New Drugs Approved by Health Canada in 2018

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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.

Overview of Clinical Trials

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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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Top 10 Generic Drugs Facts

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1. Health Canada reviews and approves all drugs (brand-name and generic) before they can be sold in Canada. 
2. Health Canada mandates that a generic drug is designed to work the same way in the body as the original brand-name drug.
3. 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.
4. 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.
5. Generic drugs must also have the same amount of active ingredient in the prescription.
6. 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.
7. 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.
8. 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.
9. About two-thirds of all prescriptions in Canada are filled with generic drugs.
10. Everyday in Canada, approximately one-million prescriptions are filled using generic drugs.

From The Canadian Generic Pharmaceutical Association (CGPA)

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5 Keys Tips for PEBC Evaluating Exam Prep

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Tip#1: Start early! The curriculum is extensive.

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:

Note Taking Guide

http://wps.pearsoned.co.uk/ema_uk_pp_studyskills/128/33013/8451396.cw/index.html

Tip#4. Study as many practice questions as you can! Practice, practice and practice!

Tip#5. Review your written notes. Your notes represent a concise summary of the core subject areas.

Finally, Take the FREE Computer-based EE Readiness Exam at cpepreponline.com

Disclaimer: These exam review tips are general guidelines and do not in anyway guarantee succeeding any exam.

Exam Strategies for PEBC EE Candidates

-Relax
-Manage your time wisely
-Read questions carefully
-Attempt the questions that are easiest for you first. Come back and do the harder ones later.
-Circle or underline important terms. Some important terms called modifiers and qualifiers are: only, always, sometimes, rarely, never, none, usually, sometimes, frequently and often
-Try to think of the answer before looking at the options

When you don’t know the answer
-Never leave a question blank
-Eliminate choices you know are incorrect at first glance to narrow the options
-If two of the alternatives are similar, give them your consideration!

Good Luck!!

Disclaimer: These exam strategies are general guidelines and do not in anyway guarantee succeeding any exam.
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