Strategy for surveillance of adverse drug events

Food and Drug Law Journal

Volumn 62, Issue 3, 2007, Pages 605-615

  Bright, Roselie A ^a  

^a Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

COMPUTER PROGRAM; DATA MINING; DRUG LABELING; DRUG MARKETING; DRUG MONITORING; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEALTH CARE DELIVERY; HEALTH SURVEY; HUMAN; REGISTER; REVIEW; RISK FACTOR; SIDE EFFECT; ARTICLE; DRUG INDUSTRY; METHODOLOGY; POSTMARKETING SURVEILLANCE; QUALITY CONTROL; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG INDUSTRY; DRUG MONITORING; HUMANS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL; REGISTRIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 35548931246     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (36)

1. "Surveillance is a continuous and systematic process of collection, analysis, interpretation, and dissemination of descriptive information for monitoring health problems. . . . [B]roadly, surveillance provides a basis for shaping public health policy." Kenneth J. Rothman & Sander Greenland, eds. MODERN EPIDEMIOLOGY. 2nd ed Surveillance by James W. Buehler, Lippincott-Raven, Philadelphia, PA (1998).
2. Epidemiology is "the study of the occurrence of illness" and causes that can explain that occurrence. Kenneth J. Rothman & Sander Greenland, eds., MODERN EPIDEMIOLOGY, 2nd ed, Lippincott-Raven, Philadelphia, PA (1998).
3. American Academy of Pediatrics Committee on Drugs, Uses Of Drugs Not Described In The Package Insert (Off-Label Uses). 110 PEDIATRICS 181-183 (2002).
4. See Buehler supra note 1.
5. Brian L. Strom, ed., PHARMACOEPIDEMIOLOGY, 4th ed., Spontaneous Reporting in the United States by Syed Rizwanuddin Ahmad, Roger A. Goetsch & Norman S. Marks, 135-159, and Prescription-Event Monitoring by Saad A.W. Shakir, 203-216, John Wiley & Sons, Ltd (2005).
6. Id.
7. See Ahmad supra note 5.
8. See Ahmad and Shakir supra note 5.
9. FDA Announces The Use Of New Electronic Drug Labels To Help Better Inform The Public And Improve Patient Safety, www.fda.gov/bbs/topics/NEWS/ 2005/NEW01252.html (Nov. 2, 2005).
10. Drug Application Regulatory Compliance, www.fda.gov/cder/ regulatory/applications/compliance.htm (Mar. 8, 2001).
11. Id.
12. Id.
13. Drug Master Files, www.fda.gov/cder/dmf/ (Feb. 21, 2007) and Federal Register Report And FDA Web Site On Postmarketing Studies, www.fda.gov/bbs/topics/answers/2003/ans01223.html (May 22, 2003).
14. Adverse Event Reporting System (AERS), www.fda.gov/cder/aers/ default.htm (Mar. 22, 2007).
15. See Ahmad supra note 5 and David Kessler & Diane Kennedy, MedWatch: FDA's New Medical Products Reporting Program. 18 J. CLIN. ENG. 489-492 (1993).
16. Juliaette Johnson, Overview of DQRS, FARS and BPDRs, www.fda.gov/cder/offices/crms/dqrs2002/FAR-DQRS-BPD-FY2006.pdf (Jan. 18, 2007).
17. See supra notes 10, 16, and Enforcement Story: Fiscal Year 2006, Pages 26-27, www.fda.gov/ora/about/enf_story/ch3/default.pdf.
18. See Federal Register Report And FDA Web Site On Postmarketing Studies supra note 13.
19. Guidance For Industry: Development And Use Of Risk Minimization Action Plans, www.fda.gov/cber/gdlns/riskminim.htm (Apr. 19, 2005).
20. See Johnson supra note 16, Enforcement Story supra note 17, and Drug Quality Reporting System (DQRS), www.fda.gov/cder/Offices/CRMS/ DQRS.htm (Jan. 18, 2007).
21. Enforcement Story: Fiscal Year 2006. Pages 27-28, www.fda.gov/ora/about/enf_story/ch3/default.pdf.
22. Managing The Risks From Medical Product Use. Appendix C, Cooperative Agreements and Collaborative Resources, www.fda.gov/oc/tfrm/AppendixC.html (May 1999).
23. Verispan, www.verispan.com.
24. First DataBank. www.firstdatabank.com.
25. Aaron B. Mendelsohn, The National Electronic Injury Surveillance System: Cooperative Adverse Drug Events Surveillance System (NEISS-CADES), (May 18, 2005) www.fda.gov/ohrms/dockets/ac/05/slides/2005-4143S1_09_Mendelsohn. ppt.
26. Overview: Fact Sheet: Centers for Education and Research on Therapeutics, AHRQ PUBLICATION No. 07-P003-EF, http://www.ahrq.gov/ clinic/certsovr.htm (Feb. 2007).
27. Gerald J. Dal Pan, CDER's Office of Surveillance and Epidemiology, www.fda.gov/cder/audiences/iact/forum/200609_dalpan.pdf (Nov. 27, 2006).
28. Id.
29. FDA Newsroom, www.accessdata.fda.gov/news/.
30. Bharati Manda, Carol R. Drinkard, Deborah Shatin & David J. Graham, The Risk Of Esophageal Obstruction Associated With An Anti-Allergy Medication (Claritin-D® 24-Hour Original Formulation), 13 PHARMACOEPIDEMIOL. DRUG SAF. 29-34 (2004).
31. Marie R. Griffin, C. Michael Stein, David J. Graham, James R. Daugherty, Patrick G. Arbogast & Wayne A. Ray, High Frequency Of Use Of Rofecoxib At Greater Than Recommended Doses: Cause For Concern, 13 PHARMACOEPIDEMIOL. DRUG SAF. 33943 (2004).
32. David J. Graham, Judy A. Staffa, Deborah Shatin, Susan E. Andrade, Stephanie Schech, Lois LaGrenade, et al. Incidence Of Hospitalized Rhabdomyolysis In Patients Treated With Lipid-Lowering Drugs, 292 JAMA. 2585-2590 (2004).
33. Stephanie Schech, David Graham, Judy Staffa, Susan E. Andrade, L. La Grenade, Margaret Burgess, David Blough, Andy Stergachis, K. Arnold Chan, Richard Platt & Deborah Shatin, Risk Factors For Statin-Associated Rhabdomyolysis, 16 PHARMACOEPIDEMIOL, DRUG SAF. 352-8 (2007).
34. Stephen R. Benoit, Aaron B. Mendelsohn, Parivash Nourjah, Judy A. Staffa & David J. Graham, Risk Factors For Prolonged QTC Among US Adults: Third National Health And Nutrition Examination Survey, 12EUR J CARDIOVASC PREV REHABIL 363-368 (2005).
35. David J. Graham, D. Campen, R. Hui, M. Spence, C. Cheetham, G. Levy, S. Shoor, Wayne A. Ray, Risk Of Acute Myocardial Infarction And Sudden Cardiac Death In Patients Treated With Cyclo-Oxygenase 2 Selective And Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Nested Case-Control Study, 365 LANCET 475481 (2005).
36. Deborah Shatin, J.S. Gardner, Andy Stergachis, David Blough & D. Graham, Impact Of Mailed Warning To Prescribers On The Co-Prescription Of Tramadol And Antidepressants, 14 PHARMACOEPIDEMIOL, DRUG SAF. 149-54 (2005).