MAS Directions

1. Citation and commencement

1.1 These Directions may be cited as the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2016 and come into force on 1 August 2016.

2. Interpretation

2.1 In these directions, unless the context otherwise requires:

“the Act” means the National Health Service (Scotland) Act 1978

“the 2009 Regulations” means the National Health Service (Pharmaceutical Services) (Scotland) regulations 2009

“the 2011 Directions” means the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2011;

“the 2011 Regulations” means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011

“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 2010

“consultation” means a consultation with a pharmacist under the Minor Ailment Service

“eligible person” means a person who at the time of initial registration, and at the time of any subsequent consultation falls within the following categories of person:

  1. a person who is under the age of 16 years

  2. a person who is under the age of 19 years and is receiving qualifying full time education within the meaning of paragraph 7 of Schedule 11 to the Act;

  3. a person who is 60 years of age or over;

  4. a woman to whom a Health Board has issued an exemption certificate on the ground that she is an expectant mother or has within the last 12 months given birth to a live child or a child registrable as still-born under the Registration of Births, Deaths and Marriages (Scotland) Act 1965;

  5. a person with a valid exemption certificate;

  6. a person to whom the Secretary of State has issued a valid exemption certificate in respect of the supply of drugs and appliances for the treatment of accepted disablement but only in respect of those supplies to which the certificate relates;

  7. a person who falls within the categories of person specified in regulation 4(2) of the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) Regulations 2003 ;

  8. except that a person who would be eligible by virtue of (a) to (g) is not an eligible person if that person is:

    1. not registered on a permanent basis with a GP in Scotland; or

    2. persons whose main or usual residence is a care home,

and “eligible persons” shall be construed accordingly.

“exemption certificate” means a certificate issued by a Health Board to a named patient under Regulation 4 of the 2011 Regulations

“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 2012;

“MAS provider” means a person with whom a Health Board has made arrangements for the provision of a Minor Ailment Service as described in paragraph 5.1;

“Minor Ailment Service” or “MAS” has the meaning ascribed in paragraph 3.1

“Minor Ailment Service stationery” or “MAS stationery” means forms, approved by Scottish Ministers, on which -

  1. the details of a patient registered for MAS are recorded; and

  2. the details of a registered patient’s MAS transactions are recorded, including:

    1. any consultation undertaken

    2. any supply of medicine or appliance

    3. any referral to another healthcare practitioner

“patient record” means a record maintained for each recipient of 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 20109 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976

“Pharmacy (P) medicine” has the meaning ascribed to “pharmacy medicine” in The Medicines (Pharmacy and General Sale-Exemption) Order 1980

“registration” means registration for the Minor Ailment Service in terms of paragraphs 3 to 5 of Schedule 2, and “registered” shall 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 Other words and phrases used in these Directions have the same meaning as they have in the Act and in the 2009 Regulations.

  1. a registered patient in terms of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 200412;
  2. a registered patient in terms of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 200413; or
  3. 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

  1. to a numbered paragraph, is a reference to a paragraph bearing that number in these Directions

  2. to a numbered Schedule, is a reference to the Schedule to these Directions bearing that number; and

  3. 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 Minor Ailment Service

3.1 The Minor Ailment Service is a service for the provision of pharmaceutical care to persons who are registered to receive MAS by a person who is authorised to provide 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 are comprised in MAS are specified in Schedule 1 and schedule 4.

4. Health Board duty to arrange for a Minor Ailment Service

4.1 Until otherwise directed, Health Boards have a duty to arrange for the provision of Minor Ailment Services (MAS) for persons in their area as additional pharmaceutical services.

4.2 Health Boards must inform MAS providers of the formulary or prescribing guidelines that apply to the provision of MAS in their area. The products that a Health Board may include on their 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 services14 (the “black list”);

(ii) dressings and appliances from Part 2 of the Drug Tariff; (iii) approved appliances from Part 3 of the Tariff; and

(iv) any Prescription Only Medicines (POMs) that are detailed in a Patient Group Direction in relation to MAS.

5. Persons authorised to provide the Minor Ailment Service

5.1 Health Boards may only enter into arrangements for the provision of MAS with:

    1. a person who is a registered pharmacist; or

    2. a person other than a registered pharmacist who, by virtue of section 69 of the Medicines Act 1968 , 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

    1. is on the pharmaceutical list maintained by the Health Board in terms of regulation 5 of the 2009 Regulations ; and

    2. undertakes that all MAS shall be provided either by or under the direct supervision of a registered pharmacist.

6. Compliance and Conditions

6.1 The arrangements made by a 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 provider of MAS must comply.

6.2 Where a MAS provider requires a pharmacist to provide MAS, the MAS provider has ultimate responsibility for ensuring that the MAS service is provided in accordance with these Directions.

7. Payment for the provision of a Minor Ailment Service

7.1 Remuneration for the provision of 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 a MAS provider for any preparations or appliances that he or she may supply to patients registered for MAS in connection with providing MAS will be in accordance with the provisions set out in Part 1 of the Drug Tariff.

8. The Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2011

8.1 These Directions revoke and supersede the 2011 Directions.

8.2 Notwithstanding paragraph 8.1, the 2011 Directions shall continue to apply in respect of any MAS provided on or before 31 July 2016.

Schedule 1 - Services To Be Provided As A Minor Ailment Service

1. The service comprises a consultation with a pharmacist and advice on the condition(s) that the patient presents 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), he or she will refer the patient to that person.

2. The products that can be supplied by the pharmacist are listed in a nationally set formulary, which includes:

  1. Pharmacy (P) and General Sales List (GSL) medicines that are not listed in directions given by Scottish Ministers under section 17N(6) of the Primary Medical Services (Scotland) Act 2004

  2. dressings and appliances from Part 2 of the Drug Tariff

  3. selected items from Part 3 of the Tariff; and

  4. any Prescription Only Medicines (POMs) that are detailed in a Patient Group Direction (PGD) in relation to MAS.

Schedule 2 - Terms And Conditions Of The Provision Of A Minor Ailment Service

1. A MAS provider must not advertise or offer incentives to the public to register for MAS, or set targets for employee pharmacists or staff to recruit people for MAS or for any other aspects of MAS.

2. A MAS provider may only issue or display the publicity material and patient information leaflet made available by Scottish Ministers in respect of MAS and the provision of MAS to promote and raise public awareness of the service.

3. Where a person is an eligible person and wishes to register for the service, a MAS provider must ensure that the registration process is undertaken in accordance the procedures set out in Schedule 4, and in particular that:

  1. evidence is seen to confirm the person’s eligibility;

  2. only MAS stationery approved by Scottish Ministers is used for the registration process;

  3. the patient’s, or their representative’s agreement to register has been obtained and recorded; and

  4. a patient record is established.

4. For the purposes of MAS the ‘patient record’ is a pharmacy retained record (paper and/or electronic) that as a minimum must include:

  1. the name and address of the patient;

  2. 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;

  3. the grounds for the patient’s eligibility to register for MAS;

  4. the date of each MAS consultation; and

  5. the services provided to the registered patient as MAS, to include:

    1. information on whether advice, treatment or onward referral was provided;

    2. details of any treatment provided; and

    3. the name, quantity, form and strength of any product supplied

5. MAS can be provided to a patient only from the premises at which the patient is registered for MAS.

6. Subject to the provisions of any Regulations made under section 69 of the 1978 Act, all drugs, containers and appliances supplied for MAS shall be supplied free of charge.

7. A MAS provider is to use MAS stationery to record details where a patient registered for MAS

  1. receives advice;

  2. is supplied with medicines and appliances for treatment purposes;

  3. is referred to another healthcare practitioner; or

  4. is no longer eligible for MAS and registration must be withdrawn.

8. Where a MAS provider supplies medicines, dressings and appliances he or she must have regard to any local formulary that the Health Board applies.

9. The products that may be supplied under MAS are:

10. The supply of medicines, dressings or appliances is to be performed by or under the direct supervision of a pharmacist.

11. Where the pharmacist referred to at paragraph 9 is employed, the pharmacist must not be one:

  1. who, has been disqualified under section 29B(2) of the Act , or

  2. who is suspended by direction of the Tribunal, or

  3. who is the subject of a corresponding decision in England, Wales or Northern Ireland.

12. In providing MAS a MAS provider shall do so:

  1. in compliance with all procedures and processes described in the service specification included at Schedule 4 of these directions;

  2. having regard to and, where required, in compliance with, stated standards and administrative guidance that is from time to time produced by Scottish Ministers; and

  3. in conformity with the standards generally accepted in the pharmaceutical profession.

13. The provisions at paragraphs paragraph 12 of Schedule 1 of the 2009 Regulations with regard to and referred to as a “complaints procedure” shall apply to the provision of MAS

14. A MAS provider must ensure that –

  1. where that MAS provider is an individual, they provide MAS in accordance with these directions; and

  2. where a MAS provider requires a pharmacist to provide MAS, that the pharmacist provides the MAS service in accordance with these directions.

Schedule 3 - Payment For The Minor Ailment Service

1. Where a provider of MAS complies fully with these directions, payment for the provision of a Minor Ailment Service will be paid monthly in arrears at the rates set out in the Drug Tariff.

2. Capitation payments will be calculated on the number of patients registered with the MAS provider for MAS on the last day of each month.

3.

  1. Where a person registered to receive MAS is no longer an eligible person, the MAS provider with whom that person is so registered must terminate that registration as soon as that change in status is known by the provider. In the event that the provider fails to do so, the Agency shall be entitled to refuse to make any payment in respect of MAS to the provider in respect of that person

  2. Notwithstanding sub-paragraph (a) of this paragraph, in the event that the Agency is made aware that a person registered to receive MAS is no longer eligible, the Agency will terminate that registration as soon as that change in status is known, and notify the relevant provider accordingly.

4. A registered person who has not used a MAS provider for 12 months and whose registration for MAS is deemed lapsed shall not be included in the number of registered patients on which the capitation payment is calculated.

5. A person whose registration for MAS was deemed lapsed but whose registration is reactivated shall be included in the number of registered patients of that MAS provider on which the capitation payment is calculated with effect from the last day of the month in which reactivation occurs.

6. Confirmation of patient registration and withdrawal, and claims for reimbursement of any medicines or appliances supplied to a registered patient, are to be made on MAS stationery and submitted within every two months to Practitioner Services Division of the Common Services Agency (NHS National Services Scotland) by the dates it specifies.

7. Health Boards will be entitled to take such reasonable steps as are necessary to ensure that MAS providers are:

  1. providing MAS as specified in Schedule 1 and complying with the provisions of Schedules 2 and 4 ; and

  2. only displaying the agreed patient information leaflets and publicity materials made available by Scottish Ministers in respect of MAS.

8. Payments made to providers for providing MAS will be subject to post-payment verification checks and investigation by the Agency.

9. Where after suitable investigation a Health Board is satisfied that a MAS provider is not providing the services listed in Schedule 1 and/or complying with the provisions of Schedule 2 and 4, but is receiving payment in terms of this Schedule and the rates set out in the Drug Tariff, it may (without prejudice to any other action which may be open to it):

  1. write to the provider advising of the conclusion reached by the investigation;

  2. inform the provider that payments will be stopped with immediate effect;

  3. recover any payments made to the provider under this Schedule and the Drug Tariff in respect of any period(s) when the provider was not providing the services specified in Schedule 1 and/or complying with the provisions of Schedule 2 and 4; and

  4. in exceptional circumstances, such as deliberate or repeated non-compliance with the provisions of Schedules 2 and 4, withdraw the service from the MAS provider and notify the General Pharmaceutical Council.

Schedule 4 - MAS Specification