62.—(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 M1 (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 medicine is not specified in any directions given by the Secretary of State in regulations under section 88 of the Act M2 (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 contract;
(c)the 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 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 [F1listed prescription item] ordered under arrangements made by the Secretary of State or [F2NHS England] for the [F3item’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 when 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 have 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 a 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 in regulations made under section 88 of the Act M3 (GMS contracts: prescription of drugs etc) as being a medicine which may not be ordered for patients in the provision of medical services under the contract;
(d)if it is a prescription for a prescription only medicine which 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 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)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 the 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
F1Words in reg. 62(2)(c)(iii)(bb) substituted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 19(2)(a)
F2Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
F3Word in reg. 62(2)(c)(iii)(bb) substituted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 19(2)(b)
Marginal Citations
M1S.I. 2012/1916. There are no amendments to regulation 215.
M2See the National Health Service (General Medical Services Contracts) (Prescription of Drugs, Medicines and Appliances etc) Regulations 2004 (S.I. 2004/639) for the Directions given by the Secretary of State under section 88 of the Act. S.I. 2004/639 was amended by S.I. 2004/3215, S.I. 2009/2230, S.I. 2010/2389, S.I. 2011/680 and 1043, S.I. 2013/ 363 and 2494 and S.I. 2014/1625.
M3See the National Health Service (General Medical Services Contracts) (Prescription of Drugs, Medicines and Appliances etc) Regulations 2004 (S.I. 2004/639) for the Directions given by the Secretary of State under section 88 of the Act. S.I. 2004/639 was amended by S.I. 2004/3215, S.I. 2009/2230, S.I. 2010/2389, S.I. 2011/680 and 1043, S.I. 2013/363 and 2494 and S.I. 2014/1625.