Pharmacopoeia

The earliest extant Chinese pharmacopoeia, the Shennong Ben Cao Jing was compiled between 200-250 AD.[9] It contains descriptions of 365 medications.[10]

The earliest known officially sponsored pharmacopoeia was compiled in 659 AD by a team of 23 pharmaceutical scientists led by Su jing during the Tang dynasty (618-907 AD) and was called the Xinxiu Bencao (Newly Revised Canon of Materia Medica). The work consists of 20 volumes with one dedicated to the table of contents, and 25 volumes of pictures with one volume dedicated to the table of contents. A third part consisting of seven volumes contained illustrated descriptions. The text contains descriptions of 850 medicines with 114 new ones. The work was used throughout China for the next 400 years.[11]

A dated work appeared in Nuremberg in 1542; a passing student Valerius Cordus showed a collection of medical prescriptions, which he had selected from the writings of the most eminent medical authorities, to the physicians of the town, who urged him to print it for the benefit of the apothecaries, and obtained the sanction of the senatus for his work. A work known as the Antidotarium Florentinum, was published under the authority of the college of medicine of Florence[1] in the 16th century. In 1511, the Concordie Apothecariorum Barchinone was published by the Society of Apothecaries of Barcelona and kept in the School of Pharmacy of the University of Barcelona.[12]

Engraved frontispiece of the 1703 Pharmacopoeia Bateana

The term Pharmacopoeia first appears as a distinct title in a work[13] published at Basel, Switzerland, in 1561 by A. Foes, but does not appear to have come into general use until the beginning of the 17th century.[1]

Before 1542, the works principally used by apothecaries were the treatises on simples (basic medicinal ingredients) by Avicenna and Serapion; the De synonymis and Quid pro quo of Simon Januensis; the Liber servitoris of Bulchasim Ben Aberazerim, which described preparations made from plants, animals, and minerals, and was the type of the chemical portion of modern pharmacopoeias; and the Antidotarium of Nicolaus de Salerno, containing Galenic formulations arranged alphabetically. Of this last work, there were two editions in use — Nicolaus magnus and Nicolaus parvus: in the latter, several of the compounds described in the large edition were omitted and the formulae given on a smaller scale.[1]

Also Vesalius claimed he had written some "dispensariums" and "manuals" on the works of Galenus. Apparently he burnt them. According to recent research communicated at the congresses of the International Society for the History of Medicine by the scholar Francisco Javier González Echeverría,[14][15][16] Michel De Villeneuve (Michael Servetus) also published a pharmacopoeia. De Villeneuve, fellow student of Vesalius and the best galenist of Paris according to Johann Winter von Andernach,[17] published the anonymous " ''Dispensarium or Enquiridion" in 1543, at Lyon, France, with Jean Frellon as editor. This work contains 224 original recipes by De Villeneuve and others by Lespleigney and Chappuis. As usual when it comes to pharmacopoeias, this work was complementary to a previous Materia Medica[18][19][20][21] that De Villeneuve published that same year. This finding was communicated by the same scholar in the International Society for the History of Medicine,[16][22] with agreement of John M. Riddle, one of the foremost experts on Materia Medica-Dioscorides works.

Nicolaes Tulp, mayor of Amsterdam and respected surgeon general, gathered all of his doctor and chemist friends together and they wrote the first pharmacopoeia of Amsterdam named Pharmacopoea Amstelredamensis in 1636. This was a combined effort to improve public health after an outbreak of the bubonic plague, and also to limit the number of quack apothecary shops in Amsterdam.

Until 1617, such drugs and medicines as were in common use were sold in England by the apothecaries and grocers. In that year the apothecaries obtained a separate charter, and it was enacted that no grocer should keep an apothecary's shop. The preparation of physicians’ prescriptions was thus confined to the apothecaries, upon whom pressure was brought to bear to make them dispense accurately, by the issue of a pharmacopoeia in May 1618 by the College of Physicians, and by the power which the wardens of the apothecaries received in common with the censors of the College of Physicians of examining the shops of apothecaries within 7 m. of London and destroying all the compounds which they found unfaithfully prepared. This, the first authorized London Pharmacopoeia, was selected chiefly from the works of Mezue and Nicolaus de Salerno, but it was found to be so full of errors that the whole edition was cancelled, and a fresh edition was published in the following December.[1]

At this period the compounds employed in medicine were often heterogeneous mixtures, some of which contained from 20 to 70, or more, ingredients, while a large number of simples were used in consequence of the same substance being supposed to possess different qualities according to the source from which it was derived. Thus crabs’ eyes (i.e., gastroliths), pearls, oyster shells, and coral were supposed to have different properties. Among other ingredients entering into some of these formulae were the excrements of human beings, dogs, mice, geese, and other animals, calculi, human skull, and moss growing on it, blind puppies, earthworms, etc.[1]

Although other editions of the London Pharmacopoeia were issued in 1621, 1632, 1639, and 1677, it was not until the edition of 1721, published under the auspices of Sir Hans Sloane, that any important alterations were made. In this issue many of the remedies previously in use were omitted, although a good number were still retained, such as dogs’ excrement, earthworms, and moss from the human skull; the botanical names of herbal remedies were for the first time added to the official ones; the simple distilled waters were ordered of a uniform strength; sweetened spirits, cordials and ratafias were omitted as well as several compounds no longer used in London, although still in vogue elsewhere. A great improvement was effected in the edition published in 1746, in which only those preparations were retained which had received the approval of the majority of the pharmacopoeia committee; to these was added a list of those drugs only which were supposed to be the most efficacious. An attempt was made to simplify further the older formulae by the rejection of superfluous ingredients.[1]

In the edition published in 1788 the tendency to simplify was carried out to a much greater extent, and the extremely compound medicines which had formed the principal remedies of physicians for 2,000 years were discarded, while a few powerful drugs which had been considered too dangerous to be included in the Pharmacopoeia of 1765 were restored to their previous position. In 1809 the French chemical nomenclature was adopted, and in 1815 a corrected impression of the same was issued. Subsequent editions were published in 1824, 1836, and 1851.[1]

The first Edinburgh Pharmacopoeia was published in 1699 and the last in 1841; the first Dublin Pharmacopoeia in 1807 and the last in 1850.[1]

The preparations contained in these three pharmacopoeias were not all uniform in strength, a source of much inconvenience and danger to the public, when powerful preparations such as dilute hydrocyanic acid were ordered in the one country and dispensed according to the national pharmacopoeia in another. As a result, the Medical Act of 1858 ordained that the General Medical Council should publish a book containing a list of medicines and compounds, to be called the British Pharmacopoeia, which would be a substitute throughout Great Britain and Ireland for the separate pharmacopoeias. Hitherto these had been published in Latin. The first British Pharmacopoeia was published in the English language in 1864, but gave such general dissatisfaction both to the medical profession and to chemists and druggists that the General Medical Council brought out a new and amended edition in 1867. This dissatisfaction was probably owing partly to the fact that the majority of the compilers of the work were not engaged in the practice of pharmacy, and therefore competent rather to decide upon the kind of preparations required than upon the method of their manufacture. The necessity for this element in the construction of a pharmacopoeia is now fully recognized in other countries, in most of which pharmaceutical chemists are represented on the committee for the preparation of the legally recognized manuals.[1]

There are national and international pharmacopoeias, like the EU and the U.S. pharmacopoeias. The pharmacopeia in the EU is prepared by a governmental organization, and has a specified role in law in the EU. In the U.S., the USP-NF (United States Pharmacopeia – National Formulary) has been issued by a private non-profit organization since 1820 under the authority of a Convention that meets periodically that is largely constituted by physicians, pharmacists, and other public health professionals, setting standards published in the compendia through various Expert Committees.[23] In the U.S. when there is an applicable USP-NF quality monograph, drugs and drug ingredients must conform to the compendial requirements (such as for strength, quality or purity) or be deemed adulterated or misbranded under the Federal food and drug laws.[24]

The Soviet Union had a nominally supranational pharmacopoeia, the State Pharmacopoeia of the Union of Soviet Socialist Republics (USSRP), although the de facto nature of the nationality of republics within that state differed from the de jure nature. The European Union has a supranational pharmacopoeia, the European Pharmacopoeia; it has not replaced the national pharmacopoeias of EU member states but rather helps to harmonize them. Attempts have been made by international pharmaceutical and medical conferences to settle a basis on which a globally international pharmacopoeia could be prepared,[1] but regulatory complexity and locoregional variation in conditions of pharmacy are hurdles to fully harmonizing across all countries (that is, defining thousands of details that can all be known to work successfully in all places). Nonetheless, some progress has been made under the banner of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),[25] a tri-regional organisation that represents the drug regulatory authorities of the European Union, Japan, and the United States. Representatives from the Pharmacopoeias of these three regions have met twice yearly since 1990 in the Pharmacopoeial Discussion Group to try to work towards "compendial harmonisation". Specific monographs are proposed, and if accepted, proceed through stages of review and consultation leading to adoption of a common monograph that provides a common set of tests and specifications for a specific material. Not surprisingly, this is a slow process. The World Health Organization has produced the International Pharmacopoeia (Ph.Int.), which does not replace a national pharmacopoeia but rather provides a model or template for one and also can be invoked by legislation within a country to serve as that country's regulation.