GSK, Takeda agree to add stronger warnings of heart failure to diabetes drug packaging
WASHINGTON Manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, the Food and Drug Administration reported. The information will be included in the form of a “boxed” warning—FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
The FDA determined, following a postmarketing study of the drugs’ adverse effect, that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. The FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda Pharmaceutical, to address these concerns.
“Under the FDA’s postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.”
The FDA’s review found cases of significant weight gain and edema—warning signs of heart failure. In some reports, continuation of therapy has even been associated with death.
The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
The review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
McKesson and Pharmitas link up for move to electronic record keeping
BOSTON In order to alleviate the time-consuming, and often tedious, business of keeping paper-based logbooks, McKesson Pharmacy Systems, a division of the McKesson Corp., and Pharmitas, a technology solutions compliance provider, announced that they have formed a strategic relationship to offer an integrated software solution module that will enable MPS pharmacy customers the ability to quickly, easily and efficiently manage the sale of regulated over-the-counter medications.
The module the Pharmitas Pharmacy Solution uses is an electronic data capture and management system that instantly reads consumers’ identification and product purchases. It provides end-to-end compliance with all local, state and federal regulations for the sale of over-the-counter drugs, including pseudoephedrine products (as mandated by the Federal Combat Methamphetamine Epidemic Act of 2005).
“There are a growing number of regulated consumer products that do not flow efficiently through the pharmacy workflow and carry unique risks and costs for retailers,” said Tom Michalski, MPS director of product development. “Our pharmacy customers have requested systems that allow them to spend more time consulting with their patients and less time filling out onerous paperwork. The addition of the Pharmitas Solution reinforces McKesson’s commitment of providing our customers with the most comprehensive pharmacy systems and front-end business solutions to enhance their efficiency and profitability.”
“Working with McKesson was a strategic step in Pharmitas’ development and preparation for rapid growth,” said Chris Parsons, president and chief executive officer at Pharmitas. “By partnering with the world’s largest healthcare services company, we can extend our reach to provide powerful, innovative solutions and world-class support to pharmacies nationwide.”
Taking its case to state lawmakers, pharmacy works to ease Medicaid cuts
CINCINNATI The new Medicaid pharmacy payment model has arrived, and pharmacy leaders fear its long-term impact could be a severe drop in profitability as the Centers for Medicare & Medicaid Services adopts a new reimbursement formula. In response, the National Association of Chain Drug Stores and other stakeholders have shifted many of their efforts to stave off the worst effects of the new regulations to the states.
Those efforts are showing results. Working through its state government affairs division, NACDS is helping to conduct “value of pharmacy” tours of local pharmacies for state legislators as part of a broad grass-roots campaign to spotlight the importance of the profession and the potential damage that could be wrought by the Deficit Reduction Act, and by the new Medicaid reimbursement regulations CMS adopted in response to the DRA.
One official spearheading those efforts is Dale Masten, NACDS regional government affairs manager for Ohio and the Southeast. Working with the Ohio Pharmacy Association, Masten and other pharmacy representatives invited state Rep. Lynn Wachtmann to tour two drug stores operated by Walgreen Co. and Meijer in Defiance, Ohio.
“At a briefing we were doing on the Deficit Reduction Act, I mentioned it to him and he was very interested … and we set it up,” Masten recalls. “I think it was very beneficial. It makes a huge difference to see pharmacists delivering patients drug therapy management, or advising them at the counter on how to take their medications.
“There’s so much that a pharmacist does that a lot of times a general assembly member just doesn’t know about,” he added. “It’s just a whole broad education for them on the impact the Deficit Reduction Act can have, on the role pharmacists can play, and on the technologies that are out there in the pharmacy.”
As a result of the Wachtmann visit, Masten continued, “I think he has a much better understanding of what a pharmacist goes through, and that it’s not just counting pills.”
Wachtmann is former chairman of the Senate Health Committee and is now vice chairman of the House Health Committee, so is influential in advancing a health policy agenda.
Wachtmann’s interest in pharmacy affairs—an interest promoted by his tours of Walgreens and Meijer—may make a big difference in the way the new Medicaid payment model plays out for Ohio pharmacies. In June, following his visit, the state legislature passed a bill to ease the impact of the Medicaid cuts to pharmacies when the new regulations take full effect next year. The governor quickly signed the bill into law as part of Ohio’s budget process.
“Rep. Wachtmann spoke out quite loudly on the ‘hold harmless’ legislation that was passed with the budget,” said Masten. That legislation, he added, requires the state’s Medicaid program to study the effects of the Deficit Reduction Act within 30 days of the CMS rule implementation next Jan. 30.
Within 10 days of that study’s completion, Masten said, Medicaid in Ohio will be required to boost dispensing rates to offset the impact of the new federal payment guidelines for pharmacies, pending approval of the state’s reimbursement plan by CMS.
“It’s budget neutral, because whatever savings Medicaid incur as a result of these lower reimbursements, that amount is used to increase pharmacy funding,” he said.
NACDS, Masten added, “worked very closely with the Ohio Pharmacists Association and the Ohio chain drug companies” to enlist the support of lawmakers. “It was a great coalition…in working with the [state] Medicaid [office] and helping to draft this legislation,” said Masten.
“I’ve already talked to another state representative who’d like to do the same thing” by seeing pharmacies in action face-to-face, he added. “Clearly, Rep. Wachtmann … is educating his colleagues on the importance of pharmacy.”
Pharmacy groups like NACDS and NCPA, along with state pharmacy associations, local pharmacy retail operators and other groups, are also finding some success in other states in convincing state lawmakers to help close the payment shortfall most pharmacy leaders anticipate once the new Medicaid payment regulations go into effect. “A glaring example is in North Carolina, where chains and independents mustered up 9 or 10,000 letters and e-mails that went to the North Carolina General Assembly, and that helped avert a 5 percent reimbursement reduction for Medicaid,” said Masten. “So I think working closely with legislatures can really help.”