O. Reg. 168/15: GENERAL

Link to law: http://www.ontario.ca/laws/regulation/r15168
Published: 2015-06-19

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ontario regulation 168/15

made under the

Naturopathy Act, 2007

Made: May 29, 2015
Approved: June 17, 2015
Filed: June 19, 2015
Published on e-Laws: June 22, 2015
Printed in The Ontario Gazette: July 4, 2015


General

CONTENTS


PART I
INTERPRETATION




1.


Definitions




PART II
CONTROLLED ACTS




2.


General




3.


Standards of practice, s. 4 (1) of the Act




4.


Internal examinations




5.


Administering substances by injection or inhalation




6.


Moving the joints of the spine




7.


Communicating a naturopathic diagnosis




8.


Taking blood samples for performing prescribed naturopathic examinations




9.


Prescribing a drug




10.


Dispensing a drug




11.


Compounding a drug




12.


Selling a drug




13.


Mandatory referral




PART III
DELEGATION




14.


Definitions




15.


Limits on delegation




16.


Responsibility




17.


Conditions before delegating




18.


How made




19.


Records, etc.




20.


Accepting delegation, etc.




21.


Contents of record




22.


Delegation of communication of diagnosis




PART IV
COMMENCEMENT




23.


Commencement




Table 1


Prescribed substances that may be administered by inhalation




Table 2


Prescribed substances that may be administered by injection




Table 3


Drugs that may be prescribed




Table 4


Drugs that may be dispensed




Table 5


Drugs that may be compounded




Table 6


Drugs that may be sold




Part I
Interpretation

Definitions

1. In this Regulation,

“controlled act” means a controlled act set out in subsection 27 (2) of the Regulated Health Professions Act, 1991; (“acte autorisé”)

“drug” means a drug as defined in the Drug and Pharmacies Regulation Act. (“médicament”)

Part II
Controlled Acts

General

2. (1) A member shall not perform a controlled act under the authority of subsection 4 (1) of the Act except in accordance with this Part.

(2) Where the provisions of this Part are inconsistent with a law of Canada respecting the sale, dispensing, compounding, prescribing or injection of a drug or other substance, including a drug or substance related to a targeted substance, the law of Canada shall prevail and the provisions of this Part, to the extent they are inconsistent with that law, shall not apply.

(3) Where the provisions of this Part are inconsistent with the provisions of the

Narcotics Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of this Part, to the extent they are inconsistent with that Act, shall not apply.

Standards of practice, s. 4 (1) of the Act

3. (1) A member shall not perform any controlled act under the authority of paragraph 1, 2, 3, 4 or 6 of subsection 4 (1) of the Act unless he or she performs it in accordance with all of the following standards of practice of the profession:

1. The member must have a naturopath-patient relationship with the patient and, before performing the controlled act, must record the patient’s health history.

2. Before performing the controlled act, the member must inform the patient or the patient’s authorized representative about,

i. the purpose of the controlled act,

ii. the risks inherent in performing it,

iii. alternative treatments that the member knows or ought to know are available within the practice of the profession, and

iv. treatments that the member knows or ought to know are available to the patient if he or she were to be treated by a member of another College under the Regulated Health Professions Act, 1991.

3. Before performing the controlled act, the member must receive an informed consent from the patient or his or her authorized representative.

4. Before performing the controlled act, the member must determine that the patient’s condition warrants performing the controlled act, having considered,

i. the known risks and benefits to the patient of performing the controlled act,

ii. the predictability of the outcome,

iii. the safeguards and resources available in the circumstances to safely manage the outcome of performing the controlled act, and

iv. other relevant circumstances specific to the patient.

5. The member must ensure that appropriate infection control procedures are in place at all times and that the controlled act is performed in an environment that is clean, safe, private and comfortable for the patient.

6. The member must have the knowledge, skill and judgment,

i. to perform the controlled act safely and ethically, and

ii. to determine whether the patient’s condition warrants performance of the controlled act.

(2) It is a further standard of practice of the profession that a member is prohibited from taking or collecting a specimen from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, unless the specimen that is taken or collected is identified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act and related to a specific laboratory test set out in the regulations made under that Act.

(3) It is a further standard of practice of the profession that a member is prohibited from performing a laboratory test or taking blood samples or other specimens from a patient for the purpose of performing a laboratory test, unless the laboratory test that the member performs is specified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act and the blood samples or other specimens taken from a patient are identified in and related to a specific test in the regulations made under that Act.

(4) It is a further standard of practice of the profession that a member is prohibited from ordering a laboratory test unless the test is one specified in the regulations made under the Laboratory and Specimen Collection Centre Licensing Act.

Internal examinations

4. (1) For the purposes of paragraphs 1 and 2 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to perform the following controlled acts:

1. Putting an instrument, hand or finger beyond the labia majora but not beyond the cervix.

2. Putting an instrument, hand or finger beyond the anal verge but not beyond the rectal-sigmoidal junction.

(2) It is a standard of practice of the profession that a member may only perform a controlled act described in subsection (1) for one or more of the following purposes:

1. Examining a patient in the course of an assessment or to formulate a naturopathic diagnosis.

2. Treating the patient with naturopathic treatments or remedies.

3. Taking or collecting a specimen.

Administering substances by injection or inhalation

5. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to perform the following controlled acts:

1. Administering a substance specified in Table 1 by inhalation to a patient, in accordance with any limitations respecting the substance set out in the Table.

2. Administering a substance specified in Table 2 by injection to a patient using the routes of administration respecting the substance that are set out in the Table and in accordance with any limitations respecting the substance that are set out in the Table.

(2) It is a standard of practice of the profession that a member who performs the controlled act referred to in paragraph 1 of subsection (1) and who, in doing so, mixes, prepares, packages or labels two or more substances specified in Table 1 for the purpose of administering a customized therapeutic product to a patient by inhalation must comply with all the standards of practice set out in subsection 11 (2), with any necessary modifications.

(3) It is a standard of practice of the profession that a member who performs the controlled act referred to in paragraph 2 of subsection (1) and who, in doing so, reconstitutes, dilutes, mixes, prepares, packages or labels two or more substances specified in Table 2 for the purpose of administering a customized therapeutic product to a patient by injection must comply with all the standards of practice set out in subsection 11 (2), with any necessary modifications.

(4) It is a standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed,

(a) a course on prescribing that has been approved by the Council; and

(b) an examination on prescribing that is administered or approved by the Council.

(5) Where the administration of a substance referred to in paragraph 2 of subsection (1) is by intravenous injection, it is a standard of practice of the profession that a member may only perform the controlled act if he or she has successfully completed, in addition to the requirements under clauses (4) (a) and (b),

(a) a course on administering a substance by intravenous injection that is approved by the Council; and

(b) an examination on administering a substance by intravenous injection that is administered or approved by the Council.

(6) A member who, immediately before section 6 of the Act came into force, was registered to practice under the Drugless Practitioners Act by The Board of Directors of Drugless Therapy and authorized by The Board to administer a substance by intravenous injection to a patient shall be deemed to have met the standards of practice in subsections (4) and (5), subject to subsection (7).

(7) It is a standard of practice of the profession that a member described in subsection (6) shall successfully complete the course and examination mentioned in subsection (4) within six months of the coming into force of section 6 of the Act.

(8) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (4) (a) or (b) or (5) (a) or (b).

Moving the joints of the spine

6. (1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to move the thoracic, lumbar and sacral joints of the spine and the cervical joints of the spine.

(2) A member may perform an act described in subsection (1) only if he or she meets all of the following standards of practice:

1. The member shall use only one or more of the following low amplitude thrust procedures when he or she manipulates a patient’s cervical joints of the spine:

i. Supine lateral flexion.

ii. Supine rotary.

iii. C2-C7 seated rotary.

2. The member shall not perform a controlled act described in subsection (1) if, at the time that the controlled act is proposed,

i. the patient has or may have one or more of the contraindications listed in subsection (3), or

ii. the member is in doubt about the accuracy of the patient’s health status or health history respecting any of the contraindications listed in subsection (3).

(3) The contraindications mentioned in subparagraphs 2 i and ii of subsection (2) are the following:

1. Anomalies, including dens hypoplasia, unstable os odontoideum and similar diseases, disorders or dysfunctions.

2. Acute fracture.

3. Spinal cord tumour.

4. Acute infection of the spine, including osteomyelitis, septic discitis and tuberculosis of the spine.

5. Meningeal tumour.

6. Haematomas, whether spinal or intracanalicular.

7. Malignancy of the spine.

8. Frank disc herniation with accompanying signs of progressive neurological deficit.

9. Basilar invagination of the upper cervical spine (vertebrobasilar ischemia).

10. Symptomatic Arnold-Chiari malformation of the upper cervical spine.

11. Dislocation of a vertebra.

12. Aggressive types of benign tumours, such as an aneurismal bone cyst, giant cell tumour, osteoblastoma or osteoid osteoma.

13. Internal fixation/stabilization devices.

14. Neoplastic disease of muscle or other soft tissue.

15. Positive Kernig’s or Lhermitte’s signs.

16. Congenital, generalized hypermobility.

17. Syringomyelia.

18. Hydrocephalus of unknown aetiology.

19. Diastematomyelia.

20. Cauda equina syndrome.

21. Any other disease, disorder or dysfunction that the member knows or ought to know contraindicates performance of the controlled act in the relevant circumstances of the patient.

Communicating a naturopathic diagnosis

7. (1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member who meets all of the standards of practice in this section may communicate a naturopathic diagnosis to a patient that identifies the cause of his or her symptoms as being a disease, disorder or dysfunction that may be identified through an assessment using one or more of the following:

1. The patient’s health history.

2. The findings of an objective patient evaluation, including a physical examination of the patient.

3. The results of any relevant tests or investigations.

(2) The member shall perform the controlled act described in subsection (1) only if he or she meets all of the following standards of practice:

1. The member must have a naturopath-patient relationship with the patient.

2. The member must have the knowledge, skill and judgment to perform the controlled act safely, accurately and ethically.

Taking blood samples for performing prescribed naturopathic examinations

8. (1) For the purposes of paragraph 6 of subsection 4 (1) of the Act, a member who meets all of the standards of practice of the profession in this section and section 3 of this Regulation is authorized to take blood samples from veins or by skin pricking for the purpose of performing one or more of the following naturopathic examinations on a patient’s blood sample:

1. BTA Bioterrain Assessment.

2. Glucose.

3. Live blood cell analysis.

4. Hemoglobin – A1C.

5. Mononuclear Heterophile Antibodies (monospot).

6. Fatty acids, free.

7. Blood Group – ABO and RhD.

(2) The member shall perform the controlled act described in subsection (1) only if he or she meets all of the following standards of practice:

1. The member shall perform the controlled act only for the purpose of,

i. assessing the patient’s health status,

ii. communicating a naturopathic diagnosis, or

iii. monitoring or evaluating the patient’s response to treatment.

2. Subject to paragraph 3, the member shall only perform the specified naturopathic examination on a patient’s blood sample using a Class III medical device that has been approved by Health Canada.

3. Where no Health Canada approved Class III medical device exists for the purpose of performing a specified naturopathic examination, but another Health Canada approved medical device exists that can be used for the purpose, the member must use such a device, in accordance with the purpose intended by the manufacturer of the device, and in accordance with the manufacturer’s instructions.

4. The member shall ensure that any instrument or device used for taking, collecting or examining a blood sample is used solely for the purpose intended by the manufacturer of the device and in compliance with the manufacturer’s specifications.

5. The member is prohibited from taking a blood sample from a patient except for the purpose of performing the controlled act mentioned in subsection (1).

Prescribing a drug

9. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may prescribe a drug designated in Table 3 only if all of the standards of practice of the profession in this section are met.

(2) The following are standards of practice for the purposes of subsection (1):

1. The member must have a naturopath-patient relationship with the patient for whom the drug is prescribed.

2. The member must prescribe the drug for therapeutic purposes only.

3. The member must possess sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient.

4. The member must have determined that the patient’s condition warrants prescribing the drug, having considered the known risks and benefits to the patient of prescribing the drug and other circumstances relevant to the patient.

5. The member must give a written prescription for the drug to the patient or his or her authorized representative.

6. The member must notify the patient’s other primary health care providers, if any, within a reasonable time that the member prescribed a drug for the patient and provide details respecting the prescription, unless the patient refuses to consent to the notification.

7. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 3, a member shall only prescribe that drug in compliance with the limitation and in accordance with the route of administration and dosage specified.

(3) It is an additional standard of practice of the profession that a member who prescribes a drug to a patient as described in subsection (1) must ensure that the following information is recorded on the prescription:

1. The name and address of the patient for whom the drug is prescribed.

2. The name, strength (where applicable) and quantity of the prescribed drug.

3. Directions for the use of the drug, including its dose, frequency, route of administration and any special instructions.

4. The name, signature, address, telephone number and College registration number of the member issuing the prescription.

5. The date the prescription was issued by the member.

6. The number of refills that the member authorized, if applicable.

7. Any other information required by law.

(4) It is an additional standard of practice of the profession that a member who prescribes a drug under this section must maintain a patient record that includes details of the member’s rationale for his or her decision to prescribe the drug to the patient and the following information, if applicable:

1. A copy of the prescription that the member gave to the patient or the patient’s authorized representative.

2. A record of the results of any laboratory or other tests that the member considered in making the decision to prescribe the drug.

3. The names and addresses of the patient’s other primary health care providers, the date on which the member notified those other providers about the prescription and the method by which the notification occurred.

(5) It is an additional standard of practice of the profession that a member may only perform the controlled act described in subsection (1) if he or she has successfully completed,

(a) a course on prescribing that has been approved by the Council; and

(b) an examination on prescribing that is administered or approved by the Council.

(6) Despite anything in this section, a member may perform the controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clauses (5) (a) and (b).

Dispensing a drug

10. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may dispense a drug designated in Table 4 only if all of the standards of practice of the profession in this section are met.

(2) The following are standards of practice for the purposes of subsection (1);

1. Unless subsection (3) applies, the member must have a naturopath-patient relationship with the patient for whom the drug is dispensed.

2. The member must dispense the drug for therapeutic purposes only.

3. Unless subsection (3) applies, the member must provide the drug directly to the patient or the patient’s authorized representative.

4. The member must advise the patient or his or her authorized representative that the drug may be available at a pharmacy.

5. The member must have the knowledge, skill and judgment to dispense the drug safely and ethically.

6. The member must have ensured that the drug has been obtained and stored in accordance with any applicable laws.

7. The member must have ensured that the drug has not expired and will not expire before the date on which the patient is expected to take the last of the drug.

8. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 4, a member shall only dispense that drug in compliance with the limitation and in accordance with the route of administration and dosage specified.

9. The member must dispense a reasonable quantity of the drug having regard to the patient’s condition, availability of the drug and the patient’s ability to obtain the drug elsewhere.

10. The member must ensure that the container in which the drug is dispensed, or, if there is insufficient space on the container, a document attached to the container, lists the following information:

i. An identification number, if applicable.

ii. The member’s name and title.

iii. The name, address and telephone number of the place from which the drug is dispensed.

iv. The identification of the drug as to its name, its strength (where applicable) and, if available, its manufacturer.

v. The quantity of the drug dispensed.

vi. The date the drug is dispensed.

vii. The expiry date of the drug, if applicable.

viii. The name of the patient for whom the drug is dispensed.

ix. The directions for use of the drug, including its dose, frequency, route of administration and any special instructions.

11. The member must retain a copy of the information set out under paragraph 10 in the patient’s record, and, if applicable, a copy of the prescription required under clause (3) (d).

(3) It is a further standard of practice of the profession that if the member does not have a naturopath-patient relationship with the person for whom the drug is dispensed, the member must not dispense the drug unless,

(a) at the time the drug is dispensed, the member possesses the prescription for the drug;

(b) the person who prescribed the drug is another member;

(c) the prescription contains all the information required under subsection 9 (3); and

(d) the member retains a copy of the prescription in the member’s records.

(4) It is a further standard of practice of the profession that a member may only perform the controlled act described in subsection (1) if he or she has successfully completed,

(a) a course on prescribing that has been approved by the Council; and

(b) an examination on prescribing that is administered or approved by the Council.

(5) Despite anything in this section, a member may perform the controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clauses (4) (a) and (b).

Compounding a drug

11. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may compound a drug designated in Table 5 only if all of the standards of practice of the profession in this section are met.

(2) The following are standards of practice for the purposes of subsection (1):

1. The member must have a naturopath-patient relationship with the patient for whom the drug is compounded.

2. The member must have the knowledge, skill and judgment to engage in the controlled act safely, competently and ethically.

3. Before performing the controlled act, the member must have considered the patient’s condition, the risks and benefits to the patient and any other relevant circumstances specific to the patient.

4. The member must ensure that the controlled act is performed in an aseptic preparation area using aseptic techniques to minimize the risk of contamination.

5. The member must provide the compounded drug directly to the patient or the patient’s authorized representative.

6. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 5, a member shall only compound that drug in compliance with the limitation and in accordance with the route of administration and dosage specified.

7. The member must compound the drug for the purpose of providing a customized therapeutic solution for a particular patient.

8. The member must advise the patient or his or her authorized representative that the drug may be compounded at a pharmacy.

9. The member shall only engage in the controlled act when a supply of a Health Canada approved, commercially prepared product that meets the patient’s needs is not reasonably available.

10. The member must have ensured that the drugs or other substances used in the compounding have been obtained and stored in accordance with any applicable laws.

11. The member must have ensured that the drugs or other substances used in the compounding have not expired and will not expire before the date on which the patient is expected to take or use the last of the compounded drug.

12. The member must ensure that the container holding the compounded drug, or if there is insufficient space on the container, a document attached to the container, lists the following information:

i. An identification number, if applicable.

ii. The member’s name and title.

iii. The name, address and telephone number of the place where the drug was compounded.

iv. The identification of the drugs, substances and any other ingredients used in the compounding, their names and strength and, if available, their manufacturer.

v. The amount or percentage of each of the drugs, substances and any other ingredients used to make the compounded product and the quantity of the compounded product in the container.

vi. The date that the compounded drug was prepared and the date that the compounded drug was dispensed to the patient.

vii. The expiry date of the compounded drug.

viii. The name of the patient for whom the drug was compounded.

ix. The directions for the storage and use of the compounded drug, including its dose, frequency, route of administration and any special instructions.

13. The member must retain a copy of the information described in paragraph 12 in the patient’s record.

(3) It is a further standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed,

(a) a course on prescribing that has been approved by the Council; and

(b) an examination on prescribing that is administered or approved by the Council.

(4) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (3) (a) or (b).

Selling a drug

12. (1) For the purposes of paragraph 7 of subsection 4 (1) of the Act, a member may sell a drug designated in Table 6 only if all of the standards of practice of the profession in this section are met.

(2) The following are standards of practice for the purposes of subsection (1):

1. Unless subsection (3) applies, the member must have a naturopath-patient relationship with the patient for whom the drug is sold.

2. Unless subsection (3) applies, the member must sell the drug directly to the patient or the patient’s authorized representative.

3. The member must sell the drug for therapeutic purposes only.

4. Where a limitation, a route of administration or a dosage is indicated in the column opposite the drug in Table 6, a member shall only sell that drug in compliance with the limitation and in accordance with the route of administration and dosage specified.

5. The member must advise the patient or his or her authorized representative that the drug may be purchased at a pharmacy.

6. The member must have made reasonable inquiries and be satisfied that,

i. the patient does not have reasonable or timely access to a pharmacy,

ii. the patient would not otherwise buy the drug,

iii. the patient does not have the financial resources to obtain the drug if not sold by the member, or

iv. the drug is not reasonably available in a pharmacy.

7. The member must not sell the drug if the selling provides a profit to him or her or a direct or indirect personal or financial benefit.

8. The member must have ensured that the drug to be sold has been obtained and stored in accordance with any applicable laws.

9. The member must have ensured that the drug to be sold has not expired and will not expire before the date on which the patient is expected to take the last of the drug.

10. Unless subsection (3) applies, the member must retain in the patient’s record a record that the drug was sold to the patient or his or her authorized representative and the price charged, and where subsection (3) does apply, a copy of the prescription required under clause (3) (d).

(3) If the member does not have a naturopath-patient relationship with the person to whom the drug is sold, the member must not sell the drug unless,

(a) at the time the drug is sold, the member possesses the prescription for the drug;

(b) the person who prescribed the drug is another member;

(c) the prescription contains all the information required under subsection 9 (3); and

(d) the member retains a copy of the prescription in the member’s records.

(4) Paragraphs 5 to 9 of subsection (2) apply, with necessary modification, to the member mentioned in clause (3) (b).

(5) It is a further standard of practice of the profession that a member may only perform a controlled act described in subsection (1) if he or she has successfully completed,

(a) a course on prescribing that has been approved by the Council; and

(b) an examination on prescribing that is administered or approved by the Council.

(6) Despite anything in this section, a member may perform a controlled act described in subsection (1) if he or she does so while taking part in a course or examination required under clause (5) (a) or (b).

Mandatory referral

13. (1) If a patient’s life is or may be at risk, it is a standard of practice of the profession that the member shall immediately call emergency services to transfer the patient to a hospital.

(2) If the patient’s condition prevents the member from communicating a naturopathic diagnosis because the condition is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to,

(a) a member of the College of Physicians and Surgeons of Ontario;

(b) a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class; or

(c) a member of another health profession College where the patient’s condition would fall within that member’s scope of practice under his or her health profession Act.

(3) If treatment of the patient’s condition is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to,

(a) a member of the College of Physicians and Surgeons of Ontario;

(b) a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class; or

(c) a member of another health profession College where the patient’s condition would fall within that member’s scope of practice under his or her health profession Act.

(4) If the treatment of the patient’s condition requires diagnostic, monitoring or treatment related technology that is beyond the scope of practice of the profession, it is a standard of practice of the profession that the member shall refer the patient to,

(a) a member of the College of Physicians and Surgeons of Ontario; or

(b) a member of another health profession College where the diagnostic, monitoring or treatment related technology would fall within that member’s scope of practice.

(5) If the patient or the patient’s authorized representative asks the member to refer the patient to another member or a member of another health profession College, it is a standard of practice of the profession that the member shall immediately make the referral in accordance with the request of the patient or his or her authorized representative.

(6) It is a standard of practice of the profession that the member must immediately refer the patient to a member of the College of Physicians and Surgeons of Ontario or a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class if the patient’s laboratory test result from a laboratory licensed under the Laboratory Specimen Centre Collection Licensing Act is a critical value test result.

(7) It is a standard of practice of the profession that the member must refer the patient to a member of the College of Physicians and Surgeons of Ontario or a member of the College of Nurses of Ontario who holds a certificate of registration as a registered nurse in the extended class if the response of a patient to the treatment offered by a member is not adequate and is not likely to improve based on alternative treatments available from the member, or if the patient’s condition significantly deteriorates and is likely to continue to do so without a referral.

(8) Nothing in this section prohibits a member who has referred a patient from providing that patient with supportive or other health services within the member’s scope of practice after the patient has been referred, as long as the member works in collaboration with the person to whom the patient was referred and the patient.

(9) In this section,

“critical value test result” means a laboratory test result that shows a marked deviation from the reference ranges, with no clear indication to the laboratory that these are expected deviations.

Part III
Delegation

Definitions

14. In this Part,

“delegatee” means a person to whom a controlled act is delegated; (“délégataire”)

“delegator” means a person who delegates a controlled act. (“délégant”)

Limits on delegation

15. A member shall not, except in accordance with this Part, delegate a controlled act or perform a controlled act that was delegated to him or her.

Responsibility

16. (1) A member who delegates a controlled act is responsible for the decision to delegate the controlled act.

(2) A member who performs a controlled act that is delegated to him or her is responsible for the decision to carry out the controlled act and for its performance.

Conditions before delegating

17. (1) A member shall ensure, before delegating any controlled act, that he or she,

(a) has the authority under the Act and its regulations to perform the controlled act himself or herself;

(b) has the knowledge, skill and judgment to perform the controlled act safely and ethically;

(c) has a naturopath-patient relationship with the patient for whom the controlled act will be performed;

(d) has considered whether delegation of the controlled act is appropriate, bearing in mind the best interests and needs of the patient;

(e) after taking reasonable steps, is satisfied that sufficient safeguards and resources are available to the delegatee so that the controlled act may be performed safely and ethically;

(f) has considered whether delegation of the controlled act should be subject to any conditions to ensure that it is performed safely and ethically and has made the delegation subject to conditions, if necessary;

(g) has put in place a communication plan between himself or herself and the delegatee that deals with the appropriate management of any adverse events that may occur as a result of the delegation.

(h) after taking reasonable steps, is satisfied that the delegatee is a person who is permitted to accept the delegation;

(i) after taking reasonable steps, is satisfied that the delegatee is a health care provider who has a professional relationship with the patient, a person in the patient’s household or a person who routinely provides assistance or treatment to the patient; and

(j) after taking reasonable steps, is satisfied,

(i) that the delegatee has the knowledge, skill and judgment to perform the controlled act safely and ethically, where the delegatee is a member of a health profession other than the profession of naturopathy, or

(ii) that the delegation is appropriate for the patient and that the delegatee has the knowledge, skill and judgment to perform the controlled act safely and ethically where the delegatee is not a member of a health profession set out in Schedule 1 to the Regulated Health Professions Act, 1991.

(2) A member shall not delegate a controlled act that was delegated to him or her to perform.

(3) A member who has delegated a controlled act but has reasonable grounds to believe that the delegatee no longer has the ability to perform the controlled act safely and ethically shall immediately cease to delegate the controlled act to that delegatee and shall take measures to ensure that the delegatee ceases to perform any controlled acts previously delegated by the delegator but not yet completed.

How made

18. The delegation of a controlled act may be made orally or in writing.

Records, etc.

19. (1) A member who delegates a controlled act shall,

(a) ensure that a written record of the particulars of the delegation is available in the place where the controlled act is to be performed before it is performed;

(b) ensure that a written record of the particulars of the delegation, or a copy of the record, is placed in the patient’s record at the time the delegation takes place or within a reasonable period of time afterwards; or

(c) record the particulars of the delegation in the patient record either at the time the delegation takes place or within a reasonable period of time afterwards.

(2) A record created under subsection (1) must include a copy of the communication plan required under clause 17 (1) (g).

Accepting delegation, etc.

20. (1) A member shall not accept the delegation of a controlled act unless the person delegating the controlled act was, at the time of the delegation, a member of another health profession set out in Schedule 1 to the Regulated Health Professions Act, 1991 who is authorized to perform that controlled act by a health profession Act governing his or her profession.

(2) A member shall not perform a controlled act that was delegated to him or her by a person to whom the controlled act was delegated.

(3) A member shall only perform a controlled act delegated to him or her if, before performing the controlled act, the member ensures that he or she,

(a) has the knowledge, skill and judgment to perform the controlled act safely and ethically;

(b) has a naturopath-patient relationship with the patient for whom the controlled act is to be performed;

(c) has considered whether performing the controlled act is appropriate, bearing in mind the best interests and needs of the patient;

(d) after taking reasonable steps, is satisfied that there are sufficient safeguards and resources available to ensure that the controlled act can be performed safely and ethically;

(e) has no reason to believe that the delegator is not permitted to delegate that controlled act; and

(f) has ensured that any conditions have been met, if the delegation is subject to any conditions.

(4) A member who performs a controlled act that was delegated to him or her shall record the particulars of the delegation in the patient’s record, unless,

(a) a written record of the particulars of the delegation is available in the place where the controlled act is to be performed;

(b) a written record of the particulars of the delegation, or a copy of the record, is present in the patient’s record; or

(c) the particulars of the delegation have already been recorded in the patient’s record.

Contents of record

21. Any record of the particulars of a delegation must include,

(a) the date of the delegation;

(b) the delegator’s name, if the controlled act was delegated to the member;

(c) the delegatee’s name, if the controlled act was delegated by the member; and

(d) the conditions, if any, applicable to the delegation.

Delegation of communication of diagnosis

22. It is a standard of practice of the profession that a member shall not delegate the controlled act described in paragraph 5 of subsection 4 (1) of the Act.

PART IV
Commencement

Commencement

23. This Regulation comes into force on the later of the day section 6 of the Act comes into force and the day it is filed.

Table 1
prescribed Substances that may be Administered by Inhalation


Substance


Limitations




Acetylcysteine


No limitation specified.




Glutathione


No limitation specified.




Ipratropium Bromide


Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer a maximum daily dose of 0.5 mg but only after the member has administered Salbutamol to the patient.




Salbutamol


Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer a maximum of two doses, each dose 2.5 mg.




Saline


No limitation specified.




Therapeutic Oxygen


No limitation specified.




Table 2
prescribed Substances that may be Administered by Injection


Substance


Route of Administration


Limitation




Acetylcysteine


Intravenous


Must be in combination with other amino acids.




Adenosine triphosphate


Intravenous


No limitation specified.




Alanine


Intravenous


Must be in combination with other amino acids.




Arginine


Intravenous


Must be in combination with other amino acids.




Aspartic Acid


Intravenous


Must be in combination with other amino acids.




Atropine


Intravenous


Administered to a patient by the member in his or her office only in emergency circumstances. In an emergency, administer 0.5-1 mg q3-5 min. Dose must be 0.5 mg or higher but must not exceed 2 mg. 




Biotin


Intravenous


No limitation specified.




Calcium Chloride


Intravenous


No limitation specified.




Calcium Gluconate


Intravenous


No limitation specified.




Calcium Glycerophosphate


Intravenous


No limitation specified.




Carbohydrates in sodium chloride solution


Intravenous


No limitation specified.




Chromium


Intravenous


No limitation specified.




Copper Sulfate


Intravenous


No limitation specified.




Cupric Chloride


Intravenous


No limitation specified.




Dextrose Injection


Intravenous


No limitation specified.




Diphenhydramine Hydrochloride


Intravenous, Intramuscular


Administered to a patient by the member in his or her office only in emergency circumstances with a maximum dose of 100 mg.




Epinephrine Hydrochloride


Intramuscular


Administered to a patient by the member in his or her office only in emergency circumstances with a maximum dose of 1.5 mg.




Ferrous Sulphate


Intramuscular


Must be administered by z-track only.




Folic Acid


Intravenous, Intramuscular


No limitation specified.




Glutamine


Intravenous


Must be in combination with other amino acids.




Glutamic Acid


Intravenous


Must be in combination with other amino acids.




Glycine


Intravenous


Must be in combination with other amino acids.




Glutathione


Intravenous, Intramuscular


No limitation specified.




Histidine


Intravenous


Must be in combination with other amino acids.




Hydrochloric Acid


Intravenous


In ratio of 1:1000 or 1:500.




Isoleucine


Intravenous


Must be in combination with other amino acids.




L-Tryptophan


Intravenous


No limitation specified.




Lactated Ringer’s Solution


Intravenous


No limitation specified.




Leucine


Intravenous


Must be in combination with other amino acids.




Levocarnitine and its salts


Intravenous


No limitation specified.




Lysine


Intravenous


Must be in combination with other amino acids.




Magnesium Sulfate


Intravenous, Intramuscular


Must never be administered by the member for the treatment of eclampsia or pre-eclampsia.




Magnesium Chloride


Intravenous, Intramuscular


Must never be administered by the member for the treatment of eclampsia or pre-eclampsia.




Manganese


Intravenous


No limitation specified.




Methionine


Intravenous


Must be in combination with other amino acids.




Molybdenum


Intravenous


No limitation specified.




Ornithine


Intravenous


Must be in combination with other amino acids.




Phenylalanine


Intravenous


Must be in combination with other amino acids.




Potassium Chloride


Intravenous


In dosage form not more than 0.3 mEq/kg/hr.  Must never be administered as a single agent or by intravenous push.




Potassium Phosphate


Intravenous


In dosage form not more than 0.3 mEq/kg/hr. Must never be administered as a single agent or by intravenous push.




Proline


Intravenous


Must be in combination with other amino acids.




Ringer’s Solution (sodium, chloride, potassium and calcium)


Intravenous


No limitation specified.




Saline Solution


Intravenous, Intramuscular


No limitation specified.




Selenium


Intravenous


No limitation specified.




Serine


Intravenous


Must be in combination with other amino acids.




Sodium Bicarbonate


Intravenous


No limitation specified.




Sodium Iodide


Intravenous


Must be in combination with other minerals.




Sterile Water


Intravenous, Intramuscular


Must be in combination with other substances.




Strontium and its salts


Intravenous


No limitation specified.




Taurine


Intravenous


No limitation specified.




Threonine


Intravenous


Must be in combination with other amino acids.




Vanadium


Intravenous


Must be in combination with other minerals.




Viscum Album


Intravenous, Subcutaneous


No limitation specified.




Vitamin A


Intravenous


Maximum daily dose of 10,000 International Units.




Vitamin B1


Intravenous


No limitation specified.




Vitamin B2


Intravenous


No limitation specified.




Vitamin B3


Intravenous


No limitation specified.




Vitamin B5


Intravenous


No limitation specified.




Vitamin B6


Intravenous


No limitation specified.




Vitamin B12


Intravenous, Intramuscular


No limitation specified.




Vitamin C


Intravenous


Must administer no more than 15 g per day when patient’s G6PD is deficient.




Vitamin D


Intravenous, Intramuscular


No limitation specified.




Vitamin E


Intravenous


No limitation specified.




Vitamin K1


Intramuscular


No limitation specified.




Zinc Chloride


Intravenous


No limitation specified.




Zinc Sulphate


Intravenous


No limitation specified.




Table 3
Drugs that may be Prescribed


Drug


Limitations, routes of administration, dosages




Adenosine triphosphate


Only if prescribed for intravenous injection to be administered by the member in his or her office to the patient.




Calcium Chloride


Only if prescribed in injectable form for intravenous injection to be administered by the member to the patient.




Calcium Gluconate


Only if prescribed in injectable form for intravenous injection to be administered by the member to the patient.




Colchicine


Must not be prescribed unless the drug is botanical colchicine, compounded from the corm of colchicum autumnale.




Dextrose Injection


May only be prescribed when in concentrated solutions for intravenous injection to be administered by the member to the patient.




Digitalis Purpurea and its glycosides


Only if prescribed in conjunction with monitoring of patient’s serum levels by member.




Estrogen (bioidentical)


Only if prescribed in topical or suppository form.




Folic Acid


Only if prescribed in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest recommended daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid.




L-Tryptophan


Only if prescribed for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose.  Recommended daily dose must not exceed 12g and must be provided.
May be prescribed as a single ingredient intended for intravenous injection.




Levocarnitine and its Salts


Only if prescribed for the treatment of primary or secondary levocarnitine deficiency.




Nitroglycerin


Administered to a patient by the member in his or her office only in emergency circumstances and only for angina pectoris. Dosage: 1 to 2 metered doses (0.4 or 0.8 mg nitroglycerin)  administered on or under the tongue, without inhaling. The mouth must be closed immediately after each dose (up to 3 doses in total, at least 5 minutes apart). A sublingual tablet may be used (0.3 or 0.6 mg for initial dose). Maximum dose of 1.8 mg.




Pancreatin


Only if prescribed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pancrelipase


Only if prescribed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pilocarpine and its salts


Must not be prescribed unless, 1. the drug is botanical pilocarpus, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s drug levels during treatment with the drug and, 3. the drug is never prescribed to treat a patient with glaucoma.




Podophyllotoxin


Must not be prescribed unless, 1. the drug is botanical podophyllotoxin compounded from podophyllum peltatum and, 2. the drug is never prescribed to treat a patient with rheumatoid arthritis.




Progesterone (bioidentical form)


Only if prescribed in a topical or suppository form.




Rauwolfia


No limitation, etc., specified.




Thyroid


No limitation, etc., specified.




Vitamin A


Only if prescribed in oral dosage form containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A.




Vitamin D


Only if prescribed in oral dosage containing more than 1,000 International Units of Vitamin D per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1,000 International Units of Vitamin D.




Vitamin K1


Only if prescribed in oral dosage when the maximum daily dose is more than 0.120 mg.




Vitamin K2


Only if prescribed in oral dosage when the maximum daily dose is more than 0.120 mg.




Yohimbine and its salts


Must not be prescribed unless  the drug is botanical yohimbine, compounded from the bark of pausinystalia yohimbine.




Table 4
Drugs That May be Dispensed


Drug


Limitations, routes of administration, dosages




Colchicine


Must not be dispensed unless the drug is botanical colchicine, compounded from the corm of the colchicum autumanle.




Digitalis Purpurea and its glycosides


Only if dispensed in conjunction with monitoring of patient’s serum level by the member.




Estrogen (bioidentical)


Only if dispensed in topical or  suppository form.




Folic Acid


Only if dispensed in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid.




L-Tryptophan


Only if dispensed for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose.  Recommended daily dose must not exceed 12g and must be provided in 3 to 4 equally divided doses.




Levocarnitine and its salts


Only if dispensed for the treatment of primary or secondary levocarnitine deficiency.




Pancreatin


Only if dispensed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pancrelipase


Only if dispensed in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pilocarpine and its salts


Must not be dispensed unless, 1. the dispensed drug botanical pilocarpus compounded  from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s drug levels during treatment with the drug and, 3. the drug is never dispensed to treat a patient with glaucoma.




Podophyllotoxin


Must not be dispensed unless, 1. the dispensed drug is botanical podophyllotoxin compounded from podophyllum peltatum and, 2. the drug is never dispensed to treat a patient with rheumatoid arthritis.




Progesterone (bioidentical form)


Only if dispensed in a topical or suppository form.




Rauwolfia


No limitation, etc., specified.




Thyroid


No limitation, etc., specified.




Vitamin A


Only if dispensed in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A.




Vitamin D


Only if dispensed in oral dosage containing more than 1,000 International Units of Vitamin D per dosage or, where the largest recommended daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1,000 International Units of Vitamin D.




Vitamin K1


Only if dispensed in oral dosage when the maximum daily dose is more than 0.120 mg.




Vitamin K2


Only if dispensed in oral dosage when the maximum daily dose is more than 0.120 mg.




Yohimbine and its salts


Must not be dispensed unless the dispensed drug is botanical yohimbine compounded from the bark of pausinystalia yohimbine.




Table 5
Drugs that may be Compounded


Drug


Limitations, routes of administration, dosages.




Adenosine triphosphate


Only if compounded for intravenous injection.




Colchicine


Must not be compounded unless the drug is botanical colchicine compounded from the corm of colchicum autumnale.




Dextrose Injection


Only if compounded when in concentrated solution for intravenous injection.




Digitalis Purpurea and its glycosides


Only if compounded in conjunction with monitoring of the patient’s serum levels by the member.




Estrogen (bioidentical)


Only if compounded in topical or suppository form.




Folic Acid
 


Only if compounded in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid.




L-Tryptophan


Only if compounded for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose. Recommended daily dose must not exceed 12g and must be provided in 3 to 4 equally divided doses.
May also be compounded as a single ingredient intended for intravenous injection.




Levocarnitine and its Salts


Only if compounded for the treatment of primary or secondary levocarnitine deficiency.




Pancreatin


Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pancrelipase


Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pilocarpine and its salts


Must not be compounded unless, 1. the drug is botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s serum levels during treatment with the drug and, 3. the drug is never compounded to treat a patient with glaucoma.




Podophyllotoxin


Must not be compounded unless, 1. the drug is botanical podophyllotoxin, compounded from podophyllum peltatum and, 2. the drug is never compounded to treat a patient with rheumatoid arthritis.




Progesterone (bioidentical )


Only if compounded in topical or suppository form.




Rauwolfia


No limitation, etc., specified.




Thyroid


No limitation, etc., specified.




Vitamin A


Only if compounded in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A.




Vitamin D


Only if compounded in oral dosage containing more than 1,000 International Units of Vitamin D per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1,000 International Units of Vitamin D.




Vitamin K1


Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg.




Vitamin K2


Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg.




Yohimbine and its salts


Must not be compounded unless the drug is botanical yohimbine, compounded from the bark of pausinystalia yohimbine.




Table 6
Drugs That May be Sold


Drug


Limitations, routes of administration, dosages.




Colchicine


Must not be sold unless the drug is botanical colchicine, compounded from the corm of colchicum autumnale.




Digitalis Purpurea and its glycosides


Only if sold in conjunction with monitoring of the patient’s serum levels by the member.




Estrogen (bioidentical)


Only if sold in topical or suppository form.




Folic Acid


Only if sold in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid.




L-Tryptophan


Only if sold for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose.  Recommended daily dose must not exceed 12g and must be provided in three to four equally divided doses.




Levocarnitine and its Salts


Only if sold for the treatment of primary or secondary levocarnitine deficiency.




Pancreatin


Only if sold in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pancrelipase


Only if sold in a dosage form that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.




Pilocarpine and its salts


Must not be sold unless, 1. the drug is botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s serum levels during treatment with the drug and, 3. the drug is never sold to treat a patient with glaucoma.




Podophyllotoxin


Must not be sold unless, 1. the drug is botanical podophyllotoxin, compounded from podophyllum peltatum and, 2. the drug is never sold to treat a patient with rheumatoid arthritis.




Progesterone (bioidentical form)


Only if sold in topical or suppository form.




Rauwolfia


No limitation, etc., specified.




Thyroid


No limitation, etc., specified.




Vitamin A


Only if sold in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A.




Vitamin D


Only if sold in oral dosage containing more than 1,000 International Units of Vitamin D per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1,000 International Units of Vitamin D.




Vitamin K1


Only if sold in oral dosage where the maximum daily dose is more than 0.120 mg.




Vitamin K2


Only if sold in oral dosage where the maximum daily dose is more than 0.120 mg.




Yohimbine and its salts


Must not be sold unless the drug is botanical yohimbine compounded from the bark of pausinystalia yohimbine.




Made by:
Pris par :

Transitional Council of the College of Naturopaths of Ontario:
Le Conseil transitoire de l’Ordre des naturopathes de l’Ontario :

Tom Ellis

President/président

Andrew Parr

Registrar/registrateur

Date made:May 29, 2015.
Pris le : 29 mai 2015.

 

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