Latebreakers

October 24, 2005

Drug wholesalers should be licensed by the federal government instead of state pharmacy boards, according to a position paper issued by the Healthcare Distribution Management Association (HDMA).

Rx wholesalers back federal licensure

OIG: Medicare Part B payment rates are adequate

Baxter infusion pumps impounded

The FDA has seized Baxter Healthcare's Volumetric Infusion Pumps, Colleague CX Volumetric Infusion Pumps, and Syndeo PCA Syringe Pumps warehoused in two of the company's facilities in northern Illinois. The FDA said the firm has continually failed to follow medical device manufacturing requirements. The Deerfield, Ill., firm said that, due to the FDA action, it could not provide loaner pumps to customers whose pumps have malfunctioned because of problems with the devices. Hospitals and other customers that have Baxter pumps should continue to use them as directed. See earlier story.

CMS issues final rule requiring immunizations in LTC facilities

CMS has issued a final rule requiring long-term care facilities to offer each resident immunization against influenza annually, as well as lifetime immunization against pneumoccocal disease. LTC facilities will be required to ensure that before offering the immunization, each resident or the resident's legal representative receives education regarding the benefits and potential side effects of immunization. The regulation went into effect on Oct. 7.

Humira gains two new indications

Abbott's Humira (adalimumab) has received FDA approval for first-line treatment of moderate to severe rheumatoid arthritis (RA). In addition, the agency approved the TNF-blocker for the treatment of psoriatic arthritis. Psoriatic arthritis is the first new disease indication for Humira beyond RA. Humira was originally approved in 2002 to treat patients with moderately to severely active RA who had not responded to one or more disease-modifying antirheumatic drugs.

Hamacher, Caregivers Group tie knot

Hamacher Resource Group has acquired the Caregivers Group, which includes the Caregivers Marketplace and the Caregivers Advisory Panel. The Caregivers Group is a provider of healthcare products and information designed to help manufacturers, retailers, and wholesalers understand and meet the needs of family caregivers.

Alert issued for Menactra vaccine

The FDA and CDC are alerting healthcare professionals and consumers about five reports of Guillain-Barré syndrome (GBS) that occurred following administration of Sanofi Pasteur's Menactra meningococcal vaccine among persons aged 17 to 18 years. Though no causal relationship has been established between the vaccine and GBS, the timing of the five cases is of concern. The FDA and CDC are asking persons with knowledge of any possible GBS cases occurring after Menactra administration to report them to the Department of Health & Human Services' Vaccine Adverse Event Reporting System on-line or by phone at 1-(800) 822-7967.