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Pharmacovigilance the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effect, of medicines (Source: The Importance of Pharmacovigilance, WHO 2002). Generally speaking, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: Pharmacology (in Greek: pharmacon (φάÏμακον) meaning drug, and logos (λόγος) meaning science) is the study of how substances interact with living organisms to produce a change in function. ...
Part of a scientific laboratory at the University of Cologne. ...
Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ...
Medicine is a branch of health science and the sector of public life concerned with maintaining or restoring human health through the study, diagnosis, treatment and possible prevention of disease and injury. ...
Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ...
Oral medication A medication is a licenced drug taken to cure or reduce symptoms of an illness or medical condition. ...
Dioscorides’ Materia Medica, c. ...
The term traditional medicine is used with two main meanings. ...
- identifying new information about hazards associated with medicines
- preventing harm to patients.
The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.” Etymology is the study of the origins of words. ...
Pharmacovigilance is particularly concerned with Adverse Drug Reactions, or ADR, which are officially described as: ‘A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.’ WHO Technical Report No 498 (1972) An adverse drug reaction (abbreviated ADR) is a term to describe the unwanted, negative consequences sometimes associated with the use of medications. ...
It is gaining importance for doctors and scientists as the number of stories in the media of drug recalls increases. Because of this it is attracting increasing numbers of entrants who see this as a quick way to the top rather than actually doing a proper scientific or medical role.
Because clinical trials involve, at most, several thousand patients, less common side effects and Adverse Drug Reactions (ADRs) are often unknown at the time a drug enters the market. Even very severe ADRs, such as liver damage, are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining and investigation of case reports to identfy the relationships between drugs and ADRs. An adverse drug reaction (abbreviated ADR) is a term to describe the unwanted, negative consequences sometimes associated with the use of medications. ...
Data mining (DM), also called Knowledge-Discovery in Databases (KDD) or Knowledge-Discovery and Data Mining, is the process of automatically searching large volumes of data for patterns using tools such as classification, association rule mining, clustering, etc. ...
Risk in Medicine Medicines have helped to bring improved health and longer life to the human race. They affect the lives of hundreds of millions of people every day. But they are not without risk, and have caused, do cause and will continue to cause lesser or greater harm to many people, alongside the many who benefit. There are also large numbers of people who experience no evident effect at all from the drugs they take.
What about the risks of medical treatment?
- While medicines have led to major improvement in the treatment and control of diseases, they also produce adverse effects on the human body from time to time
- While many drugs are precisely targeted to the causes and mechanisms of disease, they may also have minor or distressing effects on other parts of the body, or interact negatively with the systems of the particular individual or with other drugs or substances they are taking, or, not work well or at all for some, many or all of those who take them
- No-one really believes that doctors are perfect, (though doctors, in the past, may have encouraged the idea, and patients have been willing to accept this) but science is a complex and uncertain pursuit; doctors are fallible, may overestimate their knowledge, and do, from time to time, make mistakes, sometimes serious
- There is no such thing as a safe drug. There are risks in any intrusion into the human body, whether chemical or surgical. Nothing in this field is entirely predictable - except that the interaction between science and the human body may produce surprises.
Terms commonly used in drug safety - Benefits are commonly expressed as the proven therapeutic good of a product, but should also include the patient’s subjective assessment of its effects
- Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population; the probability of an occurrence
- Harm is the nature and extent of the actual damage that could be caused. It should not be confused with risk
- Effectiveness in pharmacovigilance expresses the probability of the drug working as expected (opposite to its risk of harm)
- Efficacy is used to express the actual extent to which a drug works as expected in practice.
For use in social policy, see the article social welfare. ...
For other uses, see Risk (disambiguation). ...
Harm can be defined as causing physical or psychological/emotional damage or injury to a person, animal or other entity. ...
Effectiveness means the capability of, or success in, achieving a given goal. ...
Efficacy is the ability to produce a desired amount of a desired effect. ...
Finding the risks of drugs Clinical Trials: Pharmaceutical companies are required by law in all countries to have tested new drugs on people before they are made generally available. They usually select a representative sample of patients for whom the drug is designed - at most a few thousand - along with a comparable control group. The control group may receive a placebo or another drug that is already marketed for the disease. In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...
The purpose of clinical trials is to discover
- if a drug works and how well
- if it has any harmful effects, and
- its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?
Clinical trials do, in general, tell us a good deal about how well a drug works and what potential harm it may cause. They provide information which should be reliable for larger populations with the same characteristics as the trial group - age, gender, state of health, ethnic origin, and so on.
The variables in a clinical trial are specified and controlled and the results relate only to the population of which the trial group is a representative sample. A clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, there is nothing that could tell you the whole story, but a clinical trial must tell you enough; ‘enough’ being determined by legislation and by contemporary judgements about the acceptable balance of benefit and harm.
Spontaneous Reporting This is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some places consumers) to identify and report any suspected adverse drug reaction to their national pharmacovigilance centre or to the manufacturer. Spontaneous reports are almost always submitted voluntary. An adverse drug reaction (abbreviated ADR) is a term to describe the unwanted, negative consequences sometimes associated with the use of medications. ...
One of the system’s major weaknesses is under-reporting, though the figures vary greatly between countries and in relation to minor and serious ADRs.
The problem with this voluntary system of ‘spontaneous reporting’, is that hard-pressed medical personnel don’t always see it as a priority. If the effects are not serious, they may not get to know about them at all, and even if they are serious, they may not be recognised as the effect of drugs.
Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the WHO Database, which includes around 3.7 million reports (September 2006), growing annually by about 250,000.
Other reporting methods Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit reports they receive from healthcare providers to the national authority. Others have intensive, focused programmes concentrating on new drugs, or on controversial drugs, or on the prescribing habits of groups of doctors, or involving pharmacists in reporting. All of these generate potentially useful information. Such intensive schemes, however, tend to be the exception.
International Vigilance The principal of international collaboration in the field of pharmacovigilance is the principle basis for the WHO International Drug Monitoring Programme, through which over 80 member countries have systems in place which encourage healthcare personnel to record and report adverse effects of drugs in their patients. These reports are assessed locally and may lead to action within the country. Through membership of the WHO Programme one country can know if similar reports are being made elsewhere. (The European Union also has its own scheme.)
Member countries send their reports to the Uppsala Monitoring Centre where they are processed, evaluated and entered into the WHO International Database. When there are several reports of adverse reactions to a particular drug this process may lead to the detection of a signal – an alert about a possible hazard communicated to members countries. This happens only after detailed evaluation and expert review.
Pharmacovigilance in Europe The pharmacovigilance effort in Europe is coordinated by the European Medicines Agency (EMEA) and conducted by the national competent medicines authorities (NCA). The main responsibility of the EMEA is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community. The system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions. The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ...
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and also for following the marketing authorisation of medicinal products in the European Economic Area (EEA). ...
By 20 November 2005 new European legislation requires the individual marketing authorisation holders (drug companies), to submit all received adverse reactions in electronic form (safe in exceptional circumstances). The reporting obligations of the various stakeholders are defined in the Community legislation, in particular:
This can be done with commercial software developed for the purpose or with a web utility called EVWEB accessible through the EudraVigilance homepage. Registration for use of EVWEB is necessary. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. ...
Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products...
Risk Management In 2002 Heads of Medicines Agencies[1] agreed on a mandate for an ad hoc Working Group on establishing a European risk management strategy. The Working Group considered the conduct of a high level survey of EU pharmacovigilance resources to promote the utilisation of expertise and encourage collaborative working.
Pharmacovigilance inspections
See Also The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. ...
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. ...
The Boston Collaborative Drug Surveillance Program (BCDSP), established in 1966, was a pioneer in the field of drug epidemiology, pharmacoepidemiology . ...
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and also for following the marketing authorisation of medicinal products in the European Economic Area (EEA). ...
The Yellow Card Scheme is a UK initiative run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) to gather information on Adverse Drug Reactions (ADRs) to medicines. ...
In medicine, an Adverse effect is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as a result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ...
The Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) was developed by the United States Food and Drug Administration (FDA) for the coding, filing and retrieving of post-marketing adverse reaction reports. ...
MedDRA or Medical Dictionary for Regulatory Activities is the international medical terminology for all phases of the drug development process. ...
The WHO Adverse Reactions Terminology (WHOART) is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. ...
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