Helping patients optimise the use of their medication safely and effectively is a fundamental responsibility of community pharmacists. This month’s Medication Optimisation Update highlights the EMA response to paracetamol use in pregnancy; an IPU CPC initiative to improve asthma care; a recent IMSN safety alert; and how to report shortages of veterinary medicines.  

Regulatory Update

Use of paracetamol during pregnancy

In September in the US, the FDA issued a letter to doctors stating that “in recent years, evidence has accumulated suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children”. It goes on to say; “To be clear, while an association has been described in many studies, a causal relationship has not been established, and there are contrary studies in the scientific literature . . . clinicians should consider minimising use of acetaminophen during pregnancy for routine low-grade fevers.” The messaging that hit the headlines was different and was alarming. Patients may need reassurance as to whether they can continue to use paracetamol safely in pregnancy. In the EU, the EMA, the next day, released a news item stating that there is, “currently no new evidence that would require changes to the EU recommendations for use. As stated in the SPCs, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of malformations in the developing foetus or in newborns. In 2019, the EMA reviewed available studies and found that the results were inconclusive and no link with neurodevelopment disorders could be established. The EU will continue to monitor the safety of medicines containing paracetamol.” Advice for patients in the pharmacy:

• When needed, paracetamol can be used during pregnancy;
• Follow instructions and guidance when taking paracetamol;
• Always read the medicines information leaflet supplied with medication; and
• As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest time possible, and as infrequently as possible.

Resources:

• fda.gov/media/188843/download?attachment
• hpra.ie > News & Events > HPRA statement on use of paracetamol medicines during pregnancy (23/09/2025)
• ema.europa.eu > News & Events > Use of paracetamol during pregnancy unchanged in the EU (23 September 2025);
• ‘Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability’, available at ncbi.nlm.nih.gov/38592388; and

 

IPU Practice Support

IPU Community Pharmacy Committee (CPC) SABA sticker campaign

The IPU CPC are running a health promotion campaign regarding the overuse of short-acting beta agonist (SABA) inhalers.  This campaign highlights a crucial message to patients who are prescribed SABA reliever inhalers. It encourages them to avoid being over-reliant on their SABA inhaler, particularly if they are not using their inhaled corticosteroid (ICS) inhaler regularly. Consistent use of the ICS inhaler is essential for reducing asthma exacerbations and maintaining control of the condition. As part of this campaign, the IPU and the Asthma Society of Ireland have developed reminder  who are prescribed SABA inhalers to promote their safe use. The stickers can be stuck onto the box of SABA inhalers by the pharmacy team prior to collection by the patient. These stickers are included with this month’s IPU Review.  

Useful reference source

IMSN Safety Alert: Constipation in patients with Parkinsons Disease

Constipation is one of the most common and distressing non-motor symptoms of Parkinson’s Disease (PD) occurring in 50 to 80 per cent of persons with PD. The Irish Medication Safety Network (IMSN), in collaboration with Parkinson’s Ireland have prepared a third alert in a series of articles looking at safe medicines use in patients with PD. The September 2025 article is focusing on constipation in patients with Parkinsons. The series of articles is available at imsn.ie/parkinsons-a3-2025.

 

Professional guidance

Shortages of veterinary medicines

Shortages of medicines can have a detrimental effect on animal welfare. Therefore, the rational use of medicines needs to be stressed when there is a shortage of specific veterinary medicines. The Department of Agriculture, Food and the Marine (DAFM) have a notification process in place for the reporting of shortages of medicines relating to veterinary medicines. The form to be used by end users, i.e., pharmacists to notify DAFM about a shortage of vet medicines is available at gov.ie > Departments > Department of Agriculture, Food and the Marine > Department Divisions > Animal Health > Veterinary Medicine & Residues > Sector Notification Form of Veterinary Medicine Product Shortage.