OpenFDA: An innovative platform providing access to a wealth of FDA's publicly available data

Journal of the American Medical Informatics Association

Volumn 23, Issue 3, 2016, Pages 596-600

  Kass Hout, Taha A ^a   Xu, Zhiheng ^a   Mohebbi, Matthew ^b   Nelsen, Hans ^b   Baker, Adam ^b   Levine, Jonathan ^a   Johanson, Elaine ^a   Bright, Roselie A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Iodine Inc   (United States)

Author keywords

Adverse event; API; Application programming interface; Drug safety; Open data; Open source; OpenFDA

Indexed keywords

ACETYLSALICYLIC ACID;

ARTICLE; CLOUD COMPUTING; COMPUTER INTERFACE; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; INTERNET PROTOCOL; SEX DIFFERENCE; DRUG SURVEILLANCE PROGRAM; GOVERNMENT REGULATION; INFORMATION PROCESSING; ORGANIZATION AND MANAGEMENT; PRODUCT RECALL; SOFTWARE; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATASETS AS TOPIC; DRUG LABELING; GOVERNMENT REGULATION; OWNERSHIP; PRODUCT RECALLS AND WITHDRAWALS; SOFTWARE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84978973659     PISSN: 10675027     EISSN: 1527974X     Source Type: Journal    
DOI: 10.1093/jamia/ocv153     Document Type: Article

References (44)

1. Executive Summary: Strategic Plan for Regulatory Science. Food and Drug Administration (FDA). Updated: January 16, 2013. http://www.fda.gov/ ScienceResearch/SpecialTopics/RegulatoryScience/ucm268095.htm. Accessed December 10, 2014.
2. Executive Order - Making Open and Machine Readable the New Default for Government Information. Office of the Press Secretary, The White House. May 9, 2013. http://www.whitehouse.gov/the-press-office/2013/05/09/executive- order-making-open-and-machine-readable-new-default-government-. Accessed May 7, 2014.
3. HHS Open Government Plan. US Department of Health and Human Services. Last reviewed January 2, 2015. http://www.hhs.gov/open/plan/opengovernmentplan/ initiatives/initiative.html. Accessed March 1, 2014.
4. Kass-Hout T. OpenFDA: Innovative Initiative Opens Door to Wealth of FDA's Publicly Available Data. Food and Drug Administration. June 2, 2014. FDA. http://blogs.fda.gov/fdavoice/index.php/2014/06/openfda-innovative-initiative- opens-door-to-wealth-of-fdas-publicly-available-data. Accessed March 5, 2015.
5. Reports Received and Reports Entered into FAERS by Year. Food and Drug Administration. August 6, 2014. http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm070434.htm. Accessed July 18, 2015.
6. The Adverse Event Reporting System (AERS): Older Quarterly Data Files. Food and Drug Administration. August 15, 2013. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm083765.htm. Accessed July 18, 2015.
7. FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files. Food and Drug Administration. June 16, 2015. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm082193.htm. Accessed July 18, 2015.
8. Kass-Hout T. Providing easy public access to prescription drug, over-thecounter drug, and biological product labeling. Food and Drug Administration. August 18, 2014. https://open.fda.gov/update/drug-product- labeling/. Accessed December 10, 2014.
9. DailyMed. National Library of Medicine, US National Institutes of Health. http://dailymed.nlm.nih.gov/dailymed/. Accessed July 18, 2015.
10. Enforcement Reports. Food and Drug Administration. July 15, 2015. http:// www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. Accessed July 18, 2015.
11. FDA 101: Product Recalls - From First Alert to Effectiveness Checks. Food and Drug Administration. Updated April 29, 2015. http:// www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm. Accessed July 18, 2015.
12. Kass-Hout T. OpenFDA provides ready access to recall data. Food and Drug Administration. August 8, 2014. https://open.fda.gov/update/openfda-provides- ready-access-to-recall-data. Accessed July 2015.
13. Manufacturer and User Facility Device Experience Database - (MAUDE). Food and Drug Administration. May 7, 2015. http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ ReportingAdverseEvents/ucm127891.htm. Accessed July 18, 2015.
14. FedRAMP Compliant Systems. FedRAMP, US General Services Administration. https://www.fedramp.gov/marketplace/compliant-systems/. Accessed July 18, 2015.
15. FDA/openFDA. GitHub, Inc. 2015. https://github.com/FDA/openfda. Accessed July 18, 2015.
16. StackExchange. StackExchange. http://stackexchange.com/search?q =openFDA. Accessed July 18, 2015.
17. OpenFDA. Stack Exchange. https://opendata.stackexchange.com/search?q =openFDA. Accessed July 18, 2015.
18. James G. (@gupta_james). "see how men & women get different drug side effects genderedreactions.com - a @GenderMedKI and @TheThinkTrain project using @openFDA data." September 1, 2014, 2:23pm. Tweet.
19. Glenn V. (@TusculumGolfer). "do any of your drug databases have both the @US_FDA @FDA_Drug_Info NDC and @WHO ATC codes listed for each drug? To cross reference." December 10, 2014, 7:07pm. Tweet.
20. Request for Quotation (RFQ) 4QTFHS150004 for the Establishment of Multiple Award Blanket Purchase Agreements (BPAs for Agile Delivery Services (ADS I). US General Services Administration. https://pages.18f.gov/ ads-bpa/assets/ADS_RFQ_Final.pdf. Accessed July 18, 2015.
21. The Agile Delivery BPA is (almost) here! US General Services Administration. June 15, 2015. https://18f.gsa.gov/2015/06/15/agile-bpa-is-here/. Accessed July 18, 2015.
22. GitHub. GitHub, Inc. https://github.com. Accessed July 18, 2015.
23. Create, review and deploy code together. GitLab. https://about.gitlab.com/. Accessed July 18, 2015.
24. Your team, your code, connected. Atlassian, Inc. https://bitbucket.org. Accessed July 18, 2015.
25. Track, report, or subscribe to side effects of drugs, vaccines and medical devices. RecallGuide. https://www.recallguide.org. Accessed July 18, 2015.
26. Drug Side Effects. PatientsVille. 2015. http://www.Patientsville.com. Accessed February 20, 2015.
27. Welcome to ResearchAE.com. Social Health Insights LLC. 2014. http:// www.researchae.com. Accessed December 10, 2014.
28. Ramstein E. openFDA drug adverse events dataviz. YouTube. June 8, 2014. https://www.youtube.com/watch?v=qtSfJUSbMmI&feature=youtu.be. Accessed May 15, 2015.
29. Levine J. openFDA RR. https://open.fda.gov/static/docs/openFDA-analysisexample. pdf. Accessed July 18, 2015.
30. Levine J. openFDA RR-Event. https://open.fda.gov/static/docs/openFDAanalysis- example.pdf. Accessed July 18, 2015.
31. Levine J. openFDA Dynamic PRR. https://open.fda.gov/static/docs /openFDA-analysis-example.pdf. Accessed July 18, 2015.
32. Levine J. openFDA Change Point Analysis. https://open.fda.gov/static/docs /openFDA-analysis-example.pdf. Accessed July 18, 2015.
33. Levine J. Report Browser. https://open.fda.gov/static/docs/openFDA-analysis- example.pdf. Accessed July 18, 2015.
34. Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Food and Drug Administration, US Department of Health and Human Services. March, 2005. http://www.fda.gov/ downloads/regulatoryinformation/guidances/ucm126834.pdf. Accessed February 20, 2015.
35. Tsong Y. Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting. J Biopharm Stat. 1995;5:95-114.
36. McAdams M, Staffa J, Dal Pan G. Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis. Pharmacoepidemiol Drug Safety. 2008;17(3):229-239.
37. Dasgupta N, Mandl KD, Brownstein JS. Breaking the news or fueling the epidemic? Temporal association between news media report volume and opioid-related mortality. PLoS One. 2009;4(11):e7758.
38. Bate A, Evans S. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009;18(6):427-436.
39. Szarfman A, Tonning JM, Doraiswamy PM. Pharmacovigilance in the 21st century: new systematic tools for an old problem. Pharmacotherapy 2004;24(9):1099-1104.
40. Subedi FH, Joshi PH, Jones SR, et al. Current guidelines for high-density lipoprotein cholesterol in therapy and future directions. Vasc Health Risk Manag. 2014;10:205-216.
41. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. National Guideline Clearinghouse, Agency for Healthcare Research and Quality. 2012. www.guideline.gov/content. aspx?id=38432&search=niacin. Accessed May 15, 2015.
42. Stone NJ, Robinson J, Lichtenstein AH, et al. ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults. Circulation. 2013;129(25 Suppl 2):S1-S45. DOI: 10.1161/ 01.cir.0000437738.63853.7a.
43. Drugs@FDA: FDA Approved Drug Products. Searched for "Zestril". Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm. Accessed May 15, 2015.
44. Cefali EA, Simmons PD, Stanek EJ, et al. Aspirin reduces cutaneous flushing after administration of an optimized extended-release niacin formulation. Int J Clin Pharmacol Ther. 2007;45(2):78-88.