A Taste of IRB + A Pharmacy Student’s Battle Cry to Action

Yummmm. You see that delicious plate right there? That’s what you could be eating, if you went to the Institutional Review Board (IRB) meeting.

As a participant of the MCRiT program, a few weeks ago I was allowed to go to an IRB meeting. I got a first hand account on what happens during those important meetings.

For those of you unfamiliar with what the IRB does, essentially it is an ethics committee that must approve of all research studies before they can commence. In the past, researchers did not take into account patient safety, and many patients were seriously harmed or other ethical violations occurred. This led to the Federal Government creating these IRB to ensure patient safety in research studies. One way that the IRB works to ensure patient safety is by including non-researchers on the board: there was community representation, prisoner representation (prisoner participants in research has a cruel history), and other non-scientists present.

This is what the IRB meeting looks like:

Sitting in this meeting, it reminded me of the City Council meetings you see on C-SPAN. Everything was official and professional. I found the whole experience rather intellectually stimulating. To get a sense of what happens, imagine Dean Welage’s Evidence Based Medicine Class when we critically appraised articles and studies. Now imagine a room full of professional researchers who do this. You will hear words and phrases tossed around like: minor increase over minimal risk, APO (approved pending office), APR (approved pending reviewer). It again showed me how critical proper study design is – from recruitment and compensation to patient withdrawal policies. After they review the case, the board votes – favor, oppose, or abstain on the research proposal or amendment.

Here’s a picture of my mentor for the meeting. Thank you again Dr. Stephan Taylor!

The University of Michigan actually has multiple IRBs. We aren’t called the Leaders and Best without reason. I learned that there are 5 IRBs alone in the Medical School (for human subject research) and 1 IRB located on Central Campus for Health Behavior Research (psych, physics experiments, etc).

Sitting through the IRB, I learned how vital it is that Pharmacists be pro-active and take initiative to expand our profession. Unfortunately, there wasn’t any Pharmacy representation at the IRB I was in. I only hope that we are represented on the other IRBs because I know we have the clinical knowledge to be effective on these boards. There was a study pending approval regarding a prospective randomized control of simvistatin on the prevention of COPD being lead by a physician and not a pharmacist. I always assumed that we were the drug experts. Perhaps I need a better understanding of the US Health Care System and its politics. But regardless, my point is that we are at a tipping point in our great profession. The time to expand our scope of practice can only be achieved if we get out of our comfort zones of dispensing and demonstrate how we can improve patient care with our knowledge and training. UofM is teaching and preparing me the clinical knowledge, but I know it will be up to me to either actively participate or simply sit on the sidelines when I graduate.

I hope that by the time I practice, I will continue to have this fire to push our profession and inspire those around me to do the same.

Go Blue!

Next Steps...

Hey guys,

It feels like it’s been forever since I last updated. Life’s been busy with my friend’s wedding this past weekend and the week prior was my group’s Final presentation at the North Campus Research Complex (NCRC). I’m happy to say that the presentation went well! The grueling 3 hour meetings late into the evening to plan and prep helped immensely as our group walked out relatively unscathed from the barrage of questions from our Alzheimer's-Depression presentation for the senior clinical researchers, coordinators, and PI’s present in the audience.

Here is a picture of my awesome team.


Dr. Charles Burant, aka Chuck, if you’re reading this, thank you, thank you again for your dedication to mentoring our group. You definitely lead us, pushed us, and your experience with writing research grants helped us immensely as we were able to correctly predict what type of questions the audience were going to ask before the actual presentation. We were well prepared. Also, your enthusiasm is a rarity and I hardly see anyone who loves their job more.

Yesterday was my last day at the Taubman General Medicine clinic. I’ve reached the quota of patients and now shift my research responsibility focus into data entry and writing. I have over 200 surveys that I need to input into an Excel spreadsheet, then play around with the SPSS statistical software, and finally see what data I’ve obtained. Then I’ll write an abstract (due in a week, another deadline!), my report (what findings did I make/observe?) and finally make a poster of my results! I’m also hoping to write a paper and get it published, and have my own imprint in the science literature world (there’s something cool about contributing to knowledge). I’m excited because this will be my first poster, abstract, and report and I have BIG VISIONS for all.

I actually ran into a Psychiatry resident friend at my church a few Sundays ago, and told him the type of research I’ve been working on all summer. He was interested in what I’ve seen so far and my future results. He explained that at the psych clinic where he works, the doctors have been telling their patients about the inexpensive generic medication programs but they don’t know if their patients have actually utilized them. This is where my research can help. I will have REAL DATA to show how many patients (in general) have actually utilized an inexpensive generic medication program when the physicians or pharmacists tell their patients about such a program during their clinic visit. (As I blogged earlier, the Taubman General Medicine clinic doctors have informed their patients as well.) This research study could potentially open up more research opportunities, in that if we find that monetary reasons are not the reason why patients are not compliant in taking their medicine, then there must be some other variable that we are not aware of and need to investigate further. In fact, this outcomes report, I HOPE to distribute to ALL the physicians and pharmacists at the Taubman outpatient clinics at the University of Michigan Hospitals as well as the geriatric clinics who might benefit from reading the study.

The study may affect the way physicians/pharmacists practice to help their patients become more compliant in taking their medications, with the overall goal of seeing their heaths improve. I talked to Dr. Erickson about it recently, and what we’re doing this summer could potentially be an intermediate outcome (medication compliance), with the long term outcome being the overall health improvement of patients utilizing a generic inexpensive program. To monitor improvements in the patient's health we can obtain information from their charts and monitor their numbers (cholesterol, hA1c levels, blood pressure, etc). I would then try to get it published and possibly show how a physician/pharmacists intervention actually led to better health outcomes and that it can be implemented at hospital nationwide. Not bad from an idea that came from a summer research project.

Last thoughts on my time at the Taubman General Medicine Clinic: I’m grateful for the experience. It’s been a while since I’ve talked to real patients, and heard their burdens with their diseases, medications, and the U. S. health care system. Too often during the school year I’m just trying to survive my classes that I forget the reason why I went into health care – and that is to improve the lives of patients in a definite way. I’m also grateful for this summer experience because I got a chance to learn more about the state of Michigan (I’m from California). I constantly met retirees from the auto industry at the clinic and saw how important the auto industry is for Michigan residents and this made the recent downhill in the car industry more impactful to my life.

Finally, I ran into a Michigan Senator at clinic! Unbeknownst to me at the time, I asked Michigan Senator Robert Patterson to participate in my research. And after I found out he was a Senator, we got to talk about an assortment of topics before he was called in. We talked about the recent Michigan election, his thoughts on the recent (and future) health care reform, living a public life, and how hostile politics have become recently. Unfortunately he was called in before I could talk about ways that Pharmacists can be used to improve the health care delivery and system. But I did get a chance to take a photo with him and got his business card. This is one bridge I certainly want to continue building!

Studies Galore

I was on vacation last week so I didn’t have a chance to blog. My son, Brady, is turning one year old so we took him to Grandma’s and Grandpa’s to celebrate. The summer is quickly drawing to a close and there have been some interesting new studies taking place in IDS.

Last week we opened a study dealing with novel treatments for sarcomas. The study drug is a vaccine that stimulates the production of antibodies which have been shown to eliminate free tumor cells from the blood and lymphatic systems. The vaccine is stored in a special freezer at -80C.

Most study drugs that we maintain have specific storage conditions and temperatures that must be maintained. Every month, study sponsors send representatives called monitors to make sure that their drug is being maintained under proper conditions. The monitors also verify inventory levels and check to see that all our drug dispensing is recorded properly. As an intern I am responsible for making sure our records are well kept and accurate for each monitor visit. We typically have between 5 to 15 monitor visits each week.

Another interesting study that has been going on for a few months is investigating treatment options for brain tumors. Brain tumor antigen removed from patients is presented to their own immune system via their own dendritic cells. This allows the patient’s immune system to systematically target the tumor. Many of the oncology drugs being investigated at IDS are highly targeted which means the patient experiences less systemic toxicity.

The IDS internship allows me to work with many great pharmacists. I learn about not only investigational drugs and procedures, but basic clinical methods that I will be able to carry with me throughout my career.

I want it for FREE!!....Wait....I don't???

Currently in the Johns Hopkins Hospital there is a "sample prohibition" on the way. What is a "sample"? In health care, it refers to those free drug samples you get from your physician, or that discount card you receive to get a free medication from your community pharmacist. From a consumer and patient perspective, it's hard to see the any drawbacks to receiving free drugs. I have to admit, I was puzzled when I attended meetings discussing how Johns Hopkins was going to get rid of all the free drug samples in the hospital, and prevent vendors from donating products to any of the health system's satellite hospitals and clinics.

As a future pharmacist, I want all of my patients to have access to necessary medication. If companies are willing to give away their brand-name drugs for free, who am I to stand in their way? I finally had to ask for an explanation. The response I received was somewhat surprising.

Samples come from a manufacturer trying to promote its product, but not all manufacturers supply free samples to hospitals. Let's say a patient comes into a hospital/clinic and is diagnosed with mild form of asthma. The physician knows that the patient lacks prescription drug coverage and believes that the cost of medication therapy would deter the patient from getting his/her medication. So the physician decides to give the patient a free sample of Advair, because that's what he has on hand. But is Advair the right drug to give this patient? Not according to the physician's initial diagnosis. Advair is reserved for moderate to severe asthmatic symptoms, which is not the diagnosis.

So what happens if the patient runs out of the free Advair sample? If the patient is responding well to the drug therapy, standard protocol is to keep the patient on the drug. But Advair is one of the most expensive inhalers on the market. What now? The patient may have had difficulty paying for an albuterol inhaler or nebulizer, but a single cycle of Advair can exceed $350. So how will the patient pay for prescription refills?

Well I will tell you how they get their refills, the hospital pharmacy gives it to them for free, or the patient gets Medical Assistance which will then pay for the drug. Both option cause the health system and the hospital time, money and stress. All of this from one sample of a drug, now multiply that by the nearly 100,000 samples given out by the Hopkins hospital alone last year and the picture becomes a little less hazy. Samples aren't only restricted to drugs, when new moms and their babies leave the hospital companies give them free cases of their formula for the baby. It's a way to hook them on their product from day one, a lot of times the free product is the most expensive product and not necessarily the best product.

I know a lot of you may be thinking, well if we get rid of samples how can we ensure that the patient gets the medication they need. Well that all comes full circle back to one of my previous postings when I talked about 340B. We can offer patients drugs at our 340B pricing which is more than free but usually less than a dollar or give away generic drugs for pennies. Either way it saves the system and hospital in the long run. All very interesting when you change your perspective.

Shadowing

In the past few weeks, I have had two shadowing experiences through my internship. The first experience was in psychiatry. This is a field of pharmacy that I've been thinking about going into for a while now. I watched the pharmacist work for three hours one morning. We first went to a large multidisciplinary meeting which involved physicians, social work, nursing, and us. Everyone had input about the patients and many aspects of the patient were discussed. It was really a neat conversation to be involved with! We then were able to participate in rounds and speak with the patients. If I were able to stay longer, I think I would have also been able to watch the pharmacist counsel some of the patients on their medications. This area of pharmacy definitely still makes my "short list" for possible future careers. However, I'm still torn, especially after my other shadowing experience...

A few days ago I shadowed a pharmacist who works in administration. I feel like administration could be a natural fit for me: I love efficiency and organization and think I am pretty good at handling what some people may consider difficult situations. This shadow was an entire day. We attended two meetings with other administration staff. In the first, we discussed improvements made following our recent Joint Commission visit. During the second, we discussed problems and ideas for the future. I helped the pharmacist create a new policy and also watched as he held a meeting with an employee he oversees. At the end of the day, we went to a multidisciplinary meeting to discuss some new policies the hospital may be adopting. I loved watching the pharmacist at work and hearing about all of his tips on successful leadership. (One of the neatest tricks he told me has has done was to put 5 pennies in one pocket at the beginning of the day and then transfer a penny to the other pocket for each compliment he gives. He won't leave work until all of the pennies have been transferred--what a great way to keep positive and make sure people hear how much you appreciate them!)

I would recommend shadows like these for all pharmacy students. I hope to schedule some more in the coming year and a half before I go to midyear and need to narrow my "short list" down: will it be a traditional PGY1 or possibly an administrative residency?

Avoiding the "Donut Hole"

Even if you are not interested in geriatrics, still take Dr. Remington’s class….

As the summer goes on, I continue making my MTM calls. But the more calls I do, the more I realize that a comment complaint among the members is hitting the “donut-hole”. It is inevitable though, as your age increases so do the number of your prescriptions. Even though more and more generic drugs are coming to market, medication costs are still on the rise. But this is where pharmacists can play a crucial role to members (or “patients” for the rest of you).

As a student it’s hard to believe that we can really impact a patient’s drug therapy or reduce the overall costs of their medications. But we can! This is why I say take Dr. Remington’s class – even if you don’t have any interest in geriatrics. I can honestly say I am a peds person all the way and still benefited greatly from her class.

In Dr. Remington’s class, she gives an assignment which requires you do reduce a patient’s medication. Now, avoiding the donut-hole has nothing to do with what the patient actually pays at the pharmacy but with the actual drug cost. For example a member is receiving pantoprazole and pays the lowest copay since this is a generic medication ($10 for 90-day supply). So is there a reason to switch this patient to another PPI? Yes! If you look at the actual cost of the medication (wholesale cost) a 90-day supply of pantoprazole is $319.95, where a 90-day supply of omeprazole is $149.98. As a result, switching the member to omeprazole would save $679.88 per year. And that’s just ONE medication!

As you can see, modifying a member’s drug therapy - even just one medication - can make a huge difference. Think about how much we as pharmacists can do for a member in cutting their prescription costs to help them avoid the donut hole.

Deadlines Looming

Things are stressful at the moment. In 2 days, my group (composed of Pharmacy, Dentistry, and Social Work students) are responsible to submit a grant proposal and give a presentation about Alzheimer’s Disease. This is the final objective of the MCRiT summer practicum: participation in a “virtual group research project” . To guide us, we’ve been paired with Charles Burant MD, Ph.D, a professor in the School of Medicine who has been OUTSTANDING as a mentor. Unfortunately, we’ve only been given 2 weeks to make this project happen, and unfortunately, life doesn’t just stop when you have deadlines looming.

My observation is that research can start off incredibly slow and dry - when you’re being trained, trying to put a project together, or coming up with a hypothesis- , but can become quite stressful whenever deadlines approach ( ie annual reports, renewal of grants, presentation of work thus far). I’ve also discovered research doesn’t always end when the clock strikes 5 pm. These past few days, my day started with clinic but then afterwards have been filled with meetings and reading up on Alzheimer’s Disease in my free time. Some days there have been meetings that extended late into the evening to ensure we get our work done.

And your personal life doesn’t stop too. I went to a wedding on Saturday and I’m attending another in 2 weeks.

Though I’m super busy working on my portion of the Virtual Group project – I’m in charge of the data analysis ( statistics again!) and figuring out which statistical test is appropriate, patient safety ( to pass IRB) and the estimated budget (to hypothetically hire a Primary Investigator, study coordinator, purchase supplies, etc) – I really wanted to write this post and share what I think happens annually in research, and that is reporting and presenting what you’ve done all year. We’ve had seminars for each step of the research process – now it’s time to incorporate everything and demonstrate what we’ve learned in the past 9 weeks!

This is a picture of our whiteboard from a late evening brainstorming session to develop a testable hypothesis about Alzheimer’s Disease.

A little help

I have a small dilemma. At the end of the internship each intern is required to make a presentation to the directors, managers, residents and remaining interns. Mine is of course the last one...because you save the best for last. Unfortunately I have no idea which of my dozens of projects I should actually present on that will also engage the crowd. One of my favorite projects happen to be my simplest project in which I know I could bring it to life and have tons of fun with it. On the other hand it borders on un-professionalism, but should I really worry about that?
I have about 15 different projects that I am involved with out of those 15 none of them are actually completed. This is due to no fault of my own here a simple project can span into a year-long headache. I knew this before coming and accepted that things I started would most likely be finished by someone else and maybe within a year I will see the fruits of my labor. The biggest project that I will try to get updates on during the school year is the Creative Alternatives packaging. I found alternative packaging for this program through a product called DisPill. It's actually really innovative and all signs point to them moving forward with the packaging in the coming months. More than just finding it through a google search I had to work with our IT department to ensure that the programing would integrate with our current computer system. Discussing the operational impact of packaging change and the costs per patient associated with the new packaging. I also had the opportunity to work with producers of DisPill to change their software to benefit our target population. I have a problem presenting this as my final presentation as it only has application here at Johns Hopkins. I want to present something that no matter where their career takes them they can think back and remember the presentation. It looks as though I will have to search through my projects and find the one...

It's all about the people

I just wanted to spotlight some of the great people I have had the opportunity to work with as this will be the last week we are all together. This year there were 24 interns accepted into the Johns Hopkins Internship program and I am grateful for the opportunity to meet each and every one of them. I won't go through all of them but I did want to talk about a few people who have made my experience incredible.
The preceptors are the people that make it possible for us to have this program. My preceptor is Nathan Thompson the Director of Outpatient Pharmacy. Other notable preceptors include: Yvonne LeBlanc (Clinical Applications Manager), Jim DiPaula (Operations Manager), Bridgette Thomas (PharmIS Manager), Krista Decker (Quality & Safety Manager), Brendan Reichert (PharmIS Director), Brian Pinto (Drug Use and Policy Director), and Edina Avdic (Pharmacoeconomics Manager). I was able to spend at least one full day with each of these preceptors and want to thank them for their time. A lot of other people have acted as a reference and guide this summer and hopefully mentors as my career progress these people include; John Hopkins (that's his real name, no relation) and Jim Van Daniker who both serve as the business managers for the outpatient pharmacy and Dan Ashby (Director of Pharmacy) I have to send a special thanks to Luis Simbala who is not a pharmacist but taught me so much the summer about Microsoft programs that Bill Gates himself should write this guy a check.
The interns helped me keep my sanity and made me laugh every day. First up is Abbie Shallop who we all know since she goes to school with us. It was great to get to know Abbie more of the summer we had some great laughs together and I want to wish the best of luck on her marriage and hopes that she enjoys it before classes begin again. Then there is Rami Beiram who is like the big brother I always wanted. He is a third-year student at Harding University by way of Atlanta, Georgia, he and I share the same humor and make quite the comedic duo. Then there's Tamara Fawall, the little sister I never wanted. Actually she's great her and I have the same exact birthday so you can imagine what a female version of me is like to deal with. Tamara is also a third-year student at Rutger's University, I finally found my Jersey girl. Without the three of them I would not have enjoyed myself nearly as much and I will keep in contact with all of them as we go forward, Abbie has no choice since I'll sit right next to her in class but the other two I will bother them through other media. This Monday will be our last day together as Rami heads back to Atlanta before heading back to school at Harding University. I swear... I'm not going to cry...

IPSF-SEP Taiwan- Part IV

My last week in Taiwan came and went quickly. My schedule at the hospital this week included a variety of activities such as rounding with the ID team, evaluation of a new drug for addition into the formulary, and observation at the outpatient pharmacy (which is incredibly fast-paced, serving >2000 patients between 8am-10pm).

Taiwan has a national health insurance scheme and healthcare services are affordable and accessible to all its citizens. At Shuang Ho Hospital, patients pay a nominal registration fee of NT$150 (about US$5) for each physician appointment. There is no out-of-pocket cost for medications unless the patient is taking drugs that are not covered by the national health insurance. Private clinics are not common in Taiwan as most patients prefer going to larger hospitals.

Medications are dispensed in “prescription bags” which are about the size of a sheet of paper. These are labeled with standard information such as drug name/dose, patient’s name, DOB, prescriber’s name, pharmacy address and contact number, etc. There is also additional information such as common adverse effects, storage information, and tablet description. Labels would indicate the correct tablet shape, color, imprint, and scoring. Thus, patients are able to verify whether they received the correct medication. I think this is an excellent way of empowering patients and improving patient safety.

My SEP experience has been a rewarding one, both professionally and culturally. With ~15 SEP students in Taiwan this year, not only do I learn from Taiwanese students and pharmacists, I have also learned a lot from other students from Canada, UK, Singapore, Poland, etc.

And what’s next? Taipei to Singapore, and Singapore to Ann Arbor. I’ll be on the plane for close to 30 hours over the next 3 days!!

The New Era of 340B

It's been a bit since my last update. I know that my blog contains no pictures so I seem boring but I completely planned to upload pics soon. Then I had a serious disagreement with my iPhone and it decided to reset itself and delete everything that was in the phone over the past 5 months. Meaning that I lost all the pics I took this summer, I'll try to get some pics from the other interns and take more pics before the end of the internship, which is only a month away.
Enough complaining this Monday I was invited to the annual 340B Coalition Summit held in Washington, D.C. The conference attracts pharmacist, physicians, nurses and business managers from all over the country to discuss the future of 340B. The Affordable Care Act (ACA) or Health Care Reform is the first change to the 340B change since it's creation in 1992. To give a brief rundown on what exactly 340B is and how it relates to hospitals I will attempt to make it as painless as possible.
Almost every hospital participates in a form of charity. As health care professionals it is not in the nature of our job to turn away patients in need. When a hospital services a disproportionate number of patients who neither qualify for Medicare or Medicaid assistance that hospital outpatient pharmacy can now apply for the 340B program. The official percentage is 11.75% of your population must fit in this description of need. So now what? Say normally I purchase a bottle of Drug A for $1.00 and I normally sell that bottle of Drug A for $1.75, well my profit margin for that drug is $0.75. Now I am part of the 340B program and under this program I can purchase drugs for a deeply discounted price. For the same bottle of Drug A I can now buy it at a price of $0.75, well I am still going to sell it for normal price of $1.75. What changed? Well now my margin on the same product is now $1.00 compared to $0.75. The goal of this increased margin however is not to pocket the savings but put the savings back into the charity fund. This allows the hospital to either increase the number of patients they serve or close the gap in the dollar value of drugs given to patients without insurance. Also a few things to note 340B is that it is only used for outpatient drugs, not inpatient and only a few clinic drugs. 340B is important because like I said most hospitals have a form a charity it is beneficial to be part of the 340B program to increase your margins and close the gap in charitable funds and revenue collected.
Back to business the summit was actually over three days but I was only able to go to the first day. The two big questions that were going to be debated over the conference were: 1) if everyone is now covered in some form or another with insurance will their be a need for 340B? and 2) if manufactures can afford to offer 15-30% discounts on the drugs currently under the program than what kind of prices are they charging? Two great questions without solid answers. As health care providers it is in our best interest to serve our population any way possible without going broke and that's what 340B allows. What about the millions of Americans that health care reform leaves out, who still wont have insurance? All valid questions and this is just a small portion of the ACA. I bring attention to this because pharmacist play a crucial role in the years moving forward at least when it comes to 340B pharmacist have taken the leadership role and advocated for their patients which is great. When law is finally signed there could be substantial changes to 340B like getting is extended into the inpatient setting, it could disappear all together. I guess only time will tell...
P.S. - Love walking through the conference with my Johns Hopkins badge on, they treat you like a freakin rock star. No joke

A Taste of Grey's Anatomy in Ann Arbor

Have you ever watched those medical shows with those handsome doctors who talk oh so lovely to their patients to enroll them into a clinical trial they are conducting? Well that's what my life has been like this summer except for the lack of a McDreamy hair cut and the fooling around with medical interns in the on-call room.

These past 8 weeks, I've been at the Taubman General Medicine Clinic at the University of Michigan Health System Hospital doing a study with the Pharmacists and Physicians on where their patients go to obtain their prescription medications. Co-blogger Alex Tungol actually did a similar study 2 years ago with Dr. Erickson through the summer MCRiT program as well. This gives me the ability to compare my results with hers, after I analyze my data with statistics. It will be interesting to see if any trends have developed in the two years. It's been a while since I've taken Statistics (and I never knew how significant it is to research) so this provides an opportunity to freshen up in my Excel and SPSS programing. Once I get my results, Dr. Erickson and I will analyze it, make a research poster, write a paper on it, and hopefully get published in a scientific journal!

For this project, specifically we're looking at whether the Recession and the two year advertisement campaign of the $4 inexpensive generic programs offered by major chain pharmacies ( such as Kroger, Walmart, and Target) have had any effect on the behavior of general medicine patients of where they go to get their prescriptions filled. We'll also be able to see if these incentive program have lead to increased medication adherence and other prescription behaviors. Furthermore, this outcome research affects the Physicians and Pharmacists directly at the Taubman Medical Clinic because many have been pushing their patients to utilize these types of prescription programs.

My primary job these past 8 weeks have been to enroll patients into the study. I've been humbled to say the least. From this experience, I now understand how difficult it is to enroll patients into any study - whether it be a simple 15 minute psychology study or a complicated clinical trial involving a new experimental drug for cancer patients undergoing chemotherapy. What I found to be alarming is that there are thousands of studies that are going on at UofM right now, but each year many studies lose their funding because they do not enroll sufficient patients the grant requires for their federal funding. This explains why I'm always bombarded with fliers (and now e-mails) asking me to participate in a study with cash incentives or ipod giveaways. It's serious business. And quite stressful if you're the clinical coordinator in charge of getting enough patients for the study. Your funding depends on it!

My study required me to enroll ~200 patients. To say it bluntly, I've never been rejected so many times in my life. Some days were good, others were not so good. Great days were when I enrolled 17 patients into the study and walked out of the clinic triumphantly! But there were many days when I only got 4 or 5 patients in a span of six hours at clinic and left feeling dejected. I guess in research, some days things will go your way, but other days they won't. The important thing is to persevere, not quit, and plan for the unexpected. A quote by Louis Pasteur provides insight : "luck favors the prepared."

One thing this research project has allowed me to do is to talk to patients again - something I haven't done so much since my days working at a community pharmacy. I'll be the first to admit, I do not have McDreamy hair or a McSteamy body, but I love to talk with people. My chief duties was to provide informed consent - specifically that the study was completely voluntarily and that there would be no benefit for participating. Since there was no compensation, I had to win them over with my McTastic smile! :)

I learned as much from the patients as they learned from me. I met at clinic a professional baker who explained to me the science of baking by enlightening me with how it's as much science as art - do not add too much salt when baking bread or the yeast will die and your dough won't rise! I met at clinic a couple who crossed the Canadian border monthly to get some of their prescriptions because of the drastic savings. And I even ran into the Dean of Admissions of the College of Pharmacy, Dean Perry, at clinic! She graciously volunteered to participate in my study (see the re-enactment picture at the end of the post)!

To pass the time on those extra slow days, I created activities to keep myself busy. I read.....a lot, and I kept a journal each day at clinic to record my observations and my thoughts. This practice is a good habit to develop now in my young professional career - to write down every observation I see in research. They are great resources to go back to when I write my final report but also helped pass the time on those extra slow days of research. I've found research to be a slow, methodical, surgical process....but without this process there would be no good science that results from it. I'll be keeping Louis Pasteur's famous words in mind: Luck favors the prepared.

If anyone has questions about MCRiT send an e-mail to me at : cqtruong@umich.edu

“We represent more than ourselves.”

“We represent more than ourselves.” My preceptor's words reminded me of partially why I have been so determined to get this internship.

During P1 year, I was very excited to learn about Public Health Service pharmacists through a class project assigned by Dr. Gaither. During P2 year, I was assigned to an IHS site in Arizona but did not end up going due to personal circumstances. During P3 year, I reapplied to JRCOSTEP, because I knew it would be an experience I would not forget.

A notion of admiration and gratitude welled up when my preceptor discussed with me the expectations bestowed on a Commissioned Corps officer. Unlike civil service pharmacists who are evaluated on conduct and performance, Commissioned Corps pharmacists are evaluated on character and performance. We then discussed the meaning of character, which can be summed up as:

Character: /kærɪktər/ noun; upholding one's integrity and doing what is right even when no one is around, even under pressure, and even when no one else is doing it

The Commissioned Corps pharmacists are evaluated differently from other pharmacists because they represent more than themselves and more than the pharmacy profession. They are working at the front lines of health promotion for our country, providing services whenever and wherever necessary. Victims of the earthquake in Haiti, prisoners isolated from society, and Native Americans on reservations have all benefited from their contributions. Their willingness to take on these responsibilities is definitely worth noting.

“This is why I want to be here,” I told him.

“We’re happy to have you,” he replied.

On a side note...

At the local Indian Pueblo Cultural Center, I came upon this quote...

I’m continuously fascinated by the rich culture of the Native American people, exemplified by their pottery, jewelry, dances... all of which I had the pleasure of witnessing this weekend. Below is a snapshot of the "Buffalo Dance" by the Cellicion Traditional Zuni Dancers.

Hola!!

Week two in Barcelona came and went quickly, too quickly. On the upside, my Catalan is coming along, albeit slowly, but everyday I can understand a little bit more. And after another week in the pharmacy I finally feel that I have a routine. So as not to mislead you about what I do each day, because I know you are anxiously waiting, I am basically the stock girl. Since I cannot speak Catalan this shouldn´t be too much of a surprised. But on with my day....I begin the day by loading the robot (which I think is pretty amazing). And then throughout the day other deliveries come and that´s where the fun begins. I make sure everything is accounted for, then I stock the shelves before bringing the boxes downstairs. Did I mention that it is hotter than hades at 86 degrees and a maximum humidity of 76%!!! Needless to say I look like a tomato and feel like I need a shower after ten minutes in the pharmacy. I know I am making the work seem unbearable and boring but it really isn´t. I enjoy going to work everyday. I am learning the alternative names of many drugs and also learning about the different drugs/products that are available here but not at home. The pharmacist I work with, Tat, is extremely nice. She is working on her english as much as I am working on my catalan. There are times when neither of us can explain what we need or want; we just laugh and move on or try charades. She finds it completely amusing how we pronounce "drawer" (cajón in spanish) and the first time I said my name she was trying to find the spanish equivalent. I guess "Kaleena" isn´t very common...thanks mom.
**Explaining the pictures above: the first one is the cathedral of Barcelona and that is what I look out to everyday from my pharmacy; next is a picture of my pharmacy; and last is the infamous robot!!!**

Hopefully, since my last post, some of you are keeping up to date on the world cup because Spain won!!!!! It was definitely an experience to be here; one that I will never forget. After the match we went to plaça de espanya which is where the city showed the match on a big screen in the square. It was incredible how many people were there! Of course just like any celebration with a few thousand people things started to get a little out of control. I won´t go into the gritty details but it did take us a very long time to get home since all the cabs were taken, the metro was closed for the night and the buses were packed and had limited routes. The next day at work was a bit of a blur. My cafe con leche helped me get through that day.

For those of you who know me, I am quite pasty. I have been working on this, slowly, the past two weeks by going to the beach. Even though I come from California I am not a beach-going, sun-bathing girl; I would rather be in the mountains snowboarding. I think the reason I don´t enjoy the beach is the sand. Two weeks later you are still finding grains of sand in weird places - my belly button comes to mind. No matter how thoroughly you shower, they never leave. But regardless I have been trying. I actually like going to the beach here. It is always packed which means there is always something or someone to entertain you as you bake and sweat. It is really crazy how late the sunset is. At 7:30 the beach is still packed as though it is noon.

Since this is a blog about pharmacy let me revert back to that topic. There are many differences between pharmacies in the U.S. and pharmacies in Spain. One big difference that I find surprising is that the pharmacists do not put labels on the prescription medications. This is baffles me since at home the government is very strict about the use of another´s medication. And also, if the patient loses the copy of their prescription how do they know how to take or give the medication?? They also have an interesting way of filing the prescriptions. Those that come in with paper prescriptions, the bar code from the box is cut off and taped to the paper. Those prescriptions that are accessed via a computer system, those bar codes are taped to a piece of paper that contains barcodes from different patients (I don´t know if this makes any sense so I apologize). So there isn´t a central location that contains the medication history of patients; at least from what I have seen. And another thing! Some women have come in for birth control, which requires a prescription, but they do not cut the barcode off...?! This also occurs with different medication and I can´t understand why they don´t cut off the barcode.

The locations of pharmacies in Spain are closely monitored by the government. In order to open a pharmacy at least three requirements need to be filled: (1) have money, (2) your pharmacy must be a certain distance from any other pharmacy and (3) in order to even open a pharmacy, the neighborhood you serve must have a certain number of people. What would Walgreens, CVS, Longs, Kroger, Target, Ralphs............say about that? We obviously have a very different way of setting up pharmacies - one on every corner. I´m not complaining by any means, I may be working at one of those many pharmacies in the future.

There are many questions I still have to ask Tat in the next two weeks. I will do my best but charades will only get me so far. I may have to come in with a transcript.

Off to study some catalan over cervezas and tapas!!!

Adéu!!!

IPSE-SEP Taiwan- Part III

My hospital attachment this week had been quite an experience. I was at a day care center for schizophrenia patients. Most of the patients I saw were adults who were affected by the disease since their teenage years or early adulthood.

I was not involved with managing drug therapy for these patients since they were mostly stable on their current regimen. However, observing these patients gave me a lot of insights into the impact of the disease and the side effects of medications. One day, I sat at the nursing station where I could see patients participating in group activities. I noticed 1 patient who appeared to be constantly chewing on something and I also thought that he had really weird facial grimaces. Reading over his charts, I knew that this was a patient who developed tardive dyskinesia on haloperidol.

I had learned about the side effects of anti-psychotics in class. However, seeing an actual patient is so much more impactful than reading about it from textbooks or watching it on YouTube..... Monitoring drug therapy is an important part of what we do as pharmacists and I am convinced that promptly assessing patient response is extremely critical in this special patient population.

Relative to my hospital experience last week, my weekend had been much more lighthearted- friends, movies, and not forgetting delicious Taiwanese snacks! I have been pampered by the variety of local food since I arrived. And my favorite? It is大肠包小肠, literally translated as "big sausage wrapping small sausage":)

You never know what they've been through...

Recently, my fellow interns and I went to a state-of-the-art simulation center on the Mayo medical campus. The facility was created to help doctors, nurses, and pharmacists practice real life situations in a controlled environment. There are rooms where surgeons can practice surgeries, nurses can practice suturing, and rooms like the one we used where individuals can work on patient counseling.

The exercise we participated in involved speaking with a “patient” who is actually an actor trained to portray certain personality characteristics. This exercise was similar to those done in many of our PCare courses and was a great way for me to improve on the patient counseling skills I have gained through the extensive amount of counseling I’ve done this summer, in addition to what I’ve already learned in school.

The prescriptions I had to counsel on during the simulation were ciprofloxacin and albuterol (thankfully, not too tough). My patient wasn’t as difficult as I expected. She was in a hurry because she was going on a cruise so I had to make sure to relay the important points of her medications in a timely manner to ensure both of us were satisfied with the amount of information shared and the time it took for this interaction to occur.

Although this was a simulation, I can attest to the fact that this is just one of many types of patients that come into the pharmacy every day. In the 8 weeks I’ve spent as an intern this summer, I’ve dealt with yelling patients, crying patients, and MANY who are in a hurry. Realizing that they are probably going through a difficult time and not to take anything personally has helped me deal with the most difficult of patients, although, it’s not all bad. In contrast to the difficult patients, I’ve had individuals who were extremely grateful that I took the time to explain their medications, potential interactions, and possible side effects. Many patients are unaware of the side effects with their medications and have developed symptoms that are actually due to a new medication. They are confused as to why they are experiencing these new symptoms and have a feeling of uneasiness surrounding this. Now when I counsel, I try to point out at least three side effects with each medication. This may seem like a lot but I feel like it’s better for them to know about it and then not get it versus not knowing and then wondering why they’re experiencing sun sensitivity, increased effects of caffeine, or tendonitis (all of which are effects associated with ciprofloxacin).

20 Year at No. 1

This post is to congratulate Johns Hopkins Hospital for their ranking as the Number 1 Hospital in the Country for the 20th. year in a row. Those of you know who know me know that I have huge pride in my hometown of Baltimore, Maryland and Maryland in general. It's great to be here when the hospital wins their 20th No.1 award because theres a lot of free food and swag. Also to note that the University of Michigan Hospitals and Health Centers, Ann Arbor also are represented again on the Top 15 Hospitals in the country again this year. I will attach the article at the bottom. I will end this blog with a GO BLUE!! And a LOVE MD!!

http://health.yahoo.net/articles/healthcare/best-hospitals-2010-11-honor-roll

MCRiT Part 2 - Seminars

Besides participating in a research project under the guidance of a mentor doing hands-on clinical research, a second component of the Multidisciplinary Clinical Researchers in Training (MCRiT) program is to attend weekly seminars that guide us through the steps of the research process. What's really awesome about this component of the program is that we get to have lectures from some of the brightest people and seasoned veterans that do research at UofM. To illustrate my point, I'm going to share our experiences when the College of Pharmacy's own Dr. Bruce Meuller gave a lecture on Study Design.

If you're not aware of Dr. Mueller's teaching style, he prefers classroom interaction -inducing students to actively participate in discussion- rather than the traditional passive learning style (ie lectures) we've been accustomed to since grade school. His style was perfect for helping us design a mock research product proposal from its inception, to marketing it in front of a mock Board of Directors meeting.

We were split into 3 teams, and each team contained a plethora of skill sets and backgrounds: pharmacy, public health, clinical psychology, medicine, social work, and dentistry. My team was responsible for designing a good study that would show that our newly isolated compound, which has been formulated into an intravenous product against Pseudomonas aeruginosa, is safe and effective.

From this interactive workshop (a trademark of Dr. Mueller), I learned first-hand how intense it can be to design a study and why good study design is crucial no matter if you're a small startup company with a limited budget or a large pharmaceutical company. Without good study design from the start, your product will: 1. never get funding 2. never get approval by the FDA and 3. cost more money to re-do the study. Key questions Dr. Mueller made us pay close attention when designing our studies were :

what will we be measuring? when will we measure it?

who will be in our trial and who will be excluded?

where will the study be conducted?

I've also learned that the research process involves a whole different set of departments that we must go through in order to get it funded. New players introduced to me were venture capital firms- who often search the labs of the University to find good ideas that can be turn into a profitable business, a board of directors - who vote on projects their company will invest and partake in, and federal government agencies - such as the National Institutes of Health (NIH) and National Science Foundation (NSF) that award lucrative federal dollars annually to fund research.

The mock Board of Directors meeting showed me how competitive research can be. There were three groups with different products competing, but only one team that received the funding. While I’m happy to say that my group won (our study design is at the bottom), the victory was not all sweet. I realized that in research you must properly account for everything when designing and planning, otherwise your grant proposal or your project will be turned down. Think of the thousands of grants the NIH or NSF receive each year. They can’t fund everybody. Only those with the best study design with the proper outcome measurements will be awarded lucrative federal research money.

As I delve more into this research beast, I'm learning the importance of critically appraising everything I read in medical journal studies and analyzing for myself why the researchers designed their study in that particular way. Terms such as: cohort study, cross-over design, and minimal risk, are becoming part of my everyday vocabulary.

As promised, here is the new revolutionary drug that received the green light for funding from GoBlue Pharmaceuticals!: Weapon-X ( The code-name for Wolverine)