[New drugs require nw follow-up surveillance].
The marketing of new drugs has been sped up considerably, partly as a consequence of the common EU regulatory system. At the time of approval the documentation concerning long-term effects and health economic outcomes of a new drug is scanty. This is of particular relevance to chronic and debilitating diseases like rheumatoid arthritis. In the field of rheumatology new, expensive, and clinically effective drugs have been marketed recently. This has lead to subsequent problems in the setting of priorities at the clinical as well as the administrative level. The demand for appropriate systems for following up of effects, toxicity and economy of these drugs has compelled the Swedish Society for Rheumatology and the Medical Products Agency to establish a surveillance system for TNF-blockers. This was implemented already in the pre-marketing phase, and is presently being continued as an observational study after approval. Experience from the development phase of this system and some preliminary results are presented.
Feltelius
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Institutionen för medicin, Karolinska sjukhuset/Karolinska institutet, Stockholm. nils.feltelius@mpa.se
Lindblad
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S
D016907:Adverse Drug Reaction Reporting Systems; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D017277:Drug Approval; D004346:Drug Information Services; D005500:Follow-Up Studies; D006801:Humans; D010606:Pharmacy and Therapeutics Committee; D018124:Receptors, Tumor Necrosis Factor / Q000037:antagonists & inhibitors*; D013548:Sweden
D018501:Antirheumatic Agents; D018124:Receptors, Tumor Necrosis Factor