Ministry of Health will rename drugs

A new order from the Russian Ministry of Health comes into force on November 17, prohibiting the registration of medicines with similar names but different compositions and effects. This rule will apply both to new drugs and to medications already on the market that require re-registration. Experts say there are currently so many medicines with similar names that even doctors and pharmacists get confused. This leads to medical errors, sometimes with fatal outcomes.

Until now, the only document regulating the selection of drug names has been the methodological recommendations approved by the Russian Ministry of Health in 2005. As the ministry told Izvestia, with the enactment of this order, these recommendations become mandatory. The main goal is to prevent confusion of medications due to their similar-sounding names. For example, children's vitamins "Pikovit" and nasal decongestant drops "Pinovit" are currently sold in pharmacies, as are children's fever reducer "Ibufen" and a medication for women's hot flashes "Abyufen."

The order applies to the names of medications that will undergo state registration with the Ministry of Health after this document comes into force—that is, during the initial registration of a medication or during its secondary registration (after five years). If, during secondary registration, a company provides all necessary documents and confirms the safety and efficacy of the drug, it receives a permanent registration certificate.

Alexander Yavorsky, Scientific Secretary of the Federal State Budgetary Institution "Scientific Center for Expertise of Medical Products" of the Ministry of Health and author of the book "Trade Names of Medicinal Products," told Izvestia that the order will ensure the implementation of recommendations from the World Health Organization (WHO) and the Council of Europe on preventing medical errors related to confusion between similar-sounding trade names of drugs that differ in composition and action.

"Russian medical statistics do not keep track of such errors. But, for example, in the US, about 7,000 patients die because of them every year," said Alexander Yavorsky.

David Melik-Guseinov, Director of the Research Institute for Healthcare Organization and Medical Management, also noted that cases are not uncommon in Russia where, due to confusion in names, pharmacists dispense one drug instead of another to sick people, leading to disruptions in the treatment process.

According to Melik-Guseinov, marketers create a drug's trade name based on the name of the active substance, the disease, or the method of administration. A name is considered good if it is short and memorable. When a company creates a new brand for a drug used, for example, in cardiology, it typically analyzes the names of drugs that are part of that same mini-market. Meanwhile, a similar-sounding name might belong to a drug for oncology therapy. In David Melik-Guseinov's opinion, the Ministry of Health's order will eliminate clinical errors related to name confusion.

"Naming is very important not only from a marketing but also from a clinical point of view, because a doctor can mix up medications. But Russia is the richest country in the world in terms of the number of drugs circulating on the market. We register everything that is offered to us; there is no filter to screen out drugs the market doesn't need. This diversity leads to the emergence of similar-sounding names, as the alphabet is limited," says David Melik-Guseinov.

Nikolay Bespalov, Head of the Rating Projects Department at the CMI "Pharmexpert," believes the order will affect the turnover of medicines and dietary supplements and will close a loophole used by unscrupulous pharmaceutical companies.

"Advertising prescription drugs is prohibited, while over-the-counter drugs and dietary supplements can be advertised. Therefore, manufacturers release different types of products with confusingly similar names and promote prescription drugs in the media," explained Nikolay Bespalov.

Also, in his opinion, the Ministry of Health's order will stop the practice where pharmaceutical companies intentionally launch analogues of well-known drugs with similar names onto the market. By capitalizing on confusion, they achieve high sales without promotion costs.

Legal disputes over drug names are ongoing. For example, companies "PIK-Pharma" and Zentiva recently were in court. One sold hypertension tablets "Koronel," and the other sold angina medication "Koronal." The manufacturers of "AntiGrippin" and "Antigrippin Maksimum" have been disputing for several years.