The pharmacopoeia is what? Pharmacopeia: description, history, content

What is a pharmacopeia? If you start from afar, then for sure every person at least once came to mind how doctors manage to memorize so many drugs, they know their dosage, chemical composition and mechanism of action. In this they are helped by numerous directories and compendiums containing the necessary information. And their authors, in turn, draw inspiration from the pharmacopoeia. So what is this?

Definition

Pharmacopoeia is a collection of official documents that indicate the quality standards of medicinal raw materials, excipients, ready-made medicines and other medications used in medicine.

To establish the "gold standard" attract specialists in the field of chemistry and pharmaceutical analysis, conduct randomized international double-blind controlled studies 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 for all organizations of the country engaged in the manufacture, storage, sale and use of medicines. For violation of the rules fixed in the document, a legal or physical person faces criminal liability.

History of the International Pharmacopoeia

Thoughts on the creation of a single list of drugs with indication of dosages and standardization of nomenclature appeared in the scientific medical community in the late nineteenth century, in 1874. The first conference on this issue was held in Brussels in 1092. On it, experts came to an agreement on common names for drugs and the form of their discharge in prescriptions. Within four years, this agreement was ratified in twenty countries. This success was the starting point for further development of the pharmacopeia and its publication. Twenty years later, the second conference was held in Brussels, attended by representatives of forty one countries of the world.

Since that time, the concern for the publication and revision of the pharmacopoeia has passed to the League of Nations. At the time of the agreement, the principles of galenic preparations and the dose of 77 drugs were included in the compendium. Twelve years later, in 1937, an expert commission was established from Belgium, Denmark, France, Switzerland, the United States, the Netherlands and the United Kingdom, who familiarized themselves with all the provisions of the pharmacopoeia and decided to extend it to an international document.

The Second World War interrupted the work of the commission, but already in 1947 the 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 Non-Proprietary Names for the Unification of the Nomenclature of Medicines.

First Edition

The pharmacopoeia is an international document, which 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. 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 to three widely spoken languages in Europe: English, French and Spanish. After a short period of time there were publications in German and Japanese. The first pharmacopeia is a collection of normative 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 for all medical workers to designate. To collect the necessary information, experts were involved in biological standardization, as well as narrow specialists on the most endemic and dangerous diseases.

Subsequent editions of the International Pharmacopoeia

The second edition appeared in 1967. It was devoted to quality control of pharmaceutical products. In addition, the mistakes of the first edition were taken into account and 162 preparations were added.

The third edition of the pharmacopoeia was geared towards developing countries. It contained 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 issued in 1975. New edits to the document were made only in 2008. They concerned the standardization of medicines, the methods of their manufacture and distribution.

The contents of the pharmacopoeia

Pharmacopoeia is a book that combines not only the nomenclature of medicinal substances, but also instructions for their manufacture, storage and administration. This book contains a description of the chemical, physical and biological methods of drug analysis. In addition, it contains information on reagents and indicators, medicinal substances and preparations.

The WHO Committee 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 normative document that is used in most European countries in the process of manufacturing pharmaceutical products on a par with the International Pharmacopoeia, complements it and focuses on the specific features 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 pharmacopeia 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, reissue was in 2005.

National Pharmacopoeias

Since the International Pharmacopoeia is not legally binding and is more recommendatory, individual countries have issued national pharmacopoeias for the domestic management of drug-related issues. At the moment most countries in the world have individual books. In Russia, the first pharmacopoeia was issued in 1778 in Latin. Only after twenty years did the Russian version come 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 one during the existence of the USSR, appeared in the early nineties of the last century. The compilation, addition and re-issue of the document was earlier assigned to the Pharmacopoeia Committee, but now the Ministry of Health, Roszdravnadzor and the General Medical Insurance Fund are engaged 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 adjusted, the quality of medicines was regulated through the pharmacopoeial articles of the enterprise (FSP) and general pharmacopoeial articles (FBS). 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 European Pharmacopoeia Commission . The twelfth edition consists of five parts, each of which includes the basic standards and standard provisions for the manufacture, purpose or sale of medicines. This book was published in circulation in 2009.

Six years later the twelfth edition was edited. At the end of 2015 on the official website of the Ministry of Health of the Russian Federation there was a state pharmacopeia - 13th edition. This was an electronic option, since the release was carried out at the expense of funds from the sale. Therefore, at the legislative level, it was accepted that every pharmacy and wholesale trade enterprise should have a state pharmacopeia (13th edition). This enabled the book to self-pay.

What is a pharmacopoeial article?

There are two types of pharmacopoeial articles: the substance and the finished dosage form. Each article "on substance" has a name in two languages: Russian and Latin, the international non-proprietary and chemical name. It shows the empirical and structural formulas, the molecular weight and the 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 packing, manufacturing, storage and transportation are stipulated. And also the expiry date.

The article for the finished dosage form, in addition to all the above, contains the results of clinical and laboratory tests, the permissible norms of the deviations in weight, the volume and size of the drug substance particles, as well as the maximum single and daily dosages for children and adults.