其 他 安 全 警 示
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| Canada: Tacrolimus and the risk of graft rejection due to medication errors: inadvertent switching between different oral formulations (English only) |
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Health Canada announces that graft rejection and other adverse reactions have been reported as a consequence of medication errors where patients received the wrong formulation of oral tacrolimus.
Tacrolimus is an immunosuppressant drug given orally to prevent or treat organ transplant rejection. Tacrolimus has a narrow therapeutic index, and even minor differences in blood levels can cause graft rejection and other adverse reactions. Three distinct formulations with different dose requirements are authorized in Canada, which could increase the potential for inadvertent switching to the wrong product and lead to dosing errors.
Cases of graft rejection from under-exposure and other adverse reactions such as decreased renal function resulting from over-exposure to tacrolimus have been reported internationally as a consequence of confusion about the different formulations. Health Canada has received 9 reports of medication errors in Canada where distinct formulations of tacrolimus products were inadvertently switched. None of the Canadian reports resulted in graft rejection reactions. Two Canadian reports described renal effects.
If a prescriber intends to switch between formulations, careful medical supervision and therapeutic monitoring are required. Dose adjustments may be necessary to ensure that blood levels remain in the therapeutic range.
To reduce the potential for product confusion, Health Canada has worked with manufacturers of tacrolimus products to implement product naming and labelling strategies to highlight the product formulation.
In order to prevent inadvertent switching between tacrolimus formulations, healthcare professionals are advised to:
- Add prominent descriptors for the different formulations (e.g., ‘IMMEDIATE release’, ‘EXTENDED release’, or ‘PROLONGED release’) when identifying tacrolimus products, including on written orders, on the drug selection screens of prescribing and dispensing information systems, and in storage locations.
- Use brand/product names throughout the medication use process to confirm which specific formulation is intended for the patient.
- Consider an automated alert for computerized prescriber and pharmacy order entry that includes a warning that these formulations are not interchangeable, as well as a dosing frequency reminder.
- Fully explain the medication and the different formulations to patients and/or their caregivers, and encourage them to talk to their healthcare professional if they notice a change in their medication.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../70511a-eng.php
In Hong Kong, there are 22 registered pharmaceutical products containing tacrolimus which are oral preparations. All products are prescription-only medicines. So far, the Department of Health (DH) has received 25 cases of adverse drug reaction related to tacrolimus, but these cases are not related to inadvertent switching between formulations. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency and Singapore Health Sciences Authority, and was posted on the Drug Office website on 25 May 2012, 29 May 2013 and 25 Nov 2017. Letters to inform local healthcare professionals were issued by the DH on 25 May 2012. Acute rejection and toxicity caused by inadvertent switching between different oral formulations of tacrolimus is documented in reputable drug references such as Martindale: The Complete Drug Reference. DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Jul 23, 2019
Issued at HKT 16:00
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