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:

DMEPA|OMEPRM|OSE|CDER|FDA

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:

Projects:

• 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

Meetings:

• 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: http://abcnews.go.com/GMA/video/consumer-product-safety-commissions-test-lab-13827984)

ASHP Headquarters

USP Headquarters

Pentagon

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

Rotation 3- Community: Still Going Strong

Posted by E. Caliman at Tuesday, August 25, 2015

I'm doing my Community Rotation at a local compounding pharmacy. I enjoyed compounding during P1 year and was interested in it even before starting pharmacy school. After the fungal meningitis outbreak from the New England Compounding Center in 2012, I thought that a community compounding pharmacy would be a nice, slower-paced rotation as compared to a chain community pharmacy.

I was wrong. I was so very wrong.

Compounding pharmacies are very much alive and well, even with piles of restrictions and new regulation. It's likely due to the fact that compounding pharmacies provide patients with medications they can't find at a regular community pharmacy and the personal level of service because many of them have fewer patients.

Slow days here are few and far between. I started off on a week where almost 100 scripts were filled each day. It's always busy. If you're not filling, you're probably tackling the pile of drug information questions patients and doctors call you about, from drug stability of compounded medications, to drug interactions, to helping them navigate insurance issues, since many insurance companies no longer pay for compounded medications.

Naturally, I got to spend time in the compounding lab. The pharmacy can compound capsules, suspensions, topical creams, ointments, lotions, suppositories, as well as sterile products. I got to try a little bit of each. The experience was more automated than I expected (there's a machine that mixes the topicals and you don't fill capsules by hand), but a little more labor intensive than P1 year would have you believe. Even so, I still enjoy compounding and it's still a career option.

Some of my other projects include updating policies and forms, as well as doing research into regulation and new business opportunities. I researched how a pharmacy in the partnership could provide a new service for the county and updated a privacy practice form to reflect that the pharmacy could now text patients with their permission. Overall I had a great experience and am looking forward to the next rotation.

Rotation 2: I'll Take a General Kit, Please

Posted by Unknown at Saturday, August 01, 2015

My entire life I've been terrified of blood, so imagine my shock and horror when I found out I was assigned to the operating room pharmacy for my health system/hospital rotation!  In the first hour of my first day I was handed a syringe of morphine mixed with blood to empty, and thus began my 5-week journey of desensitization.

A typical day kept me constantly moving and looked something like this:

0600 - 0730: Pass out kits
The OR pharmacy had pre-made drug packs containing various narcotics that the CRNAs and doctors could sign out for their patients.  There were kits for ECT, codes, PACU, the medical procedures unit (MPU), and, most popular, kits for general surgery.  Doctors and CRNAs could ask for additional add-ons, such as ketamine or Dilaudid, as well as pick up non-controlled medications, such as Tylenol, Neurontin, and Precedex, and request infusions.  This time was particularly busy, as all 30 ORs had a shotgun start at 7:30.  During this time, we also received several kits that were used overnight, and had to reconcile those with the provider while he or she was standing there.

0730 - 1000: Verify, topic discussions, and LOTS of paperwork
The next 2.5 hours were spent talking about various topics related to anesthesia, opioids, or other OR drugs, verifying the pre-op medications for the next day, and reconciling and completing the returned kit paperwork.  The paperwork could be very tedious at times, as we could have as few as 2 kits returned or as many as 20 or more if there was a weekend or holiday! The paperwork had to be double checked against what was actually returned and against the Omnicell.  Anything returned in syringes had to be refracted to ensure that what was documented to be in the syringe was actually in there.

1030 - 1430: Pharmacy adventure!
Every day I went to a new place to learn about a new area of pharmacy.  On Mondays, I went to the main pharmacy in the children's hospital, where I was able to check prescriptions, participate in cart fill, learn about dosing children, and chemotherapy dosing.  On Tuesdays, I went to the OR in the children's hospital, where I performed very similar tasks to my responsibilities in the adult hospital.  On Wednesdays, I worked with the medication safety officer on a medication use project.  On Thursdays, I went to the Investigational Drug Service and learned how to verify a prescription for a study, how to read a protocol, and how to write guidelines for pharmacists dispensing based on the protocol.  On Fridays, I stayed in the OR and filled pre-op orders for the next day.

One of my favorite days in the OR was a day I never thought would happen: I spent four hours walking in and out of various surgeries and intently watching the procedures.  I walked around with an amazing anesthesiologist, who showed me how she uses all the drugs I had seen coming in and out of the pharmacy every day, which was fascinating.  I was also able to watch a kidney transplant, brain tumor biopsy, ear canal tumor removal, and a prostatectomy using the da Vinci robot.  Watching those surgeries showed me that I had come a long way in those five weeks with regards to my blood sensitivity!

Overall, this was a fantastic rotation and nothing like I expected it to be.  It was a lot of work, but well worth the effort!