64.2% of people who consume tobacco on a daily basis have considered quitting, and 41.9% have not only considered it, but have tried, according to the latest Survey on alcohol and other drugs in Spain of the Ministry of Health. Consequently, it is not surprising that when Todacitan was added to the catalog of drugs financed by the National Health System at the beginning of February, it disappeared from pharmacies in a matter of hours. Since then, the only drug for smoking cessation that has been financed has been on the list of products “with supply problems” of the Spanish Agency for Medicines and Health Products. Even when?
Todacitan, whose active ingredient is cytisine, has been marketed in Europe since 2013, but was not authorized in Spain until November 2018. While it was supplied as an unfunded medicine (at a price of almost 200 euros per treatment), there were no problems with supply, explains Antoni Torres, president of the employers’ association Federació d’Associacions de Pharmacies de Catalunya. As soon as it was financed, the price dropped to 116 euros, of which you only have to contribute the co-payment percentage that the law establishes according to income and socioeconomic situation, although the average will be around 41%.
“There are many customers who come asking about pharmacies,” says Torres. But there are no stocks.
They sold out immediately the moment the financing was announced, and the wholesalers made a first request, which was met and reached pharmacies in February: 19,951 containers, boxes of 100 tablets, equivalent to a complete treatment. The shelves emptied quickly again and the product has not been available again. Pharmacists suspect that the laboratory has not had enough production capacity at its plant in Poland to cope with the sudden and considerable increase in demand. “If you are producing 1,000 containers a day, you cannot suddenly increase production to 50,000”, illustrates a professional.
However, sources from the Polish pharmaceutical company Aflofarm, manufacturer of the drug, assure La Vanguardia that there is no problem with production capacity, or stock, or a lack of active ingredient or other ingredients. There is a batch of 29,000 units ready for sale in Spain but it is blocked due to a simple “labeling problem”, according to the company. “We are putting all our efforts into restoring the supply and as soon as this batch can be released, the demand from pharmacies will be answered.” Aflofarm estimates that very soon, in the middle of this month, the product may be removed from the Ministry of Health’s list of “medicines with supply problems” in a situation of “temporary shortages” in which it has been listed since February 21, if the date expected resolution of the incident.
Although it may seem strange, the labeling problem argument is plausible. Not long ago there was a shortage of a certain presentation of an antibiotic because the producer did not have adequate paper weight to print the leaflet and that would fit in the package. The packaging and the leaflets are regulated in detail, and although the laboratories can request changes, the process can take several months, explains Torres.
A woman smoker from Madrid explains that her family doctor prescribed Todacitan on February 13 but she has not been able to find it. “The prescription expires in ten days and the pharmacy has already told me that I will have to go to the family doctor to have it done again,” she says. To carry out the prescription of this pharmacological treatment for smoking cessation, Health requires that the patient be included in an individual or group support program and have “an express motivation to quit smoking”, that is, that they have tried at least once. time in the last year.
The great advantage of this therapy, which mimics the mechanisms that nicotine awakens in the brain, is that it lasts 25 days and has a higher success rate than other similar pharmacological therapies. Up to 60% outgrow smoking during the duration of treatment, although the percentage of users who still do not quit smoking after one year is much lower.