[The importance of patient perspective in drug surveillance systems].
OBJECTIVE
using data from the German biologics register RABBIT we investigated which gain in information can be achieved by integrating patient-reported adverse drug reactions (ADRs) into drug surveillance systems.


METHODS
patients with rheumatoid arthritis enrolled in the longitudinal cohort of the German biologics register between May 2001 and September 2006 who had undergone at least one follow-up were included in the study. All ADRs reported to the register either by the treating rheumatologists or the patients were coded with the same coding system (MedDRA®). The agreement between patients and physicians was analysed for the most frequently reported ADRs using the patient as gold standard.


RESULTS
data from 4246 patients with a mean observation time of 2 years were analysed. Patients reported on average 1.2 ADRs per patient year (PY), while physicians indicated 1 ADR per PY (p<0,001). The ADR most frequently reported by patients was nausea (93.8 per 1000 PY), followed by fatigue (72.5 per 1000 PYs) and alopecia (60.6 per 1000 PYs). These ADRs were significantly less often reported by physicians. Agreement between patients and physicians was higher in more objective symptoms, such as injection site reaction (in 60.0% of cases where the patient reported this symptom, the physician did so too) or rash (53.0%), than in more subjective symptoms such as fatigue (17.4%). Agreement was highest in life-threatening events.


CONCLUSIONS
patients report a higher number of ADRs than their treating physicians. Patients report subjective symptoms impacting on quality of life more frequently than physicians. Patient-physician agreement on known or clinically relevant ARDs is high. Integration of patient reports on ADRs into clinical routine could enhance the patient-physician partnership and improve compliance as well as awareness of signs and symptoms of possible ADRs.
Forschungsbereich Epidemiologie, Deutsches Rheuma-Forschungszentrum Berlin, Charitéplatz 1, 10117, Berlin.
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Gäwert
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Hierse
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Zink
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Strangfeld
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology*; D001688:Biological Products / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000706:statistics & numerical data*; D012042:Registries / Q000706:statistics & numerical data*; D018570:Risk Assessment; D012307:Risk Factors; D014409:Tumor Necrosis Factor-alpha / Q000627:therapeutic use*
D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha