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July 21, 2014   Download print version

Hospital chain fined $1.55 million for missing drugs

FDA warns of deadly dangers of powdered caffeine

‘There is no such thing as Ebola’

Pill look different? Shape and color changes may prompt lapses

AbbVie is biggest to quit U.S. address in $55 billion Shire deal

Drug alert - Lack of sterility assurance in sterile drug products by Downing Labs

FedEx charged with assisting illegal pharmacies

First dengue vaccine 'shows promise'


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Hospital chain fined $1.55 million for missing drugs

An investigation into 20,000 tablets of prescription narcotics missing from St. Joseph's Medical Center in Stockton has led to Dignity Health, the state's largest hospital chain, paying a $1.55 million penalty for mishandling medications, federal prosecutors said Wednesday.

Investigators claimed Dignity Health facilities in the Sacramento area - including St. Joseph's hospital in Stockton - failed to properly record hundreds of transactions involving controlled substances and had insufficient procedures and controls on the distribution of such drugs.

In its agreement with the U.S. Attorney's Office in Sacramento, the hospital will pay $1.25 million immediately, while the remaining $300,000 penalty will be deferred as Dignity Health institutes a two-year plan to correct its record-keeping systems and improve its ability to detect and prevent diversion of prescription drugs.

Reported losses of more than 20,000 tablets of hydrocodone, an opioid narcotic, from the outpatient pharmacy at St. Joseph's triggered a Drug Enforcement Administration investigation of Dignity Health in late 2010 and 2011. A DEA audit revealed significant shortages of a number of the controlled substances at the pharmacy, and further investigation revealed that several Dignity Health locations failed to keep the required records.

Prosecutors said Dignity Health executive leadership worked cooperatively with the DEA and the U.S. Attorney's Office throughout the probe. Visit the Record for the report.



FDA warns of deadly dangers of powdered caffeine

The death of an Ohio teenager is prompting the Food and Drug Administration to warn consumers about the dangers of consuming pure powdered caffeine sold online. Even a teaspoon of the powder could be lethal — it is equivalent to 25 cups of coffee. Logan Stiner, 18, of LaGrange, OH, died May 27 after consuming the product, officials said. The FDA said it is investigating caffeine powder and will "consider taking regulatory action."

Teenagers and young adults may be particularly drawn to the powder, which is a stimulant. Caffeine powder is marketed as a dietary supplement and is unregulated, unlike caffeine added to soda. FDA spokeswoman Jennifer Dooren said those who drink coffee, tea or soda may be aware of caffeine's less serious effects, like nervousness and tremors, and may not realize that the powdered form is a pure chemical. "The difference between a safe amount and a lethal dose of caffeine in these powdered products is very small," she said. Symptoms of caffeine overdose or toxicity include rapid or erratic heartbeat, seizures, vomiting, diarrhea and disorientation. Visit NBC News for the story.



‘There is no such thing as Ebola’

“I don’t believe in Ebola,” Craig Manning’s local driver told him as he chauffeured the viral emergency specialist through Freetown, Sierra Leone, where infection rates are rising. The man came from a rural part of the country where people were already dying from the virus. He was adamant, like many others in his community, that “there is no such thing as Ebola.”

He is wrong. The epidemic, the deadliest on record, continues to batter Sierra Leone, Guinea and Liberia, with 85 new cases and 68 new deaths reported in only four days earlier this month, according to the World Health Organization (WHO). Sierra Leone bore the brunt of new infections and deaths, with 49 new cases and 52 deaths reported. The total number of cases stands at 982, with 613 deaths as of July 17.

Yet, as the Ebola virus continues to spread in West Africa, so do the rumors. Some say you can contract Ebola from a motorcycle helmet. Others say you can cure the deadly virus by drinking Nescafé mixed with cocoa and sugar — or with two large onions. It’s Manning’s job to take onions out of the equation.

A health communications strategist with the Viral Special Pathogens Branch of the Centers for Disease Control and Prevention, Manning was sent to Guinea at the first outbreak of the Ebola crisis in March. When one of his colleagues, Pierre Roland, an expert on Ebola, gave a presentation at the U.S. Embassy in Conakry about mitigating risks of transmission, Manning recorded him. He then had the edited 30 second snippets translated into 10 local languages and broadcast over local radio stations and TV.

When the virus spread to Sierra Leone, Manning followed it, teaming up with BBC Media Action to bring together radio station managers from across the country to help spread the word.

Manning said aggressive intervention is necessary to prevent more people from becoming infected, but ensuring local populations understand Ebola first is essential. For instance, in areas where the virus has spread, relatives wash bodies by hand before funerals, putting families at risk of new infections.

“People do not easily accept the idea that teams will take their deceased loved one, put them in a bag and bury them somewhere different,” said Manning. “The challenge is to strike a balance.”

This balance demands communication, according to WHO spokesperson Daniel Epstein.

Doctors Without Borders has been unable to gain access to some affected areas due to hostility from the people there. Local communities fear outsiders are bringing the virus with them or want to exterminate the infected, since so few who get treatment return alive.

WHO is helping coordinate information sessions on Ebola to train local leaders how the virus is transmitted and how people can stop it.

WHO has been operating emergency Ebola hotlines in the affected countries that get 200 to 300 calls a day. The organization is exploring text messaging, since 40 percent of affected populations use mobile phones.

Doctors Without Borders have brought anthropologists on board in an attempt to better understand the traditions and cultures of the people they are treating.

While expert advice is important, the key to getting the message through to communities in more isolated areas is building a network of local spokespersons and engaging religious and cultural leaders.

There have been small victories. Manning said his driver had come to trust him. Visit the Washington Post for the article.



Pill look different? Shape and color changes may prompt lapses

In a decade, Americans have saved an estimated $1.2 trillion by taking generic drugs instead of the high-priced originals. But the booming market in copycat prescription pharmaceuticals - coupled with insurance companies' efforts to keep healthcare costs low - often means that when they refill a prescription, patients get a familiar medication in a new shape or color. That may be a bad idea, a new study says.

Research suggests that switches in a given medication's color or shape may prompt many patients to discontinue needed medicine. The authors of the study - a group of prescription drug researchers from Boston's Brigham and Women's Hospital - urge the Food and Drug Administration to rethink its hands-off policy when it comes to regulating the appearance of generic medications.

It's a timely problem. In recent years, the makers of dozens of the nation's most prescribed medications have lost their exclusive marketing rights to drugs they developed. And generic manufacturers have rushed in to offer less-expensive generic versions of those drugs. Statin medications, blood pressure drugs, antidepressants and sleep aids that were long available in just one form are now offered in shapes and colors that differ from the first-to-market drugs they imitate.

Under FDA rules, all generic versions of the statin drug Lipitor (known as atorvastatin), for instance, must have the same active ingredient as the original, and that medication must be delivered in the same way. But the generic versions of Lipitor are typically different from one another, and the Pfizer-made original, in size, shape, color and formulation.

The drug manufacturers who make these generics negotiate deals with pharmacies, mail-order pharmacy benefit managers and hospital formularies, which are constantly shopping for the best prices. As a result, a mail-order pharmacy, for instance, may dispense one generic manufacturer's statin drug one month and refill it a month later with the same drug made by a different manufacturer. Unwitting patients will often have no idea why this month's prescription medication looks different from last month's.

The authors surmised that such patients may lose confidence in their medication's safety or effectiveness, or that the change causes the kind of confusion that leads to medication errors such as failing to take one drug or doubling up on another. Most of the patients studied were sent home from the hospital with a number of prescription medications, so keeping medication schedules straight would probably have been challenging enough even before the pharmacy dispensed medications that are changed in color or shape.

The latest study compared heart attack victims who, after leaving the hospital, continued for a year to take common heart medications with similar patients who discontinued their medications in the year following their heart attack. Among those who lapsed in taking medications to prevent a second heart attack, the discontinuation followed a change in the shape or color of the pill they were dispensed in 7% of the cases.

More than color changes, a reconfiguration of a pill's shape raised the likelihood of a patient failing to adhere to his or her medication regimen. In a recent study focusing on epilepsy drugs, the same researchers found a similar pattern, in which changes in a pill's shape made a bigger impact than changes in its color.

Compared with those who continued to take their heart medications, those who lapsed were 30% more likely to have experienced a change in their medication's shape or color, the researchers found.

The study was published in the Annals of Internal Medicine. Visit the Chicago Tribune for the study.



AbbVie is biggest to quit U.S. address in $55 billion Shire deal

AbbVie Inc. agreed to buy Shire Plc for about 32 billion pounds ($54.8 billion), becoming the latest U.S. healthcare company to shift its tax residence abroad in a record surge in industry deals.

AbbVie Inc. and Shire Plc’s deal will make AbbVie the largest U.S. company to move its legal address abroad to lower its taxes as U.S. lawmakers seek ways to curb the transactions.

The acquisition comes in a record period of pharmaceutical deals. It will allow North Chicago, IL-based AbbVie to move its legal residence, though not its operations, to the U.K., lowering its tax rate in 2016 to 13 percent from 22 percent.

Shire’s drugs for attention deficit hyperactivity disorder and rare diseases will diversify AbbVie’s portfolio, dominated by the rheumatoid arthritis medicine Humira.

Analysts asked if the deal was done primarily for tax reasons. “This is a transaction that we believe has excellent strategic fit, well beyond the tax impact,” AbbVie Chief Executive Officer Richard Gonzalez said on a conference call. “We wouldn’t be doing it if it was just for the tax impact.” At the same time, Gonzalez said the higher corporate tax rate in the U.S. is pushing companies abroad. “Companies like ours need access to our global cash flows,” he said. “Today we’re at a disadvantage compared to our foreign competitors, and that’s the debate we should be having around inversions and our tax code.”

The U.S. government has been scrutinizing so-called tax inversions, and Senator Ron Wyden, a Democrat from Oregon, is proposing a bill that would make them more difficult to do. A congressional panel estimated this year that preventing future inversions would preserve $19.5 billion in otherwise forgone tax revenue over the next 10 years.

In the negotiations, Shire sought protection in case the U.S. passes a law undercutting the tax gains and puts the deal’s closing at risk, said two people with knowledge of the matter. The agreement calls for AbbVie to pay Shire a breakup fee of 3 percent of the deal’s value, or about $1.6 billion, or reimburse costs of not less than $500 million, if the purchase falls through, according to the statement.

AbbVie was split off from Abbott Laboratories in January of last year, creating a brand-drug company out of the larger healthcare conglomerate that’s now focused on medical devices and nutrition products. Abbott was involved in a tax inversion this month as well, selling part of its off-patent drugs business to Mylan Inc., allowing the generic drugmaker to shift its legal address abroad. Visit Bloomberg for the article



Drug alert - Lack of sterility assurance in sterile drug products by Downing Labs

FDA is alerting healthcare professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483 issued July 16, 2014). The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.

Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their healthcare professional. Read the FDA Drug Alert.



FedEx charged with assisting illegal pharmacies

Federal authorities on Thursday charged FedEx with assisting illegal pharmacies by knowingly delivering painkillers and other dangerous drugs to customers without prescriptions.

The indictment was filed in federal court in San Francisco, and the Department of Justice announced the charges in Washington, DC. The indictment alleges that FedEx Corp. conspired with two related online pharmacies for 10 years ending in 2010.

The Memphis, TN-based delivery company is accused of shipping powerful sleeping aid Ambien, anti-anxiety medications Valium and Xanax, and other drugs to customers who had no legitimate medical need and lacked valid prescriptions.

FedEx insists it did nothing wrong. FedEx first disclosed the federal investigation in a regulatory filing in November 2012. The company said at that time it had done nothing wrong and intended to fight any charges.

Rival shipping company UPS Inc. paid $40 million last year to resolve similar allegations, and the Atlanta-based company said it would ‘‘take steps’’ to block illicit online drug dealers from using its delivery service.

Both companies said in regulatory filings that they were served with grand jury subpoenas between 2007 and 2009. The investigation of the country’s two largest shippers stems from a blitz against online pharmacies that was launched in 2005 in San Francisco. Since then, dozens of arrests have been made, thousands of websites shuttered, and tens of millions of dollars and pills seized worldwide as investigators continue to broaden the probe beyond the operators.

Google Inc. agreed to pay $500 million to settle allegations by the Justice Department that it profited from ads for illegal online pharmacies.

A federal jury in 2012 convicted three men of operating illegal pharmacies that used FedEx and UPS to deliver drugs without proper prescriptions. Seven others were convicted in San Francisco previously. (Associated Press) Visit the Boston Globe for the article.



First dengue vaccine 'shows promise'

Scientists say they have developed the world's first vaccine against dengue fever seen to work in large-scale trials. Research in the Lancet journal suggests more than 50% of children who are given the vaccine are protected against the disease. Half the world's population is at risk of catching the mosquito-borne virus.

Experts say though the long-awaited study is promising, vaccines with greater effectiveness are crucial. There are currently no treatments to prevent dengue fever - an illness which affects more than one million people a year.

In the largest late-stage trial of a vaccine to date, researchers from five centers across Asia treated 6,000 children aged between two and 14 years old. Some 56% were seen to have protection against the virus at the end of two years. It worked best for children with certain subtypes of the virus and those who had been exposed to it before.

And the vaccine had an even greater impact on severe forms of the disease, reducing the number of people needing treatment in hospital and preventing 80% of cases of hemorrhagic fever - a potentially life-threatening complication.

Lead author Dr Maria Rosario Capeding, from the Research Institute for Tropical Medicine in the Philippines, told the BBC: "Given that dengue is a major public health problem in most Asian countries the findings have the potential to have a huge impact on public health.

Prof Martin Hibberd of the London School of Hygiene and Topical Medicine who was not involved in the study said: "The biology of dengue is complex and has troubled researchers for many years. “I am very glad they have tackled this, but I am disappointed the vaccine is only 56% effective - much lower than our normal targets. Nevertheless this is the most significant reduction we have seen to date - the best we have so far.  And many nations spend huge amounts of money trying to prevent the spread of this disease."

He suggests people who have been given the vaccine should be monitored for at least five years to ensure it remains effective and safe. And further questions need to be addressed, including how much of an impact it will have in other parts of the world.

Sanofi-Pasteur, the company funding the research, plans to apply for approval once the results of its second trial across Latin America and the Caribbean have been analyzed. Visit BBC for the study.