The availability of oral contraceptives in pharmacies, without a doctor’s prescription, is being considered by Government, according to President of the Irish Pharmacy Union (IPU) Mr Dermot Twomey.
The IPU had been informed that this measure will be considered under plans to expand age eligibility for the free contraception scheme in 2023. The scheme was launched in September for 17-to-25-year-old women and is due to extend to 16-to-30-year-olds next year.
The union has long argued that expanding the remit of community pharmacists will improve healthcare accessibility. Community pharmacy could also be better utilised to alleviate pressures on GPs, it has said.
“In terms of expansion of services, we would see areas such as contraception without a prescription, and an expanded minor ailments scheme, as being beneficial from the perspective of the patient, in terms of accessibility,” Mr Twomey commented recently.
In 2016, the Pharmaceutical Society of Ireland (PSI), the regulator of pharmacy practice, published a research paper that also envisaged an enhanced role for the profession in the context of patient needs and alleviating some of the challenges to the health system.
This document, Future Pharmacy Practice in Ireland, made several recommendations pertaining to community pharmacists, including expanding their role in supporting patients to treat minor and self-limiting conditions; and exploration of mechanisms to enable pharmacists and GPs to work more closely together in chronic disease management (ie, supplementary prescribing activities, such as dosage adjustment or therapy continuation by the pharmacist in line with agreed protocols).
‘READY TO RESPOND’
A PSI spokesperson said: “The PSI’s intention is to continue to work with the relevant stakeholders – Department of Health, the HSE and the pharmacy sector – and to be ready to respond to policy developments driven by the Department of Health, and to be prepared from a regulatory perspective to support pharmacy policy direction and its implementation. The PSI is an active participant in the HSE-led Community Pharmacy Planning Forum chaired by Pat Healy of the HSE. The intended purpose of this Forum is that its participants will work together to progress the Sláintecare agenda in respect of community pharmacy. The work of this Forum is at the initial stage.”
The spokesperson added: “Ongoing projects intended to position pharmacy to best meet future demands include review of the CPD [continuing professional development] model for pharmacists; consideration of the emerging risks to the future pharmacy workforce; and revision of the core competency framework for pharmacists. Our proposal to expand our approach to the regulation of retail pharmacies by the addition of a standards-based approach is also something in early development.”
The PSI will be available to engage “ on any evolution of service provision that may be considered as part of the revision of the HSE community pharmacy contract as and when requested to do so”. The Programme for Government in 2020 committed to commencing talks with pharmacists on a new contract and “enhancement of their role”, including via e-prescribing and issuance of repeat prescriptions.
A Department of Health spokesperson commented: “The work of the Community Pharmacy Planning Forum, established during the Covid-19 pandemic, has now transitioned to discussing the strategic direction of the community pharmacy profession. This will prove invaluable in the context of future contractual reform. Of course, any publicly funded pharmacy service expansion should address unmet public healthcare needs, improve access to existing public health services, and provide better value for money.”
The value of care provided by community pharmacists was recognised by the Minister, the spokesperson said.
The potential to make some forms of prescription contraception available through pharmacies without a doctor’s prescription “is a wider issue than the free contraception scheme”, added the Department’s spokesperson. However, this was considered as part of the work of the Department’s contraception implementation group and was deemed to require consideration by an expert group.
“Accordingly, the matter has been referred to clinical experts in the HSE, requesting a formal recommendation,” said the spokesperson. “The clinical expert group includes pharmacists, nurses and midwives, obstetricians, and general practitioners; the group are currently examining clinical considerations and the national and international guidance in order to underpin a formal response.” The advice is expected to be received by the Department before the end of the year.
To date, the Health Products Regulatory Authority (HPRA) has not received an application from a pharmaceutical company to reclassify an oral contraceptive medicine to permit sale and supply without a prescription.
However, the Authority was “open” to reviewing such applications. “This is in line with the HPRA’s policy to make medicines and health products available at the most convenient point of access for people, where it is safe and appropriate to do so,” said a HPRA spokesperson.
RECRUITMENT AND RETENTION
The permitted scope of practice “has not moved on a huge amount in the last 20 years”, according to Mr Twomey, Owner and Pharmacist at Cloyne Pharmacy, Co Cork. “There have been some wins in the areas of vaccination and emergency contraception, but there is far more that can happen.”
The development of pharmacists’ role is important for recruitment and retention, added Mr Twomey. “If we want to attract and retain our best and brightest, we have to make it possible for pharmacists to practice to the fullest of their scope.”
The IPU has highlighted a growing shortage of community pharmacists, which it said is becoming a “major threat to community healthcare”. It has cited a number of drivers, including limitations on scope of practice, underfunding, and excessive form-filling and paperwork requirements.
Community pharmacists are under significant workload pressures and any expansion of services would need to be implemented gradually, Mr Twomey agreed.
Mr Twomey noted that direct access to oral contraceptives from community pharmacists has been implemented in several jurisdictions. In July 2021, the UK government announced that women would be able to buy progestogen-only oral contraceptives in pharmacies without a prescription. The Royal College of Obstetricians and Gynaecologists, UK, supported this policy change.
“There is plenty of evidence there for pharmacists working under a protocol to expand their scope,” commented Mr Twomey.
Nevertheless, some physician organisations have opposed such moves. Last year, the Australian Medical Association opposed reclassification proposals on the grounds that “pharmacists are not trained to properly assess patients for key risk factors or provide advice on other, potentially more effective forms of contraception”.
Australia’s Therapeutic Goods Administration (TGA) subsequently issued an interim decision against the reclassification of certain oral contraceptives (the proposals had included mitigations, such as prior prescription by a doctor).
The TGA interim decision considered that “the adverse effects of oral contraceptive substances, and the potential for evolving risks over time, are significant and require management by a medical practitioner”. The TGA interim decision noted that the use of oral contraceptive pills could cause significant adverse effects that were not consistent with over-the-counter (OTC) medicines. These effects included weight gain, anxiety, heavy bleeding, and thromboembolism, particularly with increasing age.
The final decision, released in December 2021, also noted that regular reassessment by a medical practitioner allowed routine preventive health screening as well as regular review of the suitability of continued oral contraception compared to other forms of long-acting reversible contraceptives (LARCs), which were not available without a prescription.
Conversely, in June, the American Medical Association expressed strong support for availability of oral contraception as an OTC medication in order to improve access.
According to Mr Twomey: “The reality is, we don’t see ourselves in competition with our medical colleagues. I have great relationships with the doctors we work with closely, I have huge respect for the work they do, I believe they have respect for the work I do as well… I think it is good to be flexible and look at what the needs are for the patient….”
‘UNCONSCIOUS BIAS’
IMO GP committee Chairperson Dr Denis McCauley said a key point on contraception was that general practice could offer patients all available options, including LARCs (not all GPs fit LARCs, but cross-refer to GP colleagues who provide this service). Dr McCauley said that with due respect to pharmacists, there may be unconscious bias where a service can only offer one type of option.
“I think it is better that a person goes to a ‘one-stop shop’ where that lady has full information about all the products and can choose one, rather than going into one environment where there is only one thing on offer.”
The medical assessments for the oral contraceptive pill were not always straightforward, he added. The consultation may require cross-reference with various information on the patient record, “because people don’t always remember all of their relevant health information there and then.” It was in the best interests of the patient to attend a healthcare professional who had “full information and possession” of their medical facts and the relevant skills to analyse this information.
Asked if he saw any role for community pharmacy in direct supply of oral contraceptives, Dr McCauley said: “I think in the initiation, no.”
Any additional role for pharmacists in the provision of contraception initiated by GPs could not be countenanced in the absence of appropriate clinical governance and health information transfer systems, he indicated. Assurance of competency was also required.
On a minor ailments scheme, Dr McCauley said there was a substantial training requirement to become skilled in differentiating minor from non-minor ailments.
Without the required expertise and knowledge, the tendency to refer was greater. He acknowledged that pharmacists provided advice to patients every day and were “very sensible, practical people”
“But to put it into an actual clinic… how far further from what they are doing now are you going….
“It all sounds good, but you have to look at what you are asking them to do and to what level are they trained, and you want somebody immediately reassured and not referred [where appropriate].”
In regard to the majority of consultations in general practice, “we analyse [the presentation] and we can reassure them on the spot, and they leave quite happy. Anything that prolongs that diagnostic journey inappropriately adds to extra pressure and stress.”
Notwithstanding the capacity issues in general practice, “it is better, if you are going to present yourself to a healthcare professional, that you get the best trained person there to give you the most succinct advice to hopefully reassure you and if necessary – if there is something up – to spot it competently so they refer appropriately.”
Dr McCauley emphasised that “pharmacists are very good at what they do” and acknowledged their important role in the ongoing Covid-19 vaccination programme.
Mr Twomey of the IPU said a protocol for consultations on contraception would need to be developed and should include information on LARCs. He said a protocol for pharmacist consultations on emergency hormonal contraception had incorporated information on methods of contraception and sexually-transmitted infections, for example. Emergency hormonal contraception has been available from community pharmacists in Ireland without a doctor’s prescription since 2011.
On potential fragmentation of care and loss of opportunistic interventions by GPs, Mr Twomey maintained such matters could be addressed by appropriate protocols. He said pathways to share information with GPs would be vital.
“We would be happy to work within appropriate protocols and guidance. Let us be clear on this: There are a number of online consultations [by online doctor services] that happen for oral contraception that are not even a consultation at all, in fact many of the online doctors ask the pharmacy to check BMI or blood pressure as well….”
MINOR AILMENTS
Mr Twomey added that a minor ailments scheme was essentially in operation for private patients.
“Medical card patients are disadvantaged there in that, if they want to get products for hay fever, indigestion, thrush, head lice, a lot of those products, if they don’t have money in their pocket they go to their GP to get a prescription, whereas what we would like to see, working in a collaborative approach, is that there would be certain conditions that it would be possible for medical card patients to get [medications] without a prescription from their pharmacist through a protocol.” This would also help free-up GPs to do more specialised work in the face of increasing pressures and patient multimorbidity, he said. “We see it at pharmacy level. A lot of patients have polypharmacy… there is a lot of complex stuff going on.”
Mr Twomey cited research led by the University of Aberdeen (Community Pharmacy Management of Minor Illness: MINA Study), which was published in 2014. A systematic review, conducted under the MINA Study, derived evidence that suggested community pharmacy-based minor ailment schemes were “an effective and cost-effective strategy for managing patients”. Analysis of routine data showed that the prevalence of ED and general practice consultations deemed to involve minor ailments suitable for management in community pharmacy was 5.3 per cent and 13.2 per cent, respectively.
A cohort study as part of MINA research suggested equivalence of health-related outcomes for pharmacy-managed patients presenting with symptoms similar to those presenting to GPs and emergency departments (and at lower cost). The four target conditions in the cohort study were musculoskeletal pain (aches or pain in arms or legs or back or hands or feet); eye discomfort; upper respiratory tractrelated (sore throat or cough or cold or sinus problems); and gastrointestinal disturbance (nausea or vomiting or diarrhoea or constipation).
Internationally, minor ailments services in pharmacy are operational in a number of health systems, including in the NHS.
Mr Twomey said there were ongoing training requirements for pharmacists and requirements set down by the regulator.
“It is important that there are appropriate protocols in place… and that appropriate questions are asked. We do that anyway… we do it for emergency hormonal contraception, where we have the consultation in a consultation room. We are trained in emergency medicine, such as adrenaline for anaphylaxis, and many pharmacists are trained in other areas [including] using salbutamol for emergency asthma.”
In 2016, the HSE conducted a three month feasibility study, across four centres, on a pharmacy-delivered minor ailment service. The conditions included were dry eye; dry skin; scabies; threadworms; and vaginal thrush. Later, the Department stated that while the pilot successfully tested operational and administrative procedures, the patient take-up was small and “no meaningful clinical or outcome data emerged”. It indicated in subsequent statements that more extensive trialling would be required to assess the proposal.
The ICGP, the professional body for GPs, has acknowledged that pharmacists already treat several minor ailments, “such as minor coughs and respiratory infections and some skin infections, among other ailments”. This helped to reduce pressure on the hospital emergency services and on other parts of the health service.
“A community pharmacist-provided minor ailments scheme would require clear guidelines, protocols, and governance structures, as well as training of pharmacy support staff.”
Asked about the potential future introduction of independent pharmacist prescribers, as well as pharmacist supplementary prescribing as part of shared care with a GP, the College stated: “A highly-trained pharmacist prescriber under the governance and supervision of the managing GP would be an additional valuable resource in the community. If care is shared with GPs and is guided and directed by the GP, then a pharmacist prescriber would add to the community support team for patients. Pharmacist prescribers would require extra training and thorough and comprehensive guidelines and protocols in order to ensure patient safety and wellbeing.”
WARFARIN SERVICE
Mr Twomey is particularly well-placed to discuss extended practice in community pharmacy, having provided a warfarin (anticoagulant) service since 2010. It includes patient consultation, point-of-care blood testing, and dose adjustments as required.
He was the first community pharmacist in Ireland to embark on this practice, having undertaken a period of training under two consultant haematologists who supervised his work and deemed his level of expertise as appropriate. Mr Twomey has continued to work under the protocols set out by the consultants.
“Warfarin is not as popular a medicine as it once was, so I have much less patients. Having said that, every week we still manage our patients on warfarin. We have shown we can provide a high level of care in certain conditions when working under a protocol and our clinic has been independently reviewed by academic research, which showed we have done it to a higher standard than the local hospital.”
Patients were transferred either from their GP or local hospitals to access the warfarin service and Mr Twomey has regularly communicated with GPs where difficulties have arisen (ie, an excessively high INR level).
Mr Twomey said his practice always collaborates with the patient’s GP in such circumstances. “It is very important if we are managing that level of care that the communication is seamless.”
Currently, there is no joined-up electronic healthcare record capability between community pharmacists and GPs nationally. “But this is the future, where a person’s health data will be accessible across a spectrum of healthcare professionals to help with their healthcare needs.”
