Dáil Éireann Debate, Thursday - 9 February 2023
304. Deputy Paul Kehoe asked the Minister for Health the process in writing by which pregnant women are experiencing extreme nausea and vomiting can obtain cariban; and if he will make a statement on the matter. [6380/23]
Amharc ar fhreagraFollowing the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment;
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed;
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community schemes eligibility – either the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS) – and submits the claim using the relevant administrative code in their monthly submission to PCRS.
