Self-Care Training Program Co-Sponsored by Nurse Practitioner Healthcare Foundation

Posted on 18th May 2012 in Uncategorized

As more Americans turn to over-the-counter (OTC) medications to combat the high price of health care and prescription drugs, nurse practitioners, physician assistants and pharmacists are often the first to answer patient questions about self-care. To support these health care providers, the NPHF announces the OTC Advisor – a free online training tool that helps clinicians offer the best counsel to patients using OTC medications and home diagnostic products.

“Nurse practitioners focus on personalizing care to meet an individual patient’s needs. The ability to answer questions about the wide array of OTC products requires a broad knowledge base of all of these products,” says Phyllis Zimmer, MN, ARNP, FAAN and NPHF president. “The Nurse Practitioner Healthcare Foundation provides educational programs, such as the OTC Advisor, to ensure that information given to the public by nurse practitioners (NPs) and other clinicians is up-to-date and evidence-based. We view this as a wonderful resource for the NP profession, particularly those who practice in convenient care settings.”

The OTC Advisor is co-sponsored by the NPHF, the American Academy of Physician Assistants and the American Pharmacists Association through an educational grant from Procter & Gamble. The program consists of online modules that can be completed over time, and participants can receive up to 18.5 free continuing education credits. The modules cover OTC care for the following health issues:
Pain management

Fever and cold symptoms

Gastrointestinal disorders

Skin disorders

Popular herbal and dietary supplements

Use of home diagnostic products

“As an organization that supports the delivery of healthcare in locations accessible to patients, we are excited about the potential this program holds for clinicians practicing in community settings, such as convenient care clinics,” says Zimmer. “This program provides the information needed by clinicians to assist their patients in making good choices of over-the-counter healthcare products.”

Notes:

For additional information, or to participate in the OTC Advisor program visit nphealthcarefoundation and click on the OTC Advisor program.

The Nurse Practitioner Healthcare Foundation

In 2005, a group of pioneering nurse practitioners launched the Nurse Practitioner Healthcare Foundation. The foundation is dedicated to raising the bar in health care, contributing to excellence in care and bringing NPs to the forefront of the larger health care arena. The NPHF works on behalf of the entire nurse practitioner profession to make high-quality, effective care accessible through research, education, health policy, service and philanthropy. The Nurse Practitioner Healthcare Foundation is an IRS 501(c)(3) non-profit organization. Visit nphealthcarefoundation for more information and for a listing of continuing education opportunities for NPs.

Source: Danielle Davis

Manning Selvage & Lee

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Mini Med School highlights chronic pain, end of life care, Toronto

Posted on 17th May 2012 in Uncategorized

University of Toronto’s Mini-Med School is back for a third year with new topics, new speakers and new electives, including sessions on chronic pain and end-of-life care.

The popular six-session, continuing-education course teaches students – ranging from high schoolers to seniors – about the workings of their bodies while helping them to become better-informed health consumers.

“I describe Mini-Med School as self-education leading to self-awareness and finally to self-management,” says Dr. Mike Evans, a family practitioner who serves as course director. “We teach the principles of evidence-based medicine: how to separate the wheat from the chaff.”

The 2004-2005 course, which is given in the fall and again in the spring, features prominent physicians who are U of T faculty members teaching about six key areas of the body: the brain, the heart, the ear, the eye, the liver and the kidney. The fall session runs six consecutive Thursday evenings from 7 to 9:30 p.m. Tuition is $105 for full-time students and seniors and $195 for adults.

This year, Mini-Med School also offers four new electives. Each runs for two or three nights and is priced accordingly. The topics are Understanding Chronic Pain; Women’s Health; End of Life Care: Death, Dying, Grief & Bereavement and Lifestyle Change: Be Your Own CEO. The latter is Evans’ personal passion and he helps teach the course.

“Today, more than ever, we’re in charge of our own health,” says Evans. “Each of us has the opportunity to become an expert on our own physical well-being.”

For registration details, visit mini-med.utoronto for additional information or call 416-978-2719.

CONTACT:
Jessica Black Elaine Smith
Course Administrator U of T Public Affairs
416-946-8389 416-978-5949
jessica.blackutoronto elaine.smithutoronto

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Dorgan, McCain, Snowe Introduce Bill To Allow Prescription Drug Reimportation

Posted on 16th May 2012 in Uncategorized

Sens. Byron Dorgan (D-N.D.), John McCain (R-Ariz.) and Olympia Snowe (R-Maine) on Wednesday introduced a bill (S 525) that would allow the reimportation of lower-cost prescription drugs from other nations, Bloomberg reports. The lawmakers said that the legislation would save the U.S. $50 billion, which includes $10 billion in savings for the U.S. government, over the next 10 years. According to a statement from the lawmakers, the legislation would “bring consumers immediate relief and will ultimately force the pharmaceutical industry to lower drug prices in the U.S.” Julia Wanzco, a spokesperson for Snowe, said, “We do expect this to pass” in part because President Obama in his fiscal year 2010 budget proposal announced a “strong interest in implementing this policy.”

The Pharmaceutical Research and Manufacturers of America opposes the legislation because of safety concerns. In a statement, Ken Johnson, senior vice president at PhRMA, said, “The worldwide counterfeit threat is knocking at America’s door and will soon be greeted if prescription drug importation moves forward,” adding, “Interest in prescription drug importation is waning in part due to the millions of seniors accessing medicines and saving money through the Medicare prescription drug program and consumer weariness in the aftermath of recalled tainted foreign products” (Randall, Bloomberg, 3/4).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Pharmacies Offering No-Cost Antibiotics Should Promote Responsible Use, CDC Says

Posted on 15th May 2012 in Uncategorized

CDC last week sent out letters to several chain pharmacies that offer no-cost prescription antibiotics to low-income consumers urging them to promote responsible use of antibiotics, the New York Times reports. According to the Times, the agency is concerned that the no-cost drugs could promote the wrong message and might worsen the problem of drug resistance.

Pharmacies that are offering no-cost antibiotics to low-income consumers include Giant Food Stores, Meijer, Publix, ShopRite, Stop & Shop and Wegmans Food Markets. According to the Times, “The generic antibiotics included in the free programs are relatively inexpensive compared to other drugs, in part because they typically are used for limited periods and are not refilled.” The Times reports that pharmacies have adopted the programs “to promote customer loyalty and compete for the business of major retailers.”

Lauri Hicks, medical director for CDC’s Get Smart Program, said, “If a patient believes that they can get an antibiotic quite easily or for free, then it may increase the pressure on health care providers to prescribe it” (Parker-Pope, New York Times, 3/5). Anne Gershon, president of the Infectious Diseases Society of America, said, “We don’t want to give the public the idea that we can just use (antibiotics) whenever we want. Free drugs can give that impression” (LaMendola, South Florida Sun-Sentinel, 3/4). She said, “If you give antibiotics away, it sort of implies that we should use them rather freely,” adding, “Giving away antibiotics could lead to stockpiling of drugs. We need to control antibiotic use very carefully, because more and more bacteria are becoming resistant to antibiotics.”

Last year, CDC sent similar letters to major retailers that were promoting low-cost drug programs, urging them to educate customers about drug resistance (New York Times, 3/5).

Antibiotics Not for Flu, CDC Warns
The new round of CDC warnings come as some pharmacies offering no-cost antibiotics have linked the offers to the cold and flu season, neither of which should be treated with antibiotics. Neil Fishman, chair of an antimicrobial resistance work group for IDSA and an infectious disease specialist at the University of Pennsylvania, said, “Most of the infections during cold and flu season … are due to viruses and not the result of bacteria, so antibiotics don’t work,” adding, “This is exactly the time we don’t want to encourage antibiotic use” (New York Times, 3/5).

Hicks said, “A number of the chains were advertising free antibiotics as a solution to cold and flu season. Of course we know antibiotics don’t work for colds and flu,” adding, “Perpetuating that idea is not helpful. We have been trying to combat that myth and they are not helping with those words” (South Florida Sun-Sentinel, 3/4). IDSA said the pharmacies would be providing a more important public service if they offered no-cost flu shots (New York Times, 3/5).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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California Pharmacists Honored As Key Contributors To Patient Care And The Advancement Of The Pharmacy Practice

Posted on 14th May 2012 in Uncategorized

The art and practice of pharmacy has never been more relevant and valuable than today. Lives are saved, diseases are closely monitored, and the pharmacist-patient relationship is more vital than ever in keeping patients safe and producing the best healthcare outcomes. Several pharmacists were honored for the meaningful and important contributions they make to the profession of pharmacy at Outlook 2009, the Annual Meeting and Education Faire for the California Pharmacists Association (CPhA) and the Pharmacy Foundation of California, which was recently held in Anaheim, February 19-22. This year’s honorees exemplify the best pharmacists in the State of California. They join an elite group of past winners who have gone above and beyond to serve their patients and profession with excellence.

George Yasutake, PharmD, Pharmacist of the Year

Taking top honors for Pharmacist of the Year, was George Yasutake, PharmD. In order to be nominated for this award, a pharmacist must be a leader at all levels and stimulate others to actively participate in all aspects of the profession. George Yasutake has gone above and beyond these criteria. He has been involved at every level of pharmacy leadership including local, state and national organizations. He serves as an inspiration and a sound voice of reason and responsibility.

George is an energetic leader who has encouraged many others to get involved in pharmacy and speaks to pharmacy students, residents, and fellow pharmacist-colleagues about the importance of involvement, membership, and community activities in professional pharmacy organizations. His continued activities for the betterment of pharmacy are appreciated universally. He has worked tirelessly with fellow health care providers and patients to provide state-of- the-art clinical services as a Pediatric Clinical Pharmacist and a Drug Information/Drug Usage Evaluation/Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Pharmacist also.

Additionally, George has served as CPhA President, CPhA Speaker of the House, American Pharmacists Association (APhA) Chairman of the Academy of Pharmacy Practice & Management (APPM), President of Hollywood-Wilshire Pharmacists Association, on the APhA Nominations Committee, and many more leadership roles. George is well recognized by pharmacists and others in California and nationally.

Chester Yee, PharmD, Bowl of Hygeia Award

The Bowl of Hygeia award recognizes a pharmacist for outstanding involvement both in and outside the profession of pharmacy by demonstrating how pharmacists can elevate themselves and the profession in the eyes of the public. Chet Yee has been active since his graduation from pharmacy school, where he served as Editor for the School Newsletter and APhA Student Chapter President. Chet, along with other pharmacists, banded together to form the San Mateo County Pharmacists Association and affiliated with CPhA as a local association. He has served in numerous capacities on the San Mateo County Pharmacists Association Board but most notably, as Chair of the “Talk with a Pharmacist Day.” Chet has also served as President of CPhA in 1978 and received the CPhA Pharmacist of the Year Award in 1985. During Chet’s CPhA Presidency, he started the Task Force for Pharmacy. In addition to the multiple leadership roles with CPhA, Chet was nominated and elected to the APhA Board of Trustees. Chet not only spends many hours promoting the profession but is actively involved in his community, including the local Lions Club and in his church.

Eric Gupta, PharmD, Distinguished New Practitioner of the Year

This award recognizes a new practitioner who has demonstrated energetic leadership at multiple levels, someone who is an energetic leader, who stimulates others to actively participate in the profession, and finally, someone who is well recognized by their peers. In his letter of support, Mike Pastrick stated, “I am hard pressed to think of someone more deserving than Eric Gupta.” Eric has demonstrated a high level of professional involvement since the day he entered pharmacy school, contributing to the good and welfare of the profession. He continues his involvement today as an educator at Western University of Health Sciences and as a leader on CPhA’s Board of Trustees as the Speaker of the House. Eric actively participates in a number of professional organizations such as CPhA, APhA, American Society of Health System Pharmacists (ASHP), American Association of Colleges of Pharmacy (AACP), and American College of Clinical Pharmacy (ACCP). In addition to state and national organizations, Eric is President of the Southeast Los Angeles Pharmacists Association, CE Coordinator for Kappa Psi Pharmaceutical Fraternity, served as the 2008 Chair for the Pharmacy Foundation’s Educational Advisory Committee, and more. Most recently, the members of CPhA elected Eric to serve as President-Elect.

Dana Nelson, RPh, 2009 Innovative Pharmacist

Creative, ingenious, novel, fresh, original, unprecedented: these are just a few words that define innovative. The 2009 Innovative Pharmacist, Dana Nelson, describes an innovator as a trend-setter in the profession of pharmacy. In order to quality for this award, a pharmacy must demonstrate the ability to significantly improve patient care. Dana has a highly imaginative and innovative clinical pharmacy practice where he is typically the first to set the stage for improved patient care and outcomes. Along with his wife, Dana purchased a pharmacy in San Luis Obispo and instantly became one of the top compounding pharmacies in the nation. Dana’s scope of services includes long-term care, durable medical equipment supplies, compounding, and assisting patients in managing chronic disease states. He is a national leader in bioidentical hormone replacement therapy using a cutting-edge rhythmic hormone replacement system, which ensures standardized product production and accurate and consistent patient dosing. Dana also serves as the Chief Pharmacist, Pharmacist Clinical Trainer and Standardized Transdermal Hormone Cream Production Trainer for the Wiley Protocol. Dana is a true stalwart for the practice of pharmacy, a patient advocate, and a tireless provider for his patients, practice, staff, and family.

Heather Duffer, Pharmacy Technician of the Year

Heather Duffer was given the CPhA 2009 Technician of the Year Award in recognition of her exemplary work with Inland Compounding Pharmacy in Loma Linda, California. Heather understands and clearly exemplifies the role and importance of being a pharmacy technician. In the words of her employers, Gordon & Raylene Mote, “She is a great asset to our practice – compassionate, caring and always wanting to learn.” Heather began working in the pharmacy profession in 1994 and is now pursuing a pharmacy degree. In addition to her work in the pharmacy, Heather also serves on the CPhA Academy of Pharmacy Technicians Board and has participated on the Technician Task Force for the State of California.

Vi Li, CPhA Pharmacy Student of the Year

Western University of Health Sciences, College of Pharmacy

Vi Le has shown dedication to the profession of pharmacy through her continuous involvement with local, state, national and student organizations. Vi became involved during her first year at Western University and immediately started making an impact. She increased the number of and participation in health fairs, and implemented new programs that increased the visibility and stature of the Academy of Student Pharmacists Chapter on campus. All of Vi’s activities and ideas saw a dramatic increase in student members, earning the WesternU Chapter a national award at the APhA national meeting. In addition to programs on campus, Vi reached out to the CPhA local associations in the area and created a strong relationship between them and the school. Her desire to create a foundation for greatness, dedication to the profession of pharmacy and genuine personality are testimony to the title Student Pharmacist of the Year.

Chapter of Excellence Awards

In addition to the individual honors listed above, CPhA recognized many of its local pharmacist associations who have achieved a high level of excellence through their activities and contributions to their local communities over the previous year. The Chapter of Excellence Awards were given to the Alameda County Pharmacists Association, the Orange County Pharmacists Association, the Pharmacists’ Professional Society of the San Fernando Valley, the San Diego County Pharmacists Association, the San Joaquin Pharmacists Association, the San Mateo County Pharmacists Association, and the South Bay Pharmacists Association.

About CPhA

The California Pharmacists Association is the largest state pharmacy association in the nation and the professional society representing all pharmacists in California. The mission of the Association is to act as the leader in advocating the role of the pharmacist as an essential provider of health care and to support pharmacists in providing optimal patient care.

For more information on the CPhA Awards Criteria please visit the Membership page of the CPhA website at cpha.

California Pharmacists Association

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Tools For More Accurate Dosage Of Drugs Against HIV/AIDS And Malaria

Posted on 13th May 2012 in Uncategorized

A doctoral thesis presented at the Sahlgrenska Academy, University of Gothenburg, Sweden, shows that it is possible to describe and quantify the relationships between dose, concentration and effectiveness of several drugs against HIV/AIDS and malaria. The method may allow improved treatment and fewer undesired effects for patients with these diseases.

Registered pharmacist Daniel RГ¶shammar has in his thesis studied the optimal use of certain pharmaceutical substances that are used to combat HIV/AIDS and malaria. He has analysed, among other things, data from 121 healthy volunteers from Uganda using a mathematical model known as a pharmacometric model. The study showed that both sex and genetic differences between individuals influence the way in which the body metabolises efavirenz, which is part of some anti-HIV/AIDS drugs. Other studies have focussed on 74 people from Zimbabwe with HIV/AIDS, and showed that a reduction in the daily dose of efavirenz from 600 mg to 400 mg can reduce the risk of undesired effects in those affected who have a genetically conditioned poorer ability to catabolise the substance.

“Many HIV/AIDS patients are treated with efavirenz, and they should be genetically tested using a blood test before deciding on a dose. This is particularly important in Africa, where the fraction of patients with a poorer catabolic ability is greater than it is elsewhere”, says Daniel RГ¶shammar.

Repeated measurements of the drug concentrations and virus levels in 239 previously untreated Scandinavian patients with HIV/AIDS allowed a similar model to be used in order to study the antiretroviral effects of anti-HIV/AIDS drugs. Calculations showed that treatment in which efavirenz was combined with other pharmaceutical substances was more effective than two other frequently used combination treatments.

“It may be possible in the future to use the model to predict when the treatment will lose its effectiveness for an individual patient, and explain why”, says Daniel RГ¶shammar.

Further work involved using a model to describe how the catabolism of the anti-malarial drug artemisinin increases and the concentration of the drug decreases when patients take this drug. When artemisinin was given to 97 patients in Vietnam without other drugs, approximately 37% of them were affected by recrudescent malaria. The model showed that this could not be explained solely by low drug concentrations. Another anti-malarial drug, piperaquine, may be a suitable partner for artemisinin in the treatment of malaria. An investigation of 12 Vietnamese study subjects, however, allowed scientists to estimate that the levels of piperaquine that remain in the body are too low to be effective, and this increases the risk that the malaria parasite will develop resistance.

“Research shows that pharmacometric models can be adapted to patient data in order to understand the relationships between drug concentration, effectiveness and the progress of disease, while at the same time taking into consideration differences between patients such as, for example, weight, age, sex, genetic factors, other diseases and other drugs. We expect that these tools will be important in the fight against HIV/AIDS and malaria”, says Daniel RГ¶shammar.

Source: Ulrika Lundin

University of Gothenburg

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New Genre Of Sugar-coated “quantum Dots” For Drug Delivery – Journal Of The American Chemical Society

Posted on 12th May 2012 in Uncategorized

Scientists in Switzerland are reporting an advance that could help tap the much-heralded potential of “quantum dots” – nanocrystals that glow when exposed to ultraviolet light – in the treatment of cancer and other diseases. They are publishing the first study showing that giving quantum dots an icing-like cap of certain sugars makes these nanoparticles accumulate in the liver but not other parts of the body. That selective targeting could be used to deliver anti-cancer drugs to one organ, without causing the body-wide side-effects that occur with existing cancer drugs, they suggest. Their study is in the Feb. 18 issue of the Journal of the American Chemical Society, a weekly publication.

In the new report, Peter H. Seeberger and colleagues note that quantum dots, about 1/5,000th the width of a human hair, are used in solar cells, medical diagnostic imaging, and electronics. Scientists believe these particles also show promise for drug delivery for treating cancer and other diseases. However, researchers still have not found an ideal way to target these dots to specific tissues or organs in order to maximize their effectiveness and limit toxicity.

They describe development of a new type of quantum dot coated with certain sugar molecules that are attracted to receptors in specific tissues and organs. In a study with laboratory mice, the scientists coated quantum dots with either mannose or galactosamine, two sugars that accumulate selectively in the liver. The sugar-coated dots became three times more concentrated in the mice livers than the regular dots, demonstrating their higher specificity, the researchers say.

Citation
“In Vitro Imaging and in Vivo Liver targeting with Carbohydrate Capped Quantum Dots”
DOWNLOAD FULL TEXT ARTICLE

The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. With more than 154,000 members, ACS is the world’s largest scientific society and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.

American Chemical Society

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Bunting Receives 2009 APhA-APPM Distinguished Achievement Award In Hospital And Institutional Practice

Posted on 11th May 2012 in Uncategorized

The American Pharmacists Association (APhA) has announced that Barry Bunting, PharmD, is the 2009 recipient of the APhA Academy of Pharmacy Practice and Management (APhA-APPM) Distinguished Achievement Award in Hospital and Institutional Practice. Bunting will be officially recognized at the APhA Annual Meeting and Exposition April 3-6, 2009 in San Antonio, Texas. The award was established to recognize the achievements of an individual who has made a significant contribution or sustained contributions to the provision of pharmaceutical care within hospital and institutional practice.

Bunting was selected in recognition of his significant and sustained contributions to the provision of pharmaceutical care. From 1996 to 1998, he served as Clinical Pharmacy Manager of the Metabolic Support Team at Mission Hospital, which consisted of feeding tube placement nurses, clinical dietitians and a clinical pharmacist. Their purpose was to assure that intensive care patients received early and appropriate nutrition therapy. Under his management the Metabolic Support Team was able to obtain medical staff approval for team members to write total parenteral nutrition orders, and to adjust parenteral nutrition fluid rates, electrolytes, and nutrient contents under a protocol agreement.

Aside from his work with Mission Hospital, Bunting is also very well known for his work with the Asheville Project. Recognized as a premier, profession-changing program, the Asheville Project connects pharmacists with chronic disease patients for coaching to ensure the best compliance and appropriate use of the patient’s medications in collaboration with the patient’s physician.

Bunting is Vice President of Clinical Services for American Health Care, located in Rocklin, California. He received his Bachelor of Sciences Pharmacy Degree from Ferris State University in 1972, and his Doctor of Pharmacy Degree from The University of North Carolina at Chapel Hill in 1998. He currently resides in Fairview, North Carolina.

About the American Pharmacists Association (APhA)

The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States. APhA members provide care in all practice settings, including community pharmacies, health systems, long-term care facilities, managed care organizations, hospice settings, and the uniformed services.

American Pharmacists Association

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Manhattan Institute Scholars Propose New Compensation Program For Injured Drug Users

Posted on 10th May 2012 in Uncategorized

In a new report released, “In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation,” Manhattan Institute scholars Paul Howard and James Copland respond to the recent Supreme Court Case ruling in Wyeth v. Levine. This report offers an original proposal that would both protect innovation and offer real victims a remedy- an alternative compensation program for consumers injured by unknown drug side effects. The compensation system would be modeled after the vaccine compensation program that was created by Congress in the 1980′s to redress patients injured by vaccines. A well-designed compensation program would offer as a substitute a mechanism for compensating the victims of unforeseen drug injuries, and it would do so without the uncertainty and expense of today’s version of litigation. By limiting compensation to unforeseen injuries, the program they propose would also give companies a powerful incentive to rapidly update drug labels with new safety information and to invest further in both safety and effectiveness.

Why a compensation program for pharmaceuticals makes sense:

- Like vaccines, drugs as a group have enormous public health value.

- The testing, development, and marketing of drugs and vaccines are extensively regulated by the FDA.

- Experts recognize that it is impossible to attain absolute safety and that physicians and patients benefit from a wide range of therapeutic options with different risk and benefit profiles so that patients can find a product that “works for them.”

Given the parallels, as well as society’s profound interest in spurring additional pharmaceutical innovation, policymakers should consider implementing an administrative compensation system for pharmaceuticals similar to the VICP.

Features of an administrative compensation program:

– Field Preemption of Pharmaceutical Claims

- An administrative compensation program for pharmaceuticals would be problematic-and perhaps worse than the status quo-unless coupled with field preemption for all drugs and devices. Were a substantial administrative remedy designed to operate alongside only narrow conflict or obstacle preemption rules, each case would face a separate trial-court factual determination

– Limitation of Most Claims to Unforeseen Adverse Events

- A well-designed system limiting compensation to claims arising from injuries that were not anticipated by the FDA would have the salutary effect of encouraging drug manufacturers to be forthcoming with new information of adverse events as it was discovered during routine use

– Clearly Defined Causation and Injury Requirements

- Individuals who took a drug before the adverse event or contraindication was listed on the label could make a claim for compensation. Those individuals would then have the burden of proving that the drug caused their injury, and the agency could consider the relative risk factors of the drug as well as various confounding factors in those individuals’ medical history, such as age, weight, smoking, or preexisting conditions

– System Funding

- Drug and device taxes to fund the system should initially be allocated on the basis of market share. Eventually system costs would most appropriately fall upon those manufacturers making the riskiest products

– Independent Post-Market Drug Monitoring

- This program would create a post-market review process to keep extensive records of adverse drug events. The growing prevalence of information technology and sophisticated data-mining programs would enable regulators to quickly identify underlying trends that could then be subjected to further analysis and testing

– Remaining Tort-Law Remedies

- Even though a well-constructed administrative compensation scheme would not offer a remedy to individuals affected by known side effects, they would retain the right to sue health-care providers for malpractice in the prescription of a contraindicated drug, or for the improper administration of a drug or device

To read the full report, visit here: manhattan-institute/html/fda_01.htm

Manhattan Institute

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Nurse Practitioners Don’t Realise How Much Their Prescribing Is Being Influenced By Drug Marketing

Posted on 9th May 2012 in Uncategorized

Family nurse practitioners need to be more aware of the commercial pressures they
face as a result of their increased involvement in prescribing, according to a survey
published in the March issue of the UK-based Journal of Advanced Nursing.

“Our detailed study of 84 family nurse practitioners (FNPs) showed low awareness of
how marketing by pharmaceutical companies affects clinical decisions and creates
conflicts of interest” says Dr Nancy Crigger, from William Jewell College, Missouri,
USA.

“However they were clear that some marketing activities, promotional items and gifts
were less ethical and acceptable than others. For example, gifts that benefited
patients and conferences were more acceptable than resort seminars and office
equipment.”

Dr Crigger, herself a qualified FNP, adds: “The influence of marketing on physician
prescribing has been widely researched and this indicates that the more involved
physicians are in marketing, the less likely they are to recognise when their clinical
judgement has been compromised.

“Our study suggests that the same is now happening to FNPs who have been given
greater responsibility for prescribing some types of medication.”

Key findings from the survey included:

- 5% admitted that pharmaceutical reps influenced their prescribing and 26%
said they did not, with the vast majority answering sometimes. However they
said that other FNP colleagues (18%) and physicians (25%) were more likely to
be influenced than them.

- 41% said they were not influenced by drug company marketing, but 17% said
they were. 44% believed their prescribing was positively influenced by
marketing rather than negatively, with 10% saying it wasn’t.

- Two-thirds said that promotional items did not influence their prescribing, with
just 1% saying it did. 14% said that pharmaceutical representatives may cross
ethical boundaries by giving FNPs gifts, but 42% said they did not.

- Nurses were more in favour of education gifts and those that benefited patients.
The majority said that educational gifts were ethical and appropriate (49%) and
that non-education gifts were not (47%). 51% agreed with gifts that benefited
patients and 52% opposed gifts that did not benefit patients.

- 45% said it was not acceptable or ethical to accept inexpensive gifts but 15%
said it was. 59% disagreed with expensive gifts but 7% felt they were
acceptable and ethical.

- Nurses felt more comfortable attending sponsored events such as lunches and
dinners (48%), trips (45%) and conferences (65%), but resort seminars (32%)
and happy hour events (21%) were deemed less ethical.

- 50% felt that events organised by drug companies were more educational than
promotional, but 15% disagreed.

- 62% of respondents accepted samples, 50% educational items, 41% office
supplies and 30% office equipment.

- 41% said that their advanced practice training covered conflicts of interest
when it came to drug marketing and 34% said it did not.

The FNPs who completed the 22-item questionnaire were chosen at random from a
list of licensed nurses provided by the Missouri State Board of Nursing. 42% of the
200 nurses who were approached responded. Their ages ranged from 25 to 69
(average 47) and they had been in practice for one to 33 years (average 9.4). The
majority (82%) were female and 60% served rural populations.

“Our study suggests that pharmaceutical marketing is widespread among FNPs and
that FNPs fail to recognise how they are being influenced by this practice and that
greater involvement in marketing may reduce their critical assessment of such
practices” says Dr Crigger.

“It points to the need for all FNPs to evaluate their personal attitudes and practices
concerning the ethical appropriateness of accepting gifts, meals, educational
programmes and trips from pharmaceutical companies.

“We believe that prescription decision making should be based on the best interests
of patients and on maintaining the trust of the patients and the public.

“Further research is needed to determine the impact of pharmaceutical marketing,
but until then we believe that FNPs should avoid situations that could create a
conflict of interest.”

Notes

- Nurse practitioners’ perceptions and participation in pharmaceutical marketing. Crigger et
al. Journal of Advanced Nursing. 65.3, 525-533. (March 2009).

- Journal of Advanced Nursing is read by experienced nurses, midwives, health visitors
and advanced nursing students in over 80 countries. It informs, educates, explores,
debates and challenges the foundations of nursing health care knowledge and practice
worldwide. Edited by Professor Alison Tierney, it is published 24 times a year by
Blackwell Publishing Ltd, part of the international Blackwell Publishing group.
journalofadvancednursing

- About Wiley-Blackwell

Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley’s Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed
journals and an extensive collection of books with global appeal. For more information on
Wiley-Blackwell, please visit interscience.wiley.

Wiley-Blackwell

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