Extortionists Target Major Pharmacy Processor
One of the nation's largest processors of pharmacy prescriptions said Thursday that extortionists are threatening to disclose personal and medical information on millions of Americans if the company fails to meet payment demands.
St. Louis-based Express Scripts said that in early October it received a letter that included the names, birth dates, Social Security numbers and in some cases prescription data on 75 of its customers. The authors threatened to expose millions of consumer records if the company declined to pay up, Express Scripts said in a statement.
The company's chief executive George Paz said Express Scripts has no intentions of paying the extortion demand and said his company is working with the FBI to track down the person or persons responsible for the scam.
Express Scripts is among the largest pharmacy benefit management firms, companies that process and pay prescription drug claims. It handles roughly 500 million prescriptions a year for about 50 million Americans.
The ransom note was delivered through the mail, said company spokesman Steve Littlejohn. However, he declined to say how much money the extortionists were demanding. He added that the company is still trying to determine how the data was stolen.
"We know where the data came from by looking at it, but precisely how it was accessed is still part of the investigation," Littlejohn said.
The company has set up a Web site to give concerned consumers tips on how to protect their identity. While Express Scripts doesn't interact with consumers directly, the company's name is printed on prescription cards of health care plans that use its services, Littlejohn said.
Alan Paller, director of research for the SANS Institute, a Bethesda, Md., based computer security training group, said cyber and data extortion incidents rarely make the news because most victims find it more expedient to simply pay up.
"There are thousands of companies that have already paid off extortionists in return for not having their customers' data exposed," Paller said. "This especially true in the financial industry, as some banks are now getting more than one new extortion demand per day."
Paller said for years he has been expecting extortionists to begin targeting the health care industry.
"In many ways, this is the perfect extortion target," Paller said. "Nobody is going to want to go to a health care provider if they think their private medical history is going to be revealed to the world online. Hospitals wouldn't have to think too hard about that before paying off an extortion demand."
Graham Cluley, a senior technology consultant for Sophos, a computer security company based in the United Kingdom, said Express Scripts made the right move in contacting the FBI and refusing to pay the ransom.
"Data extortion is not like if your daughter gets kidnapped: Even if something is returned to you, you can never be sure they're not going to carry on taking advantage of the situation," Cluley said. "The bad guys can always just make a copy of what they've stolen, and they can keep on coming back and asking for money, or they can still go and sell the data online."
taken from Pharmacist e-link on November 11, 2008: http://www.pharmacistelink.com/index.phpoption=com_content&task=view&id=10636&Itemid=274
Monday, November 10, 2008
Thursday, August 7, 2008
Second Annual Montana Pain Initiative Conference
Upcoming “2nd Annual Montana Pain Initiative Conference - Pain Management Policy and Practice: A Balanced Approach.” The conference will be held on September 5-6, 2008 at the Holiday Inn Downtown at the Park in Missoula, Montana. For more information, please see the brochure
Saturday, July 19, 2008
December Hearing in Proposed First DataBank AWP Settlement
December Hearing in Proposed First DataBank AWP SettlementA federal court hearing has been set for Dec. 17 in a case that NCPA's legal strategy has saved community pharmacies from a rollback in Average Wholesale Price calculations that would cost them $291 a day.
NCPA has urged U.S. District Court Judge Patti Saris in Boston to reject an amended settlement proffered by First DataBank (FDB) in a suit brought against the California-based publisher by several union health plans. McKesson and Medi-Span also were sued, but are not involved in the settlement. NCPA was not a party to the suit, but intervened to prevent grievous harm to community pharmacies. The suit alleges that the trio conspired to increase the spread between Wholesale Acquisition Cost and AWP.
"This settlement permits the sole wrongdoer, FDB, to relieve itself of liability for a mere $1 million payment to the Settlement Fund, while placing the burden of any settlement on pharmacies and consumers," NCPA told the judge. "We urge the court to not approve a settlement that creates more problems than it solves."
Judge Saris has given preliminary approval to the new proposed settlement in the class action lawsuit. Last January, citing issues raised by NCPA, Saris rejected a proposal from FDB and Medi-Span that included a 4% rollback on the markup between WAC and AWP on more than 8,000 brand name formulations.
The rollback would have cost the average independent community pharmacy about $105,000 annually-more than wiping out the average independent's profits, according to figures from the NCPA Digest. Under that proposed settlement, FDB, a Hearst company, also would have phased out publication of AWPs within two years of the date of the final settlement.
The latest proposal from FDB would reduce the number of affected drugs to about 1,400 with an effective date 90 days after approval of the final settlement. But NCPA noted that even at that reduced level, 40% of all branded drugs, which represent 80% of all prescriptions filled at independent pharmacies, would be affected by the rollback.
taken from NCPA e-NEWs Weekly: visit www.ncpanet.org
NCPA has urged U.S. District Court Judge Patti Saris in Boston to reject an amended settlement proffered by First DataBank (FDB) in a suit brought against the California-based publisher by several union health plans. McKesson and Medi-Span also were sued, but are not involved in the settlement. NCPA was not a party to the suit, but intervened to prevent grievous harm to community pharmacies. The suit alleges that the trio conspired to increase the spread between Wholesale Acquisition Cost and AWP.
"This settlement permits the sole wrongdoer, FDB, to relieve itself of liability for a mere $1 million payment to the Settlement Fund, while placing the burden of any settlement on pharmacies and consumers," NCPA told the judge. "We urge the court to not approve a settlement that creates more problems than it solves."
Judge Saris has given preliminary approval to the new proposed settlement in the class action lawsuit. Last January, citing issues raised by NCPA, Saris rejected a proposal from FDB and Medi-Span that included a 4% rollback on the markup between WAC and AWP on more than 8,000 brand name formulations.
The rollback would have cost the average independent community pharmacy about $105,000 annually-more than wiping out the average independent's profits, according to figures from the NCPA Digest. Under that proposed settlement, FDB, a Hearst company, also would have phased out publication of AWPs within two years of the date of the final settlement.
The latest proposal from FDB would reduce the number of affected drugs to about 1,400 with an effective date 90 days after approval of the final settlement. But NCPA noted that even at that reduced level, 40% of all branded drugs, which represent 80% of all prescriptions filled at independent pharmacies, would be affected by the rollback.
taken from NCPA e-NEWs Weekly: visit www.ncpanet.org
CHIP joins pharmacies to help get health insurance
Montana’s Children’s Health Insurance Plan (CHIP) is partnering with pharmacies and other health care providers all across the state to help families obtain health insurance for their children.
CHIP is a free or low-cost health insurance plan available to families who do not qualify for Medicaid, but cannot afford private insurance for their children. CHIP currently covers over 16,500 Montana children and teenagers. CHIP covers a wide array of health services, including medical, dental, vision, and prescription drugs.
Last year, CHIP reimbursed pharmacies $3.6 million in prescription claims. CHIP-enrolled children can get their prescriptions filled at most chain pharmacies, as well as over 150 independent pharmacies across the state. Co-pays are minimal ($3/generic, $5 brand name).
You can join the over 550 CHIP community partners who help Montana families learn about CHIP by having applications and brochures available at your location. CHIP supplies all of the materials. You can also encourage your clients to visit the CHIP website at www.chip.mt.gov. Parents can fill out the application right on their computer.
Please help us get more Montana children enrolled in CHIP. There is no waiting list, so now is a great time for families to apply for CHIP.
If you would like to receive a CHIP brochure holder and/or a supply of brochures and applications, please give me a call or e-mail me at the number/address below. Posters are also available.
Thank you for supporting Montana families.
Michael Mahoney
Community Relations Manager
Children’s Health Insurance Plan
406-444-7877
mmahoney2@mt.gov
CHIP is a free or low-cost health insurance plan available to families who do not qualify for Medicaid, but cannot afford private insurance for their children. CHIP currently covers over 16,500 Montana children and teenagers. CHIP covers a wide array of health services, including medical, dental, vision, and prescription drugs.
Last year, CHIP reimbursed pharmacies $3.6 million in prescription claims. CHIP-enrolled children can get their prescriptions filled at most chain pharmacies, as well as over 150 independent pharmacies across the state. Co-pays are minimal ($3/generic, $5 brand name).
You can join the over 550 CHIP community partners who help Montana families learn about CHIP by having applications and brochures available at your location. CHIP supplies all of the materials. You can also encourage your clients to visit the CHIP website at www.chip.mt.gov. Parents can fill out the application right on their computer.
Please help us get more Montana children enrolled in CHIP. There is no waiting list, so now is a great time for families to apply for CHIP.
If you would like to receive a CHIP brochure holder and/or a supply of brochures and applications, please give me a call or e-mail me at the number/address below. Posters are also available.
Thank you for supporting Montana families.
Michael Mahoney
Community Relations Manager
Children’s Health Insurance Plan
406-444-7877
mmahoney2@mt.gov
Wednesday, July 9, 2008
Comments Requested: CMS Proposed Changes to Medicare Advantage and Prescription Drug Programs
Advantage and Prescription Drug Programs As a result of the evaluation of the initial year of the program, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule in the Federal Register (73 FR 28556) that would make changes to the Medicare Advantage program regarding special needs plans, medical savings accounts, and definitions related to the Medicare Part D prescription drug benefit. The proposal's comment period closes on July 15, 2008...Read APhA's summary of the proposed rule. ››
on APhA website
on APhA website
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial DrugsSeeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupt
FDA News
FOR IMMEDIATE RELEASE July 8, 2008
Media Inquiries: Christopher Kelly, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial DrugsSeeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.
The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.
Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).
Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients' and prescribers' understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.
Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.
The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.
Information for Healthcare Professionals on Fluoroquinolone Antimicrobial Drugs: http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm.
FDA Home Page Search FDA Site FDA A-Z Index Contact FDA
FOR IMMEDIATE RELEASE July 8, 2008
Media Inquiries: Christopher Kelly, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial DrugsSeeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.
The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.
Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).
Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients' and prescribers' understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.
Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.
The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.
Information for Healthcare Professionals on Fluoroquinolone Antimicrobial Drugs: http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm.
FDA Home Page Search FDA Site FDA A-Z Index Contact FDA
FDA Revises Process for Responding to Drug Applications
FDA News
FOR IMMEDIATE RELEASEJuly 9, 2008
Media Inquiries: Christopher DiFrancesco, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."
Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.
In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.
For more information, see:
Link to the Complete Response Final Rulehttp://www.fda.gov/cder/regulatory/complete_response_FR/default.htm
Link to the drug approval process pagehttp://www.fda.gov/fdac/special/testtubetopatient/default.htm
FOR IMMEDIATE RELEASEJuly 9, 2008
Media Inquiries: Christopher DiFrancesco, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."
Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.
In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.
For more information, see:
Link to the Complete Response Final Rulehttp://www.fda.gov/cder/regulatory/complete_response_FR/default.htm
Link to the drug approval process pagehttp://www.fda.gov/fdac/special/testtubetopatient/default.htm
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