“Clinical corners get cut and standards quickly drop” is one doctor’s prediction if the OCP is downscheduled to S3, as the Guild highlights the importance of continuity
Doctors have slammed the proposal to downschedule some substances to Pharmacist Only medicines where they are used as oral contraceptives.
The TGA has now released public consultation on the proposal, which could see Ethinylestradiol (at 35 micrograms or less per maximum daily dose in combination with levonorgestrel or norethisterone) in combination with levonorgestrel or norethisterone moved to S3.
The TGA’s consultation document notes that, “In the proposal, the guidelines for pharmacists would specify all patients must have had the same substance prescribed by an authorised health professional within the previous two years”.
“The pharmacist can determine if it is appropriate and safe to maintain ongoing supply of the medicine or refer the patient to an authorised prescriber for further assessment,” it says.
Ten more substances—ethinylestradiol, estradiol and mestranol (when each is combined with a progestogen), levonorgestrel, cyproterone, desogestrel, dienogest, drospirenone, gestodene, and nomegestrol (when each is combined with an estrogen)—would also move to S3 under the proposal.
“Pharmacists are highly educated and trained health professionals, committed to continuing professional development, with the competency to safely supply oral contraceptives to patients for continuation of therapy,” the TGA’s document notes.
“Rescheduling of these substances used in oral contraceptive pills would harmonise Australia’s scheduling with New Zealand, and provide patients with increased access to effective contraception for continuing treatment.”
The Royal Australian College of General Practitioners has published its submission, highly critical of the suggestion, to the TGA the matter.
“The proposals are both unsafe and unnecessary. Women’s health is more than just a prescription service,” wrote national president Dr Karen Price in the submission.
“The increased risk to patients does not outweigh the doubtful benefits, for which there is no substantiation. Safe clinical governance frameworks must not be compromised unnecessarily for benefits of a dubious nature.”
She writes that a patient visiting a GP for the oral contraceptive pill would be given a “necessary” medical review which would not be available at pharmacies.
RACGP publication newsGP spoke to Dr Evan Ackermann, who has been critical of the pharmacy channel on numerous occasions, about the possible downschedule.
He said that, “While the proposal of pharmacists prescribing the pill may have superficial appeal, the reality of implementation in community pharmacy shopfronts, raises significant concerns”.
“Clinical corners get cut and standards quickly drop,” he told newsGP’s Morgan Liotta.
“You only have to look at mystery shopper studies of Australian population and emergency contraception to show this – the lack of privacy, poor assessment by the pharmacist, lack of ongoing advice, role transfers are recurrent findings.
Anthony Tassone, Victorian branch president of the Pharmacy Guild, also noted that “Pharmacists are highly educated medicine and health experts and the most accessible healthcare professionals in Australia”.
He said that adaptations made to handle the COVID-19 crisis have already shown that pharmacists are competent in this space.
“The Guild supports pharmacists being able to manage the risks and contraindications for oral contraceptive use, as has been demonstrated throughout the COVID-19 pandemic when patients were unable to attend face-to-face appointments with prescribers and would require their pharmacist to complete the risk screening process prior to supply of continuation of oral contraceptive treatment,” he told the AJP.
“We know that many patients have greatly appreciated and benefited from continued dispensing and medication continuation provisions put in place during the COVID-19 pandemic for a wide range of prescription medicines including the oral contraceptive pill.
“It has become the difference between patients continuing therapy and treatment without interruption or not.”
Mr Tassone said that the use of a suitable screening tool such as the globally recognised Medical Eligibility Criteria for OCP use would support pharmacists in supplying oral contraceptive pills as Schedule 3 medicines.
“This system provides clear guidance on medical conditions that would warrant refusal of supply and patient referral to a medical professional for further evaluation,” he said.
“This system would be easily incorporated into pharmacy practice, and studies have shown that pharmacists can successfully identify patients without contraindications for hormonal contraception using this system, along with the measurement of blood pressure and body mass index.
“The requirement for patients who are stable on therapy to have a valid prescription for ongoing supply is creating an unnecessary barrier to access and can lead to treatment interruptions resulting in unplanned pregnancy,” he warned.
“Unplanned pregnancy is a public health issue in Australia; an issue that improved access to oral contraceptives could address.
“The risk of developing venous thromboembolism (VTE) is highest in the first year of use. However, it is important to note that the risk of developing VTE is higher during pregnancy and immediately following giving birth than it is in patients taking the OCP, and therefore unintended pregnancy can pose a greater risk of VTE to a patient than the use of the OCP.”
He said that the Guild acknowledges that there are risks associated with the use of OCPs and supports the risk mitigation strategies outlined in Appendix M in the scheduling framework, including supply only for continuation of treatment, only after the first 12 months following initiation of treatment and regular clinical review by a prescriber or pharmacist.
“If used correctly the OCP is highly effective at preventing pregnancy, with a failure rate of 0.3% annually,” he said.
“The effectiveness of the OCP reduces when used inconsistently or incorrectly, with the failure rate increasing to 9% annually.
“Difficulty in accessing the OCP in a timely manner can result in treatment interruptions or ceasing of continuous treatment which leads to inconsistent use and non-compliance.
“One of the identified barriers to individuals being able to access the oral contraceptive pill in a timely manner is the requirement for a valid prescription.
“It is important that if the OCP is to reach its maximum efficacy it must be taken without interruption.
“Whilst peak medical bodies can insist that patients visit them for all of their health needs and not utilise other health professionals within their scope of practice – this is not a patient-centric view and out of touch with the realities of the challenges faced by patients in accessing care.”