Latest Blog Post
14 MAY 2020
The Therapeutic Goods Administration (TGA) is having a busy year. Along with the current consultation around the down-scheduling of CBD that we discussed last week, they are also proposing a change to the scheduling for of ibuprofen 400 mg to a Schedule 2 listing, limited to a pack size of 12 doses.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used pharmacological agents worldwide to treat mild to moderate pain. Amongst NSAIDs Ibuprofen is the most commonly used drug.
We know that many people living with chronic pain opt to self-medicate their condition. With the upscheduling of Modified Release Paracetamol by June 2020, as well as the broader reforms to opioids, consumers will face increasing barriers in accessing affordable pain medications.
The move to downshift Ibuprofen 400mg appears to be sound as it will provide consumers with an effective, safe and accessible option to relieve strong pain.
As with all changes in scheduling of medications, there are upsides and downsides. Painaustralia always endeavours to provide a balanced view based on feedback from clinicians and consumers as well as relying on the clinical evidence.
In this instance, some consumers have flagged concerns around the proposed down-scheduling such as this comment:
“Most people who take Nurofen or ibuprofen are used to the dosage of "take 2" which works for the widely available 200mg tablets/capsules. If you make 400mg ibuprofen available without pharmacist advice people will still take 2 because that's what they're used to.”
This concern raises potential safety issues, especially in the older people with chronic pain who commonly rely on the use of NSAIDs for pain management and may be more susceptible to overdose issues.
Painaustralia has supported the down-scheduling as outlined in our submission to the consultation. Among NSAIDs, ibuprofen has a comparatively favourable safety profile and is an effective analgesic for many acute and chronic pain conditions, although like other NSAIDs ibuprofen is not without some risk. All medications have side-effects and many can be harmful if used over the long-term. This is where the balance of risks versus benefits is an important consideration in rescheduling decisions.
An important part of the equation involves consideration of quality of life issues for consumers and the context in which medicines are used as part of a pain management approach. Medication alone is generally not helpful for the management of chronic pain and it is usually recommended that it be taken in combination with other treatment strategies to help manage pain long term.
We have known for decades now that the gold standard for pain management is multidisciplinary care; the scale is so overwhelmingly tipped in its favour. The challenge is to complement single modality treatments with a range of integrated treatments and supports that provide options tailored to the diverse range of individual needs.
As part of the risk/benefit equation, Painaustralia recommends monitoring the impacts of changes to scheduling particularly in terms of the costs associated with potentially increasing primary reliance on medications and a shift from lifestyle and holistic interventions to pharmaceutical interventions. In short, and in reviewing the pros and cons of any health policy decision, where is the optimum overall public health benefit of this decision?
Finally, any changes to scheduling of medicines should involve appropriate clinical advice and review to ensure that there are no unintended consequences.
While we support the addition of more tools to the pain management toolkit, and pain medicines are a very important tool, we also need to equip people living with chronic pain with the capacity to establish a comprehensive approach to their pain management.
Carol Bennett,
Painaustralia CEO