DoHAC unveils opioid dependence transition protocol

GP clinics that order buprenorphine injections directly should be able to continue business as usual until 30 November, along with other non-PBS dosing sites.

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GP and state-run opioid dependence clinics will have five months to transition patients over to a community pharmacy, where they will be able to access PBS-subsidised treatment for the first time.

The changes were announced as a budget measure in May and are set to go ahead from 1 July.

Under the altered PBS listing, methadone oral liquid, buprenorphine sublingual tablets, buprenorphine + naloxone sublingual films and long-acting injectable buprenorphine products will all become subject to the Section 100 Highly Specialised Drug Program arrangements.

Given the rapidly approaching go-live date, there has been confusion over how private and state-run opioid treatment programs, which have typically ordered opioid treatment medicines directly from suppliers, would manage the shift.

New Department of Health and Aged Care guidance confirms that state- or territory-approved private clinics and non-PBS dosing sites can continue to order stock from their regular wholesalers and distributors at no cost until 30 November.

This includes GP clinics that offer long-acting injectable buprenorphine.

The DoHAC advises clinics seeking approval to participate in the transitional arrangements to contact their state or territory opioid dependence programs.

GPs will continue to be able to offer long-acting buprenorphine to patients past 30 November, so long as the medicine is dispensed through a PBS pharmacy.

Paper scripts written before 1 July will remain valid, with the DoHAC advising that pharmacists will be able to dispense the medicine under the PBS.

The exception is for patients with electronic prescriptions written before 1 July, who will need to organise a temporary paper prescription or a new electronic PBS prescription.

RACGP alcohol and other drugs spokesman Dr Hester Wilson said her colleagues in state health had been working “around the clock” to make sense of the changes.

“it’s a huge shift for prescribers, it’s a huge shift for community pharmacies and a huge shift for our public system as we all try to make sense of how we support people to stay in treatment and hopefully to increase access,” she told TMR.

“There are some real complexities, but they will all settle with time.”

There are still some outstanding logistical issues to be sorted – practice software, for example, will need to be updated for GPs to write electronic authority scripts for the medicines.

“Some of my colleagues have ordered [injectable buprenorphine] directly from the company and have stored it in their S8 fridges or S8 safes and have just gone ahead and done it [for patients] when needed,” Dr Wilson said.

“That’s all going to shift and it’s not entirely clear [what the process will be].

“It’s great that it’s changing, but it seems like the legislative instrument was just put in place, bam, 1 July.”

On a practical level, the changes mean that patients will now only pay the PBS dispensing fee of $30– or $7.30 once they have reached the safety net threshold – for a 28-day medicine supply.

Pharmacies will no longer be able to charge a separate dosing or dispensing fee, even if patients are prescribed supervised doses.

As per the National Health Act 1953, only approved PBS suppliers can dispense PBS medicines, meaning that patients will have to start picking up their treatment at community pharmacies.

According to the DoHAC fact sheet, private clinics and non-PBS dosing sites can apply for approval to become a PBS approved supplier.

However, doctors tend to only be given PBS supplier approval if they work in a rural or remote area where the community does not have convenient access to a PBS approved pharmacy.

RACGP president Dr Nicole Higgins encouraged GPs to liaise with local pharmacies in preparation for the transition.

“These opioid dependence treatment drugs make such a key difference in turning someone’s life around … given these drugs are now on the PBS they are being mainstreamed and normalised, just like insulin for a person with diabetes,” she said.