• 02 OCT 19

    Proposed Amendments to the Designated Drugs and Standards of Practice Regulation

    Ontario optometrists have been authorized to prescribe drugs for the treatment of conditions of the eye and vision system since 2011. A list of drugs that optometrists can prescribe is included in Schedule 1 of the Designated Drugs and Standards of Practice Regulation (O. Reg. 112/11).

    On May 30, 2019, the Minister of Health asked the College to ‘amend its drug regulation to reflect categories of drugs from which your members may prescribe’. The Minister also asked the College to develop the appropriate infrastructure to support the regulation and to actively engage with system partners.

    Categories

    The current regulation, which provides a list of specific drugs, poses challenges to providing optimal care. The regulation is difficult to revise and can prevent patients from accessing newer drugs, which are often the indicated best treatment. For example, several years of consultation were required before difluprednate, cyclosporine, tafluprost, brinzolamide/timolol, and other drugs, were added to the drug list in 2017. Presently, brinzolamide/brimonidine, latanoprostene bunod, lifitegrast, and other newer eye drops are not available to patients because of the rigidity of the current drug list.

    The move from drug lists to categories has significant benefits:

    • It ensures that optometrists have the flexibility to prescribe up-to-date medications, improving access to indicated care; and
    • it avoids the need to make a regulation change every time a new drug is approved.

    The College is proposing to replace the list of drugs in Schedule I with the following categories of drugs from which optometrists will be able to prescribe:

    ANTIBACTERIALS (oral) – for the purpose of treating conditions of the eye and adnexa only

    ANTIVIRALS (oral) – for the purpose of treating conditions of the eye and adnexa only

    CARBONIC ANHYDRASE INHIBITORS (oral) – to lower intraocular pressure only, and

    1. a member shall immediately refer the patient to a physician or to a hospital in the event of acute angle closure; or
    2. only in collaboration with a physician with whom the member has established a co-management model of care

    SECRETAGOGUES (oral) – for Sjögren’s syndrome only and only in collaboration with a physician with whom the member has established a co-management model of care

    OPHTHALMIC DRUGS AND PREPARATIONS (topical) – for the purpose of treating conditions of the eye and adnexa only

    OPHTHALMIC DIAGNOSTIC AGENTS (topical)

    SKIN AND MUCOUS MEMBRANE AGENTS (topical) – for the purpose of treating conditions of the eye and adnexa only

    The topical category “Ophthalmic Drugs and Preparations” captures new topical drugs, and new types of topical drugs, as they may be approved by Health Canada for use in eye care.

    Scope & Safety

    In addition to the category limitations set out in the proposed regulation described above, optometrists may only prescribe within their scope of practice, which is defined in the Optometry Act, 1991 as follows:

    3) The practice of optometry is the assessment of the eye and vision system and the diagnosis, treatment and prevention of,

      1. disorders of refraction;
      2. sensory and oculomotor disorders and dysfunctions of the eye and visions system; and
      3. prescribed diseases.

    Prescribed diseases are set out in Part VIII of the Optometry Act:

      • In relation to diagnosis and prevention, diseases of the eye and vision system that can be determined by the findings from an oculo-visual assessment.
      • In relation to treatment, diseases of the eye and vision system that can be treated by other than the application of surgery.

    It is the College’s view that the proposed regulation, which limits prescribing within the categories to “for the purpose of treating conditions of the eye and adnexa only”, or for particular conditions (e.g., to lower intraocular pressure only, or for Sjogren’s syndrome only), will ensure safe prescribing.

    What changes? What stays the same?

    The College’s proposal is summarized as follows:

    What Changes                                                                                       What Stays the Same

    • The list of drugs is replaced with categories of drugs
    • The 14-day restriction on the prescribing of oral antibacterials is revoked
    • The management of Patients with Dry Eye featuring lid disease, is a common use case where antibacterials may be prescribed for longer duration for their anti-inflammatory properties, typically at concentrations sub-MIC (minimum inhibitory concentration). References: OPR 7.12, TFOS – DEWS II
    • The types/categories of drugs that optometrists are authorized to prescribe
    • Regulatory standards of practice related to glaucoma management by optometrists
    • Regulatory standards related to prescribing oral pilocarpine (Secretagogues) and oral acetazolamide (Carbonic Anhydrase Inhibitors)
    • Regulatory standards related to co-management with physicians

     

    Supporting the Regulation

    In order to support the regulation, there has been discussion about the utility of a drug list. That is, while the movement to categories will enable optometrists to prescribe up to date drugs, there is value to making the drug list available to optometrists, pharmacists and the public, so there is clarity about what drugs are available.

    The Ontario Association of Optometrists (OAO) currently has an app that sets out all the drugs that optometrists may prescribe, with detailed information about formulation. This app can be searched by brand/generic or drug name, drug category, generic availability, Ontario Drug Benefit coverage, and includes detailed information regarding format (e.g., gel, ointment, solution), pediatric and nursing indicators, preservative-free availability, adverse effects, contraindications and interactions.

    Discussions are ongoing to make an abridged list of drugs available via the College website to ensure that it is accessible to optometrists, other health-care providers and the public. Making the list available will ensure that it can be easily updated when drugs change within categories. For detailed information, optometrists are encouraged to continue to refer to the OAO TPA app.

    Regulatory Mechanisms: The College already has mechanisms in place to ensure that optometrists prescribe appropriately. These include:

    1. a requirement for training prior to prescribing, which has been incorporated into both undergraduate and graduate training and entry to practice requirements;
    2. comprehensive standards of practice set out in the Optometric Practice Reference, which includes a section on ‘The Use and Prescribing of Drugs in Optometric Practice’ and will be updated to reflect any revisions to the regulation; and
    3. regulatory processes such as investigations and assessments to ensure both early identification of prescribing problems as well as the ability to respond should any issues arise.

     

    Materials for Review

    Proposed Amendments to the Designated Drugs and Standards of Practice Regulation (O. Reg. 112/11) – showing amendments in track changes

    Proposed Amendments to the Designated Drugs and Standards of Practice Regulation (O. Reg. 112/11) – without track changes

    We Want to Hear From You

    Your input is important. Please take a moment to submit your feedback via this brief survey, or send us your comments by email, mail, or fax.

    College of Optometrists of Ontario
    Consultation Feedback
    65 St. Clair Ave. E., Suite 900
    Toronto ON M4T 2Y3

    Fax: 416-962-4073

    Deadline for comments is December 1, 2019.