Date: 9/5/2008 4:58 PM
By RICARDO ALONSO-ZALDIVAR
Associated Press Writer
WASHINGTON (AP) _ The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients.
The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.
Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.
“My message to patients is this: Don’t stop taking your medicine,” said Dr. Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”
At least five of the drugs on the list had problems that already have been publicized. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in youngsters.
One emerging concern that previously got little attention involved Tysabri, a newer, widely used multiple sclerosis drug. The FDA said it is investigating a potential link to skin melanoma, a dangerous cancer. Doctors in Boston had reported two cases of melanoma in Tysabri patients in a letter to the New England Journal of Medicine in February. Tysabri suppresses the immune system, and it has also been linked to a rare kind of brain infection that is often fatal. Manufacturer Biogen Idec Inc. said it does not believe there is an increased risk of melanoma.
The FDA said drugs will be placed on the list based on reports it receives from hospitals, doctors and patients.
“What’s new here is that we are telling the public really at the earliest stage what we are working on,” said Dr. Gerald Dal Pan, head of the FDA’s drug safety office. “I think the public told us, ‘We want to know what you are working on.’ And we are responding to that.”
The list is not just a reflection of raw data, but more like what a police officer would call “probable cause.” Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.
“Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list,” said Dr. Paul Seligman, who is responsible for the FDA’s safety communications.
Consumer advocates called the listing a positive step, but said it needs to be fleshed out.
“It’s a good thing to get started but it needs to have much more detail if it’s to have significant safety value,” said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices. “A table with just a few words of description is quite limited.”
“It’s just the most basic warning system,” said Diana Zuckerman, president of the National Research Center for Women and Families. “It’s not going to say how many reports there were. It’s not going to say how many died and how many were hospitalized.”
Nor is it clear how drugs suspected of a problem will be removed from the list if later exonerated.
The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.
“Our reservation is that patients will be abruptly stopping therapy,” said Alan Goldhammer, a vice president of the organization. “One can’t generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients.”
___
On the Net:
FDA drug evaluation and research: http://tinyurl.com/5bu2om
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Regulator says hospitals need strict heparin rules
Date: 9/24/2008 12:02 AM
By LINDSEY TANNER
AP Medical Writer
CHICAGO (AP) _ A regulatory group told hospitals Wednesday to adopt strict measures to prevent errors involving blood thinners including heparin — mistakes that have been made nearly 60,000 times and led to dozens of deaths in recent years.
The Joint Commission issued a safety alert saying hospitals need to adopt prevention measures that could include bar-coding technology for medicines or computerized drug orders. It advised hospitals to more closely monitor patients on these drugs and make sure that adult-strength heparin is stored nowhere near children’s units.
The alert said 28 deaths are among 32 reports of drug errors involving blood thinners that it received between 1997 and last year.
“We know that there are many more (deaths) and … that’s the reason for issuing this alert,” said Dr. Mark Chassin, president of the Oakbrook Terrace, Ill.-based commission.
Recent errors include accidental life-threatening heparin overdoses given to actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. In July, 14 babies received accidental heparin overdoses at a hospital in Corpus Christi, Texas.
Commission investigators will make unannounced visits to make sure hospitals are adopting strict measures to prevent blood thinner errors, and those who fail to do so could see their accreditation revoked, Chassin said.
The commission is a private group that sets hospital standards and accredits most of the nation’s hospitals. Accreditation brings prestige and federal dollars.
A total of 59,316 medication errors involving blood thinners were reported between 2001 and 2006 to a database run by U.S. Pharmacopeia, a group that sets drug standards, the alert said. Nearly 3 percent, or roughly 1,700, resulted in patient harm or death, the commission said.
Blood thinners are particularly tricky to use because too much can cause hard-to-control bleeding internally and from every body opening; too little can result in life-threatening blood clots, Chassin said.
Heparin is usually given intravenously. Warfarin, another blood thinner cited in the alert, is available in pills patients can take at home but can cause bad reactions when mixed with other medicines.
The recommendations “absolutely” will make a difference and hospitals will pay attention, said James Conway, senior vice president of the nonprofit Institute for Healthcare Improvement in Cambridge, Mass.
___
On the Net:
Commission: http://www.jointcommission.org
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
By LINDSEY TANNER
AP Medical Writer
CHICAGO (AP) _ A regulatory group told hospitals Wednesday to adopt strict measures to prevent errors involving blood thinners including heparin — mistakes that have been made nearly 60,000 times and led to dozens of deaths in recent years.
The Joint Commission issued a safety alert saying hospitals need to adopt prevention measures that could include bar-coding technology for medicines or computerized drug orders. It advised hospitals to more closely monitor patients on these drugs and make sure that adult-strength heparin is stored nowhere near children’s units.
The alert said 28 deaths are among 32 reports of drug errors involving blood thinners that it received between 1997 and last year.
“We know that there are many more (deaths) and … that’s the reason for issuing this alert,” said Dr. Mark Chassin, president of the Oakbrook Terrace, Ill.-based commission.
Recent errors include accidental life-threatening heparin overdoses given to actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. In July, 14 babies received accidental heparin overdoses at a hospital in Corpus Christi, Texas.
Commission investigators will make unannounced visits to make sure hospitals are adopting strict measures to prevent blood thinner errors, and those who fail to do so could see their accreditation revoked, Chassin said.
The commission is a private group that sets hospital standards and accredits most of the nation’s hospitals. Accreditation brings prestige and federal dollars.
A total of 59,316 medication errors involving blood thinners were reported between 2001 and 2006 to a database run by U.S. Pharmacopeia, a group that sets drug standards, the alert said. Nearly 3 percent, or roughly 1,700, resulted in patient harm or death, the commission said.
Blood thinners are particularly tricky to use because too much can cause hard-to-control bleeding internally and from every body opening; too little can result in life-threatening blood clots, Chassin said.
Heparin is usually given intravenously. Warfarin, another blood thinner cited in the alert, is available in pills patients can take at home but can cause bad reactions when mixed with other medicines.
The recommendations “absolutely” will make a difference and hospitals will pay attention, said James Conway, senior vice president of the nonprofit Institute for Healthcare Improvement in Cambridge, Mass.
___
On the Net:
Commission: http://www.jointcommission.org
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Drug takeback programs stymied by federal regs
Date: 9/16/2008 12:01 AM
By MARTHA MENDOZA
AP National Writer
DALY CITY, Calif. (AP) _ When her father died in 2004, Adrienne Tissier faced the sad task of cleaning out his belongings — clothes, furniture, bags of medication. The drugs, including painkillers and sedatives, prompted a tricky question: Where to toss them?
Tissier, who was aware of the impact pharmaceuticals can have on the environment, checked with local authorities.
“No one seemed to know. They didn’t have much to offer,” said Tissier. “You’d think tossing out medicines would be pretty straightforward, but it’s not.”
Tissier was in a position to do something: She was a newly elected member of the board of supervisors of San Mateo County, just south of San Francisco.
She began calling meetings. With her staff, Tissier talked to the Drug Enforcement Administration and local law enforcement. They talked to the Environmental Protection Agency and local environmental officials. They talked to pharmacists and medical authorities.
And they tried to figure out what other communities were doing about this.
“Not much,” was Tissier’s conclusion.
The biggest challenge, she found, is a federal law that prohibits anyone from receiving a narcotic or other controlled substance from someone else. Anyone, that is, except a law enforcement agent.
Tissier approached local police and found they wanted to help, in part because local teens were consuming handfuls of whatever pills they could find at “pharma parties.”
It’s a growing problem. A study in Florida found that deaths caused by prescription drugs were three times the number caused by illegal drugs in that state last year.
In California, Tissier had a solution: a dozen white, metal pharmaceutical drop boxes — starting with three refurbished postal collection boxes — were placed outside police and sheriff departments around the county.
The results have been stunning.
In the first year, more than two tons of medications were dropped off. The costs have been less than $7,000, including hauling the drugs to a nearby medical waste disposal company that ships them to out-of-state incinerators specially designed for pharmaceutical waste.
“It’s one of those things that seems so simple but it really can make a difference,” Tissier said, standing outside the Daly City Police Department, where a property officer was removing bags of drugs from a drop box.
There have been dozens of drug drop-off and collection programs across the U.S., though few have lasted more than several months because of limited funds.
In 2006, a one-day drug return program at 25 locations in Chicago netted 1,600 pounds of medications — some more than 50 years old. Separate one-day takeback programs in Michigan and Milwaukee last year each yielded more than a ton of medicine.
About 101,300 pills were returned, mostly to San Francisco Bay-area pharmacies, during the last seven months of 2007 through the Green Pharmacy Program of Teleosis Institute in Berkeley, a program report says. Half of the pills originally sold were returned — a surprisingly big share, but one in line with predictions of some health professionals.
Chances are, many of those pills would have ended up in the sewers.
In Washington state, where a pilot program that collected 9,000 pounds of medications is running out of funding, Rep. Dawn Morrell, a registered nurse, has introduced a law that would require drug companies to design and fund a takeback program. She points out that these same companies spend more than $1 billion a year marketing their medicines in her state.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
By MARTHA MENDOZA
AP National Writer
DALY CITY, Calif. (AP) _ When her father died in 2004, Adrienne Tissier faced the sad task of cleaning out his belongings — clothes, furniture, bags of medication. The drugs, including painkillers and sedatives, prompted a tricky question: Where to toss them?
Tissier, who was aware of the impact pharmaceuticals can have on the environment, checked with local authorities.
“No one seemed to know. They didn’t have much to offer,” said Tissier. “You’d think tossing out medicines would be pretty straightforward, but it’s not.”
Tissier was in a position to do something: She was a newly elected member of the board of supervisors of San Mateo County, just south of San Francisco.
She began calling meetings. With her staff, Tissier talked to the Drug Enforcement Administration and local law enforcement. They talked to the Environmental Protection Agency and local environmental officials. They talked to pharmacists and medical authorities.
And they tried to figure out what other communities were doing about this.
“Not much,” was Tissier’s conclusion.
The biggest challenge, she found, is a federal law that prohibits anyone from receiving a narcotic or other controlled substance from someone else. Anyone, that is, except a law enforcement agent.
Tissier approached local police and found they wanted to help, in part because local teens were consuming handfuls of whatever pills they could find at “pharma parties.”
It’s a growing problem. A study in Florida found that deaths caused by prescription drugs were three times the number caused by illegal drugs in that state last year.
In California, Tissier had a solution: a dozen white, metal pharmaceutical drop boxes — starting with three refurbished postal collection boxes — were placed outside police and sheriff departments around the county.
The results have been stunning.
In the first year, more than two tons of medications were dropped off. The costs have been less than $7,000, including hauling the drugs to a nearby medical waste disposal company that ships them to out-of-state incinerators specially designed for pharmaceutical waste.
“It’s one of those things that seems so simple but it really can make a difference,” Tissier said, standing outside the Daly City Police Department, where a property officer was removing bags of drugs from a drop box.
There have been dozens of drug drop-off and collection programs across the U.S., though few have lasted more than several months because of limited funds.
In 2006, a one-day drug return program at 25 locations in Chicago netted 1,600 pounds of medications — some more than 50 years old. Separate one-day takeback programs in Michigan and Milwaukee last year each yielded more than a ton of medicine.
About 101,300 pills were returned, mostly to San Francisco Bay-area pharmacies, during the last seven months of 2007 through the Green Pharmacy Program of Teleosis Institute in Berkeley, a program report says. Half of the pills originally sold were returned — a surprisingly big share, but one in line with predictions of some health professionals.
Chances are, many of those pills would have ended up in the sewers.
In Washington state, where a pilot program that collected 9,000 pounds of medications is running out of funding, Rep. Dawn Morrell, a registered nurse, has introduced a law that would require drug companies to design and fund a takeback program. She points out that these same companies spend more than $1 billion a year marketing their medicines in her state.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney