Natural Health Products

1
Natural Health Products

• Natalie Jonasson BSc Phm
• Family Medicine,Elisabeth Bruyère Health Centre

2
Natural Health Products in Canada A history

• Natural health products include
• herbal remedies, homeopathic medicines,
  traditional medicines, vitamins, probiotics etc.
• Subject to the Food and Drugs Act
  (www.napra.org/docs/0/93/144.asp)
• Regulations to ensure quality and safety
  nonexistent or ineffective.

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Drug or Food?

• Could be sold as a drug
• Drug Identification Number (DIN) granted based
  on
• Folklore or anecdotal evidence or
• Premarket assessment for efficacy, labelling, and
  quality.
• Could be sold as a food
• No DIN number
• Intended to be used as drugs.

4
Safety/Quality Concerns

• Consumers may not know
• Proper dose, duration
• Adverse effects
• Contraindications.
• Undeclared ingredients or
• If proper method of preparation used.

5
Todays Situation

• Natural Health Product Directorate
• Natural Health Products Regulations
• Came into force January 2004
• Six year transition period.
• 2 years- site licensing
• 6 years- product licensing (NPN numbers).

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Adverse Reaction Reporting

• Will now be mandatory for industry
• E.g. of safety concerns
• St. Johns wort
• Potent inducer of CYP P450 3A4
• Serotonin reuptake inhibitor
• 45 spontaneous reports between 1998 and 2003.

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Key Points

• Be aware of the adverse reaction (AR) reporting
  system for natural health products
• Report ARs to Health Canada. Forms online, or in
  the CPS.
• Patients may not admit to using natural health
  products. ASK!
• Encourage patients to seek medical advice.

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Useful Websites

• AR reporting Form
• http//www.hc-sc.gc.ca/dhp-mps/medeff/report-decla
  ration/form/index_e.html
• Natural Health Products Directorate
• http//www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
  dgpsa/nhpd-dpsn/index_e.html
• Natural Medicines Comprehensive Database
• http//www.pharmacistsletter.com/(hycbd5r0liilibbt
  lvcqaiig)/home.aspx?li0st0cssND
• MedlinePlus Herbal Medicine
• http//www.nlm.nih.gov/medlineplus/herbalmedicine.
  html