NABP e-News: November 12, 2009

CDC Alerts Practitioners to Key Issues Concerning Treatment With Antivirals
The Centers for Disease Control and Prevention (CDC) reports that while use of influenza antiviral drugs has increased, not all people recommended for treatment are receiving it. CDC emphasizes that treatment with oseltamavir or zanamavir can be beneficial for the following groups of people, even if begun more than 48 hours after onset of symptoms:

  • Hospitalized patients with suspected or confirmed 2009 H1N1.
  • Outpatients, particularly those at risk for severe illness, or those who appear to be getting worse.
  • Some people without risk factors for severe illness.

CDC reminds practitioners that there are ample supplies of children’s oseltamavir capsules, which can be mixed with syrup at home. Also, pharmacists can compound adult oseltamavir capsules into a suspension for treatment of ill infants and children. Finally, CDC stresses that treatment with antivirals for 2009 H1N1 influenza should not be delayed while waiting for laboratory confirmation. Additional updated information can be found on CDC's Web site. 

FDA’s Safe Use Initiative Aims to Reduce Preventable Harm from Medication Use 
On November 4, 2009, US Food and Drug Administration (FDA) announced the launch of the Safe Use Initiative, a program designed to reduce the likelihood of preventable harm from medication use. The report, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines,” describes the program in detail. Through the program, FDA aims to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm, and to develop, implement, and evaluate cross-sector interventions to reduce harm. To further advance the Safe Use Initiative, FDA intends to hold a series of public meetings to gather feedback and will open a public docket to receive comments on the report and proposed candidate cases. FDA also released a new draft guidance document for industry, “Dosage Delivery Devices for OTC Liquid Drug Products,” for advanced viewing; the guidance is one example of a step that helps ensure safer medication use.

FDA Posts Consumer Questions and Answers Regarding Antiviral Medications  
FDA posted to the agency’s Web site pages with consumer questions and answers about Tamiflu and Relenza. The topics include appropriate use of the antiviral medications, dosing, use during pregnancy, and side effects. The information also emphasizes the use of vaccines in preventing influenza and provides links to additional information about 2009 H1N1 influenza.     

FDA Releases New Guidance for Compounding Multiple Prescriptions of Tamiflu Oral Suspension
To assist pharmacists in meeting demand during shortages of commercially manufactured Tamiflu oral suspension, FDA released “Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions,”  on October 31, 2009. This publication provides instructions for compounding the suspension in advance of receiving prescriptions when demand is high, a practice FDA considers acceptable if the amount compounded is commensurate with the number of valid prescriptions reasonably anticipated by the pharmacy within 24 hours. The update includes instructions for compounding Tamiflu oral suspension in advance, as well as for storing, dispensing, and counseling patients regarding the medication. Also, as explained in the “FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension,” pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug to avoid dosing errors.

FDA Authorizes Emergency Use of the Investigational Intravenous Antiviral Peramivir for 2009 H1N1 Influenza
On October 23, 2009, FDA announced that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients who are admitted to a hospital with confirmed or suspected 2009 H1N1 influenza infection. Peramivir may only be used for hospitalized adult and pediatric patients, based on one or more of the following reasons:

  • The patient is not responding to either oral or inhaled antiviral therapy.
  • When drug delivery by a route other than an IV route – eg, enteral (absorbed by the intestines) or inhaled – is not expected to be dependable or feasible.
  • For adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

The EUA was issued in response to a request from the CDC, and will expire when the declaration of emergency is terminated or the authorization is revoked by the agency. FDA emphasizes that peramivir is the only intravenously administered influenza treatment currently authorized for use under the EUA for 2009 H1N1 infections.

Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 375 as of November 5, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Butler Animal Health Supply, LLC, distributes prescription drug items and animal care supplies to veterinarians. The company received accreditation for facilities located in Alsip, IL and Des Moines, IA.
  • Indiana Blood Center, collects, processes, and distributes whole blood and derivatives, and received accreditation for its facility in Indianapolis, IN. The organization also stocks and distributes Rhogam to rural hospitals outside of Indianapolis.

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