Rotation 2: Non-traditional - Food and Drug Administration (FDA)

Posted by Polly at Tuesday, August 27, 2019

My second rotation was at the FDA in Silver Spring, Maryland. I was looking forward to this rotation since I first heard about it in my P1 year. I have always been interested in non-traditional pharmacy and most of my internship and extracurriculars are geared towards the non-traditional roles of pharmacy. I lived on the University of Maryland (UMD) campus. This was at most a 20-minute drive to the FDA if there was traffic. I was lucky because my rotation was during the summer where many students were looking for subleasers! Unlike some of my peers, I had better luck finding cheaper housing options.

My first day was a whirl wind of meetings, badging appointments, security checks, and trying to figure out what all the acronyms were for each department. I was the only Michigan student onsite during this rotation, so it was definitely a scary experience being alone in a new city. The APPE students there besides me came from all over the country and it was a great networking experience.

My preceptor is the Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance. She deals with securing our supply chain for pharmaceutical products and was a helpful mentor. She took the time out of her busy schedule to have one on one meetings with me almost each day to see how I was doing and to see if I was interested in attending meetings with her. It was nerve wracking to be in the same meeting as some of these officers and oversea agencies. Aside from my preceptor I worked on projects from many other departments.

My schedule was not as clear cut as my first rotation. A lot of my time went into networking with people from the FDA and lectures given to us by PharmDs from different departments. The rest of my time was projects from a variety of departments. My projects varied from data analysis for MedWatch, reviewing 501k submissions for medical devices, a variety of written work, and a presentation on FDA's Medical Devices Regulatory Process.

Here are some tips when you go on the road to Maryland for those of you who get chosen:

1. If you choose to drive, it is a 9 hour car ride and you need to bring at at least $40 dollars for the toll roads. I drove alone and it was very boring so either bring fun music or listen to a podcast.
2. Silver Spring is on the edge of DC and I highly suggest visiting! Get a SmarTrip Card and just google your way around. I wouldn’t suggest looking at the maps on pamphlets they have because it can get annoying really quickly. Google maps is your best friend and you get alerts for when the train is delayed or if the stop gets switched to a different area. The trains are very well kept and is not as confusing as I thought they would be.
3. BRING REUSUABLE BAGS. They charge money per bag you use and it can add up especially if you are grocery shopping.
4.  I went in July. It was hot. It was sunny. It was humid. Even when it rains, the humidity and heat does not let up. It was disgusting weather and I never thought I would experience heat on par with southern Asia in the United States. Find an Airbnb or apartment with AC and don’t even bother packing a hoodie or a long sleeve shirt. That will only take up room. The fall is nice though from what I heard.

Overall, the rotation gave me an understanding of the work the FDA does and has solidified my intent to pursue a fellowship after graduation.

Rotation 5- Keeping it Under Control

Posted by E. Caliman at Wednesday, November 18, 2015

Rotation 5 would have to be my favorite rotation so far. I rotated at the FDA with the Controlled Substances Staff, the people who handle concerns with the controlled substances coming through the pipeline as well as the drugs that affect them (ex. naloxone). Every day was something new and I got to do things most pharmacy students would not get to do, such as help my preceptor prepare for the World Health Organization's summit on international drug control and summarize a report requesting Schedule I substances for research. I also helped edit a drug label for a controlled substance that has since been approved and researched a topic of interest to my preceptor and other members of the staff.


One of the great things about the FDA rotation is that you get to go on a lot of field trips. You can go to the Pentagon as well as visit APhA and ASHP headquarters, all of which are in the area. Even though you are assigned to one department, you can attend lectures given by people working in various departments so you learn the broad scope of the FDA. It will force you to manage your time well, as there can be several lectures in a day and you'll have a project or two to work on.


I thoroughly enjoyed my time at the FDA and genuinely did not want to leave (and it's not just because the high was in the 70-80 range at the beginning of November). The people were great and the projects I worked on were very interesting. If you have any remote interest in regulatory affairs, definitely apply to do a rotation or an internship.


If you are lucky enough to be chosen for a rotation, here are some helpful tips I wish I knew before coming to the FDA.

1. Locate which campus you'll be on. Odds are, you'll be at either White Oak or Hillendale, both of which are on the same stretch of road, New Hampshire Ave.

2. If you're driving down from Michigan, bring about $40 in cash for the toll roads, mainly in small bills.

3. When you get here, you should get a SmarTrip card. It's like a pre-paid debit card that allows you to ride the public transportation in the area, including the Metro Rail, Metro Bus, and Montgomery County Bus. It can also be used to pay at parking meters. It will get you $1 off each Metro Rail ride and will serve as your transfer between the above modes of public transportation. There may be some days where you'll be traveling offsite on different field trips, so driving may not make sense. You can pick them up at any of the Metro Rail stations. Starting in 2016, they'll be the only thing you can use for the Metro Rail. Buses and Metro Extra Buses are $1.75 per ride.

4. When dealing with public transportation, there is no "Ride Guide", like we have in Ann Arbor. Each route is published on a separate pamphlet. You can access the website at wmata.com. You'll also note that the buses do not display the route name and number, followed by the destination (ex. Washtenaw, to Ypsilanti). Instead, they just display the route number and the destination.

5. Parking at the FDA is free, but if you're in one of White Oak's parking decks, it may be difficult to find a parking space where a permit is not required, so you may end up on the roof. If you enter the parking deck late enough, you may notice that the attendants have parallel parked some cars that are blocking a row of cars in.

6. Bring reusable shopping bags. There's a 5 cent charge per plastic bag you use when shopping if you use the store's plastic bags. Also, the sales tax is 6% in Maryland, 5.75% in DC.

7. The FDA is very close to the borders of Washington, DC and Virginia, so don't be too surprised if you hear about people commuting from Virginia.

8. Pack warm clothes if you're going from October to March. The highs may still be in the 60-70 range in early October, but in the mornings, it's in the 40-50 range.

9. This one is crucial: email your preceptor to find out when your badging appointment is. You'll have an appointment to get your ID badge, and they won't do that without all of your paperwork. You may experience some backups with the Badging Office. The sooner you can get your badge, the better. On the first day, you'll sign in at a check-in kiosk and get a sticker name tag. When you have this, you have to be escorted everywhere, but with a badge, you don't need an escort.

10. Some days, your preceptor will work from home. They'll tell you what days those are, but they'll likely be around for the first week, unless they're traveling.

Rotation 4: Alphabet Soup

Posted by Unknown at Sunday, October 11, 2015

ORP, OCC, DMEPA, OGD.  On my first day, while I was waiting to meet my preceptor, a man struck up a conversation with me (apparently I looked lost).  He asked me where I worked, and I spelled it out, Office of Regulatory Policy.  He nodded with recognition: "Oh, ORP! I'm from OSE!"  I guess I looked confused, because he started explaining some of the abbreviations before he had to run to a meeting.  Five weeks later, I still see and hear abbreviations daily that I need to look up.

Working in ORP was completely different from what I expected, but I still absolutely loved it.  I was surprised to learn (although it is somewhat implied in the name) that the office is filled with lawyers. Interacting with lawyers in a healthcare setting is very different from working with other healthcare professionals.  Some of my office's main responsibilities included participating in the development of rules and regulations and responding to citizen petitions (documents individuals, groups, and companies can write to FDA to try to persuade them to change something, such as remove a drug from the market, issue a guidance or rule, or make labeling changes).  In both of these cases, I appreciated having different disciplines working on these projects together.  As a healthcare professional, advice and knowledge I felt was obvious was not always clear to others, and vice versa.  Having multiple experts from a variety of areas allowed for the clearest documents to be released to the general public.

FDA was not all work and no play, however.  I attended nearly daily meetings to learn about all the different departments and met individually with pharmacists from several departments.  I also went on several field trips, including the Bureau of Prisons, American Pharmacists Association, United States Pharmacopeia, and the Pentagon.  Pharmacists are working all over the world in places you would never expect to find them, and hearing about the variety of opportunities available for those looking for a non-traditional path was informative - many jobs I had never considered, or even heard of before!

Overall, this was a fantastic rotation that went by too fast.  I loved the idea that I was affecting pharmacy at a national level by assisting with the creation of various policies.  I have always wanted to effect change on a grander scale than one patient, one pharmacy, or one hospital, and at FDA I was able to accomplish that.  I look forward to hopefully returning one day, but until then, onwards to pediatrics!

The Final Rotation

Posted by Adam Loyson at Sunday, June 15, 2014

Lightning McQueen fast. That is how quick my rotations seemed to go by in my final year of pharmacy school. For those of you who have joined me in completing their pharmacy education, congratulations! For those starting rotations or beginning your summer break, I write to you about my final rotation with the pediatric emergency department team.

As a prelude, the foundation of this pharmacy rotation was similar to that of the adult emergency department rotation I completed last August. Nonetheless, I was very excited to work with children and soon discovered the many unique pharmacy aspects there are to consider when working with this young population. I started the rotation with a bang and the excitement just kept building from there!

A diverse population

Children make up approximately a quarter of the population. Yet, about 60% of medications do not have FDA approval or dosing recommendations for pediatric patients. From premature infants to children big enough to be considered adults, several challenges exist when considering pharmacotherapy for children. There are differences in pharmacokinetics and pharmacodynamics, limited evidence for medication use, and lack of appropriate formulations.

With much of the data extrapolated from adult patients, I quickly found working in pediatric pharmacy more of an art than a science. Recognizing that children are not just little adults, I was faced with the challenge of taking absorption, distribution, metabolism, and elimination into consideration for each individual patient. Dosing was no longer constant, but calculated per body weight and surface area. Vital signs and laboratory values were also different from adult patients, which drove home the need for pediatric health care providers to have an eye for detail and accuracy.

Ready to work

Realizing that standardized treatment algorithms for disease states in pediatrics are extremely hard to come by, I rolled up my sleeves and prepared to round up treatment evidence in the National Library of Medicine. Monitoring patient admissions, I quickly discovered the wide level of acuity that children present with when arriving at the emergency department. Although there were a large number of children with low acuity conditions, such as mild playground injuries, but there were also many that required extensive health care provider input. These cases included asthma exacerbations, anaphylactic emergencies, traumatic brain injury, diabetic ketoacidosis, seizures, headache/migraines, cystic fibrosis, and many others.

As the student pharmacist on rotation, I was responsible for assisting physicians and recommending treatment options, providing transitions of care medication reconciliations, antibiotic kinetics, and counseling about discharge medications. This was no ordinary rotation though. I experienced a heart-tugging desire to do everything I could to help the sick children.

Another really neat aspect of my rotation was extensively helping the health care team with incoming traumas. It was not uncommon for me to anticipate the use and draw up a wide array of medications for resuscitation (epinephrine, atropine, calcium, magnesium), along with those used for rapid sequence intubation (procedure for a breathing tube), antiarrhythmics, anti-seizures, and medications used for pain control. I also frequently communicated information about the rate of administration and methods of drug delivery. I was always up to the challenge, knowing that each second counted.

Dream come true

Finishing my rotations as a student pharmacist has been bittersweet. I have had amazing hands-on learning experiences, great preceptors, and will miss the many opportunities to make a difference in so many different health care environments. From working with patients with chronic kidney disease on dialysis to studying the implications resulting from the New England Compounding Center meningitis outbreak to providing medication therapy management services to Native Americans, I couldn't have asked for a better final year. I can’t wait to use my knowledge gained to make an immediate impact after graduation.

Looking to the future, I am happy to announce that I have recently accepted a job offer to work at FDA in the Office of Generic Drugs–Division of Bioequivalence as a pharmacist project manager. In this role, I will supervise a team of pharmacologists and will act as a lead liaison to industrial applicants. As someone who has dreamed about entering the public health field right out of pharmacy school, I couldn't be more excited to see where the future takes me!

I have really enjoyed writing about my rotations in the UofM College of Pharmacy's On Rotation blog and hope I shed light on the rotations and highlighted new career opportunities that you might want to pursue in the future. I look forward to new practitioner life and continue to support the pharmacists of tomorrow.

Once again, congratulations to all of this year’s graduating pharmacists!

Adam Loyson is a 2014 graduate.

The Best of Both Worlds: Emergency Medicine and FDA

Posted by Adam Loyson at Thursday, December 26, 2013

The last time I wrote to you I described my rotation in critical care, where I provided medication management to patients with a wide variety of medical conditions. I thoroughly enjoyed my experience but little did I know, my rotation experiences were about to get supercharged! In my next rotation, I found myself providing pharmacy services to anyone and everyone who entered the emergency department (ED) doors in a large academic teaching hospital.

It was time to grab the ropes quickly for this APPE rotation because each second of faster patient care initiation could very well be a second closer to saving a life. Shortly after this ED rotation, I entered the world of nontraditional pharmacy practice with a rotation at the FDA.

Breadth of learning opportunities

To my surprise, the ED is comparable to a health care superhighway with patients continuously seen and treated by multiple health care members. Patients are evaluated for the imaginable (animal bites and dehydration) to  the unimaginable (automobile accidents and occupational hazards).With the American Heart Association’s adult cardiac arrest algorithms committed to memory, I regularly participated with the emergency response team of physicians and nurses by preparing necessary drug dosages before they were needed and seamlessly relaying communications to the clinical pharmacist. With airway control and adequate respiration a priority in the management of any seriously ill or injured person, I also assisted in the proper selection and use of paralytic and sedating drug agents to aid in tracheal intubation.

There is nothing like coming right out of the gate on rotation and making an immediate impact in patient care. Staying current with disease management practices, I performed daily appraisals of clinical reviews and topic research on drug overdose/toxicology, trauma-burn, pain management, infectious disease, and cardiology.

Sky is the limit

Although providing high levels of care to patients in critical condition through a team-based approach was a priority in the ED, I also created in-service nursing education on vaccinations, an orientation manual for new ED pharmacists, and standardized the ED’s medication supply chain.

Don’t let this fool you though; there were also plentiful opportunities for patient interactions . In a profession focused on advocacy and provider status, there is nothing better than being one of the first professionals to enter a patient’s room, greeting them, and letting them know that a pharmacist is there to help them.

Navigating the unknown

After an exciting experience in emergency medicine, my next rotation brought me to the country’s heart of drug regulation at the FDA in Washington, DC. I was responsible for reporting to the Office of Compliance within the Center of Drug Evaluation and Research.

During my rotation, students were invited to participate in an extensive daily seminar series to assist with learning how the FDA works. Along with the 20 other students on rotation, I learned about the FDA’s involvement in the revolving drug approval process; the FDA’s role in adverse event review and analysis; and the presence of counterfeit drugs and other supply chain risks. What makes the FDA unique is the combination of employed civilian employees and United States Public Health Service (USPHS) personnel. In working with USPHS staff at the FDA, I learned much more about federal pharmacy opportunities post-graduation and was encouraged to apply.

Influential impact

My specific project at the FDA focused on the review of inspections of compounding pharmacies.  Currently, the FDA does not know how many licensed community pharmacies are actually engaged in activities that more closely resemble the manufacturing of drug products. and  has written warning letters to firms whose practices appear to exceed the scope of pharmacy compounding as outlined in the Federal Food, Drug, and Cosmetic Act of 1938., However, many of these firms believe that their practices fall under the compounding and drug product safety exemptions outlined in the Food and Drug Administration Modernization Act of 1997.

With the recent New England Compounding Center’s meningitis outbreak, the project I chose for my rotation included the review of existing pharmacy compounding inspection documents and recurrent citations (FDA Form 483). I believe the FDA could use my research in the immediate future to support portions of a current U. S. Senate bill that was recently passed by the U.S. House of Representatives, called the Drug Quality and Security Act, which focuses on compounding pharmacy regulations.

Box of chocolates

Overall, I greatly appreciate the vast hands-on involvement while working in emergency medicine and with the FDA. My career goals for the future are slowly coming together with the increased knowledge from these two rotations. Forrest Gump had it down when he said that life is like a box of chocolates and that you never know what you’re going to get. Reflecting on APPE rotations, you never know what great experiences will come your way. Bring on the next rotation!

FDA!

Posted by Rebecca Lalani at Sunday, September 04, 2011

Day 1 of my only away rotation. I arrived at Baltimore Washington International Airport Sunday morning, excited about the prospect of spending the next 4 weeks working for the FDA! Today was my prep day: I would set up my new digs, buy supplies, stock the fridge and of course, do my pre-rotation research (Go in prepared!) But as I found out upon my arrival at my sublet, even the best laid plans can go awry. My first day in Maryland was marred by the lingering effects of Hurricane Irene that struck the area only the night before. My landlord informed me that the power had been out since the previous night, with restoration nowhere in sight. “It’s daylight” I think as I march towards the closest grocery store and RiteAid location. Much to my chagrin, everything is shutdown. There isn’t a place I can even grab food. Hungry, tired and devoid of even the most basic of necessities, I shuffle my way back to my new place. I hope the power company can accomplish the miracle I’m praying for: I would REALLY appreciate some electricity! I spent the evening sitting in the dark, chatting with my new roommate and although my wishes were eventually fulfilled, it would not come to pass until the following day. So Day 1 of my only away rotation… was spent at home.

Day 2 of my only away rotation. That was much more exciting! I’m in the Office of Compliance under the auspices of Dr. Ilisa Bernstein. I’ve been assigned to work for the nascent Drug Integrity and Security Program, addressing the increasing drug imports that find their way to the American consumer. All rotation students are also given a lecture schedule that involves a variety of topics pertinent to pharmacy at the FDA. As far as my mentors go, I couldn’t have asked for a more supportive group. I’m pleased to report then that I am 2/2 for amazing rotation experiences. Working with Dr. Rozelle Hegeman-Dingle (Pfizer, Medical Outcomes Specialist) during rotation 1 was an absolute delight. With this track record, I’m looking forward to what rotation 3 has to offer!