Tim O'Malley (Limerick East, Progressive Democrats)

Amendments are being made to the Irish Medicines Board Act, the Misuse of Drugs Acts and the Health Act 1970 to allow regulations to be made for nurse prescribing. It is not intended that all nurses will prescribe all drugs. Rather it is intended to permit the introduction of a scheme for prescription for medicinal products or certain classes of medicinal products or certain controlled drugs — for example, in palliative care situations — to be issued in prescribed circumstances by certain registered nurses. The various circumstances and the procedures to be complied with in the issue of such prescriptions will be set out in regulations under the Irish Medicine Board Act and in accordance with the standards and requirements of An Bord Altranais.

Amendments Nos. 4 and 5 are technical amendments. Amendment No. 6 amends the definition of "practitioner" in the Misuse of Drugs Act 1977 to include a registered nurse. It also defines a "registered nurse" as a person registered with An Bord Altranais. This is required for the introduction of nurse prescribing as provided for in amendments Nos. 7, 9 and 64 as well as in part of amendment No. 38.

As regards amendment No. 7, a new section is being inserted to amend section 5 of the Misuse of Drugs Act 1977. This will allow regulations to be made to permit registered nurses or classes of registered nurses to prescribe certain controlled drugs. A new subsection 1A is being inserted which stipulates that the Minister shall only make regulations in respect of nurses where he or she is satisfied that it is safe to do so following consideration of the type of controlled drug concerned.

Subsection (c) excludes a nurse from the provision of section 5(2)(a) which allows a registered medical practitioner, a registered dentist and a veterinary surgeon to prescribe, administer, manufacture, compound or supply a controlled drug. A new subsection is being inserted so that regulations can be made in order that it is not unlawful under the Misuse of Drugs Act for nurses, subject to section 13 of the Misuse of Drugs Act, to prescribe, administer, manufacture, compound or supply a controlled drug. These subsections facilitate the making of regulations for nurse prescribing for certain controlled drugs in specified circumstances.

As regards amendment No. 9, a new section is being inserted to amend section 8(7) of the Misuse of Drugs Acts 1977, as amended by section 3 of the Misuse of Drugs Act 1984. Section 8 provides that the Minister may issue a special direction against a practitioner. This new section provides that where the Minister has issued a special direction against a nurse, he or she should send a copy of the report to An Bord Altranais. This is a consequential amendment to the enabling provision for nurse prescribing.

As regards amendment No. 38, the amendment inserted between lines 29 and 30 inserts two new paragraphs (l) and (m) which deal with different issues. The main purpose of paragraph (l) is to provide power to the Minister to make regulations, which would provide for nurse prescribing in certain circumstances as would be set out in the regulations. In the context of this provision, it also became necessary to set out in the Bill all those who would be entitled to issue prescriptions for prescription-only medicines under any regulations that would be made.

Subparagraph (i) of the new paragraph (l) is intended to continue the traditional position in relation to practitioners' ability to prescribe medicinal products within the scope of their professional practice. Subparagraph (ii) establishes the entitlement of nurses to issue a prescription in respect of medicinal products as may be specified by regulations. Provision is made so that the authority to issue prescriptions could be made available to nurses generally or to nurses of a particular class having regard to the particular education and training of the class of nurse concerned. It is also provided that the issuing of prescriptions by nurses shall be subject to such conditions, if any, as may be set out in the regulations.

Subparagraph (iii) provides for the supply of medicinal products in certain emergency circumstances in accordance with provisions that would be set out in regulations. This also preserves the limited authority available to pharmacists to supply certain medicinal products in certain emergency situations and the availability of certain medicinal products for use by emergency medical technicians, that is, ambulance personnel.

Paragraph (m) has, as it main purpose, the prescription and non-prescription control of medicinal products as classified by the Irish Medicines Board acting in its capacity as the competent authority for the granting of marketing authorisation in respect of medicinal products placed on the market in this country. Products which are not to be subject to prescription control may also be controlled by being made available only in pharmacies and, as appropriate, in other outlets according to the classifications in that respect to be assigned by the board.

This arrangement will enable regulations to be made to give direct effect to the various classifications that are currently being assigned by the Irish Medicines Board in the grant of the relevant marketing authorisations. This proposed control in respect of non-prescription products is a national control and is intended to rationalise the current three-tiered system that has, to date, operated in respect of medicinal products. The three tiers are those specified in the Irish Medicines Board product authorisations, the prescription and control of supply regulations and in the poisons regulations. As part of this rationalisation process, it is intended to remove medicinal products for human use from the scope of the poisons regulations.

Amendment No. 47 proposes the insertion of two new subsections (11) and (12) into section 32 of the Irish Medicines Board Act. Subsection (11) refers to the proposed regulation-making powers under the new subsection (2)(1) which relates to the control of medicinal products on prescription and the issue of prescriptions. This new subsection sets out in greater detail the criteria to be taken into account in the introduction of the prohibitions and exceptions that may be made in regard to the issue of prescriptions and the supply of medicinal products on foot of such prescriptions, including those medicinal products that may be supplied on the prescription of nurses or certain classes of nurses.

Subsection (12) refers to the proposed regulation making powers under the new subsection (2)(m)(ii) which relate to those non-prescription medicinal products that may be sold otherwise than in pharmacies. This subsection sets out in greater detail the criteria which would be applicable to such products in terms of their nature, purpose and safety.

Amendment No. 48 is a technical amendment as a result of the earlier insertion of new subsections (11) and (12). Amendment No. 50 is a technical drafting amendment arising from amendment No. 51. Amendment No. 51 inserts a new subsection which defines "relevant profession" for the purposes of subsection 2(k) which enables regulations to be made in regard to who may administer medicinal products and subsection 2(1) which relates to the control of medicinal products on prescription. This is a generic description, which is intended to cover registered medical practitioners, and registered dentists who heretofore had a traditional entitlement to administer to patients under their care all classes of medicinal products which they considered necessary for the treatment of their patients.

Amendment No. 64 provides for the amendment of section 59(2) of the Health Act 1970 to allow for prescriptions written by nurses to be reimbursable under the drug treatment schemes. Eligibility for free medical services and drugs under the Health Act 1970 is provided for under sections 58 and 59(1) for fully eligible persons, that is, those in the GMS scheme; and under section 59(2) and (3) for limited eligibility persons under the drugs payment scheme and the long-term illness scheme. It is necessary to amend section 59(2) in regard to the drugs payments scheme. The existing subsection (2) provides for reimbursement of expenditure on drugs, medicines and medical and surgical appliances by limited eligibility persons, above the defined monthly threshold for the DPS, on the prescription of a registered medical practitioner. The proposed amendment would permit the reimbursement to a contracted pharmacist of the prescription of a registered nurse within the parameters to be defined for such prescribing.