PHARMACY

Pharmacy leaders urge Congress to remove final e-script roadblocks

BY Jim Frederick

WASHINGTON Hoping to break the logjam preventing physicians from electronically prescribing controlled substances, SureScripts chief executive Kevin Hutchinson and the National Association of Chain Drug Stores and Rite Aid vice president of pharmacy services Mike Podgurski urged a Senate panel today to help overturn federal restrictions on the practice.

Testifying before the Senate Judiciary Committee, Hutchinson asked Congress to encourage the Drug Enforcement Administration to end its restrictions on the electronic prescribing of controlled substances. Such a move, he said, “would have an immediate impact on e-prescribing adoption and utilization and significantly increase the efficiency and safety of a prescribing process relied on by millions of patients every day.

“What’s more, by moving from paper to electronic prescribing of controlled substances, society will benefit from greater accountability of a class of medications whose system of distribution, by their very definition as ‘controlled substances,’ demands the utmost integrity and control,” Hutchinson told the committee.

The SureScripts chief executive officer said the inability to electronically prescribe controlled substances is one of the reasons doctors give most often for holding back on their adoption of e-prescribing. “We have heard from many physicians that as long as these restrictions are in place, e-prescribing does not make sense for them because it requires practices to maintain two separate processes for prescribing: one that is paper-based for controlled substances, and another that is electronically based for non-controlled substances,” Hutchinson told lawmakers.

In written testimony presented to the panel, NACDS reaffirmed that view, calling the inability to e-prescribe controlled drugs “a hindrance to widespread prescriber adoption.

“E-prescribing is safe and secure,” NACDS testified. “It is an effective tool that is saving lives, improving the quality of health care and reducing the costs of care. The inability to e-prescribe controlled substances is preventing patients, prescribers and payers from taking advantage of these benefits.

“Moreover,” added the group, “the current federal roadblock is also depriving law enforcement of a tool that could help stop illicit prescribing and doctor-shopping and assist with diversion control.”

The chairman of the Senate Judiciary Committee, Rhode Island Democrat Sheldon Whitehouse, has already indicated his support for lifting the ban. “While e-prescribing could reduce adverse drug events, increase adherence to prescription regimens, and save billions of dollars each year, federal regulations still require paper prescriptions for controlled substances often used to treat attention-deficit disorder, anxiety, pain and other ailments,” Whitehouse said last week. “This requirement means that many doctors default to writing all prescriptions by hand, rather than maintaining two systems.”

During his testimony, Hutchinson disclosed the results of the first National Progress Report on E-Prescribing. Published by SureScripts and based on data derived from the operations of the Pharmacy Health Information Exchange, the report features statistics measuring the current status of e-prescribing in the U.S.

Among its findings:

  • There were more electronic prescriptions in the first three quarters of 2007 than in 2004, 2005 and 2006 combined, and the 2007 total will reach 35 million—or 2 percent of the estimated 1.47 billion new prescriptions and renewals eligible for electronic routing in the U.S.
  • Of the 563,000 office-based physicians in the U.S., only 6 percent are now e-prescribing. SureScripts estimates the number of electronic prescribers will grow to approximately 85,000 next year.
  • More than 40,000 pharmacies are now accepting e-scripts, and that total should grow to 45,000 in 2008, according to the e-prescribing platform provider. 
  • Estimates are that 100 million electronic prescriptions/refills will go through the SureScripts network next year.

“There is a fully operational, nationwide infrastructure that closely adheres to all industry and government-approved standards for e-prescribing,” Hutchinson testified. He added, however, “Despite strong momentum and growth, this national asset is grossly underused. Every time a paper prescription is written, it is a lost opportunity to improve patient care.”

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Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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