Written answers

Tuesday, 13 February 2024

Department of Health

Medicinal Products

Photo of Chris AndrewsChris Andrews (Dublin Bay South, Sinn Fein)
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554. To ask the Minister for Health if he will intervene in the case of a person (details suppled) and ensure that their prescription only drug will be made available to them. [6065/24]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Ozempic is licensed for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Novo Nordisk, the company responsible for supplying Ozempic, has notified of supply issues with its glucagon-like peptide-1 (GLP-1) receptor agonist products including Ozempic.

Novo Nordisk has outlined that these supply issues are due to increased global demand for GLP-1 products coupled with manufacturing capacity constraints at manufacturing sites. The company anticipates that intermittent supply issues will continue throughout 2024.

Novo Nordisk has informed the Health Products Regulatory Authority (HPRA) that it has implemented monthly allocations to help ensure continuity of supply and equitable distribution of stock to patients and is working on increasing its capacity to increase production of Ozempic.

The HPRA is engaging closely with the company and the wholesalers involved in the supply of this product to keep the health system and the public informed - ozempic-availability-september---info-for-hcps-and-patients---1-sept-2023701f152697826eee9b55ff00008c97d0.pdf (hpra.ie).

Novo Nordisk has issued letters to relevant stakeholders, including healthcare professionals to ensure they are aware of this supply issue and its management –

ema-mandated-victoza-amp-ozempic-direct-healthcare-professional-communication-(dhpc).pdf (hpra.ie).

Further information and HSE guidance is also available relating to Ozempic supply interruption for healthcare professionals and patients - glp1-ra-shortage-clinical-advice-ncpd-01112023.pdf (hpra.ie).

I recognise that medicine shortages can be challenging for patients, carers, healthcare professionals and their teams. Based on shortages notified to the HPRA, this matter has been the subject of engagement across Health Service stakeholders. Where at all possible, all parties are focused on pre-empting and responding to any potential impacts on medicines supply. Where a shortage cannot be prevented, we will aim to provide useful information to healthcare professionals and patients.

The HPRA maintains a list of current and resolved shortages on its website, where the details, including the information above, are detailed. The webpage is updated daily as new information is received.

With regard to the pharmacy, S.I. 488 of 2008 provides for the safe and appropriate supply of medicines:

“Review of medicine therapy and counselling of patients in the supply of medicinal products on foot of a prescription

9. (1) A person carrying on a retail pharmacy business, the superintendent pharmacist and the supervising pharmacist shall ensure that, prior to the dispensing of each prescription and prior to the supply of the medicinal product concerned, a registered pharmacist reviews the prescription having regard to the pharmaceutical and therapeutic appropriateness of the medicine therapy for the patient.

(2) The review provided for in paragraph (1) shall include screening for any potential therapy problems which may arise out of the use of any medicinal product that may have been prescribed and which the registered pharmacist is, or, in the course of his professional practice, ought reasonably to be, aware of. The potential problems to be screened for shall include those which may be due to therapeutic duplication, interactions with other medicinal products (including serious interactions with non-prescription medicinal products, herbal products or foods), incorrect dosage or duration of treatment, allergic reactions, and clinical abuse and/or misuse.”

The legislation provides for a pharmacist to reject dispensing a medication if they feel it is not pharmaceutically and therapeutically appropriate. I don’t have knowledge as to why this patient hasn’t been supplied with the Ozempic and it would not be appropriate for me to comment on individual cases.

Where this shortage impacts ongoing treatment for a patient, prescribers and pharmacists, in conjunction with patients, should discuss with their Healthcare professional the most appropriate course of action, based on suitable alternative treatment options available.

If you are not happy with the treatment you have received in a pharmacy, or you have a concern about a pharmacist's conduct or behavior, you can make a complaint to the Pharmacy Regulator (PSI).

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