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Written question asked by Lord Warner (Crossbench) on Tuesday, 8 January 2019, in the House of Lords. It was due for an answer on Tuesday, 22 January 2019. It was answered by Baroness Manzoor (Conservative) on Tuesday, 22 January 2019 on behalf of the Department of Health and Social Care.

Prescription Drugs

Question

To ask Her Majesty's Government, in relation to the proposed changes to the Human Medicines Regulation 2012, as outlined in the document Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal, published on 4 January, what assessment they have made of whether allowing pharmacists to lead on medicines substitution and override physicians would (1) reduce the transparency of communication across the health system about medicines supplied, (2) confuse patients and physicians, and (3) affect the quality of care delivered by the NHS; and whether those proposed changes are consistent with the outcome of the public consultation on automatic generic substitution in 2010.

Answer

Community pharmacists have an important role in ensuring that patient get the medicines they need. If a serious shortage protocol is in place they can dispense an alternative but only as prescribed in the protocol.

A protocol would increase the transparency of communication across the health system and reduce confusion amongst patients and prescribers as the protocol will give prescribers clarity about what will happen in the event a prescription only medicine is unavailable.

A protocol would support the quality of care delivered by the National Health Service. In particular, in a situation with multiple large shortages, serious shortages protocols can have an important role in reducing delays in getting patients their medicines and freeing up general practitioners’ time.

The serious shortage protocol provisions would enable retail pharmacies to provide a generic medicine when the brand has been prescribed but only if there is a serious shortage of that particular branded medicine and only if the protocol, developed with and signed off by clinicians, allows for the substitution. This is not automatic generic substitution of branded medicines by retail pharmacies which is currently not allowed and the Department has no plans to change this.

Secondary information

Type
Written question
Reference
HL12686
Session
2017-19
Subjects
Doctors Patients Pharmacy Prescription drugs Regulation Shortages Brexit
Legislation
Human Medicines Regulations 2012
Link
View this Written question on www.parliament.uk