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Written question asked by Lord Warner (Crossbench) on Monday, 7 January 2019, in the House of Lords. It was due for an answer on Monday, 21 January 2019. It was answered by Baroness Manzoor (Conservative) on Monday, 21 January 2019 on behalf of the Department of Health and Social Care.

NHS: 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 supply triggers would be applied under the “Serious Shortage Protocol” for pharmacists to dispense (1) reduced quantities of medicine, (2) alternate dosage forms, (3) generic versions of the prescription-only medicine substitution, (4) similar medicinal products, and (5) medicines that have a similar therapeutic effect; whether there will be a full risk assessment performed for the types of medication and clinical circumstances to be included in the protocol; and whether this protocol will be (a) legally defined, and (b) developed with clinical experts.

Answer

A serious shortage protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate. A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. For each shortage the Department assesses the risk to patients and decides what tools to use to mitigate the impact on patients which could include a serious shortage protocol. The triggers for considering a protocol and the protocol itself will be different depending on the medicines and the supply situation, including whether alternatives are available.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol. Each protocol would clearly set out what alternative can be dispensed by the retail pharmacy, under what circumstances, for which patients and during which period.

Secondary information

Type
Written question
Reference
HL12629
Session
2017-19
Subjects
Drugs NHS Pharmacy Medical equipment Regulation Shortages Risk assessment Clinical trials Brexit
Legislation
Human Medicines Regulations 2012
Link
View this Written question on www.parliament.uk