Quality use of an unlicensed medicine and off label use of a medicine

Vasilka Nicha,Maja Simonoska Crcarevska,Marija Glavas Dodov,Renata Slaveska Raichki

doi:10.33320/maced.pharm.bull.2014.60.01.008

Abstract

This paper gives an overview of the concept and process of quality use of unlicensed medicines and off label use of medicines, with special attention on the professional roles and responsibilities of prescribers and pharmacists. It also focuses on the policy requirements, sets of guidelines, recommendations, best practices, and other aspects addressed under this topic that represent the state of update knowledge. As a complex and specific issue, the use of an unlicensed medicine and off label prescribed medicine in different health care levels is of particular importance for the healthcare settings in the Republic of Macedonia since, the existing regulatory structure requires adoption and development of a comprehensive strategy relating to this topic in the near future with an aim of encouraging and supporting the development and maintenance of a sound health system with high standards of medication-use policies.

Highlights

The legal foundation of the approval process of a medicinal product for human use Marketing authorizations (MA) for medicines and medical devices for human use are fundamentally granted by a competent regulatory authority in the form of an official approval for a certain time period, based on a rigorous and comprehensive scientific, clinical, quality and cost- effective evaluation procedure
As a country with candidate status for EU membership and for reasons of approximation to the European legislation, an EU harmonized national MA system was installed by the latest Law on Medicinal Products and Medical Devices, promulgated in 2007 (LMPMD, 2007)
In this context, according to Article 11 from LMPMD, medicinal product can be placed on the Macedonian market when:

Summary

EMA WHO FDA

Prepared Medicines “Off-label” and “offlicense” use of med- Unlicensed medicines Specials icine. The practice is experiencing greater challenges since the categories of UL and OL use of licensed medicine are vulnerable to misunderstanding by professionals and public. These raise many questions and sometimes cause confusion and concerns that can serve as indication point for more consideration and attention by all interested parties

Drug prescribed for indications outside of those listed in the SmPC

Roles and responsibilities of pharmacists regarding OL product

Promotion of OL medicines

Findings

Conclusion