Developing Drugs (and skills)

Posted by Jim Stevenson at Thursday, April 28, 2011

My non-traditional elective was in the drug industry with a consulting company called United BioSource. United BioSource works with a number of pharmaceutical companies to provide guidance and input during a drug’s development. For the most part, United BioSource positioned me with one of their clients, Esperion Therapeutics. Esperion has an interesting background – it started as a small pharmaceutical company in 1998, then was bought up (for a handsome sum) by Pfizer in 2004, and then split off once again in 2008. Esperion’s area of interest is in basic metabolism-related conditions. Their CEO, Dr. Roger Newton, was co-discoverer and champion of Lipitor while at Pfizer.

While I was working with Esperion, they were designing a Phase 2B trial for a drug they are developing. Interestingly, they were investigating the same compound for multiple indications. My work entailed reviewing literature on the actions and development of similar compounds. The published manuscripts of phase 2 trials for similar drugs were invaluable resources. For example, a power calculation needed to be performed for the phase 2 trial I was assisting with. The magnitude of effect of various biomarkers and the duration of similar trials were major considerations. Also, the study population was a major discussion point. With an unproven drug, it becomes an ethical dilemma to perform a long placebo-controlled trial in patients with active disease (as half will be on placebo therapy and half will be treated with an unproven drug).

It was a very interesting experience to learn about all of the considerations that must be made during a drug’s development. There is an incredible amount of consequences to consider with each decision. In a world where a small difference in p-values or a single rare adverse event can cost billions of dollars, there is spirited discussion about every aspect of a drug’s development. Perhaps one day I will see use of (or even use myself) the compound that I worked on this winter.

March 23rd

Posted by Zhe Han at Sunday, April 10, 2011

I remember this date and I am sure all my classmates pursuing residencies remember it as well. It is the ASHP Residency Match Day this year. Applicants receive an email containing their match result from the National Matching Services (NMS) that morning.

Residency application can be a stressful and time-consuming process, beginning in late November when students start looking at programs in preparation for Midyear through late March when match results are released. Having just gone through this process, I have several tips for those who are interested in residency training in the future.

1. Prepare for Midyear.

Know what you are looking for and generate a list of programs you plan to speak to at the residency showcases. Based on my own experiences, speaking with 5-6 programs at each showcase is very doable. Sometime in November, ASHP website posts maps of the exhibition hall with all booths labeled. Print a copy and map out your route so that you are not wasting time figuring out where things are. When you are at the showcase, make it a point to speak with both program director/preceptors and residents. Program directors and preceptors can be your future interviewers and despite speaking with many students at the showcase, I am surprised by how well they remember faces. One of my interviewers said "I remember talking to you at Midyear"! Its good to have that little connection.

Several questions I hope I had asked at the showcase:
- Do you plan to expand the size of your residency class next year?
- Any changes to your program requirement next year? (if yes, information you gathered online is no longer accurate)
- How long has your program been established? (do you like a very structured program or a newer one where residents may have a greater impact in shaping the program)
- Any plans to start new PGY2 programs?

2. Once you come back from Midyear, finalize your list of programs to apply to and get your materials in early.

Some programs review applications as they come in. The sooner you get your materials in, the sooner they review and chances are they will contact you earlier so that you have more options for interview dates.

3. Expect to hear back from programs from mid January through late February (emails, phone calls)

One thing which surprised me in this process was most programs that invited me for onsite interviews notify me via the phone (I was expecting emails). So if you are on rotations and can't answer phone calls all the time, check your voice message. Also, if you get a missed call from a number you don't recognize, be sure to call back!!!

4. Prepare for interviews.

Besides preparing for standard interview questions, go through your CV line by line and make sure you can speak intelligently about EVERYTHING listed there. If necessary, review your notes from your previous presentations/inservice/journal clubs to refresh yourself on the content. You may be asked to tell your interviewers about your journal club presentation on a rotation 6 months ago!! (yes, it CAN happen)

5. Don't forget the logistics!!

Know where you will be going on your interview day. Always have the pharmacy department's phone number on hand. If a resident is going to meet you at the main entrance, get his/her cell phone # and have it with you. When you are unsure if you are waiting at the correct location, ask around or call, if you are at the wrong location, you want to find out sooner rather than later so that you are not late for your actual interview.

I hope these tips are helpful to those who are looking at residencies in the future. Good luck!!

Pharmacy, It's Bloody Brilliant

Posted by Jody at Thursday, April 07, 2011

My rotation this month is non-traditional pharmacy in Bath, UK. This rotation incorporated both hospital pharmacy and community, with an emphasis on community.

Week 1: Bristol Royal Infirmary

At the BRI, I was placed in Medicines Information (i.e. drug info). In the morning I would visit the ward with the pharmacist to complete medication reconciliation on each patient, review med charts, and evaluate discharge medications. In the afternoon I answered drug info questions from GP’s (general physician in the community) or retail pharmacists. In the hospital setting, pharmacy technicians play a much larger role. They are active on the floor - interacting with patients, and assisting pharmacists with med rec. And of course tea time occurred daily at 10:30am.

Week 2: Boot’s Pharmacy

Boot’s is a popular chain pharmacy company within England. Retail pharmacy is much more relaxed with only one insurance company and absolutely no rejections when processing claims. All prescriptions, regardless of brand or generic, have one set price. However, most patients are exempt from prescription fees. The first thing I noticed was the difference in OTC’s: codeine, fluconazole, sumatriptan, and tamsulosin

Week 3: Lifestyle Pharmacy

This pharmacy is an independent pharmacy located in the center of Bath. Here I was able to understand pharmacy contracts and the drug tariff. All pharmacies must have a contract with the NHS (National Health Service). There are three contracts: essential, advanced, and enhanced. Each contract incorporates different services the pharmacy must provide. Among the services offered is methadone treatment for recovering heroin addicts. The drug tariff is a book published monthly by the NHS, which lists reimbursement costs for any medication dispensed.

Week 4: Hawes Whiston, Chemist

Pharmacists in the UK are often referred to as chemists. This pharmacy was also an independent pharmacy. The owner explained the classification of medications: GSL (general sales list), P (pharmacy), and POM (prescription only medication).

- GSL: Medications that can be sold outside of the pharmacy (i.e. supermarkets), such as 16 tablets of paracetamol (aka acetaminophen)

- P: Medications that must be sold within a pharmacy while a pharmacist is present. These medications can be sold in larger quantities than GSL products, such as 32 tablets of paracetamol.

- POM: Medications that can only be dispensed with a prescription.

The opportunity to experience pharmacy in another country was a fantastic experience and something I would recommend to every student. It was a chance to see first-hand the differences in pharmacy practice compared to the US as well as how pharmacists interact with other healthcare professionals.

Small Voice with a Big Impact

Posted by Jody at Wednesday, April 06, 2011

I am currently on my internal med rotation at Mercy Memorial Hospital. Mercy is a smaller community hospital located in Monroe, MI. There is one central pharmacy that dispenses for the entire hospital.

Mercy does not have the “traditional” rounds we think of when it comes to inpatient rotations. So, what do clinical pharmacists do at a smaller hospital?

My responsibilities on rotation:

- Anticoagulation

o Monitoring warfarin, lovenox, fondaparinux

- Renal Dosing

o Reviewing all medications for patients with renal insufficiency and recommending alternative treatment options to physicians

- Kinetics

o Dosing and monitoring antibiotics, ordering drug levels

- Drug Information

o Answering physician questions regarding medications and dosing since there is no drug info department

o Calling drug companies to determine stability and compatibility

- Administration

o Helped implement new programs and policy for the pharmacy department. Specifically, I assisted with the Fall Prevention and Safety Policy.

As you can see, the pharmacists have all the typical responsibilities that any pharmacist would have at any institution, plus a little more. At smaller hospitals, such as Mercy, the role of each pharmacist is a mix of responsibilities incorporating not just clinical but administrative roles as well as drug information tasks.

Infectious Diseases

Posted by Omo at Saturday, April 02, 2011



My seventh rotation was at Sinai Grace Hospital in Detroit. I got the opportunity to work with the Infectious Disease pharmacist, focusing on antimicrobial stewardship. It was a very rewarding experience. I engaged in daily patient work-ups where I was assigned about three different patients everyday. Similar to other clinical rotations, I had to go through each patient’s profile and analyze their medication history with big emphasis on their antibiotic medications. I would go through blood cultures, urine cultures and sputum cultures to see if the antibiotic(s) the patient was on had good coverage against the bugs grown. The choice of antibiotic was not only based on good coverage. Like any other hospital, it was also dependent on what was on formulary, cost, patient’s renal function etc. So there was a lot to consider. Streamlining was another big part of the antimicrobial stewardship. It involved choosing the best antibiotic to cover the patient’s bug without broad-spectrum coverage to prevent resistance to drugs. If a patient was on a broad-spectrum antibiotic and a much narrow spectrum antibiotic could do the same coverage (after cultures have been thoroughly examined), we would de-escalate the patient’s therapy. De-escalate is synonymous to streamlining. For any intervention we made, we would consult with the ID physician and most times, they would take our recommendation for change.

Besides patient case work-ups, we also did daily discussions covering several ID topics such as Clostridium difficile, candidiasis, meningitis, endocarditis, pneumonia and intra-abdominal infections to name a few. My partner and I would teach each other the topics and our preceptor would add to the discussion after we each presented. We also did journal club presentation for the pharmacy staff mostly but some ID physicians at the hospital also showed up.

Overall, this rotation was a very rewarding learning experience. Unlike most clinical rotations, we didn’t get the opportunity to go on rounds with the medical team for several reasons but I still got a lot out of the rotation and I am grateful for such exposure.