Midterm Flashcards
What is a regulatory body?
- Mandate of public protection established in legislation
- Membership - mandatory
-> Authority to restrict entry or revoke - Accountable to the public
What is an Association?
- “union”
- Advocacy body - mandate to further the interests of its membership
- Membership - voluntary
-> No authority over practice - Accountable to governing board & membership of association
What is the Section 3(2) Duty of the College?
- The college has a duty to serve and protect the public interest
What is Section 2.1 Health Professions Procedural Code?
Work in consultation w/ the Minister to ensure, as a matter of public interest, that the people of Ontario have access to adequate numbers of qualified, skilled & competent regulated health professionals
What is Section 3(1) Objects of the College?
- To develop, establish & maintain programs and standards of practice to assure the quality of the practice of the profession
- To develop, establish & maintain standards of knowledge and skill and programs to promote continuing evaluation, competency and improvement among the members
- To develop… standards of professional ethics
Beneficence
- To benefit
- Pts seek our care & services b/c they trust we will apply our knowledge, skills & abilities to help make them better
Non Maleficence
- Do no harm
- Diligent in our efforts to do no harm and whenever possible, prevent harm from occurring
- Proactive in identifying red flags
Respect for Persons/justice
- autonomy
- Must treat all pts fairly and equitably and respect their vulnerability autonomy and right to be decision makers in their own health
Accountability
- Fidelity
- Keep our promise to our pts & society and inevitably act in their best interests and not our own
Explain Boundary Violations
- Boundary violation - is the point at which a relationship changes from professional & clinical to unprofessional and inappropriate
- Boundary violations exploit the power imbalance inherent in the registrant-patient relationship
What does it mean to be a Professional?
- Duty to prioritize pt benefit above all else
- Accountable to society
- Holding each other accountable to meet the standards of ethics and care
What is the Mandate of the College?
- to serve & protect the public
Code of ethics vs. Standards of practice
- Code of ethics - set of aspirational goals based around the values of integrity, respect & responsibility
- Standards of practice - the minimum standards of practice a pharmacist must meet & against which their performance will be measured
- These work together, and have some overlap
What are MSOPs?
- Model standards of practice that all licensed Canadian Pharmacists must meet
- Not applicable ONLY to Ph at entry to practice
- NAPRA acknowledges Ph fulfill a number of professional roles
- When performing specific role, the Ph must meet ALL of MSOP associated w/ this role
List the 4 MSOP Domains
- Expertise in medications & medication use (central domain)
- Collaboration (central domain)
- Safety & Quality (critical attribute)
- Professionalism & Ethics (critical attribute)
MSOP - Expertise and medication use
- 61 general standards
- Phs maintain their competence
- Phs apply their medication & medication-use expertise while performing daily activities
- Phs provide evidence of application of their medication & medication-use expertise through documentation
MSOP - Collaboration
- 21 general standards
- Phs work constructively w/ students, peers & members of inter-professional team
- Phs communicate effectively
MSOP - Safety & Quality
- 16 general standards
- Phs undertake continuing professional development, quality assurance & quality improvement
- Phs respond to safety risks
MSOP - Professionalism and Ethics
- 11 general standards
- Phs demonstrate professionalism & apply ethical principles in their daily work
- ** this is where we see overlap w/ CoE
Why do we have MSOPS?
- Creates the foundation of our profession
- Sets levels of accountability for all
- Reflects the progress of the profession
- To support workplace initiatives
- For advancement of the profession
- Basis for other College programs such as Registration, QA, complaints & discipline
Main themes in new NAPRA MSOPs
- Giving pharmacists & pharmacy techs a broader, more holistic framework to guide their practice
- Emphasizing the importance of health system collaboration, where pharmacy professionals are integral parts of a pt’s circle of care
- Reinforcing the importance of being a parnter in a pt’s health decison-making
- Using professional judgement in decision making
List the 5 new MSOP Domains
- providing care
- knowledge & expertise
- communication & collaboration
- leadership & stewardship
- professionalism
What is Bill 179?
- The Regulated Health Professionals Statute Law Amendment Act 2009
- Significantly amended the Pharmacy Act creating a greater role for RPh’s in the delivery of primary health care
- Allowed pharmacists to inject, test blood, help w/ inhalation products
US vs. Canada Self care market
- US - 2 class of regulated products (prescription & OTC), unregulated misc product
- Can - 3 schedules, 4 catgories of regulated drugs (I, II, III, U), regulated misc products
Current regulatory structure (fed & prov)
- Fed (health canada) - decided whether it should be rx or non-rx
- Prov (pharm regulatory authorities) - we use NAPRA
- decide on scheduling
Principles for requiring prescription
- supervision by HCP is necessary
- level of uncertainty or it’s effects justify HCP supervision
- use can cause harm or risk to the public that can be mitigated by HCP supervision
Non-RX Drug regulation
- scientific evidence required
- facts table labelling
- mandatory recall
- fines & penalties up to $5M
Natural Health Product (NHP) regulation
- broad standard of evidence, recognize traditional forms of evidence
- no standard format for labelling
- no inspections
- voluntary recall
- fines & penalties up to $5000
Self-care Framework Proposal
- oversight proportional to risk
- similar evidence for similar claims
- informed consumer choice
- Risk-based post-market overnight
3 category risk-based approach
- Moving away from a system based on claim, source of ingredients, and uncertainty
- Category 1 - least we are concerned w/
- Category 2 - all routes (oral, rectal), relieve your symptoms
- Category 3 - most stringent, use too much of ingredient cause a problem, ALL NSAIDs
Risk-based Approach - Category 1
Must meet all of the following:
* topical/dental only
* attests to pre-cleared info
* self-limiting conditions
* not sterile
Risk-based Approach - Category 2
- all routes of admin
- relief symptoms
Risk-based Approach - Category 3
If ONLY 1 met:
* safety concern w/ ingredient
* no pre-cleared info
* serious risk that requires review
* condition could worsen
* indicated for HCP use only
How are Herbal Products typically Prepared?
- typically an extract
- fresh or dried plant material is soaked in solvent followed by filtering, then concentrated and prepared as dry form or liquid form
Issues w/ Herbal Products
- Complex mixtures of compounds
- Active ingredient(s) may be unknown
- Plant misidentification
- Adulteration/contamination w/ “drugs”, other species etc.
- Microbial or heavy metal contamination
- Exaggerated claims, misleading advertising
- Products w/ multiple herbs
- Quantity of active ingredient different than label
Standardization of Herbal Products
What and how?
- created by identifying a suspected active ingredient & altering manufacturing process to obtain a consistent amount
- Methods of analysis include chemical fingerprinting (using HPLC), microscopy of plant material etc.
Vitamins & minerals
- Vitamin D, Calcium, Multivitamins
- Can be used to correct deficiency (ex. Iron for anemia) or for pharmacological purposes (ex. Niacin for dyslipidemia)
- Can be natural-source or synthetic
What is Homepathy?
- System of alternative medicine
- Homeopathic remedies can use plant, animal or mineral substances as starting material
- Principle 1 - law of similars
- Principle 2 - use very small doses
Take extract & dilute it
What are Traditional Medicines?
- Traditional Chinese medicine
- Herbal medicines are used (along w/ other modalities such as acupuncture) to restore balance of yin and yang
- Typically use combination of herbs
Common examples - ginseng, licorice, Ma huang
- Typically use combination of herbs
- Herbal medicines are used (along w/ other modalities such as acupuncture) to restore balance of yin and yang
- Ayurveda
- A system of traditional medicine native to India- Incorporates herbal therapies
What are Probiotics?
- Live microorganisms which when administered in adequate amounts confer a health benefit on the host
- Usually bacteria but can be yeast as well
- Common probiotics: Lactobacillus sp., Bifidobacterium sp., Saccharomyces boulardii
- Common use - treatment of antibiotic-associated diarrhea, IBS, infantile colic, bacterial vaginosis
How are NHPs regulated?
- NHPs are regulated by Natural Health Product Regulations, which came into effect 2004
- Regulated as a subset of drugs
- Pre-market review required for NHP to obtain a product license
- Approved products are given either a Natural Product Number (NPN) or DIN-HM (homeopathic medicines)
- Product license application must contain info on safety, efficacy, quality & proposed label text
Compendial Applications
- only need to refer to single ingredient or product monographs, available from Health Canada
- Applications do not require additional data supporting safety or efficacy
Traditional Health Claims
- Non-compendial applications
- Evidence must demonstrate use of medicine ingredient(s) as part of a recognized system of traditional medicine
- Efficacy is based theories/belief systems of the healing paradigm
- Must show >2 generations of traditional use
Modern Claims
- Non-compendial applications
- More stringent requirements for scientific evidence
- Sources of evidence - clinical studies, pharmacopeias, textbooks, peer-reviewed published articles, pre-clinical studies, reputable regulatory authority reports, expert opinion reports
When are Randomized Controled Trials required for NHPs?
- Randomized controlled trials - only needed for “high risk” claims
- Compendial applications do not require independently conducted RCTs
- Traditional use claims do not require RCTs
Homeopathic Medicine Licensed
- Require a product license application (given DIN-HM)
- Ingredients must be based on those found in a pharmacopeia
- Evidence for efficacy is typically pharmacopeias, homeopathy encyclopedias
- Must be labeled as homeopathic medicine/remedy/preparation
What info is listed in the Licensed National Health Database?
- Product name
- Product license holder
- NPN/DIN-HM
- Medicinal and non-medicinal ingredients
- Dosage form
- Recommended use/purpose (ie health claim or indication)
- Risk info (cautions, warnings, contra-indications)
What is the safety of NHPs
- usually safe
- Potential for drug-NHP interactions
- Adverse effects
- Safety in pregnancy, lactation, children, specific conditions - Often not established
What are the COE principles?
- beneficence
- non-maleficence
- respect for persons/justice (autonomy)
- accountability (fidelity)
What is circle of care?
- ability of certain health info custodians to assume and individual’s implied consent to collect, use or disclose personal health info for the purpose of providing health care in circumstances defined in PHIPA