2014-2015 STUDENT CLINICAL DIGEST

Presented by the Student College of Clinical Pharmacy— the official UGA chapter of American College of Clinical Pharmacy

Volume 1, Issue 4

Clinical Pharmacist Focus

ences and humble advice to our tered. I wanted to be a generalist students. and didn’t want to specialize out of fear of being too narrowly Why did you decide to pursue a focused and lacking variety. I residency? liked being able to dip my feet in other fields, and this has really I decided to pursue a residency helped me in the positions I’ve because of the opportunities held. available to me as a 4th year stu- dent on rotation at Emory Uni- What made you switch from versity Medical Center. During hospital to academia? this APPE, it was the 1st time I Michael Neville, Pharm. D., saw pharmacist working with the Someone told me many years ago BCPS, FASHP surgery team, internal medicine, they thought I would be a really intensive care unit, and transplant. great teacher and other people INSIDE THIS By Khushbu Tejani, Pharm D. Candi- What really impressed me was pointed it out a few more times ISSUE: date seeing the pharmacists being during my career. Both my par- proactive and contributing to ents come from an educational In this issue, we meet Dr. Michael patient care in a way that I never background and wanted me to Neville, a clinical pharmacist as saw before. While there, they got follow. I initially did not want to Clinical 1 well as former Clinical Associate to know me and asked me to pursue academia but it runs in my Pharmacist Focus Professor at the College of Phar- consider applying for their resi- blood. I enjoy teaching because I macy. Dr. Neville completed his dency program. At that time, it struggled a lot while a student Pharmacist’s Po- 1 PGY1 residency at Emory Hospi- was a great opportunity that I myself so I can relate to students tential Role in the tal and worked there as a clinical knew I didn’t want to pass up. who struggle. I enjoy seeing those Outbreak pharmacist in the following years. people learn things, see the light Prior to leaving the College in Why did you choose not to spe- bulb come on, and for them to December to assume responsibili- cialize and do a PGY2? realize they can really learn the Denying Immuniza- 3 ties as the Assistant Dean of stuff and do well with it in the tion: An Epidemic Student Affairs at Wingate School At the end of my PGY1, I was future. of Pharmacy, he was able to share more of an internal medicine with us his many clinical experi- clinical pharmacist and like the Continues on Page 2 Dyslipidemia Man- 4 variety of disease states encoun- agement Guide- lines: A Battle Field Pharmacist’s Potential Role in the Ebola Outbreak Brincidofovir: The 5 Potential New Drug for the Treatment Ebola By Brittany Chambers and most widespread Ebola out- vided as needed and can signifi- With the emergence of the Ebola break since the virus was first cantly increase the chance of virus outbreak spreading to the discovered in 1976, according to survival (1). There are currently United States in the fall of 2014, the World Health Organization. two experimental vaccines, cAd3- Drug digest in side- widespread panic has set in There are 5 species of the Ebola ZEBOV and VSV-EBOV, which bar! among the population. The out- virus and the most recent out- are undergoing Phase I trials that By Marisa Fortunato break began in Guinea in March break in 2014 was caused by the began in September and October of 2014 and with no therapies or Zaire species. Ebola virus disease of 2014 (2). If Phase I trials are vaccines against this deadly dis- (EVD) is a severe illness that can successful, it is thought that these ease, it spread to at least seven be fatal, especially if untreated. vaccines will be put on the fast- other countries by October of Currently, there are no FDA- track to FDA approval for use in 2014, including the United States. approved antiviral treatments for the current Ebola outbreak; The current outbreak is the largest EVD but supportive care is pro- Continued on Page 2 STUDENT CLINICAL DIGEST Page 2

Clinical Pharmacist Focus Continued from front page

smaller projects for each rotation. those who are willing to take con- How would you describe your typical The day-to-day activities are really structive criticism and able to be time workday as a resident and even the varied depending on the rotation. On managers. We try to figure out all of few years after residency? some services, the team rounds twice these characteristics and skills during a day, such as the ICU rotation, but the interview process. By using multi- Emory residency was very intense. I others may only do once a day. ple preceptors to ask different ques- wasn’t really a great student in phar- tions, we were able to know more macy and really only began to under- about these skills and the candidate’s stand and focus on my work at the When you were the director of the personality, motivation, and needs. end of my degree. I knew the resi- residency program, what factors did We may even give a short exam and dency was intense but still decided to you look at in your applicants? afterwards, we would get together do it. The program is laid out with an and rank each individual candidate orientation session at the beginning We looked for applicants who were and choose the ones who would do followed by month-long experiences well rounded. Because our program well and fit well into our program. indifferent specialties such as surgery had several residents (4 or 5), we or oncology, precepted by different needed them to work well together How flexible were the rotations? clinical pharmacist. The resident is and looked for these characteristics also assigned a clinical pharmacist to during the interview. We also looked There are some rotations that their be the overall mentor/advisor as a for those who weren’t too “needy” as program considered to be essential or consistent presence and guide. This well and whether our program was a required, but also reserved a few Hysingla ER (hydrocodone): clinical pharmacist is helpful when good match for what they were months where the residents were able you do your grand round presenta- looking for in a residency. Some to choose certain rotations in which Hysingla ER is a long-acting tion and research project. The re- applicants may have had multiple they showed more interested such as hydrocodone product that was approved search project is intense for those degrees whose needs were more than bone marrow transplant. by the FDA in November 2014. It has who haven’t completed a research what we could offer. Those who are Continues on Page 3 been approved for use in patients who project. In addition to that, there are self-directed and motivated really require chronic management of severe also several longitudinal projects and stood out for us. We also sought pain and who have failed previous thera- pies. It is available in strengths of 20 mg -120 mg hydrocodone and is designed to be taken once every 24 hours. Given the high potency of this product and the already widespread problem of abuse of opioid painkillers, a high potential for misuse exists. In an attempt to solve this problem, Hysingla ER has been Pharmacist’s Potential Role in the Ebola Outbreak formulated with unique physical and Continued from front page chemical properties designed to deter its abuse. The tablet itself is difficult to break and crush, which will make alter- by Brittany Chambers response against the Ebola virus (2). nate routes of ingestion more challeng- this is where a potential role for Pharmacists have gained a large and ing. Additionally, it does not dissolve pharmacists could come into play. vital role in providing immunizations easily, forming a viscous gel instead of a cAd3-ZEBOV is derived from a and with the panic and fear of the solution, making injection difficult. It is chimpanzee adenovirus and is genet- current Ebola outbreak, administer- the hope of the manufacturer, Purdue ically engineered to express glycopro- ing vaccinations against the Ebola Pharma L.P., that Hysingla will provide teins from both the Sudan and Zaire virus may become a primary duty of an effective therapeutic option for pa- species of the Ebola virus to generate pharmacists, if and when they are tients who need chronic pain manage- an immune response (2). VSV- approved. ment, while simultaneously cutting EBOV is a recombinant vesicular down on the potential for its abuse. stomatitis virus-based vaccine that References: References: encodes for the Ebola virus (EBOV) WHO: Ebola Virus Disease update, FDA News Release. “FDA approves glycoprotein in place of the of the 1 Sept. 2014. Web. 24 Nov. 2014. extended-release, single-entity hydroco- vesicular stomatitis virus (VSV) . properties”. November 20, 2014. Gao J, Yin L. "Drug Development http://www.fda.gov/newsevents/ for Controlling Ebola Epidemic - A newsroom/pressannouncements/ Race against Time." Drug Discoveries ucm423977.htm & Therapeutics 8.5 (2014): 229-31. Web. 24 Nov. 2014. . Volume 1, Issue 4 Page 3

Clinical Pharmacist Focus Continued from page 2

“Students can What educational steps did you take competitive. As a previous residency their classmates. You don’t need to to prepare yourself for residency? director, we certainly look at academ- be worry so much during 3rd year start on club ic performance but also naturally about presentations and publications, Applying to residencies today is very looked at those with a 3.4/3.5 GPA but when 4th year begins, you want different than when I was a resident, who also participated in community to think early on about doing a resi- leadership and so I’ll speak on what I understand work, pharmacy organizations, and dency. Figuring this out late in the about residencies today and my any leadership positions. We found game will leave you with little time to volunteer work to experience as a residency director. that leadership roles helped us find do everything you want to make ASHP would love for all pharmacy residents who are responsible and yourself stand out. Students can start start building graduates to pursue a residency but self-motivated and essentially didn’t on club leadership and volunteer with the statistics of how many need to hold our hands when given work to start building their CV early their CV early and positions and applicants are availa- directions. Things that people are and then add on to it during their 4th ble, it’s not possible for everyone to doing today include presentations, year with publications and presenta- then add on to it match. People really need to think publications, research projects, com- tions. about how to make themselves more munity involvement, posters, and during their 4th anything to separate themselves from year with Denying Immunization: An Epidemic publications and presentations” By Haylee McCoy

Vaccinations have been a carry the disease. Vaccines are not contain thimerosal.3 recent topic of controversy among only to protect ourselves, but all of many Americans, especially some Additional barriers in- those around us as well. When dis- clude religious and moral concerns parents, as there have been many ease is introduced to an area with misconceptions to spread like wild and the notion that the HPV vaccine low vaccination rates, outbreaks may promote promiscuity.3 Such fire. Although many of these rumors occur. This has happened in 2014 have no backing scientifically, there cases may be handled on a individual with regards to measles (Figure 1). basis, but the importance of vaccina- are parents who are electing not to There have been at least 603 cases vaccinate their children as suggested tions should be addressed as well as this year which is the highest number risk/benefit evaluation. by the CDC and vast majority of the of cases since measles elimination medical community. It is as im- There are many other was documented in 2000.2 In 1979, misconceptions regarding vaccina- portant as ever for health care pro- the number of pertussis cases and viders, including pharmacists, to tions out there. It is important that deaths skyrocketed in Japan because healthcare providers be educated and become educated on the importance of a massive decrease in pertussis of immunizations, what could hap- prepared to discuss them with their vaccination to only 10%. There were patients. This includes providing pen as vaccination rates decline, and more than 13,000 cases and 41 be able to educate their patients on them with the information necessary deaths as opposed to 393 cases in to increase their patients’ under- such. 1974 before vaccination declined.1 Due to vaccination, standing and debunk the myths in To educate patients, it is order to protect our country and the has been completely eradi- important to understand what mis- cated from the entire world. Other world from deadly, but avoidable conceptions they believe. Leading diseases. potentially devastating diseases in- the way in controversies is the no- cluding measles, rubella, diphtheria, tion that the measles-mumps-rubella References polio, and pertussis have all but (MMR) vaccine and thimerosal, a disappeared from America. To paint 1. "What Would Happen If We Stopped preservative in some vaccines, cause Vaccinations?" Vaccines and Immuniza- a more vivid picture, the CDC states autism in children. The article by AJ that “more than 15,000 Americans tions. Centers for Disease Control and Wakefield et al. that initially suggest- Prevention, 19 May 2014. Web. 24 Nov. died from diphtheria in 1921, before ed the relationship between the there was a vaccine. Only one case of 2014. MMR vaccine and autism was fully 2. "Measles Cases and Outbreaks." diphtheria has been reported to CDC retracted because some of the ele- since 2004.”1 A goal of immunizing Measles (Rubeola). Centers for Disease ments were proven false.3 Addition- Control and Prevention, 04 Nov. 2014. entire populations is to achieve herd ally, the topic has been intensively immunity so that if one of these rare Web. 24 Nov. 2014. studied and no scientific connection 3. Chatterjee, Archana, and Catherine diseases is introduced (often through between the vaccine and autism has travel to other countries) it will not O’Keefe. "Current Controversies in the been made.4,5 There are no routinely USA regarding Vaccine Safety." Expert become an epidemic because those recommended pediatric vaccines that exposed who have been vaccinated Review of Vaccines 9.5 (2010): 497-502. are immune and can not get nor Pubmed. Web. 24 Nov. 2014. Volume 1, Issue 4 Page 4

Clinical Pharmacist Focus Oralair (Sweet Vernal, Orchard, Continued from front page Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) What advice do you have for stu- how to treat patients. Searching dents who are interested in resi- online at job criteria really helps be- I think my most memorable experi- dency? cause certain positions may require ence is just really enjoying the round- residency training. Current graduates ing and working closely in an aca- What I tell people who are on the have the Internet at their disposal and demic medical center with other fence about residency is that a lot of can really use the resources that have disciplines to take care of patients. I people think about “living in the recently developed with job searches. thought it was really great, and I felt now” vs “living in the future”. It is a Having the mentality that I have like I made a difference for people in long journey to get here but also community if anything, is not really their care and could be proactive in taking the 2 years to do a residency the case anymore. Today, community their care. It was a challenge to keep also allows many doors to open and pharmacists are doing immunizations, up in the latest and greatest therapies gives skills sets that you might not therapy management, which is also but working as the residency directo- get outside of a residency. Academia requires a lot of training and experi- ry and an academic professor in the Oralair was approved in April 2014 is also very interesting. As a faculty ence. My experience is you can never nursing school at the same time was for the treatment of grass-pollen member, we have had several faculty go wrong with additional education great and difficult job. I was able to induced allergic rhinitis with or searches and some departments may especially before building a family and learn a lot about teaching and phar- without conjunctivitis. It is an not even consider someone without having an income. While you have no macology, which allowed me to keep immunotherapy agent that contains a PGY1 and/or PGY2. To open money, it is a lot easier to live off a up with current therapies. I used the these doors, two year of residency smaller income until you finish train- information I gained from the hospi- pollen extracts from five different training may be helpful. It’s not ing. tal to teach and the information I grasses. Oralair is approved for use necessarily the “be all end all” for an learned while teaching allowed me to in patients aged 10-65 who have academic position because it doesn’t What was one of your most memo- apply the newest therapies in the had positive skin testing to confirm train you for academia but more for rable experiences? hospital and stay up to date on new allergy to any of these grass species. findings. It is available in 100 IR (index of reactivity) and 300 IR sublingual tablets. The daily dose is 300 IR once daily for adults; children aged Dyslipidemia Management Guidelines: A Battle Field 10-17 should be dosed as follows: By Huong Pham 100 IR on day 1, 200 IR on day 2, line recommendations are based the some patients. and 300 IR on day 3 and thereafter. results of many clinical trials evaluat- Dyslipidemia Management Guide- Perhaps the most notable change in Treatment with Oralair should be ing the benefits of statin therapy in lines: A Battle Field the 2013 AHA/ACC guideline is that initiated 4 months before the onset preventing atherosclerotic cardiovas- target LDL values are no longer the of pollen and should be continued Dyslipidemia is a widespread prob- cular (ASCVD).3 This guideline primary focus of treatment. To some throughout the pollen season. The lem in America. According to the focuses on statin therapy and pro- extent, having no fixed goals is a very first dose needs to be adminis- American Heart Association, 43% or vides minimal recommendations more evidence-based and realistic tered in a healthcare setting with 30 98.9 million Americans over 20 years regarding the other available lipid- approach in lipid management. With minutes of monitoring for severe of age have a total cholesterol level lowering therapies.4 the previous LDL targets in the ATP allergic reactions. Subsequent of 200 mg/dL or higher.1 Hyper- doses may be taken at home, but The 2013 AHA/ACC guideline III guidelines, many patients were lipidemia is one of the modifiable the patient should be prescribed an identifies four statin benefit groups unable to achieve their treatment risk factors for heart disease, a lead- epinephrine auto-injector in case which include Clinical ASCVD— goals.7,8 ing cause of deaths (600,000 people allergic reactions are experienced in secondary prevention, Primary LDL- annually) in America.2 Dyslipidemia The 2013 AHA/ACC focuses on the future. Oralair is a pregnancy C ≥190 mg/dL - primary prevention, management becomes very im- statin therapy for the 4 statin benefit category B drug; it is not known if Age 40-75 with diabetes & LDL-C portant in primary and secondary groups; however it carries certain Oralair is excreted in breast milk, 70-189 mg/dL - primary prevention, heart disease prevention; however, limitations which need addressing to so women who are nursing should Age 40-75 with LDL-C 70-189 mg/ the landscape for management of better manage patients with avoid use of this therapy. dL, and estimated 10-yr ASCVD risk dyslipidemia has changed dramatical- dyslipidemia. References: ly since the introduction of the new- ≥7.5%> - primary prevention. It Oralair [package insert]. Lenoir, est lipid guidance. The 2013 Ameri- introduces a new tool to calculate 10- References NC: Greer Laboratories. the Treatment of Blood Cholesterol age. This tool is available online and report from the American Heart Association. Circulation 2013;127:e6-e245. http://www.centerwatch.com/drug (2013 AHA/ACC) was a long await- found on apps for Android and iPhone platforms. It replaces the -information/fda-approved-drugs/ ed and much anticipated guideline Centers for Disease Control and Prevention. drug/1313/oralair-sweet-vernal- Framingham CVD risk calculator (2014). FastStats. Retrieved from http:// replacing the National Cholesterol www.cdc.gov/nchs/fastats. orchard-perennial-rye-timothy-and- Education Program Adult Treatment used in ATP III which did not en- kentucky-blue-grass-mixed-pollens- Panel III Guidelines (ATP III) which compass cerebrovascular risk.5 Stone NJ, Robinson JG, Lichtenstein AH, et al. allergen-extract There have been some initial con- 2013 ACC/AHA Guideline on the Treatment of has been the primary hyperlipidemia Blood Cholesterol to Reduce Atherosclerotic cerns that the 10-year ASCVD risk guideline since 2001. The evidence- Cardiovascular Risk in Adults: A Report of the based 2013 AHA/ACC lipid guide- calculator may overestimate risks in American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2013;129:S1-S45. Volume 1, Issue 4 Page 5

Dyslipidemia Management Guidelines: A Battle Field Continued from Page 4 Contrave (naltrexone HCl and bupropion HCl extended-release):

Expert Panel on Detection, Evaluation, and cholesterol medication use. The Minnesota Treatment of High Blood Cholesterol in Adults. Survey, 1980 – 1982 to 2000 – 2002. Circulation Executive summary of the third report of the 2005;112:3884–3891. National Cholesterol Education Program Lloyd-Jones D, Adams RJ, Brown TM, et al. (NCEP) Expert Panel on Detection, Evaluation, Executive summary: Heart disease and stroke and Treatment of High Blood Cholesterol in statistics – 2010 update: A report from the Adults (Adult Treatment Panel III). JAMA 2001; American Heart Association. Circulation 285:2486–2497. 2010;121:948–954. Akosah KO, Schaper A, Cogbill C, et al. Prevent- ing myocardial infarction in the young adult in the first place: how do the National Cholesterol Education Panel III guidelines perform? J Am Coll Cardiol 2003;41:1475–9. Hecht HS, Superko R. Electron beam tomogra- phy and national cholesterol education program guidelines in asymptomatic women. J Am Coll Contrave was approved in September Cardiol 2001;37:1506–11. 2014 as a weight loss agent. In Arnett DK, Jacobs Dr Jr, Luepker RV, Blackburn combination with exercise and calorie- H, Armstrong C, Claas SA. Twenty-year trends in reducing lifestyle modifications, it is serum cholesterol, hypercholesterolemia, and approved for use in adult patients with a BMI of 30 kg/m2 or higher or in patients with a BMI of 27 kg/m2 or higher with at least one weight-related comorbidity. Contrave combines the action of Brincidofovir: The Potential New Drug for the naltrexone, an opioid antagonist, with that of bupropion, a norepinephrine and Treatment Ebola dopamine reuptake inhibitor. These agents are thought to work together to decrease appetite and curb hunger brincidofovir being the only poten- cravings. A strict dose titration schedule By: Payal Kakadiya tial treatment for the Ebola virus, it lasting 4 weeks must be followed when The drug is currently in Phase III becomes a commodity and worth starting Contrave, and evaluation of Ebola has made its comeback and clinical trials for use against the millions. However, it must still this time it has affected people in the and adenovirus and undergo Phase III trials of FDA efficacy is needed at 12 weeks. If there U.S. Because of the outbreak of the has received the FDA Fast Track approval in order to become the go has not been at least a 5% weight deadly virus, the research and devel- Designation. Because of brincidofo- -to treatment for Ebola. With reduction by week 12, Contrave should opment sectors of various pharma- vir’s unique inhibition of viral DNA research underway, there is hope be discontinued. A number of side ceutical companies have gone head replication, the FDA authorized the that brincidofovir will follow effects may be associated with Contrave, Emergency Investigational New first into finding a cure. through and become the leading including a black-boxed warning of Drug application of brincidofovir on treatment for all types of DNA increased risk of suicide due to Chimerix, Inc. is the developer of October 6, 2014 for the treatment of viruses. bupropion. Patients should therefore be brincidofovir, an antiviral for treat- the Ebola virus. carefully evaluated before the decision is ment of DNA viruses such as cyto- References megalovirus, adenoviruses, BK virus, Brincidofovir was given to the first Florescu, D.F., Keck, M.A. Development of made to initiate Contrave. small pox, and . patient in the U.S. diagnosed with CMX001 (Brincidofovir) for the treatment of Sources: Ebola in Dallas. It was administered serious diseases or conditions caused by It is also believed that it may have dsDNA viruses. Expert Review of Anti- FDA News Release. “FDA approves weight- potential as treatment of the Ebola six days after the hospital admission, Infective Therapy. 2014,12(10):1171-1178. management drug Contrave.” September 2014. virus. however, the patient passed away http://www.fda.gov/NewsEvents/Newsroom/ four days later. The patient had been Quenelle, Debra C.; Lampert, Bernhardt; Collins, Deborah J.; Rice, Terri L.; Painter, PressAnnouncements/ucm413896.htm Brincidofovir is the prodrug of critically ill so the effects of the George R.; Kern, Earl R. Efficacy of CMX001 http://www.centerwatch.com/drug-information/ . Cidofovir resembles the antiviral were unknown because he against Herpes Simplex Virus Infections in fda-approved-drugs/drug/100032/contrave- could have died from not being able Mice and Correlations with Drug Distribution structure of cytidine, a DNA nucleo- Studies. The Journal of Infectious Diseas- naltrexone-hcl-and-bupropion-hcl- tide. It is used up by DNA polymer- to tolerate the side effects or from es. 2010;202 (10):1492–1499. ases because it looks similar and the his deteriorating status. Brincidofovir was also given to an Ebola patient at http://www.chimerix.com/c/discovery-clinical incorporation of cidofovir causes -trials/brincidofovir-ebola.php inefficient DNA synthesis, thus Nebraska Medical Center. He was inhibiting viral replication. Brin- pronounced Ebola-free and released cidofovir was created by adding a from quarantine. lipid chain making it more potent, increasing its oral bioavailability, and The antiviral has now moved into reducing kidney toxicity. Because of Phase II trials to test for its safety, its increase in lipophilicity, brin- tolerability, and efficacy in the treat- cidofovir releases cidofovir intracel- ment of the Ebola virus. It is cur- lularly increasing its activity against rently available in the tablet form for viral DNA. immediate use in clinical trials. With