PHRM100 - WEEK 9 Study Guide

PHRM100 - WEEK 9 Study Guide

Food and Drugs Act

  • Overview of the Food and Drugs Act detailing its importance in the regulation of pharmaceutical products and safety standards.

Verbal Prescription Guidelines

  • Definition: A verbal prescription is an order given by a licensed practitioner directing dispensing of a specified drug or mixture of drugs.

  • Required Information on a Verbal Prescription:

    • Date: The date the prescription is issued.

    • Patient's Information: Name and address of the patient.

    • Doctor's Information: Name, address, and phone number of the prescribing doctor.

    • Drug Information: Drug name, strength, and dosage form.

    • Quantity: The amount of drug to be dispensed along with the refills if authorized.

    • Directions for Use: Instructions on how the medication is to be taken.

    • Signature: Signature of the person receiving the prescription.

  • Additional Considerations:

    • Ask for an identifying piece of information such as date of birth or health card number for patient verification.

    • Request a callback phone number for questions regarding the prescription.

    • Collect the CPSO number to verify the prescriber.

    • Inquire about allergies or medical conditions if appropriate.

    • Discuss special considerations related to the delivery of the medication.

Manufacturer's Labels

Required Information on Manufacturer’s Labels:

  • Proper Name & Brand: The brand name given by the manufacturer.

  • Quantitative List: A list of all medicinal ingredients present in the product.

  • Common (Generic) Name: Generic name of the drug for easier identification.

  • Lot Number: The batch number assigned to production for quality tracking.

  • Expiry Date: Indicating the date through which the drug maintains labeled potency, expressed as MM/YY.

  • Directions for Use: Instructions indicating how to properly use the drug.

  • Storage Conditions: Recommended environmental conditions to keep the drug effective.

  • Additional Information: Includes barcodes, cautionary statements, and diseases/disorders for which the drug can be used.

Drug Scheduling Regulations

  • Prescription Drug List: Overview of drug scheduling according to NAPRA categories.

    • Example: Acetylsalicylic Acid (ASA) scheduling based on dosage strength and intended use:

    • ASA 80 mg or less/dose (<24/pk)

    • ASA 81 mg for adult use

    • ASA 650 mg or greater

Child Resistant Packaging

  • Requirement: All prescription drugs must be dispensed in child-resistant packaging unless there is a specific request from the patient or prescriber for an easier-open alternative.

  • Documentation: An acknowledgment form must be signed, and this must be recorded in the prescription filling software.

Definitions from FDA Definitions

  • Common Name: Refers to the generic name of the drug.

  • Expiration Date:

    • Definition: Indicates the date during which a drug maintains its potency, after which the manufacturer recommends it not be used.

    • Expression: Presented in a MM/YY format.

  • Internal Use: Refers to medications ingested orally or applied to mucous membranes.

  • Official Drug: A drug for which standards are established in regulations.

  • Parenteral: Refers to medications administered via syringe, through the skin or mucous membranes.

  • Practitioner: Authorized individuals who are allowed to prescribe medications as per provincial regulations.

  • Pharmacist: Registered professionals who practice pharmacy and operate dispensaries.

  • Pharmacy Technician: Individuals authorized to practice as pharmacy technicians in their respective provinces.

Prescription to OTC Status

  • Transition: Some prescription drugs can be moved to over-the-counter (OTC) status if the associated risk is considered low.

    • Examples: Nicorette, Plan B, Nexium, Nizoral, Rogaine, Zantac, Motrin, Aleve.

Expiry Dates and Refills

  • No legislated time frame exists for patients to fill a prescription, except for T/C (controlled substances).

  • Pharmacists are required to document any repeats including date, quantity, and signature.

  • New legislations enable pharmacists to extend refills when necessary. If a physician passes away, all associated refills become invalid.

Coursework and Homework Assignments

  • Upcoming assignments:

    • NAPRA Drug Schedules Quiz (5%) due November 9th.

    • Review FDA Module/Self Study Guide for FDA Quiz (2%) due November 9th.

    • Prepare for the verbal prescription assessment (10%) to be held in class on November 10th.

Conclusion

  • The study guide provides essential information regarding the Food and Drug Act and verbal prescription guidelines, highlighting the necessary legal definitions, regulations, and practical implications relevant for pharmacy practice.