Transcript Document
Natural Health Products
Natalie Jonasson BSc Phm
Family Medicine,
Elisabeth Bruyère Health Centre
7/16/2015
1
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.
7/16/2015
2
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:
7/16/2015
No DIN number
Intended to be used as drugs.
3
Safety/Quality Concerns
Consumers may not know:
7/16/2015
Proper dose, duration;
Adverse effects;
Contraindications.
Undeclared ingredients; or
If proper method of preparation used.
4
Today’s Situation
Natural Health Product Directorate:
Natural Health Products Regulations
Came into force January 2004
Six year transition period.
7/16/2015
2 years- site licensing
6 years- product licensing (NPN numbers).
5
Adverse Reaction Reporting
Will now be mandatory for industry
E.g. of safety concerns:
St. John’s wort
7/16/2015
Potent inducer of CYP P450 3A4
Serotonin reuptake inhibitor
45 spontaneous reports between 1998 and 2003.
6
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.
7/16/2015
7
Useful Websites
AR reporting Form
Natural Health Products Directorate
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfbdgpsa/nhpd-dpsn/index_e.html
Natural Medicines Comprehensive Database
http://www.hc-sc.gc.ca/dhp-mps/medeff/reportdeclaration/form/index_e.html
http://www.pharmacistsletter.com/(hycbd5r0liilibbtlvcqaiig)/home.
aspx?li=0&st=0&cs=&s=ND
MedlinePlus: Herbal Medicine
7/16/2015
http://www.nlm.nih.gov/medlineplus/herbalmedicine.html
8