Irish Pharmacist
Sunday 1 January 2012
PSI issues guidance on domperidone
The PSI has issued new guidance to pharmacists regarding the use of medicines containing domperidone.
The guidance follows on from new information which has become available on the cardiac risks associated with medicines containing domperidone.
According to this guidance, recent epidemiological studies provide some evidence that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death, and that these risks may be higher in patients older than 60 years or at daily oral doses of more than 30mg.
As pharmacists have a key role in supporting the safe and rational use of medicines, and particularly of non prescription medicines, the PSI has asked pharmacists to be particularly vigilant in respect of non-prescription medicines containing domperidone.
This guidance states:
• The supply of non-prescription domperidone containing medicines should only be by a registered pharmacist.
• Prior to supply, all pharmacists should consult with the patient to determine if it is safe and appropriate to supply a domperidone containing medicine to the individual patient.
• Pharmacists are advised that caution should be exercised in patients over the age of 60 years and in patients who have existing prolongation of cardiac intervals particularly TQc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure, and patients who are known to be taken prescribed medicines for these conditions.
• All patients should be advised that domperidone containing medicines shold be taken at the lowest effective dose and that extra caution is advised for doses above a 30mg daily dose.
• Pharmacists should be aware that the maximum daily dose currently specified in the SPC and PIL for the non prescription products on the Irish market ranges from 40mg daily to 80mg daily.
• There are currently four authorised medicinal products containing domperidone that are available in Ireland without prescription through pharmacies only; Motilium 10mg film-coated tablets, Motilium Fastmelts 10mg tablets, Motilium 10mg film coated tablets and Domerid Relief 10mg tablets.
• If in their professional opinion the pharmacists deems it is not safe to supply the medicine to the patient, they should consult with, or refer the patient to, the patient’s GP. In situations where a pharmacist deems the supply to be inappropriate, they should clearly explain to the patient the reasons they do not consider it safe to supply, and facilitate the patient with an alternative treatment or referral to a medical practitioner for further assessment.
• Superintendent and supervising pharmacists should ensure that all relevant staff are made aware of this new guidance, and that procedures are put in place to ensure that all patients presenting with relevant symptoms or requesting the product by name are referred to the pharmacist.
Further guidance on the storage and promotion of domperidone medicines has also been issues to pharmacists.