Assessment of Outpatient Dispensing of Products Proposed for Treatment or Prevention of COVID-19 by US Retail Pharmacies During the Pandemic | Clinical Pharmacy and Pharmacology | JAMA Internal Medicine | JAMA Network
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Figure.  Retail Dispensing Trends for Selected Products Proposed for Treatment or Prevention of COVID-19, December 21, 2019-December 18, 2020
Retail Dispensing Trends for Selected Products Proposed for Treatment or Prevention of COVID-19, December 21, 2019-December 18, 2020

COVID-19 indicates coronavirus disease 2019. Projected weekly numbers of prescriptions dispensed from US retail pharmacies in the 52-week period December 21, 2019, to December 18, 2020. Data are from IQVIA National Prescription Audit Weekly, accessed on December 28, 2020. National estimates of weekly prescriptions indicated by scatter plot; modeled projections indicated by a solid line; and inflection points indicated by a triangle.

A, Four hydroxychloroquine segments were identified, with average percentage change as follows: −0.3% (95% CI, −1.9% to 1.2%), 32.5 (95% CI, 11.9 to 56.9), −9.8% (95% CI, −13.2% to −6.4%), and 0.3% (95% CI, 0.1% to 0.5%). B, Six ivermectin segments were identified, with average percentage change as follows: 27.0% (95% CI, −4.2% to 68.4%), 0.4% (95% CI, −0.3% to 1.0%), 16.0% (95% CI, 0.8% to 33.6%), −5.3% (95% CI, −8.2% to −2.3%), 5.8% (95% CI, 3.1% to 8.6%), and 46.6% (95% CI, 27.3% to 68.8%). C, Six zinc segments were identified, with average percentage change as follows: 1.7% (95% CI, 0.7% to 2.7%), 25.6% (95% CI, 7.0% 47.5%), −7.0% (95% CI, −8.7% to −5.4%), 9.7% (95% CI, 7.3% to 12.0%), −7.7% (95% CI, −12.3% to −2.9%), and 9.2% (95% CI, 8.3% to 10.0%). D, Six dexamethasone segments were identified, with average percentage change as follows: 1.3% (95% CI, 0.5% to 2.1%), −16.6% (95% CI, −26.0% to −6.0%), 1.3% (95% CI, −0.3% to 2.9%), 7.3% (95% CI, 5.6% to 9.0%), −2.8% (95% CI, −4.3% to −1.2%), and 5.9% (95% CI, 5.2% to 6.6%).

Table.  Estimated Increases in Dispensed Retail Prescriptions for Selected Products Proposed to Treat or Prevent COVID-19—United States, March-December 2020 vs 2019a
Estimated Increases in Dispensed Retail Prescriptions for Selected Products Proposed to Treat or Prevent COVID-19—United States, March-December 2020 vs 2019a
1.
Shehab  N, Lovegrove  M, Budnitz  DSUS.  US Hydroxychloroquine, Chloroquine, and Azithromycin Outpatient Prescription Trends, October 2019 Through March 2020.   JAMA Intern Med. 2020;180(10):1384-1386. doi:10.1001/jamainternmed.2020.2594PubMedGoogle ScholarCrossref
2.
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. US Department of Health and Human Services, National Institutes of Health. Accessed December 28, 2020. https://www.covid19treatmentguidelines.nih.gov/
3.
American Society of Health-System Pharmacists. Assessment of Evidence for COVID-19-Related Treatments. Accessed December 28, 2020. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHP-COVID-19-Evidence-Table.ashx
4.
US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Joinpoint Trend Analysis Software. Accessed December 28, 2020. https://surveillance.cancer.gov/joinpoint/
5.
US Department of Health and Human Services, Centers for Disease Control and Prevention. CDC COVID Data Tracker - Daily Trends in Number of COVID-19 Cases in the United States Reported to CDC. Accessed December 28, 2020. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
6.
US Department of Health and Human Services, Food and Drug Administration. COVID-19 Emergency Use Authorizations: Drug and Biological Products. Accessed December 28, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
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    Research Letter
    Less Is More
    February 11, 2021

    Assessment of Outpatient Dispensing of Products Proposed for Treatment or Prevention of COVID-19 by US Retail Pharmacies During the Pandemic

    Author Affiliations
    • 1CDC COVID-19 Response Team, Atlanta, Georgia
    JAMA Intern Med. Published online February 11, 2021. doi:10.1001/jamainternmed.2021.0299

    Prior to November 2020, there were no US Food and Drug Administration-authorized products for outpatient coronavirus disease 2019 (COVID-19) prevention or treatment. There have been surges in prescriptions for products (such as hydroxychloroquine1) proposed to treat COVID-19, but only approved for other conditions. We sought to determine if outpatient retail dispensing frequency of proposed treatments for COVID-19 increased since the March 13, 2020, declaration of a national emergency due to COVID-19.

    Methods

    We used IQVIA National Prescription Audit Weekly nationally projected data for prescriptions dispensed from US retail pharmacies for 17 systemically administered potential treatments selected from the National Institutes of Health COVID-19 Treatment Guidelines,2 and the American Society of Health-System Pharmacists Assessment of Evidence for COVID-19-Related Treatments.3 The National Prescription Audit Weekly aggregates prescription data from 48 900 retail pharmacies across the US, representing approximately 92% of all retail prescription activity, and uses a proprietary algorithm to project national-level estimates of dispensed prescriptions. We compared weekly numbers of dispensed prescriptions in the period March 14 to December 18, 2020, to prepandemic baselines. For treatments with dispensed prescriptions of 50% or more above baseline, we used piecewise (segmented) regression4 to identify inflection points and calculate average changes in weekly dispensing for the 52-week period ending December 18, 2020. Analyses were conducted as part of public health surveillance activities and determined exempt from human subjects approval by the US Centers for Disease Control and Prevention (CDC). This report complies with the STROBE reporting guideline for cross-sectional studies.

    Results

    Peak dispensing occurred the week ending March 20, 2020, for 9 of 17 proposed treatments (Table). Estimates of weekly national retail dispensing increased 50% or more above prepandemic baselines for ivermectin, chloroquine, zinc, hydroxychloroquine, vitamin C, dexamethasone, and lopinavir-ritonavir.

    Based on segmented regression, dispensing of hydroxychloroquine peaked the week ending March 20, 2020 (Figure, A). In 2020, ivermectin dispensing peaked the week ending July 24 and rose again through December 18 (Figure, B). In 2020, zinc dispensing peaked the weeks ending April 10 and August 7, and rose again through December 11 (Figure, C). In 2020, dexamethasone dispensing decreased starting the week ending March 13, reaching a nadir the week ending April 3, before increasing to a peak 25% above baseline the week ending July 24, and rising over 50% above baseline through December 18 (Figure, D).

    Discussion

    After the national emergency declaration of March 2020, retail dispensing of 7 proposed COVID-19 treatment products significantly increased above prepandemic baselines.

    Single peaks in hydroxychloroquine, chloroquine, and lopinavir-ritonavir dispensing in March to April, 2020, coincided with increases in cases, and did not recur as evidence of lack of efficacy in treating or preventing COVID-19 accumulated. Although the National Institutes of Health COVID-19 Treatment Guidelines Panel has not recommended outpatient use of ivermectin, zinc, or dexamethasone for treatment or prevention of COVID-19, increased dispensing of each of these products has coincided with a national increase in COVID-19 cases beginning in July 2020 and another national increase in the fall which continued into December 2020.5

    Limitations of these data include lack of prescribing indication and incomplete capture of products purchased over the counter (eg, famotidine, vitamin C, zinc). These trends in prescribing practices suggest that clinicians consider the most recent recommendations from the National Institutes of Health and the US Food and Drug Administration before prescribing unproven therapies for COVID-19 to outpatients outside of clinical trials. With availability of newly authorized treatments and COVID-19 vaccines,6 it is particularly important to emphasize to patients the benefits of therapies demonstrated in randomized clinical trials compared with medications with uncertain benefits. National monitoring of outpatient dispensing of proposed products for treatment of COVID-19 should continue, particularly for medications with risk for serious adverse events (eg, hydroxychloroquine, dexamethasone) and without established efficacy for COVID-19 treatment in outpatients (eg, ivermectin).

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    Article Information

    Accepted for Publication: January 27, 2021.

    Published Online: February 11, 2021. doi:10.1001/jamainternmed.2021.0299

    Corresponding Author: Andrew I. Geller, MD, CDC COVID-19 Response Team, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion, CDC, 1600 Clifton Rd NE, Mailstop V18-4, Atlanta, GA 30329 (ageller@cdc.gov).

    Author Contributions: Dr Geller had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Geller, Lovegrove, Budnitz.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Geller.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Lovegrove.

    Obtained funding: Budnitz.

    Administrative, technical, or material support: Geller, Lovegrove, Lind.

    Supervision: Datta, Budnitz.

    Conflict of Interest Disclosures: None reported.

    Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC.

    References
    1.
    Shehab  N, Lovegrove  M, Budnitz  DSUS.  US Hydroxychloroquine, Chloroquine, and Azithromycin Outpatient Prescription Trends, October 2019 Through March 2020.   JAMA Intern Med. 2020;180(10):1384-1386. doi:10.1001/jamainternmed.2020.2594PubMedGoogle ScholarCrossref
    2.
    COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. US Department of Health and Human Services, National Institutes of Health. Accessed December 28, 2020. https://www.covid19treatmentguidelines.nih.gov/
    3.
    American Society of Health-System Pharmacists. Assessment of Evidence for COVID-19-Related Treatments. Accessed December 28, 2020. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHP-COVID-19-Evidence-Table.ashx
    4.
    US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Joinpoint Trend Analysis Software. Accessed December 28, 2020. https://surveillance.cancer.gov/joinpoint/
    5.
    US Department of Health and Human Services, Centers for Disease Control and Prevention. CDC COVID Data Tracker - Daily Trends in Number of COVID-19 Cases in the United States Reported to CDC. Accessed December 28, 2020. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
    6.
    US Department of Health and Human Services, Food and Drug Administration. COVID-19 Emergency Use Authorizations: Drug and Biological Products. Accessed December 28, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
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