What is a pharmacopoeia? If you start from afar, then surely it occurred to every person at least once how doctors manage to memorize so many drugs, know their dosages, chemical composition and mechanism of action. Numerous reference books and compendiums containing the necessary information help them in this. And their authors, in turn, draw inspiration from the Pharmacopoeia. So what is it?
Definition
Pharmacopoeia is a collection of official documents that indicate the quality standards of medicinal raw materials, excipients, finished medicines and other drugs used in medicine.
To establish the "gold standard", experts 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 standards 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 of the country involved in the manufacture, storage, sale and use of medicines. For violation of the rules recorded in the document, legal or natural person faces criminal liability.
History of the International Pharmacopoeia
Thoughts on creating a unified 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. At it, experts came to an agreement on common names for drugs and the form of their extract in recipes. Four years later, this agreement was ratified in twenty countries. This success was the starting point for the further development of the pharmacopeia and its publication. Twenty years later, the second conference was held in Brussels, which was attended by representatives of forty-one countries of the world.
From that moment, the care for the publication and revision of the Pharmacopoeia passed to the League of Nations. At the time of the agreement, the compendium included principles for the preparation of galenic 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 in 1947, experts returned to their occupation. By the fifty-ninth year, 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 Nonproprietary Names to unify the nomenclature of medicines.
First edition
The Pharmacopoeia is an international document that already had four reprints, and after each of them it acquired something new.
The first edition was approved at the Third World Assembly of WHO. The Permanent Secretariat of the International Pharmacopoeia has been established. The book was published in 1951, and four years later the second volume was published with additions in three languages common in Europe: English, French and Spanish. After a short period of time, German and Japanese editions appeared. The first pharmacopoeia is a collection of regulatory documents on 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 diagnosis.
The headings of the articles were in Latin, as it was a uniform way of naming for all medical professionals. Experts in biological standardization, as well as narrow specialists in the most endemic and dangerous diseases, were involved to collect the necessary information.
Subsequent editions of the International Pharmacopoeia
The 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 preparations were added.
The third edition of the Pharmacopoeia was targeted at developing countries. It presented a list of substances that are widely used in health 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 introduced only in 2008. They concerned the standardization of medicines, methods for their manufacture and distribution.
Pharmacopoeia content
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 has compiled lists of toxic (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 along with the International Pharmacopoeia, supplements it and focuses on the peculiarities of medicine in this region. This book was developed by the European Directorate for the Quality of Medicines, which is part of the Council of Europe. The Pharmacopoeia has a legal status different 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, reprint was in 2005.
National Pharmacopoeia
Since the International Pharmacopoeia has no legal force and is rather of a recommendatory nature, some countries have issued national pharmacopeias for the internal regulation of issues related to medicines. Currently, most countries in the world have individual books. In Russia, the first pharmacopoeia was released in 1778 in Latin. Only twenty years later, the Russian-language version came out, 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 compilation, addition and reprinting of the document was previously entrusted to the Pharmacopoeia Committee, but now the Ministry of Health, Roszdravnadzor and the General Health Insurance Fund are involved in this with the involvement of leading scientists of the country.
State Pharmacopoeia of the Russian Federation 12 and 13 editions
In the period when the state pharmacopoeia was subject to adjustment, the quality of medical products was regulated through the pharmacopoeial articles of the enterprise (FSP) and general pharmacopoeial articles (OFS). 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 the basic standards and regulatory provisions for the manufacture, prescription or sale of medicines. This book was published in 2009.
Six years later, the twelfth edition was edited. At the end of 2015, the State Pharmacopoeia - 13th edition - appeared on the official website of the Ministry of Health of the Russian Federation. It was an electronic version, since the issue was carried out at the expense of the sale. Therefore, at the legislative level, it was adopted that every pharmacy and wholesaler should have a state pharmacopoeia (13th edition). This made it possible for the book to self-sustain.
What is a pharmacopeia article?
There are two types of pharmacopeia articles: on the substance and on the finished dosage form. Each article “on substance” has a title in two languages: Russian and Latin, an international non-proprietary and chemical name. It contains the 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 drug substance, quality control criteria, solubility in liquids, and other physical and chemical properties. The conditions of packaging, manufacturing, storage and transportation are stipulated. As well as the expiration date.
The article for the finished dosage form, in addition to all of the above, contains the results of clinical and laboratory tests, acceptable norms for deviations in mass, volume and particle size of the drug substance, as well as maximum single and daily dosages for children and adults.