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

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Interpretation and applicationS

This section has no associated Executive Note

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(1);

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

[F1“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(2);

“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)(3) as to the drugs or other substances–

(a)

which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(b)

except where the conditions in paragraph 40(2) of [F2schedule 6 of] the GMS Contracts Regulations(4) 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(5);

“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(6);

“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 [F3regulation 8(1) of the Human Medicines Regulations 2012];

[F4“collection and delivery arrangement” means an arrangement within the meaning of regulation 248(2) of the Human Medicines Regulations 2012,]

[F5“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(7);

“dentist” means a dental practitioner;

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

[F6“dispensing doctor” means a medical practitioner who provides services corresponding to pharmaceutical services—

(a)

under the terms of a general medical services contract which gives effect to [F7paragraph 44 of schedule 6 of the GMS Contracts Regulations]; or

(b)

under the terms of a section 17C agreement which gives effect to [F8paragraph 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(8);

“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(9);

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

[F9“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–

(a)

in England, [F10[F11NHS 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;

(b)

in Wales, a Local Health Board or in relation to any time prior to 1st April 2003 a Health Authority;

(c)

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 [F12the 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);

[F13“independent nurse prescriber” means a person—

(a)

who is registered in the Nursing and Midwifery Register; and

(b)

against 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(10);

“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)

a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC(11); or

(b)

any 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(12);

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

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

[F5NHS funded services” means—

(a)

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; and

(b)

pharmaceutical services provided by a person on a Board’s pharmaceutical or provisional pharmaceutical list;]

[F5“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–

(a)

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 [F14regulation 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; or

(b)

where 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 [F14regulation 321(3) of the Human Medicines Regulations 2012]) of the list of names prepared and published under [F15regulation 318 of those Regulations], its approved name;

F16...

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001(13);

“optometrist independent prescriber” means a person–

(a)

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(14)F17...; and

(b)

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 an optometrist independent prescriber;

[F18“pandemic treatment protocol” means a protocol that—

(a)

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

(b)

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

[F19“paramedic independent prescriber” means a person—

(a)

registered in Part 8 of the register maintained under article 5 of the [F20Health Professions Order 2001]; and

(b)

against 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 [F21regulation 213 of the Human Medicines Regulations 2012];

[F6“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(15) but not including directed services;

“pharmacist” means [F22a person who is registered as a pharmacist in Part 1 F23... 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 (16);

“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(17), 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;

[F24“physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the [F25Health 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;]

[F24“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 [F26Health 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;]

[F27“prescriber” means—

(a)

a doctor,

(b)

a pharmacist independent prescriber,

(c)

a [F28independent nurse prescriber],

(d)

an optometrist independent prescriber,

(e)

a physiotherapist independent prescriber,

(f)

a podiatrist or chiropodist independent prescriber, F29...

(fa)

[F30a therapeutic radiographer independent prescriber, F31...]

(fb)

[F32a paramedic independent prescriber, or]

(i)

a supplementary prescriber under an agreed clinical management plan;]

“prescription form” means–

(a)

a form provided by the Board or the Agency–

(i)

on which the provision of pharmaceutical services may be ordered by–

(aa)

a Board;

(bb)

a dentist pursuant to the provisions of his or her terms of service;

(cc)

a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; or

(dd)

a prescriber; F33...

(ii)

F34...

and includes a prescription form provided and issued under equivalent arrangements having effect in England, Wales or Northern Ireland; or

(b)

data that are created in an electronic form for the provision of pharmaceutical services ordered by–

(i)

a dentist pursuant to the provisions of his or her terms of service;

(ii)

a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; or

(iii)

a prescriber,

and signed with such a person’s advanced electronic signature and transmitted as an electronic communication through the ePharmacy service; or

(c)

a form on which domiciliary oxygen has been ordered–

(i)

by a prescriber in England or Wales for a patient normally resident in England or Wales; and

(ii)

in relation to [F35a 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;

[F36“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;

[F37“PTP” means a pandemic treatment protocol,]

“registered pharmacy” means a registered pharmacy within the meaning of section 74 of the 1968 Act(18);

“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)

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; or

(b)

except where the conditions in paragraph 40(2) of [F38schedule 6 of] the GMS Contracts Regulations(19) 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;

[F39“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—

(a)

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—

(i)

a specified drug or appliance, or

(ii)

drugs or appliances of a specified description,

(b)

provides for the supply by a pharmacist or dispensing doctor, where there is an order on a prescription form or serial prescription for—

(i)

the specified drug or appliance, or

(ii)

a 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, and

(c)

specifies the period for which, and the parts of Scotland (which may be all of Scotland) for which the Scottish SSP is to have effect,]

[F39“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,]

[F39“SSP” means a serious shortage protocol,]

“supplementary prescriber” means a person whose name is registered in–

(a)

the Nursing and Midwifery Register;

(b)

[F40Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010;]

(c)

the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

(d)

the part of the register maintained by the Health Professions Council in pursuance of article 5 of the [F41Health Professions Order 2001] relating to–

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; F42...

(iii)

diagnostic or therapeutic radiographers; F43...

(iv)

[F44dietitians; or]

(e)

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;

“supply form” means a form issued by a Board to record a supply of pharmaceutical services under the terms of a Patient Group Direction issued by a Health Board in accordance with [F45regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012];

“suspended by direction of the Tribunal” means suspended as respects the provision of pharmaceutical services by a direction of the Tribunal made pursuant to section 32A(2) or section 32B(1) of the Act(20) or to any provisions in force in England and Wales or Northern Ireland corresponding to those provisions;

“terms of service” means the terms of service for pharmacists and pharmacy contractors contained or referred to in Schedule 1;

[F46“therapeutic radiographer independent prescriber” means a person—

(a)

registered in Part 11 of the register maintained under article 5 of the [F47Health Professions Order 2001]; and

(b)

against whose name in that register is recorded—

(i)

an entitlement to use the title “therapeutic radiographer”; and

(ii)

an annotation signifying that the person is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;]

“the Tribunal” means the Tribunal constituted under section 29 of the Act(21).

(2) These Regulations shall apply to a person, firm or body corporate (other than a dental practitioner) providing pharmaceutical services (which includes the supply of appliances by appliance suppliers) as they apply to a pharmacist.

(3) Unless the context otherwise requires–

(a)any reference in these Regulations–

(i)to a numbered regulation is a reference to the regulation bearing that number in these Regulations,

(ii)to a numbered Part or Schedule is a reference to the Part of, or Schedule to, these Regulations bearing that number,

(iii)to a form thereby prescribed includes a form substantially the same; and

(b)any reference in a regulation or in a Schedule to these Regulations to a numbered paragraph is a reference to the paragraph bearing that number in that regulation or Schedule.

Textual Amendments

Commencement Information

I1Reg. 2 in force at 1.7.2009, see reg. 1

(2)

Section 10 was amended by the 1980 Act, Schedule 6, paragraph 2, the 1990 Act, Schedule 10, paragraph 1, the Health Act 1999 (c. 8) (“the 1999 Act”), Schedule 4, paragraph 44 and the Health and Social Care (Scotland) Act 2005 (asp 13) (“the 2005 Act”), Schedule 2, paragraph 2.

(3)

Section 17N was inserted by the Primary Medical Services (Scotland) Act 2004 (asp 1) (“the 2004 Act”), section 4. The current directions are the “Directions 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” given on 18th March 2004, and published on Scottish Health on the Web (SHOW) at http://www.show.scot.nhs.uk/sehd/pca/PCA2004(M)11.pdf.

(4)

Paragraph 40(2) was amended by S.I. 2007/206.

(5)

Section 9 was amended by the 1990 Act, section 29(4) and (5) and the 1999 Act, Schedule 4, paragraph 43(a) and (b).

(6)

Section 2(1)(a) was amended by the 1983 Act, Schedule 7, paragraph 1, the 1990 Act, section 28(a), the National Health Service Reform (Scotland) Act 2004 (asp 7), schedule 1, paragraph 1(2) and the 2005 Act, schedule 2, paragraph 2(2).

(7)

Section 32D was inserted by the 2005 Act, section 27.

(8)

1978 c. 30, the definition of “registered medical practitioner” was amended by the Medical Act 1983 (c. 54), Schedule 5, paragraph 18.

(9)

The definition of “electronic communication” was amended by the Communications Act 2003 (c. 21) Schedule 17, paragraph 158.

(11)

O.J. No. L 311, 28.11.2001, p.67.

(12)

Section 130 was amended by the Animal Health and Welfare Act 1984 (c. 40), Schedule 1, paragraph 3 and S.I. 1994/3119, 2005/50 and 2006/2407.

(13)

S.I. 2002/253 to which there are no relevant amending instruments.

(14)

1989 c. 44; section 7 was amended by S.I. 2005/848.

(17)

Section 69 was amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1, Part XII, and S.I. 1976/1213 (N.I. 22), 2007/289 and 3101.

(18)

Section 74 was amended by the Statute Law (Repeals) Act 1993, Schedule 1, Part XII.

(19)

Paragraph 40(2) was amended by S.S.I. 2007/206.

(20)

Sections 32A and 32B were inserted by section 8 of the National Health Service (Amendment) Act 1995 (c. 31).

(21)

Section 29 was amended by the Health and Social Security Act 1984, Schedule 8, Part I and by the National Health Service (Amendment) Act 1995, sections 7 and 9 and the Schedule.

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