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

Provision of pharmaceutical services

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

(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) to (iv) and the patient named on the form, or a person on the patient’s behalf, requests the provision of drugs or appliances in accordance with that prescription and 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.

(2) In this paragraph–

(a) “chronic medication 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 chronic medication service;

(b) “serial prescriber” means a doctor 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 2(1) of the GMS Contracts Regulations where the doctor 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 regulation 2 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004(1) where the doctor is providing primary medical services in terms of an agreement under section 17C of the Act; or

(iii) a patient registered to receive 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,

and such patient has registered with a pharmacy contractor for the provision of the chronic medication service;

(a) “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 48 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 the pharmacy contractor with whom the patient has registered for the provision of the chronic medication service.

(b) “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.

(3) Where a person has registered with a pharmacy contractor for the provision of the chronic medication 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(2), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001(3).

(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 and 5 to the Misuse of Drugs Regulations 2001(4).

(11) A relevant pharmacist may refuse to supply drugs or appliances ordered on a prescription form or a serial prescription where–

(a) the pharmacist or other person is subjected to or threatened with violence by the person presenting the prescription form or serial prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or serial prescription, or by any person accompanying that person; or

(b) the person presenting the prescription form or serial prescription, or requesting the provision of drugs or appliances in accordance with an electronic prescription form or serial prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(12) 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) 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.

(14) (a) Subject to sub-paragraphs (b) and (c) a pharmacist shall, before supplying a prescribed item to any person presenting a non electronic prescription form or a supply form or a serial prescription with a declaration claiming either charge exemption under regulation 7 of the National Health Service (Charges and Drugs and Appliances) (Scotland) Regulations 2008(5) (“the 2008 Regulations”) or charge remission under the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) Regulations 2003(6), or a declaration of entitlement to such exemption or remission in relation to an electronic prescription form, request evidence of the patient’s entitlement to such exemption or remission.

(b) Sub-paragraph (a) shall not apply in respect of claims for exemption under regulation 7(1)(a) or (c) of the 2008 Regulations where–

(i) the prescription form is an electronic prescription form and the person’s date of birth is specified in the electronic prescription form; or

(ii) the prescription form is a non-electronic prescription form and the person’s date of birth has been printed by means of a computer on the non-electronic prescription form or serial prescription.

(c) Sub-paragraph (a) shall not apply in respect of claims for exemption under regulation 7(1)(a) to (i) of the 2008 Regulations where the pharmacist has information in the pharmacist’s possession at the time of supplying the item which confirms that the patient is entitled to the exemption claimed.

(d) Where the person presenting a non electronic prescription form or a supply form, or declaration of entitlement to exemption in relation to an electronic prescription form or serial prescription does not show valid evidence of entitlement and the pharmacist, in respect of a claim for exemption made under regulation 7(1)(a) to (i) of the 2008 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 non electronic prescription form or a supply form or that patient’s declaration of entitlement to exemption in relation to an electronic prescription form or serial prescription 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 the Poisons Rules 1982(7) or 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(8), a pharmacist shall provide pharmaceutical services only in response to and, subject to sub-paragraphs (16), (17), (18) and (29), 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 Article 12C of the Prescription Only Medicines (Human Use) Order 1997 (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction), 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 paragraph (4) of article 8 of the Prescription Only Medicines (Human Use) Order 1997 are satisfied, before receiving a prescription form, if the pharmacist is satisfied that it is appropriate to do so.

(1)

S.S.I. 2004/116, to which there are no relevant amending instruments.

(2)

1971 c. 38.

(3)

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

(4)

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

(5)

S.S.I. 2008/27. Amended by S.S.I. 2008/105 and 2009/37.

(6)

S.S.I. 2003/460. Amended by S.S.I. 2004/102 and 166, 2005/3 and 179, 2006/142, 183 and 440, 2007/225, 259 and 391 and 2008/27, 147, 288 and 390. S.S.I. 2006/142 was revoked by S.S.I. 2006/183.

(7)

S.I. 1982/218. Amended by S.I. 1985/1077, 1986/10 and 1704, 1989/112 and 1992/2293.

(8)

1985 c. 72.