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7 posts from October 2012

10/29/2012

The Meningitis Tragedy – More Regulation is Not the Answer

By Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Twenty-four deaths and 317 people ill with meningitis at the time I prepare this commentary.  And the story is far from complete. Meningitis, Deaths, Compounding Pharmacies, New England Compounding Center (NECC) have dominated the media headlines in recent weeks.  Most of the deaths and illness from meningitis are considered to be attributable to a heretofore obscure fungal organism (Exserohilum rostratum) that was a contaminant in presumably sterile formulations of methylprednisolone that were administered by epidural injection for the treatment of back pain.  The product was prepared by the New England Compounding Center in Massachusetts and distributed to physicians and hospitals in numerous state.

Tragedy
I do not use the word “tragedy” lightly.  It is the strongest word that I think of to describe the consequences of the situation that has occurred.  It is an appropriate description for one death that was preventable, but this situation is multiplied many times over.  In addition, hundreds of patients have been diagnosed with meningitis, and thousands of others have received injections from the same lots of medication and not experienced complications but are fearful that they will. There are many components of this experience that will continue to be examined and discussed in depth.  However, none of them should be allowed to diminish the concern and compassion for the families of those who died, and the efforts to accomplish the recovery of those who are ill with meningitis.

The New England Compounding Center
Information provided by the Food and Drug Administration and other agencies, as well as news reports, strongly suggest that there were multiple failures on the part of the NECC with respect to compliance with standards, procedures, and safeguards that are applicable to the preparation of sterile products.  I can’t explain the reasons for these failures and will not attempt to defend them.  Extensive discussion has centered around the questions as to whether NECC should be considered a compounding pharmacy or a pharmaceutical manufacturer, and which regulatory agency is responsible for monitoring its operations.

Compounding pharmacies
At one time all pharmacies compounded prescriptions but, at present, most pharmacies do little or no compounding.  However, in recent years there has been an increased awareness that the health needs of many patients can be best served by combinations of medications and inactive ingredients and/or special dosage forms that are not commercially available.  Compounded prescriptions can be considered to be the original personalized medicines.  Accordingly, many pharmacists have emphasized compounding as an important component of their practice and the practices of some pharmacists are entirely committed to the compounding of prescriptions and related services.  In addition to being licensed by a state board of pharmacy, there is a voluntary accreditation process in which many of these pharmacies participate and are evaluated.

Some pharmacists limit the extent of their compounding to non-sterile formulations whereas others have the facilities, equipment, and procedures to also prepare sterile products and other specialized formulations.  The number of prescriptions dispensed by most compounding pharmacies is relatively small when compared with the number of prescriptions dispensed in traditional pharmacies, and the patients served are in the local community.  A smaller number of compounding pharmacies prepare a much larger number of prescriptions for patients in a larger geographical area.  However, regardless of whether the number of compounded prescriptions is small or large, a central tenet of a compounding pharmacy practice is that each prescription is prepared for a particular patient.

Manufacturing
The manufacturing of pharmaceutical products has been the responsibility of pharmaceutical companies that then provide the products to pharmacies, physicians, or others that are authorized to provide the medications to patients.  The Food and Drug Administration (FDA) is the agency that has the authority to regulate pharmaceutical manufacturers.  However, the FDA does not have the authority to regulate the practice of pharmacy or the practice of medicine.  This is the responsibility of the state licensing boards.

An important question that has emerged in the tragedy resulting from the use of contaminated injections is whether the NECC functioned as a compounding pharmacy and supplied medications for individual patients, or whether it functioned as a manufacturer that supplied products for subsequent use in individuals for whom it did not have names or records.  Three lots of methylprednisolone injection, representing a total of 17,676 vials, have been implicated in the occurrence of meningitis that has been attributed to contamination of the product.  This large number of vials coupled with the apparent lack of patient names on the labels of vials, as well as additional information derived from the multiple investigations that are underway, give every appearance that NECC was engaged in manufacturing.         


More regulation is not the answer!
State Boards of Pharmacy have regulations that are applicable to the practice of pharmacy and the operation of pharmacies, and the FDA has regulations that are applicable to the companies that manufacture pharmaceutical products.  Some of the news reports of the meningitis tragedy have made reference to the “loosely-regulated” area of compounding pharmacy, and some legislators and others are calling for tighter regulations for these pharmacies.  However, I would contend that the current regulations are sufficient and provide appropriate authority for the regulatory agencies.

News reports indicate that both the FDA and the Massachusetts Board of Pharmacy had communicated concerns to NECC on previous occasions.  Apparently there was an awareness of existing problems or the potential for such.  In my opinion, the problem in the current situation is that existing regulations were not adequately monitored and enforced with appropriate actions.  I feel that the FDA and boards of pharmacy do not have adequate resources and staffing to appropriately fulfill their responsibilities and this situation must be addressed.  More regulation is not the answer – instead, we must direct our efforts to increase the monitoring and effective utilization and enforcement of regulations we have now.

In an area such as compounding pharmacy, it is unlikely that the officials and investigators of the FDA or a board of pharmacy will have significant experience and expertise in the operations and responsibilities being evaluated.  I recommend that these agencies appoint advisory panels of pharmacists, and others as appropriate, with pertinent experience and expertise who can provide objective recommendations that will be of value to the agencies in making the most appropriate decisions.  The current use of advisory committees by the FDA to make recommendations regarding the approval of new drugs provides a model that can be considered.

Daniel A. Hussar

10/25/2012

Don’t Worry Jeremy…A Job in Exercise Science Awaits

Jeremy Epstein, a 20-year old EXERCISE SCIENCE major asked the presidential candidates for reassurance for himself and his parents about post-graduation employment. Did the candidates realize that Jeremy is in a rapidly developing field with a plethora of opportunities! Exercise Science is a quietly booming program for the student who not only has the degree but who graduates with certifications, internships, and fieldwork experience. These acquired skills are what separate the USciences’ Exercise Science & Wellness Management majors from the rest of the competition.

A Field In Demand

Exercise Science & Wellness Management majors are in demand particularly in corporate wellness. More employers than ever are looking for exercise specialists, program directors and wellness managers to lower their company’s healthcare costs, improve productivity and employee morale. Human Resource Management (2006) states that 62% of employers already have wellness programs in place. The job growth of wellness professionals, particularly health educators, is expected to increase by 37% through 2020 (Bureau of Labor Statistics, 2012).  The healthcare reform provides for employers to incentivize employees to participate in wellness programs by offering a 20% reduction in healthcare premiums.  The incentive increases to 30% by 2014. The focus is now on preventive action and the Exercise Science & Wellness Management student is in desperately needed to lead the way. National initiatives such as Exercise is Medicine, Health People 2020, Couch to 5K, 10,000 Steps A Day and even treadmill workstations are now common in the corporate world.

Exercise Science & Wellness Management students may also find positions in colleges, high schools and community centers and recreation areas as strength & conditioning specialists, wellness directors, health educators, public health specialists and even as wellness coaching entrepreneurs.

Training and Certification Program Comes to USciences

USciences is hosting the National Wellness Institute Certified Worksite Wellness Specialist training and certification in April 2013.  Over 125 wellness practitioners and several of our students will partake in this intense training and national qualifying exam to become Certified Worksite Wellness Specialists. Our students who graduate from our accredited Exercise Science & Wellness Management program with a minimum GPA of 2.75 are also eligible to receive the Certified Wellness Practitioner (CWP) designation. We offer our students certification classes in Professional Rescuer CPR/AED & First Aid and preparatory classes for the American Council on Exercise Personal Trainer Exam and the National Strength & Conditioning Association Certified Strength & Conditioning Specialist (CSCS) exam as well as provide instruction in vital sign assessments such as cholesterol and glucose testing, blood pressure, pulse oximetry, muscular strength and endurance, cardiorespiratory endurance and biofeedback technology.

Don’t you worry, Jeremy…the Exercise Science & Wellness Management jobs are out there.  The American Journal of Health Promotion (2012) affirms that wellness is a billion dollar industry. Students from USciences are the qualified professionals who will be hired for these positions without someone telling them “the future is bright.” We already know it is.

10/21/2012

Public Health and Pharmacy - Videos Communicate Healthcare Messages

Pharmacy and Public Health students created public health video messages in conjunction with Dorrance H. Hamilton Media Commons at WHYY.  Messages were geared toward health related themes such as medication use, hepatitis B, and even fracking.  See here for links to the videos themselves. Link to public health videos and full story

 

 

10/14/2012

New book: Edge of the Universe

I'm pleased to announce that my new book "Edge of the Universe: A Voyage to the Cosmic Horizon and Beyond" is now available.  It offers a look at cutting-edge theories in cosmology, the science of the universe.  Here's a link to more information:

Edge of the Universe: A Voyage to the Cosmic Horizon and Beyond

 

Interviewing physicist John Wheeler

When I received a Guggenheim Fellowship back in 2002, one of the joys it offered was getting a chance to interview some of the greats in the field of physics. A particular pleasure was meeting John Archibald Wheeler, who was a student, collaborator, and mentor of some of the most notable physicists of the 20th century. Wheeler famously coined the expression "black hole."  

 

In his 90s at the time, Professor Wheeler still maintained an office at Princeton and visited weekly. When I was researching the history of higher dimensions, a project that ended up becoming my book The Great Beyond, he generously gave several hours of his time for a morning interview.

I was very much impressed by his keen memory of certain events of the 1930s through the 1950s, particularly his interactions with Einstein who was his neighbor. Einstein was kind to Wheeler’s children and later to Wheeler’s students. For one of the first relativity classes ever offered, Einstein offered a friendly hand.  In 1948, after Wheeler’s student Feynman proposed Quantum Electrodynamics, Wheeler recalled how Einstein was dubious.

Wheeler’s sense of humor and gracious attitude were readily apparent. It was easy to see why he was so beloved by his students. At one point I commended him for his book (with Thorne and Misner) Gravitation. He proceeded to show me a copy in Chinese, and dryly commented that I could use the book to learn that language.

Wheeler spoke of winning the inaugural Einstein prize for general relativity, along with Peter Bergmann. He had called Bergmann to congratulate him and had left a message, but before they could speak on the phone, Bergmann had passed away.

Wheeler showed me some of the photographs of him with certain notables such as Yukawa, and explained his interest in discerning the “why” of life. What a remarkable figure in physics, who contributed so much to modern thought.

Wheeler passed away in 2008 at the age of 96.

10/11/2012

Our Professional Autonomy and the Health of our Patients are at Risk!

We Need More Independence in our Practice Responsibilities and More Independent Pharmacies

By Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Our profession of pharmacy has made some notable advances in recent years and we should be encouraged by what has been accomplished. However, we must also be prepared to identify and challenge the situations and influences that compromise our efforts and restrict the extent to which we can use our knowledge and skills regarding drug therapy for the benefit of our patients and society.

At the same time that our authority and autonomy for making decisions that influence drug therapy is growing in some areas, it is declining in other areas. Although most pharmacists might claim that they have the freedom to exercise their best professional judgment in making decisions regarding drug therapy, is this really the case? I would contend that the situations in which pharmacists have decision-making authority in their practice environment are declining rather than increasing.

Most Americans have insurance coverage and/or a prescription benefit plan that covers a large part of the cost of prescription medications. The government agencies, insurance companies, and PBMs dictate the policies and terms of the prescription programs, including the formulary of medications that are covered, situations requiring prior authorization, and the compensation to be provided for professional services and reimbursement of the cost of the drug product.

Most prescriptions provided to ambulatory patients are dispensed by employee pharmacists in chain pharmacies and other large retail stores, and in mail-order pharmacies. The policies and procedures of these pharmacies are typically developed by executives and managers who are not pharmacists and who are motivated more by the economics of the business and pleasing shareholders rather than the scope and quality of professional services for patients. Many chain pharmacists voice repeated concerns about inadequate staffing that results in their not having the time to contact a physician to verify the validity of a prescription for a narcotic or to seek clarification for a drug interaction alert for which an override is an easy option. Mail-order pharmacists do not see or speak with their "patients," and the nature of the mail-order system results in many individuals not receiving their medications on a timely basis. Do these pharmacists actually have the autonomy and opportunity to practice in a manner that will best serve and protect the health care interests of their patients? The answer is, "No!"

Even in hospitals, in which a commitment to the provision of the most comprehensive and intensive patient care is expected, pharmacists often do not have the authority and autonomy to practice in a manner in which there is optimum use of their expertise and skills. Although some hospital pharmacists have assumed expanded responsibilities in hospital administration, they often encounter economic and political realities that require higher-priority attention than their desire to provide additional pharmacy services. Hospital pharmacists often have important positions in Pharmacy and Therapeutics Committees and other forums within the hospital. However, they are usually not successful in "competing" with medicine, nursing, etc. for scarce institutional resources that could be used to extend the scope of the services provided by pharmacists. Some will respond that I am understating the accomplishments of pharmacists in the hospital setting. My response is that, if the scope and quality of pharmacy services in the hospital were where they should be, we would have seen a dramatic reduction in the occurrence of medication errors. As in the community setting, the autonomy of pharmacists is also very limited in the hospital setting.

Physicians
It is noteworthy that the profession of medicine and individual physicians are facing many of the same challenges that pharmacy is. The number of physicians in individual private practices has sharply declined as group practices of physicians have been established. Although the authority and autonomy of an individual physician are reduced when compared to a private practice, the authority still rests with the group of physicians. However, with increasing frequency, hospitals are acquiring physician practice groups with the result that the physicians relinquish most of the decision-making authority they had previously. There are also situations in which insurance companies are acquiring hospitals.

There are sharp differences of opinion regarding recent changes pertaining to health care (e.g., Medicare coverage of prescription drugs for outpatients, Obamacare). However, if there is one situation in which there is almost complete agreement, it is that there is now or soon will be a huge shortage of primary care physicians that will continue well into the future. I recently became aware of the following situation that has very important implications with respect to the supply of primary care physicians and other health professionals, including pharmacists. A group medical practice comprised of approximately 10 primary care physicians plus physician assistants and nurse practitioners is owned by the local hospital. The group practice has two practice sites and most of the patients at one of the practice sites receive health care services that are funded by the Medicaid program. The hospital reaches a conclusion that it is losing too much money at this practice site and makes a decision to reorganize the group practice. The result is that several primary care physician positions are eliminated and replaced with positions for lower-salaried physician assistants and nurse practitioners. Although the physicians who were affected by this reorganization of the group practice identified other positions, there was a challenging transition in their responsibilities. In addition, there was a disruption in the continuity of care for hundreds of patients who now had either a different primary care practitioner, or a different practice group to which they transferred to stay under the care of the same physician.

I understand the importance of the economic concerns that have dominated the recent consideration of health care issues. These concerns must be effectively addressed but that is beyond the scope of this editorial. Rather, my focus is on the question of who is making the most important decisions regarding health care or, more specifically, who is not making these decisions. In most situations it is not physicians, pharmacists, or other health professionals who are making the decisions that will have the greatest influence on the scope and quality of health care. Health professionals have lost much of our autonomy and decision-making authority, and are at risk of losing more.

Consequences
To a large extent the challenges and problems experienced by the health professions are self-inflicted. We have not been accountable, we have not been transparent, we have not been willing enough to communicate and collaborate both within the individual health professions and between the professions. However, those at greatest risk are our PATIENTS, who so often are the victims of our haste, negligence, errors, and lack of sufficient caring. Is there really any excuse for the extent that medication errors and drug-related problems such as drug interactions and noncompliance continue to occur?

The September 22-23, 2012 issue of The Wall Street Journal includes a feature article (page C1) titled, "How to Stop Hospitals from Killing Us." Written by a surgeon, Marty Makary, the article includes experiences and statistics that all would agree are unacceptable. The author also identifies an "unspoken rule"Ñ"to overlook the mistakes of our colleagues." Dr. Makary has written a book that I plan to read - Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care.

Far too many of our patients are at risk. My expectation is that an even larger number of patients will be at risk if there is a continuation of the erosion of autonomy and decision-making authority of pharmacists and physicians.

Recapturing our autonomy
I am not suggesting that we have to return to the system in which almost all community pharmacies are owned by pharmacists and almost all medical practices are owned by physicians. However, in my opinion, the pendulum has swung too far to the other extreme in which a large majority of health professionals are employees of corporations, hospitals, etc., in which individuals who are not health professionals have the authority to make decisions that will influence the health care and safety of patients.

We must recapture our autonomy! The health of our patients is at risk! Our license to practice could be at risk if we do not take the time and provide the information and services that patients need to assure optimum outcomes from their drug therapy. I know that it is difficult to voice a concern to an employer or manager when you sense that there will not be receptiveness to your recommendation. But we must not tolerate situations that represent a disservice or risk to patients whose health we are committed by our license and conscience to protect and improve.

More independent pharmacies are needed
I am of the strong belief that the future progress and success of the entire profession of pharmacy is inextricably linked to the extent that independent pharmacies are able to survive and thrive. Independent pharmacists are the members of our profession who have the best opportunity to provide face-to-face personalized advice and services for patients. They are the "front-line," but all pharmacists are the beneficiaries of the reputation for integrity and ethics that our profession enjoys and for which independent pharmacists are primarily responsible. The challenges facing independent pharmacists are formidable but the issues are so important for both our patients and our profession that we must strongly support the efforts of our colleagues who are best positioned to promote and advance the services we are capable of providing. I recommend consideration and support for the following as part of a strategy to accomplish these goals:

  1. The entire profession of pharmacy and our organizations must demonstrate a strong commitment to increase the number of independent pharmacies and to support and advance progressive models of practice in these pharmacies.

  2. Independent pharmacists and the organizations in which they are participants must communicate more effectively and collaborate in addressing challenges and working toward professional goals. I recommend that the National Community Pharmacists Association (NCPA) convene a national meeting of the "stakeholders" (e.g., independent pharmacist leaders, wholesalers, buying groups of independent pharmacists) to start developing strategies and plans in this direction.

  3. The required community pharmacy rotation in the Advanced Pharmacy Practice Experience (APPE) programs administered by the colleges of pharmacy should be provided in independent community pharmacies. Regrettably, many current students and recent graduates are hardly aware of the professional and entrepreneurial opportunities available in independent pharmacies because neither their employment experience nor college-directed experience programs have been in this setting.

  4. Independent pharmacists should actively pursue collaborative working relationships with family practice physicians in their communities. Many family practice physicians have voiced concern regarding the establishment of "clinics" in some chain pharmacies that are typically staffed by nurse practitioners. As considered earlier, many physicians are experiencing challenges that are similar to the ones that pharmacists are facing. Opportunities exist for working relationships between independent pharmacists and family practice physicians that would be mutually beneficial and of value in improving the scope and quality of care for the patients served.
Daniel A. Hussar

10/04/2012

Simple Steps to Avoid Trips and Falls

A Health Tip from University of the Sciences in Philadelphia

By:  Frank Kunkle

Falls Prevention Awareness day may have passed, but it is never a bad time to take steps to prevent avoidable trips and falls, particularly for older adults. According to the National Council on Aging, one in three Americans aged 65+ fall each year.

“We know older adults make up the at-risk population when we begin thinking about preventing falls. A few environmental changes prove to be very helpful, but an inter-disciplinary approach is often best,” said Pamalyn Kearney, assistant professor of occupational therapy at USciences.

Kearney and Dr. Carol Maritz, associate professor of physical therapy, urge older adults and those caring for loved ones to make a few changes this season.

Fall Prevention Tips:

  • Clean up that clutter—clear pathways are essential for older adults. Think twice before leaving items on stairs and evaluate placement of a pet’s food dish. Also, consider eliminating throw rugs—they can wrinkle easily or slide across the floor.
  • The bathroom can be one of the most hazardous rooms in the house. Use rubber mats to keep the tub surface from becoming slippery and install grab bars for stability. The wall soap dish and towel rack are not meant to hold human weight and can be very dangerous to use as support.
  • Use a strategically placed nightlight since it takes time for human eyes to adjust at night. Check the lighting on stairs and remember, light that is too bright can cause a glare, making it just as dangerous as poor lighting. 
  • Older adults should carry a cellphone or a life support button at all times—even in the house—to summon help quickly.
  • Are appliances and dishes frequently used in the kitchen within easy reach? If not, reorganize. Only use a stepstool with a handle, not a dining room chair.
  • Many older adults use their cane or walker only when they go out but in reality, they are no steadier in their own home. Unlike your assistive devices, grabbing furniture presents a risk because it can move or break.

Beyond these environmental modifications, Kearney and Dr. Maritz recommend older adults take an inclusive approach to their well-being. They should be doing strength-building exercises and a meeting with doctors to discuss medications. In addition, a physical therapist can help determine a person’s deficits and recommend a variety of resources, while an occupational therapist can evaluate how a person goes about their daily activities and suggest lifestyle changes.

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