Reporting of Adverse Reactions Reporting of Adverse Reactions for Naturopathic Doctorsfor Naturopathic Doctors
Vital Link in the Patient Safety ChainPrepared by
Health Canada and the Canadian College of Naturopathic Medicine
Learning Objectives
• Recognize the importance of reporting adverse reactions
• Describe an adverse reaction• Apply adverse reaction reporting in your
current practice• Report an adverse reaction • Use Health Canada’s adverse reaction
resources
Why report adverse reactions?
• Over 50% of newly approved health products have serious side effects discovered after the product is on the market
• For every adverse reaction reported, up to 10 go unreported
• Practitioners often discontinue or change a patient’s treatment protocol because of adverse reactions or interactions
• A way to monitor health products for new safety information
Why should Naturopathic Doctors report Adverse Reactions?
• Primum non nocere- First, do no harm
“Provide the most effective health care available with the least risk to his/her patients at all times.”
• Responsibilities to society-
“… strive to improve the standards of medical care and promote health and safety for the individual, the public and the global community.”
Why you are important
• Overview of patient’s treatments
• Length of patient visits
• Depth of patient history
• Knowledge of product lines
Before 2004: Regulation of health products in Canada
1) Food
“manufactured, sold or represented for use as food or drink for human beings”
2) Drug
“manufactured, sold or represented for use in
the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms”
“restore, correct or modify organic functions”
Natural Health Products• Natural Health Product“manufactured, sold or represented for use in the
diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans”
“restore, correct or modify organic functions inhumans, such as modifying those functions in a manner that maintains or promotes health”
1. A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material 2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is
identical to that which it had prior to its extraction or isolation 3. Any of the following vitamins: biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, vitamin A,
vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E 4. An amino acid 5. An essential fatty acid 6. A synthetic duplicate of a substance listed in any of 2 to 5 above 7. A mineral 8. A probiotic -alone or as a combination of these substance OR a homeopathic or traditional medicine
Addressing New Safety Concerns: the Options
• Changes to the conditions of use
- indications
- contraindications
- dose
- duration of use
- cautions and warnings
• Health Professional and Public communications
Case Presentation• 27 year old female with IBS and
anxiety/depression• prescribed Tian Wang Bu Xin Dan
(Celestial Emperor Nourish Heart pills) • to Emergency with abdominal pain
radiating to right shoulder• liver enzymes elevated and ultrasound
showed non-obstructing mobile gallstones• required hospitalization for 3 days
Case Presentation cont'd
• While hospitalized– patient taken off herbal formula
– liver enzymes decreased, returning to normal within a week
• Next steps– patient management
– Health Canada’s monitoring AR reports
Case Presentation cont'd
• Suspected adverse reaction, so
- report it to Health Canada
• Approaches to this case- health status
- treatment
Why this could be an adverse reaction…
• Adverse reaction: a harmful and unintended response
• Undesirable patient effects include:– any unintended effect – health product abuse– overdose– interactions e.g., drug-NHP, NHP-food– unusual lack of therapeutic efficacy
Health Canada wants to know
• Suspected adverse reactions that:– are serious
• whether expected or not
– are unexpected • regardless of severity
– involve recently marketed products (< 5 years) • regardless of nature or severity
– involve unauthorized products• No DIN, NPN, or DIN-HM
Serious Adverse Reactions
• What is ‘serious’? – hospitalization (initial and prolonged)
– congenital malformation
– disability
– required intervention to prevent damage/permanent impairment
– life-threatening
– death
– otherwise medically significant
Also very important
• Unexpected adverse reactions
- not consistent with the product monograph or label
• Involving recently-marketed products
- less than 5 years on the Canadian market
• Unauthorized products
- no DIN, NPN, or DIN-HM on label
Where to Start• Health Canada’s Adverse Reaction report
form– In the CPS
(Compendium of Pharmaceuticals and Specialties)
– On-line- MedEffect websitehttp://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html
– From a Regional Adverse Reaction Centre
• Fax, mail or phone reports to your Health Canada Regional Adverse Reaction Centre
‘Must Have’ Entries
A) Identifiable patient
B) Description of the reaction
C) Suspected health
product(s)
D) Identifiable reporter
Patient Information
• Identify patient for your own reference• Follow-up purposes • Code recognizable to the reporter only
– no names, initials, birth date, social insurance number, etc.
Required Information
Concerns about liability?
• To date, Health Canada has never pursued litigation towards any health professional involved in adverse reaction reports received by Health Canada
• Understood that reports are received in good faith
Value Added• Date of reaction
– 06/09/2005
• Therapy dates – 22/08/2005 to 06/09/2005
• Relevant tests/lab data– AST/ALT values
• Other relevant history– Smokes (one pack/week)
Value Added
• Reaction abated after use stopped or dose reduced– Yes
• Reaction reappeared after reintroduction – n/a
• Concomitant health products– no other products taken
Products Reported on the AR Form
• Prescription drugs
• Non-prescription drugs
• Natural health products
• Radiopharmaceuticals
• Biologics• blood products
• biotech drugs
• therapeutic and diagnostic vaccines
Products NOT Reported on this Form
• Vaccines – prevention of infectious disease– report to public health authorities– Vaccine Safety Unit, Public Health Agency of
Canada
• Medical Devices– Health Products and Food Branch Inspectorate– Medical Device Incident Report
Will Health Canada contact the Reporting Practitioner?
• Acknowledgement letter– thank you
– reference number
• Future reference– follow-up, additional information or
clarification
What does Health Canada do with the AR report form?
• Reports Received and Initial Screening
• Data Entry – Canadian Adverse Drug Reaction Monitoring
Program Adverse Reaction Database
• Report Assessment – (serious, medical terminology)
• Detection of Signals
A reminder: here’s where you get the form
• Internet – Health Canada Website - MedEffect Section
• CPS
• Health Canada Regional Adverse Reaction Centre
What do I do with the form?
• Toll free fax (1-866-678-6789)
• Mail (Local or National AR centre)
• Toll free telephone (1-866-234-2345)
• Online (Health Canada Website- MedEffect section)
Reference Material
http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html
Reference Material
http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html
