Pdf introduction to pharmacovigilance researchgate. The full text of this article hosted at is unavailable due to technical difficulties. Malaria pharmacovigilance in africa, drug safety 10. Strengthening pharmacovigilance in south africa scielo sa. Ushma mehtas research works university of cape town. Safety of medicines and vaccines in pregnancy under the. Ushma mehta independent pharmacovigilance consultant, johannesburg. Developing a lesson plan an pharmacovigilance author. Ushma mehta s 52 research works with 662 citations and 2,854 reads, including. Ushma mehta, mukesh dheda, gavin steel, marc blockman, augustin ntilivamunda, gary maartens, yogan pillay, karen cohen abstract this report outlines findings and recommendations of a national pharmacovigilance workshop held in august 2012 in south africa sa. South africa has been engaged in pharmacovigilance pv activities to assess the impact of adverse drug. Pharmacovigilance methods and postauthorisation safety studies. Pharmacovigilance vaccine safety stakeholders communication immunization of. Differentiating between programmatic and regulatory.
Nevertheless, there is no agreement on the best method for. Mehta, with 65 highly influential citations and 36 scientific research papers. Pharmacovigilance pv or phv, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Ushma mehta is a consultant for the division of clinical pharmacology, department of medicine, university of cape town uct, south africa and an independent pharmacovigilance consultant based in cape town, south africa. Pdf on may 1, 2016, pinki mishra and others published introduction to pharmacovigilance find, read and cite all the research you need on researchgate. Rationale professionals involved in vaccine safety come from different backgrounds.
Between jan 23, and aug 15, 2018, we randomly assigned 268 mothers to dolutegravir 5 or efavirenz 3. Ushma mehta cape town area, south africa professional. All mothers and their infants were included in the safety analysis, and 250 mothers 125 in the dolutegravir group, 125 in the efavirenz group and their infants in efficacy analyses, by intentiontotreat analyses. Any healthcare professional can report on this adverse event. Mortality from adverse drug reactions in adult medical inpatients at. Adrs is routinely performed in regulatory pharmacovigilance and in epidemiological adr surveys. Pharmacovigilance pharmacovigilance pv drug safety it is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse reaction with pharmaceutical products.
She has who in developing and auditing regulatory and programmatic pharmacovigilance systems in several countries. The lesson plan helpful hints use examples to illustrate your points. Regulation eu 12352010 of the european parliament and of the council of 15 december 2010 amending, as regards pharmacovigilance of medicinal products for human use, regulation ec no 7262004 laying down community procedures for the authorization and supervision of medicinal products for. South african context largest arv treatment programme in the world 3. She started her career as the manager of the national adverse drug event monitoring centre and has assisted who in developing regulatory and programmatic pharmacovigilance systems in several countries. Interrater agreement of two adverse drug reaction causality. Malaria pharmacovigilance in africa p background and objectives. Strengthening pharmacovigilance in south africa mehta south. Rossiter, gary maartens, and karen cohen fabio rapallo. Pdf strengthening pharmacovigilance in south africa. Mortality from adverse drug reactions in adult medical inpatients at four hospitals in south africa. Pharmacovigilance to inform policy in south africa. Pharmacovigilance of antimalarial treatment in uganda.
Dr ushma mehta, division of clinical pharmacology, department of medicine, university of cape town, observatory 7925, south africa. Bioanalytical laboratory, division of clinical pharmacology. Sa data centrestaff afa patients health care workers who report how can we help you. Jan 09, 20 lessons from a pilot project in mpumalanga province, south africa 1,2 2,3 4 5 ushma mehta, david durrheim, aaron mabuza, lucille blumberg, 1 1 elizabeth allen and karen i. Establishing pharmacovigilance programs in resourcelimited. University of cape town school of public health and family. Generic and biosimilar medicines south africa present a. Pharmacovigilance, signal detection and signal intelligence. Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines who. S outh africa has been engaged in pharmacovigilance pv activities to assess. View the profiles of professionals named ushma mehta on linkedin. See the complete profile on linkedin and discover ushma s connections and jobs at similar companies. Ushma mehtas research works university of cape town, cape. Provincial malaria control program, limpopo province.
Identifying adrs in africa special challenges malaria pansystemic clinical features. As their jobs are all interrelated and codependent, they need a common language in order to ensure smooth collaboration. For approval of drug product, pharmacovigilance is necessary. Prior to the introduction of artemisininbased combination antimalarial therapy in mpumalanga province, south africa, a. Barnes 1 division of clinical pharmacology, university of cape town, cape town, south africa 2 school of public health and tropical medicine, james. Identifying adrs in africa special challenges malaria pansystemic clinical features lifethreatening condition realworld trial assp and coartem safety profile appears to be very good. The new legislation on pharmacovigilance is based on two new legislative acts. Feb 06, 2007 written by an international team of outstanding editors and contributors, pharmacovigilance, 2nd edition is the definitive text on this important subject.
It offers the learner options to work at the speed and depth he prefers, recognizing his prior knowledge. Pharmacovigilance is also known as drug safety and is defined by the world health organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problems 1,2. South africa 1,2 2,3 4 5 ushma mehta, david durrheim, aaron mabuza, lucille blumberg, 1 1 elizabeth allen and karen i. While the term signal has been used commonly and widely in the area of pharmacovigilance for years, its definition has evolved over the past few years. In this adverse event reporting is the commonly associated. Pharmacovigilance to inform policy in south africa hospital. Adverse drug reactions in adult medical inpatients in a. The unprecedented levels of political, technical and financial support for improved malaria control, and particularly for changes in the malaria treatment policy, have heralded a renewed appreciation of the role of pharmacovigilance, its relationship with. Pharmacovigilance methods spontaneous reporting is the mainstay of pharmacovigilance definition. Ba i kopantseng ele ho arolelana tse bohlokwa tse amang. Ushma c mehta, pharm d drph independent pharmacovigilance consultant and consultant for who tropical diseases research. Malaria pharmacovigilance in africa pdf free download. Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is the science of adverse drug reactions adrs and drugrelated.
Our aim was to compare the interrater agreement achieved. Tel 021 406 6829 tel 086 110 0531 fax 021 448 0503 sms071 840 1572 email pha. Mouton jp, mehta u, rossiter dp, maartens g, cohen k 2017. Ushma mehta is a consultant for the division of clinical pharmacology, department of medicine. Adequate pharmacovigilance boosts health and increases patients trust in the health system. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and. Basic principles of pharmacovigilance and data sources joerg hasford, m.
Aug 08 dr ushma mehta pharmacovigilance sep 12 prof john joska hiv and psychiatric disorders oct 10 to be confirmed nov 14 rulan griesel pharmacokinetics and pharmacodynamics january 2017 february 2017 march 2017 april 2017 m t w t f s s m t w t f s s m t w t f s s m t w t f s s. Dr ushma mehta, university of cape town pdf, 636kb preliminary findings tld. South africa has been engaged in pharmacovigilance pv activities to assess the impact of adverse drug reactions on public safety and health for 40 years. To obtain a clear overview of all pharmacovigilance activities being conducted in the public sector at a national and provincial level in south africa. A new method to assess causality of suspected adverse drug reactions, the liverpool adverse drug reaction causality assessment tool lcat, showed high interrater agreement when used by its developers. Accommodating the different mechanisms between regions and nations is a challenge to any global course. Pharmacovigilance pv or drug safety is the branch of pharmacological science which deals with the collection, detection, assessment, monitoring and prevention of adverse effects of pharmaceutical products. Barnes 1 division of clinical pharmacology, university of cape town, cape town, south africa 2 school of public health and tropical medicine, james cook university. In developing countries in africa, these systems are mostly absent and their performance under any circumstance is difficult to predict. Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. Activities have evolved from passive regulatory reporting to encompass active surveillance systems. Pharmacovigilance is the science of collecting, monitoring, researching, assessing, and. Dr ushma mehta dr mehta has been involved in medicines regulation since 1996. Centre for medical parasitology at the department of international health, immunology and microbiology, university of copenhagen, denmark.
Independent pharmacovigilance consultant, johannesburg, south africa. Establishing pharmacovigilance programs in resourcelimited settings. Building teratovigilance capacity in africa global. Ushma mehtas 52 research works with 662 citations and 2,854 reads, including. Department of global health and development, london school of hygiene and tropical medicine, london, uk. Recent trends in pharmacovigilance reproduced with permission from wci 2 signal detection in pharmacovigilance 2. Overview of pharmacovigilance international journals. Adverse drug reactions in adult medical inpatients in a south. Ibe pharmacoepidemiology research group department of medical informatics, biometry and epidemiology, university of munich email.
Division of clinical pharmacology, department of medicine, university of cape town. Serious adverse drug reactions at two childrens hospitals in south. Basic introduction and specifics for malaria programmes 24 march 2 april 2003, lusaka, zambia because of increasing levels of resistance to antimalarial drugs several endemic countries are in the process of introducing combinations of artemisinin derivatives as 1stline or 2nd line treatment of. Ushma mehta, mukesh dheda, gavin steel, marc blockman, augustin ntilivamunda, gary. South africa is continually developing and evaluating programmes to monitor the care of patients and to assess the use of medicines in the country, from improving antimicrobial use messina et al. The etymological roots for the word pharmacovigilance are. By definition, pharmacovigilance is, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problems. Mortality from adverse drug reactions in adult medical. Study protocol open access protocol for a drugs exposure.
Dr elvis temfack, msf, malawi pdf 252kb roll out and pharmacovigilance of dolutegravir in the zambia. Establishing pharmacovigilance programs in resource. Strengthening pharmacovigilance in south africa mehta. Local paediatric drug safety data could potentially contribute to clinical. Ushma mehta medicines control council, south africa, robert pless public health agency of canada, siti asfijah abdoellah nadfc indonesia, prima yosephine epimoh, indonesia, sherli karolina epimoh, indonesia. View ushma mehta s profile on linkedin, the worlds largest professional community. Spontaneous adverse drug reaction reporting in rural. Adverse drug reaction reporting and pharmacovigilance. Ushma mehta has been involved in pharmacovigilance and medicines regulation since 1996 initially in her role as manager of the medicines control councils national adverse drug event monitoring centre. Serious adverse drug reactions at two childrens hospitals in south africa. Pharmacovigilance is drug safety process, it is also known as post may differ from subject to subject and duration is also limited. Pharmacovigilance pv or phv, otherwise called tranquilize wellbeing, is the pharmacological science identifying with the accumulation, discovery, appraisal, observing, and counteractive action of unfriendly impacts. Whats new in pharmacovigilance qppv update pharmacovigilance it systems eudravigilance major achievements in 2016 to support eudravigilance stakeholders and partners during this period of change, the eudravigilance website has been redesigned and enhanced to publish important information on the new and existing eudravigilance system. Spontaneous notification an unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation e.
Pharmacovigilance an overview sciencedirect topics. South african context sahiv society conference 2018. Dolutegravir versus efavirenz in women starting hiv. The elearning course on vaccine safety basics meets different starting points, learning needs and country contexts.
The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. School of public health and tropical medicine, james cook university, townsville, queensland, australia. Pdf south africa has been engaged in pharmacovigilance pv activities to assess the impact of. Importance of pharmacovigilance, pharmacovigilance importance. Pharmacy ya afrika borwa kajeno public group facebook. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicinerelated problem as defined by who this program for international drug monitoring was established by who as a result of the thalidomide disaster detected in 1961. Detection, assessment, understanding and prevention of short and long term adverse effects of medicines.
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