Latebreakers: April 17, 2006

HHS to states: Protect community pharmacies under Medicaid

Perhaps heeding the dire warnings that pharmacies will be driven out of Medicaid by a new drug pricing formula, HHS issued a Roadmap to Medicaid Reform that reminds states that they can pay higher dispensing fees to independent pharmacies, pharmacies serving a large number of low-income beneficiaries, or pharmacies in rural areas to ensure access. The roadmap also said states could pay more to R.Ph.s who improve quality and reduce drug costs through disease management.

N.J. R.Ph.s protest Part D pay

Alert for rectal med

The FDA has issued an alert for health professionals and patients regarding complaints of small cracks found at the base of the plastic tip applicator of the 10- and 20-mg Diastat AcuDial (diazepam rectal gel) prefilled syringes. Manufacturer Valeant Pharmaceuticals warned that the cracks could lead to leakage of the medication and possibly a subtherapeutic dose of diazepam. The gel is indicated for use in selected refractory epileptics who take antiseizure medications but require occasional use of diazepam to control bouts of seizure activity. Pharmacists are advised to notify patients using the gel to inspect their applicators for cracks and return any affected product to the pharmacy for replacement. Pharmacists should also inspect their stock and contact Rx Hope at (1)-800 511-2120 for replacements. Valeant claims it is working to correct the problem. However, new syringes will not be available until June or July. For now, according to the FDA alert, the available prefilled syringes may be dispensed as long as the applicator is without cracks. To view an example of a cracked applicator tip, pharmacists can visit http://www.diastat.com/.

Antirejection drug approved

Astellas Pharma has received authorization to market Prograf (tacrolimus) for the prevention of graft rejection in recipients of heart transplants. Both the injection and capsule form of the drug were previously approved to prevent the rejection of grafts in liver and kidney transplants. In two separate trials, tacrolimus showed similar survival of patients and grafts at 12 and 18 months after heart transplant compared with cyclosporine. According to the FDA, this marks the first product approval in the United States for heart transplantation in eight years.

Supplemental approval granted for zanamivir

In addition to oseltamivir (Tamiflu, Roche), there is now another option for the prevention of influenza A and B in adults and children. The FDA has given GlaxoSmithKline the go-ahead to market zanamivir inhaler (Relenza Diskhaler) for this new indication. The antiviral was previously approved for the treatment of both viruses. Prior to the approval, zanamivir was tested in four clinical trials; two studies were performed in household settings and two in community outbreaks. The results showed that the risk for acquiring influenza was reduced approximately sixfold in the patients taking zanamivir versus those taking placebo. The FDA stated that use of the inhaler is not a substitute for flu vaccine, and the manufacturer warned that the inhaler is not recommended for the treatment and prophylaxis of seasonal influenza in people with underlying airway disease such as asthma.

New dosing option for Aranesp