Download response to ontario association of optometrists

RESPONSE TO ONTARIO ASSOCIATION OF OPTOMETRISTS
REQUEST TO HPRAC
FOR THE EXPANSION OF SCOPE OF PRACTICE
FROM
COLLEGE OF OPTICIANS OF ONTARIO
JUNE 17, 2005
The College of Opticians of Ontario (COO) is pleased to provide comments on the Ontario
Association of Optometrists (OAO) submission to Health Professions Regulatory Advisory Council
(HPRAC) requesting an expansion of their scope of practice. The COO welcomes this opportunity to
respond to the OAO’s proposals and to participate in this very important process which impacts greatly
on the citizens of Ontario.
The College of Opticians of Ontario is a regulatory agency created under the Regulated Health
Professions Act, 1991 (RHPA) and its component parts, the Health Professions Procedural Code
(the Code) and the Opticianry Act. The scope of practice for the profession, under the Opticianry
Act, is "the provision, fitting and adjustment of sub normal vision devices, contact lenses or
eyeglasses other than simple magnifiers." Opticians have one authorized act, namely "... dispensing
sub normal vision devices, contact lenses or eyeglasses".
Executive Summary
The letter of referral from the Minister of Health and Long-Term Care and subsequent request from
HPRAC for comments on submissions by stakeholders make it clear that the primary focus of this
present referral is the public interest. The welfare of patients/clients should always be first and foremost
on the minds of government regulators when considering changes to existing legislation.
Regulations to support this change would need to be developed and the regulations
governing optometric scope of practice would also have to be amended to allow
treatment with pharmaceutical agents“1.
The referral letter from the Minister of Health and Long-Term Care sought HPRAC’s advice on their
previous report regarding:
The currency of, and any additions to, the council’s recommendations in relation to
optometrists prescribing pharmaceutical agents.
The Optometrist’s Association of Ontario (OAO) has requested an increase in their scope to include
treatment of “prescribed diseases” with therapeutic pharmaceutical agents (TPA’s). The COO agrees
that the expansion of scopes of practice is a facet of the development of a health profession, and
accordingly supports the increase in scope of practice that the OAO is requesting; with some limitations
and only if the appropriate public protection mechanisms are in place. Any increase in a scope of
practice should only be granted if there is sufficient education and enforceable evidence-based standards
of practice. Additionally, there needs to be a system in place to address any deficiencies in the current
membership’s education and experience and a system for ensuring that only practitioners with the
required skills, knowledge and qualifications will be permitted to perform the additional acts included in
an increased scope of practice.
The COO does not agree with the OAO’s request for use of anti-glaucoma medications, due to the
serious systemic affects they may have on a patient. While we support co-management of such
1
Submission To The Health Professions Regulatory Advisory Council (HPRAC), Ontario Association of Optometrists, “Our Proposal”
Page 16, April 29th, 2005.
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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diseases with physicians, the severe systemic implications of the medications used in treating this
condition are, in our view, beyond the present body of knowledge of optometry. Optometrists in
Ontario are well versed in the diagnosis of ocular pathogens and conditions; however, the treatment
is far more harmful than diagnosis.
The OAO has set out a list (“Table 5” attached as Appendix A) of Therapeutic Pharmaceutical
Agents that can be used by Optometrists.
The COO recognizes that diagnosis and prescribing of ocular diseases is not within its scope of
practice, however concerns and questions from the public and that of others professions, can only
assist a profession in establishing a regulatory system which balances the need for public protection
with the desire to maximize patient choice and minimize health care costs.
One of the concerns the COO has is the approved TPA’s for the treatment of Glaucoma. While the
OAO has submitted a thorough proposal, we find the College of Optometrists of Ontario’s standards
of Practice to lack any clear direction on how optometrists will deal with an adverse reaction to these
agents when it occurs. A simple search of the Internet and text references illustrates the serious
systemic reactions to anti-glaucoma agents.
Glaucoma
Glaucoma is a disease characterized by progressive injury to the nerve; this results in loss of vision,
which can be detected on a visual field test. The response to anti-glaucoma medications varies
among individuals. Some individuals respond well to a single agent; others may require multiple
medications to control their disease and prevent further vision damage. The desired or "target"
intraocular pressure is chosen by the treating physician. This “target” is based upon the extent of the
glaucoma damage, the intraocular pressure at which the damage occurred, and other factors.
Malignant glaucoma is also known as "aqueous misdirection" and presents the greatest diagnostic
and treatment challenge of any of the angle-closure glaucoma. In aqueous misdirection, aqueous
(the fluid in the eye) is secreted into the vitreous (a gel-like substance that fills the centre region of
the eye), building up the pressure in the vitreous, and pushing the lens forward into the trabecular
meshwork (area that the fluid drains through) to cause angle-closure glaucoma which does not
respond to iridotomy (a surgical procedure) and can lead to an angle-closure glaucoma attack.
Aqueous misdirection is difficult to understand, not always easy to diagnose, and difficult to treat
successfully. Patients with this condition need argon laser peripheral iridoplasty (another kind of
surgical procedure) to break the attack and then require definitive treatment for whatever mechanism
is causing the aqueous misdirection after the iridoplasty.
Anti-Glaucoma Agents:
Acetazolamide (Diamox)
Side Effects:
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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This drug is considered to be a sulfa drug because of its chemical properties. Although rare, severe
reactions have been reported with sulfa drugs. Side effects cannot be anticipated.
BODY AS A WHOLE: Headache, malaise, fatigue, fever, pain at injection site, flushing, growth
retardation in children, flaccid paralysis, anaphylaxis
DIGESTIVE: Gastrointestinal disturbances such as nausea, vomiting, diarrhea
HEMATOLOGICAL/LYMPHATIC: Blood dyscrasias such as aplastic anemia, agranulocytosis,
leukopenia, thrombocytopenia, thrombocytopenic purpura, melena
HEPATO-BILIARY DISORDERS: Abnormal liver function, cholestatic jaundice, hepatic
insufficiency, fulminant hepatic necrosis
METABOLIC/NUTRITIONAL: Metabolic acidosis, electrolyte imbalance, including hypokalemia,
hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration,
hyper/hypoglycemia
NERVOUS: Drowsiness, paraesthesia (including numbness and tingling of extremities and face),
depression, excitement, ataxia, confusion, convulsions, dizziness
SKIN: Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome,
toxic epidermal necrolysis
Drug Interactions:
By decreasing the gastrointestinal absorption of primidone, acetazolamide may decrease serum
concentrations of primidone and its metabolites, with a consequent possible decrease in
anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of
acetazolamide in patients receiving primidone.
Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not
advisable.
Acetazolamide may increase the effects of other folic acid antagonists.
Acetazolamide may increase or decrease blood glucose levels. Consideration should be taken in
patients being treated with antidiabetic agents.
Acetazolamide decreases urinary excretion of amphetamine and may enhance the magnitude and
duration of their effect.
Acetazolamide reduces urinary excretion of quinidine and may enhance its effect.
Acetazolamide may prevent the urinary antiseptic effect of methenamine.
College of Opticians of Ontario response to the Ontario Association of Optometrists
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Acetazolamide increases lithium excretion and the lithium may be decreased.
Acetazolamide and sodium bicarbonate used concurrently increases the risk of renal calculus
formation.
Acetazolamide may elevate cyclosporine levels.
Methazolamide
Side Effects:
Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum
levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland
failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the
development of hepatic encephalopathy.
Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a
"tingling" feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of
appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting and diarrhea;
polyuria; and occasional instances of drowsiness and confusion.
Metabolic acidosis and electrolyte imbalance may occur.
Transient myopia has been reported. This condition invariably subsides upon diminution or
discontinuance of the medication.
Other occasional adverse reactions include urticaria, melena, hernaturia, glycosuria, hepatic
insufficiency, flaccid paralysis, photosensitivity, convulsions, and rarely, crystalluria and renal
calculi.
Drug Interactions:
Methazolamide should be used with caution in patients on steroid therapy because of the potential
for developing hypokalemia.
Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as
anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose
aspirin and carbonic anhydrase inhibitors
Timolol
Side Effects:
BODY AS A WHOLE: Asthenia/fatigue and chest pain.
CARDIOVASCULAR: Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block,
cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris,
College of Opticians of Ontario response to the Ontario Association of Optometrists
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palpitation, cardiac arrest, pulmonary edema, dizziness, edema, claudication, Raynaud’s
phenomenon, and cold hands and feet.
DIGESTIVE: Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.
IMMUNOLOGIC: Systemic lupus erythematosus.
NERVOUS SYSTEM/PSYCHIATRIC: Depression, increase in signs and symptoms of myasthenia
gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances
including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.
SKIN: Alopecia and psoriasiform rash or exacerbation of psoriasis.
Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory
failure, dyspnea, nasal congestion, and cough.
Drug Interactions:
Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally
and Timolol GFS should be observed for potential additive effects of beta-blockade, both systemic
and on intraocular pressure. Patients should not usually receive two topical ophthalmic betaadrenergic blocking agents concurrently.
Calcium antagonists: Caution should be used in the co-administration of beta-adrenergic blocking
agents, such as Timolol GFS, and oral or intravenous calcium antagonists because of possible
atrioventricular conduction disturbances, left ventricular failure, or hypotension. In patients with
impaired cardiac function, co-administration should be avoided.
Brimonidine
Drug Interactions:
Although specific drug interaction studies have not been conducted, the possibility of an additive or
potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics)
should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in
using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or
cardiac glycosides is advised.
Betaxolol
Side Effects:
AUTONOMIC: flushing, salivation, sweating.
BODY AS A WHOLE: allergy, fever, malaise, pain, rigors.
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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CARDIOVASCULAR: angina pectoris, arrhythmia, atrio ventricular block, heart failure,
hypertension, hypo tension, myocardial infarction, thrombosis, syncope.
CENTRAL AND PERIPHERAL NERVOUS SYSTEM: ataxia, neuralgia, neuropathy, numbness,
speech disorder, stupor, tremor, twitching.
GASTROINTESTINAL: anorexia, constipation, dry mouth, increased appetite, mouth ulceration,
rectal disorders, vomiting, dysphagia.
Hearing and Vestibular: earache, labyrinth disorders, tinnitus, deafness.
HEMATOLOGIC: anemia, leucocytosis, lymphadenopathy, purpura, thrombocytopenia.
LIVER AND BILIARY: increased AST, increased ALT.
METABOLIC AND NUTRITIONAL: acidosis, diabetes, hypercholesterolemia, hyperglycemia,
hyperkalemia, hyperlipemia, hyperuricemia, hypokalemia, weight gain, weight loss, thirst, increased
LDH.
MUSCULOSKELETAL: arthropathy, neck pain, muscle cramps, tendonitis.
Psychiatric: abnormal thinking, amnesia, impaired concentration, confusion, emotional lability,
hallucinations, decreased libido.
REPRODUCTIVE DISORDERS: Female: breast pain, breast fibroadenosis, menstrual disorder;
Male: Peyronie's disease, prostatitis.
RESPIRATORY: bronchitis, bronchospasm, cough, epistaxis, flu, pneumonia, sinusitis.
SKIN: alopecia, eczema, erythematous rash, hypertrichosis, pruritus, skin disorders.
URINARY SYSTEM: cystitis, dysuria, micturition disorder, oliguria, proteinuria, abnormal renal
function, renal pain.
VASCULAR: cerebrovascular disorder, intermittent claudication, leg cramps, peripheral ischemia,
thrombophlebitis.
VISION: abnormal lacrimation, abnormal vision, blepharitis, ocular hemorrhage, conjunctivitis, dry
eyes, iritis, cataract, scotoma.
CENTRAL NERVOUS SYSTEM: Reversible mental depression progressing to catatonia, an acute
reversible syndrome characterized by disorientation for time and place, short-term memory loss,
emotional lability with slightly clouded sensorium, and decreased performance on
neuropsychometric tests.
Drug Interactions:
College of Opticians of Ontario response to the Ontario Association of Optometrists
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Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with betablocking agents. Patients treated with a beta-adrenergic receptor blocking agent plus a
catecholamine depletor should therefore be closely observed for evidence of hypotension or marked
bradycardia, which may produce vertigo, syncope, or postural hypotension. Should it be decided to
discontinue therapy in patients receiving beta-blockers and clonidine concurrently, the beta-blocker
should be discontinued slowly over several days before the gradual withdrawal of clonidine.
Risk of Anaphylactic Reaction: Although it is known that patients on beta-blockers may be
refractory to epinephrine in the treatment of anaphylactic shock, beta-blockers can, in addition,
interfere with the modulation of allergic reaction and lead to an increased severity and/or frequency
of attacks. Severe allergic reactions including anaphylaxis have been reported in patients exposed to
a variety of allergens either by repeated challenge, or accidental contact, or with diagnostic or
therapeutic agents while receiving beta-blockers. Such patients may be unresponsive to the usual
doses of epinephrine used to treat allergic reaction.2
Other Jurisdictions
TPA use by optometrists in Canada is permitted in Alberta, New Brunswick, Saskatchewan, the
Yukon Territory, Nova Scotia and Quebec. It is important to note that all of these jurisdictions
provide parameters for optometrists’ ability to use TPA’s; each province attempts to balance
consumer needs with public safety.
Virtually all jurisdictions, which have approved optometrists’ use of therapeutic pharmaceutical
substances, require some form of specialized training and education.
Nova Scotia
Optometrists may administer TPA’s for the treatment of ocular anterior segment disorders only; the
province does not allow the administering of anti-glaucoma agents by optometrists. Additionally,
Nova Scotia requires, among others things, 40 hours of clinical training.
Saskatchewan
Saskatchewan does not allow use of anti-glaucoma agents. Furthermore, the Bylaws of the
Saskatchewan Association of Optometrists which were approved in December 1997 contain the
following:
4.15 The Board of Examiners shall review, develop, administer and recommend to
Council the educational standards and examinations required for members to be eligible
for a diagnostic pharmaceutical agents certificate or a therapeutic pharmaceutical
agents certificate.
10.3 The Registrar may issue a Diagnostic Pharmaceutical Agents Certificate to a
member who provides satisfactory evidence that the member:
2
RxList.LLC 1324 West K Street, Benicia, CA 94510
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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has graduated subsequent to the year 1979 from either the University of Montreal or the
University of Waterloo Schools of Optometry with full credit for a course in pharmacology;
or
has graduated subsequent to the year 1979 from a school or college of Optometry with full
credit for a course in pharmacology judged by the Board of Examiners to be the equivalent
to the course presented at either the University of Montreal or the University of Waterloo
Schools of Optometry; or
has completed a course in pharmacology approved by the Board of Examiners and passed
the examinations prescribed by the Board of Examiners.
In order to renew their certificate, optometrists must provide written proof of successful completion
of 10 hours of continuing education acceptable to the board of examiners. Members holding a TPA
certificate may only administer topical TPA’s for the treatment of ocular diseases and abnormal
conditions. However, there are regulatory limitations on their use. For example, they cannot treat
glaucoma or posterior uveitis. Moreover, members administering corticosteroid agents for the
treatment of anterior uveitis must refer to an Ophthalmologist if no improvement is noted.
Alberta
The Alberta College of Optometry requires Optometrists to successfully complete a post graduate
course for TPA’s that is composed of 100 hours on instruction of which, 40 hours are in a clinical
setting using TPA’s. Optometrists must also pass an examination administered by the College of
Optometrists or the Canadian Examiners in Optometry. Designated registered Optometrists are
allowed to administer TPA’s, however, anti-glaucoma agents may only be administered in a
consultative co-management arrangement with an Ophthalmologist who is licensed to practice in
Canada.
New Brunswick
In New Brunswick only a “Certified Therapeutic Optometrist” may administer TPA’s. These
Optometrists are certified through the Pharmaceutical Certification Board (PCB) to administer
TPA’s. The board has imposed limitations on certification, which include, successful completion of
a board approved postgraduate course for TPA’s of no less than 100 hours. Members must also
successfully pass an examination approved by the board. In order to renew their certification,
optometrists must provide written proof of successful completion of 10 hours of continuing
education in the use of TPA’s.
Yukon
If an Optometrist is a graduate of an accredited school of optometry prior to 1995, they must provide
proof of successful completion of at less 100 hours in the treatment and management of ocular
diseases from an accredited school of optometry, or pass the examination “treatment and
management of ocular diseases” administered by the National Board of Examiners in Optometry.
When optometrists treat glaucoma, the Yukon employs a collaborative Co-management arrangement
with a licensed Ophthalmologist for the treatment of glaucoma. Additionally, in order to renew their
certificate, optometrists must provide written proof of successful completion of 12 hours of
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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continuing profession education, of which at least 6 hours must be in the treatment and management
of ocular diseases.
Standards of Practice
The standards of practice as set out by the College of Optometrists of Ontario are merely guidelines
and not standards of practice that can be used to regulate optometrists or the administration of
TPA’s. The COO believes that proper, evidence-based, enforceable standards of practice and
regulations should be in place prior to an increase in scope of practice of any profession. As the
custodians of public safety and trust, it is the mandate of a regulatory College to ensure that the
proper mechanisms are established to uphold public safety and address any deficiencies that may
exist within its membership. The Colleges proposed standards contain little more than a table of
approved agents and a collection of brief examples when TPA’s should be administered.
Accessibility
The COO applauds the OAO’s desire to increase the public’s access to health care. However,
increased accessibility cannot result in increased risk to the citizens of Ontario. Prior to any increase
in scope of practice, even on a limited basis, there must be adequate public protection mechanisms in
place.
The COO’s understanding of what occurs currently with respect to TPA’s is taken from the Hansard
Transcript from the Legislative Assembly of Ontario, Feb. 3, 2003, in which the President of the
OAO at the time explained the process for the prescribing of TPA’s
“Dr Parks: I think every physician does what they feel comfortable doing. Some, I think,
because they personally would know me -- the ones I would deal with -- may just take what
I tell them at face value and write the prescription. Others probably, if it's a physician I
don't know or I don't have a relationship with, probably would bring the patient in and have
a look at the eye. So I'm not sure what the process is after they leave my office; I don't think
any of us really are. In some cases, though, they will certainly take what we write at face
value and just prescribe that. Usually we see the patient afterwards. They go off, they get
their prescription and then they'll come back and see us a week later to make sure it
worked, or see us if it doesn't work.”
Clearly this scenario of the current state of affairs is not desirable if the goal is to provide safe,
accessible treatment for the public. Greater collaboration and a shared-care model should be in place
prior to increasing the scope of practice for Optometrists.
Conclusion
Given the proven risk of harm associated with the treatment of Glaucoma and looking to other
Canadian jurisdictions for guidance, the COO respectively submits that Optometrists should be
permitted to administer TPA’s for the treatment of ocular anterior segment disorders only.
Optometrists should not be permitted to administer anti-glaucoma agents. Prior to being permitted to
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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administer TPA’s of any form, Ontario Optometrists must have enforceable standards of practise and
regulations in place prior to any increase in scope of practice.
The necessary legislative changes need to be in place to provide the College of Optometrists with the
ability to effectively regulate their members and impose conditions and limitations on those
members that are not adequately trained to prescribe TPA’s.
The COO believes these safeguards must be in place to ensure the protection of the public and to
minimize the risk of harm to patients.
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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Appendix A
College of Opticians of Ontario response to the Ontario Association of Optometrists
HPRAC Submission – June 17, 2005
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