UMORE - Pharmacy

Program 5

Program 5: Understanding Product Information

Program 5 course image

This Program covers the scientific, medical and the therapeutic information contained in product information, with the incorporation of practical activities and scenarios. The program elaborates upon how product information is structured to comply with the Therapeutic Goods Administration requirements.

Program 5 is comprised of 5 modules and is estimated to take approximately 18 hours to complete.

Intended Learning Outcomes

  • Describe the roles the product information (PI), Minimum PI and CMI play within the pharmaceutical industry
  • Demonstrate understanding of the format and content of the PI
  • Use the PI to communicate key information on a product’s use
  • Explain the roles of the different product naming conventions used in Australia
  • Identify the Australian categories for prescribing medicines in pregnancy
  • Differentiate between an Adverse Event (AE) and an Adverse Drug Reaction (ADR) and interpret and apply DAEN database information
  • Classify medicines based on Schedules 2, 3, 4 and 8 in the poisons schedule
  • Explain the Black Triangle Scheme and black box warnings
  • Describe the PI approval process for a new product or a new indication for an existing product

Module contents

This module will introduce background information about the Product Information. We will investigate the overall format of the PI and develop knowledge of its general content.

This module will cover sections 1 & 4.1 to 4.7 of the PI

This module will cover sections 4.8 and 4.9 of the PI

This module will cover sections 5 to 10 of the PI

This section will cover PI Approval and Updates

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