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Hospitals Keeping A Wary Eye on Heparin Recall
Hospitalists across the nation stand ready for a possible shortage of Baxter Healthcare Corporation-produced heparin, a blood thinner linked to 785 reported serious injuries and 19 deaths.
The initial January recall of multidose vials of the anticoagulant—used for surgery, dialysis and for the bedridden—broadened in February after magnetic resonance imaging tests uncovered that as much as 20% of the product’s active ingredient was a heparin mimic blended in with the actual product. The most serious injuries and death occurred in patients who received high doses of heparin during short periods of time.
The contaminant, an altered form of chondroitin sulfate, was identified in March.
Heparin is made from pig intestines. The raw product bought by the Waunaukee, Wis.-based Scientific Protein Laboratories was produced in small, unregulated family workshops in China and processed in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter sells the finished product.
Pharmacist Gerard Barber of the University of Colorado Hospital sent an e-mail to staff there warning of the “erratic supply chain” caused by the heparin recall involving Baxter-produced heparin products.
“Ultimately there may be a true short supply of heparin, particularly when used subcutaneously for prophylaxis of DVTs—but we have managed to maintain an adequate supply of heparin product thus far,” he wrote in a March 7 e-mail.
Barber says the Department of Pharmacy has been aware of the situation since early February and took the added precaution of sequestering the product.
“Currently, we have managed to secure enough heparin product to avoid therapeutic interchanges to other heparin volumes (e.g., 5,000 units per 0.5 mL to 5,000 units per 1 mL) thus far,” he wrote.
Barber was still trying to procure “the same concentrations of heparin we’ve long used” in April.
“For as much heparin as all the [doctors] use, with the widened recall we’re particularly keeping an eye on other sizes (1,000 units/mL, 30 mL) for areas very, very dependent on the drug such as dialysis and perfusion for cardiothoracic surgery,” Barber says. “In areas like these it would be very difficult if at all possible to use alternative agents as we could if needed for DVTs and switching to low-molecular weight products.”
Joseph Li, MD, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston, says it will be incumbent upon other manufacturers to “ramp up” production of the drug.
“Certainly, if hospitalists were unable to use unfractionated heparin, providers can reach for low molecular weight heparin [LMWH] products,” he says.
William D. Atchley Jr., MD, medical director of the Division of Hospital Medicine for the Sentara Medical Group in Norfolk, Va., agrees with Dr. Li that use of LMWH could be a viable alternative.
“The impact in our system has been directed by the clinical pharmacists,” he says when asked how his group is handling the recalls. “We have received no notification regarding heparin that we presently use.”
Baxter International Inc., announced Feb. 28 it would voluntarily recall all remaining lots and doses of its heparin sodium injection multidose and single-dose vials, as well as its HEP-LOCK heparin flush products, according to a press release posted on the U.S. Food and Drug Administration’s Web site.
On Jan. 17, the company initially recalled nine lots of heparin sodium injection multidose vials as a precautionary measure due to a “higher than usual number of reports of adverse patient reactions,” the release noted.
Nearly all adverse reactions were seen in patients receiving high doses of heparin during short periods of time. Reactions patients reported included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure, which in some cases led to life-threatening shock. Such reactions were not seen in patients receiving lower doses of the drug or those who received higher doses over longer periods. TH
Molly R. Okeon is a journalist based in California.
Hospitalists across the nation stand ready for a possible shortage of Baxter Healthcare Corporation-produced heparin, a blood thinner linked to 785 reported serious injuries and 19 deaths.
The initial January recall of multidose vials of the anticoagulant—used for surgery, dialysis and for the bedridden—broadened in February after magnetic resonance imaging tests uncovered that as much as 20% of the product’s active ingredient was a heparin mimic blended in with the actual product. The most serious injuries and death occurred in patients who received high doses of heparin during short periods of time.
The contaminant, an altered form of chondroitin sulfate, was identified in March.
Heparin is made from pig intestines. The raw product bought by the Waunaukee, Wis.-based Scientific Protein Laboratories was produced in small, unregulated family workshops in China and processed in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter sells the finished product.
Pharmacist Gerard Barber of the University of Colorado Hospital sent an e-mail to staff there warning of the “erratic supply chain” caused by the heparin recall involving Baxter-produced heparin products.
“Ultimately there may be a true short supply of heparin, particularly when used subcutaneously for prophylaxis of DVTs—but we have managed to maintain an adequate supply of heparin product thus far,” he wrote in a March 7 e-mail.
Barber says the Department of Pharmacy has been aware of the situation since early February and took the added precaution of sequestering the product.
“Currently, we have managed to secure enough heparin product to avoid therapeutic interchanges to other heparin volumes (e.g., 5,000 units per 0.5 mL to 5,000 units per 1 mL) thus far,” he wrote.
Barber was still trying to procure “the same concentrations of heparin we’ve long used” in April.
“For as much heparin as all the [doctors] use, with the widened recall we’re particularly keeping an eye on other sizes (1,000 units/mL, 30 mL) for areas very, very dependent on the drug such as dialysis and perfusion for cardiothoracic surgery,” Barber says. “In areas like these it would be very difficult if at all possible to use alternative agents as we could if needed for DVTs and switching to low-molecular weight products.”
Joseph Li, MD, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston, says it will be incumbent upon other manufacturers to “ramp up” production of the drug.
“Certainly, if hospitalists were unable to use unfractionated heparin, providers can reach for low molecular weight heparin [LMWH] products,” he says.
William D. Atchley Jr., MD, medical director of the Division of Hospital Medicine for the Sentara Medical Group in Norfolk, Va., agrees with Dr. Li that use of LMWH could be a viable alternative.
“The impact in our system has been directed by the clinical pharmacists,” he says when asked how his group is handling the recalls. “We have received no notification regarding heparin that we presently use.”
Baxter International Inc., announced Feb. 28 it would voluntarily recall all remaining lots and doses of its heparin sodium injection multidose and single-dose vials, as well as its HEP-LOCK heparin flush products, according to a press release posted on the U.S. Food and Drug Administration’s Web site.
On Jan. 17, the company initially recalled nine lots of heparin sodium injection multidose vials as a precautionary measure due to a “higher than usual number of reports of adverse patient reactions,” the release noted.
Nearly all adverse reactions were seen in patients receiving high doses of heparin during short periods of time. Reactions patients reported included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure, which in some cases led to life-threatening shock. Such reactions were not seen in patients receiving lower doses of the drug or those who received higher doses over longer periods. TH
Molly R. Okeon is a journalist based in California.
Hospitalists across the nation stand ready for a possible shortage of Baxter Healthcare Corporation-produced heparin, a blood thinner linked to 785 reported serious injuries and 19 deaths.
The initial January recall of multidose vials of the anticoagulant—used for surgery, dialysis and for the bedridden—broadened in February after magnetic resonance imaging tests uncovered that as much as 20% of the product’s active ingredient was a heparin mimic blended in with the actual product. The most serious injuries and death occurred in patients who received high doses of heparin during short periods of time.
The contaminant, an altered form of chondroitin sulfate, was identified in March.
Heparin is made from pig intestines. The raw product bought by the Waunaukee, Wis.-based Scientific Protein Laboratories was produced in small, unregulated family workshops in China and processed in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter sells the finished product.
Pharmacist Gerard Barber of the University of Colorado Hospital sent an e-mail to staff there warning of the “erratic supply chain” caused by the heparin recall involving Baxter-produced heparin products.
“Ultimately there may be a true short supply of heparin, particularly when used subcutaneously for prophylaxis of DVTs—but we have managed to maintain an adequate supply of heparin product thus far,” he wrote in a March 7 e-mail.
Barber says the Department of Pharmacy has been aware of the situation since early February and took the added precaution of sequestering the product.
“Currently, we have managed to secure enough heparin product to avoid therapeutic interchanges to other heparin volumes (e.g., 5,000 units per 0.5 mL to 5,000 units per 1 mL) thus far,” he wrote.
Barber was still trying to procure “the same concentrations of heparin we’ve long used” in April.
“For as much heparin as all the [doctors] use, with the widened recall we’re particularly keeping an eye on other sizes (1,000 units/mL, 30 mL) for areas very, very dependent on the drug such as dialysis and perfusion for cardiothoracic surgery,” Barber says. “In areas like these it would be very difficult if at all possible to use alternative agents as we could if needed for DVTs and switching to low-molecular weight products.”
Joseph Li, MD, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston, says it will be incumbent upon other manufacturers to “ramp up” production of the drug.
“Certainly, if hospitalists were unable to use unfractionated heparin, providers can reach for low molecular weight heparin [LMWH] products,” he says.
William D. Atchley Jr., MD, medical director of the Division of Hospital Medicine for the Sentara Medical Group in Norfolk, Va., agrees with Dr. Li that use of LMWH could be a viable alternative.
“The impact in our system has been directed by the clinical pharmacists,” he says when asked how his group is handling the recalls. “We have received no notification regarding heparin that we presently use.”
Baxter International Inc., announced Feb. 28 it would voluntarily recall all remaining lots and doses of its heparin sodium injection multidose and single-dose vials, as well as its HEP-LOCK heparin flush products, according to a press release posted on the U.S. Food and Drug Administration’s Web site.
On Jan. 17, the company initially recalled nine lots of heparin sodium injection multidose vials as a precautionary measure due to a “higher than usual number of reports of adverse patient reactions,” the release noted.
Nearly all adverse reactions were seen in patients receiving high doses of heparin during short periods of time. Reactions patients reported included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure, which in some cases led to life-threatening shock. Such reactions were not seen in patients receiving lower doses of the drug or those who received higher doses over longer periods. TH
Molly R. Okeon is a journalist based in California.
Hospital Medicine Continues to Make Inroads Overseas
Attendees at this year’s SHM Annual Meeting in San Diego brought with them exciting news of international developments that might broaden the scope of the specialty.
For example, Efren Manjarrez, MD, director of clinical operations for the division of hospital medicine of the Leonard M. Miller School of Medicine at the University of Miami, recently discovered a 500-plus-bed facility at the Universidad de Navarra during his trip to Pamplona, Spain.
Because Dr. Manjarrez is bilingual, past SHM President Mark Williams, MD, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, asked him to give a lecture.
“[The Universidad de Navarra] has one of the top two medical schools in Spain and they had the very first symposium on the management of the hospitalized patient,” Dr. Manjarrez says. “They had the very first hospitalist conference in Spain and quite possibly in Europe.”
While in Spain, Dr. Manjarrez realized hospitalists there were “at the grassroots level, where we were about 10 to 12 years ago,” just starting to have a few hospital medical units. The clinic in at the Universidad de Navarra had about five units, and there was a small hospitalist group near Valencia, as well.
Dr. Manjarrez is highly complimentary of the university’s “top-flight medical school,” where he said doctors perform liver transplants.
“They could compete favorably with any city in the United States,” he notes. “They’re interested in organizing hospitalists like Mark Williams and what people ahead of me did for SHM.”
Dr. Manjarrez and Dr. Williams have discussed what will happen with the hospital medicine movement internationally. They forecast that the work begun in the U.S. will globalize fairly soon.
“The Spaniards are very, very on the ball to ask us over there to see what’s going on to get a jump on it,” Dr. Manjarrez says. “SHM needs to start thinking ahead and have an international chapter and plan international meetings abroad to have SHM’s message spread globally. The time is ripe to export what SHM and hospital medicine is doing here”
Dr. Manjarrez notes that Argentina has small pockets of hospitalists. And, Guilherme Brauner Barcellos MD, specialist in internal medicine and intensive care at the Nossa Senhora de Conceicao Hospital in Brazil, is excited about the establishment of a hospital medicine program there. He finds the attempts to develop the specialty in his country “fascinating and challenging.”
“The implementation of hospital medicine, especially those aspects that involve more than just having a general medicine physician dealing with inpatient care, is brand new in Brazil,” Dr. Barcellos says. “We understand there is a long journey ahead.”
Dr. Barcellos is president of the recently formed Brazilian Society of Hospital Medicine and became a member of SHM last year, attending May’s meeting in Dallas. He says the number of hospitalists in Brazil is limited, but “a rapid expansion is predicted.”
“As in the U.S. several years ago, the case for hospitalists in Brazil is still being made,” he notes. “We did a hospital medicine meeting last October, and it led to the formation of the Brazilian Society of Hospital Medicine. We definitely fostered the discussion about the specialty and the model in Brazil.”
He hopes more people will talk about the topic through the new group’s Web site (www.medicinahospitalar.com.br) and in hospitals throughout the country.
“Before the year of 2005, the majority of people here didn’t know about the hospitalists,” he explains. “After that, we had a period in which people were confused, thinking hospitalists were the same as doctors who work in the rapid response teams only. Currently, everybody at least knows about hospital medicine.”
Dr. Williams notes that hospital medicine organizations are forming in Chile, Argentina, Australia, and New Zealand.
Dr. Barcellos believes hospitals across his country “will awake to hospital medicine” when they realize that traditional models aren’t property servicing hospitalized patients anymore. “Much of what is present is wrong, obsolete or out of time, and we should try new attempts to create a different organization,” he says. TH
Molly R. Okeon is a journalist based in California.
Attendees at this year’s SHM Annual Meeting in San Diego brought with them exciting news of international developments that might broaden the scope of the specialty.
For example, Efren Manjarrez, MD, director of clinical operations for the division of hospital medicine of the Leonard M. Miller School of Medicine at the University of Miami, recently discovered a 500-plus-bed facility at the Universidad de Navarra during his trip to Pamplona, Spain.
Because Dr. Manjarrez is bilingual, past SHM President Mark Williams, MD, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, asked him to give a lecture.
“[The Universidad de Navarra] has one of the top two medical schools in Spain and they had the very first symposium on the management of the hospitalized patient,” Dr. Manjarrez says. “They had the very first hospitalist conference in Spain and quite possibly in Europe.”
While in Spain, Dr. Manjarrez realized hospitalists there were “at the grassroots level, where we were about 10 to 12 years ago,” just starting to have a few hospital medical units. The clinic in at the Universidad de Navarra had about five units, and there was a small hospitalist group near Valencia, as well.
Dr. Manjarrez is highly complimentary of the university’s “top-flight medical school,” where he said doctors perform liver transplants.
“They could compete favorably with any city in the United States,” he notes. “They’re interested in organizing hospitalists like Mark Williams and what people ahead of me did for SHM.”
Dr. Manjarrez and Dr. Williams have discussed what will happen with the hospital medicine movement internationally. They forecast that the work begun in the U.S. will globalize fairly soon.
“The Spaniards are very, very on the ball to ask us over there to see what’s going on to get a jump on it,” Dr. Manjarrez says. “SHM needs to start thinking ahead and have an international chapter and plan international meetings abroad to have SHM’s message spread globally. The time is ripe to export what SHM and hospital medicine is doing here”
Dr. Manjarrez notes that Argentina has small pockets of hospitalists. And, Guilherme Brauner Barcellos MD, specialist in internal medicine and intensive care at the Nossa Senhora de Conceicao Hospital in Brazil, is excited about the establishment of a hospital medicine program there. He finds the attempts to develop the specialty in his country “fascinating and challenging.”
“The implementation of hospital medicine, especially those aspects that involve more than just having a general medicine physician dealing with inpatient care, is brand new in Brazil,” Dr. Barcellos says. “We understand there is a long journey ahead.”
Dr. Barcellos is president of the recently formed Brazilian Society of Hospital Medicine and became a member of SHM last year, attending May’s meeting in Dallas. He says the number of hospitalists in Brazil is limited, but “a rapid expansion is predicted.”
“As in the U.S. several years ago, the case for hospitalists in Brazil is still being made,” he notes. “We did a hospital medicine meeting last October, and it led to the formation of the Brazilian Society of Hospital Medicine. We definitely fostered the discussion about the specialty and the model in Brazil.”
He hopes more people will talk about the topic through the new group’s Web site (www.medicinahospitalar.com.br) and in hospitals throughout the country.
“Before the year of 2005, the majority of people here didn’t know about the hospitalists,” he explains. “After that, we had a period in which people were confused, thinking hospitalists were the same as doctors who work in the rapid response teams only. Currently, everybody at least knows about hospital medicine.”
Dr. Williams notes that hospital medicine organizations are forming in Chile, Argentina, Australia, and New Zealand.
Dr. Barcellos believes hospitals across his country “will awake to hospital medicine” when they realize that traditional models aren’t property servicing hospitalized patients anymore. “Much of what is present is wrong, obsolete or out of time, and we should try new attempts to create a different organization,” he says. TH
Molly R. Okeon is a journalist based in California.
Attendees at this year’s SHM Annual Meeting in San Diego brought with them exciting news of international developments that might broaden the scope of the specialty.
For example, Efren Manjarrez, MD, director of clinical operations for the division of hospital medicine of the Leonard M. Miller School of Medicine at the University of Miami, recently discovered a 500-plus-bed facility at the Universidad de Navarra during his trip to Pamplona, Spain.
Because Dr. Manjarrez is bilingual, past SHM President Mark Williams, MD, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, asked him to give a lecture.
“[The Universidad de Navarra] has one of the top two medical schools in Spain and they had the very first symposium on the management of the hospitalized patient,” Dr. Manjarrez says. “They had the very first hospitalist conference in Spain and quite possibly in Europe.”
While in Spain, Dr. Manjarrez realized hospitalists there were “at the grassroots level, where we were about 10 to 12 years ago,” just starting to have a few hospital medical units. The clinic in at the Universidad de Navarra had about five units, and there was a small hospitalist group near Valencia, as well.
Dr. Manjarrez is highly complimentary of the university’s “top-flight medical school,” where he said doctors perform liver transplants.
“They could compete favorably with any city in the United States,” he notes. “They’re interested in organizing hospitalists like Mark Williams and what people ahead of me did for SHM.”
Dr. Manjarrez and Dr. Williams have discussed what will happen with the hospital medicine movement internationally. They forecast that the work begun in the U.S. will globalize fairly soon.
“The Spaniards are very, very on the ball to ask us over there to see what’s going on to get a jump on it,” Dr. Manjarrez says. “SHM needs to start thinking ahead and have an international chapter and plan international meetings abroad to have SHM’s message spread globally. The time is ripe to export what SHM and hospital medicine is doing here”
Dr. Manjarrez notes that Argentina has small pockets of hospitalists. And, Guilherme Brauner Barcellos MD, specialist in internal medicine and intensive care at the Nossa Senhora de Conceicao Hospital in Brazil, is excited about the establishment of a hospital medicine program there. He finds the attempts to develop the specialty in his country “fascinating and challenging.”
“The implementation of hospital medicine, especially those aspects that involve more than just having a general medicine physician dealing with inpatient care, is brand new in Brazil,” Dr. Barcellos says. “We understand there is a long journey ahead.”
Dr. Barcellos is president of the recently formed Brazilian Society of Hospital Medicine and became a member of SHM last year, attending May’s meeting in Dallas. He says the number of hospitalists in Brazil is limited, but “a rapid expansion is predicted.”
“As in the U.S. several years ago, the case for hospitalists in Brazil is still being made,” he notes. “We did a hospital medicine meeting last October, and it led to the formation of the Brazilian Society of Hospital Medicine. We definitely fostered the discussion about the specialty and the model in Brazil.”
He hopes more people will talk about the topic through the new group’s Web site (www.medicinahospitalar.com.br) and in hospitals throughout the country.
“Before the year of 2005, the majority of people here didn’t know about the hospitalists,” he explains. “After that, we had a period in which people were confused, thinking hospitalists were the same as doctors who work in the rapid response teams only. Currently, everybody at least knows about hospital medicine.”
Dr. Williams notes that hospital medicine organizations are forming in Chile, Argentina, Australia, and New Zealand.
Dr. Barcellos believes hospitals across his country “will awake to hospital medicine” when they realize that traditional models aren’t property servicing hospitalized patients anymore. “Much of what is present is wrong, obsolete or out of time, and we should try new attempts to create a different organization,” he says. TH
Molly R. Okeon is a journalist based in California.