146
Views
2
CrossRef citations to date
0
Altmetric
Original Research

Effects of a Safety Letter on Metoclopramide Use in Korea: An Interrupted Time-Series Analysis

ORCID Icon & ORCID Icon
Pages 1335-1341 | Published online: 25 Aug 2020

References

  • DiPiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 6th ed New York: McGraw-Hill Medical; 2014.
  • Shin H-W, Chung SJ. Drug-induced parkinsonism. J Clin Neurol. 2012;8(1):15–21. doi:10.3988/jcn.2012.8.1.1522523509
  • Blanchet PJ, Kivenko V. Drug-induced parkinsonism: diagnosis and management. Res Rev Parkinsonism. 2016;6:83–91.
  • Kim S, Cheon S-M, Suh HS. Association between drug exposure and occurrence of parkinsonism in Korea: a population-based case-control study. Ann Pharmacother. 2019;53(11):1102–1110. doi:10.1177/106002801985954331216861
  • Food and Drug Administration. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs. Available from: https://wayback.archive-it.org/7993/20170112033201/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149533.htm. Accessed 720, 2020.
  • Ehrenpreis ED, Deepak P, Sifuentes H, et al. The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. Am J Gastroenterol. 2013;108(6):866–872. doi:10.1038/ajg.2012.30023735907
  • European Medicines Agency. European medicines agency recommends changes to the use of metoclopramide; Published 2013 Available from: https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-changes-use-metoclopramide. Accessed 720, 2020.
  • Rhew K, Han N, Oh JM. Impact of safety warning on domperidone prescribing for geriatric patients in South Korea: analysis of national insurance claim data. Int J Env Res Pub He. 2019;16(16):2985. doi:10.3390/ijerph16162985
  • Kim M-S, Shin J-Y, Kim J-Y, et al. Analysis of safety letters and alerts in Korea food & drug administration, 20012011. Korean Soc Pharmacoepidem Risk Manag. 2013;6(1):37–42.
  • Chung S, Ahn S-H, Kim S, et al. Development of systematic target drug prioritization process in Korea. International Conference on Pharmacoepidemiology & Therapeutic Risk Management; 8 26, 2013; Montréal, QC.
  • Ramsay CR, Matowe L, Grilli R, Grimshaw JM, Thomas RE. Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies. Int J Technol Assess Health Care. 2003;19(4):613–623. doi:10.1017/S026646230300057615095767
  • Kim J-A, Yoon S, Kim L-Y, Kim D-S. Towards actualizing the value potential of korea health insurance review and assessment (HIRA) data as a resource for health research: strengths, limitations, applications, and strategies for optimal use of HIRA data. J Korean Med Sci. 2017;32(5):718–728. doi:10.3346/jkms.2017.32.5.71828378543
  • Ministry of Foods and Drugs Safety. Issuance of a safety letter for medications containing metoclopramide. Available from: https://nedrug.mfds.go.kr/pbp/CCBAC01/getItem?totalPages=26&limit=10&searchYn=true&page=1&title=%EB%A9%94%ED%86%A0&safeLetterNo=117. Accessed 720, 2020.
  • Kesselheim AS, Donneyong M, Dal Pan GJ, et al. Changes in prescribing and healthcare resource utilization after FDA drug safety communications involving zolpidem containing medications. Pharmacoepidemiol Drug Saf. 2017;26(6):712–721. doi:10.1002/pds.421528449404
  • Kesselheim AS, Campbell EG, Schneeweiss S, et al. Methodological approaches to evaluate the impact of FDA drug safety communications. Drug Saf. 2015;38(6):565–575. doi:10.1007/s40264-015-0291-y25968811
  • Park J, Han E, Lee SO, Kim D-S, Wang Y-T. Antibiotic use in South Korea from 2007 to 2014: A health insurance database-generated time series analysis. PLoS One. 2017;12(5):e0177435. doi:10.1371/journal.pone.017743528520761
  • Park C-M, Lee K-S, Han E, Kim D-S. Effects of delisting nonprescription combination drugs on health insurance expenditures for pharmaceuticals in Korea. Health Policy. 2016;120(6):590–595. doi:10.1016/j.healthpol.2016.05.00327241339
  • Han E, Chae S-M, Kim N-S, Park S. Effects of pharmaceutical cost containment policies on doctors’ prescribing behavior: focus on antibiotics. Health Policy. 2015;119(9):1245–1254. doi:10.1016/j.healthpol.2015.05.00526119997
  • Colón A, Gómez Gómez D, Gómez Esteban A, et al. DI-086 Influence of the recommendations of the european medicines agency regarding the modification of the prescription pattern of metoclopramide. Eur J Hosp Pharm. 2015;22(Suppl 1):A108. doi:10.1136/ejhpharm-2015-000639.260
  • Jandoc R, Burden AM, Mamdani M, Lévesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations. J Clin Epidemiol. 2015;68(8):950–956. doi:10.1016/j.jclinepi.2014.12.01825890805
  • Penfold RB, Zhang F. Use of interrupted time series analysis in evaluating health care quality improvements. Acad Pediatr. 2013;13(6):S38S44. doi:10.1016/j.acap.2013.08.002
  • Wagner AK, Soumerai SB, Zhang F, Ross‐Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27(4):299–309. doi:10.1046/j.1365-2710.2002.00430.x12174032
  • Cochrane Effective Practice and Organisation of Care (EPOC). Interrupted time series (ITS) analyses: EPOC resources for review authors; Published 2017 Available from: https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/interrupted_time_series_analyses.docx.
  • Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017;46(1):348–355. doi:10.1093/ije/dyw09827283160
  • Slavova S, Costich JF, Luu H, et al. Interrupted time series design to evaluate the effect of the ICD-9-CM to ICD-10-CM coding transition on injury hospitalization trends. Inj Epidemiol. 2018;5(1):1–12. doi:10.1186/s40621-018-0165-829308538
  • Ma Z-Q, Kuller LH, Fisher MA, Ostroff SM. Peer reviewed: use of interrupted time-series method to evaluate the impact of cigarette excise tax increases in pennsylvania, 2000–2009. Prev Chronic Dis. 2013;10(120268):1–10. doi:10.5888/pcd10.120268
  • Caswell J Interrupted time series analysis for single series and comparative designs: a guide for beginners with sas macro; 2017 Available from: https://www.academia.edu/35275583/Interrupted_Time_Series_Analysis_for_Single_Series_and_Comparative_Designs_A_Guide_for_Beginners_with_SAS_Macro. Accessed 720, 2020.
  • Bernal JL. The Use of Interrupted Time Series for the Evaluation of Public Health Interventions [Dissertation]. London: London School of Hygiene & Tropical Medicine; 2018.
  • Miller LG, Jankovic J. Metoclopramide-induced movement disorders: clinical findings with a review of the literature. Arch Intern Med. 1989;149(11):2486–2492. doi:10.1001/archinte.1989.003901100700152684075
  • Choi D, Choi M, Ko A. Current status of pharmaceutical safety management in Korea. J Korean Med Assoc. 2012;55(9):827–834. doi:10.5124/jkma.2012.55.9.827
  • Shin JY, Jung SY, Ahn SH, et al. New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and risk management (KIDS). Pharmacoepidemiol Drug Saf. 2014;23(11):1115–1122. doi:10.1002/pds.371525251052
  • Jeong HE. Prescribing Trend of Pioglitazone After Safety Warning Release in South Korea [Dissertation]. Seoul: Graduate school of Seoul National University; 2018.
  • Bjerre LM, Parlow S, De Launay D, et al. Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK. BMJ Open. 2018;8(10):e020150. doi:10.1136/bmjopen-2017-020150
  • Thomas SK, Hodson J, McIlroy G, Dhami A, Coleman JJ. The impact of direct healthcare professional communication on prescribing practice in the UK hospital setting: an interrupted time series analysis. Drug Saf. 2013;36(7):557–564. doi:10.1007/s40264-013-0057-323657825
  • Stewart KA, Natzke BM, Williams T, et al. Temporal trends in anti‐diabetes drug use in tricare following safety warnings in 2007 about rosiglitazone. Pharmacoepidemiol Drug Saf. 2009;18(11):1048–1052. doi:10.1002/pds.181919655338