Dear Pharmacist,

Women of child bearing age who take medicines containing valproate are at an increased risk of abnormal pregnancy outcomes. The medicines are known to pose a considerable risk of malformations and developmental problems in babies who are exposed to valproate in the womb. The PSI expects all pharmacists to inform women of child bearing age of these potential risks when supplying valproate containing medicines. All relevant information about valproate containing medicines must be relayed to these patients. As previously stated pharmacists must provide counselling, and include a Package Leaflet and Alert Card with each supply of these medicines, whether the supply is made to the patient in the manufacturer’s original packaging or not.

A public hearing of the European Medicines Agency (EMA) was held about valproate and related substances in September 2017. Following this hearing, the EMA’s experts in medicines safety - the Pharmacovigilance Risk Assessment Committee (PRAC) – on the 9th of February 2018 published new measures to avoid exposure of babies to valproate medicines in the womb. The PSI is working closely with the HPRA, the HSE and other national stakeholders on the implementation of those new recommendations. We will advise you of any further national measures introduced in this regard.

Patients will have been prescribed this treatment by another healthcare professional and pharmacists are reminded of the key role that they play as part of a safe system of care for patients.

Supervising pharmacists, in whole-time charge of the operation of a pharmacy, in conjunction with a superintendent pharmacist, have particular responsibilities and they must:

• ensure that all pharmacist and pharmacy staff members in the pharmacy are aware of the risks associated with valproate containing medicines,
• ensure that all patients are counselled on the risks associated with valproate-containing medicines, and that all patients receive a Package Leaflet and Alert Card at each supply of these medicines,
• monitor on-going safe practice in relation to this matter and take actions necessary to ensure patient safety.

We have circulated information on the risks and related dispensing requirements for valproate medicines on several occasions, in previous issues of the PSI newsletter (2015 and 2017), and with a direct email to all registered pharmacists again in November last year. Pharmacists should also be in receipt this week of a circular from the HSE’s PCRS on this same matter.

Educational materials, which include a Patient Information Card or Alert Card, are available from the license holders for valproate containing medicines, and further useful information can be found on the HPRA website.

The patient safety implications in relation to this medicine are of serious concern and we have also issued a public statement on the matter.

The PSI continues to be concerned about recent reports in the media which have highlighted, again, instances where pharmacists allegedly have not supplied Package Leaflets, to patients receiving valproate containing medicines. To ensure the health and safety of your patients, superintendent pharmacists should immediately address any gaps identified in the supply of valproate containing medicines to women of child bearing age, in all pharmacies under your responsibility.