The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

Made: 14th May 2009

Laid before the Scottish Parliament: 18th May 2009

Coming into force: 1st July 2009

In accordance with paragraph 24(1) and (3) of Schedule 7 to the Tribunals Courts and Enforcement Act 2007[^f00002] they have consulted the Administrative Justice and Tribunals Council and its Scottish Committee.

Citation and commencement

1

These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 and come into force on 1st July 2009.

Interpretation and application

2

• (1) In these Regulations unless the context otherwise requires–

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

• “the 1968 Act” means the Medicines Act 1968[^f00003];

• “additional professional services” has the meaning assigned to it in regulation 4;

• “advanced electronic signature” means an advanced electronic signature within the meaning given in Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC;

• “the Agency” means the Common Services Agency for the Scottish Health Service constituted under section 10 of the Act[^f00005];

• “appliance” means an appliance which is a listed appliance within the meaning of section 27(1) of the Act;

• “appropriate non-proprietary name” means a non-proprietary name which is not mentioned in any directions given by the Scottish Ministers under section 17N(6) of the Act (other mandatory contract terms)[^f00006] as to the drugs or other substances–which may not be ordered for patients in the provision of primary medical services under a general medical services contract;except where the conditions in paragraph 40(2) of schedule 6 of the GMS Contracts Regulations[^f00007] are satisfied, which can only be ordered for specified patients and specified purposes;

• “Area Medical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act[^f00008];

• “Area Pharmaceutical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;

• “Board” means a Health Board within the meaning of section 2(1)(a) of the Act[^f00009];

• “chemical reagent” means a chemical reagent included in a list for the time being approved by the Scottish Ministers for the purposes of section 27 of the Act;

• “clinical management plan” has the meaning ascribed in regulation 8(1) of the Human Medicines Regulations 2012;

• “collection and delivery arrangement” means an arrangement within the meaning of regulation 248(2) of the Human Medicines Regulations 2012,

• “controlled locality” is to be construed in accordance with paragraph 1A of Schedule 3;

• “corresponding decision” has the same meaning as in section 32D of the Act[^f00011];

• “dentist” means a dental practitioner;

• “directed services” means additional pharmaceutical services within the meaning of section 27A of the Act;

• “dispensing doctor” means a medical practitioner who provides services corresponding to pharmaceutical services—under the terms of a general medical services contract which gives effect to paragraph 44 of schedule 6 of the GMS Contracts Regulations; orunder the terms of a section 17C agreement which gives effect to paragraph 16 of schedule 1 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018;

• “doctor” means a fully registered medical practitioner within the meaning of Schedule 1 to the Interpretation Act 1978[^f00012];

• “drugs” includes medicines and chemical reagents;

• “Drug Tariff” has the meaning assigned to it in regulation 12;

• “electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000[^f00013];

• “electronic prescription form” means a prescription form as defined in paragraph (b) of the definition of “prescription form”;

• “electronic signature” has the meaning given to it by section 7(2) of the Electronic Communications Act 2000;

• “emergency requiring the flexible provision of pharmaceutical services” means an emergency declared by means of a direction to Boards under section 2(5) of the Act to the effect that, as a result of the threatened damage to human welfare caused or which may be caused by the illness designated in the direction, Boards must for a specified period exercise one or more of their functions under regulation 6 or regulation 11(5), subject to any conditions or limitations set out in the direction;

• “ePharmacy service” means the electronic system provided by the Agency by which electronic messages are transmitted between pharmacy contractors, doctors and the Agency;

• “equivalent body” means–in England, NHS England , or in relation to any time prior to 1st April 2013 and after 30th September 2002 a Primary Care Trust, or in relation to any time prior to 1st October 2002 a Health Authority;in Wales, a Local Health Board or in relation to any time prior to 1st April 2003 a Health Authority;in Northern Ireland, a Health and Social Services Board;or any successor body;

• “equivalent list” means a list kept by an equivalent body;

• “GMS Contracts Regulations” means the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018;

• “health centre” means premises provided by the Scottish Ministers in accordance with the provisions of section 36(1)(b) of the Act;

• “hypodermic needle exchange services” has the meaning assigned to it in regulation 3(3);

• “independent nurse prescriber” means a person—who is registered in the Nursing and Midwifery Register; andagainst whose name is recorded in that register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;

• “joint discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006[^f00015];

• “listed drugs” means such drugs and medicines as are included in a list for the time being approved by the Scottish Ministers for the purposes of section 27(1) of the Act;

• “medicinal product” means–a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC[^f00016]; orany product which is not a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, but which is a medicinal product within the meaning ascribed to it in section 130 of the 1968 Act[^f00017];

• “minor relocation” has the meaning assigned to it in regulation 5;

• “National Appeal Panel” means the panel constituted under Part II of Schedule 4;

• “NHS funded services” means—primary medical services provided by a person under arrangements with a Health Board for the purpose of meeting that Health Board’s duty to provide or secure the provision of primary medical services as respects their area; andpharmaceutical services provided by a person on a Board’s pharmaceutical or provisional pharmaceutical list;

• “nominated community representative” means a person nominated by one or more Community Councils from amongst their elected members for the purpose of making representations in accordance with the procedures set out in Schedule 3;

• “non-electronic prescription form” means a prescription form as defined in paragraph (a) of the definition of “prescription form”;

• “non-proprietary name” in relation to a drug means–where the drug is described in a monograph in the current edition in force at the time of the supply of the drug, (as defined in regulation 321(3) of the Human Medicines Regulations 2012), of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of the name, at the head of that monograph or, where the name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; orwhere the drug is not so described but has an approved name, being the name which appears in the current edition in force at the time of the supply of the drug, (as defined in the said regulation 321(3) of the Human Medicines Regulations 2012) of the list of names prepared and published under regulation 318 of those Regulations, its approved name;

• ...

• “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001[^f00019];

• “optometrist independent prescriber” means a person–who is a registered in the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989[^f00020]...; andagainst whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

• “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, andis approved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease),

• “paramedic independent prescriber” means a person—registered in Part 8 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;

• “Patient Group Direction” has the meaning ascribed in regulation 213 of the Human Medicines Regulations 2012;

• “pharmaceutical care services plan” means a document prepared by the Board annually, comprising a summary of the pharmaceutical services provided in the area of the Board together with an analysis by the Board of where in its area it believes there is a lack of adequate provision of pharmaceutical services;

• “pharmaceutical discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006;

• “pharmaceutical list” has the meaning assigned to it in regulation 5;

• “pharmaceutical services” means those services as defined by section 27 of the Act and includes the provision to persons who are in a Board’s area of listed drugs and medicines which are ordered for those persons by a dental practitioner in pursuance by such dental practitioner of the performance of personal dental services within the meaning of section 1(8) of the National Health Service (Primary Care) Act 1997[^f00023] but not including directed services;

• “pharmacist” means a person who is registered as a pharmacist in Part 1 ... of the register maintained under article 19 of the Pharmacy Order 2010 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 [^f00025];

• “pharmacy contractor” means a contractor who provides pharmaceutical services, or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act[^f00026], who provides pharmaceutical services in terms of arrangements made by a Board under section 27 of the Act;

• “pharmacist independent prescriber” means a pharmacist against whose name in the relevant register is recorded an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

• “physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

• “podiatrist or chiropodist independent prescriber” means a podiatrist or chiropodist who is registered in Part 2 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the podiatrist or chiropodist is qualified to order drugs, medicines and appliances as a podiatrist or chiropodist independent prescriber;

• “prescriber” means—a doctor,a pharmacist independent prescriber,a independent nurse prescriber,an optometrist independent prescriber,a physiotherapist independent prescriber,a podiatrist or chiropodist independent prescriber, ... a therapeutic radiographer independent prescriber, ... a paramedic independent prescriber, or a supplementary prescriber under an agreed clinical management plan;

• “prescription form” means–a form provided by the Board or the Agency–on which the provision of pharmaceutical services may be ordered by–a Board;a dentist pursuant to the provisions of his or her terms of service;a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; ora prescriber; ......and includes a prescription form provided and issued under equivalent arrangements having effect in England, Wales or Northern Ireland; ordata that are created in an electronic form for the provision of pharmaceutical services ordered by–a dentist pursuant to the provisions of his or her terms of service;a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; ora prescriber,and signed with such a person’s advanced electronic signature and transmitted as an electronic communication through the ePharmacy service; ora form on which domiciliary oxygen has been ordered–by a prescriber in England or Wales for a patient normally resident in England or Wales; andin relation to a form which contains an order by a prescriber in England, the patient named on the form (or a person on the patient’s behalf) completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid;

• “prescription only medicine” has the meaning given in regulation 5 of the Human Medicines Regulations 2012,

• “provisional pharmaceutical list” has the meaning assigned to it in regulation 8;

• “PTP” means a pandemic treatment protocol,

• “registered pharmacy” means a registered pharmacy within the meaning of section 74 of the 1968 Act[^f00027];

• “relevant service” means whole-time service in the armed forces of the Crown in a national emergency or otherwise, or compulsory whole-time service in those forces, including service resulting from any reserve liability, or any equivalent service by a person liable for compulsory whole-time service in those forces;

• “restricted availability appliance” means an appliance which is approved for particular categories of persons or for particular purposes only;

• “scheduled drug” means–a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which may not be ordered in the provision of primary medical services under a general medical services contract; orexcept where the conditions in paragraph 40(2) of schedule 6 of the GMS Contracts Regulations[^f00028] are satisfied, a drug, medicine or other substance which is specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract;

• “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, ordrugs 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, ora 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, andspecifies 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,

• “supplementary prescriber” means a person whose name is registered in–the Nursing and Midwifery Register; Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010; the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to–chiropodists and podiatrists;physiotherapists; ...diagnostic or therapeutic radiographers; ... dietitians; or the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989,and against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;