The National Health Service (General Medical Services Contracts) (Wales) Regulations 2023

Prospective

PART 5E+WPrescribing and dispensing

Prescribing: general E+W

48.—(1) The contractor must ensure that—

(a)any prescription form or repeatable prescription for drugs, medicines or appliances issued by a prescriber, and

(b)any home oxygen order form issued by a health care professional,

complies, as appropriate, with the requirements in this Part.

(2) In this Part, a reference to “drugs” includes contraceptive substances and a reference to “appliances” includes contraceptive appliances.

Orders for drugs, medicines and appliances E+W

49.—(1) Subject to sub-paragraphs (2) and (4) and to the restrictions on prescribing in paragraphs 55 and 56, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the contract by—

(a)issuing to the patient a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or

(b)creating and transmitting an electronic prescription in circumstances to which paragraph 50(1) applies,

and a non-electronic prescription form, non-electronic repeatable prescription or electronic prescription that is for health service use must not be used in any other circumstances.

(2) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in sub-paragraph (1)—

(a)the prescriber is able, without delay, to order the drug, medicine or appliance by means of an electronic prescription,

(b)the Electronic Prescription Service software that the prescriber would use for that purpose provides for the creation and transmission of electronic prescriptions without the need for a nominated dispenser, and

(c)none of the reasons for issuing a non-electronic prescription form or a non-electronic repeatable prescription given in sub-paragraph (3) apply,

the prescriber must create and transmit an electronic prescription for that drug, medicine or appliance.

(3) The reasons given in this sub-paragraph are—

(a)although the prescriber is able to use the Electronic Prescription Service, the prescriber is not satisfied that—

(i)the access that the prescriber has to the Electronic Prescription Service is reliable, or

(ii)the Electronic Prescription Service is functioning reliably,

(b)the patient, or where appropriate the patient’s authorised person, informs the prescriber that the patient wants the option of having the prescription dispensed elsewhere than in Wales, or

(c)the patient, or where appropriate the patient’s authorised person, insists on the patient being issued with a non-electronic prescription form or, a non-electronic repeatable prescription for a particular prescription and in the professional judgement of the prescriber the welfare of the patient is likely to be in jeopardy unless a non-electronic prescription form or a non-electronic repeatable prescription is issued.

(4) A health care professional must order any home oxygen services which are needed for the treatment of any patient who is receiving treatment under the contract by issuing a home oxygen order form.

(5) A prescriber may order drugs, medicines or appliances on a repeatable prescription only where the drugs, medicines or appliances are to be provided more than once.

(6) In issuing a non-electronic prescription form or a non-electronic repeatable prescription, the prescriber must—

(a)sign the prescription form or repeatable prescription in ink in the prescriber’s own handwriting, and not by means of a stamp, with the prescriber’s initials, or forenames, and surname, and

(b)only sign the prescription form or repeatable prescription after particulars of the order have been inserted in the prescription form or repeatable prescription.

(7) A prescription form or repeatable prescription must not refer to any previous prescription form or repeatable prescription.

(8) A separate prescription form or repeatable prescription must be used for each patient, except where a bulk prescription is issued for a school or institution under paragraph 57.

(9) A home oxygen order form must be signed by a health care professional.

(10) Where a prescriber orders the drug buprenorphine or diazepam or a drug specified in Part 1 of Schedule 2 to the Misuse of Drugs Regulations 2001(1) (controlled drugs to which regulations 14 to 16, 18 to 21, 23, 26 and 27 of those Regulations apply) for supply by instalments for treating addiction to any drug specified in that Schedule, the prescriber must—

(a)use only the prescription form provided specially for the purposes of supply by instalments,

(b)specify the number of instalments to be dispensed and the interval between each instalment, and

(c)order only such quantity of the drug as provides treatment for a period not exceeding 14 days.

(11) The prescription form provided specially for the purpose of supply by instalments must not be used for any purpose other than ordering drugs in accordance with sub-paragraph (10).

(12) In an urgent case, a prescriber may request an NHS pharmacist to dispense a drug or medicine before a prescription form or repeatable prescription is issued or created, only if—

(a)that drug or medicine is not a Scheduled drug,

(b)the drug is not a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Part 1 of Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001, and

(c)the prescriber undertakes to—

(i)provide the NHS pharmacist, within 72 hours beginning with the time of the request, with a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or

(ii)transmit an electronic prescription by the Electronic Prescription Service within 72 hours, beginning with the time of the request.

(13) In an urgent case, a prescriber may request an NHS pharmacist to dispense an appliance before a prescription form or repeatable prescription is issued or created, only if—

(a)the appliance does not contain a Scheduled drug, or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26),

(b)where the appliance is a restricted availability appliance, the patient is a person, or the appliance is for a purpose, specified in the Drug Tariff, and

(c)the prescriber undertakes to—

(i)provide the NHS pharmacist, within 72 hours beginning with the time of the request, with a non-electronic prescription form or non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or

(ii)transmit an electronic prescription by the Electronic Prescription Service within 72 hours, beginning with the time of the request.

Electronic prescriptions E+W

50.—(1) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription if the prescription is not—

(a)for a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001, or

(b)a bulk prescription issued for a school or institution under paragraph 57.

(2) If a prescriber orders a drug, medicine or appliance by means of an electronic prescription, the prescriber must issue the patient with—

(a)subject to sub-paragraph (4), an EPS token, and

(b)if the patient, or where appropriate the patient’s authorised person, so requests, a written record of the prescription that has been created.

(3) On and after the contractor’s EPS go live date, if the order is eligible for Electronic Prescription Service use, the prescriber must ascertain if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

(4) The prescriber must not issue the patient with an EPS token if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

(5) A health care professional may not order home oxygen services by means of an electronic prescription.

Nomination of dispensers for the purposes of electronic prescriptions E+W

51.—(1) A contractor authorised to use the Electronic Prescription Service for its patients must, if a patient, or where appropriate the patient’s authorised person, so requests, enter into the particulars relating to the patient which are held in the Welsh Demographic Service managed by DHCW or the Personal Demographic Service managed by NHS England—

(a)where the patient does not have a nominated dispenser, the dispenser chosen by the patient, or where appropriate the patient’s authorised person, and

(b)where the patient does have a nominated dispenser—

(i)a replacement dispenser, or

(ii)a further dispenser,

chosen by the patient, or where appropriate the patient’s authorised person.

(2) Sub-paragraph (1)(b)(ii) does not apply if the number of the nominated dispensers would thereby exceed the maximum number permitted by the Electronic Prescription Service.

(3) A contractor must—

(a)not seek to persuade a patient or a patient’s authorised person to nominate a dispenser recommended by the prescriber or the contractor, and

(b)if asked by a patient or a patient’s authorised person to recommend an NHS pharmacist whom the patient or the patient’s authorised person might nominate as the patient’s dispenser, provide the patient or, as the case may be, the patient’s authorised person with the list given to the contractor by the Local Health Board containing all NHS pharmacists in the area who provide an Electronic Prescription Service.

Repeatable prescribing services E+W

52.—(1) A contractor may only provide repeatable prescribing services to a person on its list of patients if the contractor—

(a)satisfies the conditions in sub-paragraph (2), and

(b)has notified the relevant Local Health Board of its intention to provide repeatable prescribing services in accordance with sub-paragraphs (3) and (4).

(2) The conditions referred to in sub-paragraph (1)(a) are—

(a)the contractor has access to computer systems and software which enable it to issue non-electronic repeatable prescriptions and batch issues, and

(b)the practice premises at which the repeatable prescribing services are to be provided are located in an area of the Local Health Board in which there is also located the premises of at least one NHS pharmacist who has undertaken to provide, or has entered into an arrangement to provide, repeat dispensing services.

(3) The notification referred to in sub-paragraph (1)(b) is a notification, in writing, by the contractor to the relevant Local Health Board that it—

(a)wishes to provide repeatable prescribing services,

(b)intends to begin to provide those services from a date specified in the notification, and

(c)satisfies the conditions in sub-paragraph (2).

(4) The date specified by the contractor under sub-paragraph (3)(b) must be at least 10 days after the date on which the notification specified in sub-paragraph (1) is given.

(5) Nothing in this paragraph requires a contractor or prescriber to provide repeatable prescribing services to any person.

(6) A prescriber may only provide repeatable prescribing services to a person on a particular occasion if—

(a)that person has agreed to receive such services on that occasion, and

(b)the prescriber considers that it is clinically appropriate to provide such services to that person on that occasion.

(7) The contractor may not provide repeatable prescribing services to any person on its list of patients to whom any person specified in sub-paragraph (8) is authorised or required by the Local Health Board to provide pharmaceutical services in accordance with arrangements under section 80 (arrangements for pharmaceutical services) and section 86 (persons authorised to provide pharmaceutical services) of the Act.

(8) The persons referred to in sub-paragraph (7) are—

(a)in the case of a contract with an individual medical practitioner, that medical practitioner,

(b)in the case of a contract with two or more individuals practising in partnership, any medical practitioner who is a partner,

(c)in the case of a contract with a company limited by shares, any medical practitioner who is both a legal and beneficial shareholder in that company, or

(d)any medical practitioner employed by the contractor.

Repeatable prescriptions E+W

53.—(1) A prescriber who issues a non-electronic repeatable prescription must at the same time issue the appropriate number of batch issues.

(2) Where a prescriber wants to make a change to the type, quantity, strength or dosage of drugs, medicines or appliances ordered on a person’s repeatable prescription, the prescriber must—

(a)in the case of a non-electronic repeatable prescription—

(i)give notice to the person, and

(ii)make reasonable efforts to give notice to the NHS pharmacist providing repeat dispensing services to that person,

that the original repeatable prescription is no longer to be used to obtain or provide repeat dispensing services and make arrangements for a replacement repeatable prescription to be issued to the person, or

(b)in the case of an electronic repeatable prescription—

(i)arrange with the Electronic Prescription Service for the cancellation of the original repeatable prescription, and

(ii)create a replacement repeatable prescription in respect of the person and give notice to the person that this has been done.

(3) Where a prescriber has created an electronic repeatable prescription for a person, the prescriber must, as soon as practicable, arrange with the Electronic Prescription Service for its cancellation if, before the expiry of that prescription—

(a)the prescriber considers that it is no longer safe or appropriate for the person to—

(i)receive the drugs, medicines or appliances ordered on the person’s electronic repeatable prescription, or

(ii)continue to receive repeatable prescribing services,

(b)the prescriber has issued the person with a non-electronic repeatable prescription in place of the electronic repeatable prescription, or

(c)it comes to the prescriber’s notice that the person on whose behalf the prescription was issued has been removed from the list of patients of the contractor.

(4) Where a prescriber has cancelled an electronic repeatable prescription in respect of a person in accordance with sub-paragraph (3), the prescriber must give notice of the cancellation to the person as soon as possible.

(5) A prescriber who has issued a non-electronic repeatable prescription in respect of a person must, as soon as possible, make reasonable efforts to give notice to the NHS pharmacist that that repeatable prescription must no longer be used to provide repeat dispensing services to that person, if, before the expiry of that repeatable prescription—

(a)the prescriber considers that it is no longer safe or appropriate for the person to—

(i)receive the drugs, medicines or appliances ordered on the person’s repeatable prescription, or

(ii)to continue to receive repeatable prescribing services,

(b)the prescriber issues or creates a further repeatable prescription in respect of the person to replace the original repeatable prescription other than in the circumstances referred to in sub-paragraph (2)(a) (for example, because the person wants to obtain the drugs, medicines or appliances from a different NHS pharmacist), or

(c)it comes to the prescriber’s notice that the person on whose behalf the prescription was issued has been removed from the list of patients of the contractor.

(6) Where the circumstances in sub-paragraph (5)(a) to (c) apply in respect of a person, the prescriber must, as soon as possible, give notice to that person that their repeatable prescription must no longer be used to obtain repeat dispensing services.

Prescribing for electronic repeat dispensing E+W

54.—(1) Subject to paragraphs 49, 50, 52 and 53(2)(b) to (4), where a prescriber orders a drug, medicine or appliance by means of an electronic repeatable prescription, the prescriber must issue the prescription in a format appropriate for electronic repeat dispensing where it is clinically appropriate to do so for that patient on that occasion.

(2) In this regulation, “electronic repeat dispensing” means dispensing as part of pharmaceutical services or local pharmaceutical services which involves the provision of drugs, medicines or appliances in accordance with an electronic repeatable prescription.

Restrictions on prescribing by medical practitioners E+W

55.—(1) A medical practitioner, in the course of treating a patient to whom the practitioner is providing treatment under the contract, must comply with the following sub-paragraphs.

(2) The medical practitioner must not order on a listed medicines voucher, prescription form or a repeatable prescription, drugs, medicines or other substances specified in any directions given by the Welsh Ministers in regulations made under section 46 of the Act (GMS contracts: prescription of drugs etc) as being drugs, medicines or other substances which may not be ordered for patients in the provision of medical services under the contract.

(3) The medical practitioner must not order on a listed medicines voucher, a prescription form or repeatable prescription drugs, medicines or other substances specified in any directions given by the Welsh Ministers under section 46 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which can only be ordered for specified patients and for specified purposes unless—

(a)the patient is a person of the specified description,

(b)the drug, medicine or other substance is prescribed for that patient only for the specified purpose, and

(c)if the order is on a prescription form, the practitioner includes on the form the reference “SLS”.

(4) The medical practitioner must not order on a prescription form or repeatable prescription a restricted availability appliance unless—

(a)the patient is a person, or the restricted availability appliance is for a purpose, specified in the Drug Tariff, and

(b)the practitioner includes on the prescription form the reference “SLS”.

(5) The medical practitioner must not order on a repeatable prescription a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23 26 and 27) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001.

(6) Subject to regulation 21(2)(b) and to sub-paragraph (7), nothing in the preceding sub-paragraphs prevents a medical practitioner, in the course of treating a patient to whom this sub-paragraph refers, from prescribing a drug, medicine or other substance or, as the case may be, a restricted availability appliance or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), for the treatment of that patient under a private arrangement.

(7) Where, under sub-paragraph (6), a drug, medicine or other substance is prescribed under a private arrangement, if the order is to be transmitted as an electronic communication to an NHS pharmacist for the drug, medicine or appliance to be dispensed—

(a)if the order is not for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001, it may be transmitted by the Electronic Prescription Service, but

(b)if the order is for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001, it must be transmitted by the Electronic Prescription Service.

Restrictions on prescribing by supplementary prescribers E+W

56.—(1) The contractor must have arrangements in place to secure that an individual who is a supplementary prescriber may—

(a)issue or create a prescription for a prescription only medicine,

(b)administer a prescription only medicine for parenteral administration, or

(c)give directions for the administration of a prescription only medicine for parenteral administration,

as a supplementary prescriber only under the conditions set out in sub-paragraph (2).

(2) The conditions referred to in sub-paragraph (1) are that—

(a)the individual satisfies the applicable conditions set out in regulation 215 of the Human Medicines Regulations 2012(2) (prescribing and administration by supplementary prescribers), unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of those Regulations;

(b)the drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract;

(c)the drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—

(i)the patient is a person of the specified description,

(ii)the medicine is prescribed for that patient only for the specified purposes, and

(iii)if the supplementary prescriber is giving a prescription, he or she endorses the face of the form with the reference “SLS”.

(3) Where the functions of a supplementary prescriber include prescribing, the contractor must have arrangements in place to secure that that person may only give a prescription for—

(a)an appliance, or

(b)a medicine which is not a prescription only medicine,

as a supplementary prescriber under the conditions set out in sub-paragraph (4).

(4) The conditions set out in this paragraph are that—

(a)the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time the supplementary prescriber acts and which contains the following particulars—

(i)the name of the patient to whom the plan relates,

(ii)the illness or conditions which may be treated by the supplementary prescriber,

(iii)the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan,

(iv)reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan,

(v)any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan,

(vi)relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances,

(vii)the arrangements for notification of—

(aa)suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan,

(bb)incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient, and

(viii)the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the medical practitioner or dentist who is a party to the plan,

(b)the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any medical practitioner or dentist who is a party to the plan,

(c)if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract,

(d)if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—

(i)the patient is a person of the specified description,

(ii)the medicine is prescribed for that patient only for the specified purposes, and

(iii)when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”,

(e)if it is a prescription for an appliance, the appliance is listed in Part IX of the Drug Tariff, and

(f)if it is a prescription for a restricted availability appliance—

(i)the patient is a person of a description mentioned in the entry in Part IX of the Drug Tariff in respect of that appliance,

(ii)the appliance is prescribed only for the purposes specified in respect of that person in that entry, and

(iii)when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”.

(5) In sub-paragraph (4)(a), “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)the patient to whom the plan relates,

(b)the medical practitioner or dentist who is a party to the plan, and

(c)any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan.

Bulk prescribing E+W

57.—(1) A prescriber may use a single non-electronic prescription form where—

(a)a contractor is responsible under the contract for the treatment of 10 or more persons in a school or other institution in which at least 20 persons normally reside, and

(b)the prescriber orders, for any 2 or more of those persons for whose treatment the contractor is responsible, drugs, medicines or appliances to which this paragraph applies.

(2) Where a prescriber uses a single non-electronic prescription form for the purpose mentioned in sub-paragraph (1)(b), the prescriber must (instead of entering on the form the names of the persons for whom the drugs, medicines or appliances are ordered) enter on the form—

(a)the name of the school or other institution in which those persons reside, and

(b)the number of persons residing there for whose treatment the contractor is responsible.

(3) This paragraph applies to any drug, medicine or appliance which can be supplied as part of pharmaceutical services or local pharmaceutical services and which in the case of—

(a)a drug or medicine, is not a prescription only medicine, or

(b)an appliance, does not contain such a product.

Excessive prescribing E+W

58.—(1) The contractor must not prescribe drugs, medicines or appliances the cost or quantity of which, in relation to a patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of the patient.

(2) In considering whether a contractor has breached its obligations under paragraph (1), the Local Health Board must seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the contract.

Provision of drugs, medicines and appliances for immediate treatment or personal administration E+W

59.—(1) Subject to paragraphs (2) and (3), a contractor—

(a)must provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, where such provision is needed for the immediate treatment of the patient before provision can otherwise be obtained, and

(b)may provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, which the contractor personally administers or applies to the patient.

(2) A contractor must only provide a restricted availability appliance under paragraph (1)(a) or (b) if it is for a person or a purpose specified in the Drug Tariff.

(3) Nothing in paragraph (1) or (2) authorises a person to supply a prescription only medicine to a patient otherwise than in accordance with Part 12 of the Human Medicines Regulations 2012 (which relates to dealings with medicinal products).

Provision of dispensing services E+W

60.—(1) The contractor may only provide, and must ensure that those employed or engaged by it only provide, pharmaceutical services or dispensing services in the circumstances provided for in the Pharmaceutical Regulations.

(2) Where the contractor, or a person employed or engaged by the contractor, is included in the Local Health Board’s dispensing doctor list, the contractor must ensure that in the provision of any pharmaceutical services or dispensing services the contractor, and the dispensing doctor (and any person authorised to dispense on their behalf under the Pharmaceutical Regulations)—

(a)complies with the terms of service applicable to the person providing those pharmaceutical services or dispensing services by virtue of regulation 12(2) of the Pharmaceutical Regulations, and

(b)ensures that the patient to whom they are seeking to provide those services is aware that the relevant drugs or appliances are not only available from them (or by a person with whom the contractor is associated) and that the patient has the option to obtain those drugs or appliances from any NHS pharmacist.