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Tuesday, May 29, 2012

by Michael R. Cohen, R.Ph.

The U.S. Food and Drug Administration (FDA) and the organization I work for, the nonprofit Institute for Safe Medication Practices (ISMP), have long shared a common goal of helping consumers prevent medication errors. Now, to reach as many consumers as possible, FDA’s Center for Drug Evaluation and Research (CDER) has formally strengthened its relationship with ISMP so the two agencies can work together to provide consumers with information on how to use medicines safely.

Reviewing information from reported errors and timely posting of crucial information on both agencies’ Web sites are just two of the ways that ISMP and FDA are working together towards this goal. For example, late in 2011, both FDA and ISMP received reports of dosing confusion involving a new, less concentrated form of acetaminophen for infants. A more complete picture of the problem was possible by combining the reports submitted to both agencies. Then, ISMP and FDA both issued advisories with tips to help consumers avoid confusion and dosing errors. Click here to link to ISMP’s advisory on this topic, or click here to watch an FDA podcast about infant acetaminophen safety.

More recently, a similar situation developed when ISMP and FDA were alerted to a tragedy involving a little boy who swallowed a drug patch containing fentanyl, a powerful narcotic that’s applied to the skin. The little boy found the patch while visiting his great grandmother, who was staying at a nursing home. The patch was somehow left in reach of the child when the person applying a fresh patch failed to properly discard the used one. The used patch contained enough drug to be lethal after the boy swallowed it. Both FDA and ISMP alerted health professionals and the public through widely disseminated national safety alerts.  

Posted by MIchael R. Cohen, R.Ph. @ 8:00 AM  Permalink | File Under: Michael Cohen | Post a comment
Friday, May 25, 2012

by Robert I. Field, J.D., Ph.D. 

What’s the point of health insurance if it doesn’t cover much?

Many policies today are so skimpy they leave patients with thousands of dollars in medical bills even after the coverage kicks in. They’re hardly worth the cost of the premiums.

This kind of barebones policy is sold mostly to individuals, rather than through employers. If you get your health insurance at work, odds are you have good coverage. But if you buy it straight from an insurance company, there’s a good chance you do not.

Posted by Robert I. Field, J.D., Ph.D. @ 7:42 AM  Permalink | 3 comments
Thursday, May 24, 2012

Earlier this month, an influential federal panel rejected PSA (prostate-specific antigen) screening for prostate cancer, stirring controversy and raising questions.

Given the trade-offs, men should stop having the screening test, which measures the level of prostate-specific antigen in the blood, said the government-sponsored report, published in the Annals of Internal Medicine.

Urologists and advocacy groups immediately decried the advice - as they did when a draft version was released last October - calling it "inappropriate and irresponsible." You can read more about the decision here.

What should men do?

On Wednesday, May 30 from 3:30 to 4:30 p.m., Richard C. Wender, M.D. will answer your questions in a live chat. Wender is alumni professor and chair of the Department of Family and Community Medicine at Thomas Jefferson University in Philadelphia.

In addition to being a practicing family doctor, Dr. Wender_s major area of academic focus has been cancer prevention and screening. He was the editor of the American Cancer Society Primary Care Physicians Newsletter for 10 years and is now on the Editorial Advisory Board of CA: a Cancer Journal for Clinicians. Dr. Wender served as President of the Philadelphia Division of the American Cancer Society and first President of the newly formed Commonwealth Division, now known as the Pennsylvania Division of the American Cancer Society.

You will be able to join the chat by returning to this entry on May 30 at 3:30 p.m.

In the meantime, please feel free to submit questions ahead of time to Dr. Wenders by sending them to checkup@phillynews.com.


Posted by @ 4:16 PM  Permalink | Post a comment
Wednesday, May 23, 2012

by Daniel R. Hoffman, Ph.D.

An article published last year addressed a factor generally associated with corporate failure and success. Although it mentioned the drug industry only peripherally, it says a great deal about why pharma remains stuck in its current down cycle.

The article's author was Benjamin Gilad, a former faculty member at Rutgers School of Management who now teaches competitive intelligence to aspiring, mid-level managers at a private company. Therein lies a major irony because Gilad argues that when companies in most industries fail, it generally does not result from competitors surprising and outmaneuvering them. That is the sort of thing competitive intelligence seeks to discern and prevent, but Gilad considers it a minor factor in a company's ultimate success or failure. Instead he draws a distinction between competitive intelligence and what he calls strategic intelligence. A company's capability at the latter function, together with a willingness to take action based on it, represent what Gilad considers the differentiating factors between corporate survival and extinction.

In industries where the major competitors are large, highly capitalized companies, Gilad maintains that a collapse occurs when all of them start failing to effectively address customer needs. The basic problem of companies in such industries does not result from poor tactical decisions against competitors. Instead, their entire approach to doing business runs aground and, in this respect, they share a common blind spot.

Posted by Daniel R. Hoffman, Ph.D. @ 10:03 AM  Permalink | File Under: Daniel Hoffman | Post a comment
Tuesday, May 22, 2012

by Michael R. Cohen, R.Ph.

I don’t usually stray too far from medication-related topics for my blogs each week. However, something crossed my desk a few days ago from the American Association of Poison Control Centers that caught my attention, and I think it’s worthwhile mentioning.

The poison centers want to call attention to a surge in the number of young children and toddlers who swallow those single unit packets of laundry detergent that look like tiny balloons. Dishwasher detergents also come in these packets.

If you’ve ever handled them, you know that even the slightest amount of moisture touching the packets will cause the “skin” that covers the detergent to start to dissolve, exposing the substance inside. That’s what’s happening when kids touch these to their tongue or put them in their mouth. Some of them are then swallowing it. 

Posted by Michael R. Cohen, R.Ph. @ 10:27 AM  Permalink | File Under: Michael Cohen | Post a comment
Friday, May 18, 2012

by Robert Field, J.D., M.P.H., Ph.D.

Big business could be the biggest loser if the Supreme Court overturns Obamacare. To be more precise, one business in particular faces an enormous risk – the insurance industry.

Health insurance companies could lose about $1 trillion in revenue through 2020 if health reform is struck down. That’s according to a new study by Bloomberg Government. The shortfall would equal almost one-tenth of their total expected earnings.

Looked at another way, the loss represents about one-half of a percent of America’s entire gross domestic product over that time period. It is twice as much as the revenue expected to be earned by the five largest banks. 

Posted by Robert I. Field @ 10:09 AM  Permalink | File Under: Robert Field | 1 comment
Wednesday, May 16, 2012

by Daniel R. Hoffman, Ph.D.

One way of viewing the drug industry's current situation — underperforming the S&P 500 by more than 790 basis points this year — involves asking whether pharma possesses the innovative skill to discover and develop new offerings or, alternatively, prop up its legacy business and lose another trillion dollars of capitalization by 2020, the same amount it lost over the past decade. 

Large, multinational corporations seldom have to face that sort of choice. Internal functions at big companies such as strategic planning, business development and others typically scan the horizon to preempt such do or die situations. Then if management gives these groups the attention they deserve, the companies stick separate fingers into emerging opportunities that may emerge.

Small businesses that achieve some success, on the other hand, often find themselves facing this sort of dilemma. Having found a way to make good money, they are loath to let go of it or even de-emphasize it in favor of something altogether different.

Posted by Daniel R. Hoffman, Ph.D. @ 10:01 AM  Permalink | File Under: Daniel Hoffman | Post a comment
Tuesday, May 15, 2012

Last October the New York Times published a story about a 13-month-old boy who died after swallowing pills from a prescription medicine bottle. His parents had given him the bottle to play with as a rattle, believing he could not open the child-resistant cap.

The bottle contained Suboxone, a medicine used to treat people who are addicted to illegal or prescription pain medicines. The boy was put in his crib to sleep. His mother checked him a short time later and found the bottle open. The pills had fallen out and one of them was wet. She took them away from him, gave him a bottle of milk, and went to sleep. In the morning, the boy was found unconscious in his crib. The parents called 911, but the child had died by the time he reached the hospital.

Using a syringe as a toy led to another recent accident, but in this case, the child fortunately survived. A nurse gave a young hospitalized girl an empty syringe to play with during the day. The girl used the syringe to drink liquids and eat ice cream. The next morning the girl called for the nurse, saying she had pain in her chest and a cough. The girl told the nurse she had connected the syringe to her intravenous line and pushed the plunger in, pretending to give herself medicine. The syringe only contained air, but an injection of air into the bloodstream can be deadly. The child’s pain and shortness of breath were caused by the injected air, which had blocked the blood vessels leading to her lungs. Fortunately, steps were taken to treat the girl who later recovered from this accident.

Stories like these should serve as a reminder that children should not be allowed to play with medicines (not even empty bottles) or other supplies used to administer medicines. Children are curious and creative. They like to explore and mimic the actions of adults. So, if they see you taking medicine or using a syringe, they will likely try to follow suit. Infants learn by putting things in their mouths, and even very young children have been able to open a child-resistant cap.

Posted by Michael Cohen @ 4:03 PM  Permalink | File Under: Michael Cohen | Post a comment
Sunday, May 13, 2012

Health care costs too much. Everyone agrees. But no one seems to know what to do about it.

If Obamacare survives Supreme Court review and takes effect in 2014, it will go a long way toward reducing the number of people without insurance. But it leaves the problem of rising costs relatively untouched. 

Obama’s plan is modeled on the Massachusetts law signed by then Governor Mitt Romney in 2006. When the state implemented that plan, it led the country in attacking the problem of uninsurance.

Massachusetts stands on the verge of leading again, this time in addressing high costs. Similar bills were introduced last week in each house of the state legislature to limit annual spending increases. Both would implement an aggressive new approach that is yet to be tested anywhere else.

Posted by Robert Field @ 8:43 AM  Permalink | File Under: Robert Field | Post a comment
Wednesday, May 9, 2012

by Daniel R. Hoffman, Ph.D.

The perfect storm into which pharma has navigated itself means that the most constructive observations ought to point out potentially fruitful, new directions for the industry. That has been the main emphasis from this quarter in 2012, but sometimes the week brings news so astonishing that gentle encouragement must step aside. So it was with the news that Abbott Labs agreed to pay $1.6 billion in fines and admit its guilt for marketing its anti-seizure medication, Depakote, to nursing homes for unapproved uses.

The penalties levied on Abbott, depending on how they're calculated, were the second or third highest in pharma history, yet taking into account the audacity of violations and the vulnerability of affected patients, the company got off lightly. The matter was not limited to an over-ambitious sales district or a brand team that paid speakers to spin fables for physicians at dinner meetings. Instead the company organized and trained a special sales force to sell Depakote for treating aggression and agitation in elderly dementia patients confined to nursing homes. For six years, starting in 2001, Abbott also promoted Depakote as an adjunct to antipsychotic drugs for treating schizophrenia, despite the fact that their own studies failed to show any benefit from adding the second drug.

As flagrant and deliberate as these Depakote violations were, they were not Abbott's first foray into illegal behavior. In 2001 a joint venture of Abbott and Takeda paid an $875 million fine for conspiring with physicians to bill Medicare for samples of a prostate cancer medication that Abbott gave the doctors for free. Two years later, Abbott paid another $600 million fine because its nutritional products sales people helped hospital and long-term care facilities pull a similar scam on health insurers. Abbott sold the providers liquid meal products at discount prices and then corroborated reimbursement requests the institutions submitted to insurers for the full price.

Posted by Daniel R. Hoffman, Ph.D. @ 12:47 PM  Permalink | File Under: Daniel Hoffman | Post a comment
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About Check Up

Check Up is your guide to health and medicine across the Philadelphia region.

Brought to you by Philly.com/health and the Philadelphia Inquirer's Health and Science team, this blog covers major health events in our region and offers everything from personal health advice to an expert look at health reform.

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