Methodological Concepts: What Could We Know and What Should We Know in Drug Epidemiology?

  • K. Überla
Conference paper

Abstract

Epidemiologists and clinical pharmacologists do not always have the same view of things. During the years Professor Kewitz and I have learned to respect the sound scientific principles of both. I am glad to join you in this meeting and to contribute some simple thoughts.

Keywords

Lawson Mandel 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Anonymous (1977) Towards a more rational regulation of the development of new medicines. Report of a european workshop held at Sestri Levante, Italy. Eur J Clin Pharmacol 11:233–238CrossRefGoogle Scholar
  2. Anonymous (1975) Adverse drug reactions in the United States. An analysis of the problem and recommendations for furture approaches. Medicine in the public interest (F.Karch and L. Lasagna) WashingtonGoogle Scholar
  3. Anonymous (1980) Report of the joint commission on prescription drug use. Final report. RockvilleGoogle Scholar
  4. Anonymous (1983) Risk assessment. A study groups report. The Royal Society, LondonGoogle Scholar
  5. Anonymous (1985) Pharma-Jahresbericht 1984/85. Bundesverband der Pharmazeutischen Industrie.Google Scholar
  6. Feinstein AF (1974) Clinical biostatistics XXVIII. The biostatistical problems of pharmaceutical surveillance. Clin Pharmacol Ther 16:110–123PubMedGoogle Scholar
  7. Finkle W (1980) Sample size requirement for detection of drug induced disease. In: Joint commission on prescription drug use (ed) Report of joint commission on prescription drug use. Rocheville. App V.Google Scholar
  8. Finney DJ (1965) The design and logic of a monitor of drug use. J Chron Dis 18: 77–89PubMedCrossRefGoogle Scholar
  9. Finney DJ (1971) Statistical aspects of monitoring for dangers in drug therapie. Methods of Information in Medicine 10:1–8PubMedGoogle Scholar
  10. Finney DJ (1974) Systematic signalling of adverse reactions to drugs. Methods of Information in Medicine 13:1–10PubMedGoogle Scholar
  11. Finney DJ (1980) Statistical logic in the monitoring of reactions to therapeutic drugs. In: Inman WHW (ed) Monitoring for drug safety. MTP Press, Lancester, pp 383–400Google Scholar
  12. Griffin JP, Darcy PF (1981) Adverse reaction to drugs — the information lag. Side effect of drugs essay 1981. Annual.Google Scholar
  13. Hasford J (1983) Die Spontanberichterstattung als Teilsystem der postmarketing surveillance: Gegenwärtiger Stand, Analysen und Empfehlungen. Unpublished manuscript, MünchenGoogle Scholar
  14. Hasford J (1985) Methoden zur Erfassung unerwünschter Arzneimittelwirkungen. In: Dölle W et al. (eds) Grundlagen der Arzneimitteltherapie — Entwicklung, Beurteilung und Anwendung von Arzneimitteln. Wissenschaftsverlag, Mannheim, chap 3.3.1Google Scholar
  15. Hasford J (1986) Möglichkeiten und Grenzen der Erfassung von unerwünschten Arzneimittelwirkungen am Beispiel der Antihypertensiva und Lipidsenker: Biometrische Gesichtspunkte. In: Bock, Anschütz (eds) Hugenpott-Symposium 1985Google Scholar
  16. Hasford J, Selbmann HK (1983) Effektivität von Mißbildungsregistern. Dtsch Ärzteblatt 80:26–32Google Scholar
  17. Hutchinson et al. (1979) An algorithm for the operational assessment of adverse drug reactions II. Demonstration of reproducibility and validity. JAMA 242:633–638PubMedCrossRefGoogle Scholar
  18. Inman WHW (ed) (1980) Monitoring for drug safety. MTP Press, LancesterGoogle Scholar
  19. Inman WHW (1981a) Postmarketing surveillance of adverse drug reactions in general practice I: search for new methods. Br Med J 282:1131–1132CrossRefGoogle Scholar
  20. Inman WHW (1981b) Postmarketing surveillance of adverse drug reactions in general practice II: prescription event monitoring in the university of Southampton. Br Med J 282:1216–1217CrossRefGoogle Scholar
  21. Jick H, Miettinen OS et al. (1970) Comprehensive drug surveillance. JAMA 213:1455–1460PubMedCrossRefGoogle Scholar
  22. Jones JK (1983) Adverse reaction reporting in the US 1983. In: Grosdanoff P, Schnieders B, Überla K (eds) Arzneimittelsicherheit. BGA-Schrift 1/83, MMW-Verlag, München, pp 43–48Google Scholar
  23. Jones JK et al. (1984) Medicaid drug-event data: an emerging tool for evaluation of drug risks. Acta Med Scand [Suppl] 683:127–134Google Scholar
  24. Kramer MS et al. (1979) An algorithm for the operational assessment of adverse drug reactions I. Background, description and introduction for use. JAMA 242:623–632PubMedCrossRefGoogle Scholar
  25. Lassagna L (1984) Techniques for ADR reporting. Skandia International Symposia. Detection and prevention of ADRs. Stockholm, pp 146–151Google Scholar
  26. Lawson DH (1980) Intensive monitoring in hospitals I. Boston collaborative drug surveillance program (BCDSP). In: Inman WHW (ed) Monitoring for drug safety. MTP Press, LancesterGoogle Scholar
  27. Lawson DH, Shapiro S et al. (1972) Drug surveillance: problems and challenges. Pediatr Clin North Am 19:117Google Scholar
  28. Leventhal et al. (1979) An algorithm for the operational assessment of adverse drug reactions III. Results of tests among clinicians. JAMA 242:1991–1994PubMedCrossRefGoogle Scholar
  29. Levine A, Mandel SPH, Snatamaria A (1977) Pattern signalling in health information monitoring systems. Methods of Information in Medicine 16:138–144PubMedGoogle Scholar
  30. Mandel SPH, Levine A, Belena GE (1976) Signalling increase in reporting in international monitoring of adverse reactions to therapeutic drugs. Methods of Information in Medicine 15:1–10PubMedGoogle Scholar
  31. Mann JI (1980) Principles and pitfalls in drug epidemiology. In: Inman WHW (ed) Monitoring for drug safety. MTP Press, Lancester, pp 401–415Google Scholar
  32. Moir DC (1980) Intensive monitoring in hospitals II. The Aberdeen-Dundee system. In: Inman WHW (ed) Monitoring for drug safety. MTP Press, LancesterGoogle Scholar
  33. Moussa MAA (1978) Statistical problems in monitoring ADRs. Methods of Information in Medicine 17:106–112PubMedGoogle Scholar
  34. Musch E, Gugler R (1981) Wechselwirkungen zwischen Arzneimitteln. Dtsch Ärzteblatt 78: 1627–1639Google Scholar
  35. Neiß A, Köpeke W, Überla K (1982) Fallzahlschätzungen und Zwischenauswertungen. Internist 23:195–200PubMedGoogle Scholar
  36. Remington RD (1978) Post-marketing surveillance: a comparison of methods. Publication series of the center for the study of drug development. Boston.Google Scholar
  37. Royall BW, Venulet J (1972) Methodology for international drug monitoring. Methods of Information in Medicine 11:75–86Google Scholar
  38. Schiesselmann JJ (1982) Case control studies. Oxford University Press, New YorkGoogle Scholar
  39. Slone D, Jick H et al. (1966) Drug surveillance utilising nurse monitors. Lancet 2:901PubMedCrossRefGoogle Scholar
  40. Skegg DCG (1980) Medical record linkage. In: Inman WHW (ed) Monitoring for drug safety. MTP Press, LancesterGoogle Scholar
  41. Überla K (1980 a) Statistische Gesichtspunkte zur Überwachung unerwünschter Nebenwirkungen zugelassener Medikamente. In: Mehnert H, Stand E (eds) Metformintherapie. Schattauer, Stuttgart, pp 47–58Google Scholar
  42. Überla K (1981a) Practical problems in long term clinical trials. In: Bithell JF, Coppi (eds) Proceedings of the European Symposium on medical statistics. Academic, London, pp 173–189Google Scholar
  43. Überla K (1981b) Randomized clinical trials — why not? Controlled Clin Trials 1:295–303PubMedCrossRefGoogle Scholar
  44. Überla K (1982 a) Wieviele Patienten braucht man für eine Therapiestudie? Gesichtspunkte der klinischen Forschung. MWM 124:437–440Google Scholar
  45. Überla K (1982b) Asymmetrien bei der Risiko-Nutzen-Ab wägung in der Medizin. Pharm Ind 44: 1982, 431–436Google Scholar
  46. Überla K (1982c) Sicherheit und Risiko im Arzneimittelbereich: Fiktion und Realität. MWM 124: 743–746Google Scholar
  47. Überla K (1983) Perspektiven der Erfassung und Bewertung unerwünschter Arzneimittelwirkungen. In: Grosdanoff P, Schnieders B, Überla K (eds) Arzneimittelsicherheit. BGA-Schriften 1/83, MW-Verlag, München, pp 57–59Google Scholar
  48. Venning GR (1982) Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarm. Br Med J 284: 249–252CrossRefGoogle Scholar
  49. Venning GR (1983) Identification of adverse reactions to new drugs III: alerting process and early warning system. Br Med J 286:458–460CrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin, Heidelberg 1987

Authors and Affiliations

  • K. Überla
    • 1
  1. 1.ISB - Institut für Medizinische Informationsverarbeitung, Statistik und BiomathematikLudwig-Maximilians-UniversitätMünchen 70Federal Republic of Germany

Personalised recommendations