Drugs/Substances and Laboratory Tests – Consultation

Background

The College has been moving forward with the process to identify, research and recommend changes to the schedules of drugs/substances and lab tests that are available to naturopaths in the General Regulation under the Naturopathy Act, 2007 and in the Laboratory Specimen Collection Centre Licensing Act. This work is being led by the Scheduled Substances Review Committee (SSRC) on behalf of the College’s Council. The process involves multiple stages and components that are outlined below.

Feedback can be provided by no later than Sunday, April 7, 2019. 

Process

Last fall, the Council approved a list of “priority 1” drugs/substances and lab tests proposed by the SSRC. At that time, Council also directed the SSRC to conduct additional pharmacological and technical research to confirm evidence that would support the “priority 1” additions. The SSRC had created the proposed lists based on feedback and stakeholder submissions received from its 2017 consultation asking for proposed additions.

The College contracted the Ontario Pharmacists Association’s Drug Information and Resource Centre (DIRC) to conduct an independent review and provide the SSRC with a formal third party analysis and report on the approved list of drugs, substances and tests being proposed.

The DIRC report received by the SSRC reviewed and summarized data pertaining to the efficacy, safety, and dosage/administration of the identified drugs and substances.  The report included the following information, where available, for each drug or substance:

  • efficacy of use in the proposed indications;
  • all potential routes of administration, including information about dosage forms not commercially available in Canada;
  • safety information including contraindications, warnings and precautions as well as black box warnings and recent (within one year) recalls and/or safety alerts;
  • monitoring parameters including measures of efficacy, lab monitoring requirements, and indicators of harm;
  • prescribing restrictions, such as recommended practice setting for administration, or type of practitioner who should prescribe;
  • situations that warrant co-management of the patient with a physician.

The DIRC report on laboratory tests included the following information, where available, for each identified test:

  • clinical indications or applications;
  • assay or analyte properties;
  • reference values and interpretation;
  • alternative or relevant tests; and
  • referred specimen type or collection details.

The SSRC met in the fall of 2018 and reviewed the DIRC reports as well as the original stakeholder submissions received from the public consultation conducted by the College in 2017. (Note: all stakeholder submissions were anonymized to remove any potential conflict of interest). 

Using a decision guidance tree, the SSRC reviewed all priority 1 drugs, substances and laboratory tests and drafted proposed amendments to Tables 2, 3, 4, 5, and 6 of Ontario Regulation 168/15. It also drafted proposed amendments to the Laboratory and Specimen Collection Centre Licensing Act.

On January 31, 2019, the College Council approved these proposed amendments. Because proposed changes to regulations and legislation must be consulted on before they can be sent to the Ministry of Health and Long-Term Care for consideration, the College is launching a new 60-day consultation on the changes.

Summary of Drugs/Substances and Laboratory Tests

The table below summarizes the recommendations being proposed by the SSRC with regards to the 22 drugs and substances authorized by Council for further investigation. The specific changes are attached in the downloads below.

 Drug/Substance  Recommendation
 Alpha Lipoic Acid Add to Table 2 with limitation. 
 B Complex Amend route of administration of Biotin, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, and Vitamin B6 in Table 2 to include intramuscular. 
 Carnitine No change necessary.  Already included on Table 3, 4, 5 & 6.   
 Cortisone Add to Table 3, 4, & 6 in oral form. 
 Dehydroepiandosterone (DHEA) Add to Table 3, 4, 5 & 6 in topical or oral form. 
 Dextrose No change.
Already included on Table 2 for IVIT.  
 Estrogens Remove (bioidentical) and current limitation from Table 3, 4, 5 & 6. 
 Glycyrrhizic Acid No change.
Insufficient information to support amendment.
 
 Hydrocortisone Acetate Add to Table 3, 4, 5 & 6 in topical form. 
 Iron Dextran Add to Table 2 with limitation. 
 Levothyroxine (T4) Add to Table 3, 4, & 6. 
 Liothyronine (T3) Add to Table 3, 4 & 6. 
 Magnesium Sulphate No change.
Already included on Table 2 for IVIT and IM.
 
 Methionine No change.
Already included on Table 2 for IVIT.
insufficient information to support amendment.
 
 NADH 1, 4 – Dihydronicotinamide Adenine Dinucleotide No change.
More information needed.
 
 Oral Micronized Progesterone Remove (bioidentical) and current limitation from Table 3, 4, 5 & 6. 
 Phosphatidylcholine Add to Table 2.  
 Pyridoxine Amend route of administration to include:
intramuscular, subcutaneous.
 
 Silybinin and its salts No change.
Information does not support the addition.
 
 Testosterone Add to Table 3, 4, & 6 in topical form. 
 L-Tyrosine Add to Table 2 with limitation. 
 Vanadium No change.
Already included on Table 2 for IVIT.
insufficient information to support amendment.
 

The following table summarizes the recommendations being proposed by the SSRC with regard to the 37 laboratory tests authorized by Council for further investigation.  The specific changes are attached in downloads below.

 Laboratory tests  Recommendation
 8-OHdG Add Oxidative Stress Analysis.
Ordered test on urine.
 Acrylamide metabolites Add Environmental Pollutants.
Ordered test on urine.
 
 Alkylphenols Add Environmental Pollutants.
Ordered test on urine.
 
 Alpha-Fetoprotein Add Alpha-Fetoprotein.
Ordered test on blood.
 
 Anti-DNase-B Add Anti-DNase-B.
Ordered test on blood.
 
 Anti-Mullerian Hormone No change.
Already have access.
 
 Anti-Phospholipid Antibody Testing Add Anti-Phospholipid Antibody.
Ordered test on blood.
 
 Atrazine Metabolites Add Environmental Pollutants.
Ordered test on urine.
 
 Biological Response to   Mold No change.
Would be addressed by IgE testing and Mycotoxin testing.
 
 Cotinine No change.
Insufficient information to support addition.
 
 Diamin Oxidase Add Diamin Oxidase.
Ordered test on blood.
 
 2,4   Dichlorophenoxyacetic   Acid Add Environmental Pollutants.
Ordered test on urine.

 N,N – Diethyl-Meta-   Toluamide (DEET) Add Environmental Pollutants.
Ordered test on urine.
 
 Environmental Toxicity Panel Add Environmental Pollutants.
Ordered test on urine.
 Genetic Testing – Single Nucleotide Polymorphisms Add Genetic Testing: Single Nucleotide Polymorphisms (SNP).
Ordered test on blood and Saliva.
 Glyphosate and Metabolites Add Environmental Pollutants.
Ordered test on urine.
 HCG – Qualitative and Quantitative Add Human Chorionic Gonadotropin – Qualitative and Quantitative.
Ordered test on blood.
 
 Malondialdehyde (MDA) No change.
Already have access to this test to be performed in office.
 
 Metabolites of Pollutants Add Environmental Pollutants.
Ordered test on urine.
 Methylmalonic Acid (MMA) Add Methylmalonic Acid (MMA)
Ordered test on blood.
 Mycotoxin Testing Add Mycotoxin testing.
Ordered test on urine.
 
 Organophosphates Add Environmental Pollutants.
Ordered test on urine.
 
 Organophosporus Pesticide Dialkyl Add Environmental Pollutants.
Ordered test on urine.
 
 Parabens Add Environmental Pollutants.
Ordered test on urine.
 
 Perchlorate Add Environmental Pollutants.
Ordered test on urine.
 
 Perfluorochemicals Add Environmental Pollutants.
Ordered test on urine.
 Phospholipids A2 Add Lipoprotein Phospholipase A2
ordered test on Blood.
 Polybrominated Diphenyl Ethers Add Environmental Pollutants.
Ordered test on urine.
 Polycyclic Aromatic Hydrocarbons Add Environmental Pollutants.
Ordered test on urine.
 
 Pyrethroids Add Environmental Pollutants.
Ordered test on urine.
 
 Saliva PH No change.
Insufficient information to support amendment.
 Serum Bile Acid Testing Add Serum Bile Acid Testing.
Ordered Test on Blood.
 Sperm DNA Fragmentation Add Semen DNA Fragmentation Analysis.
Ordered test on Tissue/Discharge/Sputum.
 Urine Halides Add Environmental Pollutants.
Ordered test on urine.
 Urine Iodine Amend Toxic Metal testing to: Toxic and Essential Elements.
Ordered test on urine.
 Urine Oxalate Acid Add Oxalate Acid.
Ordered test on urine.
 Urinary Neurotransmitters  Add Neurotransmitter Testing.
Ordered test on Urine.

 

What we want to know:

  • Feedback and recommendations about the proposed changes to the tables of drugs/substances;
  • Feedback and recommendations about the changes to the proposed list of laboratory tests; and
  • any recommendations with regards to limitations or restrictions that should be added.

Have your say

Feedback can be provided in the following ways by no later than Sunday, April 7, 2019:

  1. Email: info@collegeofnaturopaths.on.ca
  2. Mail: College of Naturopaths of Ontario
                attn.: SSRC
                150 John Street, 10th Floor
                Toronto, ON M5V 3E3
  3. Fax: 416-583-6011

All feedback is carefully considered, even that which is not reflected in the College’s final recommendations or documents.

Next steps

The SSRC will review the information submitted, as well as information from conversations with stakeholder groups, and make recommendations to the College Council. If accepted, the College will formally submit the proposed lists to the Ministry of Health and Long-term Care for approval.

Downloads