Journal of Pharmacovigilance

Clinical trials pharmacy service

2^nd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

November 18-19, 2013 Hilton San Antonio Airport, TX, USA

Eugenia Hong

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

The clinical trials pharmacy service offers a variety of services to achieve the highest possible standards of care for study participants and successful conduct of clinical trials. The primary objective of a clinical trials pharmacy service is to optimize quality use of investigational drugs. The other objectives are to support and promote the safe and ethical use of investigational drugs, apply the principles of best pharmacy practice to the evaluation of new drugs and ensure pharmacy aspects of investigational drug use comply with relevant legislative acts, standards and guidelines. Clinical trials pharmacy provides accurate management of investigational drugs including appropriate storage, accurate dispensing, high standards of manufacturing and stock control, emergency 24-hour access to the service, subject randomization and preparation of placebo and special dosage forms. Clinical trials pharmacists can also provide assistance in study design and protocol development as well as counsel study participants and monitor compliance. In support of clinical research, clinical trials pharmacists enforce the relevant requirements of Good Clinical Practice relating to study medications, assist with adherence to clinical trials protocols and perform therapeutic drug monitoring and adverse drug reaction reporting. The services provided by clinical trials pharmacy and involvement of clinical trials pharmacistas a member of multidisciplinary teams in professional management of investigational drugs will contribute to successful conduct of clinical research and development of new drugs.

Biography :

Eugenia Hong is a senior pharmacist in charge of clinical trials pharmacy at the Royal Melbourne Hospital, Melbourne Health, Australia. She leads clinical trials pharmacy which provides a comprehensive clinical research service for over 300 studies conducted in Melbourne Health. She is a committee member of The Society of Hospital Pharmacists of Australia and involved in development of Standard of Practice for Pharmacy Investigational Drugs Services in Australia.