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ERNEST MARIO SCHOOL OF PHARMACY VOL.2 ISSUE 2 OCTOBER 29, 2012

EMSOP

CHRONICLES x brought to you by the Pharmacy Governing Council

Issues in Non-Adherence: Unfilled Childrens’ Prescriptions

by Smita Jaggernauth, PP2

Pharmacists and their patients alike know that patients don’t always follow their prescribed drug regimens. A new study shows that this issue may be more common than ever before, particularly with regard to children’s prescriptions. The study, which was published in the journal Pediatrics, examined 4,883 children who were being treated at the Lurie Children’s Hospital of Chicago and receiving assistance through Medicaid. The study found that 22 percent of the 17,000 prescriptions issued during the two-year span of the study went unfilled. Researchers also discovered that different types of medications yielded different adherence rates. While antibiotics had a 91 percent fill rate, dietary supplements were filled only 65 percent of the time. What causes this non-adherence? According to Dr. Rachel Zweigoron, lead researcher of the study, parents often feel a more urgent need to fill prescriptions for

Table of Contents

short-term illnesses like infections, as compared to vitamin and mineral prescriptions, which may not seem to be as pressing. This tendency may have been a factor lowering the overall fill rate. Another explanation offered within the study was convenience. Electronic prescriptions, which were digitally sent to pharmacies, were 50 percent more likely to be filled than traditional ones. The study concluded that more research would be needed in order to give more definitive answers to explain this trend. What is clear, though, is that physicians and pharmacists alike must increase medication adherence advocacy. Parents are not always aware of the importance of filling prescriptions, but consistent adherence to medication is neccessary to ensure the best possible treatment of the child. References: Norton, Amy. “Kids’ prescriptions often going unfilled.” 25 September 2012. <http://news.yahoo.com/kids-prescriptions-often-goingunfilled-153713768.html>

References:

Health Topics.................................2 OTC Ads De-Emphasize Harm......3 A Guide to the ACA ......................4 School News..................................7 An IPPE Hospital Report..............8 Book Review..................................9

“Off-label promotion of divalproex leads to $700 million fine.” Drug Topics. 5 October 2012. http://drugtopics.modernmedicine.com/drugtopics/The+Latest/Off-label-promotion-of-divalproex-leads-to-700-mil/ ArticleStandard/Article/detail/791567?contextCategoryId=49628 fda.gov [homepage on the Internet.] Silver Spring, MD: US Food and Drug Administration. [Updated 2011 Nov 22; cited October 2012] Office of Criminal Investigations, Duties and Functions. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm136613.htm Abbott Laboratories. Depakote® package insert. Chicago, IL;2009, Nov.

Abbott Fined $700 M for Divaloprolex Misbranding by Jin Ah Jong, P3 On October 2nd, 2012, Abbott Laboratories Inc. was sentenced to a $700 million fine for misbranding one of its drugs, divalproex (Depakote®). In what was a violation of the Federal Food, Drug, and Cosmetic Act (FDCA), Abbott Laboratories Inc. promoted off-label indications of Depakote, which included the treatment of schizophrenia and the control of behavioral disturbances in patients with dementia. The drug is only FDA-approved for the treatment of epilepsy, prophylaxis of migraines, and treatment of manic episodes associated with bipolar disorder. According to a U.S. Department of Justice press release, Abbott Laboratories Inc. promoted the drug for off-label indications as early as 1998 up to 2006. The company admitted to training employees to market its off-label uses to control agitation and aggression in elderly patients with dementia residing in nursing homes. Abbott Laboratories will be placed into a five-year probation. U.S. Attorney for the Western District of Virginia, Timothy Heaphy, spoke of the pharmaceutical company’s settlement: “Abbott unlawfully targeted a vulnerable population, the elderly, through its off-label promotion. The court’s sentence makes clear that those who engage in such conduct will be prosecuted and held accountable.”


Popular Antibiotics May Carry Serious Side Effects by Yixin Lin, PP2 Sick? Take an antibiotic. Actually, think again. Before patients take anything, they should think carefully since this simple remedy can produce serious side effects. Levofloxacin (Levaquin®), which belongs to an important class of antibiotics known as fluoroquinolones, was the best-selling antibiotic in the United States in 2010, but was subjected to more than 2,000 lawsuits by 2011 from patients who had suffered severe reactions after taking it. Dr. Mahyar Etminan, a pharmacological epidemiologist at the University of British Columbia, showed in a study in The Journal of the American Medical Association that users of fluoroquinolones had five times the risk of suffering a potentially blinding retinal detachment than nonusers. In another study submitted for publication, he also showed that users also had a significantly increased risk of acute kidney failure. These severe reactions are in addition to the “black box” warning of tendinitis and tendon rupture and the recently added warning of the potential for neuromuscular blockade. Lloyd Balch, a 33-year-old patient who took fluoroquinolone, showed symptoms of being unable to walk uphill or climb stairs; vision problems and dry eyes, mouth and skin; ringing in his ears; delayed urination; uncontrollable shaking; burning pain in his eyes and feet; occasional tingling in his hands and feet; heart palpitations; and muscle spasms in his back and around his eyes. While Balch’s is a rare case, some of his side effects are indeed reported by others. If this antibiotic is so horrible, why do patients take it? Many patients are not alerted to the risks of taking the drug by their doctors. The real root of the problem, however, is that fluoroquinolones are often inappropriately prescribed for ailments that can be treated with less potent drugs or nondrug remedies, instead of being used against serious life-threatening bacterial infections. According to the Centers for Disease Control and Prevention, fluoroquinolones are wrongfully being prescribed as “one

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2012 West Nile Virus Outbreak

by Jazmin Turner, P2

With 3,969 cases and 163 deaths reported so far, the 2012 outbreak of West Nile Virus will likely be one of the worst in U.S. history, according to the U.S. Centers for Disease Control and Prevention (CDC). Infections in humans, birds, and mosquitos have been reported in all 48 of the contiguous states, with 70% of those cases in Texas, California, Louisiana, Mississippi, South Dakota, Michigan, Oklahoma, and Illinois. A third of the total cases were reported in Texas alone. Rates of West Nile virus infection were on the decline since 2003 until this year.

size fits all.” As put by Dr. Etminan, these drugs are overused “by lazy doctors who are trying to kill a fly with an automatic weapon.” What is a patient to do? When an antibiotic is prescribed, they should get all of the facts by asking what the drug is and whether it is necessary, what side effects to be on alert for, whether there are effective alternatives, when to expect the diagnosed condition to resolve, and when to call their doctor if they aren’t feeling better in a certain time frame or if they are feeling worse from adverse effects. Pharmacists can help in this education by highlighting what patients may expect from the medications and what to do if they experience any side effects. Reference: Brody, Jane E. “Popular Antibiotics May Cause Serious Side Effects.” The New York Times. 10 September 2012. <http://well.blogs. nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-sideeffects/?ref=health> Photo credits: http://img.nobledrugstore.com/upload/Levaquin.jpg https://healthy.kaiserpermanente.org/static/drugency/images/ MCN15251.JPG http://www.freepharmacy.biz/media/catalog/product/cache/51/small_im age/170x170/9df78eab33525d08d6e5fb8d2713 http://lifespanmeds.com/img/Levaquin.jpg 6e95/g/e/generic_levaquin_levofloxacin_250mg.jpg

About 80% of people infected with the virus will not have any symptoms, and 20% will develop mild symptoms such as fever, vomiting, headache, and rash. One in 150 will develop symptoms of neuroinvasive illness, such as high fever, vision impairment, neck stiffness, convulsions, coma, and even death. Fifty-one percent of this year’s reported cases have been neuroinvasive, leading to meningitis and encephalitis. It is estimated that only 2% to 3% of all non-neuroinvasive West Nile are diagnosed and reported to the CDC. The CDC released a statement saying that it would be nearly impossible to make any long range predictions regarding West Nile virus outbreaks; prior to this year, experts questioned whether the virus would remain a public health concern. The unpredictable outbreaks also make it difficult to conduct substantial research in clinical trials with enough statistical power, so there is no vaccine or treatment available. The best way to stay protected against the virus is to stay indoors during dusk and dawn when mosquito activity is at its peak, avoid standing water where mosquitoes breed, and wear long-sleeved shirts and insect repellent with DEET when outside. References: LeBlond, Lawrence. “2012 One Of The Worst Years For West Nile Virus In US History.” 5 October 2012. <http://www.redorbit.com/news/ health/1112707640/west-nile-virus-2012-100512/> Weiss, Daniel. “West Nile Virus Outbreak Worst in Years.” Pharmacy Times. 4 September 2012. <http://www.pharmacytimes.com/news/ West-Nile-Virus-Outbreak-Worst-in-Years>


Direct-to-Consumer (DTC) Ads De-Emphasize Harm to Patients by Lauren Sparrazza, P3 Once medications are approved to be sold over-the-counter (OTC), they are often advertised to the consumer as harm-free pills. A study that was published in the September 12, 2012 Journal of the American Medical Association described such findings in their investigation of direct-toconsumer (DTC) advertisements before and after the OTC-switch of four widely used medications: loratadine (Claritin®), cetirizine (Zyrtec®), omeprazole (Prilosec®), and orlistat (Alli®). The research team analyzed all print and TV ads for these medications for the 24 months before the drug went OTC and the six months after the drug shifted from prescription to OTC. Loratadine was made available OTC in 2002, omeprazole in 2004, orlistat in 2007, and cetirizine in 2008. Their associated ads were analyzed based on descriptive characteristics, presentation of health benefits, and potential health harm. The research showed that 70% of the ads that ran when the medications were available only by prescription presented potential harms, whereas only 11% of the ads that ran after the switch to OTC presented this information. 94% of the ads for the prescriptions products mentioned the generic name, compared to 52% of ads when the medications went OTC. If the pharmaceutical company does not mention the generic name of the drug, consumers cannot seek information on the risks, benefits, and costs of the medication as easily or effectively. The main explanation for the different advertising is different regulations: prescription drug advertising is regulated by the FDA and OTC drug advertising is regulated by the Federal Trade Commission (FTC). The FDA mandates a “fair balance” of risks and benefits, but the FTC only checks to make sure that ads are not misleading to a “reasonable consumer.” The FTC does not consider that not all consumers are equally knowledgeable. Consequently, many patients assume that

if a medication is available OTC, then it must be safe. However, there are serveral examples of hazardous OTC medications. Acetaminophen is a major cause of emergency room visits and liver failure. Another example is ibuprofen, which causes gastrointestinal bleeding and has been associated with an increased risk of heart disease. A solution to this issue suggested by Jeremy Green, MD, PhD, of Brigham and Women’s Hospital in Boston, is to have the FDA continue to oversee advertising

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of prescription medications once they become available OTC or to have the FTC apply different standards to OTC drug advertising. As things stand, pharmacists have a critical role to complete due diligence and educate patients on OTC drugs each and every day in order to keep patients safe. Reference: Weiss, Daniel. “After OTC Shift, Ads Deemphasize Drug Harms.” Pharmacy Times. 18 September 2012. <http://www.pharmacytimes. com/news/After-OTC-Shift-Ads-Deemphasize-Drug-Harms>

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The Affordable Care Act: A Guide for Students

What is the Insurance “Exchange?” by Ashley Brower, P3 Before the Affordable Care Act (ACA), individuals and smaller companies were often subjected to higher insurance costs because there was no bargaining power. One aim of the ACA is to create a competitive insurance market called the “Exchange.” It will require insurance companies to provide a comprehensive summary of pricing, quality, and physician and hospital networks to the public. This forum of insurance shopping could save individuals 7-10% on insurance premiums. Each state will offer an “Exchange” that will offer quality health plans, facilitate comparison, inform patients of their eligibility, and facilitate enrollment. In order to be offered by the “Exchange,” insurance plans must meet certain criteria of “quality health plans” which will be specified by the state. In a more transparent process, patients will need to fill out a simple application to determine their eligibility. Then the states will offer services and education to help individuals and businesses determine an appropriate plan. By creating awareness of the options in a transparent, competitive market, the hope is that patients will pay a fair price for their insurance. References: http://www.healthcare.gov/news/factsheets/2011/07/ exchanges07112011a.html http://cciio.cms.gov/programs/exchanges/index.html

What the ACA Means for Young Adults by Daniel Dipsia, PP2 The Affordable Care Act, otherwise known as “Obamacare,” has been the topic of discussion between the presidential candidates, pharmacists, and the general public. For young adults between the ages of 18-25, many are unaware about what is in the law itself other than what the media has described (and possibly misconstrued). It is essential that young adults in this age group be informed of how their healthcare will change come 2014, for those changes. Coverage Under Parents’ Plan In the past, insurance companies had the power to remove children from family plans the moment they reached nineteen years of age (sometimes at an older age if the child was a full time student). Now, families will be able to add or keep their children on their policies until their children turn twenty-six years old. This extension in age limit helps young adults to retain coverage even after graduation; for those who are unable to become employed and get their own health insurance, this is especially crucial. Even if young adults are married, not living at home, financially independent, or eligible for their employer’s plan (unless grandfathered in as an existing plan), they will not be taken off the family policy. For many people here at Rutgers, this continuation of coverage can help save the $373 health insurance premium that is added each semester to term bills. In addition, students also avoid the stress of shopping around for health insurance, and handling the paperwork that takes time and energy away from studying.

“One of the goals of this law was to raise the number of insured adults between the ages of 18-25 after providing easier, affordable, and understandable provisions for gaining health coverage.” 4

New Plan Requirements There are a few new requirements for insurance companies (not grandfathered in) to cover certain preventative services. These “preventive services,” will be guaranteed full coverage without a copayment, co-insurance, or meeting a deductible requirement. Some preventive services include alcohol misuse screening and counseling, blood pressure and cholesterol screening, depression screening, type 2 diabetes screening, and immunizations. With these services assured coverage, it is easier for students to seek the care they need at almost any medical office that takes their insurance, without paying more out-ofpocket. Once these requirements are added to the insurance policy, the new policy can be added or bought by the young adults during a 30-day period starting September 23rd of each year. By the Numbers Today One of the goals of this law was to raise the number of insured adults between the ages of 18-25 after providing easier, affordable, and understandable provisions for gaining health coverage. So far, the new law does seem to be helping because as of December 2011, over 3.1 million young adults have gained health insurance coverage with the provisions of the Affordable Care Act. As a result, those working or going to school can feel more secure that their health costs will not affect their ability to continue their education or afford their necessities. References: http://www.healthcare.gov/law/features/choices/young-adult-coverage/ index.html http://www.healthcare.gov/law/features/rights/preventive-care/index. html http://www.healthcare.gov/news/factsheets/2011/08/young-adults.html http://www.healthcare.gov/news/factsheets/2012/06/youngadults06192012a.html http://cciio.cms.gov/resources/files/adult_child_faq.html


The ACA and Hospital Pharmacy by Yingzhi G. Zhang, P2 The Affordable Care Act (ACA), to be fully implemented in 2014, brings with it several changes that will broadly affect the practice of pharmacy across the United States. Programs like Medication Therapy Management – already a required portion of Medicare Part D under the Medicare Modernization Act of 2003 – will become more consistent under the ACA and will require pharmacist involvement to help achieve better medication outcomes and optimal therapy in the community. The plan will be supportive of pharmacist involvement in a hospital setting as well, continuing

Hospitals will also start to face penalties under the ACA if they show higher than average readmissions rates from heart failure or pneumonia. A large number of readmissions occur because of patient nonadherence or adverse drug interactions – particularly in instances where pre-existing medications may have been changed to follow the hospital formulary, or where new medications are implemented during the patient’s stay. In fact, study results have shown that 76 percent of Medicare readmissions in 2007 were preventable, suggesting that about $15 billion in readmissions costs were potentially avoidable. This is another area where pharmacists can

“Study results have shown that 76 percent of Medicare readmissions in 2007 were preventable, suggesting that about $15 billion in readmissions costs were potentially avoidable [...] an area where pharmacists can provide better outcomes.” the trend toward stronger clinical roles for pharmacists. One way that the ACA will help pharmacists become more directly involved in clinical patient care is simply by limiting reimbursement, shifting medical care toward quality rather than quantity. In 2007, the Centers for Medicare and Medicaid Services stopped reimbursement for certain hospital-acquired conditions (HACs), including conditions resulting from blood clots, death or injury from medication errors, and certain types of infection. The ACA plans to tighten these strictures by decreasing payments to hospitals with the worst performance on HACs. These are areas where pharmacists have a proven track record for better patient outcomes. A 2004 study of more than 700,000 Medicare patients on anticoagulation therapy showed that hospitals without pharmacist-provided heparin management had 11.4 percent higher death rates, 10 percent longer length-of-stay, 6.6 percent higher Medicare charges, 3 percent higher bleeding complications, and 5.4 percent higher tranfusion rates required. The research found similar results with warfarin and discovered that out of hospitals surveyed, only about 37 percent routinely utilized pharmacists to manage anticoagulation. Thus, there is a great deal of room to increase pharmacist involvement; not only will patients benefit from better healthcare, but hospitals stand to reduce costs and increase reimbursement as well.

provide better outcomes. Having pharmacists involved with patient transitions – including medication reconciliation upon admission, medication therapy review and counseling upon discharge, and follow-up and collaboration with the patient’s community pharmacist – can greatly improve adherence and reduce readmissions due to non-adherence or medication errors. With the increasing complexity of modern medication therapy, more and more hospitals are discovering the benefit of having pharmacists on staff as the experts on medication. The ACA’s focus on improving the quality of medical care and reducing the cost of hospitalization will ultimately help drive the pharmacist’s role as a key member of the clinical team, and provide better results for hospital patients. References: Aston, Geri. These Days, They’re Indispensible: Pharmacists Step Up. Hospitals and Health Networks [homepage on the Internet]. Chicago: Health Forum, Inc.; c2012 [updated Feb 2011; cited Sep 2012]. Available from: http://www.hhnmag.com/hhnmag/jsp/articledisplay. jsp?dcrpath=HHNMAG/Article/data/02FEB2011/0211HHN_FEA_ clinical&domain=HHNMAG American Pharmacists Association. [homepage on the internet]. Washington, DC: APhA; c2012 [Updated Sep 2012; cited Sep 2012]. Healthcare Reform – the Affordable Care Act [about 7 screens]. Available from: http://www.pharmacist.com/health-care-reform-affordable-care-act American Pharmacists Association. Improving Care Transitions: Optimizing Medication Reconciliation, March 2012. Washington, DC: 2012. Available from: http://www.pharmacist.com/sites/default/files/files/2012_improving_care_transit

Pre-Existing Conditions and the ACA by Ashley Brower, P3 One population that has already seen a tangible benefit from the Affordable Care Act are patients who were unable to get insurance coverage because of a pre-existing disease. As a result of the Affordable Care Act, if a patient has been denied coverage and been uninsured for 6 months, they now qualify for The PreExisting Condition Insurance Plan (PCIP). All 50 states offer coverage, but depending on the state that the patient resides in, the state or federal government program will manage their care. The New Jersey PCIP is a state-run program and the details are below. PCIP program requirements, plans, premiums, and eligibility vary by state. PCIPs cover all aspects of healthcare including primary care, specialty care, hospital stay, and prescriptions. 5 billion dollars of federal funds has been allocated to fund the PCIP programs. The PCIP program is currently running until 2014 when the competitive “exchange” will open. In 2014, PCIP programs will close because the competitive insurance “exchange” will open and the provision of the ACA that prohibits discrimination based on pre-existing condition.

New Jersey Specifics: Premium: $245 to $947 per month Deductible: $2,500 for Plan C 80/70 (Horizon BCBSNJ); $0 for Plan C 100/70 (Horizon BCBSNJ); $2,500 for Plan C 90/70 (AmeriHealth) Out of pocket limit: $5,000 for all plans References: http://www.healthcare.gov/law/features/choices/pre-existing-conditioninsurance-plan/nj.html http://www.healthcare.gov/law/features/choices/pre-existing-conditioninsurance-plan/index.html http://cciio.cms.gov/programs/pcip/index.html

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The Affordable Care Act: What Does It Mean For Women? by Jennifer Kim, P2 Through the years, women have commonly paid more for their healthcare than men. This difference in healthcare costs is due to factors such as biased preexisting conditions restrictions, differences in premium costs, and the cost of oral contraceptives and other preventative measures. Many of these factors have been eliminated with the implementation of specific statutes of the 2010 Affordable Care Act (ACA) this past August. Before the ACA was passed, it was difficult for women to find healthcare coverage and maintain coverage that was all-encompassing. Pre-existing conditions restrictions such as pregnancy or even domestic abuse were in place, which could have made a woman ineligible for insurance. For many women who have “non-grandfathered” insurance – that is insurance purchased after March 23, 2010, the preexisting conditions restrictions have been removed. In addition, there used to be annual limits on how much an insurance plan would spend on a woman’s care. These restrictions have now been lifted1. Another difficulty women have faced is the “gender gap2” -- women have consistently paid more for premiums for about the same coverage as men. Due to a practice known as “gender rating3” in several states, there is a disparity in what women are being charged solely based on their gender. In reality, research has shown that

“As these services are now co-pay free, this helps offset higher premium rates and allows about forty-seven million women to take care, and to take control of their health care.” for preventative services, for both females and males, may lead to an overall decrease in premium charges, as well as an increase in overall health.5 In August, free basic preventative services for women were added to health plan coverage under the ACA. For example, the coverage of contraceptives has been implemented as a preventative service, except in religious institutions that choose not to do so, and women no longer have to pay a co-pay.6 Previously, oral contraception had never been considered a preventative service, and women had to pay out-of-pocket for its usage. According to the U.S. Department of Health and Human Services, this addition to total benefits will not increase the cost of premiums.7 Provision of contraception has been shown to offset costs due to unintended pregnancy, prenatal care, and childbirth.7 In addition to contraception coverage, women can get a variety of services that can be potentially life-saving. “Well woman visits,” screening and counseling for interpersonal and domestic violence, breastfeeding support, and Human Papillomavirus (HPV) DNA testing1 are a few of the seven supplemental services that are included in the Affordable Care

“Due to a practice known as ‘gender rating’ in several states, there is a disparity for what women are being charged solely based on their gender.” females make more physician visits, get more regular check-ups, and take more medications than males. This can be attributed to reasons such as greater rates of certain illnesses in females4 or due to pregnancy and childbirth. One may think that the extra costs for medical services should be enforced on women to offset their more frequent utilization of health care. However, evidence shows that coverage

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is a huge step for women, and not only is an example of a new path for equality in health care, but in government as a whole. For additional information on the required health plan coverage guidelines for women’s preventative services, visit the U.S. Department of Health and Human Services: Health Resources and Services Administration website at: www.hrsa.gov/ womensguidelines/. References: 1)United States. U.S. Department of Health and Human Services. Women and the Affordable Care Act – Fact Sheets. Washington D.C., 2011. <http://www.healthcare.gov/news/ factsheets/2011/08/women.html>. 2)Pear, Robert. “Gender Gap Persists in Cost of Health Insurance.” The New York Times. 19 March 2012. <http://www.nytimes. com/2012/03/19/health/policy/women-still-pay-more-for-healthinsurance-data-shows.html?_r=0> 3)Andrews, Michelle. “Health Insurance Prices For Women Set To Drop.” Shots , NPR’s Health Blog. National Public Radio. 17 July 2012. <http://www.npr.org/blogs/health/2012/07/17/156895577/ leveling-the-playing-field-for-women-s-premiums>. 4)Kliff, Sarah. “The Cost of Being a Woman.” Newsweek. 18 October 2009. <http://www.thedailybeast.com/newsweek/2009/10/18/the-costof-being-a-woman.html> 5)Cadena, Christine. “Preventative Care: The New Strategy in Offsetting the Increase in Health Insurance Premiums.” Yahoo! Voices. 24 Oct 2007. Web. <http://voices.yahoo.com/preventative-carestrategy-offsetting-the-611601.html>. 6)United States. White House. Health Reform for American Women, The Affordable Care Act Gives Women Greater Control Over Their Own Health Care. Washington D.C., 2012. <http://www.whitehouse. gov/files/documents/health_reform_for_women.pdf>. 7)Ranji, Usha and Ranji Salganicoff. “Insurance Coverage of Contraceptives.” Health Reform Source. The Henry J. Kaiser Family Foundation. 21 Feb 2012. <http://healthreform.kff.org/notes-onhealth-insurance-and-reform/2012/february/insurance-coverage-ofcontraceptives.asp&xgt;. 8)Jarrett, Valerie. “Affordable Care Becomes a Reality for Women and Families.” Huff Post Politics: The Blog. The Huffington Post. 1 Aug 2012. <http://www.huffingtonpost.com/valerie-jarrett/womens-healthcare_b_1729303.html>.

Act. As these services are now co-pay free, this helps offset higher premium rates and allows about forty-seven million women8 to take care, and to take control of their health care. For too long, women have been penalized based on gender differences, and now some of those penalties have been removed or ameliorated. The Affordable Care Act

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School News

EMSOP News and Pharmacy Events on Campus

SNPhA Expands its Horizon of Service on Children’s Health and Safety Day 2012 several workshops held that day focused on

by Vivian Wu, P1

Putting aside the customary health fairs, student clinics, and social soirees hosted by SNPhA, the organization took on a new endeavor this past summer to further extend their hand of service to the public community. On June 16, 2012, SNPhA volunteered for Children’s Health and Safety Day at BAPS Charities in Clifton, New Jersey. Being the first of its kind, this charity event attracted a great number of people, amounting to about 300. There were several pharmacy students representing SNPhA among the prominent crowd of diverse healthcare professionals and specialists including pharmacists, dentists, optometrists, specialty therapists, nurses, EMT, and more. Throughout the day, educational lectures emphasized awareness of mental health, child development, and sun safety to children and parents alike. The

maintaining an active lifestyle called the “Let’s Move! Activity,” providing tours of the local fire truck and ambulance, and explaining corresponding safety rules. The event also hosted a conjoining Health and Safety Fair, which consisted of informative and enjoyable booths run by numerous participants, including members of SNPhA. Using their acquired knowledge, these student pharmacists educated children on important topics such as physical therapy, healthy food choices, first aid, poison prevention, nutrition, and hand hygiene among others, while making it entertaining and interactive for the children. At the closing of the event, there were many raffled Build-a Bears, gift baskets, hygienic products, first aid kits, and vitamins awarded to the children who participated. Children’s Health and Safety Day at BAPS

Charities turned out to be a great success, both in number and in quality of the education that the children received. There has already been expressed praise and gratitude from the attendees of this charity event that it was indeed educational, enlightening, and, most importantly, necessary to be hosted every year. SNPhA played a key role alongside the many other healthcare professionals in this event’s success and offered their insight on motivating change in the lifestyles of the children and parents. SNPhA’s contribution to educating these children at a young age truly makes a difference in their lives concerning their well-being and safety.

Pharmacy and Therapeutics: A Doorway to New Sides of Pharmacy

by Jonathan Rosen, P3

This past April, Ernest Mario School of Pharmacy (EMSOP) sent a team to San Francisco to compete in the 2012 Academy of Managed Pharmacy/Foundation for Managed Care Pharmacy (AMCP/ FMCP) Pharmacy and Therapeutics (P&T) competition. While the group was there, they made history for the pharmacy school. The team not only placed first in the competition, but they were also the first team from EMSOP to be placed among the top three teams in the nation. Armed with knowledge about the topic of the year (Pradaxa®, an anticoagulant), the team of Delong Cen, Lisa Chen, Patrick Liu, and Jonathan Rosen presented their formulary decision to three judges and then defended their decision during the ensuing Q&A session. However, the presentation that these students made was only a small part of an arduous journey that lasted over months.

The journey initially began in October of 2011, when AMCP released the drug topic for the competition, Pradaxa®. Once the topic was announced, twenty-one teams from EMSOP began an undertaking to become part of the competition. They were asked to determine if Pradaxa® should be included in a mock formulary provided by AMCP. To determine if Pradaxa® was truly safe, effective, and cost-effective for a managed care formulary, the groups were required to read the provided dossier – a document that the manufacturer submits to the FDA with clinical and economic data, as well as research external sources for things the manufacturer missed – unintentionally or not.

The teams set out – some more overwhelmed than others – in the attempt to learn everything there was to know about Pradaxa®. The P2s, who had forgotten material from pharmacy economics, found that they had to learn it all again, and the P1s, who had never seen a clinical trial in

their life, were forced to analyze one. Aiding the troubled students were Dr. Saira Jan, faculty advisor to AMCP, and Xiao Zhang, the coordinator for the project. The two set up classes to help the students learn how to properly analyze pharmacoeconomic and clinical data. These classes were held throughout the fall semester and were generously taught by the esteemed Rutgers faculty. Before long, winter break had also passed, and all the competition material was submitted to faculty judges for evaluation. The judges evaluated the drug monographs and four essays of each team and selected the top four teams. These four teams now had to compete at a local competition where one team would be selected to go on to San Francisco for nationals. On the day of the local competition, the teams already had been up for hours practicing. Their goal was to be able to

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The Student Voice Opinions and Commentary

Saint Barnabas Behavioral Health: Psychiatry in the Modern Era by Neil Foglio, P3 While most students either requested or were assigned a traditional IPPE 2 rotation this past summer, my first choice site was far from the norm. Saint Barnabas Behavior Health (SBBH), located in Toms River, NJ, is a 100-bed short-term facility which provides inpatient hospitalization and outpatient programs for adults diagnosed with psychiatric disorders. Throughout my time at SBBH, I witnessed the strategies and outcomes of both pharmacological and behavioral therapy firsthand with encouragement from a team of helpful and enthusiastic healthcare professionals. Psychiatric illness can affect anyone at any age at any time. The most common psychiatric admissions at SBBH were for major depression, dementia, mixed bipolar disorders, and drug abuse. Most referrals to SBBH follow an evaluation by PESS, the Psychiatric Emergency Screening Services program, which operates out of major area medical centers and emergency rooms. Patients must be medically cleared for admission to the behavior hospital, and if any extensive medical care beyond oral antibiotics for uncomplicated infections is required, the patient is transferred to Community or Kimball Medical Center (Toms River, NJ, Lakewood, NJ, respectively) for further treatment. For this reason, SBBH does not compound intravenous bags or other sterile pharmaceutical products on-site. The average census of the hospital is 85, and the patient population is diverse both in demographics and clinical presentation of psychiatric illness. After a week of familiarization with the pharmacy work-flow and the responsibilities of the pharmacist and pharmacy technicians, I was given an opportunity to go on rounds and perform workups on newly admitted patients with the psychiatrist and treatment team which consisted of a psychiatrist with primary prescribing authority, a licensed social

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worker (LSW), an adjunct therapist, and a registered nurse. Every patient is guaranteed to see a psychiatrist once a day and have a treatment team meeting every week. In the initial treatment team meeting, the patient is questioned about his reason for admission, goals for treatment, social/family life, any stressors or barriers the patient has, and the patient’s plans upon discharge. A mini-mental status examination is performed, in which the patient is asked to give the date, tell us where he currently is, and tell us about himself. Short term and long term memory is also assessed, as is his ability to perform ADLs – activities of daily life – which include bathing, eating, etc.

The site’s LSWs and mental health associates conduct group psychotherapy sessions daily, in which patients are taught coping skills for stress, diversion methods to violence, and ways to prevent relapse and substance abuse. Active positive participation in groups, in addition to adherence to medications, is usually a sign of marked improvement. For a patient to be discharged, he must demonstrate marked improvement of his psychosis, not pose a danger to himself or others, and have confirmed housing, either with family or in group residential facilities. Those patients who are admitted on an involuntary basis must testify for commitment hearings in front of an Ocean County municipal court judge once every two weeks, where it is determined whether the patient should continue commitment or is fit to be released with referral to an outpatient program. . In some cases, the patient’s psychiatric condition manifests during the testimony, which does not work in the patient’s favor – such was the case when the diabetic patient called the pharmacy a “house of evil,” and said that

we were not giving him FDA approved medications, or another patient who told the judge that he is a leprechaun! Unlike community practice, in the isolated and secure environment of SBBH in which patients have a daily visit with a psychiatrist, it was possible for me to observe the advantages and effects of pharmacotherapy directly. One of my most vivid memories at SBBH was the outcome of a patient treated with lurasidone (Latuda®), a newer atypical antipsychotic. Patient A.J., a 53-year-old male, was involuntarily admitted from the ER due to psychiatric decompensation with signs and symptoms consistent of major depressive disorder with psychotic and manic features. AJ had no previous psychiatric history. During the initial workup of this patient, he presented as truly manic – he would not answer the questions at hand, would speak very fast about irrelevant stories and topics, and appeared irritable with a labile affect and no insight into his condition. This type of presentation is typical of the patient that SBBH can help the most – one that has the capacity to understand his mental illness, and requires only short term care for safety and stabilization. The patient was initially started at a daily dose of 900mg lithium carbonate, but experienced an adverse reaction. Lithium was discontinued, and the patient was put on lurasidone 40mg daily, topiramate 50mg, and benztropine 0.5mg daily to prevent extrapyrimidal side effects. The patient was compliant with his medications and showed continuous improvement. During his follow-up visit, A.J. presented calm, had insight into his illness, showed a willingness to improve and listen, and answered questions appropriately and directly. He was discharged from the

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Saint Barnabas Behavioral Health Continued from previous page

hospital that day. Although the full benefits of most atypical antipsychotics will not present for a couple weeks, short-term improvement of psychotic symptoms is common. For me, the “complete 180” from his initial presentation clearly demonstrated the benefits of antipsychotic medications in improving a patient’s quality of life. I would highly recommend this rotation to any student with an interest in psychiatric disorders and behavioral therapy. Ms. Kim Walsh, RPh, and her staff of knowledgeable and enthusiastic pharmacists and pharmacy technicians, provide opportunities for learning at every turn, be it practicing sterile technique by making oral vancomycin syringes, designing research questions relevant to pharmacy practice, filling a Pyxis machine, or inviting rotation students to root-cause analysis meetings. Just as patients are treated individually at SBBH, I felt as though my preceptor and her staff made strong efforts in getting to know me personally, figured out what I was interested in taking out of this experience, and subsequently created opportunities for my own personal and professional growth. As pharmacists, it is important for us to realize that not every illness is of a physical nature. The effects of a chemical imbalance in the brain must not be minimized and instead should be met with empathy and sensitivity. Although short-term rehabilitation centers are often described as a “revolving door” for some patients, healthcare professionals must consider every admission with fresh eyes, professional judgment, and understanding. In this type of setting, it is easy to become jaded by seemingly endless cases of opiate abuse where it could become routine to just “write a script” for Suboxone®, but in treating psychiatric disorders of any kind, our profession becomes one in which total behavioral therapy must be personalized to those patients willing to receive the help we can provide. Neil J. Foglio is a P3 pharmacy student currently enrolled in the PharmD Honors Research Program under the direction of Dr. Tobias Gerhard. His academic and research interests include statistics, pharmacoepidemiology, antipsychotic medications, and health outcomes. The views expressed in this article do not reflect those of St. Barnabas Healthcare System, its employees, or its affiliates.

The Human Right to Health: A Book Review

by Maryann Torres, P2

What do we need to do to make health a human right? Representatives of international health conferences agree: humans have a right to health. In fact, the World Health Organization’s (WHO) Constitution states that “the highest attainable standard of health is one of the fundamental rights of every human being.” Health is not a privilege for those lucky enough to attain health care – at least, it shouldn’t be. The unfortunate truth is that, globally, millions of deaths are caused by preventative diseases. Then, are we all truly attaining the highest standard of care? Jonathan Wolff, director of the Centre for Philosophy, Justice, and Health at University College London, discusses global health issues in his book, The Human Right to Health.

Photo credit: http://www.hhropenforum.org/wp-content/ uploads/wolff.png

Wolff begins the book by defining human rights and how health fits in, referencing General Comment 14 by the United Nations Committee on Economic, Social, and Cultural Rights that delineates the process of making health a human right. Wolff states that there are four elements that successfully make health a human right:

There are countless examples of the need for health initiatives to inform the world, from AIDS to tuberculosis. Wolff then brings up that, although these initiatives help promote health as a human right, economists counter that the “vertical programs” lead officials to center on a single cause, thus taking focus away from other diseases.

1) Availability – A nation must have enough public health and health care facilities to meet the needs of its people. 2) Accessibility – A nation’s facilities and health information must be open to all, without discrimination, within physical reach, and economically. 3) Acceptability – To be accepting of all cultures 4) Quality – This includes not only the quality of the health care professionals, but also of the treatments provided.

To account for the amount of time that it takes to achieve health as a human right in a nation, Wolff presents the term “progressive realization,” which the UN Committee on Economic, Social, and Cultural Rights created. Progressive realization allows countries leeway to accept health as a human right at each their own pace.

For any nation, from third world to first, it is easier said than done. Wolff uses the topic of HIV/AIDS to exemplify this. When AIDS began to surface, it took a lot of time for the world to understand that AIDS was not a disease exclusive to the gay community. In fact, AIDS was once called Gay Related Immune Deficiency, or GRID. A victim of AIDS was not only suffering an incurable debilitating disease, but was also criticized by society. AIDS support groups formed, leading public health initiatives to end the discrimination and promote support and treatment. It was an issue of accessibility and acceptability.

Where does America stand in progressive realization? WHO ranks America’s health care in 37th place. There is no doubt that America has greatly achieved the quality element – we have highly trained health care professionals and top quality treatments. Yet, do all Americans have access to the great health care the country can provide? Unfortunately, they do not. Of all four elements, accessibility is the hardest to reach. The cost of health care defines health as a privilege, not a right. Wolff introduces the idea that if drug companies, donors, and international organizations would agree to make health care more affordable, then health as a right would be easier to achieve. Reference: Wolff, J. The Human Right to Health. 1st ed. New York: W.W. Norton & Company, Inc; 2012.

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AMCP P&T Competition Continued from page 7

field all the questions that the judges could ask them during their oral presentation. One team at a time entered the judging room with shaky hands. The faculty judges picked apart each team’s presentation and material to thoroughly test the presenters’ knowledge of the drug and its usage in a managed care setting. After much deliberation, the judges chose one team to represent EMSOP and Rutgers at nationals. The selected team consisted of two P4 students and two P2 students – a diverse group of people who hardly knew each other at the start. But over the weeks of working together, one would have thought they had worked together all their lives. Ahead of the national competition, the members overhauled their materials and fine-tuned their presentation. Before they knew it, it was five AM on the day of the competition and the team was about to present in four hours. “One last run through” seemed to be the theme of the night, and the team worked tirelessly until deadline. Once again with shaky hands, the group now presented in front of a national panel. The presentation itself went fairly well with no major bumps, but sure enough, the first question asked by the judges stumped the students. Desperately, they glanced into the audience, expecting the answer appear in front of them. It did not. But the group powered through, and finished the rest of the questions with relative ease. The next day was the awards ceremony, where the students gathered, excited and nervous for what loomed in their future. The first school called was the University of Illinois at Chicago: third place. Respectable, and the Rutgers team would have been happy with that, but it was not them. The University of Georgia placed second, and the Rutgers students hung their head low, ears half open to hear what school placed first. As the announcer said the name “Rutgers University” for first place, the team was surprised and ecstatic. At that moment, EMSOP and Rutgers history was made. This is an important year for EMSOP. It is another opportunity to show what the school of pharmacy is capable of. Students can show that EMSOP is a serious contender in the long run and that last year was not a fluke. The road is challenging; there is no doubt of that, but the reward is far greater – for the school and for the individual. To students of all professional years, challenge yourself and compete in the P&T competition. Take everything you have learned about pharmacy and connect it with this project. You will not be disappointed.

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An Oldie But a Goodie: Metformin Proven Cheap and Effective (Again) by Yimin Xu, P3

mild kidney impairment. The patients who stand to benefit most from these findings Metformin has long been a standard are older patients who have impaired renal medication for treating diabetes. Its function and are less able to afford newer, availability in generic form makes it a more expensive medications. cheap and effective method of managing the disease. However, side effect risks have A possible consequence of this research is made new medications more attractive to that brand name medications like Januvia many doctors and patients. New research, may see decreased revenue, which in turn however, may help this older drug see a means less money for pharmaceutical resurgence. companies to invest into new medications. Combination products such as Janumet – Researchers in Sweden have recently found a combination of Januvia and Metformin that the risks of metformin usage in patients – may continue to see widespread use. with reduced kidney function – traditionally On the whole, if metformin were to see a a barrier to the utilization of this medication revival, there may be a thinning of ranks in – may have been vastly overstated. The similar, less effective “me-too” drugs. side effect in question is lactic acidosis, a major disorder which could potentially Moreover, with healthcare reform taking lead to organ failure and the exacerbation shape, the cheap and effective metformin of other diseases. With such serious side is poised to see an upsurge in usage, effect considerations, it is no wonder that while more expensive medications may some doctors and patients have decided gain higher co-pays, or be moved to coto go with newer, supposedly safer antiinsurance. With the influx of newly-insured hyperglycemic medications. However, with patients, some with pre-existing diabetes, such a finding, patients and doctors may insurance providers will be trying to cut soon be switching back to metformin as costs, and thus will be taking a long hard their diabetes drug of choice for patients look at this old drug that is still considered with mild to moderate kidney impairment. by many to be the best. Another study showed metformin to be more effective than other glucoselowering medications in reducing the risk of cardiovascular disease, serious infection, and death due to hyperglycemia in diabetic patients with normal kidney function or

Reference: “Considerably more patients may benefit from effective antidiabetic drug.” World Pharma News. 18 September 2012. <http://www. worldpharmanews.com/research/2208-considerably-more-patientsmay-benefit-from-effective-antidiabetic-drug>

Editors-in-Chief: Ashley Brower & Christina Zikos Contributing Editors: Jin Ah Jong Yingzhi G Zhang Yixin Lin Jennifer Kim Stephanie Wang Stacy Lee Maryann Torres Jazmin Turner Daniel Dipsia Disclaimer: The opinions expressed in EMSOP Chronicles do not reflect the views of the Pharmacy Governing Council or Ernest Mario School of Pharmacy. For questions, comments, and information on how to get involved, e-mail

emsopchronicles@gmail.com

EMSOP Chronicles F2012 Issue 2  

Special Edition on the Affordable Care Act and its impact on special populations