Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital.
OBJECTIVE
To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them.


METHODS
A qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text.


RESULTS
Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADR(S) diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous reporting were to define the kind of ADR(S) which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities.


CONCLUSIONS
The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADR(S) in specialized healthcare.
Vallano
A
A
Fundació Institut Català de Farmacologia, WHO Collaborating Centre for Research and Training in Pharmacoepidemiology, Barcelona, Spain. tv@icf.uab.es
Cereza
G
G
Pedròs
C
C
Agustí
A
A
Danés
I
I
Aguilera
C
C
Arnau
J M
JM
D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics / Q000458:organization & administration*; D001291:Attitude of Health Personnel; D003142:Communication; D016265:Conflict of Interest; D064420:Drug-Related Side Effects and Adverse Reactions; D005246:Feedback; D017144:Focus Groups; D006784:Hospitals, Teaching; D006801:Humans; D008505:Medical Staff, Hospital / Q000523:psychology*; D012308:Risk Management; D013030:Spain; D016526:Workload