ERNEST MARIO SCHOOL OF PHARMACYVOL.4 ISSUE 2DECEMBER 2014

EMSOPCHRONICLES

brought to you by Pharmacy Governing Councilx

Table of Contents

Diet and Genes.............................2

Health Literacy.............................3

Social Media: FDA vs. Pharma...4

Ebola Treatments.........................5

Inside Industry.............................8

Interview with Dr. Kar.................9

by Sara Se, PP2

RWJ Researchers May Have Found a Potential Drug to Reverse Diabetesby John Daniel, P2

New Method of Blood Testing in Pharmacies

References

1. Crane, R. She’s America’s youngest female billionaire – and a dropout. CNN. http://money.cnn.com/2014/10/16/technology/theranos-elizabeth-holmes. Published October 16, 2014. Accessed November 18, 2014. 2. Rago, J. Elizabeth Holmes: The breakthrough of instant diagno-sis. The Wall Street Journal. 2013. http://online.wsj.com/articles/SB10001424127887324123004579055003869574012. Accessed November 18, 2014.3. Roper, C. This woman invented a way to run 30 lab tests on only one drop of blood. Wired. http://www.wired.com/2014/02/elizabeth-holmes-theranos. February 18, 2014. Accessed November 18, 2014.4. Bolt, B. Bringing painless blood testing to the pharmacy. Pharmacy Times. 2014. http://www.pharmacytimes.com/contribu-tor/beth-bolt-rph/2014/11/bringing-painless-blood-testing-to-the-pharmacy. Accessed November 18, 2014.

Researchers at Robert Wood Johnson Medical School have developed a drug called niclosamide ethanolamine salt (NEN), which is shown to be effective for treating type 2 diabetes in preclinical trials.

Type 2 diabetes is a chronic metabolic disease, which results from an increased levels of glucose in the blood affecting over 25 million Americans. This chronic illness can lead to complications such as cardiovascular disease and kidney failure.

RWJ continued on page 7

Photo Credit: http://singularityhub.com/wp-content/uploads/2013/11/drop-theranos.jpg

There is no doubt that trypanophobia, the fear of needles and injections, can be found in people of all ages. However, who would have thought that many people avoid medi-cal treatment due to this fear? Elizabeth Holmes, a Stanford University dropout who founded a company called Theranos with her tuition money, may have found just the solution to this problem. Holmes mentioned that forty to sixty percent of Americans to-day are not compliant with even basic tests that their physicians give them because they often cannot afford it, or because they are scared of needles.1 Holmes started this company in order to make health informa-tion more accessible to people everywhere, and to create major improvements to change the health care system for the better.

Two Theranos advances that are prominent in this revolutionary way of blood testing are the way the blood samples are taken and its testing accuracy. The technician will first increase the patient’s blood flow by ap-plying a wrap to his or her hand,2 then will

use a fingerstick to draw a few droplets of blood from the capillaries at the end of his or her hand. The blood will be collected in a “nanotainer,”which holds microliters of a sample of blood. In addition to this, Holmes believes that the chain of conven-tional laboratory custody introduces too many opportunities for error. Hence, accu-

racy is improved because manual handling of samples is eliminated. This new, quick method of drawing blood even provides analysis results within hours instead of days. Furthermore, unlike any other test-ing industry, Theranos lists its prices on its website in order to make the blood test-ing more transparent: blood typing, $2.05; cholesterol, $2.99; iron, $4.45. 3 The com-pany claims that if these tests were per-formed in the United States at these prices, it could save Medicaid $104 billion and Medicare $98 billion over the next decade.

Theranos has partnered with Walgreens and

introduced the first testing center in Palo Alto, California about one year ago. Wal-greens has also announced plans to include Theranos Wellness Centers inside all of its 8,200 pharmacies. 4 One reason why Ther-anos decided to start the business working with pharmaceutical companies is so that the companies could run an adaptive clini-cal trial in which they could change the dos-ing for a patient in real time or in a premed-itated way based on the data collected from the blood test.3 Holmes also mentions that “The reality within our health-care system today is that when someone you care about gets really sick, by the time you find that out it’s most often too late to do anything about it. It’s heartbreaking.” 2 Likewise, we pharmacists should have the heart to im-prove healthcare so that people can quick-ly change undesirable health outcomes.

2

Does Your Diet Fit Your Genes?by Melanie Chen, P1

Prescription Pain Killer Abuse in the U.S.by Aamer Attaar, P1

The newest trend in nutrition counseling suggests that, in order to find a patient’s best diet plan, they should look at the very ba-sics of themselves—their genes. In a study published online in the journal PLoS One, researchers at the University of Toronto (U of T) report that personalized dietary advice based on a person’s genetic make-up, or genome, improves eating habits.

“We conducted the first randomized con-trolled trial to determine the impact of disclosing DNA-based dietary advice on eating habits,” says primary investigator Ahmed El-Sohemy, an Associate Profes-sor in Nutritional Sciences at U of T and Canada Research Chair in Nutrigenom-ics. “We found that people who receive DNA-based advice improve their diet to a greater extent than those who receive the standard dietary advice. They’re also the ones who need to change it the most.”1

What Dr. El-Sohemy refers to as “stan-dard dietary advice” are the current dietary recommendations that most nutritionists advise, such as eating two cups of fruit and six ounces of whole-grain breads per day.2 According to the study, ments after

twelve months. Interestingly, sodium in-take was especially affected. Compared to the group that was given standard dietary advice, subjects who were informed that they carried a certain gene linked to in-creased salt consumption and hypertension significantly reduced their sodium intake by being choosier about the foods they ate.3

While previous studies focused on disease risk prevention rather than pinpointing the genes that affected certain components of diet, Dr. El-Sohemy explains that “this is the first time that the impact of dietary ad-vice based on diet-related genes with spe-cific actionable advice has been tested.”1

“One of the major problems that we have found regarding one-size-fits-all dietary reommendations is people’s adherence to them,” says Jose Ordovas, director of nu-trition and genomics at Tufts University. He supports the study’s implications that DNA-based recommendations can be more beneficial for the individual. Specifically, he hopes that DNA-based advice will in-crease nutritionists’ abilities to prevent chronic diseases, such as heart disease and

Diet continued on page 5

With the recent delegation of hydrocodo-ne as a C-II drug and tramadol HCl as a C-IV, the Drug Enforcement Administra-tion (DEA) has been taking a closer look at which drugs should be on which schedule, in order to combat prescription abuse. DEA Administrator Michele Leonhart expressed her sentiments about hydrocodone by stat-ing “‘almost seven million Americans abuse controlled-substance prescription medica-tions, including opioid painkillers, result-ing in more deaths from prescription drug overdoses than auto accidents.’”1 Leonhart and other drug analysts believe that hydro-cone’s change in schedule will help lessen the number of opioid overdoses by limiting access to certain drugs for both initial and continuous therapy. It will also limit the number of prescribers who will prescribe a powerful analgesic for mild operative pro-cedures, such as getting wisdom teeth re-moved. However, will moving Vicodin and other drugs to a higher schedule result in fewer cases of abuse, even with the grow-ing trend in prescription pain killer abuse?

To answer this question, knowledge of how drugs are diverted is required. The majority of drug diversion of prescription painkillers involves receiving the drug for free from a friend or relative who has a prescrip-tion. This accounts for 55% of diversion of pain killers, while purchasing it from a dealer only accounts for 4.4% of drug diversion.2 Clearly, the problem of abuse then arises from a lack of education on two matters: federal drug laws and the prescrip-tion filling process. Both sets of standards hold pharmacists responsible, but with a greater emphasis on physicians in the latter. Prescription Drug Monitoring Programs (PDMPs) are a principal way to mitigate the dispensing of prescriptions for illegiti-mate purposes. They not only require the pharmacist to check the online database for cases of “doctor shopping,” but also penal-ize physicians for prescribing analgesics outside the medication guidelines. If the prescription is legitimate, it is vital for the pharmacist to let the patient know that the

drug is to be used only by the patient and that use of any controlled substance would be considered illegal if used by someone else. By moving certain drugs to a higher sched-ule, the DEA is limiting physicians from prescribing potent analgesics for initial and continuous therapy. However, in or-der to decrease the upward trend in pain killer abuse, PDMPs have to be utilized to their full potential. Not only do PD-MPs help pharmacists pinpoint evidences of illegitimate prescriptions, but they also force physicians to make sure the right analgesic is being administered for post-operative or regular administration.

References

1. DEA to Tighten Access to Some Narcotic Painkillers. WebMD. Pub-lished August 21, 2014. http://www.webmd.com/news/20140821/us-to-tighten-access-to-certain-narcotic-painkillers. Accessed November 11, 2014.2. Policy Impact: Prescription Pain Killer Overdoses. Centers for Dis-ease Control and Prevention. http://www.cdc.gov/homeandrecreational-safety/rxbrief/ Accessed November 11, 2014.

Photo Credit: http://drpacholec.com/5-big-payoff-diet-changes/

there is no “one size fits all” diet, so these guidelines may not apply to all patients.

In the study, the researchers collected data on caffeine, sodium, vitamin C and sugar intake from 138 healthy adults.3 The subjects were then randomized into two study groups; one was given DNA-based dietary advice for each of these four dietary intake components, while the other group was given current stan-dard dietary advice for the same com-ponents with no genetic information.

Changes in eating habits were assessed after three and twelve months. The re-searchers found that subjects who received DNA-based dietary advice started to show improvements to their diets after three months, with even more drastic improve

3

References:

1. Glassman P. Health literacy. National Network of Libraries of Medicine Web site. http://nnlm.gov/outreach/consumer/hlthlit.html. Published 2013. Accessed November 12, 2014.2. Martin D. Improving health literacy could improve healthcare; save an estimated $73 billion a year. Saporta Report Web site. http://saportareport.com/leadership/healthcarepractice/2014/10/06/improv-ing-health-literacy-improve-healthcare-save-estimated-73-billion-year. Published 2014. Accessed November 12, 2014.3. Health Literacy. Centers for Disease Control and Prevention Web site.http://www.cdc.gov/healthliteracy/learn. Published 2014. Accessed November 12, 2014.

by Cindy Tu, P2

by Lydia Chou, P2

Pharmacist Provider Status Bill Quickly Gaining Momentum

What is Health Literacy?A patient approaches a pharmacist, asking for refills for his own medications. After looking up the patient's profile, the pharmacist, to verify, asks what medications are to be refilled.

Patient: I don't know. Pharmacist: Do you know what you’re taking the medications for?Patient: How am I supposed to know? Ask my doctor - he wrote them! All I know is that I dropped them off last month, and I’m running out.

Unfortunately, the scenario above is all too common. More often than not, patients rely entirely on healthcare professionals to handle their health, with minimal participation on their end of the stick. Having the professionals on board to tend to an individual’s health is vital, but that individual should play a role in his or her own health as well, especially in an outpatient setting. October is Health Literacy Month. Although the month has passed, health literacy is a topic that can and should be discussed at any time. According to the Institute of Medicine, health literacy is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” 1 Patients should take more responsibility in the management of their own health while

working together with healthcare providers, whether it be a physician, pharmacist, or nurse, in providing the best care and making the appropriate health decisions.

In 2009, the World Health Organization (WHO) described three levels of health literacy: functional, conceptual, and empowerment. Functional health literacy relates to one’s ability to read. For 32 million American adults, or 14 percent of the population, illiteracy already sets them back from those who can read the doctor’s scrawl on the scripts, the label on the prescription bottle, and printed information regarding health plans and premiums. An additional 21 percent of adults can read, but below a fifth grade level, which can leave them utterly confused when faced with complicated instructions left by their healthcare providers. Conceptual literacy comprises of the skills to pursue, inquire, understand, and use health information, which people build over a lifetime. Technology and the internet have facilitated our ability to find out about disease states, medications, and much more. Looking up important health information and actually utilizing that knowledge in day-to-day activities has played a significant role in the quality of life, helping people make informed decisions and decreasing the risks of adverse events. The last level is empowerment. With health literacy, individuals are entrusted with their right to properly take care of their

own health as well as to confidently steer their way through the healthcare system, using and comprehending the resources and options that are provided to them by healthcare stakeholders. 2

As reported by the Institute of Medicine, 90 million Americans are health illiterate, which leads to increases in healthcare spending. A whopping estimated $73 billion could be saved by creating a health literate society. Healthcare professionals serve a crucial role in improving health literacy in our nation. Providers should have good communication skills, using simple language to elucidate difficult information. In addition, providers should try to understand the culture behind the patients’ thinking. Culture plays a part in literacy, influencing the values and attitudes regarding healthcare. Taking culture into account can decrease nonadherence, provide better outcomes, and narrow the gap between provider and patient.2 Everyone – healthcare providers, government agencies, educators, businesses, media, and individual patients – can do their part in promoting health literacy.3

Despite the professional training, rigorous curriculum and proficient communication abilities, pharmacists are still not considered health care providers. However, earlier this year, on March 11, 2014, a bill was introduced into the House of Representatives that called for the recognition of pharmacists as official health care providers.1 The bill, titled H.R 4190, was introduced by representatives Brett Guthrie, G.K. Butterfield, and Todd Young.1 Recently, on September 9th, 2014, this bill reached a milestone by gaining the support of 100 congressional co-sponsors.2

If successful, this bill will amend the Social Security Act of 1935 to include

pharmacists as Medicare Part B providers. It will increase the profession's power and allow pharmacists to receive government reimbursement for their services. State-licensed pharmacists will be recognized for their role on the health care team and receive payment for providing care for patients in medically underserved locations.1 The services that pharmacists will be able to provide include diabetes screenings, cardiovascular screenings, immunizations, self-management patient education and behavioral therapy.2

The change will address care gaps in the U.S. health care system because pharmacists are easily accessible, well-trained in patient counseling and retail pharmacies have

long hours that offer timely convenience.1

Douglas Hoey, the Presdient of NCPA (National Community Pharmacists Association) stated that:

"Most of these providers are located in smaller communities and approximately 1,800 independents are the only pharmacy option in their rural communities. In other areas, independent pharmacies cater to diverse populations for whom English may be a second language. In these scenarios and others, independent community pharmacists are ideally positioned to play a greater role in health care."1

Provider continued on page 7

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by Prianka Das, P3

Social Media and Medication Adherenceby Jenny Shah, P1

Big Pharma Unhappy with FDA’s New Social Media

Rules

Medication non-adherence, which ranges from leaving the pharmacy before the prescription is filled to not even bringing the prescription to the pharmacy, is a serious problem in today’s society. This problem can be attributed to a wide variety of reasons including the high cost of medications, the fear of side effects, and misunderstandings about the proper drug regimen. According to an estimate made by Express Scripts in the Drug Trends Report, the cost of medication non-adherence to the United States healthcare system in 2013 was $337 billion.1 Clearly, this is a significant clinical and financial problem which needs to be addressed.

According to the study “Association Between Different Types of Social Support and Medication Adherence,” which evaluated fifty journal articles, there is a positive correlation between social support and greater medication adherence.2 Social

support includes online social networking websites, which can offer both practical and emotional support.2 For example, social media allows individuals to ask questions and make comments online. Additionally, patients who fear the side effects of a drug can use social media sites to read about other people’s experiences regarding the drug.3 Pharmacists can also use these sites in order to better understand the patient’s perspective regarding specific drugs. This can potentially help pharmacists in counseling and reassuring patients. 3

Another technique that may increase patient adherence is the use of medication apps. According to Craig Cocchio, PharmD, BCPS, who practices Emergency Medicine at Robert Wood Johnson University Hospital, these apps are currently being used in the emergency department, a place where time is of the essence and it is necessary to have the most up-to-date patient history possible.4 The iOS 8 operating system that

comes with the iPhone 4S and subsequent generations allows individuals to input a Medical ID record that includes past medical history, allergies, primary care physician, etc. This app and others similar to it can provide alerts and notifications to improve patient adherence. Furthermore, pharmacists can potentially use the detailed medical records that these apps provide to identify individuals who have a risk of being uncompliant with their medication regimen and take initiatives to increase compliance in these patients. Essentially, medication adherence is a significant issue, but it has the potential to be resolved through a variety of tactics. References:

1.“The 2013 Drug Trend Report.”Lab.expresscripts.com. Express Scripts, 1 Apr. 2013. Web. 16 Nov. 2014.2.Scheurer, Danielle. “Association Between Different Types of Social Support and Medication Adherence.” American Journal of Managed Care(2012): 461-67. Web. 16 Nov. 2014.3.Mantel, Gideon. “How Much Are Non-Adherent Patients Influenced by Social Media?” Eyeforpharma. N.p., 12 Feb. 2013. sWeb. 16 Nov. 2014.4.Cocchio, Craig, PharmD, BCPS. “Medication History: There’s an App for That.” Medication History: There’s an App for That. Pharmacy Times, 5 Nov. 2014. Web. 16 Nov. 2014.

The FDA has recently been sending warning letters to companies stating that they are violating FDA regulations regarding how their products are being marketed in the media.1 Earlier this year, Zarbee’s Naturals received a FDA warning letter for claiming to treat coughs (supplements are not allowed to make these claims) and also for the company’s Facebook “likes” and Twitter “tweets”.1 The FDA explained that if a consumer comments on Zarbee’s Facebook page about a cure or use that a product is not approved for, and the company in turn “liked” or replied to that comment, then that is equivalent to endorsing that comment.1 The FDA’s issue with Zarbee’s reflects the extent the agency is willing to take to crack down on social media. In June 2014, the FDA released two draft guidelines for the pharmaceutical and medical device industries and how they should communicate about their products via the

Internet and social media.2 The first one stated that both the risks and benefits of a product need to be presented online, even with character restrictions (such as on Twitter).1 In the second set of guidelines, the agency provided an outline for how the manufacturers should go about correcting any inaccurate information about their products posted by third parties.1

Many pharmaceutical companies are having major issues with these new guidelines. Jeffery K. Francer, vice president and senior counsel with Pharmaceutical Research and Manufacturers of America argues,,1 “If the FDA is going to require the same type of fine print that you see in a magazine ad to be in a tweet, then the FDA is essentially taking that tool away from patients who may want to hear from companies as well as healthcare professionals.” Francer believes the guidelines clash with First Amendment rights.

Pharmaceutical companies are worried that the FDA would hold them responsible for

misleading information about their products posted by third parties that their company has no control over. Novartis, Eli Lilly, and Pfizer have all found issues with the guidelines and disagree with some of their aspects. Pfizer said that the FDA, “does not have any general authority to regulate what constitutes labeling or advertising.” 3 They argue that “firms are not responsible for and do not need to submit other pages within a third-party website that are independent of the page or pages that the firm controls.” 3 Novartis echoed Pfizer’s thoughts and stated that firms should only be “required to submit the pages surrounding their product promotion…if they had direct control or influence (e.g. authorship or editorial control) over the content appearing on the surrounding pages”.3 Even with all the criticism and disapproval surrounding the FDA’s social media guidelines, the agency will continue its monitoring to ensure that drug products are being marketed truthfully and are not being misrepresented.

References:

1. Sifferlin A. The FDA is Cracking Down on Big Pharma Social Media Time. http://time.com/2976537/the-fda-is-cracking-down-on-big-pharma-social-media/. Published 2014. Accessed November 14, 2014. 2. Pharma companies urge FDA to Alter Draft Social Media Rules. http://www.ihealthbeat.org/articles/2014/9/24/pharma-companies-urge-fda-to-alter-draft-social-media-rules. Published 2014. Accessed November 16, 2014. 3. Brennan Z. Anti social? Big Pharma balks at US FDA social media guidance. http://www.in-pharmatechnologist.com/Regulatory-Safety/Anti-social-Big-Pharma-balks-at-US-FDA-social-media-guidance. Published 2014. Accessed November 16, 2014.

5

Ebola Very Treatable Despite Media Frenzyby Irene Yang, P1The media portrays Ebola as a ravaging disease, causing epidemics as it barrels through communities and towns, leaving death in its wake. In reality, “Ebola can be an eminently treatable disease” with early and aggressive care, according to Amesh Adalja, senior associate at the Center for Health Security at the Univer-sity of Pittsburgh Medical Cen-ter. 1 In fact, eight of the nine people treated for Ebola in the United States have returned home safely to their families. 2

No treatment options have been officially approved by the FDA, but a variety of experi-mental drugs have shown to be effective in treating Ebola. On November 5th, the FDA unveiled a plan to test multiple drugs in order to expedite the process of finding a proven cure. 3 Although the FDA would not disclose the drugs being considered, it is very likely that the drugs used in the eight American Ebola survivors could be possi-ble candidates for treatment. Some of these drugs are experimental treatments for Eb-ola while others were developed for other indications, but data shows that they could be used off-label to fight Ebola as well. 3

The first two people in America to be diag-nosed with Ebola received the drug Brin-cidofovir. The experimental antiviral drug was initially developed by the biopharma-ceutical company Chimerix to treat life-threatening viruses like smallpox. After the Ebola outbreak, Chimerix ran in vitro tests that showed Brincidofovir to be ef-fective against Ebola. It was later approved by the FDA for emergency use on Thomas

Eric Duncan, the patient with the first case of Ebola diagnosed in the United States. 4

ZMapp, a drug developed by Mapp Bio-pharmaceutical Inc., has shown immense success in treating Ebola. A total of seven patients received the drug, with noticeably improved results. Ebola survivor Dr. Kent

Brantly, a U.S. medical missionary who contracted Ebola in July while working as a doctor in Liberia, did not receive the drug until he had been sick for nine days. But after an hour of receiving the medica-tion, his condition improved dramatically. One of his doctors described the change in patient status as “miraculous”. However, creating this drug is time-consuming and expensive, so scientists are currently look-ing for alternative ways to administer it. 4

A more accessible drug, lamivudine, was discovered to be effective in treating Eb-ola by Dr. Gorbee Logan in rural Liberia. After being inundated with Ebola pa-tients, Dr. Logan administered this HIV drug out of sheer desperation to fifteen patients. The thirteen who received the

drug in the first five days of illness survived, while the two patients who did not survive received the treat-ment between days five and eight. 5

In addition to treatments, scientists are also working diligently to create vaccines against Ebola. Ten potential

vaccines have been developed and two should enter mid- to late- state testing in December or January. 3

These many success-ful treatment options for Ebola show that diagnosis of the dis-ease is not the death sentence that the me-dia depicts it to be. With proper treatment and prevention, Ebola is completely contain-

able, especially in coun-tries like the United States, which boasts a health-care system that is ready to respond to such epidemics.

References

1 Szabo L. U.S. Ebola experience changes thinking about disease. USA Today. November 12, 2014: http://www.usatoday.com/story/news/nation/2014/ 11/11/american-ebola-surviv-al/18863723/ Accessed November 12, 2014

2 Nabarro D. Ebola is not a death sentence. CNN. November 11, 2014: http://www.cnn.com/2014/11/11/opinion/nabarro-ebola-response/ Accessed November 12, 2014

3 U.S. fast-tracks testing of Ebola treatments. CBSNews. November 5, 2014: http://www.cbsnews.com/news/u-s-officials-unveil-plan-to-test-ebola-drugs/ Accessed November 12, 2014

4 Christensen J. Ebola drugs are in the works. CNN. October 8, 2014: http://www.cnn.com/2014/10/06/health/ebola-drugs-in-the-works/ Accessed November 11, 2014

5 Cohen E. Doctor treats Ebola with HIV drug in Liberia—seem-ingly successfully. CNN Health. September 20, 2014: http://www.cnn.com/2014/09/27/health/ebola-hiv-drug/ Accessed November 11, 2014

Photo Credit: http://www.ibtimes.com/zmapp-ebola-treatment-what-know-about-exper mental-drug-made-tobac-co-1650870

Diet continued from page 2

diabetes, through dietary approaches.1

Scientists have been investigating the con-cept of personalized nutrition for decades. Today, supermarket shelves stock special formulations of food products geared to-wards particular populations. Examples include nutrition drinks for the elderly and soy-spiked oatmeal for menopausal wom-

en.4,5 Pricking a finger for a blood test or urinating in a cup to send a specimen to a lab may be the newest link in that chain.

References:

1. Genetic testing for personalized nutrition leads to better outcomes. November 2014 ; Available from: http://www.sciencedaily.com/releas-es/2014/11/141114181115.htm (Accessed November 2014 )2. Dietary Recommendations for Adults. January 2014 ; Available from: http://www.ccsmed.com/dietary-recommendations-for-adults.aspx (Ac-cessed November 2014 ).

3. El-Sohemy, A. Disclosure of Genetic Information and Change in Dietary Intake: A Randomized Controlled Trial. No-vember 2014 ; Available from: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0112665 (Accessed November 2014 ).4. Black, A. Good news for menopausal women: You can avoid hot flashes by changing your diet Learn more: http://www.naturalnews.com/019538_hot_flashes_womens_health.html#ixzz3JXWIa3F6. July 2006 ; Available from: http://www.naturalnews.com/019538_hot_flashes_womens_health.html (Ac-cessed January 2014 ).5Goodwin, K. The Scoop On Nutritional Energy Drinks: Ensure, Boost, Carnation Instant Breakfast & Resource. September 2006 ; Available from: http://www.thedietchannel.com/scoopon.htm

(Accessed November 2014 ).

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by Sonia Kumar, P2

MDMA-assisted Psychotherapy in Patients with PTSD

In the past few years, there has been an ini-tiative through the Multidisciplinary As-sociation for Psychedelic Studies (MAPS) to answer the question of whether or not MDMA-assisted psychotherapy has a place in the treatment of PTSD. So far there have been two phase II studies that evaluated this concept and five more studies that are cur-rently underway. These studies have been featured in such media as Oprah magazine, Dr. Phil, and most recently on CNN with Dr. Sanjay Gupta. Interest has been grow-ing in this topic because MDMA, also known as 3,4-methylenedioxymethamphet-amine, is best known to the public as the street drug ecstasy, a rainbow colored pill kids at concerts take to “feel the music” .

In reality, MDMA in its pure form is not the same as ecstasy, which may contain a mixture of a variety of drugs. MDMA has pharmacological effects including releas-ing serotonin, stimulating the 5HT2 recep-tor , and increasing levels of oxytocin, pro-lactin and cortisol. Oxytocin is a hormone that may be involved in building relation-ships, and it also influences how we per-ceive emotion. Oxytocin has been observed to reduce activation in the amygdala when exposed to fear-inducing stimuli. 1 These effects are why there has been a push to research MDMA in patients with PTSD.

Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder at its root. It is related to re-living past events and experiencing hyper-arousal and avoidance symptoms when these memories resurface. In the United States, the lifetime chance of getting PTSD is between 6% to10%That rate increases in veterans, for whom the rates are as high as 18%. PTSD is a chronic condition and a comorbidity to disability, suffering, drug abuse and suicide.1

The current FDA approved therapy for PTSD is selective serotonin reuptake inhibitors (SS-RIs). Even though SSRIs show significant benefits over placebo, there is still a need for research into new drug therapy. Psycho-therapy is also a mainstay of treatment. Psy-chotherapy treatment involves revisiting the traumatic experience, thus inducing the ab-normal fear response, and then extinguishing

it. Patients find this difficult to do since it is emotionally tolling (maybe switch to draining?) and difficult to tolerate. Since MDMA has the ability to temporarily “re-duce fear and increase interpersonal trust” without “inhibiting access to emotions” it could possibly be used effectively along-side psychotherapy (Mithoefer et al.).1

In the study performed by Mithoefer et al., MDMA-assisted psychotherapy was compared to placebo-assisted psy-chotherapy. There were 20 randomized subjects, and the study design was dou-ble blind (patient, therapist, and evalu-

ator of the patient were all blind). Their primary goal was to see a significant change in the patient’s Clinician Admin-istered PTSD Scale (CAPS) compared to the placebo group. There was also a secondary goal to see if there was a sig-nificant change in self-reported measures of PTSD through the Impact of Events Scale-Revised (IES-R) and the Symp-tom Checklist 90-Revised (SCL-90-R). Neuro-cognitive changes were also moni-tored. Treatment consisted of an all-day (8-10 hour) MDMA/placebo psychother-apy session followed by an overnight stay in the clinic. The patient would then be evaluated using the scales Patients also underwent 90 minute non-drug integra-tion sessions weekly. This process was repeated once more during the study.

The results showed that there was a clinically significant improvement in CAPS, IES-R and SCL-90-R scores in the MDMA group compared to the pla-cebo group. Three patients in the MDMA

group who were unable to work because of PTSD were able to return to work. Patients in the placebo group were allowed to try the MDMA therapy after the conclusion of the study. Seven of the eight placebo patients received the MDMA-assisted psychother-apy and saw a significant improvement in their scores. In total, 17 out of the 19 sub-jects who eventually underwent therapy with MDMA were no longer classified as having PTSD during the follow up period.1 A long term follow up study 3 and a half years later showed that 14 of the 19 subjects had no relapse. Additionally, none of the patients reported any negative effects from the treatment.5 There were several issues in the trial, including the blinding (almost all the patients and therapists were able to tell if they were or were not on MDMA, but the CAPS evaluators of the patients remained blind), the small sample size, and the follow up time of only two months. The patients who received the treatment experienced some adverse effects; however, these were minimal (jaw tightness, cold, nausea, diz-ziness, loss of appetite, impaired balance). Patients in the placebo group also expe-rienced some adverse effects, including anxiety, insomnia, headache, and fatigue.

Oehen et al. performed the other com-pleted MAPS sponsored study; they found that there was not a significant dif-ference between placebo and MDMA-assisted psychotherapy regarding the CAPS scale. They did find a clinical dif-ference regarding a self-reported Post-traumatic Diagnostic Scale. Again, the sample size was small - 12 patients - so it is difficult to say whether or not a type II error was made in this particular study. 2

Although there is a lot of interest surround-ing this therapy, it is extremely difficult for trials to be conducted due to the fact that MDMA is a Schedule I drug. Because of this there is a low incentive for research to be done in this area. MDMA also has the potential to be dangerous, but frankly so does every other drug. The treatment con-ducted in the trials was performed in an extremely controlled environment where MDMA was being used as an additive to

PTSD continued on page 7

Photo Credit:http://www.barendspsychology.com/wp-content/up-loads/2014/09/PTSDbrain1.jpg

7

Researchers at Robert Wood Johnson Med-ical School have developed a drug called niclosamide ethanolamine salt (NEN), which is shown to be effective for treat-ing type 2 diabetes in preclinical trials.Type 2 diabetes is a chronic metabolic disease, which results from an increased levels of glucose in the blood affecting over 25 million Americans. This chronic illness can lead to complications such as cardiovascular disease and kidney failure. Treatment focuses on decreasing glucose intake and pharmacotherapy that increases insulin release or the liver’s sensitivity to insulin, though drug effects may attenuate over time. According to Shengkan Jin, an associate professor in the Department of Pharmacology at Robert Wood Johnson Medical School (RWJMS), the main cause of diabetes is because of excess amounts of fats in the liver, muscle, and adipose cells in the body. High concentrations of lipids interfere with the cellular response to insulin, preventing cell glucose reab-sorption, and ultimately result in increased levels of glucose in the bloodstream. Dr. Jin believes that this newly discovered drug would target the cause of the disease rather than just controlling the symptoms.1

The mechanism of action of niclosamide ethanolamine salt (NEN) occurs through mitochondrial uncoupling. Mitochondria are where fat is burned and spread as heat throughout the body. When lipid levels drop in the cells, especially in the liver, the cells can activated in response to glucose. In an experiment done with mice that were fed with a high fat diet, NEN prevented the onset of type 2 diabetes and the progres-sion of disease, possibly even curing it.1

The drug improved glycemic control, in-creased energy expenditure, and lipid me-

tabolism, while also prevented and treated liver steatosis and insulin resistance.2

NEN is the salt form of a drug, niclosamide, which is already approved by the Food and Drug Administration (FDA) to be safe to treat parasitic infections in the intestines by the uncoupling of the mitochondria of para-sites.1 NEN was shown to be even safer than niclosamide because it has a short half life, poor water solubility, and most is bound to albumin in the plasma. In addition, while body temperature usually increases in the presence of mitochondrial uncouplers, this was not the case with the mice that were administered with NEN.1,2 Since it works differently than other drugs and dosing should be less frequent, NEN is expected to have a relatively low drug resistance.1

The results of the study detailing the events on mice were published in the Nature Medicine journal on October 5th. Cur-rently, toxicology studies are taking place2 for the drug, so its safety can be evaluated by the FDA before the FDA is able to ap-prove it for clinical trials. A company co-founded by Jin, Mito BioPharm, has the rights to the patent while Rutgers owns the patent.1 Considering the success shown in preclinical studies, this drug shows excel-lent prospects in the antidiabetic market and could be the next major success for Rutgers and patients with type 2 diabetes.

RWJ continued from page 1

References:

1. Pharmacist Provider Status Bill Introduced in Congress. Pharmacy Times. http://www.pharmacytimes.com/news/Pharmacist-Provider-Sta-tus-Bill-Introduced-in-Congress. Published March 17, 2014. Accessed November 16, 2014.2. Provider Status Bill Reaches 100 Co-Sponsors. Pharmacy Times. http://www.pharmacytimes.com/association-news/Provider-Status-Bill-Reaches-100-Co-Sponsors. Published September 9, 2014. Accessed November 16, 2014.3. Landmark Provider Status Bill Introduced in Congress. ASHP website http://www.ashpintersections.org/2014/03/landmark-provider-status-bill-introduced-in-congress/. Published March 12, 2014. Ac-cessed November 17, 2014.

This legislation will also enable a mechanism to pay for pharmacist provider services. Pharmacists will be able to earn a percentage of the current physician fee schedule or there will be a pharmacist specific code as part of the fee schedule.3 This will be especially beneficial to patients in medically underserved communities who have limited access to health care services.3 While earning the support of 100 co-sponsors is an impressive achievement, we must continue to work as a profession to be recognized for our abilities.

References

1.Zhang, W. Rutgers researchers develop medicine tackling type 2 diabetes. The Daily Targum Web site. http://www.dailytargum.com/article/2014/10/rutgers-researchers-develop-medicine-tackling-type-2-diabetes-58e0. Published October 19, 2014. Accessed November 17, 2014.2.Boyles, S. Tapeworm tx eases diabetes in mice. Medpage Today Web site. http://www.medpagetoday.com/Endocrinology/Diabetes/47941. Published October 5, 2014. Updated October 27, 2014. Accessed November 17, 2014.

Provider continued from page 3

psychotherapy. Additionally, both phase II trials found that there was no long lasting adverse effects associated with the therapy. Another difficulty in conducting PTSD trials is finding volunteers. A study of vet-erans found that many do not seek PTSD treatment because of three main reasons: lack of access to a clinic; not realizing they have PTSD; and lack of social support. 3 As with any mental health disorder, there is a stigma around PTSD which makes it dif-ficult for volunteers to come forward and seek treatment. This therapy will only have a chance to move forward when people are willing to support it. MAPS gains fund-ing through private donations, and they approximate that 2.5 million dollars and three more years will be needed to get them ready for their end of phase II meet-ing with the FDA. Beyond that, potentially 16 million dollars and five more years will be needed to complete a phase III trial.4

It will be a long and arduous process for MDMA-assisted psychotherapy to ever be part of a phase III trial, let alone clinical ther-apy. But the fact that big names like Oprah, Dr.Phil, and Sanjay Gupta have mentioned these studies means that we may be trend-ing towards a more open-minded approach to treating PTSD. Psychoactive drugs are still drugs, and although they have the po-tential for abuse it is still reasonable to re-search all their potential benefits, especially when they can possibly help people deal-ing with disorders as distressful as PTSD.

This article is sponsored by the College of Pyschiatric and Neurological Pharmacists

References1. Mithoefer MC, Wagner MT, Mithoefer AT, et al. The safety and ef-ficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psycho-therapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharma-col. 2011;25(4): 439-52.2. Oehen P, Traber R, Widmer V, et al. A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). J Psychopharmacol. 2013; 27(1): 40-52. 3. Office of Research & Development. (2014, April 24). Retrieved November 18, 2014, from http://www.research.va.gov/currents/spring2014/spring2014-25.cfm4. Mithoefer MC, Wagner MT, Mithoefer AT, et al. Durability of im-provement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymetham-phetamine-assisted psychotherapy: a prospective long-term follow-up

study. J Psychopharmacol. 2013; 27: 1 28-39.

PTSD continued from page 6

8

by Sekwon Park, P1In the past, the pharmacist’s role has been often limited to compounding and dispensing within a community pharmacy. However, nowadays the role of the pharmacist has become critical in inpatient and outpatient set-tings, as well as in fields where the clinical knowledge of pharmacists is readily applicable, such as in the research and business of pharmaceutical companies.

So if one tries to seek a job in the pharmaceutical company, what does he or she do at first? It is very important for students to recognize that many different departments exist in a pharmaceutical company, just like in any other company. Each of them requires candidates with different levels of academic degree. For example, Research & Development departments would favor those who hold PhDs in chemistry, biology, or any other relevant science, since the R&D department focuses more on scientific research rather than sales and marketing. On the contrary, having a PharmD degree satisfies the qualification to work entry level in most departments. Therefore, it is necessary for one to start to figure out what academic degree he or she will need to pursue in the future. Furthermore, it is essential for one to hone his or her communication skills in advance. The “cross-functional team atmosphere” is one of the characteristics of the workplace in pharma, in which conveying a message concisely and effectively is absolutely critical. In addition to communication skills, one needs to manage time effectively and meet strict deadlines.

Moreover, having summer internships, summer placements, or any other relevant activities or industry jobs as early as pos-sible would be beneficial for students. This is due to the fact that those experiences shape one into a more well-rounded person, ultimately enhancing social skills and extending networks. Also, each company has a different process of recruitment; thus, individuals should dedicate time to submit their resumes at each company in the designated time period. Applications for big pharmaceutical companies usually starts around Christmas, whereas relatively small companies get applications from candidates around Easter.

Rutgers pharmacy students have an advantage with an alternative route to get involved in the field of pharmaceutical industry the Rutgers Pharmaceutical Industry Fellowship program. This program started in 1984 and was specifically designed for indi-viduals with PharmDs to enhance their experiences and skills in Pharma. Due to its geographical location, Rutgers University is located where many big pharmaceutical companies are in New Jersey. Rutgers University has been able to offer this unique and excellent fellowship program to all pharmacy student candidates; therefore, many qualified pharmacy students across the nation annually come and seek a fellowship here. A vast majority of fellows consists of Rutgers students each year! During the fellowship program, students are expected to take leadership roles in teaching and conducting classes as well as partici-pating in various projects and extending networks. After completion of the program, in one year or two years, students will most likely get job offers from a company. Keep in mind that time, effort and correct information are key elements.

References:

1.Page, E. Getting Started in the pharmaceutical industry. Tomorrow’s Pharmacist. September 12, 2014. Avaialable from http://www.pharmaceutical-journal.com/publications/tomorrows-pharmacist/getting-started-in-the-pharmaceutical-industry/20066290.article. Accessed November 16, 2014

2.Rutgers: Institute for Pharmaceutical Industry Fellowships. Rutgers Pharmacy Fellows Website. Available from http://pharmafellows.rutgers.edu Accessed November 16, 2014

Inside IndustryExplore Career Paths in Pharma

Photo Credit: pharmfellows.rutgers.edu

Nontraditional Role of Pharmacist Rising in the Field of Pharmaceutical Industry

Wishing everyone good luck on finals and a great holiday season!

9

School NewsAn Interview with Drug Information Resident, Dr.

Indrani KarAs pharmacy students advance in school and begin to consider potential career paths, many may choose to explore non-traditional avenues. One particular career path that is often overlooked is the field of drug information, also known as DI. Although it doesn’t receive nearly as much recognition as tra-ditional pharmacy careers, DI is a field in which the specialized knowledge and skills of PharmD’s are essential. Dr. Indrani Kar is a current resident in the Robert Wood Johnson Drug Information residency program. She also assists teaching the P2 Drug Information and Literature Evaluation Class. Here, she has agreed to clarify questions students may have about DI and discuss her experiences in the residency program.

1.Tell us about your background. Which pharmacy school did you graduate from? Why did you choose pharmacy? a.I graduated from the University of Pittsburgh School of Phar-macy in Pittsburgh, PA. Go Pitt Panthers! I chose pharmacy be-cause of the impact pharmacists have on patients’ lives. I have seen this first hand with many family members and myself.

2.How did you know that you were interested in drug infor-mation? What prompted you to ultimately pursue a drug information residency?a.I became interested in drug information during pharmacy school rotations, when I saw the policy recommendations I was making, based on evidence in the literature, were directly affecting patient care. I pursued a residency and fellowship to gain additional skills to prepare for my career.

3.What is Drug Information and what does it entail? a.Good question! Drug Information is the assessment of evi-

dence-based literature to make recommendations for questions, policy, and formulary management. It usually entails working on many projects, serving on the Pharmacy & Therapeutics committee, and teaching pharmacists.

4.What are some of your responsibilities as a resident? What are some of the responsibilities of pharmacists who work in Drug Information? a.As a resident, I assist with running the Drug Information Cen-ter, teach and precept students, participate in the Pharmacy & Therapeutics Committee, evaluate literature for policy develop-ment, and complete research projects.

5.What are the necessary skill sets pharmacists need in order to work in this field? a.A desire to learn, time management, and writing skills.

6.What are the settings in which pharmacists trained in Drug Information would practice? a.Everywhere! Hospitals, medical writing/communication firms, industry, academia, etc.

7.Do you have any advice for students interested in pursuing a career in Drug Information? Or any advice for pharmacy students in general? a.General advice – Take advantage of speaking to your profes-sors and upperclassman. Learn as much as you can about the different areas of pharmacy through networking and organiza-tion involvement, so you can identify the niche you love. These connections both locally and nationally will open up many opportunities. Be involved in your learning!

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Staff Writers-Prianka Das, Sonia Kumar, Brittany Yalamanchili, Sara Se, Aamer Attaar, Jenny Shah, Sekweon Park

Disclaimer: The opinions expressed in EMSOP CHRONICLES do not reflect the views of the Pharmacy Gov-erning Council (PGC) or Ernest Mario School of Pharmacy (EMSOP).

For questions, comments, and information on how to get involved, e-mail emsopchronicles@gmail.com

by Smita Jaggernauth, P2

Pharmacy Organization and Events on Campus