The National Health Service (Pharmaceutical Services) Regulations 2005

Regulation 3(b)

SCHEDULE 2 TERMS OF SERVICE OF DISPENSING DOCTORS

Incorporation of provisions

1.  Any provisions of the following affecting the rights and obligations of dispensing doctors shall be deemed to form part of the terms of service for dispensing doctors—

(a) the Regulations;

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of section 41 of the Act;

(c) so much of Part II of the National Health Service (Service Committees and Tribunal) Regulations 1992(1) as relates to—

(i) the investigation of questions arising between dispensing doctors and persons receiving pharmaceutical services and other investigations to be made by the pharmaceutical discipline committee and the joint discipline committee and the action which may be taken by the Primary Care Trust as a result of such investigations, and,

(ii) appeals to the Secretary of State from decisions of the Primary Care Trust; and

(d) so much of regulation 3 of the Patients' Forums (Functions) Regulations 2003(2) as relate to the entry and inspection of premises either owned or controlled by the dispensing doctor or where pharmaceutical services are provided by him.

Persons duly authorised to dispense on behalf of dispensing doctors

2.  Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which he has duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—

(a) that other person must comply with that requirement; and

(b) that dispensing doctor must secure compliance with that requirement by that other person,

and references in this Schedule to a dispensing doctor shall be construed accordingly.

Dispensing of drugs and appliances ordered by another prescriber

3.—(1) In this paragraph, “signed” includes signature with a prescriber’s advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to a dispensing doctor 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 other than the dispensing doctor,

(ii) an order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations, signed by a prescriber other than the dispensing doctor, and including the reference “SLS”, or

(iii) an order for restricted availability appliances, signed by a prescriber other than the dispensing doctor and including the reference “SLS”; or

(b) subject to sub-paragraph (4), the dispensing doctor receives from the ETP service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

(i) any person requests the provision of drugs or appliances in accordance with that prescription, or

(ii) the dispensing doctor has previously arranged with the patient that he will dispense that prescription on receipt,

and the dispensing doctor is authorised or required by virtue of Part 5 of these Regulations to provide the drugs or appliances so ordered, he shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

(3) Subject to the following provisions of this Part, where—

(a) any person presents to a dispensing doctor a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971(3), other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001(4), signed by a prescriber other than the dispensing doctor who is a repeatable prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being 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, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, or

(iv) an order for a restricted availability appliance, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, and including the reference “SLS”,

and also presents an associated batch issue; or

(b) the dispensing doctor receives an electronic repeatable prescription from the ETP service which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii) the dispensing doctor has previously arranged with the patient that he will dispense that repeatable prescription on receipt,

and the dispensing doctor is authorised or required by virtue of Part 5 of these Regulations to provide the drugs or appliances so ordered, he shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

(4) A dispensing doctor 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 Schedule 4 or 5 to the Misuse of Drugs Regulations 2001.

(5) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) the dispensing doctor has that prescription in his possession; and

(b) that person presents, or the dispensing doctor has in his possession, an associated batch issue.

(6) Drugs and listed appliances provided under this paragraph shall be provided in a suitable container.

Dispensing of drugs and appliances ordered by the dispensing doctor

4.  In circumstances where paragraph 3 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor is authorised or required by virtue of Part 5 of these Regulations to provide a drug or appliance to a person—

(a) he shall record an order for the provision of any drugs or appliances which are needed for the treatment of the patient on—

(i) a prescription form completed in accordance with the term of a contract which gives effect to paragraph 39(3) of Schedule 6 to the GMS Regulations or an equivalent provision applying in relation to that contract, or

(ii) if paragraph 39A(1) of Schedule 6 to the GMS Regulations applies, an electronic prescription form;

(b) he shall provide those drugs or appliances in a suitable container;

(c) he shall provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied; and

(d) he shall provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

Preliminary matters before providing ordered drugs or appliances

5.  Before providing any drugs or appliances in accordance with paragraph 3, or in the circumstances set out in paragraph 4—

(a) the dispensing doctor shall ask any person who makes a declaration that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations by virtue of either—

(i) entitlement to exemption under regulation 8(1) of the Charges Regulations, or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations,

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of regulation 8 of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 4(2)(e), (j) or (k) of the Remission of Charges Regulations, and at the time of the declaration the dispensing doctor has such evidence available to him;

(b) if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (a), is produced to the dispensing doctor, the dispensing doctor shall endorse the form on which the declaration is made to that effect; and

(c) in the case of an electronic prescription, the dispensing doctor shall transmit to the ETP service—

(i) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(aa) the exemption category specified in regulation 7(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case; and

(bb) whether or not satisfactory evidence was produced to him as required by sub-paragraph (a),

(ii) in any case where a charge is due, confirmation that the relevant charge was paid, and

(iii) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

Provision of Scheduled drugs

6.—(1) Subject to sub-paragraph (2), a dispensing doctor shall not provide for a patient any Scheduled drug, except that, where he or an independent prescriber has ordered a drug which has an appropriate non-proprietary name either by the name or by its formula, he may provide a drug which has the same specification notwithstanding that it is a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non-proprietary name).

(2) Nothing in this Schedule shall prevent a doctor providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Refusal to provide drugs or appliances ordered

7.—(1) A dispensing doctor may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) the dispensing doctor reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because he reasonably believes it has been stolen or forged); or

(b) it appears to the dispensing doctor that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to the dispensing doctor’s clinical judgement.

(2) A dispensing doctor may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription, or which he is otherwise authorised or required to provide by virtue of Part 5 of these Regulations, where—

(a) the dispensing doctor or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person; or

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

(3) A dispensing doctor shall refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) he has no record of that prescription;

(b) he does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to him;

(c) it is not signed by a repeatable prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than six months previously;

(f) if the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) where he has been informed by the repeatable prescriber that the prescription is no longer required.

(4) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that he makes such a request), a dispensing doctor shall only provide the drugs or appliances ordered if he is satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient’s treatment;

(b) that the medication regimen of the patient to whom the prescription relates has altered in a way which indicates the need or desirability of reviewing the patient’s treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient’s treatment.

Fees and charges

8.—(1) The terms of a GMS contract giving effect to regulation 24 of, and Schedule 5 to, the GMS Regulations (fees and charges) apply in respect of the provision of any drugs or appliances by a dispensing doctor as they apply in respect of prescriptions for drugs and appliances.

(2) Where a dispensing doctor provides a drug or appliance under pharmaceutical services—

(a) in accordance with this Schedule; and

(b) had the drug or appliance been provided by a contractor providing dispensing services under a GMS contract, the contractor would have been entitled to a payment in respect of the drug or appliance by virtue of directions given by the Secretary of State under section 28T of the Act,

the Primary Care Trust shall credit him with the payment.

Complaints procedures

9.—(1) Where a dispensing doctor—

(a) is a GMS contractor, or is engaged or employed by a GMS contractor, the complaints procedure established in accordance with the terms of a GMS contract which give effect to paragraph 92 of Schedule 6 to the GMS Regulations;

(b) is a PMS contractor, or is engaged or employed by a PMS contractor, the complaints procedure established in accordance with the terms of a PMS agreement which give effect to paragraph 86 of Schedule 5 to the PMS Regulations;

(c) is an APMS contractor, or is engaged or employed by an APMS contractor, the complaints procedure established by the relevant APMS contract to deal with complaints in relation to the provision of primary medical services;

(d) is employed or engaged by a Primary Care Trust for the purposes of providing services within a PCTMS practice, the complaints procedure established by that PCTMS practice to deal with complaints in relation to the provision of primary medical services,

shall apply in relation to any matter reasonably connected with the provision of pharmaceutical services as it applies as respects to services provided under that contract or agreement, or within that practice.

(2) Accordingly, the term of any relevant GMS contract which gives effect to paragraph 97 of Schedule 6 to the GMS Regulations or the equivalent provision in the PMS Regulations also applies in relation to complaints about such matters.

Inspections and access to information

10.—(1) A dispensing doctor shall allow persons authorised in writing by the Primary Care Trust to enter and inspect any premises he uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not the dispensing doctor is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by the dispensing doctor, in the course of providing pharmaceutical services, for patient care and treatment, and

(ii) the management by the dispensing doctor of the pharmaceutical services he provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Pharmaceutical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by the dispensing doctor;

(c) the person authorised in writing carries written evidence of his authorisation, which he produces on request; and

(d) he does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) A dispensing doctor shall, at the request of the Primary Care Trust or of a person authorised in writing mentioned in sub-paragraph (1), allow it or him access to any information which it or he reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of the Primary Care Trust, in connection with its functions that relate to pharmaceutical services.

(1)

S.I. 1992/664.

(2)

S.I. 2003/2124. Regulation 3 has been amended by S.I. 2004/540, 696 and 865.

(3)

1971 c. 38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

(4)

S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432.