Latebreakers: December 11, 2006

Hospitals must comply with new Medicare/Medicaid standards

CMS has issued a final rule on four conditions hospitals must satisfy to participate in Medicare and Medicaid. Three of them are drug related. They involve authenticating verbal orders, securing medications, and completing postanesthesia evaluations. The new requirements call for verbal orders to be authenticated promptly by the prescriber or another practitioner responsible for the patient's care, Schedule II through V drugs to be kept locked within a secure area with access by authorized personnel only, and a postanesthesia evaluation to be documented within 48 hours after patient surgery. Published in the Nov. 27 Federal Register, the new rules go into effect on Jan. 26.

CMS stymied finding needy Part D beneficiaries

FDA safety warning for methadone

The unique pharmacological properties of methadone may be one reason for unintentional overdose of the drug, according to a new FDA alert. The agency has reviewed reports of death and life-threatening adverse events and has found they may also be due to drug interactions and methadone's cardiac toxicities, including QT prolongation and torsades de pointes. The FDA reminded healthcare professionals and patients that pain relief from methadone does not last as long as methadone stays in one's body, with an elimination half-life of eight to 59 hours and an analgesic action of four to eight hours. Initiation and titration to analgesic effect and dosage adjustments should be performed cautiously and in consideration of these properties. The FDA warned that, with chronic use, methadone may be retained in the liver and slowly released, prolonging the duration of action despite low plasma concentrations. Physicians are advised to avoid prescribing methadone 40-mg dispersible tablets, except for the detoxification and maintenance treatment of narcotic addiction. (For more information, see.)

Higher target hemoglobin levels put one at greater risk

If you're being treated with an erythropoiesis-stimulating agent, such as Procrit/Epogen (epoetin alfa, Amgen) or Aranesp (darbepoetin alfa, Amgen), to a target hemoglobin concentration of 13.5 gm/dl, you are at significantly increased risk for serious and life-threatening cardiovascular complications compared with those patients being targeted to levels of 11.3 gm/dl. This is according to findings from a new clinical study appearing in the Nov. 16 issue of the New England Journal of Medicine. The study, Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR), reported the primary endpoint as time to event analysis for a composite cardiovascular endpoint (death, myocardial infarction, hospitalization for congestive heart failure, or stroke). The study results emphasize the importance of not exceeding the target hemoglobin level of 12 gm/dl. The FDA suggests hemoglobin levels be measured twice a week for two to six weeks after any dosage adjustment to ensure that hemoglobin has stabilized. In addition, dosages should be decreased when hemoglobin levels increase by more than 1 gm/dl in any two-week period.

Expanded Herceptin use OK'd for postsurgical treatment