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Pharmacopoeia or pharmacopoeia (literally, 'drug-making'), in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
The word derives from Ancient Greek (pharmakopoieia), from (pharmako-) 'drug', followed by the verb-stem (poie-) 'make' and finally the abstract noun ending (-ia). These three elements together can be rendered as 'drug-mak-ing'.
In Latin, the Greek spellings (k),(oi),(ei) are respectively written as c, Å“ and i, giving the spelling pharmacopÅ“ia. In English, the Latin Å“ may be rendered as oe or e, giving us the two Engling spellings pharmacopoeia and pharmacopeia.
Although older writings exist which deal with herbal medicine, such as Edwin Smith Papyrus in Egypt, Pliny's pharmacopoeia and De Materia Medica a five volume book originally written in Greek by Pedanius Dioscorides, are considered the major initial works in the field. The later is considered to be precursor to all modern pharmacopoeias, and is one of the most influential herbal books in history. In fact it remained in use until about CE 1600.
A number of early pharmacopoeia books were written by Persian physicians. These included The Canon of Medicine of Avicenna in 1025, books by Abu-Rayhan Biruni in the 11th century, Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century.
1.1.1) Types of Pharmacopoeia:
Name of pharmacopoeia
Country or organization
United State of pharmacopoeia(USP)
World health Pharmacopoeia
1.2) National Pharmacopoeia:
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.
There are national and international pharmacopoeias, like the EU and the US pharmacopoeias. All the pharmacopoeias were issued under the authority of government, and their instructions have the force of law in their respective territories, except that of the United States, which was prepared by commissioners appointed by medical and pharmaceutical societies, and has no other authority, although generally accepted as the national textbook.
1.3) International Pharmacopoeia:
Increased facilities for travel have brought into greater prominence the importance of an approach to uniformity in the formulae of the more powerful remedies, in order to avoid danger to patients when a prescription is dispensed in a different country from that in which it was written. Attempts have been made by international pharmaceutical and medical conferences to settle a basis on which an international pharmacopoeia could be prepared, but due to national jealousies and the attempt to include too many preparations nothing has yet been achieved.
Nonetheless, some progress has been made under the banner of the ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human a tri-regional organization 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 Pharmacopoeia Discussion Group to try to work towards "compendia harmonization"'. 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.
1.4) British Pharmacopoeia (BP):
The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research,development,manufacture and testing.
The British Pharmacopoeia is published for the Health Ministers of the United Kingdom on the recommendation of the Commission on Human Medicines in accordance with section 99(6) of the Medicines Act 1968 and notified in draft to the European Commission in accordance with Directive 98/34/EEC.
The monographs of the European Pharmacopoeia (as amended by Supplements published by the Council of Europe) are reproduced either in the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia (Veterinary).
In the Pharmacopoeia certain drugs and preparations are included regardless of the existence of actual or potential patent rights. Where substances are protected by Letters Patent their inclusion in the Pharmacopoeia neither conveys, nor implies, license to manufacture.
The 1968 Medicines Act established the legal status of the British Pharmacopoeia Commission and of the BP as the UK standard for medicinal products under section 4 of the Act. The British Pharmacopoeia Commission continues the work of the earlier Commissions appointed by the GMC and is responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping them up to date. Under Section 100 of the Medicines Act, the British Pharmacopoeia Commission is also responsible for selecting and devising British Approved Names (BANs)
The current edition of the British Pharmacopoeia comprises six volumes which contain nearly 3,000 monographs for drug substances, excipients and formulated preparation, together with supporting General Notices, Appendices (test methods, reagents etc) and Reference Spectra used in the practice of medicine, all comprehensively indexed and cross-referenced for easy reference. Items used exclusively in veterinary medicine in the UK are included in the BP (Veterinary).
Volumes I and II
Blood related Preparations
Infrared Reference Spectra
British Pharmacopoeia (Veterinary)
British Pharmacopoeia (Veterinary)
British Approved Names
The BP is prepared by the Pharmacopoeial Secretariat working in collaboration with the BP Laboratory, the British Pharmacopoeia Commission (BPC) and its Expert Advisory Groups (EAG) and Advisory Panels. The development of pharmacopoeial standards receives input from relevant industries, hospitals, academia, professional bodies and governmental sources, both within and outside the UK.
The BP Laboratory provides analytical and technical support to the British Pharmacopoeia. Its major functions are:
Development of new pharmacopoeial monographs - the laboratory undertakes the development and validation of qualitative and quantitative test methods for new BP monograph specifications and refines and revalidates test methods for existing BP monographs.
British Pharmacopoeia Chemical Reference Substances (BPCRS) - the laboratory is responsible for the procurement, establishment, maintenance and sale of BPCRS. The catalog currently contains nearly 500 BPCRS, which are needed as standards for monograph tests in both the BP and the BP (Veterinary).
A new website for the British Pharmacopoeia Commission opened in 2008.
1.7) United States of Pharmacopeia (USP):
The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Prescription and over-the-counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF. USP also sets standards for food ingredients and dietary supplements.
SP establishes written (documentary) and physical standards for medicines, food ingredients, dietary supplement products and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist. Many other countries use the USP-NF instead of issuing their own pharmacopeias, or to supplement their government pharmacopoeia
USP's standards for food ingredients can be found in its Food Chemicals Codex (FCC). The FCC is a compendium of standards used internationally for the quality and purity of food ingredients like preservatives, flavorings, colorings and nutrients. While the FCC is recognized in law in countries like Australia, Canada and New Zealand, it currently does not have broad legal recognition in the United States. USP obtained the FCC from the Institute of Medicine in 2006.
USP also conducts verification programs for dietary supplement products and ingredients. These are testing and audit programs. Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letters "USP" alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified products
1.8) Healthcare information:
USP develops information relating to various aspects of drug use and disseminates this information to practitioners, pharmacists, and others who make decisions about health care. One such initiative is the development of a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their formularies. USP also plays a role in the naming of both pharmaceutical ingredients and products. This has a place in law via USP's membership in the United States Adopted Names Council. The council is tri-sponsored by the American Medical Association, the American Pharmacists Association and USP.
The Promoting the Quality of Medicines (PQM) Program is a $35 million cooperative agreement with the U.S. Agency for International Development (USAID), a U.S. government agency. The program's work is implemented by USP. Its purpose is to improve drug quality and the appropriate use of drugs in countries in Asia, Africa and Latin America. It is focused on medicines intended to treat malaria, HIV/AIDS and tuberculosis. Much of the PQM Program's activities are designed to reduce the presence of substandard and counterfeit medicines, which pose threats to the lives of individual patients who take them and can contribute to growth of drug-resistant strains of these disease
2.1 Ethics ;
Ethics is the science of morals or morals philosophy. All written or unwritten principles which are accepted in any profession as the basis of proper Behaviour constitute of ethics of the profession. Law & ethics may differ in the sense that while law is enforced by the state, a code of ethics morally binding. The law itself has a basis in ethics ; in general, it reflects the moral standard of the community
2.2 professional ethics;
Professional ethics is the professions interrelation of the will of society for the conduct of the members of that profession augmented & the special knowledge that only the members of the profession possess.
2.3 Code of ethics;
The code of ethics on pharmacy practice is intended to set the standard of professional behaviour for all the pharmacists. This is because in any organized profession, more than mere existence of an intellectual discipline is necessary.
2.3.1 pharmacist's code of ethics;
This is a guide to the pharmacists in their relationship with the patients, fellow practitioners & other health professionals & the public. A pharmacist should realized that ultimate success of the health profession largely depends how effectively the pharmacist has been able to make, store & dispense the drug to the public.
The pharmacist code of ethics was published by pharmacy council on 14th January,1988 & adopt by the council on 4th Jul
3.1) BANGLADESH NATIONAL FORMULARY:
A National Formulary is a manual containing a list of medicines that are approved for prescription throughout the country, indicating which products are interchangeable. It includes key information on the composition, description, selection, prescribing, dispensing and administration of medicines. Those drugs considered less suitable for prescribing are clearly identified.
In some countries, there are regional or provincial formularies instead of or in addition to the national formulary.
By the turn of the millennium, 156 countries had national or provincial essential medicines lists and 135 countries had national treatment guidelines and/or formulary manuals.
4.1) BRITISH NATIONAL FORMULARY(BNF):
The British National Formulary (BNF) is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service (NHS), including indication(s), contraindications, side effects, doses, legal classification, names and prices of available proprietary and generic formulations, and any other notable points. Though it is a national formulary, it nevertheless also includes entries for some medicines which are not available under the NHS and must be prescribed and/or bought privately tablets or monoxide solution). A symbol clearly denotes such drugs in their entry.
It is used by doctors (both general practitioners and specialist practitioners), and by other non-prescribing healthcare professionals (such as nurses, paramedics, and pharmacists) to help them use drugs optimally to care for patients as appropriately as possible. For example, it would be a useful reference source for nurses who administer medications on hospital wards, and even for patients and others seeking an authoritative source of advice on any aspect of pharmacotherapy.
Many individuals and organizations contribute towards the preparation of the BNF. It is jointly published by the Royal Pharmaceutical Society of Great Britain and the BMJ Group, which is owned by the British Medical Association. It is published under the authority of a Joint Formulary Committee which comprises representatives of the two professional bodies and the Department of Health.
Information on drugs is drawn from the manufacturers' product literature, medical and pharmaceutical literature, regulatory authorities and professional bodies. Advice is constructed from clinical literature and reflects, as far as possible, an evaluation of the evidence from diverse sources. The BNF also takes account of authoritative national guidelines and emerging safety concerns. In addition, the Joint Formulary Committee takes advice on all therapeutic areas from expert clinicians; this ensures that the BNF's recommendations are relevant to practice.