Aindrias Moynihan (Cork North West, Fianna Fail)
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296. To ask the Minister for Health the measures that are being taken to address the issue of shortage of supplies for penicillin; if pharmacists can have the facility to change prescriptions to another form of antibiotic; and if he will make a statement on the matter. [62713/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Unfortunately, medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects.

Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. Ireland has a multi-stakeholder medicines shortages framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

The HPRA is generally informed of a medicine shortage by the relevant pharmaceutical company. Shortages can also be notified to the HPRA by other stakeholders across the health system. In each case, the HPRA will work with relevant stakeholders as necessary, including the HSE, to coordinate an effective approach to the management of a confirmed product shortage. There are shortages of some antibiotics affecting Ireland and other EU countries currently. These relate to manufacturing delays, production capacity issues and increased demand. The supply situation is more complex currently due to the concern over Strep A infections and the time of the year.

The HPRA are currently engaging with the MAHs for each of the products in short supply to understand the reason and seek solutions. They continue to liaise with other stakeholders such as the marketing authorisation holders (MAHs) of alternative products and the HSE in addition to publishing the shortage information on the HPRA’s shortage webpage (which includes the product name, active ingredient, the reason for the shortage, the start date, estimated return date and additional information such as the communication from the companies and clinical guidelines developed by the HSE.

As well, the HPRA is identifying and engaging with the suppliers of treatments and alternatives, as indicated by the HSE’s AMRIC team, to highlight the likely increase in demand and provide information on the availability of medicines. To that extent, we understand that alternative strengths, brands and generic medicines are available to ensure continuity of treatment.

The HPRA maintains a policy of accelerated regulatory approval to supply a product originally intended for other markets as Irish-authorised products, if available. The HPRA has engaged with wholesalers to ensure mechanisms are in place to ensure equitable distribution of treatments for cough and cold as well as antibiotics, having received information from one supplier, for example, that individual pharmacies were looking to stockpile by ordering 200 packs of a particular brand of antibiotic. As well, the HPRA has discussed this issue internationally with the EMA and other Member States to coordinate approaches to handling the shortages at an EU level.

In many instances a shortage of a particular medicine is effectively addressed to ensure continuity of care for a patient including through the substitution for a generic version (in the case of a branded medicine short supply) or a generic version from a different manufacturer (in the case of a generic medicine in short supply). Under the Health (Pricing and Supply of Medical Goods) Act 2013 medicines which are deemed to be interchangeable can be directly substituted for one another by a pharmacist.

Where an interchangeable product is not available in Ireland, a pharmacist, in consultation with the prescriber, can source a medicine containing the same active ingredient in order to ensure that continuity of patient care is maintained, wherever possible. Such medicines may be sourced in another European Member State, or by a specialist wholesaler in a third country, and are known as exempt medicinal products (EMPs). EMPs have not been granted a marketing authorisation in Ireland by the HPRA but are sourced in response to a bona fide unsolicited order in order to fulfil the special needs of a patient. These medicines will however have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in another EU Member State or third country by the respective competent authority for medicines.

In other instances, where a medicine shortage occurs due to a more global issue affecting multiple countries, a patient may be directed to return to their clinician to consider prescribing an alternative medicine for the treatment of their condition.

It is important to note that any health system must use evidence base for prudent use of antibiotics.

Antimicrobial resistance has been declared by the WHO as one of the top 10 global public health threats facing humanity, with the misuse and overuse of antimicrobials being the main drivers in the development of drug-resistant pathogens .

Ireland has recently joined to support a Non Paper originating with the NL, regarding Novel stimuli for the development and keeping on the market of antimicrobials. One of the key tenets of this paper is that the revision of the EU pharmaceutical legislation should incorporate measures for prudent and standardised use of antibiotics, such as personalised and evidence-based treatment, the classification of all antibiotics as prescription-only, and harmonisation of product information. Such harmonisation could aid in reducing differences in the prevalence of infectious diseases and antimicrobial resistance in the EU.

The HSE maintains a reimbursement list of medicines that are provided under the General Medical Services (GMS) scheme or the Drugs Payment Scheme (DPS). These products are approved for the schemes by the HSE. In some cases, an alternative product sourced to maintain continuity of care in the event of a medicine shortage may be more expensive than the original medicine prescribed and will not ordinarily be included in the reimbursement list.

However, GMS medical card holders can apply to the local HSE health office to have these costs covered under the discretionary hardship arrangements. Under the DPS an individual or family will pay no more than €80 each calendar month for approved prescribed medicines. In certain cases, the cost of EMPs can be included in the total costs of medicines up to the threshold of €80. Patients are advised to consult with their pharmacist or clinician, who can make an application under the discretionary hardship arrangements on their behalf or to have the product covered by the relevant scheme.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.

Bernard Durkan (Kildare North, Fine Gael)
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297. To ask the Minister for Health the availability to the fullest possible extent of medications to treat cystic fibrosis; the extent to which such drugs are readily available having been tested and approved at European and national level; the extent to which kaftrio is readily available to patients who require its use as a matter of urgency; if there are any issues surrounding its availability which require his intervention; and if he will make a statement on the matter. [62748/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Bernard Durkan (Kildare North, Fine Gael)
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298. To ask the Minister for Health if and when the drug kaftrio will be made available in the case of the children of a person (details supplied); if the drug can be made available as a matter of urgency given the extent of the negotiations that have occurred heretofore; if there is any action that he can take to ensure its immediate availability; and if he will make a statement on the matter. [62749/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.