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:
- identifying new information about hazards associated with medicines
- preventing harm to patients.
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
- 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 for illness.
- There are risks in any intrusion into the human body, whether chemical or surgical. Nothing in this field is entirely predictable as the interaction between chemicals 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 Risk concerns the deviation of one or more results of one or more future events from their expected value. Technically, the value of those results may be positive or negative. However, general usage tends to focus only on potential harm that may arise from a future event, which may accrue either from incurring a cost or by failing to attain some 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 physics, an effective theory is, similar to a phenomenological theory, a framework intended to explain certain effects without the claim that the theory correctly models the underlying (unobserved) processes. An example is an effective field theory that "pretends" that certain effects are caused by a field even if it is known that is used to express the extent to which a drug works under real world circumstances, i.e., clinical practice (not clinical trials).
- Efficacy In a healthcare context, efficacy indicates the capacity for beneficial change of a given intervention (e.g. a medicine, medical device, surgical procedure, or a public health intervention) is used to express the extent to which a drug works under ideal circumstances (i.e., in clinical trials).
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:
- 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 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:
- Regulation Regulation is "controlling human or societal behavior by rules or restrictions." Regulation can take many forms: legal restrictions promulgated by a government authority, self-regulation by an industry such as through a trade association, social regulation , co-regulation and market regulation. One can consider regulation as actions of (EC) No 726/2004
- for human medicines, 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 Directive 2001/83/EC 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. The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the as amended and Directive 2001/20/EC
- for veterinary medicines, Directive 2001/82/EC as amended.
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
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
- ^ Source: The Importance of Pharmacovigilance, WHO 2002
- ^ WHO Technical Report No 498 (1972)
- ^ 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
- ^ S Z Rahman, R A Khan, Varun Kumar, Misbahuddin, Pharmacoenvironmentology – A Component of Pharmacovigilance, Environmental Health 2007, 6:20 (24 Jul 2007)
- ^ 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
- ^ Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008, 42:409-419.
- ^ http://www.who-umc.org/DynPage.aspx?id=13140&mn=1514, accessed 10 February 2009.
- ^ Pharmacovigilance. Mann RD, Andrews EB, eds. John Wiley & Sons Ltd, Chichester, 2002.
- ^ http://heads.medagencies.org/
External links
- Current Problems in Pharmacovigilance
- "Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment" (PDF). Food and Drug Administration. March 2005. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf. Retrieved 2009-07-20.
- Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
|
|||||||||||||||||||||||||
Categories: Pharmacology | Pharmacy | Healthcare quality | Drug safety
|
Thu, 17 Jun 2010 18:46:16 GMT+00:00
MD needed for Medical Director role with mid-sized Pharma FierceBiotech Our client, an exciting global mid-sized pharmaceutical company, is offering a unique opportunity for a US-trained drug safety physician with extensive ...
Ed Silverman
Wed, 14 Jul 2010 15:47:39 GM
Ian Spatz, a former Merck lobbyist and now public policy advisor, suggests all of the above, and then adds Castellani and PhRMA should also address . drug safety. (and improve media relations, since PhRMA is difficult to deal with and ...
Q. Can N.Y.P.D. School Safety arrest for drug violation?
Asked by ONYX - Tue Mar 14 17:25:41 2006 - - 1 Answers - 0 Comments
A. If they are actual NYPD then they can, they still have full police authority even though they are detailed out to the school system.
Answered by rattyb2000 - Tue Mar 14 17:26:35 2006


