Needed: A shared understanding among staff of how patients on chronic opioid therapy are managed.
Primary care clinics are feeling the weight of the opioid addiction crisis. And while newly developed medical devices will help them address the problem, a more important step will be improving the way practices manage chronic opioid therapy.
“The sheer numbers of patients taking a prescription opioid medication for long-term chronic pain has placed an enormous burden on primary care, where the majority of opioid prescriptions are written,” according to researchers at the University of Washington in Seattle.
“This burden may contribute to burnout and stress in primary care settings, where both prescribers and clinic support staff struggle daily to balance risks and the potential for abuse and diversion with empathy for the suffering of chronic pain patients,” write the researchers in an article in the Journal of the American Board of Family Medicine.
Since 1999, nearly 400,000 people in the United States have fatally overdosed on opioid-containing drugs, with 47,600 deaths in 2017 alone, reports the National Institutes of Health. Many people with opioid use disorder, who initially were prescribed oral drugs to treat pain, now inject prescribed or illegal opioids. High-risk injection practices such as needle-sharing are causing a surge in infectious diseases. Additionally, risky sexual behaviors associated with injection drug use have contributed to the spread of sexually transmitted infections.
In 2016, 66% of the 63,632 drug overdose deaths in the United States involved an opioid, according to the Centers for Disease Control and Prevention. In 2017, among 70,237 drug overdose deaths, 47,600 (67.8%) involved opioids. From 2016 to 2017, synthetic opioid-involved overdose death rates increased 45.2%.
SUBHEAD: Medical device options
The U.S. Food and Drug Administration believes that newly developed medical devices can help providers prevent and treat opioid use disorder.
In 2018, the FDA’s Center for Devices and Radiological Health (CDRH) launched an “Innovation Challenge” to spur the development of medical devices – including digital health technologies and diagnostic tests – that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.
Eight submissions were selected:
- Brainsway, Ltd (Brainsway Deep Transcranial Magnetic Stimulation (DTMS) Device).
- Avanos (pain therapy device).
- iPill Dispenser (iPill dispenser).
- Masimo Corporation (overdose detection device).
- ThermoTek, Inc. (NanoTherm™ and VascuTherm™ Systems) (thermal compression therapy devices).
- Milliman (opioid prediction service).
- Algomet Rx, Inc. (rapid drug screen).
- CognifiSense, Inc. (virtual reality neuropsychological therapy).
Although these products will not automatically receive marketing authorization from the FDA, device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review.
“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” writes Jonathan Jarow, M.D., a chief medical officer, Office of Device Evaluation, Center for Devices and Radiological Health, in a December 2018 statement. “For example, the development of a diagnostic device, whether it be an in vitro diagnostic test, software or a mobile medical app, could be highly impactful in identifying those patients for whom extra caution should be exercised when prescribing opioids for acute or chronic pain.”
Building blocks to better management
Even more important than therapeutic and diagnostic devices, however, is better management of chronic opioid therapy by primary care providers, according to experts. A good start is following “best practice” pain prescription guidelines, such as those released by the CDC, according to the University of Washington researchers. And that already seems to be happening.
A study published in March from Harvard Medical School showed a dramatic drop – 54 percent – in the rate of monthly opioid prescriptions to patients who have never used these drugs or had been off them for at least six months. (First-time prescriptions are deemed an important gateway to long-term opioid use and misuse, and are a target for risk reduction, the researchers said.)
Primary care providers should also address clinic systems and workflows across the entire clinic — not just practices by individual prescribers. To that end, the Harvard researchers offer the following “Six Building Blocks.”
Block One: Leadership and consensus. Leadership plays an important role by both prioritizing the work and creating opportunities for conversations among providers and staff to reach a shared understanding of how patients on chronic opioid therapy are managed. They help set goals for clinic-wide performance targets and help providers and staff understand their roles and responsibilities with patients on long-term opioid therapy.
Block Two: Policies, patient agreements and workflows. Clinic policies about opioid prescribing for chronic pain create a shared understanding and agreed-upon standards about how patients on long-term opioid therapy are to be managed. Defining standards for patient agreements, urine drug tests, and 28-day refill cycles can give providers the support they need when encountering resistance from patients.
Block Three: Tracking and monitoring patient care. Implement proactive population management before, during, and between clinic visits of all patients on long-term opioid therapy. This is an “at-risk” population, and identifying them provides an opportunity to risk-stratify them and prevent them from “falling between the cracks” of a busy primary care clinic, according to the researchers. A population tracking system can help the practice identify care gaps between scheduled visits and conduct follow-up with those patients.
Block Four: Planned, patient-centered visits. Prepare and plan for the clinic visits of all patients on long-term opioid therapy. Care gaps can be identified by “scrubbing charts” the day before or during the morning huddle, and delegating tasks to different team members to close the gaps. Who will review the new patient agreement form with the patient and get their signature? Who will be responsible for checking the state prescription monitoring program database before the visit? Clinicians and staff can also briefly rehearse potentially difficult conversations with patients who have demonstrated aberrant behaviors, such as early prescription refill requests or an abnormal urine drug test.
Block Five: Caring for complex patients. Some patients require more support because their chronic pain is complicated by other conditions, such as mental/behavioral health challenges. Others have developed opioid use disorder or an addiction. Identifying additional resources for these patients and creating systems to connect patients to these resources is essential for an effective chronic pain management plan. Some of these resources might be developed or brought in-house within the primary care clinic setting, while others will need to be identified in the local community and linkages established to them.
Block Six: Measuring success. Teams need to see that the changes they are asked to implement are having the desired effect. Selecting a set of one or more measures to track over time, and providing that information to the entire clinic team at the local level, is crucial to improving and sustaining the work.
Additional resources:
Six Building Blocks: A Team-Based Approach to Improving Opioid Management in Primary Care, https://depts.washington.edu/fammed/improvingopioidcare/6-building-blocks/https://depts.washington.edu/fammed/improvingopioidcare/6-building-blocks/
Primary Care Clinic Re-Design for Prescription Opioid Management, Journal of the American Board of Family Medicine, Jan-Feb 2017, Vol 30 No. 1, https://depts.washington.edu/fammed/improvingopioidcare/wp-content/uploads/sites/12/2018/02/JABFM-article_2017.pdf
CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, Recommendations and Reports, March 18, 2016, https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm