Shire comment for MHRA web discussion regarding medicine information online
• Is the intent to move away from the physical Patient Information Leaflet (PIL) in the pack? There may be numerous benefits to this approach as the latest information would be available to patients and Healthcare professionals more quickly. For example:
• Physicians being able to access latest information. This may for example minimise risk of medication errors.
• Electronic versions afford the ability to increase the font on the computer screen for improved readability of the medicine information.
• Patients would be able to access information about their medicines more readily e.g. whilst on holiday
• MHRA should consider whether the online information be value added or a duplication of information already available through the well established eMC site?
• If for any reason the patient has not received a PIL with their medicine e.g. if a pharmacist has split a pack, they would be able to access the latest PIL.
• Would industry be given an opportunity to review their Summary of Product Characteristics (SPCs)/PILs before being posted onto the website?
• How soon would the SPC/PIL be loaded onto the website after approval? Would there be an indication given as to whether a product was marketed?
• To avoid queries would available pack sizes be flagged?
Why the contribution is important
Regarding the discussion process, is this discussion and request for opinion the precursor for a formal Consultation period requested by the MHRA?