Rotation 8 at the FDA

Posted by Unknown at Wednesday, April 30, 2014

FDA rotation

Rotation block 8 took me to Silver Spring, Maryland and provided the opportunity to learn about the US Food and Drug Administration (FDA). This was by far the best experience I've had all year. The largest contributing factor was that I enjoy the administrative aspect of pharmacy and this rotation was project based and involved a lot of paperwork and meetings – perfect fit! The other contributing factors include having a wonderful preceptor who really tailored my experience to my personal interests, meeting new friends from other colleges of pharmacy across the country, and attending all the student programming provided by the FDA.

My FDA experience was in the Office of Regulatory Policy (ORP) in the Center for Drug Evaluation and Research (CDER). My preceptor was Ellen Molinaro, RPh and she was the only pharmacist in the office I was assigned to. (FYI…Pharmacists make great Project Managers because of the multitasking and interpersonal skills required.) Most of the people in ORP are lawyers. I would start my day at 8:30 am and end at 5:00 pm.  Usually there was at least one student programming event to attend. These consisted of mostly one hour presentations given by pharmacists about the different offices in the FDA. This really provided a nice overview of the role and function of the FDA. The other student programming involved site visits to places like the United States Pharmacopeial Convention (USP), American Society of Health-System Pharmacists (ASHP), American Pharmacists Association (APhA), National Institutes of Health (NIH), and even a tour of the Pentagon. [I didn't actually get to attend the NIH visit because the government had a snow day on the date it was scheduled]

When I wasn't busy attending student programming, I would be working on the projects assigned to me by various people in the office. Many of my projects were related to topics I mentioned to my preceptor that I had personal/professional interest in. I also attended meetings in which these issues were being discussed.

I also assisted with an update to a document to be published in the Federal Register. Each project was interesting and really allowed me to appreciate the intricacies of federal documentation and legal language/terminology. 

I can't say enough how much I enjoyed this rotation. I’m really grateful that we are provided this opportunity at Michigan. 

The pictures below include one with some of the great students I spent a lot of my time with (we are at the APhA headquarters) and one of many historical posters displayed on the White Oak campus.

Rotation 9: Community Pharmacy - Manchester Pharmacy, Manchester, MI

Posted by Jennifer at Tuesday, April 29, 2014

My last rotation was a great one on which to end P4 year.  Manchester Pharmacy is one of the Hometown Pharmacies which are located throughout Michigan.  Established in 1996, there are now 36 Hometown pharmacies in the state.


In the beginning of my rotation, I learned the workflow layout and computer system and further enhanced my knowledge of pharmacy laws in Michigan.  Towards the end of the rotation, I practiced verifying prescriptions and medicines for accuracy and appropriateness.  I would also discuss various pharmaceutical needs with patients and healthcare providers alike.  My preceptor, Dr. Jay Demski, set a great example as an ideal community pharmacist and helped me to improve my skills for working in a community pharmacy.


In the community pharmacy setting, patients have the opportunity to directly ask their pharmacist questions.  Patients often asked for a recommendation of an over-the-counter product or had questions about some of their prescriptions, and pharmacists are a ready and available information source. 


My rotation at Manchester Pharmacy has been an excellent experience! 

Rotation 8: Managed Care – Health Alliance Plan of Michigan, Detroit, MI

Posted by Jennifer at Tuesday, April 29, 2014

For this rotation, I was able to see a different aspect of a pharmacy at Health Alliance Plan of Michigan (HAP).  HAP is a not-for-profit health plan that provides health coverage for patients, either individually or through their employer.  HAP is also related to the Henry Ford Health System. 

Certain pharmacists at HAP are assigned to analyze medication requests that come into a computer queue.  Some medications require a prior authorization.  This means that some drugs are flagged for the pharmacist to review the medication for appropriateness for the specific patient before HAP will provide coverage.  HAP has a formulary with criteria for eligibility usage for specific drugs that is based upon evidence based medicine, and this is one resource that assists the pharmacists in determining whether or not a prior authorization should be approved.  Prior authorizations help to mitigate inappropriate use of medications to make sure that the safest and most cost effective therapy is used.

Generally during the day I would work on projects.  These projects mainly involved assembling detailed documents for new medications to be reviewed by the Pharmacy and Therapeutics Committee.  The purpose of the review was to help the P&T Committee to determine whether to add the drug as formulary or non-formulary and to decide if there should be specific criteria that must be met in order for HAP to approve the use of a drug for a patient.

I also discussed prior authorization cases with the pharmacists and participated in determining whether to approve or deny a request based upon the formulary as well as research that I sometimes needed to conduct. Throughout the day, sometimes I assisted the pharmacists in answering drug questions, which required me to complete research regarding specific prior authorization cases that the pharmacists were working on.  For example, sometimes a medication was requested for an off-label use, so I would look for any research supporting the off-label use.

I enjoyed seeing the role of pharmacists in the managed care setting.  Pharmacists in this area encounter a wide variety of medications and need a solid overall drug knowledge base.  I enjoyed working with all of the pharmacists at HAP and am very glad to have had this experience!

Rotation 7: Infectious Diseases – St. Joseph Mercy Hospital, Ann Arbor, MI

Posted by Jennifer at Tuesday, April 29, 2014

During pharmacy school, I found that the one of the most difficult therapeutic areas was infectious diseases (ID), primarily due to the many different antibiotics which each cover different types of infections.  I knew that I wanted to strengthen my knowledge in this area, so I was very glad to be matched to an ID antimicrobial stewardship rotation.

What is an antimicrobial stewardship?  It has several purposes, including making sure that antimicrobials are being used correctly (best drug, appropriate dose, route of administration, and duration of therapy), so that the best patient outcomes may be obtained while minimizing adverse drug effects.  Other purposes include decreasing hospital stays, decreasing costs, and limiting the ever-increasing antimicrobial resistance to antibiotics.  In an effort to help with these goals, some antimicrobials are restricted, meaning that there are certain criteria that a patient must satisfy in order to be able to receive a  drug.  For example, perhaps a patient needs to have tried and failed a few other antibiotics before resorting to a stronger antibiotic.  These rules are in place for the benefit of the patient and for helping to manage antibiotics appropriately.

My day would start out at the hospital looking at computer profiles of patients who had an infection.  I would find out what infection they were suspected/determined to have and then look at the current antimicrobial therapy and determine if therapy was appropriate.  I would try to determine if there was a better, more optimal regimen and then meet with my preceptor and a PGY1 resident later on to discuss the patients.  We also had specific valuable topic discussions about specific diseases and their treatments.  Later on in my rotation, I went on ID rounds with the ID team and visited the patients whose medication profiles I was monitoring. 

I definitely improved my ID knowledge while on this rotation, but there is of course much more to learn!  It was great to see first-hand how an antimicrobial stewardship works.

Rotation 6: Ambulatory Care – Ypsilanti and Livonia, MI

Posted by Jennifer at Tuesday, April 29, 2014

During this rotation, I traveled to two different clinics throughout the week, one located in Ypsilanti and the other located in Livonia.  At these clinics, my preceptor helps patients mainly in managing their diabetes, hypertension, and dyslipidemia.  In this setting, my preceptor has a collaborative practice agreement with a physician which gives him the right to prescribe medications within his defined disease areas (mainly diabetes, hypertension, and dyslipidemia).  This is a unique position for pharmacists, as typically pharmacists do not prescribe medications.

Before coming into clinic, I would work up my patients at home so that I could determine what the most crucial issues were that should be discussed with the each patient.  During the first hour of the day, my preceptor and I would talk about each patient.  We had valuable discussions about therapy regimens, and this helped me to review and improve my therapeutic knowledge.  During this time, we would also determine what we should talk about with the patient and what the next steps might be in the patient’s drug therapy.  Thinking of plans A, B, and C regarding changes in a patient’s medication regimen ahead of time was valuable.  Sometimes patients did not want to try certain drug therapies, so we would have a back-up plan in place. 

My preceptor and I would either see patients during a 30-minute in-person clinic visit, or we would talk with them over the phone during a 15-minute conversation.  During clinic visits, I would manually measure blood pressure and did a few foot exams for diabetic patients.  Talking with patients during this rotation was a great learning experience.  The goal of these encounters was to let the patient set the agenda of what issues they would like to talk about, and at the same time it was also important for me to gather specific information.  It was challenging at times to balance these two needs while staying on track time-wise, but I found that the more patients that I spoke with, the better I learned how to balance these goals. It was also interesting to be able to follow-up with patients a week or two after visits to see how the medication and/or lifestyle changes we discussed had affected their health. 

A pharmacist in the ambulatory care setting plays a unique and beneficial role in patient’s health, and it was great to participate in this first-hand!

Rotation 5: Drug Info – Michigan House, University of Michigan, Ann Arbor, MI

Posted by Jennifer at Tuesday, April 29, 2014

My fifth rotation brought me back to Ann Arbor for a drug information rotation at the University of Michigan Health System Michigan House.  U of M – affiliated healthcare professionals may call, page, or email questions to the drug information department.  Another classmate was on this rotation with me, so we would take turns answering drug questions.  One of us would answer questions in the morning and one in the afternoon.  I learned about many new drug information resources and became more adept in navigating old ones. 

I received a variety of questions, some of which involved questions about the administration of medications through a gastric or jejunal tube, if a refrigerated medication was still usable even though a refrigerator went out of range, if a medication contained preservatives, recipes for compounding, if titration was needed when switching from one medication to another, and possible side effects of herbal medications. Researching the answers to these questions required utilization of databases, websites, books, and sometimes calling the manufacturer of a specific drug product.  Then, I would discuss my findings with a pharmacist before responding to the healthcare professional who had asked the question. I actually worked with four different pharmacists while at Michigan House.  I had a main preceptor and three other pharmacists who I worked with on projects, and they were all wonderful to work with.

When I was not answering questions, I worked on several projects.  I created two drug monographs for presentation to the Pharmacy and Therapeutics Committee and wrote a newsletter article for Pharmacy for UM.   I was fortunate to be able to attend several different meetings, including a P&T Committee meeting and a pain management committee meeting. 

Overall, this rotation helped me to become more competent in navigating through the different drug references, and this applies to any area of pharmacy!

Using a Lifeline: Drug Information

Posted by Adam Loyson at Tuesday, April 22, 2014

With the end of the semester approaching, final exams on the horizon, and commencements just around the corner, I write to you about my exciting tour on rotation with drug information (DI).  On this second to last rotation, I made sure to put in extra effort and learn as much knowledge as possible before my chapter as a student pharmacist later comes to a close.  I also continued to grow my skills in conducting systematic searches for information and providing clear and concise evidence-based answers to a variety of healthcare professionals.  Routine day on rotation you say?  Definitely not!  There were so many more opportunities to get involved while working in DI, some of the most rewarding I elucidate on below. 

The Basics

Today, there is an abundant amount of health information on the internet with much of it sketchy at best.  DI services, therefore, are a valuable resource to provide accurate and quality information in a timely manner.  The Drug Information Service I worked with while on rotation was responsible for servicing a tertiary healthcare center comprised of an adult hospital, a children’s hospital, 120 outpatient clinics, and 40 health centers, comprising a total of over 900 patient beds.  In addition, the service also provided pharmacotherapy consultation services for practitioners in southeastern Michigan.  The DI call center’s volume was rated at approximately 1,800 questions annually.  While on rotation, I had the opportunity to explore and find answers to the most common questions (medication’s therapeutic use, pharmacokinetics, dosing, drug interactions, toxicity, pregnancy/lactation use, compatibility, shortage availability) to the more extraordinary inquiries (homeopathic use, tapering regimens, stability in refrigerator/freezer outages, compounding regulations).  To answer effectively, I participated in weekly topic discussions and evidence-based medicine assessments to review most helpful DI resources, including those found online.

Of the more interesting requests during rotation, I was tasked to find out more on the use of oseltamivir in national strategic stockpiles, specifically the proper emergency preparedness handling of expired medications.  As someone hoping to enter public health after graduation, this was right up my alley!  After contacting the Food and Drug Administration, Centers for Disease Control, and my state’s community health department, I discovered that select lots of oseltamivir may receive extensions to their expiration dating via FDA announcement in emergent times of natural disaster.  Another interesting request came from a transplant pharmacist wanting to know more about the bioavailability and safety profile of magnesium treatments complexed with protein.  Early studies demonstrate more patients tolerating this organic chemical identity as compared to magnesium oxide.  I also found that larger trials were currently being conducted by the manufacturer, who agreed to send my institution notice as soon as they were published.

More than just an Operator

While answering drug information requests was a primary responsibility, I also participated in numerous projects associated with the Pharmacy and Therapeutics (P&T) committee, ambulatory infusion formulary committee, the cancer pharmacy committee, and the product and vendor selection subcommittee within the health system.  As the opportunity presented, I completed a P&T drug monograph on a monoclonal antibody aimed at inducing remission for those with ulcerative colitis and Crohn’s disease.  I also completed several MedWatch reports detailing drug adverse events and wrote a newsletter article to be sent out to the entire health system outlining the new guidelines released by the US Public Health Service detailing HIV post-exposure prophylaxis in occupational healthcare providers.  Of high value to the health system, I concluded my rotation by finishing a medication use evaluation on intravenous immunoglobulin to ensure proper ordering and dispensing of this extremely expensive blood product to patients.

Fuel for the Future

DI was just the rotation I needed to boost my skill set and confidence.  I now task other healthcare providers and students to give me their best shot.  If I don’t know the answer, I’ll know where to find it.  With another rotation completed, I continue on my path to being a professional with newly learned integration and collaboration skills necessary to help in determining the most appropriate course of action in a given healthcare situation.

Rolling in the Deep: Preparing for Life Beyond Rotations

Posted by Adam Loyson at Sunday, April 06, 2014

I hope everyone has been staying warm these past few winter months and ready for spring! Since last writing about my rotation with the U.S. Indian Health Service, I find my rotation experience taking a twist. I am currently in the pediatric emergency department, preparing applications for postgraduate opportunities and beefing up my interviewing skills. As an attendee of the recent American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting, I’d like to share my tips to help those who are pursuing residencies and fellowships and planning to attend next year’s meeting. For those with postgraduate training, entry-level job, and summer internship interviews looming on the horizon, I also provide valuable advice on networking skills and how to prepare for an interview.

Successful networking

   As a student pharmacist looking into nontraditional career paths, I found great networking communication skills a cornerstone for discovering unique opportunities and resources. The primary tool I used when reaching out to individuals outside of the college and at ASHP Midyear was my elevator speech as a personal introduction. I found that creating a 30-second summary of who I am, what I can contribute, why I wanted the position, and my future goals, was a very time-effective way to share my interests with others. It also gave those listening a helpful backdrop for providing advice. After creating an elevator speech, practicing with my pharmacy preceptors was a great way to receive valuable feedback and perfect my initial presentation. 

You’ve introduced yourself using an elevator speech; now what? I preplan my conversations by researching the individual’s background and outlining specific points I want to cover. After an elevator speech, I remember to keep the person I am talking with engaged in genuine conversation to show that I care about what he or she is saying. I do this by making good eye contact, using professional language, and periodically confirming I am listening by asking thoughtful questions. At the end of the conversation, I offer to exchange business cards for follow-up later. I receive the person’s business card with both hands and express my gratitude. This act displays respect, since in some cultures business cards serve as an extended representation of the person.

ASHP Midyear

    The networking skills I described above definitely helped me out at ASHP Midyear. At a conference where more than 20,000 attendees from more than 80 countries are competing to talk with representatives of postgraduate programs, every second of communication counts. Whether you attend the residency showcase, interview through the Personal Placement Service for residencies and fellowships, or seek entry-level positions at the exposition, the single most important thing is being prepared.  

Research the programs you are most interested in, find out where and when the program representatives will be available to talk to interested students, and bring a few copies of your updated CV. Don’t forget to dress business professional and prepare a few intelligent questions to ask of your own. Remember, you are also trying to find out if they will be a good fit for you.

Preparing to interview

    The key to getting an interview is an excellent CV. However, after you get the interview invitation, what do you do? My best advice is to be prepared (sense a theme?), be on time, and be professional. Based on my own experience, I can tell you that practice makes perfect. During an interview, demonstrate your interest in the position, show enthusiasm, be confident, and relax. Be yourself—the interviewers just want to get to know you better. Searching online for commonly asked interview questions beforehand can give you a feel for what to expect. If behavioral interview questions are asked, my recommendation is to answer using the STAR approach: describe the Situation, the Task, the Action, and the Result. After the interview, don’t forget to follow up by acknowledging your appreciation, your interest in the position, and reaffirming your qualifications with your interviewer. 

The next step

    Following the nontraditional pharmacy career pathway, I am seeking positions within the U.S. Public Health Service after graduation. After reaching out to individuals at FDA and Bureau of Prisons, reflecting on completed rotation experiences, and reviewing past shadowing opportunities, I have decided to apply for entry-level positions within both agencies. As future interviews approach, I will be following my own advice and hope my recommendations are useful for you as well.

Infectious Diseases with Dr. Jarod Nagel

Posted by Patrick at Saturday, April 05, 2014

Managing antibiotic therapy is a core competency for the inpatient pharmacist and I am very grateful to have had the opportunity to spend five weeks honing my skills under the guidance of Dr. Jarod Nagel.

The rotation was split into two halves. For the first half, I joined the infectious disease consultation team. Myself, as well as one of the PGY2 residents, spent the mornings on topic discussions and examining patient charts. At 1:15 pm, we joined “micro-rounds” for a 15 minute microbiology slide show put together for the medical students on a topic relevant to recent patient cases (malaria, Chagas disease, and other tropical maladies were common during my time there). We then spent the afternoons rounding with the infectious diseases consult team, making recommendations when there were pharmacy relevant problems. Most of our recommendations were related to medication dosing and potential drug interactions. Working with the consult team was an excellent way to learn the nuts and bolts of managing complex antibiotic regimens. In school, we learned about the “big gun” antibiotics (as Dr. Carver calls them), but directed most of our energy towards the management of the more common antibiotics that pharmacists see much more regularly in practice. On the consult service, I had the opportunity to grapple with decisions regarding the tradeoffs of linezolid versus daptomycin versus tigecycline for various vancomycin resistant enterococcus. I also became very familiar with the side effect profiles of these agents and had the chance to participate in the management of various adverse events. As a result, I feel that my drug monitoring skills reached a new level over these five weeks.

After my time on the consult service ended, I moved on to the stewardship part of the rotation. I had a much expanded patient list, but was evaluating them on somewhat narrower criteria. The “list” was a collection of patients newly started on a list of restricted antibiotics (examples include daptomycin, meropenem, linezolid, collistin, and voriconazole). My role was to evaluate each patient and make recommendations as to whether the “restricted” antibiotic was appropriate. The hospital has particular criteria and I would read each patient’s case and make a judgment as to whether they either a). fit the criteria as written, or b). were such an unusual case that the therapy was appropriate despite not quite fitting the written criteria exactly, or c). the therapy was inappropriate. In the case of inappropriate therapy, I would (after conferring with my preceptor) make recommendations to the pharmacist directly covering that service to have a discussion with the primary team regarding a timeline for discontinuation.

As the decades progress, our arsenal of effective antibiotic agents becomes more limited by the changing patterns of antibiotic resistance. It is the job of the stewardship pharmacist to understand these trends in a quantitative way and to respond in a dynamic fashion. In addition to the active management of restricted antibiotic agents, the stewardship team is responsibility for the development of a large share of the hospital’s policies and procedures regarding appropriate antimicrobial use. They work with the physician stewardship team and the P&T committee to answer questions such as: For which patient populations will we sanction the use of fidaxomicin in place of vancomycin for C. Difficle infections? My primary project was in this sort of policy development. My role was to evaluate the recent literature regarding the use of probiotics for C. Difficile prevention. This type of project has traditionally been one of my strong suits, but as I delved deeper, it turned into something of a mess. It turned out that the question I had sought to answer, “Are probiotics save and effective for the prevention of C. Difficile infections?” was both too broad and too narrow. The necessary questions, for a hospital to actually produce a policy and make a decision required an evaluation of which probiotic and an evaluation of safe and effective in which patient populations. As for a summary of what I found, here is a one-liner: Many small, relatively low quality studies in high risk populations show a benefit to probiotic therapy; the one large, randomized controlled trial in a relatively low risk population showed no benefit. Making decisions based on this sort of conflicting data may be the core intellectual challenge of the job.