Cytisine will be available in the UK in January 2024
Consilient Health have announced that Cytisine will be available as a prescription only stop smoking medication from 22nd January 2024.
The NCSCT are preparing a briefing on cytisine which we will publish before the end of the year. We are also developing online and virtual training content to support practitioners to prescribe/recommend cytisine.
October 23rd 2023
We have received further clarification from GSK on the resupply of Zyban (bupropion hydrochloride 150 mg):
• As directed by regulatory authorities (including EMA and US FDA) GSK, along with other Pharmaceutical Industries, have been reviewing our products for the potential presence of nitrosamine impurities. As part of this programme, we conducted testing on Zyban tablets.
• In October, 2022 the EMA introduced a temporary Acceptable Intake (AI) limit of 178ng/day for marketed medicines containing one or more nitrosamines until formal AI were established. Zyban tablets were placed on hold at this time as a precautionary measure until the permanent limit was established.
• In July 2023, the EMA removed this temporary (AI) limit and a formal limit of 1500ng/day was published for N-nitroso buproprion. The MHRA is aligned with EMA’s position and the published limit for N-nitroso buproprion. As a result of the published limit we have resumed supply of Zyban across the EU and the UK.
• The risk/benefit of Zyban’s use for smoking cessation remains positive when taken in accordance with the prescribing information.
The NCSCT has completed the process of updating information on its website and e-learning programme.
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October 16th 2023
Bupropion (Zyban) is now back in stock and being supplied.
More details to follow. The NCSCT is in the process of updating information on its website and e-learning programme.
Adverse Event Profile Changes
Only one change has occurred since Zyban was out of stock. This was in Section 4.4 Special Warnings and Precautions where the following was added:
Brugada syndrome
Bupropion may unmask Brugada syndrome, a rare hereditary disease of the cardiac sodium channel with characteristic ECG changes (ST segment elevation and T wave abnormalities in the right precordial leads), which may lead to cardiac arrest and/or sudden death. Caution is advised in patients with Brugada syndrome or risk factors such as a family history of cardiac arrest or sudden death.
The full Zyban Summary of Product characteristics can be found here: https://www.ncsct.co.uk/publication_bupropion.php
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On 1st December 2022 GSK placed an immediate hold on the batch release and distribution into EU markets (including the UK and Switzerland) of Zyban (bupropion hydrochloride) 150 mg prolonged release tablets.
GSK has been reviewing its manufacturing processes for the potential presence of nitrosamine impurities. GSK conducted testing and the results indicate there is the potential for the presence of nnitroso-bupropion.
GSK has initiated a root cause investigation is determining the best course of action. At this point it's not possible to provide an indication of timings for the Root Cause Analysis completion as this is due to the complexity of the investigation. GSK will provide an update when available.
On this page is an advisory document summarising alternatives to bupropion and an FAQ document that might be helpful.
Champix out of stock
28th October 2021
Today the Department of Health and Social Care issued an updated Supply Disruption Alert confirming that there is no resupply date of varenicline from Pfizer and no alternative supplier. See first attachment below.
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14th October 2021
Pfizer, in agreement with the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA), have announced that all Champix (varenicline) batches that were found to contain levels of N-nitroso-varenicline above the acceptable level of intake set at both EMA and MHRA level are being recalled at pharmacy and wholesale level. See Champix recall statement from Pfizer dated 14th October below.
There is no news on when supplies might recommence but it is unlikely to be in the short term.
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25th June 2021
The second document below is a statement from Pfizer that identifies the presence of nitrosamines in some batches of Champix "above Pfizer’s acceptable level of daily intake (ADI)".
Some nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The statement goes on to say: "For those patients currently prescribed Champix we believe the benefits outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime."
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24th June 2021
The third document below is a supply disruption alert issued by MHRA and the NHS.
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23rd June 2021
We have updated the contact information for Pfizer from that contained in the announcement document of the 16th June.
Updated information: Further questions on switching medication and on supply of Champix can be addressed to Pfizer. The central number is 01304 616 161 and is manned between 9am to 5pm, calls to this number will be routed appropriately. Outside of these hours, enquiries can be submitted via an online form available at: www.pfizermedicalinformation.co.uk/en-gb/front
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16th June 2021
Pfizer have announced that with immediate effect, there are supply issues with Champix (varenicline). Click on the icon below for the full announcement.
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Best practice for delivering remote consultations
In response to the suspension of face-to-face stop smoking consultations, we have produced this basic guidance on providing support to smokers remotely. The guidance includes advice on delivering behavioural support via telephone and video conferencing, plus mailing of NRT to clients.
COVID-19: Face-to-face consultations and CO monitoring
UPDATE: 13th January 2021
The last guidance on face-to-face stop smoking consultations issued in November 2020 by the NCSCT on behalf of PHE was very clear that there is no national mandate to resume face-to-face consultations:
"Any decision by service providers to resume face-to-face provision should be considered alongside local coronavirus restrictions, as well as operational practicalities within the stop smoking service"
"Remote behavioural support remains a practical option for continuity of stop smoking provision, where services consider that this remains the best local option."
The guidance remains current.
Protecting smokers from COVID-19
In light of the rapid spread of COVID-19 the NCSCT is recommending that face-to-face stop smoking consultations cease immediately. This document gives further advice. We will revise this recommendation as guidance from PHE and NHSE is published.