State Pharmacopoeia of the Russian Federation: description, history, content
Many of us do not even think about how doctors manage to memorize huge lists of medicines. In this case, experts know everything about each drug: its dosage, the chemical composition, the principle of action, as well as side effects and contraindications. It turns out that behind the tips they turn to the state pharmacopoeia, and to be more precise, to the numerous directories, the authors of which derive the information precisely from this "bible" of pharmacists and physicians.
The pharmacopeia is nothing more than a collection of documents that contain information about the quality standards of medicines and raw materials used, auxiliary components, as well as other chemical and organic substances used in medicine today. To establish appropriate norms and give them an official status, leading scientists, chemists, specialists in the field of pharmaceutical analysis are invited to work on the project, conduct randomized studies, including double-blind and control international tests. Qualit
Meaning of the document in the manufacture of therapeutic products
To understand what a pharmacopeia is, it's the easiest to use with an example of a specific medicine: the finished product, its form of release and pharmacological properties must not contradict any of the current provisions of this document. Accordingly, the worthy quality of pharmaceutical products is ensured by strict rules of its production.
The State Pharmacopoeia is a kind of standard that has legal force in the territory of a certain country, and its observance is protected by state supervision bodies. Absolutely all the recommendations, regulations and requirements that are present in it, are binding for all enterprises whose activities are related to the production, storage, sale or prescription of drugs. For violation and disregard of the rules contained in the document, an individual or organization faces criminal punishment under the current legislation.
Contents of the
collection The pharmacopeia is a complex that combines not only the nomenclature of the active medicinal components, but also recommendations for their production, saving and prescribing. The collection includes a detailed description of various methods for the analysis of medicines, including chemical, physical and biological.
In addition, the pharmacopeia contains information on reagents and indicators, the substances of medicinal plant material. As a basis for the list of drugs in the pharmacopoeia in most countries, use of "List A"( poisonous substances) and "List B"( strong components), compiled by the committees of the World Health Organization.
Norms for the quality of drugs and raw materials
Here we are talking about pharmacopoeial articles, which are divided into two groups: one contains information on the raw material base, others - about the finished drug.
The document for each substance is listed in Russian and Latin, and it also marks the international non-proprietary name. An empirical and structural formula of the active substance, its molecular weight and percentage can be present in the article.
In some cases, the appearance of the chemical composition or herbal raw material, its consistency and quality criteria, the degree of solubility in various liquids, the interaction with other pharmacological groups, etc., are described in detail. Also, the conditions for manufacturing the packing of raw materials are fixed. The pharmacopoeial article must contain recommendations for the storage of the drug and its transportation, the exact shelf life.
In contrast to the detailed description of the substance, the document for the finished pharmacological product, in addition to the above criteria, is supplemented by the results of clinical and laboratory studies, indicating the permissible errors in mass, volume and particle size of the active ingredient. Of particular importance is the definition of the maximum permitted single and daily doses for patients of different ages.
How the first document ofappeared
On the compilation of a single international list of medicines, the scientific medical and pharmaceutical community was pondering for the first time at the end of the century before last. Then, scientists and practitioners, standing guard over the health of citizens of European countries, began actively working on the development of a standardized nomenclature. Ultimately, the document should include all known at that time preparations with an indication of the appropriate dosage of active and auxiliary substances to each of them.
The 1902 Brussels conference was devoted to the creation of the first edition of the International Pharmacopoeia. Having gathered at a round table, experts came to an agreement on the adoption of common names for the medicines used and the form of their prescription in official prescriptions. A few years later the agreement was ratified in twenty states. In 1922, the second conference was held in Brussels, attended by representatives of research communities in more than 40 countries.
Obtaining official international status
During the same period, cases related to the publication and revision of points of pharmacopoeial articles were transferred to the League of Nations. At the beginning of the XX century in the compendium there were principles of making galenic medicines and dosing 77 medicines. Another change awaited the pharmacopoeia in 1937.Experts from France, the United Kingdom, Belgium, the United States, Switzerland and other countries established the appropriate commission. Experts, having familiarized themselves with the content of the document, considered it obsolete and irrelevant, and therefore decided to expand and assign the international status of the compendium. A long process of modernization of the pharmacopoeial arch was interrupted by the Second World War. The experts returned to work in 1947.
The pharmacopeia is a document for interstate and international application. At the moment the collection, which was reprinted four times, contains the latest data on medicines all over the world. The first publication of the book dates back to 1951.The publication was approved at the Third World Assembly of WHO, which, by the way, established the secretariat of the International Pharmacopoeia. A few years after the publication of the collection, the second volume was released, which was distinguished by the presence of non-principal additions in three European languages - English, French, Spanish, and later there were Japanese and German editions.
Contents of the book
The collection includes:
- 344 items containing a description of medicinal substances;
- 183 provisions determining the dosage of drugs in different forms of release;
- characteristics of 84 methods of clinical and laboratory diagnosis.
The titles of the articles were published in Latin, because Latin was the same for medical and pharmacological designations. At that time, experts were involved in the work on biological standardization and specialists in infectious diseases.
Despite the fact that the International Pharmacopoeia is not legally valid and is of the nature of recommendations, some states have decided to issue intranational documents for the regulation of public relations related to the manufacture, storage and prescription of medicines. Similar books, which indicate the predominant part of the drugs used in the country, are available in most countries of the world.
State Pharmacopoeia of the Russian Federation
The Russian pharmacopoeia was published much earlier than the international one. The first sample of the book with the list of medicines was released back in 1778, but from the first to the last chapter, it contained information in Latin. A few decades later, the light saw a Russian-language version. This document was the first book of this type, but the development of scientists of that time could not be called official. The State Pharmacopoeia of the 1st edition was published in 1866.Over the entire period of existence, the compendium was republished more than ten times.
In the USSR, in the early 90's, the Pharmacopoeia Committee adopted the 11th edition of the collection containing updated information on the production, administration and storage of medicines. With the collapse of the Soviet Union, the functions and responsibilities of the committee fell on the shoulders of the Ministry of Health, the General Health Insurance Fund and Roszdravnadzor. Leading pharmacists and doctors of medical sciences are involved in the work to supplement and reissue the book.
Domestic publications of recent years
During periods of adjustment of pharmacopoeia, the production of medicines in the country was regulated through general pharmacopoeial articles. If we compare the 11th and 12th editions, the latter is significantly different from the previous versions. A huge role in the release of this collection was played by the fact of attracting leading Russian pharmacists in the work of the European Pharmacopoeia Commission. The Compendium is five interconnected parts. Each of the elements contains current standards and norms for the manufacture and use of active chemicals and herbal medicinal raw materials. The collection was released in 2009.
Six years later, in 2015, the State Pharmacopoeia of the Russian Federation was again edited. This time, the Ministry of Health refused to publish the collection for free. First, the electronic publication of the State Pharmacopoeia 13 of the publication appeared on the agency's website. Later at a meeting of ministers, it was decided to make compulsory availability of a collection for pharmacies and wholesale organizations of medicines. Thus, the release of the pharmacopoeia to the state was completely self-sufficient.
This document appeared relatively recently. Especially young he looks on the background of the State Pharmacopoeia of the Russian Federation. To date, the book is used in most European countries on a par with the international collection. The use of the European pharmacopeia in the process of manufacturing medicines allows us to orient the manufacturer on the nuances of medicine in a particular region.
A set of pharmacopoeial articles was created by the European Directorate for the Quality of Medicines, which is part of the Council of Europe. Standards, the official language of publication of which is French, have a special legal status. The book was reprinted several times. The last, sixth, edition was in 2005.