Showing posts with label USP 797. Show all posts
Showing posts with label USP 797. Show all posts

Sunday, October 28, 2012

Rotation 4: Nuclear Medicine

Posted by Alison Van Kampen at Sunday, October 28, 2012


My fourth rotation this year was at Covance Laboratories in Madison, WI.  This was a unique experience because I not only learned a lot about nuclear medicine but also about Phase 1 research.  I spent the majority of my time at the Clinical Research Unit where they primarily conduct research in humans examining the AME properties of new products.

In this setting I was able to observe how radio-labeling is used to detect drug serum concentrations, route of administration, route of excretion, and length of time that the medication is in the body.  The role of the pharmacists in this setting was primarily drug preparation, determining if and how client specifications could be met, and participating in meetings with clients for quality assurance.  The pharmacists also were responsible for ensuring equipment integrity and that all staff were knowledgeable and followed standard operating procedures.  

I learn a lot about how phase 1 research is carried out, about imaging studies, precautions that are taken during preparations with radioactive or "hot" material, and why and how these products are used.  While I was there I primarily attended client meetings with my preceptor, observed preparations, helped with equipment qualification, worked on projects, and went on "field trips."  

Client meetings were interesting because I was able to see all the work that goes into setting up research.  Several times each week, a company with a new product that is currently working with or may work with Covance on a study, will have a teleconference with employees at Covance.  This meeting can be anything from going into great detail about how the study will be conducted (number of participants, types of participants, route of administration, special monitoring, etc) to periodic checks during a study for quality assurance.

The preparation was different for each study and so each presented it's own challenges.  Each study needed to have a mock preparation that was evaluated for appropriate strength, purity, and contamination.  They prepared sterile and non-sterile as well as "hot" (radioactive) and "cold" (non-radioactive) products.  Products were prepared on regular lab benches, in vertical flow hoods, and in ISO class 5 glove boxes, which, by the way, are very difficult to use. Just putting on the three pairs of gloves was  very difficult on it's own, let alone try to avoid contaminating the products.  I also did a qualification of two of the pipettes.  Twice a year they need to check all of their equipment to ensure that it is working properly and is accurate.  This was a way that I could learn and contribute to the clinic, and I am proud to say that I was able to pass both of the pipettes, which is more difficult that it sounds.

I was also given some small and large projects to work on during the rotation.  The main projects that I worked on were two journal clubs that were related to nuclear medicine and that I presented to the pharmacists, medication coordinators, and the physicians working at the clinic.  I also had two other presentations to give which were related to some of the work being done at the clinic.  One presentation was on appropriate aseptic technique using non-sterile product and the other was a large project about vaccines, specifically influenza vaccine produced in tobacco plants. This second project I found to be especially interesting and was comparable to a second seminar presentation.  So even though this was a lot of work, I now have two projects that I can possibly present, should it be required in any future interviews.  Not a bad deal. :)  I also had a few small projects like calculating the amount of hot and cold drug needed for a study, calculating how much radioactivity each patient would receive per dose, and looking up information on different radioactive products.

Finally I was sent on "field trips." The field trips were day trips to nuclear pharmacies so I could see how radio-labeled products were used in imaging and treatment of certain disease states. This was really cool when I visited the University of Wisconsin Hospital and saw not only how they prepared the products but all the imaging equipment and even where they were able to create radioactive particles in their cyclotron.  I know sounds like a mad science project and that is what it looked like too, but it was really neat.

Last thing, Madison is a really cool city.  There are a lot of fun things to do there and even though the rotation has a lot of projects, you get time to work on them during the day and can still spend time enjoying the city.  Cool things to do include going to the free zoo, Saturday farmers market, Wisconsin football games, trails near Picnic Point, lots of bars and restaurants down town Madison, and you must try cheese curds, delicious.  Overall, this was a pretty good rotation, very different and very interesting.

Thursday, October 6, 2011

Staff pharmacist

Posted by Matthew Lewis at Thursday, October 06, 2011

This rotation is all about figuring out what it would be like to be a general staff pharmacist, and it's at the VA (veteran's affairs) if you haven't read my previous post. The first thing that stuck me was where this VA is, which is right next to a college (Wayne State) and several other hospitals (Detroit Medical Center and Karmanos Cancer Institute to name a few) so it's at the heart of a medical complex. I've already done quite a few different things. The life of a staff pharmacist can pretty much be what you want to make it. You could be asked to take charge of the anticoagulation clinic, or make decisions about non-formulary medications. Your job might be to check physician orders and medication fills mostly.

Speaking of checking medications, the hospital inpatient setting employs a tech-check-tech system where properly trained and trusted pharmacy technicians check each other's work for accuracy. You might think it unsafe, but literature has shown that this system is just as accurate as a pharmacist check. tech-check-tech is an up and coming practice which allows pharmacists to get out onto the floor more often and help the medication ordering and administration process, which is where most medication errors occur.

Making IVs was fun, and interesting. You have to scrub in and gown up according to our fairly new industry practice of USP 797 guidelines which dictates how sterile IVs should be made. The actual mixing of the standard IVs isn't hard since most medications aren't toxic to any degree. I did not get the special chemo drug training though, since that is so dangerous even to people who follow the guidelines and have the two pairs of gloves on, the sterile disposable jacket, hair covering, mask, eye protection, mixing hoods with particular airflow and filters put in place among other things (As you can see, there are a lot of things to consider when implimenting USP 797.).

Now I'm just going on rounds and offering suggestions to the team to best manage the medications. Part of the job the pharmacist I round with is to make sure the vancomycin troughs are appropriate, and all the anticoagulation pharmacy follows is done by this pharmacist as well. I've learned quite a bit from that pharmacist as to the real-life application of medications which have narrow therapeutic ranges. In school, we learn with the impression that we can get patients' drug concentrations to the exact middle of our precise desired range, but in real practice there are mistakes as to when patients get lab draws, physicians of varying experience might not take your recommendations, or the patient might not "fit the mold" and metabolize the medication in some super fast or slow manner just to name a few things fighting against a pharmacist trying to get that perfect concentration.

That's what this rotation is all about for now, I'll keep you updated as things change.