british pharmacopoeia assignment

An Introduction to BRITISH PHARMACOPOEIA/BP:

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 the year 1864 the first British Pharmacopoeia was published by combining the three old and reputed Pharmacopoeias namely Pharmacopoeia Londinensis (1618) Edinburgh Pharmacopoeia (1699) and Dublin Pharmacopoeia (1807). New editions and addendum was released quickly. The 2nd edition was released in 1867. The 3rd  and 4th  edition was published in the year 1885 and 1898 respectively. Addendum to 2nd and 3rd edition was released in the year 1874 and 1890 respectively.

Separate parts such as preparation of compounds are included in the 1864 British Pharmacopoeia. As per practice of several other Pharmacopoeias in this edition of British Pharmacopoeia the contents had been arranged alphabetically. A gap in revision belated the next edition of British Pharmacopoeia until 1914.

In Britain it was realized that technical complexity of the drug specifications was increasing and a different kind of set up was needed to prepare the Pharmacopoeias after publication of the British Pharmacopoeia 1914. Hence the further edition was published in 1928  and  1932.   There  after  the  commission  was  recommended  to  revise  the  British Pharmacopoeia every ten years once .

A range of diagnostic materials was included in 1932 revision. An important addition was inclusion of standards and tests for antitoxins and insulin. Seven addenda covered the interim between 1932 and next edition of 1948. In this 1948 edition (7th) , for substances newly introduced into medicine, generic names were provided. Methods of analysis such as disintegration tests for tablets and sterilization methods were expanded. Many new monographs related to sex hormones and penicillin’s were included. Due to the rapid development of pharmaceutical and pharmacological progress at this time it was decided that the normal interval between new editions should be five instead of ten years.

The next edition was released in the year 1953.  In this edition of British Pharmacopoeia, the titles of drugs and preparations were given in English instead of Latin. Abbreviated Latin title was retained as a synonym. Capsules, constituted as new group of formulation and the implant methods for sex hormones and their standards were also described in this edition. The 9th  edition (1958) contains 160 new monographs. Spectrophotometric analysis and inclusion of tranquillizing drugs are the other features of this edition. The next i.e., tenth edition was published in 1963.

The duties of the British Pharmacopoeia commission were defined clearly in medicines order 1970. The first edition of British Pharmacopoeia that was prepared strictly under the provisions of Medicines Act was the thirteenth edition which was published in the year 1980. Due to an expansion of drug information latter the British Pharmacopoeia was decided to publish in two volumes.

Authoritative standard for the quality of many substances preparation and articles used in medicine and pharmacy for some 130 years was provided in 1993 edition of British Pharmacopoeia. For the convenience of user this edition consolidates and extends the 1988 edition with its 1989, 1991, and 1992 addenda. Moreover monographs of the European Pharmacopoeia were also included in this particular edition.

British Pharmacopoeia 2013 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 are comprehensively indexed and cross-referenced for easy reference. Items used exclusively in veterinary medicine in the UK are included in the BP (Veterinary).

The volume I and II deals with medicinal substances, whereas volume III describes about formulated preparations, blood related preparations, immunological products, radiopharmaceutical preparations, surgical materials and homeopathic preparations. The volume IV contains appendices, infrared reference spectra and index. The volume V is for veterinary purpose i.e., British Pharmacopoeia (Veterinary). The volume VI is the CD-ROM version of British Pharmacopoeia, British Pharmacopoeia (Veterinary) and British approved names.

The 2013 edition of 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 1,30,000 plus hypertext links within the text.

The British Pharmacopoeia 2013 package comprises five volumes of the British Pharmacopoeia 2013 and a single volume of the British Pharmacopoeia (Veterinary) 2013, along with a fully searchable CD-ROM and online access which provided flexible resources.

The British Pharmacopoeia 2013 was legally effective from 1 January 2013 and contains 41 new British Pharmacopoeia monographs, 40 new European Pharmacopoeia monographs, 619 amended monographs, 6 new and 1 amended infrared reference spectra and European Pharmacopoeia 7th edition material up to and including Supplement 7.5. In addition updates in  January,  April  and  July  to  harmonise  with  the  European  Pharmacopoeia  was  also provided.

The current edition of the British Pharmacopoeia i.e., British Pharmacopoeia 2022 comprises five volumes and a single volume of the British Pharmacopoeia (Veterinary) 2014, along with a fully searchable CD-ROM and online access to provide with flexible resources.

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Pharmacology: Citing references

• Key resources
• Using EndNote

General guidance on referencing

• Videos on referencing, avoiding plagiarism, using Turnitin, using quotes and paraphrasing

Which referencing style should I use?

The School of Pharmacy recommend two different styles of referencing depending on the type of assignment: Harvard  (a name-date style) and Vancouver (a numbered style). The versions of these styles used are based on guidance given in the ' Cite Them Right' book. Note that other versions of these styles are not acceptable. 

This guidance applies to students on the MPharm, Pharmacology, Physician Associate and CIPPET programmes.

To reference correctly you need to provide the full details for each source in a list at the end of your document AND have a citation in the text to indicate which parts came from each source. The style you use for these will depend on whether you are using Harvard or Vancouver.

• Vancouver referencing guidance and examples
• Harvard referencing guidance and examples

Further support with writing references

For further help with formatting your references consult your Academic Liaison Librarian, Jackie Skinner - email, come to the weekly drop-in, or make an appointment (contact details below).

This video gives an overview of why and how you should reference materials used in your assignments. You will need to login with your University username and password to view this video.

The next video gives tips on how to use references in your work to avoid being accused of plagiarism:

If you are unable to view this video on YouTube it is also available on YuJa - view the Avoiding Unintentional Plagiarism video on YuJa (University username and password required)

When you submit your work you will be asked to do so through the Turnitin similarity checker. This video explains what this does and how you can use it to improve your writing.

If you are unable to view this video on YouTube it is also available on YuJa - view the Getting the most out of Turnitin video on YuJa (University username and password required)

The next two videos give guidance on using supporting evidence from publications in your assignments by using quotes or paraphrasing.

If you are unable to view this video on YouTube it is also available on YuJa - view the How to use long and short quotes video on YuJa (University username and password required)

If you are unable to view this video on YouTube it is also available on YuJa - view the Using paraphrases video on YuJa (University username and password required)

Quick links to referencing guidance

Guidance on using the name-year Harvard referencing style.

Guidance on using the numbered Vancouver style of referencing.

Citing tables, figures & images

Referencing visual elements taken from other sources.

Secondary referencing

Guidance on citing a source you have read about in another source

Harvard referencing - click on the tabs for guidance on specific publications

• General guidance
• Harvard video intro
• Chapters in edited books
• Journal articles
• British Pharmacopoeia
• NICE guidelines
• Local guidelines
• SmPCs/PILs on EMC
• Systematic reviews on The Cochrane Library
• Clinical trials
• Materials posted on Blackboard

The 'Cite Them Right' Harvard style is an author-date system. In-text citations include the author and year of the reference. Full references are listed at the end in alphabetical order by the author's surname. See the other tabs in this box for guidance on citing specific types of publication in this style.

In-text citations

For the Harvard style, your in-text citation should include:

• The author of the cited work
• The year of publication of the cited work.

There are two ways of including an in-text citation and you can use both depending on how you want to structure each sentence. You can include the citation with the author’s surname and date in brackets at the end of the sentence:

Medical systems need to be carefully considered and designed to reduce the likelihood of medication errors (Ferner, 2020).

Or, you can include the author’s surname as part of your sentence, in which case only the date is in brackets:

More recently, a paper by Ferner (2020) has suggested that...

You can use a mix of these approaches in your assignment.

How many authors do I need to include in the in-text citation?

If the citation has two authors.

List both authors with 'and' or '&' in between (but be consistent in your use of 'and' or '&').

A recent study by Morbey and Smith (2021) found that...

... (Morbey and Smith, 2021) .

If the citation has three authors

List all three authors with a comma after the first author, '&' or 'and' before the last author (but be consistent in your use of 'and' or '&').

A recent study by Chen, Savana and Patel (2022) found that...

... (Chen, Savana and Patel, 2022) .

If the citation has four or more authors

Use the first author's name followed by " et al. " in italics.

A recent study by Rang et al. (2020) found that...

It has been shown previously (Rang et al. , 2020) that....

Note: you will need to include ALL authors in the full reference at the end of your document.

Other citation questions

How do i cite more than one source for a sentence.

List the sources chronologically, separated by semi-colons.

There are many studies that have examined the effect of alcohol on cognitive impairment (Chen and Xi, 2012; Patel, 2020; Hussein et al ., 202 2) .

How do I differentiate references by the same author in the same year?

Differentiate them using letters after the year - both in the in-text citation and the full reference.

Chen and Hussein (2021a) ... and Chen and Hussein (2021b) ...

Can I cite a work by a company or organisation?

Many works by organisations do not have individually named authors. In this case, you can use the name of the organisation or company, such as Cancer Research UK or National Institute for Health and Care Excellence (NICE), as the author. This is known as a corporate author. 

Asthma UK (2015) studies have shown...    ...  (Asthma UK, 2015) .

What if I have multiple references by the same author in a sentence?

If you need to refer to two or more sources by the same author in different years, you do not need to keep repeating the author's surname in the citation. Include the surname and the oldest year first, then separate the other years by semicolons (;). The sources should be ordered by year of publication, with the oldest first.

NHS (2016; 2019; 2021) studies have consistently shown    ... (NHS, 2016; 2019; 2021)

You must include all of the sources separately in your reference list.

Do I need to include page numbers in my citation?

You only need to include a page number if directly quoting from a work. Enclose the quote in single quotation marks and include a page number in the in-text citation. For example:

More recently, a paper by Walker et al. (2020) stated that 'student pharmacists are valuable and important to practice model transformation' (p. 47) .

A recent paper stated that 'student pharmacists are valuable and important to practice model transformation' (Walker et al.,  2020, p. 47) .

How do I refer to a source referenced in another work?

This type of referencing is known as secondary referencing and should be avoided wherever possible , as the author citing the work may bring their own bias or misinterpretation. It is better to seek out the original reference and cite it directly if it is useful.

See further guidance on secondary referencing below.

Reference list

References must be listed at the end of your document in  alphabetical order by author surname/organisation name.  If you use the same source more than once, just use the same in-text citation as previously to refer to the same full reference. 

Author names

Cited using Surname, Initials - place a comma and a space between the surname and initials. Full stops between initials e.g.:

Multiple authors

List all of the authors in the full reference in the order they appear on the publication.

Additional guidance

See the tabs in this box for additional guidance and relevant examples. Our Harvard guidance is closely aligned with that given in the 'Cite them right' book and website (below). You can find extra publication types and examples via this website. Note that we deviate from this guide in some case to make references simpler e.g. only requiring DOI or web address for articles which do not have page numbers or an article reference number.

• Harvard referencing guidance in Cite Them Right

You will need to login with your University username and password to view this video.

Citing books and e-books

Most books and e-books can be cited in the same way. If you are viewing the PDF of a printed book there is no need to include the web address in your reference if you have the place published and publisher.

Include the following in your reference:

• Author/Editor name(s) in the format 'Surname, Initials'
• Year of publication (in round brackets)
• Book title (in italics or underlined) followed by a full stop.
• Edition (if 2nd edn or later)
• Place of publication followed by a colon e.g. London:

Copy the format and punctuation of these examples.

Example: book with a single author/editor

Citation in the text:      (Houghton, 2020)

Full reference:      Houghton, A.R. (2020) Making sense of the ECG: a hands-on guide.  5th edn. Boca Raton: CRC Press.

Example: book with two authors/editors

Citation in the text:   (Jeukendrup and Gleeson, 2019)

Full reference: Jeukendrup, A. and Gleeson, M. (2019) Sport nutrition . 3rd edn. Champaign: Human Kinetics.

Example: book with four or more authors/editors

Citation in the text:    (Ritter  et al. , 2023)

Full reference: Ritter, J.M., Flower, R.J., Henderson, G., Loke, Y.K., MacEwan, D., Robinson, E. and Fullerton, J. (2024)  Rang & Dale's pharmacology,  10 th edn. London: Elsevier.

Note that all authors are included in the full reference.

Citing online only books

Where an e-book looks like a printed book (usually PDFs) and you can find all the publication information (including place published and publisher) - cite it in the same way as a printed book (above). You do not need to include the web address. 

Some books are born digital and are not published in a traditional format. Where it is not possible to find the publication information include the web address and date accessed instead, as in the examples below:

Citation in the text:    (UK Health Security Agency, 2020)

Full reference: UK Health Security Agency (2020) Immunisation against infectious disease (The Green Book) . Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book (Accessed: 21 January 2024).

Citation in the text:    (Grabrucker, 2021)

Full reference: Grabrucker, A.M. (ed.) (2021)  Autism spectrum disorders.  Available at: https://www.ncbi.nlm.nih.gov/books/NBK573612/ (Accessed: 25 January 2024).

Note: Using StatPearls? Follow the guidance on  citing an online only book chapter .

EndNote tips

• Use the Reference Type 'Book'
• Author: in the format surname, initials, each author on a separate line
• Place published:
• Edition: if not the first - just add the number e.g. 2nd, 3rd
• Use the Reference Type  'Edited book'
• Editor: in the format surname, initials, each editor on a separate line
• Other fields the same as above
• Use the Reference Type 'Electronic Book'
• Date Accessed: the date you looked looked at the book in the format day month year e.g. 17 January 2024
• URL: paste in the web link

Citing book chapters

• Chapter author name(s) in the format 'Surname, Initials'
• Chapter title in single quotation marks
• in followed by book editor(s) name(s) in the format 'Surname, Initials' followed by (ed.) or (eds)
• Book title (in italics)
• Edition (if second edition or later)
• Publisher's name
• Chapter pagination preceeded by pp.

Include the page extent of the whole chapter when writing your full citation. Put just the pages you have referred to in the in-text citation.

Example: book chapter with three authors

Citation in the text:      (Singh, Khurana and Singh, 2018, p. 38)

Full reference:     Singh, H., Khurana, L.K. and Singh, R. (2018) 'Pharmaceutical development', in Vohora, D. and Singh, G. (eds) Pharmaceutical medicine and translational clinical research . London: Academic Press, pp.33-46.

Example: book chapter with four or more authors

Citation in the text:      (Hosznyak  et al ., 2012, p. 199)

Full reference: Hosznyak, R., Hosznyak, E., Westaway, A. and Graveson, J. (2017) 'Eye, ear, nose and throat assessment', in Ranson, M. and Abbott, H. (eds)  Clinical examination skills for healthcare professional . 2nd edn. Keswick: M & K Publishing, pp. 126-137.

Citing chapters in online only books

Where an e-book chapter looks like a printed book chapter (usually PDFs) and you can find all the publication information (including place published and publisher) - cite it in the same way as a printed book (above). You do not need to include the web address.

Where it is not possible to find the publication information include the web address and date accessed instead:

• Chapter author(s) in the format 'Surname, Initials' 
• Chapter title in single quotation marks. Capitalise only the first letter of the first word and any proper nouns.
• 'in' followed by book editor(s) name(s) in the format 'Surname, Initials' followed by (ed.) or (eds)
• Book title (in italics). Capitalise only the first letter of the first word and any proper nouns.
• Edition (if 2nd or later)
• Available at: https://doi.org... or web address
• Accessed: date in round brackets (date in this format 25 January 2022)

Copy the format and punctuation of these examples:

UK Health Security Agency (2013) 'Immunisation by nurses and other healthcare professionals', in  Immunisation against infectious disease (The Green Book) . Available at: https://www.gov.uk/government/publications/immunisation-by-nurses-and-other-health-professionals-the-green-book-chapter-5 (Accessed: 3 February 2024)

Kawakami, S and Otsuka, S. (2021) 'Multisensory processing in autism spectrum disorders', in Grabrucker, A.M. (ed.)  Autism spectrum disorders . Available at: https://www.ncbi.nlm.nih.gov/books/NBK573612/ (Accessed: 7 January 2024)

Squadrito, F.J. and del Portal, D. (2022) 'Nitrofurantoin', in  StatPearls . Available at: https://www.ncbi.nlm.nih.gov/books/NBK470526/ (Accessed: 1 February 2024).

• Use the Reference Type  'Book Section'
• Author: in the format surname, initials. Each author on a separate line.
• Title: title of chapter 
• Editor: (include all the editors in the format surname, initials. Each editor on a separate line)
• Book title:
• Pages: page numbers for the chapter e.g. 301-335
• Use the Reference Type 'Electronic Book Section'
• Complete the details above (as much as possible)
• Add URL: paste in the web link
• Add Access Date: the date you looked looked at the book in the format day month year e.g. 3 February 2024

Note that the way you enter an online only chapter on EndNote for the Harvard style is different from the way you enter it for the Vancouver style. It is not possible to reuse one entry in both styles.

Note that the default 'Cite Them Right Harvard' style in EndNote does not handle e-book sections very well. Download and use our amended style which corrects these issues:

• Reading Cite Them Right Harvard style Once downloaded open the style and go to 'File' and 'Save as' and 'Save'. This should save it into a location where EndNote can find it and use it. You will then need to select the 'Reading Cite Them Right-Harvard' style from the list of styles in Word (click on 'Select another style' to find it).

Alternatively as a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the reference to match the guidance above.

Citing journal articles which have page numbers or article reference numbers

• ALL Author name(s) in the format 'Surname, Initials'
• Year of publication (in brackets)
• Article title - in lower case apart from the first letter of the first word and any proper nouns
• Journal title (in italics) - give the journal name in full, not abbreviated. Use initial capital letters on all significant words.
• Volume number
• Issue number (if present, in round brackets)
• Page numbers or reference number (Include the page numbers of the whole article when writing your full citation, not just the pages you have referred to)

Example: journal article with a single author

Citation in the text:    (Rhee, 2022)

Full reference:    Rhee, E. (2022) 'The influence of obesity and metabolic health on vascular health',  Endocrinology and Metabolism,  37(1), pp. 1-8.

Example: journal article with two authors

Citation in the text:    (Rana and Neeland, 2022)

Full reference:     Rana, M.N. and Neeland, I.J. (2022) 'Adipose tissue inflammation and cardiovascular disease: an update',  Current Diabetes Reports,  22(1), pp. 27-37.

Example: journal article with four or more authors and an article reference number

Citation in the text:    (Zheng  et al ., 2021)

Full reference: Zheng, Y., Phillips, C.L., Sivam, S., Wong, K., Grunstein, R.R., Piper, A.J. and Yee, B.J. (2021) 'Cardiovascular disease in obesity hypoventilation syndrome – a review of potential mechanisms and effects of therapy',  Sleep Medicine Reviews,  60, pp. 101530.

You must include all authors in the full reference.

Citing online journal articles without page numbers or article reference numbers

• Available at: DOI (preceded by https://doi.org/) or Web link If including a weblink make sure it is as short as possible and doesn't include intermediate websites or your search string. 
• Accessed: date you looked at the article in the format day month year e.g. 12 January 2024.

Copy the format and punctuation of these examples:

Article with no page numbers or reference number:

Citation in the text:    (Azpiroz  et al ., 2017)

Full reference: Azpiroz, F., Dubray, C., Bernalier-Donadille, A., Cardot, J.M., Accarino, A., Serra, J., Wagner, A., Respondek, F., Dapoigny, M. (2017) 'Effects of scFOS on the composition of fecal microbiota and anxiety in patients with irritable bowel syndrome: a randomized, double blind, placebo controlled study'. Neurogastroenterology & Motility , 29(2). Available at: https://doi.org/10.1111/nmo.12911 (Accessed: 29 January 2024)

In Press article

Articles are often made available before they receive their official publication details (volume and issue number). If an article is shown as 'In press' or 'Online ahead of print' and doesn't yet have these details, just use (in press) after the journal name and add the DOI web address and date accessed.

Citation in the text: (Vaghari-Tabari  et al ., 2023)

Full reference: Vaghari-Tabari, M., Jafari-Gharabaghlou, D., Mohammadi, M., & Hashemzadeh, M.S. (2023). Zinc oxide nanoparticles and cancer chemotherapy: helpful tools for enhancing chemo-sensitivity and reducing side effects?  Biological Trace Element Research  (in press). Available at: https://doi.org/10.1007/s12011-023-03803-z (Accessed: 25 January 2024)

You should be able to download details for most articles from databases such as Summon, Web of Science, Scopus and PubMed. If you need to type one in from scratch this is the information to include.

For most articles

• Use the Reference Type 'Journal Article'
• Author: in the format surname, initials - each author on a separate line
• Title: title of the article - in lower case apart from the first letter of the first word and any proper nouns
• Journal: name of the journal - give the journal name in full, not abbreviated. Use initial capital letters on all significant words.
• Issue: (if present)
• Pages: page numbers or article reference number

For online only articles without page numbers or an article reference number and 'In press' articles

• Use the reference Type 'Electronic Article'
• Periodical Title: name of the journal - give the journal name in full, not abbreviated. Use initial capital letters on all significant words.
• Issue: (put in press here for articles currently being published)
• Date Accessed: the date you looked at the article in the format day month year e.g. 25 January 2024.
• URL: If there isn't a DOI add the web address for the article in the URL field. If there is already a URL in the box check that it goes to the article, not back to the reference on the database you downloaded it from. When including a web address make sure it is as short as possible and doesn't include intermediate websites or your search string. 

Citing web pages or web sites

You should avoid citing webpages unless you are clear of their quality and suitability for inclusion in academic work. See the 'Websites' tab within this guide for more information on evaluating webpages.

Only follow this guidance if the item you want to reference is not a book, a book chapter or a journal article.  When you search the internet you will find many different types of content. The first step to referencing correctly is to recognise what you are looking at.

• Could it be a book? Is it a PDF? Does it have a title page giving the title and the authors/editors? Does it have a place published and publisher on the following page? If 'Yes' it is probably a book - follow the guidance on citing a book.
• Could it be a book chapter? Does it say 'Chapter' on it? Does it have page numbers? If 'Yes' it could be a book chapter - follow the guidance on citing a book chapter.
• Could it be journal article? Does it have an abstract or summary? Does it mention the name of a journal and have a volume number? If 'Yes' it could be a journal article - follow the guidance on citing a journal article.

For guidance on citing specific, commonly used pharmacy-related sources see the other tabs in this box.

Citing reputable websites and webpages

• Author name(s) in the format 'Surname, Initials', or organisation that created the page
• Year information was created or last edited (in brackets). You might need to scroll to the bottom of the page to find it. If there is no date put (no date)
• Page title (in italics and in lower case apart from the first letter of the first word and any proper nouns)
• Available at: followed by the web address. Make sure the address is as short as possible and doesn't include intermediate websites or your search string. 
• Accessed: date in round brackets

Example: webpage with a named author

Citation in the text:    (Reynolds, 2023)

Full reference:  Reynolds, M. (2023) How the team monitoring new and emerging infectious diseases could help prevent the next pandemic . Available at: https://ukhsa.blog.gov.uk/2023/08/08/how-the-team-monitoring-new-and-emerging-infectious-diseases-could-help-prevent-the-next-pandemic/ (Accessed: 2 February 2024) 

Examples: webpages with an organisation as the author

Citation in the text:      (DrugBank, 2024)

Full reference:  DrugBank (2024)  Ranitidine . Available at: https://www.drugbank.ca/drugs/DB00863 (Accessed: 8 February 2024).

Citation in the text:     (Office for Health Improvement & Disparities, 2024)

Full reference: Office for Health Improvement & Disparities  (2024)  Cardiovascular disease . Available at: https://fingertips.phe.org.uk/profile/cardiovascular [Accessed: 31 January 2024]

Example: webpage without a date

If there isn't a date on the website, even at the bottom of the page, use 'no date'. 

Citation in the text:     (IUPHAR/BPS, no date)

Full reference: IUPHAR/BPS (no date)  Ibuprofen . Available at: https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=2713 [Accessed: 6 February 2024]

• Use the Reference Type 'Web Page'
• Author: in the format surname, initials - each author on a separate line Organisation as the author? Put a comma after the name to ensure it formats correctly e.g. British Nutrition Foundation,
• Year: use the updated date for the page, if there isn't a date use 'no date'
• Title: (in lower case apart from the first letter of the first word and any proper nouns)
• Access Date: the date you looked at the site in the format day month year e.g. 17 January 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 17 January 2024)
• URL: paste in the web link. Make sure it is as short as possible and doesn't include intermediate websites or your search string. 
• Organisation as the author? Put a comma after the name to ensure it formats correctly e.g. British Nutrition Foundation,

You can also download our amended 'Cite Them Right-Harvard' style to correct the issue with the missing closing bracket:

Citing the BNF

Update December 2023: You can now choose which version of the BNF to use in your work: in print; on the NICE website; on the MedicinesComplete website; or via the BNF App. There's guidance on citing each below.

When citing the BNF you only need one generic reference, not specific references for each drug or piece of information you have used. Just make it clear in your text which drug/section you are referring to. 

Print version

• Author - Joint Formulary Committee
• Title - British National Formulary (BNF) in italics
• Place of publication: London
• Publisher: BMJ Group and Pharmaceutical Press

Use the format and punctuation shown in this example - update the edition and year to the one you are using:

Citation in the text:       (Joint Formulary Committee, 2023)

Full reference: Joint Formulary Committee (2023)  British National Formulary (BNF)   86 . London: BMJ Group and Pharmaceutical Press.

Online versions (NICE and MedicinesComplete)

• For the NICE website version take the year from the 'Last updated' date on the BNF homepage.
• For the MedicinesComplete version use the year from the 'Publication last updated' date from the top of the page instead of the date the individual drug was updated
• For the NICE website version take this from the 'Last updated' date on the BNF homepage.
• For the MedicinesComplete take this from the 'Publication last updated' date from the top of the page.
• Available at: https://bnf.nice.org.uk/ (Accessed: date) OR Available at: https://www.medicinescomplete.com (Accessed: date) Note that you just use the site web address, not the page address for the specific drug you are using. The accessed date is the date you looked at the information in the format day month year e.g. 25 January 2024.

Citation in the text:       (Joint Formulary Committee, 2023)

Full reference (NICE version): Joint Formulary Committee (2023)  British National Formulary (BNF). 13 December 2023 . Available at: https://bnf.nice.org.uk/ (Accessed: 8 February 2024)

Full reference (MedicinesComplete version): Joint Formulary Committee (2023)  British National Formulary (BNF). 9 January 2024 . Available at: https://www.medicinescomplete.com (Accessed: 8  February 2024 )

• Year of publication (in round brackets) - use the year given on the homepage of the app
• Title - British National Formulary (BNF) app in italics
• BNF update date - use the month and year from given on the homepage of the app
• Format: [Mobile app].
• Available at (use the Google Android or Apple Mac link depending on which you are using) followed by (Accessed: date): Available at: https://play.google.com/store/apps/details?id=com.pharmpress.bnf (Accessed: date) Available at: https://apps.apple.com/gb/app/bnf-publications/id1045514038 (Accessed: date) The accessed date is the date you looked at the information in the format day month year e.g. 25 January 2024.

Copy the format and punctuation of this example:

Citation in the text:       (Joint Formulary Committee, 2024)

Full reference: Joint Formulary Committee (2024)  British National Formulary (BNF) app. January 2024 . [Mobile app]. Available at: https://play.google.com/store/apps/details?id=com.pharmpress.bnf (Accessed: 25 January 2024).

For the print version

• Author: Joint Formulary Committee, (make sure you put the comma after the name to make it format correctly)
• Title: British National Formulary (BNF) followed by Version number e.g. British National Formulary (BNF) 86

For the online versions:

• Use the Reference Type 'Web Page'
• Year: 
• Title: followed by the update date e.g. British National Formulary (BNF). January 2024 OR 9 January 2024 (depending on which version you are using)
• Access Date: the date you looked at the site in the format day month year e.g. 4 February 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 4 February 2024)
• URL: https://bnf.nice.org.uk/ OR https://www.medicinescomplete.com (depending on which version you are using)
• Note that if you have added Type of Medium 'Internet' to comply with the Vancouver style, you will need to remove it to create a correct Harvard reference. 

For the app:

• Title: followed by the update date e.g. British National Formulary (BNF). January 2024 
• Type of medium: Mobile app
• URL: https://play.google.com/store/apps/details?id=com.pharmpress.bnf OR https://apps.apple.com/gb/app/bnf-publications/id1045514038 (depending on which version you are using)

Citing the British National Formulary for children (BNFC)

Update December 2023: You can now choose which version of the BNFC to use in your work: in print; on the NICE website; on the MedicinesComplete website; or via the BNF App. There's guidance on citing each below.

When citing the BNFC you only need one generic reference, not specific references for each drug or piece of information you have used. Just make it clear in your text which drug/section you are referring to. 

• Author(s): Pediatric Formulary Committee
• Title: British National Formulary for children (in italics) and version
• Publisher: BMJ Group, Pharmaceutical Press and RCPCH Publications

Copy the format and punctuation of this example.  Make sure you check the date and edition of the version you are using.

Citation in the text:      (Pediatric Formulary Committee, 2022)

Full reference: Pediatric Formulary Committee (2022)  British National Formulary for children   2022-2023 . London: BMJ Group, Pharmaceutical Press and RCPCH Publications.

• Year of publication (in round brackets) For the NICE website version take the year from the 'Last updated' date on the BNFC homepage. For the MedicinesComplete version use the year from the 'Publication last updated' date from the top of the page you are viewing.
• Title: British National Formulary for children (BNFC)  (in italics)
• BNFC update date For the NICE website version take this from the 'Last updated' date on the BNFC homepage. For the MedicinesComplete take this from the 'Publication last updated' date from the top of the page.
• Available at: https://bnfc.nice.org.uk/ (Accessed: date) OR Available at: https://www.medicinescomplete.com (Accessed: date) Note that you just use the site web address, not the page address for the specific drug you are using. The accessed date is the date you looked at the information in the format day month year e.g.5 February 2024.

Copy the format and punctuation of this example.  Make sure you check the date and edition (month and year) of the version you are using.

Citation in the text:      (Pediatric Formulary Committee, 2023)

Full reference (NICE version): Pediatric Formulary Committee (2023)  British National Formulary for children (BNFC) . 13  December 2023 . Available at: https://bnfc.nice.org.uk/ (Accessed: 4 February 2024)

Full reference (MedicinesComplete version): Pediatric Formulary Committee (2023)  British National Formulary for children (BNFC) . 9 January 2024 . Available at: http://www.medicinescomplete.com (Accessed: 4 February 2024)

• Author - Pediatric Formulary Committee
• Title - British National Formulary for children (BNFC) app in italics
• BNFC update date - use the month and year from given on the homepage of the app
• Available at (use the Google Android or Apple Mac link depending on which you are using) followed by (Accessed: date): Available at: https://play.google.com/store/apps/details?id=com.pharmpress.bnf (Accessed: date) Available at: https://apps.apple.com/gb/app/bnf-publications/id1045514038 (Accessed: date) The accessed date is the date you looked at the information in the format day month year e.g. 1 February 2024.

Citation in the text:       (Pediatric Formulary Committee, 2023)

Full reference: Pediatric Formulary Committee (2023)  British National Formulary for children (BNFC) app. December 2023 . [Mobile app]. Available at: https://play.google.com/store/apps/details?id=com.pharmpress.bnf (Accessed: 4 February 2024)

• Author: Pediatric Formulary Committee, (make sure you put the comma after the name to make it format correctly)
• Title: followed by version e.g. British National Formulary for children 2022-2023
• Place published: London
• Publisher:  BMJ Group, Pharmaceutical Press and RCPCH Publications
• Author: Pediatric Formulary Committee, (make sure you put the comma after the name to make it format correctly)
• Title: followed by the latest update date (see above for where to find this date) e.g.  NICE version: British National Formulary for children (BNFC). December 2023 MedicinesComplete version: British National Formulary for children (BNFC). 9 January 2024.
• URL: https://bnfc.nice.org.uk/ OR https://www.medicinescomplete.com (depending on which version you are using)
• Title: followed by the update date e.g. British National Formulary for children (BNFC). December 2023 

Citing the British Pharmacopoeia

When citing the British Pharmacopoeia you only need one generic reference, not specific references for each drug or section you have used. Just make it clear in your text which drug/section you are referring to. 

• Author: British Pharmacopoeia Commission
• Title: British Pharmacopoeia. Version. (in italics)
• Available at: https://www.pharmacopoeia.com (Accessed: date)

Copy the format and punctuation of this example (make sure you change the Version and dates to match the ones you use):

Citation in the text:      (British Pharmacopoeia Commission, 2024)

Reference list: British Pharmacopoeia Commission. (2024).  British Pharmacopoeia . Ph. Eur. 11.4 update. Available at: https://www.pharmacopoeia.com (Accessed: 8 February 2024)

• Author: British Pharmacopoeia Commission, (make sure you put the comma after the name to make it format correctly)
• Title: followed by the update date e.g. British Pharmacopoeia. Ph. Eur. 11.4 update
• Access Date: the date you looked at the site in the format day month year e.g. 8 February 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 8 February 2024)
• URL: https://www.pharmacopoeia.com

Access the British Pharmacopoeia

Access to the latest edition of The British Pharmacopoeia (BP), the leading collection of standards for UK medicinal products and pharmaceutical substances.

Help and guidance How to use the BP

Citing NICE guidelines

• Author: National Institute for Health and Care Excellence (NICE)
• Year created/updated (use the most recent date) in round brackets
• Title of document/page  (in italics) followed by the guideline reference number in round brackets
• Available at: followed by the web address

Copy the format and punctuation of this example.

In-text citation:   (National Institute for Health and Care Excellence (NICE), 2021)

Full reference: National Institute for Health and Care Excellence (NICE) (2021)  Acute heart failure: diagnosis and management (CG187).  Available at: https://www.nice.org.uk/guidance/cg187 (Accessed: 28 January 2024)

• Author: National Institute for Health and Care Excellence (NICE), - make sure you put a comma after the name so it formats correctly Organisation as the author? Put a comma after the name to ensure it formats correctly e.g. British Nutrition Foundation,
• Access Date: the date you looked at the site in the format day month year e.g. 28 January 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 28 January 2024)
• URL: paste in the web link (For a shorter reference use the link for the webpage instead of the longer PDF link)

Citing local guidelines

Local guidelines, although authored by individuals, should be ratified by a designated committee therefore are the work of the organisation.

Print guidelines

• Author - organisation name
• Year of publication in round brackets
• Title of policy and Version (in italics)
• Place of publication
• Publisher (often the same as the author)

Use the text formatting and punctuation shown in this example.

Citation in the text:     (Imperial College Healthcare NHS Trust, 2023)

Full reference: Imperial College Healthcare NHS Trust (2023)  Non-medical prescribing policy .  Version 5. London: Imperial College Healthcare NHS Trust.

Online guidelines

• Title of policy and Version  (in italics)

Citation in the text:     (North East London Health & Care Partnership, 2023)

Full reference: North East London Health & Care Partnership  (2023)  North East London (NEL) management of infection guidance for primary care . August 2023 . Available at: https://gp-website-cdn-prod.s3.amazonaws.com/prescribing-guideline-downloads/1697724608-4663d459fc894709f71ce7beaa8662db.pdf (Accessed: 8 February 2024)

For print guidelines

• Use the Reference Type 'Book'
• Author: in the format surname, initials, each author on a separate line. If the author is an organisation put a comma after the name to make sure it formats correctly e.g. Imperial College Healthcare NHS Trust,
• Title: (in lower case apart from the first letter of the first word and any proper nouns) include the Version after the title e.g. Non-medical prescribing policy. Version 5

For online guidelines

• Use the Reference Type 'Web Page' 
• Author: in the format surname, initials, each author on a separate line. Organisation as the author? Put a comma after the name to ensure it formats correctly e.g. e.g. North East London Health & Care Partnership,

Citing SmPCs (Summaries of Product Characteristics) OR PILs (Patient Information Leaflets) on the Electronic Medicines Compendium

• Author - drug company who wrote the SmPC
• Year updated on EMC
• Title followed by Electronic Medicines Compendium.  (in italics)

Copy the format and punctuation of these examples.

Citation in the text:     (Wockhardt UK Ltd, 2017)

Full reference: Wokhardt UK Ltd (2017)  Aciclovir 400mg tablets summary of product characteristics . Electronic Medicines Compendium . Available at: https://www.medicines.org.uk/emc/product/2352/smpc (Accessed: 25 January 2024).

Citation in the text:      (Dermal Laboratories Limited, 2024)

Full reference: Dermal Laboratories Limited (2024)  Ibugel patient information leaflet . Electronic Medicines Compendium . Available at: https://www.medicines.org.uk/emc/product/3759/pil (Accessed: 7 February 2024).

• Use the Reference Type 'Web Page'
• Author: company name. Put a comma after the company name to ensure it formats correctly e.g. Wockhardt UK Ltd,
• Title: (in lower case apart from the first letter of the first word and any proper nouns). Add ': Electronic Medicines Compendium' after the title.
• Access Date: the date you looked at the site in the format day month year e.g. 7 February 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 7 February 2024)

Citing systematic reviews on The Cochrane Library database

• Author(s) in the format Surname, Initials
• Title of review (in single quotation marks)
• Database name (in italics)
• Issue number
• Article number (CD ...)
• DOI or Available at: web address (Accessed: date)

Citation in the text:     (Crowe, Chang and Wallace, 2016)

Reference list: Crowe, L., Chang, A., and Wallace, K. (2016) 'Instruments for assessing readiness to commence suck feeds in preterm infants: effects on time to establish full oral feeding and duration of hospitalisation',  Cochrane Database of Systematic Reviews,  8, CD005586, DOI: 10.1002/14651858.CD005586.pub3

• Use the Reference Type 'Electronic article'
• Title: title of the review - in lower case apart from the first letter of the first word and any proper nouns
• Periodical Title: The Cochrane Database of Systematic Reviews
• Volume: Issue number, Article number e.g. 8, CD005586

Note that the way you enter a Cochrane Review on EndNote for the Harvard style is very different from the way you enter it for the Vancouver style. It is not possible to reuse one entry in both styles.

Access The Cochrane Library

Systematic reviews, protocols and trials on the effects of interventions in health care. Free to UK residents

Includes: -The Cochrane Database of Systematic Reviews (Cochrane Reviews) -The Cochrane Central Register of Controlled Trials (CENTRAL) -The Cochrane Database of Methodology Reviews (Methodology Reviews) Help and guidance You can find training materials and videos by registering with the Cochrane Library Training Hub (requires an e-mail address).

Citing clinical trials

Although most references refer to the published paper as this details the results of the clinical trial, depending on the context of what you write you may need to reference the clinical trial itself.

• Author(s) in the format Surname, Initials (this will be the primary contact for the trial)
• Title of trial (in single quotation marks)
• Database/registry name (in italics)
• Trial reference number

Example 1: with a DOI

Citation in the text:     (Crooks, 2023)

Full reference: Crooks, M. (2023) 'An investigation into how adding an inhaled steroid to COPD treatment may potentially protect against heart disease',  ISRCTN , ISRCTN29148209. DOI: 10.1186/ISRCTN29148209 .

Example 2: without a DOI

Citation in the text:     (Lingor, 2023)

Full reference: Lingor, P. (2023) 'Safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease',  ClinicalTrials.gov,  NCT05931575. Available at: https://clinicaltrials.gov/study/NCT05931575 (Accessed: 9 January 2024).

• Periodical Title: Database/Registry name
• Volume: Trial number
• Date Accessed: date you looked at it in the format day month year e.g. 9 January 2024 Note there is a fault in the Cite Them Right Harvard style which omits the closing bracket after the date. Just type the closing bracket after the year in EndNote for it to appear e.g. 9 January 2024)
• DOI: add DOI if it has one
• URL: the web link if no DOI
• Note that the way you enter a Clinical Trial on EndNote for the Harvard style is very different from the way you enter it for the Vancouver style. It is not possible to reuse one entry in both styles.

Citing materials posted on Blackboard

Always check with your tutor if you are allowed to refer to course materials in your own work. It is preferable to use published sources where possible, such as articles and books. 

• Author's name in the format Surname, Initials
• Year in round brackets
• Title of document/presentation as given on Blackboard (in single quotation marks)
• Medium in square brackets e.g. [PowerPoint presentation, Lecture, Recorded lecture)
• Module code: module title (in italics)
• Institution
• Available at: https://www.bb.reading.ac.uk (Accessed: date)  Note that you do not need to give the specific web address for the material you are citing. The address for Blackboard is sufficient.

Example 1: PowerPoint slides

Citation in the text:     (Cottrell, 2023)

Full reference: Cottrell, G. (2023) 'The molecules of life: proteins' [Presentation slides]. PM1PY2: Fundamentals of Cell Biology . University of Reading. Available at: https://www.bb.reading.ac.uk (Accessed: 2 December 2023).

Example 2: Handout

Citation in the text:     (University of Reading, no date)

Full reference: University of Reading (no date)  'Direct observation of procedural skills (DOPS) assessment form' [Handout]   PM2PY1: Professional Practice 2 . University of Reading. Available at: https://www.bb.reading.ac.uk (Accessed: 20 November 2023).

For guidance on citing other types of materials posted on Blackboard see Section G7 of the following book:

• Use the Reference Type  'Web Page' 
• Series title: module code and title
• Publisher: University of Reading
• Access Date: date you looked at it in the format day month year e.g. 25 January 2024
• Type of Medium: add the Format here e.g. Presentation slides, Lecture notes, Recorded lecture, Handout
• URL: https://www.bb.reading.ac.uk 

Note that even with the information entered as above the default 'Cite Them Right-Harvard' style in EndNote will not quite format the reference correctly - the title of the document should be enclosed in single quotes and be in plain text; the module details should be in italics; there should be closing bracket after the access date; the Type of Medium should be after the document title. To correct this, as a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the references.

Vancouver referencing - click on the tabs for guidance on specific publications

• Vancouver video intro
• Systematic reviews on the Cochrane Library

Vancouver is a numbered style. Each piece of work cited should have a unique number, assigned in order (your first reference is 1, your second is 2 etc.). It is a very plain style with little punctuation and no text formatting such as italics, underlining or bold.

When adding an in-text citation to your document you can write the number in brackets:

Medical systems need to be carefully considered and designed to reduce the likelihood of medication errors (1).

How do I cite multiple sources together?

• When citing two or more sources at once, write a number for each separated by a comma e.g. (1, 2) or (6, 12)
• When citing more than two sources which are numbered consecutively, use a hyphen instead of a comma e.g. (3-5)

For example:

There are many studies that have examined the effect of alcohol on cognitive impairment (1,2, 4-7, 9).

How should I refer to authors in the text?

You do not have to refer to the authors' names in the text but it may help the flow of your writing to do so.

Two authors: give both author's surnames linked with 'and'. For example:

A recent study by Chen and Lee (4) found that...

Three or more authors: use the first author's surname followed by "et al.". For example:

A recent study by Rang et al. (2) found that...

An organisation: give the full name with any recognised abbreviation in brackets afterwards e.g. National Institute for Health and Care Excellence (NICE). Thereafter you can refer to it using the abbreviation. Give the full name and abbreviation in the full reference. For example:

A survey by Asthma UK found that one in 20 people suffer from severe asthma (6).

How do I include a quote from a source?

If directly quoting from a work, you need to use single quotation marks. Include a page number in the in-text citation. For example:

More recently, a paper by Walker et al. (3) stated that 'student pharmacists are valuable and important to practice model transformation' (p. 47).

A paper by Walker et al.stated that 'student pharmacists are valuable and important to practice model transformation' (3, p. 47).

This type of referencing is known as secondary referencing and should be avoided wherever possible, as the author citing the work may have their own bias or misinterpretation. It is better to seek out the original reference (in this example, Ahmed’s) and cite it directly if it is useful.

You need to include both authors' names in the body of your text to show that you have not read the original article. In the final reference list, you should only include the reference you have read yourself (Jones in this example):

According to Ahmed as cited in Jones (5)...

References must be listed at the end of your document in numerical order based on the order of citation.  If you use the same source more than once, the original citation number should be used. 

Cited by Surname Initials - there is no comma between the surname and initials, nor any full stop or space between initials.

Authors should be listed in the order they appear on the publication. Only list the first six authors followed by et al. 

Monzer NL, Hartmann M, Buckert M, Wolff K, Nawroth P, Kopf S et al. 

See the tabs in this box for additional guidance and relevant examples. Our Vancouver guidance is closely aligned with that given in the 'Cite them right' book and website (below). You can find extra publication types and examples via this website. Note that we deviate from this guide in some case to make references simpler. For instance you should put journal names in full not abbreviated.

• Vancouver referencing guidance in Cite Them Right
• Author(s) or editors in the format Surname Initials (no full stops or spaces between initials). For books with more than six authors list the first six followed by 'et al.'
• Title of book (capitalise only the first letter of the first word and any proper nouns)
• Edition (if not the first)
• Place of publication: Publisher; Year. You can usually find this information on the title page or following page.
• Ritter JM, Flower RJ, Henderson G, Loke YK, MacEwan D, Robinson E, Fullerton J. Rang & Dale's pharmacology. 10th ed. London: Elsevier; 2024.
• Ashley C, Dunleavy A, editors. The renal drug handbook: the ultimate prescribing guide for renal practitioners. 5th ed. Boca Raton: CRC Press; 2019.

Some books are born digital and are not published in a traditional format. If the book does not have a Place published and Publisher then you will need to follow this guidance. Include the following in your reference:

• Author(s) or editors in the format Surname Initials (no full stops or spaces between initials) For books with more than six authors list the first six followed by 'et al.'
• Year. 
• [cited year month day] - the date you looked at it e.g. [cited 2022 Jun 18] You can usually find this information on the title page or following page.
• Available from: https://doi.org... or web address

Note: if you are unable to find a place published and publisher you will need to cite the item following the web page guidance.

• UK Health Security Agency. Immunisation against infectious disease (The Green Book) [Internet]. 2021 [cited 2024 Jan 26]. Available from: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book.
• Grabrucker AM, editor. Autism spectrum disorders [Internet]. 2021 [cited 2024 Feb 10]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK573612/.

Note: Using StatPearls? Follow the guidance on citing an online only book chapter .

• Same as above but instead of the Author field fill in the Editor field 
• Type of Medium: Internet
• Year Cited: in the format 2024
• Date Cited: in the format month day e.g. Jan 23
• URL: paste in the web link
• Note that even with the information entered as above EndNote will not quite format the reference correctly - the edition will not appear and for edited e-books 'editors' will not be added after the editor names. To correct this, as a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the references to match the guidance above.

Citing chapters in printed books and e-books with publication details

Follow this guidance to cite a printed book or an e-book which has the publisher and place published information. Include the following in your reference:

• Chapter author(s) in the format Surname Initials (no full stops or spaces between initials)
• Title of chapter. (capitalise only the first letter of the first word and any proper nouns)
• Editor(s) of the book followed by , editors
• Title of book. (capitalise only the first letter of the first word and any proper nouns)
• Place of publication: Publisher; Year.
• Page numbers of the chapter preceded by p. Abbreviate where appropriate e.g. 110-128 would be 110-28, 450-455 would be 450-5.

Copy the format and punctuation of this example

• Singh H, Khurana LK, Singh R. Pharmaceutical development. In: Vohora D, Singh G, editors. Pharmaceutical medicine and translational clinical research. London: Academic Press; 2018. p. 33-46.
• Davies J, Nuttall D. Prescribing for specific groups. In: Nuttall D, Rutt-Howard J, editors. The textbook of non-medical prescribing. 3rd ed. Hoboken: Wiley; 2020. p. 238-73.

Some books are born digital and are not published in a traditional format. When citing chapters in these include the following in your reference:

• Chapter author(s) in the format Surname Initials  (no full stops or spaces between initials)
• Title of chapter. (capitalise only the first letter of the first word and any proper nouns)
• [cited year month day] - the date you looked at it e.g. [cited 2022 Jun 18]
• Page numbers of the chapter if available preceded by p. Abbreviate where appropriate e.g. 110-128 would be 110-28, 450-455 would be 450-5.
• UK Health Security Agency. Immunisation by nurses and other healthcare professionals. In: Immunisation against infectious disease (The Green Book) [Internet]. 2013. p. 35-9 [cited 2024 Feb 3]. Available from: https://www.gov.uk/government/publications/immunisation-by-nurses-and-other-health-professionals-the-green-book-chapter-5.
• Kawakami S, Otsuka S. Multisensory processing in autism spectrum disorders. In: Grabrucker AM, editor. Autism spectrum disorders [Internet]. 2021 [cited 2024 Jan 7]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK573612/.
• Squadrito FJ, del Portal D. Nitrofurantoin. In: StatPearls [Internet]. 2022 [cited 2024 Feb 1]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470526/.

Endnote tips

• Use the Reference Type 'Book Section'
• Pages: page numbers for the chapter
• Use the Reference Type 'Electronic Book Section'
• Title: chapter title
• Editor: (if there is one)
• Book Title:
• Type of Work: Internet
• Access Date: in the format year, month (abbreviated to three letters) day e.g. 2024 Jan 21
• Note that even with all the required information entered in EndNote it will not format the reference correctly - the Edition and Type of Work will not be in the correct place. For edited e-books 'editors' will not be added after the editor names. The Access Date will be repeated at the end. To correct this, as a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the references to match the guidance above.

Note that the way you enter a chapter on EndNote for the Vancouver style is different from the way you enter it for the Harvard style. It is not possible to reuse one entry in both styles.

• Article author(s) in the format Surname Initials (no full stops or spaces between initials). For articles with more than six authors list the first six followed by 'et al.'
• Title of article. (capitalise only the first letter of the first word and any proper nouns)
• Journal title in full (use a capital letter at the start of each significant word in the title) Note: we are not following the 'Cite them right' guidance to abbreviate journal names.
• Issue number in brackets (where present)
• Page numbers or article reference number. Abbreviate page ranges where appropriate e.g. 110-128 would be 110-28, 450-455 would be 450-5.

Copy the format and punctuation of this example:

Rana MN, Neeland IJ. Adipose tissue inflammation and cardiovascular disease: an update. Current Diabetes Reports.   2022; 22(1):27-37. 

Monzer NL, Hartmann M, Buckert M, Wolff K, Nawroth P, Kopf S et al. The cardiac autonomic response to acute psychological stress in type 2 diabetes. PloS One. 2022;   17(3):e0265234.

• Article author(s) in the format Surname Initials (no full stops or spaces between initials). For articles with more than six authors list the first six followed by 'et al.'
• Available from: https://doi.org/... or web address if no DOI. When including a web address make sure it is as short as possible and doesn't include intermediate websites or your search string. 

Azpiroz F, Dubray C, Bernalier-Donadille A, Cardot JM, Accarino A, Serra J, Wagner A, Respondek F, Dapoigny M. Effects of scFOS on the composition of fecal microbiota and anxiety in patients with irritable bowel syndrome: a randomized, double blind, placebo controlled study. Neurogastroenterology & Motility [Internet]. 2017 [cited 2024 Jan 24] ;29(2). Available from: https://doi.org/10.1111/nmo.12911.

Note: if an article is in press and doesn't yet have a volume number treat like as above but add 'Forthcoming' before the year:

Vaghari-Tabari M, Jafari-Gharabaghlou D, Mohammadi M, Hashemzadeh MS. Zinc oxide nanoparticles and cancer chemotherapy: helpful tools for enhancing chemo-sensitivity and reducing side effects? Biological Trace Element Research [Internet]. Forthcoming 2024 [cited 2024 Jan 28]. Available from: https://doi.org/10.1007/s12011-023-03803-z

For online only articles without page numbers or an article reference number and 'In press' articles:

• Use Reference Type 'Electronic Article'
• Volume: (if the article doesn't yet have a volume number add 'Forthcoming ' before the year - as in the above example)
• Issue: (put in press here for articles currently being published).
• Date Cited in the format month day e.g. Feb 5.
• URL: paste in the web link for the article or move the DOI from the DOI field and add https://doi.org/ in front of it e.g. https://doi.org/10.1136/ejhpharm-2021-003215 If there is already a URL in the box check that it goes to the article, not back to the reference on the database you downloaded it from. Replace any database links with the DOI with https://doi.org/ in front of it or add the direct link to the article. When including a web address make sure it is as short as possible and doesn't include intermediate websites or your search string. 

Citing websites or webpages

• Author(s)/Organisation name
• Title of page/document (capitalise only the first letter of the first word and any proper nouns)
• [Internet].
• Year created/updated (for webpages with no date omit this element - see the final example)
• [cited year month day] - the date you looked at it e.g. [cited 2022 Feb 18]
• Available from: web link. When including a web address make sure it is as short as possible and doesn't include intermediate websites or your search string. 

Use the format and punctuation shown in these examples:

• Reynolds M. How the team monitoring new and emerging infectious diseases could help prevent the next pandemic [Internet]. 2023 [cited 2024 Feb 2]. Available from: https://ukhsa.blog.gov.uk/2023/08/08/how-the-team-monitoring-new-and-emerging-infectious-diseases-could-help-prevent-the-next-pandemic/.
• DrugBank. Ranitidine [Internet]. 2024 [cited 2024 Feb 8]. Available from: https://www.drugbank.ca/drugs/DB00863.
• IUPHAR/BPS. Ibuprofen [Internet]. [cited 2024 Feb 6]. Available from:  https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=2713. (this example is for a webpage without a date)
• Type of Medium: Internet
• URL: paste in the web link. When including a web address make sure it is as short as possible and doesn't include intermediate websites or your search string. 

Update December 2023: You can now choose which version of the BNF to use in your work: in print; on the NICE website; on the MedicinesComplete website; or via the BNF App. There's guidance on citing each below.

When citing the BNF you only need one generic reference, not specific references for each drug or piece of information you have used. Just make it clear in your text which drug/section you are referring to. 

• Author - Joint Formulary Committee.
• Title - British National Formulary (BNF).
• Place of publication - London:
• Publisher -  BMJ Group and Pharmaceutical Press;
• Joint Formulary Committee. British National Formulary (BNF). 86 ed. London: BMJ Group and Pharmaceutical Press; 2023.
• [cited year month day] - the date you looked at it e.g. [cited 2024 Feb 4]
• Available from: https://bnf.nice.org.uk/  OR Available from: https://www.medicinescomplete.com

Copy the format and punctuation of these examples:

Full reference (NICE version): Joint Formulary Committee. British National Formulary (BNF). 13 November 2023 [Internet]. 2023 [cited 2024 Feb 4]. Available from: https://bnf.nice.org.uk/.

Full reference (MedicinesComplete version): Joint Formulary Committee. British National Formulary (BNF). 9 January 2024 [Internet]. 2024 [cited 2024 Feb 4]. Available from: https://www.medicinescomplete.com.

• Title - British National Formulary (BNF) app followed by the update date e.g. British National Formulary (BNF) app. January 2024.
• Year of publication - use the year given on the homepage of the app
• Available from: https://play.google.com/store/apps/details?id=com.pharmpress.bnf  OR Available from: https://apps.apple.com/gb/app/bnf-publications/id1045514038

Citation in the text:      (Joint Formulary Committee, 2024)

Full reference: Joint Formulary Committee. British National Formulary (BNF) app. January 2024 [Mobile app]. 2024 [cited 2024 Feb 4]. Available from: https://play.google.com/store/apps/details?id=com.pharmpress.bnf 

• Title: followed by the update date e.g. British National Formulary (BNF). December 2023 OR 13 December 2023 (depending on which version you are using)
• Year Cited: in the format 2024
• Date Cited: in the format month day e.g. Feb 4
• Title: followed by the update date e.g. British National Formulary (BNF) app. January 2024

Citing the BNF for children

• Title - BNF for children
• Publisher -  BMJ Group, Pharmaceutical Press and RCPCH Publications;

Use the format and punctuation shown in this example:

• Pediatric Formulary Committee. BNF for children. 2022-2023 ed. London: BMJ Group, Pharmaceutical Press and RCPCH Publications; 2022. 

Online versions (NICE and MedicinesComplete)

• Title - British National Formulary for children (BNFC)
• Update date For the NICE website version take this from the 'Last updated' date on the BNF homepage. For the MedicinesComplete take this from the 'Publication last updated' date from the top of the page.
• Year published For the NICE website version take this from the 'Last updated' date on the BNF homepage. For the MedicinesComplete take this from the 'Publication last updated' date from the top of the page.
• Available from: https://bnfc.nice.org.uk/  OR Available from: https://www.medicinescomplete.com

Copy the format and punctuation shown of these examples:

Full reference (NICE version): Pediatric Formulary Committee. British National Formulary for children (BNFC). 13 December 2023 [Internet]. 2023 [cited 2024 Feb 4]. Available from: https://bnfc.nice.org.uk/.

Full reference (MedicinesComplete version): Pediatric Formulary Committee. British National Formulary for children (BNFC) . 9 January 2024 [Internet]. 2024 [cited 2024 Feb 4]. Available from: https://www.medicinescomplete.com.

• Title - British National Formulary for children (BNFC) app followed by the update date e.g. British National Formulary for children (BNFC) app. January 2024.
• Year of publication - use the year given on the homepage of the BNFC section of the app

Citation in the text:      (Pediatric Formulary Committee, 2024)

Full reference: Pediatric Formulary Committee. British National Formulary for children (BNFC) app. January 2024 [Mobile app]. 2024 [cited 2024 Feb 4]. Available from: https://play.google.com/store/apps/details?id=com.pharmpress.bnf 

• Title: followed by version e.g. BNF for children 2022-2023
• Title: followed by the update date e.g. British National Formulary (BNF). 13 December 2023
• Title: followed by the update date e.g. British National Formulary for children (BNFC) app. January 2024 

Provides access to the British National Formulary, British National Formulary for Children and Stockley’s Drug Interactions.

• Author - British Pharmacopoeia Commission
• Title - British Pharmacopoeia
• Version e.g. Ph. Eur. 11.4
• [cited year month day] - the date you looked at it e.g. [cited 2024 Feb 8]
• Available from: https://www.pharmacopoeia.com

Use the format and punctuation shown in this example (make sure you change the Version and dates to match the ones you use):

• British Pharmacopoeia Commission. British Pharmacopoeia. Ph. Eur. 11.4 update [Internet]. 2024 [cited 2024 Feb 8]. Available from: https://www.pharmacopoeia.com.
• Date Cited: in the format month day e.g. Feb 8
• Author - National Institute for Health and Care Excellence (NICE)
• Title of page/document including reference number in round brackets (capitalise only the first letter of the first word and any proper nouns)
• Year created/updated 
• Available from: web link (For a shorter reference use the link for the webpage instead of the longer PDF link)
• National Institute for Health and Care Excellence (NICE). Vaccine uptake in the general population (NG218) [Internet]. 2022 [cited 2024 Feb 9]. Available from: https://www.nice.org.uk/guidance/ng218.
• National Institute for Health and Care Excellence (NICE). Acute heart failure: diagnosis and management (CG187) [Internet]. 2021 [cited 2024 Jan 10]. Available from: https://www.nice.org.uk/guidance/cg187.
• Date Cited: in the format month day e.g. Jan 13
• Title of policy (capitalise only the first letter of the first word and any proper nouns) and Version
• Publisher (usually the same as the author)

Use the format and punctuation shown in this example:

• Imperial College Healthcare NHS Trust. Non-medical prescribing policy: Version 3. London: Imperial College Healthcare NHS Trust; 2016.
• Title of page/document (capitalise only the first letter of the first word and any proper nouns) and Version
• Year created/updated (for guidelines with no date just use the cited date)
• [cited year month day] - the date you looked at it e.g. [cited 2022 June 18]
• Available from: web link
• North East London Health & Care Partnership. North East London (NEL) management of infection guidance for primary care. August 2023 [Internet]. 2023 [cited 2024 Feb 8]. Available from: https://gp-website-cdn-prod.s3.amazonaws.com/prescribing-guideline-downloads/1697724608-4663d459fc894709f71ce7beaa8662db.pdf
• Year Cited: in the format 2022
• Date Cited: in the format month day e.g. Dec 20

Citing Summaries of Product Characteristics (SmPCs) or Patient Information Leaflets (PILs) on the Electronic Medicines Compendium

• Author - drug company who wrote the SmPC
• Title (capitalise only the first letter of the first word and any proper nouns) followed by Electronic Medicines Compendium 
• Year created/updated
• [cited year month day] - the date you looked at it e.g. 2024 Jan 29
• Available from: web link 

Use the format and punctuation shown in these examples.

• Wokhardt UK Ltd. Aciclovir 400mg tablets summary of product characteristics. Electronic Medicines Compendium [Internet]. 2017 [cited 2024 Jan 29]. Available from: https://www.medicines.org.uk/emc/product/2352/smpc.
• Dermal Laboratories Limited. Ibugel patient information leaflet. Electronic Medicines Compendium [Internet]. 2024 [cited 2024 Feb 9]. Available from: https://www.medicines.org.uk/emc/product/3759/pil.
• Author: company name. Put a comma after the company name to ensure it formats correctly e.g. Accord-UK Ltd.,
• Date Cited: in the format month day e.g. Jan 20

Citing systematic reviews in the Cochrane Library

• Title of review
• Year month day of review
• Title of database: The Cochrane Library
• Article number
• Available from: web address or DOI
• Crowe L, Chang A, Wallace K. Instruments for assessing readiness to commence suck feeds in preterm infants: effects on time to establish full oral feeding and duration of hospitalisation. 2016 August 23. In: The Cochrane Database of Systematic Reviews [Internet]. Issue 8.  Art. No.: CD005586. Available from: https://doi.org/10.1002/14651858.CD005586.pub3.
• Title: title of the review - in lower case apart from the first letter of the first word and any proper nouns. Add the year month day of review after the title e.g. Instruments for assessing readiness to commence suck feeds in preterm infants: effects on time to establish full oral feeding and duration of hospitalisation. 2016 August 23.
• Book title: The Cochrane Database of Systematic Reviews
• Edition: Issue 8. Article no.: CD005586
• Type of Work: Internet

Note that the way you enter a Cochrane Review on EndNote for the Vancouver style is very different from the way you enter it for the Harvard style. It is not possible to reuse one entry in both styles.

If a trial is still ongoing you may need to refer to it directly instead of to a published paper. 

• Author - primary contact for the trial
• Trial title
• Database/registry name
• [cited year month day] - the date you looked at it e.g. [cited 2024 Jan 18]
• Available from: DOI or web address

Use the format and punctuation shown in these examples:

• Crooks M. An investigation into how adding an inhaled steroid to COPD treatment may potentially protect against heart disease. In: ISRCTN Registry [Internet]. 2023 [cited 2024 Jan 18]. Available from: https://doi.org/10.1186/ISRCTN29148209.
• Lingor P. Safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease. In:  ClinicalTrials.gov [Internet]. 2023 [cited 2024 Feb 9]. Available from: https://clinicaltrials.gov/study/NCT05931575.
• Title (in lower case apart from the first letter of the first word and any proper nouns) followed by . In: [name of Database/Registry] e.g. Implementing improved asthma self-management as routine. In: ISRCTN Registry

Note that the way you enter a Clinical Trial on EndNote for the Vancouver style is very different from the way you enter it for the Harvard style. It is not possible to reuse one entry in both styles.

Always check with the academic who set the assignment if you are allowed to refer to course materials in your own work. It is preferable to do your own research and use published sources, such as articles and books, instead of referring to lecture materials.

• Author's name in the format Surname Initials
• Title of document/presentation as given on Blackboard
• Format in square brackets e.g. [PowerPoint presentation, Lecture notes, Recorded lecture, Handout]
• Place of publication:
• Institution;
• Course details, date
• [cited year month day] - the date you looked at it e.g. [cited 2024 Jan 18]
• Available from: https://www.bb.reading.ac.uk Note that you do not need to give the specific web address for the material you are citing. The address for Blackboard is sufficient.

Cottrell G. The molecules of life: proteins [PowerPoint presentation]. Reading: University of Reading; PM1PY2: Fundamentals of Cell Biology; 2023 [cited 2023 Dec 2]. Available from: https://www.bb.reading.ac.uk.

Example 2: Handout with no date

University of Reading. Direct observation of procedural skills (DOPS) assessment form [Handout] Reading: University of Reading; PM2PY1: Professional Practice 2. [cited 2023 Nov 30]. Available from: https://www.bb.reading.ac.uk.

• Use the 'Web Page' Reference Type
• Place published: Reading
• Type of Medium: add the Format here e.g. PowerPoint presentation, Lecture notes, Recorded lecture, Handout
• Contents: module code and title e.g. PM2PY1: Professional Practice 2
• Date Cited: in the format month day e.g. Jan 20
• URL: https://www.bb.reading.ac.uk

Note that even with the information entered as above EndNote will not quite format the reference correctly - the module details will be in the wrong place. To correct this, as a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the references.

Citing tables, figures & images

Images, graphs, charts, diagrams and tables that you have used from books, websites and other texts should be referenced in the same way that you would any other material.

The captions for both tables and figures should include a citation if taken from or based on another source (name-year or number depending on the style you are using). When you refer to it in your writing, use the figure/table number. Give a full citation in the reference list for the source of the image.

Citing tables

Tables should be sequentially numbered with the title/legend above the table - as in this example which uses the Harvard referencing style:

Example of referring to a table in a sentence:

The macronutrient content of the diets used in the study is shown in Table 2. 

Full details for reference list (Harvard style):

Mitchell, N.S. and Ard, J.D. (2021) 'Weight loss, lifestyle, and dietary factors in cardiovascular diseases in African Americans and Hispanics', in Ferdinand, K.C., Taylor, H.A. and Rodriguez, C.J. (eds)  Cardiovascular disease in racial and ethnic minority populations . Cham: Humana Press, pp. 167-182.

Citing figures (images, graphs and diagrams)

Images, graphs and diagrams should be labelled as 'Figure' and sequentially numbered with the caption below - as in this example which uses the Harvard referencing style:

Example of referring to a figure in a sentence:

The prebiotics can induce direct or indirect effect on the gut-associated epithelial and immune cells (Figure 3).

Pujari, R. and Banerjee, G. (2021) 'Impact of prebiotics on immune response: from the bench to the clinic',  Immunology and Cell Biology , 99(3), pp. 255-273.

Decorative images

If the image is purely decorative you should still acknowledge the creator and source but there is no need to include a full reference.

See the example on the right which includes the caption: 'Image: [creator] via [website image captured from]'.

If it is a picture you have taken use this format:

'Image by author'.

Compiling your own table from multiple sources

If you are taking information from multiple sources and compiling your own table you still need to acknowledge those sources. 

The following link shows two ways of doing this. Although this is a guide to using the APA style the approaches can be adapted for use with Harvard and Vancouver.

• How to cite sources in a table (APA)

Secondary referencing (citing a source you have read about in a different source)

A secondary reference is used when you are referring to a source which you have not read yourself, but have read about in another source.  Where possible, you should always try to read the original of anything you wish to refer to ; otherwise you are relying on the author who cited the reference to have interpreted it correctly and not taken it out of context. Use the reference list at the end of the source you are reading to find details of the reference and search for it using the search boxes below.

Find books using the Enterprise catalogue

Just type in the first author's surname and a few words from the title.

Find journal articles using Summon

Just type in the first author's surname and first part of the article title.

If you can't get hold of the original source you'll need to do a secondary reference and you should make clear that you are not using the original source. Only include the source you have used in your list of references following the guidance above on citing that type of publication. Indicate in your in-text citation that it is a secondary reference by preceeding the citation with 'as cited in' or 'as quoted in'.

Vancouver example

In-text citation:

According to France as cited in Weingart et al. (4) , hospitals use internal reporting procedures to identify...

4. Weingart, SN, Zhang L, Sweeney M, Hassett M. Chemotherapy medication errors. The Lancet Oncology, 2018; 19(4): e191-e199.

Harvard example

According to France (2003, as cited in Weingart et al. , 2018), hospitals use internal reporting procedures to identify...

Reference: 

Weingart, S.N., Zhang, L., Sweeney, M, & Hassett, M. (2018) 'Chemotherapy medication errors',  The Lancet Oncology , 19(4), pp. e191-e199.

Vancouver - just edit your text as in the example above and insert the reference for the paper you have read in the usual way.

• Insert the in-text citation for the paper you have read in the usual way.
• Right-click on the in-text citation and select ' Edit Citation(s) ' and ' More... '. 
• In the prefix box type the year of the paper you haven't read followed by a comma and space and 'as cited in ' (as in the example above). Click OK.
• In front to the in-text citation type in the author name(s) for the paper you haven't read (as in the example above), including the correct number of authors.

Quotes and copying information

• Copying information
• Example 1 (prose)
• Example 2 (standards)
• When taking information from a reference source which you are not putting into your own words i.e. copying and pasting you need to put quotes around the words to indicate that it is not your own work
• Students are expected to put the majority of information into their own words to demonstrate their understanding and independent thought - the amount of information in quotes should therefore be minimal
• Quotes should be reserved for situations where no alternative wording is possible and/or where it is not appropriate (e.g. quoting a standard or particular statement which supports your argument)
• Wenger (1998, p. 181) argues that 'Engagement, imagination and alignment each create relations of belonging'.
• The focus of Wenger's discussion is on the way that different aspects come together to build notions of identity (Wenger, 1998).
• Theorists have considered the impact of a variety of circumstances on the creation and expansion of identity (Wenger, 1998; Lee, 2013; Morton and Grainger, 2009).

Avoid quoting large blocks of text:

The NICE guidance for hypertension (NICE, 2019) states the following:

'Beta-blockers are not a preferred initial therapy for hypertension. However, beta-blockers may be considered in younger people, particularly:

• those with an intolerance or contraindication to ACE inhibitors and angiotensin II receptor antagonists or
• women of child-bearing potential or
• people with evidence of increased sympathetic drive'

Instead this could be paraphrased as:

NICE no longer recommend beta-blockers to be used as initial therapy for hypertension, although it is recognised that there may be circumstances in which younger patients may benefit from beta-blockers (NICE, 2019).  In my practice I may review younger patients, therefore I will consider the recommendations from NICE on appropriate prescribing of beta-blockers, for example women of child-bearing age, patients with increased sympathetic drive or unable to take ACE inhibitors and angiotensin II receptor antagonists.

• Reading School of Pharmacy referencing guide A summary and printable version of the School's referencing guidance (note this does not include as much detail as the information on this page).
• Using quotes and paraphrases How to build references into your writing, using short and long quotes and paraphrases.

Support from your librarian

Using a reference management system is vital when you do your final year projects and useful for creating accurate references for other assignments. EndNote is one such system which can be used to store references, and then insert the citation in your Word document, automatically building the bibliography for you in the correct style.

Use the following styles in EndNote:

• Cite Them Right-Harvard

There are tips for using EndNote for each type of publication in the Vancouver and Harvard referencing guidance on the left. However, for some non-standard publications EndNote may not format your references correctly. To overcome this insert the reference in EndNote following the guidance and add it to your Word document. As a final step before submission, create a plain text version of your document. Go to the EndNote toolbar in Word and select 'Convert citations and bibliography' to 'Plain text' (this will be under 'Tools' on the Mac version of the toolbar). This will create a copy of your document which is divorced from EndNote so that you can make final tweaks to the references.

Find out more in the EndNote page in this guide:

• Using EndNote for pharmacology students
• << Previous: Key resources
• Next: Using EndNote >>
• Last Updated: Apr 3, 2024 1:47 PM
• URL: https://libguides.reading.ac.uk/pharmacology

About the BP

• Omitted texts
• How to use the BP
• Example test results
• Notice of intent to revise BP monographs
• Contribute to draft texts

Pharmacopoeias that have legal status within the UK are the British Pharmacopoeia (BP), including the BP (Veterinary), and the European Pharmacopoeia (Ph. Eur.). The BP provides the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products and:

• is published every year in August
• becomes effective on 1 January of the following year
• incorporates all the monographs and texts of the Ph. Eur.

The BP is a vital reference tool for all individuals and organisations involved in pharmaceutical:

• development
• manufacture
• quality control and analysis

The most comprehensive collection of authoritative official standards for the UK pharmaceutical substances and medicinal products.

What does the BP contain

• general notices (providing general information applicable to all texts)
• general monographs (apply to all dosage forms)
• active pharmaceutical ingredients
• formulated preparations (licensed and unlicensed products)
• herbal drugs, herbal drug products and herbal medicinal products
• materials for use in the manufacture of homoeopathic preparations
• blood-related products
• immunological products
• radiopharmaceutical preparations
• infrared reference spectra
• supplementary chapters (providing additional guidance)
• comprehensive index

British Pharmacopoeia (Veterinary)

The BP (Veterinary) is published as a companion volume to the British Pharmacopoeia. It contains standards for substances and products used solely in the practice of veterinary medicine in the UK.

The BP (Vet) also incorporates monographs and texts of the European Pharmacopoeia.

European Pharmacopoeia

The Ph. Eur. is published by the  European Directorate for the Quality of Medicines & HealthCare .

The European Pharmacopoeia Commission is responsible for the publication of the Ph. Eur. The UK is a member of the EP Commission and is involved at all stages of Ph. Eur. monograph development.

Post UK EU transition information

Legal framework

The British Pharmacopoeia (BP) continues to be part of the Medicines and Healthcare products Regulatory Agency’s public health role.

The UK was a founding member of the Convention on the Elaboration of a European Pharmacopoeia and continues to be a member of the European Pharmacopoeia (Ph. Eur.). The UK continues to be a member of the Council of Europe (CoE) in its own right.

The British Pharmacopoeia (BP) continues to reproduce Ph. Eur. text for the convenience of our customers.

In the absence of European Pharmacopoeia standards, Directive 2001/83/EC allows the continued applicability of BP standards (as a third party pharmacopoeia) for medicines and their components. Where the BP is appropriately referenced in the regulations of an EU member state, it may be considered a national pharmacopoeia of that EU member state.

References to EU requirements

There are instances in BP text that refer to EU requirements and further information about these are provided below.

1. EU regulations that have been transposed into domestic UK law and their UK equivalent:

2. EU regulations that will be retained in UK law and fixed on 1 January 2021 with examples of where the text can be found in the BP (the monographs are not an exhaustive list):

BPCRS customers in the EU

The BP values all our British Pharmacopoeia chemical reference substances (BPCRS) users. The BP continues to provide products and post-sale support of the highest standard to our users in the EU and across the world to help them demonstrate compliance with monographs of the BP. 

We would like to continue to provide advice to EU customers now the UK has left the EU: 

• The key point from a commercial perspective is that the UK is now a “third country” in regards to its relationship with the EU.
• This means that BPCRS imported from the UK into Europe may be subject to additional customs checks and/or subject to import duties.
• BPCRS are made under Delivery at Place (DAP) incoterms. The BP is responsible for the goods during transport until delivery. Ownership is transferred to the buyer when the goods are available for unloading. The customer is responsible for import clearance and any applicable local taxes or import duties.
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The British Pharmacopoeia – in 2017 and beyond

Posted: 22 February 2017 | James Pound (British Pharmacopoeia) | No comments yet

The British Pharmacopoeia (BP) is a collection of authoritative and publicly available quality standards for medicines, supported by guidance and additional value-adding information. First published in 1864, the BP has an illustrious history that has been built on quality and continually responds to the needs of stakeholders and users.

The BP Secretariat is an integral part of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), strategically located within the Inspection, Enforcement and Standards Division since 2003. As such, it has access to expertise, experience and resources that mean it is well placed to maintain the BP’s strong reputation and build on ongoing successes. 2017 will be an important year for the British Pharmacopoeia (BP), with a number of exciting initiatives and new content being published.

As the BP 2017 is legally effective from 1st January 2017, it is timely to consider the changes that are shaping the life sciences landscape, as well as current and future challenges and opportunities in ensuring the quality of medicines. Like other pharmacopoeias, the BP continues to evolve to meet the need for medicines’ quality in the 21st Century. Some of the important trends in the global pharmacopoeial landscape are summarised as follows.

Global supply chains

There are complex and diverse supply chains that are truly global across mature and developing markets. Quality standards make an important contribution to securing the global supply chain and there is a growing need for pharmacopoeias to consider global stakeholder input on the development of appropriate quality standards for medicines.

Harmonisation

Good progress has been made in harmonising pharmacopoeial standards by the Pharmacopoeial Discussion Group (PDG), however, stakeholders continue to desire greater harmonisation. More recent initiatives, such as the World Health Organisation’s (WHO) good pharmacopoeial practices and informal bilateral harmonisation between the BP and the United States Pharmacopoeia (USP), seek to build new mechanisms for aligning and synchronising pharmacopoeial standards.

Biologics and biotech

Biological products are predicted to form an increasing percentage of total spending on medicines 1 . The BP’s unique positioning and access to the knowledge and skills at the National Institute for Biological Standards and Control (NIBSC) means it is well placed to engage with stakeholders on how standards can evolve to meet the challenges of newer and complex medicines such as monoclonal antibodies and advanced therapies.

Technology and innovation

Quality standards in the pharmacopoeia must reflect the industry and community that they seek to serve. As innovative products reach the market and new manufacturing and analytical technology is introduced, the pharmacopoeias must work to ensure that, over time, they evolve to accommodate these new advances.

Collaboration and partnership

So how is the BP addressing these trends? One approach is forging collaborations. In a globalised world with complex supply chains, it is critical that the BP works with its partners in the pharmacopoeial community and the biopharma ceutical industry to develop appropriate quality standards for medicines. The BP’s strong bilateral relationships, the ability to tap into the MHRA’s wide and deep network of stake holders and the wide global usage of the BP (over 100 countries) means it is well placed to continue to play an important global role in developing quality standards for medicines.

In Europe, the UK was one of the eight founding signa – tories to the Convention on the Elaboration of a European Pharmacopoeia, which led to the establishment of the Ph Eur in the early 1960s as a means to develop harmonised quality standards for medicinal substances across the member states of the Council of Europe.

The BP, as the UK’s National Pharmacopoeial Authority, provides significant support and expertise to the Ph Eur and its expert groups. The BP is a strong supporter and advocate for the important and valuable work of the European Pharmacopoeia.

In addition, the BP has bilateral collaboration agreements with a number of European authorities for the partial or whole reproduction of BP monographs in their respective publications, with a view to supporting the development of competent national pharmacopoeial authorities in these countries.

In North America, the BP has developed a close and productive relationship with the USP. This includes a number of exciting initiatives to develop informally harmonised standards for drug products, and collaboration and knowledge sharing on new developments such as standards for biological medicines, such as monoclonal antibodies, as well as the appli cation of Quality by Design (QbD) concepts to analytical procedures.

Asia-Pacific is a critically important region for the development and manufacture of medicines and starting materials; maintaining and growing key relationships in this region has, and will continue, to be a high priority for the BP.

To support continued and expanded close working with the Chinese Pharmacopoeia, a memorandum of understanding (MoU) was signed in May 2016 which identified joint development of quality standards across a range of medicines and medicinal products as a key priority. Staff exchanges have also been undertaken to build knowledge and understanding of the differences and similarities in the pharmacopoeial and regulatory environments in each country. Similarly, the BP and Indian Pharmacopoeial Commission are working in close collaboration under the aegis of the MoU between the MHRA and the Central Drugs Standard Control Organisation to undertake joint working and knowledge sharing.

Figure 1: Additional guidance on the use of DNA barcoding as a tool for botanical identification of herbal drugs was included in BP 2017

The BP greatly values its contribution to the global public health agenda through its cooperation with the WHO and the work of the International Pharmacopoeia. BP is a strong contributor to the work of the WHO/IP both in the form of a collaboration agreement for the development of quality standards and active support and participation in initiatives such as good pharmacopoeial practices.

Collectively, these relationships support the BP’s ability to understand and respond to the need of a globalised industry, and to align and harmonise standards.

New medicines – biologics

As part of the MHRA, the BP is committed to ensuring the quality of biological medicines through its activities in the development of pharmacopoeial quality standards. 

One of the key priorities in the Agency’s corporate plan 2 is to promote international standardisation and harmonisa tion to assure the efficacy and safety of biological medicines. The success of the merger with the NIBSC in 2013 has ensured the MHRA continues to play a world-leading role in this field.

With the increasing importance of biological medicines to global healthcare strategies, it is important that the BP continues to ensure the quality of these medicines using authoritative pharmacopoeial quality standards as well as considering how standards can act as enablers for innovation now and in the future. For example, the UK Medicines Manufacturing Industry Partnership advanced therapies taskforce has identified standards as a key area to support the development and manufacture of new and innovative medicines 3.

Figure 2: The end user’s digital experience is held in high regard by the BP Secretariat

Drawing on expertise from the BP and NIBSC, the MHRA is developing a strategy for the creation of pharmacopoeial public quality standards for biological medicines. A public consultation launched in early January 2017 by the MHRA seeks to obtain feedback and input from stakeholders regarding how standards can be developed, used and improved 4 .

The BP frequently reviews the latest developments in analytical science and the manufacturing and quality control of medicines to ensure it best meets the needs of users and reflects emerging practice. This is well aligned with broader UK Government and Agency priorities, for example, the UK Strategy for Life Sciences 5 .

Two excellent examples of the BP’s exploration and adoption of new technology and the facilitation of innovation are the projects on the use of molecular biology for the quality control of herbal medicines and the application of Quality by Design (QbD) concepts to analytical procedures in the pharmacopoeia.

The work on the use of molecular biology techniques has already borne fruit with the publication of a new appendix for DNA-based identification techniques for herbal drugs in the BP 2016, including a worked example for holy basil and supported by a first-in-class nucleic acid reference material, developed jointly with NIBSC. This was supplemented in the BP 2017 by the inclusion of additional guidance on the use of DNA barcoding as a tool for botanical identification of herbal drugs (see Figure 1).

The QbD project was initiated in 2013 with a view to better understanding industry proposals regarding the application of QbD to analytical procedures and how such concepts could potentially be adopted or facilitated by the pharmacopoeia. This includes the use of quality risk management tools and Design of Experiments methodology to better understand analytical methods and how the analytical target profile can serve as an enabler for method development and ensuring that analytical methods are fit for their intended purpose.

A working party comprised of experts from within the MHRA and from across industry was formed in 2015 and a pilot project initiated to study the application of these concepts to a candidate monograph (atorvastatin tablets). This project has already yielded many useful insights and has provided an opportunity to collaborate with the USP’s method lifecycle activities 6 . It is anticipated that the outcomes of this project will be published in 2017.

Ultimately the success of the BP’s work to address the changing trends in the pharmacopoeial landscape is translated into the content of each new edition of the publication. The BP 2017, legally effective from 1st January 2017, includes the following important new content:

• 29 new BP monographs
• 234 amended monographs
• Four new formulated preparation monographs for biological medicines
• Two new monographs for unlicensed formulations
• A new informally harmonised drug product monograph (Aprepitant Capsules)
• A new supplementary chapter on DNA barcoding
• A new supplementary chapter on the Aseptic Preparation of Unlicensed Medicines
• All European Pharmacopoeia monographs integrated (8th Edition as amended by Supplements 8.1 to 8.8)
• Three in-year website and offline download updates to harmonise with the European Pharmacopoeia 9th Edition (9.0) and Supplements 9.1 and 9.2.

The BP 2017 is available in a range of product formats; hardcopy, download and online. Regular users of the BP will be aware of the successful redevelopment of the BP website in 2015 following usability feedback from a range of stakeholders. This product enhancement was undertaken in line with best practice for UK Government websites to ensure the greatest value to the end user. The BP Secretariat remains committed to continually improving the products and services, with a particular focus on enhancing the end user’s digital experience (see Figure 2).

In summary, the BP continues to adapt and evolve to the changing world including new medicines, technology and emerging science. We can only ever serve the needs of stakeholders and users by engaging in an open conversation and would welcome feedback on the BP’s products and services from stakeholders.

About the author

James Pound is currently the Editor in Chief of the British Pharmacopoeia (part of the MHRA) and previously worked in a variety of roles in the Pharmacopoeia since joining in 2008. He holds an honours degree in chemistry and has held a range of positions focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.

• IMS Health Report The Biologics Market
• Corporate Plan 2013-2018, Medicines and Healthcare products Regulatory Agency. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/ file/350879/con261796__1_.pdf
• Action Plan for UK to capture the next generation of medicines manufacturing jobs, The Association of the British Pharmaceutical Industry. Available at: http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/Action-Plan-for-UK-to-capture-the-nextgeneration-of-medicines-manufacturing-jobs.aspx
• Strategy for pharmacopoeial public quality standards for biological medicines, Medicines and Healthcare products Regulatory Agency. Available at: https://www.gov.uk/ government/consultations/strategy-for-pharmacopoeial-public-quality-standards-forbiological-medicines
• Strategy for UK Life Sciences, Department for Business, Innovation & Skills. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32457/11- 1429-strategy-for-uk-life-sciences.pdf
• Lifecycle Management of Analytical Procedures: Method Development, Procedre Performance Qualification, and Procedure Performance Verification. Available at: https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/lifecycle_pdf.pdf

If you would like to give feedback on the BP’s products and services, please send an email to: [email protected]

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About BP guidance materials

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Like our legally effective standards, BP guidance materials are designed to ensure the quality, efficacy, and safety of medicines available in the UK market, however the BP guidance materials are non-mandatory and can be engaged with on a voluntary basis.

These materials are intended to support your method development and validation programme, whether that’s for small molecules, advanced therapies or to support you make sustainability changes to your laboratory and quality control testing. 

Advanced Therapy Medicinal Products (ATMP)

With complexity and risk associated with each stage of assay development, our ATMP guidance offers a practical and phase-appropriate validation tool to help your cell and gene therapy programme succeed

You can learn more about ATMP guidance and download a copy here .

Analytical Quality by Design (AQbD)

AQbD is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.

The AQbD guidance will help you ensure that the analytical methods you use are robust and fit-for-purpose. This will enable a better assessment of product quality, and ultimately provide greater assurance to safeguard patient safety

You can learn more about and access AQbD guidance here .

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You can learn more about and download a copy of the environmental sustainability information pack.

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When I use a word . . . Medicines regulation—the British Pharmacopoeia

• Related content
• Peer review
• Jeffrey K Aronson
• Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
• Follow Jeffrey on X (formerly Twitter): @JKAronson

The 1858 Medical Act in the UK established what is now called the General Medical Council, and with it an order that the council should produce a British Pharmacopoeia , as a way of standardising the formulation of medicinal products. A follow-up Medical Act in 1862 made it clear that the intention was that the new pharmacopoeia would replace all three previous UK pharmacopoeias, the London, Edinburgh, and Dublin pharmacopoeias. The first edition of the British Pharmacopoeia , published in 1864, was full of errors and omitted many commonly used medicines, faults that were corrected in the 1867 edition. Since then many editions and supplementary volumes have appeared. Under section 4 of the 1968 Medicines Act a new British Pharmacopoeia Commission was established in 1970, to take over responsibility of production from the General Medical Council, and today a new edition of the British Pharmacopoeia appears every year.

The General Medical Council

The main purpose of the Medical Act of 1858, “An Act to regulate the Qualifications of Practitioners in Medicine and Surgery,” was the establishment of the General Medical Council, so that “Persons requiring Medical Aid should be enabled to distinguish qualified from unqualified Practitioners.” 1 The full title of the council so established was “The General Council of Medical Education and Registration of the United Kingdom.”

The first 46 sections of the act dealt with various aspects of the constitution and actions of the council and its members and the registration and actions of “legally qualified Medical Practitioners.”

Among the final nine sections of the act, the government of the day took the opportunity of including other matters, including the possibility that the Queen might grant new charters:

● to the Royal College of Physicians of London, to be renamed the Royal College of Physicians of England;

● to the Royal College of Physicians of Edinburgh, to be renamed the Royal College of Physicians of Scotland;

● to a new Royal College, in the event that the Royal College of Surgeons of Edinburgh amalgamated with the Faculty of Physicians and Surgeons at Glasgow, under the joint title of the Royal College of Surgeons of Scotland;

● to the King and Queen's College of Physicians in Ireland, to be renamed The Royal College of Physicians of Ireland.

Only the last of these was adopted, in 1890. In 1909 the Glasgow Faculty became The Royal Faculty of Physicians and Surgeons of Glasgow and in 1962 a Royal College.

The British Pharmacopoeia

Section LIV of the 1858 Medical Act empowered the new General Council to “cause to be published under their Direction a Book containing a List of Medicines and Compounds, and the Manner of preparing them, together with the true Weights and Measures by which they are to be prepared and mixed, and containing such other Matter and Things relating thereto as the General Council shall think fit, to be called ‘British Pharmacopoeia’.”

The history of the British Pharmacopoeia starts with that of the Pharmacopoeia Londinensis , which was first published on 7 May 1618, but withdrawn, because the physicians who had compiled it claimed that the first edition had been botched at the printers’ shop. 2 Then, on 7 December 1618, the London College of Physicians issued a greatly expanded revised version, which they designated the first edition.

The Pharmacopoeia Londinensis laid the foundations for other UK national pharmacopoeias, the Edinburgh Pharmacopoeia (1699) and the Dublin Pharmacopoeia (1807). The last edition of the London Pharmacopoeia , the 11th, appeared in 1851. By then the need for harmonisation had become clear, particularly since the Poor Law Amendment Act of 1834, with the institution of infirmaries and dispensaries, had resulted in increasing demands for medicines. Furthermore, there were concerns about variability in the manufacture of different formulations of medicines by different manufacturers, and standardisation was clearly desirable. Hence the decision to empower the new General Medical Council to produce the British Pharmacopoeia , also known at that time as the Pharmacopoeia Britannica , in the 1858 Medical Act. That the new pharmacopoeia would replace the three regional pharmacopoeias was specified in the Medical Council Act of 1862, which formally incorporated the council. 3

The first edition

With the collaboration of three committees, in London, Edinburgh, and Dublin, agreement was reached on the format and contents of the new pharmacopoeia, which was published in 1864. 4 Part 1 of the pharmacopoeia was titled “MATERIA MEDICA” and it contained descriptions of just over 300 medicines, from Acacia to Zingiber, the names being given in both Latin and English. Each gave, to a greater or lesser extent, information about the origin of the medicine, its appearance, some chemical information about it, chemical tests for its identification, and the types of formulation available. Here, for example, is the entry on Digitalis:

“Digitalis purpurea Linn . Purple Foxglove.

The dried Leaf; from wild indigenous plants, gathered when about two thirds of the flowers are expanded.

Characters .—Ovate-lanceolate, shortly petiolate, rugose, downy, paler on the under surface crenate.

Preparations .—D igitalinum , Infusum, Tinctura.”

Part II, titled “PREPARATIONS AND COMPOUNDS,” contained details of how to make up the formulations, a recipe book in effect. Here is the information given about Digitalinum:

“Pour on the Digitalis [40 ounces of powdered leaf] two gallons of Rectified Spirit; digest at a heat of 120° for six hours; and separate the tincture by filtration and subsequent expression. Distil off the spirit, and treat the extract with five ounces of the Water, acidulated with the Acetic Acid. Digest with a quarter of an ounce of the Animal Charcoal, filter, and dilute the filtrate with the Water, so that it shall have the bulk of a pint. Now add the Ammonia nearly to neutralization, and afterwards the Tannic Acid dissolved in three ounces of the Water. Wash the precipitate thus obtained with a little of the Water; mix it with a small quantity of the Spirit, and carefully rub it in a mortar with the Litharge. Place the mixture in a flask, and add to it four ounces of the Spirit; raise the temperature to 160°, and maintain it for about an hour. Then add the rest of the Animal Charcoal, filter, and remove the spirit by distillation. Lastly, wash the residue repeatedly with the Ether.”

The pharmacopoeia included four appendices, two detailing the chemicals used, a table of 31 elements from aluminium [ sic ] to zinc with their symbols and atomic weights, and a list of the weights and measures used in the pharmacopoeia. A bibliography and an index completed the volume, 444 pages in all.

The pharmacopoeia was not a textbook of therapeutics; neither doses nor instructions for use were given.

Many commonly used medicines were omitted from the first edition and many errors were reported. As a result, of 28 000 copies that were printed about half had to be destroyed. 5

These deficiencies were rectified in the next edition, published in 1867, which added 120 previously omitted formulations, altered the titles of about 180 others, altered the compositions of 27, included doses, and included metric measures as well as the imperial ones; 40 000 copies were printed. A further addendum was published in 1890.

A third edition appeared in 1895 and a fourth in 1898, and since then many more editions have appeared. Currently a new edition is published every year.

The 1968 Medicines Act and the British Pharmacopoeia

The Medicines Act 1968 dealt with the British Pharmacopoeia in Part VII, Sections 98–103: “If by any instrument executed after the passing of this Act the General Medical Council assign [ sic ] to Her Majesty the copyright in the British Pharmacopoeia, in so far as that copyright is invested in the Council, then on the date on which that assignment is expressed to take effect … section 47 of the Medical Act 1956 (which relates to the publication of the British Pharmacopoeia under the direction of the Council) shall cease to have effect.”

In fact, a new British Pharmacopoeia Commission was established in 1970, as a Section 4 committee under the 1968 Medicines Act, 6 and it replaced the commission that the General Medical Council had established. The functions of the new commission were listed as follows:

(a) the preparation of any new edition of the British Pharmacopoeia;

(b) the preparation of any amendments of the edition of the British Pharmacopoeia published in 1968 or any new edition of it; and

(c) the preparation of any list of names and the preparation.

The British Pharmacopoeia Commission is specifically responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping them up to date. It is also responsible for selecting and devising British Approved Names (BANs) of medicines. However, since 2000 the British Approved Names of almost all medicines have been the same as the International Nonproprietary Names (INNs) that the World Health Organization devises. 7 The exceptions are the BANs adrenaline (INN epinephrine) and noradrenaline (INN norepinephrine). 8

“Pharmacopoeia”

A pharmacopoeia is “an authoritative or official treatise containing listings of approved drugs with their formulations, standards of purity and strength, and uses.” 9 In the early 18th century it also came to mean a dispensary or collection of medicines, as Nathan Bailey put it in his Universal Etymological English Dictionary of 1721, but it is the earlier meaning that prevails today.

The Greek word ϕαρμακοποιία , literally “drug-making,” came from the post-classical (Hellenistic) dialect called Koinē. Instances in mediaeval Latin include the titles of books such as Pharmacopoeia seu de medicamentorum simplicium delectu: praeparationibus, mistionis modo by Jacques Dubois (Basel, 1552) and Pharmacopoeia, medicamentorum omnium, quae hodie ad publica medentium munia in officinis extant by Anutius Foesius (Basel, 1561).

“Pharmacopoeia” entered English at the start of the 17th century. Coincidentally, the first recorded instance is from 1618, the year in which the Pharmacopoeia Londinensis was first published, and is found in a reference to a “Pharmacopaea” by Querketanus in a translation by Thomas Bretnor of a Latin text by Angelus Sala Vincentinus Venitus (1576–1637) called Opiologia: or, A treatise concerning the nature, properties, true preparation, and safe use and administration of opium. For the comfort and ease of all such persons as are inwardly afflicted with any extreame grief, or languishing pain, especially such as deprive the body of all natural rest, and can be cured by no other means or medicine whatsoever .

An earlier word still, “pharmacopinax,” came from the Greek word πίναξ , a board or plank, a platter, a public notice board, and a board or plate for painting, drawing, or printing on, a writing-tablet. In post-classical Latin it meant an astronomical table or a table for calculating the date of Easter. It also appeared in several Latin titles, such as Pinax iconicus antiquorum ac variorum in sepulturis rituum by Lilius Gregorius Giraldus (Lyon, 1556), Pinax theatri botanici by Caspar Bauhin (Basel, 1623), and Pinax rerum naturalium Britannicarum , by Christopher Merrett (London, 1666).

However, the only English pharmacopoeial instance of which I am aware is Pharmaco-Pinax, or a Table and Taxe of the Pryces of all vsuall Medicaments, Simple and composed, contained in D. Gordon’s Apothecarie and Chymicall Shop , published in Aberdeen in 1625.

So a pharmacopoeia is, as it were, a table of tablets.

Competing interests: JKA chairs the British Pharmacopoeia Commission’s Joint Expert Advisory Groups on Pharmacy and Nomenclature and is a member of the WHO’s Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations.

Provenance and peer review: not commissioned; not externally peer reviewed.

• Legislation.gov.uk
• ↵ Aronson JK. The 1618 Pharmacopoeia Londinensis . BMJ Opinion. 2 Nov 2018. https://blogs.bmj.com/bmj/2018/11/02/jeffrey-aronson-when-i-use-a-word-the-1618-pharmacopoeia-londinensis/
• ↵ Anonymous. Medical Council Act 1862 (1862 c 91). In: A Table of All the Statutes passed in the Fourth Session of the Eighteenth Parliament of the United Kingdom of Great Britain and Ireland. London: George Edward Eyre and William Spottiswoode, 1862: 486.
• British Pharmacopoeia
• Cartwright AC
• ↵ Legislation.gov.uk. The Medicines (British Pharmacopoeia Commission) Order 1970. https://www.legislation.gov.uk/uksi/1970/1256/made .
• Aronson JK ,
• ten Hacken P ,
• Williams A ,
• ↵ “pharmacopoeia | pharmacopeia, n.”. Oxford English Dictionary . Oxford University Press, July 2023. doi: 10.1093/OED/8841861169 .

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A Brief History of Pharmacopoeias: A Global Perspective

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

The global and historical perspective presented herein is critical to understanding the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias, as well as providing a deeper appreciation of the important harmonization progress achieved to date. Also, by understanding the lack of harmonization, the reader will appreciate the complexity it adds to a company’s processes for compendial monitoring and compliance.

Pharmacopoeias–A global perspective and brief history

According to the latest index compiled by the World Health Organization (WHO) (1), there are as many as 40 pharmacopoeias published around the world, with as many as 60 active pharmacopoeia commissions who carry out the work of developing and maintaining these pharmacopoeias ( Table I ).

To better understand the situation today, it is instructive to consider the history of pharmacopoeias. A timeline is provided in Figure 1 indicating the year when many of the pharmacopoeias were created. Although the earliest work presenting medical knowledge and herbal remedies may date back more than 3000 years to ancient Egypt (2), it was De Materia Medica , which appeared in the 1st century CE in Greece and Rome that perhaps represents the first example of a “pharmacopoeia” (3). (The word “pharmacopoeia” translates from the ancient Greek as “drug-making”.) This treatise on medical matters compiled herbal remedies known at the time, along with their methods of preparation. Beginning in the 16th century, several pharmacopoeias containing medical prescriptions were prepared for apothecaries and physicians in important cities of Europe, including Nuremburg (4), London, Edinburgh, and Dublin (5).

BP and USP –early efforts to harmonize pharmacopoeias

In the 19th century, it was recognized that there were inconsistencies in the information contained in the various pharmacopoeias which then existed. As a result, there was an emerging focus on efforts to standardize and harmonize the content in the pharmacopoeias. An early example of the need for pharmacopoeial harmonization was the creation of the British Pharmacopoeia ( BP ) in 1858 to overcome the inconveniences and dangers resulting from the existence of three different pharmacopeias in the United Kingdom and Ireland, those of London, Edinburgh, and Dublin (5). Even earlier, in 1820, the United States Pharmacopeia ( USP ) was established by a group of 11 physicians who held the first United States Pharmacopeial Convention (USP) in the US Capitol building in Washington, because they recognized the need for consistent standards for the medicines that were being used in the separate states of the relatively young “united” country. Information contained in the preface to the first edition of the USP provides an early reference to the historical purpose, value, and usefulness of the pharmacopoeias, which also provides interesting perspectives for today (6). Modern pharmacopoeias strive to achieve similar value and usefulness, while shifting away from historical “recipes” that described methods of preparation for medicines, to instead focus on the attributes of drug products and ingredients that help ensure their identity, strength, quality, and purity. The preface to the first edition of the USP continues with the following remarkable comments that speak to the need and value of harmonization to achieve consistency in pharmacopoeial standards (6):

“In the United States the evil of irregularity and uncertainty in the preparation of medicines has been felt with peculiar weight.”

“… (A) number of Pharmacopoeias … have been produced in different parts of the Union … and of course the character of medicinal preparations is liable to vary in every state and city of the Union.”

“… (A) National Pharmacopoeia … should be established and adopted … being evidently the only mode by which a uniform system could be introduced at once into all parts of the American territory.”

The work of the convention that introduced this uniform system of drug standards and led to the initial creation of the pharmacopoeia of the United States continues today, with the next meeting of stakeholders scheduled in May 2020, marking the 200th anniversary of the USP. However, the establishment of the USP in 1820 occurred long before modern bio/pharmaceutical manufacturing capabilities and regulatory systems that are in place today around the world to control the quality, safety, and efficacy of drug products. Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drug Act (7), nearly a century after the first USP was published. The USP and National Formulary ( NF ) were subsequently recognized as official compendia in the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act). In 1975, USP acquired the previously separate compendium NF and the first combined edition of the USP–NF , as it is known today, was released in 1980. The USP–NF remains unique today among pharmacopoeias, because it is developed by a private, non-governmental standards-setting organization. Unlike most other pharmacopoeias, which are affiliated with, or formally part of the regulatory agency in that country or region, the USP–NF is not part of, nor is it affiliated with the US FDA. Still, USP and FDA have a long-standing collaboration and maintain official contact through a number of established channels to help ensure the standards that are published in USP–NF and enforced by FDA (among their many other responsibilities) contribute to the quality of medicines. The historical context and practical considerations in the development of the USP and FDA have led to instances where the pharmacopoeia and regulatory requirements in the US are not fully aligned, making it difficult to comply with both standards.

Historical perspective for other pharmacopoeias

A broader consideration of today’s global community reveals a more complex situation with compliance challenges that result from the lack of broad harmonization across the various pharmacopoeias and regulatory agencies around the world. The publication of the USP in 1820 and the BP in 1858 aimed to bring consistency to drug standards for the benefit of pharmacy and medical practitioners and their patients. This objective has been pursued in other countries, continuing to modern times, with the initial development and subsequent updates to their pharmacopoeias. As noted earlier, there are currently as many as 40 pharmacopoeias published around the world, each with its own rich and unique history, while sharing a common goal of providing quality standards for medicines to benefit patients. Additional historical examples bring awareness of the overall timeline for development of the pharmacopoeias and provide the larger global context to aid in understanding the continuing efforts to achieve some degree of compendial harmonization.

Based on traditions for curing illnesses dating back to the 2nd millennium BCE, the classic Shen-nung Pen-ts’ao Ching represents the oldest known pharmaceutical work in China, a compilation of traditional Chinese materia medica (8). The current Chinese Pharmacopoeia ( ChP ) also has an interesting history for the establishment of quality standards for medicines, reflecting the great importance attached to medicine and healthcare by the Chinese government for the people of China (9). In 1949, the year the People’s Republic of China was founded, the Ministry of Health convened a meeting of medical and pharmaceutical experts to compile a national pharmacopoeia for China. Over the following several years, a process for developing the pharmacopoeia was established, including a secretariat and experts charged with carrying out the practical and technical aspects of the work. The first edition of the Chinese Pharmacopoeia was published in 1953, containing 531 monographs for drug substances and products, including chemical medicines and traditional medicines of plant and animal origin. The first addendum to the 1953 edition was published in 1957. Since then, the content in the pharmacopoeia has continued to expand. The latest (10th) edition of the Pharmacopoeia of the People’s Republic of China , referred to as the ChP , was published in 2015 and consists of four volumes covering traditional Chinese medicines, modern chemical medicines and antibiotics, biologics, excipients, and general chapters (10). ChP 2015 contains more than 5600 monographs, 10 times the number in the first edition, including more than 1000 new monographs since the previous edition that was published in 2010, and more than 300 general chapters and requirements. The next edition of ChP is in development, with publication planned for 2020.

The history of the Indian Pharmacopoeia ( IP ) (11) began in 1833, when a committee recommended publication of a pharmacopoeia, which was first completed in 1844 and mainly consisted of commonly used indigenous remedies. A subsequent publication in 1868 included not only the indigenous drugs used in India, but also the drugs of the British Pharmacopoeia . Then in 1885, the BP was made official in India. After independence from Britain, the Indian Pharmacopoeia Commission was established in 1948, with its main function being the publication of IP as the national pharmacopoeia. The first edition of the modern IP was published in 1955, and the current 8th edition was published in 2018.

Elsewhere, the first edition of the Russian Pharmacopoeia (now the State Pharmacopoeia of the Russian Federation or SP RF ) dates back to 1866 (12); it is now in its 14th edition, which was published (in Russian and on-line only) by the Russian Ministry of Health in December 2018, with implementation required by January 2022. The Japanese Pharmacopoeia ( JP ) was first published in 1886 (13) and is now in its 17th edition including two supplements, with the 18th edition planned for publication in 2021. The pharmacopoeias in Mexico and Argentina were first published in 1846 and 1898, respectively (1). The first edition of the Brazilian Pharmacopoeia was published in 1929 (1) and is currently in its 5th edition including two supplements, with an updated 6th edition nearing completion. The Korean Pharmacopoeia was first published in 1958 (1); the Indonesian Pharmacopoeia in 1962 (12). Other recent examples include the pharmacopoeias in Vietnam, Thailand, the Philippines, and Kazakhstan, first published in 1970, 1987, 2004, and 2008, respectively (1).

Each pharmacopoeia was initially established to standardize medicines and serve the needs of patients within their respective country. Today, a global view is necessary in order to meet the needs of global patients. Within this perspective, there is a special place held by the European Pharmacopoei a ( Ph. Eur. ) and the International Pharmacopoeia ( Ph. Int. ), each of which deserves further consideration.

Ph. Eur. –Creation of a modern, harmonized pharmacopoeia

In their historical context, the development of the USP and BP were intended to harmonize drug standards. But unlike the USP , BP , and many other pharmacopoeias, the more recent creation of the Ph. Eur. occurred within the context of modern manufacturing and regulatory systems in Europe and around the world, providing a recent and successful example of harmonization. In 1964, the Convention on the Elaboration of a European Pharmacopoeia, set forth by eight member states of the Council of Europe, established harmonized standards for medicines in Europe (5). The convention facilitated the free movement of medicines throughout member states and ensured access to medicines by European citizens. Today, this convention has 39 signatory parties from Europe, including the European Union, in which there is mandatory compliance with the requirements of the Ph. Eur . These member states participate and vote in the European Pharmacopoeia Commission sessions, where the standards published in the Ph. Eur. are adopted (14). Currently, there are also 30 observers from all over the world, including the US, China, and WHO, that are able to participate in the scientific work of the Commission and benefit from the European experience in this area. Observers also gain access to the work on the quality control of medicines and the methods of analysis in the Ph. Eur. , which could further support compendial harmonization through adoption or adaptation of the Ph. Eur. standards.

The Ph. Eur. marks the creation of a single, unified regional pharmacopoeia-it may be argued even an international pharmacopoeia-providing legally binding standards for the quality of medicines and their ingredients in Europe for the signatories to the convention, where previously there had been separate pharmacopoeias in each member country. This represents an important advance in the historical evolution of pharmacopoeias to move toward global standards. With this achievement, why are there still pharmacopoeias in some individual countries in Europe? Maintaining a national pharmacopoeia in these countries provides text that is either of interest to one member state only, or out of scope of the Ph. Eur. (e.g., national formularies) (15). Three main approaches were taken in Europe following the creation of the Ph. Eur. , with the decision being country specific:

• Discontinuation of the national pharmacopoeia (e.g., Sweden, Finland, Netherlands); Ph. Eur. established as the only pharmacopoeia, potentially translated into the national language
• Inclusion of the Ph. Eur. content in the national pharmacopoeia (e.g., United Kingdom [ BP ], Spain)
• Publication of the national pharmacopoeia in addition to the Ph. Eur. (e.g., France, Germany, Switzerland, Austria).

Regardless of the approach taken, the standards contained in the Ph. Eur. remain mandatory in these countries, even as their national pharmacopoeia serves to complement the content of the Ph. Eur. by including standards for drug products and ingredients that are applicable in that individual country.

An article written by the Director of the European Directorate for the Quality of Medicines and HealthCare (EDQM) provides perspective on the continuing role of the pharmacopoeia in the 21st century (3). The article describes how pharmacopoeias continue to modernize in changing times to support the availability of affordable medicines without compromising their quality, safety, and efficacy. The 9th edition of the Ph. Eur. , which became official in January 2017, has continued to add new and revised general chapters and monographs, including the publication of the first monograph for a finished product containing a chemically defined active substance. The Ph. Eur. has moved to allow the use of reverse osmosis for the production of water for injections (WFI) and has increased focus on impurities, quality by design (QbD), process analytical technology (PAT), and biotherapeutic products, including monoclonal antibodies (mAbs). EDQM, which publishes the Ph. Eur. , has also recognized that a high percentage of APIs come from outside Europe, Japan, and the US, leading to even further need to strengthen the collaboration among pharmacopoeias. To mark the publication of the 10th edition of the Ph. Eur. , which is official in January 2020, EDQM organized an international conference in Strasbourg in June 2019, bringing together leading scientists and experts to exchange views and share experiences on all aspects of the quality of medicines. The conference, titled “EDQM and European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines,” highlighted developments in the Ph. Eur. to help ensure that modern pharmacopoeias continue to make a vital contribution to the protection of public health.

Other regional pharmacopoeia initiatives

There have been other efforts to support the harmonization of pharmacopoeia standards between several countries in a particular region, drawing on the successful experience of the Ph. Eur. The MERCOSUR pharmacopoeia is being developed to provide harmonized compendial standards for four Southern Common Market (South American) countries: Brazil, Argentina, Paraguay, and Uruguay. The Eurasian Economic Union (EAEU) pharmacopoeia, currently under development, is intended to provide a core set of requirements for the quality of medicinal products in the countries of the Eurasian Economic Union, which includes the Russian Federation, Armenia, Belarus, Kazakhstan, and Kyrgyzstan. It will be interesting to monitor the continued development of these pharmacopoeias, including how the published compendial standards are received and accepted by the health authorities in these countries and around the world. It remains to be seen if the existing national pharmacopoeias will continue to exist, or if they will be discontinued or absorbed in the new regional publication.

Ph. Int. –Toward global pharmacopoeia standards

With the inclusion of “international” in its title and considering the numerous other pharmacopoeias also in existence today, it is useful to understand the history and specific role played by the Ph. Int. in the global pharmacopoeia landscape.

Among its many responsibilities, WHO provides important support to global healthcare through the publication of the International Pharmacopoeia . The work on the Ph. Int . is carried out in collaboration with members of the WHO Expert Advisory Panel on the International Pharmacopoeia and the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Also involved in this work are specialists from regulatory authorities, from industry and from other institutions, including national drug quality control laboratories, WHO collaborating centers, and other standards-setting organizations (16). The eighth edition of Ph. Int. was published in 2018 and constitutes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances and dosage forms. These are intended to serve as source material for reference or adaptation by any WHO Member State (194 countries) wishing to establish pharmaceutical requirements (17). From a compliance perspective, it is important to understand that the Ph. Int. only has legal status whenever a national or regional authority expressly introduces it into appropriate legislation.

The ultimate goal of the Ph. Int. is to provide quality control specifications to help enable access to quality medicines worldwide. The Ph. Int. is published by WHO with the aim to achieve wide global harmonization of quality specifications for selected pharmaceutical products, excipients, and dosage forms. Compared to other pharmacopoeias, priority is given to medicines that are included in the WHO Model List of Essential Medicines and to medicines that are important for WHO health programs; the needs of developing countries are taken into account (17). However, this focus on essential medicines and developing countries is a fairly recent development and was not always the primary intention of the Ph. Int. Indeed, the goal of achieving harmonized pharmacopoeia standards for drug quality is deeply rooted in the history of Ph. Int., which dates back to 1874 when the need to standardize terminology and to specify dosages and composition of drugs led to attempts to produce an international pharmacopoeia (18). In 1937, the League of Nations set up an expert committee in response to repeated calls from pharmaceutical experts in various countries to coordinate the work of national pharmacopoeia commissions and develop a unified pharmacopoeia. The first committee comprised seven experts from Belgium, Denmark, France, the Netherlands, Switzerland, the United Kingdom, and the United States.

In 1947, WHO took over the work begun under the League of Nations for the unification of pharmacopoeias. The first edition of the Ph. Int. was published in two volumes (1951 and 1955) and a supplement (1959) in English, French, and Spanish, and also translated into German and Japanese. The Ph. Int . was originally published with the aim of creating a worldwide, unified pharmacopoeia and relied on collaboration with national pharmacopoeia commissions for its preparation. However. it was recommended that Ph. Int. was not intended to be a legal pharmacopoeia in any country unless adopted by the pharmacopoeial authority of that country. In 1975, the purpose of the Ph. Int . was reconsidered. It was decided that the publication should focus more on the needs of developing countries, applying simple, classical chemical techniques for the testing of medicines. Priority would be given to drugs that were widely used throughout the world, with emphasis on the therapeutic value of these drugs. High priority would be accorded to drugs important to WHO health programs, and to those likely to contain impurities arising from degradation or due to difficulties in their manufacture. Since 1979, monographs in Ph. Int. have provided specifications for the identification, purity and content for drugs in the WHO Model List of Essential Medicines.

As with all pharmacopoeias, the activities related to Ph. Int. provide an important element in the overall quality assessment of bio/pharmaceuticals, thereby contributing to the safety and efficacy of medicines. Currently, the focus for Ph. Int. is on essential medicines, and more recently on priority medicines of major public health importance, for instance, medicines to treat malaria, tuberculosis, and HIV/AIDS, as well as medicines for children. However, from the earliest times, dating back to 1874, the objective had actually been to create a unified pharmacopoeia that could be used around the world-truly an international pharmacopoeia.

The history of the pharmacopoeias around the world reveals a common purpose to support the health of the population through consistent standards for medicines. Early examples, like the creation of the USP and BP at a national level, as well as later examples, such as the Ph. Eur. on a regional level, also show an emphasis on trying to harmonize the quality standards contained in the pharmacopoeias. The history of the Ph. Int. demonstrates that the vision of creating a unified, international pharmacopoeia is not new; the goal of such a pharmacopoeia, which could support public health at a global level goes back nearly 150 years.

The next articles in this series will use the historical context presented in Part 3 to further explore the need for harmonization of compendial standards, with discussion about some of the approaches that are underway to reach this important goal. Later articles will build on this information to propose a practical basis for classifying pharmacopoeias as “global” or “national”, which enables a thorough consideration of the variety of approaches that may be taken by bio/pharmaceutical companies to meet health authority expectations around the world in regard to pharmacopoeia compliance.

Acknowledgment

The authors gratefully acknowledge the contribution of Susan J. Schniepp for her technical review and helpful suggestions during the preparation of this series of articles.

,” World Health Organization, Working Document QAS/11.453/Rev.10, January 2018.  2. New York Academy of Medicine, “ Academy Papyrus to be Exhibited at the Metropolitan Museum of Art ,” Press Release, July 2005, Accessed September 9, 2019. 3. S. Keitel, PDA Letter , April 2019. 4. A. Arber, Herbals, Their Origin and Evolution: A Chapter in the History of Botany, 1470–1670, (Cambridge University Press, p. 66, 1912). 5. S. Keitel, Pharmaceutical Technology 34 (4), pp. 120-121 (April 2010). 6. USP, The Pharmacopoeia of the United States of America, Copyright United States Pharmacopeial Convention, Inc. , Facsimile of First Edition (1820), Published by the American Institute of the History of Pharmacy, Madison, Wisconsin (2005). 7. FDA, “ The History of FDA’s Fight for Consumer Protection and Public Health ,” FDA.gov , Accessed July 11, 2019. 8. P. U. Unschuld, Medicine in China: A History of Pharmaceutics (University of California Press, pp. 14-16, 1986). 9. Chinese Pharmacopoeia Commission, “History of the Pharmacopoeia of the People’s Republic of China,” ChP , Vol. 1, pp. XIII - XXIII (China Medical Science Press, 2015). 10. Chinese Pharmacopoeia Commission, “Preface,” ChP , Vol. 1, pp. IX - XII (China Medical Science Press, 2015). 11.  Indian Pharmacopoeia Commission, “ About IP–History of IP, ” ipc.gov.in, Accessed July 11, 2019. 12. WHO, “ International Meeting of World Pharmacopoeias ”, WHO.int, Accessed June 26, 2019. 13.  PMDA, “JP History and Legal Status”, Japanese Pharmacopoeia–About JP , pmda.go.jp, Accessed June 26, 2019. 14. EDQM, “ Membership & Observership ,” EDQM.eu , Accessed July 18, 2019. 15. C. Vielle, “

,” Presentation at the Workshop The Chinese and European Pharmacopoeias–The New Editions, Strasbourg, France (October 17, 2016). 16. WHO, The International Pharmacopoeia (Ph. Int.) , WHO.it, Accessed June 10, 2019. 17. WHO, The International Pharmacopoeia, 8th Edition , Library Homepage (WHO Department of Essential Medicines and Health Products, 2018), 18. WHO, The International Pharmacopoeia, 8th Edition , Background to Previous Editions (WHO Department of Essential Medicines and Health Products, 2018),

Related Content:

Different monographs and formularies available and their major contents

Table of Contents

What are Monographs?

Monographs are detailed, written documents that provide comprehensive information about a specific subject or item. In the context of pharmaceuticals and medicine, monographs serve as official documents containing detailed specifications and standards for individual drug substances, dosage forms, and other related products. These documents are typically created and published by pharmacopoeial organizations or regulatory agencies.

Here are some key features of pharmaceutical monographs:

• Specifications: Monographs outline the specifications and standards that a particular drug or substance must meet. This includes details about the identity, purity, strength, quality, and other relevant characteristics.
• Testing Procedures: Monographs often include specific testing procedures that laboratories can use to verify whether a drug or substance complies with the specified standards. These procedures ensure consistency and quality in the manufacturing and testing of pharmaceutical products.
• Dosage Forms: Monographs provide information on various dosage forms, such as tablets, capsules, injections, and topical formulations. This includes details on formulation ingredients, manufacturing processes, and testing requirements.
• Reference Standards: Monographs may reference specific standards or reference materials that should be used for testing and quality control purposes. These standards help ensure uniformity in testing across different laboratories.
• Regulatory Compliance: Monographs play a crucial role in regulatory compliance. Pharmaceutical companies must adhere to the standards outlined in monographs to obtain regulatory approvals for their products.
• International Harmonization: Many countries have their own pharmacopoeias with monographs, and efforts are made for international harmonization to align standards across different regions. For example, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) works towards global harmonization of guidelines and standards.

Several pharmacopoeias, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.), and others, publish monographs as part of their official compendia. These monographs are regularly updated to reflect advancements in science, changes in manufacturing processes, and improvements in testing methodologies.

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In summary, pharmaceutical monographs are detailed documents that set the standards for the identity, quality, and purity of drugs and related substances. They play a crucial role in ensuring the safety and efficacy of pharmaceutical products and provide a reference for regulatory authorities, manufacturers, and healthcare professionals.

Indian Pharmacopoeia

The Indian Pharmacopoeia (IP) is an authoritative compilation of standards for drugs and pharmaceuticals in India. It serves as a reference text for the pharmaceutical industry in the country and ensures the quality, safety, and efficacy of medicinal products. The Indian Pharmacopoeia Commission (IPC) is responsible for the development and maintenance of the Indian Pharmacopoeia.

Early Years:

• The history of the Indian Pharmacopoeia dates back to the late 19th century. The first edition, known as the “Pharmacopoeia of India,” was published in 1868 under the British colonial administration. This publication aimed to standardize the quality of drugs and pharmaceuticals used in medical practice across British India.

Pharmacopoeia of India:

• The “Pharmacopoeia of India” continued to be revised and updated, reflecting advances in pharmaceutical science and changes in medical practice. It served as an essential reference for healthcare professionals, pharmacists, and the pharmaceutical industry.

Independence and the Formation of IPC:

• After India gained independence in 1947, there was a need to reassess and update the pharmacopoeial standards to align with the evolving healthcare landscape and scientific advancements.
• In 1956, the Indian Pharmacopoeia Committee (IPC) was established to oversee the preparation and publication of the Pharmacopoeia of India. The committee consisted of experts from various fields, including pharmacology, chemistry, and medicine.

Indian Pharmacopoeia Commission (IPC):

• The Indian Pharmacopoeia Commission (IPC) was formally established in 1957 under the Ministry of Health and Family Welfare, Government of India. The IPC took over the responsibility of the preparation, revision, and publication of the Indian Pharmacopoeia.
• The IPC is an autonomous body with a mandate to develop and maintain standards for drugs and pharmaceuticals in India.

Modernization and Global Harmonization:

• Over the years, the IPC has actively worked towards modernizing the Indian Pharmacopoeia to meet international standards and practices.
• The IPC collaborates with national and international organizations, pharmaceutical industry stakeholders, and regulatory agencies to ensure the harmonization of pharmacopoeial standards.

Editions and Revisions:

• The actual process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra. The I. P. list was first published in the year 1946 and was put forth for approval. The titles are suffixed with the respective years of publication, e.g., IP 1996.
• The IPC regularly updates the pharmacopoeial standards to reflect changes in drug development, manufacturing practices, and quality control methodologies.

Legal Status and Regulatory Compliance:

• The standards outlined in the Indian Pharmacopoeia have legal significance in India. Compliance with these standards is often a regulatory requirement for the approval, production, and marketing of pharmaceutical products in the country.
• The IPC plays a crucial role in supporting regulatory agencies in ensuring the quality, safety, and efficacy of pharmaceuticals in the Indian market.

Major Contents

• General Notices: Providing information on the purpose, scope, and interpretation of the IP.
• Monographs: Specifications for drugs and pharmaceuticals.
• Test Methods: Describing procedures for quality control.

In summary, the Indian Pharmacopoeia has evolved from its colonial origins to become a dynamic and essential reference for the pharmaceutical industry and regulatory authorities in India. The commitment to global harmonization and continuous updates reflects the IPC’s dedication to maintaining high standards in the field of drugs and pharmaceuticals.

British Pharmacopoeia

The British Pharmacopoeia (BP) is a comprehensive reference work that contains quality standards for medicinal substances and pharmaceutical products used in the United Kingdom. It serves as a vital resource for ensuring the quality, safety, and efficacy of medicines. Here are some key points about the British Pharmacopoeia:

Purpose and Scope

• The primary purpose of the British Pharmacopoeia is to establish standards for the quality and purity of medicinal substances, formulated preparations, and pharmaceutical products.
• It provides guidance for manufacturers, healthcare professionals, and regulatory authorities to ensure that medicines meet specific quality criteria.

Development and Publication

• The first edition of the British Pharmacopoeia was published in 1864.
• The BP is updated regularly to incorporate new scientific and technological advancements in the field of pharmaceuticals.
• It is published by the British Pharmacopoeia Commission (BPC), which operates under the auspices of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
• Monographs: Similar to the USP, the BP provides specifications for medicines, including information on identity, purity, and strength.
• General Notices: Describes the structure and use of the BP, including legal and advisory statements.
• Appendices: Additional information on topics like reagents, indicators, and reference spectra.

Legal Status

• Compliance with the standards outlined in the British Pharmacopoeia is often a legal requirement for the manufacture and sale of pharmaceutical products in the UK.
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for enforcing pharmacopoeial standards in the country.

United States Pharmacopeia (USP)

The United States Pharmacopeia (USP) is not a theory but rather a compendium of standards for quality in the field of pharmacy and healthcare products. However, the use and implementation of USP standards are based on certain principles and concepts. Here are some key aspects related to the theoretical foundations of the USP:

• Quality Standards: The primary objective of the USP is to establish and promote quality standards for drugs, dietary supplements, and other healthcare products. These standards ensure that products are of consistent quality, purity, strength, and identity.
• Public Health Focus: The USP operates with the goal of safeguarding public health. By setting and updating standards for pharmaceuticals and related products, the USP aims to protect consumers from substandard or adulterated drugs, ensuring the efficacy and safety of medications.
• Scientific Rigor: The development of USP standards is a scientific process that involves input from experts in various fields such as pharmacy, medicine, chemistry, and pharmacology. The standards are based on the latest scientific knowledge and technological advancements.
• Monographs and General Chapters: The USP contains monographs that provide detailed specifications for individual articles, including drug substances, dosage forms, and dietary supplements. General chapters cover broader topics, such as testing procedures, quality control, and good manufacturing practices.
• International Recognition: While the USP is rooted in the United States, its standards have gained international recognition. Many countries refer to or adopt USP standards as part of their own regulatory frameworks, contributing to global harmonization in pharmaceutical quality standards.
• Regulatory Influence: Although the USP itself does not have regulatory authority, its standards are widely accepted and often referenced by regulatory agencies, including the U.S. Food and Drug Administration (FDA). Compliance with USP standards is commonly required for regulatory approval of pharmaceutical products.
• Continuous Revision and Updates: The USP is a dynamic compendium that undergoes regular revisions and updates. This dynamic nature allows the standards to evolve with advancements in science, technology, and regulatory expectations. Supplements to the USP are published to incorporate these changes.
• Official Standards: USP contains standards for drugs, dietary supplements, and other healthcare products. These standards ensure the quality, purity, strength, and consistency of these products.
• General Chapters: These cover various topics such as dosage forms, compounding, and testing procedures.
• Monographs: Detailed specifications for individual drug substances, dosage forms, and compounded preparations.

Japanese Pharmacopoeia

The Japanese Pharmacopoeia (JP) is an official document that provides standards for the quality, safety, and efficacy of drugs and medicinal products in Japan. It plays a crucial role in ensuring the uniformity and consistency of pharmaceutical products in the country. The JP is developed and maintained by the Ministry of Health, Labour and Welfare (MHLW) in Japan.

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Here are some key points about the Japanese Pharmacopoeia:

• Regulatory Authority: The MHLW is responsible for overseeing the development and updates of the Japanese Pharmacopoeia. The Pharmaceuticals and Medical Devices Agency (PMDA) is also involved in the evaluation and approval of drugs in Japan.
• Legal Status: The JP has legal significance in Japan, and compliance with its standards is mandatory for pharmaceutical manufacturers. The standards set by the JP cover a wide range of topics, including the identity, purity, strength, and quality of drugs.
• Publication: The Japanese Pharmacopoeia is published in print and electronic formats. It is regularly updated to incorporate new and revised standards for drugs and medicinal products.
• Monographs: The JP contains monographs that describe the specifications and testing methods for individual drugs and medicinal substances. These monographs provide detailed information about the quality standards, including physical and chemical characteristics, tests for identification, and purity criteria.
• General Notices and General Chapters: In addition to monographs, the JP includes general notices and general chapters that provide information on the interpretation and application of the standards. These sections cover topics such as dosage forms, packaging, and storage conditions.
• Harmonization: Efforts are made to harmonize the Japanese Pharmacopoeia with international pharmacopoeial standards, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). This is important for global pharmaceutical development and trade.
• Supplements and Revisions: The JP is subject to periodic updates through supplements and revisions. These updates may include the addition of new monographs, modification of existing standards, or removal of obsolete content.
• Compliance and Quality Assurance: Pharmaceutical manufacturers in Japan are required to comply with the standards outlined in the JP to ensure the quality, safety, and efficacy of their products. Compliance with these standards is critical for obtaining regulatory approval for drug registration and marketing.
• Influence on Industry: The Japanese Pharmacopoeia has a significant impact on the pharmaceutical industry in Japan. It sets the benchmark for quality standards, and companies must adhere to these standards to ensure that their products are safe and effective.
• General Information: Introduction, legal basis, and guidelines.
• Standards for Drugs: Monographs for drugs and other medicinal substances.
• Test Methods: Procedures for testing the quality of drugs.

Formularies

Formularies are systematic lists of pharmaceutical and medicinal preparations, along with their descriptions and formulations, that are approved and recommended by a recognized body or authority. These lists are used by healthcare professionals, including physicians, pharmacists, and other prescribers, to guide the selection, prescription, and dispensing of medications for patient care.

United States Pharmacopeia-National Formulary (USP-NF):

• USP Monographs: Detailed specifications for drugs and other healthcare products.
• NF Monographs: Information on excipients, dietary supplements, and other non-drug substances.
• General Chapters: Covering various aspects of pharmaceutical development and quality control.

British National Formulary (BNF):

• Drug Monographs: Information on the use, dosage, side effects, and contraindications of medications.
• Guidance on Prescribing: Recommendations for prescribing and managing medicines.
• Formulary: List of medicines approved for use within the National Health Service (NHS) in the UK.

WHO Model Formulary:

• Essential Medicines List: Focus on medications necessary for a basic healthcare system.
• Guidelines for Use: Information on dosage, administration, and monitoring of essential medicines.
• Formulary Information: Supporting rational medicine use globally.

Martindale: The Complete Drug Reference:

• Monographs: Comprehensive information on drugs, including pharmacology, indications, and adverse effects.
• Appendices: Additional information on topics like poisoning and drug interactions.
• Index: Facilitates quick access to drug information.

AHFS Drug Information:

• Monographs: Detailed drug information organized by therapeutic category.
• Therapeutic Classifications: Systematic classification of drugs based on therapeutic use.
• Patient Education: Information for patients on medication use and safety.

Merck Index:

• Chemical Information: Comprehensive data on chemicals, drugs, and biologicals.
• Monographs: Detailed descriptions of substances, including physical properties and uses.
• Indexes: Facilitate quick access to information based on various criteria.

Conclusion:

Monographs and formularies play a crucial role in ensuring the quality, safety, and efficacy of pharmaceuticals and healthcare products. They provide a standardized reference for professionals in the pharmaceutical industry, regulatory bodies, healthcare practitioners, and researchers. Regular updates and revisions are essential to keep pace with advancements in science, technology, and healthcare practices. The information contained in these resources is vital for the development, manufacturing, prescribing, and dispensing of medications, contributing to the overall goal of improving global public health.

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• v.30(5); 2022 May

Pharmacopoeia roles and responses: A systemic resilience approach to COVID-19 pandemic

The Coronavirus Disease (COVID-19) is sweeping around the world at a rapid pace resulting in severe health crises across the globe. The pandemic condition has forced the government, regulatory authorities, bio/pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The race for development of medicines and vaccines for treatment of COVID-19 is well under way and regulatory authorities are making efforts to safely deliver it into hands of public. As ever, pharmacopoeias played an active role in providing a framework of standards for the development, manufacturing, and quality of life-saving COVID-19 related medicines. The COVID-19 crisis has compelled the pharmacopoeias to redefine their role and show unprecedented levels of flexibility in extending their services to the stakeholders, developing new drug standards, and simultaneously ensuring the safety of their staff. During this pandemic, pharmacopoeias operated in a triangular chain system with regulators and pharmaceutical manufacturers to evaluate potential products for treatment of COVID-19. The present article provides an insight on the roles, challenges, and responses of the pharmacopoeias to deal with the current situation due to COVID-19 and emphasizes on new opportunities for collaborations to set standards for COVID-19 related drugs.

1. Introduction

In January 2020, World Health Organization (WHO) has declared novel coronavirus (COVID-19) as a world health emergency and in March 2020 the same was declared as a pandemic, the highest level of world emergency. As of December 2021, most of the cases of COVID-19 were reported from the USA, India, Brazil, and Russia ( WHO, 2020 ). During the initial phase of pandemic, various repurposing drugs have been attempted for treatment and management of COVID-19 cases; however, owing to limited clinical evidence their use was restricted ( Jean et al, 2020 ). The pandemic condition has forced the governments, regulatory authorities, pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The ongoing COVID-19 disaster has led to a dramatic global impact on the pharmaceutical industry operations and pharmaceutical sectors are struggling hard to maintain productivity, workforce, securing operations, and mobility thereby limiting access to essential medicines for end users ( Ayati et al, 2020 ). Aside from responding to the immediate threat, the organizations have to adapt quickly to ensure that they can be pliant to disruption and can work in a more agile way in the post-covid environment ( Hiscott et al, 2020 ).

Responding to the COVID-19 pandemic, the health authorities are also compelled to work in a way that is normally reserved for natural disasters. Several national and international organizations are working in collaborations to develop new policies, procedures, and therapeutic interventions ( Hiscott et al, 2020 ). Their working is now based on fast-track approval of essential drugs, emergency regulations, and mutual agreement to deliver the drugs safely into hands of patients ( Harrison, 2020 ). In the sphere of public health, pharmacopoeias have the responsibility to ensure quality of the marketed medicinal products to help protect the patients from adulterated and counterfeited medicines. Pharmacopoeias discharge this responsibility by defining the quality standards of the active pharmaceutical ingredients (API) and finished pharmaceutical preparations (FPPs). In addition, pharmacopoeia bodies establish and distribute reference standards for assessment of the quality of medicines following monograph specifications. For the process of standards’ setting, pharmacopoeia bodies consult and collaborate with regulatory authorities, health authorities, pharmaceutical industry, and other stakeholders. Compliance with the pharmacopoeia standards is legal regulatory requirement in countries and regions where pharmacopoeia is applicable ( Wiggins and Albanese, 2020a , Wiggins and Albanese, 2020b ).

Current COVID-19 pandemic has posed a serious challenge to the working of pharmacopoeia bodies globally and pharmacopoeias have prioritized their activities and functions to support the healthcare system by assuring availability and access to the drug standards for the stakeholders. Present article covers the perspective in redefining the roles of pharmacopoeias during COVID-19 realities with respect to their challenges, responses, and opportunities to strengthen the drug standards to deal with the pandemic.

2. Pharmacopoeias: Global perspective

WHO has compiled an index of the pharmacopoeias published across the globe. As per the latest index compiled, there are as many as 60 pharmacopoeias published around the world ( WHO, 2021b ). These pharmacopoeias are embedded in their own national or regional regulatory legislation and thereby making them legally binding to comply with (Wiggins and Albanese, 2020a). For example, the European Pharmacopoeia (Ph. Eur.) is mandatory when requesting marketing authorization in the member states of European Pharmacopoeia Commission, as prescribed in the European Union Directives 2001/83/EC and 2001/82/EC ( Stemplewski, 2018 ). Similarly, the Indian Pharmacopoeia (IP) is the official book of drug standards as per the second schedule of the Drugs and Cosmetics Act, 1940 and Rules 1945 there under for obtaining marketing authorization in India ( Malik, 2014 ). The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard testing methods necessary to properly assure the quality of drugs in Japan, based on Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy, and Safety of Products including Pharmaceuticals and Medical Devices ( Kameyama et al, 2019 ). Also, the United States Pharmacopeia (USP) is used to control the quality of drugs distributed in the United States, as prescribed in Sections 201(g) and 501(b) of the Federal Food, Drug, and Cosmetic Act ( USP, 2021b ). Further information in this regard is published elsewhere and is beyond the scope of present article.

3. COVID-19 pandemic: roles and responses of pharmacopoeias

The resilience of pharmacopoeia organizations worldwide is being tested to combat the new challenges posed by COVID-19. Though the pharmacopoeia bodies constantly made efforts to remain operational and to support pharmaceutical industry, regulatory authorities, and health authorities to manage the pandemic situation, new challenges have emerged that need to be responded by each of the pharmacopoeias. These include, but not limited to, continuing their operations with respect to monograph development and modernization through public consultations, maintaining supply chain of reference standards, and above all ensuring the safety of their staff.

In response to the COVID-19 pandemic, WHO under umbrella of International Meeting of World Pharmacopoeias, initiated global pharmacopoeia alert meetings with participation of various pharmacopoeias like Brazilian, British, European, Indian, International, Japanese, Mexican, and United States. As per the information displayed on the WHO website, pharmacopoeial alerts are a mechanism that permits rapid discussions between pharmacopoeias to respond to pressing public health need ( WHO, 2021a ). The goal of this alert was knowledge sharing among the pharmacopoeias to figure support strategies for drug manufacturers, regulators, and other stakeholders in response to current pandemic along with providing support on medicines vital to the COVID-19 response. These discussions were immensely useful for individual pharmacopoeias to learn from the experiences of other pharmacopoeias to better plan innovative strategies to continue with their functions during the challenging time. Pharmacopoeia alerts also provided a scope to follow the harmonized approach for monograph development and revision in addition to the development of new drug standards particularly those used in treatment, management, and prophylaxis of COVID-19. Such interactions are expected to help ensure the availability of affordable quality medicines for COVID-19 in days to come.

Globally, the pharmacopoeias have discretionary actions and different working approaches in response to COVID-19 pandemic. Confronted with COVID-19 pandemic, British Pharmacopoeia (BP) worked closely with Medicines and Healthcare products Regulatory Agency (MHRA) to anticipate and meet health product needs. This involved maintaining access to drug standards and developing new standards ( BP, 2021 ). Likewise, Ph. Eur. considered the fact that availability and access to quality medicines is more important and accordingly has taken several measures. Ph. Eur. collaborated with BP to make pharmacopoeia texts (monographs, general chapters, appendices, and supplementary chapters) available to users ( BP, 2021 ). Similarly, IP was actively engaged in providing important healthcare-related services to its users. The supply of IP reference standards and impurity standards remained uninterrupted to all the stakeholders including pharmaceutical manufacturers and drug testing laboratories so that there is no hurdle in the release of medicines into the market. IP also provided its support to health authorities by extending its analytical laboratory for testing of the drugs received from various government agencies including the National Health Programmes (NHPs) (IP, 2021). Technical queries related to IP monographs continued to be addressed after consultation with the Expert Working Groups through virtual meetings. In order to strengthen the quality standards of the COVID-19 related drugs, several monograph revisions were initiated. Considering the requests of the pharmaceutical manufacturers, publication of the IP Addendum was also extended by six months. This extension helped pharmaceutical industry to be better prepared for ensuring compliance with the new drug standards included therein ( IP, 2020 ). International Pharmacopoeia (Int. Ph.) was engaged in speeding up the development, production and distribution of vaccines, diagnostics, and therapeutics for COVID-19. The JP restricted its work to 30% in accordance with Japan’s emergency statement; although, JP has adapted to support industry and other stakeholders as the need arises. The Pharmacopoeial Discussion Group remained functional to work on pharmacopoeial harmonization of general monographs and excipients. Specific measures were taken by the JP along with the Ministry of Health for enforcing the availability of disinfectants and priority review of COVID-19 related drugs and products (JP, 2021 ). The USP played a critical role in the public health response to COVID-19 by providing uninterrupted access to USP’s quality standards and support services to manufacturers, scientists, healthcare practitioners, and regulatory bodies ( USP, 2021a ). Various initiatives were taken by the USP to support industry e.g., shortening the development time of possible treatments, giving 6 months complimentary access to USP-NF online, extending implementation, and comment period for USP publications by 6 months, etc. The USP also offered technical assistance to industry on vaccine development, antibody therapies, and antiviral therapies and scaling up production of approved therapeutics such as secondary medications needed for patients on ventilators ( USP, 2021a ). USP has also published recommendations for compounding alcohol-based hand sanitizers for use during shortages associated with the COVID-19 pandemic.

4. COVID-19: challenges and opportunities for pharmacopoeias

COVID-19 has displayed the most severe impact on every sphere of the health sector, including hospitals, disease prevention, treatment, management, policy making, pharmaceutical industry, and drug regulation ( Nicola et al, 2020 ). Pharmacopoeias worldwide have responded to the crisis using a range of regulatory instruments, including maintenance of supply chain of reference standards, interaction with the industry and regulators, development of new standards, and taking appropriate measures for staff safety. The biggest challenge before the pharmacopoeias was that there was no approved therapy or vaccine available for diagnosis, treatment, and prevention of COVID-19, and therefore, the action points and work areas were not defined for the pharmacopoeias.

4.1. Comparative status of drug monographs in pharmacopoeias

In order to have concrete efforts to deal with the challenges posed by COVID-19 and to co-ordinate the activities of different pharmacopoeias, WHO has organized pharmacopoeia alert meetings on regular basis and these meetings have contributed to the compilation and publication of the monograph status of different pharmacopoeias for medicines critical to COVID-19 response. In this regard, a dashboard has been developed and displayed on the websites of the USP and WHO for public access ( USP, 2021a; WHO, 2021a ). It is observed from this dashboard that the USP (n=138) lists the maximum number of monographs, followed by BP (n=131) and IP (n=99) while Vietnamese Pharmacopoeia (n=27) has listed the minimum number of monographs. These differences in monograph numbers are to be attributed to variations in policies and related regulations across the pharmacopoeias ( Kameyama et al, 2019 ). USP has a policy of including standards for all drugs, including drug formulations that are legally marketed in the USA whereas the JP focuses primarily on drugs that are essential for health care and medicinal treatment rather than all drugs marketed in Japan. Likewise, the Ph. Eur. has historically focused on the development of API and excipients monographs while IP gives priority to those drugs which are used in the NHPs and critical for treatment of diseases prevalent in India. This comparative information on status of drug monographs in different pharmacopoeias would be found useful by the pharmaceutical manufacturers, drug regulators, and health authorities to help in drug development and thereby responding to urgent public health needs during present global pandemic. Monograph deficiencies in the individual pharmacopoeias could be taken up by them as the starting point for setting drug standards based on the specific monograph inclusion criteria adopted by the individual pharmacopoeias.

4.2. Status of disinfectant monographs in pharmacopoeias

Sanitizers containing 70% alcohol have been recommended for sanitization of hands to avoid infection due to COVID-19 and two types of alcohols used in the manufacture of hand sanitizers are either ethyl alcohol or isopropyl alcohol. Similarly, a 1% solution of sodium hypochlorite has also been recommended in India for cleaning surfaces to prevent the spread of COVID-19 infection. USP played an integral role in issuance of guidance on the formulation of alcohol-based sanitizers to help authorities to contain spread of COVID-19 which is essentially in line with the guidance available from the WHO ( WHO, 2010 ). This guidance intended to address the shortages of alcohol-based hand sanitizers and was not official in nature.

In addition to the drug monographs, pharmacopoeias also prescribe standards for various disinfectants, and a comparison of such monographs in IP, USP, and BP is given in Table 1 . This comparison shows that there are variations in the listing of disinfectant monographs among the pharmacopoeias. Based on this comparison, individual pharmacopoeia may also initiate the development of monographs for the key disinfectants that would help ensuring the quality of the marketed disinfectant products. Also, when we analyzed the requirements of disinfectant monographs like isopropyl alcohol and isopropyl rubbing alcohol among three pharmacopoeias, differences were observed in the test methods and the specifications (data not shown). In order to address these differences, IP initiated monograph revision and harmonization for isopropyl alcohol and isopropyl rubbing alcohol. Methods and specifications of UV test and benzene were included in isopropyl alcohol monograph. Similarly, a gas chromatography based test for related substances was included in isopropyl rubbing alcohol to detect possible impurities in the hand sanitizers. This becomes important as an alert for possible contamination of methanol in hand sanitizers has been issued by the USFDA ( FDA, 2020 ) and gas chromatography would enable detecting such adulterations in marketed products.

Comparative status of disinfectant monographs in IP, USP and BP.

4.3. Quality specifications of COVID-19 related drugs

Several drugs, including anti-malarial drugs (Hydroxychloroquine and Chloroquine), anti-parasitic drugs (Ivermectin), antiretroviral drugs (Lopinavir and Ritonavir), antibiotics (Azithromycin), etc. have been proposed as a potential treatment of the COVID-19 ( Alsuliman et al, 2020 ) though limited clinical evidences are available to support these claims. Among the monographs available for these drugs in different pharmacopoeias, there are variations with respect to their test parameters, test methods, and acceptance criteria. Here we elaborate such variations by taking an example of Hydroxychloroquine, a drug suggested as possible treatment against the COVID-19 ( Cortegiani et al, 2020 ). IP took an initiative to revise the standards for Hydroxychloroquine API in order to ensure the monograph standards are updated and harmonized. Table 2 summarizes a comparison of Hydroxychloroquine API specifications available in the IP, USP, and BP. It is evident from this comparative analysis that there are differences in these monographs among the three pharmacopoeias and therefore, IP made efforts in consultation with the industry to update and harmonize Hydroxychloroquine API monograph. This harmonization is primarily focused with respect to the test for related substances and assay. IP adopted stability indicating HPLC methods for these tests. Similar harmonization in the quality standards laid down by various pharmacopoeias may contribute to globalization of the drug market and decrease the burden on the manufacturers and testing laboratories to perform analytical procedures using different methods and acceptance criteria and thereby making them accessible to the end-user ( Kameyama et al, 2019 ).

Comparison of Hydroxychloroquine monographs in IP, USP and BP.

IR, infrared spectroscopy; UV, Ultra-violet Visible spectroscopy; HPLC, High Performance Liquid Chromatography; PPM, Parts per Million; NMT, Not more than; NA, Not Available.

4.4. Development of pharmacopoeia monographs

In current scenario, various pharmaceuticals have been approved by the drug regulatory authorities and are available in market for emergency use by the patients to treat COVID-19. Pharmacopoeias started working on development of standards for such drugs with industry and stakeholder support. These include, but not limited to, Remdesivir and Favipiravir, for which monographs have been developed by the IP and the Int. Ph. In India, IP has taken up priority activity of monograph development for Remdesivir and Favipiravir with support of the pharmaceutical industry as several of the Indian manufacturers have been granted marketing authorization for these drugs. Due to pandemic situation, IPC organised virtual consultations with manufacturers, regulators, and other stakeholders beside inviting public comments by hosting draft specifications on IPC website. These consultations resulted in finalization of specifications for APIs and FPPs of both drugs with generic attributes that can assess quality of all the marketed products in India. Monographs on Remdesivir and Favipiravir have been published and become official in IP Addendum 2021 and with this IP became the first pharmacopoeia having monographs of these drugs.

4.5. Establishment of reference standards

IPC also identified the need for establishment of new reference standards to support IP monographs of COVID-19 related drugs. Manufacturers were requested to donate physical materials to be considered for use as reference standard after their evaluation. Candidate materials were tested in multiple collaborative laboratories along with IPC lab following the predefined protocol based on the analytical procedures given in IP monographs along with other methods for rigorous characterization of the candidate materials. Based on the lab testing data the materials were assessed for their suitability as IP reference standard and released for use after approval. These reference standards include: Favipiravir, Hydroxychloroquine Sulphate, Azithromycin, Doxycycline Hydrochloride, Ivermectin, and Dexamethasone. Once adopted by the IP, official reference standards became available for distribution and use in pharmaceutical analysis according to the corresponding monograph of the IP ( IP, 2021 ). These reference standards will support the monograph specifications in the IP and are intended to be used as primary standards for physical and chemical tests and assays described therein.

5. Conclusions

The development in pharmaceutical sector is traditionally slow and change is only possible when there is an external force. This situation exactly happened during COVID-19 pandemic when regulators encouraged pharmaceutical manufacturers for possible collaborations. Although, regulatory authorities adopted fast track approval pathways but careful post implementation review is important to ensure the safety and efficacy of the medicines. In order to supplement these developments, pharmacopoeias also adopted several novel processes to help regulatory and health authorities by setting new drug standards and initiating monograph revisions for ensuring availability of quality medicines for treatment and management of COVID-19 patients.

Quality specifications of pharmacopoeias comprise of a set of appropriate tests and specifications that confirm the identity, purity, safety, and strength of the medicinal products to enable assessment of the quality of marketed products. The WHO document on ‘Good Pharmacopoeial Practices’ defines a pharmacopoeia’s core mission as protecting public health by creating and making available public standards to help ensure the quality of drugs ( WHO, 2016 ). The existence of such pharmacopoeial specifications and requirements is of utmost importance for the proper functioning of regulatory control of drugs in a given setting. Pharmacopoeia functions are driven by collaborations with the pharmaceutical manufacturers, drug testing laboratories, drug regulatory authorities, research institutions, academia, and the public.

Pharmacopoeial specifications and requirements represent the basis of the technical norms for regulatory drug control in a given country or region. There are obvious differences among the pharmacopoeias with respect to the listing of the drug monographs as well as the specifications prescribed in the individual monographs. As pharmacopoeias continue to grapple with the unprecedented challenges thrown up by the COVID-19, a specific area of concern has been the uncertainty surrounding the impact of the COVID-19 pandemic on pharmacopoeia functions and operations that needs to be redefined. During the COVID-19 pandemic when there was a worldwide lockdown to contain the spread of infection, functions of pharmacopoeia bodies were also severely hit. Pharmacopoeias were compelled to adopt innovative approaches to remain operational and to meet the challenges imposed by the COVID-19. Despite all the hardship faced by the pharmacopoeias, commitment has been shown to extend support to the users for different pharmacopoeia services particularly for continuous supply of reference standards, development and modernization of monographs, and resolution of the technical queries on the pharmacopoeia texts. Though COVID-19 had forced the staff to work remotely, new solutions were quickly adopted to continue with pharmacopoeia operations and to extend services to the users.

During the COVID-19 crisis, we have witnessed a worldwide upsurge in the pharmaceutical and clinical research to develop new therapeutics and prophylactic candidates for the COVID-19 which have been shown to produce beneficial effects in different settings; however, little scientific and clinical evidence are available to support these claims. Efforts to develop vaccine candidates are also well underway yet projected to take considerable time ( Alsuliman et al, 2020 ). This has resulted in the search for repurposed drugs to treat and reduce deaths from COVID-19. In such a scenario, the role of pharmacopoeia becomes important to help its stakeholders in providing solutions through the development of new monographs, revision of existing specifications and requirements, monograph modernization, harmonization, and establishment of new reference standards to support the pharmacopoeial specifications. This demands industry for the development of monograph specifications for new drugs and their physical reference standards. The pharmacopoeias under the current pandemic circumstances have wider functions and greater responsibilities than ever before. In order to meet the challenges of the current COVID-19 pandemic, there is need to establish harmonized monographs of the drugs being used in its treatment or management. The availability of harmonized monographs would be a big step forward to make available the affordable generic versions of such drugs because differences in the pharmacopoeia and regulatory requirements in different countries and regions are the well-known facts for cost increases and delayed access to drugs (Harrison, 2020). Harmonization of pharmacopoeia standards would reduce the burden associated with redundancy in regulatory drug testing and is the need of the hour to better combat the threat posed by the COVID-19. The development of harmonized monographs essentially requires understanding the differences across individual pharmacopoeias and to identify preferred areas for collaboration among the pharmacopoeias. For efficient collaboration among the pharmacopoeias, it is essential to prioritize the areas of collaboration and make the best use of the limited resources available with each pharmacopoeia.

This article also made an attempt to summarize the availability of selected pharmacopoeial monographs and their specifications among major pharmacopoeias for the drugs being used for COVID-19 treatment across the globe. The differences in the listing of drug monographs are evident from the WHO dashboard. Although, deciphering the detailed differences in monograph specifications among the pharmacopoeias was beyond the scope of this article, we have summarized the differences among the IP, BP, and USP with the example of Hydroxychloroquine in Table 2 . It is evident that assay limit and related substances test limits have been harmonized, however testing methods still differ among the three pharmacopoeias. This comparison highlights the importance of analyzing the specifications of monographs listed among the pharmacopoeias and understanding the source of the differences in specifications before harmonization of pharmacopoeia text is initiated. Such an analysis would be of utmost importance for providing the technical inputs required as a step toward further convergence of pharmacopoeia standards for COVID-19 related drugs. Further, a closer co-operation with the health officials, drug regulatory authorities, and pharmaceutical industry experts must be considered to improve the specifications and to speed-up the revision of monographs.

We would like to emphasize here that there are currently no authorized medicines to prevent or treat COVID-19 and therefore, the drug monographs discussed in the present article shall not be inferred as recommendations for the treatment of COVID-19. However, the strategies discussed in the present article would be a good starting point to frame pharmacopoeia policies and procedures towards better addressing the challenges posed by COVID-19 global pandemic.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgements

We express our sincere gratitude to the Secretariats of the British Pharmacopoeia, European Pharmacopoeia, International Pharmacopoeia, Japanese Pharmacopoeia, and US Pharmacopoeia for valuable discussions during pharmacopoeia alert meetings convened by the WHO. Technical inputs received from the members of the Expert Working Groups of the Indian Pharmacopoeia are also acknowledged. Financial support from the Ministry of Health & Family Welfare, Government of India is duly acknowledged.

The views expressed in this article are the personal views of the authors and shall not be understood or quoted as being made on behalf of or reflecting the position of the Indian Pharmacopoeia.

Peer review under responsibility of King Saud University.

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HPLC analysis of ammonium glycyrrhizate listed in the European, United States, and Japanese Pharmacopoeias under reported and modified conditions: revision of the peak assignment for 18α-glycyrrhizin in the European and United States Pharmacopoeias

• Published: 06 September 2022
• Volume 77 , pages 202–206, ( 2023 )

Cite this article

• Kazuaki Kamata 1   nAff3 ,
• Jin Tatsuzaki 1 ,
• Tsutomu Ishikawa   ORCID: orcid.org/0000-0003-4516-153X 1 ,
• Ryoko Arai 2 ,
• Takashi Hakamatsuka 2   nAff4 &
• Nahoko Uchiyama 2  

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We examined ammonium glycyrrhizate listed in the monographs of the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) as well as in the reagents and solutions used in the general test of the Japanese Pharmacopoeia by performing HPLC on their sample standards or reference reagents under reported and modified conditions. Comparative experiments involving five authentic samples, namely, 18β-glycyrrhizin ( 1 ), 18α-glycyrrhizin ( 2 ), licorice–saponin G2 ( 3 ), licorice–saponin H2 ( 4 ), and galacturonic acid-replaced glycyrrhizin (the 4″-epimer of 18β-glycyrrhizin) ( 5 ), led us to propose the revision of the peak assignment of 18α-glycyrrhizin ( 2 ) and postscript a possible co-existence of galacturonic acid-replaced glycyrrhizin ( 5 ) as a hidden component in the EP and USP. We also proposed that the α-configuration used in the nomenclature of the glycosidic bond between aglycone and the sugar units of ammonium glycyrrhizate and impurities in the EP and USP should be revised to the β-configuration.

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Kazuaki Kamata

Present address: Gunma University Center for Food Science and Wellness, 4-2 Aramaki-machi, Maebashi, Gunma, 371-8510, Japan

Takashi Hakamatsuka

Present address: Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, 10281 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan

Authors and Affiliations

Tokiwa Phytochemical Co., Ltd, 158 Kinoko, Sakura, Chiba, 285-0801, Japan

Kazuaki Kamata, Jin Tatsuzaki & Tsutomu Ishikawa

National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki, Kanagawa, 210-9501, Japan

Ryoko Arai, Takashi Hakamatsuka & Nahoko Uchiyama

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Kamata, K., Tatsuzaki, J., Ishikawa, T. et al. HPLC analysis of ammonium glycyrrhizate listed in the European, United States, and Japanese Pharmacopoeias under reported and modified conditions: revision of the peak assignment for 18α-glycyrrhizin in the European and United States Pharmacopoeias. J Nat Med 77 , 202–206 (2023). https://doi.org/10.1007/s11418-022-01649-8

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Received : 07 July 2022

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DOI : https://doi.org/10.1007/s11418-022-01649-8

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The Supplementary Chapters contain non-mandatory information and guidance. If you need advice to understand a test or calculate results in the BP, the supplementary chapters may contain the information you are looking for (Volume V of the hard copy).

British Pharmacopoeia (Veterinary)

The BP (Vet) contains the sections described above for pharmaceutical and medicinal products that are only used in veterinary medicine (Volume VI of the hard copy).

Following a monograph

This section is designed to provide a broad explanation of how to apply and interpret a BP formulated preparation monograph, using the BP 2019 Aspirin Tablets monograph as an example.

When using a monograph for a drug product:

• you should read the General Notices; these form the foundation of pharmacopoeial requirements and define the terms used in monographs
• you should apply the requirements of the general monograph for the particular dosage form, e.g. Tablets, and the general monograph for Pharmaceutical Preparations. These can be found in the Formulated Preparations: General Monographs section in the publication table of contents
• the analytical techniques used should meet the specifications and requirements set out in the relevant appendices e.g. Appendix III Chromatographic Separation Techniques and Appendix III D Liquid Chromatography when using LC. Appendices form part of the official requirements of the BP where specified in a monograph. Supplementary Chapters are explanatory texts provided for information and to assist users
• you should confirm that the methods are suitable for the particular drug product being tested e.g. that excipients in the product do not affect the analysis

EXPLANATORY NOTES

• provide useful information on using the BP
• explain that a product should comply with the monograph, if tested
• explain which sections of the monographs are mandatory & which are advisory
• explain that alternative tests to the ones described in the monograph can be used.

MONOGRAPH EXAMPLE

Aspirin tablets.

Acetylsalicylic Acid Tablets

Action and use

Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory.

Aspirin Tablets contain Aspirin.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of aspirin, C 9 H 8 O 4

95.0 to 105.0% of the stated amount

IDENTIFICATION

Shake a quantity of the powdered tablets containing 0.5 g of Aspirin with 20 mL of absolute ethanol , filter (Whatman GF/C is suitable), evaporate the filtrate and dry the residue at 60° for 1 hour. The infrared absorption spectrum of the residue, is concordant with the reference spectrum of aspirin (RS 483) .

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1 .

TEST CONDITIONS

• Use Apparatus 1, rotating the basket at 50 revolutions per minute.
• Use 500 mL of a pH 4.5 buffer prepared by mixing 29.9 g of sodium acetate and 16.6 mL of glacial acetic acid with sufficient water to produce 10 litres at a temperature of 37°, as the medium.
• After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 265 nm, Appendix II B using dissolution medium in the reference cell.
• Measure the absorbance of a suitable solution of aspirin BPCRS using dissolution medium in the reference cell.

DETERMINATION OF CONTENT

Calculate the total content of aspirin, C 9 H 8 O 4 , in the medium using the declared content of C 9 H 8 O 4 in aspirin BPCRS .

Related substances

Carry out the method for liquid chromatography, Appendix III D , using the following solutions prepared immediately before use.

• Mix with the aid of ultrasound for 15 minutes a quantity of the powdered tablets containing 0.10 g of Aspirin with 40 mL of acetonitrile , allow to cool, dilute to 100 mL with water and filter through a 0.45-μm PTFE filter.
• Dilute 1 volume of solution (1) to 50 volumes and further dilute 1 volume of the resulting solution to 10 volumes with the mobile phase.
• 0.003% w/v of salicylic acid (impurity C) in the mobile phase.
• 0.1% w/v of aspirin impurity standard BPCRS in the mobile phase.

CHROMATOGRAPHIC CONDITIONS

• Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 μm) ( Kromasil C18 is suitable).
• Use isocratic elution and the mobile phase described below.
• Use a flow rate of 1.0 mL per minute.
• Use an ambient column temperature.
• Use a detection wavelength of 237 nm.
• Inject 20 μL of each solution.
• Allow the chromatography to proceed for 1.2 times the retention time of impurity F.

MOBILE PHASE

2 volumes of orthophosphoric acid , 400 volumes of acetonitrile and 600 volumes of water .

When the chromatograms are recorded under the prescribed conditions, the retention times relative to aspirin (retention time about 5 minutes) are: impurity A, about 0.6; impurity B, about 0.7, impurity C, about 1.4 and impurity F, about 8.0.

SYSTEM SUITABILITY

The test is not valid unless, in the chromatogram obtained with solution (4) the resolution between the peaks due to aspirin and impurity C is at least 6.

In the chromatogram obtained with solution (1):

• the area of any peak corresponding to impurity C is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (3%) ;
• the area of any other secondary peak is not greater than half of the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);
• the sum of the areas of any other secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
• Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%) .

Weigh and powder 20 tablets . Carry out the method for liquid chromatography, Appendix III D , using the following solutions prepared immediately before use.

• Mix with the aid of ultrasound for 15 minutes a quantity of the powdered tablets containing 60 mg of Aspirin with 40 mL of acetonitrile , allow to cool, dilute to 100 mL with water and filter through a 0.45-μm PTFE filter.
• 0.06% w/v of aspirin BPCRS in the mobile phase.

The chromatographic procedure described under Related substances may be used.

The test is not valid unless, in the chromatogram obtained with solution (3) the resolution between the peaks due to aspirin and impurity C is at least 6.0.

Calculate the content of C 9 H 8 O 4 in the tablets from the chromatograms obtained using the declared content of C 9 H 8 O 4 in aspirin BPCRS .

The label states that the tablets contain Aspirin, unless this word appears in the name of the tablets. This requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed.

The impurities limited by the requirements of this monograph include those listed under Aspirin .

The BP is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. It contains all texts and monographs of the European Pharmacopoeia (signposted with a chaplet of stars), as well as the national standards developed by the BP.