Thursday, December 26, 2013

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!