Globalization of the Safety Sections of the Periodic Safety Update Report

Abstract

The recent implementation of the International Conference on Harmonization’s E2C Guidelines was an important step toward globalizing the activities of drug safety departments. While many details have not yet been addressed, the primary objective of this initiative is clear: the preparation and worldwide submission of standardized periodic reviews of a marketed product’s safety record. This article presents a strategy for integrating suréillance activities and epidemiological principles into periodic safety update reporting (PSUR), while at the same time meeting the regulatory requirements set forth in the ICH E2C Guidelines. A stepwise approach to PSUR compilation, interpretations of critical subsections of the ICH E2C Guidelines, and issues unique to the United States reporting environment are discussed.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    Food and Drug Administration. International Conference On Harmonisation: Guideline On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. Availability Notice. Federal Register. (Docket No. 96D-0041]. 1997; 62(96,Mayl9):27470–27476.

    Google Scholar 

  2. 2.

    Goldsmith DL. The impact of the international conference on harmonization (1CH) on pharmacoepidemiology and phannacovigilance. Pharmacoepi Drug Safety. 1998;7:289–291.

    CAS  Article  Google Scholar 

  3. 3.

    Venulet J. Possible strategies for early recognition of potential drug safety problems. Adv Drug React Ac Pois Rev. 1988;1:39–12.

    Google Scholar 

  4. 4.

    Royall BW, Venulet J. Methodology for international drug monitoring. Meth Inform Med. 1972;2:75–86.

    Google Scholar 

  5. 5.

    Food and Drug Administration. FDA Web Page: AERS. 1998.

    Google Scholar 

  6. 6.

    Seidl LG, Thornton GF, Smith JW, Cluff LE. Studies on the epidemiology of adverse drug reactions. III. Reactions in patients on a general medical service. Johns Hopkins Med J. 1966;119:299–315.

    Google Scholar 

  7. 7.

    Kramer MS. Assessing causality of adverse drug reactions: Global introspection and its limitations. Drug Inf J. 1986;20:433–437.

    Article  Google Scholar 

  8. 8.

    Kramer MS. Leventhal JM. Hutchinson TA, Feinstein AR. An Algorithm for the operational assessment of adverse drug reactions: I. Background, description, and instructions for use. JAMA. 1979; 242:623–632.

    CAS  Article  Google Scholar 

  9. 9.

    Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I. Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions Clin Pharmacol Ther. 1981;30: 239–245.

    CAS  Article  Google Scholar 

  10. 10.

    Hutchinson TA, Lane DA. Assessing methods for causality assessment of suspected adverse drug reactions. J Clin Epidemiol. 1989;42:5–16.

    CAS  Article  Google Scholar 

  11. 11.

    Lane DA. The logic of uncertainty: Measuring degree of belief. Drug Inf J. 1986;20:445–453.

    Article  Google Scholar 

  12. 12.

    Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a Bayesian approach. Pharmaceut Med. 1987;2:265–283.

    Google Scholar 

  13. 13.

    Edwards IR, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible drug reactions. The Lancet. 1990;336:156–158.

    CAS  Article  Google Scholar 

  14. 14.

    Blum MD, Graham DJ. McCloskey CA. Temafloxa-cin syndrome: Review of 95 cases. Clin Inf Dis. 1994:18:946–950.

    CAS  Article  Google Scholar 

  15. 15.

    The Pink Sheet. 1998; June 29:13-14.

  16. 16.

    Venning GR. Identification of adverse reactions to new drugs. I: What have been the important adverse reactions since thalidomide? Br Med J. 1983;286: 199–202.

    CAS  Article  Google Scholar 

  17. 17.

    Li D, Lindquist M. Edwards IR. Evaluation of early signals of drug-induced Stevens-Johnson Syndrome in the WHO ADR Database. Pharmacoepi Drug Safety. 1992;1:11–18.

    Article  Google Scholar 

  18. 18.

    Food and Drug Administration. International Conference On Harmonisation: Guideline On Clinical Safety Data Management: Definitions And Standards For Expedited Reporting. Availability Notice, Federal Register [Docket No. 93D-O203]. 1995; 60(40.Marl):11284–11287.

    Google Scholar 

  19. 19.

    Federal Register. Vol 62, Number 122, June 25, 1997:34166-34168.

  20. 20.

    Napke E. Drug adverse alerting program. Can Pharm J. 1968;20:251–254.

    Google Scholar 

  21. 21.

    Finney DJ. Statistical aspects of monitoring for danger in drug therapy. Meth Inform Med. 1971;10:1–8.

    CAS  Article  Google Scholar 

  22. 22.

    Royall BW. International aspects of the study of adverse reactions to drugs. Biometrics. 1971;27:689–698.

    CAS  Article  Google Scholar 

  23. 23.

    Tsong Y. False alarm rates of statistical methods used in determining increased frequency of reports on adverse drug reaction. J Biopharm Stat. 1992;2:9–30.

    CAS  Article  Google Scholar 

  24. 24.

    Norwood PK. Sampson AR. A statistical methodology for postmarketing surveillance of adverse drug reaction reports. Stat Med. 1988;7:1023–1030.

    CAS  Article  Google Scholar 

  25. 25.

    Tubert-Bitter P, Begaud B, Moride Y, Chaslerie A, Haramburu F. Comparing the toxicity of two drugs in the framework of spontaneous reporting: A confidence interval approach. J Clin Epidemiol. 1996;49:121–123.

    CAS  Article  Google Scholar 

  26. 26.

    Rossi AC, Hsu JP, Faich GA. Ulcerogenicity of piro-xicam: An analysis of spontaneously reported data. Br Med J. 1987;294:147–150.

    CAS  Article  Google Scholar 

  27. 27.

    Tubert P, Begaud B, Haramburu F. Pere JC. Spontaneous reporting: How many cases are required to trigger a warning? Br J Clin Pharmac. 1991;32:407–408.

    CAS  Article  Google Scholar 

  28. 28.

    Begaud B, Moride Y. Tubert-Bitter P, Chaslerie A, Haramburu F. False-positives in spontaneous reporting: Should we worry about them? Br J Clin Pharmac. 1994;38:401–404.

    CAS  Article  Google Scholar 

  29. 29.

    21 C.F.R. § Section 314.80. C2(ii) (1995).

  30. 30.

    Medicines Control Agency. MCA News. Mail 101: May/June 1997;2–3.

    Google Scholar 

  31. 31.

    Fed. R. Evid. 801(d)(2)(D).

  32. 32.

    Restatement (Third) Torts: Products Liability.

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Stephen L. Klincewicz DO, MPH, JD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Klincewicz, S.L., Clark, J.A., Arnold, B.D.C. et al. Globalization of the Safety Sections of the Periodic Safety Update Report. Ther Innov Regul Sci 33, 887–898 (1999). https://doi.org/10.1177/009286159903300330

Download citation

Key Words

  • Periodic safety update reports
  • International Conference on Harmonization
  • Pharmacoepidemiology
  • Adverse event signaling
  • Postmarketing surveillance