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219 Cards in this Set
- Front
- Back
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definition of CAM
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anything that isn't conventional medicine
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classifications of CAM (5)
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alternative medical systems
mind-body interventions biological-based therapies manipulative and body-based methods energy therapies |
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example of alternative medical systems (3)
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TCM
naturopathy homeopathy |
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example of mind-body interventions
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meditation
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example of biological-based therapies (2)
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herbs
supplements |
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which classification of natural products:
herbs supplements |
biological-based
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which classification of natural products:
meditation |
mind-body interventions
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which classification of natural products:
TCM naturopathy homeopathy |
alternative medical systems
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2 examples of manipulative and body-based methods
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chiropractic
massage |
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which classification of natural products:
chiropractic massage |
manipulative and body-based methods
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2 examples of energy therapies
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therapeutic touch
Reiki |
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which classification of natural products:
therapeutic touch Reiki |
energy therapies
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3 top CAM providers (for Canadians(
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chiropractic
massage therapy acupuncture |
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regional distribution of CAM use across Canada
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most common in BC
use decreases slightly further east |
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List of chronic conditions that people see CAM providers for (in order from greatest % of people with that condition) (10)
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%
fibromyalgia (37%) back problems multiple chemical sensitivies bowel disorders migraine chronic fatigue syndrome thyroid disorders asthma ulcers arthritis/rheumatism (22%) |
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% of people with no chronic health conditions who see CAM providers
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16
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% Canadians who have ever used an NHP
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73
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% Canadians who use NHPs on a daily basis
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32
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most common NHPs that people use
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Know the first 3
vitamins and minerals omega 3 fatty acids/fish oils herbal teas antioxidants Echinacea homepathic stuff amino acids glucosamine tea tree oil |
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what do people with no health conditions use NHPs for
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prevention
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3 pushes that lead patients to seek CAM
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adverse effects of conventional treatments
lack of efficacy of conventional treatments perceived poor doctor-patient interactions |
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3 pulls that draw patients toward CAM
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perception that natural is better
perception that CAM is safe congruence with beliefs about the nature of health and illness |
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preferred methods of receiving info about NHPs (in order
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1. doctor
2. pharmacists 3. health canada website 4. health canada publications |
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trend in people's desire to hear about NHPs from their pharmacists
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increasing
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why patients don't disclose CAM use (5) (in order from most common to least common reason)
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no one ever asked
don't consider it medicine didn't think it was important fear of rejection MDs don't know anything about it |
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does the province or the country regulate CAM practitioners
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province
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does the province or the country regulate CAM products
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country
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general trend of regulation of CAM practitioners
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largely unregulated
wide variation in training and credentials |
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list the regulated CAM providers (in Canada - but varies among the provinces)
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chiropractors
naturopaths TCM acupuncture RMT |
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in which provinces are chiropractors regulated
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all
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in which provinces are naturopaths regulated
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BC
AB SK MN ON NS |
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in which provinces are TCM practitioners regulated
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BC
Ontario |
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in which provinces are acupuncture practitioners regulated
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Quebec
BC Ontario |
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in which provinces are RMTs regulated
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most
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what do naturopaths do
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basics of:
acupuncture manipulation massage nutrition TCM homeopathy |
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how the regulation of naturopaths is changing
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currently under drugless practitioner act
soon to be under the regulated health professions act |
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who can perform acupuncture in Quebec
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physicians only
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what is Ayurvedic medicine
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native to India
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name 3 specific unregulated CAM providers
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homeopathy
herbalists ayurvedic practitioners |
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which CAM practitioners are soon to be regulated in ONtario
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homeopathy
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problem with unregulated CAM providers
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some are really good
some suck no way to tell |
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where are homeopaths soon to be regulated
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Ontario
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mandate of NHPD
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to ensure that all canadians have ready access to nhps that are safe effective ad high quality while respecting freedom of choice and philosophical and cultural diversity
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to ensure that all canadians have ready access to nhps that are safe effective ad high quality while respecting freedom of choice and philosophical and cultural diversity
who said this |
NHPD
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problems with NHPD original mandate
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sometimes the 2 parts come into conflict
ie. people want medicines that are not safe |
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NHP regulations relationship with the food and drug act
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NHP regulations and Food and Drug regulations both fall under the food and drugs act
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criteria of NHP
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1. has to exist in nature
2. medicinal use 3. self-use |
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to be an NHP you have to exist in nature - what does this mean
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can't take it from nature and the modify it in a lab
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substances that meet the requirement of existing in nature
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herbs
vitamins minerals plant animal fungi micro-organism |
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exclusions from the NHP definition
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biologic
tobacco marijuana injectables |
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according to the NHP definition, what makes something used for health purposes
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in dosage form
with a health claim |
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who needs a site license wrt NHPs (5)
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manufacturers
packagers labellers importers distributors |
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3 things u need to get a site license (NHPs)
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1. maintain proper distribution records
2. have proper procedures: product recalls handling storage delivery 3. good manufacturing practices |
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GMPs include (8)
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1. premises
2. equipment 3. personnel 4. sanitation 5. quality assurance 6. stability 7. records 8. recall reporting |
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product licensing requirements apply to
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any person or company that manufactures packages, labels and/or imports NHPs for sale in Canada
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who do product licensing requirements not apply to (2)
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health care practitioners who compound products on an individual basis for their patients
retailers of NHPs because manufacturers are just going to let a patient self-select it |
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how do you know if an NHP has been approved
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it gets an NHP number
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what must NHPs have before they can be sold in Canada
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product license
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can manufacturers apply for a general license for a bunch of products
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no - one for each individual product
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approval of products is based on
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safety
effectiveness quality |
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2 names for the number that NHPs get
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NPN natural product number
DIN-HM |
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2 ways to know if a product has a license
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NPN or DIN-HM on label
search Health Canada's Licensed Natural Health Products Database |
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the level of evidence required (type and amount) to support safety and efficacy of an NHP depends on
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proposed claims
overall risk profile whether the product is making a modern or traditional health claim so the more risk there is to the patient if a product doesn't work as claimed, the more evidence there needs to be |
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claim based on evidence from clinical studies, animal studies, in vitro studies, pharmacopoieas, and regulatory authority reports
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modern health claim
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claim based on the sum total knowlege, skils and practices based on theories, beliefs and experiences indigenous to a specific culture used in prevention or treatment of disease
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traditional health claim
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the level of evidence needed for a modern health claim is similar to
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OTC product
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why can products make traditional health claims (ie. why was this allowed)
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to allow stuff to stay on the market when it hasn't been studied
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what are the requirements for a traditional health claim
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what is the claim
what culture/system does it come from has to have been used for that purpose for 50+ years dose in the bottle must be the same as the traditional dose |
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problem with traditional health claims
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just because something has been done for a long time doesn't make it right
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what if we discover that traditional health product does not work (hard to prove the negative) or that there are safety issues
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safety trumps tradition
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information required on the label of a NHP (16)
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1. brand name
2. product number (preceded by the designation NPN) 3. dosage form 4. net amount (weight, measure or number) 5. name and address of product license holder 6. proper name and common name of each medicinal ingredient 7. strength or potency of the medicinal ingredients (by proper name) 8. qualitative list of all non-medicinal ingredients 9. recommended use or purpose 10. recommended route of admin 11. recommended dose and duration of use 12. risk info: cautions, warnings, contraindications, adverse reactions 13. recommended storage conditions 14. lot number 15. expiration date 16. description of the source material |
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why were transitional provisions instituted
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takes a long time to review all the product licenses
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when did the transition from DINs to NHPNs begin
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2010
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what do products get while they are awaiting approval for their NHPN
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exemption number
EN-XXXXXX |
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when did new exemption numbers for NHPs stop being granted
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Feb 2013
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how are ENs being phased out
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the government is making final decisions about the products
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when you are reporting a suspected NHP adverse reaction, how sure do you have to be about the cause and effect relationship
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not at all sure
suspicion is sufficient |
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where do you report NHP adverse reactions
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Health Canada website
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how successful are pharmacists at reporting NHP AEs
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not at all
many pharmacists suspect NHP related AEs but very few reported it to health Canada |
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reason that pharmacists cite for not reported suspected NHP related AEs
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no time
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Dr. Boon's response to pharmacists who didn't have time to report AEs
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it doesn't take very much time
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how good are patients at reporting AEs associated with NHPs
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they suck
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why do patients report less AEs for NHPs than for conventional drugs (6)
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1. it never occurs to them that the AE could be caused by NHP
2. feel like they are responsible for dealing with any problems since they were self-medicating 3. think HCP will laugh at them 4. don't see HCP as being willing/able to help 5. worried about bad PR for NHPs 6. don't know anything about the adverse event reporting system |
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in the chart for NHP drug interactions, what does red mean
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clinical trial evidence for interaction
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in the chart for NHP drug interactions, what does orange mean
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animal data
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SJW claim to fame
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one of the most interactiony NHPs
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genus-species name of SJW
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Hypericum-perforatum
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primary use of SJW
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anti-depressant
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traditional use of SJW
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sedative for relief of restlessness or nervousness
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active ingredients of SJW
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hypericin
other anthraquinone derivatives hyperforin |
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pharmacology/mechanism of action of SJW
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1. MAOI activity does not explain antidepressant effect because this compound breaks down before it can have an effect
2. may decrease reuptake of 5HT, NE, D 3. may cause upregulation of 5-HT receptors 4. anti-viral activity (may increase photoactivation) 5. sedative 6. anti-inflammatory |
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potential anti-viral activity of SJW is directed against which organisms
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HIV
influenza |
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note about the multi-component formulation of SJW
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single components don't work nearly as well as the combo
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results of the Cochrane Review of SJW (3)
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1. better than placebo for major depression
2. approximately equally efficacious compared to standard antidepressants for mild to moderate depression 3. fewer side effects (AEs and interactions) than standard antidepressants |
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2 reasons that SJW is not commonly prescribed
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1. prescribers are unfamiliar with it
2. hard to control the dosage (patients can buy as much as they want) |
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adverse effects of SJW (common) (7)
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GI
skin fatigue/sedation restlessness/anxiety dizziness headache dry mouth |
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adverse effects of SJW (less common) (11)
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serotonin syndrome:
rigidity hyperthermia delerium confusion autonomic instability coma photosensitivity hypomania anxiety reversible liver enzyme elevations |
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side effects of SJW compared to other antidepressants
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similar
except photosensitivity which is unique to SJW |
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which drugs does SJW interact with (documented)
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digoxin
HIV-1 protease inhibitors (indinavir) HMG-Co A reductase inhibitors (statins) cycosporin oral contraceptives warfarin |
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how does INR change with SJW on top of warfarin admin
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decreased
because 3a4 induction therefore more warfarin is broken down |
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1 theoretical digoxin interaction
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drugs causing photosensitization
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which enzymes does SJW induce
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3a4
1a2 2cp |
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what effect does SJW have on liver enzymes (induction or inhibition)
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induction
may inhibit 3a4 acutely and then induce with repeated admin |
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other than enzyme induction, how does SJW cause interactions
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may affect p-glycoprotein
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results of a study done in pharmacies about NHPs are adverse events
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40% of people used drugs and NHPs concurrently
3% reported an AE some these were assessed in detail and 1/3 of them were identified as probably causally linked to NHP use take home message: active surveillance improves identification and reporting of AEs associated with concurrent NHP use |
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3 roles of the pharmacist wrt NHPs
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1. practice pharmaceutical care
2. provide NHP information 3. educate |
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One of the roles of the pharmacist wrt NHPs is to practice pharmaceutical care - what does this mean (5)
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1. create opportunity for open dialogue with patients about NHPs
2. inquire about patient NHP usage 3. consider patient NHP usage when identifying potential or actual drug therapy problems 4. integrate knowledge of NHPs into patient care plans 5. document patient's NHP use when appropriate |
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One of the roles of the pharmacist wrt NHPs is to provide NHP information - what does this mean (3)
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1. find and access credible NHP references
2. identify evidence based indications for use and expected outcomes of NHPs 3. identify clinically relevant potential actual interactions with drugs or disease states, as well as adverse effects or precautions associated with NHPs |
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One of the roles of the pharmacist wrt NHPs is to educate - what does this mean (2)
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1. integrate knowledge of NHPs into routine education when appropriate
2. educate patients and other health care providers about appropriate NHP information sources |
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conclusions regarding the role of pharmacists in NHPs
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1. additional education about NPs is necessary in both undergraduate and continuing education programs
2. adoption of NHP-related core competencies will help to ensure that practicing pharmacists are able to provide appropriate advice to patients |
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where should we look for NHP information (2)
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Natural Standard
Cochrane Reviews |
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where should patients look for NHP info
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National centre for Complementary and Alternative Medicine
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ISMP Canada
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independent not-for-profit organization dedicated to reducing preventable harm from medications
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goal of ISMP Canada
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create safe and reliable systems for managing medications in all healthcare environments
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ISMP stands for
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institute for safe medicine practices
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there are sections on the ISMP website for (2)
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practitioner reporting of medication incidents
consumer reporting |
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adverse event vs. adverse drug event
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adverse event: undesired and unplanned occurrence directly associated with the care or services provided to a patient. Includes preventable and non-preventable injuries
adverse drug event: injury from medicine or lack of intended medicine. includes ADRs and harm from medication incidents |
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definition of safety according to the safety lecture
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freedom from accidental injuries
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freedom from accidental injuries
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safety
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injury from medicine or lack of intended medicine. includes ADRs and harm from medication incidents
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adverse drug event
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undesired and unplanned occurrence directly associated with the care or services provided to a patient. Includes preventable and non-preventable injuries
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adverse event
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temporary or permanent impairment in body functions or structures. include mental, physical, sensory functions and pain
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harm
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definition of harm
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temporary or permanent impairment in body functions or structures. include mental, physical, sensory functions and pain
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an incident resulting in serious harm (loss of life, limb or vital organ) or significant risk thereof
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critical incident
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definition of critical incident
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an incident resulting in serious harm (loss of life, limb or vital organ) or significant risk thereof
need for immediate investigation and response (to identify why it happened and how to prevent it from happening again) |
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definition of serious harm
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loss of life, limb or vital organ
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near miss
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event that could have resulted in unwanted consequences, but did not, because (either by chance or timely intervention) the event did not reach the patient
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event that could have resulted in unwanted consequences, but did not, because (either by chance or timely intervention) the event did not reach the patient
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near miss
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what is not a near miss
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an event that reaches the patient that does not cause harm
as soon as it reaches the patient, it is no longer a "miss" even if it does not cause any harm |
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high alert medications
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drugs that bear a heightened risk of causing significant patient harm when they are used in error
error is not more likely but if there is an error, it is more likely to cause harm |
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drugs that bear a heightened risk of causing significant patient harm when they are used in error
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high alert medications
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3 high alert medications
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opioids
anticoagulants insulin |
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rank of medicalerror as a cause of death in the US
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8th
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preventable medical mistakes cause more deaths than
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car accidents
breast cancer AIDs |
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% of adverse events that are related to medication or fluid admin
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25
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% of adverse events that were deemed to be preventable (Canadian adverse events study)
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37
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main type of medication errors that cause death
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not administration errors (ex. 10fold errors)
pharmaceutical care errors (people don't get drugs they need, or get doses inappropriate for their organ function |
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compare rate of academic centre adverse events to a community hospital
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higher in the academic
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top 2 areas of adverse events
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surgery
drugs |
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how does Canada rank compared to other countries wrt adverse events
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middle of the pack
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% distribution of where in the medication use process errors occur
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39% prescribing
12% transcribing 11% dispensing 38% administering |
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% distribution of where in the medication use process harm occurs
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28% prescribing
11% transcribing 10% dispensing 51% administration |
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at what stage of the medication use process is there most harm
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administration
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why is there most harm at the administration end of the medication use process
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other errors can be caught further along the line
catch rate at the administration end is low (2%) |
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which stages of medication use are most amenable to error prevention (In long term care)
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ordering
monitoring |
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there is an increased risk of events with 3 drugs (in long term care)
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antipsychotics
diuretics anti-epileptic agents |
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overall dispensing accuracy in a survey of US pharmacies
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98%
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systems theory
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healthcare professionals are taught to take care to avoid mistakes
this is necessary but not enough systems have to be re-designed to improve processes, systems and environment in which people work rather than attempting to only improve individual skills and performance We can't change the human condition but we can change the conditions under which humans work |
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swiss cheese model of error
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each barrier we build to protect patients has holes in it. if the holes line up right, harm can happen
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the systems approach recognizes that
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1. humans are incapable of perfect performance
2. accidents are caused by flaws in the system (working environment) and human errors that are an expected part of any working environment 3. accidents can be prevented by building a system that is resilient to expected human errors ie. expect that people are going to make mistakes |
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what is the theory called that states: in order to prevent medication errors, we have to change the working environment rather than the individual practitioners
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systems theory or systems approach
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HFE
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human factors engineering
a discipline concerned with design of systems, tools, processes, and machines that takes into account human capabilities, limitations, and characteristics |
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2 examples of machines or systems that lack HFE in their design
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1. we turn off our laptops by pressing the start button
2. exit signs are red - this implies "stop". In Europe exit signs are green |
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human factors that we have to consider when designing our systems
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1. working memory
2. workload 3. task demands 4. workflow 5. repetition 6. fatigue 7. inattentional blindness 8. high noise-to-signal ratio (information overload) 9. work area design (ex. lighting, noise distractions) |
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applications of HFE (6)
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medical devices
computer software labelling and packaging medication distribution systems work environment design workflow design |
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what causes people to "see" information that confirms our expectations rather than info that contradicts our expectations
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confirmation bias
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example of when confirmation bias is a problem
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similar packaging
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how the monkey video works
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your brain unconsciously filters out information that it does not think is important. if you are counting passes you are ignoring everything else. most of our perceptual processing occurs outside of conscious awareness
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2 options of safety strategies
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eliminate: remove the hazard
control: provide safeguards |
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hierarchy of effectiveness of safety precautions
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most effective
1. forcing functions and constraints 2. automation/computerization medium 1. simplification/standardization 2. reminders, checklists, double checks least 1. rules and policies 2. education and information |
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why rules and policies and education aren't the best safety precaution
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if people can't remember, they probably won't look it up
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example of how standardization works
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all docs in a FHT decide to treat pneumonia with the same drug (for the average patient, set variations for penicclin allergies for example)
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the math of reducing error with double checks
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each person's chance of error is 1/100
multiply these to get overall chance of error: 1/10 000 problem: sometimes people make the same mistake |
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where is incident reporting well-established and poorly established (3)
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good = hospitals
poor = community pharmacies probably non existent = solo practices (ex. doctor's office) |
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2 examples of high reliability organizations (tend to be very safe)
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aviation, nuclear power
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3 qualities of high reliability organizations (tend to be very safe)
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1. collective preoccupation with possibility of failure
2. expect to make errors and train their workers to recognize and recover from them 3. continually rehearse familiar scenarios of failure |
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success of aviation in preventing errors
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accidents per million departures has dramatically decreased since 1960
incident reports have increased but the number of high risk incident reports has decreased this suggests that reporting has improved, and so has safety |
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how should we respond to HCP errors
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encourage/applaud them for reporting
focus on how the problem can be fixed rather than the individual involved |
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does the non-punitive approach to errors mean blame free?
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no - we are all accountable for things within our scope of practice
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what are pharmacy technicians responsible for (scope of practice)
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technical components of Rx
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what are pharmacists responsible for (scope of practice)
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therapeutic component of Rx - is the drug appropriate for the patietnt
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a weird name for creating a reporting environment where people feel that they can report their errors
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just culture
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the person approach to errors
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assign blame
punish or retrain |
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things that HCPs think when they make an error
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I should have done _____
this has not happened before this will not happen again |
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the five rights of the second victim
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how we should help a HCP who has committed an error
T - treatment that is just R - respect U - understanding and compassion S - supportive care T - transparency and the opportunity to contribute |
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why HCPs dont report their errors (4)
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failure to recognize error
failure to look beyond incident to whole system lack of certainty - is it really an error? (everything turned out ok, so why report) punitive culture (fear of reporting) |
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4 thoughts about error and how to constructively reevaluate them
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who did it? --> what allowed it?
punishment --> thank you for reporting errors are rare --> errors are everywhere add more layers --> simplify/standardize |
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apology legislation
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you can apologize to a patient without admitting fault
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organized efforts of society to keep people healthy, prevent injury, illness, premature death
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public health
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what is public health not
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publically funded health care
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6 functions of public health
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population health assessment
health, disease, injury surveillance health promotion disease and injury prevention health protection (ex. sanitation laws) emergency response |
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mandation of public health
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municipalities don't get to choose whether or not they participate in the organized efforts of public health. The government mandates that this must occur.
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early history of public health in Canada
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Constitution 1967) quarantine and establishment and maintenance of marine hospitals
(because diseases used to come on boats) most other hospitals and medical services were provincial responsibility Medicine Chest clause: a medicine chest be kept at the house of each Indian agent for the use and benefit of the Indians at the direction of such Agent This is now interpreted to mean that there must be health care available to natives living on reserve |
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priorities of Minister of Health - Rona Ambrose
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health care efficiency
domestic violence |
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which components of public health is the federal government responsible for (18)
|
Criminal Law, Oversight and Approval
controlled substances drugs and food medical devices industrial and consumer products cosmetics tobacco radiation-emitting devices (microwaves, TVs, sun lamps) pest control products First Nations and the Inuit active and veteran members of the military ranking members of RCMP prisoners in federal penitentiaries health requirements for immigrants occupational health and safety for employees in federally regulated industries patents for medicines environmental research and monitoring fitness and amateur sport (ex. own the podium initiative fitness for duty of air traffic controllers and pilots |
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Federal Agencies for Public Health (7)
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Public Health Agency of Canada
Health Canada First Nations Inuit Health Canadian Food inspection agency national defense, transportation, environment |
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role of ministry of transportation in public health
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prevention of auto accidents
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which Canadian agency is modelled on the US CDC
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Public Health Agency of Canada
Public Health Ontario |
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role of Health Canada
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health protection (ex. approving medications)
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SARS led to a collection of reforms in public health as recommended by ____
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Naylor report
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12 greatest achievements of the 100 years of the Canadian public health association
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1. safer and healthier foods
2. control of infectious diseases 3. healthier environments 4. vaccination 5. recognition of tobacco use as health hazard 6. motor vehicle safety 7. decline in deaths from coronary heart disease and stroke 8. healthier mothers and babies 9. safer workplaces 10. universal policies 11. acting on social determinants of health 12. family planning |
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Federal Health Leadership (title and name)
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Minister of Health: Rona Ambrose
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the Naylor report suggested a new leadership position in public health (title and name)
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Chief Public Health Officer of Canada
Dr. David Butler Jones |
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provincial health leadership (title and name) (2)
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Minister of Health and Long Term Care
Chair of the Cabinet Committee on Poverty Reduction Honourable Deb Matthews Chief Medical Officer of Health Dr. Arlene King |
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provincial role in public health (departments)
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Chief Medical Officer of Health
Public Health Division (MOHLTC) Ministry of Health Promotion and Sport (has been merged back into the Ministry of Health) MCYS (Ministry of Children and Youth Services) MOE (Ministry of the Environment) Ontario Agency for Health Protection and Promotion |
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public health legislation that the province is responsible for
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Health protection and promotion act
other health legislation |
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who decides on the Chief Medical Officer of Health
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appointed by Ontario Agency for Health Protection and Promotion
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what is the significance of the fact that the Chief Medical Officer of Health is appointed
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can't be fired easily
can say unpopular things (ex. we did it wrong, we need to do this) allows public health to be free of political agenda |
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recommendations in the Naylor report
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1. Chief Public Health Officer of Canada
2. Public Health Ontario (WAS: Ontario Agency for Health Protection and Promotion) |
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Ontario Agency for Health Protection and Promotion had its name changed to
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Public Health Ontario
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Public Health Ontario roles
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provide technical advice and research to the chief medical officer of health
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how Public Health Ontario differs from Public Health Canada
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Canada: deputy minister reports to the minister. He is "in the box"
Ontario: more independent. unbound by certain rules of government. but not at the decision making table |
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components of the Health Protection and Promotion Act
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Each municipality is required to have a board of health, which has the following elements:
1. Medical Officer of Health 2. reportable diseases 3. deal with health hazards 4. standards for programs 5. reportable diseases 6. staff: nurses, inspectors, dieticians |
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staff of Boards of Health (municipal organization)
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nurse
inspector dietician |
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do boards of health require pharmacists
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no
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Components of the Ontario Public Health Standards
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Principles
Foundational Standard and Protocol Program Standards and Protocol |
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Principles of the Ontario Public Health Atlas
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Every Health Unit should:
1. look at their own specific needs 2. assess how well their initiatives 3. consider capacity: do they have sufficient staff? 4. work together with other organizations (ex. school boards, workplaces, etc.) |
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Health Unit vs. Board of Health
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every Health Unit is governed by a board of health
groups of municipalities come together to form these |
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protocol vs. standard for Boards of Health
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protocol = you must do this
standard = you can do this |
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how many LHINs in Ontario
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14
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role of LHINs
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local decision making wrt health care
ex. hospital budget |
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how many public health units in Ontario
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36
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LHINs vs. public health units
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LHINs have more equal population sizes
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LHINs attempted to equalize population sizes - what is the problem with this
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can't just divide the budget equally
some LHINs have hospitals that serve much wider areas |
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LHINs and Public Health Units are distinct. what else is independent of LHINs
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independent practices of physicians and pharmacists
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who is the leader of Public Health Units and who is it for Toronto
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Dr. David McKeown
Medical Officer of Health |
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municipal role in determinants of health
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drinking water
waste water waste zoning economic development parks transit roads EMS long termcare day care social assistance |
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other local public health partners (other than LHINs and Public Health Units)
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community based physicians
pharmacists HCPs school boards business associations NGOs Faith organizations |
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role of pharmacists in health promotion (3)
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screening clinics (ex. cholesterol, diabetes management)
flu shot clinics days |
