D

Detailed Policy Landscape

THE DEPARTMENT OF VETERANS AFFAIRS/DEPARTMENT OF DEFENSE CLINICAL PRACTICE GUIDELINES

The Department of Veterans Affairs (VA) and Department of Defense (DoD) have several joint clinical practice guidelines (CPGs) on specific health care topics that are evidence based and capture best clinical practice with the goals of reducing variation in care and providing quality care. Topics reflect domains such as pain, mental health, chronic disease in primary care, rehabilitation, and women’s health (VA, 2024a). The VA/DoD’s stated goal for the CPGs “is to improve the patient’s health and well-being by providing evidence-based guidance to providers who are taking care of patients on or being considered for [long-term opioid treatment]” (VA/DoD, 2017). Four CPGs, introduced in 2003 and updated in 2010, 2017, and 2022, address opioid initiation and continuation, dosage, tapering/discontinuation, screening/assessment/evaluation, and risk mitigation (VA/DoD, 2022, 2017, 2010, 2003). Beginning in 2010, the CPGs included literature reviews and graded recommendations based on the evidence.

For opioid initiation, all VA/DoD CPGs recommended beginning with a low or lowest dose. Later CPGs added that “there is no absolutely safe dose of opioids” (VA/DoD, 2017) and recommended against initiating opioid therapy in individuals with chronic non-cancer pain (VA/DoD 2022, 2017). Maximum opioid dose levels were stated in CPG 2010 (a reasonable level of less than 200 morphine milligram equivalents (MME)/day), and VA/DoD CPG 2017 recommended against doses over 90 MME/day for chronic pain.

Opioid pharmacotherapy tapering (reduced dose or discontinuation) guidelines continue to evolve as well. In the first VA/DoD CPG (2003), recommendations to consider tapering were when opioids are not efficacious in managing pain, pain is resolved, or the individual requests this. In addition, discontinuation should be made on an individual basis. The 2010 VA/DoD CPG continued to recommend these indications and added to consider when harms (real or potential) outweigh potential benefits. In VA/DoD CPG (2017), opioid tapering is recommended when risks outweigh the benefits. In addition, discontinuing abruptly is recommended to be avoided. However, the current VA/DoD CPG (2022) noted “insufficient evidence to recommend for or against any specific tapering strategies.” In addition, opioid tapering should be patient centered and approached collaboratively. The workgroup noted the low quality of evidence due to limitations in the relevant studies (e.g., differences among treatment groups, lack of certainty in outcomes and treatment adherence) (VA/DoD, 2022). Concerns of interactions with benzodiazepines first appeared in CPG 2010, and subsequent CPGs since 2017 include a recommendation against concurrent use of opioids and benzodiazepines (VA/DoD, 2022, 2017, 2010).

OTHER AGENCIES

In addition to VA policies and guidelines, other federal agencies followed VA and released guidelines or warnings related to opioid prescribing, tapering, and discontinuation.

Centers for Disease Control and Prevention

Similar to VA, the Centers for Disease Control and Prevention (CDC) release CPGs to provide guidance to clinicians for prescribing opioids for pain. The CDC released the first CPG for the treatment of pain with opioids in 2016, with another in 2022. The CPG included a literature review and guidance on opioid initiation, pain management, and tapering.

The 2016 CDC CPG for Prescribing Opioids for Chronic Pain recommended using the lowest effective dose. Guidelines recommended assessing evidence before increasing above >50 MME/day and avoiding >90 MME/day. The 2016 CPG described a decrease of 10 percent of an original dose per week as a reasonable starting point for tapering. However, all tapering plans should be individualized based on patient concerns and/or goals (Dowell et al., 2016).

In 2022, CDC published an updated CPG that recommended that clinicians prescribing opioids for opioid-naïve patients with pain (acute, subacute, or chronic) should choose the lowest effective dosage, often equivalent to a single dose of about 5–10 MME or a daily dosage of 20–30 MME/day. While the CPG recognized that evidence supporting specific opioid tapering rates is limited and the rate of tapering should be based on the patient’s unique clinical situation, opioid tapering of 10 percent per month or slower in patients who have been taking opioids for longer periods are likely to be better tolerated (Dowell et al., 2022).

U.S. Food and Drug Administration Drug Administration

Black Box Warnings

Given the concerns regarding the use and co-prescribing of benzodiazepine and opioid pharmacotherapy, in 2016, the Food and Drug Administration (FDA) added a black box warning to benzodiazepines, opioids, and opioid-containing cough medicines. The warning highlighted the potential dangers of independent or combined benzodiazepine and opioid use (FDA, 2016). Additional information on FDA activities and significant events addressing substance use and overdose prevention can be found in FDA (2024a).

Opioid Analgesic Risk Evaluation and Mitigation Strategy

Through the FDA Amendments Act of 2007, FDA is required to obtain a risk evaluation and mitigation strategy (REMS) from manufacturers to ensure that “benefits of a drug or biological product outweigh its risks” (FDA, 2015). The FDA requires manufacturers of extended-release and long-acting (beginning in 2012) and immediate-release opioid analgesics (beginning in 2018) to implement an opioids REMS. The program is now called the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), which serves as an effort at the national and state levels aiming to reduce “the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics” (FDA, 2024b). A core element of the OA REMS is accredited continuing education. OA REMS requires the availability of education to all health care providers involved in pain management and treatment and for drug companies to “provide unrestricted grants to accredited continuing education providers for the development of education courses” (FDA, 2024b).

Centers for Medicare and Medicaid Services

The Centers for Medicare & Medicaid Services also released guidance and education to providers regarding opioid prescribing and co-prescribing with benzodiazepines (CMS, 2019).

Department of Health and Human Services

In 2019, the Department of Health and Human Services released a guide for clinicians on the “Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.” It does not specify a tapering strategy for clinicians but suggests a reduction of 5–20 percent every 4 weeks (in reference to CDC 2016 and VA/DoD 2017 CPGs). It also highlights a patient-centric approach that is tailored to individual needs and outlines various scenarios in which clinicians could consider tapering or discontinuation (HHS, 2019).

The National Action Plan for Adverse Drug Event Prevention, released in 2014, was established to address two objectives: “1) identify common, preventable, and measurable adverse drug events (ADE) that may result in significant patient harm; and 2) align the efforts of federal health agencies to reduce patient harms from these specific ADEs nationally” (HHS, 2014). Three types of ADEs were deemed “common, clinically significant, preventable, and measurable” and are considered high-priority targets of the plan: anticoagulants (ADE: bleeding), diabetes agents (ADE: hypoglycemia) and opioids (ADE: accidental overdoses/ oversedation/respiratory depression). The ADE Action Plan presents a four-pronged approach to reducing patient harms: surveillance, prevention, incentives and oversight, and research (HHS, 2014).

Veterans Health Administration

The Opioid Safety Initiative

Expanding on the VA safe opioid prescribing strategies, which date back to the 1990s, the Veterans Health Administration (VHA) implemented the Opioid Safety Initiative (OSI) in 2013 “to help decrease prescribing practices associated with adverse outcomes” and promote safer prescribing in VHA (Lin et al., 2017). The OSI goals are increased education, monitoring, safe and effective prescribing and development and implementation of management methods, tool development, collaboration, and use of alternative pain treatments (GAO, 2018). The OSI aimed to reduce overdependence on opioids for pain management in VHA by limiting opioid use to safe and effective doses only when clinically indicated (Lin et al., 2017). The OSI has been integrated into the VHA’s electronic health record (EHR) to identify patients who may be at increased risk for adverse outcomes related to use of opioids and providers whose prescribing practices may not reflect best evidence (VA/DoD, 2022). In addition, the OSI was set up around a dashboard using aggregated EHR-based facility-, provider-, and patient-level opioid prescribing data to facilitate leadership audit and feedback (Lin et al., 2017). There are nine key components to the OSI designed to improve patient outcomes (Table 1: GAO, 2018):

1. Educate opioid prescribers regarding the effective use of urine drug screening.
2. Increase the use of urine drug screening.
3. Facilitate the use of Prescription Drug Monitoring Program (PDMP) databases.
4. Establish safe and effective veterans integrated service network (VISN) tapering programs for veterans using opioids and benzodiazepines.
5. Develop tools to identify veterans at a higher risk for adverse events while using opioids.
6. Improve prescribing practices around long-acting opioid formulations.
7. Review treatment plans for veterans on high doses of opioids.
8. Offer complementary and alternative medicine modalities for chronic pain at all medical facilities.
9. Develop new models of mental health and primary care collaboration to manage the prescribing of opioids and benzodiazepines in patients with chronic pain.

Additional OSI efforts include the Opioid Overdose Education and Naloxone Distribution program, a risk mitigation strategy aimed at reducing overdose deaths. The program includes education and training on the following: overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote (VA, 2024b,c,d; Oliva et al., 2016). Other efforts include the OSI Toolkit, which

contains materials to inform clinical decision making regarding opioid pharmacotherapy and safe prescribing, and “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-Term Opioid Therapy for Chronic Pain” (VA, n.d.).

Research indicates progress in the improvement of opioid safety through the OSI. VHA has met six of the nine OSI goals; however, it is unclear whether the remaining three goals have been fully achieved (GAO, 2018). An assessment of the impact of OSI on opioid prescribing among veterans in 2017 found a decreasing trend in high-dosage prescribing after OSI implementation across the VHA, with a 16 percent reduction in patients receiving daily doses of over 100 MME in 2014 (Lin et al., 2017). Research by Lin and colleagues (2017) investigating the effectiveness of the OSI reported a reduction in both veterans’ daily opioid MME and in those receiving concomitant benzodiazepine pharmacotherapy 2012–2014. An assessment of 2012–2020 VHA Pharmacy Benefits management services data found that since the implementation of OSI, the number of veterans being prescribed opioids has reduced by 56 percent, and concomitant prescribing of opioids and benzodiazepines has reduced by 83 percent (Sandbrink et al., 2020).

Recent VHA Directives

VHA issued several directives aiming to achieve department-wide changes in prescriber behaviors that were reflective of changing guidelines and clinical knowledge. VHA Directive 1306, in 2016, required VHA providers to register for their state PDMP, abide by state PDMP law, query the state PDMP for patients receiving a controlled substance prescription for longer than 5 days or for shorter courses with refills (except for hospice care), and document PDMP results in EHRs (Sandbrink et al., 2020; VA, 2016). These queries provide clinicians with a history of controlled substance prescriptions, across all care locations, to inform prescribing decisions (VA, 2016).

VHA Directive 1005 in 2014 required an “Opioid Pain Care Agreement” between the provider and patient. It outlines “the exchange of information between a health care provider and patient regarding the expectations, responsibilities, and obligations of patients to receive opioid therapy” (VHA, 2020) and generally advises patients to take the medications only as directed, adhere to drug testing, not request early refills or replacements, and not use illegal drugs. The updated VHA Directive 1005 in 2020 amended requirements to make patient education and informed consent before opioid prescribing mandatory and prohibit such agreements in the VHA (VHA, 2020). In addition to the outlined VA/DoD CPGs and directives, VHA has implemented additional risk mitigation strategies, such as requiring informed consent before initiating long-term opioid treatment (LTOT), ongoing assessment of opioid effectiveness, the routine urine drug monitoring and pill counts (VA/DoD, 2017).

Relevant Federal Legislation

Veterans Choice Act (2014)¹

The Veterans Choice Act (also known as “Veterans Choice Program” (VCP)) was passed in 2014. This federal legislation expanded non-VHA service options for veterans to receive care.

Comprehensive Addiction and Recovery Act (2016)²

The Comprehensive Addiction and Recovery Act (CARA) became national legislation in 2016. Several aspects were relevant to opioid management within VA. First, CARA directed the VA Secretary to extend the OSI to all VHA-approved non-VHA health facilities. In addition, CARA required that all VHA-approved providers prescribing opioids to VHA veterans be educated on safe opioid prescribing practices, specifically in compliance with CPGs. Third, VA worked to ensure VHA prescribers have access to their own state PDMPs. Finally, through

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¹ Public Law 113-146, 113th Congress, Veterans access, Choice and Accountability Act of 2014, August 7, 2014.

² Public Law 114-198, 114th Congress, Comprehensive Addiction and Recovery Act of 2016, July 22, 2016.

the extension of OSI practices, all VHA-approved providers were required to submit veteran prescription fills of controlled substances from VHA pharmacies to state PDMPs.

Mission Act (2018)³

In 2018, Congress passed the Mission Act, which was designed to strengthen and improve the quality of the VHA system and improve timely access to quality care. This expanded ongoing efforts by VHA to enable veterans to access non-VHA facilities to receive health care, with VHA covering the costs, including non-urgent care outside VHA and local non-VHA community facilities. The Mission Act established the Veterans Community Care Program (VCCP), which replaced the VCP. The VCCP enabled eligible veterans to receive care from community providers in the regional network, paid for by VA, when VA cannot provide it.

Relevant State Level Policies and Contributions

Prescription Drug Monitoring Programs

PDMPs are designed to facilitate the collection, analysis, and reporting of controlled drug prescribing and dispensing within a state (Brandeis University, 2018). Through the PDMP, registered clinicians can obtain information on patients receiving controlled medications, other providers prescribing controlled medications, prescribed dosages, date dispensed, and name of prescribing clinician. States implemented the PDMPs at various times. California was the first state to do so, in 1939. Additional states followed (eight in 1990, 27 in 2000–2010). As of 2023, Missouri is the only state without fully operational PDMP legislation; however, a statewide PDMP has been activated (Missouri PDMP, 2023; Brandeis University, 2018; Clark et al., 2012). The PDMP is intended to mitigate risks in opioid prescribing through monitoring; however, complexities in the effective use of PDMPs remain (Rhodes et al., 2019; VA OIG, 2019).

Given that many veterans use more than one health care system, PDMPs can help monitor prescribing of controlled medications, especially among veterans obtaining care in the VHA and through non-VHA providers (Carico et al., 2018; Gellad et al., 2018; Becker et al., 2017; Park et al., 2015). In 2012, 13.2 percent of eligible veterans dually enrolled in VHA and Medicare Part D insurance received prescribed opioids from both sources (Gellad et al., 2018). VHA veterans were more likely to be queried in the PDMP if they were ethnically Hispanic, resided in an urban area, received methadone, had average daily MMEs >20, or received a urine drug screening during the study period (Andrea et al., 2021). Veterans less likely to be queried were those who had a rural address, received mail order medications, had a cancer diagnosis, or had a provider working in in a low-complexity facility (Andrea et al., 2021).

Continuing Provider Education

Several efforts exist to promote continuing education (CE) of providers involved in pain management and treatment. As mentioned earlier, FDA’s OA REMS program is an example of efforts ongoing at the federal level. In addition, states also require CEs of providers, such as physicians and dentists, to maintain licensure (Xu et al., 2017). Additional information on provider education can be found in Educating Together, Improving Together: Harmonizing Interprofessional Approaches to Address the Opioid Epidemic (NASEM, 2021).

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³ Public Law 115-182, 115th Congress, VA Mission Act of 2018, June 6, 2018.

REFERENCES

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