The Minister for Health Stephen Donnelly TD (Wicklow, Fianna Fáil) has continued to face multiple questions surrounding the possible expansion of the role of pharmacy.

 James O’Connor TD (Cork East, Fianna Fáil) questioned the Minister on his Department’s plans to “expand the scope of practice for pharmacists”.

Minister Donnelly said that his “Department is actively considering the potential role that pharmacy may play in the development and implementation of future healthcare reform, especially in regard to the aims and vision of Sláintecare.”

According to the Minister, “a number of proposals and ways to progress the potential extension of the scope of practice of community pharmacists in the short, medium and longer term are being scoped out, considered and progressed”.

Outlining some of these proposals, Minister Donnelly referred to the Minor Ailments Scheme, the expansion of the free contraception scheme and the serious shortage protocol.

Seán Crowe TD (Dublin South West, Sinn Féin) also raised the topic, asking the Minister to update the Health Committee about the implementation of a Minor Ailments Scheme.

Responding to the Deputy, Minister Donnelly stated that the Department is working closely with the HSE and the Irish Pharmacy Union to enhance pharmacy care. He added, “We are considering a number of approaches. One is the introduction of a Minor Ailments Scheme, which is something that the IPU has rightly sought for a long time.”

Emer Higgins TD (Dublin Mid West, Fine Gael) also questioned the Minister for Health on expanding the role of pharmacies in terms of vaccinations: “if there are plans to transition the current COVID-19 vaccine roll-out programme from being administered at vaccine centres to being solely administered through pharmacies and GPs in order to best utilise the healthcare budget and staffing resources being used to run current vaccination centres.”

Responding, Minister Donnelly stated, “As we enter the fourth year of the pandemic it is necessary that the Vaccination Programme continues to transition towards a more sustainable model of vaccine delivery. The CMO has therefore also requested that the HSE take appropriate steps to ensure that the programme’s capacity corresponds to the scale of vaccination recommended by the National Immunisation Advisory Committee (NIAC).”

FEMPI cuts

Denis Naughten TD (Roscommon-Galway, Independent) challenged the Minister for Health on the timeline for unwinding the FEMPI cuts to pharmacists.

Minister Donnelly stated that he recognises “the significant role community pharmacists play in the delivery of patient care and acknowledge the potential for this role to be developed further in the context of health service reform”. Minister Donnelly did not indicate a timeframe to Naughton.

Health Minister questioned on various medications

The Minister for Health has faced many questions concerning a wide array of medicines.

This has once again included several questions surrounding Cariban. Duncan Smith TD (Dublin Fingal, Labour) pressed the Minister for an “update as of April 2023 on the production and publication of a review of the access and reimbursement issues surrounding the availability and access to the drug Cariban”.

Minister Donnelly responded to the Deputy by stating that he has asked the HSE, who is reviewing the availability and access to Cariban under the current arrangement, to respond directly to him.

Both Paul Donnelly TD (Dublin West, Sinn Féin) and Marian Harkin TD (Sligo-Leitrim, Independent) questioned Minister Donnelly on the current review of the access and reimbursement of Cariban. Meanwhile, Catherine Connolly TD (Galway West, Independent) referenced “the requirement that the initial prescriber be a consultant obstetrician”.

Responding to the three deputies together, Minister Donnelly stated, “Following a review of the available evidence, the HSE considered the potential for a time-limited, quantity-dependent reimbursement arrangement for women with hyperemesis gravidarum, to access Cariban, when prescribed by a consultant obstetrician and in line with clear clinical criteria, as set out by the HSE.”

Continuing, Minister Donnelly said, “However, on the recognition that women suffering hyperemesis gravidarum may need access to Cariban before their first consultation with their specialist/obstetrician, and in light of the fact that GPs prescribe Cariban to private patients without an initial prescription from a specialist, I asked the HSE to review the current arrangement and report back to me.”

The HSE have confirmed that its review will involve an analysis of current arrangements and of the access to Cariban provided to patients since January 2023.

Richard Bruton TD (Dublin Bay North, Fine Gael) questioned the Minister on the “inquiry into the situation of families affected by a medication sodium valproate”.

Responding, Minister Donnelly expressed his frustration at the speed of the inquiry but outlined the scope of the inquiry stating, “This inquiry will be designed to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVSD) and their families. It will seek to document the regulation of sodium valproate and the control practices in place around prescribing and dispensing.”

Aindrias Moynihan TD (Cork North West, Fianna Fáil) has sought clarification from the Minister of Health on potential “plans to reclassify the drug pregabalin, marketed as lyrica, as a class C or controlled drug”.

Pregabalin is used to treat epilepsy, anxiety and nerve pain caused by illnesses, including diabetes and shingles. Pregabalin is only available on prescription.

Minister Donnelly said that while Pregabalin is not a controlled drug, “it is subject to the provisions of Statutory Instrument. No. 540/2003 – Medicinal Products (Prescription and Control of Supply) Regulations 2003, specifically the restrictions on dispensing of prescriptions”.

Furthermore, Minister Donnelly confirmed that, “the Department of Health is always willing to examine evidence in relation to the use of pregabalin in order to determine the most appropriate course of action to reduce harm caused by the use of the drug.”

Codeine classification

Minister for Health Stephen Donnelly TD has also faced questions surrounding codeine. Duncan Smith TD (Dublin Fingal, Labour) asked the Minister “his views on reports his Department is seeking to change access to codeine-based medicines from over-the-counter to prescription supply”.

Responding to Deputy Smith, Minister Donnelly stated that “As a painkiller codeine is most often used in combination with other analgesics such as paracetamol or ibuprofen. But there is a potential for misuse.”

Following this, Minister Donnelly confirmed the existence of a review into the over-the-counter sale of codeine, saying the HPRA “are currently conducting an independent review examining the method of sale and supply of codeine-containing medications”.

Minister Donnelly said his officials will engage with the HPRA and other stakeholders to assess the recommendations.

David Cullinane TD (Waterford, Sinn Féin) also questioned the Minister on a number of aspects regarding codeine, including “the latest guidelines and regulations which govern the sale and supply of codeine-containing products by retail pharmacy businesses”, and “the number of inspections conducted by the Pharmaceutical Society to ascertain compliance with guidelines”.

Responding to the questions posed to him by Deputy Cullinane, Minister Donnelly stated: “The PSI uses a variety of regulatory actions to promote and enforce compliance in line with its remit as the pharmacy regulator. This includes information gathering, inspections and investigations, handling complaints made by members of the public about a pharmacist or pharmacy, and sharing information that promotes safe pharmacy practice and effective and reliable patient care.”

Minister Donnelly further provided the Deputy with statistics surrounding the “enforcement actions, or actions otherwise taken to correct or address poor practice, behaviour, or performance by pharmacists or by pharmacies, taken by the Pharmaceutical Society against retail pharmacy businesses”, upon Deputy Cullinane’s request.

Ozempic shortages

Shortages of diabetes medication Ozempic have been topical in the Dáil this month. Aodhán Ó Ríordáin TD (Dublin Bay North, Labour) has asked the Minister for Health if “he is aware of reports of a market shortage of a semaglutide (Ozempic) and if he is aware of the causes of any shortage”.

In response Minister Donnelly stated the reason for shortages “are linked to the increased demand which has been attributed to the off-label use of the product to treat obesity”.

Minister Donnelly confirmed to Deputy Ó Ríordáin, that the suppliers of the drug, Novo Nordisk, have implemented measures to combat shortages. These measures include “monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients”. Novo Nordisk has also issued letters to relevant stakeholders, including healthcare professionals, to ensure they are aware of this supply issue and its management.

Cian O’Callaghan TD (Dublin Bay North, Social Democrats), similarly asked the Minister for Health “what measures are in place to combat the shortages of Ozempic, the reason for the ongoing shortages and what long-term solutions are in place to prevent these shortages recurring in the future”.

Denise Mitchell TD (Dublin Bay North, Sinn Féin) also questioned the Minister for Health on Ozempic, asking the Minister to confirm that there is currently a shortage. In response, Minister Donnelly confirmed the current shortage of the drug and noted that Novo Nordisk “anticipates that intermittent supply will continue throughout 2023. Similar supply constraints are being experienced in other EU countries.”

Patricia Ryan TD (Kildare South, Sinn Féin) also asked questions about Ozempic querying “if Ozempic will be made available to medical card patients who have had gastric by-pass/sleeve surgery and who are regaining weight due to lack of consultation since COVID”.

Responding to Deputy Ryan, Minister Donnelly stated; “Ozempic was approved by the HSE in 2018 for addition to the reimbursement list for the treatment of diabetes. Ozempic has not been approved for reimbursement for any other indication. Reimbursement support for Ozempic for the treatment of diabetes only is available to those with eligibility under the General Medical Services (GMS) Scheme or the Long-Term Illness (LTI) Scheme.”

Medical cards

The Minister for Health has faced several questions on medical cards. Duncan Smith TD (Dublin Fingal, Labour) queried the Minister over “whether or not “unlicensed medicines” in pharmacies for medication where the regularly prescribed medication is unavailable are covered by the medical card, in this instance, an “unlicensed alternative” for the medicine.”

In response, Minister Donnelly noted that, “The HSE advise that where a licensed product is not available to those with medical card eligibility and there are no suitable therapeutic alternatives on the GMS Reimbursement List. An individual application can be made for reimbursement support through Discretionary Hardship Arrangements for the unlicensed formulation with the same active ingredient.”

Delays with the Discretionary Hardship Scheme were then raised to Minister Donnelly by Eoin Ó Broin TD (Dublin Mid West, Sinn Féin), who asked “average length of time it takes to process an application under the discretionary hardship scheme to provide an explanation for the current delay in processing applications for the scheme in the Dublin West area.”

Minister Donnelly responded to Deputy Ó Broin by informing him that he had instructed the HSE to respond directly.

Neasa Hourigan TD (Dublin Central, Green Party) raised the cost of prescription charges for medical card holders, asking the Minister “the estimated cost to the State to abolish prescription charges for all medical card holders”.

Minister Donnelly responded by highlighting that for people over 70, the charges have been reduced to €1 per item with a maximum monthly charge of €10 per person or family per month. Adding that for people under 70, where charges were reduced to €1.50 per item with a maximum monthly charge of €15 per person or family.

Minister Donnelly estimated that the minimum cost of abolishing prescription charges for all eligible people would be approximately €60 million per annum.

Thomas Pringle TD (Donegal, Independent) further pressed the Minister of Health on prescription charges for medical card holders, asking “if the medical card levy, which places a financial burden on many older and vulnerable people, will be removed completely in Budget 2024”.

In response, Minister Donnelly stated, “While preparations in respect of Budget 2024 are ongoing, any health measures introduced will be in the context of the implementation of the health commitments in the Programme for Government and the funding available. A consideration of further reductions to the level of prescription charges, or to their removal entirely, will take place in that context.”

Paul Murphy TD (Dublin South West, RISE), meanwhile, questioned Minister Donnelly over “whether pharmacies use a different supplier for medical card holders and those who are buying their medications”.

Minister Donnelly stated in response that he has referred this question to the HSE for a direct response.

Drugs Payment Scheme

The Minister for Health has faced questions surrounding differing aspects of the Drug Payment Scheme. Holly Cairns TD(Cork South West, Social Democrats) questioned the Minister on hormone replacement treatment, asking “his views on enabling individuals to purchase six-months of HRT in one calendar month to avail of the drugs payment scheme given that this medication is not being provided for publicly”.

In response, Minister Donnelly stated that “the length or duration of a prescription is at the clinical discretion of the prescriber, but ordinarily a prescription in Ireland is valid for a maximum period of six months. The rationale for this time limit is to ensure that appropriate medical care continues to be afforded to persons in receipt of prescriptions.”

The Minister explained that, “It has always been the position that only one month’s supply should be dispensed under the GMS scheme or other community drug schemes, including the DPS. Pharmacies can dispense more than one month supply to private patients in circumstances where no patient safety issues arise and there are no concerns in respect of the continued supply of the product.”

Cannabis usage for medical reasons

Gino Kenny TD (Dublin Mid West, People Before Profit Alliance) has twice raised issues surrounding medical cannabis.

Deputy Kenny first raised an expansion of the medical cannabis access programme, stating that “30 people can get access via a prescription” to Taoiseach Leo Varadkar (Dublin West, Fine Gael).

In response the Taoiseach stated that he would get the Minister for Health to directly respond to the Deputy, noting that “There is a medical cannabis programme, as the Deputy knows, but there are still differing views in the medical profession in particular as to the clinical efficacy and appropriateness of prescribing cannabis.”

Deputy Kenny also raised the issue of medical cannabis with Minister for Justice Simon Harris TD (Wicklow, Fine Gael) regarding an individual incarcerated for supplying medical cannabis to individuals illegally.

Minister Harris stated that “Sentencing is of course a matter for the Judiciary, who are entirely independent in the exercise of their functions. I cannot intervene in the outcome of any court proceeding.”

Contraception scheme

Seán Sherlock TD (Cork East, Labour) has asked several queries surrounding the contraception scheme’s scope, including questions on the scheme’s uptake.

In response, the Minister of State with responsibility for Public Health, Well Being and the National Drugs Strategy, Hildegarde Naughton (Galway West, Fine Gael) stated that, “As of Q4, 2022, over 2,200 GPs, primary care centres, family planning centres and student health clinics have signed contracts with the HSE to provide services under the free contraception scheme, with additional providers pending. Similarly, over 1,850 pharmacies are also participating.”

Continuing, Minister for State Naughton said that, “Data relating to the number of people accessing services under the scheme, the uptake of specific forms of contraception and specific services claimed under the scheme is currently being gathered by the HSE; records regarding the numbers of GPs, family planning clinics and pharmacies contracted under the scheme are also maintained.”

eHealth on the agenda

The issue of eHealth records and prescribing has been raised again with the Minister for Health. Richard Bruton TD (Dublin Bay North, Fine Gael) asked Minister for Health Stephen Donnelly TD, “if he will provide a progress report on investment in a proper system of electronic health records; if he will indicate the barriers, if any, to more rapid progress; the estimated penetration to date; and the initiatives planned to accelerate and complete the project.”

In response, Minster Donnelly said, “We are now investing a significant amount of resources in Digital Health to support the implementation of Sláintecare. Capital funding for ICT has increased from €85 million in 2018 to €140 million in 2023.”

Minster Donnelly continued by saying that, “Our engagements with health systems in other parts of the world, that are considered leaders in digital health, all indicate that patient access to digital health records is a long-term project with very few, if any, examples where this has been achieved simply by deploying a single, national enterprise EHR solution. These programmes must be clinically led, informed by patients, and address the needs of healthcare professionals, patients and the health system itself that is responsible for managing the service.”

Status of relevant legislation

We will provide an update on these pages several times a year of the status of legislation relevant to the pharmacy profession.

Legislative process explained:

• Drafting: There is usually a consultation process before the Government publishes a Bill.

• Pre-legislative scrutiny: The general scheme, or draft heads, of a Government Bill undergoes scrutiny by an Oireachtas Committee before the text of the Bill is finalised.

• First Stage: The Bill is initiated in either the Seanad or the Dáil.

• Second Stage: The general principles of the Bill are debated.

• Third Stage: Committee Stage. Committee Stage is a detailed examination of each section of the Bill and an opportunity for Government and Opposition Members to make changes to the text.

• Fourth Stage: Report Stage. Report Stage is the last opportunity for Members to make amendments to the text of a Bill. Members may not bring forward any new amendments, only amendments which arise from Committee Stage.

• Fifth Stage: Final Stage. During the fifth stage no amendments may be tabled and there is generally no in-depth discussion of the Bill. When a Bill passes the Final Stage in the House in which it was initiated, it is sent to the other House. There, it must go through the Stages of debate, beginning on Second Stage.

• Enactment: Once a Bill has been passed by the Dáil and Seanad, the President signs it into law. It becomes an Act and is added to the Statute Book.