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2 posts from March 2017

03/29/2017

21st Century Cures Act – Promises or Problematic?

Late last year a new healthcare act was passed.  The 21st Century Cures Act has been lauded by many on both sides as a compromise that would help many sick individuals. The 21st Century Cures Act promised to bolster new cures and create faster regulatory processes that would help the nation get promising innovative cures to those who need them.   The basis of these claims is that the nation’s current set-up slows down innovation by asking for randomized control trials (RCTs) and spending too little on finding new cures. While these claims seem true on the surface, many criticize the new healthcare act for its incentives for pharmaceutical companies.  Personally, I have a saying that goes “A good compromise will probably leave both sides unhappy.”  So when an act passes with as much praise and speed as the new act did, I cannot help but wonder if the disadvantages would outweigh the advantages.  For this reason,  I will analyze the act’s contents to determine strengths and weaknesses of the act, then make an informed conclusion as to whether it is a net positive or negative.

The positives of the 21st Century Cures Act are numerous.  The biggest benefit for society  would have to be funding for the National Institute of Health (NIH).  The NIH is an invaluable part  of research funding in the nation.   Since the NIH does a large portion of its research through grants, organizations can more efficiently allocate money given to them in ways that benefit their research.  That established,  the new act has secured over 4 billion dollars for the NIH over the next 10 years.  The NIH is probably the single greatest driver of innovation owing to the intrinsic costs of pathophysiologic research.  The fact is that pharmaceutical companies can make no guarantee that the research to discover the pathophysiology of a disease will yield them any wealth.  It is actually a well-known fact that as much as $3 billion can be invested in new drug discovery research and no new drug may be approved by the Federal Drug Administration (FDA).  This is because the complexities of biology prevent researchers from always knowing the effect of changes they make.  In essence, intended benefits and side-effects generally do not yield actual benefits and side-effects.  So, funding the NIH to do the burden of such research frees pharmaceutical companies to aim more money on specific treatments. This will make it cheaper to find cures for disease with few or no treatments and expand the treatments already in existence.

One of the major concessions of the act, from a safety stand point, is that the 21st Century Cures Act has eroded the FDA’s strength to determine the value of new cures.  The problem with the act comes in the degradation of the data that is being given to the FDA.  It is no secret that RCTs are regarded as incredibly valuable data.  This owes to the fact that personal experience is subject to many external factors including one’s own biology.  The bigger issue with the new law and the FDA is “real-world experience.”  From a scientific standpoint, RCTs are “ideal-world experience”.  RCT’s do not give perfect data of all the flaws of a drug, they set a relatively high bar that allows the FDA to make reasonable assumptions about the safety of a drug.  By moving over to “real world experiences”, more side-effects could be missed.  This is important because many drugs carry risks that are not discovered until years after they have been in the market.  Considering that it takes 12 years to get a black box warning on a medication and 5 to get it removed, the negative implications of rapid approval start to become more worrying.   Without expediting the process of getting black box warnings added or getting drugs removed from the market, it becomes worrying that many new drugs are being added to the market. 

The 21st Century Cures Act’s most worrying aspect is that it could lead to many dangerous drugs coming to market, without novel drugs that may help ever seeing the light of day.  The FDA was created at a time when dangerous substances with little or no medical value were being peddled as cures.  The act could end up creating more overall problems caused by an expansion of medications known as me-too drugs.  To be fair, me-too drugs do come with benefits.  In the statin class, many me-too drugs currently exist for the sole purpose of competing with other drugs in that class.  Because the market, dyslipidemia, is so large even a small percentage can be worth billions over a decade.  If one can make an improvement in this class then the benefits are net positive.  Me-too drugs can also increase economic output via creating a need for advertising, production and other media.  Another noteworthy advantage is that it could lead to drugs that are not as potent as a competitor getting priced more cheaply to undercut the competition.  The problem is that, it could also jeopardize patient safety by adding many new drugs with too little information on them.  The lack of information could lead to inappropriate use creating harm or death.  For example, 81 mg aspirin is no longer sold under the therapeutic label of “baby aspirin”.  This is because it was noted that 81 mg aspirin could cause Reye’s syndrome in children with viral infections.   Adults are not subject to this same deadly adverse effect, and with the existence of other drugs such as ibuprofen or acetaminophen, it was decided that aspirin would no longer be used in children.  Since even well-known drugs can have interactions that are not well known for years, adding more medications with less data could have effects that will not bode well in time for society.  While adding new classes of drugs can hold many of the same negatives, it also gives a unique form of treatment.  In the long run, new drug classes could potentially be used in conjunction with existing therapy.  In this way, the funding for new drugs comes off as dubious.

In summation, while the 21st Century Cures Act was a well-intentioned idea, its overall likelihood for net negative healthcare is high.  The positives are noteworthy.  We will see more drugs enter the market.  This will almost assuredly increase the number of jobs and boost the economy in general.  New cures will help patients and lead to instances of better outcomes.  At the same time a rational person can look at the situation and say that the possibility for negatives does exist.  Adding 1 or two more high intensity statins could help the healthcare industry, but if a patient is statin intolerant then 20 new cure does not help.  Also, those who are already doing well on a statin but might need an additional medication will not benefit from this new act.  Adding more problems is the lack of data that is compounding this problem.  In the healthcare industry, mistakes can be life altering or threatening.  Adding more potential cures without sufficient data to assess them is not a good idea.  In this respect, the 21st Century Cures Act is problematic legislation that will not help patient healthcare as much as it was promised to do.

Adekunle O. Adejare, PharmD Candidate – ‘19

03/22/2017

More Faculty, Staff, and Student Acheivements

USciences American Society of Consultant Pharmacists chapter volunteered at the Star Harbor Senior Center in March to introduce the Vial of Life program, which encourages individuals to have their complete medical information ready in their home in the event that first responders and emergency medical workers are called. The information would allow them to know about the person’s medications, allergies, and illnesses.

The chapter has had a productive year, expanding opportunities on campus and off in the areas of leadership service, inter-professional education, working toward our mission for seniors’ medication safety, and networking.

In April 2016, PCP ASCP members joined a regional planning team with student and pharmacist members of Pennsylvania and Maryland ASCP chapters to plan the student track for the Mid-Atlantic ASCP Annual Conference held in August 2016.  In addition to planning, five PCP students attended this regional event in Alexandria, VA.

In the fall, the chapter raised funds for the Alzheimer’s Association and participated in the Walk to End Alzheimer’s at Citizens Bank Park.

Fall was also the kickoff for the First Annual Geriatrics Day on University of the Sciences campus.  This event took place during the National Week of Fall Prevention (coinciding with the start of Fall) and was an interactive, fun and educational event for the whole campus and local community.  ASCP students prepared baskets of questions related to both fall prevention and geriatric cognitive impairment. 

The chapter members also volunteered at the Stone Harbor Senior Center for Medication Education Day, sponsoring pharmacy bingo and providing additional activities related to medication safety, medication adherence, and immunization education.


A group of pharmacy students, led by Anika Fanlo PharmD’19, are participating in the Script Your Future Challenge. The group attended 14 events over the last two months including the MLK Day of Service Adult Health Clinic at Mt. Zion Baptist Church, Sunray Drugs Pharmacy, Sayre Health Center, West Philadelphia Community Center, The Watermark Rehabilitation and Skilled Nursing Home, Know Your Numbers Men’s Health Initiative 2017 at Enon Tabernacle Baptist Church, Clark Park Farmers’ Market, and the Cooper Rowan Student Clinic

The students distributed medication list wallet cards, pill boxes, posters, and encouraged patients to sign the pledge to take their meds. They also addressed health-related questions such as OTC recommendations, identified common side effects, counseled on device use such as inhalers, discussed risk vs benefit of adherence to patient’s chronic conditions such as hypertension, high cholesterol, diabetes, and asthma.

In total, they were able to get 170 signed pledges, distributed more than 250 wallet cards, and reached about 500 patients. Even after the competition is over, the group will continue outreach efforts to fortify current relationships and build new ones. They will also measure patient impact in West Philadelphia through patient surveys and adherence assessments.


USciences’ Community and Government Affairs, Philadelphia College of Pharmacy, Mayes College of Healthcare Business and Policy, and the Exercise and Wellness Management Program were all involved in The Healthier You Conference 2016 held in South Philadelphia on October 8. The event attracted hundreds of adults from the region for a day of fun activities to promote healthy living.

Event founder, Kristin Motley, PCP Field Supervisor and Compliance Coordinator, started the conference two years ago to encourage adults to make small changes in their lives now so they can avoid preventable health conditions like heart disease, diabetes, and certain types of cancer. Nidhi Bagga set the tone for the day by leading a Morning Meditation and Yoga class. Heidi Freeman facilitated an interactive mindfulness workshop, while PCP students, Lauren Farmer, Swara Kasbekar, and Amit Gupta hosted information tables on healthy eating, stress management, and smoking cessation. Elizabeth Greene and Andrew Mina from the USciences CPR Team was on hand to give live CPR demonstrations. Allen Choi, Shon Mathew, Christopher Geraci, and Anu Kurria, pharmaceutical and healthcare business majors, were conference interns and worked with the Executive Board to plan and promote the conference. 


The 2nd annual American Society for Brewing Chemists (ASBC) LABS Workshop in Philadelphia was held on Friday, March 10th at the University of the Sciences.  The USciences Brewing Science program opened their teaching laboratories for a hands-on lab in brewing microbiology.   Participants practiced ASBC methods for microbiology by evaluating a yeast slurry for potential spoilers.  Activities included microscopy, differential media, and bacteria ID methods. Volunteer Lab Leaders from breweries and USciences instructed the attendees.


Lia Vas, professor of mathematics, was invited to give presentations at several prestigious Australian universities during her sabbatical leave at Western Sydney University.

  • Western Sydney University, Feb 9
  • The University of Wollongong, Feb 23
  • The University of Sydney, Feb 28
  • The University of New South Wales, Mar 7

Paul Halpern was the keynote speaker at the inaugural Paul Ehrenfest Best Paper for Quantum Foundations Award Ceremony at the Institute for Quantum Optics and Quantum Information in Vienna, Austria on December 2, 2016: http://www.iqoqi-vienna.at/ehrfenfest-award/


PCP received notice from Accreditation Council for Pharmacy Education (ACPE) Continuing Education (CE) Commission that the Continuing Pharmacy Education Program was granted accreditation until January 31, 2022. 


The ASHP Foundation awarded the Philadelphia College of Pharmacy- University of the Sciences a $25,000 Pharmacy Residency Expansion Grant. This grant will support the PGY2 Critical Care Residency Program offered in conjunction with Cooper University Hospital. The goal of this grant program is to expand the number of ASHP-accredited residency positions.


Yardlee Kauffman PharmD, Assistant Professor of Pharmacy, was recently appointed to the PPA Editorial Board and acknowledged as an Adjunct Fellow with the Penn Center for Public Health. Kauffman also recently published an article about metabolic monitoring of second-generation antipsychotics. 


Dan Hussar PharmD spoke on the topic, “New Drugs of 2016,” at the Mid-Winter Conference of the Connecticut Pharmacists Association on February 2 in Southington, CT.  He and P4 student William Tidwell coauthored a paper, “New Drugs:  Elbasvir/grazoprevir, Velpatasvir/sofosbuvir, and Eteplirsen,” that was published in the January/February issue of the Journal of the American Pharmacists Association.


Philadelphia College of Pharmacy contributions at American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Clinical Nutrition Week (February 18-21, 2017, Orlando, FL):

    • Diana Solomon (Class of 2016) was recognized as the A.S.P.E.N. New Practitioner Award recipient for the Pharmacy Practice Section.
    • Basic Skills in Parenteral Nutrition Management: It’s All About the Acid-Base, No Trouble: Identification and Treatment of Simple Acid-Base Disorders: presentation by Angela Bingham
    • Nutrition and Metabolism Research Paper Session: Parenteral Nutrition— Metabolic complications occur more frequently in elderly patients receiving parenteral nutrition; high scoring abstract selected as one of six parenteral nutrition abstracts for oral presentation; Research team: Angela BinghamLaura Pontiggia, Laura Siemianowski, Colleen Smith, Rich Song, Jim Hollands
    • Parenteral Nutrition Appropriateness Consensus Recommendations: Monitoring Parameters to Promote Optimal Parenteral Nutrition Therapy: presentation by Angela Bingham as a representative for task force; Angela served on the Parenteral Nutrition Appropriateness Consensus Task Force for A.S.P.E.N. since 2014 with 11 multidisciplinary clinicians. This effort resulted in consensus recommendations regarding “When is Parenteral Nutrition Appropriate?” which was published online ahead of print on 2/17 and presentation at Clinical Nutrition Week. (http://journals.sagepub.com/doi/pdf/10.1177/0148607117695251)

Chris Dorian, P2, reported: PCPediatrics & PCP-SSHP recently collaborated to put on a Pediatric Pharmacy Roundtable event which was a huge success! Almost 100 PCP students met with 13 pharmacists in health-system pediatrics and it was a huge success!


Eric Simpson PharmD'19,  Operation Heart Patient Care Coordinator, worked with other Philadelphia College of Pharmacy student members to promote “Valentines for Heart Patients.”  This was designed to promote the American Heart Association campaign – February is Heart Month.  The volunteers set up in the STC atrium and invited students and faculty to sign a valentine card and add their personal message. 

The PCP students who volunteered are Monica Nguyen, ( NJPhA Coordinator); Anisha Benny, Telvin Mannat, Kevin Pak, Nina Vo, Bethina Escala.

Sixty cards were delivered to the Center for Advanced Heart Failure Care at Hahnemann University Hospital. Eric visited the center to hand deliver the valentines cards.


The members of the Center for Advanced Heart Failure Care dressed “red” to promote National Wear Red Day on February 3, 2017.  Grace Earl, PharmD participated in the National Wear Red Day, an American Heart Association campaign, to promote women’s health.  Dr. Earl is a faculty member in the Department of Pharmacy Practice and Administration, PCP, and her practice site is at the Center for Advanced Heart Failure Care at Hahnemann University Hospital.  


Philadelphia College of Pharmacy/USciences was well represented at the ASHP Midyear Clinical Meeting in Las Vegas from December 5 to 9, 2016. Ninety-one students were in attendance, mostly to interview for post-graduate pharmaceutical industry fellowship positions with most others pursing PGY1 residency positions including attendance at the residency showcases. There were 30 research posters presented by 45 students with many alums and preceptors visiting the posters. Students presenting posters received a travel stipend funded by alumni donations to the PCP Student Engagement Fund.

 

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