Wednesday, January 17, 2018
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June 2016
Announcements
Health-System Pharmacy Goes Global
by Nancy Palamara, NJSHP President-Elect

The Oath of a Pharmacist begins, “I vow to devote my professional life to the service of all humankind…” and continues “I will consider the welfare of humanity and relief of human suffering my primary concern.” It does not describe service to patients or citizens but to humanity. This has never meant more to me than since I began a new professional journey that has taken my service global.

In 2012 Holy Name Medical Center acquired The CRUDEM Foundation, Inc., a non-profit devoted to providing financial, volunteer and medical resources to Hôpital Sacré Coeur (HSC), the largest (125 bed) private hospital in the North of Haiti. Among the many challenges of providing quality health care in Haiti is the unreliable and very limited supply chain for pharmaceuticals.

Last spring, I made my first trip to HSC and met my pharmacy director counterpart, Marcelle Etienne. There was an instant comradery which strengthened as we compared our experiences and challenges. To my great surprise, as Marcelle rattled off her list of challenges, I ticked them off one by one against my own at home; never enough staff, not enough space, expense woes, lack of understanding of what pharmacists are capable, and the list goes on. Our geography, culture, and socioeconomics were vastly different, but the things that kept us up at night were exactly the same. We worried about the safety of our patients, job satisfaction of our employees, unexpected drug shortages, how to work collaboratively and successfully with the medical staff, and how to provide quality care while meeting all of the regulatory requirements.

Just weeks ago in May, we completed a pharmacy goal set prior to my involvement. Marcelle’s pharmacy was divided into 2 locations. One location was on campus where they dispensed to both inpatients and outpatients and the other off campus where they stored bulk inventory and packaged medications for dispensing. The exceptional challenge here was that the off campus depot resided a distance away equivalent to several city blocks on a very busy road. The result was a negative impact on inventory control, efficiency, staff oversight and unity. Our team of 10 Holy Name employees (only two of us from Pharmacy), took on the task of moving the two locations into one newly renovated space in one day while the HSC staff continued to work and care for their patients.

The work was incredibly rewarding as we witnessed not just the pharmacy staff, but all the hospital staff and patients look on in great interest. This seemingly small change to us, marked great progress at HSC and for the community it serves. At the end of the week, despite language barriers and cultural differences, the HSC and Holy Name pharmacies had become for me, one entity. Our efforts now shift to securing a consistent and affordable source of drugs and that too has expanded my interactions internationally as I find myself on video calls with a sales manager at a distribution company in the Netherlands. And so my global journey continues.

Headlines
NJSHP News
President's Message
As we begin a new year at NJSHP, I want to express my profound thanks to Steve Aragona for his work as our President for the last year. Steve has been a fantastic role model to me during my term as President-Elect, and he has done an incredible job with the Board of Directors and all of our constituent groups within the Society. NJSHP is truly one of the best state affiliates in the country, and Steve has been a great leader for us. I am truly indebted to him for his great work.

I also want to welcome our new members of the Board of Directors. All of our new Board members participated in an orientation session on May 9 prior to our regular Board meeting. This orientation session went through the basics of being a member of the Board of Directors, including our policies and procedures, our constitution and bylaws, and the responsibilities that a Board member has to the membership of the Society. It was also a great way for our new Board members to get to know each other and the existing Board members.

We continued our orientation on Friday, June 24, at our annual strategic planning meeting. Kimberlee Berry from the ASHP office of affiliate relations will once again be our facilitator for this important session. Kim has been a great resource to the Board of Directors for the last year, and we have made great strides in implementing the plan that was created in 2015. I am excited to see how our strategy is renewed by our new Board of Directors this year.

It is an exciting time to be a pharmacist in New Jersey! Our profession is evolving very quickly, and we as your leadership team for the Society want to make sure that we are representing you and the needs of the health system pharmacy community. You will be receiving a survey soon asking what you need from the Society. Please take a few minutes and complete the survey using the online tool. This will greatly help us to develop our goals and focus our efforts on the areas that you tell us are of primary importance.

On a final note, I want to once again congratulate our friend Carlo Lupano for being named as a Fellow of ASHP. Carlo was awarded his fellowship at the ASHP Summer Meetings on June 14, and was the only pharmacist from New Jersey to be named as a Fellow for this year. Carlo has been a leader in the health systems pharmacy community for many years, and his fellowship is well deserved. Carlo currently serves on the state level as our Chair for the Council on Public Policy, and I am thankful to have him with us on the Board for the next two years.

Thank you all for your active membership in NJSHP, and have a great summer!

PTCB Job Analysis Survey - Earn 1 Free CE
PTCB is asking all CPhT’s certified with PTCB to complete a job analysis survey. The survey will collect data on the tasks, knowledge, and skills of pharmacy technicians in every state and practice setting. PTCB will use the survey results to analyze the requirements of the occupation, and develop content for the next update of PTCB's Pharmacy Technician Certification Examination (PTCE) and to determine other important job¬ related standards and requirements. Your input is extremely valuable and will make a significant contribution to your occupation. Please complete the survey no later than July 4, 2016. CPhTs certified with PTCB will be eligible to earn 1 CE hour after completing the survey. To complete the survey go to https://www.humrro.org/PTCBstudy.
ASHP Board of Delegates: New Jersey Delegation Report - June 2016
The ASHP House of Delegates convened for the annual in-person session on June 12 and 14, 2016, as part of the ASHP summer meetings in Baltimore, Maryland. The New Jersey delegation of Timothy Reilly, Luigi Brunetti, and Paul Goebel worked with a total of 190 delegates to address the policies and resolutions brought forward for consideration.

A total of 24 policies were reviewed and considered during the past year, and were passed either in the March 2016 virtual House session or in person at the June 2016 in person House session. As the official policy-making body of ASHP, the House of Delegates is your representative body to the Society. The most important policy to be passed by the House this year is policy 1624, which advocates for a ban on direct-to-consumer advertising of prescription drugs and medication-containing devices. The House also passed important policies related to the timely licensing of pharmacists, career opportunities for pharmacy technicians, and many other issues at the forefront of health-system pharmacy practice.

The House also considered a resolution to change the existing policy, ASHP policy 9915, ASHP Position on Assisted Suicide. The resolution proposed amending this policy to state that ASHP oppose pharmacist participation assisted suicide, and to reaffirm that pharmacists have the right to refuse to participate in assisted suicide without retribution. The House voted in favor of referring this resolution to the appropriate ASHP Council for further study. This resolution will come back before the House for consideration either during one of the House of Delegates virtual sessions or by the 2017 House of Delegates in-person session.

As your elected delegates to ASHP, we encourage you to participate in the legislative process for the Society with us. Please send us your comments and suggestions either to the NJSHP office or by electronic mail at njshpdelegates@gmail.com. A full report of the policies passed by the House of Delegates, as well as all other reports related to activities of the House can be seen at www.ashp.org/hod.

Tri-State Health-System Pharmacy Summit 2016 - Friday, September 30th
Please mark your calendar to attend our 4th annual Tri-State Summit (NJ, NY, CT), which will be convened on September 30th at the DoubleTree by Hilton Hotel Tarrytown, 455 South Broadway, Tarrytown, NY 10591. More details will follow.
Save-The-Dates - 2017 Annual Meeting
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ASHP News
ASHP Attends White House Meeting on Efforts to Tackle Opioid Abuse
Pharmacist Group Stresses Need to Ensure Appropriate Pain Management for Patients

5/27/2016
ASHP participated in a meeting yesterday with several senior White House officials to discuss the Obama Administration’s efforts to address the opioid overdose and misuse epidemic. The session, coordinated by the Office of National Drug Control Policy, is the first in a series of meetings with healthcare provider and patient advocacy groups that are working to expand access to opioid treatment, prevention, and recovery resources.

Read More

WSJ Op-Ed Calls for Including Pharmacists on Patient Care Teams
5/23/2016
A recent Wall Street Journal op-ed assessing ways to reduce medical errors in the U.S. strongly recommends including pharmacists on care teams. “How to Make Hospitals Less Deadly” by James B. Lieber notes that pharmacists’ extensive knowledge of medications offers an important barrier to common medical errors. “Doctors have only glancing knowledge of how an ever-multiplying number of drugs interact with diet, age, disease, body type and each other,” he writes, pointing to a study that showed placing pharmacists in patient areas decreased errors by 45% and cut errors leading to death or severe harm by 94%.

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ASHP Launches Certificate Program in Sterile Compounding
Online Continuing Education Provides Practice-based Training in Fundamentals of Aseptic Processing

5/23/2016
ASHP recently released the latest offering from its Professional Certificate line, the Sterile Product Preparation Training and Certificate Program. The online continuing education program provides pharmacists and pharmacy technicians with the knowledge and essential skills necessary for safe and effective sterile product preparation.

Read more

Maine Enacts Statewide Limits on Opioid Prescribing
[June 15, 2016, AJHP News]

Kate Traynor

BETHESDA, MD 20 May 2016 - Healthcare providers in Maine have about six months to rethink their approach to pain treatment before a new state law limiting opioid dosages and the duration of therapy takes effect.

The law, which goes into effect on January 1, 2017, restricts opioid prescriptions to a dosage of no more than 100 morphine milligram equivalents (MME) per day of any opioid or combination of opioid-containing medications.

Read more

In Indiana, Decongestant Access Hinges Partly on Pharmacists’ Judgment
[June 15, 2016, AJHP News]

Cheryl A. Thompson

BETHESDA, MD 20 May 2016 - With partial credit to the Indiana Pharmacists Alliance, a new law in the Hoosier state leverages pharmacists’ judgment to accomplish two goals: (1) to keep pseudoephedrine available without a prescription to residents with a clinical need for the decongestant and (2) to disrupt the supply chain for methamphetamine production.

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Pharmacy News
Telepharmacy Pulls Hospital Through Storm
Drug Topics (04/10/16) Vecchione, Anthony
When Winter Storm Jonas hit North Carolina in January, some personnel, including pharmacists, were prevented from getting to work. However, other pharmacists who worked in their home offices far from the storm were able to verify orders remotely as a result of technology from PipelineRx. Working in conjunction with hospital IT personnel, PipelineRx's certified pharmacists gained access to patients' electronic health records (EHR) remotely through a secure channel such as virtual private network (VPN). The ability to have a pharmacist verify orders remotely decreases the pharmacy's burden or can eliminate the need for having a pharmacist on call, says Lindsay Burke, PharmD, director of pharmacy at North Carolina Specialty Hospital. At present, the hospital employs the services of PipelineRx over weekends, on holidays, and during weather emergencies. Brian Roberts, CEO of PipelineRx, says PipelineRx employs about 120 experienced hospital pharmacists (PharmDs) who work from home offices nationwide. "We have customers between 200 and 1,000 beds — large medical centers where they give us a wing or a portion of their hospital," says Roberts. Some hospitals that need 1.5 fulltime equivalents (FTEs) at night might outsource half the FTEs to PipelineRx, where they work side-by-side with the nighttime pharmacist. PipelineRx's client base also includes surgery centers, long-term-care centers, and rehab hospitals. Recently, the company started selling or leasing its technology back to large hospital chains.
Williamson Medical Center Antibiotic Program Draws Applause
Tennessean (05/17/16) Fletcher, Holly
An initiative by Williamson Medical Center of Franklin, TN, to curb unnecessary antibiotic use has been lauded in a recent report from Pew Charitable Trusts' antibiotic resistance project. The report examines how different facilities are trying to design programs to make sure antibiotics are prescribed appropriately. CDC reports that antibiotic-resistant strains of bacteria are concerning to public health officials because more than 2 million patients are infected annually with resistant organisms. Antibiotic stewardship programs, such as the one developed by Williamson Medical Center, helps clinicians decide when is appropriate to use antibiotics, said David Hyun, MD, senior officer of Pew Charitable Trusts' antibiotic resistance project. Officials at Williamson Medical Center began talking about a stewardship program in 2009 when a "forward thinking" physician wanted to tackle how the hospital was prescribing antibiotics, said Montgomery Williams, an internal medicine and antibiotic stewardship pharmacist at Williamson Medical Center. The hospital has a microbiology department and lab on site that tests cultures. A team of pharmacists makes recommendations for modified treatments, and the hospital has a system to track how often the recommendations are accepted by physicians. Williams attributes much of the success of the program—pharmacist recommendations were accepted more than 87% of the time in 2014—to the physicians' willingness to work with the pharmacists.
Inspectors Find California Hospital's Pharmacy Posed Infection Risk
Kaiser Health News (05/19/16) Terhune, Chad
State records show that 7,300 patients at Paradise Valley Hospital in National City, CA, may have been exposed to infection from contaminated medications last year. Inspectors found "dust, stains, and foreign material" in a supposedly sterile environment where thousands of I.V. drugs were prepared between January and August. The report also stated that the hospital's head of infection control both neglected the compounding lab in question and falsified documents to cover up her failure. She was fired in August. The hospital was fined $17,500 in December, and a spokesman said it is appealing the fine, noting that outside lab tests found no contamination of the pharmacy or medications. According to a spokeswoman for Prime Healthcare Services, which owns Paradise Valley, it was not necessary to notify patients who received the compounded medications during the 8-month period because "further analysis found no evidence of contamination during this time period."
The Top 10 C-Suite Points Bringing Pharmacy Out of the Basement
Hospitals & Health Networks (05/16) Sloane, Todd
As the health industry shifts to value-based care, C-suite executives are turning to pharmacists to anchor multidisciplinary care teams aimed at managing patients with chronic conditions. There are many situations that executives will face in which pharmacists can help, including adverse drug events, tougher compounding medication regulations, opioid abuse, pharmacy leadership issues, and antibiotic stewardship. Pharmacists may be the necessary contacts for these pain points, providing both knowledge and insight pertaining to the specifics of drugs and their effects as well as information regarding patient safety. Other issues facing the C-suite include health system integration, the 340B Drug Pricing Program, hospital readmissions, accreditation, and rising drug costs. Pharmacists can assist in all of these areas because pharmacy plays a critical role in patient care and health system operations. In addition, pharmacists can help formulate plans to usher in a new era of national policy that lowers drug costs and makes health safer and more affordable for patients.
Inventing a Machine That Spits Out Drugs in a Whole New Way
NPR Online (05/23/16) Bebinger, Martha
A prototype machine developed at the Massachusetts Institute of Technology (MIT) produces 1,000 capsules in 24 hours, a process that can take months for some batches at a big pharmaceutical manufacturing plant. The device—which is about the size of a kitchen refrigerator—raises the possibility that hospitals and pharmacies could make their own tablets as needed, potentially lowering the high costs of medications by creating competition between manufacturers. The drug industry has two key concerns about the widespread use of the device: intellectual property rights and safety. Drug manufacturers own exclusive rights to produce the drugs they develop for a period of time, and worries about safety include continuous monitoring of machines to ensure safety and quality. MIT developers are currently focused on making a smaller more portable unit, producing more and more complex drugs, and seeking FDA approval for the device.
Money-Back Guarantee: The New Trend in Drug and Device Marketing
STAT News (05/31/16) Numerof, Rita E.
To overcome price resistance for costly drugs and medical devices, manufacturers increasingly are offering hospitals, insurers, and other buyers money-back guarantees. Cigna, for example, has promised to lower the price paid for two new cholesterol drugs if actual patient outcomes are not on par with clinical trial results. Meanwhile, Stryker agreed to pony up as much as $5 million in legal costs if its tracking technology misses a sponge accidentally left in a surgical patient. This shared-risk model positions drug and device makers to champion the true value and performance of their products, writes Rita E. Numerof, PhD, president of Numerof & Associates. "Embracing true reform of the payment model is one way [the pharmaceutical industry] can begin winning back goodwill," adds Numerof, whose company guides health care-related businesses to strategies for winning in dynamic markets. "This is market-based health care at work, which is a good thing for us all."
Education, Reminders Reduce Risky Prescriptions for Older Adults
Medscape (05/21/16) Harrison, Laird
A program that provides systematic education and reminders in an emergency department (ED) can greatly reduce the risk of inappropriate medications being given to older patients. Researchers, who presented their work at the American Geriatrics Society 2016 Annual Scientific Meetings, discussed the EQUiPPED (Enhancing Quality of Prescribing Practices for Older Veterans Discharged From the Emergency Department) program. The program is made up of a team of geriatricians, gerontologists, geriatric pharmacy specialists, and others—all working to reduce the proportion of risky prescriptions prescribed to older veterans to less than 5%. To do this, the team educated the providers and scheduled one-on-one meetings to talk about medications that could be risky. Then they collected the data and modified prescription order sets to work safer and more effectively for older patients. At four separate sites, the proportion of potentially inappropriate medical prescriptions dropped after applying the EQUiPPED program. The EQUiPPED program is now being used in eight Veterans Affairs medical centers, and the team is helping other EDs and non-VA hospitals to implement the program.
FDA Delays Rule on Generic Drug Labels
New York Times (05/20/16) Thomas, Katie
The Food and Drug Administration (FDA) will wait until next year to decide whether generic drug companies can be sued for failing to update warning labels to reflect new risks. While both brand-name and generic makers are obliged to make the change, the Supreme Court in 2011 ruled that patients harmed by generic versions of a drug could not take legal action because the manufacturers had no control over the language in the warning labels. The FDA proposed 2 years later to hold generic companies to the same standard as brand-name manufacturers but has yet to take action on this front. While the delay in decision making comes as a frustration to consumers advocates and representatives for trial lawyers, generic drug makers, pharmacists, hospitals, physicians, and other interests applaud the agency's unrushed approach. "FDA clearly appreciates the strong concerns articulated by a majority of health care experts, particularly those closest to patient prescribing," said Generic Pharmaceutical Association CEO Chip Davis.
How Patent Troll Legislation Can Increase Timely Access to Generic Drugs
JAMA Internal Medicine (05/16/16) Treasure, Carolyn L.; Kesselheim, Aaron S.
Congress has rolled out legislation to rein in "patent trolls," which acquire patents for the sole purpose of suing companies that develop products infringing on those rights. Although the measure likely will have the biggest impact on the technology sector, there are also implications for the generic drug industry, write Carolyn L. Treasure and Aaron S. Kesselheim of Brigham and Women's Hospital and Harvard Medical School. Off-brand medications are routinely delayed from entering the market for years through secondary patents, sought during clinical testing and based on small changes in product formulation or other minute differences. These 20-year secondary patents, which overlap the 20-year primary patent and thus afford drugmakers prolonged market exclusivity for a medication, could become easier for generic drug companies to beat in court if the Protecting American Talent and Entrepreneurship (PATENT) Act becomes law. By introducing the inter partes review process, a much less costly and more streamlined proceeding than litigation, the PATENT Act would make it possible for generic drugmakers to challenge frivolous patent lawsuits without spending millions of dollars. The biopharmaceutical and biotechnology industries naturally are opposed to the law and have lobbied for a blanket exemption to the inter partes process, without much success so far.
Three New FDA Draft Guidance Documents for Drug Compounders
Regulatory Affairs Professionals Society (04/15/2016) Brennan, Zachary
FDA on April 15 released three draft guidance documents for drug compounders, describing the agency's interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act, how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term "facility," in reference to section 503B of the FD&C Act. Each draft guidance document is available for public comment for 90 days. Lee Rosebush, a partner with the law firm BakerHostetler, says the guidance "is going to hurt traditional compounding pharmacies, as it is clear they are not going to be able to do office use compounding." FDA has also expanded the role of a 503B facility, particularly into the hospital market, he says. The draft guidance on prescription requirements notes: "Hospitals, clinics, and health care practitioners can obtain non-patient-specific compounded drug products from outsourcing facilities registered under section 503B. Outsourcing facilities, which are subject to CGMP requirements, FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that provide greater assurance of the quality of their compounded drug products, may, but need not, obtain prescriptions for identified individual patients prior to distribution of compounded drug products." Rosebush says there will be a major impact on hospital pharmacies as "a pharmacy in a hospital cannot compound medication and send to another hospital in the same system unless the hospital pharmacy is registered as a 503B facility with the FDA."
 
June 2016
Sponsors
Boehringer Ingelheim
Bristol-Myers Squibb
GNYHA Services, Inc.
Grifols USA
H. D. Smith
Octapharma
Omnicell, Inc.
Pharmatek Systems
PharMEDium Services
Safecor Health
Silvergate Pharmaceuticals
The Medicines Company

About NJSHP
To be visibly engaged in the enhancement of healthcare through professional development of our members in the practice of pharmacy.



Follow us on Twitter at @njshp or tag us in your posts using the hashtag #njshp

New Jersey Society of Health-System Pharmacists
760 Alexander Rd
P.O. Box 1
Princeton, NJ 08543-0001
(609) 936-2205

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About ASHP
ASHP is a 35,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP is the only national organization of hospital and health-system pharmacists and has a long history of improving medication use and enhancing patient safety.

American Society of Health-System Pharmacists
7272 Wisconsin Avenue
Bethesda, MD 20814
301-657-3000

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Calendar
National Pharmacy Preceptors Conference
8/11/16 - 8/13/16
Washington Hilton, Washington D.C.,
August 11-13, 2016
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