National Health Service Citation and commencement 1 These Regulations may be cited as the National Health Service (Serious Shortage Protocols) (Miscellaneous Amendments) (Scotland) Regulations 2019 and come into force on 31 October 2019. Amendment of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 2 The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 are amended in accordance with regulations 3 and 4. 3 In regulation 2(1) (interpretation and application)— a after the definition of “prescription form” insert— “prescription only medicine” has the meaning given in regulation 5 of the Human Medicines Regulations 2012 , , and b after the definition of “scheduled drug” insert— “Scottish SSP” means a Scottish serious shortage protocol which is a written protocol in respect of any drug or appliance which is not a prescription only medicine that— is issued by the Scottish Ministers in circumstances where Scotland or any part of Scotland is, in the opinion of the Scottish Ministers, experiencing or may experience a serious shortage of— a specified drug or appliance, or drugs or appliances of a specified description, provides for the supply by a pharmacist or dispensing doctor, where there is an order on a prescription form or serial prescription for— the specified drug or appliance, or a drug or appliance of the specified description, of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist, subject to such conditions as may be specified in the Scottish SSP, and specifies the period for which, and the parts of Scotland (which may be all of Scotland) for which the Scottish SSP is to have effect, “serious shortage protocol” means, in respect of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012 , “SSP” means a serious shortage protocol, . 4 In paragraph 4 (provision of pharmaceutical services) of schedule 1 (terms of service for pharmacists and pharmacy contractors)— a in sub-paragraph (23) after “and (29)” insert “to (33)”, and b after sub-paragraph (29) insert— 30 This sub-paragraph applies where— a a person requests a prescription only medicine— i from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act , and ii in accordance with a prescription form or serial prescription, and b a SSP has effect in respect of— i the requested prescription only medicine, or ii prescription only medicines of a specified description, and the requested prescription only medicine is of that description. 31 Where sub-paragraph (30) applies, a pharmacist may supply a prescription only medicine in accordance with a SSP where— a the conditions specified in regulation 226A of the Human Medicines Regulations 2012 are satisfied, and b the pharmacist is able to do so with reasonable promptness. 32 This sub-paragraph applies where— a a person requests a drug or appliance— i from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act , and ii in accordance with a prescription form or serial prescription, and b a Scottish SSP has effect in respect of— i the requested drug or appliance, or ii drugs or appliances of a specified description, and the requested drug or appliance is of that description. 33 Where sub-paragraph (32) applies, a pharmacist may supply a different drug or appliance or quantity or strength of a drug or appliance to that ordered on the prescription form or serial prescription where— a the pharmacist is able to do so with reasonable promptness, b to do so is in accordance with the Scottish SSP, and c the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that the supply of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist is reasonable and appropriate. 34 Where sub-paragraph (30) or (32) applies— a a pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and b the pharmacist is able to supply the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale, but not with reasonable promptness, the requirements to act with reasonable promptness in sub-paragraphs (1), (1A)(a) and (3) are to be read as requirements to act within a reasonable timescale. 35 A pharmacist must refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where— a sub-paragraph (30) or (32) applies, and b alternative supply has already taken place in accordance with the SSP or the Scottish SSP. 36 A pharmacist may refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where— a sub-paragraph (30) or (32) applies, b the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and c the pharmacist is unable to provide the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale. 37 Where a pharmacist refuses to supply a prescription only medicine or other drug or appliance under sub-paragraph (36), the pharmacist must contact the prescriber or dentist to discuss alternative arrangements. 38 Where a pharmacist supplies a prescription only medicine in accordance with a SSP or other drug or appliance in accordance with a Scottish SSP the pharmacist must— a include in the dispensing label on the packaging of the prescription only medicine or other drug or appliance, for the patient’s benefit, information to the effect that the prescription only medicine or other drug or appliance is being supplied in accordance with a SSP or a Scottish SSP, identifying the particular SSP or Scottish SSP, and b supply the prescription only medicine or other drug or appliance in a suitable container. . Amendment of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018 5 The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018 are amended in accordance with regulations 6 and 7. 6 In regulation 3(1) (interpretation) after the definition of “Scheduled drug” insert— “Scottish SSP” has the meaning given in regulation 2(1) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 , . 7 In paragraph 44 (provision of dispensing services) of schedule 6 (other contractual terms) after sub-paragraph (10) insert— 11 A contractor who is required or authorised by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) may do so in accordance with a Scottish SSP. . Amendment of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018 8 The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018 are amended in accordance with regulations 9 and 10. 9 In regulation 3(1) (interpretation) after the definition of “Scheduled drug” insert— “Scottish SSP” has the meaning given in regulation 2(1) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009, . 10 In paragraph 16 (provision of dispensing services) of schedule 1 (content of agreements) after sub-paragraph (10) insert— 11 A provider who is required or authorised by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) may do so in accordance with a Scottish SSP. . JEANE FREEMAN A member of the Scottish Government St Andrew’s House, Edinburgh 10th September 2019