Related to the topic of drug product development, manufacture, and regulation is the complicated issue of compounding pharmacies. When a pharmacy makes or modifies a product, and it can be as simple as adding a flavor to a children’s cough syrup, it comes under the category of “compounding”. Pharmacists have a long history of using this skill; often they are formulating something for a small number of patients who otherwise would not have access to the product or particular dosage form. Traditionally this aspect of pharmacy has been regulated by the states, under each state’s Board of Pharmacy. Over the years, the FDA, a federal agency, has tried to provide some oversight but they have always met with resistance.
On a larger scale, there are compounding pharmacies that are behaving more like manufacturers, rather than the neighborhood pharmacy which is customizing a small batch. You may have read about the numerous deaths that occurred from sale of contaminated product produced by New England Compounding Center.
This module assignment:
Read the article from the Washington Post located at this site:
http://www.washingtonpost.com/national/health-science/compounding-pharmacies-have-been-linked-to-deaths-illnesses-for-years/2013/02/07/5ba90132-6b19-11e2-ada3-d86a4806d5ee_story.html (Links to an external site.)
For this exercise, you do not need to follow APA format.
Submit the assignment to Canvas as a Word document.
Read the article from the Washington Post referenced above
Submit your paper, totaling 450-600 words, and not more!! Check the word count as you write. Use the 4 distinct headings that are described below
Please practice writing good paragraphs. If you’d like a refresher on what makes a proper paragraph, review this excellent reference: https://owl.english.purdue.edu/owl/resource/606/01/ (Links to an external site.)
Please be sure to put your name on your submission.
Please use ONLY these 4 headings in your assignment:
Who are the Stakeholders
What’s at stake
For section 1, Summary, briefly explain the key points of the story (summarize). What is the story reporting? What are the key points? You won’t have room for detail, so work hard to highlight the essential points.
For section 2, describe all of the stakeholders related to the issue of regulation of compounding pharmacies.
For section 3, concisely state what is at stake for the various groups or stakeholders who are involved with compounding drugs.
For section 4, think about all of the angles of this story, then (and there is no right or wrong answer in this section) describe how you feel about the issue of FDA regulation of compounding pharmacies. Feel free to read other sources, including this brief story from the Arizona Republic about the local compounding scene, that Dr. Sandra Shire, one of the ASU instructors had an opportunity to contribute to: AZ Republic Custom Drug Compounding.pdf.
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