What is a pharmacopoeia? If you start from afar, then it must have occurred to every person at least once how doctors manage to memorize so many drugs, know their dosages, chemical composition and mechanism of action. In this they are helped by numerous reference books and compendiums containing the necessary information. And their authors, in turn, draw inspiration from the pharmacopoeia. So what is it?
Definition
Pharmacopoeia is a collection of official documents that specify the quality standards of medicinal raw materials, excipients, finished drugs and other drugs used in medicine.
In order to establish the "gold standard", specialists in the field of chemistry and pharmaceutical analysis are involved, randomized international double-blind controlled trials are conducted to find out everything possible about medicinal raw materials and preparations from it. Compliance with all norms ensures the quality of pharmaceutical products.
The State Pharmacopoeia is a pharmacopoeia that has legal force and is under state supervision. The requirements and recommendations set forth in it are binding on all organizations in the country involved in the manufacture, storage, sale and use of medicines. For violation of the rules fixed in the document, a legal or natural person faces criminal liability.
History of the International Pharmacopoeia
Thoughts about creating a single list of drugs indicating dosages and standardizing the nomenclature appeared in the scientific medical community at the end of the nineteenth century, in 1874. The first conference on this subject was held in Brussels in 1092. On it, experts came to an agreement on common names for drugs and the form of their extract in prescriptions. Within four years, this agreement was ratified in twenty countries. This success became the starting point for the further development of the pharmacopoeia and its publication. Twenty years later, the second conference took place in Brussels, which was attended by representatives of forty-one countries of the world.
From that moment on, the care of publishing and revising the pharmacopoeia passed to the League of Nations. At the time of the agreement, the compendium included principles for the preparation of herbal preparations and doses of 77 medicinal substances. Twelve years later, in 1937, a commission of experts from Belgium, Denmark, France, Switzerland, the USA, the Netherlands and Great Britain was established, who familiarized themselves with all the provisions of the pharmacopoeia and decided to expand it to an international document.
The Second World War interrupted the work of the commission, but already inIn 1947, the experts returned to their work. By 1959, the commission was called the Committee of Experts on the Specification of Pharmaceutical Preparations. At one of the WHO meetings, it was decided to create a program of International Generic Names to unify the nomenclature of medicines.
First Edition
Pharmacopoeia is an international document that has already had four editions, and after each of them it acquired something new.
The first edition was approved at the third World Assembly of WHO. A permanent secretariat of the International Pharmacopoeia was established. The book was published in 1951, and four years later the second volume was published with additions in three common European languages: English, French and Spanish. After a short period of time, publications appeared in German and Japanese. The first pharmacopoeia is a collection of regulatory documents for all drugs known at that time. Namely:
- 344 articles on medicinal substances;
- 183 articles on dosage forms (tablets, capsules, tinctures, solutions in ampoules);
- 84 methods of laboratory diagnostics.
The headings of the articles were in Latin, as it was the only way of designation for all medical workers. To collect the necessary information, experts in biological standardization were involved, as well as narrow specialists in the most endemic and dangerous diseases.
Subsequent editions of the InternationalPharmacopoeia
Second edition appeared in 1967. It was dedicated to quality control of pharmaceutical products. In addition, the errors of the first edition were taken into account and 162 drugs were added.
The third edition of the pharmacopoeia was aimed at developing countries. It presented a list of substances that are widely used in he alth care and at the same time have a relatively low cost. This edition contained five volumes and was released in 1975. New revisions to the document were made only in 2008. They concerned the standardization of medicines, the methods of their manufacture and distribution.
Pharmacopoeia contents
Pharmacopoeia is a book that combines not only the nomenclature of medicinal substances, but also instructions for their manufacture, storage and purpose. This book contains a description of the chemical, physical and biological methods of drug analysis. In addition, it contains information about reagents and indicators, medicinal substances and preparations.
The WHO Committee compiled lists of poisonous (list A) and potent substances (list B), as well as tables of maximum single and daily doses of drugs.
European Pharmacopoeia
The European Pharmacopoeia is a regulatory document that is used in most European countries in the production of pharmaceutical products on a par with the International Pharmacopoeia, complements it and focuses on the peculiarities of medicine in this region. ThisThe book was developed by the European Directorate for the Quality of Medicines, which is part of the Council of Europe. The Pharmacopoeia has a different legal status from other similar documents, which was given to it by the Cabinet of Ministers. The official language of the European Pharmacopoeia is French. The last, sixth, reissue was in 2005.
National pharmacopoeias
Since the International Pharmacopoeia has no legal force and is rather advisory in nature, individual countries have issued national pharmacopoeias for domestic regulation of drug-related issues. At the moment, most countries in the world have individual books. In Russia, the first pharmacopeia was published in 1778 in Latin. Only twenty years later a Russian-language version was published, becoming the first book of this type in the national language.
In 1866, half a century later, the first official Russian-language pharmacopeia was published. The 11th edition, the last during the existence of the USSR, appeared in the early nineties of the last century. The preparation, addition and reissue of the document used to be the responsibility of the Pharmacopoeial Committee, but now the Ministry of He alth, Roszdravnadzor and the General Medical Insurance Fund are involved in this with the involvement of the country's leading scientists.
State Pharmacopoeia of the Russian Federation 12th and 13th editions
In the period when the state pharmacopoeia was subject to adjustment, the quality of medicines was regulated through the pharmacopoeial articles of the enterprise (FSP)and general pharmacopoeial articles (GPM). The twelfth edition of the State Pharmacopoeia of the Russian Federation was significantly influenced by the fact that Russian specialists were involved in the work of the Commission of the European Pharmacopoeia. The twelfth edition consists of five parts, each of which includes basic standards and regulations for the manufacture, prescription or sale of medicines. This book was published in 2009.
Six years later, the twelfth edition has been revised. At the end of 2015, the State Pharmacopoeia, 13th edition, appeared on the official website of the Ministry of He alth of the Russian Federation. It was an electronic version, since the release was carried out at the expense of funds from the sale. Therefore, at the legislative level, it was decided that each pharmacy and wholesaler should have a state pharmacopoeia (13th edition). This enabled the book to pay for itself.
What is a monograph?
There are two types of pharmacopoeial articles: for the substance and for the finished dosage form. Each article "on the substance" has a title in two languages: Russian and Latin, international non-proprietary and chemical name. It contains empirical and structural formulas, molecular weight and amount of the main active substance. In addition, there is a detailed description of the appearance of the medicinal substance, quality control criteria, solubility in liquids, and other physical and chemical properties. The terms of packaging, manufacturing, storage and transportation are stipulated. BUTalso expiration date.
The article for the finished dosage form, in addition to all of the above, contains the results of clinical and laboratory tests, permissible deviations in mass, volume and particle size of the medicinal substance, as well as the maximum single and daily dosages for children and adults.
