Took The Wrong Medicine By Mistake? Study Finds Such Errors Are On The Rise Courtney Columbus – July 12, 2017 12:52 PM ET


The rate of serious medication errors that occur outside of health care facilities doubled from 2000 to 2012, a new study finds.

Gillian Blease/Getty Images

When people take medicine at home, mistakes happen.

Some people end up taking the wrong dose of a medication or the wrong pill. Sometimes, they don’t wait long enough before taking a second dose.

Other times, it’s a health professional who’s at fault. A pharmacist might have dispensed a medication at the wrong concentration, for example.

These kinds of mistakes are on the rise, according to a study published Monday in the journal Clinical Toxicology.

The researchers looked at a small subset of the medication errors that happen in the U.S. every year. The FDA estimates that about 1.3 million people are injured by medication errors annually in the U.S.

The study analyzed data collected by poison control centers across the U.S. and counted only errors that happened outside health care facilities and resulted in serious medical outcomes. That’s defined in the study as symptoms that typically require some treatment to life-threatening situations and even death.

They found that the number of these cases doubled, from 3,065 cases in 2000 to 6,855 cases in 2012. In the 13 years covered by the study, more than 67,000 such errors occurred, and 414 people died as a result. Most of the mistakes were preventable, the study finds.

“We know that a third of the cases in this study resulted in hospital admissions, so these aren’t minor errors. These can be pretty significant,” says Nichole Hodges, a research scientist at Nationwide Children’s Hospital in Columbus, Ohio, and the study’s lead author. She says errors at home represent a significant public health burden and are likely undercounted.

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FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market – Rob Stein June 8, 2017 8:56 PM ET


Opana ER, a potent extended-release opioid, was approved by the FDA for pain management in 2006. But the agency says Endo’s attempts to reformulate the pills to make them harder to crush, dissolve and inject have not been successful.

Rich Pedroncelli/AP

The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER — its extended-release version of Opana.

The FDA says the move marks the first time the agency has taken steps to remove an opioid from the market because of “public health consequences of abuse.”

An increasing number of people, the FDA says, are abusing the powerful prescription pills by crushing, dissolving and injecting them. The sharing of needles by these drug users has fueled an outbreak of associated infectious diseases — HIV, hepatitis C and another serious blood disorder.

“We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” says Dr. Scott Gottlieb, the FDA’s commissioner, in announcing the move.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb says.

In a written statement, Endo says the company is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.” The company defended its drug, a version of the medicine oxymorphone hydrochloride, citing the opioid’s effectiveness in alleviating pain and Endo’s efforts to prevent abuse.

“As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients, while at the same time taking comprehensive steps to minimize the potential misuse of its products,” according to the firm’s statement.

The FDA says if the company fails to voluntarily withdraw the drug the agency will force Opana ER’s removal from pharmacy shelves by revoking its market approval.

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How the FDA Approved a $300,000-a-Year Drug Its Own Experts Didn’t Believe Worked – By Susan Pulliam and Brody Mullins


After trial data for a new medicine proved inconclusive, Sarepta Therapeutics joined with the parents of sick boys to persuade officials it helped

Jennifer McNary, a stay-at-home mother, was desperate to find a medicine that might spare her two sons an early death from a rare form of muscular dystrophy.

Chris Garabedian, the chief executive of a pharmaceutical firm, was desperate to find a profitable drug that would reverse his company’s slow fall.

They met in June 2012 at a conference on Duchenne muscular dystrophy and joined forces, often behind the scenes and with little public disclosure, in a yearslong mission to push the government to approve a drug to treat DMD, as it is known.

At the time, it wasn’t at all clear the firm’s drug worked. Faced with government skepticism, a consultant to Mr. Garabedian’s company helped Ms. McNary and other parents prepare slickly packaged testimony to convince the Food and Drug Administration that the drug was helping their sick children, according to parents, company managers and the consultant.

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The One Thing President Obama Could Have Done to Fix Food—But Didn’t – TOM PHILPOTT OCT. 21, 2016 6:00 AM


Recipe wizard Mark Bittman dishes on how the next president could overhaul the system.

Bite

17 – Mark Bittman’s Recipe for the Next Presidency

00:00 /25:08

Like a huge plow roaring through a prairie, the 2016 presidential election has broken plenty of new ground. We’ve had a national conversation about a nonexistent sex tape involving a former Miss Universe; we’ve debated whether boasting of groping women’s genitals amounts to “locker room talk” or the admission of a crime; and we’ve entertained the idea that one of the major candidates might, if his campaign is successful, have the other one tossed in jail.

But like nearly every election before it, the current one has been nearly 100 percent free of any debate around the federal government’s massive role in shaping and regulating the food system. To get a grip on the vital food and farm issues we’re not hearing about, I interviewed Mark Bittman, the legendary home-cooking master and pundit. Back in 2015, Bittman stepped away from a four-year stint as an editorial columnist for the New York Times—a forum he used almost exclusively to weigh in on food and farm policy. He remains deeply involved with the topic, though, serving as a fellow at the Union of Concerned Scientists Food & Environment Program.

Bittman’s political analysis is as direct and pungent as that classic “Minimalist” dish of his, fried chickpeas with chorizo and spinach. He offered a harsh analysis of how President Barack Obama dealt with food and farm issues, echoing a recent New York Times Magazine piece by Michael Pollan. The current president once “talked a fairly decent game on changing the food system,” Bittman said, “but did virtually nothing in eight years.”

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The hidden danger in your hand soap | Sarah Ades and Kenneth Keiler Sunday 18 September 2016 09.00 EDT


Antibacterial agents in handsoaps have been banned in the US. That’s good news – they seep into urine and breast milk, and can promote bacterial resistance

‘Triclosan had become so prevalent in household products that in 2003 a nationwide survey of healthy individuals found it in the urine of 75% of the 2,517 people tested.’

A US Food and Drug Administration ruling this month bans the use of triclosan, triclocarban and 17 other antiseptics from household soaps because they have not been shown to be safe or even have any benefit.

About 40% of soaps use at least one of these chemicals, and the chemicals are also found in toothpaste, baby pacifiers, laundry detergents and clothing. It is in some lip glosses, deodorants and pet shampoos.

The current FDA action bans antiseptics like triclosan in household soaps only. It does not apply to other products like antiseptic gels designed to be used without water, antibacterial toothpaste or the many fabrics and household utensils in which antibacterials are embedded. Data suggest that the toothpastes are very effective for people suffering from gum disease, although it is not clear if they provide substantial benefits for those who don’t have gingivitis.

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FDA Moves To Speed Access To Compassionate-Use Drugs – RACHEL BLUTH June 8, 2016


Medicine

ZhangXun/Getty Images

The Food and Drug Administration has reduced an obstacle from its compassionate use policy, streamlining paperwork that physicians must submit to obtain experimental drugs for patients with life-threatening illnesses.

Doctors will now file an application for FDA approval that contains just 11 questions, 15 fewer than the old form. They should be able to complete this new version in 45 minutes, the FDA said. The new form is simpler because it was designed for individual patients, replacing an all-purpose format that had been used by doctors acting on behalf of individuals or groups of patients.

There had been concerns that doctors might have been deterred from applying for compassionate access, which is also known as expanded access, says FDA spokeswoman Sandy Walsh.

The policy is intended to help patients with incurable diseases who have tried all standard therapies and hope to extend their lives by taking experimental drugs not yet approved by the FDA, says Dr. Edward Kim, chair of the Department of Solid Tumor Oncology at the Carolinas HealthCare System’s Levine Cancer Institute.

The FDA’s old form was a “pretty laborious process,” Kim said. When doctors are serving patients whose time is running out, every minute saved on paperwork can help, he said.

In streamlining its path to approval, the FDA has bolstered a larger movement to make experimental drugs more accessible. Currently, 20 states have “right to try” laws aimed at improving terminally ill patients’ access to experimental treatments, according to the Regulatory Affairs Professionals Society.

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The FDA just made the most significant changes to the nutrition label in years – Updated by Julia Belluz on May 20, 2016, 11:02 a.m. ET


Bryan Solomon/Shutterstock

Bryan Solomon/Shutterstock

Trying to understand how healthy your food is by reading the nutrition labels on packaging is like trying to complete an advanced math equation: It’s possible, but requires a lot of effort.

Now, deciphering the labels will finally get easier. The US Food and Drug Administration just announced their final ruling on a long-anticipated overhaul of calorie labels on packaged foods.

The new Nutrition Facts labels will appear on millions of food packages within two years, finally telling you more about what you really need to know about your food for health — especially how much sugar has been added.

 FDA
Most food companies will be required use this new nutrition label in 2018.

There are five key changes to look out for:

  • The calories in a serving and the serving size will be presented in bigger and bolder text.
  • The amount of added sugars per serving will also be reported for the first time. Labels will also show how much that accounts for the daily value of sugar a person should be eating, as they have for carbohydrates, fats, and sodium for years.
  • Serving sizes will better reflect the amount of food people eat instead of telling you how much energy you get out of half a granola bar or three-fourths of a cup of yogurt.
  • Vitamin D, iron, calcium, and potassium will now be added to labels (because Americans aren’t consuming enough) but reporting the values of vitamins A and C will no longer be required (these deficiencies are now rare).
  • Instead of showing “calories from fat,” the label will now include “total fat” and sub-types like “saturated fat” and “trans fat.”  This reflects the research that certain types of fat are more harmful to health than others.

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