Statutory Instrument. S.I. No. 510 of Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005

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1 Statutory Instrument S.I. No. 510 of 2005 Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 PUBLISHED BY THE STATIONERY OFFICE, DUBLIN To be purchased directly from the GOVERNMENT PUBLICATIONS SALE OFFICE, SUN ALLIANCE HOUSE, MOLESWORTH STREET, DUBLIN 2. Or by mail order from GOVERNMENT PUBLICATIONS, POSTAL TRADE SECTION, 51 ST. STEPHEN S GREEN, DUBLIN 2. (Tel: /35/36/37; Fax ). Or through any bookseller. Prn. A5/

2 S.I. No. 510 of 2005 Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 In exercise of the powers conferred on the Minister for Health and Children by section 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 (S.I. No. 308 of 1997) and which said powers are delegated to me by the Health and Children (Delegation of Ministerial Functions) (No. 3) Order 2004 (S.I. No. 844 of 2004), I, Seán Power, Minister of State at the Department of Health and Children, hereby make the following regulations:- 1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations These Regulations shall be construed as one with the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003) and may be cited together with those Regulations as the Medicinal Products (Prescription and Control of Supply) Regulations 2003 and The Medicinal Products (Prescription and Control of Supply) Regulations 2003 are hereby amended by:- (a) the insertion in paragraph (1) of Regulation 4 of the following definitions administer means administer to a human being, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in these Regulations to administering a medicinal product is a reference to administering it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle, and cognate words shall be construed accordingly; ; advanced paramedic, paramedic emergency medical technician and pre-hospital emergency care provider have the same meaning as in the Pre-Hospital Emergency Care Council (Establishment) Order 2000, as amended by the Pre-Hospital Emergency Care Council 2

3 (Establishment) Order 2000 (Amendment) Order 2004 (S.I. No.575 of 2004); clinical practice guidelines or CPG means the clinical practice guidelines prepared and published by PHECC; Opticians Board means the Board established by section 5 of the Opticians Act 1956 (No. 17 of 1956); ; PHECC means the Pre-Hospital Emergency Care Council established by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (S.I. No. 109 of 2000); ; registered dispensing optician means a person registered in the Register of Dispensing Opticians established under the Opticians Acts 1956 and 2003; ; (b) the insertion of the following Regulation after Regulation 4: 4A. It shall not be a contravention of the provisions of these Regulations for (a) any person to administer to another any medicinal product which is not subject to prescription control by virtue of these Regulations; (b) a registered medical practitioner or registered dentist to administer to a patient any medicinal product subject to control by virtue of these Regulations; (c) any person, other than a registered medical practitioner or registered dentist, to administer to a patient, in accordance with the directions of a registered medical practitioner or registered dentist, any medicinal product subject to control by virtue of these Regulations. ; (c) the substitution of paragraph (1) of Regulation 5 by the following (1) Subject to the provisions of these Regulations, a person shall not supply a medicinal product of any of the following classes except in accordance with a prescription, namely - (a) any medicinal product which is or which contains a substance specified in Column 1 of the First Schedule; (b) any medicinal product which is intended for parenteral administration; (c) any medicinal product which is or which contains a new chemical molecule; 3

4 and the supply shall be made by a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts 1875 to 1977 and by or under the personal supervision of an authorised person. ; (d) the substitution of paragraph (2) of Regulation 6 by the following (2) Paragraph (1) of this Regulation shall not apply to a medicinal product which (a) contains a substance specified in Part 2 of the Second Schedule, (b) conforms with the requirements specified opposite each such substance in Columns 2, 3 and 4 of the said Part 2, and (c) is not otherwise subject to prescription control by virtue of these Regulations. ; (e) the insertion of the following paragraph in Regulation 7, after paragraph (8): (9) The prescription in the case of a medicinal product, not being a medicinal product for external use, which consists of or contains Isotretinoin, and which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment on foot of the said prescription shall not exceed a period of thirty days. ; (f) the substitution in Regulation 10(1)(d) of the words regulation 14(1)(a) by the words Regulation 20(1)(a) ; (g) the substitution of paragraph (3) of Regulation 10 by the following (3) A person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts 1875 to 1977 shall preserve and keep readily available for inspection at such shop for a period of two years from the relevant date - (a) the register kept under paragraph (1); (b) in the case of a health prescription, the duplicate copy thereof and in the case of any other prescription, the prescription; and (c) every order or invoice referred to in paragraph (2)(c). ; 4

5 (h) the insertion in Regulation 19 of the following paragraph after paragraph (3) (4) The provisions of this Regulation shall not apply to a medicinal product which by virtue of these Regulations may be supplied otherwise than in accordance with a prescription. ; (i) the substitution of paragraph (1)(b) of Regulation 20 by the following: (b) subject to paragraphs (2) and (2A), the supply of a medicinal product by way of wholesale dealing. ; (j) the substitution in Regulation 20(2)(b) of the words Regulation (5) by the words Regulation 5 ; (k) the insertion in paragraph (2)(c) of Regulation 20 of the words Fluorescein sodium after the words Cyclopentolate hydrochloride ; (l) the insertion in Regulation 20 of the following paragraph after paragraph (2) (2A) (a) The exemption provided for in paragraph (1)(b) shall not apply to the supply of a medicinal product to a registered dispensing optician, who has a Certificate of Entitlement to fit Contact Lenses issued by the Opticians Board, except where the medicinal product (i) contains fluorescein sodium, (ii) is not intended for parenteral administration, and (iii) is supplied to the said dispensing optician on foot of a signed order given by him or her to the supplier for the purpose of each such supply; (b) The provisions of Regulation 5 shall not apply as respects the administration only of a medicinal product as aforesaid, to a patient of his or her by a registered dispensing optician in the course of his or her professional practice. ; (m) the insertion of the following provision after paragraph (7) of Regulation 20 (8) The provisions of Regulations 5, 6, 13 and 14 shall not apply to the supply to a pre-hospital emergency care provider (a) of a medicinal product specified in Column 1 of Part 1 of the Seventh Schedule for use by an advanced paramedic in the course of his or her duties as such a person, by a route of administration specified in Column 2 of the said Part 1 and in 5

6 accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 1; (b) of a medicinal product specified in Column 1 of Part 2 of the Seventh Schedule for use by a paramedic in the course of his or her duties as such a person, by the route of administration specified in Column 2 of the said Part 2 and in accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 2; (c) of a medicinal product specified in Column 1 of Part 3 of the Seventh Schedule for use by an emergency medical technician in the course of his or her duties as such a person, by the route of administration specified in Column 2 of the said Part 3 and in accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 3. ; (n) the insertion of the following Regulation after Regulation 20 20A. The Seventh Schedule as contained in the Schedule to these Regulations is inserted after the Sixth Schedule. ; (o) the substitution in paragraph (4) of Regulation 21 of the words paragraph (8) by the words paragraph (9) ; (p) the insertion of the following entry in the First Schedule thereto Circumstances excluding products from prescription-only control Column 5 Substance Part in Schedule Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum Dose and Maximum Daily Dose Methylcobalamine B 25mcg (MS) 25mcg (MDD) Nitrous Oxide A (q) the substitution of the entries in respect of the substances listed in Column 1 of the following Table for the entries in respect of the said substances listed in the First Schedule thereto 6

7 Circumstances excluding products from prescription-only control Column 5 Substance Part in Schedule Budesonide B Felodipine B Tramadol Hydrochloride A Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum Dose and Maximum Daily Dose (r) the insertion in Part 1 of the Second Schedule thereto of the substance Diclofenac Sodium ; (s) the substitution of Part 2 of the Second Schedule thereto by the following: Aspirin Part 2 (Regulation 6(2)) Circumstances in which the substances when contained in nonprescription medicinal products may be supplied in non-pharmacy outlets Maximum Use, pharmaceutical Maximum Dose and Substance Strength and/or form or manner of Maximum Daily Dose pack size administration Colecalciferol Cyanocobalamin Ergocalciferol Folic Acid Hypericum perforatum L. Ibuprofen Nicotinic acid 200mg (MS) 12 (MPS) Tablets or capsules for use in adults and children over the age of 12 years only and for the short-term management of mild to moderate pain such as headache, dental pain, period pain, muscular strain and backache and for the management of feverishness and the symptoms of colds and influenza 400mg (MD) 1200mg (MDD) Pyridoxine Hydrochloride 7

8 Retinol Retinol Acetate Retinol Palmitate Sodium Fluoride Sodium Monofluorophosphate Stannous Fluoride (t) the insertion in the Fourth Schedule thereto of the substance Isotretinoin. Schedule Seventh Schedule Part 1 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Advanced Paramedics (Regulation 20(8)(a)) Medicinal Product Route of Conditions of Authority to Administration Administration Administer Amiodarone injection Intraosseous Cardiac arrest Atropine injection syringe Benzylpenicillin injection Cyclizine injection Dextrose 10% Solution for infusion Endotracheal Intraosseous Intraosseous Cardiac arrest, Bradycardia. Children: Bradycardia Suspected or confirmed meningococcal sepsis To prevent or treat opiate induced nausea and vomiting Hypoglycaemia 8

9 Medicinal Product Route of Conditions of Authority to Administration Administration Administer Diazepam injection Intraosseous Seizures Diazepam rectal solution Epinephrine (Adrenaline) 1mg/1ml (1:1 000) syringe Epinephrine (Adrenaline) injection syringe (auto) Epinephrine (Adrenaline) 1mg/10ml (1:10 000) syringe Glucagon for injection Glyceryl trinitrate aerosol Hartmann s Solution for infusion Ibuprofen Tablets or Capsules Lidocaine Hydrochloride Injection Lorazepam Injection Morphine Injection Naloxone for injection Per Rectum Endotracheal Intraosseous Subcutaneous Sublingual Intraosseous Orally Endotracheal Subcutaneous Seizures Cardiac arrest, Bradycardia, Hypoglycaemia Cardiac chest pain Hypovolaemic shock, Children: Pain Cardiac arrest Seizures Adults and Children: Moderate to severe pain Respiratory depression secondary to known or suspected narcotic overdose 9

10 Route of Conditions of Authority to Medicinal Product Administration Administration Administer Nitrous oxide - Oxygen Pain relief for medical, mixture By Inhalation surgical or trauma - medical gas conditions Ondansetron Hydrochloride Injection Paracetamol suppositories Salbutamol for nebulisation Salbutamol inhaled aerosol Sodium Chloride 0.9% for infusion Per rectum Inhalation Inhalation To prevent or treat opiate induced nausea and vomiting Children: Pyrexia Bronchospasm in anaphylaxis, and acute asthma Bronchospasm in anaphylaxis, and acute asthma Hyperglycaemia To keep vein open, Cannula flush Tetracaine Gel 4% Topical Anaesthesia prior to venepuncture PART 2 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Paramedics (Regulation 20(8)(b)) Medicinal Product Route of Conditions of Authority to Administration Administration Administer Cyclizine Injection and vomiting To prevent or treat opiate induced nausea Diazepam rectal solution Epinephrine (Adrenaline) 1mg/1ml (1:1 000) syringe Per Rectum Seizures 10

11 Medicinal Product Route of Conditions of Authority to Administration Administration Administer Epinephrine (Adrenaline) Injection syringe (auto) Glucagon for injection Glyceryl trinitrate aerosol Hartmann s Solution for infusion Morphine Injection Naloxone for injection Nitrous oxide - Oxygen mixture - medical gas Paracetamol suppositories Salbutamol for nebulisation Salbutamol inhaled aerosol Sodium Chloride 0.9% for infusion Subcutaneous Sublingual Subcutaneous By Inhalation Per rectum Inhalation Inhalation Hypoglycaemia Cardiac chest pain Hypovolaemic shock, Adults and Children: Moderate to severe pain Respiratory depression secondary to known or suspected narcotic overdose Pain relief for medical, surgical or trauma conditions Children: Pyrexia Bronchospasm in anaphylaxis, and acute asthma Bronchospasm in anaphylaxis, and acute asthma Hyperglycaemia To keep vein open, Cannula flush Tetracaine Gel 4% Topical Anaesthesia prior to venepuncture 11

12 PART 3 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Emergency Medical Technicians (Regulation 20(8)(c)) Medicinal Product Route of Conditions of Authority to Administration Administration Administer Cyclizine Injection and vomiting To prevent or treat opiate induced nausea Epinephrine (Adrenaline) injection syringe (auto) Glyceryl trinitrate aerosol Morphine Injection Naloxone for injection Nitrous oxide - Oxygen mixture - medical gas Salbutamol inhaled aerosol Sublingual Subcutaneous By Inhalation Inhalation Cardiac chest pain Adults and Children: Moderate to severe pain Respiratory depression secondary to known or suspected narcotic overdose Pain relief for medical, surgical or trauma conditions Bronchospasm in anaphylaxis, and acute asthma Given under my hand this 9 th day of August, SEAN POWER Minister of State at the Department of Health and Children 12

13 EXPLANATORY NOTE ( This note is not part of the Instrument and does not purport to be a legal interpretation. ) The purpose of these Regulations is to update the controls in respect of the supply of medicinal products as set out in the Medicinal Products ( Prescription and Control of Supply ) Regulations 2003 ( S.I. No. 540 of 2003 ). The Regulations provide for: (a) clarification with regard to the administration of medicinal products; (b) clarification of the role of authorised persons with regard to supervision of the supply of prescription - only medicinal products; (c) the availability of certain medicinal products in non pharmacy outlets; (d) further restrictions on certain medicinal products containing Isotretinoin; (e) clarification on the record keeping requirements in respect of pharmacies; (f) the exemption of non prescription medicinal products from the prohibition on the sale of medicinal products by mail order; (g) the extension of the availability of fluorescein sodium to optometrists and dispensing opticians for professional use; (h) the availability and use of certain medicinal products by various grades of ambulance personnel; (i) the addition of certain products to the schedules of prescription only medicinal products; (j) the correction of certain minor errors and omissions which have come to light since publication of the principal Regulations. 13

STATUTORY INSTRUMENTS. S.I. No. 300 of 2014 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS 2014

STATUTORY INSTRUMENTS. S.I. No. 300 of 2014 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS 2014 2 [300] S.I. No. 300 of 2014 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL