Regulatory update  

Risperdal 1mg/1ml Oral Solutions — Medication Errors 

The HPRA issued a Safety Notice in February concerning a risk of medication errors with Risperidone 1mg/1ml Oral Solutions, leading to accidental overdose in children and adolescents. In Ireland, these medicines are licenced for use from age five. The starting dose is 0.25mg or 0.5mg once daily (depending on weight) with an optimum dose of 0.5mg or 1mg once daily for most patients, with some requiring 1.5mg once daily. 

These errors were primarily attributed to small dose volumes prescribed for the paediatric population (0.25 ml –1.5 ml), which may cause confusion when administered with larger dosing devices.  

The notice states that there is variability in dosing devices across different risperidone liquid products.  

Pharmacists should: 

• Advise the caregiver/patient to carefully read the package leaflet; 

• Provide clear guidance on how to read the dosing scale, highlighting where to take volume readings on the syringe. Particular attention should be paid to differences in scale positions, such as on the plungers versus the syringe body; 

• Demonstrate how to measure small volumes; 

• Advise the caregiver/patient to use only the dosing device supplied with the product; 

• Emphasise the importance of rinsing the dosing device with plain water and letting it air dry after each use; and 

• Advise caregivers/patients to urgently seek medical attention in case of overdose or if overdose symptoms occur. 

The notice states that there is variability in dosing devices across different risperidone liquid products.  

The most frequent incidents were linked to decimal point errors, resulting in ten-fold overdosing.  

Symptoms reported in the overdose cases included drowsiness, sedation, tachycardia, hypotension, extrapyramidal symptoms, QT prolongation, and convulsions. Cardiovascular and central nervous system events, particularly QT prolongation and convulsions, can be life-threatening for vulnerable patient groups. 

See hpra.ie > Safety information > Safety Notices, and search Risperidone, 28 February 2025. 

Recall of Atomoxetine ULM Capsules

Medisource and Uniphar issued pharmacy level recalls of Glenmark Atomoxetine 25mg, 40mg and 80mg capsules (available as EMP/ULM) in February. This is due to the presence of a nitrosamine impurity, N-Nitroso Atomoxetine at levels which exceed the current acceptable intake. The affected batches below should be quarantined and returned to your wholesaler. 

The affected batches and recall letters can be found at ipu.ie > Support > IPU Product File > Product Information and Recalls. 

Recall of Neupogen 30MU (0.3mg/ml) 1ml Vials  

Amgen issued a pharmacy level recall of Neupogen 30MU (0.3mg/ml), 5 x 1ml vials, PA 1026/001/001 in March, due to out of specification results for purity at 36-months. The affected batches below should be quarantined and returned to your wholesaler. 

The full recall letter is available at ipu.ie > Support > IPU Product File > Product Information and Recalls. 

IPU Practice support 

The IPU Veterinary Service page has been updated to reflect the changes made to national legislation regarding the sale and supply of veterinary medicines from a retail pharmacy business and the implementation of the National Veterinary Prescription System (NVPS). Please note that the NVPS only applies to prescriptions issued to food-producing animals and equines. For more information about this matter visit ipu.ie > Professional.  

Palliative Meds Info Service 

The Palliative Meds Info service is a national service providing information for health professionals on all aspects of medicines use in palliative care. This service is based at Our Lady’s Hospice and Care Services’ Pharmacy Department, and responds to enquiries received by phone or email. The website has a range of frequently used palliative meds information documents, including an opioid conversion chart and a searchable ‘Essential Medicines for Palliative Care in the Community list’. Further information can be found at olh.ie > Health & Social Care Professionals > Palliative Meds Info. 

Professional Guidance 

The PSI has published an overview of the inspection findings for 2024. One of the areas identified for improvement related to the accessibility of pharmacy records. It was noted that some pharmacies maintain certain pharmacy records in a digital format (for example, quality assurance records, SOPs, temperature logs, out-of-date medicines log, dispensing error and near-miss logs, etc). When maintaining digital records, please remember that the format should maintain the integrity of the record and only authorised personnel should be permitted to edit/amend them. Managing access to digital records is important, therefore those in governance should ensure that the pharmacy team can access these records and are familiar with how to navigate them and/or utilise them.  

For further information on this topic please visit: 

• PSI’s Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business — Version 4, March 2024, available at psi.ie Practice Supports > Guidance and Guidelines For Pharmacists and Pharmacies; and 

• Learning from inspections: July-December 2024, available at psi.ie > Practice Supports > Practice Updates and Learnings.