National Health Service Citation and commencement 1 1 These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2020. 2 Subject to paragraph (3) these Regulations come into force on 24 January 2021. 3 Regulation 4(2), (3) and (4) come into force on 12 February 2021. 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 to 5. 3 In regulation 2(1) (interpretation and application)— a after the definition of “optometrist independent prescriber”, insert— “pandemic treatment protocol” means a protocol that— relates to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of a disease being imminently, pandemic and a serious risk, or potentially a serious risk, to human health, and is approved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease), , and b after the definition of “provisional pharmaceutical list”, insert— “PTP” means a pandemic treatment protocol, . 4 1 Paragraph 4 (provision of pharmaceutical services) of schedule 1 (terms of service for pharmacists and pharmacy contractors) is amended as follows. 2 In sub-paragraph (2)— a in head (a)— i for “chronic medication service”, where it appears for the first time, substitute “Medicines: Care and Review Service”, and ii for “chronic medication service”, where it appears for the second time, substitute “service to assist patients with drugs, medicines and appliances and the management of long term illnesses, diseases or health conditions”, b after head (a), insert— aa “prison” means— i a prison within the meaning of section 43 of the Prisons (Scotland) Act 1989 , ii a remand centre within the meaning of section 19(1)(a) of that Act, or iii a young offenders institution within the meaning of section 19(1)(b) of that Act , , c in head (b)— i after “doctor” in each place it occurs, insert “, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber”, ii in sub-head (i), for “2”, substitute “3”, iii in sub-head (iii)— aa after “receive”, insert “those”, and bb after “3 months,”, insert “or where that patient receives primary medical services in prison,”, and iv in the text after sub-head (iii), from “registered” to the end of head (b), substitute “a long-term illness, disease or health condition that requires ongoing management over a period of a year or longer,”, and d in head (c)(ii)— i for “the”, where it appears before “pharmacy contractor”, substitute “a”, and ii omit from “with whom”, to the end of sub-head (ii). 3 After sub-paragraph (2), insert— 2A A pharmacy contractor must ensure that drugs or appliances ordered on a serial prescription are not supplied to a patient unless the patient has registered with that pharmacy contractor for the provision of the Medicines: Care and Review Service. . 4 In sub-paragraph (3)— a for “has”, substitute “is”, and b for “chronic medication service”, substitute “Medicines: Care and Review Service”. 5 In sub-paragraph (11)— a for “ordered on a prescription form or a serial prescription”, substitute “in accordance with these Regulations”, b in head (a)— i omit “presenting the prescription form or serial prescription or”, and ii for “an electronic prescription form or serial prescription”, substitute “these Regulations”, and c in head (b)— i omit “presenting the prescription form or serial prescription, or”, and ii for “an electronic prescription form or serial prescription”, substitute “these Regulations”. 6 In sub-paragraph (23), for “(33)”, substitute “(43)”. 7 After sub-paragraph (38), insert— 39 A pharmacist may supply a prescription only medicine in accordance with a PTP where— a a PTP has effect in respect of the prescription only medicine, b the requirements specified in the PTP are satisfied, and c the pharmacist is able to supply the prescription only medicine with reasonable promptness. 40 A pharmacist may refuse to supply a prescription only medicine in accordance with a PTP where in the pharmacist’s professional judgement it is unreasonable or inappropriate to do so. 41 Where a pharmacist supplies a prescription only medicine in accordance with a PTP the pharmacist must— a include in the dispensing label on the packaging of the prescription only medicine, for the patient’s benefit, information to the effect that the prescription only medicine is being supplied in accordance with a PTP, identifying the particular PTP, and b supply the prescription only medicine in a suitable container. 42 A pharmacist may provide pharmaceutical services in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012 where the conditions specified in that regulation are satisfied. 43 A pharmacist may provide pharmaceutical services in response to an announcement of the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form of prescriptions) of the Misuse of Drugs Regulations 2001 . . 5 For paragraph 10(8) (method of payment) of schedule 1 (terms of service for pharmacists and pharmacy contractors), substitute— 8 No pharmacy contractor will be paid in respect of the supply of drugs or appliances— a indicated on a prescription form or serial prescription, b in terms of regulation 225 (emergency sale etc by pharmacist: at patient’s request) of the Human Medicines Regulations 2012 , c in terms of a Patient Group Direction issued by a Health Board in accordance with regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012 , d in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012 , e in accordance with a SSP or a Scottish SSP, f in accordance with a PTP, or g in response to an announcement by the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form or prescriptions) of the Misuse of Drugs Regulations 2001 , unless that supply takes place at a registered pharmacy included in the pharmaceutical list in respect of that pharmacy contractor. . JEANE FREEMAN A member of the Scottish Government St Andrew’s House, Edinburgh 8th December 2020