The use of insulin, considered a high-risk medication with APINCHs classification,5 Ms Barwick notes, provides justification for a Home Medicines Review (HMR). ‘There’s an advantage to going into the home to observe the patient’s diet, consider potential interactions, and educate patients on the best effects and outcomes,’ she says.
Advice around cleaning blood glucose level (BGL) monitors to ensure accuracy can also be provided. ‘Pharmacists can explain how to put test drops through and clean blood spills on the monitor, common in pregnancy due to higher blood volume,’ says Ms Barwick.
With only 50% of women diagnosed with GDM receiving tests for heart disease and type 2 diabetes post-pregnancy,6 HMRs can be beneficial at this stage of the journey, too.
‘Along with conversations around diet choices, exercise regimes and sleep, I also explain how often testing is required over the next 5–10 years, and how to monitor for signs of the development of diabetes,’ Ms Barwick advises.
Nausea and vomiting in pregnancy
The presence of iron in pregnancy multivitamins may exacerbate symptoms of nausea and vomiting in some pregnancies, according to Ms Barwick.
‘Pharmacists can recommend a trial cessation of the iron component of pregnancy vitamins, often unnecessary in pregnancy,’ she says.
In 2020, photographer Bobbi Lockyer created a Birthing on Country project to highlight and create awareness around birthing issues and outcomes in Aboriginal women. For more, see 
Suzanne Nielsen MPS[/caption]
The Therapeutic Goods Administration (TGA) has made a final decision on the rescheduling of modified release (MR) paracetamol due to safety concerns.
The safety of MR paracetamol preparations has been under the spotlight since reports of its potential toxicity emerged. In line with international concerns, the TGA initiated a scheduling review of the medicine.
An interim decision by the TGA to up-schedule MR paracetamol from Schedule 2 (Pharmacy Medicine) to S3 (Pharmacist Only) was made in June this year.1 The interim decision has been upheld in a final decision, and comes into effect on 1 June 2020.
The TGA review followed the decision by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee to suspend all MR paracetamol products in the European Union in September 2017. That decision was based on increased risks to people who overdosed on the MR formulation compared to immediate release (IR) paracetamol. The TGA decided to take a more measured approach and initiate a scheduling review.2
The decision was not referred to an expert advisory committee, but rather made by a TGA delegate. Delegate-approved changes are added to Appendix H of the Poisons Standard, per requirement of the Therapeutic Goods Act.2
PSA has supported the reclassification of MR paracetamol, concerned about large pack size availability within an S2 classification. This will allow for greater supervision and education to ensure that intentional and unintentional overdoses are avoided.
While paracetamol is a commonly used over-the-counter analgesic, misuse and accidental overdose are of increasing concern. Toxicity can occur even at doses lower than the recommended daily maximum dose. Gaps in patient knowledge, particularly around the perceived safety of paracetamol, are contributing factors to misuse and accidental overdose. Used appropriately, under supervision and advice from pharmacists, MR paracetamol is considered safe.
MR paracetamol is sometimes labelled as ‘sustained release’, ‘slow release’ or ‘extended release’ and is formulated with 665 mg paracetamol per tablet compared to IR paracetamol at 500 mg per tablet. The MR formulation releases the drug slowly into the body, allowing a more convenient 8-hourly dosing regimen compared to the IR products (usually taken 4–6-hourly).2 Pharmacists need to ensure consumers are aware of maximum paracetamol doses, especially if MR, IR and combination products are used together.
What does this mean for patients?
Patients will be required to consult a pharmacist before purchasing these products to receive appropriate advice on their use and to discuss the best treatment options available for ongoing pain. No prescription is necessary.
These changes do not apply to the IR paracetamol products available on the market, including from supermarket and convenience store outlets.
What does this mean for pharmacies?
Once the change is implemented, MR paracetamol products will need to be placed behind the counter, where pharmacists will be able to better ensure appropriate use.
MR products may continue to be advertised and included in catalogues.
Pharmacy staff should start thinking about workflow changes now, particularly around the amount of stock they are holding, and future buy-in quantities.
PSA has emphasised the importance of medicine safety in both its Medicine Safety: Take Care and Pharmacists in 2023 reports. Measures such as harm minimisation of widely used paracetamol products, including this rescheduling change, are a positive move for patient safety and should be embraced by pharmacists.
Learn more about the supply of S2 and S3 medicines in PSA’s online course: Support the supply of Pharmacy Medicines and Pharmacist Only Medicines (S2/S3). Click here to register: https://my.psa.org.au/s/training-plan/a117F0000019vdGQAQ/support-the-supply-of-pharmacy-medicines-and-pharmacist-only-medicines-s2s3
References
- Therapeutic Goods Administration. Interim decision in relation to paracetamol (modified release). June 2019. At: https://www.tga.gov.au/book-page/15-interim-decision-relation-paracetamol-modified-release
- Therapeutic Goods Administration. Changes to the way modified release paracetamol products are supplied. August 2019. At: https://www.tga.gov.au/changes-way-modified-release-paracetamol-products-are-supplied-questions-and-answers
