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U.S. Department of Health and Human Services

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Roxanol (morphine sulfate) Dear Healthcare Professional Letter Jun 2003

The following is the text of a letter from Elan Pharmaceuticals. Contact the company for a copy of any referenced enclosures.



Elan Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego , CA 92121
T (858) 457 2553 F (858) 457 2555

June 13, 2003

Dear Healthcare Professional:

Serious adverse events and deaths have resulted from accidental overdose of high concentration morphine sulfate oral solutions. In most of these cases, morphine oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product, resulting in 20-fold overdoses. For example, a prescribed dose of 5 mg was mistakenly administered as 5 mL (100 mg) of the morphine sulfate concentrated solution.

Elan Biopharmaceuticals currently distributes three concentrated morphine sulfate oral solutions:

  • RoxanolT CII (morphine sulfate) Concentrated Oral Solution (20 mg/mL); available in 30 mL and 120 mL bottles with calibrated dropper
  • Roxanol-TT CII (morphine sulfate) Concentrated Oral Solution (20 mg/mL) -Tinted, Flavored; available in 30 mL and 120 mL bottles with calibrated dropper
  • Roxanol 100T CII (morphine sulfate) Concentrated Oral Solution (20 mg/mL); available in a 240 mL bottle with calibrated patient spoon

Prescribers and dispensers should be aware that these and other concentrations of morphine sulfate are available from various manufacturers with the concentration expressed in mg/tablespoon (5 mL).

To assure that your patient receives the proper dose of morphine sulfate oral solution, please write a prescription for morphine sulfate oral solution clearly by including the following:

(1) the concentration of morphine sulfate oral solution to be dispensed AND (2) the intended dose of morphine in milligrams (mg) with the corresponding volume in milliliters (mL or cc) written out in the directions.

To demonstrate, a dose of 15 mg of morphine oral solution should be written as:

Roxanal 20 mg/mL

Sig: 15 mg (0.75 mL or cc) q 4 hours prn.

Dispense: 30 mL

 

Roxanal 20 mg/mL

Sig: 15 mg (0.75 mL or cc) q 4 hours prn.

Dispense: 120 mL

 

Roxanol 100 - (20 mg/mL)

Sig: 15 mg (0.75 mL or cc) q 4 hours prn.

Dispense: 240 mL

 

It is important that the prescription is filled with the proper concentration of morphine sulfate oral solution to prevent potential medication errors. If the specified morphine sulfate oral solution is unavailable, please contact the prescriber.

We hope you find this letter helpful in clarifying the importance of proper ordering and dispensing of morphine sulfate oral solution in order to prevent medication errors. If you have any further questions or would like additional Information, please contact our Medical Information Services Department at 1-888-638-7605.

Sincerely,

Chris O'Brien, MD
Vice President, Medical Affairs