Medicines Healthcare Products Regulatory Agency
National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)
On 30 August, we issued a National Patient Safety Alert to support organisations to update their policies and procedures on procurement, provision, prescribing, servicing and maintenance of these devices in line with the MHRAs updated guidance on the management and safe use of bed rails. This follows reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, (also known as bed safety rails), trolleys, bariatric beds, lateral turning devices and bed grab handles (also known as bed levers or bed sticks).
Letters
In August 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In August 2023, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial), EL (23)A/28. Issued 21 August 2023. Further to EL(23)/A26 medac GmbH (t/a medac Pharma LLP) has informed the MHRA that further batches that are impacted have been identified. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in the notification due to particles detected during long-term stability tests. Healthcare professionals are advised to stop supplying the batched referred to in the recall. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets, EL (23)A/29. Issued 22 August 2023. Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches referred to in the notification. The PIL does not include the most up-to-date safety information regarding the signs and symptoms of liver issues and the need to seek medical advice if they occur. There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL, which can be downloaded from the Accord website.
Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30. Issued 23 August 2023. Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches referred to in the notification. The PIL does not include the most up-to-date safety information regarding the contraindication for Gilberts syndrome. There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL, which can be downloaded from the Accord website.
Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml), EL (23)A/31. Issued 29 August 2023. Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine. The details of the key packaging differences for Ireland versus the UK product have been risk-assessed as having minimal safety implications for the patient. Healthcare professionals are advised to exercise caution when dispensing the affected batch of Loceryl 5% w/v Medicated Nail Lacquer. Where possible, please provide the current UK-approved copy of the PIL to the patient and remind them to read the leaflet in its entirety before using the medicine.