Skip to main content

Abstract

The term postmarketing surveillance should convey the meaning that the use of a drug after marketing is surveyed both for efficacy and safety; however, as the term is currently used, the emphasis is on safety rather than efficacy. One of the reasons for the lack of emphasis on efficacy has been the fact that the originating pharmaceutical company will organise the necessary studies to demonstrate the efficacy of their products.

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

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight 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

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Deitch, R. Adverse reactions to drugs. Lancet, 1980, 17 May, 1095

    Google Scholar 

  2. Harrow, D.W.G., Griffiths, K. and Shanks, R.G. Debendox and congenital malformations in Northern Irelarid. Br. Med. J., 1980, 281, 1274–1381

    Google Scholar 

  3. Anon. Pertussis vaccine. Br. Med. J., 1981, 22 (6276), 1563

    Google Scholar 

  4. Anon. Crying wolf on drug safety. Br. Med. J., 1982, 284 (6311), 219

    Article  Google Scholar 

  5. Anon. Hunting rare adverse drug reactions. Br. Med. J., 1981, 282, 342–343

    Google Scholar 

  6. Martys, C.R. Adverse reactions to drugs in general practice. Br. Med. J., 1979, 2, 1194–1197

    Article  CAS  Google Scholar 

  7. Gifford, L.M., Aeugle, M.E., Myerson, R.N. and Tannenbaum, P.J. Cimetidine postmarket surveillance program. J.A.M.A., 1980, 243 (15), 1532

    Article  CAS  PubMed  Google Scholar 

  8. Rawlins, M.D. and Dollery, C.T. Postmarketing surveillance of adverse reactions to new medicines. Medico-pharmaceutical Forum Publication No. 7, 1977

    Google Scholar 

  9. O’Neill, R. Appendix 1 of Reference 169

    Google Scholar 

  10. Boman, G. The nordic countries. In Momtoring for Drug Safety (ed. W. H. W. Inman), M. T. P., 1980

    Google Scholar 

  11. Liljestrand. In Drug Induced Sufferings: Medical, Pharmaceutical and Legal Aspects (ed. T. Soda), Excerpta Medica, Amsterdam, 1980, p.234

    Google Scholar 

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

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  13. Inman, W.H.W. and Vessey, M.P. Investigation of deaths from pulmonary coronary and cerebral thrombosis and embolisrn in women of childbearing age. Br. Med. J., 1968, 2, 193–199

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  14. Inman, W.H.W., Vessey, M.P., Westerholm, B. and Engelind, A. Thromboembolic disease and the steroidal content of oral contraceptives. Br. Med. J., 1970, 2, 203

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  15. Cahal, D.A. Adverse reactions to nalidixic acid. Lancet, 1965 ii, 441

    Article  Google Scholar 

  16. Wade, G.L. In Adverse Drug Reactions (ed. D.J. Richards and R.K. Rondel), Churchill Livingstone, 1972, p.52

    Google Scholar 

  17. Anon. How the yellow card system might be improved. Pharm. J., 1983, 6 Aug., 160

    Google Scholar 

  18. Griffin, J. P. Postmarketing surveillance of licensed medicinal and other products. Health Trends, 1981, 13, 87

    Google Scholar 

  19. Inman, W.H.W. and Rawson, N.S.B. Erythromycin estolate and jaundice. Br. Med. J., 1983, 286, 1954–1955

    Article  CAS  Google Scholar 

  20. Wiholm, B.E., Agenäs, I. and Boethius, G. Improving the evaluation of adverse drug reactions by use of drug utilisation and morbidity data. Proc. S. P. S., B. P. S., 5–6 July 1982, 596

    Google Scholar 

  21. Scrip, 1981, No.639, November, 1

    Google Scholar 

  22. Follath, F., Burkart, F. and Schweizer, W. Drug-induced pulmonary hypertension. Br. Med. J., 1971, 1, 265

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  23. Fraumeni, J.F. Bone marrow depression induced by chloramphenicol and phenylbutazone. J.A.M.A., 1967, 20 (1), 828

    Article  Google Scholar 

  24. Constant, K.W., Worlledge, S., Dollery, C.T. and Breckenridge, A. Methyl Dopa and haemolytic anaemia. Lancet, 1966, 22 January, 201

    Google Scholar 

  25. Rich, M.L., Rittehof, R.J. and Hoffmann, R.J. A fatal case of aplastic anaemia following chloramphenicol (chloromycetin) therapy. Ann. Intern. Med., 1950, 33, 1459–1467

    Article  CAS  PubMed  Google Scholar 

  26. Wright, P.E. Skin reaction to practolol. Br. Med. J., 1974, 2, 560

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  27. Dollery, C.T. and Rawlins, M.D. Monitoring adverse reactions to drugs. Br. Med. J., 1977, 1, 96–97

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  28. Lawson, D.H. and Henry, D.A. Monitoring adverse reactions to new drugs: restricted release or monitored release. Br. Med. J., 1977, 1, 691–692

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  29. Inman, W.H.W. Recorded release: a proposal for postmarketing surveillance of new drugs. Paper read at Symposium on Drug Control in General Practice, June 1977

    Google Scholar 

  30. Wilson, A.B. Postmarketing surveillance of adverse reactions to new medicines. Br. Med. J., 1977, 2, 1001–1003

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  31. Walden, R.J. and Prichard, B.N.C. Postmarketing drug surveillance. Br. J. Clin. Pharmacol., 1978, 6, 191–192

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  32. C.S.M. Suggestions for monitoring adverse drug reactions. Pharm. J., 1977, 9 July, 30–31

    Google Scholar 

  33. Anon. New strategies for drug monitoring. Br. Med. J., 1977, 1, 861

    Article  Google Scholar 

  34. Moir, D.C. Drug monitoring. Br. Med. J., 1981, 282, 632

    Article  CAS  Google Scholar 

  35. Skegg, D. C. G. Adverse reaction monitoring in the future. In Pharmaceutical Medicine (ed. N. McLeod), Churchill Livingstone

    Google Scholar 

  36. Lawson, D.H. Detection of drug-induced disease. Br. J. Clin. Pharmacol., 1979, 7, 13–18

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  37. Spriet--Pourra, C. Different approaches of postmarketing surveillance: their realism and interest. Curr. Ther. Res., 1979, 25 (2)

    Google Scholar 

  38. Inman, W. H. W. Recorded release. In Drug Monitoring (ed. F.H. Gross and W.H.W. Inman), Academic Press, 1977

    Google Scholar 

  39. Heaseman, M.A. and Lipworth, L. Accuracy of Certification of Cause of Death. Studies on Medical and Population Subjects, 1966, No. 20, H.M.S.O.

    Google Scholar 

  40. Rose, G. Bias. Br. J. Clin. Pharmacol., 1982, 13, 157–162

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  41. Finney, D.J. The design and logic of a monitor of drug use. J. Chron. Dis., 1965, 18, 77–98

    Article  CAS  PubMed  Google Scholar 

  42. Skegg, D. C. G. Medical Record Linkage. In Monitoring for Drug Safety (ed. W.H.W. Inman), M.T.P.

    Google Scholar 

  43. Ichänpään-Heikkila, J. Population monitoring: medical linkage for drug safety surveillance. In Drug Monitoring (ed. F.H. Gross and W.H.W. Inman), Academic Press, 1977

    Google Scholar 

  44. Miller, R.R. Comprehensive prospective drug surveillance — A report from the Boston Collaborative Drug Surveillance Program. Pharm. Weekbl.. 1974, 109, 461–481

    Google Scholar 

  45. Moir, D.C. Intensive monitoring in hospital, II: The AberdeenDundee System. In Monitoring for Drug Safety (ed. W.H.W. Inman), M.T.P.

    Google Scholar 

  46. Friedman, G.O., Collen, M. F., Harris, L. E., Van Brunt, E.E. and Davis, L.S. Experience in monitoring drug reactions in outpatients — The Kaiser-Permanente Drug Monitoring System. J.A.M.A., 1971, 217 (5), 567–572

    Article  CAS  PubMed  Google Scholar 

  47. Crombie, I.K. Dundee Record Linkage Study. In Monitoring for Adverse Drug Reactions (ed. S. Walker and A. Goldberg), M. T. P., 1984

    Google Scholar 

  48. Jones, J.K. Postmarketing surveillance. An FDA perspective presented at the annual Society for Clinical Pharmacology and Therapeutic Postgraduate Course, New Orleans, 1981

    Google Scholar 

  49. Title XIX’s Medicaid Management Information System as a Data Resource for Conducting Postmarketing Surveillance Studies and Evaluation of this Data Base for Drug Utilization Studies. Principal Investigators, L. Moise and A. Leroy. Health Information Design Inc. Contract Nos. 223–80–3026, 223–78–3018

    Google Scholar 

  50. Scrip. 1982, 24 February, 670

    Google Scholar 

  51. Tukey, J.W. Some thoughts on clinical trials, especially problems of multiplicity. Science, 1977, 198, 679–684

    Article  CAS  PubMed  Google Scholar 

  52. Anon. Benoxaprofen photosensitivity — a test for prescription monitoring. Lancet, 1982, 3 April, 811

    Google Scholar 

  53. Lawson, D.H. Postmarketing surveillance in U.K.: a study or cimetidine recipients. In Drug Safety and Controversies (ed. M. Auriche, J. Burk and J. Duchier, Pergamon Press, 1981

    Google Scholar 

  54. Colin-Jones, D.G., Langman, M.J.S., Lawson, D.H. and Vessey, M.P. Postmarketing surveillance. In Cimetidine in the 80s (ed. J.H. Baron), Churchill Livingstone, 1981

    Google Scholar 

  55. Colin-Jones, D.G., Langman, M.J.S., Lawson, D.H. and Vessey, M. P. Postmarketing surveillance of the safety of cimetidine. 12 monthly mortality report. Br. Med. J., 1983, 286, 1713–1716

    Article  CAS  Google Scholar 

  56. Drury, M. and. Hull, F.M. Prospective monitoring for adverse reactions to drugs in general practice. Br. Med. J., 1981, 283, 1305

    Article  CAS  Google Scholar 

  57. Horowitz, R. and Feinstein, A.R. The application of therapeutic trial principles to improve the design of epidemiological research — a case control study suggesting that anticoagulants reduce mortality in patients with myocardial infarction. J. Chron. Dis., 1981, 34, 575–581

    Article  Google Scholar 

  58. Mantel, N. and Haenzell, W. Statistical aspects of the analysis of data from retrospective studies of disease. J. Natl Cancer Inst., 1959, 22 (4), 719–748

    CAS  PubMed  Google Scholar 

  59. Sackett, D.L. Bias in analytical research. J. Chron. Dis., 1979, 32, 51–63

    Article  CAS  PubMed  Google Scholar 

  60. Smith, M.W. The case control or retrospective study: in retrospect. J. Clin. Pharmacol., 1981, 21, 269–274

    Article  CAS  PubMed  Google Scholar 

  61. Horowitz, R.I. and Feinstein, A.R. The problem of protopathic bias in case control studies. Am. J. Med., 1980, 68, 255–258

    Article  Google Scholar 

  62. Spriet-Pourra, C. Postmarketing surveillance by the drug industry. Discussion on postmarketing surveillance of drug effects organised by the Drug Surveillance Research Unit on behalf of the European Community, Southampton, 8–10 April, 1981

    Google Scholar 

  63. Pryor, J.P. and Castle, W.M. Peyronie’s disease associated with chronic degenerative arterial disease and not with betaadrenoceptor blocking agents. Lancet, 1982, 17 April, 917

    Google Scholar 

  64. Jick, H. Cohorts from data banks. In Drug Safety and Controversies (ed. M. Auriche, J. Burk and J. Duchier), Pergamon Press, 1981

    Google Scholar 

  65. Westlin, W.E., Cuddihy, R.V., Bursik, R.J., Seifert, B.G. and Koelle, J.G. One method for the systematic evaluation of adverse drug experience data within a pharmaceutical firm. Methods Inf. Med., 1977, 16 (4), 240–241

    CAS  PubMed  Google Scholar 

  66. Castle, W.M. Placing adverse reaction reports in perspective. In Proceedings 7th Annual Conference of A.I.O.P.I., 1980, pp. 48–50

    Google Scholar 

  67. Begaud, B., Pére, J.-C. and Dangoumau, J. Mise en oeuvre d’une critére. La bibliographie. Thérapie, 1981, 36, 233–236

    CAS  PubMed  Google Scholar 

  68. Sullman, S.F. A resumé of the pharmaceutical industry’s experience with monitored release. in Post-marketing Surveillance of Adverse Reactions to New Medicines. Medico-Pharmaceutical Forum, Publication No. 7, 1977

    Google Scholar 

  69. A.B.P.I. (Personal communication)

    Google Scholar 

  70. Rossi, A. C., Knapp, D.E., Anello, C., O’Neill, R. T., Grahan, C.F., Mendelis, P.S. and Stoinley, G.R. Discovery of adverse reactions. A comparison of selected Phase IV studies, with spontaneous reporting methods. J.A.M.A., 1983, 249, 2226–2228

    Article  CAS  PubMed  Google Scholar 

  71. Anello, C. The use, design and limitations of selected Phase IV studies in the USA. Droit et Pharmacie Essais Clinique Post Marketing, 1983, Vol. III

    Google Scholar 

  72. Perry-Evans, D. Monitoring adverse reactions to drugs. M.D. Thesis, University of London, 1976

    Google Scholar 

  73. Stephens, M.D.B. Monitoring for Adverse Drug Reactions. A Workshop under the Auspices of the UK Centre for Medicines Research, M.T.P., 1984

    Google Scholar 

  74. Code of practice for the clinical assessment of licensed medicinal products in general practice. Br. Med. J., 1983, 286, 1295–1297

    Google Scholar 

  75. Bruppacher, R. Dual purpose of inpatient drug monitoring by physicians in two teaching hospitals in Berne. In Computer Aid to Drug Therapy and Drug Monitoring, Chapter 6 (ed. Ducrot et al.), North-Holland, 1978

    Google Scholar 

  76. Venulet, J., Berneker, G. C. and Ciueei, A. (Eds). Assessing Causes of Adverse Drug Reaction, Academic Press, 1982

    Google Scholar 

  77. Loupi, E., Ponchon, A., Ventre, J.J., Descotes, S.J. and Evreux, J.–C1. La réadministration (rechallenge) est-elle necessaire a une imputabilité maximale? (Valeur comparée dans sept méthodes d’imputabilité) Cinquieme Journée Francaises de Pharmacovigilance, 1983

    Google Scholar 

  78. Hammond, K.R. and Joyce, C.K.B. Psychological influences on human judgement, especially of adverse reactions. In Drug Monitoring (ed. F.M. Gross and W.H.M. Inman), Academic Press, 1977, p.272

    Google Scholar 

  79. Stephens, M.D.B.Deliberate drug rechallenge. Hum. Toxicol., 1983, 2, 573–577

    Article  CAS  PubMed  Google Scholar 

  80. Klatskin, G. and Kimberg, D.V. Recurrent hepatitis attributable to halothane sensitization in an anaesthetist. New Engl. J. Med., 1969, 280 (10), 515–522

    Article  CAS  PubMed  Google Scholar 

  81. Douglas, J. G., Munro, J. F., Kitchin, A. H., Muir, A. L. and Proudfoot, A.T. Pulmonary hypertension and fenfluramine. Br. Med. J., 1981, 283, 881–883

    Article  CAS  Google Scholar 

  82. Mathison, D.A. and Stevenson, D.D. Hypersensitivity to non-steroidal anti-inflammatory drugs. Indications and methods for oral rechallenges. J. Allergy Clin. Immunol., 1979, 64 (6), 669–674

    Article  CAS  PubMed  Google Scholar 

  83. Baumelou, A. Les etudesde Phase IV en France: Analyse des differentes commissions de la direction de la pharmacie et du medicament. Essais Clinique Post-marketing Vol. III, Chapter 8, Droit et Pharmacie, Paris, Sept., 1983

    Google Scholar 

  84. Jones, J.K. Criteria for journal reports of suspected adverse drug reactions. Clin. Pharm., 1982, 1, 554–555

    CAS  PubMed  Google Scholar 

  85. Rogers, M.L. National abstracts: U.K. hospital pharmacists collaborative computerised database. In The Impact of Computer Technology on Drug Information (ed. P. Morrell and S.G. Johansson), North-Holland, 1982, pp.187–188

    Google Scholar 

  86. Simkins, M.A. A comparison of databases for retrieving references to the literature on drugs. Information Processing and Management, 1977, 13, 141–153 267. Anon. Adverse Drug Reactions Advisory Committee Report for 1978. Med. J. Aust., 1980, 1, 207–208

    Google Scholar 

  87. Moriey, D. CAIRS. In Minis, Micros and Terminals for Libraries and Information Services (ed. Gilchrist), Haydon, 1981, pp.78–89

    Google Scholar 

  88. Helling, M. Use of computers in drug monitoring. In Monitoring for Drug Safety (ed. W.H.W. Inman), 1980, M.T.P.. pp/141–164

    Google Scholar 

  89. Wright, P. and Haybittle, J. Design of forms for clinical trials (1). Br. Med. J., 1979, 2, 529–530

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  90. Idem, 1979, 2, 590–592

    Google Scholar 

  91. Idem, 1979, 2, 650–651

    Google Scholar 

  92. Rycroft, D. and; Smith, D.E. Provision of poisons and safety data. Aslib Proc., 1980, 32 (5), 235–240

    Article  Google Scholar 

  93. Ravenscroft, T. and Smith, D.E. The development of Clindata. A clinical trial data management system. J. Inf. Sci., 1981, 3, 129–136

    Article  Google Scholar 

  94. National Adverse Drug Reaction Directory COSTART (Coding Symbols for Thesaurus of Adverse Reaction Terms), US Dept of Health, Education and Welfare, F.D.A.

    Google Scholar 

  95. W. H.O. International Classification of Diseases. Manual of the International Statistics Classification of Diseases, Injuries and Causes of Death. Vol. 1 and Vol. 2, Alphabetical index, 9th revision (1975), HMSO, 1977

    Google Scholar 

  96. National Library of Medicine, Medical Subject Headings (MeSH). Annotated alphabetical Iist, 1984

    Google Scholar 

  97. Oxmis Problem Codes (ed. J. Perry), Oxmis Publications, Oxford, 1978

    Google Scholar 

  98. Perry, J. A primary care morbidity code based on the international classification of diseases. In Medical Data Processing (ed. M. Laudet, J. Anderson and F. Bregon), Taylor and Francis, 1976, pp.719–725

    Google Scholar 

  99. Cote, R.A. (ed.). Systematised Nomenclature of Medicine (SNOMED). Vol. I, 2nd edn, College of American Pathologists, 1979 (Numeric index)

    Google Scholar 

  100. Idem. Vol. II, 2nd edn, College of American Pathologists, 1979 (Alphabetic index)

    Google Scholar 

  101. Cote, R.A. and Robboy, S. Progress in medical information management. Systematised Nomenclature of Medicine (SNOMED). J.A.M.A., 1980, 243, 756–762

    Article  CAS  PubMed  Google Scholar 

  102. Anon. International monitoring of adverse reactions to drugs. Adverse reaction terminology 1980. Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

    Google Scholar 

  103. Monthly Index of Medical Specialties (MIMS). Haymarket PubIishing, London (published monthly)

    Google Scholar 

  104. British National Formulary, Number 6, 1983. Pharmaceutical Press, London (updated 6-monthly)

    Google Scholar 

  105. Dendy, P.R. Indexing Medicines for Monitoring Adverse Reactions. Oxford Drug Monitoring Conference — Workshop on Drug Information System, 1977. Oxford Community Health Project, A1–A4

    Google Scholar 

  106. Dunleavy, J. and Perry, J. Appendix B. Oxmis problem codes and drug codes. Idem, B24–B25

    Google Scholar 

Download references

Authors

Copyright information

© 1985 M.D.B. Stephens

About this chapter

Cite this chapter

Stephens, M.D.B. (1985). Postmarketing Surveillance (PMS). In: The Detection of New Adverse Drug Reactions. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-07250-7_5

Download citation

Publish with us

Policies and ethics