Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014

• Jurisdiction: Ireland

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 8th July, 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 2014.

2. 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:

“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 Administration Conditions of Administration Authority to Administer Column 1 Column 2 Column 3 Column 4 Adenosine Solution for Injection Intravenous Adults: Supraventricular tachycardias (SVT). According to CPG or on registered medical practitioner’s instructions. Aminophylline Intravenous Adults and children: Acute severe asthma. According to CPG or on registered medical practitioner’s instructions. Amiodarone Injection Intravenous Adults and children: Cardiac arrest, Tachyarrhythmia. According to CPG or on registered medical practitioner’s instructions. Aspirin (various oral dosage forms) Oral Adults: Acute Cardiac Syndrome, Decompression illness. According to CPG or on registered medical practitioner’s instructions. Atropine Injection Intravenous Endotracheal Adults and children: Cardiac arrest, Bradycardia, Poisoning. According to CPG or on registered medical practitioner’s instructions. Benzylpenicillin Injection Intravenous Intramuscular Adults and children:Suspected or confirmed sepsis. According to CPG or on registered medical practitioner’s instructions. Calcium Gluconate 10% Intravenous Intramuscular Adults and children: Hypotension. According to CPG or on registered medical practitioner’s instructions. Calcium Gluconate Gel Topical Adults and children: Hydrofluoric acid burns. According to CPG or on registered medical practitioner’s instructions. Cefotaxime Powder for Injection Intravenous Intramuscular Adults and children:Suspected or confirmed sepsis. According to CPG or on registered medical practitioner’s instructions. Ceftriaxone Powder for Injection Intravenous Intramuscular Adults and children: Suspected or confirmed sepsis. According to CPG or on registered medical practitioner’s instructions. Chlorphenamine Injection (otherwise Chlorpheniramine Injection) Intravenous Intramuscular Adults and children: Allergic reactions, Anaphylaxis. According to CPG or on registered medical practitioner’s instructions. Chlorphenamine Tablets (otherwise Chlorpheniramine Tablets) Oral Adults and children: Allergic reaction, Anaphylaxis. According to CPG or on registered medical practitioner’s instructions. Clopidogrel Tablets Oral Adults: Acute Coronary Syndrome. According to CPG or on registered medical practitioner’s instructions. Cyclizine Injection Intramuscular Intravenous Adults and children: To prevent or treat opiate induced nausea and vomiting,Anti emetic. According to CPG or on registered medical practitioner’s instructions. Dextrose 5% Solution for Infusion Intravenous Adults and children: Dilutant for medications. According to CPG or on registered medical practitioner’s instructions. Dextrose 10% Solution for Infusion Intravenous Adults and children: Hypoglycaemia, Dilutant for medications. According to CPG or on registered medical practitioner’s instructions. Diazepam Injection Intravenous Intramuscular Adults and children: Seizures,Sedation. According to CPG or on registered medical practitioner’s instructions. Diazepam Rectal Solution Per rectum Adults and children: Seizures. According to CPG or on registered medical practitioner’s instructions. Dobutamine (12.5mg/ml) Concentrate for Infusion Intravenous Adults and children: Septic shock, Cardiogenic shock. According to CPG or on registered medical practitioner’s instructions. Dopamine Hydrochloride (40mg/ml) Concentrate for Infusion Intravenous Adults and children:Cardiogenic shock. According to CPG or on registered medical practitioner’s instructions. Enoxaparin Sodium Solution for Injection IntravenousSubcutaneous Adults: ST- elevation myocardial infarction (STEMI). According to CPG or on registered medical practitioner’s instructions Epinephrine (Adrenaline) 1 mg/1ml (1:1000) Injection Intramuscular Adults and children: Anaphylaxis, Bronchospasm. According to CPG or on registered medical practitioner’s instructions. Epinephrine (Adrenaline) (1:1000) for Nebulisation Inhalation Children:Croup, Asthma. According to CPG or on registered medical practitioner’s instructions. Epinephrine (Adrenaline) 1 mg/10ml (1:10 000) Solution for Injection Intravenous Endotracheal Adults and children: Cardiac arrest, Bradycardia, Anaphylaxis. According to CPG or on registered medical practitioner’s instructions. Ergometrine Injection 500 mcg/ml Intravenous Intramuscular Adults: Post partum haemorrhage. According to CPG or on registered medical practitioner’s instructions. Fentanyl Citrate (100mcg in 2 ml) Intravenous Intranasal Buccal Adults and children: Pain management. According to CPG or on registered medical practitioner’s instructions. Furosemide Injection Intravenous Intramuscular Adults: Pulmonary oedema. According to CPG or on registered medical practitioner’s instructions. Glucagon for Injection Intramuscular Subcutaneous Adults and children: Hypoglycaemia. According to CPG or on registered medical practitioner’s instructions. Glyceryl Trinitrate Aerosol Sublingual Adults: Cardiac chest pain, Congestive heart failure. According to CPG or on registered medical practitioner’s instructions. Haloperidol Injection 5 mg/ml Intravenous Intramuscular Adults:Sedation. According to CPG or on registered medical practitioner’s instructions. Hartmann’s Solution for Infusion Intravenous Adults and children: Hypovolaemic shock, Anaphylaxis, Decompression illness, Cardiac arrest, Bradycardia, Dilutant for medications. According to CPG or on registered medical practitioner’s instructions. Heparin Sodium Solution for Injection Intravenous Adults and children: Deep vein thrombosis, Pulmonary embolism, Unstable angina, Acute peripheral arterial occlusion. According to CPG or on registered medical practitioner’s instructions. Hydrocortisone Powder for Solution for Injection Intravenous Intramuscular Adults and children: Bronchospasm, Anaphylaxis, Addison’s disease. According to CPG or on registered medical practitioner’s instructions Hydroxocobalamin Powder for Solution for Injection Intravenous Intramuscular Adults and children: Cyanide poisoning. According to CPG or on registered medical practitioner’s instructions Ibuprofen (various oral dosage forms) Oral Adults and children: Pain. According to CPG or on registered medical practitioner’s instructions. Influenza Vaccines Intramuscular Adults and children:Prophylaxis for influenza infection. According to CPG or on registered medical practitioner’s instructions Ipratropium Bromide Nebuliser Solution Inhalation Adults and children: Bronchospasm. According to CPG or on registered medical practitioner’s instructions. Ketamine Hydrochloride Injection Intravenous Intramuscular Adults and children: Procedural sedation. According to CPG or on registered medical practitioner’s instructions. Lidocaine Hydrochloride Injection Intravenous Endotracheal Subcutaneous Topical Adults: Cardiac arrest, Local anaesthetic, Jelly fish sting. According to CPG or on registered medical practitioner’s instructions. Lidocaine Hydrochloride spray 4% Topical Local anaesthetic, Jelly fish sting. According to CPG or on registered medical practitioner’s instructions. Lidocaine Hydrochloride Gel 2.5%. Topical Local anaesthetic, Jelly fish sting. According to CPG or on registered medical practitioner’s instructions. Lorazepam Injection Intravenous Intramuscular Adults and children: Seizures, Sedation. According to CPG or on registered medical practitioner’s instructions. Lorazepam Tablets Oral Adults and children: Sedation. According to CPG or on registered medical practitioner’s instructions. Magnesium Sulphate Injection BP Intravenous Adults and children: Cardiac arrest, Bronchospasm, ...