S.I. No. 449/2015 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015.

0. 5ml for single administration, in accordance with the summary of product characteristics of the product administered and the specific timing of, and need for re-vaccination as determined by the Immunisation Guidelines for Ireland, as published and updated by the National Immunisation Advisory Committee of the Royal College of Physicians of Ireland

Salbutamol 100 mcg multi-dose inhaler

Salbutamol pressurised inhalation solution 100mcg multi-dose inhaler

Oral inhalation

Adults and children: For the emergency treatment of acute asthmatic attack

In accordance with the summary of product characteristics of the product administered

”.

1. The name of the organisation to be listed.

2. The address of the organisation to be listed.

3. The name of the accountable person(s) that the organisation proposes to appoint in accordance with Regulation 4E to ensuring compliance with these Regulations.

4. The business name or trading style to be used by the organisation, where that name is different to the name required to be provided by paragraph 1.

5. In the case of a corporate body registered under the

Companies Act 2014

—

(

a

) the registered name of the body,

(

b

) the address of the registered office of the body, and

(

c

) the Companies Registration Office number of the body.

6. The permanent address of the premises at which the medicinal products are to be stored and from which they are to be supplied.

7. The starting date of the activity of holding medicinal products for use in emergencies.

8. The name of the medicinal product or products the organisation wishes to procure.

9. A declaration that the procurement, storage, supply and administration of medicinal products for use in emergencies will be conducted in compliance with these Regulations.

”.

GIVEN under my Official Seal,

15 October 2015.

LEO VARADKAR,

Minister for Health.

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 provide for the supply and administration of specified prescription-only medicinal products without a prescription to a person by a pharmacist or by an individual appointed by a listed organisation for the purpose of saving life or reducing severe distress in emergency situations, where that pharmacist or individual has completed an approved course of training regarding the administration of such products and the management of any adverse reaction.

These Regulations provide for the creation of a list of organisations that may procure the specified medicinal products for supply and administration in an emergency by trained persons in the organisation.

The Regulations also set out the records to be kept by pharmacists, pharmacy owners, persons who supply and administer medicinal products in emergencies, listed organisations and accountable persons in such organisations, in respect of each supply and administration of a specified prescription-only medicinal product without a prescription in accordance with these Regulations.

These Regulations also provide for the inclusion of additional vaccines, namely Pneumococcal and Zoster Vaccines, that a Pharmacist may supply and administer in the course of his or her professional practice, subject to the completion of approved training and the Immunisation Guidelines for Ireland, as published and updated by the National Immunisation Advisory Committee of the Royal College of Physicians of Ireland.

These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015.

10. Regulation 20 (as amended by Regulation 3 of the Regulations of 2014) of the Principal Regulations is amended by inserting after paragraph (9) the following paragraphs

“(10) The provisions of Regulation 5 shall not apply to the supply to a listed organisation of a medicinal product specified in column 1 of the Tenth Schedule if, and only if—

(

a

) the listed organisation complies with these Regulations,

(

b

) the medicinal product is for use in emergencies by persons who have successfully completed a course of training in accordance with Regulation 4C(

c

) and hold a valid certificate,

(

c

) the medicinal product is obtained from a supplier who is entitled to supply the listed organisation with the specific medicinal product,

(

d

) the medicinal product is authorised for sale or supply in the State or is naloxone pre-filled injection, and

(

e

) an order signed by the accountable person, appointed by the listed organisation concerned pursuant to Regulation 4E, is presented stating—

(i) the name and address of the listed organisation for which the medicinal product is required,

(ii) the name of the accountable person appointed by the listed organisation to ensure compliance with these Regulations,

(iii) the permanent address of the premises at which the medicinal product is to be stored and from which they are to be supplied, where this differs from the address at (i),

(iv) the name, and except where it is apparent from the name, the pharmaceutical form and strength of the product, and

(v) the total quantity required.

(11) The provisions of Regulations 5 shall not apply to the supply, for use in emergencies, of a medicinal product specified in column 1 of the Tenth Schedule by a listed organisation to a person engaged or employed by it if, and only if—

(

a

) the listed organisation complies with these Regulations,

(

b

) the medicinal product is for use in emergencies by persons who have successfully completed a course of training in accordance with Regulation 4C(

c

).”

11. The Principal Regulations are amended by deleting Regulation 20A (inserted by Regulation 24 of the Medicinal Products (Control of Placing on the Market) Regulations 2007).

12. The Principal Regulations are amended by substituting for the Eighth Schedule (inserted by Regulation 8 of the Regulations of 2011) the following

“EIGHTH SCHEDULE

MEDICINAL PRODUCTS WHICH MAY BE SUPPLIED AND ADMINISTERED BY AUTHORISED PERSONS PURSUANT TO REGULATION 4B

Medicinal Product

Form and presentation of product administered

Route of administration

Indication for which the medicinal product may be administered

Dosage and conditions of administration

Column 1

Column 2

Column 3

Column 4

Column 5

Epinephrine (adrenaline) injection

Epinephrine (adrenaline) injection presented as a pre-filled syringe or ampoule

Intramuscular or subcutaneous injection

Adults and Children: For the emergency treatment of anaphylactic shock

In accordance with the summary of product characteristics of the product administered and relevant national guidelines

Glucagon for injection

Glucagon hydrochloride for injection

Intramuscular or subcutaneous injection

Adults and children: For the emergency treatment of hypoglycaemia

In accordance with the summary of product characteristics of the product administered

Glyceryl trinitrate aerosol

Glyceryl trinitrate sublingual spray

Sublingual spray

Adults: For the emergency treatment of severe angina attack

In accordance with the summary of product characteristics of the product administered

Herpes zoster vaccine for injection

Live, attenuated, varicella-zoster virus powder and solvent for suspension for injection

By subcutaneous injection only

Prevention of zoster and zoster-related post-herpetic neuralgia.

13. The Principal Regulations are amended by inserting after the Ninth Schedule the following Schedules

“TENTH SCHEDULE

MEDICINAL PRODUCTS WHICH MAY BE SUPPLIED AND ADMINISTERED BY PERSONS ENGAGED OR EMPLOYED BY LISTED ORGANISATIONS IN EMERGENCIES PURSUANT TO REGULATION 4C

Medicinal Product

Route of administration

Conditions of administration

Column 1

Column 2

Column 3

Epinephrine (adrenaline) auto-injector presented as a 300 mcg pre-filled syringe

Intramuscular injection

Adults: For the emergency treatment of anaphylactic shock in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Epinephrine (adrenaline) auto-injector presented as a 150 mcg pre-filled syringe

Intramuscular injection

Children: For the emergency treatment of anaphylactic shock in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Glucagon hydrochloride for injection

Intramuscular or subcutaneous injection

Adults and children: For the emergency treatment of hypoglycaemia in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Glyceryl trinitrate sublingual spray

Sublingual spray

Adults: For the emergency treatment of severe angina attack in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Medical gas mixture consisting of 50% nitrous oxide and 50% oxygen

By inhalation

Adults and children: Pain relief in emergency rescue situations in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Naloxone hydrochloride 1 mg/ml pre-filled injection

Intramuscular injection

Adults and children: For the emergency treatment of respiratory depression secondary to known or suspected narcotic overdose in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

Salbutamol 100 mcg multi-dose inhaler

Oral inhalation

Adults and children: For the emergency treatment of acute asthmatic attack in accordance with Clinical Practice Guidelines approved by the Pre-Hospital Emergency Care Council, or by another body nominated by the Minister.

ELEVENTH SCHEDULE

PARTICULARS TO BE INCLUDED IN NOTIFICATION BY ORGANISATION WISHING TO PROCURE MEDICINAL PRODUCTS FOR USE IN EMERGENCIES

Regulation 4D(2)(c)

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

23

rd October

, 2015.

I, LEO VARADKAR, 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