Latebreakers

August 22, 2005

DEA has issued a final rule regarding the reporting of theft of controlled substances (CSs). DEA said pharmacists should notify DEA in writing of any theft or significant loss of CSs within one business day of discovery of the incident.

DEA releases final rule on reporting narcotic thefts

DEA has issued a final rule regarding the reporting of theft of controlled substances (CSs). DEA said pharmacists should notify DEA in writing of any theft or significant loss of CSs within one business day of discovery of the incident. All, not just significant, in-transit losses of CSs must be reported. Pharmacists must also complete and submit DEA Form 106 when they suffer a loss. The rule also lists six determining factors to help pharmacists decide whether their loss is significant or not. The rule was published in the Aug. 12 Federal Register.

FDA strengthens acne drug safeguards

Feds loosen buprenorphine restrictions

A new federal law permits each physician in a group practice or hospital to prescribe buprenorphine (Suboxone, Reckitt Benckiser) for up to 30 patients. The previous limit was 30 patients for an entire group practice or hospital, regardless of the number of physicians. The drug, which blocks the intoxicating effects of opioids, can be prescribed only by physicians who have completed eight hours of training or have equivalent specialty training.

Employers endorse PBM transparency

The HR Policy Association coalition of 52 large employers, representing five million lives and $3.7 billion in annual drug spend, has endorsed an Rx purchasing model that requires PBMs to disclose and pass on acquisition costs and manufacturer rebates. Three major PBMs have signed on-Aetna Pharmacy Management, MedImpact Healthcare Systems, and Walgreens Health Initiatives. NCPA executive VP-CEO Bruce Roberts applauded the initiative to change the way PBMs operate.

Medicare Rx premiums lower than expected

Due to competition among would-be drug plan sponsors, the average monthly Medicare Part D premium will be $32.29, about $5 lower than previously estimated, according to CMS. The total cost to Uncle Sam will be about $15 less per month for each beneficiary as well. Scheduled to announce participating Rx plans on Sept. 14, CMS is still reviewing applications. One factor under scrutiny is whether plans ensure that beneficiaries can get their drugs at pharmacies close to their homes.

Guidelines focus on postoperative AF

The first evidence-based clinical guidelines for the prevention and management of postoperative atrial fibrillation (AF) after cardiac surgery have been released by the American College of Chest Physicians. Originally published in the August issue of CHEST, the guidelines offer specific recommendations on cardiac pacing, anticoagulation therapy, pharmaceutical prophylaxis, intraoperative interventions, and pharmacologic control of ventricular rate and rhythm. The guidelines recommend the use of beta-blockers over calcium-channel blockers, a standard therapy for chronic AF, for general prevention of postoperative AF and control of ventricular rate. They also include a caution about the routine use of magnesium and digitalis for the prevention of postoperative AF.

Levaquin OK'd for five-day treatment of acute bacterial sinusitis

Ortho-McNeil has received FDA approval for the use of Levaquin (levofloxacin) as a five-day, 750-mg once-daily regimen in the treatment of acute bacterial sinusitis. A clinical study determined that this shorter treatment regimen is as effective as the traditional regimen of 500 mg daily for 10 days. The company reports that this regimen is the first and only short-course fluoroquinolone regimen approved for this indication. This regimen is also approved to treat adults with community-acquired pneumonia caused by susceptible organisms.