10/9/2003

FDA Warns of Dispensing Errors with Keppra, Roxanol

Donna Young

The Food and Drug Administration (FDA) warned pharmacists and other health care providers yesterday on its MedWatch Web site about the risk of dispensing errors involving two drugs with look-alike and sound-alike names.

In a second MedWatch alert, the agency warned about ordering and dispensing errors concerning a morphine oral solution in which the unit milligram (mg) is often mistakenly switched to milliliter (mL) in orders of the product.

In a "Dear Healthcare Professional" (PDF) letter, UCB Pharma advised about the risk of dispensing errors between the company's antiepileptic medication levetiracetam, marketed under the brand name Keppra, and Abbott Laboratories's antiretroviral lopinavir–ritonair, or Kaletra.

Patients erroneously receiving either medication could have an adverse event, the company alerted in its letter.

A patient with epilepsy who does not receive the correctly prescribed antiepileptic drug because of a dispensing error could "experience serious consequences" including status epilepticus—recurrent or continuous seizures, UCB Pharma warned.

The company appealed to prescribers to "take great care when writing a prescription for Keppra" by making sure that the name of the drug could be easily read by pharmacists and pharmacy technicians.

Poor handwriting by prescribers adds to confusion for pharmacists dispensing medications with look-alike and sound-alike names, according to the Institute for Safe Medication Practices.

Florida enacted a law in July that requires prescribers to legibly write prescriptions. Washington passed a similar law in 2000.

FDA's Drug Safety and Risk Management Advisory Committee, which includes ASHP Executive Vice President Henri R. Manasse Jr. as a member, is meeting in December to discuss problems about drugs with look-alike and sound-alike names.

UCB Pharma advised prescribers to tell patients to carefully check all medications they receive and immediately contact their pharmacist about any problems, questions, or concerns about a drug.

Keppra 250-mg tablets are blue, 500-mg tablets are yellow, and 750-mg tablets are orange, the company said in its letter.

Keppra oral solution is a clear, colorless, grape-flavored liquid supplied in 16-oz bottles containing 500 mg of levetiracetam per 5 mL.

Abbott's Kaletra is available in orange gelatin capsules or oral solution that is a yellow–orange colored liquid supplied in amber 160-mL glass bottles.

Elan Pharmaceuticals issued a "Dear Healthcare Professional" letter on October 6 reporting serious adverse events and deaths resulting from accidental overdose of high-concentration morphine sulfate oral solutions.

In most of the cases reported, the company said, morphine oral solutions ordered in milligrams were mistakenly interchanged for milliliters of the product, resulting in a 20-fold overdose.

Elan distributes three concentrated morphine sulfate oral solutions:

  • Roxanol 20 mg/mL available in 30-mL and 120-mL bottles with a calibrated dropper,           
  • Roxanol-T 20 mg/mL available in 30-mL and 120-mL bottles with a calibrated dropper,           
  • Roxanol 100 20 mg/mL available in a 240-mL bottle with a calibrated patient spoon.

Prescribers should clearly write the concentration of morphine sulfate oral solution to be dispensed and the intended dose of morphine in milligrams with the corresponding volume in milliliters on the prescription, the company advised.

Pharmacists should contact the prescriber if the specified morphine sulfate oral solution is unavailable.


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