All steam ahead on prescription cytisine for smoking cessation: RACGP

But over-the-counter access would be a step too far for the college.

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Proposed amendments to the Poison Standard to allow GPs to prescribe cytisine for smoking cessation have been welcomed by the RACGP. 

But concerns remain regarding over-the-counter access. 

The Advisory Committee on Medicine Scheduling has undertaken a public consultation on a proposal to create new schedule 3 (over the counter) and 4 (prescription) listings for nicotine dependency treatment cytisine. 

In its submission to the consultation, which closed last Friday, RACGP president Dr Nicole Higgins said that although the college supported making cytisine more available, it would not support pharmacy prescribing. 

“Enabling access to this low cost first-line medicine must be balanced by mitigating the risks of possible contraindications, drug interactions and fragmented care,” she said. 

“The contraindications of cytisine include common patient comorbidities and pharmacists do not have adequate access to patient medical histories.” 

Dr Higgins said patients often lacked awareness of their medical conditions, which could be contraindicated. 

“For instance, patient awareness of chronic kidney disease (CDK) is low, with only 1 in 4 patients aware of a low estimated glomerular filtration rate and coded diagnosis rates for CKD in Australia are low,” she said. 

“As noted by the TGA application, there is limited clinical experience for cytisine use in individuals with kidney or liver impairment and as such, cytisine may not be suitable for these patient groups.” 

Dr Higgins added that the over-the-counter listing provided insufficient safeguards. 

She said the listing should include provision of a private consultation space for proper patient counselling, a full protocol to exclude contraindications and/or drug interactions and information relay to patients’ GPs. 

Speaking to The Medical Republic, RACGP addiction medicine special interest group chair Dr Hester Wilson said her concern with over-the-counter access was the lack of ongoing support. 

“[Cytisine] being potentially available over the counter at the pharmacy does increase access,” she told TMR. 

“One of my concerns there, and we know this from studies that have been done on nicotine replacement therapies, is that a really important aspect of smoking cessation is the support.  

“Certainly for me as a GP, the people that I see that I’m helping to give up smoking are people that have quite high nicotine dependency.  

“They’ve had failed attempts at ceasing smoking before, and so they do need a level of support – I feel like I’m a bit of a cheerleader.  

“I know that [the RACGP] does not support pharmacy prescribing.  

“I think the thing for me is having a private consultation space to have those conversations, so they’re not happening out in the middle of your community pharmacy.  

“But also, how are pharmacists paid for that time.” 

According to Dr Wilson, cytisine has been used in Eastern Europe for years, but there have been barriers to its uptake in the West. 

“It’s because it’s generic, you can’t patent it,” she said. 

“So it’s difficult for a pharmaceutical company to put the money and energy into it when they can’t actually put a price premium on it. 

“How do we make sure that it is accessible and that there is product available? Who’s going to import it? Who’s going to be the distributor?”  

The proposal would list the drug for smoking cessation. 

Dr Wilson said it would be great if this could be extended to including vaping cessation, a move backed by the college 

“There is a dearth of strong evidence supporting any pharmacological approaches to managing vaping cessation and the RACGP supports the cautious prescribing of cytisine to assist with vaping cessation, in conjunction with behavioural support,” said Dr Higgins in the college’s submission. 

Dr Wilson encouraged GPs to look into this new medication and keep an eye out for the college’s smoking cessation guidelines. 

The college is currently updating its Supporting smoking cessation: A guide for health professionals resource, which will including information on vaping cessation and will now be updated to include cytisine for nicotine dependence. 

The proposed amendments to the Poison Standard were recommended to be implemented by 1 October.