WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Close this folderGeneral information
View the documentAdvertising of medicinal drugs in the media - regulations
View the documentContainer and closure testing in lieu of sterility testing - draft guidance available
View the documentExtended release oral dosage forms - draft guidance available
View the documentHuman plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
View the documentIron-containing supplements and drugs - small entity compliance guidance available
View the documentMedication errors - the "look-alike/sound alike" problem: name confusion
View the documentMedication errors: esmolol - another fatal case
Open this folder and view contentsVeterinary medicine

Medication errors: esmolol - another fatal case

United States of America. The ISMP has received another report of a fatal error involving esmolol (BreviblocR) due to accidental direct injection of the contents of a 10 ml ampoule (2.5g) instead of a 10 ml (100 mg) vial for a loading dose. Although a company-affixed label stating "amp must be diluted" was present on the ampoule neck, it failed to prevent the error.

The nurse drew up the ampoule contents into the syringe then handed it to a doctor, assuming that he would further dilute it in an IV bag. Unfortunately, he injected the syringe contents directly into the patient, whose heart stopped immediately from the massive overdose.

The ISMP has received 30 reports of death or serious injuries related to the ampoule form of the drug, and has brought the problem to the attention of both the manufacturer and the Food and Drug Administration. The manufacturer is now working to repackage the drug to prevent the concentrate from being injected. In the meantime, the ISMP suggests that hospitals should evaluate how essential it is to continue providing the drug in ampoule form to patient care areas, including the operating room. Not supplying it may be the only way to ensure that more errors do not occur.

[See also Pharmaceuticals Newsletter No. 3, March 1996]

Reference: ISMP Medication Safety Alert!, 28 January 1998.

Self-medication - medicines now available without prescription

United Kingdom. The following medicines are now available without prescription:

• ketoconazole shampoo (Nizoral Dandruff Shampoo)

Indication: Treatment and prevention of dandruff and seborrhoeic dermatitis.

• clotrimazole with hydrocortisone cream (Canesten Hydrocortisone)

Indication: Athlete's foot and candidal intertrigo in adults and children aged 10 years and over.

• azelastine hydrochloride, non-aerosol aqueous form (Rhinolast Hayfever)

Indication: Treatment of seasonal allergic rhinitis in adults and children aged 12 years and over.

Reference: Current Problems in Pharmacovigilance Vol. 23, December 1997.


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