Drug regulation and discovery in canada Flashcards
(30 cards)
1
Q
history of canadian pharmacy
A
- during the 1800s, drugs in canada were unregulated
- opium was widely available without a prescription
- travelling medicine shows proclaimed the latest ‘ miracle cure’
- there were major concerns regarding the purity of imported drugs
2
Q
what are the 4 general ways the practice of pharmacy is controlled in canada
A
- courts
- federal, provincial and local legislatures
- federal and provincial regulatory agencies ie NAPRA and NBPhS
- professional organizations, ie CAPT, NB college of pharmacists, CPhA, NB dental hygienists associations, canadian dental hygienists associations
3
Q
how are drugs regulated
A
- 1884 - adulteration act
- 1920 + amendments in 1950 - food and drug act
- federal acts, like canada health act, controlled drugs and substances act, and food and drugs act
- provincial acts, like pharmacy act, health professions act and tobacco act
4
Q
what is the canada health act
A
- canada’s federal health insurance legislation
- ensure that all eligible residents of canada have reasonable access to medically necessary insured services on a prepaid basis, without direct charges at the point of service for such services
5
Q
what are insured health care services
A
- medically necessary hospital, physician and surgical-dental services provided to insured persons
6
Q
what are extended health care services
A
- certain aspects of long-term residential care (nursing home intermediate care and adult residential care services), and the health aspects of home care and ambulatory care services
7
Q
who are insured persons
A
- eligible residents of a province or territory
8
Q
who would be excluded under the canada health act
A
- serving members of the canadian forces or RCMP
- inmates of federal penitentiaries
- WCB claimants
9
Q
what is the food and drugs act
A
- ensure products that affect human health are identified
- cannot make unsubstantiated claims about efficacy
- regulates production and distribution of many drugs
- ensure drugs cannot be marketed without NOC (notice of compliance) and DIN (drug identification number)
10
Q
food and drugs act schedules
A
- schedule a - diseases and health. conditions where unsubstantiated advertising claims relate to
- schedule b - list of standards for identification and classification of drugs
- schedule c - radiopharmaceuticals
- schedule d - substances derived from humans, animals or microorganisms
- schedule f - prescription drugs
- schedule g - controlled drugs
- schedule j - restricted drugs
11
Q
what is a drug identification number (DIN)
A
- assigned to a brand name, generic, or OTC product to identify the manufacturer, drug, and packaging size
12
Q
issues in administration of controlled substances
A
- narcotics are stored in a locked cabinet
- keys are issued according to unit policy
- drug counts are performed at change of shift
- discrepancies are reported immediately
- special records are required each time a narcotic is dispensed
13
Q
what is the controlled drugs and substances act
A
- controls the purchase and use of substances that are dangerous to the public (narcotics, street drugs, benzodiazepines)
14
Q
how are the controlled drugs and substances classified
A
- into 8 schedules
- schedule I - narcotics
- schedule II - cannabis
- schedule III - amphetamines
- schedule IV - barb, benzo
- schedule V - propylhexedrine
- schedule VI - precursors to make controlled substances
- schedule VII - cannabis >3 kg (trafficking)
- schedule VIII - cannabis <30 g (resin < 1kg) = possession
15
Q
what is NAPRA
A
- national association of pharmacy regulatory authorities
- goal is to develop national consistency
- what drugs go on what schedules
- how various prescriptive issues handles
16
Q
what are the national drug schedules (NAPRA schedule)
A
- harmonization of drug classification
- 4 schedules:
- schedule I - prescription products
- schedule II - non patient access products
- schedule III - patient self-selection area with pharmacist intervention
- schedule IV - unscheduled; for any sale in any establishment
17
Q
what are the 3 provincial acts
A
- pharmacy act
- medical act
- health professions act
18
Q
why don’t we see drugs advertised on canadian television
A
- health canada prohibits advertising to the general public of any food, drug, cosmetic or device for the treatment or cure of any diseases listed on schedule A
19
Q
why do we ban the advertisement of drugs in canada
A
- prevent fraud
- prohibit advertising for cures where no cures exist
- prohibit advertising of self-treatments when self-treatments aren’t safe
- encourage people to seek medical attention
20
Q
how long does it take to develop a new drug
A
- 1 in 10,000 drugs will be approved for sale
- developing a new drug is a 10-15 year, $1 billion effort
- extended patents allow drug companies to recoup these costs
- benefits greater than risks
- regulated by therapeutic products directorate (TPD) of health canada (health protection branch = HPB)
- first ensure drugs are safe and effective
21
Q
what must go on a drug label
A
- Pr symbol
- DIN
- manufacturer
- strength
- generic name and drug form
- lot and expiration
- active ingredients and their strength
- drug facts
- required on all OTC drug package labels
- help consumer understand how to use product
22
Q
what must be in each prescription product packaging for pharmacists
A
- HPB requires manufacturers to provide scientific information to pharmacists in the form of a product package insert (PPI) for all prescription drugs
23
Q
what is the drug recall process
A
- process of withdrawing a drug from the market by health canada or the drug manufacturer for the serious adverse effects or other defects in the product
- health canada may issue a drug recall when the risk outweighs the perceived benefit, or a manufacturer may voluntarily withdraw a drug because of future liability concerns
24
Q
what are generics
A
- once a brand name drug is off patent, generic versions can be produced
- generic drug applications are abbreviated:
- do not require preclinical or clinical data
- must instead prove that the generic is bioequivalent to the brand name drug
25
what is the abbreviated new drug application (aNDA)
- the process by which applicants must scientifically demonstrate to HPB that their generic product is bioequivalent to, or performs in the same way as, the innovator drug
26
what is a generic drug
- a drug that contains the same active ingredients as the brand name product and delivers the same amount of medication to the body in the same way and in the same amount of time; a drug that is not protected by a patent
27
what does bioequivalent mean
- a generic drug that delivers approximately the same amount of active ingredient into a healthy volunteer's bloodstream in the same amount of time as the innovator, or brand name, drug
28
what does pharmaceutically equivalent drug product mean
- a drug product that contains the same amount of active ingredient in the same dosage form and meets the same standards (ie strength, quality, purity, and identity)
- can be substituted without contacting the prescriber
29
what does pharmaceutical alternative drug product mean
- a drug product that contains the same active therapeutic ingredient but contains different salts or different dosage forms
- cannot be substituted without the prescriber's authorization
30
how do generic drugs help control the high cost of pharmaceuticals
- dispensing of generics saves 30 to 80% compared to brand name drugs
- multiple companies may manufacture generics, thereby fostering competitive pricing
- generics save customers over $10 billion each year
