Full story: ASHP
The database will allow state boards of pharmacy to better regulate nonresident pharmacies that want to do business in the state, he said.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, December 31, 2012
Activist says Mass. Department of Public Health stalling release of Lyme disease report
December 31, 2012
STURBRIDGE - A Lyme disease activist and sufferer claims two high-ranking state Department of Public Health officials are stalling the release of a report that could shed more light on the disease.
Patricia A. McCleary of Sturbridge said state epidemiologist Dr. Al DeMaria and state veterinarian Dr. Catherine Brown are not endorsing the findings of the Massachusetts Lyme Disease Commission’s report, which was originally slated to be released in October.
Mrs. McCleary, Dr. DeMaria and Dr. Brown all served on the 21-member commission that researched the report.
Mrs. McCleary said Dr. DeMaria and Dr. Brown told members of the commission they didn’t realize they were representing their department and, as a result, did not have the authority to sign off on the final report.
“They have delayed us now for a couple of months, and now they’re saying, no, we will not sign off on it, knowing that it is going to hold up future legislation that could come from this report that could help people,” Mrs. McCleary said. “This is holding up a huge process for people who really need it and it’s not OK that our DPH is getting away with this.”
State Rep. David P. Linsky, D-Natick, commission chairman, said neither Dr. DeMaria nor Dr. Brown has supported the findings of the report.
“I am disappointed that the DPH appointees chose not to sign the final version of the report,” Mr. Linsky said. “I have asked the DPH commissioner for a specific list of reasons why they cannot and I am waiting for that response.”
On April 28, 2011, the House of Representatives approved creation of a Lyme Disease Commission to investigate the need for new screening programs and other steps to combat the illness, which is spread by bacteria from bites by infected ticks.
The amendment authorizing the commission charged it with studying the value of public health screening in high-risk areas, more prevention steps in schools and more medical research on the progression and treatment of Lyme disease.
“If you look at the language of the statute that set up the commission, there were various people that were appointed by various agencies and they were there to represent the interests of their agencies or organizations,” Mr. Linsky said. “From day one, the people of the commission should have had the authority to speak on behalf of their agencies or organizations.”
Although no one has officially signed the Lyme Disease Commission’s final report, Mr. Linsky said there is a consensus of the commission to the report’s current text, with the exception of the DPH appointees.
When it is signed and finalized, Mr. Linsky said the report will be published and posted and he and his fellow legislators serving on the commission will file any necessary legislation based on the findings and recommendations agreed on in the report. However, issues dealing with the budget will have to be taken up during the budget process.
Mrs. McCleary said she is not surprised by the state Department of Public Health’s stance on the matter, calling them “gatekeepers” for the Center for Disease Control and Prevention and the Infectious Disease Society of America.“We can go forward without them but it sure would have been nice when we’re talking about such a crisis and epidemic here that the Massachusetts Department of Public Health is concerned about it and want to improve on what’s happening. And once again, they’re showing us they’re not.”
But Sam R. Telford III — a commission member and professor in the department of biomedical sciences and infectious diseases at Cummings School of Veterinary Medicine at Tufts University in North Grafton — said he thinks the delay in Department of Public Health members’ signatures has to do with all the difficulties the department has had in the last two months.
In mid-September, state Public Health Commissioner John Auerbach and Lab Bureau Chief Dr. Linda Han both resigned and Julie Nassif, the director of the state’s analytic chemistry division, was fired in the wake of the scandal at the state drug lab. State chemist Annie Dookhan allegedly tampered with drug evidence for tens of thousands of criminal cases.
A national fungal meningitis outbreak was linked to New England Compounding Center in Framingham, a speciality pharmacy that was regulated by the agency’s Board of Registration in Pharmacy.
Laura Smith is serving as the department of public health’s interim commissioner.
“My guess is that it’s an administrative glitch because of the flux in leadership at the Department of Public Health,” Mr. Telford said. “The DPH has done a marvelous job considering the limited resources that they have in terms of defining the problem here.”
Anne Roach, media relations manager at the Department of Public Health, said her department commends the commission “for its efforts to produce a meaningful report that examines the seriousness of Lyme disease in Massachusetts.”
“The department’s first priority is to protect the public health and it will continue to identify ways to reduce the transmission of Lyme disease and all tick-borne illnesses,” Ms. Roach said. “As part of its efforts to increase awareness about the growing extent and seriousness of Lyme disease in Massachusetts, DPH is working collaboratively with the commission. DPH focuses its efforts on the promotion of proven prevention methods through educational materials available online as well as outreach to local boards of health and community groups.”
Mrs. McCleary said the report has “some pretty shocking” stories from chronic Lyme disease sufferers, as well as “good and really important” recommendations, including the need for better testing methods, better education of physicians about Lyme disease’s symptoms and treatment, and more up-to-date information readily available to the public, especially on the department’s website.
“The standard treatment that is available right now is not working for people, quite frankly, and there are other options out there,” Mrs. McCleary said. “In Massachusetts, people have to go out of state and they have to self-pay for their treatment and that’s not OK.”
Mrs. McCleary said her husband and their two adult sons have been treated for Lyme disease.On top of that, Lyme disease has cost the McCleary family a small fortune.
“By the time we saved my life, there was no college fund or anything when it came time for my kids to go to school. We are hanging by a thread. Our house is on the market. But you do what you have to do,” she said. “Anybody who got this disease is in debt, unless they are a millionaire.”
Source found here
STURBRIDGE - A Lyme disease activist and sufferer claims two high-ranking state Department of Public Health officials are stalling the release of a report that could shed more light on the disease.
Patricia A. McCleary of Sturbridge said state epidemiologist Dr. Al DeMaria and state veterinarian Dr. Catherine Brown are not endorsing the findings of the Massachusetts Lyme Disease Commission’s report, which was originally slated to be released in October.
Mrs. McCleary, Dr. DeMaria and Dr. Brown all served on the 21-member commission that researched the report.
Mrs. McCleary said Dr. DeMaria and Dr. Brown told members of the commission they didn’t realize they were representing their department and, as a result, did not have the authority to sign off on the final report.
“They have delayed us now for a couple of months, and now they’re saying, no, we will not sign off on it, knowing that it is going to hold up future legislation that could come from this report that could help people,” Mrs. McCleary said. “This is holding up a huge process for people who really need it and it’s not OK that our DPH is getting away with this.”
State Rep. David P. Linsky, D-Natick, commission chairman, said neither Dr. DeMaria nor Dr. Brown has supported the findings of the report.
“I am disappointed that the DPH appointees chose not to sign the final version of the report,” Mr. Linsky said. “I have asked the DPH commissioner for a specific list of reasons why they cannot and I am waiting for that response.”
On April 28, 2011, the House of Representatives approved creation of a Lyme Disease Commission to investigate the need for new screening programs and other steps to combat the illness, which is spread by bacteria from bites by infected ticks.
The amendment authorizing the commission charged it with studying the value of public health screening in high-risk areas, more prevention steps in schools and more medical research on the progression and treatment of Lyme disease.
“If you look at the language of the statute that set up the commission, there were various people that were appointed by various agencies and they were there to represent the interests of their agencies or organizations,” Mr. Linsky said. “From day one, the people of the commission should have had the authority to speak on behalf of their agencies or organizations.”
Although no one has officially signed the Lyme Disease Commission’s final report, Mr. Linsky said there is a consensus of the commission to the report’s current text, with the exception of the DPH appointees.
When it is signed and finalized, Mr. Linsky said the report will be published and posted and he and his fellow legislators serving on the commission will file any necessary legislation based on the findings and recommendations agreed on in the report. However, issues dealing with the budget will have to be taken up during the budget process.
Mrs. McCleary said she is not surprised by the state Department of Public Health’s stance on the matter, calling them “gatekeepers” for the Center for Disease Control and Prevention and the Infectious Disease Society of America.“We can go forward without them but it sure would have been nice when we’re talking about such a crisis and epidemic here that the Massachusetts Department of Public Health is concerned about it and want to improve on what’s happening. And once again, they’re showing us they’re not.”
But Sam R. Telford III — a commission member and professor in the department of biomedical sciences and infectious diseases at Cummings School of Veterinary Medicine at Tufts University in North Grafton — said he thinks the delay in Department of Public Health members’ signatures has to do with all the difficulties the department has had in the last two months.
In mid-September, state Public Health Commissioner John Auerbach and Lab Bureau Chief Dr. Linda Han both resigned and Julie Nassif, the director of the state’s analytic chemistry division, was fired in the wake of the scandal at the state drug lab. State chemist Annie Dookhan allegedly tampered with drug evidence for tens of thousands of criminal cases.
A national fungal meningitis outbreak was linked to New England Compounding Center in Framingham, a speciality pharmacy that was regulated by the agency’s Board of Registration in Pharmacy.
Laura Smith is serving as the department of public health’s interim commissioner.
“My guess is that it’s an administrative glitch because of the flux in leadership at the Department of Public Health,” Mr. Telford said. “The DPH has done a marvelous job considering the limited resources that they have in terms of defining the problem here.”
Anne Roach, media relations manager at the Department of Public Health, said her department commends the commission “for its efforts to produce a meaningful report that examines the seriousness of Lyme disease in Massachusetts.”
“The department’s first priority is to protect the public health and it will continue to identify ways to reduce the transmission of Lyme disease and all tick-borne illnesses,” Ms. Roach said. “As part of its efforts to increase awareness about the growing extent and seriousness of Lyme disease in Massachusetts, DPH is working collaboratively with the commission. DPH focuses its efforts on the promotion of proven prevention methods through educational materials available online as well as outreach to local boards of health and community groups.”
Mrs. McCleary said the report has “some pretty shocking” stories from chronic Lyme disease sufferers, as well as “good and really important” recommendations, including the need for better testing methods, better education of physicians about Lyme disease’s symptoms and treatment, and more up-to-date information readily available to the public, especially on the department’s website.
“The standard treatment that is available right now is not working for people, quite frankly, and there are other options out there,” Mrs. McCleary said. “In Massachusetts, people have to go out of state and they have to self-pay for their treatment and that’s not OK.”
Mrs. McCleary said her husband and their two adult sons have been treated for Lyme disease.On top of that, Lyme disease has cost the McCleary family a small fortune.
“By the time we saved my life, there was no college fund or anything when it came time for my kids to go to school. We are hanging by a thread. Our house is on the market. But you do what you have to do,” she said. “Anybody who got this disease is in debt, unless they are a millionaire.”
Source found here
County stung by meningitis deaths in 2012
December 31, 2012
Lilian Cary knew she wasn't feeling well, but what the late Howell resident didn't know — what no one knew — was that she would be among the first victims of a fungal meningitis outbreak whose impact will continue into the new year and beyond.
While remembered for her kindness and friendliness, the 67-year-old Cary's death Sept. 30 from fungal meningitis put a local focus on the national outbreak.
Livingston County remained at the forefront, even as the outbreak grew nationwide.
Meningitis is an inflammation of the membranes surrounding the brain and spinal cord.
By year's end, 13 Michigan residents had died, including four from Livingston County, and more than 200 others required medical treatment for meningitis or related symptoms.
Nationally, the outbreak claimed 39 lives, with at least 620 cases reported in 19 states from Florida to Idaho. Michigan, with at least 223 cases, was the state most heavily affected.
Many of those who fell ill had previously received steroid shots to relieve back pain at Michigan Pain Specialists, a Genoa Township-based medical facility. The steroid solutions, however, had been contaminated during mixing at the New England Compounding Center, a now-closed facility in Framingham, Mass.
Substances found in the contaminated steroid solutions were likened to black mold.
Due to the rising number of local cases, Saint Joseph Mercy Hospital in Washtenaw County gained emergency state permission to expand operating room capacity and add equipment to handle the outbreak.
The hospital system had earlier consolidated its meningitis treatment facilities at the Ypsilanti-area site, but officials admitted the outbreak was unlike any other.
"We don't have a lot to draw on — and by that, I mean the medical community at large," Dr. Lakshmi Halasyamani, Saint Joseph's chief medical officer, said in mid-October as the outbreak took hold.
The outbreak came in two waves. While the number of patients who developed meningitis began to taper off by late October, a second wave of patients developed epidural abscesses — painful infections near the injection site which themselves could have spread meningitis if left untreated.
Among Michigan residents, there were 64 cases of meningitis, including 38 with additional epidural abscesses; 142 reports of abscesses alone; 20 joint infections; and one meningitis-related stroke, in addition to the fatalities.
At the same time, Congress, began debating tougher restrictions on compounding facilities, like NECC, which produce large amounts of drugs for national distribution.
Compounding facilities, including neighborhood pharmacies, have generally been exempt from U.S. Food and Drug Administration regulation because their newly created compounds are made from already-approved drugs.
U.S. Rep. Mike Rogers, R-Brighton, was central to the initial congressional investigation as a member of the House Energy and Commerce Committee, which held a mid-November hearing on the outbreak.
At the same time, the Rogers' stepmother was being treated for a meningitis-related abscess at Saint Joseph Mercy Hospital.
Congressional hearings didn't forestall individuals from filing lawsuits against the compounding center.
In subsequent news, the compounding center linked to the outbreak filed for Chapter 11 bankruptcy protection, while its owners promised to create a fund to compensate victims.
It remains to be seen whether that action will forestall additional lawsuits, which could take years to resolve.
Families of those whose loved ones were still in treatment, or slowly recovering at home said they were worried the outbreak would soon fade from memory even as their struggles continued.
It also remains to be seen whether Congress will expand federal oversight into compounding pharmacies.
Contact Daily Press & Argus reporter Wayne Peal at 517-548-7081 or at wpeal@gannett.com.
Source found here
Subscribe to:
Posts (Atom)