Statutory Instruments
2005 No. 1507
MEDICINES
The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005
Made
6th June 2005
Laid before Parliament
8th June 2005
Coming into force
30th June 2005
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety, acting jointly in exercise of the powers conferred upon them by sections 15(1), 57(1) and (2), 58(1), (4), (4A), (4B) and (5) and 129(4) of the Medicines Act 1968( 1 ), or, as the case may be, those powers conferred by the said provisions and now vested in them( 2 ), 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 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:—
PART 1 GENERAL
Citation, commencement and interpretation
1. —(1) This Order may be cited as the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 and shall come into force on 30th June 2005.
(2) In this Order—
“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997( 3 );
“the Prescribing Order” means the Medicines for Human Use (Prescribing) Order 2005( 4 );
“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale— Exemption) Order 1980( 5 ).
PART 2 AMENDMENT OF THE PRESCRIBING ORDER
Amendment of article 1 of the Prescribing Order
2. In article 1 of the Prescribing Order (citation, commencement, extent and interpretation), in paragraph (4)—
(a) after the definition of “registered midwife”, insert the following definition—
“ “registered optometrist” means a person whose name is entered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 ( 6 ) ; ” ;
(b) in the definition of “relevent register”—
(i) in paragraph (b) omit “and”;
(ii) in paragraph (c), after “that register;” insert “and”; and
(iii) after paragraph (c), insert—
“ (d) in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989; ” ;
(c) in the definition of “supplementary prescriber”—
(i) in paragraph (c), omit “or”;
(ii) in paragraph (d), after “radiographers: diagnostic or therapeutic,” insert “or”; and
(iii) after paragraph (d), insert—
“ (e) a registered optometrist, ” .
PART 3 AMENDMENT OF THE POM ORDER
Amendment of article 1 of the POM Order
3. In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2)—
(a) after the definition of “the Act”, insert the following definition—
“ “additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register; ” ;
(b) in the definition of “relevant register”( 7 )—
(i) in paragraph (b) omit “and”;
(ii) in paragraph (c), after “that register” insert “; and”; and
(iii) after paragraph (c), insert—
“ (d) in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989; ” ;
(c) in the definition of “supplementary prescriber”( 8 )—
(i) in paragraph (c), omit “or”;
(ii) in paragraph (d), after “radiographers: diagnostic or therapeutic;” insert “or”; and
(iii) after paragraph (d), insert—
“ (e) a registered optometrist, ” .
Amendment of article 7 of the POM Order
4. In article 7 (exemption for parenteral administration in an emergency to human beings of certain prescription only medicines)—
(a) for “Chlorpheniramine Injection”, substitute “Chlorphenamine Injection”;
(b) for “Cobalt Edetate Injection”, substitute “Dicobalt Edetate Injection”;
(c) omit “Dextrose Injection Strong B.P.C.” and “Diphenhydramine Injection”;
(d) after “Glucagon injection”, insert “Glucose Injection 50%”; and
(e) for “Mepyramine Injection”, substitute “Naloxone Hydrochloride”.
Amendment of article 13A of the POM Order
5. In article 13A( 9 ) of the POM Order (exemptions relating to prescriptions given by nurses), in paragraph (1)—
(a) in paragraph (c), omit “or”;
(b) in paragraph (d), after “radiographers: diagnostic or therapeutic,”, insert “or”; and
(c) after paragraph (d), insert—
“ (e) a registered optometrist, ” .
Amendment of Schedule 3A to the POM Order
6. In the table in Schedule 3A of the POM Order (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration)—
(a) after the entry for “Bemiparin sodium”( 10 ), insert the following entry—
| “ Benzylpenicillin sodium | Parenteral ” ; |
(b) omit the entries for “Levomepromazine (methotrimeprazine) maleate” and “Levomepromazine (methotrimeprazine) hydrochloride”; and
(c) in the entry for “Vaccine – Combined Tetanus, diphtheria, acullular pertussis, inactivated poliomyelitis and haemophilus influenza type B”( 11 ), in column 1, for “acullular pertussis”, substitute “acellular pertussis”.
Amendment of Schedule 5 to the POM Order
7. —(1) In the table in Part I of Schedule 5 to the POM Order (exemption from restrictions on sale or supply)—
(a) in paragraph 5, in column 2, omit “Physostigmine sulphate”; and
(b) after paragraph 6, insert the following paragraphs—
| “ 6A Persons lawfully conducting a retail pharmacy business within the meaning of section 69. | 6A Medicinal products not for parenteral administration, which are prescription only medicines by reason only that they contain any of the following substances: Acetylcysteine Atropine sulphate Azelastine hydrochloride Dicofenac sodium Emedastine Homotropine hydrobromide Ketotifen Levocabastine Lodoxamide Nedocromil sodium Olopatadine Pilocarpine hydrochloride Polymyxin B/bacitracin Polymyxin B/trimethoprim Sodium cromoglycate. | 6A The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist. |
| 6B Additional supply optometrists . | 6B Prescription only medicines specified in column 2 of paragraph 6A . | 6B The sale or supply shall be only— (a) in the course of their professional practice, and (b) in an emergency. ” . |
(2) In the table in Part II of Schedule 5 to the POM Order (Exemptions from the restriction on supply), after paragraph 3, insert the following new paragraph—
| “ 3A Persons employed or engaged in the provision of lawful drug treatment services. | 3A Ampoules of sterile water for injection containing not more than 2 ml of sterile water. | 3A The supply shall be only in the course of provision of lawful drug treatment services. ” . |
PART 4 AMENDMENT OF THE PHARMACY AND GENERAL SALE ORDER
Amendment of article 1 of the Pharmacy and General Sale Order
8. In article 1 of the Pharmacy and General Sale Order (citation, commencement and interpretation), in paragraph (2)—
(a) after the definition of “the Act”, insert the following definition—
“ “additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register; ” ;
(b) for the definition of “registered ophthalmic optician”, substitute—
“ “registered optometrist” means a person whose name is entered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989; ” ;
(c) in the definition of “relevant register”( 12 )—
(i) in paragraph (b) omit “and”;
(ii) in paragraph (c), after “that register” insert “; and”; and
(iii) after paragraph (c), insert—
“ (d) in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989; ” ;
(d) in the definition of “supplementary prescriber”( 13 )—
(i) in paragraph (c), omit “or”;
(ii) in paragraph (d), after “radiographers: diagnostic or therapeutic,” insert “or”; and
(iii) after paragraph (d), insert—
“ (e) a registered optometrist, ” .
Amendment of Schedule 1 to the Pharmacy and General Sale Order
9. —(1) In the table in Part 1 of Schedule 1—
(a) in paragraph 2, in column 1, for “registered ophthalmic opticians”, substitute “registered optometrists”; and
(b) after paragraph 2, insert the following new paragraph—
| “ 2A. Additional supply optometrists | 2A.Medicinal products which are prescription only medicines by reason only that they contain any of the following substances: Acetylcysteine Atropine sulphate Azelastine hydrochloride Dicofenac sodium Emadastine Homotropine hydrobromide Ketotifen Levocabastine Lodoximide Nedocromil sodium Olopatadine Pilocarpine hydrochloride Polymyxin B/bacitracin Polymyxin B/trimethoprim Sodium Cromoglycate | 2A.The sale or supply shall be only in the course of their professional practice and only in an emergency. ” . |
(2) In the table in Part II of Schedule 1, after paragraph 6, insert the following new paragraph—
| “ 6A. Persons employed or engaged in the provision of lawful drug treatment | 6A. Ampoules of sterile water for injection containing not more than 2 ml of sterile water. | 6A. The supply shall be only in the course of provision of lawful drug treatment services. ” . |
Signed by authority of the Secretary of State for Health
Jane Kennedy
Minister of State for Quality and Patient Safety,
Department of Health
6th June 2005
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
L.S.
D. C. Gowdy
Permanent Secretary
Department of Health, Social Services and Public Safety
6th June 2005
1968 (c. 67) . The expression “the appropriate Ministers” and the expression “the Ministers”, which are relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 , by article 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 , and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 ; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c. 28) by section 63 of the Health and Social Care Act 2001 (c. 15) and by article 54(3) of, and paragraph 2(b) of Schedule 5 to, S.I. 2002/253 .
In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 ; and in the case of the Department of Health, Social Services and Public Safety, by virtue of the powers vested in the Ministers in charge of that Department by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) , which may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1) ; the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.I.) .
S.I. 1997/1830 ; relevant amending instruments are S.I. 2002/549 , 2003/ 696 , 2004/1771 and 2005/765 .
S.I. 2005/765 .
1989 c. 44 ; section 7 was amended by article 7(1) of the Opticians Act 1989 (Amendment) Order 2005; S.I. 2005/ 848 , which will come into force on 30th June 2005.
The definition of “supplementary prescriber” was inserted by S.I. 2003/696 and amended by S.I. 2004/1771 and S.I. 2005/765 .
The entry for “Bemiparin sodium” was inserted by S.I. 2005/765 .
This entry was inserted by S.I. 2005/765 .