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

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

2 2 [300] S.I. No. 300 of 2014 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS 2014 I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995), hereby make the following regulations: 1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations In these Regulations Principal Regulations means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003). 3. Regulation 20(2)(c)(as amended by Regulation 3(k) of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (S.I. No. 510 of 2005)) of the Principal Regulations is amended by substituting for Fluorescein sodium the following: Fluorescein sodium, Lidocaine, Proxymetacaine hydrochloride, Tetracaine hydrochloride, 4. The Principal Regulations are amended by substituting for the Seventh Schedule (as amended by Regulation 12(b) of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 (S.I. No. 512 of 2008)) the following: Notice of the making of this Statutory Instrument was published in Iris Oifigiúil of 8th July, 2014.

3 [300] 3 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)) Adenosine Solution Intravenous Adults: According to CPG or for Injection Supraventricular tachycardias (SVT). Aminophylline Intravenous Adults and children: According to CPG or Acute severe asthma. Amiodarone Injection Intravenous Adults and children: According to CPG or Cardiac arrest, Tachyarrhythmia. Aspirin (various oral Oral Adults: According to CPG or dosage forms) Acute Cardiac Syndrome, Decompression illness. Atropine Injection Intravenous Adults and children: According to CPG or Endotracheal Cardiac arrest, Bradycardia, Poisoning. Benzylpenicillin Intravenous Adults and children: According to CPG or Injection Intramuscular Suspected or confirmed sepsis. Calcium Gluconate Intravenous Adults and children: According to CPG or 10% Intramuscular Hypotension. Calcium Gluconate Topical Adults and children: According to CPG or Gel Hydrofluoric acid burns. Cefotaxime Powder Intravenous Adults and children: According to CPG or for Injection Intramuscular Suspected or confirmed sepsis. Ceftriaxone Powder Intravenous Adults and children: According to CPG or for Injection Intramuscular Suspected or confirmed sepsis.

4 4 [300] Chlorphenamine Intravenous Adults and children: According to CPG or Injection (otherwise Intramuscular Chlorpheniramine Allergic reactions, Injection) Anaphylaxis. Chlorphenamine Oral Adults and children: According to CPG or Tablets (otherwise Chlorpheniramine Allergic reaction, Tablets) Anaphylaxis. Clopidogrel Tablets Oral Adults: According to CPG or Acute Coronary Syndrome. Cyclizine Injection Intramuscular Adults and children: According to CPG or Intravenous To prevent or treat opiate induced nausea and vomiting, Anti emetic. Dextrose 5% Intravenous Adults and children: According to CPG or Solution for Infusion Dilutant for medications. Dextrose 10% Intravenous Adults and children: According to CPG or Solution for Infusion Hypoglycaemia, Dilutant for medications. Diazepam Injection Intravenous Adults and children: According to CPG or Intramuscular Seizures, Sedation. Diazepam Rectal Per rectum Adults and children: According to CPG or Solution Seizures. Dobutamine Intravenous Adults and children: According to CPG or (12.5mg/ml) Concentrate for Septic shock, Infusion Cardiogenic shock. Dopamine Intravenous Adults and children: According to CPG or Hydrochloride (40mg/ml) Cardiogenic shock. Concentrate for Infusion Enoxaparin Sodium Intravenous Adults: According to CPG or Solution for Injection Subcutaneous ST- elevation myocardial infarction instructions (STEMI). Epinephrine Intramuscular Adults and children: According to CPG or (Adrenaline) 1 mg/1ml (1:1000) Anaphylaxis, Injection Bronchospasm.

5 [300] 5 Epinephrine Inhalation Children: According to CPG or (Adrenaline) (1:1000) for Nebulisation Croup, Asthma. Epinephrine Intravenous Adults and children: According to CPG or (Adrenaline) Endotracheal 1 mg/10ml (1:10 000) Cardiac arrest, Solution for Injection Bradycardia, Anaphylaxis. Ergometrine Injection Intravenous Adults: According to CPG or 500 mcg/ml Intramuscular Post partum haemorrhage. Fentanyl Citrate Intravenous Adults and children: According to CPG or (100mcg in 2 ml) Intranasal Buccal Pain management. Furosemide Injection Intravenous Adults: According to CPG or Intramuscular Pulmonary oedema. Glucagon for Intramuscular Adults and children: According to CPG or Injection Subcutaneous Hypoglycaemia. GlycerylTrinitrate Sublingual Adults: According to CPG or Aerosol Cardiac chest pain, Congestive heart failure. Haloperidol Injection Intravenous Adults: According to CPG or 5 mg/ml Intramuscular Sedation. Hartmann s Solution Intravenous Adults and children: According to CPG or for Infusion Hypovolaemic shock, Anaphylaxis, Decompression illness, Cardiac arrest, Bradycardia, Dilutant for medications. Heparin Sodium Intravenous Adults and children: According to CPG or Solution for Injection Deep vein thrombosis, Pulmonary embolism, Unstable angina, Acute peripheral arterial occlusion. Hydrocortisone Intravenous Adults and children: According to CPG or Powder for Solution Intramuscular for Injection Bronchospasm, Anaphylaxis, instructions Addison s disease.

6 6 [300] Hydroxocobalamin Intravenous Adults and children: According to CPG or Powder for Solution Intramuscular for Injection Cyanide poisoning. instructions Ibuprofen (various Oral Adults and children: According to CPG or oral dosage forms) Pain. Influenza Vaccines Intramuscular Adults and children: According to CPG or Prophylaxis for influenza infection. instructions Ipratropium Bromide Inhalation Adults and children: According to CPG or Nebuliser Solution Bronchospasm. Ketamine Intravenous Adults and children: According to CPG or Hydrochloride Intramuscular Injection Procedural sedation. Lidocaine Intravenous Adults: According to CPG or Hydrochloride Endotracheal Injection Subcutaneous Cardiac arrest, Topical Local anaesthetic, Jelly fish sting. Lidocaine Topical Local anaesthetic, According to CPG or Hydrochloride spray Jelly fish sting. 4% Lidocaine Topical Local anaesthetic, According to CPG or Hydrochloride Gel Jelly fish sting. 2.5%. Lorazepam Injection Intravenous Adults and children: According to CPG or Intramuscular Seizures, Sedation. Lorazepam Tablets Oral Adults and children: According to CPG or Sedation. Magnesium Sulphate Intravenous Adults and children: According to CPG or Injection BP Cardiac arrest, Bronchospasm, Pre eclampsia, Stroke. Meropenem Powder Intravenous Adults and children: According to CPG or for Injection Suspected or confirmed sepsis. Methoxyflurane for By inhalation Adults and children: According to CPG or Inhalation Pain relief.

7 [300] 7 Methylprednisolone Intramuscular Adults and children: According to CPG or Sodium Succinate Intravenous Powder for Injection Bronchial inflammation. Metoclopramide Intramuscular Adults and children: According to CPG or Solution for Injection Intravenous To prevent or treat opiate induced nausea and vomiting, Anti emetic. Midazolam Solution Intravenous Adults and children: According to CPG or for Injection Intramuscular Intranasal Seizures, Subcutaneous Sedation. Midazolam Solution Buccal Adults and children: According to CPG or (Buccal) Seizures. Morphine Injection Intravenous Adults and Children: According to CPG or Intramuscular Moderate to severe pain. Morphine Oral Oral Adults and children: According to CPG or Solution Pain. Naloxone for Intravenous Adults and children: According to CPG or Injection Intramuscular Subcutaneous Respiratory Intranasal depression secondary to known or suspected narcotic overdose. Nifedipine Capsules Oral Adults: According to CPG or Inhibition of labour. Nitrous oxide By inhalation Adults and children: According to CPG or Oxygen mixture medical gas Pain relief. instructions Noradrenaline Intravenous infusion Adults and children: According to CPG or (Norepinephrine) Acid Tartrate Acute hypotension. (1:1000) Concentrate instructions for Solution for Injection Ondansetron Intramuscular Adults and children: According to CPG or Hydrochloride Intravenous Injection To prevent or treat opiate induced nausea and vomiting, Anti emetic.

8 8 [300] Oseltamivir Capsules Oral Adults and children: According to CPG or Treatment of influenza. Oseltamivir Powder Oral Adults and children: According to CPG or for Oral Suspension Treatment of influenza. Oxytocin Solution for Intravenous Adults: According to CPG or Injection Intramuscular Post partum haemorrhage. Paracetamol Per rectum Children: According to CPG or suppositories Pyrexia. Paracetamol (various Oral Adults and children: According to CPG or oral dosage forms) Pain, Pyrexia. Paracetamol IV Intravenous Adults and children: According to CPG or solution Pain, Pyrexia. Prasugrel Tablets Oral Adults: According to CPG or Acute Coronary Syndrome. Prednisolone Tablets Oral Adults and children: According to CPG or Anti-inflammatory, Allergic conditions, Acute asthma. Salbutamol for Inhalation Adults and children: According to CPG or Nebulisation Bronchospasm in anaphylaxis, and acute asthma. Salbutamol Inhaled Inhalation Adults and children: According to CPG or Aerosol Bronchospasm in anaphylaxis, and acute asthma. Sodium Bicarbonate Intravenous Adults and children: According to CPG or Injection BP Crush injury, Poisoning, Cardiac arrest.

9 [300] 9 Sodium Chloride Intravenous Adults and children: According to CPG or 0.9% for Infusion Anaphylaxis, Bradycardia, Burns, Cannula flush, Cardiac Arrest, Crush injury, Decompression illness, Dehydration, Dilutant for medications, Hyperglycaemia, Hypothermia, Hypovolaemic shock, To keep vein open. Succinylated Gelatin Intravenous Adults and children: According to CPG or Solution for infusion Hypovolaemia. Tenecteplase Powder Intravenous Adults: According to CPG or for Injection ST- elevation myocardial infarction (STEMI). Tetanus Intramuscular Adults and children: According to CPG or Immunoglobulin Post exposure prophylaxis and treatment of tetanus infection. Tetracaine Gel 4% Topical Adults and children: According to CPG or Anaesthesia prior to venepuncture. Tetracaine Topical Adults and children: According to CPG or Hydrochloride 0.5% w/v Eye Drops Conjunctival anaesthesia. Terbutaline Sulphate Inhalation Adults: According to CPG or Metered Dose Powder Inhaler Inhibition of labour. Terbutaline Sulphate Intravenous Adults: According to CPG or 0.5mg/ml Solution for Subcutaneous Injection or Infusion Inhibition of labour. Thiamine Injection Intravenous Adults: According to CPG or Intramuscular Unresponsive patients with long term alcohol abuse, Delirium tremens. Ticagrelor tablets Oral Adults: According to CPG or Acute Coronary Syndrome.

10 10 [300] Tramadol Oral Adults and children: According to CPG or Hydrochloride 50 mg Capsules Pain. Tranexamic Acid Intravenous Adults and children: According to CPG or 500mg/5ml Solution for Injection or Haemorrhagic shock, Infusion Epistaxis. Vasopressin Injection Intravenous Adults and children: According to CPG or Septic shock, Cardiogenic shock. Zanamivir Inhalation Inhalation Adults and children: According to CPG or Powder Treatment of influenza. PART 2 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Paramedics (Regulation 20(8)(b)) Aspirin (various oral Oral Adults: According to CPG or dosage forms) Acute Cardiac Syndrome, Decompression illness. Benzylpenicillin Intramuscular Adults and children: According to CPG or Injection Suspected or confirmed meningococcal sepsis. Calcium Gluconate Topical Adults and children: According to CPG or gel Hydrofluoric acid burns. Chlorphenamine Intramuscular Adults and children: According to CPG or Injection (otherwise Chlorpheniramine Allergic reactions, Injection) Anaphylaxis. Chlorphenamine Oral Adults and children: According to CPG or Tablets (otherwise Chlorpheniramine Allergic reactions, Tablets) Anaphylaxis.

11 [300] 11 Clopidogrel Tablets Oral Adults: According to CPG or Acute Coronary Syndrome. Cyclizine Injection Intramuscular Adults and children: On registered medical To prevent or treat opiate induced nausea and vomiting, Anti-emetic. Dextrose 10% Intravenous Adults and children: According to CPG or Solution for Infusion Hypoglycaemia. Diazepam Rectal Per rectum Adults and children: On registered medical Solution Seizure. Epinephrine Intramuscular Adults and children: According to CPG or (Adrenaline) 1mg/1ml (1:1 000) Anaphylaxis. Injection Epinephrine Intravenous Adults and children: According to CPG or (Adrenaline) 1 mg/10ml (1:10 000) Cardiac arrest. Solution for Injection Fentanyl Citrate Intranasal Adults and children According to CPG or (100mcg in 2 ml) Buccal Pain management. Glucagon for Intramuscular Adults and children: According to CPG or Injection Subcutaneous Hypoglycaemia. GlycerylTrinitrate Sublingual Adults: According to CPG or Aerosol Cardiac chest pain, Congestive heart failure. Hartmann s Solution Intravenous Adults and children: According to CPG or for Infusion Hypovolaemic shock, Anaphylaxis, instruction Decompression illness, Burns, Cardiac arrest, Bradycardia, Dilutant for medications. Hydrocortisone Intramuscular Adults and children: According to CPG or Powder for Solution for Injection Anaphylaxis, Addison s disease. instructions

12 12 [300] Hydroxocobalamin Intramuscular Adults and children: According to CPG or Powder for Solution for Injection Cyanide poisoning. Ibuprofen (various Oral Adults and children: According to CPG or oral dosage forms) Pain. Influenza Vaccines Intramuscular Adults and children: According to CPG or Prophylaxis for influenza infection. instructions Ipratropium Bromide Inhalation Adults and children: According to CPG or Nebuliser Solution Bronchospasm. Methoxyflurane for By inhalation Adults and children: According to CPG or Inhalation Pain relief. Midazolam Solution Intranasal Adults and children: According to CPG or for Injection Intramuscular Subcutaneous Seizures, Palliative sedation. Midazolam Solution Buccal Adults and children: According to CPG or (Buccal) Seizures. Morphine Injection Intravenous Adults and children: On registered medical Intramuscular Moderate to severe pain. Naloxone for Intramuscular Adults and children: According to CPG or Injection Subcutaneous Intranasal Respiratory depression secondary to known or suspected narcotic overdose. Nitrous oxide By inhalation Adults and children: According to CPG or Oxygen mixture medical gas Pain relief. Ondansetron Intramuscular Adults and children: According to CPG or Hydrochloride Injection To prevent or treat opiate induced nausea and vomiting, Anti emetic. Oseltamivir Capsules Oral Adults and children: According to CPG or Treatment of influenza.

13 [300] 13 Oseltamivir Powder Oral Adults and children: According to CPG or for Oral Suspension Treatment of influenza. Oxytocin Solution for Intramuscular Adults: According to CPG or Injection Post partum haemorrhage. Paracetamol Per rectum Children: On registered medical suppositories Pyrexia. Paracetamol (various Oral Adults and children: According to CPG or oral dosage forms) Pain, Pyrexia. Prasugrel Tablets Oral Adults: According to CPG or Acute Coronary Syndrome. Prednisolone Tablets Oral Adults and children: According to CPG or Inflammatory disorder, Allergic disorder, Acute asthma. Salbutamol for Inhalation Adults and children: According to CPG or Nebulisation Bronchospasm in anaphylaxis and acute asthma. Salbutamol Inhaled Inhalation Adults and children: According to CPG or Aerosol Bronchospasm in anaphylaxis, and instructions acute asthma. Sodium Chloride Intravenous Adults and children: According to CPG or 0.9% for Infusion Anaphylaxis, Bradycardia, Burns, Cannula flush, Cardiac Arrest, Crush injury, Decompression illness, Dehydration, Dilutant for medications, Hyperglycaemia, Hypothermia, Hypovolaemic shock, To keep vein open. Tetanus Intramuscular Adults and children: According to CPG or Immunoglobulin Post exposure prophylaxis and treatment of tetanus infection.

14 14 [300] Tetracaine Gel 4% Topical Adults and children: On registered medical Anaesthesia prior to venepuncture. Tetracaine Topical Adults and children: According to CPG or Hydrochloride 0.5% w/v Eye Drops Conjunctival anaesthesia. Ticagrelor tablets Oral Adults: According to CPG or Acute Coronary Syndrome. Tramadol Oral Adults and children: According to CPG or Hydrochloride 50 mg Capsules Severe pain. Zanamivir Inhalation Inhalation Adults and children: According to CPG or Powder Treatment of influenza. PART 3 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Emergency Medical Technicians (Regulation 20(8)(c)) Aspirin (various oral Oral Adults: According to CPG or dosage forms) Acute Cardiac Syndrome, Decompression illness. Calcium Gluconate Topical Adults and children: According to CPG or Gel Hydrofluoric acid burns. Chlorphenamine Intramuscular Adults and children: According to CPG or Injection (otherwise Chlorpheniramine Allergic reaction, Injection) Anaphylaxis. Chlorphenamine Oral Adults and children: According to CPG or Tablets (otherwise Chlorpheniramine Allergic reaction, Tablets) Anaphylaxis. Cyclizine Injection Intramuscular Adults and children: On registered medical To prevent or treat opiate induced nausea and vomiting.

15 [300] 15 Epinephrine Intramuscular Adults and children: According to CPG or (Adrenaline)1 mg/1ml (1:1000) Anaphylaxis. Injection Epinephrine Intramuscular Adults and children: According to CPG or (Adrenaline) injection 1mg/1ml Anaphylaxis. (1:1000) - prefilled disposable syringe (auto) Glucagon for Intramuscular Adults and children: According to CPG or Injection Subcutaneous Hypoglycaemia. GlycerylTrinitrate Sublingual Adults: According to CPG or Aerosol Cardiac chest pain. Ibuprofen (various Oral Adults and children: According to CPG or oral dosage forms) Pain. Influenza Vaccines Intramuscular Adults and children: According to CPG or Prophylaxis for influenza infection. instructions Methoxyflurane for By inhalation Adults and children: According to CPG or Inhalation Pain relief. Midazolam Solution Intramuscular Adults and children: According to CPG or for Injection Subcutaneous Intranasal Palliative sedation, Seizures. Midazolam Solution Buccal Adults and children: According to CPG or (Buccal) Seizures. Morphine Injection Intravenous Adults and children: On registered medical Intramuscular Moderate or severe pain. Naloxone for Intramuscular Adults and children: According to CPG or Injection Subcutaneous Intranasal Respiratory depression secondary to known or suspected narcotic overdose. Nitrous oxide By inhalation Adults and children: According to CPG or Oxygen mixture medical gas Pain relief.

16 [300] Ondansetron Intramuscular Adults and children: On registered medical Hydrochloride Injection To prevent or treat opiate induced nausea and vomiting, Anti emetic.

16 16 [300] Ondansetron Intramuscular Adults and children: On registered medical Hydrochloride Injection To prevent or treat opiate induced nausea and vomiting, Anti emetic. Paracetamol (various Oral Adults and children: According to CPG or oral dosage forms) Pain, Pyrexia. Salbutamol for Inhalation Adults and children: According to CPG or Nebulisation Bronchospasm in anaphylaxis and acute asthma. Salbutamol Inhaled Inhalation Adults and children: According to CPG or Aerosol Bronchospasm in anaphylaxis and acute asthma. Tetanus Intramuscular Adults and children: According to CPG or Immunoglobulin Post exposure prophylaxis and treatment of tetanus infection. GIVEN under my Official Seal, 2 July JAMES REILLY, Minister for Health.

17 [300] 17 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 (a) to update the list of medicinal products that the profession of optometrists can be supplied with, and hold a small stock of, and then to administer these products directly to patients in the course of a patient consultation, and (b) to update the list of medicinal products that may be supplied to the various grades of ambulance personnel (i.e. advanced paramedics, paramedics and emergency medical technicians) for use in the course of their work in pre-hospital emergency care. These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014.

BAILE ÁTHA CLIATH ARNA FHOILSIÚ AG OIFIG AN tsoláthair Le ceannach díreach ó FOILSEACHÁIN RIALTAIS, 52 FAICHE STIABHNA, BAILE ÁTHA CLIATH 2 (Teil: 01-6476834 nó 1890 213434; Fax: 01-6476843) nó trí

18 BAILE ÁTHA CLIATH ARNA FHOILSIÚ AG OIFIG AN tsoláthair Le ceannach díreach ó FOILSEACHÁIN RIALTAIS, 52 FAICHE STIABHNA, BAILE ÁTHA CLIATH 2 (Teil: nó ; Fax: ) nó trí aon díoltóir leabhar. DUBLIN PUBLISHED BY THE STATIONERY OFFICE To be purchased from GOVERNMENT PUBLICATIONS, 52 ST. STEPHEN'S GREEN, DUBLIN 2. (Tel: or ; Fax: ) or through any bookseller Wt. (B30688) /14. Clondalkin. Gr

STATUTORY INSTRUMENTS. S.I. No. 530 of 2018 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS 2018

STATUTORY INSTRUMENTS. S.I. No. 530 of 2018 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS 2018 2 [530] S.I. No. 530 of 2018 MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL