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

This is a safety critical and straightforward National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) supported by Chief Pharmacists, Chief Nurse and Head of Procurement/Supplies or equivalent roles, as well as leaders in general practice and community pharmacy, in collaboration with Directors of Public Health/Commissioners and providers of drug treatment and prevention services and other relevant service.

National Patient Safety Alert Reference Number

NatPSA/2022/009/MHRA

PL Number

Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe, PL 12064/0125

MDR Number

MDR 219-10/22

Company name

Macarthys Laboratories (Trading as Martindale Pharma, an Ethypharm Group Company)

[Marketing authorisation holder: Aurum Pharmaceuticals Ltd]

Product description

Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe, PL 12064/0125

Active Pharmaceutical Ingredient: naloxone hydrochloride

Explanation of identified safety issue

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.

Although no reports of UK marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two (2) needles in all distributed batches (specified above) 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.

Prenoxad kits are packed with two (2) Terumo 23 gauge 1 inch needles, along with the pre-filled syringe containing the active ingredient (naloxone hydrochloride), and a Patient Information Leaflet.

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.

Healthcare professionals and service providers should note the actions required before supplying Prenoxad kits.We ask providers to contact individuals supplied with Prenoxad kits where possible and support checks to ensure kits contain two (2) needles in each kit. Support should be provided to individuals with kits who are unsure how to check their kits. See below and supplementary information.

Actions required

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 1 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 te
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