Data:

1999 – Present

3 waves:

• 1999; 2010; and 2013
• 1999 – Rise in Prescriptions
• 2010 – Rise in Heroin
• 2013 Rise in Synthetics (fentanyl)

2019-2020 saw

• Opioid death rates Increase by 38%
• Rx opioid-involved death rates increase by 17%
• Heroin-involved death rates increase by 7%
• Synthetic opioid-involved death rates increased by 56%

CDC Recommendations:
12 Primary Recommendations (Several reviewed below)
Defines treatment:

• Acute treatment (less than 1 month)
• Sub-acute treatment (1-3 months of treatment)
• Chronic (Greater than 3 months of treatment)

Recommendation 1
Non-opioid therapies are preferred for subacute and chronic pain when clinically appropriate.

Recommendation 2
Non-opioid therapies are at least as effective as opioids for many common types of acute pain.

• Examples of non-opioid therapies: patches, creams, incense, gels and antidepressants
• Goal is to incorporate into these recommendations into the facility culture and standard of care.

Recommendation 6

Prescribe the least effective dose for the least amount of time as clinically appropriate

Recommendation 7

• Assess and consider risk/benefit of continued opioid use within 1-4 weeks of starting for all patients on a newly prescribed opioid
• Goal to use these when starting or increasing dosage. Consider what the original intent of length of treatment was when considering continuing or increasing.

Recommendation 8

• Discuss risk with patients
• Offer naloxone
• Ensure all staff is trained on, and aware of,
• High-risk patients are of relevance

Recommendation 11

• Patients receiving concurrent benzodiazepine
• Patients receiving concurrent central nervous system depressants such as gabapentin or drugs for muscle weakness

Prescribing Practices: If high risk: Decrease dosage and increase monitoring

• High risk:
  • Patients with renal/hepatic impairment
  • Patients with sleep disordered breathing and/or sleep apnea
    • Associated with increased risk of CNS/respiratory depression
  • Patients with mental health conditions and/or history of substance use disorder
    • Patients with depression, PTSD, or anxiety, may be at increased risk of substance use disorder
    • Recommend alternatives to opioids if possible

Integration of CDC Guidelines into the LTC community

• Ensure the lowest opioid dose for the shortest duration possible. Consider non-opioid as the first-line Frequent evaluation/assessment of:
• Patients newly started on an opioid
• Patients with a recent opioid dose escalation

Address risk/benefit with patient

• Discuss risk and potential harms with patients before starting opioid treatment
• Offer and counsel on use of Naloxone
• Place special emphasis on patients at an increased risk of adverse effects associated with opioids

The 7 Core-Elements of Opioid Stewardship for Nursing Homes:

1. Leadership Commitment: Dedicating necessary human, financial, and information technology resources.
2. Accountability: Appointing a single leader responsible for program outcomes. This Opioid Stewardship Champion may be any qualified HCP within a LTCF. Experience with successful stewardship show that a leader can be effective.
3. Drug Expertise: Identifying a source of medication expertise for working to improve opioid use.
4. Action: Implementing at least one recommendation action, such as systemic evaluation/reevaluation of resident pain and pain-management therapies.
5. Tracking: Monitoring opioid prescribing patterns and outcomes.
6. Reporting: Regular reporting on opioid use and adverse drug events (ADEs) to doctors, nurses, and relevant staff.
7. Education: Educating clinicians, families, and residents about pain and optimal regimens

Opioid Stewardship Program – Regulatory Compliance

Key Highlights for Regulatory Compliance

• Reduce tags associated with unnecessary medications (F-Tag 757)
• Increase pharmacy oversight and mitigate potential for tags associated with medication (F-Tag 755)
• Freedom from misappropriation/exploitation (F-Tag 602)
• Drug diversion can be considered misappropriation/exploitation of a resident
• Strengthens the monthly Drug Regimen Review (F-Tag 756)

Data: 2019 – 47.2 million narcotic doses were diverted

Of those doses: 94% were opioids of those doses 57% occurred in SNF and PAC facilities

Drug Returns:

• Narcotic drug returns should be outlined in your organization’s policy & procedures, following all state, federal, DEA and OSHA regulations for controlled drug returns.
• Current standards of practice include that the documentation/ chain of custody for the controlled med be reconciled and removed out of general use areas (med cart) and submitted to DON/designee for safe keeping in a secured, locked system (safe).
• Many Post-Acute care facilities will have someone from the Pharmacy to come onsite periodically to document and dispose of the controlled substances. Make sure you maintain the documentation provided from the pharmacy on the drug pickup or waste.

Drug Destruction:

• Organizational policy & procedures in place that adhere to state, federal, DEA, and OSHA requirements.
• This is mandated that the SNF/post-acute care facility has a strict oversight of the process of controlled substance drug destruction.
• Controlled medications that need to be wasted require a witness and to be disposed off properly, in approved narcotic disposal system, such as DrugBuster.
• For patches, utilizing the DrugBuster process or flushing the patch. Both processes require a witness. Documentation must be in place by the nurse performing the waste and the witnessing nurse.

Drug Diversion:

One of the key strategies to prevent narcotic diversion is the security of the narcotics in your facility. Other areas that can assist in preventing drug diversions/contribute to diversion:

• Procurement & Storage: orders, packing slips, documents being maintained and reconciled, management of the delivering & tracking of narcotics, use of med dispense type systems & inventory, oversight of DEA 222 forms
• Prescribing: prescription pads are diverted/forged orders for controlled substance
• Preparation & Dispensing: controlled substances are replaced with other products with similar appearance, removing volume & replacing with saline, multi dose vials/containers with poor visual indicators for amounts, prepared syringes being replaced
• Administration: controlled substances are removed on D/C’d or transferred residents; medication signed out on count sheet but not on MAR, documented as given but didn’t reach residents
• Waste/Removal & Destruction: poor chain of possession and documentation

Drug Documentation:

• Documentation begins when narcotics are delivered to the facility.
• Nurse receives medication tote from pharmacy driver
• Tote must be immediately reconciled with two nurses
• Once the tote has been checked, both nurses should sign the delivery sheet and fax back to pharmacy and place original in DON box/designated area.
• Medications should immediately be placed on the cart. Narcotics are placed in the narcotic box and count sheets sent by pharmacy are placed in the notebook.
• The newly received narcotics should be added to the count sheet.
• Narcotic files must be maintained in the DON’s office/designated area for minimum of 3 years at a time. Then placed in facility storage/designated area in labeled boxes.

Best Practices of the 4 Ds

• As Nursing Administration in your facilities-Having ongoing active involvement with checks & balances in place to secure and manage narcotics and medication safety in your facility
• Be diligent in your monitoring and auditing the practices
• Foster compliance of safe narcotic practice culture
• Active surveillance

Best Practices to Manage Drug Diversion

• Understand the Issue; educate staff
• Oversight of your processes, all documentation
• Seek to limit overprescribing/monitor current controlled substances
• Document chain of possession/chain of custody; review these documents; Resident Safety and Medication Management
• Work closely with Consulting Pharmacy/Pharmacist; complete monthly/periodic inspections and random audits, review discharged/wasted narcotic record keeping
• Utilize your technology systems if available

Staff must understand they are to report a discrepancy/concern immediately.

• Reporting Suspicion:
  • Once an employee suspects impairment or diversion, resident safety concerns require that it be reported immediately.
  • Certainty, e.g. firm conviction that something is the case, is not required; it’s just a good faith concern.
  • Once reported, employee/s are suspended and accompanied by management for drug screen (Following your own organizational policy) and an investigation is initiated. This may require:
    • Police notification
    • BON notification
    • Pharmacy and DEA notification

Enforcing the 4 Ds of standard practice in post-acute care settings:

• Will help prevent drug diversions and maintain medication safety for your resident’s and your organization.
• Regulatory & Compliance definitions,
  • drug diversion occurs when medication is redirected from its intended destination for personal use, sale, or distribution to others. It includes:
    • drug theft, use, or tampering (adulteration or substitution).
• Ensuring staff understand that drug diversion is a felony that can result in an employee’s criminal prosecution and loss of license or certification.
• If residents are harmed/negative experience, an employee may risk permanent exclusion from working in healthcare.
• Employees could be sued by patients who’ve been denied appropriate pain relief or exposed to bloodborne pathogens as a result of tampering with medications

https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm (CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022)