The list of vital drugs decided to be “castrated”

The list of vital and essential drugs (VED), perhaps for the first time in its history, was decided to undergo a serious “castration”. It has already been officially announced that more than 200 positions of various forms of medicines will be excluded from it. The full list of proposed changes is published on the website of the Department for Regulation of Circulation of Medicines and Medical Devices of the Ministry of Health.

Antibiotics, antifungals, drugs for the treatment of gastrointestinal disorders, gastroreflux disease, blood diseases, antitumor drugs, etc. are on the list for “deductions”. The main reason is that the listed dosage forms have not been in circulation for a long time. Some of them have not been on the market since 2019. For example, betahistine capsules, furosemide injection or retinol pills.

Recall that Vital and Essential Drugs includes drugs that must be in any pharmacy and any hospital in the country. In addition, the state regulates prices for all positions presented in the Vital and Essential Drug List. However, until now, no law imposes an obligation on manufacturers to produce the drugs listed in the list in our country, and even more so to supply them to us from abroad. And if on some day someone decides to curtail their production or cancel the supply, there is no responsibility for this.

But, what is most amusing, there is responsibility for their absence in the retail pharmacy trade. To such an extent that if an audit reveals that a pharmacy does not have a medicine that has not been produced for a hundred years, but is still on the list, it will start with a large fine, and then the deprivation of the license.

And there are such examples. For example, for several months in the Russian Federation there has been no drug at all, known to the people as biseptol (more precisely, all drugs with the active substance co-trimoxazole or sulfamethoxazole + trimethoprim). Once upon a time, Polish Biseptol was a very popular antibiotic that doctors liked to prescribe for stomach infections, cystitis, prostatitis, and salmonellosis. However, it hasn’t been delivered to us from abroad for a long time (what’s really there, foreign manufacturers that produce it in tablets are not registered with us at all), and all Russian analogues in the form of tablets have also stopped being produced – today they are not available on any stock. This does not prevent the drug from being included in the minimum medicinal assortment so far. However, Roszdravnadzor, as part of preventive visits and unscheduled inspections, issues a warning to pharmacies due to the lack of this drug.

The same story was with ranitidine, for the lack of which the sale was mercilessly fined for almost two years. Its removal from the list was approved in 2021, but only recently the decision was approved by the government: the country canceled the registration of all medicines containing ranitidine. A remarkable story came out with him: in September 2019, potentially dangerous impurities of N-nitrosodimethylamine were found in the pharmaceutical substances of ranitidine produced by a number of Indian companies, so the drug was suspended on the market in Europe and Russia, and domestic companies withdrew more than two hundred series of drugs from the market. But! Removal of ranitidine from the minimum list of pharmacies occurred only after almost two years since the termination of its production. During this time, a bunch of pharmacies managed to be fined for not having the drug on sale. According to the director of the SRO Association of Independent Pharmacies, head of the Alliance of Pharmaceutical Associations Victoria Presnyakova, the story of ranitidine, which became the most penalized drug in 2021, is now repeating itself: “Following the letter of the law, formally, there were violations of mandatory licensing requirements in the actions of the pharmacy. But the actual circumstances indicate the absence of another element of the offense – guilt, since if the suppliers of the necessary medicines do not have the pharmacy, it is not possible to independently produce or otherwise import and ensure the availability of medicines in civil circulation in the Russian Federation. Taking into account the current realities, any position from the minimum assortment can fall into a local or persistent defect.”

But the realities, alas, are such that many drugs, the availability of which should be provided both in pharmacies and in hospitals, have long since left our market for one reason or another, and since February the outflow has only intensified. Officially, since February 2022, only two imported drugs have left our market: Cialis (a drug for the treatment of erectile dysfunction, not exactly vital, besides having many analogues) and botulinum toxins (few people know that these are not only “beauty injections” , but also a drug for the treatment of many neurological disorders, as well as hyperhidrosis).

But de facto, we are already missing a lot of things. During the day with fire, you can’t find nicotinol xanthate (a drug to improve the functioning of small vessels). Almost nowhere is there alprostadil – a remedy not only for the treatment of potency, but also for its diagnosis, and there is neither the original drug nor analogues. And doctors say that there is nothing to replace it. In addition, there are serious problems with antidepressants (the demand for them is growing at an avalanche pace), some drugs for pressure, antibiotics.

And although there are a lot of junk among the candidates for “expulsion”, there are also new, sought-after drugs – for example, clotting factors used in the treatment of hemophilia. Perhaps they will find a replacement. In the meantime, there remains a banal, but universal advice: do not get sick! Otherwise, the only thing left for us is traditional medicine.

Published in the newspaper “Moskovsky Komsomolets” No. 28889 dated October 13, 2022

Newspaper headline:
Pharmacies will get rid of drugs