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November 23, 1979, Vol 242, No. 21 >
ARTICLE | November 23, 1979

Postmarketing Follow-up FREE

Hershel Jick, MD; Alexander M. Walker, MD, MPH; Claude Spriet-Pourra, MD
[+] Author Affiliations

Reprint requests to Boston Collaborative Drug Surveillance Program, 400 Totten Pond Rd, Waltham, MA 02154 (Dr Jick).


JAMA. 1979;242(21):2310-2314. doi:10.1001/jama.1979.03300210036019
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References

THERE is a general but strongly held view that, after drugs are marketed, additional epidemiologic information is needed on their clinical effects, particularly adverse effects. This notion is based soundly on the limited size and scope of the clinical experience with a drug before marketing. Recently, considerable interest has been evident in this area and has focused on the term "postmarketing surveillance" (PMS). That the interest is widespread and intense is reflected in the many meetings that have taken place, articles that have been written, and committees that have been formed to consider the designing of large formal systems of PMS.1-15 Given the diffuse nature of the subject, it is essential to take an objective and informed look at the legitimate needs in this area and to consider practical means of satisfying these needs. Without a clear understanding of the nature of the problems that can be addressed epidemiologically

REFERENCES

1 +
 Toward a more rational regulation of the development of new medicines . Eur J Clin Pharmacol 11:233-238, 1977;.
2 +
Gross FH, Inman WHW:  Drug Monitoring . Proceedings of an international workshop, Honolulu, Jan 24-28, 1977 . London, Academic Press Inc, 1977;.
3 +
Post-Marketing Surveillance of Adverse Reactions to New Medicines . Medico-Pharmaceutical Forum publication No. 7, report of a meeting held on Dec 7, 1977. London, Medico-Pharmaceutical Forum, 1977;.
4 +
Harris EL:  Surveillance des médicaments mis sur le marché: Distribution contrôlée , in Contrôle des Médicaments: Évaluation Clinique . Symposium organisé par le Bureau Régional de l'Europe de l'OMS, Heidelberg, Germany, Sept 24-27, 1973. OMS, Copenhagen, Bureau régional de l'Europe, 1975;.
5 +
 The proposed US drug and devices administration . Int Drug Therapy Newsletter 11:13-16, 1976;.
6 +
 Towards better prescribing . Lancet 1:1249-1250, 1976;.
7 +
Walden RJ, Prichard BNC:  Post-marketing drug surveillance . Br J Clin Pharmacol 6:191-192, 1978;.
8 +
Dollery CT, Rawlins MD:  Monitoring adverse reactions to drugs . Br Med J 1:96-97, 1977;.
9 +
Remington RD: Post-marketing surveillance: A comparison of methods . The Center for the Study of Drug Development, publications series 7811-1-17, New York, University of Rochester (NY), 1978;.
10 +
Lawson DH, Henry DA:  Monitoring adverse reactions to new drugs: "Restricted release" or "monitored release." Br Med J 1:691-692, 1977;.
11 +
Wilson AB:  Post-marketing surveillance of adverse reactions to new medicines . Br Med J 2:1001-1003, 1977;.
12 +
Jick H:  The discovery of drug-induced illness . N Engl J Med 296:481-485, 1977;.
13 +
 Intensified adverse drug reaction reporting scheme . NZ Med J 85:157-158, 1977;.
14 +
Howie JGR:  Drug monitoring and adverse reactions . Br Med J 1:1467, 1977;.
15 +
Drury M:  Monitoring adverse reactions to drugs . Br Med J 1:439, 1977;.
16 +
Brown P, Baddeley H, Read AE, et al:  Sclerosing peritonitis, an unusual reaction to a β-adrenergic-blocking drug (practolol) . Lancet 2:1477-1481, 1974;.
17 +
Oakley GP Jr:  The neurotoxicity of the halogenated hydroxyquinolines . JAMA 225:395-397, 1973;.
18 +
Ziel HK, Finkle WD:  Increased risk of endometrial carcinoma among users of conjugated estrogens . N Engl J Med 293:1167-1170, 1975;.
19 +
Smith DC, Prentice R, Thompson DJ, et al:  Association of exogenous estrogen and endometrial carcinoma . N Engl J Med 293:1164-1167, 1975;.
20 +
Jick H, Miettinen OS, Shapiro S, et al:  Comprehensive drug surveillance . JAMA 213:1455-1460, 1970;.
21 +
Jick H, Slone D, Borda IT, et al:  Efficacy and toxicity of heparin in relation to age and sex . N Engl J Med 279:284-286, 1968;.
22 +
 Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours, Boston Collaborative Drug Surveillance Program . Lancet 1:1399-1404, 1973;.
23 +
Wood AJJ, Moir DC, Campbell C, et al:  Medicines evaluation and monitoring group: Central nervous system effects of pentazocine . Br Med J 1:305-307, 1974;.
24 +
Paddock R, Beer EG, Bellville JW, et al:  Analgesic and side effects of pentazocine and morphine in a large population of post-operative patients . Clin Pharmacol Ther 10:355-365, 1969;.
25 +
Koch-Weser J, Sidel VW, Dexter M, et al:  Adverse reactions to sulfisoxazole, sulfamethoxazole, and nitrofurantoin . Arch Intern Med 128:399-404, 1971;.
26 +
Koch-Weser J, Sidel VW, Federman EB, et al:  Adverse effects of sodium colistimethate: Manifestations and specific reaction rates during 317 courses of therapy . Ann Intern Med 72:857-868, 1970;.
27 +
Bottiger LE, Westerholm B:  Drug induced blood dyscrasias in Sweden . Br Med J 3:339, 1973;.
28 +
Bottiger LE, Strandberg I, Westerholm B:  Drug induced febrile mucocutaneous syndrome . Acta Med Scand 198:22, 1975;.
29 +
Porter J, Jick H:  Drug-induced anaphylaxis, convulsions, deafness, and extrapyramidal symptoms . Lancet 1:587-588, 1977;.
30 +
Jick H, Herman R:  Oral-contraceptiveinduced benign liver tumors—the magnitude of the problem . JAMA 240:828-829, 1978;.
31 +
Jick H, Dinan B, Herman R, et al:  Myocardial infarction and other vascular diseases in young women . JAMA 240:2548-2552, 1978;.
32 +
Jick H, Watkins RN, Hunter JR, et al:  Replacement estrogens and endometrial cancer . N Engl J Med 300:218-222, 1979;.
33 +
Skegg DCG (1978):  Use of record linkage for drug surveillance , in Ducrot H, Goldberg M, Hoigne R (eds): Computer Aid to Drug Therapy and to Drug Monitoring . Amsterdam, North-Holland Publishing Co, 1978;, pp 77-83.
34 +
Skegg DCG, Richards SM, Doll R:  Minor tranquillisers and road accidents . Br Med J 1:917-919, 1979;.
35 +
Goldacre MJ, Clarke JA, Heasman MA, et al:  Follow-up of vasectomy using medical record linkage . Am J Epidemiol 108:176-180, 1978;.
36 +
 Royal College of General Practitioners' Oral Contraception Study: Mortality among oral-contraceptive users . Lancet 2:727-731, 1977;.
37 +
Vessey MP, McPherson K, Johnson B:  Mortality among women participating in the Oxford-Family Planning Association Contraceptive Study . Lancet 2:731-733, 1977;.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
 Toward a more rational regulation of the development of new medicines . Eur J Clin Pharmacol 11:233-238, 1977;.
2 +
Gross FH, Inman WHW:  Drug Monitoring . Proceedings of an international workshop, Honolulu, Jan 24-28, 1977 . London, Academic Press Inc, 1977;.
3 +
Post-Marketing Surveillance of Adverse Reactions to New Medicines . Medico-Pharmaceutical Forum publication No. 7, report of a meeting held on Dec 7, 1977. London, Medico-Pharmaceutical Forum, 1977;.
4 +
Harris EL:  Surveillance des médicaments mis sur le marché: Distribution contrôlée , in Contrôle des Médicaments: Évaluation Clinique . Symposium organisé par le Bureau Régional de l'Europe de l'OMS, Heidelberg, Germany, Sept 24-27, 1973. OMS, Copenhagen, Bureau régional de l'Europe, 1975;.
5 +
 The proposed US drug and devices administration . Int Drug Therapy Newsletter 11:13-16, 1976;.
6 +
 Towards better prescribing . Lancet 1:1249-1250, 1976;.
7 +
Walden RJ, Prichard BNC:  Post-marketing drug surveillance . Br J Clin Pharmacol 6:191-192, 1978;.
8 +
Dollery CT, Rawlins MD:  Monitoring adverse reactions to drugs . Br Med J 1:96-97, 1977;.
9 +
Remington RD: Post-marketing surveillance: A comparison of methods . The Center for the Study of Drug Development, publications series 7811-1-17, New York, University of Rochester (NY), 1978;.
10 +
Lawson DH, Henry DA:  Monitoring adverse reactions to new drugs: "Restricted release" or "monitored release." Br Med J 1:691-692, 1977;.
11 +
Wilson AB:  Post-marketing surveillance of adverse reactions to new medicines . Br Med J 2:1001-1003, 1977;.
12 +
Jick H:  The discovery of drug-induced illness . N Engl J Med 296:481-485, 1977;.
13 +
 Intensified adverse drug reaction reporting scheme . NZ Med J 85:157-158, 1977;.
14 +
Howie JGR:  Drug monitoring and adverse reactions . Br Med J 1:1467, 1977;.
15 +
Drury M:  Monitoring adverse reactions to drugs . Br Med J 1:439, 1977;.
16 +
Brown P, Baddeley H, Read AE, et al:  Sclerosing peritonitis, an unusual reaction to a β-adrenergic-blocking drug (practolol) . Lancet 2:1477-1481, 1974;.
17 +
Oakley GP Jr:  The neurotoxicity of the halogenated hydroxyquinolines . JAMA 225:395-397, 1973;.
18 +
Ziel HK, Finkle WD:  Increased risk of endometrial carcinoma among users of conjugated estrogens . N Engl J Med 293:1167-1170, 1975;.
19 +
Smith DC, Prentice R, Thompson DJ, et al:  Association of exogenous estrogen and endometrial carcinoma . N Engl J Med 293:1164-1167, 1975;.
20 +
Jick H, Miettinen OS, Shapiro S, et al:  Comprehensive drug surveillance . JAMA 213:1455-1460, 1970;.
21 +
Jick H, Slone D, Borda IT, et al:  Efficacy and toxicity of heparin in relation to age and sex . N Engl J Med 279:284-286, 1968;.
22 +
 Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours, Boston Collaborative Drug Surveillance Program . Lancet 1:1399-1404, 1973;.
23 +
Wood AJJ, Moir DC, Campbell C, et al:  Medicines evaluation and monitoring group: Central nervous system effects of pentazocine . Br Med J 1:305-307, 1974;.
24 +
Paddock R, Beer EG, Bellville JW, et al:  Analgesic and side effects of pentazocine and morphine in a large population of post-operative patients . Clin Pharmacol Ther 10:355-365, 1969;.
25 +
Koch-Weser J, Sidel VW, Dexter M, et al:  Adverse reactions to sulfisoxazole, sulfamethoxazole, and nitrofurantoin . Arch Intern Med 128:399-404, 1971;.
26 +
Koch-Weser J, Sidel VW, Federman EB, et al:  Adverse effects of sodium colistimethate: Manifestations and specific reaction rates during 317 courses of therapy . Ann Intern Med 72:857-868, 1970;.
27 +
Bottiger LE, Westerholm B:  Drug induced blood dyscrasias in Sweden . Br Med J 3:339, 1973;.
28 +
Bottiger LE, Strandberg I, Westerholm B:  Drug induced febrile mucocutaneous syndrome . Acta Med Scand 198:22, 1975;.
29 +
Porter J, Jick H:  Drug-induced anaphylaxis, convulsions, deafness, and extrapyramidal symptoms . Lancet 1:587-588, 1977;.
30 +
Jick H, Herman R:  Oral-contraceptiveinduced benign liver tumors—the magnitude of the problem . JAMA 240:828-829, 1978;.
31 +
Jick H, Dinan B, Herman R, et al:  Myocardial infarction and other vascular diseases in young women . JAMA 240:2548-2552, 1978;.
32 +
Jick H, Watkins RN, Hunter JR, et al:  Replacement estrogens and endometrial cancer . N Engl J Med 300:218-222, 1979;.
33 +
Skegg DCG (1978):  Use of record linkage for drug surveillance , in Ducrot H, Goldberg M, Hoigne R (eds): Computer Aid to Drug Therapy and to Drug Monitoring . Amsterdam, North-Holland Publishing Co, 1978;, pp 77-83.
34 +
Skegg DCG, Richards SM, Doll R:  Minor tranquillisers and road accidents . Br Med J 1:917-919, 1979;.
35 +
Goldacre MJ, Clarke JA, Heasman MA, et al:  Follow-up of vasectomy using medical record linkage . Am J Epidemiol 108:176-180, 1978;.
36 +
 Royal College of General Practitioners' Oral Contraception Study: Mortality among oral-contraceptive users . Lancet 2:727-731, 1977;.
37 +
Vessey MP, McPherson K, Johnson B:  Mortality among women participating in the Oxford-Family Planning Association Contraceptive Study . Lancet 2:731-733, 1977;.

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