The Prescription Only Medicines (Human Use) Amendment Order 2003

Insertion of Schedule 3B of the principal Order

16.  After Schedule 3A to the principal Order, insert the following Schedule—

Regulation 3B(3)(a)(iii)

“SCHEDULE 3B PARTICULARS FOR CLINICAL MANAGEMENT PLANS

A clinical management plan shall contain the following particulars—

(a) the name of the patient to whom the plan relates;

(b) the illnesses or conditions which may be treated by the supplementary prescriber;

(c) the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;

(d) reference to the class or description of medicinal product which may be prescribed or administered under the plan;

(e) any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;

(f) relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g) the arrangements for notification of—

(i) suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and

(ii) suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and

(h) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.”