NACDS urging flexible health IT approach as HHS works to adjust patient records law
WHAT IT MEANS AND WHY IT’S IMPORTANT Shifting the nation’s sprawling and disconnected healthcare system to an integrated platform, based at last on health information technology and electronic health records, is a worthy and overdue undertaking. But striking the right balance between opening the spigot of patient information to streamline care and improve decision-making by health professionals, while protecting patient privacy, is a challenge that both health professionals and government policy-makers have been grappling with since the advent of computers in physicians’ offices and pharmacies.
(THE NEWS: White House continues health IT drive as CMS offers matching funds to states. For the full story, click here)
There’s no disputing the value health IT and EHRs can bring to this nation’s fractured and sometimes irrational system of health care. A fully integrated network that exchanges patient records among health professionals would revolutionize the whole system, knocking down silos and linking up the doctors, labs, pharmacies, nursing groups and health plans that all play a key role in a patient’s health and wellbeing, and getting them finally to talk to one another. The result could be a dramatic reduction in costs for needless and redundant tests, double-filled prescriptions, drug interactions and non-adherence. It would mean a smarter and far more cost-effective network for improving patient outcomes and rationalizing the decisions made by health stakeholders in patients’ care regimens.
Understandably, the federal health officials charged with driving the health IT revolution are moving cautiously, even as they continue to open the stimulus funding spigot for adoption of EHRs to more states.
Their goal: to avoid compromising the privacy of patients’ health records in the conversion to electronic recordkeeping and transmission of patient data. But privacy concerns, argue pharmacy advocates, needn’t block the necessary flow of protected patient data that must occur if a more integrated and rational health care system is to become more than just an elusive and always out-of-reach pipe dream.
On Monday, the National Association of Chain Drug Stores took another stab at the issue, with a written plea to Secretary of Health and Human Services Kathleen Sebelius. Essentially, NACDS is asking the White House to maintain a flexible and workable approach as it uses its stimulus funds and regulatory powers to usher in the electronic health revolution.
That means, NACDS told Sebelius, that the government shouldn’t impose on pharmacies and physicians a requirement that they obtain prior authorization from patients for the use and transmission of protected health records.
NACDS is on solid ground here. Two major considerations support their plea to HHS: one, the privacy of patient data is already amply protected by the privacy statutes embodied in the Health Information Portability and Accountability Act of 1996, or HIPAA. Two, the imposition of disclosure requirements and “opt-in, opt-out” prior-authorization rules on every patient exchange with a doctor or pharmacist could create enough confusion and bottlenecks to ground the nation’s critically important transformation to health IT to a halt.
House committee to hold hearing over J&J recall
WASHINGTON House Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Thursday announced that the committee will hold a hearing Sept. 30 at 10 a.m. to examine the circumstances surrounding Johnson & Johnson’s recall of more than 135 million bottles of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare, including children’s Tylenol, infant’s Tylenol, children’s Motrin and children’s Benadryl.
The hearing also will examine the circumstances surrounding a “phantom recall” of a particular Motrin product, which became public as a result of the committee’s hearing on May 27.
“This is about the safety of trusted medication that our children and grandchildren use,” Towns stated. “The evidence we have uncovered since our first hearing is extremely troubling.”
Witnesses invited to testify include Bill Weldon, J&J chairman and CEO, and Colleen Goggins, J&J worldwide chairman, consumer group.
The hearing will be webcast on the committee’s website, Oversight.house.gov.
Forest Pharmaceuticals pays $313 million in settlement deal
SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.
The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.
One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.
The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.
“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”