Update on Domperidone

October 2014: 

Subsequent to the below, the PSI issued Guidance for pharmacists on the safe supply of non-prescription medicinal products containing domperidone. See related information in Safe Supply of Medicines section of this website.

June 2014:

Pharmacists will be aware of recent new advice on the safe use of domperidone products. Due to concerns regarding cardiac adverse effects associated with domperidone use, an evaluation of the benefits and risks of domperidone was recently undertaken by the European Medicines Agency (EMA). This review has now been completed and the full outcome of that review is available here.

Following the EMA review the HPRA issued updated advice on the use of domperidone. In addition, the National Medicines Information Centre has also issued an update in their recent newsletter. Pharmacists have a key role in the safe supply of this medicine to patients and therefore pharmacists should be aware of all the changes to the indications and use of domperidone containing products as highlighted in these communications.

In particular the PSI would like to highlight the following points:

  • Domperidone should now only be used in the relief of nausea and vomiting symptoms, and not in other indications.
  • Non-prescription domperidone products are not recommended for use in patients with underlying cardiac disease without medical supervision.
  • Domperidone should be recommended at the lowest effective dose for the shortest possible period (not usually exceeding 1 week).
  • The new recommended dose of domperidone in adults and adolescents ≥ 35 kg is 10 mg orally up to 3 times daily with a maximum dose of 30 mg per day or 30 mg twice daily when used in a suppository.

The EMA decision will be sent to the European Commission, which will take an EU-wide, legally binding position. At this point, it is expected that the product information for domperidone will be amended appropriately to reflect these recommendations. Ahead of this change to the product information, pharmacists should be supplying domperidone products and counselling patients in accordance with the new revised clinical information.

The PSI guidance to pharmacists on domperidone is that:

  • The supply of non-prescription domperidone containing medicines should only be by a registered pharmacist.
  • Requests for domperidone should be directed to the pharmacist to ensure appropriate patient review and counselling.
  • Appropriate counselling and advice should be provided to the patient by the pharmacist in order to ensure the correct use of these products in line with the new recommendations.
  • Domperidone containing non-prescriptions medicines should be stored in an area under the direct management and supervision of the pharmacist. The recommended location is in the dispensary, unless for justifiable reasons e.g. shortage of storage space, an alternative area of the pharmacy is used. This area must be close to the dispensary and therefore under the pharmacist's direct supervision.

(This was included in Issue 5 of the PSI Newsletter (June) 2014 )