WWW.CIOMS.CH Special Newsletter | 29 August 2018

This is the first of a series of special newsletters describing the work of CIOMS member organizations and partners. It describes the programme within the World Health Organization (WHO) that assigns International Nonproprietary Names (INNs) to medicines.

The WHO INN Programme: International Nonproprietary Names for pharmaceutical substances

With tens of thousands of medicines on the market, confusion between  Medicine names: a safety issue medicine names can have serious consequences for patient safety.  How INNs are defined WHO assigns single, unique, globally accepted names to  INNs – a map to medicines classes pharmaceutical substances. The International Nonproprietary Names  The INN MedNet (INN) nomenclature provides a common language for people all over  The School of INN (SoINN) the world—including the CIOMS Working Groups—to work together for  INNs for better medicines use the safe and effective use of medicines.

Medicine names: a safety issue This variety of names can cause confusion, which A medicine can be identified in different ways: by its might lead to errors. brand name (“”) or its chemical name Patient safety is a primary concern of WHO. In (acetylsalicylic acid). Furthermore, historically some 1950 the Organization established the INN regulatory authorities have approved nonproprietary Programme for pharmaceutical substances to names for pharmaceuticals in their jurisdictions (e.g., mitigate the risk of name confusions and medication in Europe, acetaminophen in the US). errors. The main objective of the programme is to A brand name can designate a medicine containing define a single, unique, globally accepted name for more than one active substance, and often the same each pharmaceutical substance. active substance is sold under different brand names.

The variety of names for medicines can lead to confusion, with a potential impact on patient safety.

Illustration from: School of INN. YouTube video. Link available at: www.who.int/medicines/services/inn/ 1 WWW.CIOMS.CH Special Newsletter | 29 August 2018

How INNs are defined The INN MedNet The selection of a new INN relies on a strict The WHO INN MedNet—a secure electronic platform procedure which is based on a broad consultative administered by WHO—offers two services related to process. Pharmaceutical companies or national INNs: naming authorities—such as the United States (1) On-line queries of WHO INN information on Adopted Names Council (USANC)—submit an specific medicines (see example below), lists of application to the WHO INN Secretariat. The INN proposed and recommended INNs, and status Expert Group then collaborates with national tracking for new INNs within the consultation nomenclature commissions, pharmacopoeial and publication process; and commissions, academics and regulatory authorities (2) a link to the Programme’s e-Application system to select a name. to apply for new INNs electronically. The lists of proposed INNs are published in the Access to the INN MedNet is free of charge and can WHO Drug Information journal1 for a four-month be requested at http://mednet.who.int/inn. comment period. If no objection is raised to the INN proposed name during that period, the INN becomes salbutamol a norm recommended to all WHO Member States. WHO makes INNs universally available in the public domain, hence their designation as nonproprietary. They can be used without any restriction whatsoever Latin salbutamolum to identify pharmaceutical substances. Nowadays the French salbutamol national nonproprietary names are typically adopted Spanish salbutamol Russian сальбутамол سالبوتامول in countries once an INN is recommended by WHO. Arabic Differences between INNs and national names are Chinese 沙丁胺醇 therefore becoming more and more rare. Phonetic salbutamol

In recent years the INN Programme has opened Molecular formula C13H21NO3 R03AC02 the door for frequent dialogue with a wide range of ATC Codes R03CC02 parties. Feedback from developers and manufacturers 2 of pharmaceutical substances, health professionals’ National commission(s) Alternate name(s) DCIT salbutamolo associations, patient advocates and consumer JAN salbutamol sulfate organizations is valued and considered in the INN Ph. Int. salbutamoli sulfas selection process. This is done to raise greater RS salbutamol sulfate awareness of the INN nomenclature and to advocate USAN albuterol for its use to ensure patient safety. USAN albuterol sulfate USP albuterol 2 INNs – a map to medicines classes National commission(s) using same name: BAN; BPC; ChP; CSP; DCF; FEUM; IP; JP; Ph. Eur.; Ph. Int.; RS INNs must be distinctive in sound and spelling, and should not be liable to confusion with other names in Adapted from: INN MedNet; common use (e.g. trade marks). Usually, an INN https://mednet-communities.net/inn/db/searchinn.aspx consists of a common stem and a random, invented prefix (1). Pharmacologically related substances show 2 BAN (British approved name); BPC (British Pharmaceutical their relationship by the use of a common stem. For Codex); ChP (Pharmacopoeia of the People's Republic of China); example, angiotensin II receptor antagonists are CSP (Czechoslovak Pharmacopoeia- retired; now: Czech Pharmacopoeia); DCF (Dénomination Commune Française – given the suffix “-sartan”, as in candesartan and approved name in France); DCIT (Denominazione Comune losartan. In this way INNs provide a mapping of Italiana – approved name in Italy); FEUM (Farmacopea de los medicines classes that can be very helpful in clinical Estados Unidos Mexicanos – Mexican Pharmacopoeia); IP (Indian practice. Pharmacopoeia); JAN (Japanese Accepted Name); JP (Japanese Pharmacopoeia); Ph. Eur. (European Pharmacopoeia); Ph. Int. (International Pharmacopoeia of WHO); RS (WHO International Chemical Reference Substance); USAN (United States Adopted 1 www.who.int/medicines/publications/druginformation/innlists/ Name); USP (United States Pharmacopeia).

The WHO INN Programme 2 WWW.CIOMS.CH Special Newsletter | 29 August 2018

The School of INN (SoINN)

Why is it needed? What are the goals? Any student of pharmacology and therapeutics will The goals of the SoINN are to: tell you that remembering names of pharmaceutical . advocate for the correct and effective use of INN; substances and their mechanisms of action is one of . develop and raise interest in the science of the most challenging tasks in their courses. Students pharmaceutical nomenclature; and tend to learn medicine names by rote, which can be . cultivate the future success and harmonization of daunting when examination approaches. nomenclature programmes around the world. The challenge does not end there. Throughout The School is intended for health professionals, their career health care professionals have to keep students, academia, patients or consumers and the up with a continuous stream of names of new active . It aims to achieve its goals pharmaceutical substances introduced into clinical in three ways: (1) Regular publications and practice, their mechanisms of action and how they presentations, (2) education and training to promote work differently from existing medicines. safe and effective use of medicine and to facilitate Meetings conducted over the years and a recent learning; and (3) outreach to promote a basic survey involving more than 1000 respondents (2) understanding of INNs and how their use can revealed an emerging need for a more prominent enhance pharmaceutical outcomes. source of information on the INN nomenclature system. INNs are widely used in the scientific How does it work? literature. The survey showed that although INNs are The SoINN is a virtual school managed by the INN increasingly used in teaching, in practice many Programme. The SoINN has been developed on prescribers still prefer using brand names. Moodle, a free and open-source learning platform. A systematic understanding of INNs in different The School is designed to offer contributions from pharmacological classes would be helpful for different INN stakeholders, and provides functionality applicants, health care professionals, academic staff for ad hoc sharing of courses or information with user and students (3). To advocate for the wide and groups based on different pre-defined user profiles. correct use of the INN nomenclature, WHO has The website is organized in three main categories established the School of INN (SoINN). (see below), with additional links for announcements, navigation and searching of stems in INN names.

Sections on the School of INN website

Video about INNs A "How to" series of lessons on how to access and use Navigation INN services like the INN online application, the INN MedNet and others. Home Site announcements MedNet: On-line information services related to INN (see previous page) Courses

School of INN: a series of educational modules such as Search INN the INN training courses, INN for pharmacologists, and (limited to 5 items) others Site announcements

Forthcoming meetings

Contact the INN Programme for more information

The WHO INN Programme 3 WWW.CIOMS.CH Special Newsletter | 29 August 2018

INNs for better medicines use that are informative, short and euphonic (5). Beyond its educational aims the School of INN is INNs are widely used in clinical practice, with intended to raise interest in the science of many benefits. One of them is that they facilitate the nomenclature and help cultivate a future generation use of substitution policies: They make it easier for of INN experts. The original aim of the INN system health care professionals to select the most was to increase patient safety, making sure that affordable among different medicines that contain “a prescription filled abroad is what doctor ordered the same active ingredient(s) and have been found to back home”(4). However, the use of INNs has added be therapeutically equivalent in a regulatory benefits for individual patients and for public health. assessment. At a time of rising medicines costs in Because INNs provide a key to understanding health care systems, globally accepted names for medicine names and classes, they can assist clinicians pharmaceutical substances can help to orientate in prescribing the most appropriate medicine for health professionals and patients within a complex their patients. pharmaceutical market, empowering them to identify The number of requests for INN is constantly alternatives and access needed treatment. growing, particularly for new biological medicines such as fusion proteins, monoclonal antibodies and References advanced therapy substances. The complex structures and mechanisms of action of these 1 WHO. Guidance on the Use of International medicines pose new naming challenges. The INN Nonproprietary Names (INNs) for Pharmaceutical Programme is adapting its policies to assign names Substances. Geneva: World Health Organization; 2017. 2 Chui WK, Mignot G, Romeo A, Malan SF, Rizzi M, Balocco The inclusion of INNs on labels ensures that prescribers R. Survey about International Nonproprietary Names and patients can easily identify the active (INN). WHO Drug Information 2017; 31(4): 581-585. pharmaceutical ingredient(s) in a medicine. 3 Chui WK, Mignot G, Malan SF et al. The Science of Nomenclature. INN as Global Language for Education and Practice. 2018 (manuscript in preparation). 4 WHO Director General. In: Working for health: An introduction to WHO. Geneva: World Health Organization; 2007. 5 Robertson JS, Chui WK, Genazzani AA et al. The INN Global Nomenclature of Biological Medicines: a

Illustration from: School of INN. YouTube video. . Link available at: continuous challenge. 2018 (manuscript in www.who.int/medicines/services/inn/ preparation).

Authors CIOMS Secretariat Gilles Mignota, Adi Mesterb, Sophie Lasseurb, Secretary-General b b Dr Lembit Rägo Antonio Romeo and Raffaella Balocco Tel: +41 22 791 6410 [email protected] a INN expert and Chair of the INN School Working Group, France. Administrative Assistant b INN Programme, WHO Essential Medicines and Health Ms Sue Le Roux Products Department, World Health Organization, Geneva, Tel: +41 22 791 6439 Switzerland. [email protected] Technical Writer For more information please contact: Ms Monika Zweygarth Dr Raffaella Balocco Mattavelli, INN Programme, WHO, Tel : +41 22 791 6497 20 Avenue Appia, 1211 Geneva 27, Switzerland. [email protected] Tel: +41 22 7913695. [email protected].

The WHO INN Programme 4