Regulatory Update

Clarithromycin interaction updates

The HPRA Drug Safety Newsletter, 118^th Edition, March 2025, advised of some drug-drug interaction updates for clarithromycin which have now been updated in the SPC and PIL:

• The use of clarithromycin with ivabradine (Procoralan) is contraindicated;
• Clarithromycin should be used with caution in patients receiving Chloroquine (Avloclor) or Hydroxychloroquine (Plaquenil) due to the potential to induce cardiac arrhythmia and serious adverse cardiovascular events;
• Caution should be exercised when clarithromycin is co-administered with all DOACS such as dabigatran, rivaroxaban, apixaban and edoxaban; and
• Caution should be exercised with systemic and inhaled corticosteroids that are primarily metabolised by CYP3A (this includes dexamethasone, prednisolone, prednisone, triamcinolone, budesonide and fluticasone) due to the potential for increased systemic exposure to corticosteroids. Patients should be closely monitored for systemic corticosteroid undesirable effects.

 

Quetiapine — risk of serotonin syndrome with other serotonergic agents

The HPRA Drug Safety Newsletter, 118^th Edition, March 2025, also advised of a risk of serotonin syndrome when quetiapine is used with other serotonergic agents:

• Quetiapine is indicated for the treatment of schizophrenia and bipolar disorder. The prolonged-release tablets are also indicated for add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal responses to antidepressant monotherapy;
• Concomitant administration with other serotonergic agents, such as MAOIs, SSRIs, SNRIs, or tricyclic antidepressants, may result in serotonin syndrome, a potentially life-threatening condition;
• If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases; and

Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

 

IPU Practice Support

The IPU Gender Care webpage has been updated to support IPU members. The updated page contains the latest information available from the HSE, the PSI, and other organisations.

For further information on this topic please visit the IPU Gender Care webpage at ipu.ie > Professional > Supporting Patients > Gender Care.

 

Useful Reference Source

The HSE Antimicrobial Resistance and Infection Control (AMRIC) team has developed the following antimicrobial stewardship bite size microlearning videos:

• Viral and self-limiting respiratory tract infections;
• GREEN and RED antibiotics;
• Safer profile of fluoroquinolone antibiotics;
• Recurrent urinary tract infection; and
• Childhood infections.

These resources are available from the Irish Institute of Pharmacy (IIOP) Resource-hub.

For more information on antibiotic prescribing guidelines for treatment of community infections, please visit antibioticprescribing.ie.

 

Professional Guidance

Pharmacists can supply controlled drug medicines to a person specified in national legislation, other than on foot of a named patient prescription. This supply is made by way of a requisition.  Regulation 14 of the Misuse of Drugs Regulations 2017 (S.I. No. 173 of 2017) (as amended) sets the requirements for the supply of requisitions including:

• A list of those individuals who can request a controlled drug otherwise than on a prescription; and
• The information that must be recorded.

For further information on the supply of controlled drug medicines on foot of a requisition, please refer to:

• The Misuse of Drugs Regulations 2017 (as amended);
• PSI Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business, available at psi.ie > Practice Supports > Guidance and Guidelines for Pharmacists and Pharmacies;
• PSI EXPLANATORY NOTE on the Documentation and Other Requirements to be met by Pharmacists in Retail Pharmacy Businesses in Making Supplies of Controlled Drugs to Patients in Nursing Homes, available at psi.ie > Practice Supports > Guidance and Guidelines for Pharmacists and Pharmacies; and

Marine Notice No 60 of 2021 — Minimum safety and health requirements for improved medical treatment on board vessels, available at gov.ie > Departments > Department of Transport > Marine Notices.