Friday, August 28, 2015

Rotation 3: Meticulous Minds for Medication Error Prevention

Posted by Emily at Friday, August 28, 2015

Block three brought me to Silver Spring, Maryland (just outside of Washington DC) for a non-traditional rotation experience at the Food and Drug Administration.  This was my first rotation outside of UMHS and my first rotation where I didn’t have a classmate by my side for support.  That was a little nerve-wracking at first, but I’ve learned that putting yourself in slightly uncomfortable situations in unfamiliar environments and adapting as you go is a great way to grow personally and professionally.  The uncomfortable situation is rarely as uncomfortable the next time.

FDA Building 1
It was clear from day one that FDA loves acronyms even more than BMT.  My preceptor’s email signature read something like:


Translated: I was working in the Division of Medication Error Prevention and Analysis, housed within the Office of Medication Error Prevention and Risk Management, which is part of the Office of Surveillance and Epidemiology within the Center for Drug Evaluation and Research at the Food and Drug Administration.  (Suffice it to say I quickly began referring to my division as DMEPA just like all the other employees.)

DMEPA is full of pharmacist safety evaluators who are responsible for conducting pre- and post-marketing safety reviews of proprietary names, labels, and labeling with the end goal of preventing medication errors.  For example, if a manufacturer proposes a carton design in which the drug strength “200 mg” is too close in proximity to the quantity “100 tablets”, the safety evaluator will recommend separating the numbers physically or graphically to minimize the possibility of a busy pharmacist mistaking “100 tablets” for “100 mg” and contributing to a potential overdose.  Safety evaluators also conduct safety reviews of proposed brand names.  Part of this process involves asking employees to interpret handwritten and verbal prescriptions to see if the name they see/hear could easily be confused with an existing drug name.  I have pretty good penmanship overall, so I struggled to make my handwriting physician-worthy when I was asked to contribute prescription samples for these studies.

I was my preceptor’s first student at FDA, and he explained on the first day that the rotation was going to be more observational and self-directed than my previous clinical experiences.  That was true, but between projects, meetings, field trips, and the extensive student lecture series, I kept busy.  To keep this post from becoming too unwieldy, here are some of the projects I did and meetings/talks I attended in list form:

  • Summarized the literature on the effect of calendarized blister packaging on adherence
  • Created a chart of abuse deterrent formulation opioids
  • Conducted a literature search on best practices for standardized chemotherapy order forms (my preceptor works specifically with oncology products
  • Presented recent DMEPA interventions aimed at preventing errors with chemotherapy agents
  • ISMP monthly conference
  •  Human factors study meeting
  • DMEPA and OSE “All Hands” staff meetings
  • Advisory Committee practice meeting
Student Lecture Examples:
  • Office of Prescription Drug Promotion overview
  • Orphan Drug Product Development
  • United States Public Health Service overview
  • CDER Drug Shortage Program
  • The Scientific Basis for Drug Control Under the Controlled Substances Act
  • Unapproved Drugs
  • President’s Emergency Plan for AIDS Relief
  • Introduction to OTC Drug Regulation
 Field Trips:
  • ASHP headquarters in Bethesda, MD
  • Bureau of Prisons in Washington DC
  • United States Pharmacopeial Convention in Rockville, MD
  • Pentagon tour in Washington DC
  • Consumer Product Safety Commission in Rockville, MD  (This experience was not part of the FDA “curriculum”; my awesome preceptor arranged for me to shadow the pharmacologists at the CPSC after I told him about my interest in poison control and prevention.  The CPSC tests all kinds of consumer products, everything from bike helmets to baby cribs, ATVs to mattresses, and everything in between.  The chemists do a lot of work testing products for lead and phthalates.  The coolest part of this experience was getting to tour CPSC’s testing laboratories.  I totally felt like I’d walked onto the set of MythBusters.  You can watch a video tour of the labs here:
ASHP Headquarters
USP Headquarters
Overall, my FDA experience was positive and unique.  It was great to see pharmacists from diverse backgrounds filling these non-traditional roles, and there are TONS of pharmacists at FDA!  Most of the employees seem to enjoy their work and the work environment, and even as a student I felt like I was part of significant work and something important.  I also felt proud to introduce myself as a University of Michigan student.  It’s true that the name demands a certain degree of respect, and I was grateful to be able to represent the COP outside of Michigan.  It also turned out to be a great networking tool.  I met two other Michigan alums on my second day, and that’s not including my preceptor!  One of the alums was a resident at one of the programs I’m considering, and he was more than happy to sit down with me to discuss his experience.  I was also able to network with the other students.  There were about thirty of us in total, representing over 20 different colleges of pharmacy!

While I learned a lot on this rotation about the drug approval process (and got to see firsthand that package inserts don’t just rain down from the heavens), the most important thing I learned is that I am not interested in working at FDA.  I love direct patient care too much to be happy in a job that involves no direct patient care whatsoever.  Perhaps in the future I’ll find myself in a position where taking on a desk job is the right move for me at that time, but for now I am excited at the prospect of pursuing residency and, more immediately, starting another clinical rotation next block at the Michigan Regional Poison Control Center!  Stay tuned.

PS – If you find yourself in the DC metro area for a rotation, be sure to take advantage!  I did all kinds of touristy things in DC on the weekends, and even caught a Tigers/Orioles game at Camden Yards in Baltimore one Friday.

Salk's polio vaccine at the National Museum of American History
Tigers vs. Orioles at Camden Yards

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