Abstract
This study examined outpatient buprenorphine dispensing patterns in Texas before vs after the Drug Enforcement Administration temporarily relaxed outpatient buprenorphine prescribing regulations in March 2020 in response to the COVID-19 pandemic.
Drug overdose prevention remains critical during the coronavirus disease 2019 (COVID-19) pandemic.1 Buprenorphine for treatment of opioid use disorder reduces the likelihood of opioid overdose and can be prescribed in office-based outpatient settings.2,3 On March 13, 2020, the COVID-19 outbreak was declared a national emergency.4 In response, the Drug Enforcement Administration temporarily relaxed outpatient buprenorphine prescribing regulations.2,3,5 Revisions include permitting prescribing to new patients via telephone or telemedicine and to existing patients by any method (including email) and encouraging use of electronic prescriptions. This study determined if changes in federal regulations corresponded with changes in outpatient buprenorphine dispensing in Texas.
Methods
The RTI International Institutional Review Board deemed the study not human subjects research. Data are from the Texas Prescription Monitoring Program, which tracks all controlled substances dispensed by Texas pharmacies or to Texas residents. A third-party vendor (Appriss) linked and deidentified patient and prescriber records.
Analyses were restricted to buprenorphine indicated for opioid use disorder dispensed to in-state patients. We calculated changes in the following for the 90 days preceding (December 15, 2019, to March 13, 2020) and 90 days following (March 14 to June 11, 2020) the declaration of national emergency: number of prescriptions; number of prescribers; number of unique patients, new patients (outpatient buprenorphine fill following a break of at least 180 days), and existing patients (more than 1 outpatient buprenorphine fill within 180 days); mean days’ supply; mean daily dosage; payment type; and proportion of prescriptions filled by electronic submission. Poisson tests for differences in counts, t tests for differences in means, and χ2 tests for differences in proportions were calculated with SAS version 9.4 (SAS Institute Inc) using 2-tailed tests with a significance threshold of P < .05. Analyses were replicated with data from 1 year prior (December 14, 2018, to June 11, 2019).
Results
In the 90 days after the national emergency declaration, 36 225 patients filled prescriptions for buprenorphine, an increase from 30 013 in the preceding 90 days (P < .001) (Table). The number of new patients increased (from 4291 to 13 604; P < .001), while the number of existing patients declined (from 25 722 to 22 621; P < .001). The number of prescribers did not change significantly from 2269 (P = .66).
Table. Changes in Outpatient Buprenorphine Dispensing in Texas in the 90 Days Before and After the US National Emergency Declaration Concerning the COVID-19 Outbreak and Comparative Time Periods 1 Year Priora.
Buprenorphine prescription indicator | 90 d prior to national emergency declaration (December 15, 2019–March 13, 2020) | 90 d after national emergency declaration (March 14–June 11, 2020) | P value | Comparison | P value | |
---|---|---|---|---|---|---|
December 14, 2018–March 13, 2019 | March 14, 2019–June 11, 2019 | |||||
No. of prescriptions | 113 938 | 107 561 | <.001 | 115 839 | 115 789 | .92 |
No. of prescribers | 2269 | 2299 | .66 | 2081 | 2125 | .50 |
No. of unique patients | 30 013 | 36 225 | <.001 | 27 593 | 28 090 | .04 |
No. of existing patients | 25 722 | 22 621 | <.001 | 23 579 | 24 049 | .03 |
No. of new patients | 4291 | 13 604 | <.001 | 4014 | 4041 | .76 |
Mean (SD) days’ supply per prescription | 19.22 (11.99) | 21.06 (11.52) | <.001 | 17.12 (12.24) | 17.59 (12.19) | <.001 |
Mean days’ supply per prescription, % | ||||||
1-7 | 29.27 | 22.69 | <.001 | 36.66 | 35.09 | <.001 |
8-14 | 10.94 | 10.81 | 11.12 | 11.06 | ||
15-29 | 17.15 | 18.19 | 16.01 | 16.36 | ||
30 | 41.73 | 47.29 | 35.46 | 36.64 | ||
≥31 | 0.92 | 1.02 | 0.75 | 0.85 | ||
Dosage per prescription, mean (SD), mg/d | 14.36 (7.77) | 14.30 (7.86) | .06 | 14.54 (7.78) | 14.47 (7.64) | .03 |
Prescriptions dispensed via electronic prescribing, % | 38.56 | 46.49 | <.001 | 27.65 | 29.20 | <.001 |
Payment type, % | ||||||
Private insurance | 65.64 | 66.55 | <.001 | 67.49 | 65.68 | <.001 |
Medicaid | 1.51 | 1.62 | 1.38 | 1.42 | ||
Medicare | 5.95 | 6.46 | 5.69 | 5.97 | ||
Military | 2.97 | 2.89 | 2.61 | 2.92 | ||
Out of pocket | 19.65 | 18.18 | 19.66 | 20.55 | ||
Worker’s compensation | 0.10 | 0.12 | 0.12 | 0.13 | ||
Unknown | 4.18 | 4.18 | 3.05 | 3.33 |
SAS version 9.4 was used for all analyses: Poisson tests for differences in counts, t tests for differences in means, and χ2 tests for differences in proportions. New patients are those with a buprenorphine prescription dispensed after a break of at least 180 days in which the patient was not covered by an outpatient buprenorphine prescription.
The total number of outpatient buprenorphine prescriptions decreased from 113 938 to 107 561 (P < .001), while mean days’ supply per prescription increased from 19.22 to 21.06 (P < .001). Electronic prescribing increased from 38.56% to 46.49% (P < .001). The mean dosage did not change significantly from 14.36 mg/d (P = .06) and, while statistically significant, there were no changes of more than 1.5% for any payment category.
Overall, changes in 2019 were either not significant or of similar magnitude to those in 2020, suggesting that changes in 2020 were not due to seasonal or secular trends. For example, the number of unique patients also increased (from 27 593 to 28 090; P = .04). However, there was an increase in existing patients in 2019 (from 23 579 to 24 049; P = .03), and there was no statistical change in the number of new patients (from 4014 to 4041; P = .76).
Discussion
In the 90 days after the United States declared COVID-19 a national emergency, the number of patients receiving an outpatient buprenorphine prescription in Texas increased despite a decline in existing patients. Prescribers also increased the number of days per prescription and were more likely to use electronic prescribing.
Analyses were limited to Texas, which has the country’s highest uninsured population and limited access to outpatient buprenorphine prescribers.3,6 The increase in new outpatients could be due to factors other than relaxation of regulations, such as an increased need due to the stress of the pandemic. The Texas Prescription Monitoring Program does not track prescriptions dispensed from opioid treatment programs or hospitals; it is possible that lack of access to these facilities during the pandemic resulted in a transition of care to outpatient settings. Payment reforms (eg, telemedicine reimbursement changes by Medicare and other payers) that occurred as pandemic response could also have influenced outpatient buprenorphine prescribing. Regardless, the association found between relaxation of federal regulations and positive changes in outpatient buprenorphine dispensing in Texas adds support for policy makers to reevaluate whether these changes should remain temporary.2
Section Editor: Jody W. Zylke, MD, Deputy Editor.
References
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