NHS Circular: PCA (P)(2017) 2     Chief Medical Officer Directorate Pharmacy and Medicines Division Dear Colleague 18 January 2017 ______________________ PHARMACEUTICAL SERVICES Addresses EXTENDED MINOR AILMENT SERVICE PILOT IN INVERCLYDE HEALTH AND SOCIAL CARE For action PARTNERSHIP Chief Executive, NHS Greater Glasgow & Clyde Purpose 1. This Circular encloses Directions and a service For information specification for the Extended Minor Ailment Service Pilot Chief Executive, NHS NSS due to take place in the Inverclyde area of NHS Greater Director of Practitioner Service, Glasgow and Clyde in 2017. NHS NSS Directors of Pharmacy Background _____________________ Enquiries about pilot to: 2. The Programme for Government, published on Email: 6 September 2016, included a commitment to test the [email protected] feasibility of an expanded community pharmacy Minor Ailment Service, accessible to all patients. A pilot exercise ___________________ General Enquiries to: will commence on 30 January 2017 in the Inverclyde Health and Social Care Partnership. Elaine Muirhead Pharmacy & Medicines Detail Division 1st Floor East Rear St Andrew’s House 3. The pilot will involve the current MAS being EDINBURGH extended to all patients registered with a GP practice in EH1 3DG Inverclyde and augmented to include treatments for the most common, uncomplicated conditions normally Tel: 0131-244-3433 requiring a GP prescription. This initiative will allow an Email: extended MAS to be piloted and evaluated as part of a [email protected] whole systems approach to primary care transformational change within the Inverclyde Health and Social Care www.gov.scot Partnership area. 4. Directions providing the legal framework for the pilot and the service specification are attached as an Annex to this circular. 5. Patients in Inverclyde who are not eligible for the extended MAS pilot will be able to continue to access the national MAS, providing they meet the eligibility criteria for that service, which is unchanged. St Andrew’s House, Regent Road, Edinburgh EH1 3DG  www.gov.scot  Key Principles 6. In providing Extended MAS in Inverclyde, community pharmacy contractors are expected to give due regard to and apply the Key Principles for the provision and operation of MAS, as set out in Circular PCA(P)(2016(12), issued on 20 July 2016. Funding arrangements 7. Community pharmacy contractors who have agreed to participate in the extended MAS pilot will be entitled to a one-off start up payment of £500 and a monthly payment of £100 for the duration of the pilot, followed by a one-off final evaluation payment of £500. These payments are in addition to the existing payment and funding arrangements for MAS. 8. Community Pharmacy Scotland has been consulted on the terms of this circular and the Drug Tariff has been amended. Action 9. NHS Greater Glasgow & Clyde is asked to note the contents of this Circular and to bring it to the attention of community pharmacy contractors, GPs, local pharmacy committees and Health and Social Care Partnerships. Yours sincerely, Rose Marie Parr Chief Pharmaceutical Officer/ Deputy Director Pharmacy & Medicines Division ANNEX NATIONAL HEALTH SERVICE (SCOTLAND) ACT 1978 HEALTH BOARD ADDITIONAL PHARMACEUTICAL SERVICES (MINOR AILMENT SERVICE) (INVERCLYDE PILOT EXTENSION) (SCOTLAND) DIRECTIONS 2017 The Scottish Ministers, in exercise of the powers conferred by sections 2(5), 27A, 27B, and 105(6) and (7) of the National Health Service (Scotland) Act 19781, and all other powers enabling them to do so, give the following Directions. 1. Citation, commencement and application 1.1 These Directions may be cited as the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Inverclyde Pilot Extension) (Scotland) Directions 2017 and come into force on 30 January 2017. 1.2 These Directions apply to arrangements made between Greater Glasgow Health Board2 and a provider listed in Schedule 5 for the provision of an Extended Minor Ailment Service as an additional pharmaceutical service. 1.3 Subject to paragraph 1.4, the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2016 are dis-applied in respect of arrangements to which these directions apply. 1.4 The Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2016 continue to apply for the purpose of arrangements between Greater Glasgow Health Board and a provider listed in schedule 5 for the provision of a Minor Ailment Service to a patient who is not eligible for an Extended Minor Ailment Service. 2. Interpretation 2.1 In these Directions, unless the context otherwise requires: “the 2009 Regulations” means the National Health Service (Pharmaceutical Services) (Scotland) Regulations 20093; 1 1978 c.29; section 2(5) was amended by the National Health Service and Community Care Act 1990 (c.19), section 66(1) and Schedule 9, para. 19(1); section 27A was inserted by the National Health Service (Primary Care) Act 1997 (c.46) (“the 1997 Act”), section 27(2); section 27B was inserted by the 1997 Act, section 28(2); section 105(7) was amended by the Health Services Act 1980 (c.53), section 25(3) and Schedule 6, paragraph 5(1) and Schedule 7, the Health and Social Services and Social Security Adjudications Act 1983 (c.41), section 29(1) and Schedule 9, Part I, paragraph 24 and by the 1999 Act, section 65 and Schedule 4, paragraph 60. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998 (c.46). 2 As constituted by the National Health Service (Constitution of Health Boards) (Scotland) Order 1974 (S.I. 1974/267). “the 2011 Regulations” means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 20114; “the Act” means the National Health Service (Scotland) Act 1978; “the Agency” means to Common Services Agency for the Scottish Health Service”; “approved appliance” means an appliance which has been approved by the Practitioner Services Division of the Common Services Agency for provision under MAS; “care home” means an establishment which provides a care home service as defined in paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 20105; “consultation” means a consultation with a pharmacist under the Extended Minor Ailment Service; “eligible person” means a person who in terms of paragraph 4.1 of schedule 4 to these directions is eligible for Extended MAS, and “eligible persons” shall be construed accordingly. “Extended Minor Ailment Service” or “Extended MAS” has the meaning provided in paragraph 3. “Extended MAS provider” means a person with whom Greater Glasgow Health Board has made arrangements, in accordance with these directions, for the provision of an Extended Minor Ailment Service’ “General Sales List (GSL) Medicine” has the meaning ascribed to “medicinal product subject to general sale” by regulation 5(1) of the Human Medicines Regulations 20126; “Minor Ailment Service” or “MAS” means a service provided in accordance with the MAS Directions; “the MAS Directions” means the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2016; “Minor Ailment Service stationery” or “MAS stationery” means forms, approved by Scottish Ministers, on which - (a) the details of a patient registered for extended MAS are recorded; or 3 S.S.I. 2009/183, amended by S.S.I. 2009/209, S.S.I. 2010/128, S.I. 2010/231, S.S.I. 2011/32, S.S.I. 2011/55, S.S.I. 2012/36, S.I. 2012/1916, S.I. 2012/1479, S.I. 2012/2041, S.I. 2013/235, S.S.I. 2014/73, S.S.I. 2014/148 and S.I. 2015/968. 4 S.S.I. 2011/55, amended by S.S.I. 2012/74, S.S.I. 2013/191, S.S.I. 2014/115 and S.S.I 2015/160. 5 2010 asp 8. 6 S.I. 2012/1916. (b) the details of a registered patient’s extended MAS transactions are recorded, including: (i) any consultation undertaken; (ii) any supply of medicine or appliance; and (iii) any referral to another healthcare practitioner; “patient record” means a record maintained for each recipient of extended MAS in accordance with paragraph 4 of Schedule 2; “patient group direction” or “PGD” has the meaning ascribed to it in regulation 213(1) of the Human Medicines Regulations 2012; “pharmacist” means a person who is registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 20107 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 19768 “Pharmacy (P) medicine” has the meaning ascribed to “pharmacy medicine” in article 1 of the Medicines (Pharmacy and General Sale-Exemption) Order 19809; “the Pilot area” means the part of the area of Greater Glasgow Health Board which is within the area of Inverclyde Council10; “registration” means registration for the Extended Minor Ailment Service in terms of paragraphs 3 to 5 of Schedule 2, and “registered” shall, except where the context otherwise requires, be construed accordingly ; “Yellow Card reporting mechanism” means an arrangement set up for reporting adverse reactions to medicines to the Medicines and Healthcare products Regulatory Agency on pre- printed and postage paid yellow cards, or to www.yellowcard.gov.uk. 2.2 A person is registered on a permanent basis with a GP if that person is: (a) a registered patient in terms of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 200411; (b) a registered patient in terms of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 200412; or 7 S.I. 2010/231 8 S.I. 1976/1213 (N.I. 22) 9 S.I. 1980/1924 10 The area of Greater Glasgow Health Board is set out in schedule 1 to the National Health Service (Variation of Areas of Health Boards) (Scotland) Order 2013 (S.S.I. 2013/347). The area of Inverclyde Council is set out in schedule 1 of the Local Government (Scotland) Act 1994 (c 39) as read with section 2(1) of that Act. 11 S.S.I. 2004/115. Regulation 2 defines “registered patient”. 12 S.S.I. 2004/116. Regulation 2 defines “registered patient”. (c) otherwise registered (other than as a temporary resident) to receive primary medical services in terms of the Act. 2.3 Other words and phrases used in these Directions have the same meaning as they have in the Act and in the 2009 Regulations. 2.4 Any reference in these Directions (i) to a numbered paragraph, is a reference to a paragraph bearing that number in these Directions; (ii) to a numbered Schedule, is a reference to the Schedule to these Directions bearing that number; and (iii) to a numbered paragraph of a numbered Schedule, is a reference to a paragraph bearing that number in the Schedule bearing that number. 3. Description of the Extended Minor Ailment Service 3.1. The Extended Minor Ailment Service is a service for the provision of pharmaceutical care to persons who are registered to receive Extended MAS by a person who is authorised to provide Extended MAS in terms of paragraph 5 and, where appropriate, advice, treatment or onward referral by that person to another NHS healthcare practitioner. 3.2 The services which comprise Extended MAS are specified in Schedule 1 and Schedule 4. 4. Health Board authorised to arrange for provision of an Extended Minor Ailment Service 4.1 Until otherwise directed, Greater Glasgow Health Board may arrange for the provision of Extended Minor Ailment Services (Extended MAS) for eligible persons in the pilot area as additional pharmaceutical services in accordance with these Directions. 4.2 Greater Glasgow Health Board must inform Extended MAS providers of the formulary or prescribing guidelines that apply to the provision of Extended MAS in their area. The products that the Health Board may include on the Extended MAS formulary are: (i) Pharmacy (P) and General Sales List (GSL) medicines that are not listed in directions given by Scottish Ministers under section 17N(6) of the Act as to drugs, medicines or other substances which may or may not be ordered for a patient in the provision of primary medical services13 (the “black list”); (ii) dressings and appliances from Part 2 of the Drug Tariff; (iii) approved appliances from Part 3 of the Tariff; and 13 Directions of the Scottish Ministers as to the drugs, medicines or other substances which may, or may not, be ordered for patients in the provision of primary medical services under a general medical services contract were issued on 9 February 2011. (iv) any Prescription Only Medicines (POMs) that are detailed in a Patient Group Direction in relation to Extended MAS. 5. Persons authorised to provide the Extended Minor Ailment Service 5.1 Greater Glasgow Health Board may only enter into arrangements for the provision of extended MAS with: (a) a pharmacist; or (b) a person other than a pharmacist who, by virtue of section 69 of the Medicines Act 196814, is taken to be a person lawfully conducting a retail pharmacy business in accordance with that section; and, in the case of both (a) and (b) who: (i) is on the pharmaceutical list maintained by the Health Board in terms of regulation 5 of the 2009 Regulations15; (ii) undertakes that all Extended MAS shall be provided either by or under the direct supervision of a pharmacist; and (iii) undertakes to provide Extended MAS only from premises within the Pilot Area . 6. Compliance and Conditions 6.1 Arrangements made by Greater Glasgow Health Board in accordance with paragraphs 4 and 5 shall include the imposition of the terms and conditions specified in Schedule 2, with which the Extended MAS provider must comply. 6.2 Where an Extended MAS provider requires a pharmacist to provide Extended MAS, the Extended MAS provider has ultimate responsibility for ensuring that the Extended MAS is provided in accordance with these Directions. 7. Payment for the provision of an Extended Minor Ailment Service 7.1. Remuneration for the provision of Extended MAS will be paid at nationally negotiated rates as set out in the Drug Tariff and in accordance with Schedule 3 of these Directions. 7.2. The prices and methodology for calculating reimbursements to an Extended MAS provider for any preparations or appliances that he or she may supply to patients registered for Extended MAS in connection with providing Extended MAS will be in accordance with the provisions set out in Part 1 of the Drug Tariff. 14 1968 c.67. Section 69 was amended by the Pharmacists (Fitness to Practise) Act 1997 (c.19), section 1 and paragraph 5 of the Schedule, by the Statute Law Repeals Act 1993 (c.50), Schedule 1 (XII), para. 1 and by S.I. 2007/289, S.I. 2007/3101 and S.I. 2010/231. 15 Regulation 5 was amended by S.S.I. 2011/32 and S.S.I. 2014/148 Signed by authority of the Scottish Ministers Dr Rose Marie Parr A member of the Senior Civil Service 17 January 2017 NATIONAL HEALTH SERVICE (SCOTLAND) ACT 1978 HEALTH BOARD ADDITIONAL PHARMACEUTICAL SERVICES (MINOR AILMENT SERVICE) (INVERCLYDE PILOT EXTENSION) (SCOTLAND) DIRECTIONS 2017 SCHEDULE 1 SERVICE TO BE PROVIDED AS AN EXTENDED MINOR AILMENT SERVICE The service comprises a consultation with a pharmacist and advice on the condition(s) that the patient or patient’s representative presents, information and advice about appropriate self- care measures in respect of the condition(s) and, where the pharmacist considers it appropriate, the supply of preparations or appliances for its treatment. Where the pharmacist considers the condition is one that requires to be considered by another member of the primary care team (e.g. a GP), the pharmacist will refer the patient to that person. NATIONAL HEALTH SERVICE (SCOTLAND) ACT 1978 HEALTH BOARD ADDITIONAL PHARMACEUTICAL SERVICES (MINOR AILMENT SERVICE) (INVERCLYDE PILOT EXTENSION) (SCOTLAND) DIRECTIONS 2017 SCHEDULE 2 TERMS AND CONDITIONS OF THE PROVISION OF AN EXTENDED MINOR AILMENT SERVICE 1. An Extended MAS provider must not offer any incentives or inducements to the public to register for the Extended MAS; offer any incentives or inducements or set targets for employee pharmacists or staff to recruit people for the Extended MAS or for any other aspects of the Extended MAS. 2. An Extended MAS provider may only issue or display the publicity material and patient information leaflet made available by Scottish Ministers or by Greater Glasgow Health Board in respect of the Extended MAS and the provision of the Extended MAS to promote and raise public awareness of the service. 3. Where an eligible person wishes to register for the service, an Extended MAS provider must ensure that the registration process is undertaken in accordance the procedures set out in Schedule 4, and in particular that: ; (a) only MAS stationery approved by Scottish Ministers is used for the registration process; (b) the patient’s, or their representative’s agreement to register has been obtained and recorded; and (c) a patient record is established. 4. For the purposes of the Extended MAS the ‘patient record’ is a pharmacy retained record (paper and/or electronic) that as a minimum must include: (a) the name and address of the patient; (b) where relevant, the name and address of the person who gave consent to, or applied for, the registration and that person’s relationship to the person who is registered; (c) the GP practice at which the patient is registered; (d) the date of each Extended MAS consultation; and (e) the services provided to the registered patient as Extended MAS, to include: (i) information on whether advice, treatment or onward referral was provided; (ii) details of any treatment provided; and (iii) the name, quantity, form and strength of any product supplied. 5. Extended MAS can be provided to a patient only from the premises at which the patient is registered for Extended MAS.