Among over 1600 primary care patients prescribed long-term opioids for CNCP, monitoring with recommended risk reduction strategies was quite limited. While being treated with long-term opioids, fewer than 10% of the cohort received any urine drug testing, only half had regular office based visits, and 23% received more than one early opioid refill. Although patients at increased risk of opioid misuse were more likely to have had urine drug testing, it was still infrequent, with less than one-quarter of the patients with three or more risk factors having any urine drug test. In addition, patients at increased risk of opioid misuse were more likely to receive more than one early refill, but their office-based monitoring was no greater than for persons without any risk factors for opioid misuse. These data reveal limited monitoring of all study patients on long-term opioids and this lax monitoring extends even to patients at greater risk of misuse.
Previous studies have demonstrated limited use of opioid risk reduction strategies in primary care settings, but none has evaluated the association with opioid misuse risk factors.24,30–34
In two primary care studies, only 2 to 18% of patients received urine drug testing.24,30
We found a similar overall low rate (8%) of urine drug testing but, despite a three to sixfold increase in the adjusted odds of urine testing for patients with multiple risk factors for misuse, only a minority were tested. Reasons for limited urine drug testing by primary care physicians might include lack of knowledge about the tests,35,36
concerns that patients will feel stigmatized,37
and a limited evidence base.11
However, urine drug testing performs better in identifying misuse than clinician judgment38
or patient self-report.39,40
Physicians who monitor with urine drug tests report enhanced communication with their patients and improved safety of prescribed opioids.41–43
To our knowledge, this is the first analysis of the frequency of primary care office visits during opioid treatment. Surprisingly, only half of patients met this minimum recommended frequency of office-based monitoring of patients on long-term opioid therapy.8
Furthermore, patients at higher risk of opioid misuse were not seen more regularly in the office. This lack of face-to-face encounters represents missed opportunities for physicians to examine responses to treatment, propose alternative treatments when response is inadequate, detect side effects, and assess for misuse.
In previous studies, the proportion of patients receiving early opioid refills ranged from 4% to 41%,17,18,44
and 15% in a primary care setting.17
We found that 23% of our cohort received more than one early opioid refill. But of even greater concern, patients with a current or past drug use disorder were more likely to receive early refills. This may be due to more requests for early refills from patients with a drug use disorder.18
Indeed, these patients averaged more prescriptions per month than patients without a drug use disorder, consistent with prior observations.45
Physicians providing these early refills may be unwittingly contributing to misuse or diversion. Requests for early refills among patients with a drug use disorder may also reflect inadequate analgesia, possibly because of greater analgesic requirements,46
or because cautious physicians may restrict the dose of opioids.
We acknowledge several limitations to this study. First, we studied 8 practices in a single university health system, which limits generalizability. Second, our clinical information comes from an electronic medical record and there may be misclassification, especially for drug and alcohol use disorders, as well as unmeasured confounding that could influence documentation of risk factors. Third, our selection of risk factors was based on observational studies of varying quality. Fourth, we could not account for patient differences in the severity of each risk factor. Fifth, our outcome variables were based on expert consensus but lack evidence of their impact on safety.11
Finally, the timeframe in which we assessed the presence of opioid misuse risk factors and risk reduction strategies overlapped. Therefore, we cannot determine whether and when the physician became aware of a patient’s risk factors, or whether the diagnosis of a risk factor such as drug use disorder was made prior to, or as a result of, a risk reduction strategy being performed.
Overall, our findings reveal disturbingly low use of monitoring strategies to reduce the risk of adverse events from long-term opioid treatment and indicate that primary care physicians are not employing all these approaches more intensively for patients at increased risk of misuse. Our study supports recommendations for a more standardized approach to opioid risk reduction.11,13
A standardized approach could involve using screening tools to identify patients at increased risk for opioid misuse; 25,47–50
a treatment agreement that stipulates the necessity for regular office visits, restricted early refills, and urine drug testing;51
and team-based care to track patients’ visits, prescriptions, progress, and aberrant drug-taking behaviors.52
Our research demonstrates the need for proactive approaches to this quality of care issue that has significant public health consequences.