Principles of coaching and practice in sport Essay

Principles of coaching and practice in sport - Essay Example The autocratic dominance on older and more proficient athletes was related to a relationship to coaching behaviors that emphasized negative feedback as opposed to positive encouragement (Coach burn out). As the athlete becomes more accomplished their loss of control can be perceived as dominance. At the other end of the scale is the democratic style of coaching. In this style, the coach mandates the overall goals and training requirements of the athletes. The athletes have more freedom to choose and make suggestions for their training as well as the strategy of play. The democratic coach will consider these inputs from the players and weigh them into the final decision. Professional players who have reached a high level of competency may be allowed to simply play the game using their own best judgment. As with the autocratic style, the democratic is also broken down into two subgroups. These are the sharing and the allowing style. In the allowing style, the athletes are given much greater opportunity to make their own decisions on the training and objectives. In both groups, players choose the training session and the coach approves it based on rationality and safety. This style is appropriate where the players have sufficient skill and experience to make independent decision s. It may also be a useful style when the outcome is not highly critical such as participation simply for leisure activity. One such coaching method is the command style. The coach is a commander and the player is the receiver of the instruction. According to Brian Grasso (n.d.), President of Developing Athletics, "Coaches who display this habit believe that coaching success is based on how well the athlete can reproduce the skills as taught or demonstrated by the coach". This style can be effective in a sport where technical movements or standards must be met such as figure skating. However, it mandates that the athlete be open to total trust in the coach and their subsequent decisions. This style has been criticised because it fails to account for the various learning methods that young players may use as well as their individual needs. Coaches who are involved with highly trained and well-organised players may take the Laissez

Benefit Plan Design Analysis Research Paper Example | Topics and Well Written Essays - 500 words

Benefit Plan Design Analysis - Research Paper Example American Airlines Incorporation believes in arranging its corporate responsibility in the form of responding comprehensively towards its concerns and interests of its stakeholders. The organization seeks for gathering loyalty factor from its customers by constantly realizing and fulfilling their expectations. The benefit programs of American Airlines Incorporation at present are inclusive of primarily traveling privileges, support of ‘work-life’ plans, benefits of health and life, policies of savings and retirement and various programs for training and development of its employees. The traveling privileges provide the benefit to its employees to travel to any place in the world at discounting rates, provided the employees travel by either American Eagle or American. The support programs of the work life in the organization are inclusive of different types of resources for the purpose of accomplishing various needs, both personal as well as professional. The benefit progr ams related to health and life of the employees are inclusive of aiding incompetency of the employees with respect to vision, physical disability and dental among others.

Beethoven Symphony No. 3 any movement Essay Example | Topics and Well Written Essays - 500 words - 1

Beethoven Symphony No. 3 any movement - Essay Example However, in the year 1804, in a move to avoid paying a fee to the royal patron, Beethoven withdrew the dedication of the composition to Napoleon. He later rededicating it to the then Prince, Joseph Franz Maximilian Lobkowitz. Never the less, in the self-proclamation of Napoleon as a French Emperor on 14th May 1804, Beethoven, with his political ideologies, titled his work as Buonaparte (Berlioz, 2000). Ferdinand Ries, Beethoven’s secretary, claims that Beethoven had high esteem for Buonaparte while he was a Consul and that he had been thinking of him as the greatest Consul all over the Ancient Rome. He further claims that the name of Buonaparte, beautifully inscribed on the top of the composition, is all that Beethoven close friends saw with that Beethoven beneath the composition. However, when the news of Buonaparte reached, confirming he proclaimed himself an emperor, Beethoven tore the top title page having in mind that the person he admired will boast of his new title. Considering himself the most powerful being among his kind. The symphony received the title Sinfonia eroica only after re-writing of the top page. The composition is very interesting and soothing at some points. The reasons to why I find this piece interesting is due to its instrumentation works that provide valuable departure points. These points carry a single innovation to the point at which the horn player chips in the film. The composition of the film is considered as a classical-style, as it is long when compared to the Symphonies of other artists such as Haydn and Mozart. With exposition repetition, the initial movements are long making them typically classic symphony, thus preceding the start of the Romantic Era in classical music. Great range of emotions is evident in the second movement, ranging from the funeral match that depicted misery, to a relatively solace of happiness in major key

Obesity and Smoking Essay Example | Topics and Well Written Essays - 1250 words

Obesity and Smoking - Essay Example 935). Smoking has been estimated to account for 8% of total healthcare costs in the US, 3.8% in Canada, and 3.7% in Germany (Chang et al, 2005, pp. 2122 -2125). Dramatic variations in rates and trends of smoking are evident for specific subpopulations of women in Canada. There has recently been a disturbing trend whereby smoking rates among teenaged girls exceeded smoking rates among teenaged boys for the first time. Among girls aged 15 to 19, 25.1% reported being daily smokers in 1998 - 1999 and 26% in 2001, as compared with 18.5% and 20% respectively for boys in this age group (Chang et al, 2005, pp.2126 -2128). Girls also started smoking at a younger age, 41% of girls aged 15 to 17 reporting having smoked their first cigarette before age 13 as compared with 29% of boys. In the last decade, daily consumption increased for girls aged 15 to 19 from 11.5 cigarettes per day in 1990 to 12.7 cigarettes per day in 1999; this has decreased to 10.8 in 2001 (Statistics Canada, 2000, pp. 238- 245). In this paper we would be discussing the two issues faced by the Canadians - Obesity and Smoking. The simplest definition of obesity is an excessive amount of body fat. It must be distinguished from overweight, which refers to an excess of body weight relative to height. Obesity is probably best assessed by the visual judgment of an experienced observer. If a man, woman, or child looks fat when undressed, he or she is probably obese. Measurement of sub scapular and triceps skin-fold thicknesses with calipers is the simplest objective way to assess body fat. Data from the 2004 Canadian Community Health Survey (CCHS) indicate an obesity rate for Canada of 23.1% and an overweight rate of 59.1%. U.S. data from the National Health and Nutrition Examination Survey (NHANES) 1999 -2002 show that 65.1% of the American adult population is overweight and 30.4% are obese (Hedley et al, 2004, pp. 2847- 2848). The problem of obesity does not affect all populations equally, particularly in the U.S. The obesity rate in the U.S. is higher for women at 33.2% compared to the rate for men (27.6%). By race, these gender differences are exacerbated. F or example, the obesity rate among non-Hispanic white women is 30.7% compared to a rate of 49% among non-Hispanic black American women, whereas obesity rates across race for men do not differ significantly (Hedley et al, 2004, pp. 2849- 2850). In Canada, obesity rates do not vary substantially by sex (23.2% for women and 22.9% for men). However, obesity rates are higher for white women (24.8%) and white men (25 .5%) compared to their non-white counterparts (Hedley et al, 2004, p.2849). An estimated 80-90% of persons with type 2 diabetes mellitus in the Canadian population are overweight or obese. Obesity is also a growing problem in children with type 1 diabetes (Hypponen et al, 2000, pp.1755-1760). Furthermore, intensive insulin therapy is associated with weight gain. Weight loss has been shown to improve glycemic control by increasing insulin sensitivity and glucose uptake and diminishing hepatic glucose output (Chou et al, 2004, pp. 565-587). The risk of death from all causes, cardiovascular disease (CVD), and some forms of cancer increases with excessive body fat (Calle et al,

Any organism or group of organisms Essay Example | Topics and Well Written Essays - 1000 words

Any organism or group of organisms - Essay Example Most have two auxiliary pairs of appendages. The first is the chelicerae, or mouthparts on which you find their fangs. These are used for feeding and defense functions, grabbing or poisoning prey. The second pair is called the pedipalps. They have mainly three functions: for feeding, movement and reproducing. Another feature of arachnids that makes distinguishing insects from them easy are the fact that arachnids do not possess any antennae or wings. All arachnids also contain exoskeletons just as all arthropods. Arachnids are typically meat-eating organisms. They feed on pre-digested remains of insects and other little organisms such as flies, bees, ants, crickets, wasps, grasshoppers, beetles, bugs and even others of their kind. Only two kinds, the  harvestmen also known and commonly called as the daddy longlegs,  and several mites like the house dust mite for instance, consume solid food particles. Because of this, they are out in the open to other internal parasites, though i t is not obscure for spiders to digest their own silk. Quite a lot of groups have the ability to exude  toxin and lethal venom  from specific  ducts or glands  to poison prey or threats. ... At the back of the mouth, there is a powerful hardened pharynx. This operates as a pump, drawing the food in to the body, from the esophagus which sometimes functions as a secondary further pump. The stomach in an arachnid is shaped like a tube, with a couple of outpouchings stretching all the way through the entire body. Both the stomach and these outpouchings called diverticula manufacture digestive proteins. They also soak up nutrients from the prey. This connects to a tiny hardened intestine and anus which is found in the rear part of the abdomen of the arachnid’s body. Eyes of arachnids are complex and very complicated, having two kinds namely the median ocelli and the lateral ocelli. Compound eyes have probably evolved into the lateral ocelli. They may possibly have a  tapetum. This helps in enhancing the absorption and the gathering of light. At the same time, the median ocelli may have been arisen from a crosswise crease of the  ectoderm. These eyes, in its ancient form, were probably both present in ancestors of arachnids. In contrast, modern arachnids that we see today are either lacking in one type or the other. The  cornea  acts as a light-focusing lens. underneath is a see-through body that resembles that of glass, then the  retina and sometimes, the tapetum. Nearly all arachnids have two other sensory organs. One of the most common and the most fundamental for most arachnids are the sensory hairs that are cover up the entire body. This also provides the arachnid’s sense of touch. Most other arachnids possess other sensory organs, even more complex and intricate such as trichobothria, or elongated hair-like structures that is used in detecting

Contrasting Differences in Family Life in USA and Mexico Essay Example for Free

Contrasting Differences in Family Life in USA and Mexico Essay The family is the basic unit of any particular society or community. It is therefore imperative that for the society to exist the family has to be there to produce members into the community. The community or national character any particular country is basically determined by the nature of the family values. An individual is shaped in the early ages by the family. In the contemporary society there are increased diversity changes in the family a characteristic of the many changes in culture, political, economic, social, and psychological and even the environment. The content definition of has not been agreed upon because of the great changes that are so accommodating. In the previous many years the family was considered as the people who are related by blood. This definition based on the kinship ties has been revoked due to the influence of many forms of families which has stripped off the family its actual definition. For instance there can husband and wife who do not have any kinship ties and they go ahead to adopt children. Another case that has changed such a definition of the family based on kinship ties is the increasing number of intermarriage within the context of race or ethnicity. This brings out a mixture of offspring and therefore it is difficult to trace the family bonds based on kinship ties. The issue of who is next to kin is no longer important in the current families. The most common aspect in the current families is the bonding based on mutual understanding. The many changes of husband and wife have been changed by the introduction of lesbianism and gay. These try to go against the grain of opposite gender type of marriage. The concept of marriage has changed from opposite gender type of marriage to a mixture of gay, lesbianism and opposite gender marriages. These are some of the dynamisms that are facing the contemporary families. This paper shall give an indebt analysis of the family, the changes in roles and functions of the families and the general effects of such changes to the contemporary families. A close reference and examples shall be drawn from the US and Mexico, the countries that border each other geographically. The contrasting differences I n family issues shall be pointed out clearly. Family life in the United States The family relationship in the United States has undergone several transformations due to the effect of globalization. Race and ethnicity are the most significant factors in shaping the variety of values, attitudes and behaviour amongst the families in the United States. There are a number of changes in families in the United States. These changes range from political, social, economic, and psychological to spiritual. The social dislocations have given rise to new ideas and values especially there is increased individualism among the members of the community. In the US there increased diversity in the organizational structures. There are many cases of divorce and separation in the United Stated which has grabbed the family the unity and love that is supposed to be enjoyed. Most the single families that are common in the US are as a result of divorce and remarriage due to greater democratization. (Hines Morrison, 2005) Cultural diversity in the US is accounting for the many different types of families that have emerged in the recent past. The United States constitutes almost all races and ethnic groups in the world. For this reason there are diverse cultural values as a resulting of this contact. The factor that there are free intermarriages between these diverse races and ethnic groups has made the US to have diverse cultural values which transcend the native culture. The immigrants who move to the United State try to maintain their native language despite the fact that they are forced to learn the official language of the United States, which is English. The immigrants from Spanish speaking countries (Hispanic) when they move to the United States they try to maintain their languages. The culture of the people is usually transmitted through language and due to the numerous languages in the United States there exists different cultures. This means that there are very many family clusters formed through the sharing of the languages. For instance most of the Hispanic immigrants have formed family clusters in the sides of Florida. The black American speaks a variety of English as they identify themselves as belonging or originating from one family. These disparities have affected the notion of the family because these people are allowed to mix freely with people from different cultures. The concept of the family in the United States is changing even the more during the advent of the green card where people from different pasts acquire citizenship. Many people from different races and ethnic groups have found their way to the US and as such most of them are allowed to move with their families. The nuclear family still remains an ideal source of the society in the United States. The United States families are characterized by the great social stratification. In the United the families are organized according to different classes. Among these classes there are great disparities in terms of economic value. The choice of families has not taken shift from mutual understanding to materials and resources. This has affected relationships from a sociological point of view. This issue of the class is a dominant phenomenon among the families in the United States as those who are rich wants to maintain the status quo. This is done through the inheritance that is passed within the nuclear families. The nuclear families in the United States are created and broken up and then reconstituted. This has led to the decline of family values which consequently affects the family patterns. This diversity in family pattern has been identified as the cause of problems such as violence, crime and drug use in the united state. The parents are usually very busy with their duties (United States, Congress, 1992). The increasing cases of divorce and separation in the United States have a negative effect on maintaining the ideal norms of the nuclear family value. The families that are exposed to values outside the parental domain are likely to deviate from norms. The human rights in the United States are considered fundamental. There is protection of the universal human right which is a recipe to the process of democratization. This the reason why the US government invest huge amount of money in education health and other basic sectors so as to enhance the promotion of the human rights among the citizens. The Family Life in Mexico Most people have preferred to live in Mexico for a variety of reasons such as social, political, economic and even good climatic reasons. Living in Mexico requires one to learn the Spanish language so as to increase effective communication. This is because the families are socialized in the Spanish language. The Mexican people are extremely warm and friendly as they are organized in smaller communities that come from the mutually intelligible families. This means that the socialization process is high since there tow much contact between the families. The family bonds are tightly held together and for this reason there is cultural uniformity. The society per se is integrated under common cultural values through the common language shared. Piped water is relatively inexpensive, but not always potable (drinkable). Decades of under-investment, combined with an attitude of impertinence towards paying water bills, has left Mexicos mains water system in poor condition. As a result, most people purchase bottled water, often in 20L containers. Bottled water is very expensive. Rents in Mexico can be higher than in equivalent-sized US towns or cities if the place is popular or fashionable, particularly places within easy reach of the US border. Mexico has a centralized economy: that is, most of the countrys economic activity revolves around. The Mexican pace of life is relatively slower than in the US Especially when the life in major cities is given consideration. The families in Mexico are closely tied as most of the families have time to attend to their families. There is a high degree of parental responsibility among the families. This transcends to greater heights of good values that the society enjoys. Mexico’s culture has a rich history in a consolidated family religion, people and tradition. The Mexican people are proud of their culture that they keep on passing from one generation to another. This is because there is little infusion of the foreign cultures. The family is the basic unit in Mexico and a cornerstone to the maintenance of the culture. The rate of socialization and interaction among these people is too high. It is a usual phenomenon to meet two or more families meeting for a common interest or for a special event. This part of the family function in Mexico, people in Mexico have free time to visit resort centers for the purpose of relaxation which is not a common phenomenon in the United States, where people are too busy. (Heymann, 2006) The Mexican People are too religious which is a big contrast with the United States where people feel that they are in control; of their own life. A large number of people are Christian and they are usually committed to going to church. When you walk in the Mexican homes it is easy for you to see the religious images. In America people stay a non-religious life thus an effect of religious intermingling that has made it difficult for the people to which religious practice to adopt. Thus they resign from subscribing to any of the religious practice. The social stratification is not prevalent in the Mexican family as it is in the United States; people are seeking for money the Mexican people strive for titles. The professionals in Mexico prefer to be addressed with the titles that they deserve. This is as a result of the traditional emphasis given to the tittles within the family domain. The economic living standards in Mexico are slightly lower than in the United State. There are many poor people in Mexico than in the United States. The impact of these high levels of poverty in Mexico has necessitated the immigration of most Mexican families to the United States in search of better jobs and pay of most illegal immigrants from Mexico have gotten their way into the United States through the Mexican borders. These immigrants have settled in cities such as Florida. Working in the United States gives them better pay. This aspect of brain drain is lowering the general development of the families in Mexico as most of the people move leaving behind other family members Basically the cost of living in Mexico is lower than that of the US particularly for agricultural produce. Other sectors such as transport and communication are also lower in Mexico than I n the United States. Other utilities as electricity are more expensive compared to the United State. Working families in the United States, observing how parents struggled to find a balance between caring for children and earning a decent income. When parents split and one of the parents went from Mexico to the United States and was no longer available to give the necessary care, families suffer. What significantly exacerbates the problem is when the borders are so tight that they prevent families from reuniting. This has been a common phenomenon when the immigrants are not given the opportunity by the America to even visit their families in back home in Mexico. (Poole M. et al, 1993) Globalization of the economy created increased pressure for workers to accept lower labor standards, accept lower wages, longer hours, fewer benefits, and less paid leave. Both Nations likewise feel pressure from economic globalization not to implement family-friendly policies, such as paid leave for illness or when a child is sick, or paid parental leave. And that leaves working families struggling to balance work and their care-giving duties. The globalization process has affected families in both Mexico and United States economy was transforming the relationship between work and care-giving in similar ways everywhere. Globalization has forcing both countries to at a very high pace as far as labor standards and social policies are concerned hence leaving working parents with less and less time to raise their children. Parents work has shifted markedly around the world and that goes for every region. The child rearing process has been left in the hands of maids who offer supportive care while the parents are away working till late hours of the day. Men in particular have been moving away from one place to another in search of better jobs especially in various industries. Globalization has made men and women to work day and night and this has made them move away from their homes to go work in various places. A good example is that of outsourcing where people work in shifts where some work during the day and others at night. Women, likewise, have moved into the paid labor force and away from the home. From the period between 1960 and 2000 the number of women in the labor force went from 26 to 38 percent in America. The percentage of women in the workplace has increased both in the United States and Mexico. This has adversely affected the family care services that were provided by the women while their men were working in various sectors. This is a result of civilization which been brought about by the factors such as education, religion, work, urbanization among others. These factors have changed the various roles that were supposed to be executed by the family so as to prepare an individual to be a responsible member of the society. (Cecil, 1992) What has happened is that the world has seen women get better job opportunities which has assisted then them raise income to cater for their families. The increased number of single parent families has made it possible for the women to struggle to get money for rearing their families. While this is was going on there is also massive urbanization occurring all across the world. Thats not necessarily a bad thing, as people who move from very poor rural areas to urban areas often get better jobs, and become less dependent on, for instance, a good rain to feed their families. (Rowntree, Lewis, Price Wyckoff, 2006). References Hines D. A. , Morrison K. (2005) Family Violence in the United States: Defining, Understanding, and Combating. Sage Publisher. Heymann J. (2006) Forgotten Families: Ending the Growing Crisis Confronting Children and Working Parents in the Global Economy. Oxford University Press Poole M. et al (1993) Family: Changing Families, Changing Times. Allen Unwin publisher. Robinson, Cecil. (1992). No short journeys: The interplay of cultures in the history and Literature of the borderlands. Tucson: University of Arizona Press. Rowntree L. , Lewis M. , Price M. and Wyckoff W. (2006). Diversity amid Globalization: World Regions, Environment, Development. United States, Congress. House America’s (1992) Families: Conditions, Trends, Hopes, and Fears: Family policy. United States, Congress, House publisher.

EU Pharmacovigilance Legislation: An Overview

EU Pharmacovigilance Legislation: An Overview Susan Murphy As defined by the WHO, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine related problems. Adverse effects are whereby medicines affect the body in an unintended and harmful way. Following on from this, the underlying objectives of EU pharmacovigilance legislation are to: prevent harm from adverse reactions in humans arising from the use of authorised medicinal products promote the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. Pharmacovigilance is therefore an activity contributing to the protection of both patients and public health [1]. When a new medicine obtains marketing authorization (MA), the active substance has been tested and it has been concluded that the benefits of this new medicine outweigh the risks. There is a limited amount of information available after clinical trials so the decision to give MA is effectively a trade off between making a new medicine available as early as possible and waiting until as much as possible is know about the medicine. For testing, several hundreds or thousands of carefully selected patients will have participated in clinical trials. These trials take place under controlled conditions. However, once MA has been obtained, the medicine will now be used in normal healthcare settings where there will be many patients who may differ from those used in the population study (eg age difference, may be using other drugs, have disease interactions. and also there will be longer term effects of using the new medicine). So it is imperative to identify these new or changing risks as quickly as possible to take measures to minimize the risks to patients. [2] For companys there is a legal obligation to continuously collect data and conduct pharmacovigilance regarding any possible change to the risk-benefit balance of taking such a medicine. In this regard, pharmacovigilance regulation seeks to protect the public from emerging safety issues by monitoring the product throughout its lifetime so that it is safe and effective to use. The 2012 EU Pharmacovigilance Legislation [3] New legislation regarding pharmacovigilance came into effect in July 2012. This was the biggest change to the regulation of human medicines since 1995. Based on evidence that adverse drug reactions caused approx 197,000 deaths per year in the EU, the EC began a review of the European system of safety monitoring (an independent study with extensive public consultation) This resulted in a 2010 directive and regulation, Directive 2010/84/EU Regulation (EU) No 1235/2012 which amended the existing pharmacovigilance laws 2001/83/EC and regulation (EC) No. 726/2004. This was accompanied by the implementation regulation published in June 2012 which provided operational aspects for the new legislation (no 520/2012 19th June 2012) A further amendment was carried out in Oct 2012 following a review of the withdrawal of the medicine Mediator (benfluorex) a diabetes drug with a coronary side effect, where it was felt that the risk now outweighed the limited benefit. The amendments aimed to further protect the patients health by allowing prompt notification and assessment of patient issues. The aim of the legislation was to reduce the number of Adverse Drug reactions via Collecting data on the effects of a given medicine from a wider net Rapid and robust assessment of issues Effective regulatory action to deliver safe and effective use of medicines Better patient involvement through feedback and reporting More transparency on the effects and safety of medicines concerned For MA applicants and holders the new legislation would: Makes their roles and responsibilities clear Minimize duplication of effort Free up resources by rationalizing and simplifying reporting on safety issues Clear legal framework for post authorisation modifying In short, the main aim of the legislation was to reduce the human and financial cost burden of adverse drug reactions, to strengthen patient involvement in monitoring medicines and to make the public strongly aware of the risk-benefit nature of taking medicines. New Concepts introduced in the 2012 Pharmacovigilance Legislation The concept of additional monitoring and the black symbol were introduced by the new EU laws on the safety-monitoring of medicines, (called the pharmacovigilance legislation,) which started to come into effect in 2012. Any new medicine authorised after 1 September 2013 that is subject to additional monitoring must display the black symbol in the package leaflet and the summary of product characteristics when it is placed on the EU market. Also any educational materials relating to this medicine should indicate its additional monitoring status. The legislation affects medicines authorised in the EU after 1 January 2011. Due to this, a transition period for medicines authorised between January 2011 and August 2013 was allowed whilst companies their updated packaging and gradually phased in the new leaflets. Medicines under additional monitoring [4] This is a new process to label medicines that are being monitored closely by the regulatory authorities. A solid black upside down triangle displayed on the package leaflet and information for healthcare professionals indicates that the medicine is undergoing additional monitoring. The symbol started to appear in late 2013. A medicine may be subject to additional monitoring because Not as much data is available with this medicine Less information is available on the long term impact of using this medicine Does not imply that the medicine is unsafe. This label is now always applied for: Any new API authorized after Jan 2011 Any biological medicine authorized after Jan 2011 For medicines authorised under exceptional circumstances If there are rare side effects seen during the trial or long term usage effects which warrant more information gathering. A medicine subject to such monitoring, can remain on the Medicines subject to additional monitoring list published by the EMA for up to 5 years. Why are medicines monitored after approval? Marketing approval is granted to medicines on the basis of clinical trial results. These consist of a small number of patients trialled under controlled conditions over a relatively short period of time. In real life, however a more diverse group of people will use the medicine and there may be different interactions plus the effects of longer term use. To take any rare or long term side effects which may then come to light into account, it is vital to continue to monitor the safety of all medicines whilst they are in commercial use. Information is continuously collected after a medicine is placed on the market to monitor real-life experience with the product. European regulatory authorities closely monitor this information to make sure that the benefits of medicines continue to outweigh their risks. Standardised monitoring methods are used across the EU so that information can be effectively shared by the member states regulatory authorities. This provides a wealth of knowledge for regulators to rely upon when making decisions, and enables a rapid response when required, such as providing warnings about the medicine or restricting its usage. Reporting side effects Reporting suspected side effects is an important way to gather more information on medicines on the market. Regulatory authorities look at reports of side effects alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action. Patients and healthcare professionals are encouraged to report suspected side effects seen with any medicine. Under the new pharmacovigilance legislation, patients have the right to report suspected side effects directly to the national medicines regulatory authorities in their country if they wish. The onus is on the company to provide information on how to do this on their package leaflet. The black triangle makes it possible to quickly identify medicines that are subject to additional monitoring, encouraging end users to feed back any adverse effects .This allows new data to be analysed in a rapid and robust manner. [5] Update on effect of 2012 Pharmacovigilance Legislation A report published in 2014 summarised the key effects of introducing the new legislation [6]. The most notable of these were (during the reporting period 2012-2013) Adverse Drug reaction reporting has increased by > 175,000 more individual case safety reports > 9,000 more patient reports Label Changes from more that 47% of signals reported By August 2013 119 medicines were listed under additional monitoring list. Major public health reviews have been initiated on combined hormonal contraceptives, codeine-containing products and tetrazepam to name but a few. Better information is now available via the agencys website for therapeutic decision making Conclusion The aim of the Pharmacovigilance legislation is to enhance patient care and safety with regard to medicines and to support public health programs by providing balanced reliable information. Real life use of medicines only happens once professionals begin to prescribe or dispense. It is vital that the safety of all medicines is monitored throughout their lifetime. Adverse drug reactions account for 5% of all hospital admissions and are the 5th most common cause of hospital death. For EU citizens, the goal of the new pharmacovigilance legislation is to Strengthen patient involvement in the monitoring of medicines. This allows for continuous feedback on the effects of taking medicines through its lifecyle and consequently rapid and robust assessment of issues. Reduce the burden of ADRs Inform and engage citizens on the risk/benefit aspect of taking medicines. Full implementation is expected to save between 500 and 5000 lives a year with a cost saving to society of between â‚ ¬250million and â‚ ¬2.5billion per year [7]. There is concrete evidence that the new legislation is bringing about changes that will lead to improvement in public health. This is demonstrated by greater clarity on the roles and responsibilities for the parties involved in pharmacovigilance (MA applicants and holders, EMA, EU and member state regulatory authorities) and also greater transparency on medicine safety for the patient. This serves to increase the understanding and trust of both patients and healthcare workers on the safe and effective use of medicines in the EU[6]. References [1]Â  http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/09/WC500172403.pdf [2] EMA Pharmacoviglience 2013 23/03/2013 NC50010423.pdf [3]http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jspmid=WC0b01ac058058f32d [4]http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142430.pdf [5]http://www.ema.europa.eu (Medicines under additional monitoring) [6]Â  http://ec.europa.eu/health/files/pharmacovigilance/2014_ema_oneyear_pharmacov_en.pdf [7]Â  http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/01/WC500137839.pdf