The Prescription Only Medicines (Human Use) Amendment Order 2002

• Citation: S.I. 2002/549
• Sections: 11

Section 1 Citation, commencement and interpretation

(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2002 and shall come into force on 1st April 2002.

(2) In this Order, “the principal Order ” means the Prescription Only Medicines (Human Use) Order 1997 .

Section 2 Amendment of article 1 of the principal Order

(1) Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows.

(2) In paragraph (1)—

(a) omit the definition of “appropriate nurse practitioner”;

(b) after the definition of “cyanogenetic substances” insert the following definition—

“district nurse/health visitor prescriber” means—

a person who—

is registered in Part 1 or 12 of the professional register, and

has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983 ; or

a person who is registered in Part 11 of the professional register as a health visitor,

against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;

(c) after the definition of “dosage unit” insert the following definitions—

“Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;

“extended formulary nurse prescriber” means a person—

who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and

against whose name is recorded in that register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;

(d) in the definition of “health prescription”, for “or nurse prescriber” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;

(e) after the definition of “Primary Care Trust” insert the following definition—

“professional register” means the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001 ;

(f) in the definition of “registered midwife”, for the words from “the Register” to the end substitute “the professional register”;

(g) in the definition of “registered nurse”, for the words from “the Register” to the end substitute “the professional register”;

(h) in the definition of “state registered chiropodist”, for the words from “the Register” to the end substitute “the register of chiropodists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 ”; and

(i) in the definition of “state registered paramedic”, for the words from “the Register” to the end substitute “the register of paramedics maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001”.

(3) In paragraph (5) , for “Schedules 1, 2 and 5” substitute “Schedules 1, 2, 3A and 5”.

Section 3 Amendment of article 2 of the principal Order

In article 2 of the principal Order (appropriate practitioners), for paragraph (b) substitute the following paragraphs—

(b) in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;

(c) in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.

Section 4 Amendment of article 3 of the principal Order

For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—

Medicinal products on prescription only

(3) The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—

(a) medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;

(b) medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;

(c) medicinal products that are for parenteral administration;

(d) medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;

(e) cyanogenetic substances, other than preparations for external use;

(f) medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used.

Section 5 Insertion of article 3A in the principal Order

After article 3 of the principal Order, insert the following article—

Prescribing by extended formulary nurse prescribers

(3A)

(1) Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.

(2) An extended formulary nurse prescriber may—

(a) give a prescription for a medicinal product referred to in paragraph (1); or

(b) if that medicinal product is for parenteral administration—

(i) administer that medicinal product, or

(ii) give directions for the administration of that medicinal product,

only where he complies with any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).

(3) If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.

Section 6 Amendment of article 8 of the principal Order

Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows—

(a) in paragraph (2)—

(i) in sub-paragraph (a), after “doctor” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;

(ii) in sub-paragraph (b), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”;

(iii) in sub-paragraph (c), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”; and

(b) in paragraph (4), in sub-paragraph (a), in head (ii), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”.

Section 7 Insertion of article 13A into the principal Order

After article 13 of the principal Order (exemption in cases involving another’s default) insert the following article—

Exemptions relating to prescriptions given by nurses

(13A)

(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by a registered nurse or registered midwife who is not an appropriate practitioner in relation to that medicine where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(2) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by an extended formulary nurse prescriber where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber has complied with any condition with which he is required to comply by virtue of article 3A(2) and (3).

Section 8 Amendment of article 15 of the principal Order

In article 15 (prescriptions) , in paragraph (2)(c)—

(a) in head (iii), for “an appropriate nurse practitioner” substitute “a district nurse/health visitor prescriber, an extended formulary nurse prescriber”; and

(b) in head (iv), for “or appropriate nurse practitioner” substitute “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”.

Section 9 Insertion of Schedule 3A in the principal Order

After Schedule 3 to the principal Order, insert the following Schedule—

SUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

Section 10 Amendment of Schedule 7 to the principal Order

In Part III of Schedule 7 to the principal Order (Patient Group Directions—classes of individuals by whom supplies may be made), for the last three entries substitute the following entries—

Individuals who are registered in the register of orthoptists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered orthoptists).

Individuals who are registered in the register of physiotherapists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered physiotherapists).

Individuals who are registered in the register of radiographers maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered radiographers).

Section 11 Revocations

Articles 4 and 6 of the principal Order are revoked.