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(1) (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 listed medicine ordered under arrangements made by the Secretary of State or the Board for the medicine’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.
S.I. 2012/1916. There are no amendments to regulation 215.