The medicines scheduling committee has ruled against the PSA and Guild, deciding that diclofenac up to 2% will be removed from the Schedule 2 entry from 1 October
Late last year, a request was made to amend the Schedule 2 entry for diclofenac, exempting dermal preparations of up to 2% diclofenac from scheduling.
While dermal preparations containing 1% or less of diclofenac have been exempt from scheduling since February 2000, diclofenac gel 2% (diclofenac diethylammonium 2.32%) has been marketed in Australia as a Schedule 2 product since June 2014.
The Australian Food and Grocery Council (AFGC) and Australian Self Medication Industry (ASMI) both came out in support of the proposal, arguing that the product has been unscheduled and approved for general sale in two major and comparable markets – New Zealand (since July 2013) and the UK (since 2013) – with no issues.
ASMI argued that the safety profile of the 2% gel is comparable to that of 1% gel, and that the indications for the 2% gel are the same as for the 1% gel as well as for other topical analgesics available for general sale in Australia.
It adds that the 2% gel has been developed to provide the same total daily dose as is achieved with diclofenac 1% gel, but with less frequent daily applications (twice-daily for the former and four times daily for the latter).
“It is to be expected that less frequent application will lead to better adherence and so to better clinical outcomes,” said ASMI.
The AFGC said: “Scheduling will always be on the basis of evidence at a point in time, and just as evidence changes as new information or experience is gathered, so scheduling also must change to … relax regulation where the evidence demonstrates levels of safety and use that previously were not available.”
Meanwhile the PSA did not support the proposal to amend the Schedule 2 entry for diclofenac, warning that systemic absorption is likely and that adverse cardiovascular events have been associated with oral diclofenac.
“The TGA’s assessment and conclusions around topical diclofenac products suggest a conservative approach is warranted,” said the PSA.
The Pharmacy Guild also did not support the proposal, saying there is a lack of evidence of safety from the wider use in the community.
The Guild added that since the 2% diclofenac dosing regimen is different from the current (1%) product, “access from a pharmacist is appropriate”.
“Concomitant administration of diclofenac gel with oral NSAIDs or aspirin may result in increased adverse NSAID effects. With the unrestricted availability of aspirin and ibuprofen, there is a potential for people to combine these with topical diclofenac use, increasing the risk of systemic adverse effects.”
However in its final decision published on Thursday, the Advisory Committee on Medicines Scheduling has decided that the benefits of making 2% diclofenac available for general sale outweigh the risks.
The committee found it has proven efficacy at the proposed dose with an adverse effect profile that is comparable to placebo, and less systemic toxicity compared to oral diclofenac.
While conceding there is a potential for a very slight increase in cardiovascular toxicity, the committee pointed out that the risk is the same for the 1% gel, which is also exempt from scheduling.
Serious adverse events are rare and the likelihood of adverse effects with the topical product is lower than with oral products, it said.
The committee said it based its decision on findings that the product will:
- Reduce use of other oral NSAIDs; and
Lead to improved adherence – needing to be applied only twice a day vs four times a day.
However there will likely be new packaging requirements, as the committee found the 2% diclofenac gel and the unscheduled 1% gel are currently “insufficiently differentiated”.
It also added that the 2% diclofenac gel Patient Information Leaflet should mention slight risk of cardiovascular toxicity as per oral diclofenac, and labelling should state 12 hourly, not to use for more than 3 weeks and to cease use after 7 days if condition gets worse or no better.
The implementation date for this schedule change is 1 October 2018.