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 introduces what the Product Information is (more commonly referred to as the PI) and why it is such an important document. It outlines the Therapeutic Goods Administration’s form for, and content of, the PI which must be adhered to for all prescription and pharmacy-only medicines. By the end of this module, you should feel confident in generally navigating your way through PI documents. In the following modules, each section of the PI is examined in greater detail.

This module covers sections 1 & 4.1 to 4.7 of the form for providing product information

This module covers sections 4.8 and 4.9 of the form for providing product information

This module covers sections 5 to 10 of the form for providing product information

This module develops understanding of the Product Information (PI) approval process. It considers the similarities and differences between PI, Minimum Product Information (mPI) and Consumer Medicine Information (CMI).

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