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

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005.

2. 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 2005.

3. 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 (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;

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).”;

(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 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 1

Column 2

Column 3

Column 4

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 -

Circumstances excluding products from prescription-only control

Column 1

Column 2

Column 3

Column 4

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

Budesonide

B

Felodipine

B

Tramadol Hydrochloride

A

(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

“Part 2

(Regulation 6(2))

Circumstances in which the substances when contained in non-prescription medicinal products may be supplied in non-pharmacy outlets

Column 1

Column 2

Column 3

Column 4

Substance

Maximum Strength and/or pack size

Use, pharmaceutical form or manner of administration

Maximum Dose and Maximum Daily Dose

Aspirin

Colecalciferol

Cyanocobalamin

Ergocalciferol

Folic Acid

Hypericum perforatum

L.

Ibuprofen

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)

Nicotinic acid

Pyridoxine Hydrochloride

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 Administration

Conditions of Administration

Authority to Administer

Column 1

Column 2

Column 3

Column 4

Amiodarone injection

Intravenous

Intraosseous

Adults and children

Cardiac arrest

According to CPG or on registered medical practitioner's instructions

Atropine injection

- prefilled disposable syringe

Intravenous

Endotracheal

Intraosseous

Adults

Cardiac arrest,

Bradycardia.

Children

Bradycardia

According to CPG or on registered medical practitioner's instructions

Benzylpenicillin injection

Intravenous

Intraosseous

Intramuscular

Adults and children

Suspected or confirmed meningococcal sepsis

According to CPG or on registered medical practitioner's instructions

Cyclizine injection

Intravenous

Adults and children

To prevent or treat opiate induced nausea and vomiting

According to CPG or on registered medical practitioner's instructions

Dextrose 10% Solution for infusion

Intravenous

Adults and children: Hypoglycaemia

According to CPG or on registered medical practitioner's instructions

Diazepam injection

Intravenous

Intraosseous

Adults and children

Seizures

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

Epinephrine (Adrenaline) 1 mg/1ml (1:1 000)

- prefilled disposable syringe

Intramuscular

Adults and children

Anaphylaxis

According to CPG or According to CPG or on registered medical practitioner's instructions

Epinephrine (Adrenaline) injection

- prefilled disposable syringe (auto)

Intramuscular

Adults and children

Anaphylaxis

According to CPG or on registered medical practitioner's instructions

Epinephrine (Adrenaline) 1 mg/10ml (1:10 000)

- prefilled disposable syringe

Intravenous

Endotracheal

Intraosseous

Adults and children

Cardiac arrest,

Bradycardia,

Anaphylaxis

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

According to CPG or on registered medical practitioner's instructions

Hartmann's Solution for infusion

Intravenous

Intraosseous

Adults and children

Hypovolaemic shock, Anaphylaxis

According to CPG or on registered medical practitioner's instructions

Ibuprofen Tablets or Capsules

Orally

Children

Pain

According to CPG or on registered medical practitioner's instructions

Lidocaine Hydrochloride Injection

Intravenous

Endotracheal

Adults

Cardiac arrest

According to CPG or on registered medical practitioner's instructions

Lorazepam Injection

Intravenous

Intramuscular

Adults and children

Seizures

According to CPG or on registered medical practitioner's instructions

Morphine Injection

Intravenous

Intramuscular

Adults and Children

Moderate to severe pain

According to CPG or on registered medical practitioner's instructions

Naloxone for injection

Intravenous

Intramuscular

Subcutaneous

Adults

Respiratory depression secondary to known or suspected narcotic overdose

According to CPG or on registered medical practitioner's instructions

Nitrous oxide - Oxygen mixture

- medical gas

By Inhalation

Adults and children

Pain relief for medical, surgical or trauma conditions

According to CPG or on registered medical practitioner's instructions

Ondansetron

Hydrochloride Injection

Intravenous

Adults and children: To prevent or treat opiate induced nausea and vomiting

According to CPG or on registered medical practitioner's instructions

Paracetamol suppositories

Per rectum

Children

Pyrexia

According to CPG or on registered medical practitioner's instructions

Salbutamol for nebulisation

Inhalation

Adults and children

Bronchospasm in anaphylaxis, and acute asthma

According to CPG or on registered medical practitioner's instructions

Salbutamol inhaled aerosol

Inhalation

Adults and children: Bronchospasm in anaphylaxis, and acute asthma

According to CPG or on registered medical practitioner's instructions

Sodium Chloride 0.9% for infusion

Intravenous

Adults

Hyperglycaemia Adults and children: To keep vein open, Cannula flush

According to CPG or on registered medical practitioner's instructions

Tetracaine Gel 4%

Topical

Adults and children

Anaesthesia prior to venepuncture

According to CPG or on registered medical practitioner's instructions

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 Administration

Conditions of Administration

Authority to Administer

Column 1

Column 2

Column 3

Column 4

Cyclizine Injection

Intramuscular

Adults and children: To prevent or treat opiate induced nausea and vomiting

On registered medical practitioner's instructions

Diazepam rectal solution

Per Rectum

Adults and children

Seizures

On registered medical practitioner's instructions

Epinephrine (Adrenaline) 1mg/1ml (1:1 000)

- prefilled disposable syringe

Intramuscular

Adults and children

Anaphylaxis

According to CPG or on registered medical practitioner's instructions

Epinephrine (Adrenaline Injection

- prefilled disposable syringe (auto)

Intramuscular

Adults and children

Anaphylaxis

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

According to CPG or on registered medical practitioner's instructions

Hartmann's Solution for infusion

Intravenous

Adults and children

Hypovolaemic shock, Anaphylaxis

On registered medical practitioner's instructions

Morphine Injection

Intravenous

Intramuscular

Adults and Children

Moderate to severe pain

On registered medical practitioner's instructions

Naloxone for injection

Intramuscular

Subcutaneous

Adults

Respiratory depression secondary to known or suspected narcotic overdose

On registered medical practitioner's instructions

Nitrous oxide - Oxygen mixture

- medical gas

By Inhalation

Adults and children: Pain relief for medical, surgical or trauma conditions

According to CPG or on registered medical practitioner's instructions

Paracetamol suppositories

Per rectum

Children

Pyrexia

On registered medical practitioner's instructions

Salbutamol for nebulisation

Inhalation

Adults and children

Bronchospasm in anaphylaxis, and acute asthma

According to CPG or on registered medical practitioner's instructions

Salbutamol inhaled aerosol

Inhalation

Adults and children

Bronchospasm in anaphylaxis, and acute asthma

According to CPG or on registered medical practitioner's instructions

Sodium Chloride 0.9% for infusion

Intravenous

Adults

Hyperglycaemia Adults and children: To keep vein open, Cannula flush

On registered medical practitioner's instructions

Tetracaine Gel 4%

Topical

Adults and children: Anaesthesia prior to venepuncture

On registered medical practitioner's instructions

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 Administration

Conditions of Administration

Authority to Administer

Column 1

Column 2

Column 3

Column 4

Cyclizine Injection

Intramuscular

Adults and children

To prevent or treat opiate induced nausea and vomiting

On registered medical practitioner's instructions

Epinephrine (Adrenaline) injection

- prefilled disposable syringe (auto)

Intramuscular

Adults and children

Anaphylaxis

According to CPG or on registered medical practitioner's instructions

Glyceryl trinitrate aerosol

Sublingual

Adults

Cardiac chest pain

According to CPG or on registered medical practitioner's instructions

Morphine Injection

Intravenous

Intramuscular

Adults and Children

Moderate to severe pain

On registered medical practitioner's instructions

Naloxone for injection

Intramuscular

Subcutaneous

Adults

Respiratory depression secondary to known or suspected narcotic overdose

On registered medical practitioner's instructions

Nitrous oxide - Oxygen mixture

- medical gas

By Inhalation

Adults and children

Pain relief for medical, surgical or trauma conditions

According to CPG or on registered medical practitioner's instructions

Salbutamol inhaled aerosol

Inhalation

Adults and children

Bronchospasm in anaphylaxis, and acute asthma

According to CPG or on registered medical practitioner's instructions

Given under my hand this 9

th

day of August, 2005.

SEAN POWER

Minister of State at the Department of Health and Children

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.

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:-