Case study Essay Example | Topics and Well Written Essays - 500 words

Case study - Essay Example A patient might not understand why a particular medication may not be available in his/her country. For instance, a 46-year old woman who purchased an over-the-counter weight loss medicine in South America cannot buy the similar medication in US. Your health teaching as a care provider is to inform them of the role of FDA and the process underlying the issue. The FDA restricts and regulates imported medications to address safety of individuals. In addition to this regulation and unavailability of some drugs is the time it takes for a drug approval. The time it takes from a drug approval starting from the drug discovery to the FDA’s Inspectional Background and Data is 22 months duration of waiting (Hertzman, 9). Aside from FDA’s restriction in the drug approval process, a comprehensive risk assessment is performed to determine safety and efficacy of a certain drug to human subjects. In line with this are phases of clinical development and are categorized in Phase I to Ph ase III (Madzarevic, 49).