Adverse Drug Reaction Reporting and Monitoring Software
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Explains about responses to a drug, challenges in Adverse Drug Reaction Reporting. For more information visit: http://www.transformhealth-it.org/
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ADR AND ITS MONITORING
Adverse drug reactions are unwanted effects that occur when taking medications. They can range from mild to severe or life-threatening. Monitoring adverse drug reactions involves identifying suspected reactions, assessing the causality between the drug and reaction, documenting the details of the case, and reporting serious reactions to regulatory authorities. Serious adverse reactions must be reported within 14 days, while investigators report them to sponsors and ethics committees within 24 hours and 7 days respectively to ensure patient safety.
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The document discusses the importance of effective communication for achieving quality use of medicines. It notes that clear communication is needed between doctors and patients to explain why medicines are prescribed, address any barriers to understanding, and identify all medications patients are taking. Poor communication has been shown to be a leading cause of medication errors and patient harm. The document emphasizes the role of communication skills like briefings, handovers, patient education materials, and electronic prescribing in improving safety. Overall, it stresses that open communication between healthcare providers and patients is critical to negotiate treatment outcomes, minimize risks, and promote appropriate medication use.
Pharmacovigilance
This document discusses pharmacovigilance, materiovigilance, and haemovigilance programs in India. It defines key terms like adverse drug reactions, serious adverse reactions, causality assessment, and dechallenge/rechallenge. It describes the Pharmacovigilance Programme of India (PvPI) including its aims, ADR monitoring centers, and methods used to communicate drug safety alerts. Reporting procedures for healthcare professionals to report adverse drug events to PvPI are also outlined.
Clinical pharmacokinetics and its application
Clinical pharmacokinetics and its application--
1)definition
2) APPLICATIONS OF CLINICAL PHARMACOKINETICS
Design of dosage regimens:
a) Nomograms and Tabulations in designing dosage regimen,
b) Conversion from intravenous to oral dosing,
c) Determination of dose and dosing intervals,
d) Drug dosing in the elderly and pediatrics and obese patients.
Pharmacokinetics of Drug Interaction:
a) Pharmacokinetic drug interactions
b) Inhibition and Induction of Drug metabolism
c) Inhibition of Biliary Excretion.
Therapeutic Drug monitoring:
a) Introduction
b) Individualization of drug dosage regimen (Variability – Genetic, Age and Weight, disease, Interacting drugs).
c) Indications for TDM. Protocol for TDM.
d) Pharmacokinetic/Pharmacodynamic Correlation in drug therapy.
e) TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations
Dosage adjustment in Renal and Hepatic Disease.
a. Renal impairment
b. Pharmacokinetic considerations
c. General approach for dosage adjustment in renal disease.
d. Measurement of Glomerular Filtration rate and creatinine clearance.
e. Dosage adjustment for uremic patients.
f. Extracorporeal removal of drugs.
g. Effect of Hepatic disease on pharmacokinetics.
Population Pharmacokinetics.
a) Introduction to Bayesian Theory.
b) Adaptive method or Dosing with feedback.
c) Analysis of Population pharmacokinetic Data
Classification and mechanism of action of adr.
Adverse drug reactions (ADRs) are injuries caused by medications and can occur from a single dose or prolonged use of one or more drugs. ADRs include side effects which occur at therapeutic doses and are usually predictable, as well as toxic effects which happen at higher than usual doses. Some ADRs are allergic reactions that are not dose-related and involve the immune system. ADRs can affect many body systems and organs and cause issues like stimulation or depression of the central nervous system, changes in cardiovascular functions, respiratory effects, gastrointestinal irritation, and liver or kidney damage. The document also discusses drug interactions, withdrawal reactions, carcinogenicity, mutagenicity, teratogenicity, and definitions of acute,
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ADR AND ITS MONITORING
Adverse drug reactions are unwanted effects that occur when taking medications. They can range from mild to severe or life-threatening. Monitoring adverse drug reactions involves identifying suspected reactions, assessing the causality between the drug and reaction, documenting the details of the case, and reporting serious reactions to regulatory authorities. Serious adverse reactions must be reported within 14 days, while investigators report them to sponsors and ethics committees within 24 hours and 7 days respectively to ensure patient safety.
COMMUNICATION IN QUM.pptx
The document discusses the importance of effective communication for achieving quality use of medicines. It notes that clear communication is needed between doctors and patients to explain why medicines are prescribed, address any barriers to understanding, and identify all medications patients are taking. Poor communication has been shown to be a leading cause of medication errors and patient harm. The document emphasizes the role of communication skills like briefings, handovers, patient education materials, and electronic prescribing in improving safety. Overall, it stresses that open communication between healthcare providers and patients is critical to negotiate treatment outcomes, minimize risks, and promote appropriate medication use.
Pharmacovigilance
This document discusses pharmacovigilance, materiovigilance, and haemovigilance programs in India. It defines key terms like adverse drug reactions, serious adverse reactions, causality assessment, and dechallenge/rechallenge. It describes the Pharmacovigilance Programme of India (PvPI) including its aims, ADR monitoring centers, and methods used to communicate drug safety alerts. Reporting procedures for healthcare professionals to report adverse drug events to PvPI are also outlined.
Clinical pharmacokinetics and its application
Clinical pharmacokinetics and its application--
1)definition
2) APPLICATIONS OF CLINICAL PHARMACOKINETICS
Design of dosage regimens:
a) Nomograms and Tabulations in designing dosage regimen,
b) Conversion from intravenous to oral dosing,
c) Determination of dose and dosing intervals,
d) Drug dosing in the elderly and pediatrics and obese patients.
Pharmacokinetics of Drug Interaction:
a) Pharmacokinetic drug interactions
b) Inhibition and Induction of Drug metabolism
c) Inhibition of Biliary Excretion.
Therapeutic Drug monitoring:
a) Introduction
b) Individualization of drug dosage regimen (Variability – Genetic, Age and Weight, disease, Interacting drugs).
c) Indications for TDM. Protocol for TDM.
d) Pharmacokinetic/Pharmacodynamic Correlation in drug therapy.
e) TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations
Dosage adjustment in Renal and Hepatic Disease.
a. Renal impairment
b. Pharmacokinetic considerations
c. General approach for dosage adjustment in renal disease.
d. Measurement of Glomerular Filtration rate and creatinine clearance.
e. Dosage adjustment for uremic patients.
f. Extracorporeal removal of drugs.
g. Effect of Hepatic disease on pharmacokinetics.
Population Pharmacokinetics.
a) Introduction to Bayesian Theory.
b) Adaptive method or Dosing with feedback.
c) Analysis of Population pharmacokinetic Data
Classification and mechanism of action of adr.
Adverse drug reactions (ADRs) are injuries caused by medications and can occur from a single dose or prolonged use of one or more drugs. ADRs include side effects which occur at therapeutic doses and are usually predictable, as well as toxic effects which happen at higher than usual doses. Some ADRs are allergic reactions that are not dose-related and involve the immune system. ADRs can affect many body systems and organs and cause issues like stimulation or depression of the central nervous system, changes in cardiovascular functions, respiratory effects, gastrointestinal irritation, and liver or kidney damage. The document also discusses drug interactions, withdrawal reactions, carcinogenicity, mutagenicity, teratogenicity, and definitions of acute,
introduction to Pharmacoepidemiology
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
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Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
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The document discusses adverse drug reactions (ADRs), their causes and management. It defines an ADR as an unintended, harmful response to a drug given at normal doses. Elderly patients have the highest risk of ADRs, which are a major cause of hospitalizations. Common culprit medications include antibiotics, anticoagulants, digoxin, diuretics and NSAIDs. Management primarily involves withdrawing the suspected drug, reducing the dose if it may be dose-related, and treating any reactions while maintaining therapeutic objectives with regular patient review and simplified regimens. Monitoring at-risk patients and those on high-risk medications is important, as is assessing drug appropriateness and possible interactions during multiple drug therapies.
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complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
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This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
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Reporting of pharmacovigilance and role of pharmacist
1) All health care professionals and pharmaceutical companies can report any suspected adverse drug reactions (ADRs), regardless of severity, to the nearest ADR monitoring center.
2) The ADR reporting process involves reporting to peripheral centers, then regional, zonal, and finally the national coordinating center (NPC) and Central Drugs Standard Control Organization (CDSCO). International reporting also occurs to the WHO Uppsala Monitoring Centre (WHO-UMC).
3) Complete information is required for ADR reporting, including patient information, a description of the adverse reaction, details on the suspected drug, management of the reaction, and reporter information.
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The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
Spontaneous reporting
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
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This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
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The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
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This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
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2) It explains the uses of antimalarials for chemoprophylaxis, clinical cure of acute infections, radical cure to eliminate dormant liver stages, and as gametocides.
3) It provides recommendations for treatments of uncomplicated and severe malaria, including first-line and second-line options, and considerations for use during pregnancy.
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The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
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The document discusses adverse drug reactions (ADRs), their causes and management. It defines an ADR as an unintended, harmful response to a drug given at normal doses. Elderly patients have the highest risk of ADRs, which are a major cause of hospitalizations. Common culprit medications include antibiotics, anticoagulants, digoxin, diuretics and NSAIDs. Management primarily involves withdrawing the suspected drug, reducing the dose if it may be dose-related, and treating any reactions while maintaining therapeutic objectives with regular patient review and simplified regimens. Monitoring at-risk patients and those on high-risk medications is important, as is assessing drug appropriateness and possible interactions during multiple drug therapies.
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Drug use evaluation (DUE) is a quality improvement process that reviews prescribing patterns to promote appropriate drug use. It involves identifying a drug or therapeutic area, developing criteria and standards, collecting data, evaluating results, providing feedback, and implementing interventions. The process then reevaluates drug use and revises the DUE program as needed. The presented document outlines the 11 steps of a DUE process focusing on monitoring renal function during aminoglycoside therapy.
Reporting of pharmacovigilance and role of pharmacist
1) All health care professionals and pharmaceutical companies can report any suspected adverse drug reactions (ADRs), regardless of severity, to the nearest ADR monitoring center.
2) The ADR reporting process involves reporting to peripheral centers, then regional, zonal, and finally the national coordinating center (NPC) and Central Drugs Standard Control Organization (CDSCO). International reporting also occurs to the WHO Uppsala Monitoring Centre (WHO-UMC).
3) Complete information is required for ADR reporting, including patient information, a description of the adverse reaction, details on the suspected drug, management of the reaction, and reporter information.
Measurement of outcome v5
various measures for the measurement of outcome such as incidence prevalence and other drug us measures are briefly discussed here with suitable examples and equations
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The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
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DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
Spontaneous reporting
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
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Pharmacovigilance
This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
Unit 1 pharmacoepidemiology
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. The document discusses the definition, origins, need and applications of pharmacoepidemiology. Specifically, it notes that pharmacoepidemiology applies epidemiological techniques to study drug use and effects in populations. It also discusses limitations of pre-marketing drug trials that pharmacoepidemiology aims to address through post-marketing surveillance and other techniques.
Pharmacoeconomics
Pharmacoeconomics evaluates the costs and outcomes of pharmaceutical products and services. It involves choosing a perspective such as patient or payer, identifying costs which can be direct, indirect, or intangible, and identifying outcomes which can be clinical, economic, or humanistic. Common pharmacoeconomic methodologies include cost-consequence analysis, cost-of-illness evaluation, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Pharmacoeconomics is important for achieving maximum benefits with limited costs and aids decision making for formularies, policies, and resource allocation.
Pharmacovigilance and Method of ADR reporting
The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’SRaghavendra institute of pharmaceutical education and research .
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...
This document discusses adverse drug reactions (ADRs), including their definition, classification, types, reporting, evaluation, monitoring, prevention and management. It defines an ADR as an unintended reaction to a drug that occurs at normal doses. ADRs can be classified based on incidence (very common to very rare) or severity (mild to severe). Types of ADRs include dose-dependent (Type A), unpredictable hypersensitivity reactions (Type B), continuous effects of long-term drug use (Type C), and withdrawal reactions (Type E). The document outlines what information should be reported for an ADR, who is responsible for reporting, when and how to report ADRs, and where completed reports should be submitted
Detection, reporting and management of adverse events
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
Pharmacological Approach to Drug Discovery
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Healthcare App
Customer Healthcare app
Connect to your customer
- Have the full customer profile and overview.
- Know the history and see changes in your patients medical situation.
- Find out immediately if your customers receive generic medicals instead of heal care products.
- Relieve your service and support team by artificial intelligence and let the service bot to reply support cases.
IPS poster 2014
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ePRO_Presentation_BYOD Webinar_10Mar2016_FINAL
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Swasthya slate
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QPS IND Enabling Preclinical Studies
Partnering with QPS for a well-conceived and executed IND-enabling preclinical program will provide you with a detailed
assessment of your drug candidate and the most agile, flexible and timely pathway to filing an IND.
Research2Guidance_Mobiquity Webinar 11-19-2014_vF
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instalation of mobile app
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Bachelor Thesis: Administration of pharmaceuticals by means of smartphone
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Adverse Drug Reaction Reporting and Monitoring Software
- 1. 1 ADVERSE DRUG REACTION REPORTING AND MONITORING SOFTWARE
- 2. 2 HELLO, I’m Mammen Paul CONCEPT DEVELOPMENTDESIGN
- 3. 3
- 4. 4
- 6. 6 A D V E R S E D R U G R E A C T I O N ? Adverse Drug Reactions are responses to a drug, which are noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modifications of physiological function.
- 7. 7 CHALLENGES IN ADVERSE DRUG REACTION REPORTING COMMUNICATION ANALYSIS TIME CONSUMPTION UNAWARENESS DATA RETRIEVAL STORAGE DOCUMENTATION
- 8. 8 INNOVATION
- 9. 9 INNOVATION The challenges faced and the need for a better pharmacovigilance are the motivation behind the development of this software.PLANNING Selection of programming language. Modules to be included. Structuring database. DESIGN / DEVELOP • Front end – Microsoft Visual Studio 2008 • Back end – SQL Server 2008 M E T H O D S & R E S U L T S
- 10. 10 STRATEGY • Dashboard and shortcuts - user-friendly. • Dynamic nature of software – improves functionality. • Automatic E-mails - communication of ADR.EVALUATION/TWEAKING Live test were performed by students and staffs of Al-Shifa College of Pharmacy. Tweaks were performed based on live test. CHALLENGES FACED Making a user friendly design. Improving functionality. Communication of ADR with physicians.
- 11. 11 FEATURES
- 12. 12 F E A T U R E S ADR REPORTING MODULE ADVANCED SEARCH REPORTS (SOFT/HARDCOPY) E-MAIL PHYSICIAN NARANJO SCALE
- 13. 13
- 14. 14
- 15. 15
- 16. 16 CONCLUSION
- 17. 17 In essence the ADR reporting and monitoring software is embedded with lots of features that can be used in hospitals and other healthcare facilities for better pharmacovigilance.
- 18. 18 NEXT STEP
- 19. 19 NATIONAL PHARMACOVIGILANCE PROGRAM • The implementation of this software in healthcare facilities can advance pharmacovigilance in our country. • The software has the potential to become the backbone of National Pharmacovigilance Program. R O A D A H E A D
- 20. 20 F L Y H I G H , W H E R E N O B O D Y C A N T O U C H Y O U ! If you have the wits to chase your dreams nobody can stop you. THANK YOU!