Skip to main content
SpringerLink
Log in
Book cover

Trends and Changes in Drug Research and Development pp 53–65Cite as

Monitoring for Drug Safety

  • Chapter

  • 47 Accesses

Abstract

Monitoring for drug safety starts during preclinical pharmacological and toxicological studies, continues during the clinical phases of development, and is maintained throughout the product’s life as a marketed medicine. Preclinical studies, although useful in identifying Type A Reactions (Rawlins and Thompson, 1977) hazards that might be anticipated during clinical practice, provide little basis for determining risk (Royal Society, 1983) and even less for identifying Type B reactions (The human pharmacological and clinical investigations carried out before marketing will establish the incidence of the more common adverse effects irrespective as to whether they are Type A or Type B reactions). However, premarketing studies cannot provide complete reassurance about a drug’s safety. Relatively small numbers of patients (rarely more than 2,000 to 3,000) will have been treated at the time of the grant of a marketing licence, and the duration of exposure will have been relatively short. Patients receiving the drug during clinical trials usually will have been a homogeneous group, and have been supervised by specialists in the particular therapeutic field. Moreover, the techniques used for detecting subclinical iatrogenic conditions (especially ‘routine’ haematological and biochemical methods) have been adapted from those developed for the diagnosis of naturally-occurring disease, and are not ideal for the purpose of toxicological screening.

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Bateman D N, Rawlins M D and Simpson J M. Extrapyramidal reactions with metoclopramide. Br Med J 1985 291:930–2.

    Article  CAS  Google Scholar 

  2. Bateman D N, Rawlins M D and Simpson J M. Extrapyramidal reactions to prochlorperazine and haloperidol in the United Kingdom. QJ Med 1986; 59:549–56.

    CAS  Google Scholar 

  3. Bergman U, Boman G and Wilholm B-E. Epidemiology of adverse drug reactions to phenformin and metformin. Br Med J 1978; 2, 464–66.

    Article  PubMed  CAS  Google Scholar 

  4. Colin-Jones D G, Langman M J S, Lawson D H and Vessey M P. Cimetidine and gastric cancer: preliminary report from postmarketing surveillance study. Br Med J 1982; 285:1311–13.

    Article  CAS  Google Scholar 

  5. Committee of Principal Investigators. A co-operative trial in the primary prevention of ischaemic heart disease using Clofibrate. Br Heart J 1978; 40,1069–1118.

    Article  Google Scholar 

  6. Committee on Safety of Medicines. Emepromium bromide and oesophageal ulceration. Curr Probl 1978; No. 3.

    Google Scholar 

  7. Committee on Safety of Medicines. Amiodarone (Cordarone X). Curr Probl 1982a; No. 8.

    Google Scholar 

  8. Committee on Safety of Medicines. Mianserin (Bolvidon), (Norval) and anthropathy. Curr Probl 1982b; No. 8.

    Google Scholar 

  9. Committee on Safety of Medicines. Zimeldine (Zelmid). Curr Probl 1982c; No 11.

    Google Scholar 

  10. Committee on Safety of Medicines. Ketoconazole (Nizoral). Curr Probl 1983; No 10.

    Google Scholar 

  11. Committee on Safety of Medicines. Fansidar. Curr Probl 1985a; No 15.

    Google Scholar 

  12. Committee on Safety of Medicines. Dangers of newer antidepressants. Curr Probl 1985b; No 15.

    Google Scholar 

  13. Committee on Safety of Medicines. Deaths associated with co-trimoxazole, ampicillin and trimethoprium. Curr Probl 1985c; No 15.

    Google Scholar 

  14. Committee on Safety of Medicines. CSM Update: Non-steroidal anti-inflammatory drugs and serious gastrointestinal adverse reactions - 2. Br Med J 1986; 292: 1190–91.

    Article  Google Scholar 

  15. Committee on Safety of Medicines. CSM Update: Aspirin and Reye’s syndrome. Br Med J 1986b; 292:1590.

    Article  Google Scholar 

  16. Crombie I K. The role of record linkage in post-marketing drug surveillance. Br J Clin Pharmacol 1986; 22: 775–825.

    Google Scholar 

  17. Doll R, Speizer F, Heaf P and Strang L. Br Med J 1967; 1: 756–8.

    Article  Google Scholar 

  18. Doll R. Unwanted effects of drugs. Br Med Bull 1971; 27: 25–31.

    PubMed  CAS  Google Scholar 

  19. Dollery C T and Rawlins M D. Monitoring adverse reactions to drugs. Br Med J 1977; 1: 96–7.

    Article  PubMed  CAS  Google Scholar 

  20. Griffin J P. Survey of the spontaneous drug reaction report schemes in fifteen countries. Br J Clin Pharmacol 1986; 22: 83S-100S.

    PubMed  Google Scholar 

  21. Hall G C, Luscombe D and Walker S R. Post-marketing surveillance using a computerised general practice database. Pharm Med 1988; (In press).

    Google Scholar 

  22. Harcus A W, Ward A E and Smith D W. Methodology of monitored release of a new preparation: buprenorphine. Br Med J 1979;2:163–5.

    Article  PubMed  CAS  Google Scholar 

  23. Idanpaan-Heikkila J E. Adverse reactions and post-marketing surveillance. In: Burley D M and Binns T B eds, Pharmaceutical Medicine, London, Edward Arnold 1985; pp. 126–148.

    Google Scholar 

  24. Inman W H W. Recorded release. In: Gross F H and Inman W H W, eds, Drug Monitoring, New York, Academic Press 1977; pp. 65–78.

    Google Scholar 

  25. Inman W H W and Adelstein A M. Rise and fall of asthma mortality in England and Wales in relation to the use of pressurised aerosols. Lancet 1969; 2: 279–281.

    Article  PubMed  CAS  Google Scholar 

  26. Inman W H W and Mustrin W W. Jaundice after repeated exposure to halothane: an analysis of reports to the Committee on the Safety of Medicines. Br Med J 1974; 1: 5–7.

    Article  PubMed  CAS  Google Scholar 

  27. Inman W H W, Vessey M P, Westerholm B and Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. Br Med J 1970; 2: 203–6.

    Article  PubMed  CAS  Google Scholar 

  28. Inman W H W, 1986; in Monitoring for Drug Safety ed Inman W H W. MTP Press Ltd, Lancaster.

    Google Scholar 

  29. Lawson D H and Henry D A. Monitoring adverse reactions to new drugs, ‘restricted release’ or ‘monitored release’. Br Med J 1977; 1: 691–2.

    Article  PubMed  CAS  Google Scholar 

  30. Lawson D H 1986. Post-marketing surveillance in the UK. Br J Clin Pharmacol 1984; 22:71S-75S.

    PubMed  Google Scholar 

  31. Ledingham I M, Watts I. Influence of sedation on mortality in critically ill multiple trauma patients. Lancet 1983; 1:1270.

    Article  PubMed  CAS  Google Scholar 

  32. Lewis J A. Postmarketing surveillance; how many patients? Trends Pharmac Sci 1981; 2:93–4.

    Article  Google Scholar 

  33. Lumley C E, Walker S R, Hall G C, Staunton N and Grob P R. The under-reporting of adverse drug reactions seen in general practice. Pharm Med 1986; 1: 205–12.

    Google Scholar 

  34. Maclay W P, Crowder D, Spiro S and Turner P. Postmarketing surveillance: practical experience with ketotifen. Br Med J 1984; 288: 911–14.

    Article  CAS  Google Scholar 

  35. Mann J I. Principles and pitfalls in drug epidemiology. In: Inman W H W, ed. Monitoring for Drug Safety. Lancaster, MTP Press 1986; pp. 443–58.

    Google Scholar 

  36. Medical Research Council Working Party. MRC trial of treatment of mild hypertension: principal results. Br Med J 1985; 291: 97–104.

    Article  Google Scholar 

  37. Morbidity and Mortality Weekly Report 1986; 35: 66–7.

    Google Scholar 

  38. Penn R G, Griffin J P. Adverse reactions to nitrofurantoin in the United Kingdom, Sweden and Holland. Br Med J 1982; 284;1440–2.

    CAS  Google Scholar 

  39. Rawlins M D. Post-marketing surveillance of adverse reactions to drugs (&d).Br Med J 1984; 288: 879–80.

    CAS  Google Scholar 

  40. Rawlins, M D. The organization of long-term intervention and prevention studies. In: Steichele C, Abshager U and Koch-Weser J eds, Drugs between Research and Regulation. Damstadt: Steinkopff Verlag 1985; pp. 109–112.

    Google Scholar 

  41. Rawlins, M D. Spontaneous reporting of adverse drug reactions. QJ Med 1986; 59: 531–4.

    CAS  Google Scholar 

  42. Rawlins M D and Thomspon J W. Pathogenesis of adverse drug reactions. In: Davies D M ed. Textbook of Adverse Drug Reactions. Oxford University Press, Oxford 1977; pp. 10–31.

    Google Scholar 

  43. Royal College of General Practitioners. Oral Contraception and Health. London; Pitman Medical 1974.

    Google Scholar 

  44. Royal Society. Risk Assessment. A Study Group Report. The Royal Society, London 1983.

    Google Scholar 

  45. Somerville K, Faulkner G and Langman M. Non-steroidal anti-inflammatory drugs and bleeding peptic ulcer. Lancet 1986; 1: 462–4.

    Article  PubMed  CAS  Google Scholar 

  46. Stolley P D. The case-control method in the epidemiologic investigation of adverse drug reaction in the United States. In: Lemberger L and Reidenberg M M, eds, Proceedings of the Second World Conference on Clinical Pharmacology and Therapeutics. Bethesda, American Society for Pharmacology and Experimental Therapeutics 1983; pp. 928–32.

    Google Scholar 

  47. Tilson H. Post-marketing Surveillance: the Way Forward. London, Centre for Medicines Research 1987.

    Google Scholar 

  48. University Group Diabetes Programme. A study of the effects of hypoglycaemic agents on vascular complications in patients with adult-onset diabetes. II Mortality results. Diabetes 1970; (Suppl 2), 757–830.

    Google Scholar 

  49. Venning G R. Identification of adverse reactions to new drugs III. Alerting processes and early warning systems. Br Med J 1983; 286: 458–60.

    Article  CAS  Google Scholar 

  50. Vessey M P, Doll R, Peto R, Johnson B and Wiggins P. A long-term follow-up study of women using different methods of contraception. An interim report. Biosociol Sci 1976; 8: 373–84.

    CAS  Google Scholar 

  51. Walker S R and Goldberg A. 1986; Monitoring for adverse drug reactions MTP Press Ltd, Lancaster.

    Google Scholar 

  52. Wilson A B. Post-marketing surveillance of adverse reactions to drugs. Br Med J 1977; 2: 1001–3.

    Article  PubMed  CAS  Google Scholar 

  53. Wood S M, Mann R D and Rawlins M D. Angio-oedema with angiotensin converting-enzyme inhibitors. Br Med J 1987; 294: 91–2.

    Article  CAS  Google Scholar 

Download references

Authors
  1. M. D. Rawlins
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. The Hatfield Polytechnic, Hertfordshire, UK

    Bryan C. Walker (Former Head of Physiology and Pharmacology) (Former Head of Physiology and Pharmacology)

  2. Centre for Medicines Research, Carshalton, Surrey, UK

    Stuart R. Walker (Director, Honorary Professor of the Welsh School of Pharmacy) (Director, Honorary Professor of the Welsh School of Pharmacy)

Rights and permissions

Reprints and permissions

Copyright information

© 1988 Kluwer Academic Publishers

About this chapter

Cite this chapter

Rawlins, M.D. (1988). Monitoring for Drug Safety. In: Walker, B.C., Walker, S.R. (eds) Trends and Changes in Drug Research and Development. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-2659-2_4

Download citation

  • DOI: https://doi.org/10.1007/978-94-009-2659-2_4

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-0-85200-839-3

  • Online ISBN: 978-94-009-2659-2

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation