Quick-reference prescribing information - what is there?

 

Why do this module

Anyone who prescribes or supplies veterinary medicines needs easy access to up-to-date trustworthy prescribing information.  This is not available from any single resource. Instead there is a need to have access to several different resources and to know the strengths and weaknesses of each. This module is a critical and practical overview of what is available to UK practitioners and is an essential read for anyone who deals with veterinary medicines. 

 

Anyone who prescribes or supplies veterinary medicines needs easy access to reliable, up-to-date information to help ensure that the medicines are used effectively and safely. This includes information about indications, contraindications, doses, drug interactions, what to monitor and adverse effects. This module reviews the quick-reference sources of information on medicines available to veterinary professionals in the UK.

All licensed medicines (including generics) have an SPC. This sets out how a medicine should be used, and the effects (including adverse effects) it may have on animals (and on humans and the environment). The VMD product database has links to the SPCs of all veterinary medicines licensed for use in the UK, including products with a European-wide licence.

The SPC is a legal document. It is drafted by the company applying for authorisation to market the medicine, but the wording must be approved by the regulatory authority (the Veterinary Medicines Directorate [VMD]; or, for products centrally authorised for the European market, the European Medicines Agency [EMA]). The SPC is a summary of what has been agreed about the product as a result of the regulatory authority’s assessment, and is based on the clinical trials done during the development of the product. The SPC is updated by the company from time to time as more becomes known about the product; all changes must be approved by the regulatory authority. 

The SPC has a standard layout (see opposite). It gives the specific licensed indication(s) for the product, and so can help veterinary professionals to know when a product is being used outside the terms of the licence (so-called 'off-label use'). SPCs will often contain detailed information about a medicine that can be used to make prescribing decisions (e.g. about drug interactions, use in kidney or liver dysfunction) or help protect the animal or user from harm (e.g. mineral oil-containing vaccines).

Veterinary medicines often come with a package leaflet. This is essential if all the information required by law cannot be placed on the immediate packaging. Such information includes the indication, dosage instructions, contraindications and any warnings specified in the marketing authorisation. The contents of the leaflet are approved by the regulatory authority (VMR 2013). Package leaflets for products with a European licence can be found on the EMA website. There is no online source of package leaflets authorised by the VMD.

Click the play button below to see how to get to the SPC for a product with a Europe-wide licence

The National Office for Animal Health (NOAH) is a membership organisation for UK pharmaceutical companies that produce veterinary medicines. NOAH publishes a Compendium of datasheets that are contributed by member and some non-member companies. The datasheets are prepared by the pharmaceutical companies and contain identical information to that in the SPCs, though the information might be presented in a different order, and some information (e.g. pharmacology) may be omitted. Unlike SPCs datasheets have no legal status. The Compendium also contains datasheets for unlicensed medicines that are marketed through the Small Animal Exemption Scheme (SAES), which do not have SPCs. The Compendium is available online and as a book published annually. 

The BSAVA Small Animal Formulary, published by the British Small Animal Veterinary Association, contains monographs on drugs (licensed and unlicensed) arranged in alphabetical order of generic name. There is also a helpful index to drugs by therapeutic class at the back of the book. Each monograph includes summarised and practical information on formulations, action, uses, safety and handling, contraindications, adverse reactions, drug interactions and dosages, and indicates if a BSAVA client information leaflet is available. Monographs include some brand names of available products, but not necessarily comprehensive lists. The Formulary is compiled by an editorial panel using published and unpublished evidence. Doses are those recommended in SPCs, or are based on published articles or textbooks or on clinical experience. At the end of each monograph is a short list of references to supporting evidence. The Formulary’s editors advise that dose recommendations are guidelines; that clinical judgement must take precedence; and that the Formulary should never be used as the only source of information on an unfamiliar medicine. The Formulary is published in two separate parts: part A covers cats and dogs; part B covers exotic pets (small mammals, birds, reptiles, fish and amphibians). The book version of the Formulary is updated every 3 years (the latest edition of part A [number 9] was published in April 2017). The Formulary is also available as a PDF, an online version and as a smartphone app.

Vetstream Ltd publishes online databases of veterinary information related to the care of dogs, cats, rabbits, horses and exotic species (so far only guinea pigs); the separate databases are named CanisFelisLapisEquis and Exotis. The databases include drug monographs in a section entitled “Pharmacology and Therapeutics”. The monographs were originally sourced from the BSAVA Formulary and have been updated by named authors. They cover uses, administration (including dosage), pharmacokinetics (including advice on use in kidney, liver and heart dysfunction, pregnancy and lactation), contraindications, interactions and adverse effects, and a list of references for further reading. The monographs are linked to other sections of the database that include peer-reviewed content on diseases, diagnostic tests and pathogens. The resource is aimed at an international audience. In the UK and the Netherlands the monographs are linked to relevant product SPCs. The information on medicines is more abbreviated than in other sources described here. The date of the last update of individual monographs is not stated.

EBVM.vet is an online formulary published by the Veterinary Publishing Company Ltd. It contains prescribing information on licensed and unlicensed drugs and uses for a wide range of species and can be searched by animal or drug name. Drug monographs contain product names (with links to SPCs), indications (with separate sections on licensed and unlicensed uses), dosage, pharmacology, adverse effects, contraindications, reproduction, monitoring and administration, interactions, toxicology, and human safety. Each monograph contains extensive lists of citations to relevant published papers. Information in the monographs is assigned the publisher’s evidence rating (ranging from 0 to 4), based on the quality of the supporting evidence (EBVM.vet Evidence Quality). The date of the most recent update is included. The publisher aims to develop comprehensive information, with an evidence rating, to support safe and effective prescribing of medicines, particularly for minor animal species and unlicensed indications. This involves a collaborative approach through user feedback (McArthur & Pearson 2017). 

Plumb’s Veterinary Drugs is available as a desk book and a pocket version, and online and as an app. The digital version is continuously updated and managed by Brief Media, a veterinary publisher in the USA. The most recent edition of the book (8th) was published in January 2015 by PharmaVet and distributed by Wiley-Blackwell (corrections to this printed edition are published on the website). It has detailed monographs on a wide range of drugs and covers dogs, cats, exotic animals and farm animals. Each monograph is clearly laid out and covers uses, pharmacology, pharmacokinetics, contraindications and precautions, adverse effects, pregnancy and lactation, overdose, drug interactions, doses, monitoring, client information, storage, dosage forms and regulatory status. The monographs are well referenced and the date of update is included. The monographs often contain more detail than others described here, particularly on drug interactions and use in pregnancy. The information is focused on USA prescribers although it does make reference to variations in licensing and uses in other countries, including the UK. 

British National Formulary (BNF)

The BNF, published jointly by the BMJ Group and Pharmaceutical Press and accredited by the National Institute for Health and Care Excellence (NICE), contains prescribing information and guidance on human medicines. The BNF presents distilled and simplified information from the product SPCs and various other sources (e.g. medical literature, manufacturers, statutory regulations, consensus guidelines) in a monograph for each drug. Advice reflects, as far as possible, an evaluation of the evidence from diverse sources. The monographs list the products available in the UK. The BNF is published as a book twice a year (March and September) and is updated monthly online

SPCs and patient information leaflets (PILs) for human medicines

There is no comprehensive database of SPCs and PILs for all human medicines authorised in the UK. The most extensive collection is the electronic Medicines Compendium (eMC), an online database published by a non-profit company funded by the pharmaceutical industry; companies pay to have their SPCs and PILs included. SPCs and PILs for all centrally-authorised human medicines are on the EMA’s website. SPCs and PILs not in either of these databases may be obtained from the marketing company or from the UK regulatory authority, the Medicines and Healthcare Products Regulatory Authority (MHRA).

  • Become familiar with the resources you use.
  • Knowledge about medicines is constantly evolving and so it is important to use the most up-to-date versions. 
  • During a consultation, a veterinary practitioner may not have access to online sources or apps, or may prefer to use familiar hard copies (e.g. NOAH Compendium or BSAVA Formulary) to look up something quickly. Remember book formats quickly become out of date.
  • SPCs or datasheets describe how to use a licensed medicine safely and effectively. They contain important and helpful prescribing information
  • There is no definitive source of information on unlicensed uses. It is sensible to consult several sources. 

There is no single reference source on veterinary medicines in the UK. Veterinary professionals need to consult several sources, especially for unlicensed medicines or uses.

The summary of product characteristics (SPC) is the definitive source of information on a licensed medicine. The Veterinary Medicines Directorate (VMD) product database is the comprehensive source of this information, however the presentation of SPCs in the database is not geared to easy reference by veterinary professionals in practice. The presentation of SPC information in the NOAH Compendium is much better designed for easy reference, but is not a comprehensive source. Development of a single online source that is comprehensive and user friendly and that includes package inserts would be a great help to veterinary professionals.

Several online and book formularies are available and developing, which contain distilled information from SPCs on licensed medicines and which also provide information to help with prescribing of unlicensed medicines. A transparent editorial policy is crucial for these resources, as is inclusion of the date of preparation. These will help users determine the reliability and currency of the information.

PODCAST

If you prefer, you can listen to the whole audio presentation of this module using the following podcast. Don't forget that you can also download the podcast to your iPod, music player, tablet or smartphone using the Download link on the right of the audio player.

Click the play button below to answer the multiple choice questions on this module. Start by entering your first and second names and your email address so we can send you your CPD certificate for your records. And don't forget the reflective exercises below this player.