PHARMACY

Alaska makes e-prescribing possible throughout U.S.

BY Adam Kraemer

ALEXANDRIA, Va. Alaska this week became the 50th and final state to pass legislation allowing electronic prescribing between doctors and pharmacists.

On the heels of similar announcements over the past year by Georgia, South Carolina, Washington D.C and West Virginia, Alaska has passed changes to its laws and regulations to allow for what is known as “e-prescribing.” The news marks a major milestone for the United States healthcare system in transitioning from written or faxed prescriptions to safer, more efficient electronic prescribing.

“This is a significant milestone as momentum continues to grow nationwide for electronic prescribing,” said Bruce Roberts, National Community Pharmacists Association executive vice president and chief executive officer. “The ability for pharmacists and physicians to communicate electronically means enhanced safety and efficiency for everyone. We are pleased to see this goal realized and look forward to increased utilization between physicians and pharmacists.”

To capitalize on the opportunity for safer and more cost-efficient prescribing, SureScripts, which operates the Pharmacy Health Information Exchange, is working closely with community pharmacies throughout Alaska to immediately activate previously certified computer systems for electronic prescribing.

“When the nation’s community pharmacies launched the Pharmacy Health Information Exchange into full production at the beginning of 2004, we had the technical capability in our network to support e-prescribing between physicians and pharmacists anywhere in the nation,” said Kevin Hutchinson, president and chief executive officer of SureScripts. “At that time, however, only about half of the states had laws and regulations that would even allow electronic prescribing. Today, we are proud to announce that all 50 states plus Washington, D.C., now allow their physicians and pharmacists to electronically exchange prescriptions and lifesaving prescription information.”

“Community pharmacy is vital to the health care system, and e-prescribing is another step forward for the efficiency and safety of patient care,” said Steven Anderson, president and chief executive officer of the National Association of Chain Drug Stores. “This will prove a wise move for all 50 states.”

SureScripts has certified the software solutions being used by more than 95 percent of the nation’s retail pharmacies. As a result, the majority of Alaska’s 86 community pharmacies can now begin accepting electronic prescriptions and electronically processing refill authorizations, and join the more than two-thirds of the nation’s pharmacies actively exchanging prescription information.

In a separate but related development, RxHub, a rival e-prescribing system by the nation’s three largest pharmacy benefit managers, revealed this week it has seen a 30 percent increase in the first half of 2007 in the adoption of e-prescribing. RxHub tracked the increase through 35 million patient encounters through its National Patient Health Information Network. The network was set up to connect authorized physicians to pharmacy information for consenting patients at the point of care, according to the company, which was founded in 2001 by CVS Caremark, Express Scripts and Medco Health Solutions.

“Americans spend more than $200 billion annually on drugs. Because patients often do not comply with their medication regimen, information from the RxHub’s National Patient Health Information Network can help physicians and pharmacists work with those patients to improve compliance,” said RxHub chief operating officer J.P. Little. Little called the data generated by the system “the cornerstone for medication reconciliation and medication therapy management offerings in the marketplace.”

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PHARMACY

Esprit pays milestone to Indevus, acquires marketing rights for Sanctura XR

BY Adam Kraemer

EAST BRUNSWICK, N.J. Esprit Pharma announced this week that it has exercised its option to acquire the marketing rights of the recently approved Sancutra XR (trospium chloride extended release capsules).

Esprit paid its development and co-promotion partner, Indevus Pharmaceuticals, the milestone owed it Tuesday, following approval by the Food and Drug Administration. With the payment, Esprit secured rights to market Sancutra XR in the United States and its territories. Indevus announced on Monday, Aug. 6, that Sancutra XR had been approved by the FDA.

Sancutra XR is indicated for the once-daily treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Sancutra XR, the once-daily formulation of Sanctura, is a unique quaternary ammonium compound in a class of anticholinergic compounds known as muscarinic receptor antagonists. OAB is estimated to affect approximately 33 million Americans and represents a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men.

“The approval of Sancutra XR sets a new benchmark in the treatment of overactive bladder, further strengthens our flagship brand, and reinforces our commitment to patients who suffer from overactive bladder and the clinicians who treat them.,” stated John Spitznagel, chairman and chief executive officer of Esprit Pharma. “We are extremely excited about bringing this best in class compound to market in the near future.”

Esprit is responsible for the marketing and sales of Sancutra XR and Indevus is a sales co-promotion partner for the product through 2008.

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GSK, Takeda agree to add stronger warnings of heart failure to diabetes drug packaging

BY Adam Kraemer

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).

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