Methadone disaster looming

We are now a few days away from what is going to be the most seismic shift in opioid management therapy since the introduction nearly 50 years ago.

OMT patients are vulnerable. Their lives can be chaotic; their behaviour can be risky and their treatment with methadone or buprenorphine requires a very strict legal and clinical framework to maintain safety and minimise harm. However by working with their prescriber, pharmacist, social worker and support network lives are changed. Lives are saved. Confidence and self-worth are restored. Health is promoted. 

The changes coming are going to work against this framework in so many ways. It is painful for grass-roots pharmacists, prescribers and social workers to be ignored by regulators; many of the issues we face could have been prevented by consultation.

It should be noted that pharmacy has LONG advocated for OMT to be funded properly. Theoretically we welcome the listing of OMT products on the regular PBS but the implementation is disastrous with a real risk of patient harm. It's also important to note the heavy regulatory burden that already exists from state/territory governments to protect all parties. These clerical requirements are non-negotiable but they do appear to have been overlooked by federal regulators.

In no particular order:

July 1 is a Saturday

Manual intervention on each patient's prescription on the day BEFORE the patient turns up. Some pharmacies see hundreds of patients. Each script needs manual assessment and adjustment to make it "fit" into the PBS space. No-one is paying pharmacists for this.

Transition arrangements

The adjustments above directly impact patients because their script expiry dates (typically 3 months), will be shortened in the majority of cases. This impacts the patient's access to their prescriber who may not e available at the earlier date. That means potentially an extra cost to the patient earlier (not every consultation is bulk-billed); it also means extra disruption to work/family/child care arrangements to facilitate early access to the prescriber.

28 + 2 repeats is NOT 3 months

It's proposed that scripts be provided to last 28 days + 2 repeats. That means an appointment every 12 weeks. Typically patients see their clinic doctor every 3 months (that is 6 days longer than their script will last). EVERY clinic in Australia will need to rearrange their schedule to accommodate. This impacts doctors other professional and personal roles. There is no facility to extend a script beyond the 84 days.

Under the current arrangements very stable patients at times can have a 6-month script (usually after years of demonstrated compliance). They are now forced backwards to 84-day visits to doctors.

Product shortage

There has been a shortage of methadone for the last couple of weeks. Caused partly by pharmacists' fear of the unknown but also caused by changed logistics in the supplier space; proper consultation could have prevented this. MANY pharmacies have had supplies run out which is absolutely untenable. Those patients who were unable to be dosed are at risk. (For noting that there appears to be some emergency supplies available as of June 23).

S100 products have no clear wholesaler pathways

The CSO ensures Australians have access to PBs pharmaceuticals in a timely manner and at the price set by the PBS at wholesale and at retail. The S100 "Community Access" pathway is not part of the CSO; this means that the supply chain is unclear and not backed by government support. 

Medicare card

There are plenty of patients in Australia who don't have a Medicare card. It's inevitable that some of these patients will be on OMT. There is no facility for them which puts them at risk.

Changing location

Patients move. Patients move interstate. Patients go into care in a hospital or a facility. Their PBS script is not portable (because of the regulatory arrangements to this unique class of drug) . There is no facility for patient transfer within the new program.

Increased cost

There are some scenarios whereby patient medication costs will increase. The relatively common scenario of being on an 8mg and a 2mg film, for a general patient, will see them need to cough up $60 on day one. In the ACT they were required to pay $2.15. You can do the maths! 

Unused product

Patients at times miss doses. While nominally the does held at the pharmacy belongs to them, the pharmacy cannot issue it to them beyond the daily dosing requirements (catch up doses are not allowed and present an unacceptable risk to the patient). There is little guidance on what pharmacy should do with this excess. It is technically the patient's product having been dispensed to them and funded by the PBS. But as noted, we cannot give it to the patient. Equally we can't put it down the sink for legal and environmental reasons; disposal of narcotics is unwieldy and time consuming in every jurisdiction.

Script extensions

Under current arrangements it is possible for a doctor to phone and authorise a script extension for a patient who has gone past their 3 month checkup. it happens. People are human. There is no facility for this. Patients will experience hardship. It is absolutely impossible for a pharmacist to dispense "verbally' under the PBS system.

Clerical burden

The addition of an extra layer of documentation and recording to secure the federal funding adds a layer of complexity which increases risk of error. And the data collection is over-the-top. Why does the Department need to know a patients visit/dose schedule? Which days attended, which days were take-away, which days were missed? That data already exists in the current state/territory requirements; transferring them manually into an as-yet-to-be-defined claim portal achieves little. But one thing is certain, time and effort (and associated cost) will be a big part of the new program.

Opportunistic dosing

Injectable OMT is life changing. A weekly or monthly injection, for the right patient, will have the most enormous impact. At times, drug and alcohol outreach services have the opportunity to administer an injection if they see a candidate patient in the right frame of mind. That could be the turning point for the rest of that patient's life. Under the PBS system, a specific script for a specific patient must be written and dispensed Doctors will have no access to imprest stock for the scenario above and the lifechanging interventions described will cease.

Non-pharmacy clinics

These exist. There are thousands of patients served through these clinics and while they are being supported until November (I believe), there is no ongoing model for these patients. The expectation is that they will transition to a regular dosing point in a community pharmacy. However, see the next point

Pharmacy dosing points

You will notice above that every element relates to the impacts of this scheme on patients. However there are impacts on pharmacies. The workload will increase. The funding envelope will decrease in most locations (currently a mix of patient and state/territory funding). Discussions with my business partners and my colleagues have universally come to the same conclusion. I have already seen pharmacies reduce access hours to OMT programs. I know pharmacies are planing to reduce patient places within the program. Patients who leave will not be replaced. I am aware of dosing points who will be actively ceasing being part of the program. I know that public hospital clinics are terrified because they have no capacity to pick up the slack.

It is disappointing that what should have been such a positive step forward is being handled in such an incompetent manner. It should never have been linked with 60-day dispensing (another disaster for myriad separate reasons).

Vulnerable people are in harm's way, and Anthony Albanese 's Australian Labor Party government is responsible.