10/02/2008 06:25:19 PM PDT
By SHAYA TAYEFE MOHAJER Associated Press Writer
LOS ANGELES—Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a state agency said Thursday.
The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.
“This was really an alert that the recall system doesn’t work,” Virginia Herold, head of the state’s pharmacy board, told The Associated Press.
Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children’s Hospital of Central California in Madera. Both hospitals are appealing the charges.
Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.
The Federal Drug Administration issued a drug recall in February because “a higher than usual number” of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.
The state’s Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.
No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.
“Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don’t have a reoccurrence of this in the future,” Kathleen Billingsley, deputy director of the state’s Center for Healthcare Quality, told the AP.
In March, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.
Herold said although it’s unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.
Last week the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.
Copyright 2008 The Associated Press.
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.
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.
Heparin Contamination Can do More than Kill
It seemed so obvious, but a brain damage expert I know felt the need to say it twice: That which can kill can do a lot of damage to those who survive. The body is a closed vessel, that is designed to very closely monitor that which comes in and out, especially the things that get into the blood stream.
All organs are extremely susceptible to a disruption in what is supposed to be in the blood supply. That susceptibility applies not only to a poison that shouldn’t be there, but also if there isn’t enough of what should be there: i.e. fuel to make the body work (glucose) and oxygen to make the fuel burn. Further, if the blood isn’t circulating properly, the waste products from this biological fire will not be carried away. In a very similar way to how people will succumb to carbon monoxide poisoning, the body’s cells and organs will be injured or killed by failure to properly ventilate (via the veins) the waste products created by keeping the body running.
When you put contaminated heparin intravenously into a human body, you bypass all of the body’s filters. The blood stream directly circulates that contaminant to every cell and organ. So what happens when a toxin runs amuck in our bodies? Almost anything that can go wrong, could go wrong.
Today I will talk about just the articulated theory from the CDC and the FDA of “acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction”. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5705a4.htm What can happen with anaphylactic shock? The body goes into shock. See http://en.wikipedia.org/wiki/Anaphylactic_shock and more specifically with respect to shock: http://en.wikipedia.org/wiki/Shock_%28medical%29
Some highlights from Wikipedia:
We know that reduced blood flow is one of the common symptoms of the Heparin contamination cases, because of the hypotension (low blood pressure) reported in most of these cases. Some highlights from Wikipedia about the risk of brain damage from Hypoxia:
Symptoms of hypoxia? Cognitive problems similar to what might be expected with a concussion. Amnesia, confusion, difficulty doing complex tasks, responding to unexpected processing demands. While there is some controversy about how much hypoxia can occur without long term damage, we believe this is the most important issue to evaluate in any Heparin contamination case.
So far no one at the CDC or FDA has announced any inquiry into whether hypoxic damage to the brain or other organs has occurred. While the brain is the most susceptible to permanent damage in a healthy person, since the recipients of this contaminant were those with compromised organs (hemodialysis patients for example), other organ damage may have occurred before the evidence of cerebral hypoxia showed up. Further, as vital organs like the kidneys and liver started to malfunction, other toxins could have been circulated into the blood stream.
It is time to insist the inquiry in this matter is no longer ruled by the presumption that those who survived the allergic reaction will have no long term damage. It is unimaginable that something toxic enough to have killed 62 people while affecting as many as 5,000 others, didn’t leave some permanent damage behind.
All organs are extremely susceptible to a disruption in what is supposed to be in the blood supply. That susceptibility applies not only to a poison that shouldn’t be there, but also if there isn’t enough of what should be there: i.e. fuel to make the body work (glucose) and oxygen to make the fuel burn. Further, if the blood isn’t circulating properly, the waste products from this biological fire will not be carried away. In a very similar way to how people will succumb to carbon monoxide poisoning, the body’s cells and organs will be injured or killed by failure to properly ventilate (via the veins) the waste products created by keeping the body running.
When you put contaminated heparin intravenously into a human body, you bypass all of the body’s filters. The blood stream directly circulates that contaminant to every cell and organ. So what happens when a toxin runs amuck in our bodies? Almost anything that can go wrong, could go wrong.
Today I will talk about just the articulated theory from the CDC and the FDA of “acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction”. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5705a4.htm What can happen with anaphylactic shock? The body goes into shock. See http://en.wikipedia.org/wiki/Anaphylactic_shock and more specifically with respect to shock: http://en.wikipedia.org/wiki/Shock_%28medical%29
Some highlights from Wikipedia:
Shock is a serious, life-threatening medical condition where insufficient blood flow reaches the body tissues. As the blood carries oxygen and nutrients around the body, reduced flow hinders the delivery of these components to the tissues, and can stop the tissues from functioning properly.And guess what can happen when the tissue stops functioning properly – brain damage and other organ damage, from a condition called hypoxia. See :http://en.wikipedia.org/wiki/Hypoxic_encephalopathy
We know that reduced blood flow is one of the common symptoms of the Heparin contamination cases, because of the hypotension (low blood pressure) reported in most of these cases. Some highlights from Wikipedia about the risk of brain damage from Hypoxia:
Cerebral hypoxia refers to deprivation of oxygen supply to brain tissue. … Extended periods of cerebral hypoxia can lead to brain death or permanent brain damage. … The effects of certain kinds of severe generalized hypoxias may take time to develop. For example, the long term effects of serious carbon monoxide poisoning usually may take several weeks to appear. Recent research suggests this may be due to an autoimmune response caused by CO induced changes in the myelin sheath surrounding neurons.
Symptoms of hypoxia? Cognitive problems similar to what might be expected with a concussion. Amnesia, confusion, difficulty doing complex tasks, responding to unexpected processing demands. While there is some controversy about how much hypoxia can occur without long term damage, we believe this is the most important issue to evaluate in any Heparin contamination case.
So far no one at the CDC or FDA has announced any inquiry into whether hypoxic damage to the brain or other organs has occurred. While the brain is the most susceptible to permanent damage in a healthy person, since the recipients of this contaminant were those with compromised organs (hemodialysis patients for example), other organ damage may have occurred before the evidence of cerebral hypoxia showed up. Further, as vital organs like the kidneys and liver started to malfunction, other toxins could have been circulated into the blood stream.
It is time to insist the inquiry in this matter is no longer ruled by the presumption that those who survived the allergic reaction will have no long term damage. It is unimaginable that something toxic enough to have killed 62 people while affecting as many as 5,000 others, didn’t leave some permanent damage behind.
Issues with Survivors of Baxter Heparin Contamination
As we look forward to assessing the full extent of the impact of Baxter International’s failure to maintain purity of their drug heparin, we must challenge the assertion that those who survived this contaminant have no lasting problems.
Problems could arise in many unknown ways, but some one of the most troubling areas of inquiry include the following deals with the of brain damage or other organ damage, from either the contaminant itself or the interruption of a consistent blood flow or blood pressure. I work extensively in the area of brain injury and brain damage. See http://tbilaw.com Brain damage can be significant, even if it is subtle, without dramatic symptomotology in the early phases. See http://subtlebraininjury.com
Clearly, if there was unconsciousness associated with the reaction, inquiries into brain damage are necessary. But even without a clear cut loss of consciousness, microscopic or microvascular brain damage could have occurred.
Another troubling concern is whether there could be a delayed onset of symptoms, such as there is with other toxic exposures. One disturbing analogy is the syndrome called Delayed Neurological Sequelae (DNS) seen after carbon monoxide exposure. See http://codamage.com
Likewise, could there be other organ damage, as a result. Hypotension can cause damage to other areas, such as to the heart and lungs. Inquiries as to whether there has been any other associated organ damage are necessary, not just for the FDA and CDC, but also for any physician or advocate involved with a person surviving such toxic event.
If you or a family member is considering action against Baxter or others as a result of this heparin castastrophe, it is critical that the legal team you have that represents is looking into all avenues of potential permanent damage. It is critical that the your representatives are willing to give your case the in depth inquiry that full compensation requires.
Problems could arise in many unknown ways, but some one of the most troubling areas of inquiry include the following deals with the of brain damage or other organ damage, from either the contaminant itself or the interruption of a consistent blood flow or blood pressure. I work extensively in the area of brain injury and brain damage. See http://tbilaw.com Brain damage can be significant, even if it is subtle, without dramatic symptomotology in the early phases. See http://subtlebraininjury.com
Clearly, if there was unconsciousness associated with the reaction, inquiries into brain damage are necessary. But even without a clear cut loss of consciousness, microscopic or microvascular brain damage could have occurred.
Another troubling concern is whether there could be a delayed onset of symptoms, such as there is with other toxic exposures. One disturbing analogy is the syndrome called Delayed Neurological Sequelae (DNS) seen after carbon monoxide exposure. See http://codamage.com
Likewise, could there be other organ damage, as a result. Hypotension can cause damage to other areas, such as to the heart and lungs. Inquiries as to whether there has been any other associated organ damage are necessary, not just for the FDA and CDC, but also for any physician or advocate involved with a person surviving such toxic event.
If you or a family member is considering action against Baxter or others as a result of this heparin castastrophe, it is critical that the legal team you have that represents is looking into all avenues of potential permanent damage. It is critical that the your representatives are willing to give your case the in depth inquiry that full compensation requires.