FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza
On October 23, 2009, the Commissioner of the FDA issued an Emergency Use Authorization for the unapproved drug Peramivir IV to treat certain hospitalized adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology.
Preparing Your Medical Practice for the Swine Flu (H1N1)
Because no one is able to predict the future severity of the H1N1 virus, every medical office needs to be ready to manage an H1N1 outbreak among office staff and patients. Every medical practice should familiarize itself with the Centers for Disease Control and Prevention (CDC) guidelines for management of H1N1 exposure and administration of the 2009 H1N1 vaccine.
CMS Scam Alert Notice
The Centers for Medicare & Medicaid Services (CMS) has become aware of a scam where perpetrators are sending faxes to physician offices posing as the Medicare carrier or Medicare Administrative Contractor (MAC). The fax instructs physician staff to respond to a questionnaire to provide an account information update within 48 hours in order to prevent a gap in Medicare payments. The fax may have the CMS logo and/or the contractor logo to enhance the appearance of authenticity.
California Law Now Requires Health Plans to Provide Language Assistance Program for Patients
Effective January 1, 2009, California health plans are required to implement a language assistance program to comply with Senate Bill 853. The legislation was passed to assist those with limited English language proficiency to better communicate and participate in personal health care matters.
Obstetricians: Gen-Probe Recalls ACCUPROBE Kits
On December 30, 2008, Gen-Probe, Inc., notified its customers and distributors that it was voluntarily recalling specific lot numbers of its ACCUPROBE Group B Streptococcus (GBS) kit, ACCUPROBE Mycobacterium tuberculosis Complex (TB Complex) kit, and ACCUPROBE Mycobacterium avium Complex (M. avium Complex) kit.
Medtronic Neuromodulation SynchroMed and IsoMed Implantable Infusion Pumps
Formation of an inflammatory mass (granuloma) at or near the distal tip of intrathecal catheters has been reported with the intrathecal infusion of opioids, baclofen, pharmacy-compounded drugs, and other pharmacological admixtures.
New Medicaid Regulation for Tamper-Resistant Prescription Pads
Effective April 1, 2008, all Medicaid prescriptions must be written on pads that contain at least one industry-recognized feature to prevent copying, erasing, or counterfeiting. By October 1, 2008, all prescription pads must prevent all three forms of tampering.
State of California Enacts Adverse Event Reporting
As of July 1, 2007, a new California law (S.B.1301) mandates that the Department of Health Services (DHS) Health Facility Reporting requirements now include the "Never 27" list of serious, preventable adverse events.
Arranging Locum Tenens Coverage Is Getting Easier
We’re making it easier for our members to arrange locum tenens coverage. As of mid-2005, members are no longer required to notify us in advance of their locum tenens use.
Are Your Medical Records Safe in Storage?
Recently, The Doctors Company has become aware that the practices of some record storage companies regarding retention and destruction of patient records are inconsistent with our recommendations.
FDA Approves Silicone Gel Implants for Augmentation and Reconstruction
On November 17, 2006, the U.S. Food and Drug Administration (FDA) announced its approval of silicone gel implants for breast augmentation in patients over the age of 22 and for patients of any age for breast cancer reconstruction purposes.
Surgical Auctions
The Doctors Company Risk Management Department warns physicians—particularly plastic surgeons, dermatologists, ophthalmologists, and otolaryngologists—against participating in any practice involving the offer of professional services for auction or the sale of medical procedures within any bidding system.
FDA Issues Proposed New Rule Regarding Hydroquinone
As part of the Food and Drug Administration's (FDA's) ongoing review of over-the-counter drug products, it has issued a notice of proposed rulemaking regarding hydroquinone.
"I'm Sorry" Laws Differ in Each State
As the "I'm Sorry" movement gains momentum, more institutions and health systems across the country are implementing adverse event disclosure programs.
Major Changes in the 2005 AHA Guidelines for CPR
Late last year the American Heart Association (AHA) published the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. The Doctors Company recommends that all CPR-certified personnel—whether they have completed the health care provider or lay rescuer course—become familiar with the new guidelines.
FDA Issues Bulletin on Human Donor Tissue Recall
The Food and Drug Administration (FDA) has released a news bulletin to notify the public of its investigation of human tissue that was recovered and subsequently distributed to tissue processors.
Botox Cosmetic
On April 15, 2002, the Food and Drug Administration (FDA) approved the use of Botulinum Toxin Type A, Botox Cosmetic, for the temporary relief of moderate to severe frown lines between the brow. It is important to note, however, that the use of Botox Cosmetic for any purpose other than frown lines between the brow is still considered off-label usage and is not approved by the FDA.
Vision Problems After Spine Surgery with Controlled Hypotension
Ischemic optic neuropathy is the most frequently reported cause of postoperative visual loss following general anesthesia. The following discussion, based on a review of The Doctors Company claims and a study of the medical literature, is intended to promote an awareness of the ION syndrome and to provide an understanding of current theories about its etiology and treatment.
Fen-Phen Update
Physicians who have prescribed the diet medications popularly known as "Fen-Phen" to their patients may have been asked about the drugs' potential adverse effects upon the heart valves. Information and answers are available from three sources.