Latelines

April 1, 2002

Latelines for April 1, 2002

 

LATELINES

Air Force offers big bucks to R.Phs.

The United States Air Force is looking for a few good pharmacists—55 to be exact. And they're offering a record $30,000 signing bonus to get the pharmacy officers on board before Oct. 1 of this year. The officers will also be entitled to specialty pay while serving on active duty. The criteria for applicants include: U.S. citizenship; a degree from an accredited pharmacy school; a current state pharmacy license; and a commitment to 48 months of active duty. Interested R.Ph.s can apply through a local Air Force recruiter. Candidates accepted by the service will earn their commission through Commissioned Officer Training at Maxwell Air Force Base in Alabama. Air Force officials cite a shortage of pharmacists and the need to maintain parity with civilian pay scales as the reason for the lofty bonus.

DEA wants to reschedule narcotic

DEA is proposing to switch buprenorphine from Schedule V to Schedule III. At present, the derivative of thebaine, a major component of opium, is marketed as the injectable Buprenex (Reckitt Benckiser Pharmaceuticals) for pain management. However, DEA said that two other drugs containing buprenorphine are expected to gain approval this year. They are Subutex and Subozone, high-dose sublingual tablets for treating narcotic addiction. Comments regarding the DEA proposal are due by April 22.

Vioxx may be associated with meningitis

According to FDA, Vioxx (rofecoxib, Merck & Co.) has been associated with five cases of nonbacterial meningitis. A report published in the March 25 issue of Archives of Internal Medicine stated that the cases were among seven reported to the FDA between May 1999, when Vioxx first was approved for use in the United States, and February 2001. No deaths occurred, although all patients required hospitalization. Merck must now add meningitis to the list of potential adverse events included on the Vioxx package insert and product label.

OxyContin doctor gets jail

A Florida doctor convicted of manslaughter in the OxyContin overdose deaths of four patients was sentenced to nearly 63 years in prison. James Graves, 55, was the first U.S. doctor found guilty of manslaughter or murder in an OxyContin death. Prosecutors charged that Graves ran a pill mill catering to addicts and drug dealers. The defense plans to appeal.

Risperdal gets new indication

Risperidone (Risperdal, Janssen Pharmaceutica) has been approved by the FDA for delaying relapse in the long-term treatment of schizophrenia. The drug is currently indicated for the management of the manifestations of psychotic disorders; its efficacy had previously been established in short-term clinical trials. The agency based its approval of the new indication on study results published recently in the New England Journal of Medicine. The study investigators found that risperidone treatment of up to two years' duration reduced relapse risk by 48%, compared with treatment with haloperidol, the so-called gold standard for psychosis therapy. Risperidone is the first atypical neuroleptic to significantly reduce relapse risk. Side effects of risperidone therapy include drowsiness and extrapyramidal symptoms.

New pain med offers 24-hour relief

Meet Avinza (morphine sulfate extended-release) from Elan Corp. The capsules contain immediate- and sustained-release morphine beads, providing once-daily treatment of chronic moderate to severe pain. The drug has been licensed to Ligand Pharmaceuticals and will be launched this quarter.

Four associations offer guides for pharmacists

Several state pharmacy associations have released an assortment of educational resources to help pharmacists in their daily practice. South Dakota has issued a policy and procedures manual for retail pharmacy. Arizona has prepared a CE videotape (for two credits) on how to resolve med errors. Michigan has compiled a reference guide on ways OTCs can be abused. And Missouri has developed a three-ring binder on pharmacy error management. All the materials were crafted with funds from the National Council of State Pharmacy Association Executives/Merck State Pharmacy Association Grant Program.

Bush wants to drop HIPAA patient OK

The Bush administration proposed dropping the HIPAA requirement that patients give written consent before healthcare providers can use medical information for treatment or reimbursement. The proposed change was applauded by healthcare provider groups and attacked by proponents of patient privacy. Pharmacists had complained that the consent rule would create problems—if, for example, a caregiver came to pick up a patient's script. The proposal was to be published in the Federal Register with a 30-day comment period. A final rule will then be written and issued.

Diet drug on hot seat

Public Citizen has petitioned the FDA to pull Abbott Laboratories' Meridia (sibutramine) from the market. The consumer advocacy group said the diet drug has not only caused some deaths but also raises the blood pressure and heart rate of many patients. The company said that although 34 patients taking the weight-reducing drug have died, it believes the fatalities are related to their cardiovascular condition, not to the product itself.

PBM loses in AARP discount card suit

AdvancePCS is planning to appeal a judge's decision to limit AARP members' access to its prescription discount card called the AdvancePCS RxSavings Plan. The decision is a result of a suit AARP and UnitedHealth Group had filed against Advance. The suit charged the pharmacy benefit manager with diverting members from an AARP discount card plan formerly managed by Advance and now handled by UnitedHealth. As part of the ruling, Advance must stop using the same access code used under the AARP plan.

Will pediatric studies suffer from FDA rule change?

The FDA plans to suspend for two years a rule requiring drug manufacturers to evaluate the effect of their drugs on the pediatric population. The agency feels the rule might not be necessary since there is another law on the books that provides drugmakers with an additional six months of patent protection if they do drug testing in children. While PhRMA is pleased with this move, pediatric groups are concerned that this will discourage drug companies from engaging in pediatric studies.

McKesson and Quintiles create new company

McKesson Corp. and Quintiles Transnational Corp. have reached an agreement to form a private joint venture designed to leverage the healthcare information businesses of each company. The joint venture also combines three of the top names in the U.S. healthcare information market: McKesson's Kelly/Waldron unit, Scott-Levin, and Quintiles' SMG Marketing Group.

Cancer advocates seek Medicare oral drug coverage

The National Coalition for Cancer Survivorship (NCCS) recently joined other national advocates and cancer patients at a news conference in Washington, D.C., to urge the swift passage of the Access to Cancer Therapies Act of 2002 that extends Medicare coverage to include all oral cancer drugs. The legislation updates a 1993 change in Medicare policy that allows for coverage of oral anticancer agents when there is an intravenous equivalent. However, since that change, a number of breakthrough cancer drugs have come on the market that are in oral form only and are thus not reimbursed under Medicare.

ISMP's Cohen named award recipient

Michael Cohen, R.Ph., founder and president of the Institute for Safe Medication Practices and a renowned medication safety expert, was named the recipient of the 2002 Harvey A. K. Whitney Lecture Award, considered health-system pharmacy's highest honor. Widely recognized for his efforts to reduce medication errors and adverse events, Cohen is a pioneering supporter of the "systems approach" to reducing mishaps. He will receive the award on June 4 at ASHP's Summer Meeting in Baltimore.

 

Marina Marketos. Latelines. Drug Topics Apr. 1, 2002;146:9.