MEDICINES Citation, commencement, extent and interpretation 1 1 This Order may be cited as the Medicines for Human Use (Prescribing) Order 2005 and shall come into force on 7th April 2005. 2 Subject to paragraph (3), this Order applies to the whole of the United Kingdom. 3 Paragraphs (2) and (3) of article 2 extend to Scotland only. 4 In this Order— “ the Act ” means the Medicines Act 1968; “first level nurse” means a person registered in Sub-Part 1 of the Nurses' Part of the professional register; “medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the Act, but does not include— a medicinal product which is a veterinary drug as defined in section 132(1) of the Act; or an article or substance in respect of which section 58 has such effect where that article or substance is only to be administered to animals; “the POM Order ” means the Prescription Only Medicines (Human Use) Order 1997 ; “professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 ; “registered midwife” means a person registered in the Midwives' Part of the professional register; “relevant register” means — in relation to a first level nurse or registered midwife, the professional register; in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ; and in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— chiropodists and podiatrists; physiotherapists; radiographers: diagnostic or therapeutic, that register; “supplementary prescriber” means— a first level nurse; a pharmacist; a registered midwife; or a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— chiropodists and podiatrists; physiotherapists; or radiographers: diagnostic or therapeutic, against whose name is recorded in the relevant register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber. Exemption to the restrictions imposed by sections 7 and 8 of the Medicines Act 1968 2 1 The restrictions imposed by sections 7 and 8 of the Medicines Act 1968 do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist and consists of— a preparing or dispensing a medicinal product in accordance with a prescription given by a supplementary prescriber; or b procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a supplementary prescriber. 2 The restrictions imposed by sections 7 and 8 of the Medicines Act 1968 do not apply to anything which is done in a care home service and is done there by or under the supervision of a pharmacist and consists of— a preparing or dispensing a medicinal product in accordance with a prescription given by a supplementary prescriber; or b procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a supplementary prescriber. 3 In paragraph (2), “a care home service” has the meaning given by section 2(3) of the Regulation of Care (Scotland) Act 2001 . Amendment of article 1 of the POM Order 3 In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2)— a in the definition of “relevant register”— i in paragraph (a) omit “and”; ii in paragraph (b), after “the Pharmacy (Northern Ireland) Order 1976;” insert “and”; and iii after paragraph (b), insert— c in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— i chiropodists and podiatrists; ii physiotherapists; or iii radiographers: diagnostic or therapeutic; that register ; b in the definition of “supplementary prescriber” — i in paragraph (b), omit “or”; ii in paragraph (c), after “a registered midwife,” insert “or”; iii after paragraph (c), insert— d a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— i chiropodists and podiatrists; ii physiotherapists; or iii radiographers: diagnostic or therapeutic; ; and c after “an annotation”, insert “or entry”. Amendment of article 3B of the POM Order 4 In article 3B of the POM Order (prescribing and administration by supplementary prescribers), in paragraph (3), omit sub-paragraph (b). Amendment of article 13A of the POM Order 5 In article 13A of the POM Order (exemptions relating to prescriptions given by nurses), in paragraph (1)— a in paragraph (b), omit “or”; b in paragraph (c), after “a registered midwife;”, insert “or”; c after paragraph (c), insert— d a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— i chiropodists and podiatrists; ii physiotherapists; or iii radiographers: diagnostic or therapeutic, . Amendment of article 15 of the POM Order 6 For Article 15 of the POM Order (prescriptions) , substitute the following article — 15 1 For the purposes of section 58(2)(a), and subject to paragraph (3), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled. 2 The conditions referred to in paragraph (1) are that the prescription— a shall be signed in ink with his own name by the appropriate practitioner giving it; b shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations , in which case it may be written by means of carbon paper or similar material; c shall contain the following particulars— i the address of the appropriate practitioner giving it, ii the appropriate date, iii such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, a supplementary prescriber, a district nurse/health visitor prescriber,an extended formulary nurse prescriber, a veterinary surgeon or a veterinary practitioner, iv where the appropriate practitioner giving it is a doctor, dentist, a supplementary prescriber, a district nurse/health visitor prescriber, or an extended formulary nurse prescriber, the name, address and the age, if under 12, of the person for whose treatment it is given, and v where the appropriate practitioner giving it is a veterinary surgeon or a veterinary practitioner, the name and the address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care; d shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription; e in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date. 3 For the purposes of paragraph (1) the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (4), unless the prescription is a health prescription for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations or is given by a veterinary surgeon or a veterinary practitioner. 4 The conditions referred to in paragraph (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries). 5 The prohibition on sale or supply imposed by section 58(2)(a) shall not apply where a prescription only medicine is sold or supplied other than in accordance with a prescription given by an appropriate practitioner and – a the reason the sale or supply is not in accordance with such a prescription is that a condition specified in paragraph (2) or (4) is not fulfilled; and b the person selling or supplying the prescription only medicine has exercised all due diligence and believes on reasonable grounds that the condition is fulfilled. 6 In paragraph (2) “appropriate date” means— a in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and b in every other case, the date on which the prescription was signed by the appropriate practitioner giving it, and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where the health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates. 7 In this Article— “advanced electronic signature” means an electronic signature which is— uniquely linked to the signatory, capable of identifying the signatory, created using means that the signatory can maintain under his sole control, and which is linked to the data to which it relates in such a manner that any subsequent change of data is detectable; “electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)— by means of a telecommunication system (within the meaning of the Telecommunications Act 1984 , or by other means but while in an electronic form; and “signatory” means the appropriate practitioner giving the prescription. . Amendment of Schedule 3A to the POM Order 7 In the table in Schedule 3A to the POM Order , (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers)— a in column 1 insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entry set out in column 1 below, and in column 2, insert, against that entry, the corresponding entry in column 2 below— Column 1 Column 2 Acetylcysteine Parenteral Adrenaline Parenteral Alteplase Parenteral Amiodarone Parenteral Bemiparin sodium Parenteral Benzatropine mesilate Parenteral Calcipotriol External Calcitriol External Cefotaxime sodium Parenteral Ceftriaxone Sodium Parenteral Certoparin sodium Parenteral Chlorphenamine maleate Parenteral Cimetidine Parenteral Cyclizine hydrochloride Oral Cyclizine lactate Parenteral Dalteparin sodicum Parenteral Dexamethasone sodium phosphate Oral Dextran 70 Parenteral Dolesetron mesilate Oral and parenteral Enoxaparin Parenteral Furosemide Oral and parenteral Gelatin 3.5 – 4% Parenteral Glucose 5% Parenteral Glucose 5% with Potassium (K + 40 mmol/L) ready made infusion bag Parenteral Granisetron hydrochloride Parenteral Heparin sodium Parenteral for the purpose of cannulae flushing Hexastarch Parenteral Human soluble insulin Parenteral Hydroxyethl starch Parenteral Levomepromazine Oral and parenteral Naloxone Parenteral Omeprazole Oral Omeprazole sodium Parenteral Ondansetron Hydrochloride Oral and parenteral Oxbuprocaine hydrochloride Ophalmic Pentastarch Parenteral Prilocaine External and parenteral Prochlorperazine mesilate Oral and rectal Prochlorperazine maleate Oral, rectal and buccal Proxymetacaine hydrochloride Ophthalmic Reteplase Parenteral Sodium chloride 0.9% Parental, for reconstitution of injections and for the purpose of cannulae flushing Sodium chloride 0.9% & Glucose 5% ready made infusion bag Parenteral Sodium chloride 0.45% & Glucose 5% ready made infusion bag Parenteral Sodium chloride 0.9% with Potassium (K + 40 mmol/L) ready made infusion bag Parenteral Sodium chloride 0.45% and Glucose 5% with Potassium 20mmol per 500 ml ready made infusion bag Parenteral Streptokinase Parenteral Tacalcitol External Tenecteplase Parenteral Tetanus immunoglobulin Parenteral Tetracaine External Tinzaparin sodium Parenteral Tropicamide Ophthalmic Tropisetron hydrochloride Parenteral Unfractionated Heparin Parenteral Vaccine – Combined Tetanus, diphtheria, acullular pertussis, inactivated poliomyelitis and haemophilus influenza type B Parenteral Vaccine – Inactivated Poliomyelitis Parenteral Vaccine – Meningococcal Polysaccharide A, C, W135 and Y Parenteral b in the entry for “Beclometasone dipropionate”, in column 2, after “nasal” add “inhalation”; c in the entry for “Budesonide”, in column 2, after “Nasal” add “inhalation”; d omit the entry for “Cyclizine”; e in the entry for “Diazepam” , in column 2, omit “in palliative care”; f in the entry for “Diclofenac sodium” , in column 2, after “oral” omit “or” and after “rectal” add “or ophthalmic”; g in the entry for “Domperidone”, in column 2, omit “in palliative care”; h in the entry for “Domperidone maleate”, in column 2, omit “in palliative care”; i in the entry for “Flucloxacillin sodium”, in column 2, after “oral” add “or parenteral”; j in the entry for “Hydrocortisone sodium succinate”, in column 2, after “lozenges” add “or parenteral”; k in the entry for “Ipratropium bromide”, in column 2, after “nasal” add “inhalation”; l in the entry for “Lorazepam” , in column 2, omit “in palliative care”; m in the entry for “metoclopramide hydrochloride”, in column 2, omit “in palliative care”; n in the entry for “Midazolam” , in column 2, omit “in palliative care”; o in the entry for “Ranitidine hydrochloride”, in column 2, after “Oral” insert “or parenteral”. Amendment of Schedule 5 of the POM Order 8 In the table in Schedule 5 to the POM Order (exemption from restrictions on sale or supply), in paragraph 5 of Part I, in column 2, in sub-paragraph (c)— a omit “Atropine sulphate”, “Bethanecol chloride”, and “Carbachol”; b after “Cyclopentolate hydrochloride” insert “Fusidic Acid”; and c omit “Homatrophine hydrobromide”, “Naphazoline hydrochloride”, “Naphazoline Nitrate”, “Physostigmine salicylate”, “Philocarpine hydrochloride”, and Philocarpine nitrate”. Signed by authority of the Secretary of State for Health Warner Parliamentary Under Secretary of State, Department of Health 16th March 2005 Sealed with the Official Seal of the Department of Health, Social Services and Public Safety Deirdre Kenny A Senior Officer of the, Department of Health, Social Services and Public Safety 15th March 2005 Sealed with the Official Seal of the Department of Agriculture and Rural Development Gerald Lavery A Senior Officer of the Department of Agriculture and Rural Development 15th March 2005