The Medicines and Healthcare products Regulatory Agency (MHRA) recalled all batches of Pfizer’s varenicline medicine at a pharmacy and wholesale level “as a precautionary measure” in October 2021.
The recall was carried out due to the presence of higher than acceptable levels of a nitrosamine, N-nitroso-varenicline, than what is considered acceptable by the European Medicines Agency and the Committee for Medicinal Products for Human Use.
“Pfizer worked closely with the MHRA” on the recall, a spokesperson told C+D last week (September 16).
Almost a year later, the supply distribution alert for the product is still in place and Champix “remains unavailable”.
“We are unable to confirm a date [for] when varenicline supply can resume,” the spokesperson said.
However, they noted that “Pfizer is seeking to address this supply disruption”.
Lack of supply date “mystifying”
The continued unavailability of Champix left Stuart Gale, chief pharmacist at Oxford Online Pharmacy – part of a group that includes brick-and-mortar pharmacies – disappointed and “mystified as to why there has been so little news on what has happened to” the product .
At the time of the recall, Mr Gale thought it was “just a temporary production issue that was going to be fixed, the product would be retested and then resupplied to pharmacists”.
As Stoptober – the annual campaign encouraging patients to quit smoking permanently – looms, Mr Gale lamented that Pfizer had not been clear about “whether the manufacturing issue is fixed, or when supplies of the effective stop-smoking treatment will become available for patients”.
His pharmacy team had found Champix particularly effective at helping patients to stop smoking, he said.
An “opportunity” for pharmacy teams?
Ade Williams, lead pharmacist at Bedminster Pharmacy in Bristol, told C+D today (September 21) that while the continued supply disruption for Champix was “unfortunate”, the support pharmacy teams can offer patients wishing to stop smoking “in many ways goes beyond Champix”.
While Champix’s absence means pharmacy teams will be turning to other options of nicotine replacement therapy (NRT) and “reduction approaches like vaping”, it also offers them the opportunity to show that their strength lies in “knowing how to be there for our patients” and offering mental support.
Community pharmacy’s “unique offer” is that its teams “can stand with.” [patients] that help [them] to do this, because we know it’s not easy”, Mr Williams explained.
“This is just creating a wonderful opportunity for us to again remind the public of why community pharmacy is so important,” he stated.
Mr Williams confirmed that Bedminster Pharmacy would be running its own Stoptober campaign.
Meanwhile, Manor Pharmacy Group pharmacist and managing director Graham Phillips told C+D that while Stoptober was “a useful addition to our armamentarium”, it has “kind of got a bit lost in the weeds” as pharmacies prepare themselves to administer COVID-19 and flu jabs.
However, he said he still intends to launch the campaign in his pharmacies.
In Champix’s absence, Mr Phillips said other types of NRT products provide “good options” if “used effectively”.