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Sampling of new drugs approved by health
Canada in 2018. Get the complete list at www.cpepreponline.com
under “Free Pharmacy Resources”. Feel free to share!
Generic
Description
Flibanserin
A serotonin
agonist/antagonist for premenopausal women with hypoactive sexual desire
disorder.
Apalutamide
An androgen
receptor inhibitor for non-metastatic, castration-resistant prostate
cancer.
Cidofovir
An IV antiviral for
CMV retinitis in adults with AIDS.
Ertugliflozin
An SGLT2 inhibitor
for type 2 diabetes.
Dalbavancin
A single-dose IV
lipoglycopeptide antibiotic for acute bacterial skin/skin structure
infections.
Phase
I: The experimental drug is tested in a small group
of healthy individuals (20-80) to evaluate its safety, determine a safe dosage
range, and identify side effects.
Phase II: The experimental drug is
given to a group of patients with the disease being tested (100-300) to
determine the drug effectiveness, dosage, and to further evaluate its safety by
monitoring side effects.
Phase III: The experimental drug is
given to a larger group of patients (1,000-3,000) to confirm its effectiveness,
dosage, monitor side effects, and collect all relevant information to optimize
therapeutic use.
Phase IV: Also called post-marketing
study. The primary goal of phase IV trial is the long term assessment of the
new drug safety and effectiveness.
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CPEPrep is the only provider of Pharmacy
technician Regulation Accredited by the Canadian Council on Continuing
Education in Pharmacy (CCCEP).
Health Canada reviews and approves all drugs (brand-name and generic)
before they can be sold in Canada.
Health Canada mandates that a
generic drug is designed to work the same way in the body as the original
brand-name drug.
Health Canada requires that both brand-name and generic drug companies follow the
same rules for the manufacturing process and for ensuring the quality of
their ingredients.
Health Canada mandates that generic drugs have the same active ingredient
and that they work the same way in the body as the brand-name drug.
Generic drugs must also have the same amount of active ingredient in the
prescription.
Health Canada even regulates the non-medicinal ingredients, such as
fillers and preservatives, for both brand-name and generic drugs and they are
subject to the same approval process.
When a generic drug is approved by Health Canada that means
the medicine is as safe and as effective as the original brand-name drug and
they will work the same way.
The only difference between a generic and a brand-name drug is the
price. Generic drugs are used to fill more than 63% of all prescriptions
in Canada, but they account for only 24% of the $22.1-billion dollars Canadians
spend annually on prescription drugs.
About two-thirds
of all prescriptions in Canada are filled with generic drugs.
Everyday in Canada, approximately one-million prescriptions are filled
using generic drugs.
From
The Canadian Generic Pharmaceutical Association (CGPA)
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Tip#2: First, review the core subject areas
ideally in the following order:
1. Biomedical Sciences
2 or 3. Pharmaceutical Sciences
2 or 3. Pharmacy Practice
4. Pharmacy Administration
Tip#3: Take advantage of the POWER of note taking.
When you write down something you have a BETTER chance of remembering it! Get a
dedicated notebook and write down key learning objectives. Here is a great guide
on note taking: