FDA collaboration to improve safe use of fluoroquinolone antibiotics: an ex post facto matched control study of targeted short-form messaging and online education served to high prescribers

Keywords: Antimicrobial Stewardship, Drug Resistance, Bacterial, Fluoroquinolones, Prescription Drug Misuse, Inappropriate Prescribing, Education, Medical, Continuing, Peer Influence, Randomized Controlled Trials as Topic, United States


Objective: This ex post facto matched control study was conducted to evaluate the effect of targeted short-form messages or continuing medical education (CME) on fluoroquinolone prescribing among high prescribers.

Methods: A total of 11,774 Medscape healthcare provider (HCP) members prescribing high volumes of fluoroquinolones were randomized into three segments to receive one of three unique targeted short-form messages, each delivered via email, web alerts, and mobile alerts. Some HCPs receiving targeted short-form messages also participated in CME on fluoroquinolone prescribing. A fourth segment of HCPs participated in CME only. Test HCPs were matched to third-party-provider prescriber data to identify control HCPs. We used prescriber data to determine new prescription volume; percentage (%) of HCPs with reduced prescribing; new prescription volume for acute bacterial sinusitis (ABS), uncomplicated urinary tract infection (uUTI), and acute bacterial exacerbations of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD). Open rates for emailed targeted short-form messages were also measured.

Results: Targeted short-form messages and CME each resulted in significant new prescription volume reduction versus control. Combining targeted short-form messages with CME yielded the greatest percentage of test HCPs with reduced prescribing (80.1%) versus controls (76.2%; p<0.0001). New prescription volume decreased significantly for uUTI and ABS following exposure to targeted short-form messages, CME, or both. Targeted short-form messages containing comparative prescribing information with or without clinical context were opened at slightly higher rates (10.8% and 10.6%, respectively) than targeted short-form messages containing clinical context alone (9.1%).

Conclusions: Targeted short-form messages and CME, alone and in combination, are associated with reduced oral fluoroquinolone prescribing among high prescribers.


Download data is not yet available.

Author Biographies

Scott Winiecki

Director, Safe Use Initiative, U.S. Food and Drug Administration

Kaushal Patel

Group Vice President, Marketing Sciences, WebMD


Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Inf Dis. 2015;60(9):1308-1316. https://doi.org/10.1093/cid/civ076

Baggs J, Fridkin SK, Pollack LA, Srinivasan A, Jernigan JA. Estimating National Trends in Inpatient Antibiotic Use Among US Hospitals From 2006 to 2012. JAMA Int Med. 2016;176(11):1639-1648. https://doi.org/10.1001/jamainternmed.2016.5651

USCAST, The United States Committee on Antimicrobial Susceptibility Testing. Quinolone In Vitro Susceptibility Test Interpretive Criteria Evaluations. Report Number: USCAST 0001. Version: 1.3; Oct 15, 2018. Available from: http://www.uscast.org/documents.html (accessed Nov 6, 2019).

Bailey AM, Weant KA, Baker SN. Prevalence and risk factor analysis of resistant Escherichia coli urinary tract infections in the emergency department. Pharm Pract (Granada). 2013;11(2):96-101. https://doi.org/10.4321/s1886-36552013000200006

U.S. Food and Drug Administration, Drug Safety and Availability. FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients. Silver Spring (MD): U.S. Food and Drug Administration; Dec 20, 2018. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm (accessed Nov 4, 2019).

U.S. Food and Drug Administration, Information by Drug Class. FDA approves safety labeling changes for fluoroquinolones. Silver Spring (MD): U.S. Food and Drug Administration; updated Jul 26, 2016. Available from: https://www.fda.gov/drugs/information-drug-class/fda-approves-safety-labeling-changes-fluoroquinolones (accessed Nov 4, 2019).

Kabbani S, Hersh AL, Shapiro DJ, Fleming-Dutra KE, Pavia AT, Hicks LA. Opportunities to improve fluoroquinolone prescribing in the United States for adult ambulatory care visits. Clin Inf Dis. 2018;67(1):134-136. https://doi.org/10.1093/cid/ciy035

Leibovici L, Paul M, Andreassen S. Balancing the benefits and costs of antibiotic drugs: the TREAT model. Clin Microbiol Infect. 2010;16(12):1736-1739. https://doi.org/10.1111/j.1469-0691.2010.03330.x

Butler CC, Simpson SA, Dunstan F, Rollnick S, Cohen D, Gillespie D, Evans MR, Alam MF, Bekkers MJ, Evans J, Moore L, Howe R, Hayes J, Hare M, Hood K. Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care: practice based randomised controlled trial. BMJ. 2012;344:d8173. https://doi.org/10.1136/bmj.d8173

Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013;382(9899):1175-1182. https://doi.org/10.1016/S0140-6736(13)60994-0

Yardley L, Douglas E, Anthierens S, Tonkin-Crine S, O'Reilly G, Stuart B, Geraghty AW, Arden-Close E, van der Velden AW, Goosens H, Verheij TJ, Butler CC, Francis NA, Little P; GRACE consortium. Evaluation of a web-based intervention to reduce antibiotic prescribing for LRTI in six European countries: quantitative process analysis of the GRACE/INTRO randomised controlled trial. Implement Sci. 2013;8:134. https://doi.org/10.1186/1748-5908-8-134

Briñol P, Petty RE. Source factors in persuasion: A self-validation approach. Euro Rev Soc Psych. 2009;20(1):49-96. https://doi.org/10.1080/10463280802643640

Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012(6):Cd000259. https://doi.org/10.1002/14651858.CD000259.pub3

Ackerman SL, Gonzales R, Stahl MS, Metlay JP. One size does not fit all: evaluating an intervention to reduce antibiotic prescribing for acute bronchitis. BMC Health Serv Res. 2013;13:462. https://doi.org/10.1186/1472-6963-13-462

McCullough AR, Rathbone J, Parekh S, Hoffmann TC, Del Mar CB. Not in my backyard: a systematic review of clinicians' knowledge and beliefs about antibiotic resistance. J Antimicrob Chemother. 2015;70(9):2465-2473. https://doi.org/10.1093/jac/dkv164

NIH Grants & Funding, Department of Health and Human Services. Novel Interventions and Collaborations to Improving the Safe Use of Medications. Bethesda (MD): National Institutes of Health; updated 2011. Available from: https://grants.nih.gov/grants/guide/rfa-files/rfa-fd-11-024.html (accessed May 29, 2019).

U.S. Food and Drug Administration, Broad Agency Announcement. Falls Church (VA); FDAnews; c2015. FDABAA-15-00121. Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science; updated 2015. Available from: https://www.fdanews.com/ext/resources/files/02-15/02-25-15-FDAFundingOpportunities.pdf?1520729329 (accessed Apr 26, 2019).

Dittert B. Long form vs short form content: which to use when & why. Denver (CO): Volume Nine; c2019. Available from: https://www.v9digital.com/blog/2015/08/18/long-form-vs-short-form-content-which-to-use-when-why/ (accessed Jun 12, 2019).

Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017;2:Cd003543. https://doi.org/10.1002/14651858.CD003543.pub4

Arnold SR, Straus SE. Interventions to improve antibiotic prescribing practices in ambulatory care. Cochrane Database Syst Rev. 2005(4):Cd003539. https://doi.org/10.1002/14651858.CD003539.pub2

Curtis CE, Al Bahar F, Marriott JF. The effectiveness of computerised decision support on antibiotic use in hospitals: A systematic review. PloS One. 2017;12(8):e0183062. https://doi.org/10.1371/journal.pone.0183062

van der Velden AW, Pijpers EJ, Kuyvenhoven MM, Tonkin-Crine SK, Little P, Verheij TJ. Effectiveness of physician-targeted interventions to improve antibiotic use for respiratory tract infections. British J Gen Pract. 2012;62(605):e801-807. https://doi.org/10.3399/bjgp12X659268

Allen JM, Dunn R, Bush J. Effect of prescriber peer comparison reports on fluoroquinolone use across a 16-facility community hospital system. J Am Coll Clin Pharm. 2019;2(5):502-508. https://doi.org/10.1002/jac5.1106

Hemkens LG, Saccilotto R, Reyes SL, Glinz D, Zumbrunn T, Grolimund O, Gloy V, Raatz H, Widmer A, Zeller A, Bucher HC. Personalized prescription feedback using routinely collected data to reduce antibiotic use in primary care: A randomized clinical trial. JAMA Intern Med. 2017;177(2):176–183. https://doi.org/10.1001/jamainternmed.2016.8040

Sacarny A, Yokum D, Finkelstein A, Agrawal S. Medicare letters to curb overprescribing of controlled substances had no detectable effect on providers. Health Aff. 2016;35(3):471-479. https://doi.org/10.1377/hlthaff.2015.1025

Altiner A, Berner R, Diener A, Feldmeier G, Köchling A, Löffler C, Schröder H, Siegel A, Wollny A, Kern WV. Converting habits of antibiotic prescribing for respiratory tract infections in German primary care--the cluster-randomized controlled CHANGE-2 trial. BMC Fam Pract. 2012;13:124. https://doi.org/10.1186/1471-2296-13-124

Anthierens S, Tonkin-Crine S, Cals JW, Coenen S, Yardley L, Brookes-Howell L, Fernandez-Vandellos P, Krawczyk J, Godycki-Cwirko M, Llor C, Butler CC, Verheij T, Goossens H, Little P, Francis NA; GRACE/CHAMP INTRO team. Clinicians' views and experiences of interventions to enhance the quality of antibiotic prescribing for acute respiratory tract infections. J Gen Int Med. 2015;30(4):408-416. https://doi.org/10.1007/s11606-014-3076-6

Gifford J, Vaeth E, Richards K, Siddiqui T, Gill C, Wilson L, DeLisle S. Decision support during electronic prescription to stem antibiotic overuse for acute respiratory infections: a long-term, quasi-experimental study. BMC Inf Dis. 2017;17(1):528. https://doi.org/10.1186/s12879-017-2602-7

Gonzales R, Steiner JF, Lum A, Barrett PH, Jr. Decreasing antibiotic use in ambulatory practice: Impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA. 1999;281(16):1512-1519. https://doi.org/10.1001/jamainternmed.2016.4535

Weiss K, Blais R, Fortin A, Lantin S, Gaudet M. Impact of a multipronged education strategy on antibiotic prescribing in Quebec, Canada. Clin Inf Dis. 2011;53(5):433-439. https://doi.org/10.1093/cid/cir409

Hingorani R, Mahmood M, Alweis R. Improving antibiotic adherence in treatment of acute upper respiratory infections: a quality improvement process. J Comm Hosp Int Med Perspect. 2015;5(3):27472. https://doi.org/10.3402/jchimp.v5.27472

Gjelstad S, Høye S, Straand J, Brekke M, Dalen I, Lindbaek M. Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study). BMJ. 2013;347:f4403. https://doi.org/10.1136/bmj.f4403

Hernandez-Santiago V, Marwick CA, Patton A, Davey PG, Donnan PT, Guthrie B. Time series analysis of the impact of an intervention in Tayside, Scotland to reduce primary care broad-spectrum antimicrobial use. J Antimicrobial Chemo. 2015;70(8):2397-2404. https://doi.org/10.1093/jac/dkv095

McKay RM, Vrbova L, Fuertes E, Chong M, David S, Dreher K, Purych D, Blondel-Hill E, Henry B, Marra F, Kendall PR, Patrick DM. Evaluation of the Do Bugs Need Drugs? program in British Columbia: Can we curb antibiotic prescribing? Can J Inf Dis Med Microbiol. 2011;22(1):19-24. https://doi.org/10.1155/2011/745090

Metlay JP, Camargo CA, Jr., MacKenzie T, McCulloch C, Maselli J, Levin SK, Kersey A, Gonzales R; IMPAACT Investigators. Cluster-randomized trial to improve antibiotic use for adults with acute respiratory infections treated in emergency departments. Ann Emerg Med. 2007;50(3):221-230. https://doi.org/10.1016/j.annemergmed.2007.03.022

Hallsworth M, Chadborn T, Sallis A, Sanders M, Berry D, Greaves F, Clements L, Davies SC. Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial. Lancet. 2016;387(10029):1743-1752. https://doi.org/10.1016/S0140-6736(16)00215-4

Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016;315(6):562-570. https://doi.org/10.1001/jama.2016.0275

How to Cite
Whyte J, Winiecki S, Hoffman C, Patel K. FDA collaboration to improve safe use of fluoroquinolone antibiotics: an ex post facto matched control study of targeted short-form messaging and online education served to high prescribers. Pharm Pract (Granada) [Internet]. 2020Apr.24 [cited 2021Sep.23];18(2):1773. Available from: https://pharmacypractice.org/journal/index.php/pp/article/view/1773
Original Research