Evaluating the Effects of Opioid Prescribing Policies on Patient Outcomes in a Safety-net Primary Care Clinic

Background After decades of liberal opioid prescribing, multiple efforts have been made to reduce reliance upon opioids in clinical care. Little is known about the effects of opioid prescribing policies on outcomes beyond opioid prescribing. Objective To evaluate the combined effects of multiple opioid prescribing policies implemented in a safety-net primary care clinic in San Francisco, CA, in 2013–2014. Design Retrospective cohort study and conditional difference-in-differences analysis of nonrandomized clinic-level policies. Patients 273 patients prescribed opioids for chronic non-cancer pain in 2013 at either the treated (n=151) or control clinic (n=122) recruited and interviewed in 2017–2018. Interventions Policies establishing standard protocols for dispensing opioid refills and conducting urine toxicology testing, and a new committee facilitating opioid treatment decisions for complex patient cases. Main Measures Opioid prescription (active prescription, mean dose in morphine milligram equivalents [MME]) from electronic medical charts, and heroin and opioid analgesics not prescribed to the patient (any use, use frequency) from a retrospective interview. Key Results The interventions were associated with a reduction in mean prescribed opioid dose in the first three post-policy years (year 1 conditional difference-in-differences estimate: −52.0 MME [95% confidence interval: −109.9, −10.6]; year 2: −106.2 MME [−195.0, −34.6]; year 3: −98.6 MME [−198.7, −23.9]; year 4: −72.6 MME [−160.4, 3.6]). Estimates suggest a possible positive association between the interventions and non-prescribed opioid analgesic use (year 3: 5.2 absolute percentage points [−0.1, 11.2]) and use frequency (year 3: 0.21 ordinal frequency scale points [0.00, 0.47]) in the third post-policy year. Conclusions Clinic-level opioid prescribing policies were associated with reduced dose, although the control clinic achieved similar reductions by the fourth post-policy year, and the policies may have been associated with increased non-prescribed opioid analgesic use. Clinicians should balance the urgency to reduce opioid prescribing with potential harms from rapid change. Supplementary Information The online version contains supplementary material available at 10.1007/s11606-021-06920-4.

Pain Workgroup 2/25/14 Page 2 of 10 results that suggest that the patient does not have the prescribed medication in their system or that the patient has unprescribed controlled substances or illicit substances are concerning for potential harm due to increased risk for opioid overdose/death, opioid or other substance abuse, or opioid diversion. Although a diagnosis of substance use disorder cannot be made solely using urine toxicology testing results, results can contribute information to make this determination. Patients with an active substance use disorder are poor candidates for treatment with opioids.

IV. PROCEDURE:
A. All patients prescribed chronic opioids will be asked to submit a urine sample for toxicology testing on or before initiating therapy and at least once every 12 months while continuing therapy. a. Patients with concerning behaviors or other risk factors may be tested more often at the discretion of the provider. b. Patients must provide urine toxicology tests on the day requested. Refusal by the patient to submit a urine sample should be documented as a "Yellow Flag Tracking" note in the , and the provider may decide not to write the prescription. c. If a patient is unable to produce urine (e.g. patients with anuria or neurogenic bladder), or if a patient is mobility-impaired and requires maximal assistance to give a urine sample, providers may use pill counts as a way to monitor patient use of prescribed medications.
B. Results of the urine toxicology test will be interpreted based on the tool provided in the Appendix and information obtained at the time of collection and at the time of discussion of results.
C. If a urine test is inconsistent with the prescribed medication and/or the patient reports concerning behavior, the provider or nurse will document the result/incident, the interpretation, her/his response, and the rationale for the response in a "Yellow Flag Tracking" note. a. "Yellow Flag Tracking" notes should be updated when the concerning urine toxicology results are received, so that the plan is clear to any member of the healthcare team when the patient returns. b. Response plans will follow the guidelines in the figure and below. c.
The nurse or provider may request that the primary care provider, team nurse, team member, or another provider (as appropriate) join her/him in communicating any change in treatment plan with the patient. The patient may also be offered the option to discuss the treatment plan with their primary care provider at a later visit, if their provider is not available at that time.
Pain Workgroup 2/25/14 Page 4 of 10 consent and patient provider agreement for controlled substances if not already done. The patient will be informed that if the concerning behavior is repeated, their opioids will be discontinued. 2. The behavior must be documented in a "Yellow Flag Tracking" note. 3. Urine toxicology testing must be performed at least monthly for 3 months. 4. A CURES report must be obtained and documented in the "Yellow Flag Tracking" note. 5. A pill count is suggested.
iii. If the provider previously responded to a similar result by increasing the opioid dose and a second urine is missing the prescribed medications, opioids should be discontinued without a taper. If the opioids are not discontinued, it is the provider's responsibility to bring the case to the Yellow Flag Committee.
b. Urine is missing prescribed medication (applies only to medications dosed daily) and does contain illicit substances (e.g. cocaine, methamphetamine) or unprescribed benzodiazepines or barbiturates: i. The provider should stop prescribing opioids without a taper.
c. Urine contains prescribed opioid medication and illicit substances ( e.g. cocaine, methamphetamine) or unprescribed benzodiazepines or barbiturates. i. The provider may decide to continue prescribing opioids if there have been no similar concerning behaviors in the prior 6 months, and if the benefits of continuing opioids outweigh the risks, for example if the patient is waiting to enter residential treatment. If the provider continues the prescribed medication: 1. The patient's treatment plan will be modified to address substance use, including more frequent visits. 2. The provider or nurse must communicate their concern to the patient and remind the patient of pertinent sections of the patient provider agreement or ask the patient to read/sign the informed consent and patient provider agreement for controlled substances if not already done. The patient will be informed that if the concerning behavior is repeated, their opioids will be discontinued.
Pain Workgroup 2/25/14 Page 5 of 10 3. The behavior must be documented in a "Yellow Flag Tracking" note. 4. Urine toxicology testing must be performed at least monthly for 3 months. 5. A CURES report must be obtained and documented in the "Yellow Flag Tracking" note. 6. A pill count is suggested. ii. Otherwise, the provider should stop prescribing opioids with a taper.
iii. If non-opioid controlled illicit substances are found in the urine a second time within 6 months, prescribing should be discontinued, with a taper if the urine contains the prescribed medication at the time of discontinuation. If an exception is made, it is the provider's responsibility to bring the case to the Yellow Flag Committee.
d. Urine contains unprescribed opioids (with or without prescribed opioids) i. If unprescribed methadone is present, the provider should determine the source. If not prescribed by a methadone treatment program, follow the procedure below.
1. If the patient is in a methadone treatment program, opioids will be discontinued or tapered until care can be coordinated with the methadone treatment program and a new treatment plan developed. If the patient does not give consent to contact the methadone treatment program, opioids will be discontinued or tapered. ii. The provider should assess for under-treatment of pain and may consider increasing the dose or discontinuing opioids depending on the assessment. If opioids are continued: 1. The provider or nurse must communicate their concern to the patient and remind the patient of pertinent sections of the patient provider agreement or ask the patient to read/sign the informed consent and patient provider agreement for controlled substances if not already done. The patient will be informed that if the concerning behavior is repeated, their opioids will be discontinued. 2. The behavior must be documented in a "Yellow Flag Tracking" note.
Pain Workgroup 2/25/14 Page 6 of 10 3. A urine toxicology test should be checked at least monthly for 3 months.

A CURES report must be obtained and documented in the "Yellow
Flag Tracking" note. 5. A pill count is suggested. ii. If the provider previously responded to a similar result by increasing the opioid dose and a second urine contains unprescribed opioids, opioid medications should be discontinued with a taper.
e. Evidence that there is active alcohol use by the patient i. The provider should discuss the risks and benefits of continuing opioids with the patient. ii. If the patient meets the SBIRT definition of risky drinking (see Appendix), the provider should strongly consider discontinuing opioids until the patient commits to abstinence from alcohol. iii. The behavior must be documented in a "Yellow Flag Tracking" note.
E. If a provider has discontinued or is tapering opioids due to substance abuse (whether it be opioid, alcohol, illicit drugs, or benzodiazepines), there must be documentation of treatment and/or abstinence for a period of at least 3 months before an opioid re-start will be considered by the provider. Except for alcohol, abstinence will be documented with urine toxicology tests (at least 3 tests completed within 3 months). a. During this time, patients will continue to be seen to monitor other non-opioid and/or non-pharmacological pain treatments. b. For patients in residential treatment, the time frame may be shortened. c. If opioids are restarted, a urine tox test will be obtained at least monthly for 3 months. d. If at any time during the first 3 months after restarting opioids there are illicit substances or unprescribed controlled substances in the urine, opioids will be discontinued or tapered.
F. If opioids are discontinued a second time, it is the provider's responsibility to bring the case to the Yellow Flag Committee prior to restarting opioids.