The Impact of Off-Label, Compassionate, and Unlicensed Use on Health Care Laws in Preselected Countries

ISBN-13: 9783838201351 / Angielski / Miękka / 2010 / 174 str.

Vanessa Plate

Opis

In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use--generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Plate gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.

O autorze

Vanessa Platé was born in Germany in 1981. She is a pharmacist specialised in drug information. She completed her degree in pharmaceutical sciences at Rheinische Friedrich Wilhelm University in Bonn, Germany, in 2005. Since 2006, she was a scholarship holder and part of the research group Drug Regulatory Affairs. In this function, Platé did extensive research on NDU on behalf of the German Federal Ministry of Health. She held a postdoctoral position in pharmaceutical development and works now in a regulatory affairs department with a European focus. Her main point of interest lies on paediatric pharmacy.