MIDTERM Flashcards
Pharmacist
- qualified HCPs who help people make the best use of their medications in order to safely achieve desired health outcomes at home, in the community, and in hospitals
- research and work collaboratively with other HCPs to deliver optimal health care solutions through effective use of healthcare products and services
- incorporate best care principles that are patient-centred, outcome-oriented and evidence based
What does Professional Practice mean?
It is the practical application of the knowledge you will acquire in this program
- Medication therapy management of diseases and symptoms, and the promotion of wellness and disease prevention by incorporating best-care principles that are patient centred, outcome-oriented, evidence based
Role of the College: Health Professions Procedural Code
- 1: Health professions procedural code
- Work with the Minister to ensure that people have access to qualified, skilled, and competent regulated health professionals
- Meet all requirements of licensing
Role of the College: Objects of the College
- Develop and maintain programs to assure quality of the profession
- Maintain standards of knowledge and skill to promote continuing evaluation, competence, and improvement
- Develop and establish programs to promote members to respond to changes in environments, advancement of technology, and other emerging issues
Role of the College: Duty of College
duty to serve and protect the public interest
College Mandate
serve and protect public interest
college vision
trusted, collaborative leader that protects public and drives quality and safe pharmacy
college mission
regulates pharmacy practice to serve the interests, health, and wellbeing of the public
college values
accountability, integrity, transparency
OCP vs OPA
OCP - Ontario college of pharmacists
- regulatory college
- membership is mandatory
- accountable to the public
OPA - Ontario Pharmacists Association
- advocacy body which promotes the interest of its member
- membership is voluntary
- accountable to its members
How the college protects the public
- Ensure that the profession adheres to law
- Develop and practice the code of ethics
- Ensure registration requirements are met
- Pharmacists require accreditation
- Competency
- College holds the pharmacists accountable
How does the college regulate?
Federal Acts and Regulations
- Controlled drugs and substance act (CDSA)
- Food and Drugs Act (FDA)
Provincial Acts and Regulations
- Regulation Health Professions Act (RHPA)
- Drug and pharmacies regulation act (DPRA)
- Pharmacy Act (PA)
By-laws and guidelines
- Standards of practice
- Code of ethics
- Standards of operation
4 criteria for pharmacy healthcare professionals
- experts with complex knowledge and training
- autonomy to regulate their activities
- accountability to society
- committed first and foremost, to directly benefiting the people they serve
Professional role and commitment bound by social contract
healthcare professionals agree to serve and protect the well-being and best interest of their patients, first and foremost
society agrees to provide the profession with the autonomy to govern itself and the privileges and status afforded regulated healthcare professionals
What is the code of ethics (in general)?
sets out the minimal expectation of conduct and behaviour that all pharmacists and pharmacy technicians are responsible for and will be held accountable to
Beneficence
to benefit (our primary role and function)
patients seek our care and services because they trust we will apply our knowledge, skills and abilities to help make them better
Non Maleficence
do not harm
we must be diligent in our efforts to do not harm and whenever possible, prevent harm from occurring
involves being proactive in identifying red flags
respect for persons/justice
we must all treat patients fairly and equitably and respect their vulnerability, autonomy, and right to be decision-makers in their health
accountability (fidelity)
we must ensure we keep our promise to our patients and society to always and invariable act in their best interests and not our own
5 Professional Responsibility Principles
- Members are relied on to use their knowledge and judgement to make decisions that positively enhance health outcomes for patient care
- Pharmacists are responsible for applying therapeutic judgement to assess appropriateness of therapy given patients individual circumstances
- Communication and documentation are central to good patient care
a. Continuity of care
b. Relay information for other people to provide same level of care - Trust in the care provided by colleagues and other professionals
- Members must be diligent in identifying and responding to red flag situations
What is the 3rd leading cause of death?
Patient medication errors
- Patient receives the wrong medication
- Patient doesn’t take the medication correctly or takes it at all
- Being accountable if a med error occurred – work through the situation
Professional Boundaries
- It is a therapeutic relationship
- Responsible for establishing and maintaining professional boundaries
- Cannot be talking to them about their personal life if not wanted by patient
- Power imbalance
- Ethical principles of decision making, not our own, that must guide our decisions
- Declaration of Commitment
What is AIMS?
Assurance and Improvement in Medication Safety
-Report
-Document
-Analyze
-Share learning
Share lessons learned from medication incidents through reporting
Requires shared accountability between the operators of the pharmacy and pharmacy professionals
Code of Ethics
set of aspirational goals based around the values of integrity, respect, and responsibility
Standards of Practice
the minimum standards of practice a pharmacist must meet and against which their performance will be measured
How is the Canadian HealthCare system characterized?
publicly-funded
the national health insurance program is mandated under the Canada Health Act of 1984
42,584 pharmacists
10,572 pharmacies
Challenges of the Canadian Healthcare System
doctor shortage - causes lengthy wait times, ER traffic
DRP’s ($2-9 billion a year)
- aging population means senior requires more medications, and more chance of error
- increase in complexity of medications
What is the need for MSP?
in order to use HCP’s more effectively, theres an increased importance placed on the standards of practice for them
- due to shifting and overlapping scope of practice
- emphasis on accountability of professionals throughout their careers
- literature documented that SOP are the fundamental basis of the continuing competence
Solutions to the Canadian healthcare system?
HCP’s
- use pharmacists more effectively and allow them to expand their scope as they are both fairly accessible and competent
- ensure pharmacists practice “pharmaceutical care” to do whatever is possible to make sure the patient achieves positive outcomes from drug therapy
- regulate and utilize pharmacy technicians to aid in expanded role
what is NAPRA?
- National Association of Pharmacy Regulatory Authorities
- voluntary, not for profit corporation founded in February 1995
- represents all provincial and territorial pharmacy licensing authorities
Mission of NAPRA
Provides national leadership in pharmacy regulatory practices that enhance patient care and public protection
MSOP for Canadian Pharmacists
specify the minimum standards of practice a pharmacists must meet and against which their performance will be measured by their regulatory authority
MSOP Timeline
current MSOP developed by NAPRA in late 2007
- adopted by council in september 2009
- implemented in 2010
Goal of MSOP
specifying the standards against which pharmacists performance can be judged when the RPh’s are undertaking the activities required for safe and effective pharmacy practice
What are MSOP?
Minimum standards of practice that all licensed Canadian pharmacists must meet
not applicable only to pharmacists at entry to practice
NAPRA acknowledges that there are a number of professional roles fulfilled by pharmacists
NAPRA roles of pharmacists
patient care drug information drug distribution management education
What are the 5 domains of MSOP?
Expertise in medications and medication-use
collaboration
safety and quality
professionalism and ethics
2 Central domains for Pharmacists vs critical attributes required of RPh’s
central domain: expertise in medications and medication-use, collaboration
critical attributes: safety and quality, and professionalism and ethics
General standards for Expertise in Medication and Medication Use
61 general standards
- Pharmacists must maintain their competence
- Continued education programs, conferences, life-long learning
- Pharmacists must apply their medication and medication-sue
- Pharmacists provide evidence of application of their medication and medication-use expertise
- Recommend non-prescription drug therapy
- Must show no significant drug interactions
- Recommend self-care measures
- For disease management and cost-effective
- Educate patients
- Collaboration (central domain for pharmacists
General Standards of Collaboration
- 21 general standards
- Pharmacists must work constructively with students, peers, and members of the inter-professional team
- Pharmacists must communicate effectively
General Standards of Safety and Quality
- 16 general standards
- Pharmacists undertake continuing professional development, quality assurance and quality improvement
- Pharmacists respond to safety risks
General Standards of Professionalism and ethics
11 general standard statements
Pharmacists demonstrate professionalism
Why have MSOP?
Establishes credibility Distinguishes us from other professions Creates foundation Sets level of accountability Support workplace initiatives Advancement of the profession
MSOP FORMAT
each of the 4 domains is divided into the 5 pharmacist roles identified by NAPRA
- MSOP for pharmacists providing patient care
- MSOP for pharmacists when providing drug information
- MSOP when responsible for dug distribution
- MSOP when managing a pharmacy
- MSOP when educating pharmacy students/interns
Supplemental SOP (schedule 2 and 3 drugs)
- The pharmacy manager shall ensure that non-prescription products are in the area which is consistent with the appropriate drug classification
- The pharmacist shall respect the patients right to privacy and confidentiality
- When the patient requests a consultation regarding a schedule 2 or 3 product, the pharmacist shall collect information regarding patient knowledge and needs
- The pharmacist shall take the necessary steps to fulfill their professional obligations when recommending a schedule 2 or 3 drug
- The pharmacist shall document the patient interaction on patient profile if deemed appropriate
What are Schedule 2 and 3 Drugs?
Schedule 2 - behind the counter
Schedule 3 - sold in pharmacy but out in the self-serve area
Common characteristics/demographics of the scope of practice of pharmacy
- changing scope is a reality around the world
- Canada and UK ahead internationally regarding regulating technicians
- Canada lagging with prevention, screening, and disease specific professional services
- Alberta was leading the way for Canada with prescribing models and reimbursement
Pharmacy Act 1991
defines the scope of pharmacy practice
- the custody, compounding, dispensing of drugs the provision of non-prescription drugs, healthcare aids, and devices the provision of information related to drug use
- tells us the controlled acts we are allowed to do
- dispense, sell, compound a drug
- supervise the part of a pharmacy where drugs are kept
Bill 179: 2009, Regulated health professions statue law amendment act: DECEMBER 2009
ON passed bill 179 which permitted pharmacists to perform services normally limited to doctors, to increase access to care for Ontarians by expanding the scope of practice
- certain HCPs are given the ability to administer, by inhalation, certain substances that are designated under regulations
- physiotherapists can diagnose and order x-rays for patients conditions
- dieticians can take blood samples
Bill 179: 2009, Regulated health professions statue law amendment act: DECEMBER 2011
a change to bill 179
included an expanded list of substances to be administered and inhalation for routine purposes, including immunizations
included deletion of the clause which restricts administration of injections to demonstration purposes
What bill significantly amended the pharmacy act and pharmacy profession?
bill 179 significantly amended the pharmacy act, creating a greater role for RPh’s in the delivery of primary healthcare
Bill 179 Expert concerns:
As the spectrum of HCPs that can prescribe drug expands, patients may be taking more drugs than needed
New market opportunities for the pharmaceutical industry
Monitoring of all the HCPs with greater prescribing and dispensing abilities to ensure that they’re being diligent in acting with best interests of the patient
Ontario specific professional pharmacy services 2007 and 2010
2007 - original MedsCheck program
2010 - expanded medscheck program (LTC, diabetics, home-bound)
Ontario specific professional pharmacy services 2011
april 2011 - first stage of expanded services launched
september 2011 - program criteria altered
- pharmaceutical opinion program is an expanded professional pharmacy service in which a drug-related problem and clinical intervention are identified
- smoking cessation program: NRT for ODB recipients only
Ontario specific professional pharmacy services 2012
Oct 2012, expanded scope of practice, allowing part a pharmacists to:
- initiate smoking cessation therapy (wellbutrin and zyban)
- renew or adapt prescriptions (chronic/stable condition by renewing prescription, alter dose formulation, regimen or ROA)
- perform a procedure on tissue below the dermis
- administer substances by injection or inhalation
Ontario specific professional pharmacy services 2016
- administer travel and other vaccinations
- patients 5 years or older
- not all vaccines require a prescription from a primary care provider
- vaccines that are part of Ontario’s publicly funded immunization program are free if administered by doctor, but those who receive at pharmacy will have to pay
Ontario specific professional pharmacy services 2020
- Administer the flu vaccine to children as young as 2 years old
- Renew prescriptions in quantities up to a year’s supply
- Administer certain substances by injection or inhalation
Principles of Expanded Scope
- Members have an obligation to protect and promote health of patients
- Members are accountable for practicing within their scope of practice, know the terms, conditions, and limitations of their registration
- The services included within the expanded scope of pharmacy practice are ongoing medical care and take place in the context of a collaborative relationship between the pharmacist, patient, and patient’s primary care provider
- Members initiate, adapt, and renew prescriptions, administer substances by injection or inhalation only for the benefit of the patient and based on individual nature of the patients need/history and professional judgement exercised accordingly
- When initiating, adapting and/or renewing prescriptions, the member assumes full responsibility and liability for that prescription, documents actions as required, and undertakes notifications as appropriate
a. When adapting, you are the prescriber and assuming full responsibility and liability for the prescription
b. Must document everything and then forward on to the primary care provider - Pharmacy services are provided within the context of the legislative requirements, standards of practice, and code of ethics
Common Roles of Pharmacy tech
Held responsible and accountable for technical aspects of prescriptions, within the NAPRA standards of practice
- Registered technicians are to have liability insurance as well
- A technician can fill an Rx, as well as complete a final check
- Responsible for the right medication, strength, patient, Dr., as well as the correct quantity of the medication
- Pharmacist must check therapeutic appropriateness and counsel the patient if necessary
- Assist pharmacists in taking the best possible medication history
- Identify any drug interactions or medical conditions
- Provide information that does not require application of therapeutic knowledge to patients requiring assistance in selecting non-prescription drug
How did the pharmacy technician evolve?
-30 years of unregistered assistants or technicians assisting pharmacists in technical aspects of dispensing
Began with no status
- Required in order to maximize the time necessary for the delivery of clinical services
- With pharmacists taking on more roles, technicians took on some of the roles, so the pharmacist has more time to do other things
What are the milestones on the road to regulation?
1998 - college began process
2007 - bill 171 was passed in Ontario legislation which enabled the regulation of pharmacy technicians
2010 - pharmacy technicians became recognized as pharmacy regulated roles
What are the registering roles for pharmacy techs?
you do not need to be registered if working in community pharmacy, but DO need to be registered in a hospital
Training for Pharmacy Tech
Counsel for Accreditation of Pharmacy Programs
- 2-year program
- Graduate from CCAAP registered program
- Register with the OCP
- Complete the structured practical training (rotation)
- 35 hours a week for a minimum of 12 weeks
- JP exam
- PEBC
NAPRA SOP for Pharmacy Tech
Legal, ethical, professional responsibilities
- Meet legal requirements
- Uphold and act on ethical principles
- Demonstrate professionalism
Professional collaboration and Teamwork
- Collaborate to meet patient healthcare needs, goals, outcomes
Drug distribution: Prescription and Patient Information
- Receive prescription
- Process the prescription
- Transfer prescription
Drug distribution: product preparation
- Select, prepare, package products for release
Drug distribution: product release
- Ensure accuracy
- Collaborate with the pharmacist in the release
- Document all aspects of drug distribution activities
Drug distribution: system and inventory controls
- Manage inventory and drug distribution system
Communication and education
- Establish and maintain effective communications
- Provide information and education
- Document standards, policies, and procedures
Division of responsibilities (pharmacy assistants, tech, pharmacists)
Pharmacy assistants: job trained members that answer phones, placing orders, maintain stock levels
- Some colleges have a 1-year assistant training
Technicians: accountable and responsible for the technical aspects of both new and refill prescriptions
Pharmacists: remain responsible for the therapeutic/clinical appropriateness of all new and refill prescriptions and therapeutic consultations
Summary of Pharmacy Tech Roles
Responsible and accountable for the technical aspects of both new and refill prescriptions
Each prescription must contain the signature of both the technician (for the technical functions) and the pharmacist (for the therapeutic functions)
Perform a procedure on tissue below the dermis (lancet) under the direction of a pharmacist
Accept verbal prescriptions
- Exception: narcotics and controlled drug substances
Independently receive & provide prescription transfers ◦ Exception: narcotics and controlled drugs
What is an herbal product?
- Any form of a plant or plant product (leaves, stems, flowers, roots, seeds)
- Sold raw or as extracts
- Contains dozens of chemicals (Alkaloids, flavonoids, glycosides, fatty acids, etc.)
What are the various preparations and formulations that herbal products come in?
- Tea/infusion (water is poured over finely chopped plant material)
- Decoction (cold water is added then heated and strained)
- Plant juice
- Tincture – soaked in alcohol and water then filtered
- Extract – very popular and most common (Start with plant material (either dried or fresh), then soaked in a solvent for several hours, filtered, then concentrated and prepared as dry or liquid form)
- Tablet or capsule
- Others (lozenges, syrups)
What is the cause of the issue for variations in the active ingredients?
batch-to-batch variation variation between manufacturers plant: o Portion of plant o Extraction method o Age of plant o Season of harvest o Soil constituents o Plant origin o Growth conditions
What is homeopathy?
system of alternative medicine
- different than regular western medicine
- created in 1800 in Germany
- Homeopathic remedies can use plant, animal, mineral substances
Principle 1 of Homeopathy
like of similar
- like cures likes
- injecting a person with their allergen to cure them (cure the person with what is causing their illness)
Principle 2 of Homeopathy
using very small doses
- Mother tincture
- Dilution and Succession
Mother Tincture Extraction
- 1 small amount from the mother tincture, mixed with diluent
- 1 drops of the tincture, with 99 drops of alcohol, shaken vigorously
- Dilutes repeatedly
- More you dilute it, the stronger it gets
- More potent, more dilute
Dilution and Succession
- Every time you take a dilution, you shake it – calling it a succession
- The remedy is diluted several times (alcohol or water), and each time undergoes vigorous shaking or succession
- This potentizes or dynamizes the remedy; the energy of the active ingredient is released into the diluent
- More dilute = more potent
C scale vs X scale
C scale – diluted 100 each time
- 1C: 1 hundred times diluted
- 2C: 2 hundred times diluted
- 3C: 3 hundred times diluted
- 200C: 200 times diluted
X scale – diluted by 10 each time
- 1x = 1:10
- 5X = 1:10^5
Traditional Chinese Medicine
- Herbal medicines are used (along with other modalities such as acupuncture) to restore balance of yin and yang
- Typically use combination of herbs
- Common examples – ginseng, licorice, Ma hang
Ayurveda
- A system of traditional medicine native to India
- Incorporates herbal therapies
NHP: 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 uses – treatment of antibiotic-associated diarrhea, IBS, infantile colic, bacterial vaginosis
Ex. Florastor – contains yeast rather than bacteria
Examples of NHP
- Fish oil capsules
- Glucosamine
- Caffeine
- 5-HTP
Drugs isolated from natural sources
- Digoxin – heart failure, from the foxglove plant
- Aspirin – made from salicylic acid
- Morphine – poppy
How are NHPs regulated?
- NHPs are regulated 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 information on safety, efficacy, quality, and proposed label text
- Slightly different regulatory processes
Providing product licenses based on efficacy and safety?
- Type of evidence depends on the type of application and claim
- Compendial application – only need to refer to single ingredient or product monographs, available from Health Canada
- All other applications must submit evidence from all relevant sources to support evidence and safety for recommended conditions of use
- Evidence from human use is required
- Applicants must conduct a systematic, well-constructed literature search to review totality of evidence (favorable and unfavorable)
Compendial applications
-Are applications that rely on monographs, which are written to guide industry when preparing product license applications
Not written for patient counseling
Applicant is referencing an official NHP monograph already published
Applications do not require additional data supporting safety or efficacy
What were some of the issues that led to the need for NHP?
*Before 2004
drug interactions
- Impurities
- Quantity different than what was listed on the label
- No need to prove efficacy
- Sample study – quantity of active ingredient in St. John’s Wart
- 54 products analyzed from Canadian and USA, looking at the content of the active ingredients Hypericin and psuedohypericin
- Only 2 products contained within 10% of label claim
- Very far off from what they contained
- Capsules ranged from 0 to 108% of label claim, median 59%
A new Health Canada directorate
- NHPD – Natural Health Products Directorate was formed to mandate that all Canadians have ready access to natural health products that are safe, effective, high quality while respecting freedom of choice and philosophical and cultural diversity
- Now called: Natural and Non-prescription Health Products (NNHPD
Traditional Health Claim (NHP)
- Evidence must demonstrate use of medicinal ingredients as part of a recognized system of traditional medicine
- Efficacy is based on theories/belief systems of the healing system
- Must show >2 generations of traditional use
- Evidence comes from sources like The Pharmacopoeia of the People’s Republic of China
- Traditional claim wording examples:
Modern Health Claim
- More stringent requirements for scientific evidence
- Sources of evidence:
- Clinical studies
- Textbooks
- Peer-reviewed published articles
- Expert opinion reports
Are randomized control trials needed to support efficacy?
- not always, depends on level of risk
- only required for high risk
- not required for low risk
- Traditional claims do not require RCTs
Class 1 product license application (NHP)
Class 1 – high certainty, low level of review needed
- Quickest application review, within 60 days
- Rely on single compendial monographs
Class 2 product license application (NHP)
Class 2 – medium level certainty, medium level of premarket review
- Review takes ~ 90 days
- Rely on a combination of monographs
Class 3 product license application (NHP)
Class 3 – low level of certainty, higher level of pre-market review
- Ex. Previously unlicensed claims, never seen ingredients or combinations
- Review takes ~ 180 days
Homeopathic medicine requirements? (Licensing for NHPs)
- Require a product license application (DIN-HM)
- Ingredients must be based on those found in a pharmacopoeia such as Homeopathic pharmacopeia of the US (HPUS), and prepared based on the description in these resources
- Evidence for efficacy is typically pharmacopoeias, homeopathy, encyclopedias
- Must be classified as a homeopathic medicine
Evidence of Quality for NHP
- Standards are described in Health Canada document “evidence for quality of finished natural health products”
- Manufacturers must provide a copy of the specifications to which the natural health product will comply
Examples include:
- Product purity
- Pesticides, heavy metals, microbial contaminants
- Quantity of medicinal ingredients
- Potency
- Description of testing methods
- Chemical identification
- Tablet disintegration times
Licensed Natural Health Products Database (LNHPD)
For every licensed product listen in the LNHPD, the following details are: Product name Product license holder NPN/DIN Medicinal and non-medicinal ingredients Dosage form Recommended use/purpose Risk information
Recommend, accept or discourage NHP?
- Recommend if evidence support efficacy and safety
- Accept, maybe recommend if evidence supports safety but not all criteria is met
- Accept, if evidence for efficacy is inconclusive but is safe
- Discourage if evidence indicates inefficacy or serious risk
Natural Medicines Ratings
- Range from effective to ineffective
- Effective if the product has a very high level of reliable clinical evidence supporting its use
- Ineffective if the product has a very high level of reliable clinical evidence showing ineffectiveness for its use
- Effective, likely effective, possibly effective, possibly ineffective, likely ineffective, ineffective
What are the 7 pillars of self-care?
Knowledge and health literacy Mental wellbeing Physical activity Healthy eating Risk avoidance Good hygiene Rational use of products and services
Benefits of self-care
- Self-care contributes to improved outcomes (WHO)
- Increased coverage and access
- Increased quality of services
- Reduced health disparities and increased equity
- Reduced cost and more efficient use of healthcare resources and services
- Improved health, human rights, social outcomes
Guiding Principles of a self-care strategy?
- Accountability
- Empowering
- Resource-optimized
- Relevant
- Collaborative
- Evidence-based
- People-centred
Some statistics about NHPs to be aware of
-If just 2% of Canadians with colds, headaches, heartburn who seek professional care despite mild symptoms practiced self-care, then Canada could eliminate more than 3 million unneeded doctor visits/year and free up physician resources to allow an additional 500,000 Canadians access to a family doctor
Switching prescription drugs to non-prescription drugs
458 million in reduced cost of medicines
$290 million in reduced cost for doctor visits
1 of 7 people would go to the doctor in regard to a minor ailment
COVID enhances the knowledge for health literacy and selfcare
65% of Canadians rate healthcare as top public policy issue
Federal regulatory status of Self-care products
Federal food and drugs act
Principles for requiring a prescription:
- Supervision of HCP is necessary
- Level of uncertainty or its effects justify supervision
- Use can cause harm or risk to the public
Provincial pharmacy acts
- The provinces, through pharmacists, can set 4 conditions of sale for drugs
Schedule 1 – require prescription
Schedule 2 – professional intervention required
Schedule 3 – must be sold in a pharmacy
Unscheduled - sold anywhere
Current issues with Rx to OTC switches
Overlaps with provincial scheduling process
Inefficient, not transparent, or predictable
- NAPRA makes scheduling for everything but Quebec
No protections for innovators
- Second entry products can enter the product before the innovator which is hard to get the investments
Where is access to non-prescription medicines most restricted?
Quebec
- 98 ingredients are more restricted in Quebec pharmacies than in other provinces
Including:
- Allergy treatments
- Heart burn remedies
- Emergency contraception
- Anti-nauseants
- Hair regrowth products
- Omega-3
- Yeast infection treatments
Cosmetics vs NHP vs OTC
Cosmetics - no therapeutic claim, no inspections, no recall authorities, topical/dental/acne therapy/oral health
NHP: therapeutic claim and natural ingredient, reviews done on traditional evidence, no inspections, adverse reactions possible
OTC: therapeutic claim, product review based on science, recall authorities, averse reactions possible
NAPRA Schedule 1 non-RX
must recommended non-prescription drug therapy, and recommend self
NAPRA Standards for Schedule 2 and 3 Drugs
- Standard 1: The pharmacy manager shall ensure that non-prescription products are in the pharmacy which is consistent with the appropriate drug schedule classification stated in the legislation
- Standard 2: the pharmacist shall respect the patients right to privacy and confidentiality
- Standard 3: When the patient requests a consultation regarding a schedule 2 or 3 product, the pharmacist shall collect information to assess the patient’s knowledge and needs before providing advice
- Standard 4: the pharmacist shall take the necessary steps to fulfill their professional obligations when recommending schedule 2, 3 or unscheduled products
- Standard 5: the pharmacist shall document the patient interaction on the patient profile if deemed appropriate
How much per shift does a community pharmacist counsel on OTC?
13%
How is self-care defined?
*no universal single definition
- The ability of individuals to promote health, prevent disease, and maintain health and to cope with illness and disability
- The decision take and the practices adopted by an individual specifically for the preservation of his or her health. Simply put, encouraging self-care means encouraging healthy choices
7 Pillars of Healthcare
- Health literacy
- Self-awareness
- Physical activity
- Healthy eating
- Risk avoidance
- Good hygiene
- Rational and responsible use of products and services
Dominate themes of self-care
Shared decision making
- Consumers/patients and healthcare professionals working together to make decisions
- Associate risk and benefits, and patient preferences
Individual self-efficacy
- Individuals confidence to exert control over their behaviour
- Does an individual have the capacity to take control of their one self-care?
- Essential precursor of effective self-care in patients
4 themes of the self-care matrix?
- Self-care activities
- Self-care behaviours
- Self-care context
- Self-care environment
What is the impact of self-care on healthcare system?
- Decreased costs
- Easing workload
- Increasing healthcare access and equity
- Time and money
- The more self-care you do, the less healthcare you need
self-care can be used for…
symptomatic relief of mild conditions
controls of signs and symptoms
What is self-medication in terms of self-care?
-One element of selfcare
-The selection and use of medicines by individual to treat self-recognized illness or symptoms
-Majority of OTC purchases are made by the consumer alone using product info from packaging
-Facilitated self-medication: when consumers seek help at the point of purchase
One study found that Consumers altered their purchasing decision (25% and 43%) when proactively approached by pharmacy
What are the various self-care options?
- nonprescription medication (schedule 2 or 3 drugs)
- natural health products (vitamins/minerals/herbals)
- non-pharmacological therapy (heat pack for pain)
- diagnostic tests and monitoring devices (pregnancy/glucose tests)
- devices for treatment (ice packs, nasal strips, vaporizers)
Self-care trends in Canada
- 40% of chronic illnesses can be prevented through the practice of better self-care at all stages in life
- 90% of Canadians agree it’s important that governments in Canada provide Canadians with the resources they need to practice self-care for healthy living, so that the health-care system can remain sustainable
Universal Principles to Selfcare (pharmacist-side)
- The patient is always the partner in crime
- Advice is evidence based
- The approach to selfcare is based on patients’ improvement of health
- The relationship between pharmacist and patient is based on trust and confidence
- Pharmacist must personalize all recommendations to match the uniqueness of every patient
- Pharmacist must always be analytical: and be able to problem solve by synthesizing and integrating all information
Minor Ailments definition
Health conditions that can be managed with minimal treatment and/or self-care strategies
- Usually, a short-term condition
- Lab results aren’t usually required
- Low risk of treatment masking underlying conditions
- Medications and medical histories can reliably differentiate more serious conditions
- AKA - Common ailments, self-limiting conditions, ambulatory conditions/ailments
Minor ailments vs self-care
- The terms are not interchangeable
- Self-care is a broad approach that will be taken, minor ailment is a condition
What are some of the specific categories of minor ailments in canada?
- Muscle aches and pains (49%)
- Cold/flu (42%)
- Headaches (37%)
- Cough (27%)
- Back pain (26%)
- Heartburn/indigestion (21%)
- Allergies (15%)
- Insomnia (11%)
- Menstrual cramps (11%)
What are some of the benefits of self-treatment?
- Financial advantages
- Lightened workload for tired healthcare system
- Convenience
- Wide variety of OTC products available
What are some risks of self-treatment?
- Potential for drug-drug and drug-disease interactions
- Overuse or misuse of OTC
- Incorrect diagnosis of the self-care condition
- Misinterpretation of the drug facts label
- Patient confusion caused by combination products and brand line extensions
NDMAC (Nonprescription drug manufacturers association Canada) and minor ailments
A profile of the Canadian self-care product market, 2004
- Studies have shown that many patients are visiting doctors for treatable conditions
- 50% of physicians believe that 25% of their consultations were unnecessary and 65% were for minor complaints of the self-limiting kind
- The industry estimates that if only 10% of people who currently seek formal care as a first step in treating a self-treatable illness were to treat themselves, the Canadian system could save billions of dollars
- Cost of treatment of colds and flu-like symptoms approach $300 million
RPh’s must facilitate self-care and self-medication by providing sound, unbiased advice, information and counselling on….
Disease states
No-drug products
Nonpharmacologic therapies
Non-prescription drug products
Minor ailments and community pharmacists
- New health council of Canada report ranks Canada poorly in international comparison on ability to get timely access to a family doctor
- Expanding pharmacists’ authority and compensation to formally assess and prescribe for minor ailments will reduce costs and take pressure off the system
- Decreased physician workload, allowing them to concentrate more on acute and serious illnesses
Benefits for profession and public for minor ailment prescribing
Benefits for the profession:
- Better use of the RPh’s training and skill
- Improved relationships with patients
Benefits for the public
- Appropriate, convenient, timely access to medication and advice
- Improved patient care for a variety of conditions
- A team approach to healthcare delivery where the expertise of each HCP is utilized to their fullest potential
- RPh review of patient medication therapy to determine an effective treatment regimen
Generally speaking, adherence to medication is …. (patient care process)
adherence is poor
- up to 20% of rx’s are not filled
- up to 50% of patients disregard instructions
Collaborate vs Communicate
Collaborate
- Work jointly on an activity to produce something
- As applicable, may occur with Colleagues, patients, caregivers, family members, other pharmacists, physicians, and other healthcare practitioners
- Happens at every step
- Improves patient outcomes
- Required for standards of practice
Communicate
- Exchange information
- As applicable, may occur with Colleagues, patients, caregivers, family members, other pharmacists, physicians, and other healthcare practitioners
- Happens at every step
- Improves patient outcomes
- Required for standard of practice
- Open ended: allow for more room for conversation
- Avoid leading questions
3 types of questions to avoid
- Closed questions (yes or no)
- Avoid leading questions, already stating the outcome
- Compound/Stacked Questions (only ask 1 specific question at a time)
Rules of documenting
- “To record something in written, photographic or other form”
- Happens at every step
- Improves patient outcomes
- Required to standards of practice
- Purposes:
Legal record of care provided
Communicate information to the rest of team
If you didn’t document it, you didn’t do it
What is SCHOLAR?
about presenting illness S - Symptoms C - Characteristics H - History O - Onset L - Location A - Aggravating Factors (What makes this worse?) R - Remitting Factors (What has been done so far?)
What is HAMS?
about patient
H - Health Status (Conditions, wellness, physical assessment)
A - Allergies/Intolerances (drugs, environment)
M - Medication History
S - Social History (lifestyle, goals, preferences, beliefs)
What are the 3 prime leading questions for new Rx Counselling?
Why - Why are you on this medication? What did the doctor tell you this medication is for?
How - How did the doctor tell you to take this prescription?
What - What did the doctor tell you to expect from this medication?
What are the 3 prime leading questions for Counselling a refill rx?
Why - Why are you taking this medication?
How - How are you taking it?
What - What is it doing for you? Is it working/helping?
What is the objective during the Assess phase?
- Analyze information that has been collected to identify any real of potential drug therapy problems
- In addition to patient-specific information, requires in depth understanding of pathophysiology, pharmacology, medicinal chemistry, pharmacokinetics, therapeutics
- Drug therapy problems
- A drug therapy problem is any undesirable event experienced (or expected) by a patient that involves or is suspected to involve, drug therapy, and that interferes with achieving the desired goals of therapy and requires professional judgement to resolve
What is the order of the Patient Pharmacist Care Plan?
Collect Assess Plan Implement Follow-up
Actions of Assessment in the patient-care process?
-You will need to communicate and document your assessment
- Explain to prescriber, patient, other pharmacists’, other team members what the problem is
-Triage
No treatment needed
oRecommend therapy
oRefer but recommend self-care until other HCP seen
oRefer for medical care (ER)
What is the main goal of the pharmacist patient care process?
patient centredness
- ensuring the patient is comfortable and confident
What are the 3 A’s associated with Implementing in the Patient Pharmacist Care Process?
Action – mechanism of action, onset of action, benefits
Administration – drug name, dosage, frequency, route and time of administration, length of therapy
Adverse Effect – common side effects, side effect management
What are the guides to Monitor and Evaluating?
“If you dont follow up, you dont care”
- Tell them to come in or call if any issues
- delegate that to another member
- Continuous medication appropriateness/effectiveness/safety
- Don’t forget to communicate, collaborate, document
How are general headaches described?
- Pain or discomfort in the head, scalp, neck
- Most prevalent neurological disorder
- Lifetime prevalence of 66%
- Women»_space;> men
- 2.1 millions vs 1 million (women vs men)
- Tend to decline as individuals reach 40 years of age
- Account for 20% of work absences
Primary Headache Etiology
- ~90% of headaches
- Not associated with an underlying illness
Ex: TTH Cluster Migraine Benign exertional HA Cold-stimulus headache
Secondary Headache Etiology
Associated with organic cause; symptoms of an underlying condition
Ex:
Medication overuse headache
Sinus headache
What are some causes behind headaches?
- Infections
- Temporal arthritis (over 50 years of age)
- Subdural hematoma
- Subarachnoid haemorrhage
- Cerebral ischemia (stroke)
- Transient ischemic attack
- Systemic/CNS vasuclitides
What types of drugs list headaches as a side effect?
o ACEIs o BBs o CCBs o H2 antagonists o Nitrates o NSAIDs o Oral contraceptives and HRT o Other antihypertensives o SSRIs
Drugs associated with intracranial hypertension*
Antibiotics
Corticosteroids
Other
What is the nature and severity of pain of a TTH?
Pressing/Tightening (non-pulsating pain)
Usually mild to moderate pain
What is the nature and severity of pain of a migraine?
Throbbing and pulsating pain
Moderate to severe pain
What is the nature and severity of pain of a cluster headache?
penetrating and stabbing feeling
excruciating pain
What is the nature and severity of pain of a sinus headache?
pressure behind the eyes or face
dull type of pain, worse in the morning**
What is the onset and duration of TTH?
Gradual onset
Can last 30 minutes to 7 days
What is the onset and duration of Migraine?
sudden onset
can last for 4-72 hours
What is the onset and duration of cluster headaches?
onset is random
can last for 15-180 minutes
What is the onset and duration of sinus headache?
simultaneously with sinus issues
Can last days
What are the other symptoms of a TTH?
muscle pain radiating along the neck/trapezius muscles and scalp
bilateral pain
What is the only type of headache that is aggravated by physical activity?
Migraine
what are the other symptoms of migraine headaches?
nausea and vomiting
photophobia - cant look in light
phonophobia - sensitive to sound
unilateral (fronto-temporal)
what are the other symptoms of cluster headaches?
lacrimation, nasal congestion, sweating, eyelid swelling
unilateral pain
orbital or temporal pain
What are the other symptoms of a sinus headache?
sinus like symptoms
nasal discharge/congestion
bilateral, on the face and forehead area
- in your sinuses
What is the most common headache?
TTH (stress headache)
- no nausea or vomiting
- thought to happen because of mental stress, anxiety, depression, emotional conflicts, stimuli
What headache has an aura associated with it?
Migraine
- stress, fatigue, oversleeping, caffeine, missing a meal, menses, food
- certain foods (nitrates, oral contraceptives, hormones)
What headache is associated with upper teeth pain?
Sinus headache
- also accompanied with nasal pain, facial pain, pressure-like pain
What is the least common type of headache?
cluster headache
- in 25-50 year olds (have several attacks of them)
must be referred to emergency
- nasal congestion, facial swelling
ER Referral SSNOOPP
S - systemic: fever, N/V, appears ill S - Severe ? N - Neurologic symptoms O - onset is abrupt or new O - associated conditions P - Prior history? Headache history? P - pain? unilateral? vision?
What requires non-emergent referral ?
- secondary causes of headache
TTH or migraines - more than 8 headaches/month - therapy? - 1st headache ever
- occurrence at night or morning?
- Patient is over 50 with tenderness in temporal artery
- onset with exercise or sexual activity
- pain is a 6
When is immediate medical assessment necessary?
worst headache ever, loss of balance or consciousness, reflexes/sensations, vision, fever, mental status
When is medical assessment SOON appropriate?
chronic and progressive pain
significant change in headache patterns
What are primary headache disorders?
TTH
Migraine
Cluster headache
Medication overuse headache
When to promote self-care?
intermittent TTH
mild-moderate migraine
sinus headache in a diagnosed sinus infection
When to prescribe an Rx dose of an NSAID?
mild to moderate TTH not relieved by nonRx/self-care measures
mild to moderate migraine
What are the 4 phases of an aura during migraine headache onset?
1 - prodrome - a burst of energy or burst of fatigue (24-48 hours)
2 - Aura - Visual sensation, auditory sensations, motor issues
3 - Headache
4 - Postdrome - exhaustion, head movement causes pain
How soon should you follow up with a patient who has a severe HA?
2-10 days
How soon should you follow up with a patient with a chronic headache?
after 4-6 weeks
how soon should you follow up with a patient who has a episodic headache?
6-12 weeks
What counselling is required for with headaches?
Nonpharmacological management (HA diary) loading doses for NSAIDS, triptan use, timing if aura present - Avoidance of MOHs Side effects of chosen treatment
Nonpharmacological measures for headaches
rest in a dark, quiet room apply a cold cloth/ice pack avoid bright lights, loud sounds, and stressful situations avoid triggers stretching head and neck muscles
What is the 1st line of treatment for Episodic TTH treatment?
Ibuprofen - 400mg
Aspirin - 1000mg
Naproxen 550mg
Acetaminophen 1000mg
Prophylactic treatment of episodic TTH?
1st line treatment:
amitriptyline 10-100 mg/day
nortriptyline 10-100 mg/day
second line:
Mirtazapine 30 mg/d
venlafaxine 150mg/d
Chronic TTH treatment?
ibuprofen 400mg
Aspirin 1000mg
Naproxen 500 or 825mg
acetaminophen 1000mg
1st line treatment for migraines?
ibuprofen 400mg
aspirin 1000mg
naproxen 500mg or 825mg
acetaminophen (less effective) 1000mg
2nd line treatment for migraines
Sumatriptan 100mg
Rizatriptan 10mg
Almotriptan 12.5mg
Domperidone 10mg
Metoclopramide 10mg QID PRN
3rd line treatments for migraine?
naproxen and triptan 500-550mg
4th line of treatment for migraines
fixed dose-combination analgesics
may be with codeine if necessary
What is the absolute last resource for migraines?
opioids
Non-prescription analgesic rules to be aware of …
use of analgesics should be limited to 3 days per week
increased risk of adverse effects
medication overuse headaches
What are rebound headaches?
may occur in migraine or TTHA
may happen due to continuous HA associated with use of analgesic medication for greater than 3 months
pregnancy and lactation with headaches
1st line - nonpharmacologic measures
- migraines often improve during pregnancy
- TTHAs do not lessen during pregnancy
- breastfeeding tends to reduce migraine frequency
