CONCERNS OVER PROPOSED NEW
MHRA LEGISLATION

Medicines and Healthcare Regulatory Agency (MHRA) "Consolidation and review of UK medicines legislation"

On October 25 2011, the MHRA issued a consultation document on the need and options for consolidating the UK medicines legislation.2 This aims to rationalise and simplify existing fragmented and complex medicines legislation, to improve the coherence of the regulatory framework.


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


AUTOMATIC GENERIC SUBSTITUTION

Automatic generic substitution (AGS) is the term for a scheme proposed by the Department of Health (DH) in 2009. AGS would have allowed pharmacists to dispense a generic version of a medication (a version with the same active ingredient), even if the doctor had written the prescription for a specific brand.


The Department of Health says no to AGS

After a consultation that resulted in written responses from 423 organisations and individuals, the DH announced, on 14 October 2010, that it had stopped plans to introduce AGS by pharmacists. The DH decided that concerns over patient safety were sufficiently grounded in fact and that it was therefore not appropriate to implement AGS.1

 

Taking Action Works!

The DH decided not to proceed with AGS as it reviewed the responses to the consultation and agreed that AGS was too great a risk to patients.

The correct use of medicines is important for achieving this goal, and the role of pharmacists is fully acknowledged in helping to achieve this. However, it is important that the relevant MHRA legislation is worded accurately to ensure that generic substitution or even therapeutic substitution by pharmacists is not inadvertently embedded in medicines legislation.

Thank you to those that acted last time - we are delighted that the DH listened to us and acted on our concerns.

Useful resources

Losing the right medication for the right patient

Norgine position paper

Norgine discussion. There is no Substitute

Outcome of DoH consultation on generic substitution

14th October 2010

Contacts

Julie Hornby Winfield
Norgine
JWinfield@norgine.com
+44 (0)1895 826642

Jennifer Garratt
Burson-Marsteller
Jennifer.Garratt@bm.com
+44 (0) 207 300 6240

References

This website is sponsored by Norgine Pharmaceuticals Ltd


MEGS/2739/DEC11

Norgine Automatic Generic Substitution