Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and risks of drugs. [1]
Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by UMC. [2] In the early years the staff consisted of just three pharmacists, Sten Olsson, Cecilia Biriell and Marie Lindquist, based at the Swedish Medical Products Agency (Läkemedelsverket); [3] Currently over 150 staff work in central Uppsala. The founding chairman and acting Director was Professor Åke Liljestrand. From 1990 to 2009 the Director was Professor Ralph Edwards. [4] In 2009, Dr. Marie Lindquist became the Director until her retirement in 2020. Hervé Le Louët served from 2021 to 2022 and was succeeded by Peter Hjelmström. The Head of Research is Dr. Niklas Norén.
The work of the UMC is:
The main focus and source of data in pharmacovigilance are reports of ICSRs (individual case safety reports) from healthcare providers and patients in member countries of the WHO Programme. A WHO global individual case safety report database (VigiBase) is maintained and developed on behalf of the WHO by UMC. [5] UMC develops and provides several tools and classifications for use by organisations involved in drug safety, including the WHO Drug Dictionary – with a bridge to the MedDRA terminology and WHO ICD – tools for searching in the database, and a program for case report management, VigiFlow. [6]
UMC's research covers mainly three areas: data-driven discovery (especially statistical techniques), dis-proportionality analyses, interaction detection, patterns and duplicate case detection, safety surveillance and signaling (among which drug dependence and pediatric use) and benefit—risk analysis. As of 2023 over 200 scientific articles in peer-reviewed journals were linked on the centre's website. [7]
UMC has been active in initiatives to improve communication in areas related to medicines safety since 1996. [8] The centre has been active in presenting research in the medical literature which has included some seminal works in the field. [7] The Uppsala centre has also published books in the field of drugs safety including a regular newsletter. [6] In 2010 the 2nd edition of a crisis management guide was published, entitled 'Expecting the Worst', also translated into other languages. [9]
UMC's role in drug safety has not been without controversy for both medicines agencies and pharmaceutical companies, despite an open approach willing to engage with many parties in the pharmaceutical world. They are closely involved in outreach to developing countries and other areas where pharmacovigilance is not yet handled. [7]
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, which is also known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
The Adverse Drug Reactions Advisory Committee or ADRAC was a subcommittee of the Australian Drug Evaluation Committee (ADEC) which monitored the safety of medicines in Australia. ADRAC was replaced by the Advisory Committee on the Safety of Medicines (ACSOM) in 2010. In 2017, the Advisory Committee on Medicines (ACM) was established, consolidating the functions of the Advisory Committee on Prescription Medicines (ACPM), the Advisory Committee on the Safety of Medicines (ACSOM) and the Advisory Committee on Non-Prescription Medicines (ACNM).
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War One.
The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESOP), is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. Its official journal is Drug Safety.
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical, pharmaceutical, and scientific expertise to protect and advance public health and safety.
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
The WHO Adverse Reactions Terminology (WHOART) is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring. The system is no longer actively maintained.
Research on Adverse Drug Events and Reports (RADAR) is a pharmacovigilance team of 25 doctors who receive calls about possible adverse drug reactions (ADR) and investigate. RADAR is based at Northwestern's Feinberg School of Medicine. RADAR is led by Dennis West. Though it was without funding for its first four years, RADAR has raised about $12 million through grants from the National Institutes of Health, the American Cancer Society and other such institutions. Its work has identified safety problems with 33 drugs. Adverse drug events are a serious health problem.
Pharmacoepidemiology is the study of the uses and effects of drugs in well-defined populations.
The following outline is provided as an overview of and topical guide to clinical research:
The WHODrug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre.
William Howard Wallace Inman, MRCP, FRCP, FFPHM, also known as WHW Inman, was a British doctor and pioneer of methods and systems to detect risks of treatment with drugs. As well as holding positions in health institutions in the UK, he was active in international efforts to co-ordinate drug safety monitoring.
VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world. Since 1978, the Uppsala Monitoring Centre on behalf of WHO, have been maintaining VigiBase. Vigibase is used to obtain the information about a safety profile of a medicinal product. These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns. The data is collected from each of its 110 member states which currently comprises to over 10 million ICSRs. About a hundred thousand ICSRs are added each year.
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems. The Central Drugs Standard Control Organisation established the program in July 2010 with All India Institute of Medical Sciences, New Delhi as the National Coordination Centre, which later shifted to Indian Pharmacopoeia Commission in Ghaziabad on 15 April 2011.
Haggar Hilda Ampadu is a Ghanaian regulator, pharmacoepidemiologist and policy advocate. As of 2019, she is the Inspector-General of Schools of the National Schools Inspectorate Authority under Ghana's Ministry of Education.
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