Supply Disruption Alert: Phenelzine Sulphate 15mg tablets (Nardil®) – Updated

Supply Disruption Alert: Phenelzine Sulphate 15mg tablets (Nardil®) – Updated

July 3, 2020

On the 3rd July 2020 the Department of Health and Social Care (DHSC) confirmed the alert has been updated to reflect that ‘there is currently no confirmed resupply date’. 


Issue date: 25th June 2020
Alert reference: SDA/2020/011

The Department of Health and Social Care (DHSC) and NHS England and Improvement (NHSE&I) have issued a supply disruption alert for Phenelzine Sulphate 15mg tablets (Nardil®)

Kyowa Kirin are the sole supplier of phenelzine 15mg (Nardil®) tablets in the UK. They have experienced ongoing manufacturing issues since August 2019. The resupply date was initially outlined as October 2019, which was delayed to March 2020 and now has been advised to be the end of 2021, at the earliest.

Previously, imported supplies of unlicensed phenelzine 15mg tablets were supporting the UK market, however, due to supply issues in other markets globally, these supplies have become limited. Supplies of unlicensed phenelzine 15mg capsule specials have become available. See supporting information below.

Phenelzine is an irreversible monoamine oxidase inhibitor (MAOI) licensed for the treatment of depression, clinically characterised as ‘atypical’, ‘non endogenous’, ‘neurotic’ or which has not responded to treatment with other antidepressants.

Supporting Information

Unlicensed Imports
The following specialist importers may be able to source unlicensed phenelzine 15mg tablets (please note, there may be other companies that can also source supplies):

Importer Contact details 
Chemys Limited Tel: 02085008497
Email: orders@chemys.co.uk
Clinigen Group PLC Tel: 01932 824100
Email: ukcustomerservice@clinigengroup.com
Durbin PLC Tel: 0208 869 6555
Email: Imports@durbin.co.uk
Rokshaw Pharmaceuticals Tel: 0191 510 6500
Email: orders@rokshaw.co.uk
Sigma  Tel: 0800 597 4475
Email: specials@sigmaplc.com
UL Global Pharma Tel: 01923 204 333
Email: orders@ul-globalpharma.com

Specials
The following companies are able to supply unlicensed phenelzine 15mg capsule specials (please note, there may be other companies that can supply):

Importer Contact details 
Ascot Laboratories Tel: 01923 711 971
Email: specials@ascotpharma.com
Clinigen Group PLC Tel: 01932 824100
Email: ukcustomerservice@clinigengroup.com
Mawdsleys Tel: 0161 742 3482
Email: unlicensed@mawdsleys.co.uk
Rokshaw Pharmaceuticals Tel: 0191 510 6500
Email: orders@rokshaw.co.uk
Target Healthcare Tel: 0845 618 0036
Email: info@target-healthcare.co.uk
Sigma  Tel: 0800 597 4475
Email: specials@sigmaplc.com

Action

As supplies of licensed phenelzine 15mg tablets (Nardil®) will be unavailable for the foreseeable future, all relevant healthcare professionals in primary, secondary or specialist healthcare services should work to ensure the following actions are undertaken where applicable:

  • no new patients should be initiated on phenelzine;
  • all patients currently prescribed phenelzine should be reviewed by specialist mental health services to determine if this is still the most appropriate treatment and whether gradual withdrawal in order to stop and switch to an alternative agent is a potential management option; and
  • where unlicensed imports of phenelzine 15mg tablets are unavailable, clinicians should consider prescribing specials of phenelzine 15mg capsules to avoid abrupt withdrawal.

View full alert here

Guidance for prescribers: When prescribing a product that is not licensed in the UK due to a supply issue with the licensed alternative, prescribers must indicate on the FP10 prescription that an unlicensed product is required. This can be done by annotating the prescription with the following wording: “special order”. Further guidance can be found here.

Guidance for pharmacy teams: Where prescribing of an unlicensed product is considered appropriate by the prescriber, a prescription must be issued with the wording ‘Special Order’ next to the prescribed product to ensure that a pharmacy can dispense and be correctly reimbursed for a non-Part VIIIB special.

Prescriptions for unlicensed imported products/specials not listed in Part VIIIB of the Drug Tariff must be endorsed with the following information:

  • Amount dispensed over pack size used;
  • Invoice price per pack size from which the order was supplied less any discount or rebate;
  • Manufacturers’/importers’ MHRA licence number;
  • Batch number of the product supplied;
  • SP

Enquiries

Send enquiries about this notice to the DHSC Supply Resilience Team, quoting reference number SDA/2020/011 Email: supplyresiliencemd@dhsc.gov.uk

View full alert here



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