Sunday, April 18, 2010

Working on your behalf

Posted by Kendra Yum at Sunday, April 18, 2010

Ask any pharmacy student about what the FDA does, and you’ll likely receive a description of the agency’s role in the drug approval process. But exactly who are the pharmacists and scientists who work at the FDA? To find out, I hopped in a car and drove 500 miles to the FDA office in Maryland.
I had the opportunity to complete a rotation in a non-traditional pharmacy career and interned at the Office of Policy in Silver Spring, Maryland.

Here are a few highlights:
  • Meet & Greet Lecture Series – Each week, FDA pharmacy interns are invited to talks given by pharmacists and scientists about the Office that they work at. I met with pharmacists who are involved in the regulations of prescription drug advertising, prevention of medication errors, approval processes for over-the-counter, generic and prescription drugs. We also met with scientists who evaluate the safety of drugs during the development phase. It requires a tremendous amount of talent and efforts to ensure the safety of drugs from the start of clinical trials to after its marketing. Every step of the way necessitates safety assessments by the FDA to determine if the benefits of a drug outweigh the risk of its use.

  • Pharmacy “Field Trips” – For most pharmacy students, “US Pharmacopeia” brings to mind a thick red textbook on the shelf. I never would have imagined I could step inside the USP headquarters and see the laboratories that set the standards for all drug products sold in the US! (I also found out that Dean Ascione is part of the Convention membership that governs the USP.) Over the course of the FDA rotation, I went on multiple “field trips” to the headquarters of various pharmacy organizations. Seeing these national pharmacy organizations working to advance pharmacy interests gave me a greater understanding and appreciation of our profession.
  • Office of Policy – Within an agency as large as the FDA, how would you coordinate projects that require the collaboration of various offices and centers? Such a task is one of the many roles of the Office of Policy. One such project involves securing the drug supply chain to combat counterfeit drugs. The FDA is looking into the development of standardized numerical identifiers (SNIs) for the tracking and tracing of prescription drug packages. Securing the drug supply chain can prevent adulterated and subpotent drugs from reaching patients and compromising medication therapy.

This rotation has been truly unique in providing me with a new paradigm regarding the pharmacy profession. I had the opportunity to learn about the roles and responsibilities of the FDA and to speak directly with the many pharmacists working everyday to protect the public health by assuring the safety, effectiveness, and security of medications.

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