Systemic conditions for performance of pharmacoepidemiologic studies in Slovenia.
Pharmacoepidemiol Drug Saf
; 10(7): 675-8, 2001 Dec.
Article
en En
| MEDLINE
| ID: mdl-11980260
In Slovenia, the national health insurance system covers almost the whole population. The average patient receives six to seven prescriptions per year with an average value of 15 USD per prescription. This paper presents the systemic conditions necessary for the performance of pharmacoepidemiologic studies. A recent study addressing the use of antiepileptic drugs is an example. The current law on Personal Data Protection, which is compliant with EU Directive 95/46/EC, prevents infringement of personal integrity resulting from inappropriate use of personal data or inappropriate management and use of databases containing personal data. Since July 2000, the Law on Health Care Related Databases has defined the databases and the ways data can be acquired, processed, transferred, and exchanged among persons authorized to perform health care services. When gathering additional data not currently contained in the health care-related databases defined by the law, written consent from participants is required, and study documentation must be submitted for approval to the national Medical Ethics Committee. The main legislation covering clinical and pharmacoepidemiologic research is the Medicinal Products and Medical Devices Act of 1999, together with its by-laws, which is also in accordance with EU Directives.
Buscar en Google
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Farmacoepidemiología
/
Confidencialidad
Tipo de estudio:
Guideline
/
Prognostic_studies
Aspecto:
Ethics
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Pharmacoepidemiol Drug Saf
Asunto de la revista:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2001
Tipo del documento:
Article
País de afiliación:
Eslovenia
Pais de publicación:
Reino Unido