Preparing for the massive MS-2 Step change

All pharmacists can soon dispense MS-2 Step (mifepristone and misoprostol), following a landmark decision by the Therapeutic Goods Administration (TGA).

Restrictions preventing health professionals without additional certification, including doctors and pharmacists, from prescribing and dispensing MS-2 Step are set to be lifted, in the biggest regulatory change around the medicine since it was introduced 10 years ago.

‘This move will improve the access to care for women, making MS-2 step available in more pharmacies and in more communities in Australia,’ said PSA National President Dr Fei Sim FPS, who is also Co-Chair of the Access, Care and Outcomes Subcommittee of the National Women’s Health Advisory Council.

‘This approach recognises that pharmacists are medicine experts, and that dispensing MS-2 Step and counselling patients on its use is already within the scope of practice of pharmacists.’

Here’s six things you need to know about the changes.

1. When do they come into effect?

Restrictions on health professionals will be removed from 1 August 2023.

This means pharmacists will no longer need to be registered or undertake specific training to dispense MS-2 Step to patients across Australia. Up until this time, pharmacists must continue to be registered with the MS-2 Step program to legally dispense the medicine.

2. Why has this change been made?

The TGA’s decision to remove the restrictions, which meant only 1 in 10 doctors could prescribe MS-2 Step and 3 in 10 pharmacists could dispense it, came after an application from MS Health.

The move was designed to improve women’s access to healthcare when seeking a medical termination.

‘We know that women experience structural barriers trying to access the health care they need, particularly in regional and rural areas,’ said Assistant Minister for Health and Aged Care Ged Kearney.

‘By removing unnecessary red tape, pharmacists can help more Australian women access reproductive care, in line with international experience,’ added Dr Sim.

3. Who can prescribe MS-2 Step?

Healthcare providers with appropriate qualifications and training, including all doctors and nurse practitioners, can soon prescribe MS-2 Step.

As the medicine has moved to a streamlined Pharmaceutical Benefits Scheme (PBS) authority, prescribers no longer need to contact Services Australia before prescribing MS-2 Step.

4. What are the key points to communicate during dispensing?

When dispensing MS-2 Step, you should emphasise the importance of adhering to the correct order of ingestion, said Anna Barwick MPS, founder of PharmaOnline and advocate for female healthcare access.

‘Mifepristone, ingested orally, must be taken first and before 9 weeks gestation, confirmed by the prescriber through a dating scan,’ she said. ‘Sometimes there’s a delay in patients getting to the pharmacy after the script is written, so it’s really important to check if patients are under that 9-week gestation mark.’

Pharmacists should then advise patients to take misoprostol within 48 hours, which requires buccal administration of four tablets, held on the inside of the cheek until they dissolve.

‘If there’s still any residue remaining after 30 minutes, we encourage women to swallow the remainder of that tablet with a glass of water,’ said Ms Barwick.

Some women start to pass the contents of the uterus after taking mifepristone but this usually happens after misoprostol, so patients should be advised to take both medicines at home or somewhere they feel safe. 

‘It’s always important to have a support person because it can be quite painful,’ she said.

At the point of dispensing you should also:

• advise women to keep an eye out for unusually heavy bleeding, which includes soaking two or more sanitary pads per hour over a 2-hour period, or passing fist-sized clots
• point out the warning signs of infection, including a spike in temperature
• provide women with written material, including the MS-2 Step consumer medicine information, the 1800 022 222 Health Direct 24-hour hotline, attending the nearest hospital and contacting their prescriber
• reinforce the importance of attending a follow-up appointment with the prescriber 2 weeks later to ensure the pregnancy has been terminated.

5. What else do pharmacists need to know?

Some doctors will prescribe an ‘MS-2 Step support packet,’ which includes stronger pain relief options such as non-steroidal anti-inflammatories, codeine-based products and metoclopramide for nausea. 

‘Check with the prescriber to see if there’s a need to provide non-PBS quantities of medicine to assist with the side effects of MS-2 Step,’ said Ms Barwick.

Importantly, all discussions about MS-2 Step should take place in a private consultation room. 

‘A lot of the time, we’re reinforcing what prescribers have said. But often women feel quite anxious at that point, so they might have questions for us that they forgot to ask earlier,’ she said.

Ms Barwick also recommends having a box of MS-2 Step ‘ready to go’ before the changes take effect. 

‘We don’t want women having to bounce around multiple pharmacies trying to find stock because it can already be quite a traumatic time.’

6. Where can I get more training?

Pharmacists can undertake training for healthcare professionals to provide MS-2 Step, offered through MS Health. 

The PSA is also hosting a Person-centered consultations in sexual/reproductive health webinar on 13 September in collaboration with The Australian Contraception and Abortion Primary Care Practitioner Support Network (AusCAPPS) and The Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine. 

‘The webinar will cover early medical abortions and support pharmacists to adopt a culturally appropriate and trauma-informed approach to address healthcare access barriers, including misconceptions and stigma, in order to improve sexual and reproductive health outcomes,’ said Kevin Ou MPS, PSA Manager Training Delivery and Assessment.

For now, Ms Barwick encourages all pharmacists to join the AusCAPPS Community of Practice.

‘It’s a great resource connecting prescribers, nurses and pharmacists,’ she said. ‘You’ll have access to regular case studies and step-by-step tips for setting up an MS-2 Step service in your pharmacy.’