Tag: BP: British Pharmacopoeia

What is the British National Formulary?

Published on by Andrew MarshallLeave a comment

Introduction

The British National Formulary (BNF) is a United Kingdom (UK) pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicines available on the UK National Health Service (NHS).

Information within the BNF includes 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 purchased privately. A symbol clearly denotes such drugs in their entry.

It is used by pharmacists and doctors (both general practitioners (GPs) and specialist practitioners), and by other prescribing healthcare professionals (such as nurses, pharmacy technicians, paramedics, and dentists); as a reference for correct dosage, indication, interactions and side effects of drugs. It is also used as a reassurance by those administering drugs, for example a nurse on a hospital ward, and even for patients and others seeking an authoritative source of advice on any aspect of pharmacotherapy.

The British Pharmacopoeia (BP) specifies quality standards for the making of drugs listed in the BNF.

Development

Many individuals and organisations contribute towards the preparation of the BNF. It is jointly authored by the British Medical Association (BMA) and the Royal Pharmaceutical Society (RPS); and is jointly published by the BMJ Group (which is owned by the BMA), and the Pharmaceutical Press (owned by the RPS). It is published under the authority of a Joint Formulary Committee (JFC), which comprises representatives of the two professional bodies, and the Department of Health (DoH).

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. However, in September 2013, the National Institute for Health and Care Excellence (NICE) in the UK opened a consultation on its draft decision not to give NICE accreditation to the processes to produce BNF publications following a review by an independent advisory committee.

Brief History

It was first published in 1949 as the National Formulary, with updated versions appearing every three years until 1976. The fifth version in 1957 saw its name change to The British National Formulary. A new look version, under the auspices of Owen Wade, was released in 1981. A study in Northern Ireland looking at prescribing in 1965, reported that the BNF was likely able to serve the requirements of prescribers in general practice, while also achieving a cost saving. By 2003, issue 46 of the BNF contained 3000 interactions or groups of interactions, with about 900 of these marked by a bullet.

Editions

A new edition of the BNF book is published twice-yearly; in March and September. As of March 2022, the current edition is 83, which was published in March 2022. It is a customary tradition that the colour of each new edition is radically different from the previous.

Availability

The BNF is presently available as a book, a website, and mobile applications – the latter for use on smartphones and tablets. The book is available for purchase, and the September edition is distributed to healthcare professionals in the UK at no direct cost to them. NHS workers and healthcare professionals in the HINARI group of developing nations are entitled to free access via MedicinesComplete following registration (requires provision of a name, an address, an email address, and a phone number). Other visitors can subscribe to the BNF on MedicinesComplete. Healthcare organisations can also subscribe to a customisable BNF via their corporate online intranet. In June 2012, the National Institute for Health and Care Excellence (NICE) released applications for offline access to the BNF on iOS and Android devices. An NHS Athens log-in is required to use this application, and monthly content updates are available, over an internet connection. NICE also provides a website providing the content of the BNF to the public, including non-NHS users.

Sister Publications

The British National Formulary for Children (BNFC) book, first published September 2005, is published yearly, and details the doses and uses of medicines in children from neonates to adolescents.

The Nurse Prescriber’s Formulary for Community Practitioners (NPF) is issued in print every two years (September, odd-numbered years), for use by District Nurses and Specialist Community Public Health Nurses (including Health Visitors) who have received training to become nurse prescribers.

BNF Sections

The British National Formulary is divided into various sections; with the main sections on drugs and preparations being organised by body system.

Table of Contents

  • Preface.
  • Acknowledgements.
  • How BNF publications are constructed.
  • How to use the BNF.
  • Changes.
  • Guidance on prescribing.
  • Prescription writing.
  • Emergency supply of medicines.
  • Controlled drugs and drug dependence.
  • Adverse reactions to drugs.
  • Guidance on intravenous infusions.
  • Prescribing for children.
  • Prescribing in hepatic impairment.
  • Prescribing in renal impairment.
  • Prescribing in pregnancy.
  • Prescribing in breast-feeding.
  • Prescribing in palliative care.
  • Prescribing for the elderly.
  • Drugs and sport.
  • Prescribing in dental practice.

Notes on Drugs and Preparations

  1. Gastro-intestinal system.
  2. Cardiovascular system.
  3. Respiratory system.
  4. Nervous system.
  5. Infection.
  6. Endocrine system.
  7. Genito-urinary system.
  8. Malignant disease.
  9. Blood and nutrition.
  10. Musculoskeletal system.
  11. Eye.
  12. Ear, nose, and oropharynx.
  13. Skin.
  14. Vaccines.
  15. Anaesthesia.
  16. Emergency treatment of poisoning.

Appendices and Indices

  • Appendix 1 Interactions.
  • Appendix 2 Borderline substances.
  • Appendix 3 Cautionary and advisory labels for dispensed medicines.
  • Appendix 4 Wound management products and elasticated garments.
  • Dental Practitioners’ Formulary.
  • Nurse Prescribers’ Formulary.
  • Non-medical prescribing.
  • Index of proprietary manufacturers.
  • Special-order manufacturers.

This page is based on the copyrighted Wikipedia article < https://en.wikipedia.org/wiki/British_National_Formulary >; it is used under the Creative Commons Attribution-ShareAlike 3.0 Unported License (CC-BY-SA). You may redistribute it, verbatim or modified, providing that you comply with the terms of the CC-BY-SA.

What is the British Pharmacopoeia?

Published on by Andrew Marshall7 Comments

Introduction

The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom (UK). It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The British Pharmacopoeia is an important statutory component in the control of medicines, which complements and assists the licensing and inspection processes of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Together with the British National Formulary (BNF), the British Pharmacopoeia defines the UK’s pharmaceutical standards.

Pharmacopoeial standards are compliance requirements; that is, they provide the means for an independent judgement as to the overall quality of an article, and apply throughout the shelf-life of a product. Inclusion of a substance in a pharmacopoeia does not indicate that it is either safe or effective for the treatment of any disease.

Legal Basis

The British Pharmacopoeia is published on behalf of 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 (EC) 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, licence to manufacture.

Brief History

The regulation of medicinal products by officials in the United Kingdom dates back to the reign of King Henry VIII (1491-1547). The Royal College of Physicians of London had the power to inspect apothecaries’ products in the London area, and to destroy defective stock. The first list of approved drugs, with information on how they should be prepared, was the London Pharmacopoeia, published in 1618. The first edition of what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London, Edinburgh and Dublin Pharmacopoeias. The New Latin name that had some currency at the time was Pharmacopoeia Britannica (Ph. Br.).

In 1844, concern about the dangers of unregulated manufacture and use led William Flockhart – who had provided chloroform to Doctor (later Sir) James Young Simpson for his experiment on anaesthesia – to recommend the creation of a ‘Universal Phamacopoeia for Great Britain’ in his inaugural speech as president of the Northern British branch of the Pharmaceutical Society.

A commission was first appointed by the General Medical Council (GMC), when the body was made statutorily responsible under the Medical Act 1858 for producing a British pharmacopoeia on a national basis. In 1907, the British Pharmacopoeia was supplemented by the British Pharmaceutical Codex, which gave information on drugs and other pharmaceutical substances not included in the BP, and provided standards for these.

The Medicines Act 1968 established the legal status of the British Pharmacopoeia Commission, and of the British Pharmacopoeia, 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 Commission is also responsible for selecting and devising British Approved Names.

Since its first publication in 1864, the distribution of the British Pharmacopoeia has grown throughout the world and it is now used in over 100 countries. Australia and Canada are two of the countries that have adopted the BP as their national standard; in other countries, such as South Korea, the BP is recognised as an acceptable reference standard.

Content

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:
    • Medicinal Substances.
  • Volume III:
    • Formulated Preparations.
    • Blood related Preparations.
    • Immunological Products.
    • Radiopharmaceutical Preparations.
    • Surgical Materials.
    • Homeopathic Preparations.
  • Volume IV:
    • Appendices.
    • Infrared Reference Spectra.
    • Index.
  • Volume V:
    • British Pharmacopoeia (Veterinary).
  • Volume VI: (CD-ROM version):

The British Pharmacopoeia is available as a printed volume and electronically in both on-line and CD-ROM versions; the electronic products use sophisticated search techniques to locate information quickly. For example, pharmacists referring to a monograph can immediately link to other related substances and appendices referenced in the content by using 130,000+ hypertext links within the text.

Production

The British Pharmacopoeia is prepared by the Pharmacopoeial Secretariat, working in collaboration with the British Pharmacopoeia 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 British Pharmacopoeia 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 British Pharmacopoeia monographs.
  • British Pharmacopoeia Chemical Reference Substances (BPCRS): the laboratory is responsible for the procurement, establishment, maintenance and sale of BPCRS. The catalogue currently contains nearly 500 BPCRS, which are needed as standards for monograph tests in both the British Pharmacopoeia and the British Pharmacopoeia (Veterinary).

The current edition of the British Pharmacopoeia is available from The Stationery Office Bookshop.

Guidance

Detailed information and guidance on various aspects of current pharmacopoeial policy and practice is provided in supplementary chapters of the British Pharmacopoeia. This includes explanation of the basis of pharmacopoeial specifications, and information on the development of monographs including guidance to manufacturers.

British Approved Names

Refer to British Approved Name.

British Approved Names (BANs) are devised or selected by the British Pharmacopoeia Commission (BPC), and published by the Health Ministers, on the recommendation of the Commission on Human Medicines, to provide a list of names of substances or articles referred to in Section 100 of the Medicines Act 1968. BANs are short, distinctive names for substances, where the systematic chemical or other scientific names are too complex for convenient general use.

As a consequence of Directive 2001/83/EC, as amended, the British Approved Names, since 2002, may be assumed to be the recommended International Non-proprietary Name (rINN), except where otherwise stated. A World Health Organisation (WHO) INN identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognised, and in which no party can claim any proprietary rights. A non-proprietary name is also known as a generic name.

Related Publications

Refer to The International Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, Indian Pharmacopoeia Commission, Japanese Pharmacopoeia, and Pharmacopoeia of the People’s Republic of China.

The British National Formulary (BNF) and its related publications contain information on prescribing, indications, side effects and costs of all medication available on the National Health Service.

This page is based on the copyrighted Wikipedia article < https://en.wikipedia.org/wiki/British_Pharmacopoeia >; it is used under the Creative Commons Attribution-ShareAlike 3.0 Unported License (CC-BY-SA). You may redistribute it, verbatim or modified, providing that you comply with the terms of the CC-BY-SA.

What is a British Approved Name?

Published on by Andrew Marshall1 Comment

Introduction

A British Approved Name (BAN) is the official, non-proprietary, or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia (BP).

The BAN is also the official name used in some countries around the world, because starting in 1953, proposed new names were evaluated by a panel of experts from WHO in conjunction with the BP commission to ensure naming consistency worldwide (an effort leading to the International Nonproprietary Name system).

There is also a British Approved Name (Modified) (BANM).

Combination Preparations

BANs are unique in that names are assigned for combination preparations as well as single-drug preparations. For example, the BAN Co-amoxiclav is assigned to preparations containing amoxicillin and clavulanic acid. Most other pharmacopoeias simply refer to combination products by both ingredients in the preparation, in this example “amoxicillin with clavulanic acid”.

The prefix of “co-” is used for many combination drugs, including opioid with paracetamol or aspirin analgesics (e.g. Co-codamol, Co-codaprin, Co-dydramol, Co-proxamol). The other commonly encountered opioid combination is the anti-diarrhoeal, non-analgesic mixture of diphenoxylate and atropine, Co-phenotrope (aka Lomotil). Also antibiotics (e.g. Co-fluampicil and Co-trimoxazole), drugs to lower blood pressure (e.g. Co-tenidone), diuretics (e.g. Co-amilofruse and Co-amilozide), gastrointestinal drugs (e.g. Co-danthrusate), and anti-Parkinsonism agents such as Co-careldopa, Co-beneldopa, and others (e.g. Co-cyprindiol).

BAN Harmonisation

European Union legislation from 2001 required harmonisation of the BP with the European Pharmacopoeia (EP), as well as the adoption of International Nonproprietary Names through directives (2001/82/EC and 2001/83/EC, as amended, and 2003/63/EC). Across the EU has meant that, with the notable exception of adrenaline/epinephrine, BANs are now the same as the INNs. For example, the old BAN methicillin was replaced with the current BAN meticillin, matching the INN.

This has resulted in an interesting situation in other countries that use BANs. While the British Pharmacopoeia and BANs are the official pharmacopoeia/names defined by legislation in many of these countries, the former BANs often continue to be used, purportedly because of the difficulty of changeover. Despite the importance of the BP, there appears to be little or no movement in the direction of changing these names. In Australia, the Australian Approved Names are generally the same as BANs, but a few exceptions remain.

This page is based on the copyrighted Wikipedia article < https://en.wikipedia.org/wiki/British_Approved_Name >; it is used under the Creative Commons Attribution-ShareAlike 3.0 Unported License (CC-BY-SA). You may redistribute it, verbatim or modified, providing that you comply with the terms of the CC-BY-SA.