Shadowing an Internal Med resident

Royal Oak Beaumont pharmacy has PGY-1 and PGY-2 programs available, and I had the fortune to see a "day-in-the-life" of PGY-1 resident on their Internal Medicine rotation. 

The day started at 8:00am with us looking up patient profiles for about 10 patients, varying from those in the intensive care unit to patients awaiting discharge. Since the resident had been tracking the patients for a few days, she reviewed each profile for medication changes and lab results that were previously pending. We were able to cover a few medication profiles of the patients in depth, discussing why antibiotic changes were necessary, or what pertinent lab results would warrant a change in therapy. 

When it was time for rounds, the resident paged the resident doctors and attending physician. Rounds started with the resident doctors presenting the case to the attending physician, and with the pharmacy resident offering suggestions to change medications. With each patient visit, the pharmacy resident was able to interact with the patient directly, counseling them on proper medication use (patient questions included what the difference between rescue and maintenance inhalers, why a whole course of medication was necessary to complete, what side effects were normal to experience, and how to time taking medications in relation to food). Once a patient was counseled, the team moved to the next patient, discussing the following case while walking to the floor. This experience made me realize that it is essential to have a comprehensive work up readily available on hand for each patient, since it can often be difficult to remember all the details when on the floors.

After rounding, the pharmacy resident made a plan of action for the following day, noting which patients required closer monitoring. The rest of the day was devoted to working other residency tasks, such as making handouts for the physicians on medication dosing, creating presentations for the pharmacy department, and manuscript editing. 

Residents are certainly busy with a variety of activities to complete before they are done, but according the resident I shadowed, the experience of a residency is invaluable and truly rewarding!

In the End

Seeing that I was working in retail for the first time, and it was an internship, I took away some thoughts on retail pharmacy. The first was customer service. I learned you always have to be on your game in front of people. There is this expectation of always having a smile, quick in acknowledging the person, and speaking in simple terms. Even though pharmacy is a complex and time consuming topic, it is placed in a setting with people who have busy lives and simple medical knowledge. One time, a customer asked me about the difference between lisinopril and Dyazide. I started out describing the molecular differences then I realized this explanation is not helping her. I summed it up as they targeted two different sites in the body.

Secondly, I became experienced at being accurate and multiple tasking. At times in the pharmacy it is crazy: phones going off, customers lining up, and running out of drugs. One has to be quick, but more importantly accurate in times of stress. When counting Vicodin, we have to double count because it is a control medication. I want to quickly and accurately count the Vicodin then move onto my next task like serving the drive thru. If I am not accurate, the customer will come back saying that we shorted him. This causes more time to deal with the situation and takes away from filling today’s prescriptions. I learned to do things right the first time because it will save me time later if issues arise.

Retail taught me to be fast and to prioritize. One area I haven’t mastered just yet is drop off. I know how to work drop off but I do not have the speed for it at peak hours. One needs to prioritize when prescriptions are due then start typing them right away. And it is just not the prescriptions from walk-ins. It is ones from the drive thru, computer system, fax, and phone calls that add to the volume at drop off. One minute I am doing fine with my prescription level then five pop up on the computer, a person walks in with two and my pharmacist gives me three from phone calls. I am quick at typing but it still takes a thorough knowledge of the inventory and solving insurance problems not to be slowed down and keep up with the volume.

I realized learning and re-learning is the key to being on top of the game. Since pharmaceutics are always evolving and adding new drugs to the market, the pharmacy has to keep up with the times. Fast movers change from time to time. Brands become generics. One can get use to certain drugs and know everything about them until a customer asks you about a new drug. If I want to be great at my job, I have to look to improve myself and test my knowledge. It is easy to get in a comfort zone and think you are doing a good job when actually you can do better.

My final thought is the people I worked with this summer. They were the number one reason I enjoyed my time in the pharmacy. For being friendly, caring, and helpful, it was easy to enjoy the good and get through the crazy times in the busy retail world. I had several co-workers my age to talk about college stuff and enjoy going to the bar after a long day at work. When I leave this week for school, I won’t miss the customers, but you guys!

UMHS Patient Triage

Hello readers!

I am writing this last summer post about my experience as the pharmacy employee responsible for patient triage at the University of Michigan hospital. To start, working patient triage entails serving in one of the hospital’s inpatient unit pharmacies. The position involves completing nurse requests that originate from the pharmacy window, answering incoming phone calls into the pharmacy, responding to requests made through the University of Michigan’s medical record software called CareLink, and disseminating patient medication orders to other staff working in the unit pharmacy. These aforementioned responsibilities require good communication, team building, and leadership skills. First, fulfilling requests involves beginning, continuing, or refilling a medication in a patient’s CareLink drug regiment. This means printing out patient drug labels for compounding technicians to fill and pharmacists to check. Second, phone calls are directed to the appropriate hospital department, transferred to an available pharmacist, or are answered and provided with accurate clinical knowledge within the scope of a pharmacy technician’s role. Third, hospital staff requests through CareLink are completed in much of the same manner as phone calls are handled. Fourth, dissemination of information among unit pharmacy staff is based upon the fact that drugs are to be administered at different time periods. Since the unit pharmacy staff want to provide patients and hospital staff with medications that are new and have long hang-by and expiration timing, the technicians will usually wait until an hour before the medication is due to start compounding it or will wait for a nurse phone call to confirm if the drug is still actually needed if the medication is expensive. It is up to the employee working patient triage to accurately relay this kind of information. As always, patient triage also requires workers to pneumatically tube finished medications directly to the patient’s unit location if they are required STAT (Sooner Than Already There)!

To conclude, I want to say it has been very fun this summer. I hope that my blogs have provided you with insight on how the University of Michigan unit pharmacies inner-workings operate and the processes involved in the central pharmacy department. I hope you have enjoyed reading my blog as much as I have enjoyed writing it. I wish the rest of your summer is enjoyable and that you have success in all of your future pharmacy endeavors!

-Adam Loyson

“Watch out…here comes the term-auditor”

Being a pharmacy intern at Blue Cross has many great perks. Not only do I get to learn the meat and potato of my own team (Pharmacy Networking/Contracting), everyone always seems to be presenting me their best offers.

“Best offers” right now would surely have to be the different experiences that I’m seeing and learning everyday in the Managed Care world. And for the first time, I got to go on an auditing trip—a side of pharmacy business that I never thought I would be part of.

The way Blue Cross carries out its auditing process is different than most other insurance companies. While most insurance companies focus mainly on the expensive drugs (such as specialty drugs; ie cancer drugs) during their auditing process, Blue Cross is out to ensure that ALL drugs are billed the correct way.

Before going out to the “chosen pharmacy,” the auditor would randomly select a set number of prescriptions that have been billed to Blue Cross within the last year. Upon arriving at the pharmacy, the auditor would request few more random prescriptions to be pulled. This way, the process consists of both prepared and surprising elements that will ensure the fairness of the auditing process.

From there, the auditor will go through the hundreds of prescriptions that have been pulled, and compared them with the billing records one by one. If ANYTHING is different from the billing records—patient name, medication, quantity, missing signatures, etc, the pharmacy is subjected to a fine OR an educational lesson (aka a simple warning). If certain violations are found, the financial penalty will be EXTRAPOLATED for the entire year worth of claims filed. Such extrapolation process can be good and bad—depending how you look at it.

The actual pharmacy visit was more civil than I had imagined. We were handed the requested scripts right off the bat and were left alone to work on them for the rest of the day. Perhaps most people figured that a happy auditor can only means a happy turnout, so they all left us be. I invite whoever has been through a pharmacy auditing process to comment on this entry and let me know what it was like to be on the pharmacy side.

Overall, the trip was an experience that I will hold dearly to my heart as I progress through my career. Whichever side I end up being working for, it’s always good to know the proper rules so there’s nothing to worry about. In addition, this experience continues to amaze me just how many opportunities are out there for pharmacists.

Rx on TV

Hey all,

Even though last week was my last day in the office, I want to post one last time and provide some closure on the internship. In my previous post, I promised a session on TV advertisements, and (because I hate breaking promises) you will find it somewhere in the blog post.

PRESCRIPTION DRUG TELEVISION ADVERTISEMENTS
Have you ever turned on the telly and accidentally ended up on Good Morning America or CNN (HA…“accidentally”)? If so, you may have noticed a commercial featuring a woman doing yoga and the drug, HUMIRA® [adalimumab].

Yup, I spent a good part of my internship discussing this commercial with the rheumatology team, and I will be available next week for autographs [/brag]. But seriously, the amount of work and compromise that goes into making one television commercial is mind-boggling. Not only that, but companies have to follow the FDA Drug Guidance on Consumer-Directed Broadcast Advertisements and the Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion.

I shall break those down into three easy payments*: Adequate Provision, Major Statement, and Other Nuggets. *Not all-inclusive of requirements

Adequate Provision
Along with the broadcast itself, the ad must make “adequate provision” for disseminating approved package labeling (read: drug information). There are no official right or wrong ways to ensure this provision, but companies typically (and should) provide the following four:

1. Toll-free number: provides drug information and an option to get labeling mailed to the patient
2. Referral to print material: “Please see our ad in blah blah magazine”
3. Referral to healthcare providers: “Ask your doctor or pharmacist for more information”
4. Website: "www.saynotodrugs.com"

For visual examples of the above, I randomly chose a Plavix television ad.

Toll-free number and referral to healthcare providers


Referral to Print Material


Website

Major Statement
As mentioned in my earlier posts, print advertisements include a printed Brief Summary of side effects, contraindications, and effectiveness. TV ads, on the other hand, present this information using what is known as a Major Statement—an audio or audio/visual alternative in layman’s terms to presenting risk information.

Example of Major Statement: “This drug is indicated for moderate to severe fractures of the clavicle. When taking this drug, you may experience side effects of nausea, vomiting, diarrhea, and loss of dignity. Don’t take this drug if you desire to play an integral role in society.”

Other Nuggets
The above two requirements cover a majority of the risk information, but there are other nuances that go into TV ads. I’ll just bullet them because they are easier to read.

• Superimposed text should be easy to read and contrast well with the background
• Superimposed text should be onscreen long enough to read and understand
• Background music should be comparable in volume and should not be distracting
• Avoid distracting graphics: busy scenes, frequent cuts, vivid visuals, moving camera angles

That’s about the gist of the TV ad requirements. As always, there are more regulations to cover, but I just wanted to go over the main topics. If you’re like me, watching these ads on TV will never be the same.

THE ABBOTT INTERNSHIP
This internship exceeded all expectations. I urge everyone thinking about a future in the pharmaceutical industry to apply and check it out. Even if you’re not interested in the industry, apply and check it out—you may be pleasantly surprised. There are a lot more pharmacists in the industry than you think, especially in medical information, medical review, and regulatory affairs. In these departments, you are surrounded by very intelligent people (shout out to my managers, fellow interns, and the regulatory affairs department) who put their medical background to use on a daily basis to, ultimately, ensure patient safety. Five stars: *****.

Eric Zhao

PS Be sure to check out my new posts at: On Rotation: Life as a Fourth-Year University of Michigan PharmD Student.

I am currently was a summer intern in the Regulatory Affairs Department, and the opinions and positions expressed are my own and don’t necessarily reflect those of Abbott Laboratories.

Shots, Shots, Shots!

One of the new and cool skills pharmacist can perform now is immunizations. Every state except one allows in some form for pharmacists to immunize their community. Michigan allows trained and certified pharmacists to give vaccine shots just like physicians and nurses. I trained this week to be certified to give immunizations. It is not required for pharmacists to be certified immunizers, but it is extra skill I have wherever I end up in the medical field. I had a week to read 100 pages packed with information on vaccines and the basics for immunization, take a pre-test, attend a hour long conference call, and six hours of classroom training. Add in work and chores around the house, I kept pretty busy.

Bright and early on a Saturday morning I had to travel to Bloomfield Township for my immunization class. I wasn’t sure exactly where I was going and ended up a couple minutes late because Bloomfield Township doesn’t know how to logically order street address but that it is another story. It didn’t really matter because the teacher was still trying to figure out how to connect his computer to the overhead screen. Once he got it to work, we spent the next five and a half hours on the different immunizations we could perform. It is not just the influenza shot. He taught us about pneumococcal, hepatitis A and B, measles, mumps, and rubella, diphtheria, tetanus, pertussis, meningococcal, polio, and the human papilloma virus.

There is a lot of information to keep track of in terms of ages, contradictions, and how to administer the shot. It wasn’t until the last half an hour that we had to poke our classmates with two intramuscular (I.M.) and one subcutaneous (S.Q.) shot filled with saline solution. There were several pharmacists in my class learning to be immunizers for the first time too. One lady was so nervous giving her first shot that her hand was shaking though she was perfectly fine after doing the first one. I was a little nervous myself but performed well when it was my turn. I enjoy doing intramuscular shots more than subcutaneous because I.M. shots are at ninety degree angles while S.Q. shots are angled at forty-five degrees.

The biggest concern about giving shots is not how to poke the person or drawing up the solution but getting a needle stick once one removes the syringe from the skin. Many syringes today have safety devices where the needle retracts once the shot is given. Now these devices only work 50% of the times meaning technique and positioning of the immunizer needs to be appropriate. One’s legs needs to be on the opposite side of the body from the hand that has the syringe, and the sharps container needs to be next to the immunizer. If done correctly, it will be one fluid motion of poking the skin, injecting the vaccine, activating the safety device, removing the syringe, and placing the syringe into the sharps container. It can be all done in five seconds. At the moment, I am not giving out shots at my pharmacy, but I will have the skill if called upon in the future.

*Special Edition Post* - Pharmacy Advocacy

Greetings! I would like to tell you about my experience advancing the pharmacy profession at the nation's capital in Washington D.C.! This past weekend, I chose to attend a conference held by the American Pharmacists Association-Academy of Student Pharmacists (APhA-ASP) that ended up being a blast. During the conference, I was presented with the opportunity to visit Capital Hill and talk with multiple senators and state representatives about the current pressing issues facing student pharmacists and the pharmacy profession. The first topic that I brought up in discussion was the development of Medication Therapy Management (MTM) programs and how the inclusion of pharmacists could make a great impact by providing MTM in transitional/integrated care models (Bill H.R.891/S.274). The second topic that I discussed was the Student Pharmacist Loan Repayment Plan under the National Health Service Corps. While the NHSC performs admirable work in under-served areas of our nation, the pharmacy profession is currently not listed as one of the professions qualifying for school loan repayment. In conversation, I discussed that pharmacists serve an integral role in interdisciplinary health care teams with physicians and are the medication experts in handling patient's drug regimens. Placing a greater emphasis on the pharmacy profession could possibly save the nation $177 billion in medication errors each year (Bill S.48). My interactions with all congressmen were very pleasant with many of them becoming interested in supporting both bills or possibly co-sponsoring!
The remaining time in DC was spent at APhA-ASP's Summer Leadership Institute (SLI) where I had the great opportunity of developing my leadership skills in professional-speaker workshops, discussing pharmacy advocacy with student pharmacists from other schools, and touring the capital to see all of the national monuments. This is not even mentioning the great opportunity of networking that I had with the student pharmacists present from all 50 states! APhA-ASP's SLI conference is only one of the great things that I have been able to take apart of while being a member of the organization as a student. With additional conferences this year in Indianapolis, IN and New Orleans, LA; local chapter committees to choose from and perform patient care activities; and being able to hang out with my pharmacy friends at social events; there is almost certainly something in this organization that could be of interest to you! Feel free to check out UofM APhA-ASP's website at http://pharmacy.campusgroups.com/apha-asp/home/. I look forward seeing you at their meetings next year!

Inventory Overview: OPC Carousels

Hello everyone, I hope you are having a great summer! Today I am going to describe to you pharmacy inventory at the University of Michigan Hospital. To begin, the hospital receives it's shipment of medications almost exclusively from the largest wholesale pharmaceutical distributors: AmerisourceBergen, McKesson HBOC Inc., and Cardinal Health Inc. After delivery by either FedEx or UPS, it is up to pharmacy inventory carefully unpack the medications and place them on hospital transportation carts according to lot number. Why did I say carefully? This is because medications arriving to the hospital have specific conditions in which they have to handled. For instance, some medications arrive in Styrofoam refrigerated boxes and need to be placed in the refrigerator immediately after delivery. Other medications can be left at ambient temperature. Another important consideration is the handling of chemotherapy drugs. These drugs must be handled with great care as they can cause very hazardous conditions if exposed/opened up to the atmosphere and can even become deadly by destroying the human body's normal functioning cells. With chemotherapy drugs, safety is key! Once all the medications are unpacked onto the carts, they are scanned into an inventory-recording software call Omnicell. After scanning the bar-code of each medication, a sticker is printed out and placed on the medication indicating inventory personnel the storage location of the drug.
Alright, so all of this might sound very mundane but I haven't written about the coolest part yet: The UofM pharmacy department's OPC inventory control system! Continuing from the previous section, when the label prints, it often calls for the medication to be stored in one of three pharmacy department OPC carousels. Each of these so-called carousels span three stories high and operate four meter long horizontal storage shelves for drug storage. When receiving and stocking medications from initial inventory control, the carousel shelves move vertically, away from the user and into the ceiling. Additional shelves rotate up from the ground to the user controlling the carousel. To get a visual of the OPC carousel, I have included a picture. If you are somewhat of a technical or mechanical enthusiast, this machine is certainly one that will make your gears turn!
Aside from receiving and storing hundreds of medications each day, inventory is also responsible for replenishing "arrest" boxes that are returned from the hospital's various units. The hundred arrest boxes can be returned to pharmacy inventory for two reasons. First, the box could be used in an event of emergency and need its stock medication replenished. Second, the box could contain a medication that has expired and needs to be replaced. Medications that are included in these arrest boxes include amiodarone, naloxone, epinephrine, norepinephrine, magnesium sulfate, phenytoin, glucose, lidocaine, and calcium chloride among others. The arrest boxes also include multiple-gauge needles, multiple-volume syringes, IV piggyback bags, and IV base dilution solutions such as sodium chloride and sterile water. In summary, these kits are essential in the event of an emergency occurring anywhere in the hospital.
Overall, inventory has been a great experience for me. While not heavily clinical, I have learned a great deal about the logistical side of medication distribution and supply. For a majority of inpatient settings, patient care and recovery would be impossible if it weren't for the operation of a pharmacy inventory department indicating its immense importance. Stay tuned for my next blog entry that will include my patient-triaging experience!

Signing Out From Boston!

Hello friends!! The summer is winding down and this is the last post you are going to see from me here. Fear not- if you miss me you can head on over to the P4 rotation blog to catch up on all of my latest adventures! I cannot believe how quickly this summer went- three months just isn’t enough (sorry to all the rest of the classes who won’t even have that!)


This summer I have been working to develop a couple of quality improvement projects. The first one focused on stroke prevention in atrial fibrillation. Basically, the guidelines say that if a patient with atrial fibrillation is at risk for stroke they should receive oral anticoagulation (traditionally with warfarin). This becomes quite difficult in our members, however, as they are all elderly and many are disabled. They have difficulty complying with the monitoring requirements of warfarin, are often treated with interacting medications and are also at a high risk for falls and subsequent bleeds. With the approval of the new direct thrombin inhibitor, dabigatran (Pradaxa) in October, our clinicians now have another option for anticoagulation in this population. We identified members who had a diagnosis code for atrial fibrillation and determined their stroke risk through the use of a CHADS score (this looks at whether a patient has congestive heart failure, hypertension, is over age 75, has diabetes or has had a previous stroke). We were able to use pharmacy data in order to determine whether they were receiving warfarin, dabigatran or aspirin and from this, we developed our best guess of which patients could benefit from therapy with dabigatran. I worked to create educational material for our clinicians and to draft communications to be sent out to each of the identified patients’ primary care physician. Next year they will pull this data again and see whether a higher percentage of patients are now being appropriately anticoagulated. I wish I were staying longer so that I could be involved in the education efforts and to see the effect that all of these efforts have on patient care!

I’ve also been working on some smaller projects. I have created reports to send out to all of the different sites regarding patient adherence and cost effective prescribing. I drafted letters to be sent out to our members (after CMS/MassHealth approval of course!) regarding MTM services and regarding changes in coverage. I also drafted communications to our clinicians regarding the new simvastatin dosing guidelines.


My final project has been attempting to develop a polypharmacy quality improvement project. So far, I have done a literature review of all the different tools that exist to assess polypharmacy (this turned out to be a huge amount of information!) Tomorrow I’ll be meeting with our pharmacy director and the medical affairs department so that we can develop criteria for the identification of members to target and what intervention we can use. We will also need to identify indicators so that we can assess the progress of the project after implementation. I will definitely not be around when this project is rolled out but I have still learned so much from working on it!


I have enjoyed my summer at CCA immensely! I love thinking about the unique pharmacy issues that the elderly population faces and am definitely thinking about steering my career in that direction. I can’t wait for my rotations coming up this year where I can start to delve into this interest- see me jumping for joy?!

The INR won't budge from 6, that's therapeutic right?

So last post I left a teaser of how my first tour on clinical duty at the hospital would pan out.

At Wyandotte, the inpatient (IP) pharmacist staff is not sub-specialized to different departments like bigger hospitals (although we are trying to hire in an ID specialist). All the pharmacists rotate between order entry and typical IP maintenance, and clinical duty for the floors. Most of the time they will be upstairs in the various pharmacy offices for the floors, but if we're short on a given day they will just manage clinical from the clinical office in the IP pharmacy.

I started out my first clinical day in the clinical office the entire day, because that day happened to be a short staff day...and the clinical manager who was going to train me got in a car accident that morning. So I was pretty much stuck reading the pharmacy policies regarding dosing guidelines the rest of the day. That day was just boring except for one part. The clinical care coordinator and our new P4 were going over sticky details of how to best administer liposomal amphotericin B for a new admit, who had happened to just come in from a double lung transplant and wouldn't be able to use the common nebulizer for the amphotericin. The answer was pretty inventive; using a certain type of open-air nebulizer and a negative pressure room. The logistics behind this decision actually require some of the engineering department to get in on the discussion. Unfortunately I never did get to see how that worked out.

The rest of the first month or so went much better and I would rotate with the floor pharmacists and basically train on each floor. Aside from answering questions on everything the medical and nursing staff can throw at us, the main priorities the floor pharmacists have are to monitor the anticoag and antibiotic therapies of the patients on their floor. The most difficult and time consuming I would learn, Coumadin, was also the most fascinating.

Coumadin therapy is rather straightforward; for a given risk of developing clots, Coumadin is prescribed (sometimes with bridging heparin) to decrease this risk. In almost any case that isn't a post-op, these patients will be on Coumadin for years if not the rest of their lives. And Coumadin is scary. The therapeutic interval is extremely small, and there's a fine line for if the INR is 1.0 too low, there’s no effect, and 1.0 too high, the patient will bleed. Add to this the fact that pretty much everybody responds to Coumadin differently and hundreds of medications interact with it, Coumadin is a headache for even veteran pharmacists.

There are guidelines for how to deal with dosing Coumadin (if INR goes up, do this to dose, etc.) but they have proven to be useless for how many interindividual differences there are. One pharmacist explained it best to me; heparin therapy is like checkers, defined moves and each move has its direct consequence, and you can only go forward and back. Coumadin is more like chess; we have to think 3-4 steps ahead each dose just to attain a simple form of steady state (which by the way, the INR will never be at a steady state unless you have the text book patient, which by the way you will never have). Predicting how a patient may react is also key, but sometimes misleading. At first glance, an 85yo lady on synthroid and amiodarone might look like a 1mg patient, but then you realize it takes almost 15mg a day to keep her therapeutic. Or a 45yo 150kg male might get an INR of 5 from his first 2mg dose. To say the least, Coumadin therapy is tricky, but never, never the same.

VA Ann Arbor Pharmacy Residency Program

Most of my work this summer has been with the residency program director. We have been gathering ideas for research projects and putting together necessary information for the new residents who started July 1st. They came from the Universities of Nebraska, Connecticut, Maryland, and Purdue. It has been fun getting to know them. Last Friday, I gave them a tour of the University of Michigan Hospital and the College of Pharmacy. During our travels I was able to ask lots of questions about residency and interviews. A residency is a great way to expand your clinical knowledge and abilities as a pharmacist. I have heard it described as “your P4 year on steroids.”

The VA offers four ASHP accredited PGY1 pharmacy resident positions per year. The program emphasizes ambulatory care opportunities in a largely geriatric, male patient population. The residents engage in monthly rotations, research projects, staff in-services, journal clubs, precepting students, and other teaching activities. The core rotations include ambulatory care (4 months), acute patient care (2 months), distributive skills, drug information, administration, and elective(s) at the VA or the University of Michigan Hospital. There are a variety of ambulatory clinics at the VA, including a Pain Medication (Integrative) Clinic, Geriatrics Clinic, Palliative Care Clinic, Primary Care Clinic, Home Based Primary Care Program, and Anticoagulation clinic. If you like ambulatory care, the VA is the place to be.

My main project this summer has been the creation of an informational residency website. Due to some administrative back log, I will not be able to finish it during the summer so I will be coming back during the fall semester to finish it up. Creating the website has given me a great overall picture of the Ann Arbor VA residency program and its rotations and preceptors.

My summer internship at the VA has been a rewarding educational experience. I have worked with a variety of pharmacists on projects ranging from MUE’s to RCA’s. I would recommend it to anyone interested in expanding their overall knowledge of hospital pharmacy through project work.

Go to your room!

Greetings once again, avid readers, to Regulatory Affairs 101. Last time, we spoke about good and bad direct-to-consumer print advertisements. Today, we’ll speak about what happens when we don’t follow what our mothers tell us. Of course, when I say mother, I mean the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), AKA “The Enforcer” of advertising and promotion. They’ll send out two types of letters, a Notice of Violation or a Warning Letter, depending on whether you deserve a timeout or a thorough grounding.

“You’re In Timeout!”
Let’s start with the less serious problem—a Notice of Violation. These are written by DDMAC reviewers and are typically addressed to a regulatory affairs employee of a pharmaceutical company. They follow the same typical format:

• Dear [Name of Regulatory Professional]
• Background of drug (e.g. indications and usage)
• You’re in timeout because…
• …and you’d better stop in 14 days.

Violations usually fall in several distinct categories:

1. Overstatement of efficacy
2. Unsubstantiated claims
3. Omission/Minimization of Risk
4. Broadening of indication
5. Any other category DDMAC deems violative

So what do these letters mean to pharmaceutical companies? Well, it hurts their reputation, they lose revenue in destroying and recalling the violative material, and they also lose revenue due to lack of promotion. These letters are then published to set precedence for other pharmaceutical companies.

Click on the thumbnail below to view the most recent Notice of Violation letter from June 21, 2011 for Trisenox (arsenic trioxide).

“You’re Grounded!”
Ah yes, the infamous Warning Letter. These are given out to companies that have advertising and promotional material that may cause more serious threats to the public health. Recall that Notices of Violation are written by DDMAC reviewers and are addressed to a regulatory affairs employee. For Warning Letters, these bad boys are signed by the Director of DDMAC himself, Thomas W. Abrams, RPh, MBA, and are addressed to the CEO of the company to emphasize leadership accountability.

The letters follow a similar format of a Notice of Violation with slight changes in italics:

• Dear [Head Honcho of Company]
• Background of drug (e.g. indications and usage)
• You’re grounded because…
• …and you’d better stop in 14 days. PS fix the problem.

This means that if you spent $4M on a violative TV advertisement, you’re going to be spending an additional $4M on a separate TV advertisement “to disseminate truthful, non-misleading, and complete corrective messages” [direct quote from recent Warning Letter].

Click on the thumbnail below to view the most recent Warning Letter from May 6, 2011 for Vyvanse (lisdexamfetamine dimesylate) capsules.

Okay folks, that’s it for this installment of Regulatory Affairs 101. Tune in next time for our next lesson on TV ads. Remember kids, stay in school and always listen to your mother.

Eric Zhao

I am currently a summer intern in the Regulatory Affairs Department, and the opinions and positions expressed are my own and don’t necessarily reflect those of Abbott Laboratories.

Pediatric Satellite Pharmacy

Whenever I get a chance to work some overtime, I often spend time in Beaumont's pediatric pharmacy. This satellite is located in the Children's hospital, which features pediatric inpatient beds, neonatal and pediatric ICUs, and a surgical center.

Understandably, a major difference between this pharmacy satellite and others is that there is a daily "batch" of liquid medication doses to be syringed up for the patients. This task can test really test your attention to detail- doses range from 0.05ml to over 10ml, so its important to check yourself with each syringe (especially when drawing them up at the end of a 10-hour shift!). Another layer of detail  includes noting the number of syringes required for a set of twins (or even triplets). It can be less than straightforward, especially when BabyBoyA requires 1 dose at 1.36ml and BabyBoyB requires 2 daily doses at 0.645ml, for example.

In addition to the liquid medications, there are typical stat orders and IV compound mixtures to be made throughout the day. Other unique responsibilities involve drawing up propofol syringes for procedures, making IV Remicaide, weighing out PEG powder, and compounding starter TPN bags.

Generally, its imperative to appreciate the different dosing required for pediatric patients, as this becomes readily apparent after spending most workdays filling adult doses.

“Insurance = Evil”? Think Again.

Hi all! My name is Tony Lin and I will be a P3 in September. I apologize for those that have been dying to hear how “brain-washed” I am with my Managed Care (aka insurance company) internship…it’s better being late than never!

This summer I will be interning at Blue Cross Blue Shield of Michigan (BCBSM) Department of Pharmacy Services.

Perhaps for those that have worked in community pharmacy (or from your own personal experience), many people often view the insurance companies as these evil groups that never seem to pay for any drugs for the patients. To tell you that any “Prior Authorization” or “Rejection” messages are being displayed on your pharmacy computer screen only after complex logical calculations might be hard for you to believe. Well, the analogy I would use here is that many people think all pharmacists ever do is count pills—try again…it IS more complicated than just that!

In a nutshell, an insurance company (aka a Health Plan) pools financial resources together from clients (such as your parents’ employers) and use them effectively in paying for the claims (prescription drugs in our case) filed by beneficiaries. With limited resources, strategies must be implemented to be cost-effective.

While most of the public think that drugs are like cars—the newer the better, us pharmacists know better and realize that it is not always the case. Many drugs can easily cost hundreds or thousands of dollars per prescription or per unit. This is why insurance companies set Prior Authorization in place, ensuring generic drugs (which work just as well as brand names) or other more inexpensive alternatives have been tried first.

My specific duties this summer are to be with the Pharmacy Network team. The team prepares, reviews and manages all contracts from pharmacies in the state of Michigan. No—Blue Cross isn’t the DEFULT insurance for anyone. And yes—each individual pharmacy (chain or independent) must set up specific contract with BCBSM in order to serve patients with Blue Cross plans. More on this will come as the summer goes on.

I’m going to leave you all with few “Blue” Fast Facts:

** Total Employees: 7000 (3000 employees just moved their offices to downtown Detroit from Southfield to join the existing 3000 employees that were already in the city)

** Members: 4.3 million

** Claims paid in 2009: $19.8 billion ($5 billion paid in pharmacy claims)

** 50 million pharmacy claims annually

Did you know?

** Nearly 92 cents from every dollar BCBSM collects in premiums goes to pay for health care services.

** Of the nearly 30,000 doctors in Michigan, more than 99 percent participate with the Michigan Blues.

** Nearly 2,400 pharmacies in Michigan participate with Blues plan prescription drug coverage programs.

** There are 159 hospitals in Michigan. They all participate with the Michigan Blues and accept the Blues member ID card for health care coverage.

Optimal Compounding

Optimal Compounding is a closed-door pharmacy that specializes in veterinary compounding, hospice, and hormone replacement therapy. In my 5 weeks at Optimal Compounding thus far, I have had the opportunity to make a variety of different products including suspensions for cats, powders for horses, and vaginal creams for of course, humans. Of the products I've made, these are my most memorable experiences...

The very first product I got to compound on my own was a tuna flavored Benazepril HCl suspension for a cat. Who knew cats could be treated for hypertension? (How does one even figure out a cat has high blood pressure?) Turns out that Benazepril is indicated for chronic renal failure in cats and CHF in dogs...which maybe makes a little more sense? All in all, it's been an interesting experience working with such a unique patient population. Anyway, back to the compounding...it took me over 3 hours to make this suspension! Benazepril comes as a pink coated tablet, which I began by crushing with a mortar and pestle. The outer pink coating was extremely hard to crush so I was stuck using a homogenizer to mix the suspension with the other ingredients (totally forgot what else I added in it...glycerin?) for about an hour to no avail. If the preparation wasn't hard enough, one of the techs mistakenly wrote that the cat's owner wanted the suspension in 1ml pre-filled syringes...so in the middle of filling 30 individual syringes with 1ml of my pink speckled suspension, the pharmacist came by to point out that the prescription actually meant to dispense the suspension in an amber bottle and attach one 1ml syringe to the bottle. And after squirting all my syringes into the amber bottle, I was about 5 mls short since a lot was lost during the homogenizing and syringe-filling process. So I had to make more. On top of all that...a fish flavored benazepril suspension is the most terrible smelling flavor we have in the pharmacy. Lucky me!

Another one of my favorites was that I got to make an apple flavored metronidazole powder for a horse from start to finish. We dispense powders for horses in large powder jars that come with 5ml scoops and usually dispense enough powder for a total of 100 scoops per Rx. In order to know how much active and inactive ingredient to put into the powder, we calibrate each powder to the 5ml scoop. This is done by weighing the amount of powder that fills a scoop at least 5 times and then averaging the weights. A metronidazole powder contains metronidazole, powdered sugar, and apple flavoring in powder form. Since the scoops had already been calibrated for the powered sugar and apple flavoring, I only had to calibrate the scoop for the metronidazole powder. After doing that, I calculated how much of each powder to put into the formula based on percentages. Flavoring is usually about 11% for horse powders (don't quote me on this!), percentage of metronidazole depends on the specific strength of the Rx, and the rest is powdered sugar. So once that is figured out, all the powders are weighed out into a plastic ziplock bag and then shaken, rolled, and mixed for a very long time to ensure that it's all evenly distributed. After that, it's all poured into a powder jar, initialed, labeled, a 5ml scoop is taped to the outside, and it's ready for the pharmacist to check!

Other memorable experiences have been that I made a methimazole transdermal gel...without gloves. Being the silly naive 1 year of pharm school intern that I am, the name sounded like an antifungal to me, so I thought I'd be okay without gloves since gloves are usually only worn for vet and HRT compounding. When I was finished, after getting a lot of it on my hands since I had to dispense it in 1 ml syringes, the pharmacist told me it was a hyperthyroid medication...and I should watch out for symptoms of hypothyroidism since I didn't wear gloves. Guess that's why I still have 3 more years of pharmacy school to go through... :) (Luckily, no fatigue, sensitivity to cold, or muscle weakness was experienced)

I've also made a lot of capsules. Instead of the 10 that we learned to pack by hand in Pharm404 first semester, we have bulk capsule machines! These machines are pretty nifty and they allow us to make 100 and 200 capsules at a time. Much more efficient and easy to use. If you've never seen one of these...they are extremely ingenious creations...and I can't even begin to explain how it works. They're just fun and convenient.

Last week I made a progesterone vaginal cream and an alfalfa-flavored pergolide mesylate powder for horses. Pergolide was withdrawn for human use to treat Parkinson's due to negative effects on the heart, but it is still commonly used to treat Equine Cushing's Syndrome (ECS) in horses. Pergolide and phenylbutazone (NSAID) are the most commonly compounded meds for horses at Optimal is what I'm told.

I am sad to say that next week is my last week at Optimal Compounding, but after that it's 6 weeks at Komoto Pharmacy (retail...1200 scripts/day). At Optimal I also fill a lot of hospice prescriptions...but more on that later since this post has gotten kind of long...

Happy 4th of July weekend!

-N

Intern in the ‘ship Fast Movers

Fast Movers

There is a special section in our pharmacy that we place are most filled medications. It is easier for us to grab and not go exploring in the stock bays. There are about fifty medications on these shelves give or take a few depending on the season and changes in prescribing habits. Here are a few of our fast movers you will recognize or maybe surprised they are prescribed that often.(Generic names in parentheses)

Xanax (alprazolam)

Xanax is a controlled substance prescribed for anxiety, some depression, and panic disorders. 0.25, 0.5, and 1 miligrams are the most often doses. I was surprised the most that it is prescribed so often. I do not think there has been a day that I have not counted out these tablets. It shows that many people have anxiety or depression throughout their life and it is not a small percentage of the population. And that is alright, sometimes one needs chemical change to feel better.

Vicodin (hydrocodone- acetaminophen)

Vicodin is a controlled substance prescribed for pain, and pain and really bad pain. There are several strengths but 5mg/500mg, 7.5mg/500mg, and 7.5mg/750mg are the most common. I was not surprised this was on the fast mover shelf. If Tylenol or Advil cannot do the trick, the next step is to ask for Vicodin. It works quite well because it suppresses the brain and slows nerve firing which explains the main side effect: dizziness or drowsiness. One big counselling point is Vicodin contains the same active ingredient as Tylenol: acetaminophen. One should not take both in a day because of the possibility of over medicating.

Glucophage (metformin)

Glucophage is a drug that helps lower your sugar levels in the blood. This is not a drug that increases or replaces insulin but assists with insulin’s workload. 500 mg and 1,000 mg are stored in big jug containers and the pills are pretty big too. Rule of thumb: big white tablets should always be taken with food or you will have an upset stomach.

Zocor (simvastatin)

Zocor is a cholesterol drug called a statin which is the most popular form to lower LDL cholesterol. It is very similar to other well know drugs as Lipitor and Crestor. It comes in 20 mg and 40 mg on our fast mover shelves. Recently there have been studies warning against prescribing the 80 mg strength because of higher instance of muscle pain which is a known side effect.

Birth control -Gianvi, Apri, Loestrin

There are many kinds of birth control/contraceptives on the market. There are brand names, multiple brands for the same drug and generics for those brand names. One cannot always assume contraceptive purposes because doctors do not list a reason, but birth control can help lower pain and flow during menses. And no it is not just seventeen through twenty three year olds receiving it. Older women with kids also want to control their bodies and not have unexpected surprises.

Other well known medications that are fast movers are lisinopril and hydrochlorothiazide for blood pressure, amoxicillin and azithromycin (z-pack) for bacterial infections and albuterol for asthma.

Happy 4th everyone!

Public Health Brigade

Before our public health brigade officially began, we make the 3 hour rocky bus ride to Zuzurlar to meet the families we would be working with. On a normal day, the ride would be an hour and a half, but since the rock "bridge" we had to cross was flooded over and some of the rocks had been displaced by the rain, we had to forgo the short cut and learn to hold our pee.

Attempting to cross the river.

The community was quiet - minus the 2 little boys we came across shouting and throwing sharp rocks at each other with incredible precision. The community already had their own church and primary school (which consisted of 2 classrooms) and the Architecture Brigade was in the midst of building a secondary school. This was a huge deal because students that want to attend secondary school currently have to take the public bus for hours to reach Tegucigalpa, the capital of Honduras. Students usually are only able to make the trip once a week, and must study on their own the rest of the time.

Our first glimpse of the town of Zuzurlar.

Our projects in Zuzurlar consisted of building a latrine, stove, pila (essentially a large cement block that holds clean water), and cement floors for 2 houses. It was exciting meeting the 2 families - there were a lot of questions asked to get to know the families. What I liked most about the program is that we would be building the projects with the families. As opposed to swooping in with our American ideals and building something for someone else, we were working together with people we were getting to know to building something together.

We split up into 2 groups - one working at each home. My group worked on the home of Daniel and Nancy, newlyweds who had saved enough money to be able to move into a home of their own. The ot
her group worked with a couple with 4 children. During construction, Nancy would boil us organic coffee and Daniel, his little brother, and his brother's friend worked with us on their home.

Photo on left: Daniel and Nancy

Starting from the left with the girl with the green shirt and going clock-wise is Becca, Daniel's brother, Rachel, Vishan, Angelique, and Daniel mixing cement.

With the help of a couple of amazing and very patient masons we finished construction on day 3. The last day we were in the community consisted of the "despedida" or "farewell". We had lunch together and shared our thoughts about the last few days of construction. It was really exciting to see the finished products and that they worked!

Getting our daily doses of irons!

Hello friends!! I took a brief break from Boston in order to return to Ann Arbor for the annual College of Pharmacy Alumni & Friends Golf Scramble. I think that people were a little bit surprised that I would fly back for the event, but I’ve missed it both my previous summers and was always jealous when I heard people talking about what a blast it was. When I was asked to help coordinate the student volunteers for the event, I knew I could easily get out of it, being in Boston and all, but I also knew that I didn’t want to get through my time here without experiencing the golf outing at least once! Therefore, I happily agreed to help out with the event in any way possible.

Golf outing day started bright and early for me. Students were told to arrive at the course at 8 am and I wanted to make sure I was up to speed on what was going on so I could help direct them to where there efforts would be most appreciated. I spent the next couple of hours unloading cars, making sure students were signed up for activities throughout the day and otherwise just ran around like a crazy woman.

There were a few open spots among the golfers so I quickly offered up my services- it had been a long time since my high school golf team days, but I was excited to get back into the swing of it (pun intended)! I ended up on team Pharm Sci with Professors Greg Amidon and Steve Schwendeman and another student, a P3-to-be. We may not have been the most skillful foursome out there (we quickly realized that Prof. Schwendeman’s clubs are older than I am) but I think we definitely had the most fun. We took part in all of the student organization games- a Spelling Bee Challenge, Dizzy Putt-Putt and Beat a Student Golfer, but I think we had the most fun on the Sing Along. If you are good friends with Jenna B, you may be able to get a hold of the video that goes along with this photo- feel free to use it to blackmail me if I ever run for public office!

After the outing there was a dinner and silent auction and plenty of time to mingle with our alumni. People say it all the time, but it really is true- we have the best alumni network in the world! Everyone is so approachable, easy to talk to and supportive. In summary, if you are around next summer I strongly encourage you to attend the golf outing!