Creating knowledge about adverse drug reactions: A critical analysis of the Danish reporting system from 1968 to 2005

Social Science and Medicine

Volumn 65, Issue 6, 2007, Pages 1296-1309

  Aagaard, Lise ^a   Soendergaard, Birthe ^a   Andersen, Elin ^b   Kampmann, Jens Peter ^c   Hansen, Ebba Holme ^a  

^a Faculty of Pharmaceutical Sciences   (Denmark)

^b DANISH MEDICINES AGENCY   (Denmark)

^c The Danish Institute for Rational Pharmacotherapy

Author keywords

Adverse drug reaction reporting systems; Denmark; Drug monitoring; Knowledge; Post marketing; Product surveillance

Indexed keywords

8 QUINOLINOL DERIVATIVE; AMINOPHENAZONE; BENOXAPROFEN; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CAFFEINE; CYCLOOXYGENASE 2 INHIBITOR; DIPYRONE; EPHEDRINE; ESTROGEN; LETIGEN; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL CONTRACEPTIVE AGENT; PHENFORMIN; PRACTOLOL; ROFECOXIB; UNCLASSIFIED DRUG;

DECISION MAKING; DRUG USER; KNOWLEDGE; SAFETY;

ADVERSE DRUG REACTION; AGRANULOCYTOSIS; ANALYTIC METHOD; ARTICLE; CARDIOVASCULAR DISEASE; CORONARY ARTERY DISEASE; DEEP VEIN THROMBOSIS; DENMARK; DRUG INDUSTRY; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EYE TOXICITY; GASTROINTESTINAL SYMPTOM; HALOTHANE LIVER INJURY; HEARING DISORDER; HEART ARRHYTHMIA; HEART INFARCTION; HUMAN; HYPERSENSITIVITY; HYPERTENSION; INFORMATION PROCESSING; KNOWLEDGE; LACTIC ACIDOSIS; LOW DRUG DOSE; OBESITY; POSTMARKETING SURVEILLANCE; SIDE EFFECT; SKIN MANIFESTATION; SKIN TOXICITY; STROKE; SUBACUTE MYELOOPTIC NEUROPATHY; SUDDEN DEATH; THROMBOEMBOLISM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DENMARK; DRUG MONITORING; HUMANS; KNOWLEDGE;

DENMARK; EURASIA; EUROPE; NORTHERN EUROPE; SCANDINAVIA;

EID: 34547845289     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.socscimed.2007.04.026     Document Type: Article

References (46)

1. Aktuelle bivirkninger (praktolol, meprobamat, klordiazepoksid, galdekonstrastmidler. [Current adverse reactions (practolol, meprobamate, chlordiazepoxide, biliary contrast media).]. (1975). Ugeskrift for Laeger, 137, 1016-1018 (in Danish).
2. Alvarez-Requejo A., Carvajal A., Begaud B., Moride Y., Vega T., and Martin L.H. Under-reporting of ADRs. European Journal of Clinical Pharmacology 54 (1998) 483-488
3. Anonymous. (1970). Sammenhæng mellem østrogenindhold og tromboembolirisiko ved peroral antikonception [The relation between the oestrogen dose in oral contraceptives and the risk of thromboembolism.]. (1970). Ugeskrift for Laeger, 132, 1783-1786 (in Danish).
4. Anonymous. (1971). Indberetninger om bivirkninger under anvendelse af perorale antikonceptionsmidler i perioden 1. maj 1968-1. november 1970 [Reports of adverse reactions during the use of oral contraceptives from 1 May 1968-1 November 1970.]. Ugeskrift for Laeger, 133, 211-214 (in Danish).
5. Anonymous. (2006). Assessment of the Community System of Human Pharmacovigilance. Report to the European Commission. Munich.
6. Arnaiz J.A., Carne X., Riba N., Codina C., Ribas J., and Trilla A. The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals. European Journal of Clinical Pharmacology 57 (2001) 89-91
7. Backstrom M., Mjorndal T., and Dahlquist R. Under-reporting of serious ADRs in Sweden. Pharmacoepidemiology and Drug Safety 13 (2004) 483-487
8. Berger, P.L., & Luckmann, T. (1966). The social construction of reality. A treatise in the sociology of knowledge. New York: Anchor Books.
9. Bresalier R.S., Sandler R.S., Quan H., Bolognese J.A., Oxenius B., and Horgan K. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. New England Journal of Medicine 352 (2005) 1092-1102
10. Bruun K., Hansen E., and Jensen T. Controlling psychotropic drugs: The Nordic experience (1983), St. Martin's Press, Croom Helm
11. Damsgård T., and Juul P. Foruroligende antal indberetninger om bivirkninger under behandling med to nye antireumatika (Benoxopron, Cinopal) [Alarming number of reports on adverse reactions to treatment with two new antirheumatics (Benoxopron, Cinopal).]. Ugeskrift for Laeger 144 (1982) 42 (in Danish)
12. Dreyfus H.L., and Dreyfus S.E. Mind over machine. The power of human intuition and expertise in the era of the computer (1986), Basil Blackwell, Oxford
13. Dukes G. The law and ethics of the pharmaceutical industry (2006), Elsevier, Amsterdam
14. Døssing M., Andreasen P.B., Ranek L., and Johansen S.H. Halotanhepatitis. Muligheder for forebyggelse [Halothane hepatitis. Preventive options.]. Ugeskrift for Laeger 144 (1982) 466-468 (in Danish)
15. Døssing M., Nielsen P.E., and Kristensen M.B. Aplastisk anæmi efter kloramfenikol. Anmeldt til Bivirkningsnævnet [Aplastic anaemia following the use of chloramphenicol. Reported to the National Committee for ADRs 1968-76.]. Ugeskrift for Laeger 140 (1978) 1165-1168 (in Danish)
16. Fletcher A.P. An appraisal of spontaneous adverse event monitoring. Adverse Drug Reaction Toxicology Review 11 4 (1992) 213-227
17. Fontanarosa P.B., Drummond R., and DeAngelis C.D. Post marketing surveillance-lack of vigilance, lack of trust. Journal of the American Medical Association 292 (2004) 2647-2650
18. Fleuranceau-Morel P. How do pharmaceutical companies handle consumer ADRs reports? An overview based on a survey of French drug safety managers and officers. Pharmacoepidemiology and Drug Safety 11 (2002) 37-44
19. Geiling E.M.K., and Cannon P.R. Pathogenic effects of elixir of sulfanilimide (diethylene glycol) poisoning. Journal of the American Medical Association 111 (1938) 919-926
20. Gram L.F. Bivirkninger under brug af orale kontraceptiva. [Adverse reactions to oral contraceptives.]. Ugeskrift for Laeger 136 (1974) 2361-2366 (in Danish)
21. Gram L.F. Bivirkninger under brug af betareceptorblokerende lægemidler. Indberetninger til Bivirkningsnævnet 1968-76 [Adverse reactions in connection with the use of beta-receptor blocking drugs. Reported to the National Committee for ADRs 1968-76.]. Ugeskrift for Laeger 139 (1977) 2065-2068 (in Danish)
22. Grootheest K., de Graaf L., and de Jong-van den Berg L.T.W. Consumer adverse drug reaction reporting, a new step in pharmacovigilance?. Drug Safety 26 4 (2003) 211-217
23. Haller C., and Benowitz N.L. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. New England Journal of Medicine 343 25 (2000) 1833-1838
24. Hansen H. Technology assessment in a user perspective-experiences with drug technology. International Journal of Technology Assessment in Health Care 8 1 (1992) 150-165
25. Herxheimer A. Communicating with patients about risks and harms. PloS Medicine 2 2 (2005) e42-e43
26. Horton R. Vioxx, the implosion of Merck, and the after shocks at the FDA. The Lancet 364 9450 (2004) 1995-1996
27. Inman W.H.W., Vessey M.P., Westerholm B., and Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs. British Medical Journal 2 (1970) 203-209
28. Kohn L.T., Corrigan J.M., and Donaldson M.S. To err is human: Building a safer health system (2000), Institute of Medicine, Washington
29. Kromann-Andersen H., and Pedersen A. Reported adverse reactions to and consumption of nonsteroidal anti-inflammatory drugs in Denmark over a 17-year period. Danish Medical Bulletin 35 (1988) 187-192
30. Lazareou J., Pomeranz B.H., and Corey P.N. Incidence of ADRs in hospitalized patients. Journal of the American Medical Association 279 (1998) 1200-1205
31. Lenz W. Malformations caused by drugs in pregnancy. American Journal of Diseases of Children 112 (1966) 99-106
32. Lindsay BD. Are serious adverse cardiovascular events an unintended consequence of the Dietary Supplement Health and Education Act of 1994?. Mayo Clinic Proceeding 77 1 (2002) 12-16 45-54
33. Loke Y.K. Reports of suspected ADRs-systematic literature survey of follow-up. British Medical Journal 332 (2006) 335-339
34. Nonaka I., and Takeuchi H. The knowledge-creating company: How Japanese companies create the dynamics of innovation (1995), University Press, Oxford
35. Pedersen A. Bivirkninger af Helsingør-slankepillen [Side effects of the Ellsinore diet pill.]. Ugeskrift for Laeger 139 (1977) 1742-1743 (in Danish)
36. Pedersen A. Kollaps og pludselig død under astmaanfald, der behandles med sympatomimetika i aerosolspray [Collapse and sudden death during asthma attacks being treated with sympathomimetics in aerosol form.]. Ugeskrift for Laeger 139 (1977) 1796-1800 (in Danish)
37. Pedersen A. Tilbagetrækning af det perorale antidiabetikum fenformin (Dibein, Diparan) [Withdrawal of the oral antidiabetic, fenformine (Dibein, Diparan).]. Ugeskrift for Laeger 140 (1978) 181-182 (in Danish)
38. Pedersen A. Oksikinolderivater til peroral brug trækkes ud af handelen [Derivates of oxychinoline for oral use withdrawn from the market.]. Ugeskrift for Laeger 140 (1978) 1181 (in Danish)
39. Pedersen A. Aminofenazon- og metamizolpræparater til systemisk brug trækkes ud af handelen [Withdrawal from the market of preparations containing aminophenazone and metamizole for systemic use.]. Ugeskrift for Laeger 141 (1979) 873 (in Danish)
40. Rodriguez E.M., Staffa J.A., and Graham D.J. The role of databases in drug postmarketing surveillance. Pharmacoepidemiology and Drug Safety 10 (2001) 407-410
41. Rossi A.C., Knapp D.E., Anelio C., O'Neill O.T., Graham C.F., Mendelis P.S., et al. JAMA 249 (1983) 2226-2228
42. Stacey R.D. Strategic management and organizational dynamics. The challenge of complexity (2003), Pearson Education Limited, Essex
43. Stricker B., and Psaty B.M. Detection, verification and quantification of ADRs. British Medical Journal 329 (2004) 44-47
44. Tilbagetrækning af de "højøstrogene" p-piller [Withdrawal of oral contraceptives with 'high oestrogen"' content.]. (1974). Ugeskr for Laeger, 136, 2310 (in Danish).
45. Wallerstein R.O., Condit P.K., Kasper C.K., Brown J.W., and Morrison F.R. Statewise study of chloramphenicol therapy and fatal aplastic anemia. Journal of the American Medical Association 208 (1969) 2045-2050
46. Wardell W.H., Velo G.P., and Jarocha N.M. Drug development, regulatory assessment and postmarketing surveillance (1981), Plenum, cop., New York