Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines[1]. Pharmacology (from Greek grc φάρμακον pharmakon, "drug" and grc -λογία -logia) is the study of how Drugs Science (from the Latin scientia, meaning " Knowledge " or "knowing" is the effort to discover, and increase human understanding In Medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as Chemotherapy or Surgery. Medicine is the art and science of healing It encompasses a range of Health care practices evolved to maintain and restore Human Health by the 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:
- identifying new information about hazards associated with medicines
- preventing harm to patients. Medication, also referred to as medicine, can be loosely defined as any substance intended for use in the diagnosis cure mitigation treatment or prevention of disease Herbalism is a traditional Medicinal or Folk medicine practice based on the use of Plants and Plant extracts Herbalism is also known as The term traditional medicine ( Indigenous medicine or folk medicine) describes medical knowledge systems which developed over centuries within various societies
The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch. Etymology is the study of the History of Words &mdash when they entered a language from what source and how their form and meaning have changed over time ”
Pharmacovigilance is particularly concerned with Adverse drug reactions, or ADRs, 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. An adverse drug reaction (abbreviated ADR) or adverse drug event (abbreviated ADE) is an expression that describes the unwanted negative consequences "[2]
Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases. A physician, medical practitioner or medical doctor who practices Medicine, and is concerned with maintaining or restoring human Health "Popular press" redirects here note that the University of Wisconsin Press publishes under the imprint "The Popular Press"
Because clinical trials involve several thousand patients at most; less common side effects and 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 identify the relationships between drugs and ADRs. Data mining is the process of Sorting through large amounts of data and picking out relevant information
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Risk in Medicine
Medicines have helped to bring improved health and longer life to human beings. Medicines 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 harm to many people. There are also large numbers of people who experience no evident effect at all from the drugs they take.
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
- 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. Risk is a Concept that denotes the precise probability of specific eventualities Injury or bodily injury is Damage or Harm caused to the Structure or function of the Body caused by an outside agent or It should not be confused with risk
- Effectiveness is used to express the extent to which a drug works under real world circumstances, i. Effectiveness means the capability of producing an Effect. In Physics, an effective theory is similar to a phenomenological theory a framework intended e. , clinical practice (not clinical trials).
- Efficacy is used to express the extent to which a drug works under ideal circumstances (i. Efficacy is the capacity to produce a desired size of an effect under Ideal or Optimal conditions e. , in clinical trials)
Finding the risks of drugs
Pharmaceutical companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available. In health care clinical trials are conducted to allow safety and Efficacy data to be collected for new drugs or devices The manufacturers or their agents 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 and/or another drug that is already marketed for the disease.
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
Spontaneous reporting 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. An adverse drug reaction (abbreviated ADR) or adverse drug event (abbreviated ADE) is an expression that describes the unwanted negative consequences Spontaneous reports are almost always submitted voluntarily.
One of this system’s major weaknesses is under-reporting, though the figures vary greatly between countries and in relation to minor and serious ADRs.
Another problem is that overworked medical personnel do not always see reporting as a priority. If the symptoms are not serious, they may not notice them at all. And even if the symptoms are serious, they may not be recognised as the effect of a particular drug.
Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organization 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 collaboration
The principle of international collaboration in the field of pharmacovigilance is the principal basis for the WHO International Drug Monitoring Programme, through which over 80 member nations 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. The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in )
Member countries send their reports to the Uppsala Monitoring Centre where they are processed, evaluated and entered into the WHO International Database. The Uppsala Monitoring Centre (the UMC located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International 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 European Medicines Agency ( EMEA) is a European agency for the evaluation of medicinal products. 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 European Community (EC is one of the Three pillars of the European Union (EU created under the Maastricht Treaty (1992 The system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions. EudraVigilance ( E uropean U nion D rug R egulating A uthorities Pharmaco' vigilance') is the European data processing network
Europe requires the individual marketing authorisation holders (drug companies), to submit all received adverse reactions in electronic form (save in exceptional circumstances). The reporting obligations of the various stakeholders are defined in the Community legislation, in particular:
- Regulation (EC) No 726/2004
- for human medicines, European Union Directive 2001/83/EC as amended and Directive 2001/20/EC
- for veterinary medicines, Directive 2001/82/EC as amended. This article is for the legal term For regulation of genes see Regulation of gene expression. The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in 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
Reporting 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.
Pharmacovigilance in the United States
| U.S. drug regulation |
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| Prescription drugs Over-the-counter drugs |
Three primary branches of pharmacovigilance in the U. The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained Over-the-counter (OTC drugs are medicines that may be sold without a prescription, in contrast to Prescription drugs The name "over-the-counter" S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen). Radar is a system that uses electromagnetic waves to identify the range altitude direction or speed of both moving and fixed objects such as Aircraft, ships Public Citizen is a Washington DC -based public interest group engaged in Consumer Advocacy, government accountability clean democracy and ethical
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.
References
- ^ Source: The Importance of Pharmacovigilance, WHO 2002
- ^ WHO Technical Report No 498 (1972)
See also
- Adverse drug reaction
- Adverse effect (medicine)
- American Society of Consultant Pharmacists
- American Society of Medication Safety Officers
- Boston Collaborative Drug Surveillance Program
- Consultant pharmacist
- COSTART - Coding Symbols for a Thesaurus of Adverse Reaction Terms
- EudraVigilance
- The International Society of Pharmacovigilance
- MedDRA - Medical Dictionary for Regulatory Activities
- National Drug & Safety League
- Public health
- Pharmacoepidemiology
- Pharmacotherapy
- Therapeutic risk management
- Uppsala Monitoring Centre
- Unicus Regulatory Services
- WHOART
- Yellow Card Scheme (UK)
- DrugLogic
- MetricStream
External links
- Current Problems in Pharmacovigilance
- United States FDA Guidance on Good Pharmacovigilance Practices
Dictionary
pharmacovigilance
-noun
- (medicine) The detection, assessment, understanding and prevention of adverse effects of medicines
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