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?