Domperidone Test Purchase Exercise

Between 2015 and 2017 we carried out test purchases of domperidone products in pharmacies. This was based on changes to the marketing authorisation that were made to these products because of increased adverse cardiac risks. 

Background

In October 2014, the PSI published updated guidance on the Safe Supply of Non-Prescription Medicinal Products Containing Domperidone to highlight the increased adverse cardiac risks associated with domperidone use identified by the European Medicines Agency (EMA) and to notify pharmacists of the updated marketing authorisation.

PSI Test Purchase Exercises

Considering these changes and the updated PSI Guidance, we carried out test purchase exercises between 2015-2017 in community pharmacies, selected at random, to check whether non-prescription medicines containing domperidone were being supplied in accordance with the updated guidance.

How was the test purchase carried out?

 The test purchase scenario instructed the mystery shoppers to:

  • Request a domperidone-containing non-prescription medicine
  • Purchase the product
  • Note any question(s) asked by the pharmacy staff members and interactions with the individuals engaged in the sale/supply of the medicine
  • If questions were asked of the mystery shopper, s/he was instructed to inform the pharmacist/other staff member that the medicines were for their partner or relative who has some nausea and bloating, who is 61 years old and is on tablets for their heart
  • Ask to speak to the pharmacist once the transaction was completed to verify whether the pharmacist made the sale or not. Based on this scenario, domperidone is not a suitable medicine for this patient and a sale should not have been carried out.
Domperidone Test Purchase Results
Domperidone Test Purchase Exercise Results

Specific comparison

Of the pharmacies visited in 2016, 17% were revisited after previously failing the exercise. None of these pharmacies supplied the domperidone-containing medicine during the revisit, and this is a positive outcome.

Who made the inappropriate supply?

In 2016, 50% of the inappropriate supplies were made by a pharmacist, and the remaining 50% by another pharmacy staff member.

Outcomes and Concerns

The exercise was carried out to reinforce the importance of maintaining up-to-date knowledge of changes in the use of medicines, their contraindications and potential for harm to patients. The comparisons between the two exercises indicate a positive improvement in compliance, and awareness raised about supply of domperidone containing products. While noting the improvements in relation to this type of medicine, the supply of medicines contrary to their marketing authorisations, and PSI guidance, remains a concern to the PSI.

  • Consultation: Supplies of these products were being made where pharmacists were not carrying out a consultation, or a proper consultation, with the patient or their carer to ensure that the medicine is safe and appropriate for that person.
  • Clinical Awareness: Not all pharmacists were demonstrating full clinical awareness of the updated indications and contraindications for the use of domperidone.
  • Staff Training: All non-pharmacist staff may not have been properly trained on the updated requirements of the marketing authorisation for domperidone and the PSI guidance.
  • Storage: Some pharmacies continued to inappropriately store non-prescription domperidone-containing medicinal products behind the medicines counter or in the public pharmacy area, instead of in the dispensary.

Advice

All pharmacists are reminded to ensure that they keep their knowledge up to date and ensure that they are familiar with the updated product information for medicines containing domperidone, including the requirements of the PSI guidance.

In addition, superintendent and supervising pharmacists should ensure that all staff members are aware that requests for domperidone must be referred to the pharmacist. The pharmacy’s SOPs should be updated to reflect these changes if this has not already been completed. Refer to the Guidance on the Safe Supply of Non-Prescription Medicinal Products Containing Domperidone for detailed information.