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Previous Volume 361:1913-1914 November 5, 2009 Number 19 Next

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To the Editor: On September 23, Parker et al.¹ described a case in which Tamiflu (oseltamivir) for oral suspension was dispensed with pharmacy instructions to administer the drug in volume units (teaspoons), whereas the manufacturer's dosing syringe accompanying the product is calibrated in milligrams. Interest in the use of oseltamivir for young children has risen since the emergence of 2009 pandemic influenza A (H1N1) virus. We recognize that dosing instructions with units different from those given on the device included with the product create risks of confusion and dosing errors.

Together, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have acted promptly to provide information that emphasizes appropriate dosing and dispensing of Tamiflu for oral suspension. Communications regarding potential dosing errors were posted on the CDC and FDA Web sites, and Roche has published a "Dear Healthcare Professional" letter.² All communications recommend that, when dispensing commercially manufactured Tamiflu for oral suspension, pharmacists should ensure that the units of measure on the dosing instructions match those on the device provided. If the dosing instructions specify volumetric measures (teaspoons or milliliters), the manufacturer's syringe should be removed and replaced with an appropriate device with matching units. When dispensing this suspension for children younger than 1 year of age, according to the Emergency Use Authorization, the syringe in the package should always be replaced with an appropriate measuring device, because doses for children younger than 1 year of age cannot be measured with the manufacturer's syringe.³

On September 22, the CDC posted updated antiviral recommendations and a communication specifically for pharmacists.³ The CDC disseminated this information through the Health Alert Network Information Service and other systems. The CDC also contacted pharmacists' professional organizations, associations representing drug store chains, and other retailers with pharmacies in stores to further disseminate this information widely.

On September 24, the FDA posted a Public Health Alert: "Potential Medication Errors with Tamiflu for Oral Suspension."⁴ It reminds prescribers and pharmacists of potential errors in prescribing and dispensing Tamiflu for oral suspension in units different from those on the device in the package and recommends that providers avoid prescribing Tamiflu in teaspoons because this can lead to inaccurate dosing. The FDA also partnered with MedWatch subscribers and used social networking tools for rapid communication.

Medication-safety efforts in ambulatory settings must recognize the central role of patients and lay caregivers in medication management.⁵ Instructions and labeling should be clear, concise, consistent, and designed for the way prescriptions are written and used. As highlighted by Parker et al., dispensing liquid medications with dosing devices with markings that match the units used in the instructions on the pharmacy label is one necessary step toward safer medication use.

Daniel S. Budnitz, M.D., M.P.H.
Centers for Disease Control and Prevention
Atlanta, GA
dbudnitz{at}cdc.gov

Linda L. Lewis, M.D.
Food and Drug Administration
Rockville, MD

Nadine Shehab, Pharm.D., M.P.H.
Centers for Disease Control and Prevention
Atlanta, GA

Debra Birnkrant, M.D.
Food and Drug Administration
Rockville, MD

This letter (10.1056/NEJMc0909190) was published on September 30, 2009, at NEJM.org.

References

1. Parker RM, Wolf MS, Jacobson KL, Wood AJJ. Risk of confusion in dosing Tamiflu oral suspension in children. N Engl J Med 2009;361:1912-1913. [Free Full Text]
2. Barron H. Dear Healthcare Professional letter: important prescribing information. Roche, September 23, 2009. (Accessed October 15, 2009, at http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM183752.pdf.)
3. 2009-2010 Influenza season: information for pharmacists. Atlanta: Centers for Disease Control and Prevention, 2009. (Accessed October 15, 2009, at http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm.)
4. FDA Public Health Alert. Potential medication errors with Tamiflu for oral suspension. Silver Spring, MD: Food and Drug Administration, 2009. (Accessed October 15, 2009, at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm183649.htm.)
5. Budnitz DS, Layde PM. Outpatient drug safety: new steps in an old direction. Pharmacoepidemiol Drug Saf 2007;16:160-165. [CrossRef][Web of Science][Medline]

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