Quality use of medicines: Does the end justify the means?
Simone Henriksen1, Teddy Henriksen1, University Of The Sunshine Coast Sippy Downs 1University Of The Sunshine Coast, Sippy Downs, Qld, Australia
Abstract
QUALITY USE OF MEDICINES AND NICOTINE: DOES THE END JUSTIFY THE MEANS?
Dr Simone Henriksen PhD LLB Hons GDLP B.Pharmacy MPS
&
Dr Teddy Henriksen PhD LLB Hons GDLP B.Pharmacy MPS
Inhalation of aerosols emitted from an electronic nicotine device (‘END’) can cause cardiovascular disease and lung damage. In response to the dangers of END use, the Therapeutic Goods Administration (‘TGA’) amended the Poisons Standard on 1 October 2021 to reclassify all ENDs as prescription only medicines in Australia. This means that ENDs can only be legally purchased on a valid doctor’s prescription. The sale of ENDs from tobacconists and other retail outlets is prohibited. The amendment to the Poisons Standard is an important step towards reducing the harmful effects of ENDs. Currently, there are no TGA approved ENDs listed on the Australian Register of Therapeutic Goods (‘ARTG’). Whilst this significantly limits access to ENDs in Australia, consumer autonomy is preserved through the Personal Importation Scheme which allows consumers to legally access unapproved ENDs with a valid prescription. However, unapproved ENDs accessed through this scheme have not been assessed for their safety and efficacy by the TGA. Further, the Personal Importation Scheme can act as barrier to quality of use of medicines. In this paper, we explore the tension between the role of the TGA in ensuring the safety and efficacy of therapeutic goods in Australia and the Personal Importation Scheme and how preserving patient autonomy via the Personal Importation Scheme potentially undermines quality use of medicines in Australia.
Biography
Simone Henriksen is a legal academic at the University of the Sunshine Coast, where she holds the position of Associate Lecturer in Law. Simone is also a pharmacist. Simone’s research interest include the regulation of health and health services with a focus on alcohol and other drug treatment.