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Research Highlight

Opioid Safety and Challenges Related to Expanded Access

VA Office of Research & Development, Health Services Research & Development Service Spring 2016 Chronic pain is highly prevalent in Veterans and one of the most common reasons for outpatient healthcare utilization across the VA health system.^1/ Increasingly, Schedule II and III opioids are a main treatment modality for chronic pain, with duration of therapy lasting potentially for years. Yet, despite high rates of opioid prescribing, evidence supporting the use of opioids for chronic pain is modest, and furthermore, serious safety and addiction issues appear to be increasing.² Among those issues are unsafe medication combinations. For example, benzodiazepines potentiate the sedative properties of opioids and were listed as coingestions in 30 percent of opioid overdose deaths in 2010. Given these potential harms, experts have called for restraint in opioid use, targeting de-implementation of highdose therapy, avoidance of opioid-benzodiazepine co-prescribing, and promotion of non-pharmacological treatment.

VHA has implemented a multi-pronged approach to address this burgeoning public health crisis. This approach includes publication of safety-oriented prescriber guidelines, development of the Opioid Safety Initiative, which requires signed informed consent for the use of long-term opioid therapy, and requiring VHA facilities to contribute VHA controlled substance prescribing data to state prescription drug monitoring programs (PDMPs). PDMPs are provider-searchable databases that contain prescription data—listed by patient—of all controlled substance prescriptions filled in the state. While the degree to which Veterans access out-of-system controlled substance prescriptions is unknown, one seminal study found that 40 percent of overdose decedents had no VHA controlled substance prescriptions in the 90 days prior to death, strongly suggesting out-of-system access is a serious issue.³

Impact of VACAA and Expanded Access to Care in the Community on Opioid Safety

The Veterans Access, Choice and Accountability Act of 2014 (VACAA) covers Veterans’ visits to private pain management providers and any resulting prescriptions. Given the relatively large proportion of non- VHA reimbursed care that is pain-related (around 25 percent) and the likelihood that private pain management will include opioid prescriptions, we hypothesize that VACAA will increase participants’ risk of unsafe opioid therapy, including rapid-dose escalation, crossing into risky dose ranges and co-receipt of benzodiazepine therapy.

We have assembled a multi-disciplinary team of clinical researchers and operations partners to improve methods of measuring outside- of-VHA controlled substance receipt. This team is supported by several Centers— VHA’s Pharmacy Benefits Management, Brandeis University’s PDMP Center of Excellence, and the Pain Research, Informatics, Multi-morbidities & Education Center of Innovation—that each bring important perspectives and expertise to the work.

Pilot Findings Suggest Need for Improved Safety Measures

Using data supplied by the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system, we identified all individuals with VA source of payment for controlled substance prescriptions in Kentucky during fiscal year 2014. We divided the sample into two categories: those for whom the only source of payment was VA (“sole source”) and those for whom sources of payment were VA plus at least one other source, whether Medicare, Medicaid, private insurance, and/ or cash (“multiple source”). We then compared differences between groups on proportion of two measures of risky opioid therapy: combination opioid/benzodiazepine therapy and high-dose opioid therapy. We performed two multivariable models to examine the association between multiple sources of payment and: 1) percentage of opioid prescription days with overlapping benzodiazepine prescriptions; and 2) logistic and high-dose opioid therapy.

Of nearly 17,000 individuals included in the analyses, approximately 11,000 were sole source participants and 6,000 multiple source. Sole source participants’ rates of combination opioid/benzodiazepine therapy were well below those for multiple source participants. In terms of high-dose opioid therapy, the rates among sole source participants were just over half the rates among multiple source participants. On multivariable analyses controlling for age and gender, having multiple sources of payment was independently associated with percentage of opioid prescription days with overlapping benzodiazepine prescriptions and odds of high-dose opioid therapy. This pilot work suggests that expanded access through programs such as VACAA may indeed lead to riskier pain treatment for Veterans unless there are new measures in place to improve safety.

We are undertaking a more granular analysis using the methods piloted above in a targeted evaluation of VACAA in both Kentucky and Arizona, states with high rates of opioid use (KY) and VACAA-eligible Veterans (AZ), respectively. Ultimately, we seek to develop interventions that will help to improve the safety and quality of pain care for Veterans. For example, if our work reveals hot spots where Veterans are receiving low-quality pain care from non-VHA providers, we can target those providers for academic detailing and other provider education models developed and shown to be effective in VHA.

References

1. Hing E., Cherry D.K., Woodwell D.A. National Ambulatory Medical Care Survey: 2004 Summary. In: U.S. Department of Health and Human Services, ed.: Centers for Disease Control and Prevention, National Center for Health Statistics; 2006.

2. Chou R., Turner J.A., Devine E.B., et al. “The Effectiveness and Risks of Long-term Opioid Therapy for Chronic Pain: a Systematic Review for a National Institutes of Health Pathways to Prevention Workshop,” Annals of Internal Medicine 2015;162:276-86.

3. Bohnert A.S.B., Valenstein M., Bair M.J., et al. “Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths,” JAMA: The Journal of the American Medical Association 2011; 305:1315-21. Research Highlight