Archive: July, 2010
Michael Cohen
By guest blogger Michael Cohen:
Millions of Americans have problems sleeping. This is reflected in the tens of millions of prescriptions dispensed annually in the U.S. for sleeping pills.
While the vast majority of patients safely use these medications as directed by their doctors, one problem we occasionally hear about at the Institute for Safe Medication Practices is when individuals accidentally take their sleep medicine during the day instead of another look-alike tablet or capsule.
One report we received this past month involved a 65-year old woman who was admitted to a hospital after having sudden memory loss and strange behavior for two days. Later a nurse checked the woman's medicines and found Ambien, a prescription sleep medicine, mixed in the same container as Zetia (ezetimibe), a drug used to lower cholesterol. The white oblong pills of each medication looked very similar, which contributed to the woman taking the wrong medication.
Car accidents have happened with this type of mix-up. On June 14, 2010, an 84 year-old woman grabbed a bottle of sleep medication instead of an antibiotic. Later, while driving, she veered into oncoming traffic and hit three cars. Luckily, there were no injuries.
A particularly dangerous incident happened to a commercial airline pilot who accidentally took his sleep medicine while flying a plane with about 100 people on board. He took what he thought was his blood pressure medicine and soon became sick and confused and began to fall asleep. Fortunately, a flight attendant came to his assistance and the co-pilot took over control of the plane, averting a likely disaster.
Like all medicines, sleeping pills should be kept in their original containers. We’d recommend keeping them in the bedroom, in a secure location away from other medicines. Also, identifying pills only by their color and shape is a dangerous practice. Don’t take any medicine unless you’ve read the label. For more on this subject and a list of error prevention measures, check out our consumer website story on this topic, “Preventing dangerous sleep medication mix-ups,” here.
For information on the Institute for Safe Medication Practices' consumer website go www.consumermedsafety.org
To check out more Check Up items go to www.philly.com/checkup.
Josh Goldstein
When my oldest daughter forgets to say please or is heading to the whiny I want, I rub my stomach with my stomach with my right hand and sometimes pull her back from the brink. “Can I please have…”
The please sign is a vestige of our teaching her a little sign language starting when she was about six months old. She is an incredibly verbal child. The problem now, if there is one, is to get her to stop talking long enough for my wife and me to have an actual conversation at the end of the day. But the real point is that before she could verbalize she was able to tell us some basic things like when she wanted “milk” and “more” to “eat” and when she was “all done.”
Eventually our daughter learned more signs like please and thank you. And a wonderful daycare teacher expanded into all kinds of words, many of which remain etched in her sign vocabulary. So when our second daughter was about six months old my wife and I began the process all over again, aided this time by a proud and sign-savvy big sister.
At nine months or ten moths the baby started signing more and all done and milk, feats that I proudly proclaimed to all who were willing to listen. And the result of this is a story in Monday’s paper on signing.
Josh Goldstein
The Pennsylvania Department of Health said that 20 of 25 “mosquito pools” to test positive for West Nile Virus were located in Delaware County with additional pools found in Philadelphia, Bucks, Montgomery, and Lancaster Counties.
“This year, mosquito sampling is showing earlier and more frequent evidence of WNV circulation in Southeastern Pennsylvania than in recent years,” the state health department stated.
Thursday the Philadelphia Department of Public Health issued a health advisory that it has identified the city’s first “mosquito pool” to test positive for West Nile Virus this year.
The advisory, issued to health care providers, stated that while no human cases of the virus have been identified the detection of an unusually high number of pools at this point in the summer by the Pennsylvania Department of Health suggesting a higher risk of human infection this summer.
Daniel Hoffman
By guest blogger Daniel Hoffman:
This spring the independent equity analysts at Sanford Bernstein & Co. held a conference to assess how well the pharmaceutical industry is doing at creating new opportunities and cushioning the impact of the impending “patent cliff.”
The patent cliff is the shorthand phrase for pharma’s fast approaching revenue catastrophe, as 18 of the industry’s 20 top-selling drugs lose patent protection over the next five years. This wave of patent expirations poses a revenue crisis because the industry’s research pipeline has been woefully unproductive at developing new compounds to offset those losses.
The Bernstein analysts and their guest speakers examined four key areas where the pharmaceutical industry needs to correct its current course. These involve R&D productivity, diversification to lessen dependence on prescription pharmaceuticals, mergers and acquisitions, and controlling costs. They concluded that the industry is doing a dismal job on all fronts.
Josh Goldstein
The Hospital of the University of Pennsylvania once again made the “honor roll” in U.S. News and World Report's rankings of the nation’s top medical centers. That placed the hospital, known locally simply as HUP, among an elite groups of 14 top institutions out of the nearly 5,000 rated by the magazine.
HUP ranked in the top 20 in 15 of the 16 areas of care rated by the magazine Here is where the hospital fell: Cancer, 14; Diabetes and Endocrine Disorders, 12; Gastroenterology, 7; Gynecology 16; Ear, Nose, and Throat, 7; Geriatric Care, 16; Gynecology, 16; Heart and Heart Surgery, 10; Kidney Disorders, 11; Neurology and Neurosurgery, 15; Orthopedics, 14; Pulmonology, 10; Urology, 14; Ophthalmology, 16; Psychiatry, 14.
“We are pleased that, once again, the outstanding quality of care we deliver to our patients each and every day is recognized so publicly with this designation as one of the Best Hospitals in America,” said Garry Scheib, chief operating officer of the University of Pennsylvania Health System.
Other area institutions also made the top 20 lists in several categories including: Thomas Jefferson University Hospital which ranked 13th in orthopedics and 12th in rehabilitation; Wills Eye Hospital ranked third in ophthalmology; and Moss Rehab, part of the Albert Einstein Healthcare Network ranked tenth in rehabilitation. And still others made the U.S. News rankings but fell below the top 20.
Josh Goldstein
A Food and Drug Administration advisory panel voted 20 to 12 Wednesday to keep GlaxoSmithKline’s controversial diabetes drug Avandia on the market in the U.S., albeit recommending with stronger warnings about the increase risk of heart attacks, heart failure and stroke for those taking the medication.
Before the vote on whether or not to take Avandia off the market here, the panel had voted 21 to 4 that the medication increased the risk of heart attacks compared with other medications used to treat diabetes including the competing drug Actos by made by a Japanese pharmaceutical company.
The FDA will now decide on what action if any to take in regards to Avandia. The drug agency is not required to follow the advice of the advisory panel, but usually does. Here's the full story on Wednesday's advisory committee actions.
To check out more Check Up items go to www.philly.com/checkup.
Josh Goldstein
By a large majority an Food and Drug Administration advisory panel examining the safety of GlaxoSmithKline’s diabetes drug Avandia voted that the medication should face restrictions on sales or be withdrawn from the U.S. market.
According to the New York Times website 12 of the panel voted that the FDA should take Avandia off the market and 10 members “voted that it should continue to be sold but with serious revisions to its label as well as possible restrictions on its sale.”
Another seven panel members said more warnings should be added to the drug's label and three voted to leave Avandia on the market without any label changes or restrictions, the Times said.
The final tally of the panel was 20 to 12 to keep Avandia on the market, but a large majority of the members favored label changes and restrictions to limit the use of the drug in the U.S.
Michael Cohen
By guest blogger Michael Cohen:
Severe drug shortages are on the rise and leading to serious patient safety issues and frustration among health care workers. The lack of availability of prefilled epinephrine (adrenaline) syringes for example has lead to patient injuries and deaths.
In one report we received at the Institute for Safe Medication Practices, the shortage of the so-called “epi” syringes led to the death of a 16-year-old boy in an ER. The teen was brought to an emergency department with priapism, a painful persistent erection that can lead to permanent erectile dysfunction. A doctor ordered epinephrine to treat the teen. Unfortunately, the urologist thought the 1:1,000 ratio on drug label meant that the epinephrine had been “prediluted” by the manufacturer. So, instead of the intended 0.4 mg dose the teen got 10 times the dose - 4 mg of undiluted solution. When the epinephrine reached the teen’s blood system, he suffered a cardiac arrest and died.
That situation is just one of the shortages among the most commonly used medications, including critically important emergency drugs, pain medications and anesthetics are either hard to come by or completely unavailable.
As a result pharmacists, nurses and emergency medical response teams have been forced to come up with alternatives to commonly used drugs and familiar protocols. But using unfamiliar new medications, with different dosing methods, adds to the complexity of care. That in turn increases the risk to patient safety, especially when the drugs in question are used in high risk situations.
On July 8 the Bucks County’s Emergency Health Service notified emergency medical service (EMS) squads that the shortage of prefilled syringes of epinephrine for the EMS drug boxes carried by all ambulances in Bucks County and elsewhere. The notice provided emergency personnel with instructions to use a concentrated form of the drug after diluting it.
In the past, we’ve received reports about some health care workers misreading labels of tiny epinephrine ampuls, mixing it up with another drug, ephedrine. Or miscalculating a dose, which is often based on ratio expressions such as 1:1,000 or 1:10,000 and easily confused, leading to fatal 10-fold overdoses.
This situation with the epinephrine syringe shortage is so potentially dangerous that we, along with the American Society of Health System Pharmacists (ASHP) sent out a nationwide alert two weeks ago to warn practitioners about dangers.
Fortunately, this epinephrine shortage does not involve Epipen syringes, a different form of the drug, self injected by patients prone to severe allergic attacks. This year has seen more drug shortages than most pharmacy professionals can recall. Here are lists from the FDA and ASHP of drugs in short supply.
It is not always clear what causes these shortages. One serious concern is what appears to be an ongoing trend with older sterile injectable products (like the above prefilled epinephrine syringes) that involve fewer and fewer firms making these critical products.
Regardless, drug shortages are a major problem and it’s time for FDA to hold a public meeting and invite stakeholders to put their heads together to solve this problem. Maybe regulatory changes could be implemented so that once a company gains approval to manufacturer and distribute a drug, they aren’t allowed to simply stop making it if they don’t feel it is profitable enough, at least not until other manufacturers are lined up.
For information on the Institute for Safe Medication Practices' consumer website go www.consumermedsafety.org
To check out more Check Up items go to www.philly.com/checkup.
Josh Goldstein
After a day of conflicting testimony on the safety of GlaxoSmithKline’s diabetes drug Avandia, a Food and Drug Administration advisory panel will vote Wednesday on whether to recommend the medication be taken off the market.
Glaxo representatives at the meeting in suburban Washington, D.C. defended the drug amid sometimes biting criticism from FDA scientists and other critics of Avandia, which was approved for sale in 1999. Once a blockbuster, Avandia was first linked to higher rates of heart attacks in a 2007 study when compared to a competing diabetes drug, Actos.
On the first day of the hearing a Senate committee released documents that suggested Glaxo hid the risks of Avandia from the public and the FDA. Also Tuesday, Bloomberg News reported, based on unidentified, sources that Glaxo has agreed to settle 10,000 Avandia suits for $460 million.
Glaxo would not comment on the reported settlement. The company responded to the release of documents in a statement that said in part: “The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation. They include drafts and other documents taken out of context, which therefore are incomplete and misleading.”
Josh Goldstein
Whenever I get the chance to visit my favorite little taqueria near the Italian Market, I am hard-pressed not to fill up on the salsa and chips that they put on the table before you order. But an analysis of outbreaks of food-borne illnesses in restaurants from 1998 to 2008 by a researcher at the Centers for Disease Control and Prevention could put a damper on that diet-busting pleasure.
The CDC researcher found that salsa and guacamole accounted for one out of every 25 cases of food-borne illness associated with restaurants. These salsa- or guacamole-connected outbreaks more than doubled from 1.5 percent of the total from total between 1984 and 1997 to 3.9 percent over the next 10 years.
The CDC traced 30 percent of the outbreaks to storage issues related to improper temperatures or held too long and spoiled. Another 20 percent of the outbreaks at restaurants were due to contamination by staffers at the establishments.
“Awareness that salsa and guacamole can transmit food-borne illness, particularly in restaurants is key to preventing future outbreaks,” said Magdalena Kendall, a researcher at the Oak Ridge Institute for Science and Education who collaborated with the CDC on the study. “We want restaurants and anyone preparing fresh salsa and guacamole at home to be aware that these foods containing raw ingredients should be carefully prepared and refrigerated to help prevent illness.”
- Abington Memorial Hospital
- Agency for Healthcare Research and Quality
- American Medical Association
- Aria Health
- Centers for Disease Control and Prevention
- Centers for Medicare & Medicaid Services
- Consumer Medication Safety site from ISMP
- Cooper University Hospital
- Crozer-Keystone Health System
- ECRI Institute
- Inquirer Health & Science
- Institute for Safe Medication Practices
- Jefferson Health System
- Kaiser Health News
- Kennedy Health System
- Lourdes Health System
- Medical Society of New Jersey
- Mercy Health System
- New Jersey Department of Health and Senior Services
- New Jersey Hospital Association
- NPR.org Shots
- NYTimes.com: Well
- Penn Medicine
- Pennsylvania Department of Health
- Pennsylvania Health Care Cost Containment Council
- Pennsylvania Medical Society
- Pennsylvania Patient Safety Authority
- St. Mary Medical Center
- Temple University Health System
- Tenet Healthcare
- The ACP Advocate Blog by Bob Doherty
- The Chester County Hospital
- The Hospital & Healthsystem Association of Pennsylvania
- U.S. Department of Health and Human Services
- U.S. Food and Drug Administration
- Virtua
- WSJ.com Health
