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Dis 107

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In Canada, with ~2% of all global 2006 and 2011 pharmaceutical expenditures,[20] PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch(MHPD).[21] Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person. Canada also pays such a large amount for pharmaceuticals that it was second, next to Switzerland, for the amount of money spent for a certain amount of prescription drugs (around 130 US dollars). It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical expenditures the most from 2000-2010 with 4 percent a year (with taking inflation into account).[22]The MHPD mainly collects adverse drug reaction reports through a network of reporting centers to analyze and issue possible warnings to the public, and currently utilizes newsletters, advisories, adverse reaction centers, and an electronic mailing list. However, it does not currently maintain a database or list of drugs removed from Canada as a result of safety concerns .[23]As of August 1, 2004, Health Canada has implemented an inspection program for Good Pharmacovigilance Practices to ensure the safety, quality, and efficacy of new health products. These regulatory requirements include mandatory reporting of adverse drug reactions (ADR) and unusual failures in efficacy of new drugs to link{Health Canada, link=https://en.wikipedia.org/wiki/Health_Canada}, the department of the government of Canada with responsibility for national public health.[24] In the August of 2017, there was a government controversy in which a bill, known as “Vanessa’s Law”, to protect patients from potentially dangerous prescription drugs was not being fully realized by hospitals; Health Canada only required hospitals to report “unexpected” negative reactions to prescription drugs, rather than any and all adverse reactions, with the justification of managing “administrative overload”.[25]

FIXED --> TO BE PUBLISHED.

In Canada, with ~2% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch(MHPD). . Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person. Canada also pays such a large amount for pharmaceuticals that it was second, next to Switzerland, for the amount of money spent for a certain amount of prescription drugs (around 130 US dollars). It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical expenditures the most from 2000-2010 with 4 percent a year (with taking inflation into account) The MHPD mainly collects adverse drug reaction reports through a network of reporting centers to analyze and issue possible warnings to the public, and currently utilizes newsletters, advisories, adverse reaction centers, as well as electronic mailing lists. However, it does not currently maintain a database or list of drugs removed from Canada as a result of safety concerns.

In August of 2017, there was a government controversy in which a bill, known as “Vanessa’s Law”, to protect patients from potentially dangerous prescription drugs was not being fully realized by hospitals; Health Canada only required hospitals to report “unexpected” negative reactions to prescription drugs, rather than any and all adverse reactions, with the justification of managing “administrative overload”.[25]

GROUP 2 - EDITS TO Pharmacoepidemiology

Delete old section and add:

Modified Article: Pharmacoepidemiology is the study of utilization and effects of drugs on substantial numbers of people. Combining clinical pharmacology and epidemiology, pharmacoepidemiology studies the factors of occurence and spreading of diseases to determine the overall effect of medications on human populations.[1] Pharmacoepidemiology evaluates the risks and benefits of drugs both before their approval -- through randomized controlled trials -- and after their marketed existence -- through observational studies in the general population [1][2] Pharmacovigilance is the component of pharmacoepidemiology that collects data on the adverse side effects of marketed drugs. The field of pharmacoepidemiology then compiles the data supplied by pharmacovigilance in order to generate safety guidelines for those marketed drugs.[3]

GROUP 3 Herbal medicine differs from conventional medicine due to its usage of the entire plant in its natural state, combination of different plants for treatment, and diagnosis through observation.[1 While conventional medicine must be tested in numerous ways, herbal medicine lacks this level of intense testing which has led to the discovery of many negative side effects, such as increased potassium loss and heightened allergies.[2] Although the use of herbal medicine is seen as safe because of its “natural” label, pharmacovigilance is essential for providing safety guidelines and regulations concerning the toxicity, quality issues, and adverse reactions of herbal medicine.[3] As the global prevalence of herbal medicine practices continues to grow, it is in the interest of public health to ensure the safety and proper education of the risks associated with such medicinal methods via regulations by pharmacovigilance organizations and centers around the world.[4]

GROUP 4

European Union The EU5 (France, Germany, Italy, Spain, United Kingdom) accrued ~17% of global 2011 pharmaceutical expenditures.[20] PV efforts in the EU are coordinated by the European Medicines Agency(EMA) and are conducted by the national competent authorities (NCAs).[citation needed] 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 data processing network and management system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions.[27] The EMA requires the individual marketing authorization holders to submit all received adverse reactions in electronic form, except in exceptional circumstances; the reporting obligations of the various stakeholders are defined by EEC legislation, namely Regulation (EC) No 726/2004, and for human medicines, European UnionDirective 2001/83/EC as amended and Directive 2001/20/EC.[citation needed] In 2002, Heads of Medicines Agencies[28] 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 utilization of expertise and encourage collaborative working.[citation needed] In conjunction with this oversight, individual countries maintain their distinct regulatory agencies with PV responsibility.[29] For instance, in Spain, PV is regulated by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a legal entity that retains the right to suspend or withdraw the authorization of pharmaceuticals already on-market if the evidence shows that safety (or quality or efficacy) of an agent are unsatisfactory.[30] The Pharmacovigilance Risk Assessment Committee (PRAC) is a regulatory authority within the EU. It mainly works on the risk assessment for medicines which are for human use. Its responsibilities include handling the problems about pharmacovigilance signals, as well as doing a periodic evaluation of the reports of marketing authorization holders. Also, it is responsible for making plans of risk management, doing some studies about the marketing, and managing under surveillance drugs lists.[6]

Rest of Europe, including non-EU The remaining EU and non-EU countries outside the EU5 accrued ~7% of global 2011 pharmaceutical expenditures.[20] Regulation of those outside the EU is managed by specific governmental agencies. In Iceland, the Icelandic Medicines Control Agency is responsible for PV matters, including the supervision of markets for medicinal products and authorization of bioavailability clinical trial.[4] The Regional Medicines Information and Pharmacovigilance Centres (RELIS) in Norway provides a database for pharmacologists to input feedback in drug-related questions and adverse drug-reaction reports, allowing concerns about the potential abuse of drugs to be submitted to the Norwegian Pharmacovigilance Advisory Board for further discussion.[5] In Russia, the Federal Centre for Drugs Safety Monitoring is the current pharmacovigilance system in Russia. It was founded on the basis of Roszdravnadzor (the Federal Service on Surveillance and Control in the field of healthcare of the Russian Federation) in 2007. The Federal Centre takes care of drugs safety monitoring and conducts experts’ examinations of the facts, figures and circumstances of adverse reactions occurrences.[7]

On March 29, 2017 the United Kingdom submitted its official intention to leave the European Union, with an effective target date of March 30, 2019¹. A review published by the Journal of Pharmaceutical Policy and Practice suggests that ending cooperation with the EU and medical devices databases will hinder the UK’s ability to implement effective pharmacovigilance practices particularly as it pertains to detecting side effects and responding to safety issues². The UK government maintains the position that, following the UK’s departure from the EU, it will continue to work closely with the EU regulatory authorities such as the EMA and EUDAMED³.

GROUP 5

Japanese pharmacovigilance is overseen by PDMA, the Pharmaceuticals and Medical Devices Agency. The PDMA was founded in 2004 and is involved in clinical trial consultation, in addition to the safety review of new drugs. Reason for change: The existing entry lacked information regarding the specific role of the PDMA in drug safety oversight. Moreover, the entry did not cite sources.

From the 1960s through the 1980s, Japan began experiencing revolutions aimed at increasing the amount of information available to the public regarding innovations in technology, but ultimately failed due to an economic recession in 1973 3. The PMDA was eventually created in 2004, combining multiple smaller organizations into a single government-sponsored agency 3. Reason for change: The original page did not include any information on the history of pharmacovigilance in Japan, yet understanding the history of a subject is crucial to understanding its modern state.

The Pharmaceutical Affairs Law (PAL) was introduced in 1960. The law, revised in 2002, introduced a host of amendments concerning the administration and surveillance of pharmaceuticals6. More specifically, the revised article defined the Good Vigilance Practice (GVP) and Good Post-Marketing Study Practice (GPSP) ordinances, which effectuated regulations on the collection of medical data7. Reason for change: The section on Japan failed to mention the Pharmaceutical Affairs Law, a landmark policy on the issue of Japanese pharmacovigilance.

Japan’s pharmaceutical market, when combined with China’s, accounts for 70% of the 140 billion dollars worth market of all Asian countries 4. In order to maintain safety through pharmacovigilance implementations, Japan introduced Early Post-Marketing Phase Vigilance (EPPV) in 2001 to limit the sales of products with potential health hazards 4. According to EEPV, any discovered risks associated with the drugs has to be reported to PMDA and will result in a drug recall campaign 5. Reason for change: The original article only provided limited information regarding the size of Japan’s pharmaceutical market. The sentences above gives insight into Japan’s regulatory systems and enhances the business-related content of pharmacovigilance in Japan.