Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
The Medicine Healthcare and Regulatory Authority (MHRA) has taken the decision to reclassify the legal status for Benacort Hayfever Relief for Adults 64 micrograms nasal spray from POM to GSL. The MHRA has made this decision with the following terms of reclassification:
Commenting on their website the MHRA have said the following:
“The MHRA considers that there is no reason to believe that there is a higher risk of misuse for Benacort Hayfever Relief compared to other corticosteroid nasal sprays that are already classified as GSL. There is no evidence of abuse of these products since they were reclassified to GSL.
“GSL medicines for the treatment of hayfever have been available for decades. Therefore, a patient’s ability to self-diagnose hayfever has already been established.
“Instructions about who should not use the product, and warnings and precautions for when using it are on the label and PIL. The maximum duration of continuous use before seeking medical advice has been limited to one month, which has been emphasised clearly on the product information. Patients are advised to seek professional advice if symptoms are not controlled or persist for longer than 7 days. These limitations on use are considered safe enough for users to self-treat their condition without masking any underlying serious conditions or delaying the amount of time it takes for them to seek further advice from a healthcare professional. They are also consistent with the limitations on use for other GSL corticosteroid nasal sprays.
“The 60-actuation (spray) pack size provides a maximum of 30 days treatment (at the minimum daily dose), which is not greater than the maximum length of treatment of other GSL corticosteroid nasal sprays and aligns with the maximum recommended length of continuous treatment (at minimum dose) before seeking medical advice.
“No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons:
“The treatment of hayfever is a well-established GSL indication within the UK environment. Consumers are used to buying hayfever treatments including nasal sprays on self-selection in a general retail outlet. The MHRA accepts that the wider availability of Benacort Hayfever Relief would be beneficial to patients as it would allow access to another corticosteroid nasal spray in the GSL setting.”
This circular is being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.