The Ontario Regulation Flashcards
1
Q
What’s under the Controlled Acts Regulation for NDs?
A
controlled acts of prescribing, dispensing, compounding and selling drugs, and administering drugs by injection or inhalation
2
Q
Which NDs in Ontario can provide a patient a prescription for any of the drugs listed in Table 3 to the Controlled Acts Regulation?
A
NDs in Ontario who has met the Standard of Practice for Prescribing
3
Q
Where patients can “access” the drugs prescribed by an ND?
A
Either through a pharmacy or through the ND’s dispensary.
4
Q
In some limited cases, a ND may write a prescription for a drug in order to be able to obtain that drug for…
A
..resale from their dispensary, or in-office administration (i.e. emergency drugs).
5
Q
Where a drug is not listed in Table 3 to the Regulation, e.g. Ativan…
A
…it is because NDs are not authorized to prescribe that drug to patients.
6
Q
Where a substance is not listed in Table 3, e.g. Vitamin C, it is because…
A
…it is a natural health product, and is available without a prescription.
7
Q
Where a patient is expected to take a substance (i.e. as part of their treatment plan) which is not listed in Table 3 due to it being a natural health product (NHP), a prescription is not required. In this instance, the ND is…
A
…“recommending” the substance as opposed to prescribing it.
8
Q
Who’s responsibility is it to know when a prescription is required?
A
The ND’s responsibility
9
Q
Section 9(2) of the Controlled Acts Regulation outlines the standard of practice that applies when a ND is going to prescribe a drug on Table 3. These general requirements include, but are not limited to:
A
- the ND must have a naturopath-patient relationship with the individual receiving the prescription;
- the drug must be prescribed for therapeutic purposes only;
- the ND must notify the other primary health care providers of the prescription unless the patient does not consent to the notification.
10
Q
Another relevant standard appears in section 9(3) of the Regulation. This standard details the information that must appear on the prescription and includes:
A
- Name and address of the patient;
- Name, strength and quantity of the drug prescribed;
- Directions for use, etc.
11
Q
Section 9(4) of the Controlled Acts Regulation outlines the record keeping requirements for a member who is writing a prescription for a patient. T/F
A
True
12
Q
NDs who intend to prescribe the drugs on Table 3 are required to review, be familiar with and operate within these sections of the Regulation. T/F
A
True
13
Q
T/F Table 3 lists the drugs a ND can prescribe and the specifics around drug limitations, routes of administration and dosages.
A
True
14
Q
The “limitations, routes of administration and dosages” will provide NDs with:
A
- Information about limits on the amount of the drug that can be prescribed; or
- Circumstances about when a substance is considered a drug (i.e. due to route of administration, specific treatment indication or dosage amount).
15
Q
Podophyllum is a drug on Table 3, and in order to prescribe it to a patient, a prescription is always necessary. Why the table doesn’t include limitations for it?
A
There are no limitations on the dosage so dosage amounts are left to the knowledge, skill and judgment of the member.
16
Q
Digitalis purpurea (and its glycosides) is also a drug on Table 3, also requires a prescription whenever it is being prescribed to a patient but also carries a limitation. What is this limitation?
A
that a ND ‘must monitor the patient’s serum level.’ If a member will not or cannot monitor the serum levels, they may not prescribe this drug.
17
Q
Give two examples of where the limitations outline when a substance becomes a drug due to dosage amounts.
A
Folic Acid
Vitamin A
18
Q
What are amounts of Folic Acid to require or don’t a prescription?
A
under 1 mg per dose or where the total dosage per day is less that 1 mg is not a drug and does not require a prescription. The moment the ND increases the dosage or daily dosage above 1 mg, Folic Acid becomes a drug and a prescription is required.
19
Q
What are amounts of Vitamin A to require a prescription?
A
a dosage or daily dosage of 10,000 IU.
20
Q
A patient consults with a Naturopathic Doctor and is determined through blood laboratory testing to be Vitamin D deficient.
A
To correct this deficiency, a dosage of Vitamin D that is greater than 1000 IU is required. The ND therefore must write a prescription for the patient and inform them that the prescription may be filled at a pharmacy, or via the ND’s dispensary (if available ). The appropriate guidelines for prescription sales are outlined in Section 12 of the Controlled Acts Regulation.
21
Q
A patient arrives after lunch at their Naturopath’s office and begins to experience chest pain. Although the patient experiences angina regularly, they have forgotten to bring along their nitroglycerine patches.
A
The Naturopathic Doctor may prescribe sublingual doses of nitroglycerine to the patient in order to administer it from their emergency kit if needed. However, the ND cannot dispense more for the patient to take home after the conclusion of the patient visit. If the Naturopathic Doctor did not meet the Standard of Practice for Prescribing, the appropriate measure would be to call for emergency assistance by dialing 911. A call to emergency services would be appropriate in either case if the symptoms did not alleviate.
22
Q
A patient arrives after lunch at their Naturopath’s office and begins to experience chest pain. Although the patient experiences angina regularly, they have forgotten to bring along their nitroglycerine patches.
A
The Naturopathic Doctor may prescribe sublingual doses of nitroglycerine to the patient in order to administer it from their emergency kit if needed. However, the ND cannot dispense more for the patient to take home after the conclusion of the patient visit. If the Naturopathic Doctor did not meet the Standard of Practice for Prescribing, the appropriate measure would be to call for emergency assistance by dialing 911. A call to emergency services would be appropriate in either case if the symptoms did not alleviate.
23
Q
A post menopausal patient attends your clinic, and with recent testing has been diagnosed with osteoporosis. Alongside her pharmaceutical prescription, you prescribe 120mcg of Vitamin K2. She is unwilling to stop taking her self-prescribed multivitamin and calcium supplement that contain 40mg of Vitamin K2.
A
In this scenario, as the prescribing Naturopathic Doctor you must have met the Standard of Practice for Prescribing to prescribe the Vitamin K2, and are also required, with the patient’s consent, to notify the patient’s other primary health care provider(s) of the prescription.
24
Q
What is dispensing?
A
Dispensing is a controlled act when a ND dispenses a drug that is listed in Table 4 of the Controlled Acts Regulation.
25
Where a drug is not listed in Table 4 to the Regulation, e.g. Ativan, it is because...
...NDs are not authorized to dispense that drug to patients.
26
Where a substance is not listed in Table 4, e.g. Vitamin C, it is because...
...it is a natural health product that is available without a prescription. In such instances a ND may provide that substance to his/her patient, but are not legally dispensing it.
27
The Controlled Acts Regulation makes an important distinction between “dispensing” and “administering” a drug. What is this distinction?
Dispensing is handing out of a drug.
Administering a drug, which is not handed out per se but is given to a patient in-office by inhalation or injection.
28
There are a number of relevant standards of practice in the Controlled Acts Regulation that pertain to the controlled act of dispensing.
Section 10(2) of the Regulation establishes the primary standards of practice that a member must follow when dispensing.
29
Section 10(2) of the Regulation establishes the primary standards of practice that a member must follow when dispensing. These include but are not limited to:
* Unless the exception outlined in subsection 10(3) applies, the ND must have a patient-ND relationship with the person to whom they are dispensing the drug;
* The drug must be dispensed for therapeutic purposes;
* The ND must advise the patient or their authorized representative that the drug may be available in a pharmacy;
* The ND must comply with any of the limitations, route of administration or dosage information that appears in Table 4.
30
Standards of practice relating to labeling of a dispensed drug appear under paragraph 11 of section 10(2) of the Regulation, and include:
* The NDs name and title;
* The name, address and telephone number of the place from which the drug is dispensed;
* The identification of the drug, its name, strength and manufacturer;
* The quantity of the drug, etc.
* NDs who intend to dispense the drugs on Table 4 are required to review, be familiar with and operate within these sections of the Regulation.
31
Subsection 10(3) is unique to the naturopathic profession. It allows a ND to dispense a drug to a person who is NOT a patient, provided certain conditions apply. Those conditions are:
* The ND has the prescription for the drug in their possession;
* The prescription is from another ND (and not from any other regulated health professional);
* The prescription contains all of the necessary information required under the prescribing provisions of the Regulation;
* The ND retains a copy of the prescription in their records.
32
NDs are not allowed to dispense a drug to a person who is NOT a patient.
False, It allows a ND to dispense a drug to a person who is NOT a patient, provided certain conditions apply.
33
Which table lists the drugs a ND can dispense and the limitations, routes of administration and dosages that apply?
Table 4
34
The “Limitations, routes of administration and dosages” will provide NDs with:
- Information about limits on the amount of a drug that can be dispensed;
- Information about a substance being a drug only when dispensed over certain dosages, or;
- Circumstances about when a substance being dispensed is considered a drug.
35
Why are there several substances that appear on Table 3 (Prescribing) that do not appear on Table 4 (Dispensing)?
Table 4 is very similar to Table 3, however, there are several substances that appear on Table 3 (Prescribing) that do not appear on Table 4 (Dispensing) because they allow a ND to access the drug for use but do not allow the ND to dispense the drug.
36
Why would calcium gluconate won't appear in Table 4?
Calcium gluconate must be prescribed if being administered in an injectable form however, as it is being administered in office by the ND, the substance would not be dispensed and therefore does not appear on Table 4.
37
Following a patient check-up, you determine that your patient requires 10,000 IU of Vitamin D and 175 mg of Vitamin K2, both of which need to be prescribed.
You inform the patient that they may have the prescription filled at your clinic dispensary or at a local pharmacy. The patient opts to purchase the prescriptions from you. In dispensing these two substances you ensure that the product labels contain all of the dispensing information requirements outlined in Section 10 (2) of the Controlled Acts Regulation, a copy of this information is put into the patient’s file, and that the dosage instructions are reviewed with the patient.
38
A patient of another ND is on vacation in your city, and forgot to bring her Bio-Identical Estrogen and Progesterone creams with her. The patient inquires whether it is possible to purchase a re-fill from your office for her month away from home.
As the dispensing ND, you would be expected to contact the patient’s primary ND and obtain a new prescription for the patient. Once obtained, you would then be able to dispense the required prescription from your office, making sure that all required labeling information is included and that a copy of this information is retained on file at your office.
39
What is Selling a Drug?
Selling a drug is a controlled act when a ND sells a drug that is listed in Table 6 of the Controlled Acts Regulation.
40
Where a drug is not listed in Table 6 to the Regulation, e.g. Ativan, it is because...
...NDs are not authorized to sell that drug to patients.
41
Where a substance, is not listed in Table 6, e.g. Vitamin C, it is because...
...it is a natural health product that is available without a prescription and an ND may provide that substance to his/her patient. While a patient may purchase a publicly available product/NHP from a ND, the controlled act of selling a drug applies only to the substances listed on Table 6.
42
There are a number of relevant standards of practice in the Controlled Acts Regulation that pertain to the controlled act of selling a drug.
* The standards of practice for selling a drug may be found in Section 12(2) of the Regulation.
Examples of the standards include:
- Unless subsection 12(3) applies, a ND must have a patient-ND relationship with the person for whom the drug is sold and must only sell a drug to the patient or their authorized representative;
- The drug must be sold only for therapeutic purposes;
- The drug must be sold in accordance with any limitations set out in table 6;
- The ND must not sell the drug for a profit or where they receive a direct or indirect personal or financial benefit.
NDs who intend to sell the drugs on Table 6 are required to review, be familiar with and operate within these sections of the Regulation.
43
Subsection 12(3) is unique to the Naturopathic Profession. It allows a ND to sell a drug to a person who is NOT a patient provided certain conditions apply. Those conditions are:
- The ND has the prescription for the drug in their possession;
- The prescription is from another ND (and not from any other regulated health professional);
- The prescription contains all of the necessary information required under the prescribing provisions of the Regulation;
- The ND retains a copy of the prescription in their records.
44
Table 6 lists the drugs a ND can sell and the limitations, routes of administration and dosages that apply.
The “Limitations, routes of administration and dosages” will provide NDs with:
- Information about limits on the amount of drug that can be sold;
- Information about a substance being a drug only when sold over certain dosages; or
- Circumstances about when a substance being sold is a drug.
45
Why are there several substances that appear on Table 3 (Prescribing) that do not appear on Table 6 (Selling)?
Table 6 is very similar to Table 3, however, there are several substances that appear on Table 3 (Prescribing) that do not appear on Table 6 (Selling). For example, in an emergency, a ND may prescribe nitroglycerin; however, because the circumstances are emergency, a member may not “sell” this drug.
46
If a patient requires a take home quantity for Nitroglycerine or salbutamol, what should the ND do?
Nitroglycerine and salbutamol, these substances are within the scope of a ND (who has met the Standard of Practice for Prescribing) to use with their patients in an emergency situation in clinic; they may not be sold to patients. A patient requiring a take home quantity would require a referral to a Medical Doctor for a prescription or a prescription refill.
47
Why nitroglycerin is in Table 3 (drugs that may be prescribed) but not Table 4 (drugs that may be dispensed), Table 5 (drugs that may be compounded), or Table 6 (drugs that may be sold)?
Nitroglycerin is allowed for emergency use only, and is on the Table 3 (drugs that may be prescribed) to allow a ND to purchase it from a Pharmacist for in-office use, and to keep as part of their clinic crash cart. It is not on Table 4 (drugs that may be dispensed), as a ND cannot dispense the drug to a patient to take home. It is not on Table 5 (drugs that may be compounded) as it may not be compounded by the ND. It is not on Table 6 (drugs that may be sold), as even when given in an emergency situation, it is not expected that the ND would charge a fee for providing it to their patient.
48
A patient is diagnosed with a Vitamin D deficiency, and is prescribed a dose of 10,000 IU QD for 1 month by the ND.
The ND may dispense and sell Vitamin D, or refer the patient to a local pharmacy to have the prescription filled, depending on the patient’s preference. If the prescribed Vitamin D is sold to the patient from the ND’s dispensary it is expected that the ND charges the patient only the cost of the drug. The ND may not sell a drug if the selling provides a profit.
49
What is Compounding a Drug?
Compounding a drug is a controlled act when a ND reconstitutes, dilutes, mixes, prepares or labels two or more drugs listed in Table 5 of the Controlled Acts Regulation to create a customized therapeutic product for the patient.
50
Where a drug is not listed in Table 5 to the Regulation, e.g. Ativan, it is because...
...NDs are not authorized to compound that drug for patients.
51
Where a substance is not listed in Table 5, e.g. Vitamin C, it is because...
...it is a natural health product that is available without a prescription and a ND may reconstitute, dilute, mix, prepare or label one or more of these substances without the process being considered a controlled act; however, the ND must still comply with the Colleges standard of practice for compounding (e.g. labeling requirements).
52
An ND compounds in a number of circumstances, including:
- Compounding drugs for the purposes of prescribing, dispensing and selling the customized therapeutic product (e.g. a mixed botanical tincture);
- Compounding drugs for the purposes of administering the customized therapeutic product to a patient by inhalation (e.g. 0.9% saline and glutathione compounded for nebulizing);
- Compounding drugs for the purposes of administering the customized therapeutic product to a patient by injection (e.g. Vitamin B12 and Folic Acid IM injection);
- Compounding drugs for the purposes of administering the customized therapeutic product to a patient by intravenous infusion therapy (IVIT) (e.g. multi vitamin and mineral nutritional IV tx).
53
The premises where a ND compounds for IVIT is subject to inspection, under the Colleges Inspection Program (Regulation pending). T/F
True
54
T/F Whenever a drug is reconstituted, diluted, mixed with another drug or substances, it is compounding. For example, a ND who mixes a drug (e.g. dextrose) with saline solution for the purposes of IVIT, he/she is compounding under the Controlled Acts Regulation.
True
55
Section 11(2) of the Controlled Acts Regulation establishes the standards of practice for compounding, which include, but are not limited to the following:
- The ND must have a patient-ND relationship with the person for whom the drug is compounded;
- The ND must have the knowledge, skill and judgment to compound the drug safely, competently, and ethically;
- The ND must compound the drug in accordance with any limitations that appear in Table 5;
56
The ND may only compound a drug when...
...a supply of a Health Canada approved, commercially available prepared product that meets the patient’s needs is not reasonably available.
57
Paragraph 12 of section 11(2) outlines the standards of practice for labeling a compounded drug. These requirements include, among other requirements:
- The NDs name and title;
- The name, address, and telephone number of the location where the drug was compounded;
- The percentage of each of the drugs or substances and other ingredients used to make the compounded product and the quantity of the compounding product in the container.
58
T/F NDs who intend to compound the drugs on Table 5 need to review, be familiar with and operate within these sections of the Regulation, as well as the College’s standards of practice for compounding if intending to mix natural health products.
True
59
Table 5 lists the drugs a ND can compound and the limitations, routes of administration and dosages that apply.
The “Limitations, routes of administration and dosages” will provide NDs with:
- Information about limits on the amount of drug that can be compounded;
- Information about a substance being a drug only when compounded over a certain dosage, or;
- Circumstances about when a substance being compounded is a drug.
60
T/F Table 5 is very disimilar to Tables 3, 4, and 6.
False. Table 5 is very similar to Tables 3, 4, and 6.
61
Adenosine triphosphate is considered a drug if...
...being compounded for IVIT. If the substance was being mixed for oral use, the controlled act of compounding would not apply however, the College’s standards of practice for compounding would still need to be adhered to.
62
Rauwolfia may be compounded with other herbs to be prescribed and sold to a patient for oral use; however, it cannot be compounded for...
...either inhalation or injection therapies as it does not appear on Tables 1 or 2.
63
A patient arrives for a follow-up visit with her ND to assess the effect of the cardiovascular tincture provided to her at a previous visit. After a consult and physical exam, the ND decides that Rauwolfia would be a beneficial addition to the patient’s tincture (originally within the general scope of naturopathic medicine).
Initially, the tincture was a combination of botanicals that are within the general scope of Naturopathic medicine, but with the addition of Rauwolfia, the practitioner must have met the Standard of Practice for Prescribing to be able to prescribe this botanical, as it is classified as a drug. The patient also must continue to be monitored and assessed for response to treatment (both for positive and any adverse affect).
64
What is Administering a Drug by Inhalation?
Although the RHPA includes a controlled act of administering a substance by inhalation, the Act itself does not define what that is.
65
Who has the role of interpreting what constitutes inhalation?
The various health regulatory Colleges whose members are authorized to perform this controlled act.
66
What's The College of Naturopaths of Ontario interpretation of inhalation?
The CONO has interpreted this controlled act in the case of naturopathic practice to mean the administration of a substance using a mask, nasal cannula or aerosol inhaler.
67
Is any substance that a patient breathes in by any other means than using a mask, nasal cannula or aerosol inhaler considered inhalation by CONO?
No, is not interpreted by the College to mean the controlled act of administering by inhalation, e.g. breathing in essential oils.
68
What substances can an ND administer through inhalation?
An ND may administer by inhalation, that is, by means of a mask, nasal cannula or aerosol inhaler, only those substances listed in Table 1 of the Controlled Acts Regulation.
69
Section 5(2) of the Controlled Acts Regulation sets out the standards of practice for administration of a substance by both inhalation and injection. What notes say about an ND who mixes, prepares, packages or labels two or more substances in Tables 1 or 2 for the purposes of administering a customized therapeutic product?
It notes that if a ND mixes, prepares, packages or labels two or more substances in Tables 1 or 2 for the purposes of administering a customized therapeutic product, they do so in compliance with all of the standards for compounding as set out in the Regulation.
70
The standards of practice set out in Section 3(1) of the Regulation apply to this controlled act. These general requirements include but are not limited to:
- The ND having a patient-ND relationship and having recorded the patient’s health history;
- Informing the patient before performing the controlled act of the purpose of the controlled act, the risks inherent in its performance and alternative treatments the ND knows or ought to know are available;
- Receiving informed consent;
- Ensuring that appropriate infection control procedures are in place and that the controlled act is performed in a clean, safe, private and comfortable environment.
* NDs who intend to administer a prescribed substance by inhalation from Table 1 need to review, be familiar with and operate within these sections of the Regulation.
71
T/F Tables 1 and 2 are significantly different than Tables 3, 4, 5 and 6.
True. Where Tables 3 through 6 inclusively list the “drugs” that may be prescribed, dispensed, compounded or sold, Tables 1 and 2 are the ”Prescribed Substances” that may be administered by Inhalation and Injection.
* In simple terms, this distinction means that a ND can only administer by inhalation, a substance listed on Table 1.
72
What are the 5 substances listed on Table 1?
Table 1 lists only 5 substances:
- two of which are for use in an emergency situation only (Ipratropium bromide, Salbutamol);
- therapeutic oxygen;
- saline (usually when compounded with another substance for administration by inhalation);
- Acetylcysteine and glutathione.
* No other substances may be administered by inhalation.
* It is important to note that therapeutic oxygen does not appear on Table 3 (Drugs that may be Prescribed). Therefore, while a ND may administer it in office, they may not provide a patient with a prescription for the use of oxygen in their home.
73
A patient presents at your office with a chronic chest infection and difficulty expectorating mucous. The patient has been prescribed an antibiotic and after examining him you decide to recommend that he undergo a few nebulized glutathione treatments to support his lungs and facilitate mucous clearance. The patient inquires if it would also be ok to steam vaporize some eucalyptus essential oil when he returns home from your office.
You confirm it would be fine to use eucalyptus EO at home. The recommendation to a patient to access nebulized glutathione can be made by any actively practicing registered Naturopathic Doctor however, administering the glutathione treatment is restricted to NDs who have met the Standard of Practice for Prescribing. The recommendation to vaporize essential oils does not fall within the controlled act of administering by inhalation and does not require the ND to have met the Standard of Practice for Prescribing.
74
What is Administering by Injection?
Administration of a substance by injection is the controlled act of injecting a substance by an intramuscular injection (IM), subcutaneous injection (Sub-Q), or by intravenous infusion (IV).
75
What substances can an ND inject?
A ND may only inject a substance that is listed on Table 2 of the Controlled Acts Regulation, subject to the route of administration and any limitations outlined on the table.
* For example, Sodium Iodide may only be administered by intravenous infusion and in combination with other minerals.
76
Under Canadian and Ontario law, when an injected substance becomes a drug?
once a substance is administered below the dermis, it becomes a drug (e.g. saline solution once injected is a drug and as a result has been listed on Table 2).
77
Section 5(2) of the Controlled Acts Regulation sets out the standards of practice for administration of a substance by both inhalation and injection. It notes that if a ND mixes, prepares, packages or labels two or more substances in Tables 1 or 2 for the purposes of administering a customized therapeutic product, they do so in compliance with all of the standards for compounding as set out in the Regulation.
The standards of practice set out in Section 3(1) of the Regulation apply to this controlled act. These general requirements include but are not limited to:
* The ND having a patient-ND relationship and having recorded the patient’s health history;
* Informing the patient before performing the controlled act of the purpose of the controlled act, the risks inherent in its performance and alternative treatments the ND knows or ought to know are available;
* Receiving informed consent;
* Ensuring that appropriate infection control procedures are in place and that the controlled act is performed in a clean, safe, private and comfortable environment.
NDs who intend to administer a substance by injection (Table 2) need to review, be familiar with and operate within these sections of the Regulation. In addition to the Standard of Practice for Prescribing, NDs who wish to administer a substance intravenously must also meet the Standard of Practice for Intravenous Infusion Therapy (IVIT).
78
A Naturopathic Doctor consults with a patient who has been recently diagnosed with Celiac disease. He has also been found to be deficient in Vitamin B12 by his Medical Doctor, and was referred to the ND for assistance.
The ND explains to the patient that his best option for quick repletion would be an IM injection of Vitamin B12, but as the ND has not met the Standard of Practice for Prescribing, she is unable to administer IM injections. The ND makes a referral to a naturopathic colleague who has met the Standard of Practice for prescribing to administer the Vitamin B12 IM injection, and makes a recommendation to the patient to take a sublingual Vitamin B12 lozenge in the interim. The patient is also scheduled to re-test their Vitamin B12 blood levels in 2 months.
79
T/F Similar to Table 1, Table 2 prescribes the substances that a ND may administer by Injection, including by IVIT. If the substance a ND wishes to inject is on the list, then the ND may not inject that substance.
False
80
What's on Table 2?
Table 2 lists the substances that a ND can inject, the route of administration and the limitations and dosages that apply.
81
The “Limitations, routes of administration and dosages” will provide NDs with:
- Information about the route or routes of administration by which the substance may be injected;
- Information about limits on the amount of drug that can be injected;
- Information about combinations of substances that may be necessary.
Some minerals such as vanadium must only be administered with other minerals and not as a singular vitamin. The dosage amounts however are left up to the knowledge, skill and judgment of the ND.
Other limitations include:
- Specifics regarding technique, e.g. Ferrous sulphate must be administered by Z track only.
- Specifics regarding indication for use, e.g. emergency only substances.
Please refer to Table 2 of the Controlled Acts Regulation for the limitations and specifics with respect to prescribed substances that may be administered by injection.
82
A long standing hypertensive patient returns to your office for assistance as he has recently experienced a small elevation in his blood pressure. His cardiologist has recommended supportive treatment, but the patient has requested to consult with you for a second opinion. His blood pressure elevation is mild, and he is in robust health.
Since his blood pressure elevation is mild, and he is in robust health, you make a suggestion that he have a series of nutritional IVs to replete some vitamins and minerals known to support optimal heart function, and then re-assess his blood pressure. The patient consents to the treatment and to having you notify his cardiologist of the treatment plan, which you do, advising the cardiologist that you will follow-up with a treatment update in an appropriate length of time. Alongside potassium chloride and magnesium sulphate, you also administer an amino acid combination containing Taurine. As amino acids being administered by injection carry a limitation that they “must be in combination with other amino acids” Taurine cannot be administered as a singular amino acid. If the patient did not respond to treatment within a reasonable amount of time, a referral back to their cardiologist would be an appropriate course of action.
83
What is a Natural Health Product and When Might it be a Drug?
The Natural Health Products (NHP) Regulation and the Schedule 1 attached to it identify that a natural health product (NHP) substance is:
- A plant or plant material, an alga, a bacterium, a fungus or a non-human animal material;
- Any extract or isolate of the substances identified in the preceding bullet point;
- Any of vitamins biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, A, B6, B12, C, D, E, K1, K2;
- An amino acid;
- An essential fatty acid;
- A synthetic duplicate of a substance in bullets 2 to 5;
- A mineral;
- A probiotic.
Typically, a NHP is not considered a drug; however, there are certain unique circumstances when a NHP becomes a drug, including but not necessarily limited to:
- When the NHP is injected below the dermis (e.g. vitamin B12 injection);
- When the NHP is listed on the Prescription Drug List from Health Canada (e.g. Vitamin A > 10,000 IUs);
- When the NHP is a controlled drug or substance under the Controlled Drugs and Substances
Act (e.g. homeopathic cannabis);
- When the NHP is designed in the regulations made under the Drugs and Pharmacies
Regulation Act as a drug.
For NDs, it may not always be safe to assume that because a product is a natural health product it is available for recommendation to patients; a ND must be certain that the product has not been designated as a drug under statute and if it is, that it is authorized for use under the Controlled Acts Regulation.
84
A ND in Ontario who has met the Standard of Practice for Prescribing, can prescribe 100 mg L-Tryptophan. (T/F)
False. Only L-tryptophan >220mg per dose and at a max of 12g per day is considered a drug and can be “prescribed”. Lower doses are being “recommended” not prescribed.
85
A ND in Ontario who has met the Standard of Practice for Prescribing, can prescribe 5000 mg of Vit C. (T/F)
False. Vitamin C is a substance and not a drug thus available without a prescription
86
A prescription of 5.0 mg of folic acid requires the passing of the prescribing exam in order to prescribe it to a patient. (T/F)
T. >1.0mg is a drug
87
An Ontario ND who passed the prescribing exam is able to dispense nigroglycerine to a patient with angina pectoris. (T/F)
F. Nitroglycerine is prescribed thus administered only in emergency circumstanced for angina pectoris.
88
All of the following must be true when prescribing drug, EXCEPT:
a. The ND must have a naturopath-patient relationship with the individual receiving the prescription
b. The drug must be prescribed for therapeutic purposes only
c. The ND must notify the other primary health care provider of the prescription even if the patient does not consent
C. unless the patient does not consent to the notification
89
The follow is required on the prescription EXCEPT:
a. Name and address of the Patient
b. Date of the prescription
c. Name of the other primary health provider
d. Name and strength and quantity of the drug
e. Directions for use
C
90
You determine that your patient’s B12 levels are low (blood test). You prescribe 5000 ug of sublingual methylcobalamine per day and let the patient know that they can get it at the pharmacy or your dispensary. (T/F)
F. B12 that is not injected is not a drug, thus it is not a prescription. You can just recommend it.
91
Your patient is having an angina attack marked by chest pain. You dispense sublingual nitroglycerine to the patient because you passed the prescribing exam.
F. Dispensing means the patient takes the drug home. This cannot be done with nitro. You prescribe nitro in order to administer it in office.
92
You determine that your patient has low vit D in their blood. They are taking fish oil that has 1000 IU of vit D in it already and because you didn’t pass the prescribing exam, you just recommend 1000 IU of vit D3/day. (Good or Bad?)
Bad. The total dose is more than 1000 IU of Vit D per day and thus it becomes a drug and you must have passed the prescribing exam to prescribe it.
93
A doc that can prescribe, can prescribe oral bio-identical progesterone for their post menopausal patient. (T/F)
F. only topical or suppository
94
You are legally a prescribing ND, and your patient has rheumatoid arthritis. You decide to prescribe podophyllotoxin because you can. (Good or Bad)
Bad. It cannot be prescribed for RA. (??)
95
You can only prescribe digitalis if you are able to monitor their serum levels. (T/F)
T. I guess you are measuring digoxin in the blood???
96
You passed the prescribing exam and are stocking most of your “drugs”. A person comes into your office and was given a prescription from their physiotherapist that they need 120 mcg of vit K2. You happily sell them Vit K2. (Good or Bad)
Technically at that dose vit K2 is not a drug however, they are not a patient of yours and your dispensary is not a health food store so you should reject them due to liability.
97
All of the following are true with regards to dispensing a drug to a non-patient, EXCEPT:
a. The ND has the prescription for the drug in their possession
b. The prescription is from another a medical doctor
c. The prescription contains all of the necessary information required under the prescribing provisions of the Regulation
d. The ND retains a copy of the prescription in their records
B. prescription can only be from another ND
98
You passed the prescribing exam and are stocking most of your “drugs”. Your patient comes into your office and was given a prescription from their medical doctor for 5.0 mg of folic acid. What do you do?
Yes, they are your patient, but you cannot accept prescriptions from other regulated professions (NDs only) and so you tell them to book a visit with you.
99
When you dispense a drug, you include the prescription that outlines how to take the drug and you make sure your patient understand how to take it. (T/F)
F. this is incomplete. The drug itself has to be labeled and contain:
- NDs name and title
- name, address and phone number of the place the drug is dispensed from
And of course what should already be on the bottle: manufacturer, name, strength quantity
100
Drugs that an ND can both prescribe and sell include all of the follow EXCEPT (more than one):
a. Vit A above 10,000 IU
b. Nitroglycerine
c. Vit D above 1000 IU
d. Calcium chloride
e. Bioidentical progesterone
f. Vitamin K2 120 mcg
g. Salbutamol
B – only administered in emergency situations
D – only injected thus not sold
F – at this dose not a drug
G- administered in emerg situation only
101
In an emergency situation, you prescribe sublingual nitroglycerine. When they feel better you charge them for it. (Good or Bad)
Bad. You cannot charge them for it.
102
When selling a drug all of the following apply except:
a. Only sell a drug to a patient or their authorized representative
b. Drug sold is for therapeutic purpose
c. Drug sold will have a mark-up
d. Drug sold is in accordance with any limitations
e. Drug can be sold for a non-patient as long as they have a prescription from their naturopath
C. the ND must not sell the drug for a profit or where they receive a direct or indirect personal or financial benefit.
103
You have a patient with dry mouth and glaucoma and you prescribe botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus. (Good or Bad)
Bad. Even though pilocarpine is good for glaucoma, we can’t prescribe it to patients with glaucoma.
104
Whenever a drug is reconstituted, diluted, mixed with another drug or substance, it is compounding. (T or F)
True
105
Of the following substances to be administered via inhalation, which are only administered in an emergency?
Ipratropium bromide and salbutamol
106
The controlled act of inhalation means a drug is breathed in through the air (T or F)
F. it means the administration of a substance using a mask, nasal cannula or aerosol inhaler. Any substance that a patient breathes in by any other means is not interpreted by the College to mean a controlled act of administration by inhalation (ie breathing in essential oils)
107
An ND can administer via inhalation through a nasal cannula essential oils. (T or F)
F. only substances in Table 1 of the Controlled Acts may be administered by inhalation with a mask, nasal cannula or aerosol inhaler.
108
You didn’t pass the prescribing exam but you have a patient that would really benefit from nebulized glutathione. You thus recommend your patient to get that treatment from a colleague who does them and has passed the exam. (Good or Bad)
Good. Even if you don’t pass the exam you can recommend nebulized glutathione, you just can’t administer it yourself.
109
All of the following substances must be given via IV only and must be combined with another amino acid, EXCEPT:
a. Glutamine
b. Sterile water
c. Phenylalanine
d. Molybdenum
e. Methionine
D
110
Homeopathic cannabis is a controlled drug or substance under the Controlled Drugs and Substances Act. Thus you need to pass this exam to prescribe it!
True
