Keryx to commence phase-3 trial for Zerenex
NEW YORK Drug maker Keryx Biopharmaceuticals has finished enrolling participants for a late-stage clinical trial of a drug for patients on kidney dialysis, Keryx said Tuesday.
The company is conducting a phase-3 trial of Zerenex (ferric citrate) in patients with end-stage kidney disease on dialysis who have excessive phosphorous levels, a condition known as hyperphosphatemia.
Keryx said it expects to complete the study and report top-line data by the end of the year.
E-prescribing accelerates as U.S. adoption efforts converge
WASHINGTON —Health care’s lumbering shift to electronic prescribing and health information technology has been a long time coming. But a confluence of recent events is accelerating the transformation, as health IT gains thousands of new converts among the physician and health plan payer communities.
One breakthrough came Sept. 29, when nine national pharmacy organizations unveiled a joint task force to grapple with the challenges and opportunities posed by information technology. The new group, called the Pharmacy e-Health Information Technology Collaborative, will focus on the pharmacy profession’s technology needs “to ensure that they are addressed and integrated into the framework of the U.S. health information technology infrastructure,” the groups noted in a joint statement. “In doing so, the collaborative is committed to creating a comprehensive and unified approach, ensuring optimal integration of pharmacy’s requirements and contributions into the electronic health record.”
Among the collaborative’s founding members are the American Pharmacists Association, the National Community Pharmacists Association, Academy of Managed Care Pharmacy, Accreditation Council for Pharmacy Education, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists and National Alliance of State Pharmacy Associations.
“In order for patients to receive optimal care, pharmacists need to have the ability to access and contribute to relevant, patient-specific information from the EHR. The work of the collaborative will focus on achieving this goal,” said Tom Menighan, EVP and CEO of APhA, who chairs the group.
In a separate, but no less critical advance, pharmacy benefit management giant Medco Health Solutions and the California Public Employees Retirement System, or CalPERs, unveiled the results of an 18-month pilot project on Sept. 28 that tracked a huge jump in e-prescribing by thousands of network physicians—and a corresponding increase in efficiency, accuracy and generic dispensing rates. “Doctors participating in a CalPERS e-prescribing pilot program saw a dramatic increase in e-prescribing use over the last 18 months,” declared Medco spokeswoman Lindsey Scharf. “The number of doctors using e-prescribing in the pilot surged 79%, and overall prescription renewals were up 104%.”
What’s more, she said, paperless prescribing among the more than 12,000 physicians serving CalPERS—the nation’s second-largest public health purchaser after the federal government—was found to boost efficiency and medication safety. “Fifty percent of [participating] physicians changed at least one prescription after receiving a safety alert,” Scharf noted.
The project also led to lower prescription costs through an 11% increase in generic dispensing rates among doctors who converted to eprescribing during the pilot. Said Kim Malm, interim assistant executive officer for health benefits for CalPERS, “the e-prescribing technology…notifies prescribers of generic drug equivalents so that the provider can suggest these to our members, and the members can realize savings.”
A high-profile event on Capitol Hill last month highlighted the changes sweeping through health care. At the fifth annual Safe-Rx Awards ceremony, e-prescribing platform provider Surescripts announced that more than 200,000 office-based prescribers, or 1-outof-every-3 physicians, nurse practitioners and physician assistants in the United States, have thrown away their prescription pads.
“Today—and over 1 million times a day—pharmacies, health plans, physicians and patients in communities throughout the country benefit from the improved safety, efficiency and lower cost associated with e-prescribing,” said Surescripts president and CEO Harry Totonis. “But e-prescribing is just the first step in the nation’s plan for health information technology, and it is only one component of an electronic health record.”
Designed to draw attention to the need for paperless prescribing and recognize its supporters, Safe-Rx awards went to Massachusetts and nine other states for their adoption of e-prescribing. An award also was presented to Sen. Sheldon Whitehouse, D-R.I., who received the Safe-Rx Evangelist Award for his efforts to promote the technology. Whitehouse, who founded the Rhode Island Quality Institute, and whose home state is the first in the nation to achieve 100% adoption of e-prescribing, led a successful drive in Congress to convince the Drug Enforcement Administration to allow paperless prescribing of controlled substances.
Congress targets Rx abuse with pharm’s backing
With strong support from pharmacy leaders, Congress is moving to shut down prescription medication abuse and diversion with a multipronged legislative cudgel.
Prior to its October recess, the U.S. House of Representatives passed three industry-backed bills in September to help seal up the nation’s leaky prescription drug pipeline. The bills are expected to pass under “suspension of the rules,” which allows for expedited consideration of legislation.
The Safe Drug Disposal Act aims for a safe and effective means for consumers to dispose of their unused medications, including controlled substances. “NACDS worked…to include language ensuring that regulations by the Drug Enforcement Administration will not require any entity to establish a drug disposal program, such as a take-back program,” the pharmacy group noted on Sept. 22. “This would enable pharmacies and other entities to determine the best means for working with consumers and law enforcement to safely dispose of unused drugs.”
The National All-Schedules Electronic Reporting Reauthorization Act would fund state efforts to establish prescription drug monitoring programs. “While these programs can be useful…in combating diversion, it is important that they not be administratively burdensome or disruptive to patient care activities, and the legitimate practices of pharmacy and medicine,” NACDS urged.
The Combat Methamphetamine Enhancement Act would require all entities that sell products containing pseudoephedrine to certify with the DEA. “Chain pharmacies took voluntary, proactive steps to reduce the theft and illegitimate use of products containing pseudoephedrine and ephedrine,” NACDS noted.
NACDS president and CEO Steve Anderson praised the House of Representatives’ “legislative trifecta,” which he said “illustrates NACDS’ members commitment to ensuring that prescription and over-the-counter medications are used appropriately,” he added.
Meanwhile, Congress and the White House have taken aim at fraudulent and abusive billing practices that plague Medicare and Medicaid and cost U.S. taxpayers billions of dollars. The Centers for Medicare and Medicaid Services has proposed new regulations to help prevent what the agency said is $55 billion in annual improper payments to providers and health plans. In a related development, the House Energy and Commerce Subcommittee on Health held a hearing last month on “Cutting Fraud, Waste and Abuse in Medicare and Medicaid.”
The National Community Pharmacists Association weighed in with a statement to the House panel that accused PBMs of responsibility for much of the abuse in Medicare billing, as well as “misrepresentation to plans, patients and providers; improper therapeutic solutions; unjust enrichment through secret kickback schemes; and failure to meet ethical and safety standards.”
The Pharmaceutical Care Management Association’s view was in stark contrast to those charges. Responding to CMS’ call for tougher regulations to curb abuse, group president and CEO Mark Merritt said the government’s focus should be on preventing abuse rather than on pursuing wrongdoers after the fact for fraudulent billing practices. “Pharmacy benefit managers agree that prevention, not ‘pay and chase,’ is the key to fighting fraud,” Merritt noted.
In a separate move, the NCPA weighed in after the Department of Health and Human Services issued a proposed interim final rule on the implementation of the massive health-reform act. The agency recommended that health plans and insurers that participate in the health insurance exchanges scheduled to take effect in 2014 waive patient co-pays for certain services that could lead to long-term preventive health benefits and lower treatment costs. Among those services are certain recommended vaccines, as well as such services as blood pressure and cholesterol screening, tobacco-cessation and obesity-related counseling and intervention.