Drug distribution and regulation (1 hr Lecture+2 hrs Tutorial)

Description

This course focuses on processes, operations and regulatory aspects dealing with drug distribution. The goal of this course is to provide insight into how pharmacists can ensure safe, legal and accurate handling of drugs. Students are trained to evaluate prescriptions and medication orders, monitor the integrity of drug distribution systems, and recognize potential custodial or cold-chain breaches. As well, the requirements for accurate and safe compounding of sterile and non-sterile preparations will be emphasized. Students are expected to use critical thinking skills to recognize and resolve actual problems within the drug distribution system in addition to providing suggestions regarding potential risk mitigation.

Program

Bachelor of Pharmacy-B Pharm

Objectives

• a. Knowledge and Understanding a.1. Describe the role of regulatory authorities in drug distribution. a.2. Define prescriptions, clinical trials, drug recall and safe compounding of preparations. a.3. Outline the principles of drug and cold chain distribution. b. Intellectual Skills b.1. Contrast different regulatory bodies responsible for affording safe and effective medicines. b.2. Interpret compounded prescriptions and revise clinical phases (GCP). b.3. Select the conditions required for cold storage, distribution (GSP) and product recall. c. Professional and Practical Skills c.1 Address validity and completeness of prescriptions, safe compounding and storage of medications. c.2. Ensure cleanliness, functionality, safety and integrity of distributing and transporting medicines to the patient d. General and Transferable Skills d.1. Apply principles of safety when dealing with prescriptions, compounding and distribution of drugs.