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. Last Updated: 07/27/2016

Prescription Drugs: Doctor's Note Not Required

A number of pharmacies in Moscow are selling traditional prescription drugs over the counter, including Western antibiotics, contraceptive pills, and medications for heart conditions, as tight profit margins and a porous regulatory environment combine to create an atmosphere that is potentially ripe for abuse. In addition, the proliferation of new commercial firms that dispense pharmaceutical products outside of the traditional pharmacy system, including the Metrofarm chain of kiosks now operating in several Moscow metro stations, have made it more difficult for existing government agencies to keep control of an expanding market. "All medicines must be registered with the Health Ministry," said Alexander Machula, head of the Drug and Medical Equipment Quality Control Department at the ministry. Machula said that a regulatory regime is already in place under the aegis of the Health Ministry, which in turn oversees the activities of regional agencies. He added that the ministry keeps a list of medicines which can only be sold on prescription, although he said that "infringements of the law will happen, of course." One of the biggest problems is the absence of an overarching federal set of laws codifying the distribution and licensing of medicines and medical products, according to Klara Kulikova, deputy director of the quality control department. Rather, existing regulations are set out through individual decrees by the ministry, Kulikova said. She added that the ministry's pharmacological committee defines those medicines that can be sold with or without prescriptions. In the case of Western medicines, these guidelines are established as soon as the medicine is registered in Russia, while Russian medicines receive guidelines for their use as soon as they are developed. Rules governing pharmacies are set out by local health agencies under the supervision of the ministry, Kulikova said. According to Kulikova, the ministry is currently working with the State Duma's Health Protection Committee on a law that would regulate all aspects of the production, importation, control and dissemination of pharmaceutical products. She said that the law was expected to be ready by the end of the year. Kulikova admitted that the ministry's regulatory system is going through a "transitional period," which is complicated by the fact that rules designed for state-owned pharmacies fail to take into account many of the newer participants in the pharmaceutical trade. "Now, there are a number of active, private, commercial structures that are not yet accustomed to the procedures that government enterprises used to follow," she said. "We hope that we are now beginning to take control by creating different documentation to regulate their activities." Retailers insist that they are following regulations. "Medicines that require prescriptions are sold by prescription," said Mikhail Sharov, the executive director of Metrofarm. Sharov said that medicines requiring prescriptions were sold only through pharmacies, while Metrofarm's metro kiosks dispensed mainly remedies for colds and other light medicines. "We keep strong medicines and narcotics behind the counter," said Vachagan Yengibaryan, director of the Stary Arbat pharmacy. What constitutes a strong medicine apparently varies according to the retailer. At several central pharmacies last week, nitro-glycerine tablets for heart ailments, blood pressure medication, and the antibiotic Doxycycline, were all being sold without prescriptions. Both Machula and Kulikova said that while some antibiotics are sold over the counter, Doxycycline was required by law to be sold on prescription. Nitro-glycerine and related products for heart ailments should "absolutely always" be sold on prescription, Kulikova said. "This is not over-the-counter medicine," said Vadim Musatov, a pharmacist at the American Medical Center. Musatov added that nitro-glycerine had a number of possible side-effects, including headaches and vertigo, and that improper use of antibiotics could lead to the user developing a resistance to the drugs. The sale of contraceptive pills and intra-uterine devices (IUDs) is one area of particular controversy. Public health officials and family planning organizations are eager to curtail the habitual use of abortion as the most popular form of birth control among Russian women. Oral contraceptives have long been sold over the counter in Russia, and the practice is legal under Russian law. Alexander Schpakov, product manager for Schering, the German pharmaceutical company that produces Trikvilar, the most inexpensive and widely available contraceptive pills currently being sold in Moscow, said that he was not concerned that his company's products were being sold without prescriptions because they contained low hormone levels that are considered safe for most young, healthy women. At the same time, Schpakov insisted that, "as a rule, no woman would buy oral contraceptives without receiving a doctor's prescription." The same was true, he said, of the company's Copper T 380 IUD, which is also available over the counter. Pointing out that the package contained no directions, he said, "women can't put them in themselves. They must be put in by a medical specialist." Lola Karimova, a gynecologist with the Science and Research Institute for the Protection of Mothers and Children, disputed such a contention. She said that many women were reluctant to visit their doctor because of a "lack of knowledge" and a traditional tendency to pay little attention to preventive health. Karimova said she had seen many patients who became ill after taking birth control pills that were not suited to them and were purchased without a doctor's recommendation, as well as one woman whose IUD had become entangled with her intestines because it was implanted incorrectly by a poorly trained part-time nurse. Karimova admitted that physicians were eager to encourage women to use Western-made, low-dose contraceptives as a safer alternative to abortion, yet she said that medicines with a hormonal element should always be prescribed by physicians who were more familiar with the product and its potential side-effects. "Doctors can't control all pharmacies and commercial firms," she added. "This is the responsibility of the government." Over the past three years, the Russian government has stopped subsidizing the cost of many medicines, leaving the price of most Western drugs far out of the reach of most citizens. As a result, both Musatov and Schpakov suggested that pharmacies, facing declining sales, are under pressure to sell as much of their stock as possible, even if this means bending the regulations. "The commercial aspect dominates the medical aspect," Musatov said. Yet Kulikova said that the law on medicines currently being developed would eliminate many of the current opportunities for abuse. "When this law is in place, of course our work will be much more simple," she said.