The development and implementation of children’s dosages in the context of drug supply is a burning topic in the Russian pharmaceutical industry. The entire pharmaceutical market has a global goal to improve the quality and availability of drugs, and drug provision for the smallest patients is one of the key tasks. Albert Gayfullin, President of the PharmMedPolis cluster, head of the international project of the Republic of Tatarstan, as part of the launch of the First All-Russian Pharmaceutical Run, spoke about pressing problems and challenges in the production of children’s dosage forms.
Albert, why did you focus specifically on the problems of children’s dosage forms and dosages? & nbsp; Why is this topic highlighted in a separate problem area?
Ultra-low-dose drugs are urgently needed for newborns with low and extremely low body weight, as well as for children after surgery. To date, only 10% of the total amount used in pediatric practice is issued such forms. The decision to prescribe medications to children that have not been studied in pediatrics is unsafe and often ineffective. At the moment, there is a shortage of specific knowledge about the features of the pharmacokinetics and pharmacodynamics of drugs in childhood, their relationship with the physiology of the child, adequate doses and dosage forms for various age groups.
The development of the health system is a priority in Tatarstan, and before the issue of providing children with medicines in the required dosages was studied by the Ministry of Health of the Republic of Tatarstan together with subordinate structures, correspondence was conducted with the Minister of Health Veronika Igorevna Skvortsova. Therefore, the direct task of PharmMedPolis, as an institution for the development of the pharmaceutical and medical industry, is to contribute to solving the industry’s challenges.
What are the sharpest areas and main development areas you see in the field of children’s forms and dosages?
& nbsp; Firstly, it’s difficult to make such drugs in a pharmacy with a doctor’s prescription – there are a number of limitations. Secondly, the domestic industry practically does not produce children’s dosage forms, and drugs of foreign manufacture are not registered in the Russian Federation. Moreover, according to WHO experts, for 75% of childhood diseases there are no special pediatric drugs. In addition, there is extremely little data on the safety of the use of drugs in children and insufficiently specific pediatric dosage forms.
Also, the difficulty lies in the fact that the introduction of medicines into practice requires a long multi-stage preliminary study of the effectiveness and safety of drugs for children, including clinical trials involving minors – especially vulnerable groups of patients. At the same time, the demand for such dosage forms is not high, and business representatives are not interested in developing the necessary dosages and dosage forms in the existing regulatory conditions due to the lack of profitability.
Russian legislation on pediatric clinical trials is not only poorly developed, but also prohibits pediatric clinical trials with some exceptions. At the same time, in the USA and the European Union, on the contrary, the legislation provides for stimulating and motivating measures. Therefore, one of the main areas of development is the initiation of necessary legislative measures.
Tell, what is the main vector of the development of the Republic of Tatarstan in the field of children’s forms and dosages?
& nbsp; It is proposed to develop a package of government incentive measures so that it would be economically feasible for pharmaceutical manufacturers to manufacture and develop children’s dosage forms and dosages. Moreover, there are plans to pilot industrial production of the required dosages of existing drugs in Tatarstan in accordance with the demand for them.
Albert, and what goals and what are the ways to achieve them are facing PharmMedPolis in this area?
The history and experience of Western countries confirms the need for state participation in solving this problem. Based on this, the task of “PharmMedPolis” is to attract the attention of the state and the pharmaceutical community to this problem and to develop the necessary measures to contribute to its solution. In particular, the development of the pharmaceutical industry in the field of pharmaceutical support for children can take into account several areas, such as supporting scientific research, initiating changes in regulatory legal acts and developing new mechanisms governing the circulation and manufacture of children’s medicines. It is also necessary to develop mechanisms to stimulate the production of medicines for pediatrics or to compensate for the shortfall in income during their manufacture. At the same time, it is important to ensure a public-private partnership for the manufacture of non-marketed infant forms of drugs.
And if we talk about the country as a whole, then to what are the strategic development goals of this direction have now been highlighted?
& nbsp; The priority tasks are to conduct adequate clinical trials of drugs with the participation of children, as well as to create special dosage forms for use in pediatrics, which will subsequently allow the registration of effective and safe drugs in the child population.
What will be the situation in this area in 10 years? How do you see the development of this direction in our country?
& nbsp; The problem of children’s forms and dosages is relevant worldwide. As world experience shows, the situation with clinical trials of pediatric drugs is slowly but steadily changing for the better. For 10 years, we must reduce the gap between the West and fill the existing gaps in pediatric pharmacotherapy.
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