Overview of Clinical Trials Phases

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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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Faxing a prescription

"Facsimile transmission" means transmission of the exact visual image of a document by way of electronic equipment.
Prescription drug orders may be transmitted by facsimile by a prescriber to a pharmacy, provided that the following requirements are met:
1. The prescription must be sent only to pharmacy of the patient's choice with no intervening person having access to the prescription drug order.
2. The prescription must be sent directly from the prescriber's office, directly from a health institution for a patient of that institution, or from another location, provided that the pharmacist is confident of the prescription's legitimacy.
3. The equipment for the receipt of the facsimile prescription must be located within a secure area to protect the confidentiality of the prescription information.
4. The prescription must include the:
a) Date of issue
b) Patient's name and address
c) Name of the drug or ingredient(s) and strength where applicable
d) Quantity of the drug which may be dispensed
e) Dosage instructions for use by the patient which shall include a specific frequency or interval or maximum daily dose
f) Refill authorization where applicable, which shall include the number of refills and interval between refills
g) Prescriber's Name, address, telephone number, fax number and signature or unique identifier (as approved by the Pharmacy Regulatory Authority)
h) Time and date of transmission
i) Name and fax number of the pharmacy intended to receive the transmission
j) Signed certification that:
i. the prescription represents the original of the prescription drug order,
ii. the addressee is the only intended recipient and there are no others, and
iii. the original prescription will be invalidated or retained so that it cannot be re-issued.
5. The pharmacist is responsible for verifying the origin of the transmission and the authenticity of the prescription.
6. The prescription drug order must be maintained on permanent quality paper by the pharmacy.
7. Facsimile transmission can be accepted from a practitioner registered to practice in any Canadian province.
8. Pharmacist-to-pharmacist communication of prescription transfers (for other than narcotics and controlled drugs) may be completed by facsimile transmission. The transferring pharmacist must include his or her name and the address of the pharmacy with the other required documentation as required by federal and provincial legislation. The name of the pharmacist requesting the transfer must also be known and recorded on the document to be faxed. The receiving pharmacist must ensure the authenticity of the transmission.
From NAPRA

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10 Generic Drugs Facts

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)

Overview of NAPRA’s National Drug Schedules (NDS)

Schedule I drugs: A prescription is required. Schedule I drugs are provided to patients by the pharmacist following diagnosis and intervention of a healthcare practitioner. The sale of schedule I drugs is controlled in a regulated environment according to provincial pharmacy legislation.

Schedule II drugs: A prescription is not required. However, schedule II drugs are available only from the pharmacist and must be stored within an area of the pharmacy where there is no public access and no opportunity for self-selection. Schedule II drugs require the professional intervention of the pharmacist at the point of sale and possibly referral to a healthcare practitioner.

Schedule III drugs: A prescription is not required. However, schedule III may present risks to certain populations in self-selection. Schedule III drugs are sold from the self-selection area of the pharmacy which is operated under the direct supervision of the pharmacist, subject to any local professional discretionary requirements which may increase the degree of control. The pharmacist is available, accessible and approachable to provide assistance.

Unscheduled drugs: Unscheduled drugs can be sold without professional supervision. Adequate information is available for the patient to make a safe and effective choice. The labeling of unscheduled drugs is deemed sufficient to ensure the appropriate use of the drug.

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Top 5 Tips for EE Review

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

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.

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

Some 2013 Canadian drug approvals

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Which of the following newly approved drugs is used in the treatment of Parkinson’s disease?

A. Mirabegron
B. Rotigotine
C. Trametinib
D. Pasireotide
E. Olodaterol


Answer: B

Rotigotine is a transdermal dopamine agonist for Parkinson's disease and restless legs syndrome.
Mirabegron- A beta-3 agonist for overactive bladder; Trametinib- A kinase inhibitor for advanced melanoma; Pasireotide - A somatostatin analogue for Cushing's disease; Olodaterol- Inhaled long-acting beta-agonist bronchodilator for COPD.



Which of the following fentanyl formulations is not approved in Canada?

A. IV Solution
B. Transdermal Patch
C. Sublingual Tablet
D. Nasal Spray
E. None of the above

Answer: E

C-Fentora and D-Instanyl have been approved in 2013.
A list of new drug dosage forms approved by Health Canada in 2013 is available at www.cpepreponline.com under “Free Pharmacy Resources #1”



Integrase inhibitors also called integrase strand transfer inhibitors belong to the class of antiretroviral drugs used in the treatment of HIV infection. They inhibit the action of the viral enzyme integrase that inserts the viral genome into the DNA of the host cell. Integrase inhibitors are co-administered with other antiretroviral agents. Which of the following drugs are integrase inhibitors?

I. Raltegravir
II. Dolutegravir
III. Elvitegravir

A. I only
B. III only
C. I and II only
D. II and III only
E. I, II, and III

Answer: E
Dolutegravir and Elvitegravir have been approved in 2013.

Exam Strategies

Helpful Exam Strategies


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 at1st glance to narrow the options
If two of the alternatives are similar, give them your consideration!

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

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