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Proposed Changes to Terms of Service for NHS Pharmacists March 2019

On 9 February the Human Medicines Regulations 2012 were amended (“the 2019Amendment.  These regulations amend the Human Medicines Regulations 2012 to provide for the sale or supply of prescription only medicines by a pharmacist under an SSP issued by the Secretary of State for Health and Social Services and the Ministers of Northern Ireland (medicines regulation being a devolved matter in Northern Ireland) and either of them acting alone or both of them acting jointly.
 
The amendment regulations give  the Secretary of State for Health and Social Services and NI Ministers powers to issue SSPs where, in their opinion, the United Kingdom or part of the United Kingdom is experiencing, or may experience, a severe shortage of particular prescription only medicines. The SSPs will allow for substitution, in restricted circumstances, of a different quantity of a prescription only medicine, or a different prescription only medicine, to that ordered by the prescriber.
 
The introduction of the SSP is not a direct response to the potential for disruption to the UK medicines supply chains following EU exit. However, following EU exit, if the supply chain for a particular medicine is affected to such an extent that a severe shortage arises, the SSP will be useful in mitigating supply difficulties, particularly at community pharmacies. 
 
The SSP allows a pharmacist to dispense a different quantity, strength or form (e.g. tablets rather than capsules) of a medicine than that ordered on a prescription.  In some circumstances the SSP will allow a different medicine to be dispensed.  Where an SSP is not in place it is a criminal offence to supply a medicine other than as ordered by the prescriber. 
 
The supply of NHS prescriptions is the subject of both criminal (the Medicines Act 1968 and Human Medicines Regulations 2012) and NHS law (the NHS (Pharmaceutical Services) (Wales) Regulations 2013).
 
The terms of service for pharmacists are set out in Schedule 4 of the NHS (Pharmaceutical Services) (Wales) Regulations 2013; regulation 5(1) of the schedule requires that:
 
“…an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the prescriber in the prescription form, provide the drugs so ordered, and such of the appliances so ordered …”
 
This means whilst the Human Medicines (Amendment) Regulations 2019 provide for a pharmacist to deviate from a prescription where an SSP is in place, doing so will result in a pharmacist being in breach of their terms of service.  In England plans are in hand to amend NHS legislation to deal with this.  If Welsh Government do not make similar amendments there is a risk pharmacists in Wales will not act in accordance with SSPs which will, as a consequence, compromise our contingency arrangements for medicine supplies at the UK and national levels.
 
WG therefore intend to amend the NHS (Pharmaceutical Services) (Wales) Regulations 2013 to align with NHS England ie. to change the terms of service for pharmacists,; such that when a Serious Shortage Protocol (SSP) is issued, a community pharmacist may dispense a different quantity, strength or form (e.g. tablets rather than capsules) of a medicine from that ordered on a prescription and as specified in the SSP.  In some circumstances the SSP will allow a different medicine to be dispensed.