National Patient Safety Alert: Class 4 medicines defect information: Prenoxad 1mg/ml solution for injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA (10 November 2022)

Summary

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA that a limited number of Prenoxad kits (also called packs) in a batch marketed in France have missing needles. Naloxone is a drug that reverses the effects of an opioid overdose. If no needles are present in the kit, there is a risk that patients, members of the public and/or healthcare professionals may not be able to administer life-saving doses of naloxone from these kits in an emergency. This may impede the treatment for a patient with an opioid overdose, which may result in delay to intervention and possible death.

Although no reports of UK marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two needles in all distributed batches cannot be excluded based on the investigation by the company. However, due to the critical need for this product, the specified batches are not being recalled.

This alert is for action by: primary and secondary care, specifically those involved in outreach services.

Actions

Advice for all healthcare professionals and service providers, including community pharmacies, emergency services, and prisons. Enact an action plan to implement actions in the MHRA Class 4 Medicines Defect Information: Caution in Use by 17 November 2022. This includes:

• Check all Prenoxad kits in place at your organisation against the batches specified in this alert.
• Visually inspect the front of the kit (with the Lot number and 2D matrix facing you) against a light source to confirm two (2) needle packets are present in the kit (see images in the MHRA Class 4 Medicines Defect Information).
• If needles cannot be clearly seen by the visual inspection of the kit(s), the kit(s) can be physically opened to confirm the presence of two (2) needles inside the kit(s) (see images in the MHRA Class 4 Medicines Defect Information). The kit(s) can be closed after visual inspection. As the tamper evident seal (TES) will be broken as part of the physical inspection process, it is recommended that kit(s) are only opened at the point of dispensing or supplying to a patient/member of the public, so that they are aware of the reason for breaking the seal. Note that the clear plastic cap at the end of the pre-filled syringe must remain intact in order to maintain sterility of the medicinal product (see images in the MHRA Class 4 Medicines Defect Information).
• Where there are kit(s) in your stock without two (2) needles, quarantine these immediately and contact Ethypharm to arrange for replacement kit(s). Similarly, where there are concerns around visual or physical inspection of the kit(s), contact Ethypharm for further advice or to arrange replacement kit(s).
• Report any defective kits via the MHRA Yellow Card scheme, including if kits were without two (2) needles in the kit. Include the batch number in this report.
• If urgent use of Prenoxad is required in an emergency and needles are missing from the kit, Terumo 23 gauge 1¼ inch needles or reasonable alternative needles should be used for intramuscular administration.
• If patients or members of the public report a Prenoxad kit without two (2) needles in the kit, arrange for a replacement and visually check for the presence of two (2) needles before supplying this.
• Where healthcare professionals, service providers and local teams (including those involved in needle and syringe programmes) are able to make contact with patients and members of the public who have been supplied with Prenoxad, they should inform them to check their kits to ensure they contain two (2) needles in each pack. Support should be provided to individuals with kits who are unsure how to check their kits. The action to contact all holders of kits will depend on the local procedures for record keeping, but efforts should be made to inform all likely holders of Prenoxad. Please see Supplementary Information for the individuals, patients and/or members of the public provided in the link below.
• If patients, individuals or members of the public report a Prenoxad kit without two (2) needles in the kit, arrange for a replacement and visually check for the presence of two needles before supplying the new Prenoxad kit, as per the instructions in the appendices.
• Please see the Summary of Product Characteristics for additional information on the use and safety of this product.