At the end of 2020, the FSUE Moscow Endocrine Plant, subordinate to the Ministry of Industry and Trade of Russia, developed and launched the production of local medicines to relieve epilepsy seizures, in dosage forms convenient for children’s use - "Midazolam Buccal Solution" (from three months) and "Sibazon Rectal Solution" (from six months). The project was implemented within the strategy of import phase-out and to improve access of medicine supply on behalf of the Government of the Russian Federation, - said Ekaterina Yezhova, Deputy Director for Implementation of Drugs of Moscow Endocrine Plant.
Tonic-clonic seizures in young children in particular require emergency intervention. The use of the authorized injectable dosage forms of Midazolam and Sibazon in circulation until December 2020 in the acute period of seizures was a significant challenge even for doctors on an in-patient basis. A situation like that would require medicines, administration of which can be promptly performed on an outpatient basis, including by persons without a medical qualification.
For the past few years, these medicines and a number of others containing psychotropic substances as well, were extremely in demand for medical treatment of children suffering from convulsive disorder of various etiologies. However, their accessibility to patients was limited due to the lack of marketing authorization in Russia. Disappearance of several foreign medicines from the domestic market also contributed to the situation when the patients couldn’t just buy or otherwise legally get their live-saving products. Parents of children in need of medicine were in dire straits. Some of them decided to buy the products containing psychotropic substances on the black market understanding it was illegal, but they couldn’t see their children suffering.
In response to the requests of community-focused non-profit organizations, the Government of the Russian Federation allocated funds and authorized Moscow Endocrine Plant to systematically import the necessary medicines not authorized in Russia in the manner prescribed by law and in the amount determined by the Ministry of Health of Russia, before the start of their production in Russia.
The well-functioning system of interdepartmental interaction and the highly professional approach of each of the participants in the process of fulfilling the assignment of increased social significance made it possible to ensure the access to medicines for patients in need for medical reasons in a short time. It also eliminated the preconditions for citizens to violate the procedure for the circulation of psychotropic drugs established by the legislation of the Russian Federation.
Alongside with import arrangement, Moscow Endocrine Plant started immediately to produce its own products "Midazolam Buccal Solution" and "Sibazon Rectal Solution" for pediatric use. The composition and technology for pharmaceutical production were developed at the earliest possible date. The technological equipment was modernized for production of these medicines.
“Taking into account the importance of providing Russian patients with access to these medicines as soon as possible, the Ministry of Health of Russia and the Enterprise established a working group and compiled an appropriate roadmap involving the leading experts from both sides,” said Philip Romanov, Director of Department of State Regulation of the Circulation of Medicines of the Ministry of Health of Russia. "The documents of the registration dossier upon completion of the studies were reviewed by the Ministry of Health of Russia as soon as possible, in compliance with all requirements that meet the leading good practices."
After the Ministry of Health made approved state registration the medicines production began. The enterprise’s production facilities make it possible to provide "Midazolam Buccal Solution" and "Sibazon Rectal Solution" satisfying completely the demands of the Russian healthcare system.
“The state has created all conditions necessary for the prompt provision of children who need these drugs. The introduction of domestic developments into production will simplify access to these drugs for thousands of children in the country who need them for medical reasons. It should be emphasized that midazolam in the form of buccal solution and diazepam in the form of rectal solution are included in the international recommendations for the provision of palliative care, in particular, in the WHO Model List of Essential Medicines in the sections “Medicines used in palliative therapy" and "Anticonvulsants and antiepileptic drugs", - noted the professor of Department of Oncology, Hematology and Radiation Therapy of the Russian National Research Medical University named after N.I. Pirogov, a chief freelance pediatric specialist in palliative care of the Russian Ministry of Health, Elena Polevichenko.
“The release of these local anticonvulsant drugs is a very important event for epileptic patients,” commented the Director of the scientific production center of the specialized medical care for children named after V.F. Voino-Yasenetsky, Doctor of Medical Sciences, professor Andrey Prityko.
Thanks to collaboration of the Government of the Russian Federation, the Ministry of Industry and Trade of Russia, the Ministry of Health of Russia, public organizations and the Federal State Unitary Enterprise Moscow Endocrine Plant, patients in Russia finally received access to new forms of Midazolam and Sibazon, which are the medicines of choice for the relief of seizures in children, both on inpatient and outpatient basis.
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