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PART 9E+WPrescribing and dispensing

Prescribing: generalE+W

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

(a)any prescription form or repeatable prescription issued or created by a prescriber;

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

(c)any [F1listed prescription items] voucher issued by a prescriber or any other person acting under the agreement,

complies as appropriate with the requirements in regulations 49, 50 and 52 to 55.

[F2(2) In regulations 49, 50 and 52 to 56, a reference to “drugs” includes contraceptive substances and a reference to “appliances” includes contraceptive appliances.]

Textual Amendments

[F3Prescribing software and supply shortages etc. of medicinesE+W

48A.—(1) This paragraph applies where—

(a)the Secretary of State, in the exercise of the Secretary of State’s obligations, duties or powers in respect of ensuring that adequate supplies of English health service medicines are available—

(i)has acquired information under Part 6 of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (information about price and availability of health service medicines) about a particular English health service medicine, and

(ii)authorises the disclosure of information derived from that information (“relevant communications information”) to contractors for the purpose of ensuring, by the appropriate and effective management of—

(aa)a supply shortage of that particular English health service medicine, or

(bb)the discontinuation of the production of that particular English health service medicine,

that adequate supplies of English health service medicines are available;

(b)the contractor wishes to receive relevant communications information via the prescribing software that it has to support the issuing of prescriptions for English health service medicines (in addition to the other ways in which it may access that information); and

(c)there is a software programme available to the contractor from its supplier of prescribing software (“SPS”) that would enable that.

(2) Where paragraph (1) applies, the contractor must ensure that the arrangements it makes with a SPS to support the issuing of prescriptions for English health service medicines—

(a)include appropriate provision requiring the updating of the software to take account of relevant communications information about supply shortages of, or the discontinuation of the production of, particular English health service medicines; and

(b)are, as regards that inclusion, consistent with the authorisation referred to in paragraph (1)(a)(ii).

(3) The disclosure of relevant communications information by the Secretary of State or a person acting on the Secretary of State’s behalf to a SPS, or by a SPS to a contractor in a manner that is consistent with the authorisation referred to in paragraph (1)(a)(ii), is not a disclosure of confidential or commercially sensitive information affected by section 264B(2)(b) of the Act, in a case where but for this paragraph it would be, if the disclosure is—

(a)for the purpose of ensuring, by the appropriate and effective management by the Secretary of State (and persons acting on the Secretary of State’s behalf) of—

(i)a supply shortage of the particular English health service medicine in question, or

(ii)the discontinuation of the production of the particular English health service medicine in question,

that adequate supplies of English health service medicines are available; and

(b)proportionate to that purpose.

(4) A disclosure of relevant communications information as mentioned in paragraph (3) may be by way of permitting access to that information rather than proactive disclosure.

(5) A disclosure of relevant communications information that is as mentioned in paragraph (3) is to be treated as neither constituting a breach of confidence nor prejudicing commercial interests in any case where, but for this paragraph, it would be so treated.

(6) Section 264B(3)(f) of the Act applies to the contractor in respect of relevant communications information received as part of the arrangements mentioned in paragraph (2) as it would if the Secretary of State had disclosed that information to the contractor directly instead of via an intermediary.

(7) A SPS must not disclose relevant communications information, other than as provided for in paragraph (3), if it is confidential or commercially sensitive information that, when disclosed to a contractor by the Secretary of State, is subject to the disclosure restriction in section 264B(2)(b) of the Act.]

Textual Amendments

Orders for drugs, medicines or appliancesE+W

49.—(1) Subject to [F4paragraphs (1A), (2) and (3)] and to the restrictions on prescribing in regulations 54 and 55, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of a patient who is receiving treatment under the agreement by—

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

(b)creating and transmitting an electronic prescription in circumstances to which regulation 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.

[F5(1A) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in 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 paragraph (1B) apply,

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

(1B) The reasons given in this 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 England;

(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 judgment 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;

(d)the prescription is to be issued before the contractor’s EPS phase 4 date or the contractor has no such date.]

(2) A healthcare professional must order any home oxygen services which are needed for the treatment of a patient who is receiving treatment under the agreement by issuing a home oxygen order form.

(3) During an outbreak of an illness for which a [F6listed prescription item] may be used for a treatment or for prophylaxis, if—

(a)the Secretary of State or [F7NHS England] has made arrangements for the distribution of a [F6listed prescription item] free of charge; and

(b)that [F6listed prescription item] is needed for treatment or prophylaxis of any patient who is receiving treatment under the agreement,

a prescriber may order that [F6listed prescription item] by using a [F8listed prescription items] voucher and must sign that [F8listed prescription items] voucher [F9(with an electronic signature, if an electronic form is used)] if one is used.

(4) During an outbreak of an illness for which a [F10listed prescription item] may be used for treatment or for prophylaxis, if—

(a)the Secretary of State or [F7NHS England] has made arrangements for the distribution of a [F10listed prescription item] free of charge;

(b)those arrangements contain criteria set out in a protocol which enable persons who are not prescribers to identify the symptoms of, and whether there is a need for treatment or prophylaxis of, that disease;

(c)a person acting on behalf of the contractor, who is not a prescriber but who is authorised by [F7NHS England] to order [F11listed prescription items], has applied the criteria referred to in sub-paragraph (b) to a patient who is receiving treatment under the agreement; and

(d)having applied the criteria, that person has concluded that the [F10listed prescription item] is needed for the treatment or prophylaxis of the patient,

that person may order that [F10listed prescription item] by using a [F11listed prescription items] voucher and must sign that [F11listed prescription items] voucher [F12(with an electronic signature, if an electronic form is used)] if one is used.

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

[F13(5A) A prescriber must only order one prescription item on a prescription form or repeatable prescription that is used by the prescriber for ordering a listed HRT prescription item.

(5B) For the purposes of paragraph (5A), “listed HRT prescription item” is to be construed in accordance with regulation 17A(1)(a) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015, read with regulation 17A(7) of those Regulations.]

(6) In issuing a non-electronic prescription form or 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 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 regulation 54.

(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 Schedule 2 to the Misuse of Drugs Regulations 2001 M1 (controlled drugs to which regulations 14 to 16, 18, 21, 23, 26 and 27 of those Regulations apply) for supply by instalments for treating addiction to any drug specified in that Schedule, that prescriber must—

(a)use only the F14... 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)only order such quantity of the drug as will provide 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 paragraph (10).

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

(a)the 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 M2 (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 of importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001 M3; and

(c)the prescriber undertakes to—

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

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

(13) In an urgent case, a prescriber may only request a chemist to dispense an appliance before a prescription form or repeatable prescription form is issued or created 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)in the case of a restricted availability appliance, the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(c)the prescriber undertakes to—

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

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

Textual Amendments

Marginal Citations

M1S.I. 2001/3998. Schedule 2 was amended by S.I. 2003/1432, S.I. 2009/3136, S.I. 2011/448, S.I. 2014/1275 and 3277 and S.I. 2015/891.

M21971 c.38. Section 2 was amended by paragraphs 1 and 2 of Schedule 17 to the Police Reform and Social Responsibility Act 2011 (c. 13).

M3S.I. 2001/3998; Schedule 4 was amended by S.I. 2003/1432, S.I. 2005/3372, S.I. 2007/2154, S.I. 2009/3136, S.I. 2013/625, S.I. 2014/1275 and 3277 and S.I. 2015/891. Schedule 5 was amended by S.I. 2005/2864.

Electronic prescriptionsE+W

50.—(1) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription if—

F15(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the prescription is not—

(i)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 Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) or 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, or

(ii)a bulk prescription issued for a school or institution under regulation 56.

[F16(1A) 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 paragraph (1C), an EPS token; and

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

(1B) On and after the contractor’s EPS phase 4 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.

(1C) 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.]

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

F17(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Nomination of dispensers for the purpose of electronic prescriptionsE+W

51.—(1) A contractor authorised to use the Electronic Prescription Service for its patients must [F18, 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 Patient Demographic Service operated by [F19NHS England]M4—

(a)where the patient does not have a nominated dispenser, the dispenser chosen by the patient [F20or where appropriate the patient’s authorised person];

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

(i)a replacement dispenser, or

(ii)a further dispenser,

chosen by the patient.

(2) 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.

F21(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A contractor must—

(a)not seek to persuade the patient [F22or the patient’s authorised person] to nominate a dispenser recommended by the prescriber or the contractor; and

(b)if asked by the patient [F23or the patient’s authorised person] to recommend a chemist whom the patient [F24or the patient’s authorised person] might nominate as the patient's dispenser, provide the patient [F25or, as the case may be, the patient’s authorised person] with the list given to the contractor by [F7NHS England] of all chemists in the area who provide an Electronic Prescription Service.

Textual Amendments

Marginal Citations

M4The Health and Social Care Information Centre is a body corporate established by section 252(1) of the Health and Social Care Act 2012 (c.7).

Repeatable prescribing servicesE+W

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

(a)satisfies the conditions specified in paragraph (2); and

(b)has given notice in writing to [F7NHS England] of its intention to provide repeatable prescribing services in accordance with paragraphs (3) and (4).

(2) The conditions specified in this paragraph are that—

(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 a local authority area in which there is also located the premises of at least one chemist who has undertaken to provide, or has entered into arrangements to provide, repeat dispensing services.

(3) The notice given under paragraph (1)(b) must confirm that the contractor—

(a)wants to provide repeatable prescribing services;

(b)intends to begin providing those services from a specified date; and

(c)satisfies the conditions specified in paragraph (2).

(4) The date specified by the contractor under paragraph (3)(b) must be at least ten days after the date on which the notice under paragraph (1)(b) was given.

(5) Nothing in this regulation 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)the 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 of its patients to whom a person specified in paragraph (8) is authorised or required by [F7NHS England] to provide pharmaceutical services in accordance with arrangements under section 126 M5 (arrangements for pharmaceutical services) and section 132 M6 (persons authorised to provide pharmaceutical services) of the Act.

(8) The persons specified in this paragraph are—

(a)a medical practitioner who is a party to the agreement;

(b)in the case of an agreement with a qualifying body, any medical practitioner who is both a legal and beneficial shareholder in that body; or

(c)any medical practitioner employed or engaged by the contractor.

Textual Amendments

Marginal Citations

M5Section 126 was amended by sections 213(7)(k) and 220(7) of, and paragraph 63 of Schedule 4 to, the Health and Social Care Act 2012 (c.7) (“the 2012 Act”).

M6Section 132 was amended by paragraph 69 of Schedule 4 to the 2012 Act, section 115(1) of, and paragraphs 120 and 121 of Schedule 9 to, the Protection of Freedoms Act 2012 (c.9), and by S.I. 2007/289 and S.I. 2010/22 and 231.

Repeatable prescriptionsE+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 chemist providing repeat dispensing services to the person,

that the original repeatable prescription should no longer 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 electronic repeatable prescription relating to 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 receive the drugs, medicines or appliances ordered on the person's electronic repeatable prescription or it is no longer safe or appropriate for the person to 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 has been removed from the list of patients of the contractor on whose behalf the prescription was issued.

(4) Where a prescriber has cancelled an electronic repeatable prescription relating to a person in accordance with paragraph (3), the prescriber must give notice to the person as soon as possible to that effect.

(5) A prescriber who has issued a non-electronic repeatable prescription in relation to a person must, as soon as possible, make reasonable efforts to give notice to the chemist that that repeatable prescription should 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 receive the drugs, medicines or appliances ordered on the person's repeatable prescription or that it is no longer safe or appropriate for the person 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 paragraph (2)(a) (for example, because the person wants to obtain the drugs, medicines or appliances from a different chemist); or

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

(6) Where the circumstances in paragraph (5)(a) to (c) apply, the prescriber must, as soon as practicable, give notice to a person that the person's repeatable prescription should no longer be used to obtain repeat dispensing services.

[F26[F27Prescribing for electronic repeat dispensing]E+W

53A.—(1) Subject to regulations 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 [F28electronic repeat dispensing] [F29where it is clinically appropriate to do so for that patient on that occasion].

[F30(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 accordance with an electronic repeatable prescription.]]

Textual Amendments

Restrictions on prescribing by medical practitionersE+W

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

(2) The medical practitioner must not order on a [F31listed prescription items] voucher, prescription form or a repeatable prescription a drug, medicine or other substance specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under a general medical services contract.

(3) The medical practitioner must not order on a [F31listed prescription items] voucher, a prescription form or repeatable prescription a drug, medicine or other substance specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which can be ordered for specified patients and 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—

(i)the reference “SLS”, or

(ii)if the order is under arrangements made by the Secretary of State or [F7NHS England] for the distribution of a [F32listed prescription item] free of charge, the reference “ACP”.

(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 it 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 M7 (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 M8.

(6) Subject to regulation 18(2)(b) and to paragraph (7), nothing in the preceding paragraphs prevents a medical practitioner, in the course of treating a patient to whom this regulation 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 (controlled drugs and their classification for the purposes of that Act) for the treatment of that patient under a private arrangement.

(7) Where, under 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 a chemist 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 Schedule 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 M9, 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 Schedule 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.

Textual Amendments

Marginal Citations

M8S.I. 2001/3998. Schedule 4 was amended by S.I. 2003/1432, S.I. 2005/3372, S.I. 2007/2154, S.I. 2012/973, S.I. 2013/625, S.I. 2014/1275 and 3277 and S.I. 2015/1891. Schedule 5 was amended by S.I. 2005/2864.

M9S.I. 2001/3998. Schedules 2 and 3 were amended by S.I. 2003/1432, S.I. 2007/2154, S.I. 2009/3136, S.I. 2011/448, S.I. 2012/1311, S.I. 2014/1275 and 3277 and S.I. 2015/891.

Restrictions on prescribing by supplementary prescribersE+W

55.—(1) The contractor must have arrangements in place to secure that a supplementary prescriber may only—

(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 under the conditions set out in paragraph (2).

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

(a)the person satisfies the conditions in regulation 215 of the Human Medicines Regulations 2012 M10 (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 prescription only medicine is not specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under a general medical services contract; and

(c)the prescription only medicine is not specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs) as being a prescription only medicine 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 issuing or creating a prescription on a prescription form the prescriber includes on the form—

(aa)the reference “SLS”, or

(bb)in the case of a [F33listed prescription item] ordered under arrangements made by the Secretary of State or [F7NHS England] for the [F34item’s] distribution free of charge, the reference “ACP”.

(3) Where the functions of a supplementary prescriber include prescribing, the contractor must have arrangements in place to secure that the person may only issue or create 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 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 at which that 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 giving notice 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, and

(bb)incidents occurring with the appliance that might lead, might have led or has led to the death or serious deterioration of the 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 prescription only medicine, that prescription only medicine is not specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the agreement;

(d)if it is a prescription for a prescription only medicine, that prescription only medicine is not specified in any directions given by the Secretary of State under section 88 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 specified purposes unless—

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

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

(iii)when issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”;

(e)if it is 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 issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”.

(5) In 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.

Textual Amendments

Marginal Citations

M10S.I. 2012/1916. There are no amendments to regulation 215.

Bulk prescribingE+W

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

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

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

(2) Where a prescriber uses a single non-electronic prescription form for the purpose mentioned in 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 regulation applies to any drug, medicine or appliance which can be supplied as part of pharmaceutical services or local pharmaceutical services and which—

(a)in the case of a drug or medicine, is not a prescription only medicine; or

(b)in the case of an appliance, does not contain such a product.

Excessive prescribingE+W

57.—(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), [F7NHS England] may, if the contractor consents, seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the agreement.

Textual Amendments

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

58.—(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 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 any drug or medicine to a patient otherwise than in accordance with Part 12 of the Human Medicines Regulations 2012 M11.

Marginal Citations

M11S.I. 2012/1916; as amended by S.I. 2013/235, 1855 and 2593 and S.I. 2014/490 and 1887, S.I. 2015/323, 570, 903 and 1503.