Letters to the Editor
Quality use of generic medicines
- Aust Prescr 2005;28:80-1
- 1 April 2005
- DOI: 10.18773/austprescr.2005.023
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Editor, – The excellent editorial, 'Quality use of generic medicines' (Aust Prescr 2004;27:80-1) states 'confusion could be greatly reduced if generic names of the drugs were required to be more prominent [my emphasis] on the label than the 'brand' names'.
Recently, I was called to an elderly lady who had collapsed and was unable to get up from the floor. She was severely hypotensive because she had taken a double dose of enalapril, one that I had prescribed for her and one with a different brand name, prescribed by a locum doctor.
This is such an obvious danger that it needs to be confronted before more severe accidents and deaths occur.
How can the labelling requirement suggested in the Australian Prescriber editorial be brought about?
Dr Leonie Hunt, Director, Drug Safety and Evaluation Branch, Therapeutic Goods Administration, comments:
The issue of safe labelling of prescription medicines is under review in several areas. The Australian Pharmaceutical Advisory Committee (APAC) has a working party that is reviewing the issue of brand substitution generally. Looking at labelling specifically, the legal requirements for labelling of medicines are contained within both Australian government and state/territory legislation. The Therapeutic Goods Administration (TGA), through its Labelling Orders, regulates matters such as the minimum font size of lettering that may be used and essential information that must be included on labels for prescription medicines. The Labelling Order is currently under review.
The TGA has also been working with stakeholders from the health professions, industry and consumer groups to develop a Best Practice Labelling Guideline for Prescription Medicines.
The draft version of this document recommends equal prominence be given to the active ingredient or generic name and the brand name and makes recommendations on other aspects of label design to try to ensure that all relevant information is clearly presented to health professionals and consumers. This includes advice that both medicine names need to be displayed on at least three sides of the container for standard packaging.