Premium
Systemic conditions for performance of pharmacoepidemiologic studies in Slovenia
Author(s) -
Primozic Stanislav,
Kos Mitja,
Mrhar Ales,
Ravnik Igor
Publication year - 2001
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.646
Subject(s) - medicine , documentation , legislation , medical prescription , directive , health care , personal care , personally identifiable information , actuarial science , family medicine , medical emergency , database , law , business , nursing , computer science , political science , programming language
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. Copyright © 2001 John Wiley & Sons, Ltd.