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