BOARD REQUIREMENTS FOR THE USE OF OCULAR THERAPEUTIC DRUGS IN NEW SOUTH WALES

1. Introduction

Section 21 of the Optometrists Act 2002 provides that the Board may grant a registered optometrist an optometrists drug authority under section 17B of the Poisons and Therapeutic Goods Act 1966 if satisfied, on the basis of criteria approved under that section for assessing competency, that theoptometrist meets those competency standards.

The competency standards that an optometrist must achieve in order to be granted a drug authority are the therapeutic competencies that were developed by the Optometrists Association Australia.  The criteria to ascertain whether an optometrist meets those competency standards is through the optometrist’s provision of evidence of successful completion of an educational course or program which addresses the adopted competencies, that is recognised by the Board for this purpose and which has been accredited by the Optometry Council of Australia and New Zealand.

The following qualifications are recognised by the Board on the recommendation of the Optometry Council of Australia and New Zealand:

2. The Ocular Conditions that an Authorised Optometrist may treat

An optometrist granted a drug authority in New South Wales shall be permitted to use, supply or prescribe topical preparations in the following circumstances:

• For dry eye and related conditions;
• As an anti-infective prophylaxis after foreign body removal;
• As an adjunct to co-management of surgical cases with an attending ophthalmic surgeon;
• For non-vision threatening inflammatory diseases of the anterior segment, and
• For infectious and inflammatory disease of the anterior eye, with the exception of uveitis and herpetic conditions.

3. Application Form

Download application form (4 pages)

4. Jurisdictional Differences

An optometrists drug authority authorises the holder to possess, use, supply or prescribe, in the practice of optometry, such poisons and restricted substances as may be approved for use in New South Wales from time to time, but does not authorise the selling of such drugs.  The range of Schedule 4 medications (S4 restricted substances) approved for use in New South Wales, (see APPENDIX 1), differs from those approved in other jurisdictions. 

Optometrists may supply medications including samples or starter packs without charge in exceptional circumstances, such as in remote areas or where access to a pharmacy would prove extremely difficult.  Any S4 medication, including samples supplied to a client, must be labelled by the optometrist as a dispensed medicine, in the same manner that a pharmacist labels a medicine supplied on prescription.  Optometrists must issue Consumer Medicine Information when supplying medicines to clients.  Proper record keeping protocol must be followed in relation to the supply of all medications.

An optometrists drug authority does not authorise the holder to use, supply or prescribe a poison or restricted substance to treat an ocular condition unless that condition is one that optometrists who hold an optometrists drug authority are authorised to treat.  Optometrists who hold an optometrists drug authority may prescribe for ocular treatment only.  The range of ocular conditions for which and the circumstances under which topical preparations may be prescribed in New South Wales are listed under point 2 above.

5. Prescriptions

Prescriptions must contain:

• The prescriber’s name, professional qualifications and practice address;
• The date on which it is issued;
• The name and address of the person for whom it is prescribed;
• The name, strength and quantity of the medication and whether repeats are ordered, and
• Adequate directions for use, including the dosage and frequency of administration.

Prescriptions must be signed by the prescribing optometrist.

Optometrists who have been granted an optometrists drug authority are advised to notify their local pharmacies.  Note that prescriptions written by an optometrist in another State or Territory, where that optometrist is authorised to prescribe in that State or Territory, may be dispensed at a pharmacy in NSW.  However, a prescription written in NSW by an optometrist who does not hold an optometrists drug authority in NSW (but who is authorised to prescribe in another State or Territory), is not a valid prescription for dispensing in NSW.

6. Storage

Restricted drugs shall be stored in a locked cupboard, drawer, storeroom or other area of the premises to which the public does not have access.

7. Records

Details of supply or administration of S4 agents must be recorded and retrievable for a period of three years.

8. Management of Glaucoma

Management of Glaucoma will be under shared care arrangements with an ophthalmologist.  The approved guidelines came into effect in April  2008 and appear as Appendix 2 to this document. 

9. Referral for Specialist Medical Attention

Optometrists managing eye disease must be mindful of the potential complications of such conditions, have a clear understanding of when referral for specialist medical attention is required and ensure that this occurs in a timely fashion.

10. Continuing Education

Renewal of an optometrists drug authority is conditional upon the holder completing six (6) hours of approved continuing professional development addressing the use of therapeutic drugs in the practice of optometry during the preceding three years.

11. Pharmaceutical Benefits Scheme

With effect from 1 January 2008, certain ophthalmic drugs have been included in the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS), when prescribed by optometrists who are authorised to hold a drug authority and are approved as PBS prescribers.   The list of drugs approved under the PBS and RPBS are posted on the PBS Website at http://www.pbs.gov.au/ and contains detailed information such as name, restriction, manner of administration and form as well as the maximum quantity and repeats.  
Only therapeutically endorsed optometrists who are approved to work within the PBS (ie after having obtained a prescriber number from Medicare Australia), may prescribe pharmaceutical benefits.  Order forms for personalised PBS prescription pads should be sent to: 

Prescription Pad Order Clerk
Pharmaceutical Branch
Medicare Australia
GPO Box 9826
Sydney NSW 2001
Telephone (02) 9895 3295

Optometrist PBS prescriptions are identifiable by colour, and include the words ‘PBS/RPBS optometrist’. 

There are several rules pertaining to PBS prescriptions, most notably, prescriptions must include the optometrist’s PBS prescriber number and must be for the treatment of the person named on the PBS prescription.  The same optometrist prescription form is used to prescribe unrestricted, restricted or authority items. Only one item is allowed per form. Optometrist PBS prescriptions may include repeats. 

Pharmaceutical benefits and non-pharmaceutical benefits should not be listed together on the one PBS prescription form. A PBS prescription should be provided to the patient in duplicate, as both copies make up a valid PBS prescription. The patient should be reminded to present both the original and the duplicate copy to their local pharmacist.

A more comprehensive guide to the pharmaceutical benefits scheme, and access to the PBS Schedule Book may be gained by visiting the PBS website at: http://www.pbs.gov.au/. 

APPENDIX 1

LIST OF APPROVED SCHEDULE 4 REGISTERED RESTRICTED DRUGS FOR TOPICAL USE IN NSW AS AT 20 JULY 2005

Group 1 - Topical ocular anti-infective agents (anti-bacterial, anti-viral)

Group 2 - Topical ocular anti-allergy agents (anti-histamine, mast cell stabilisers)

Group 3 - Topical non-steroidal anti-inflammatory agents (NSAIDS)

Group 4 - Topical ocular steroid preparations

Group 5 - Topical glaucoma preparations, which may only be used following the development of a shared care model

Group 6 - Mydriatics and Cycloplegics

Group 7 - Local Anaesthetics

APPENDIX 2

GUIDELINES FOR SHARED CARE OF GLAUCOMA PATIENTS

Introduction

Under these guidelines, suitably trained optometrists who are approved to use therapeutic drugs in their practices and who have adequate professional indemnity cover, will be able to co-manage glaucoma patients in a shared care arrangement with an ophthalmologist.

Management of glaucoma patients typically includes:

• Evaluation of intraocular pressures, visual fields and ocular structures;
• Instigation of the necessary therapeutic and/or surgical treatment at the appropriate time;
• Ongoing review to monitor for any changes in ocular status (including progression of the disease and/or side effects of treatment); and
• Alteration to treatment strategies if required, (this may include changes in medication regimens, surgical intervention or other alterations).

Once the diagnosis of glaucoma is confirmed by the ophthalmologist and a treatment plan is in place for the patient, the optometrist can perform ongoing reviews to monitor the patient and prescribe topical drugs providing that:

• Periodic review demonstrates the treatment to be effective, and
• Changes to management are only initiated following consultation between treating practitioners.

Initial Referral to Ophthalmologist

An optometrist who makes a provision diagnosis of glaucoma is to refer the patient to an ophthalmologist for confirmation of the diagnosis and the development of a management plan to allow for the patient’s ongoing treatment.

Where clinically important delays are expected before the patient’s first review by an ophthalmologist, the optometrist should seek interim advice from the ophthalmologist by telephone on the patient’s management, and arrange an appointment with the ophthalmologist as soon as possible.

The patient’s consent is to be obtained by the ophthalmologist and the optometrist for all aspects of the management plan, including the sharing of care between the two practitioners.

Patient Management Plan

The management plan should specify in writing the following:

1. All the agreed components of treatment including any drug therapy;
2. Target pressures and any action to be taken if target pressures are not achieved within a specified time frame;
3. An agreed approach to monitoring visual fields and optic disc imaging and the action to be taken following changes in visual fields;
4. What changes in visual function and/or ocular status will trigger referral for more immediate ophthalmological review.  (This might include guidelines for referral based on IOP levels, visual fields, optic nerve head appearance and/or other risk factors.)
5. Likely side effects from agreed treatment and the action to be taken to address those side effects;
6. An agreed schedule for patient review by both the ophthalmologist and the specific optometrist, designating who is responsible for ensuring the patient attends agreed follow up visits.  (In most cases, a patient will have a review by an ophthalmologist at least once per year, however, practitioners may agree to a longer review interval in certain clinical circumstances.)
7. Who is responsible for performing each of the required tests (including visual fields and mydriatic disc examination) and how frequently theses tests must be done;
8. How clinical findings are communicated between parties, including General Practitioners, and mechanisms employed to ensure ongoing, open communication between all the practitioners involved.

Ophthalmologists must be available for consultation by the treating optometrist and for consultation by the patient where that consultation has been recommended or requested by the optometrist.

Glaucoma Shared Care Guidelines agreed upon by:

• Royal Australian and New Zealand College of Ophthalmologists
• Optometrists Registration Board (NSW)
• School of Optometry and Vision Sciences, University of New South Wales