Laws and Legislation Flashcards
the national parliament has the power to “make laws for the peace, order and good governance of Canada” except for __
” subjects assigned exclusively to the legislatures of the provinces”
t/f no provincial legislature can take over the powers of Parliament and vice-versa
true
what is federal law?
high-level, applies throughout the country, has precedence over provincial
what is provincial law?
builds on/supports federal law, or creates within its own authority, may vary by province
what type of law regulates the manufacturing, sale, and importation of therapeutic products?
federal
what type of law regulates the practice of pharmacy>
provincial
___ guides a pharmacist through the grey areas of the law
code of ethics
an act is also known as __
enabling legislation
an act beh=gins is what form>
draft form (a bill)
an act outlines how parliament can delegate __ to other bodies to create regulations
power
regulations are also known as
delegate r subordinate legislation
___ are not made by parliament, but someone parliament as given authority to
regulations
which is easier to change? an act or a regulation?
regulation
regulations must be consistent with the __ under which they are made
act
a ___ is the operational part of the law, the processes and procedures needed to comply with the law
regulation
what is NAPRA
national association of pharmacy regulatory authorities
what is the MSOP by NAPRA?
the model standards of practice; the minimum standards of practice a pharmacist must meet and against which their performance will be evaluated
what are the 4 domains of the MSOP?
- expertise in medications
- collaboration
- safety and quality
- professionalism and ethics
what body assigns DINs?
therapeutic products directorate of health Canada
manufacturers file for patents before/after clinical trial starts?
before
what is a patent?
a set of rights granted by a government that gives the holder the exclusive right to make and sell an invention
how does the government make sure drugs are safe?
if clinical trial shows potential therapeutic value that outweighs the risks
the way a drug works when used in the population is called the ___
effectiveness
what is a medication incident?
any preventable event that may cause or lead to inappropriate medication user patient harm while in the control of HCP or consumer
what is a hazard?
a setting or technology that has potential to cause harm
what are near misses?
events that could have resulted in unwanted consequences, but did not bc of chance (unplanned) or time intervention (planned)
what is a no harm event?
mistake reaches patient, but results in no injury
all suspected adverse drug reactions should be reported, especially those that are __
- unexpected, regardless of severity
- serious, regardless if expected or not
- reactions to recently marketed products
