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Monday, August 29, 2011

Half of hospitals buy gray market drugs

Severe shortages for life-saving medications have driven a "gray market" in the wholesale drug supply industry, a watchdog group reports.

And the mark-up on gray market drugs is a budget-buster, reports the Institute for Safe Medication Practices, a Philadelphia-based nonprofit organization devoted entirely to medication error prevention and safe medication use. Purchasing agents and pharmacists at 549 hospitals responded to a survey on gray market activities associated with drug shortages.

The report includes chilling anecdotes from the respondents about pressure from physicians and administrators to ensure drugs are available, and drastic price gouging from the gray market suppliers. Price mark-ups of 10 times or more than the contract price were reported by about a third of respondents from critical access hospitals and community hospitals, and more than half of university hospitals. Examples include a box of calcium gluconate that cost $750 instead of the contract price of $50 (1,400% mark-up), and a supply of propofol that cost $25,000 instead of $1,500 (1,567% mark-up). Oh, and there's exorbitant shipping and handling fees, too.

More than half (52%) of respondents reported buying one or more drugs from gray market vendors during the past two years. Most (80%) of these respondents said gray market purchases increased as drug shortages grew. While most respondents (54%) reported buying products from only one or two gray market vendors, a quarter (25%) of university hospitals reported purchases from more than five.

Even in states that require documentation of authenticity for pharmaceuticals, 50% of respondents bought medications from the gray market during the past two years. Of these, only 35% reported always receiving the required documentation of authenticity. Approximately two-thirds of all respondents never checked the manufacturer's website to see if the secondary distributor was authorized by the manufacturer. Most were unaware that this information is available.

And, 56% respondents get daily solicitations to buy medications no longer available through the manufacturer or usual wholesaler. They often contain high-pressure pitches more suitable to QVC than to health care, such as, "We only have 20 of this drug left and quantities are going fast." And 13% of respondents also are solicited to sell their stocks of drugs into the gray market.

In general, the most common reasons respondents did not buy gray market drugs were concerns about authenticity (74%), ethics (66%), cost (69%), and storage conditions (58%).

Up to 12% of respondents reported awareness of a product authenticity issue, medication error, or adverse drug reactions associated with the use of gray market products in the past two years. Most cited errors include a different product strength, improper storage, recalled or stolen products, illegally imported drugs, questionable chain of custody, and sale of counterfeit products and placebos.

The Institute for Safe Medication Practices suggests a four-pronged strategy:
--The Food and Drug Administration (FDA) needs greatly enhanced authority to manage drug shortages.
--Stronger regulations are needed for pharmaceutical distribution, such as a national law to limit distribution of pharmaceutical products to authorized distributors of record, and to limit price gouging during shortages.
--Minimize the need for buying gray market drugs by planning ahead, forming local coalitions to cooperatively borrow from each other, back-ordering or direct ordering from the manufacturer, and seek out alternatives for drugs in short supply.
--Take stronger regulatory and law enforcement action against illegal activities, such as counterfeiting and theft. Five drug makers are seeking stronger penalties for stealing chemotherapy drugs, for example.

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Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internist and ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

CasesBlog
Ves Dimov, MD, ACP Member, is an allergist/immunologist and Assistant Professor of Medicine and Pediatrics at the University of Chicago, where he evaluates and treats both pediatric and adult patients.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
ACP Member Mike Aref, MD, PhD, ACP Member, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

Informatics Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Medical Lessons
Elaine Schattner, MD, ACP Member, shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology, and as a patient who's had breast cancer.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

Musing of an Internist
Justin Penn, MD, ACP Associate Member, attended medical school at the University of Washington School of Medicine and trained in internal medicine at the University of Rochester, where he is serving as Chief Resident.

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

White Coat Underground
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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