Pharmacovigilance (PV) is the pharmacological Pharmacology is the study of drug action. (At the same time, φάρμακος, pharmakos, means: whipping-boy.) More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals science Science is a systematic enterprise of gathering knowledge about nature and organizing and condensing that knowledge into testable laws and theories. As knowledge has increased, some methods have proved more reliable than others, and today the scientific method is the standard for science. It includes the use of careful observation, experimentation, relating to the detection, assessment, understanding and prevention of adverse effects In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical, particularly long term and short term side effects of medicines A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.[1] 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 A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease, biological products, herbalism Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, and phytotherapy. The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain and traditional medicines Traditional medicine comprises medical knowledge systems that developed over generations within various societies before the era of modern medicine. Practices known as traditional medicines include herbal, Ayurveda, Siddha medicine, Unani, ancient Iranian medicine, Islamic medicine, traditional Chinese medicine, acupuncture, Muti, Ifá, with a view to:

The etymological Etymology is the study of the history of words and how their form and meaning have changed over time roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”

Pharmacovigilance is particularly concerned with adverse drug reactions An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as, 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."[2]

Pharmacovigilance is gaining importance for doctors A physician—also known as doctor of medicine, medical doctor, or simply doctor—practices the ancient profession of medicine, which is concerned with maintaining or restoring human health through the study, diagnosis, and treatment of disease or injury. This properly requires both a detailed knowledge of the academic disciplines underlying and scientists as the number of stories in the mass media Mass media denotes a section of the media specifically designed to reach a large audience. The term was coined in the 1920s with the advent of nationwide radio networks, mass-circulation newspapers and magazines. However, some forms of mass media such as books and manuscripts had already been in use for centuries of drug recalls increases.[citation needed]

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 Data mining is the process of extracting patterns from data. Data mining is becoming an increasingly important tool to transform the data into information. It is commonly used in a wide range of profiling practices, such as marketing, surveillance, fraud detection and scientific discovery and investigation of case reports to identify the relationships between drugs and ADRs.

Pharmacoenvironmentology: A branch of environmental pharmacology and a form of pharmacovigilance which deals entry of chemicals or drugs into the environment after elimination from humans and animals post-therapy. It deals specifically with those pharmacological agents that have impact on the environment via elimination through living organisms subsequent to pharmacotherapy[3][4][5]

Risks of medical treatment

Terms commonly used in drug safety

Finding the risks of drugs

Pharmaceutical companies are required by law in all countries to perform clinical trials Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions . These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place, testing new drugs on people before they are made generally available. 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:

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 An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as to their national pharmacovigilance center or to the manufacturer.[6] 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 (also referred to as ICSRs, individual case safety reports).

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 The World Health Organization is a specialized agency of the United Nations (UN) that acts as a coordinating authority on international public health. Established on 7 April 1948, and headquartered in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health Organization, which had been an agency of the Database, which includes around 4.6 million reports (January 2009)[7], growing annually by about 250,000.[8]

Other reporting methods

Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit,through its Qualified Person for Pharmacovigilance QPPV, all the 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 90 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 The European Union is an economic and political union of 27 member states which are located primarily in Europe. Committed to regional integration, the EU was established by the Treaty of Maastricht in 1993 upon the foundations of the European Communities. With over 500 million citizens, the EU combined generated an estimated 28% share (US$ 16.5 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 by region

Europe

The pharmacovigilance effort in Europe is coordinated by the European Medicines Agency The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products (EMA) and conducted by the national competent authorities (NCAs). The main responsibility of the EMA 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 was the first of the three pillars of the European Union (EU) between 1992 and 2009. Created by the Maastricht Treaty (1992), it was based upon the principle of supranationalism and had its origins in the European Economic Community, the predecessor of the European Union. The Treaty of Lisbon abolished the entire pillar. The system is called EudraVigilance 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 for following the marketing authorisation of medicinal products in the European Economic Area (EEA) and contains separate but similar databases of human and veterinary reactions.

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:

Reporting can be performed with software developed for the purpose or with a web utility called EVWEB accessible through the EudraVigilance homepage. Registration for use of EVWEB is necessary.

In 2002 Heads of Medicines Agencies[9] 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.

United States

Regulation of therapeutic goods in the United States The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in
Prescription drugs A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug Over-the-counter drugs Over-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are products that are safe and
Law
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Comprehensive Drug Abuse Prevention and Control Act of 1970 The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 , is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. Controlled substances are divided into five schedules (or Controlled Substances Act The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. The Act also served as the Prescription Drug Marketing Act The Prescription Drug Marketing Act of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Hatch-Waxman exemption In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute
Government agencies
United States Department of Health and Human Services The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before its education functions were split off in 1979, it Food and Drug Administration The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter Drug Enforcement Administration The Drug Enforcement Administration is a law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States. Not only is the DEA the lead agency for domestic enforcement of the Controlled Substances Act, sharing concurrent jurisdiction with the Federal Bureau of Investigation, Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the FD&C Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for new and generic
Process
Drug discovery In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered and/or designed Drug design Drug design, also sometimes referred to as rational drug design, is the inventive process of finding new medications based on the knowledge of the biological target. The drug is most commonly an organic small molecule which activates or inhibits the function of a biomolecule such as a protein which in turn results in a therapeutic benefit to the Drug development Drug development is a blanket term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery / product development, pre-clinical research and clinical trials (on humans). Few people still refer to the drug development as mere preclinical development New drug application The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Investigational new drug The United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to Clinical trial Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions . These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place (Phase I, II, III, IV) Randomized controlled trial A randomized controlled trial is a type of scientific experiment most commonly used in testing the efficacy or effectiveness of healthcare services (such as medicine or nursing) or health technologies (such as pharmaceuticals, medical devices or surgery). RCTs involve the random allocation of different interventions (treatments or conditions) to Pharmacovigilance Abbreviated New Drug Application An Abbreviated New Drug Application is an application for a U.S. generic drug approval for an existing licensed medication or approved drug Fast track approval The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or Off-label use Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied
International coordination
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical Uppsala Monitoring Centre World Health Organization The World Health Organization is a specialized agency of the United Nations (UN) that acts as a coordinating authority on international public health. Established on 7 April 1948, and headquartered in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health Organization, which had been an agency of the Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations.
Institute of Medicine Research on Adverse Drug events And Reports
This box:

Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).

See also

References

  1. ^ Source: The Importance of Pharmacovigilance, WHO 2002
  2. ^ WHO Technical Report No 498 (1972)
  3. ^ SZ Rahman, RA Khan, V Gupta & Misbahuddin. Pharmacoenvironmentology – Ahead of Pharmacovigilance. In: Rahman SZ, Shahid M & Gupta A Eds. An Introduction to Environmental Pharmacology (ISBN # 978-81-906070-4-9). Ibn Sina Academy, Aligarh, India, 2008: 35-42
  4. ^ S Z Rahman, R A Khan, Varun Kumar, Misbahuddin, Pharmacoenvironmentology – A Component of Pharmacovigilance, Environmental Health 2007, 6:20 (24 Jul 2007)
  5. ^ Ilene Sue Ruhoy, Christian G. Daughton. Beyond the medicine cabinet: An analysis of where and why medications accumulate. Environment International 2008, Vol. 34 (8): 1157-1169
  6. ^ Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008, 42:409-419.
  7. ^ http://www.who-umc.org/DynPage.aspx?id=13140&mn=1514, accessed 10 February 2009.
  8. ^ Pharmacovigilance. Mann RD, Andrews EB, eds. John Wiley & Sons Ltd, Chichester, 2002.
  9. ^ http://heads.medagencies.org/

External links

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