From 1 August 2023, limitations on prescribing early medical abortion medications have been lifted.
What has changed?
In July 2023, the Therapeutic Goods Administration (TGA) approved an application from MS Health Australia to amend restrictions on the prescribing of mifepristone and misoprostol (branded as MS-2 Step) to end pregnancy up to 63 days of gestation.
Previously, MS-2 Step could only be prescribed by a specifically certified medical practitioner, and then dispensed by an appropriately registered pharmacist.
The TGA’s decision means from the 1 August 2023, MS-2 Step can be prescribed by any GP or other health care practitioner with appropriate qualifications and training, without the need for certification.
The dispensing restrictions have also been lifted. This means that any pharmacist can now dispense.
This change is expected to significantly improve access to safe and low-cost termination of pregnancy for many patients.
What do GPs need to know
Medicolegal
The wording “appropriate qualifications and training” is considered by some to be opaque. Prior to prescribing it might be advisable to check with your Medical Defense Organisation (MDO) what they consider to be “appropriate qualifications and training”. My own MDO has advised:
“In line with the TGA changes, from 1 August 2023, [this MDO] won’t require its medical practitioner members to undertake additional training when prescribing MS-2 Step for medical terminations up to 63 days gestation. However, we continue to emphasise the importance of our members having the appropriate and recognised training, qualifications, and experience for any healthcare services they provide, to reduce the risk of claims and complaints arising”.
Practical prescribing
Training
MS Health Australia have an excellent online training program for prescribing MS-2 Step. I recommend it to any GP considering prescribing.
This Royal Australian College of General Practitioners (RACGP) article is an excellent overview on the prescribing of MS-2 step and has been heavily drawn on for the writing on this article. Although please note that the legal process mentioned is now outdated by the changes noted above.
How medical abortion works
Medical abortion is only indicated for terminations up to 63 days gestation.
It involves the use of 2 agents: mifepristone and misoprostol. Mifepristone competes with progesterone causing the pregnancy to stop progressing. Misoprostol is taken 24–48 hours after mifepristone, inducing contractions, cervical opening and evacuation of the uterine contents.
Pros and cons of medical abortion
Some advantages of medical over surgical termination of pregnancy include lower cost, avoidance of a surgical procedure and completion at home.
Disadvantages include more days to complete, may be more painful, may have more bleeding, and a small risk of being incomplete and requiring a surgical evacuation.
Processes – investigations, contraindication and side effects
Intrauterine pregnancy and gestational age (not more than 63 days) need to be confirmed and an ectopic pregnancy excluded. Initial serum beta-hCG and blood group tests are recommended.
Contraindications are chronic adrenal failure, diseases requiring long-term oral steroids, hypocoagulation diseases, anticoagulation therapy, and allergy to mifepristone, misoprostol or other prostaglandin.
Consideration should also be given to other conditions in which medical abortion is not recommended (such as anaemia, renal failure, hepatic impairment, malnutrition or cardiovascular disease). In the setting of medical termination of pregnancy before 10 weeks of gestation there is insufficient evidence to suggest the routine use of Rh D immunoglobulin.
Side effects include bleeding (patients should be advised to seek help if they soak more than 2 maxi pads per hour for more than 2 consecutive hours, feel dizzy or lightheaded, or have a racing heartbeat), pain (patients should be advised to seek help if severe pain during abortion is not controlled by analgesics) and prostaglandin effects such as nausea and vomiting.
Follow-up
It is important to confirm that the pregnancy has ended. This can be done with a repeat serum beta-hCG or low-sensitivity urine HCG at least 7 days after taking mifepristone (demonstrating a decline of at least 80 per cent). Patients seeking further advice should call healthdirect or Nurse-on-call. Both can be reached at 1800 022 222.
Women may also require ongoing contraception and sexually transmitted disease testing.
For more information
- TGA announcement – Amendments to restrictions for prescribing MS-2 Step
- MS Health Australia – MS-2 Step Training
- RACGP article – Medical Abortion
- Clinical management and referral pathways – Health Pathways
