should store their medications. Generally, the bathroom is not the best storage place. It is damp and moist, potentially resulting in potency decrements, and accessible to many people, including children and teens, resulting in potential theft or safety issues. • Ask patients not to advertise that they are taking these types of medications and to keep their medications secure. • Refer patients to community “take back” services overseen by law enforcement that collect controlled substances, seal them in plastic bags, and store them in a secure location until they can be incinerated. Contact your state law enforcement agency or visit https://www.dea.gov to determine if a program is available in your area. DISCONTINUING OPIOID THERAPY The decision to continue or end opioid prescribing should be based on a physician-patient discussion of the anticipated benefits and risks. An opioid should be discontinued with resolution of the pain condition, intolerable side effects,
PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS
Patients and caregivers should be counseled regarding the safe use and disposal of opioids. As part of its mandatory Risk Eval- uation and Mitigation Strategy (REMS) for extended-release/ long-acting opioids, the U.S. Food and Drug Administration (FDA) has developed a patient counseling document with information on the patient’s specific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medications or take them unprescribed [16]. A copy of this form may be accessed online at https:// www.fda.gov/media/114694/download. When prescribing opioids, clinicians should provide patients with the following information [16]: • Product-specific information • Taking the opioid as prescribed • Importance of dosing regimen adherence, managing missed doses, and prescriber contact if pain is not controlled • Warning and rationale to never break or chew/ crush tablets or cut or tear patches prior to use • Warning and rationale to avoid other central nervous system depressants, such as sedative- hypnotics, anxiolytics, alcohol, or illicit drugs • Warning not to abruptly halt or reduce the opioid without physician oversight of safe tapering when discontinuing • The potential of serious side effects or death • Risk factors, signs, and symptoms of overdose and opioid-induced respiratory depression, gastrointestinal obstruction, and allergic reactions • The risks of falls, using heavy machinery, and driving • Warning and rationale to never share an opioid analgesic
• Rationale for secure opioid storage • Warning to protect opioids from theft
• Instructions for disposal of unneeded opioids, based on product-specific disposal information
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