What happens at the biggest and best pharmacy event in the world? Join the best and brightest pharmacy professionals in New Orleans this December for an energizing and riching, enlightening experience like no other. Simply put, there is nothing like it. ASHP's mid-year clinical meeting offers everything you need for your career to blossom, including countless professional development and career advancement opportunities. Just imagine what you can accomplish at an event that brings together 20,000-plus pharmacy professionals from across the globe. Special rates are available when you register and book your hotel before September 27th. Learn more at midyear.ashp.org. That's m-i-d-y-e-a-r.ashp.org. Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy. Thank you for joining us for an episode of ASHP's Practice Journeys, Career Pearls for Students. In this podcast series, you will hear from pharmacists who work in various pharmacy practice settings to learn more about what a day in the life is like. You'll dive into careers you may have an interest in, but never took the time to learn about. Or you may even find out about a practice area you never knew existed. I am faith a fourth-year student at UIDW, five school of pharmacy, and an ASHP pharmacy student or advisory group member. I am joined here today with my advisory group colleagues, Alina McEwan, Sorika Satushkumar, and Nikki Kalem. And today we will be speaking with Dr. Rumini Penn to learn about career opportunities for pharmacists and the government. Dr. Penn, would you like to tell the audience a little about yourself? Thank you, Faith. Thank you for the opportunity. It is an honor to be a part of this podcast to share information and to feel the pharmacy. So I am a Lucinda Commander in the Pharmacists category with the U.S. Public Health Service Commission Corps, a Ph.S. Serving with the U.S. Food and Drug Administration as a compliance officer under the Office of Laboratory Affairs, Office of Pharmaceutical Quality Operations, Division IV. I know it's a lot, covering the western region of the United States. I received my bachelors in professional chemistry from the University of Utah and my PharmD from the University of Maryland. Since graduation, I served as the Chief Pharmacists at the Federal Bureau of Prisons at the Federal Detention Center/Federal Correctional Institution FDCFCI in Tallahassee, Florida before moving into an investigator role with the FDA in San Francisco. I served on the foreign cadre while stationed in Long Beach and served as a drug specialist, finally transitioning into my compliance officer position in Irvine, California. Awesome. Thank you so much, Dr. Penn, for sharing that about yourself. My name is Alina, and my first question for you is, when did you become interested in pursuing a career in the government? Thank you, Alina. So during my time at pharmacy school, I was able to meet pharmacists within different federal agencies, including the FDA, Centers for Medicare and Medicaid Services, also known as CMS, Indian Health Services, IHS, and within these agencies, this included both civilian and officers within the U.S. Public Health Service. Public health and health care policy have always been in the forefront of my mind and a consideration due to my exposure to people close to me growing up who did not have access to health care. Prior to pharmacy school, I was in pre-pharmacy during my undergraduate time, during the time when President Obama challenged and changed the system with a Affordable Care Act, and that is really what piqued my interest. During my time in the University of Maryland as well, in that location, having that exposure to Washington, D.C., the Congress, the different sessions, those all helped increase my interest in government affairs. Hi, my name is Sarika, and my question for you is, when you had that realization career-wise, what steps did you take from that point forward to get to where you are now? Hi, Sarika. First, I know your mentors have told you to network, and there's a lot of different meetings and connotation for networking, but networking really does help you, and what I mean by that is not necessarily attending every event or trying to reach out to every single person out there, but really by always being kind and treating others with respect in your school environment, in your work environment, in your communities, working diligently and honestly and supporting those around you. That kind of networking is what made others think of me when they had opportunities. Second, take advantage of the volunteer events at your school and in your communities and other activities, but don't stretch yourself too thin and don't do everything. Again, you don't need to tend every single networking event. Just go out there, work on what you are passionate about, be passionate about the organization, then people can see that and it will reflect in your resume and your CV as well. Take these steps, focus on your interests, and this will help guide you in your future career. I specifically intended our school legislative days on a certain legislative day. This led to discussions about pharmacy in government, led to the different rules and laws that are governing our profession. This, in turn, led me to meeting a venture and now close friend who introduced me to a senior co-star program within the US Public Health Service, which led me to the career that I'm in now. By surrounding myself where I wanted to be and the people who were in those fields, it helped me to land me at my goals. These little steps can really open up many possibilities. Hi, Dr. Penn. Thank you so much for sharing. My name is Nikki, and my question for you is, how did you transition from being more residency-bound to joining the USPHS? Hi, Nikki. Thank you for that question. I was always interested in pediatric pharmacy and that passion still remains. These are pretty different fields, but there are a few steps that gradually made me choose the area of pharmacy in the government. It was a difficult decision of which to choose to pursue. So during my time at school, I approached both pathways full on. I took advantage of any experience that would allow me to gain better insights into either of these career paths. I worked at the pediatric hospital as an intern, but I was also involved in the Public Health Association and volunteering for health advocacy for underserved minority youth. I even decided to interview for both routes. I did mock interviews and actual interviews for residencies within pediatric pharmacy. I did interviews within federal government agencies and as well as the senior co-step internship. As I moved through these motions, I determined that I wanted to go beyond and serve a more national and even global community, and that is what ultimately made my decision. There were also other benefits with my career path that I chose, such as the pension, standard weekly work hours in my work life balance, and the aspect of US patients deployments to serve the country in times of disaster and greater need. It would be a lie if I said that my daily living, daily hours didn't play a role in my final decision. Finally, I also enjoy the versatility that a US patients pharmacist within the government brings, including allowing me to work in the pediatric setting if I so choose whether it's with the Indian Health Service or, for example, on deployments where I've worked with the pediatric population. It really sounds like you have a lot of diverse experiences that have really shaped who you are today. Would you mind speaking a little bit more about your time working in the prison system and the transition to the office of regulatory affairs? Yes, I can definitely speak more on this. The prison system is definitely not something that I thought I would ever be a part of. You know, working at the Bureau of Prisons, the DOP, at the FDC, FCI, and how it has seen Florida was an eye opener. I was able to serve a community that is often overlooked. People do not realize that the incarceration itself is the punishment, and we do not deny health care as punishment. As a chief and sole pharmacist at the BOP that it was at, the BOP drastically increased my clinical experience and self-confidence. You know, fresh out of school, I was able to conduct drug reviews, lead PLT meetings. I provided interventions, and I created and held my own clinics, including anticoagulation, hepatitis, and diabetes clinics. We provided a multidisciplinary team approach, where I had a seat and a greater than equal voice at the table, among the other health care providers and administrators. My reasons for leaving the BOP and transitioning to the Food and Drug Administration were multifaceted. A huge factor for me to leave was that I was stationed in Florida, but I wanted to move closer to family. I was also interested in the FDA and regulatory affairs, so I looked at positions for both agencies within the FDA and the BOP, and I looked anywhere from Utah and West. Being a USPHS officer allows for easier and faster transitions, even to other agencies, since we already have a certain level of security clearance. When you are a civilian, you apply to USA jobs, you wait for the process, but when you are a USPHS officer within the government, you can apply what they call a direct hire and have immediate interviews and immediate hires right away. When I applied, I interviewed the following week. I was selected the second week after my application to position in San Francisco as a consumer safety officer, investigating and inspecting manufacturing facilities regulated by the FDA, including compounding pharmacies. That's how I transitioned from the Bureau of Prisons to the FDA Office of Regulatory Affairs. Thank you so much for sharing that experience. Would you be able to tell us more about your current role as compliance officer at the FDA Office of Regulatory Affairs? Yes, definitely. I love my role currently as a compliance officer. I really feel that I am making huge impact, but before I dive into the compliance officer position, I have to speak a little bit more about the background, first into what the FDA calls a consumer safety officer. A consumer safety officer is also known as an investigator or an inspector. A consumer safety officer is known as a CSO, and as a CSO, depending on your commodity area, we inspected facilities, including but not limited to manufacturing sites, laboratories, warehouses, compounding pharmacies, positron, emission, tomography sites. We conducted inspections with post adverse drug events, and CSOs in other areas that were non-pharmaceutical include the biologics, which include inspecting human tissue and blood banks, biomedical, which focuses on clinical trials. We have the foods, CSOs, who also inspect dietary supplements. We have medical devices and imports. Following an inspection, a CSO will issue what we call a form, FDA 43, observations to the firm, noting deficiencies observed while inspecting the facility. The firm can then voluntarily choose to respond or not respond to these observations. When the CSO and the supervisor determine that further action may be required to bring the firm into compliance with their laws and regulations, these inspections, reports, and evidence combined are collected and forwarded to the compliance branch, which is what I do currently. So, I was a CSO provider, and now I work as a compliance officer. So, as a compliance officer, we review the inspections and we review the responses from the firm to determine what action may be warranted. We work with our counterparts and CDER to recommend what level of compliance is needed, and we have a multitude of actions we can take, including advisory as well as judicial actions in our toolset. We can recommend actions such as requesting the firm to volunteer recall products, or we can recommend a seizure of products where we would have the US marshals be involved with saving the products. Once we review and make recommendations, we work with our counterparts at the Center for Drug Evaluation Research CDER to finalize the action that we do take. Oftentimes, most times, our actions include issuing one letters to the facility, citing the violations that the firm has, or we hold regulatory meetings to have further discussion about how we can bring the firm into compliance with our rules and regulations. We also collaborate with external stakeholders such as the FBI, DEA, state health departments, or state sports pharmacy, customs and border protection. I've even worked with Fish and Wildlife, but we work with all of these different stakeholders to determine how to best protect public health. Thank you so much for telling us more about your current role as a compliance officer. In that role, how do you stay updated on the latest developments and changes in regulatory standards, and how important is continuous learning in your field? Continuous learning, and I think with all aspects of pharmacy, no matter which field you go into within pharmacy, is very important. A key word with manufacturing and our standards is current. We focus on current good manufacturing practices, and this can change day by day, year by year. As we all know, technology is ever changing and improving, but with that comes its own risk. For example, as you develop the new system with manufacturing, there are other areas that need maintenance, or we also now utilize computer systems, automated systems, Excel systems. With all of these, we have to be able to validate our systems. And what does that mean? That means we need to ensure accuracy and data integrity, as well as reproducibility. There's a lot of things that go into the drug quality that we are reviewing. And as we improve and increase our toolset, we have to ensure that the safety and quality of the medications are kept. Now, how do we preserve original raw data in its reviewable form? How do we prevent fraudulent or tamper data? You know, the FDA continuously releases guidance into industry, which are public, to aid in the education of how CGMPs continue to change and need improvement. We will attend conferences such as Food Drug Law Institute, we have internal FDA trainings, as well as external trainings with our other external stakeholders, we have shared meetings with the boards of pharmacy, and we have partnerships with them as well, and as well as with the other state and federal agencies and state health departments. We have to be aware as new laws emerge, such as the Modernization of Cosmetics Regulation Act 2022, also known as MOCRA. We also have the Food Drug Honor This Reform Act, the door of 2022. As you can see, as new laws form, as we vote on these new laws, these affect the FDA, and we need to stay aware and knowledgeable of how it affects our daily work, as well as how it affects public health. As a pharmacist, there are certain CEs that fit in as well. Whether you take the CEs that are offered through FDA or external CEs, there's a lot of different methods that you can utilize. Finally, I have received my board certification for style compounding pharmacists, aseptic technique, whether it's in compounding pharmacy or in sterile manufacturing. It's very important in this field, and I have worked with many of these compounding and aseptic facilities. It really is incredible how valuable continuous learning is to your daily life. How do you think that your field is going to change in the upcoming years? It really ties into what we were just speaking about with continuous learning. I think technology is on the forefront of our discussions. How will AI be utilized in the future of manufacturing and deployment of machinery and services? How do we monitor and regulate this new area? Do we want a certain level of regulation? Is there over-regulation or under-regulation in order to expand this? This will really change how both medications are manufactured as well as with medical devices, how they're manufactured, or how they are going to be diagnosing patients? How do we ensure that the AI is following CEs and keeping our public safe? The FDA, like other companies, also continue to improve and modify their systems. When I started in 2014, I inspected all commodities, not just pharmaceutical, but we changed the focus on one commodity. Reports used to be only paper-based, but now we have electronic reporting system. We used to only be able to collect reports via paper, and now we are allowed to collect reports and evidence via an electronic system. Meetings used to always be in person, as you can see. But now we have podcasts, we have Zoom meetings, we have other style of virtual meetings. Different products will be invented, and that will also continue to affect the regulations. Again, the big forefront of some recent conference 16 is really how will AI affect our diagnostic devices and manufacturing systems? AI really has changed the landscape for various careers, and it's so interesting to see how it's affecting pharmacy as well. But shifting back to your time in pharmacy school, what were some of the things you did during school that you believed helped set you up for a successful career? Thank you. It may sound like a broken record here, but again, really focusing on my passions, I believe, helped set me up for a successful career. During my first year of school, I spread myself to a lot of different organizations, as I did not know what I was interested in. But within the first year, I was able to narrow it down and continue to narrow it down throughout the years of what I was involved in, to what I was specifically interested in and passionate in. As you can never spread yourself thin for too long, you'll end up just wearing yourself out. So by focusing on what I truly care about, I was able to volunteer in the local community and volunteer for the Student Government Association. These allowed me to branch out beyond pharmacy, I formed networks, and I learned better ways to communicate with our counterparts outside of pharmacists, across the different professions. Working with the different nurses, physicians, dentists, in my career now, both within the Bureau of Prisons and within the Food and Drug Administration, I worked with a huge range of professions. I actually rarely work with pharmacists on a day-to-day basis. In addition, during school, I signed up for different rotations across different organizations to gain further insight. I did an FDA rotation. I did Center for Medicaid Medical Services. I did any health services. I did the retail pharmacies and hospital pharmacies, emergency care, acute care. Just having a little bit of that variety and that versatility and flexibility and understanding that you're a non-expert at everything but can always learn really helps you and others guide you to your success. Thank you so much for recounting some of your experiences for us. What advice do you have for aspiring pharmacists or are those interested in regulatory affairs? I would highly suggest you look into both the civilian routes and the US Ph.S. Commission Corps routes. If you're interested in regulatory affairs or in other government pharmacy fields, there are pros and cons either way, and I'm happy to answer more questions on that if you wanted to go into further detail. But definitely look into both routes because it's not a one-size fits all. Utilize your networks. When I was a third-year student trying to get my fourth-year appies, I actually wasn't selected for an FDA rotation. So I reached out to some of the FDA pharmacists that I had met and asked if they knew anything about why I was selected or if they could assist. One pharmacist told me that they didn't see my application because I didn't specifically list their division or their office. She reviewed my application afterwards and selected me for her rotation. So I suggest especially those who are looking into the FDA rotations to find out who is actually taking the students before selecting your preferences on that FDA/APPE rotation application. In addition, if your first or second-year pharmacy student look into the junior coset programs, there's different internship programs with that. And if you're a third-year student and you look into the senior coset program, there are also a lot of different fellowships offered for both students and postgraduate students within the FDA and outside the FDA. So definitely look into the many different fellowships that are offered. And finally, for aspiring pharmacists, one of the greatest tips that I was provided during my school was really to screw around myself with smart and successful people. And I agree with this whole hardly and passes on to aspiring pharmacists. These people who are smart and successful will support you and elevate you. Make sure you form that network of being able to help each other. Well, yeah, I definitely love that advice about surrounding yourself with those who are just going to uplift you and continue to promote you to succeed in your career. My next question for you is, what advice do you have for students who are hoping to help their schools create more opportunities for exposure to governmental career paths? Depending on where your school is located, there may be a few different agencies nearby. And obviously, if you are in the Maryland, Virginia, D.C. area, there will be a lot more opportunities. However, be open to non-traditional roles and look out for agencies that may be in your area. The FDA is scattered across all the different regions. We have the Indian Health Center for Medicaid Medical Services also is located in a lot of different regions. From the West Coast to the East Coast, the Bureau of Prisons, there's a lot of hidden buildings that you may not realize. There are some that take students as well. Right in the heart of Philadelphia, there is a Bureau of Prison tower that you wouldn't even know unless you went right up to the sign and saw on the building itself. In Atlanta, you have a CDC, but definitely understand that there are a lot of hidden offices that are scattered around the U.S. In addition, the U.S.PHS provides a few routes for exposure. Like I mentioned, the junior is near close-up options. And you can sign up for what we call the farm tax student listserv through the U.S.PHS. This listserv will send out student opportunities and career opportunities and partnership opportunities. In addition to this, each school should have a university point of contact through this U.S.PHS farm pack. And if there isn't one, we can establish one. You know, fellow officers, pharmacists, officers are always ready, willing, and able to participate in career fairs and other booths and expos in your area. We also present conferences such as the recent ASHP mid-year. We have multiple booths there set up. So don't be afraid to go up to them, talk to them, tell them about what you're interested in. If you have projects and you want assistance, reach out. For example, I am in the Southern California region, and if a student were to reach out for my assistance in a school project or event in this area, I'm always happy to assist or at least point you in the direction of other officers who can assist. Thank you so much for your advice. It looks like we have time for one more question. What advice do you have for students who have interested in multiple areas of pharmacy as you are interested in residency and transition to regulatory affairs? I think the key is to be flexible. You know, you may have your goal in life or for your goal, for your career, but this can change. And don't be afraid to take a turn when an opportunity presents itself. If you don't have experience in something, how do you fully know that you actually won't be interested in it? I can tell you that every year, pharmacy school changed where I thought I would end up. And even now in my career, I seized opportunities as they presented themselves. I never expected to work in the BOP in Florida, especially, or live in San Francisco. But those were steps that I took, which made me grow and get experience that I wouldn't trade. You know, don't be afraid to venture to the unknown, whether it be uncomfortable locations or positions. Remember, things are only permanent if you make them permanent. So take advantage of that location, of that position, and know that if you decide you don't enjoy it and it's not your passion, you can change. You know, I've held or moved over five positions in the last 10 years, and I don't regret transitioning through any one of them. Thank you so much, Dr. Penn, for sharing your words of advice with us. That's all the time we have today, and I do want to thank you again for joining us and sharing your story. Join us here at ASHP Official and The Practice Journey's Career Pearls for Student Podcast Series as we continue to explore different careers and practice settings. Thank you for listening to ASHP Official, The Voice of Pharmacists Advancing Healthcare. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes, and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate, or leave a review. Join us next time on ASHP Official.
