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

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Provision of pharmaceutical servicesS

This section has no associated Executive Note

4.—(1) Subject to the other provisions of these Regulations where–

(a)any person presents a non-electronic prescription form which contains–

(i)an order for drugs, not being scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber; or

(ii)an order for a drug specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iii)an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iv)an order for listed drugs signed by a dentist; or

[F1(b)subject to sub-paragraphs (4) and (9), the pharmacist receives from the ePharmacy service an electronic prescription form which contains an order of a kind specified in sub sub-paragraph (a)(i)-(iv);

and the patient named on the form or a person on the patient’s behalf, requests the provision of drugs and appliances in accordance with that prescription and, in the case of a form provided and issued under arrangements having effect in England, completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid, a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as the pharmacist supplies in the normal course of business and any drugs so specified shall be in a suitable container.]

[F2(1A) In furtherance of the obligations in sub-paragraphs (1) and (3), a pharmacist, when providing drugs or appliances ordered in accordance with those sub-paragraphs must—

(a)use all reasonable endeavours to provide those drugs or appliances with reasonable promptness;

(b)refrain from taking any action which may delay or prevent the dispensing of those drugs or appliances; and

(c)contact the prescriber or dentist to discuss alternative arrangements where there is likely to be, in that pharmacist’s opinion, a clinically significant delay in the dispensing of those drugs or appliances.]

[F3(1B) A pharmacist is under no obligation to provide pharmaceutical services in respect of a prescription form issued under arrangements having effect in England unless the patient has paid any charge due to be paid by virtue of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011.]

[F4(2) In this paragraph–

(a)[F5Medicines: Care and Review Service]” means a directed service provided by a pharmacy contractor with whom a Health Board has made arrangements in accordance with directions issued by the Scottish Ministers relating to the provision of a [F6service to assist patients with drugs, medicines and appliances and the management of long term illnesses, diseases or health conditions];

[F7(aa)“prison” means—

(i)a prison within the meaning of section 43 of the Prisons (Scotland) Act 1989,

(ii)a remand centre within the meaning of section 19(1)(a) of that Act, or

(iii)a young offenders institution within the meaning of section 19(1)(b) of that Act,]

(b)“serial prescriber” means a doctor [F8, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] who in the course of the provision of primary medical services in terms of the Act orders drugs, medicines or listed appliances for–

(i)a registered patient within the meaning of regulation [F93](1) of the GMS Contracts Regulations where the doctor [F8, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] is providing primary medical services in terms of a general medical services contract under section 17J of the Act;

(ii)a registered patient within the meaning of [F10regulation 3 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018] where the doctor [F8, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] is providing primary medical services in terms of an agreement under section 17C of the Act; or

(iii)a patient registered to receive [F11those] primary medical services in terms of the Act, other than as in (i) and (ii), except where that patient is a temporary resident, being a person who is resident in Scotland for more than 24 hours and less than 3 months, [F12or where that patient receives primary medical services in prison,]

and such patient has [F13a long-term illness, disease or health condition that requires ongoing management over a period of a year or longer,]

(c)“serial prescription” means an order for drugs, medicines or listed appliances which comprises:

(i)a non-electronic prescription form generated by a computer and signed in ink by a serial prescriber containing the following information:

(aa)the drugs, medicines or listed appliances ordered for a patient;

(bb)the total quantity or period for which the drugs, medicines or listed appliances are ordered, which period shall not exceed [F1456] weeks from the date of issue of the prescription;

(cc)the quantity of the drugs, medicines or listed appliances which are to be dispensed to the patient at any one time; and

(dd)the instructions for use of the drugs, medicines or listed appliances; and

(ii)an electronic copy of that prescription form transmitted through the ePharmacy service to [F15a] pharmacy contractor F16....

(d)“relevant pharmacist” means:

(i)the pharmacy contractor, where the pharmacy contractor is a pharmacist; or

(ii)any pharmacist employed or engaged by, that pharmacy contractor; and

(iii)where the pharmacy contractor is not a pharmacist, any pharmacist employed or engaged by that pharmacy contractor.]

[F17(2A) A pharmacy contractor must ensure that drugs or appliances ordered on a serial prescription are not supplied to a patient unless the patient has registered with that pharmacy contractor for the provision of the Medicines: Care and Review Service.]

(3) Where a person [F18is] registered with a pharmacy contractor for the provision of the [F19Medicines: Care and Review Service], that pharmacy contractor shall ensure that a relevant pharmacist, with reasonable promptness, shall provide the drugs, medicines or listed appliances ordered on a serial prescription in the quantities and at the intervals specified on the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd).

(4) The patient or a person acting on behalf of the patient shall present the non-electronic copy of the serial prescription to the relevant pharmacist on the first occasion that the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription.

(5) When the patient or a person acting on behalf of the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription at any subsequent interval specified on the serial prescription, the relevant pharmacist shall supply the drugs, medicines or appliances in accordance with the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd) only after drawing down the electronic copy of that serial prescription from the ePharmacy service to check that the serial prescriber has not cancelled that serial prescription.

(6) A relevant pharmacist shall not provide under a serial prescription a controlled drug within the meaning of the Misuse of Drugs Act 1971(1), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001(2).

(7) A relevant pharmacist shall not supply any drugs, medicines or listed appliances ordered on a serial prescription if–

(a)the serial prescription was presented for dispensing for the first time more than 24 weeks after the date the serial prescription was signed by the serial prescriber;

(b)in the pharmacist’s professional judgement the supply is not appropriate for the patient;

(c)the non-electronic prescription form is not signed by the serial prescriber; or

(d)the pharmacist has been informed by the serial prescriber that the serial prescription has been cancelled.

(8) A relevant pharmacist shall ensure on each occasion that drugs, medicines or appliances are supplied on a serial prescription that such supply is appropriate for the patient.

(9) Where a relevant pharmacist reasonably believes that a form presented as a prescription form under sub-paragraph (1) or a form presented as serial prescription under sub-paragraph (4) is not a genuine order for the person named on the form the pharmacist shall refuse to supply the order for drugs or appliances on the form.

(10) A relevant pharmacist shall not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 4 [F20or] 5 to the Misuse of Drugs Regulations 2001(3).

(11) A relevant pharmacist may refuse to supply drugs or appliances [F21in accordance with these Regulations] where–

(a)the pharmacist or other person is subjected to or threatened with violence by the person F22... requesting the provision of drugs or appliances in accordance with [F23these Regulations], or by any person accompanying that person; or

(b)the person F24... requesting the provision of drugs or appliances in accordance with [F25these Regulations], or any other person accompanying that person, commits or threatens to commit a criminal offence.

(12) [F26Subject to sub-paragraph (13A),] a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, accept for dispensing any prescription form or serial prescription transmitted from or received at a registered pharmacy which is not included in the pharmaceutical list.

(13) [F27Subject to sub-paragraph (13A),] a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, supply any drugs or listed appliances ordered on a prescription form or serial prescription other than at a registered pharmacy which is included in the pharmaceutical list.

[F28(13A) Sub-paragraphs (12) and (13) do not apply to the acceptance of a prescription form or serial prescription, or to the supply of medicinal products ordered on such a form or serial prescription, which form part of a collection and delivery arrangement.]

[F29(14) (a) For the purposes of this sub-paragraph—

“prescription form” is limited to a prescription form provided and issued under arrangements having effect in England;

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

2003 Regulations” means the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) (No. 2) Regulations 2003.

(b)

Subject to paragraphs (c) and (d), a pharmacist before supplying a prescribed item to any person presenting a prescription form which—

(i)

has a declaration in terms of regulation 4(2)(a) of the 2011 Regulations claiming charge exemption; or

(ii)

has a declaration claiming charge remission under the 2003 Regulations,

shall request evidence of a patients entitlement to such exemption or remission.

(c)

Paragraph (b) shall not apply in respect of claims for exemption under regulation 4(1)(a) or (c) of the 2011 Regulations where the person’s date of birth has been printed by means of a computer on the prescription form.

(d)

Paragraph (b) shall not apply in respect of a declaration relating to a claim for exemption under regulation 4(1)(a)-(h) of the 2011 Regulations where the pharmacist has information in the pharmacist’s possession at the time of supplying the item which confirms the patient is entitled to the exemption claimed.

(e)

Where the person presenting the prescription form does not show evidence of entitlement and the pharmacist, in respect of a declaration relating to a claim for exemption made under regulation 4(1)(a)-(h) of the 2011 Regulations does not have evidence in the pharmacist’s possession to confirm that the patient is entitled to make that claim, the pharmacist shall mark that patient’s prescription form accordingly before supplying the prescribed item.]

(15) (a) A pharmacist independent prescriber shall not supply any item ordered on a prescription form by that pharmacist independent prescriber unless the conditions specified in paragraph (b) are met.

(b)The conditions referred to in paragraph (a) are–

(i)the item has been ordered in accordance with the arrangements which a Health Board has made pursuant to Directions issued by the Scottish Ministers in respect of pharmacist independent prescribers; and

(ii)the pharmacist independent prescriber reasonably considers that either–

(aa)exceptional circumstances exist whereby it is in the best interests of the patient to whom the item is to be supplied that the pharmacist independent prescriber who orders the item should supply it; or

(bb)the patient to whom the item is to be supplied, or the patient’s representative, is otherwise unlikely to be able to obtain the item without suffering excessive inconvenience or delay.

(c)A pharmacist independent prescriber who supplies an item which such pharmacist independent prescriber has ordered must endorse the prescription form for that item with the words “self-dispensed”.

(16) Where an order, not being an order to which F30... the Misuse of Drugs Regulations 2001, except Schedules 4 and 5 to those regulations, apply, issued by a prescriber or a dentist on a prescription form for drugs or listed drugs does not prescribe the quantity, strength or dosage thereof, a pharmacist may supply such strength and dosage of drugs or listed drugs so ordered as the pharmacist shall consider to be appropriate, and, subject to the provisions of sub-paragraph (23), in such quantity as the pharmacist considers to be appropriate for a course of treatment of the patient to whom the order relates, for a period not exceeding five days.

(17) Where an order to which sub-paragraph (16) applies is for–

(a)an oral contraceptive; or

(b)a drug or listed drug which is available for supply as part of pharmaceutical services only together with one or more drugs or listed drugs; or

(c)an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require supply in an unopened package,

which is not available for supply as part of pharmaceutical services except in such packages that the minimum available package contains a quantity appropriate to a course of treatment for a patient for a period of more than five days, the pharmacist may supply for the patient to whom the order relates, such minimum available package.

(18) Where any drug, not being one to which the Misuse of Drugs Regulations 2001, except Schedule 5 to those regulations, apply, ordered by a prescriber or a dentist on a prescription form, or a by a serial prescriber on a serial prescription, is available for provision by a pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is–

(a)sterile;

(b)effervescent or hygroscopic;

(c)a liquid preparation for addition to bath water;

(d)a coal tar preparation;

(e)a viscous preparation; or

(f)packed at the time of its manufacture in a calendar pack or special container,

the pharmacist shall, subject to sub-paragraph (19), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(19) A pharmacist shall not provide, pursuant to sub-paragraph (18), a drug in a calendar pack where in the pharmacist’s professional judgement, it was the intention of the prescriber or dentist who ordered the drug that it should be provided only in the exact quantity ordered.

(20) In this paragraph–

(a)“calendar pack” means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and

(b)“special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(21) All drugs and preparations supplied by pharmacists shall, where a standard or formula is specified in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary (including any Appendix published as part of that Formulary), or the Drug Tariff, conform to the standard or formula so specified, and in any other case shall be of a grade or quality not lower than the grade or quality ordinarily used for medicinal purposes.

(22) All appliances supplied by pharmacists shall conform to the specifications included in the Drug Tariff.

(23) Subject to any regulations in force under the Weights and Measures Act 1985(4), a pharmacist shall provide pharmaceutical services only in response to and, subject to sub-paragraphs (16), (17), (18) and (29) [F31to [F32(43)]], in accordance with an order on a non-electronic prescription form signed as specified in sub-paragraph (1)(a), or in accordance with an electronic prescription form received in accordance with sub-paragraph (1)(b), or in accordance with a serial prescription in accordance with the provisions in sub-paragraph (2)(c) or in accordance with the terms of a Patient Group Direction issued by a Board in accordance with [F33 regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012], except that in a case of urgency where a prescriber personally known to a pharmacist requests that pharmacist to dispense a drug or appliance the pharmacist may supply that drug or appliance before receiving such a prescription form, only if–

(a)that drug is not a scheduled drug;

(b)that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001;

(c)that appliance is not a restricted availability appliance; and

(d)in any case the prescriber undertakes to furnish the pharmacist, within 72 hours, with such a prescription form.

(24) Except as provided in sub-paragraph (25), a pharmacist shall not supply, by way of pharmaceutical services under the Act or otherwise, any scheduled drug which is ordered by name, formula or other description on a prescription form or a serial prescription.

(25) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or a serial prescription either by that name or by its formula, a pharmacist may supply a drug which has the same specification notwithstanding that it is a scheduled drug.

(26) Where a drug which is ordered as specified in sub-paragraph (23) combines more than one drug, that sub-paragraph shall apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(27) A pharmacist or pharmacy contractor shall not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person presenting an order for drugs or appliances on a prescription form or serial prescription.

(28) A pharmacist or pharmacy contractor shall not, except with the consent of the Scottish Ministers, provide at a health centre services other than pharmaceutical services in accordance with section 27 of the Act.

(29) A pharmacist may dispense a drug where the conditions for urgent supply specified in [F34regulation 225 (emergency sale etc by pharmacist: at patient's request) of the Human Medicines Regulations 2012] are satisfied, before receiving a prescription form, if the pharmacist is satisfied that it is appropriate to do so.

[F35(30) This sub-paragraph applies where—

(a)a person requests a prescription only medicine—

(i)from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii)in accordance with a prescription form or serial prescription, and

(b)a SSP has effect in respect of—

(i)the requested prescription only medicine, or

(ii)prescription only medicines of a specified description, and the requested prescription only medicine is of that description.

(31) Where sub-paragraph (30) applies, a pharmacist may supply a prescription only medicine in accordance with a SSP where—

(a)the conditions specified in regulation 226A of the Human Medicines Regulations 2012 are satisfied, and

(b)the pharmacist is able to do so with reasonable promptness.

(32) This sub-paragraph applies where—

(a)a person requests a drug or appliance—

(i)from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii)in accordance with a prescription form or serial prescription, and

(b)a Scottish SSP has effect in respect of—

(i)the requested drug or appliance, or

(ii)drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(33) Where sub-paragraph (32) applies, a pharmacist may supply a different drug or appliance or quantity or strength of a drug or appliance to that ordered on the prescription form or serial prescription where—

(a)the pharmacist is able to do so with reasonable promptness,

(b)to do so is in accordance with the Scottish SSP, and

(c)the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that the supply of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist is reasonable and appropriate.

(34) Where sub-paragraph (30) or (32) applies—

(a)a pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(b)the pharmacist is able to supply the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale, but not with reasonable promptness,

the requirements to act with reasonable promptness in sub-paragraphs (1), (1A)(a) and (3) are to be read as requirements to act within a reasonable timescale.

(35) A pharmacist must refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a)sub-paragraph (30) or (32) applies, and

(b)alternative supply has already taken place in accordance with the SSP or the Scottish SSP.

(36) A pharmacist may refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a)sub-paragraph (30) or (32) applies,

(b)the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(c)the pharmacist is unable to provide the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale.

(37) Where a pharmacist refuses to supply a prescription only medicine or other drug or appliance under sub-paragraph (36), the pharmacist must contact the prescriber or dentist to discuss alternative arrangements.

(38) Where a pharmacist supplies a prescription only medicine in accordance with a SSP or other drug or appliance in accordance with a Scottish SSP the pharmacist must—

(a)include in the dispensing label on the packaging of the prescription only medicine or other drug or appliance, for the patient’s benefit, information to the effect that the prescription only medicine or other drug or appliance is being supplied in accordance with a SSP or a Scottish SSP, identifying the particular SSP or Scottish SSP, and

(b)supply the prescription only medicine or other drug or appliance in a suitable container.]

[F36(39) A pharmacist may supply a prescription only medicine in accordance with a PTP where—

(a)a PTP has effect in respect of the prescription only medicine,

(b)the requirements specified in the PTP are satisfied, and

(c)the pharmacist is able to supply the prescription only medicine with reasonable promptness.

(40) A pharmacist may refuse to supply a prescription only medicine in accordance with a PTP where in the pharmacist’s professional judgement it is unreasonable or inappropriate to do so.

(41) Where a pharmacist supplies a prescription only medicine in accordance with a PTP the pharmacist must—

(a)include in the dispensing label on the packaging of the prescription only medicine, for the patient’s benefit, information to the effect that the prescription only medicine is being supplied in accordance with a PTP, identifying the particular PTP, and

(b)supply the prescription only medicine in a suitable container.

(42) A pharmacist may provide pharmaceutical services in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012 where the conditions specified in that regulation are satisfied.

(43) A pharmacist may provide pharmaceutical services in response to an announcement of the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form of prescriptions) of the Misuse of Drugs Regulations 2001.]

Textual Amendments

Commencement Information

I1Sch. 1 para. 4 in force at 1.7.2009, see reg. 1

(2)

S.I. 2001/398. Schedule 5 was amended by S.I. 2005/2864.

(3)

Schedule 4 was amended by S.I. 2003/1432, 2005/3372 and 2007/2154.

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