Life-threatening pathogens including the very dangerous MRSA can be transmitted from cats and dogs to humans via bite wounds — and such injuries should prompt careful clinical consideration.
Among the pet-related pathogens are Pasteurella, Capnocytophaga, Streptococcus, and Staphylococcus species — with methicillin-resistant Staphylococcus aureus on the rise. Given the potential for severe complications, the authors offer a wound management strategy. Steps include:
• Culture for aerobes and anaerobes if the patient has an abscess, severe cellulitis, devitalized tissue, or sepsis.
• Irrigate the wound with saline solution.
• Order radiographs in case of fracture or bone penetration; MRI or CT may also be indicated.
• Prescribe prophylactic antibiotics as necessary. If MRSA is suspected, first-line antibiotics include trimethoprim-sulfamethoxazole, doxycycline, minocycline, and clindamycin.
• Hospitalize the patient if there is fever, sepsis, spreading cellulitis, severe edema, crush injury, or loss of function, or if the patient is immunocompromised or likely to be nonadherent.
* Tune in tomorrow for falsified data on sleep apnea in severely obese patients.
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Friday, June 26, 2009
Thursday, June 25, 2009
A GREAT IDEA -- SPECIALIZED HEALTH CARE COURTS
“Never events are now the going payment standard of care as far as hospital re-imbursement. But that means to many a never event will probably also be viewed as representing “below standard medical care.” Thus "the mere designation of never events will likely result in both more numerous and more valuable plaintiffs’ verdicts nationwide,” says Charles Brown.
In an op-ed in the New York Times Philip K. Howard, chairman of Common Good, a legal reform coalition, writes that currently, "fear of possible claims leads medical professionals to squander billions in unnecessary tests and procedures." This practice, known as "defensive medicine," is now "so prevalent that it has become part of standard protocol," Howard notes.
And, "under instructions from lawyers," physicians "don't apologize or offer explanations when things go wrong." As a result, "patients, sensing distrust, demand second opinions." "it would be relatively easy to create a new [health] system of reliable justice, one that could support broader reforms to contain costs." But, with "special health courts aimed...delivering fair and reliable decisions," patients and physicians would have "expedited proceedings with knowledgeable staff."
He also points out that "one benefit" of a "quicker, streamlined system would" be "drastically lower legal costs." Howard concludes that "restoring trust in law," an "essential reform, can be accomplished with the creation of reliable courts." Restoring a foundation of trust requires a new system of medical justice, says Howard. Medical cases are now decided jury by jury, without consistent application of medical standards. According to a 2006 study in the New England Journal of Medicine, around 25 percent of cases where there was no identifiable error resulted in malpractice payments. Nor is the system effective for injured patients — according to the same study, 54 cents of every dollar paid in malpractice cases goes to administrative expenses like lawyers, experts and courts.
America needs special health courts aimed not at stopping lawsuits but at delivering fair and reliable decisions. A special court would provide expedited proceedings with knowledgeable staff that would work to settle claims quickly. Trials would be conducted before a judge who is advised by a neutral expert, with written rulings on standards of care.
All information about each incident, including details learned in settlements, would be compiled and disseminated so that doctors and hospitals could learn from their errors.
Proponents of special health courts have estimated that the total cost of such a new liability system would be about the same as the existing system — less than 2 percent of America’s total health care costs. One benefit would be that the quicker, streamlined system would compensate far more people, with drastically lower legal costs. Most important, it would restore faith in the reliability of medical justice. This country has a long tradition of courts and tribunals to deal with issues like bankruptcy that require special expertise. Nowhere is that expertise, along with the stability and trust it would bring, more needed than in health care.
Several prominent hospitals, including New York Presbyterian, have said they are interested in being part of a health court pilot project. Some large consumer and patient safety groups support the idea. The fastest way to do this would be for Congress to authorize and finance pilot courts around the country. These ideas already have some bipartisan support: Bills for alternative medical justice systems have been introduced in Congress.
Cutting back on the notorious inefficiency of American health care is essential to achieve universal care, as well as make the American economy more competitive.
Part of the solution — overhauling the reimbursement model so that doctors get paid only for what is needed — is unavoidably complex.
But restoring trust in law, the other essential reform, can be accomplished with the creation of reliable courts.
* Tune in tomorrow for Recommendations on Managing Infection Passed from Pets to Humans via Bite Injuries
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
In an op-ed in the New York Times Philip K. Howard, chairman of Common Good, a legal reform coalition, writes that currently, "fear of possible claims leads medical professionals to squander billions in unnecessary tests and procedures." This practice, known as "defensive medicine," is now "so prevalent that it has become part of standard protocol," Howard notes.
And, "under instructions from lawyers," physicians "don't apologize or offer explanations when things go wrong." As a result, "patients, sensing distrust, demand second opinions." "it would be relatively easy to create a new [health] system of reliable justice, one that could support broader reforms to contain costs." But, with "special health courts aimed...delivering fair and reliable decisions," patients and physicians would have "expedited proceedings with knowledgeable staff."
He also points out that "one benefit" of a "quicker, streamlined system would" be "drastically lower legal costs." Howard concludes that "restoring trust in law," an "essential reform, can be accomplished with the creation of reliable courts." Restoring a foundation of trust requires a new system of medical justice, says Howard. Medical cases are now decided jury by jury, without consistent application of medical standards. According to a 2006 study in the New England Journal of Medicine, around 25 percent of cases where there was no identifiable error resulted in malpractice payments. Nor is the system effective for injured patients — according to the same study, 54 cents of every dollar paid in malpractice cases goes to administrative expenses like lawyers, experts and courts.
America needs special health courts aimed not at stopping lawsuits but at delivering fair and reliable decisions. A special court would provide expedited proceedings with knowledgeable staff that would work to settle claims quickly. Trials would be conducted before a judge who is advised by a neutral expert, with written rulings on standards of care.
All information about each incident, including details learned in settlements, would be compiled and disseminated so that doctors and hospitals could learn from their errors.
Proponents of special health courts have estimated that the total cost of such a new liability system would be about the same as the existing system — less than 2 percent of America’s total health care costs. One benefit would be that the quicker, streamlined system would compensate far more people, with drastically lower legal costs. Most important, it would restore faith in the reliability of medical justice. This country has a long tradition of courts and tribunals to deal with issues like bankruptcy that require special expertise. Nowhere is that expertise, along with the stability and trust it would bring, more needed than in health care.
Several prominent hospitals, including New York Presbyterian, have said they are interested in being part of a health court pilot project. Some large consumer and patient safety groups support the idea. The fastest way to do this would be for Congress to authorize and finance pilot courts around the country. These ideas already have some bipartisan support: Bills for alternative medical justice systems have been introduced in Congress.
Cutting back on the notorious inefficiency of American health care is essential to achieve universal care, as well as make the American economy more competitive.
Part of the solution — overhauling the reimbursement model so that doctors get paid only for what is needed — is unavoidably complex.
But restoring trust in law, the other essential reform, can be accomplished with the creation of reliable courts.
* Tune in tomorrow for Recommendations on Managing Infection Passed from Pets to Humans via Bite Injuries
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Wednesday, June 24, 2009
Do Not Eat Nestle Toll House Prepackaged Cookie Dough
Nestle Toll House prepackaged refrigerated products were recalled on June 19, 2009, over concerns about E. coli contamination, with the FDA advising consumers to throw away any dough they may have already purchased. (Cooking the dough is not recommended, as the bacterium could contaminate one's hands or cooking surfaces.)
Since March, E. coli infections potentially linked to the dough have been reported in 66 people in 28 states, according to the FDA. There have been 25 hospitalizations —
some with hemolytic uremic syndrome — and no deaths.The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness).
The FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Retailers, restaurateurs, and personnel at other food-service operations should not sell or serve any Nestle Toll House prepackaged, refrigerated cookie dough products subject to the recall. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died.
Because the appearance of E. coli 0157 in cookie dough is so unusual, investigators are looking at a broad range of possible factors, analyzing the ingredients, the plant's equipment and interior, the health of workers and whether the facility is located near cattle. Federal officials are also considering whether the dough might have been intentionally contaminated. E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death. E. coli refers to many kinds of bacteria, most of which are harmless or even beneficial. But certain types, including E. coli 0157, produce a toxin that can cause severe illness and even death in humans. The E. coli 0157 bacterium lives in the intestines of cows and other animals -- goats, sheep, deer and elk -- and is found most often in ground beef. But over the past decade, a number of E. coli 0157 illness outbreaks have been associated with green, leafy produce, such as spinach
For more information on safe food handling practices, go to http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm.
State health officials first noticed cases of E. coli 0157 emerging in March. Initially, they suspected ground beef or strawberries. But after interviewing victims, state officials and the CDC compared notes during a conference call Tuesday and settled on the refrigerated cookie dough as the prime suspect.
The risk usually associated with cookie dough is salmonella, a bacteria that can be found in raw eggs contained in the dough. Nestlé's cookie dough is packaged with labels warning consumers not to eat it raw. But people tend to disregard the warning -- 39 percent of consumers eat raw cookie dough, according to Consumer Reports. It has become such a popular snack that many ice cream makers have developed a cookie dough flavor.
* Tune in tomorrow for A Great Idea-- Specialized Health Care Courts
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Since March, E. coli infections potentially linked to the dough have been reported in 66 people in 28 states, according to the FDA. There have been 25 hospitalizations —
some with hemolytic uremic syndrome — and no deaths.The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness).
The FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Retailers, restaurateurs, and personnel at other food-service operations should not sell or serve any Nestle Toll House prepackaged, refrigerated cookie dough products subject to the recall. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died.
Because the appearance of E. coli 0157 in cookie dough is so unusual, investigators are looking at a broad range of possible factors, analyzing the ingredients, the plant's equipment and interior, the health of workers and whether the facility is located near cattle. Federal officials are also considering whether the dough might have been intentionally contaminated. E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death. E. coli refers to many kinds of bacteria, most of which are harmless or even beneficial. But certain types, including E. coli 0157, produce a toxin that can cause severe illness and even death in humans. The E. coli 0157 bacterium lives in the intestines of cows and other animals -- goats, sheep, deer and elk -- and is found most often in ground beef. But over the past decade, a number of E. coli 0157 illness outbreaks have been associated with green, leafy produce, such as spinach
For more information on safe food handling practices, go to http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm.
State health officials first noticed cases of E. coli 0157 emerging in March. Initially, they suspected ground beef or strawberries. But after interviewing victims, state officials and the CDC compared notes during a conference call Tuesday and settled on the refrigerated cookie dough as the prime suspect.
The risk usually associated with cookie dough is salmonella, a bacteria that can be found in raw eggs contained in the dough. Nestlé's cookie dough is packaged with labels warning consumers not to eat it raw. But people tend to disregard the warning -- 39 percent of consumers eat raw cookie dough, according to Consumer Reports. It has become such a popular snack that many ice cream makers have developed a cookie dough flavor.
* Tune in tomorrow for A Great Idea-- Specialized Health Care Courts
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Tuesday, June 23, 2009
America's other drug problem
The National Council on Patient Information and Education has termed medication nonadherence "America's other drug problem.”
Approaches to improve adherence can be complex and labor intensive. The problem of medication nonadherence poses an even greater risk among elderly patients in the United States, among whom poor medication adherence is common, morbid, costly, and difficult to treat. And it is among the elderly, that polypharmacy, which is the use of multiple medications resulting in complicated drug regimens, is an important barrier to medication adherence. Of 4053 patients aged 65 years or older prescribed medications for hypertension and hyperlipidemia, the adherence to both classes of medication decreased rapidly to 40.5% at the 3-month interval, and then to 32.7% at 6 months.
Of a total of 200 elderly patients, a pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.
“Effect of a Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure, and Low-Density Lipoprotein Cholesterol A Randomized Controlled Trial” published in JAMA. 2006;296: (doi:10.1001/jama.296.21.joc60162)
Chapman RH, Benner JS, Petrilla AA, et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med. 2005;165:1147-1152.
* Tune in tomorrow for the latest Food Scare
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Approaches to improve adherence can be complex and labor intensive. The problem of medication nonadherence poses an even greater risk among elderly patients in the United States, among whom poor medication adherence is common, morbid, costly, and difficult to treat. And it is among the elderly, that polypharmacy, which is the use of multiple medications resulting in complicated drug regimens, is an important barrier to medication adherence. Of 4053 patients aged 65 years or older prescribed medications for hypertension and hyperlipidemia, the adherence to both classes of medication decreased rapidly to 40.5% at the 3-month interval, and then to 32.7% at 6 months.
- The adherence rate for medical treatments [ or non-compliance rate] averages in some studies about 50%, with a range that extends from 0% to 100% .
- A Physicians' estimates of their own patients' adherence have no better than “chance accuracy”.
- Thus the problem of low adherence can be almost invisible to the individual practitioner dealing with a specific patient. This is true even for patients whom physicians feel they know well.
- Thus, part of the problem of detecting low adherence is that clinicians often think they know a poor or good complier when they see one, perhaps cueing on such characteristics as age, gender, education, and intelligence—none of which have been shown to have any consistent relationship to adherence.
- Adherence to chronic pharmacological therapies is poor.
- This often leads to worsening disease severity and increased costs associated with higher hospital admission rates.
- Barriers to medication adherence are numerous,and are particularly prevalent among the elderly population, placing them at increased risk for medication nonadherence.
Of a total of 200 elderly patients, a pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.
“Effect of a Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure, and Low-Density Lipoprotein Cholesterol A Randomized Controlled Trial” published in JAMA. 2006;296: (doi:10.1001/jama.296.21.joc60162)
Chapman RH, Benner JS, Petrilla AA, et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med. 2005;165:1147-1152.
* Tune in tomorrow for the latest Food Scare
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Monday, June 22, 2009
Hospitals Should Aim for 'As Soon As Possible' Standard for Door-to-Balloon Time
Hospitals Should Aim for 'As Soon As Possible' Standard for Door-to-Balloon Time
Balloon time is measured in minutes from the time the patient arrives at the hospital with a heart attack [myocardial infarction] to the time appropriate coronary artery intervention is performed, usually with balloon dilation of the obstructed coronary artery via primary percutaneous coronary intervention, [PCI].
Any delay in door-to-balloon time is associated with higher mortality rates in patients undergoing PCI. Therefore hospitals should strive for times well under the recommended 90-minute benchmark, according to a thorough BMJ study. Using a national registry, researchers examined outcomes among nearly 44,000 patients who underwent PCI for ST-segment-elevation myocardial infarction. In particular, they looked at time from hospital arrival to first balloon inflation or device deployment, as well as mortality rates.
The median door-to-balloon time was 83 minutes. Patients who underwent PCI by 30 minutes had an adjusted mortality rate of 3.0%, while those with door-to-balloon times of 240 minutes had a mortality rate of 10.3%. The recommended 90-minute time yielded a mortality rate of 4.3%.The authors conclude that their data "support calls for an 'as soon as possible' standard for patients undergoing primary percutaneous coronary intervention."
The authors stated that any delay in primary percutaneous coronary intervention after a patient arrives at hospital is associated with higher mortality in hospital in those admitted with ST elevation myocardial infarction. Time to treatment should be as short as possible, even in centres currently providing primary percutaneous coronary intervention within 90 minutes Clinical guidelines recommend that hospitals providing primary percutaneous coronary intervention to patients with ST segment elevation myocardial infarction should treat patients within 90 minutes of contact with the medical system or admission to hospital.
SUMMARY:
What is already known on this topic
Clinical guidelines recommend that hospitals providing primary percutaneous coronary intervention to patients with ST segment elevation myocardial infarction treat within 90 minutes of contact with the medical system or admission to hospital
The specific shape of the relation between mortality risk and time to treatment, and the incremental benefit of reductions in door-to-balloon times beyond 90 minutes, is unclear
What this study adds
Any delay in door-to-balloon time for patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention is associated with higher mortality, even among patients treated within 90 minutes of admission
Reducing door-to-balloon time to the greatest extent possible for all patient, including those currently treated within 90 minutes of admission, might reduce mortality
* Tune in tomorrow to find out America's other drug problem
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Balloon time is measured in minutes from the time the patient arrives at the hospital with a heart attack [myocardial infarction] to the time appropriate coronary artery intervention is performed, usually with balloon dilation of the obstructed coronary artery via primary percutaneous coronary intervention, [PCI].
Any delay in door-to-balloon time is associated with higher mortality rates in patients undergoing PCI. Therefore hospitals should strive for times well under the recommended 90-minute benchmark, according to a thorough BMJ study. Using a national registry, researchers examined outcomes among nearly 44,000 patients who underwent PCI for ST-segment-elevation myocardial infarction. In particular, they looked at time from hospital arrival to first balloon inflation or device deployment, as well as mortality rates.
The median door-to-balloon time was 83 minutes. Patients who underwent PCI by 30 minutes had an adjusted mortality rate of 3.0%, while those with door-to-balloon times of 240 minutes had a mortality rate of 10.3%. The recommended 90-minute time yielded a mortality rate of 4.3%.The authors conclude that their data "support calls for an 'as soon as possible' standard for patients undergoing primary percutaneous coronary intervention."
The authors stated that any delay in primary percutaneous coronary intervention after a patient arrives at hospital is associated with higher mortality in hospital in those admitted with ST elevation myocardial infarction. Time to treatment should be as short as possible, even in centres currently providing primary percutaneous coronary intervention within 90 minutes Clinical guidelines recommend that hospitals providing primary percutaneous coronary intervention to patients with ST segment elevation myocardial infarction should treat patients within 90 minutes of contact with the medical system or admission to hospital.
SUMMARY:
What is already known on this topic
Clinical guidelines recommend that hospitals providing primary percutaneous coronary intervention to patients with ST segment elevation myocardial infarction treat within 90 minutes of contact with the medical system or admission to hospital
The specific shape of the relation between mortality risk and time to treatment, and the incremental benefit of reductions in door-to-balloon times beyond 90 minutes, is unclear
What this study adds
Any delay in door-to-balloon time for patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention is associated with higher mortality, even among patients treated within 90 minutes of admission
Reducing door-to-balloon time to the greatest extent possible for all patient, including those currently treated within 90 minutes of admission, might reduce mortality
* Tune in tomorrow to find out America's other drug problem
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Sunday, June 21, 2009
MORE HEPARIN DANGERS AS IF WE DON’T HAVE ENOUGH TO WORRY ABOUT
Two Delaware patients died after taking heparin, a widely used blood thinner made by Baxter International Inc. In addition, a third patient suffered medical problems. Indeed "all three were using heparin," however, "there was no specific evidence tying heparin to the illness.
At Beebe Medical Center in Lewes, DE, where the deaths occurred, heparin use was suspended. The new complications involve premixed intravenous bags of heparin. Because of its ability to repress clotting and coagulation, the drug can cause serious side effects if administered in too high a dose. The company, however, said on 5/15 after testing that results of forensic and analytical tests verified that the heparin used at Beebe was of the proper purity and potency, "All tests on samples obtained from the hospital, retained samples from the same lot, and samples produced before and after the lot in question confirmed that the product's formulation was within specifications and met all requirements."
Medical evaluations of the patients indicated that "the intracranial bleeding was related to underlying medical conditions and risk factors that increase the relative risks involved in using a particular drug," the statement said. "The unfortunate patient events that occurred at Beebe Medical Center were isolated, institution-specific issues. The FDA spokeswoman said agency investigators inspected Baxter's facilities and tested heparin products there as well as samples collected at Beebe and said the findings thus far confirmed Baxter's account.
This incident sparked concerns about a repeat of fatal heparin contamination in 2008.
The manufacturer of the heparin involved in the Beebe cases, Baxter Healthcare Corp., recalled batches of the drug in 2008 after the Food and Drug Administration found it was contaminated with a chemical that caused serious allergic reactions and low blood pressure in patients who received high doses. Imports from a Chinese manufacturer of an ingredient in heparin have been banned in connection with that contamination.
In the 2008 heparin deaths, however, the bulk material came from China.
In those incidents, FDA officials and Baxter believed a substance known as oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China.
No Chinese suppliers are involved in the latest incidents.
What to do to help curtail Heparin problems: Multiple Dose Heparin Vials Risky for Patients
According to The Institute for Safe Medication Practices (ISMP), a non-profit organization devoted to medication error prevention and safe medication, www.ismp.org, multiple dose Heparin vials have potentially confusing labels that can lead to dangerous overdoses.
The overdoses may cause serious injury to patients and even death. (Heparin is used to prevent blood clots.)
The problem with the vials is that although they contain 4 mL of Heparin solution, they are labeled “10,000 USP units/1 mL,” with the “10,000″ in extra large print. This labeling may cause a healthcare professional to assume that the entire vial contains 10,000 units and as a result, the professional may administer a dose of Heparin that is four times more than a patient should receive. This problem may not have been the case @ Beebe Hospital since it appears that the heparin came from premixed bags.
But, in light of this danger, the ISMP is urging hospitals, doctors, nurses, and all other healthcare professionals to carefully read the label on vials of Heparin before administering the drug to patients and is advising hospitals to consider whether they should stock any Heparin vials that contain more than 10,000 units per vial.
Recommendations
If you are hospitalized and Heparin has been prescribed for you, keep yourself safer by requesting that the drug be administered from a single dose, not a double dose, vial.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
At Beebe Medical Center in Lewes, DE, where the deaths occurred, heparin use was suspended. The new complications involve premixed intravenous bags of heparin. Because of its ability to repress clotting and coagulation, the drug can cause serious side effects if administered in too high a dose. The company, however, said on 5/15 after testing that results of forensic and analytical tests verified that the heparin used at Beebe was of the proper purity and potency, "All tests on samples obtained from the hospital, retained samples from the same lot, and samples produced before and after the lot in question confirmed that the product's formulation was within specifications and met all requirements."
Medical evaluations of the patients indicated that "the intracranial bleeding was related to underlying medical conditions and risk factors that increase the relative risks involved in using a particular drug," the statement said. "The unfortunate patient events that occurred at Beebe Medical Center were isolated, institution-specific issues. The FDA spokeswoman said agency investigators inspected Baxter's facilities and tested heparin products there as well as samples collected at Beebe and said the findings thus far confirmed Baxter's account.
This incident sparked concerns about a repeat of fatal heparin contamination in 2008.
The manufacturer of the heparin involved in the Beebe cases, Baxter Healthcare Corp., recalled batches of the drug in 2008 after the Food and Drug Administration found it was contaminated with a chemical that caused serious allergic reactions and low blood pressure in patients who received high doses. Imports from a Chinese manufacturer of an ingredient in heparin have been banned in connection with that contamination.
In the 2008 heparin deaths, however, the bulk material came from China.
In those incidents, FDA officials and Baxter believed a substance known as oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China.
No Chinese suppliers are involved in the latest incidents.
What to do to help curtail Heparin problems: Multiple Dose Heparin Vials Risky for Patients
According to The Institute for Safe Medication Practices (ISMP), a non-profit organization devoted to medication error prevention and safe medication, www.ismp.org, multiple dose Heparin vials have potentially confusing labels that can lead to dangerous overdoses.
The overdoses may cause serious injury to patients and even death. (Heparin is used to prevent blood clots.)
The problem with the vials is that although they contain 4 mL of Heparin solution, they are labeled “10,000 USP units/1 mL,” with the “10,000″ in extra large print. This labeling may cause a healthcare professional to assume that the entire vial contains 10,000 units and as a result, the professional may administer a dose of Heparin that is four times more than a patient should receive. This problem may not have been the case @ Beebe Hospital since it appears that the heparin came from premixed bags.
But, in light of this danger, the ISMP is urging hospitals, doctors, nurses, and all other healthcare professionals to carefully read the label on vials of Heparin before administering the drug to patients and is advising hospitals to consider whether they should stock any Heparin vials that contain more than 10,000 units per vial.
Recommendations
If you are hospitalized and Heparin has been prescribed for you, keep yourself safer by requesting that the drug be administered from a single dose, not a double dose, vial.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
Saturday, June 20, 2009
STUDY INDICATES HOSPITAL RAPID RESPONSE TEAMS MAY NOT PREVENT CARDIAC ARRESTS, DEATHS.
It’s been reported that, "Hospital rapid response teams, created to prevent cardiac arrest and deaths in critically ill patients, do not seem to work," according to a study published in the Dec. 3,2008 issue of the Journal of the American Medical Association. Normally, rapid response teams are "made up of doctors, nurses and respiratory therapists, whose primary role is to care for patients in the intensive care unit (ICU)." The teams may also "help evaluate patients who are not in the ICU."
For the study, investigators analyzed "the use of rapid-response teams consisting of intensive-care unit nurses and respiratory therapists at 404-bed St. Luke's Hospital of Kansas City (Mo.), and their association with lower hospitalwide cardiopulmonary arrest and hospital mortality rates,"
It is also noted that the study revealed a four percent decline in mortality rates "after rapid-response teams were introduced in late 2005," and a 33 percent decline in "mean rates for hospital-wide cardiopulmonary arrest codes." But, "after accounting for other changes occurring in the same time frame, including hospital quality-improvement programs and improved technologies, the adjusted odds ratio of 0.76 failed to reach statistical significance."
A rapid response team, also known as a medical emergency team, is a multidisciplinary team of intensive care unit (ICU) personnel charged with the evaluation, triage, and treatment of non-ICU patients with signs of clinical deterioration to reduce the rates of in-hospital cardiopulmonary arrests (codes) and their attendant morbidity and mortality. Several studies have shown that rates of non-ICU codes decrease after rapid response team implementation,7-11 but these studies, which have focused on cardiopulmonary arrests outside of the ICU, may lead to a favorable bias for rapid response teams because cardiac arrests that occurred after transferring patients with physiological decline to the ICU were not included.
In-hospital cardiac arrests are common and delays in treatment are associated with lower survival and worse neurological outcomes. Prior studies have reported that adult patients often exhibit physiological deterioration hours before cardiopulmonary arrest. As a result, the Institute for Healthcare Improvement recommended in their 100 000 Lives Campaign that hospitals implement rapid response teams as 1 of 6 strategies to reduce preventable in-hospital deaths. In response, hundreds of hospitals around the country have invested significant financial and personnel resources in implementing rapid response teams, despite the fact that limited published data support their
effectiveness.
The authors found no differences in length of hospital stay (ie, median exposure time to codes) was seen across the study years. We found that implementation of a rapid response team was not associated with lower hospital-wide code rates. Similarly, rapid response team intervention was not associated with improvements in the clinically meaningful outcome of hospital-wide mortality. Importantly, only a small percentage of deaths after rapid response team intervention and cardiopulmonary arrests were categorized as potential rapid response team undertreatment or underuse and would not have plausibly altered these findings. We believe that this study provides important new insights regarding the effectiveness and limitations of rapid response team intervention and raises critical questions about whether recommendations to disseminate rapid response teams nationally are warranted without a demonstrable mortality benefit.
Implementation of a rapid response team in the author’s tertiary care adult hospital was not associated with lower rates of either hospital-wide cardiopulmonary arrests or mortality.
Because of the lack of robust outcomes after the rapid response team intervention, well-designed multicenter adequately powered randomized controlled trials with sufficiently long follow-up should be considered to rigorously evaluate the efficacy of rapid response teams prior to endorsing their widespread implementation.
Paul S. Chan et al. Hospital-wide Code Rates and Mortality Before and After Implementation of a Rapid Response Team. JAMA. 2008;300(21):2506-2513.
For the study, investigators analyzed "the use of rapid-response teams consisting of intensive-care unit nurses and respiratory therapists at 404-bed St. Luke's Hospital of Kansas City (Mo.), and their association with lower hospitalwide cardiopulmonary arrest and hospital mortality rates,"
It is also noted that the study revealed a four percent decline in mortality rates "after rapid-response teams were introduced in late 2005," and a 33 percent decline in "mean rates for hospital-wide cardiopulmonary arrest codes." But, "after accounting for other changes occurring in the same time frame, including hospital quality-improvement programs and improved technologies, the adjusted odds ratio of 0.76 failed to reach statistical significance."
A rapid response team, also known as a medical emergency team, is a multidisciplinary team of intensive care unit (ICU) personnel charged with the evaluation, triage, and treatment of non-ICU patients with signs of clinical deterioration to reduce the rates of in-hospital cardiopulmonary arrests (codes) and their attendant morbidity and mortality. Several studies have shown that rates of non-ICU codes decrease after rapid response team implementation,7-11 but these studies, which have focused on cardiopulmonary arrests outside of the ICU, may lead to a favorable bias for rapid response teams because cardiac arrests that occurred after transferring patients with physiological decline to the ICU were not included.
In-hospital cardiac arrests are common and delays in treatment are associated with lower survival and worse neurological outcomes. Prior studies have reported that adult patients often exhibit physiological deterioration hours before cardiopulmonary arrest. As a result, the Institute for Healthcare Improvement recommended in their 100 000 Lives Campaign that hospitals implement rapid response teams as 1 of 6 strategies to reduce preventable in-hospital deaths. In response, hundreds of hospitals around the country have invested significant financial and personnel resources in implementing rapid response teams, despite the fact that limited published data support their
effectiveness.
The authors found no differences in length of hospital stay (ie, median exposure time to codes) was seen across the study years. We found that implementation of a rapid response team was not associated with lower hospital-wide code rates. Similarly, rapid response team intervention was not associated with improvements in the clinically meaningful outcome of hospital-wide mortality. Importantly, only a small percentage of deaths after rapid response team intervention and cardiopulmonary arrests were categorized as potential rapid response team undertreatment or underuse and would not have plausibly altered these findings. We believe that this study provides important new insights regarding the effectiveness and limitations of rapid response team intervention and raises critical questions about whether recommendations to disseminate rapid response teams nationally are warranted without a demonstrable mortality benefit.
Implementation of a rapid response team in the author’s tertiary care adult hospital was not associated with lower rates of either hospital-wide cardiopulmonary arrests or mortality.
Because of the lack of robust outcomes after the rapid response team intervention, well-designed multicenter adequately powered randomized controlled trials with sufficiently long follow-up should be considered to rigorously evaluate the efficacy of rapid response teams prior to endorsing their widespread implementation.
Paul S. Chan et al. Hospital-wide Code Rates and Mortality Before and After Implementation of a Rapid Response Team. JAMA. 2008;300(21):2506-2513.
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