The South Australian Government has determined that community pharmacists who have completed additional training will be able to provide resupply of approved oral contraceptive pills to eligible patients if certain criteria are met.
This article discusses the obligations for pharmacists and pharmacies participating in the new Scheme, as well as the potential safety risks of it and ramifications for patients and the medical profession generally.
Introduction
From 6 May 2024 in South Australia, community pharmacists who have completed additional training will be able to provide resupply of approved oral contraceptive pills (OCP) to eligible patients under the OCP Resupply Servies Management Protocol, which has been developed for use by pharmacists providing SA Community Pharmacy OCP Resupply Services under the Scheme. Similar schemes / pilots have been implemented in Queensland, Victoria, New South Wales, Western Australia and Tasmania.
This comes after the South Australian Government extended powers to pharmacists to supply antibiotics to women aged 18-65 for urinary tract infections (UTIs) on 1 March 2024.
As at the date of this article, over 130 pharmacists in South Australia have completed the necessary training to provide the OCP Service, with an additional 170 currently undergoing training. The purpose of the new Scheme is to make it easier for South Australian women to safely access important medications from their local pharmacist without needing to go to a doctor and to ease the burden on general practitioners and other healthcare providers.
However, some concerns have been raised about the Scheme by medical professionals. Dr Clare Keogh from the Royal Australian College of General Practitioners has stated that “I think to extend the scope of practice is a big issue and I think it raises a lot of safety concerns”.
This article discusses the obligations on pharmacists and pharmacies in relation to the Scheme and considerations for patients and the medical profession generally.
Patient eligibility
To be eligible to be considered for the OCP Service, patients will need to:
- be aged between 17 and 50 years;
- have been stabilised on an approved OCP continuously for 2 years; and
- have seen a GP or other authorised prescribing healthcare practitioner for review in the last 2 years.
Patients aged 17 to 40 years will be able to receive one original manufacturer’s pack of their OCP at any one time, with additional resupply available up to a maximum of 12 months.
Patients aged 41 to 50 years will be able to receive one original manufacturer’s pack of their OCP, with referral to their GP (or other authorised prescribing healthcare practitioner) required for review and further supply.
These services are inclusive of transgender, gender diverse, and non-binary people assigned and/or presumed female at birth.
Patients who meet the above criteria will be asked about their current treatment and undergo a clinical review to determine whether resupply is safe and appropriate. Patients who have risk factors, contraindications, or other conditions that mean resupply is not considered safe or appropriate, will be referred to a GP or other healthcare professional as appropriate.
Obligations for pharmacists
It is mandatory for pharmacists to complete approved / accredited training prior to providing SA Community Pharmacy OCP Resupply Services. Accredited training is provided by:
Further, pharmacists utilising the Scheme must:
- have unconditional general registration with the Australian Health Practitioner Regulation Agency (AHPRA);
- comply with all relevant legislation, AHPRA and the Pharmacy Board of Australia’s Code of Conduct, and the expected standards of ethical behaviour of pharmacists towards individuals, the community and society;
- refer to the OCP Resupply Services Management Protocol to assist with assessment and help guide their decisions about when resupply may be provided or where referral for further medical advice is the best option. The Protocol is based on evidence-based guidelines and provides a framework for pharmacists, including a Clinical Flow Chart that provides information to guide clinical decision-making and about appropriate referral to a GP or other health service;
- refer to relevant professional practice standards and evidence-based clinical guidelines, including the Faculty of Sexual and Reproductive Healthcare UK Medical Eligibility Criteria: for contraceptive use, UKMEC 2016 (Amended September 2019), the Therapeutic Guidelines and Australian Medicines Handbook, and the Pharmaceutical Society of Australia Professional Practice Standards 2023, version 6;
- ascertain the patient’s OCP history – this can be confirmed by sighting a previous prescription, OCP pack, or other physical and/or electronic dispensing records and My Health Record;
- ascertain the patient’s general medical history, including:
- age;
- pregnancy and breastfeeding status;
- body mass index (BMI);
- blood pressure (BP);
- smoking status;
- current medications, including adherence and satisfaction with OCP;
- drug allergies / adverse effects, including any adverse effects of OCP;
- prior use of contraceptives, tolerability, and adverse effects;
- any unexplained and un-investigated vaginal bleeding or acute, severe menstrual bleeding;
- any headaches indicative of migraines; and
- underlying medical conditions, including new or recently diagnosed medical conditions which may be a contraindication to hormonal contraception or impact of contraceptive effectiveness and choice.
- ascertain whether the use of the OCP has been continuous. If a pill break has occurred for:
- less than 2 weeks: resupply of the OCP may occur;
- more than 2 weeks but less than 4 weeks: resupply of 1 month of the OCP may occur with referral to their usual medical practitioner or other authorised prescribing healthcare practitioner;
- one month or more: do not resupply the OCP. The patient should be referred to their usual medical practitioner or other authorised prescribing healthcare practitioner. If a patient frequently takes breaks, pharmacists should exercise their professional judgement and consider referring the patient to explore alternative contraception options (e.g. long-acting reversible contraception).
- only resupply approved OCPs which are listed in Appendix 2 of the OCP Resupply Services Management Protocol;
- provide the patient with comprehensive counselling and supporting written information when required regarding:
- instructions for use;
- side effects to expect, and how to manage these side effects;
- what to do in the event of a missed pill and emergency contraception options available if required;
- importance of adherence, and avoiding stopping / starting the pill;
- when to seek further care from their medical practitioner or other authorised prescribing healthcare practitioner;
- not initiate or change a patient’s therapy;
- not supply combined OCPs with a high oestrogen dose (50 micrograms of ethinylestradiol or equivalent) or combined OCPs containing estetrol or mestranol;
- comply with the Controlled Substances Act (1984) and the Controlled Substances (Poisons) Regulations 2011 in supplying, packaging and labelling of approved OCPs;
- not sell or supply the OCPs in a quantity that exceeds one original manufacturer’s pack of the OCP;
- make a thorough record of consultations, including any resupply of OCPs. An electronic Form is available to download and print, or complete electronically to document OCP Resupply Service consultations. The completed form can be kept in the pharmacy records (electronic or physical) and a copy can also be provided to the patient or the patient’s GP (with the patient’s consent). If the pharmacy uses MedAdvisor to record professional pharmacy services, a Service form will be availably shortly.
- seek a patient’s consent prior to sharing a record of the consultation and any medicine supply with the patient’s usual treating GP or GP practice;
- seek a patient’s consent prior to uploading details of medicine supply to the patient’s My Health Record;
- inform the patient of the cost of the consultation when offering the service (pharmacists may charge a consultation fee for the service, in addition to the cost of the OCP supplied); and
- refer any patients who have risk factors, contraindications, or other conditions which mean that resupply is not considered safe or appropriate to a GP or other healthcare professional as appropriate. Any referrals made as a result of an OCP resupply consultation will need to be generated by the usual processes of the pharmacy.
Obligations for pharmacies
Community pharmacies registered by the Pharmacy Regulation Authority of South Australia (PRASA) may participate in the Scheme.
The pharmacy must have an area suitable to maintain confidentiality of the consultation, i.e., have a screened or private consulting area that:
- ensures patients’ privacy and confidentiality, including visual and auditory privacy; and
- has sufficient space to allow the presence of the patients, a carer if required, the pharmacist, and relevant equipment and documentation.
Considerations for general practitioners
GPs and practice managers should be aware they may receive referrals from Community Pharmacy OCP Resupply Services, as pharmacists may seek to assist patients who require follow up.
Considerations for the medical profession generally
As noted above, some members of the medical profession have expressed concerns regarding the increased scope of practice for pharmacists and consequential safety issues which may arise. The Royal Australian College of General Practitioners (RACGP) has spoken out against expanded pharmacy prescribing powers in South Australia.
Earlier this year, the South Australian Government expanded the scope of practice of pharmacists to prescribe antibiotics to women aged 18 to 65 suffering from UTIs.
In 2023, the RACGP President Dr Nicole Higgins and RACGP South Australian Chair Dr Sian Goodson spoke out at a Parliamentary Select Committee hearing on why expanding pharmacy powers will result in risks to patient safety.
In relation to the proposed expansion of prescribing powers to pharmacists for UTIs, RACGP President Dr Nicole Higgins stated:
- “This pharmacy prescribing expansion may well seem like a convenient option; however, patient safety and wellbeing must come first”;
- “GPs and practice teams have nothing but respect for the vital role that pharmacists perform in communities across Australia; however, they simply do not have the training and expertise to diagnose [UTIs] and prescribe these drugs and the retail setting is not a suitable environment for these consultations. Governments must keep in mind that all GPs in South Australia and across the country complete over a decade of training to diagnose and manage patients and treat conditions such as UTIs.”
RACGP South Australia Chair Dr Sian Goodson supported the President’s comments, stating:
- “… this decision is not in the best interests of patients”;
- “The World Health Organisation has declared that antibiotic resistance is a global health emergency. As the College warned today, the Australian Commission on Safety and Quality in Health Care has urged judicious prescribing of antibiotics for a range of health conditions including urinary tract infections. So, with this decision in South Australia we are heading in exactly the wrong direction, because introducing more non-medical prescribers of antibiotics through pharmacies risks undercutting our efforts to fight antimicrobial resistance.”;
- “We have known for some time that pharmacy prescribing runs counter to antimicrobial stewardship goals. To take just one example, a 2021 study here is Australia found a huge increase in topical chloramphenicol prescribing after it was rescheduled to pharmacist only in 2010. So, at a time when we are facing one of the great public health challenges of this century, there has never been a worse time to expand antibiotic prescribing.”;
- “Expanding pharmacy prescribing also runs the risk of disrupting continuity of care, because your GP will not know what your pharmacist is prescribing you and vice versa. This is another example of fragmentation of care rather than targeted funding to support pharmacists being part of multi-disciplinary teams within general practices.”; and
- “If the Government is determined to press ahead, we recommend they consult closely with medical groups, including the RACGP, to make pharmacist antibiotic prescribing as safe as possible. In Western Australia, for example, we were able to provide crucial feedback on antibiotic choice, exclusion criteria, record keeping and mandating that the dispensing record be transmitted to My Health Record. It’s far from ideal, but it is certainly better than nothing.”
Conclusion
Pharmacists and pharmacies considering utilising the SA Community Pharmacy OCP Resupply Services must be aware of their extensive obligations under the OCP Resupply Services Management Protocol. The Scheme makes it easier for women in South Australia to access the OCP and eases the burden on general practitioners. However, it remains to be seen as to whether the risks warned of by the RACGP materialise, and whether any claims arise in relation to either the SA Community Pharmacy OCP Resupply Services or the SA Community Pharmacy UTI Services. Given the extensive obligations on pharmacists under the OCP Resupply Services Management Protocol, there is certainly the potential for claims to arise in relation to failing to adhere to the Protocol.
This article is not intended to be comprehensive. If you are a pharmacist or pharmacy and you are unsure as to your obligations in relation to the Scheme, refer to the OCP Resupply Services Management Protocol or contact your professional indemnity insurance provider.
