Regulations for international non-proprietary name prescribing and substitution, relevant for cross-border ePrescribing and eDispensation services in the European Union.

Abstract

Prescribing by international non-proprietary name (INN) and substitution rules are advocated in the education and practice of rational prescribing, and for cost containment policy. Regulations that restrict or foster INN prescribing and substitution exist in all member states. The aim of this study is to describe the national regulations in European Union (EU) countries, to nation-specific tools for ePrescribing and eDispensation systems based on the standards for Identification of Medicinal Products (IDMP) in the European Health Data Space. A survey was sent to the policy makers from national competent authorities, active in UNICOM, and responsible for writing and monitoring national regulations. Data were collected from 14 EU countries. INN prescribing is mandatory in Greece, Portugal, and Estonia. It is allowed in Germany, Belgium, Norway, Spain, the Netherlands, and Italy (seldom used). Substitution based on precise substance and dose form is mandatory in Finland and Sweden, and allowed in Ireland (with a positive list). In Austria and Croatia, only brand substitution is possible. Rules for a substitution module in the cross-border ePrescribing and eDispensing services can be set up, with three possible levels of equivalent lists: brand substitution, PhPID substitution, and INN substitution. Harmonization of national rules is needed, also for exemptions and the possibility of physician's veto. This may be facilitated by the implementation of IDMP. The European Commission has the legal basis to foster this harmonization. It will have major implications for research, handling of drug shortages, and clinical care.