NQF Substance Abuse Standards
The National Quality Forum has issued a set of national, evidence-based consensus standards on identifying and treating substance abuse. The 11 practices were endorsed by 365 NQF member organizations, including health care providers, professional societies, purchasers, and federal agencies. Voluntary adoption of the standards would lead to improved patient outcomes, according to the NQF. The recommendations cover identification of substance use conditions, initiation and engagement in treatment, therapeutic interventions, and continuing care management. The guidelines can be purchased at the NQF Web site,
Settlement on Zyprexa Leaks
A former consultant to Eli Lilly & Co. has agreed to pay the drug maker $100,000 to settle complaints that he leaked confidential information about Zyprexa (olanzapine) to a plaintiffs' attorney. Dr. David Egilman was an expert witness for the plaintiffs in Zyprexa product liability suits. Under the agreement, Dr. Egilman acknowledged that he had intentionally and illegally given attorney James Gottstein documents that had been made available by Lilly during discovery, and that “he knew that these materials painted an incomplete picture of the issues related to Zyprexa,” according to a statement by Lilly. Mr. Gottstein shared the documents with the New York Times, which wrote a series of articles in December 2006 contending that Lilly had withheld information about side effects. Lilly said it would donate Dr. Egilman's settlement to the International Center for Clubhouse Development.
Court Date Set for Ayres
Psychiatrist Dr. William Ayres is set to go before a jury in San Mateo County, Calif., in March 2008 to face charges that he molested seven young male patients. In his Sept. 6 arraignment, Dr. Ayres pleaded not guilty. He has maintained his innocence since he was first arrested in April 2007 and charged with molesting at least five former patients. The arrest came after a 4-year investigation conducted by the San Mateo County Police Department. Dr. Ayres, who is 75, is a former president of the American Academy of Child and Adolescent Psychiatry.
Lawmakers OK Delay in Rx Rule
Coming down to the wire on a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1, lawmakers in the House and the Senate passed legislation in late September that would delay the mandate's start until March 31, 2008. At press time, President Bush was expected to sign the legislation, although it was not clear whether he would sign it by Oct. 1, National Community Pharmacists Association spokesman John Norton told this newspaper. The tamper-proof prescription pad mandate delay was bundled with extensions on several programs due to expire Sept. 30, including an abstinence education initiative that the Bush administration supports, Mr. Norton said. The original mandate, passed as part of war funding legislation earlier this year, requires all Medicaid prescription be written on “tamper resistant” paper to be eligible for federal reimbursement. Even though many states have similar requirements, pharmacists' organizations have maintained that most physicians do not currently use these types of pads, nor are supplies readily available.
Rise in Adverse Drug Event Reports
The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label.
Task Force Looks at Physician Gifts
In New Jersey, which is sometimes called the nation's medicine cabinet, the state's attorney general is taking a closer look at the gift-giving practices of pharmaceutical and medical device companies. The Attorney General's Advisory Task Force on Physician Compensation, which met for the first time in September, is examining the potential impact of payments and gifts to physicians from the drug and device industry. The task force will also consider possible public disclosure of gifts, direct disclosure to patients, and limits on payments to physicians. Vermont, Maine, Minnesota, West Virginia, and the District of Columbia have passed laws requiring some form of reporting of payments made to physicians by pharmaceutical and medical device companies. In response to the formation of the task force, the Pharmaceutical Research and Manufacturers of America issued a statement citing PhRMA's 2002 Code on Interactions with Healthcare Professionals as an important safeguard. The code declares all forms of entertainment to be inappropriate and says that any gifts that are given to physicians should support medical practice and be valued at less than $100. The New Jersey task force includes the state's Health and Senior Services Commissioner, members of the State Board of Medical Examiners, physicians, industry representatives, and consumer advocates.