Abstract
Since the thalidomide disaster the momentum of post-marketing surveillance has increased in an exponential way and in recent years there have been many symposia and books devoted to the subject. This chapter hopes to outline the problems involved and give reference to the most important sources of information.
Preview
Unable to display preview. Download preview PDF.
References
Deitch, R. Adverse reactions to drugs. Lancet, 1980, May 17, 1095
Harrow, D.W.G., Griffiths, K. and Shanks, R.G. Debendox and congenital malformations in Northern Ireland. Br. Med. J., 1980, 281, 1274–1381
Anon. Pertussis vaccine. Br. Med. J., 1981, 282, 1563
Anon. Crying wolf on drug safety. Br. Med. J., 1982, 284, 219
Anon. Hunting rare adverse drug reactions. Br. Med. J., 1981, 282, 342–343
Martys, C.R. Adverse reactions to drugs in general practice. Br. Med. J., 1979, 2, 1194–1197
Gifford, L.M., Aeugle, M.E., Myerson, R.N. and Tannenbaum, P.J. Cimetidine postmarket outpatient surveillance program. J.A.M.A., 1980, 243(15), 1532
Rawlins, M.D. and Dollery, C.T. Postmarketing surveillance of adverse reactions to new medicines. Medico-pharmaceutical Forum Publication No. 7, 1977, 40
Boman, G. The nordic countries. In Monitoring for Drug Safety (ed. W.H.W. Inman), MTP, 1980
Liljestrand. In Drug Induced Sufferings: Medical, Pharmaceutical and Legal Aspects (ed. T. Soda), Excerpta Medica, Amsterdam, 1980, p. 234
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)
Griffin, J.P. Postmarketing surveillance of licensed medicinal and other products. Health Trends, 1981, 13, 87
Inman, W.H.W. and Vessey, M.P. Investigation of deaths from pulmonary, coronary and cerebral thrombosis and embolism in women of childbearing age. Br. Med. J., 1968, 2, 193–199
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
Cahal, D.A. Adverse reactions to nalidixic acid. Lancet, 1965, i, 441
Wade. G.L. In Adverse Drug Reactions (ed. D.J. Richards and R.K. Rondel), Churchill Livingstone, Edinburgh, 1972, p. 52
Anon. How the yellow card system might be improved. Pharm. J., 1983, 231, 6 Aug, 160
Inman, W.H.W. and Rawson, N.S.B., Erythromycin estolate and jaundice, Br. Med. J., 1983, 286, 1954–1955
Venning, G.R., Identification of adverse reactions to new drugs: 1. What have been the important adverse reactions since thalidomide? Br. Med. J., 1983, 286, 199–202
Venning, G.R. Identification of adverse reactions to new drugs: 2. How were 18 important adverse reactions discovered and with what delays? Br. Med. J., 1983, 286, 289–292, 365–368
Venning, G.R., Identification of adverse reactions to new drugs: 3. Alerting processes and early warning systems. Br. Med. J., 1983, 286, 458–460
Venning, G.R. Identification of adverse reactions to new drugs: 4. Verification of suspected adverse reactions. Br. Med. J., 1983, 286, 544–547
Lasagna, L. Techniques for ADR reporting. In Detection and Prevention of Adverse Drug Reaction (ed. H. Boström and N. Ljungstedt), Almqvist and Wiksell, Stockholm
Venning, G.R., Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms. Br. Med. J., 1982, 284, 249–252
Strandberg, K. Experience from the WHO collaborating centre for international drug monitoring. Drug Inf. J., 1985, 19, 385–390
McEwen, J. and Vhrovac, C.B., Panel on management of ADR reports in selected national centres. Drug. Inf. J., 1985, 19, 329–344
Griffin, J.P. and Weber, J.C.P., Voluntary systems of adverse reaction reporting Part II. Adv. Drug React. Ac. Pois. Rev., 1986, 1, 23–55
Griffin, J.P., Survey of the spontaneous ADR reporting schemes in 15 countries. Br. J. Clin. Pharmac., 1986, 22, 83S–100S
Dukes, M.N.G. and Lunde, I., Common sense and communities. Pharm. Week bld., 1979, 144, 1283–1284
Moore, N., Paux, G., Bégaud, B., Biour, M., Loupi, E., Boismare, F. and Royer, R.J. Adverse drug reaction monitoring — doing it the French way. Lancet, 1985, No. 9, 1056–1058
Laporte, J-R., Developing national systems. Spain as a model. Drug Inf. J., 1985, 19, 351–355
Laporte, J-R. Spain. In Monitoring for Drug Safety, 2nd edition, 1986, pp. 143–153
Poggiolini, D. Pharmaceutical Regulating Activities in Italy, EIS, Gladbach, W. Germany
Scrip., July 1983
Moussa, M.A.A., Bayoumi, A., Al-Khars, A.A. and Thulesius, O. Adverse drug reaction monitoring in Kuwait (1981–84). J. Clin. Pharmacol., 1985, 25, 176–181
Gartmann, J., Die Tätigkeit der Schweizerischen Arzneimittel-Nebenwirkungs-Zentrale (SANZ). Ther. Umschau, 1982, 39(11), 928–933
Ott, H., Qu’est-ce que le CSPV et comment fonctionne-t-il: notions juridiques. Bull. des médicines Suisses, 1981, 62, 18, 1326
Scrip, no. 516, 20 Aug, 1980, 8
Griffin, J.P. and Weber, J.C.P., Voluntary systems of adverse reaction reporting Part I. Adv. Drug React. Ac. Pois. Rev., 1985, 4, 213–230
Crombie, I., Inherent limitations of the yellow card system for the detection of unsuspected ADR. Human Toxicology, 1984, 3, 261–269
Beeley, L., Elliott, D. and Griffiths, K. Patterns in spontaneous reports sent to a regional ADR reporting centre. Acta Pharm. Toxicol, 1986, suppl. V. Abstract, 423, p. 159
Milstien, J.B., Faich, G.A., Hsu, J.P., Knapp, D.E., Baum, C. and Dreis, M.W. Factors affecting physician reporting of ADR. Drug. Inf. J., 1986, 20, 157–164
Faich, G.A., Special report ADR monitoring. N. Engl. J. Med., 1986, 314(24), 1589–1592
Anello, C., Scrip. No. 1146, Oct. 15, 1986, p. 16
Scrip. no. 1141, 29 Sep, 1986, 16
Follath, F., Burkart, F. and Schweizer, W. Drug-induced pulmonary hypertension. Br. Med. J., 1971, 1, 265
Fraumeni, J.F., Bone marrow depression induced by chloramphenicol and phenylbutazone, J.A.M.A., 1967, 20(1), 828
Constant, K.W., Worlledge, S., Dollery, C.T. and Breckenridge, A. Methyl Dopa and haemolytic anaemia, Lancet, 1966, 1, 22 Jan, 201.
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
Wright, P.E. Skin reaction to practolol, Br. Med. J., 1974, 2, 560
Laganière, S. and Biron, P. Clinical Trials: Incomplete reporting of side effects, Curr. Ther. Res., 1979, 25(6), 743–746
Albin, H., Bégaud, B., Boisseau, A. and Dangoumau, J. Validation des publications d’effets indésirables par une méthode d’imputatilité. Thérapie, 1980, 35(5), 571–576
Péré, J.-C., Bégaud, B., Albin, W. and Dangoumau, J., Effets indésirables non-descrits de l’observation aux données de la literature. Thérapie, 1981, 31, 237–240
Bégaud, B., Péré, J.-C. and Dangoumau, J. Mise en oeuvre d’un critère, la bibliographie. Thérapie, 1981, 36, 233–236
Venulet, J., Blattner, R., Von Bülow, J. and Bernecker, G.C. How good are articles on ADR? Br. Med. J., 1982, 284, 252–254
O’Connor, P.C., McCabe, J. and Lawson, D.H., Report of ADR in general medical journals, Irish J. Med. Sci., 1982, 151, 184–187
Joyce, C.R.B. and Joyce, J. Pyramidal publication. Eur. J. Clin. Pharmacol., 1983, 25, 1–2
Davies, D.M. Special report. Adv. Drug. React. Ac. Pois. Rev., 1984, 3(4), 249–250
Venulet, J., Informativity of ADR data in medical publications. Drug Inf. J., 1985, 19, 357–365
Haramburu, F., Bégaud, B., Péré, J.C., Marcel, S. and Albin, H. Role of medical journals in ADR alerts, Lancet, 7 Sep, 1985, 2, 550–551
Rossi, A.C. and Knapp, D.E. Discovery of new ADR. A review of the FDA spontaneous reporting system, J.A.M.A., Aug 24/31, 1984, 252(8), 1030–1033
Dollery, C.T. and Rawlins, M.D., Monitoring adverse reactions to drugs. Br. Med. J., 1977, 1, 96–97
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
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
Wilson, A.B. Postmarketing surveillance of adverse reactions to new medicines, Br. Med. J., 1977, 2, 1001–1003
Waiden, R.J. and Prichard, B.N.C. Postmarketing drug surveillance, Br. J. Clin Pharmacol., 1978, 6, 191–192
C.S.M., Suggestions for monitoring adverse drug reactions. Pharm. J., 1977, 219, 9 July, 30–31
Smithells, R.N., The Liverpool Congenital Abnormality Registry. Develop. Med. Child Neurolog., 1962, 4, 320
Smithells, R.N., Drug teratogenicity. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, pp. 383–390, 1986
Keeling, D.H. Radio pharmaceuticals. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, 1986, pp. 347–356
Banes, S.B. and Turner, P. Ophthalmic opticians and ocular ADR. Pharmaceutical Med., 1985, 1, 97–98
Scrip, no. 1122, 23 July 1986, 25
Fries, J.F. The ARAMIS (American rheumatism association medical information system) PMS program, Drug Inf. J., 1985, 19, 257–262
Fraunfelder, F.T., National registry of drug-induced ocular side effects. In Monitoring for Drug Safety (ed. W.H.N. Inman), 2nd edition, 1986
Postmarketing surveillance of prescription drugs, Office of Technology assessment, No. 1982, p. 42. Library of Congress Catalog Card No. 82–600 652
Jones, J.K., Faich, G.A. and Anello, C. The United States of America. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, p. 157
Edlavitch, S.A., Feinleib, M. and Anello C. A potential use of the national death index for postmarketing surveillance, J.A.M.A., 1985, 253, 1292–1295
Wiholm, B.E. Spontaneous reporting of ADR. Cross-fertilisation with register data on morbidity and drug utilisation. In Detection and Prevention of ADR (ed. H. Boström and N.L. Jungstedt), Almqvist and Wiksell, Stockholm, pp. 152–167
Idänpään Heikkilä, J. Finland. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, 1986, pp. 83–92
Grohmann, R., Hippius, H., Müller-Oerlinghausen, B., Ruther, E. Scherer, J., Schmidt, L.G., Strauss, A. and Wolf, B., Assessment of adverse drug reactions in psychiatric hospitals, Eur. J. Clin. Pharmacol., 1984, 26, 727–734
Bruinsma W. A Guide to Drug Eruptions, 4th edition, De Zwaluw, P.O. Box 21, Oosthuizen, The Netherlands, 1986
Lawson, D.H., Intensive monitoring studies in hospitals. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), M.T.P. Press, 1986, pp. 255–276
Jick, H., Boston collaborative drug surveillance program. In Monitoring for ADR, (ed. S.R. Walker and A. Goldberg), MTP Press, 1984
Miller, R.R., Comprehensive prospective drug surveillance, a report from the BCDSP. Pharmaceutisch Weekblad., 1973, 109(20), 461–481
Cohen, M.R. A compilation of abstracts and an index of articles published by the BCDSP. Hospital Pharm., 1974, 9, 437–448
Porter, J.B., Beard, M., Walker, A.M., Lawson, D.H., Jick, H. and Kellaway, G.S.M. Intensive hospital monitoring study of intravenous Cimetidine. Arch. Intern. Med., 1986, 146, 2237–2239
Moir, D.C. Intensive monitoring in hospitals, The Aberdeen-Dundee System. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, 1986, pp. 277–291
Friedman, G.D., Screening criteria for drug monitoring. The Kaiser-Permanente drug reaction monitoring sytem. J. Chron. Dis., 1972, 25, 11–20
Friedman, G.D., 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
Jones, J.K. Postmarketing surveillance. An FDA perspective presented at the annual Society for Clinical Pharmacology and Therapeutics Postgraduate course, New Orleans, 1981
Jick, H., Madsen, S., Nudelman, P.M., Perera, D.R. and Stergachis, A. Postmarketing follow-up of Group Health co-operative of Puget Sound. Pharmacotherapy, 1984, 4(2), 99–100
Morse, M.L., Le Roy, A.A. and Strom, B.L. The Computerised On-line Medicaid Pharmaceutical Analysis and Surveillance System (COMPASS). In Monitoring for Drug Safety (ed. W.H. Inman), 2nd edition, MTP Press, 1986
Morse, M.L., The COMPASS data base, Drug Inf. J., 1985, 19(3), 249–253
Carson, J.L. COMPASS data base. An epidemiologist’s viewpoint. Proceedings of the 20th annual meeting of Drug Information Association, pp. 97–100, 1984
Carson, J.L. and Strom, B.L., Technique of postmarketing surveillance. An overview. Medical Toxicology, 1986, 1, 237–246
Strom, B.L., Carson, J.L., Morse, M.L. and Leroy, A.A., The computerised on-line Medicaid pharmaceutical analysis and surveillance system. A new resource for postmarketing drug surveillance. Clin. Pharmacol. Ther., 1985, 38(4), 350–364
Faich, G.A., Postmarketing surveillance of prescription drugs. Current status, 1986, Clinical Real Life Studies Program, Clinical Medicine Research Institute, 800 Second Ave, New York
Federspiel, C.F., Wayne, R.A. and Schaffner, W. Medicaid records as a valid data source: The Tennessee experience. Medical Care, 1976, 14, 166–172
Finkle, W.D. Studies of drug effects within the Kaiser Foundation Health Plan, Southern California region. Drug Inf. J., 1985, 19, 243–247
Stewart, R.B., Hale, W.E. and Marks, R.G. Drug use and ADR in an ambulatory elderly population: a review of the Dunedin program, Pharm. Int., 1984, pp. 149–152
Strand, L.M., Drug epidemiology resources and studies: The Saskatchewan data base, Drug Inf. J., 1985, 19, 253–256
Guess, H.A., West, R., Strand, L.M., Heiston, D., Lydick, E.G., Bergman, U. and Wolski, K.P. Fatal gastro-intestinal bleeding amongst users and non-users of non-steroidal anti-inflammatory drugs (NSAID) in Saskatchewan, Canada 1983. J. Clin. Epidemiol., 1988, 41, 35–45
Crombie, I.K., Dundee record linkage study. In Monitoring for ADR (ed. S. Walker and A. Goldberg), MTP Press, 1984
Crombie, I.K., Brown, S.V. and Hamley, J.G., Postmarketing drug surveillance by record linkage in Tayside, J. Epidemiology and Community Health, 1984, 38, 226–231
Beardon, P.H.G., Brown, S.V. and McDevitt, D.G., Postmarketing surveillance by record linkage in Tayside. Follow-up morbidity study of Cimetidine. Acta Pharm. Toxicol., 1986, suppl. V. Abstract 414, p. 157
Crombie, I.K. The role of record linkage in postmarketing surveillance. Br. J. Clin. Pharmacol., 1986, 22, 775–825
Lawson, D.H., Postmarketing surveillance in the UK 1984, Br. J. Clin. Pharmacol., 1986, 22, 71S–75S
McDevitt, D.G., Bearden, P.H.G. and Brown, S.V. Mortality amongst Cimetidine takers: results of a long-term follow-up study using record linkage. Acta Pharm. Toxicol., 1986, suppl. Abstract 415, 157
Skegg, D.C.G., Medical record linkage. In Monitoring for Drug Safety, 1st edition (ed. W.H.W. Inman), MTP Press
Sjöquist, F. and Boethius, G. Attitude to development of drug therapy in Scandinavia. Br. J. Clin. Pharmacol., 1986, 22, 19S–26S
Inman, W.H.W., Rawson, N.S.B. and Wilton, L.V. Prescription Event Monitoring. In Monitoring for Drug Safety, 2nd edition (ed. W.H. Inman), MTP Press, 1986
Inman, W.H.W., Postmarketing surveillance of adverse drug reaction in general practice (i) Search for new methods, Br. Med. J., 1981, 282, 1131–1132
Inman, W.H.W. Postmarketing surveillance of adverse drug reaction in general practice (ii) PEM at the University of Southampton, Br. Med. J., 1981, 282, 1216–1217
Drug Surveillance Research Unit: PEM News, vol. 1 1983; PEM News, vol. 2 1984; PEM News, vol. 3 1985; PEM News, vol. 4 1987; Hamble Valley Press, Southampton
Rawlins, M.D., Postmarketing surveillance of adverse reactions to drugs, Br. Med. J., 1984, 288, 879–880
Lawson, D.H., Postmarketing surveillance in UK: a study of Cimetidine recipients. In Drug Safety and Controversies (ed. M. Auriche, J. Burke and J. Duchier), Pergamon Press, 1981
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
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
An experiment in early PMS of new drugs, prepared for the FDA, 24 Oct 1978, IMS America Ltd, Ambler, PA., pp. 214–231
Oral Contraceptives and Health, The Royal College of General Practitioners, 1974, Pitman
Scrip, no. 1158, 26 Nov 1986, 26
The Guardian, 28 Nov 1984
Horwitz, R.I. 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
Mantel, N. and Haenszell, W. Statistical aspects of the analysis of data from retrospective studies of disease, J. Natl. Cancer Inst., 1959, 22, (4), 719–748
Sackett, D.L. Bias in analytical research. J. Chron. Dis., 1979, 32, 51–63
Smith, M.W. The case control or retrospective study: in retrospect. J. Clin. Pharmacol., 1981, 21, 269–274
Horwitz, R.I. and Feinstein, A.R. The problem of protopathic bias in case control studies. Am. J. Med., 1980, 68, 255–258
Vessey, M.P. Case-control studies in the assessment of drug safety. Acta Med. Scand., 1984, suppl. 683, 29–33
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
Pryor, J.P. and Castle, W.M. Peyronie’s disease associated with chronic degenerative arterial disease and not with beta-adrenoceptor blocking agents. Lancet, 1982, 1, 17 April, 917
The International Study of Agranulocytosis and Aplastic Anaemia 1983. The design of a study of the drug aetiology of agranulocytosis and aplastic anaemia. Eur. J. Clin. Pharmacol., 1983, 12, 653–658
The International Agranulocytosis and Aplastic Anaemia study. Risks of agranulocytosis and aplastic anaemia. A first report of their relation to drug use with special reference to analgesics, J.A.M.A. 3rd Oct 1986, 256, 13, 1749–1757
Scrip, no. 1128, 13 Aug 1986, p. 22
Rosenberg, L. Postmarketing surveillance. The approach of the drug epidemiology unit. Drug Inf. J., 1985, 19, 263–268
Westlin, W.F., 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), 240–247
Castle, W.M. Placing adverse reaction reports in perspective. In Proceedings 7th Annual conference of AIOPI, 1980, pp. 48–50
Bégaud, B., Péré, J-C. and Dangoumau, J., Mise en oeuvre d’une critère la bibliographie, Thérapie, 1981, 36, 233–236
Sills, J.M., Faich, G.A., Milstien, J.B. and Turner, W.M. Postmarketing reporting of ADR to the FDA. An overview of the 1985 FDA guideline, Drug Inf. J., 1986, 20, 151–156
Trombitas, I.D. and Simpson, R.L. Monitoring the world’s published literature for adverse drug experience. Drug Inf. J., 1986, 20, 57–62
Venulet, J., Informativity of ADR data in medical publications. Drug Inf. J., 1985, 19, 357–365
Scrip. No. 1012, 1st July 1985, p. 6
Sullman, S.F. A resumé of the pharmaceutical industry’s experience with monitored release. In Postmarketing surveillance of adverse reactions to new medicines. Medico-Pharmaceutical Forum, Publication No. 7, 1977
Stephens, M.D.B. The detection of new adverse drug reactions, 1st edition, Macmillan Press, p. 116
Fauchald, P., Helgeland, A. and Storm-Mathison. Treatment of hypertension with prazosin. An open study in general practice. Proceedings of the European Prazosin Symposium, 1978, Excerpta Medica
Rossi, A-C., Knapp, D.E., Anello, C., O’Neill, R.T., Graham, C.F., Mendelis, P.S. and Stanley, G.R. Discovery of adverse drug reactions. A comparison of selected Phase IV studies with spontaneous reporting methods, J.A.M.A., 1983, 249, 2226–2228
Anello, C. The use, design and limitations of selected Phase IV studies in the USA. Droit et Pharmacie Essais Cliniques Postmarketing, 1983, Editions de Santé
Perry-Evans, D. Monitoring adverse reactions to drugs, M.D. Thesis, University of London 1976
Stephens, M.D.B. Comprehensive drug surveillance. Pharmaceutical company viewpoint. In Monitoring for Adverse Drug Reactions (ed. S.R. Walker and A. Goldberg) MTP Press, 1983
Borden, E.K. Postmarketing drug surveillance, J.A.M.A., 1984, 251(6), 729–730
Rogers, A. and Tilson, H. Postmarketing surveillance. The Sponsor’s viewpoint. Proceedings of the DIA Meeting, June 1984, San Diego, pp. 101–105
Tilson, H., Methodologic issues in postmarketing surveillance. Pharmaceutical industry’s view — Burroughs Wellcome. Drug Inf. J., 1985, 19, 275–283
Scrip. No. 951, 21 Nov 1984, p. 15
Borden, E.K. and Lee, J.G. A methodologic study of postmarketing drug evaluation using a pharmacy based approach. J. Chron. Dis, 1982, 35, 803–816
Luscombe, F.A., Methodologic issues in Pharmacy based PMS. Drug Inf. J., 1985, 19, 269–274
Borden, E.K., Gardner, J.S., Westland, M. and Gardner, S.D., Postmarketing surveillance, J.A.MA., 10 Feb 1984, 251(6), 729
Linden, C.V. and Barry, W.S., Drug experience reporting in a US based multinational corporation. Acta Pharm. Toxicol., 1986, suppl. V: III World Conference on Clinical Pharmacology and Therapeutics 1986, Abstract 425, 159
Wallander, A.M-A. and Palmer, L.S. A monitoring system for adverse drug experience in a Pharmaceutical company — the integration of pre and postmarketing data. Drug Inf. J., 1986, 20, 225–235
Colin-Jones, D.G., Langman, M.J.S., Lawson, D.H. and Vessey, M.P. PMS of the safety of Cimetidine: twelve-month morbidity report. Quarterly J. Med., 1985, New Series 54, 215, 253–268
Colin-Jones, D.G., Langman, M.J.S., Lawson, D.H. and Vessey, M.P. PMS of the safety of Cimetidine morbidity during 2, 3 and 4th years of follow-up. Br. Med. J., 1985, 291, 1084–1088
Colin-Jones, D.G., Langman, M.J.S., Lawson, D.H. and Vessey, M.P. Cimetidine and gastric cancer: preliminary report from PMS study. Br. Med. J., 1982, 285, 1311–1313
Davis, T.G., Pickett, D.L. and Schlosser, J.M. Evaluation of a worldwide spontaneous reporting system with Cimetidine. J.A.M.A., 1980, 243(19), 1912–1914
Gifford, L.M., Aeugle, M.E., Myerson, R.M., Tannenbaum, P.J. Cimetidine postmarket outpatient surveillance program. J.A.M.A., 1980, 243(15), 1532–1535
McDevitt, D.G., Beardon, P.H.G. and Brown, S.V. Mortality amongst Cimetidine takers: results of a long term follow-up study using record linkage. Acta Pharm. Toxicol., 1986, suppl. V. Abstracts 414 and 415
Sneader, W. In Drug Development from Laboratory to Clinic, Wiley, 1986
Lawson, D.H., Chalmers, D. and Dombey, S. PMS of Captopril for hypertension, Abstract 730, Acta Pharm. Toxicol., 1986, suppl. V. Abstract 730, p. 156
Chalmers, D. A PMS study of Captopril utilising viewdata technology, Abstract. International symposium evaluation of the risk benefit profile in the PMS of the drug, Bergamo, Italy, Oct. 1985
Maclay, W.P., Crowder, D., Spiro, S. and Turner, P. PMS practical experience with Ketotifen. Br. Med. J., 1984, 288, 911–914
Maclay, W.P., Chapter 2.4: Cohort or case approach to validation of ADRs. In Monitoring for ADR (ed. S.R. Walker and A. Goldberg), MTP Press Ltd, 1984, pp. 69–72
Goldsmith, D.I., Yen, C.C. and Greenberg, B.P. A comprehensive system for international pharmaceutical company monitoring of ADR. Drug Inf. J., 1986, 20, 305–310
Copyright information
© 1988 M.D.B. Stephens
About this chapter
Cite this chapter
Stephens, M.D.B. (1988). Post-marketing Surveillance (PMS). In: The Detection of New Adverse Drug Reactions. Palgrave, London. https://doi.org/10.1007/978-1-349-09887-3_6
Download citation
DOI: https://doi.org/10.1007/978-1-349-09887-3_6
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-09889-7
Online ISBN: 978-1-349-09887-3
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)