ERNEST MARIO SCHOOL OF PHARMACY VOL.3 ISSUE 5 APRIL 22, 2014
brought to you by Pharmacy Governing Council
Pharmacists Recognized as Healthcare Providers Under Pennsylvania Health Records Law copies of medical records to the actual Judge R. Stanton Wettick Jr. stated that
by Melanie Chen, PP2
Earlier this year on March 23rd, the Superior Court of Pennsylvania issued an opinion in the case of Landay vs. Rite Aid that directly affected the image of pharmacists. The Superior Court ruled that pharmacists are considered health care providers for purposes of the Medical Records Act, overturning a lower state court’s decision stating that the Medical Records Act did not apply to pharmacists because they are not health care providers. The Landay vs. Rite Aid matter was brought on a class action complaint by attorneys who alleged they were overcharged by Rite Aid’s flat fee of $50 for reproducing a person’s pharmacy records1. Appellant David M. Landay and law firm Patberg, Carmody, & Ging took the issue to the Allegheny County Court of Pleas in Pittsburgh, claiming that Rite Aid violated the Pennsylvania Medical Records Act. Under the MRA, Pennsylvania healthcare professionals pharmacies are required to limit how much they charge for making
estimated expense incurred. Landay contended that Rite Aid breached this contract by charging a flat fee of $50 for reproducing as little as a single page of pharmacy records1,2.
The Allegheny County Court of Pleas dismissed the case. Rite Aid asserted that the MRA did not apply to pharmacy records, and the trial court agreed. Senior
the MRA governs only “patients” – who are “persons who describe themselves as patients of a hospital,” but “persons do not describe themselves as patients of a pharmacy”. Judge Wettick then went on to liken pharmacists more to yoga instructors than medical providers, explaining that “a person receiving services provided by a continued on page 3
A Novel Cure of Hepatitis C
Table of Contents
New Hepatitis C Therapy..............1 Penn. Health Records Law...........1 Diabetes, ESRD, & Depression...4 Pharmacist Recognition..............4 RxecognizeMe.............................5 Supplement-Drug Interactions....7
by G Zhang, P3
Gilead Sciences recently showcased their latest medication at the International Liver Congress in London. Called Sovaldi®, the novel oral medication was effective in treating hepatitis C in over 90 percent of patients over the course of a twelve week regimen. The catch? The new pill costs about $1,000 per day, running the cost of a twelve-week regimen up to $84,000. Hepatitis C is an infectious disease of the liver that affects 3.2 million people in the US alone and 130 million to 150 million people worldwide. As a blood-borne infection, the most common way that it
Photo Credit: http://www.lifebeyondhepatitisc.com
is transmitted today is through needlesharing during intravenous drug use. It can lie dormant for decades, remaining asymptomatic even while causing liver cirrhosis. Patients with such scarred livers eventually require transplant; hepatitis C is currently the number one reason for liver transplants and liver cancer in the United States. The current preferred treatment for hepatitis C – and one of the only treatments available – relies upon the drug interferon combined with the antiviral medication continued on page 3
Copy of pharmacists arrest in Bronx pharmacy by Saera Murtaza, P1 Most pharmacists deal with the struggle of trying to make sure their patients are adherent with their prescribed medication regimen. It turns out that a pharmacy in Bronx, NY has recently found itself in trouble for quite the contrary, due to the actions of its three pharmacists on staff: Ahmed Hamed, Tarek Elsayed, and Mohammed Hassan Ahmed. Allegedly, the pharmacists at the 184th Street Pharmacy, located in the Fordham Heights section of Bronx, were paying their HIV patients not to take their medications. According to the New York State Attorney General, Eric Schneiderman, these individuals preyed on HIV patients in order to obtain their expensive anti-retroviral drugs and essentially buy out the customers. Despite the oath that is taken by pharmacists, encouraging them to do what is moral and ethical, these pharmacists did the exact opposite. Not only did these pharmacists put their monetary greed before acting professionally, but they also defrauded tax payers and “…disgraced their profession,” according to Schneiderman. HIV patients were paid anywhere from $20-$200 to not take their medication, after which the pharmacy billed Medicaid $2,000 for normal dispensing charges, even though the drugs were not dispensed. Their funds added up to up to about $10 million dollars per year, robbing Medicaid tax dollars in the process. The $10 million that they allegedly stole from their patients and taxpayers was used to buy lavish items such as jewelry gifts from Tiffany’s and luxury cars, including several BMWs, a Mercedes-Benz, and even a Maserati. The operation was ongoing for less than a year as they started the illegal buyback program in March of 2013, distributing the money through a Citibank account. The pharmacists have all been charged with grand larceny and scheming of fraud against the government. Additional charges of money-laundering have also been filed against the two store owners, Hamed and Elsayed. If convicted on all charges, the owners could be looking at up to 18 years in prison; whereas the supervising pharmacist, Ahmed, would only be sentenced up to
7 years behind bars. Patients that have heard about the arrests and convictions are not only in disbelief, but they also feel violated that health-care professionals in their community compromised their moral and ethical oath towards helping patients in need; thus breaking their trust in the health care system. Some HIV patients in the community were also confused as to why some took the deal in the first place, being that nowadays retroviral medications have become quite effective in battling the previously labeled terminal disease. In the process though, these pharmacists may have brought light to an overlooked loophole that exists in the laws surrounding pharmacies. This is that anti-retrovirals are not classified as controlled substances by the Drug Enforcement Agency, and thus are not as regulated and closely monitored as drugs such as codeine. Perhaps if there
were more stringent monitoring in place, these allegedly “corrupt” pharmacists would not have had the opportunity to prey on their patients and allow some HIV patients to relapse in the disease, simply due to their extenuating financial circumstances. It is the hope that going forward, more patients will be protected against ill-gotten schemes such as this across all drug categories, as the true purpose of a pharmacy is to attain health, not money, as the source of wealth for patients.
References: 1. “3 Men Arrested For Running Alleged Illegal Prescription Buyback Scheme In Bronx.”CBS New York. CBS Local, Published Mar. 11 2014. Web. Accessed Apr. 11 2014. http://newyork.cbslocal.com/2014/03/11/3-men-arrested-for-runningalleged-illegal-prescription-buyback-scheme-in-bronx/ 2. Woodby, Christina C. “Bronx Pharmacy Busted in $10M HIV Drug Buyback scam.” New York Post. The New York Post, Mar. 11 2014. Web. Apr. 11 2014. http://nypost.com/2014/03/11/bronx-pharmacy-busted-in-10m-prescription-drug-buyback-scam/ 3. “A.G. Schneiderman Announces Arrests Of Pharmacy Owners And Pharmacist For Operating Illegal Prescription Buyback Operation.”Eric T. Schneiderman. N.p., Mar. 11 2014. Web. Apr. 11 2014 http://www.ag.ny.gov/press-release/ag-schneiderman-announces-arrests-pharmacy-owners-and-pharmacist-operating-illegal
Sebelius Out, Burwell In
by Yimin Xu, P4
Kathleen Sebelius, the former Secretary of Health and Human Services, has been receiving criticism for the botched rollout of healthcare.gov, the federal government’s health insurance exchange. Not only has the public lost faith in her, but it seems that key members of the Obama administration have as well. The result? Kathleen Sebelius officially resigned on April 10th. President Obama’s choice of replacement seems to be Budget Director Sylvia Burwell, a veteran of the Clinton administration. Burwell is the second woman to hold the position of Director of the White House Office of Management and Budget, and she is praised for her strong management skills that saw action during the Lewinsky scandal. Hopefully, Burwell’s experience with controversy will serve her well in this new position, as she attempts to fix past mistakes and implement what has been delayed, such as the mandate that employers offer health insurance. The resignation of Sebelius is an indication to some that the Patient Protection and Af-
fordable Care Act can be defeated. There will no doubt be a renewed effort from some Republicans who oppose healthcare reform. We can only hope that Burwell will be able to weather the storm while attempting to fix the system.
Sylvia Burwell Photo Credit: http://www.nytimes.com/2014/04/11/us/politics/budget-chief-sylvia-mathews-burwell-is-choice-as-newhealth-secretary.html?ref=health&_r=0 References: 1. Shear MD, Calms J, Pear R. The New York Times. Sebelius’s SlowMotion Resignation From the Cabinet. Available at: http://www.nytimes.com/2014/04/12/us/politics/sebeliuss-slow-motion-resignationfrom-the-cabinet.html?ref=health. Accessed on: April 11, 2014. 2. Shear MD. The New York Times. Budget Chief Is Obama’s Choice as New Health Secretary. Available at: http://www.nytimes. com/2014/04/11/us/politics/budget-chief-sylvia-mathews-burwell-ischoice-as-new-health-secretary.html?ref=health. Accessed on: April 10, 2014. 3. Fox News. Republicans renew fight against ObamaCare as Sebelius resigns. Available at: http://www.foxnews.com/politics/2014/04/11/ republicans-renew-fight-against-obamacare-as-sebelius-resigns/. Accessed on: April 11, 2014.
A Novel Cure of Hepatitis C
continued from page 1
ribavirin. The regimen is effective in less than half of patients due in large part to its contraindication in patients with decompensated liver failure. For patients with advanced disease, interferon is not an option. Furthermore, the treatment can cost almost $200,000 per cure, according to a professor of medicine at the University of Colorado. Sovaldi®, on the other hand, is efficacious in both new patients and those who failed earlier treatment. It is also very well tolerated with relatively few side effects compared to interferon therapy. More study is necessary to determine relapse rates and potential long-term effects, but the medication is expected to generate as much as $19 billion in revenue for Gilead. The cost of Sovaldi®, however, may prove a sticking point for many patients, healthcare providers, and insurance companies. A number of hepatitis C patients are lowincome minorities – many of whom rely on the already heavily strained Medicaid.
Even private insurers, however, have accused Gilead of exploitation. “Some patients have no other option but Sovaldi®, and we have no other option but to buy this drug at whatever price is demanded by a manufacturer of a sole source product until competition emerges or generics are allowed to enter the market,” said Chris Stenrud, government relations director at Kaiser Permanente, the largest nonprofit health plan in California. Further raising eyebrows, the price for Sovaldi® differs around the world. Citizens of the United Kingdom can expect to pay about $57,000 for a twelve-week regimen, while Germans will shell out $66,000. In Egypt and other developing countries, the cost may be as low as $900 – nearly 99 percent less than what the drug will cost in America. This may be due, in part, to the fact that the US does not regulate drug prices, but pharmaceutical industry insists that competition and innovation depends upon this very lack of regulation.
Photo Credit: http://www.steadyhealth. com/articles/new-pill-to-treat-hepatitis-ca3499.html Sovaldi® is not the only new medication poised to be introduced, however. AbbVie is hoping to release its own hepatitis C medication within the next year, and Merck and Bristol-Myers Squibb are also developing treatments. The competition may eventually force all three companies to lower their prices within a few years. References: 1. University of Texas Health Science Center at San Antonio. (2014). Hepatitis C treatment cures over 90 percent of patients with cirrhosis. [Press release]. Available from: http://www.eurekalert.org/pub_ releases/2014-04/uoth-hct041014.php 2. Costly new hepatitis C drugs from Gilead, Merck show near total cure rates. Bloomberg News. NJ.com. Available from: http://www.nj.com/ business/index.ssf/2014/04/costly_hepatitis_c_drugs_from_gilead_ merck_show_near_total_cure_rates.html 3. Lee, S. Cost of Gilead’s hepatitis C pill, Sovaldi, spurs revolt. SFGate. Available from: http://www.sfgate.com/health/article/Cost-of-Gilead-shepatitis-C-pill-Sovaldi-spurs-5398315.php
Pharmacists Recognized as Healthcare Providers Under Pennsylvania Health Records Law continued from page 1
licensed yoga instructor would not refer to himself or herself as a patient of the yoga instructor.”3 The trial court ultimately concluded that pharmacists are not health care providers, and people who have their prescriptions filled are not patients but “customers”2. The Superior Court didn’t see things that way.
Upon appeal, the Superior Court, which is one level higher on the federal court circuit than district courts such as the Allegheny County Court of Pleas, overturned the trial court’s decision and found that pharmacists are indeed considered to be health care providers. Superior Court Judge Jacqueline Shogan issued in a statement: “A pharmacist is not merely an intermediary between a vendor and consumer…We specifically note that, as part of their health care duties, pharmacists are authorized to administer injectable medications, biologicals and immunizations. Thus, the practice of pharmacy is not limited to filling prescriptions.”4 Judge Shogan went on to clarify that pharmacists are required to review patient
profiles, provide counseling, and maintain confidentiality – all of which exemplify the conclusion that pharmacy records are, in fact, medical records of a patient. The Superior Court recited sections of the Pennsylvania Code that outline the services that pharmacists provide for their patients. Throughout those pages, the court highlighted several instances in which the word “patient” was mentioned. It also cited the definition of “practice of pharmacy” under the state’s Pharmacy Act, which defines the practice as the “provision of health care services by a pharmacist.”4 “We find the fact that the court concluded that a pharmacist is a health care provider and that the recipient of prescription medication is a patient very interesting and promising, especially in light of the fact that certain government entities and others sometimes like to argue that pharmacists are not providers,” Patricia A. Epple, CAE, CEO of the Pennsylvania Pharmacists Association, said in an interview.3 According to Epple, the Pennsylvania Pharmacists Association has long asserted that pharmacists are health care providers and should be recognized as such. In fact,
the state association’s vision statement is: “Pennsylvania pharmacists will be recognized, engaged, and fairly compensated as health-care providers.”5 “I am hopeful we can use this decision in a positive and powerful way to benefit the profession,” Epple said.3
Landay vs. Rite Aid, along with these positive impacts on how pharmacists are viewed, holds another important implication: pharmacies can no longer charge a flat fee whenever an attorney or anyone else requests records. The Superior Court ruling in Landay now requires pharmacies across Pennsylvania to process pharmacy records in the same way patient records are processed in a physician’s office. References: 1. “Landay v. Rite Aid, PICS Case No. 120626 (Pa. Super. March 23, 2012) Shogan, J..” The Legal Intelligencer. The Legal Intelligencer, 03 Apr 2012. Web. 12 Apr 2014. 2. Merenda, Basil L.. “Pa. Superior Court decision with Implications for Pharmacists and Pharmacies.”Pharmacy Law Alert. Lavin, O’Neil, Cedrone & DiSipio, 30 Mar 2012. Web. 12 Apr 2014. 3. Yap, Diana. “Pharmacists included under Pennsylvania health records law.” www.pharmacist.com. American Pharmacists Association, 10 Apr 2012. Web. 12 Apr 2014. 4. Passarella, Gina. “Pennsylvania court says pharmacists are health care providers.” iarx.org. Iowa Pharmacy Association., 13 Apr 2012. Web. 12 Apr 2014. 5. “Pennsylvania Pharmacists Association.”www.papharmacists.com. Pennsylvania Pharmacists Association, n.d. Web. 12 Apr 2014.
Possible Associations between Diabetes, ESRD, and Major Depression
by Maryann Torres, P3
End-stage renal disease (ESRD) is a common sequela of diabetes, especially for patients with poorly controlled diabetes. A prospective observational study by Yu et al, “Associations between Depressive Symptoms and Incident ESRD in a Diabetic Cohort,” looked at the possible correlation between depression and an increased risk of ESRD in diabetics. The study followed a cohort of 3886 diabetic patients from 9 primary care clinics at Group Health in Washington between 2001 and 2012. Throughout the study, patients filled out surveys about their depressive symptoms using the Patient Health Questionnaire 9, as well as surveys assessing their diabetic self-care using a modified Summary of Diabetes Self-Care Activities questionnaire. Studies were collected at baseline and until the patient developed ESRD, disenrolled from Group Health, died, or until the end of the study.
Of the 3886 patients, 448 (11.5%) had symptoms of major depression, while 327 (8.4%) has symptoms of minor depression. 87 patients (2.2%) developed ESRD upon a median follow-up of 8.8 years. The authors adjusted for age, sex, race/ethnicity, marital status, education, smoking, body mass index, diabetes duration, A1c levels, baseline kidney function, microalbuminuria, hypertension, use of renin-angiotensin system blockers, and adherence to diabetes self-care. Analysis of their results showed that those patients with major depressive symptoms had a higher risk of developing ESRD. Minor depressive symptoms showed no significant associations with developing ESRD.
The authors acknowledged that a limitation to their study was the potential informational recall bias through the self-reported surveys. In addition, the authors did not address data on blood pressure, cardiovascular risk, and medication adherence changes. Bias may also exist because the population studied was insured as opposed to having limited access to care.
Photo Credit: http://www.medicalobserver. com.au/news/depression-in-diabetesincreases-renal-disease-risk Still, the authors believe that further studies should be done on how depression treatment affects renal outcomes in diabetic patients.
References: 1. Yu MK, Weiss NS, Ding X, et al. Associations between Depressive Symptoms and Incident ESRD in a Diabetic Cohort. Clin J Am Soc Nephrol. 2014 March 27. 2. Hackethal, V. Diabetes With Major Depression Raises Risk for ESRD. Medscape. [cited 12 Apr. 2014]. Available from: http://www. medscape.com/viewarticle/823535
Pharmacists – Finally Official Recognition? by Yimin Xu, P4 From counseling patients in the community to discussing with physicians on the floors, pharmacists are at the front of patient care every day. Therefore, it may come as a surprise that pharmacists are not officially recognized by Medicare as healthcare providers when it comes to reimbursement. Simply put, the government refuses to compensate pharmacists for clinical services rendered. Instead, pharmacists must bill together with physicians in a collaborative agreement rather than as separate and independent healthcare providers. There is currently a bill before the House of Representatives that would grant pharmacists this elusive title. H.R. 4190 will amend the Social Security Act to allow pharmacists to bill Medicare directly for their services. This bill is a step in the right direction; however, it does not allow phar-
maists to practice with the entire Medicare population. The bill specifies that pharmacists may bill for pharmacist services only “in a setting located in a health professional shortage area…, medically underserved area, or medically underserved population.” In other words, this bill would only allow pharmacists direct reimbursement from those most in need of increased access to health care and not the whole Medicare population. Furthermore, pharmacists will be reimbursed an amount “equal to 80 percent of the lesser of the actual charge or 85 percent of the fee [paid to] a physician.” Pharmacists would not only be limited in the patients they can serve under a direct reimbursement model, but also would be eligible for less compensation than a physician performing the same task. While H.R 4190 is a beneficial bill, more is needed for pharmacists to be recognized
officially as highly trained and knowledgeable healthcare providers. If this bill was to pass, the results will impact more than the Medicare population. Private insurers will likely follow suit, leading to increased access to healthcare for medically underserved patients. As there are baby steps towards the right direction, the next step would be to increase the option of direct billing to all patients, underserved or not.
References: 1. Thompson CA. Legislation Proposes Allowing Medicare to Reimburse for Pharmacist Services. ASHP. March 14, 2014. http://www.ashp. org/menu/News/PharmacyNews/NewsArticle.aspx?id=4024. 2. H. R. 4190 . US Congress. March 11, 2014. http://beta.congress. gov/113/bills/hr4190/BILLS-113hr4190ih.pdf. 3. Calhoun D. Healthcare Provider Status for Pharmacists is Long Overdue. NCPA. http://www.ncpanet.org/index.php/ncpa-commentary/1548healthcare-provider-status-for-pharmacists-is-long-overdue.
Pharmacy Organization and Events on Campus
RxecognizeMe: PLS and PGC Platform Encourages Leaders of Tomorrow
by Vani Kumaran, P4, Andrianna Guo, P4, and Nisha Bhide, P4
Leadership in Organizations, 4th ed., defines leadership as the process wherein an individual member of an organization influences the interpretation of events, "the choice of objectives and strategies, the organization of work activities, the motivation of people to achieve the objectives, the maintenance of cooperative relationships, the development of skills and confidence by members, and the enlistment of support and cooperation from people outside the group or organization."1 How we define the organizational role in leadership development is one area that also has been analyzed. Students at the Ernest Mario School of Pharmacy (EMSOP) have the ability to attend meetings and join organizations via our Pharmacy Governing Council (PGC) meetings. Additionally, student leaders have driven many initiatives, events, and projects to impact the local and national community. However, recognizing the organizational direction provided by those in leadership roles is difficult to quantify. Students who aspire to take on leadership roles may be discouraged when their work is not given credit by the organization and consequently weakens the organization during periods requiring member initiative. As a result, Phi Lambda Sigma (PLS), the pharmacy leadership society, in collaboration with PGC, developed a student-based recognition program to allow student leaders to identify members within their organizations who exemplify leadership and dedication with the goal of advancing the organization in a progressive direction. RxecognizeMe was developed in 2012 by PLS as a platform to encourage leadership by highlighting student pharmacists who demonstrate the potential to be an effective organization leader in the PGC forum.
Each pharmacy student organization president is given the opportunity to nominate an exceptional member in his or her organization each month. By nominating these students and having a collective assembly recognizing their achievements, the program gives current leaders the opportunity to recognize leadership potential within their organization. Additionally, it allows members to receive encouragement in PGC via a gift incentive and follows the protocol of “rewards power” as described by John French and Bertram Raven in their book, The Bases of Social Power.1
Photo Credit: http://www.uthsc.edu/pharmacy/ current_students/philambdasigma/history.php
In order to analyze the efficacy of student leadership recognition using the RxecognizeMe program, assess student pharmacists’ views of leadership, and capture their role of involvement prior to and after receiving the award, three PLS members conducted a research study. The objective of a study was to analyze how the program related in terms of contingency with student leadership and training. The study evaluated whether the program increased the ability of organizations to achieve their individual goals with more leadership and manpower and whether it increased the
collaboration among students for event planning. Students who were nominated, student leaders, and students who won this award were requested to participate in a survey to assess the impact of this program on their thoughts about leadership. The outcomes of the study did reflect a change in perspective of student winners; they initially joined organizations to participate in given activities and then they progressed to aspire towards leadership roles. Positive reinforcement additionally allowed these students to be showcased among organization presidents and exchange new ideas that have previously been completed by organizations because of these new members. Based on survey feedback, additional awareness of the program among all students and faculty is a priority for the future. Also, the study indicates the potential for this program to support existing leadership development seminars by identifying interest at an early stage. These results were published and presented at the 2013 American Society Health-System Pharmacists Midyear Clinical Meeting in Orlando, FL. Overall, the RxecognizeMe program fosters and promotes leaders to encourage and mentor younger students to prepare themselves with a successful skill set that will support the organization’s future. The program has continued over the past year with successors and organizations working collaboratively to encourage new leaders in preparation for higher roles as they proceed in their academic career. As a leadership-focused organization, PLS encourages and guides all students to challenge themselves professionally to execute new events, projects, and learn how to further develop themselves as leaders in pharmacy.
Rite Aid Receives URAC Accreditation in Specialty Pharmacy
by Linda Maa, P1
On April 8th, 2014, Rite Aid, multibillion dollar corporation and one of the top leaders in national drugstore chains, received accreditation for specialty pharmacy from the Utilization Review Accreditation Committee (URAC), an independent, nonprofit health care accreditation organization. Executive Vice President of Pharmacy for Rite Aid Corporation, Robert Thompson, remarked, “We are very proud to have received full accreditation as a specialty pharmacy provider from URAC. Every day, Rite Aid pharmacists are committed to providing all of our patients, especially those receiving specialty pharmacy treatments, with the best care possible.” Specialty pharmacy services involve the preparation of specialized, high-cost biotechnology and injectable medications that
cover disease states such as arthritis, multiple sclerosis, and hemophilia. The official URAC website states, “URAC’s Specialty Pharmacy Accreditation provides an external validation of excellence in Specialty Pharmacy Management and provides Continuous Quality Improvement (CQI) oriented processes that improve operations and enhance compliance. It also helps to assist in preparing for regulatory compliance.” The demand for specialty medications and services is growing, and the main pharmacy chains are adapting to better cater to specialty pharmacy. Walgreens Co. received the URAC accreditation on January 19, 2010, and CVS Caremark was awarded mail Service Pharmacy accreditation from URAC on June 24, 2013.
of the population. The healthcare profession as a whole must work to ensure that patients have access to the care they need, however specialized the treatment. The chain pharmacy movement toward specialty pharmacy accreditation is one step toward better care for patients with complex disease states.
In today’s healthcare market, it is imperative to respond to the developing needs
4. "Walgreen Co. Receives URAC Accreditation in Specialty Pharmacy." Walgreens News. N.p., 9 Jan. 2010. Web. 11 Apr. 2014. <http:// news.walgreens.com/article_print.cfm?article_id=5265>
lem. Under the FDA’s priority review program, which expedites the drug approval process, Evzio® (naloxone hydrochloride injection) was approved earlier this month.
The state of New York is taking the initiative as the first state in the nation to implement widespread Evzio® usage. Using $5 million from seized drug money, New York Attorney General Eric Schneiderman announced a new Community Overdose Prevention (COP) program that provides state law enforcement officers with naloxoneuse training.
References: 1. "CVS Caremark Receives URAC Accreditation for Mail Service Pharmacy." CVS Caremark. N.p., 24 June 2013. Web. 11 Apr. 2014. <http://info.cvscaremark.com/newsroom/press-releases/cvs-caremarkreceives-urac-accreditation-mail-service-pharmacy>. 2. "Rite Aid Receives URAC Accreditation in Specialty Pharmacy." Business Wire. Business Wire, 8 Apr. 2014. Web. 11 Apr. 2014. <http://www.businesswire.com/news/home/20140408005984/en/ Rite-Aid-Receives-URAC-Accreditation-Specialty-Pharmacy#.U0gfzFzzi8F>. 3. "Specialty Pharmacy." URAC. N.p., n.d. Web. 11 Apr. 2014. <https:// www.urac.org/accreditation-and-measurement/accreditation-programs/ all-programs/specialty-pharmacy/>.
FDA approves a hand-held auto-injector as an antidote for opioid overdose by Lydia Chou, P1 Each kit contains two pre-filled syringes, costs a total of approximately $60, and has the potential to reverse people from the brink of death. Deaths from drug overdose, including prescription drug overdoses, have surpassed motor vehicle crashes and are now the leading cause of injury death in the United States. But with the recent approval of Evzio®, a drug that reverses opioid overdose, the FDA and pharmaceutical industry are taking steps to combat the drug overdose prob-
Photo Credit: http://archive. news-press.com/article/20140407/ HEALTH/304070003/Living-Well-FDAapproves-pocket-protector
Currently, existing naloxone drugs have to be administered by trained medical personnel with a syringe. But the innovative design of Evzio® allows it to rapidly deliver a single dose of drug through a hand-held auto-injector that is convenient enough to be stored in a medical cabinet and carried around in one’s pocket. Evzio® activates by injection into the muscle or under the skin. After it is turned on, the device will provide oral instructions to the user telling them how to deliver the medication. This user-friendly design eliminates the need to have trained medical personnel administer the drug, so even family members and care-takers can learn how to use Evzio® in emergency situations. Once the medication is delivered, it prevents the person’s breathing from slowing down to a critically low level. Signs of suspected opioid overdose include decreased heart rate, decreased breathing rate, and a loss of consciousness.
In a pilot program that started since 2012 in Suffolk County, NY, police officers carried around naloxone for overdose emergencies. As a result, 500 lives were saved in a span of two years. With more than 2,000 opioid overdoses in New York in 2011, Schneiderman is hopeful for even more bright results, saying “it isn’t every day that we can announce that we will save lives.
References: 1. FDA approves new hand-held auto-injector to reverse opioid overdose. U.S. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm391465.htm Published April 3, 2014. Accessed April 13, 2014. 2. FDA approves easy-to-use auto-injector for heroin overdose antidote. CNN Web site. http://www.cnn.com/2014/04/03/health/fda-heroinoverdose-antidote/ Published April 3,2014. Updated April 4, 2014. Accessed April 13, 2014.
Importance of Supplement-Drug Interaction Awareness by Cindy Tu, P1 A relative of mine was on Depakote®, a mood stabilizer, for her depression. While on the medication, she decided to take red yeast rice, a natural supplement used to lower cholesterol levels. Little did she know, concurrent use of the two is a dangerous mix. After a few days, she began experiencing extreme dizziness and tightness in her chest, as well as blood pressure that was lower than usual. Afraid that this could develop into something more, she called the psychiatrist who had prescribed the Depakote®, but he knew nothing about her reactions. With no answers from the doctor, my relative requested advice from a pharmacist. The pharmacist told her to stop taking red yeast rice because it contains an ingredient that is chemically similar to the prescription drug lovastatin, an antihypercholesterolemic. Taking the two together can interfere with drug metabolism, leading to harmful effects. Following the pharmacist’s instructions, my relative stopped taking the supplement and the harmful effects resolved. My relative did not realize that supplements could interfere with prescription medication in such an adverse way, and many people may unaware as well Taking medications with a supplement can reduce the effects of drugs or lead to toxicity and overdose. Pharmacists should take the time to learn major supplement-drug interactions, since many people concurrently take supplements and drugs. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements to include vitamins, minerals, herbs, amino acids, enzymes, tissues, and metabolites. Over the years, the use of supplements has been gaining more popularity. A 2012 survey reported that 63% of American adults take one or more dietary supplements3. Furthermore, about one out of five prescription drug users take supplements at the same time4. Thus, there is great potential for interactions to occur. 55% of consumers believe that the Food and Drug Administration (FDA) approves for the safety and efficacy of supplements, indicating that a significant portion of people trust these products. In reality, however, the FDA does
not have to approve the product before it is on the market, since dietary supplements are not regulated as tightly as drugs. They are classified as food products, so the FDA takes on a more reactive than proactive stance. There is only action when there is reasonable evidence of adverse drug reactions; hence, patients may get harmed in the process. Companies also do not have to list possible dangers and side effects on supplement labels, so people may be less aware of the potential problems. Because the requirements are not as rigorous, health care providers and consumers themselves should be more aware of the effects of these supplements. Where do pharmacists enter the picture? At the recent American Pharmacists Association 2014 Annual Meeting and Exposition in Orlando, Florida, Bella Mehta, a PharmD., from The Ohio State University in Columbus, presented on the important role of pharmacists in educating patients on supplement use. "It is important for us, as pharmacists, to be aware of the evidencebased processes behind some of the most popularly used natural products … Pharmacists already know that 'natural' does not necessarily mean safe. But they should remember to look at drug interactions and the side effects that can occur from some commonly used products. They also should have resources on what products are reliable and safe for patients2.” To better inform patients, pharmacists should put more effort in educating themselves on these dietary supplements. Continuing education or CE programs online or in workshops and seminars are helpful in learning more about these supplements. Keeping references around the pharmacy is also beneficial. Pharmacists should always ask patients about their use of herbals, vitamins, and mineral supplements, and it should be a routine part of checking their medication history to ensure there will not be any interactions. Since many patients dislike sharing the products they are taking, pharmacists should ask questions in an open-ended, objective way and verify that patients really understand the uses and risks of the products1. After gathering this information,
Photo Credit: http://www.pepid. com/drug-interactions/ pharmacists should consider notifying the prescriber about these supplements. Since supplement manufacturers are not required by law to report problems to the FDA, pharmacists can ideally take on the role of reporting suspected drug-supplement interactions and adverse problems. Consumers may not truly know enough about the supplements they are taking and do not realize when supplements may be contraindicated with their prescription medications. Patients with certain chronic conditions and diseases, such as blood clotting disorders, hypertension, diabetes, liver and kidney problems, or epilepsy, should check first before taking supplements because chances are there may be interactions with chronic prescription medications. The most reported interactions with supplements are warfarin, insulin, aspirin, digoxin, and ticlopidine4. As the most accessible health care providers, pharmacists are ideal candidates to take on the active role of promoting the safe use of supplements, advising patients on what supplements to take and reminding them of the serious interactions out there. Pharmacists can provide answers while preventing any negative outcomes.
References: 1. Chavis, Linda. Pharmacy-Based Consulting on Dietary Supplements J Am Pharm Association 41(2):181-191, 2001. American Pharmaceutical Association. Web. Accessed April 6, 2014 2. Lowry, Fran. Pharmacists Well Placed to Educate About Dietary Supplements. Medscape. April 3, 2014. Web. Accessed April 6, 2014 3. Terrie, Yvette C. Drug-Supplement Interactions: Patient Awareness is Key. Pharmacy Times. October 8, 2013. Web. Accessed April 6, 2014. 4. Terrie, Yvette C. Using Herbal Supplements Safely. Pharmacy Times. March 19, 2012. Web. Accessed April 6, 2014.
Inside Industry Explore Career Paths in Pharma
Now Downloading: Mobile Medical Apps
by Raelene Osam, IPhO, P1
There is no doubting the fact that over the past decade, social media has advanced to great heights. Society has gone from talking on telephones to sending texts. Having a cell phone is now a necessity, not a luxury. The World Wide Web used to be restricted to desktop computers, but it can now be accessed from a laptop, tablet, or phone no matter where you are. With the ever-evolving technological world in which we live, social media has inevitably become a part of our everyday lives. For this reason, the drug industry is trying to take advantage of the times and reach out to customers and patients using social media outlets such as Facebook® and Twitter®. Additionally, the overwhelming prevalence of smart phone and tablet use has also caused the industry to create applications, or “apps,” for people to use. Just as everything else in the pharmaceutical industry is heavily regulated, the FDA has formulated a set of social media guidelines for companies to adhere to, which was
issued last September and can currently be found online. The government agency’s main concern was consumer safety, and the use of technology falls under that concern. Regardless, the strict guidelines set forth by the FDA are not stopping pharmaceutical companies from developing medical apps for smartphone and tablet users. Many companies from all over the world have pushed forward the development of different types of apps, ranging from medication adherence applications for patients, such as myHealth! by Merck®, to educational games for children, such as Yunmo Adventures by Sanofi®. Companies have even developed apps that target those with a specific disease state such as diabetes, including My Diabetes by Medtronic®. Health care providers are not excluded from being a part of the user audience, as there are a variety of apps for all healthcare providers to use, such as a portable medical dictionary. There are even apps for those who want to look up clinical trials nearby, which is handy for those who are interested
in participating as a physician or patient. As of right now, 72 companies have put out a total of 1717 apps available on many technological platforms all together, including big U.S. Pharma companies such as Eli Lilly, Johnson & Johnson, Merck, Sanofi, and Novartis. Consumers everywhere are able to check out the website pocket.md, which contains a directory of all medical-related apps, and look for apps based on company, condition, type of mobile device, and a number of other criteria. Having access to medical information at the touch of a button is appealing to users everywhere, and apps are the best way for companies to reach out and to encourage learning in patients and healthcare providers. Smartphones and tablets are running today’s world, and it is important for the pharmaceutical industry to be able to run with them. References: 1. “Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.” U.S. Department of Health and Human Services (n.d.): n. pag. Food and Drug Administration. 25 Sept. 2013. Web. 6 Apr. 2014.
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