ADR that result in revision of patient information
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| Australia: Administer vinca alkaloids by intravenous infusion only |
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Therapeutic Goods Administration (TGA) announces that unintended intrathecal injection of vinca alkaloids can result in fatal outcomes. To prevent this, the Product Information (PI) for vincristine, vinblastine and vinorelbine products has been changed to ensure these medicines are always given intravenously and by no other route.
Warnings that these products are for intravenous administration only are being included in the 'Dose and method of administration' section (4.2) and 'Special warnings and precautions for use' section (4.4) of the PI for these medicines. Below is a summary of the information that is being incorporated:
- 'Syringes should not be used for administration of vinca alkaloids. Preparation must be by dilution in small volume intravenous bags (the "minibag" technique), rather than in a syringe, to protect against accidental administration via the spinal route. Vinca alkaloids should be prepared for intravenous use only. Fatal if given by any other route.'
Any mention of 'injecting' is being replaced by 'infusing' throughout the PI documents for all 3 medicines.
To 1 Feb 2022, there have been 3 cases of administration error of vinca alkaloids by the intrathecal route, including one death, reported to the TGA and included in its Database of Adverse Event Notifications.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/administer-vinca-alkaloids-intravenous-infusion-only
In Hong Kong, there are registered pharmaceutical products containing vincristine (4 products), vinblastine (2 products) and vinorelbine (7 products) which are injectables. All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reaction related to vincristine (90 cases), vinblastine (3 cases) and vinorelbine (3 cases), but these case were not related to medication errors in relation to unintended intrathecal injection. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 16 Jan 2021. Letters to inform local healthcare professionals were issued by the DH on 18 Jan 2021. The matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Feb 24, 2022
Issued at HKT 16:00
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