What is Pharmacovigilance?

CIOMS And Pharmacovigilance

CIOMS is an abbreviation for the “Council for International Organizations of Medical Sciences”, which plays an important role within contemporary pharmacovigilance practice. This page provides information on the composition and activities of the organisation, which is hosted at The World Health Organisation, Geneva, Switzerland[1].

What Is CIOMS?

The organisation was founded by the WHO and UNESCO, the United Nations Educational, Scientific and Cultural Organisation, in 1949. It is an independent not-for-profit body which is not affiliated to, or funded by, any single government or nation. The organisation brings together representatives from the “biomedical scientific community” worldwide, aiming to encourage and facilitate international biomedical scientific activities whilst maintaining a relationship with the United Nations organisation (particularly WHO and UNESCO)[1]

What Does It Do?

CIOMS coordinates programmes devised to run for many years to address the following key areas of biomedicine:

  • Bioethics
  • Health Policy, Ethics and Human Values – An International Dialogue
  • Drug Development and Use
  • International Nomenclature of Diseases[1]
Why Is It Important Within Pharmacovigilance Work?

CIOMS has run a program focusing on drug safety since the early 1980s which incorporates distinct working groups. These groups have published many guidelines for practice, including:

  • Definition and Application of Terms for Vaccine Pharmacovigilance Safety
  • Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V)
  • Development and Rational Use of Standardised MedDRA Queries (SMQs)
  • Management of Safety Information from Clinical Trials (CIOMS VI)
  • Development Safety Update Reports (CIOMS VII)
  • Practical Aspects of Signal Detection in Pharmacovigilance (CIOMS VIII)
  • Benefit-risk balance for marketed drugs (CIOMS IV)
  • International Reporting of Periodic Drug Safety Update Summaries (CIOMS II)
  • Guideline for Preparing Core Clinical Safety Information on Drugs (CIOMS III).

In addition, CIOMS was involved in publishing an initiative to standardise the use of medical terms associated with adverse drug reactions. However, this has not been widely accepted in pharmacovigilance practice.

The CIOMS guidelines are individually published in paper-back book form, available on payment to CIOMS in Geneva. Some have become obsolete or superseded by other published guidelines (e.g. CIOMS II, CIOMS VII); others have helped crystallise subsequent more definitive guidance from other bodies, such as the International Conference on Harmonisation (e.g. CIOMS VII). Some of the CIOMS guidelines, such as CIOMS III,  CIOMS V and CIOMS VIII, have been hugely influential in formulating the direction in which pharmacovigilance practice worldwide has evolved, and continue to be used in their own right.

It is important to note that, although influential, CIOMS guidelines have no legal or regulatory mandate: they reflect the (then) current thinking of a self-selected group of industry and regulatory experts but cannot be considered as consensus documents, or as legally binding.

The CIOMS I Form

As well as work on pharmacovigilance and other guidelines, several years ago CIOMS developed the CIOMS Form I. This form provides a standardised format for the reporting of suspected adverse reactions to any particular medical product[2].  It has proved of enduring value in practice since the 1980s and continues to be widely used (although often significantly expanded from the original one page summary).

[1] CIOMS. (undated). About Us. [online] CIOMS. Available at: https://cioms.ch/about/ [Accessed 30/08/2017]

[2] CIOMS. (undated). CIOMS I Form. [online]. CIOMS. Available at: https://cioms.ch/wp-content/uploads/2017/05/cioms-form1.pdf [Accessed 30/08/2017]