The Medicines and Healthcare products Regulatory Agency (MHRA) recently issued a caution relating to a drug that treats adult patients with active rheumatoid arthritis or active psoriatic arthritis.
Global pharmaceutical company Sanofi informed the medical agency of the error on the Braille on the packaging of some batches of the Arava 10mg film-coated tablets. The affected batches were distributed in May 2016, August 2016, September 2016 and October 2016 with batch numbers 5JK2A, 5JK3A, 5JK6G and 6EV2A accordingly.
Nature of the medical alert
On the affected batches, the strength of the product is incorrect: reading ’20mg’ instead of ’10mg’ in Braille. The printed text on all packaging is correct. Of course, this should only affect the visually impaired relying on Braille for the strength of the tablets. There is a danger, and affected packs shouldn’t be distributed or dispensed to patients who rely solely or heavily on Braille to determine the strength of the tablets.
What should distributors/healthcare professionals do?
There is an alternative batch available for patients who rely solely on Braille; batch number 6GL5E. Distributors of Arava are encouraged to contact Sanofi Customer Services on 0800 854 430 if their wholesaler doesn’t have this batch in stock. It’s important that distributors have this alternative batch as there’ll be patients who rely on Braille exclusively.
The drug alert has recently been issued by the medical agency to all healthcare professionals. NHS regional teams who are in receipt of the letter should forward the alert to relevant clinics, dispensing GPs and community pharmacists.
Classes of drug recalls/medical alerts
The drug alert has been classified as a class 4 caution. A class 4 advises caution in use, indicating that the product doesn’t pose a threat to patient safety. As a general rule, medical alerts are graded according to the seriousness of the threat to the public’s health. They’re graded from class 1 to class 4.
Drug recalls are based on a tiered structure:
- Class 1: requires immediate recall because the product poses a serious or life-threatening risk to health.
- Class 2: specifies a recall within 48 hours because the defect could harm the patient but isn’t life threatening.
- Class 3: requires action to be taken within five days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety.
- Class 4: advises caution to be exercised when using the product but indicates the product poses no threat to patient safety.
As the Arava medical alert falls into class 4, the medical agency believes there are no threats to life and limb and thus will only apply a caution. However, the risk may be under-emphasised as patients who rely solely on Braille may be undertaking the medication due to the incorrect labelling.
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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