Changes in regulations will require that valproate-containing medicines be dispensed in the manufacturer’s original full pack, according to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has published new guidance to support dispensers in implementing this change, which will take effect on Wednesday, October 11, 2023.
The decision to amend legislation follows a government consultation aimed at ensuring that patients consistently receive important safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are included in the original full pack. These safety materials play a crucial role in informing patients about the risks to unborn babies when valproate-containing medicines are used during pregnancy.
The Department of Health and Social Care (DHSC) led a consultation on original pack dispensing and supply of medicines containing sodium valproate, and there was overwhelming support for the introduction of these new measures to further enhance the safety of valproate-containing medicines.
A majority of respondents to the consultation, 85%, agreed or strongly agreed that the full-pack dispensing of valproate-containing medicines in the manufacturer’s original pack would ensure that patients receive the safety information provided on the label and in the Patient Information Leaflet.
Dr. June Raine, Chief Executive of the MHRA, emphasised the importance of patients receiving up-to-date safety information with each prescription of valproate-containing medicines. The changes in legislation announced aim to achieve this goal. Dr. Raine also urged patients not to discontinue taking valproate-containing medicines without consulting a healthcare professional, and to seek advice if concerns about the risks arise.
Maria Caulfield, the Minister for Public Health, highlighted the significance of the safety information in keeping patients informed about the risks associated with valproate. She encouraged all dispensers of valproate to carefully review the new guidance, emphasising the government’s commitment to improving patient safety based on the experiences of those affected by valproate and their families.
Valproate-containing medicines pose a significant risk of birth defects and developmental disorders in unborn babies and children born to women who take these medicines during pregnancy. To ensure patients are fully aware of these risks and the need to avoid becoming pregnant, prescribing to women and girls of childbearing potential must comply with the conditions of the Valproate Pregnancy Prevention Programme.
Under the new legislation, dispensers, such as pharmacists, have the flexibility to round the prescribed amount of valproate-containing medicines up or down so that patients receive only complete packs. The medicines must not be repackaged into plain dispensing packaging.
Exceptions can be made on an individual patient basis in rare cases, provided a risk assessment is in place that justifies different packaging, such as a need for a monitored dosage system. In such cases, the pharmacist must ensure that the patient receives the Patient Information Leaflet and can explain why they are not receiving the manufacturer’s original full pack.
