NHS Care Services

Minor Ailment Service - Directions

1. Citation and commencement

1.1 These Directions may be cited as the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2011 and shall come into force on 1 April 2011

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

“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 ;

except in the case of (a) to (g)):

1. persons who are not registered patients in terms of either the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 , or the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 ; and

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

“GSL medicine” means a medicine which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist, in accordance with section 51 of the Medicines Act 1968

“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. (a) the details of a patient registered for MAS are recorded; and

2. (b) 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” has the meaning ascribed in Article 1(2) of the Prescription Only Medicines (Human Use) Order 1997

“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

“the 2008 Directions” means the Health Board Additional Pharmaceutical Services (Minor Ailment Service) (Scotland) Directions 2008

“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.

2.3 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.

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.

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 terms and conditions specified in Schedule 2, with which the provider of MAS shall be obliged to comply.

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.

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 2008

8.1These Directions revoke and supersede the 2008 Directions.

8.2Notwithstanding paragraph 8.1, the 2008 Directions shall continue to apply in respect of any MAS provided during the period from 22 August 2008 until 31 March 2011.

Signed by authority of the Scottish Ministers

W Scott
Scottish Executive A member of the Senior Civil Service
22 March 2011

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.

3. Where a person is an eligible person and wishes to register for the service, a MAS provider must ensure 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 registration process is undertaken in accordance with procedures specified by the Scottish Ministers; 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; and

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

1. details of the advice or treatment provided;

2. the date on which each of the above was provided;

3. with respect to treatments, the name, quantity, form and strength of any product supplied; and

4. if the patient was referred to another NHS healthcare practitioner, the name of that practitioner, the date of the referral and the reasons for the referral;

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 a consultation;

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

3. is referred to another healthcare practitioner;

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

8. Where a MAS provider supplies medicines and appliances he or she must do so in accordance with paragraph 2 of Schedule 1.

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

10. 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.

11. In the case of adverse drug reactions, the MAS provider is to consider the need to report the event through the Yellow Card reporting mechanism to ensure that medicines continue to be used both effectively and safely.

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

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

2. 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.

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 in consequence 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 who subsequently applies for the provision of MAS to the MAS provider with whom that person was registered 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 when such application was made.

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 bi-monthly to the Agency (Practitioner Services Division of 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 Schedule 2 ; 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, 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; and

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.