All strengths of the smoking cessation medicine are being recalled by the Medicines Health and Healthcare products Regulatory Agency, and there is “no date for resupply of Champix (varenicline) or availability of varenicline products until further notice”, the DH said in a supply disruption alert last week (October 28).

A DH spokesperson told C+D in June that Pfizer – the sole supplier of the Champix (varenicline) range – was “out of stock of both strengths due to further quality testing required following the detection of nitrosamine impurities”. There are no alternative suppliers of varenicline tablets.

Last month (October 14), the MHRA recalled all strengths of the medicine due to the presence of higher than acceptable levels of N-nitroso-varenicline.

Advice for healthcare professionals

Patients who want to quit smoking should not currently be initiated on Champix. However, providers of smoking cessation services can suggest alternatives such as nicotine replacement therapy or bupropion 150mg prolonged release tablets, the DH suggested.

Meanwhile, prescribers – including those offering varenicline under a patient group direction (PGD) – should review patients who are currently on Champix and “determine the length of treatment remaining”, it said.

Where patients have enough supplies of Champix, they should continue to take it “until a consultation with their prescriber has taken place”, the DH advised.

Clinicians should also assess whether the patient can be switched to an alternative product.

A smoking cessation advanced service will be commissioned for pharmacies England from January 2022.

This service will enable “NHS trusts refer patients discharged from hospital to a community pharmacy of their choice to continue their smoking cessation care pathway, including providing medication and behavioural support as required”.

During similar pilot services, pharmacists could supply varenicline to patients under a PGD. The service specification for the nationally commissioned programme is still being finalised by the DH, the Pharmaceutical Services Negotiating Committee and NHS England and NHS Improvement.