Module 1 - Regulations and Governance Flashcards
Pharmacology
“Study of Medicines”
- key intervention in relieving and preventing human suffering
- how drugs are administered
- where they travel in body
- actual response
- how drug is eliminated
Factors of Complexity
- Large volume of drugs
- >10,000 agents currently
- nomenclature can confuse communication - Each drug has own characteristics
- therapeutic applications, interactions, side effects, mechanisms of action - Each drug has more than one indication
- overlapping map of knowledge
- cannot diagnose pt by medication list - Drugs elicit different responses depending on individual factors (ie. age, sex, body ass, health status, genetics)
Evidence-based medicine
Making decision according to research.
eg. Pharmacotherapy practices EBM
Drug
chemical agent capable of producing a biological response
- a medication is a medically therapeutic drug
- synthesized in lab
Patent
Period of exclusivity, where that pharmaceutical company only determines the price of medication
- provides 20 years of protection, actual length of exclusivity is around 7-9 years in Canada due to regulatory hurdles
- Once period of exclusivity ends, generic companies can produce same drug w/ no consequence, market te generic equivalent of drug for less money and consumer savings are considerable
Point and Justification of patent
Point - for company to recover costs and make money
Justification - they have to recover money spent on clinical trials
bioequivalent
the rate and extent to which the active ingredient is:
- absorbed from a drug product and
- becomes available at site of drug action to produce effect
- if they can prove product to be bioequivalent to one that is on market, they are granted approval (no need for replication of clinical trials)
Biologics
Medications produced using biological process in living organisms such as yeast and bacteria
- complex, large molecules derived from living sources and produced through intricate steps
Examples of Biologics
- hormones (eg. Insulin made my ecoli molc) or erythropoeitin
- monoclonal antibodies (Mab)
- natural products and components
- interferon
- VACCINES (where they use an organism to make the drug)
Natural health products (NHP)
- vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics
- similar action to modern drugs, but regulated differently
Advantages of Prescription drugs
- HCP examines client and order specific drug (guaranteed expert advice)
- Amount of frequency of drug is controlled
- Instructions interactions and side effects of drug are identified and monitored (ideally)
Disadvantages of Prescription drugs
- require prescription
2. need for HCP appointment
Advantages of OTC drugs
- No HCP appt. required
2. Less expensive than prescription drugs
Disadvantages of OTC drugs
- client may choose wrong drug
- Client may not know reactions or interactions
- ineffective treatment may result in progression of disease
Canadian Drug Regulations
- purpose is to protect the Canadian public
- some drugs contained hazardous levels of dangerous and/or addictive substances
Health Products and Food Branch
- part of health canada
- responsible for ensuring health products and food are safe and of high quality
- regulates the use of therapeutic products through directorates
Therapeutic products directorate
- authorizes marketing of pharmaceutical drug (both prescription and OTC) or medical device
- products must be scientifically proven (through clinical trials ) to the Food and Drugs Act and Regulations
Biologics and Genetic Therapies Directorate
- regulates biologic drugs and radiopharmaceuticals
- examples of biologics: blood products, vaccines, tissues, organ and gene therapy products
- examples of radiopharmaceuticals : radioactive iodine for hyperthyroidism
Natural and Non-prescription Health Products Directorate
- regulates use and sale of NHPs
- conducts a review of safe and appropriate uses of each product before it can be authorized for sale
- also set up regulations for manufacturing within Canada or importation of sale in Canada
