TGA releases improved patient information

Recent findings contained in a Pharmaceutical Society of Australia (PSA) report reveal that as a result of ‘medication errors, inappropriate use, misadventure and interactions’, each year 250,000 people are hospitalised and 400,000 present to emergency departments at an annual cost of $1.4 billion. The report also states at least half of these presentations could be prevented.
 
When a patient commences a new medicine, the Therapeutic Goods Administration (TGA) recommends obtaining a copy of the relevant Consumer Medicines Information (CMI) – a document provided by doctors and pharmacists informing them of the safe and effective use of a prescription or specified over-the-counter medicine.
 
However, concerns raised by doctors, pharmacists and patients around the complexity and legibility of existing CMI documents have led the TGA to revise the documents. An updated CMI template was user tested and following positive feedback was released as a shorter, easier to navigate leaflet with a one-page summary providing essential information for patients taking the medication.
 
Since 2013, the Government has listed more than 2100 new or amended items on the Pharmaceutical Benefits Scheme (PBS), representing an average of one listing per day at an overall cost of around $10.6 billion.
 
As one of the most common healthcare interventions, medicine prescribing and use is important to manage correctly, ensuring patients’ understanding of what they are taking for maximum efficacy and safety, according to the PSA.
 
One in five people experience an adverse medication reaction at the time they receive a Home Medicines Review, with 1.2 million people experiencing an adverse reaction in the last six months, the PSA report revealed.
 
Dr Edwin Kruys, a GP who led development of the RACGP’s Medication management and supply: A guide for general practice, told newsGP the CMI update is a necessary measure to ensure patient comprehension.
 
‘It is important that the information [the patient is given] is easy to understand, using non-medical language,’ he told newsGP.
 
‘It should also be short and sweet. The current CMI leaflets are often a long and complex read.’
 
Dr Kruys also emphasised the value of healthcare professionals providing the information to patients and cites recommendations that CMI leaflets be given with any medicine supplied in the practice.
 
‘It is important that consumers actually receive the leaflets at the pharmacy and at doctors’ surgeries, especially in case of first-time prescriptions,’ he said. 
 
‘A good CMI leaflet can be used by GPs as a conversation starter, highlighting the essential points before the document is handed to the patient.
 
‘In the end it is all about avoiding medication-related complications for our patients.’
 
The TGA will publish the new CMI template along with instructions on its use. Given there are currently several thousand CMIs, there will be a transition period as the various medicine companies progressively revise their materials.
 
‘It is important to acknowledge that useability of CMI will continue to heavily rely on the quality of the content produced by the medicine companies who are responsible for these products,’ the TGA stated.

consumer medicines information medication management prescription safety TGA