2002 No. 549
The Prescription Only Medicines (Human Use) Amendment Order 2002
Made
Laid before Parliament
Coming into force
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 58(1), (4), (4A) and (5), 59, 103(2) and 129(4) of the Medicines Act 19681, or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Committee on the Safety of Medicines, pursuant to sections 58(6) and 129(7) of that Act, and taking into account the advice of the Medicines Commission, pursuant to section 129(7) of that Act, hereby make the following Order:—
Citation, commencement and interpretation1
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 19973.
Amendment of article 1 of the principal Order2
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
a person who—
- i
is registered in Part 1 or 12 of the professional register, and
- ii
has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 19834; or
- b
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—
- a
who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and
- b
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
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
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)10, for “Schedules 1, 2 and 5” substitute “Schedules 1, 2, 3A and 5”.
Amendment of article 2 of the principal Order3
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.
Amendment of article 3 of the principal Order4
For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—
Medicinal products on prescription only3
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.
Insertion of article 3A in the principal Order5
After article 3 of the principal Order, insert the following article—
Prescribing by extended formulary nurse prescribers3A
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.
Amendment of article 8 of the principal Order6
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”.
Insertion of article 13A into the principal Order7
After article 13 of the principal Order (exemption in cases involving another’s default) insert the following article—
Exemptions relating to prescriptions given by nurses13A
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).
Amendment of article 15 of the principal Order8
In article 15 (prescriptions)11, 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”.
Insertion of Schedule 3A in the principal Order9
After Schedule 3 to the principal Order, insert the following Schedule—
SCHEDULE 3ASUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION
Column 1
Column 2
Substance
Requirements as to use, route of administration, or pharmaceutical form
Aciclovir
External use
Acrivastine
Oral
Adapalene
External use
Alclometasone dipropionate
External use
Alimemazine tartrate (trimeprazine tartrate)
Oral
Amorolfine hydrochloride
External use
Amoxycillin trihydrate
Oral
Aspirin
Oral
Azelaic acid
External use
Azelastine hydrochloride
Ophthalmic use or nasal
Baclofen
Oral administration in palliative care
Beclometasone dipropionate
External use or nasal
Betamethasone dipropionate
External use
Betamethasone sodium phosphate
Aural or nasal
Betamethasone valerate
External use
Budesonide
Nasal
Carbaryl
External use
Carbenoxolone sodium
Mouthwash
Cetirizine hydrochloride
Oral
Chloramphenicol
Ophthalmic use
Cimetidine
Oral
Cinchocaine hydrochloride
External use
Clindamycin phosphate
External use
Clobetasone butyrate
External use
Clotrimazole
External use
Cyclizine
Parenteral administration in palliative care
Dantrolene sodium
Oral administration in palliative care
Dantron
Oral
Desogestrel
Oral
Desoximetasone (Desoxymethasone)
External use
Dexamethasone
Aural
Dexamethasone isonicotinate
Nasal
Diclofenac diethylammonium
External use
Domperidone
Oral or rectal administration in palliative care
Domperidone maleate
Oral administration in palliative care
Doxycycline
Oral
Econazole nitrate
External use
Erythromycin
External use
Ethinylestradiol
Oral
Etynodiol diacetate (ethynodiol diacetate)
Oral
Famotidine
Oral
Felbinac
External use
Fenticonazole nitrate
External use
Fexofenadine hydrochloride
Oral
Flucloxacillin sodium
Oral
Fluconazole
Oral
Fludroxycortide (Flurandrenolone)
External use
Flumetasone pivalate
Aural
Flunisolide
Nasal
Fluocinolone acetonide
External use
Fluocinonide
External use
Fluocortolone hexanoate
External use
Fluocortolone pivalate
External use
Flurbiprofen
Lozenges
Fluticasone propionate
External use or nasal
Fusidic acid
Ophthalmic use
Gentamicin sulphate
Aural
Gestodene
Oral
Hydrocortisone
External use
Hydrocortisone acetate
External use
Hydrocortisone butyrate
External use
Hydrocortisone sodium succinate
Lozenges
Hyoscine butylbromide
Parenteral administration in palliative care
Hyoscine hydrobromide
Oral, parenteral or transdermal administration in palliative care
Ibuprofen
External use or oral
Ibuprofen lysine
Oral
Ipratropium bromide
Nasal
Isotretinoin
External use
Ketoconazole
External use
Ketoprofen
External use
Levocabastine hydrochloride
Ophthalmic use or nasal
Levomepromazine (methotrimeprazine) maleate
Oral administration in palliative care
Levomepromazine (methotrimeprazine) hydrochloride
Parenteral administration in palliative care
Levonorgestrel
Oral
Lithium succinate
External use
Lodoxamide trometamol
Ophthalmic use
Loperamide hydrochloride
Oral
Loratadine
Oral
Mebendazole
Oral
Medroxyprogesterone acetate
Parenteral
Mestranol
Oral
Metoclopramide hydrochloride
Oral or parenteral administration in palliative care
Metronidazole
External use or oral
Metronidazole benzoate
Oral
Miconazole
Dental lacquer
Miconazole nitrate
External use
Minocycline
Oral
Mometasone furoate
External use or nasal
Nedocromil sodium
Ophthalmic use
Nefopam hydrochloride
Oral
Neomycin sulphate
Aural
Neomycin undecenoate
Aural
Nitrofurantoin
Oral
Nizatidine
Oral
Norethisterone 9
Oral
Norethisterone acetate
Oral
Norethisterone enanthate
Parenteral
Norgestimate
Oral
Norgestrel
Oral
Nystatin
External use
Oxytetracycline dihydrate
Oral
Paracetamol
Oral
Penciclovir
External use
Piroxicam
External use
Prednisolone hexanoate
External use
Prednisolone sodium phosphate
Aural
Ranitidine hydrochloride
Oral
Silver sulphadiazine
External use
Sodium cromoglycate
Ophthalmic use
Streptodornase
External use
Streptokinase
External use
Sulconazole nitrate
External use
Terbinafine hydrochloride
External use
Tetracycline hydrochloride
External use or oral
Tretinoin
External use
Triamcinolone acetonide
External use, aural, nasal or oral paste
Trimethoprim
Oral
Tuberculin PPD
Parenteral
Vaccine, Adsorbed Diphtheria
Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus
Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus For Adults And Adolescents
Parenteral
Vaccine, Adsorbed Diphtheria For Adults And Adolescents
Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis
Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis (Acellular Component)
Parenteral
Vaccine, BCG
Parenteral
Vaccine, BCG Percutaneous
Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib)
Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib) with Diphtheria, Tetanus And Pertussis
Parenteral
Vaccine, Haemophilus Influenzae Type B, Diphtheria, Tetanus And Acellular Pertussis
Parenteral
Vaccine, Hepatitis A
Parenteral
Vaccine, Hepatitis A With Typhoid
Parenteral
Vaccine, Hepatitis A, Inactivated, With Recombinant (DNA) Hepatitis B
Parenteral
Vaccine, Hepatitis B
Parenteral
Vaccine, Influenza
Parenteral
Vaccine, Live Measles, Mumps And Rubella (MMR)
Parenteral
Vaccine, Meningococcal Group C Conjugate
Parenteral
Vaccine, Meningococcal Polysaccharide A and C
Parenteral
Vaccine, Pneumococcal
Parenteral
Vaccine, Poliomyelitis, Inactivated
Parenteral
Vaccine, Poliomyelitis, Live (Oral)
Oral
Vaccine, Rubella, Live
Parenteral
Vaccine, Tetanus, Adsorbed
Parenteral
Vaccine, Typhoid, Live Attenuated (Oral)
Oral
Vaccine, Typhoid, Polysaccharide
Parenteral
Amendment of Schedule 7 to the principal Order10
In Part III of Schedule 7 to the principal Order12 (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).
Revocations11
Articles 4 and 6 of the principal Order are revoked.
Signed by authority of the Secretary of State for Health
(This note is not part of the Order)