Concerns over section 11: "Optimisation of medicines use"
Sections 11.1 and 11.3 propose that a pharmacist would be able to change the name of the product or its common name and the directions for use of the product (presumably dosage instructions), on a prescription without notifying the prescriber. Allowing pharmacists to change the name of the prescribed medicine and its directions for use could in effect lead to generic or therapeutic substitution by pharmacists. The way the proposed legislation is currently drafted, a pharmacist would be free to dispense a generic medicine against a prescription for the brand, which is not in the best interest of patients.1
To express concerns to the MHRA
All interested parties are entitled to respond to this consultation, which closes on Tuesday 17 January.
Responses to the consultation, pointing out that the currently proposed wording of the legislation may unintentionally enable generic substitution by pharmacists, will be vital to avoid a serious error by the MHRA in the drafting of the legislation, which could have significant consequences.
Should you wish to respond in this way, the information should be communicated in section 27 of the response document: "Do you agree with the proposal to facilitate the optimisation of medicines use? Why, or why not?"
Please see Norgine's position paper in the Useful Resources section on the right column of this page.
Anyone who has concerns should visit the MHRA website where they can review the consultation document and express any concerns or views here