Pharamcovigilance, Adverse drug reactions, ADR, process of Pharmacovigilance, Pharmacist, role of Pharmacist in Adverse drug reactions ADR reporting, Pharmacovigilance programme of india pvpi, Adr reporting form, need of Pharmacovigilance.
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Causality Assessment of Adverse Drug ReactionClinosolIndia
Causality assessment of adverse drug reactions (ADR) is the process of determining the likelihood or probability that a drug is responsible for causing an observed adverse event. It involves evaluating the relationship between the drug exposure and the occurrence of the adverse event based on available evidence, such as clinical data, patient characteristics, temporal association, and alternative explanations. Causality assessment is an essential component of pharmacovigilance and drug safety monitoring. Here are some commonly used methods and scales for causality assessment:
Naranjo Algorithm:
The Naranjo algorithm is a widely used causality assessment tool. It assigns a numerical score based on specific questions related to the temporal relationship, alternative causes, dechallenge/rechallenge, and previous knowledge of the drug-event association. The total score classifies the causality as definite, probable, possible, or doubtful.
World Health Organization-Uppsala Monitoring Centre (WHO-UMC) Scale:
The WHO-UMC scale is a standardized method for assessing causality in ADRs. It consists of a set of criteria that consider factors such as the time to onset of the event, the response to dechallenge/rechallenge, alternative causes, and the presence of supporting information. Causality is categorized as certain, probable/likely, possible, unlikely, or unclassified.
Bradford Hill Criteria:
The Bradford Hill criteria are a set of nine factors used to assess causality in various fields, including pharmacovigilance. These criteria include strength of association, consistency, specificity, temporality, biological plausibility, coherence, experimental evidence, analogy, and dose-response relationship. These factors are considered collectively to determine the likelihood of a causal relationship.
CIOMS (Council for International Organizations of Medical Sciences) Scale:
The CIOMS scale provides a structured approach to assessing causality by considering factors such as the temporal relationship, the presence of alternative causes, drug dechallenge/rechallenge, and the consistency of the event with the drug's known pharmacology.
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Causality Assessment of Adverse Drug ReactionClinosolIndia
Causality assessment of adverse drug reactions (ADR) is the process of determining the likelihood or probability that a drug is responsible for causing an observed adverse event. It involves evaluating the relationship between the drug exposure and the occurrence of the adverse event based on available evidence, such as clinical data, patient characteristics, temporal association, and alternative explanations. Causality assessment is an essential component of pharmacovigilance and drug safety monitoring. Here are some commonly used methods and scales for causality assessment:
Naranjo Algorithm:
The Naranjo algorithm is a widely used causality assessment tool. It assigns a numerical score based on specific questions related to the temporal relationship, alternative causes, dechallenge/rechallenge, and previous knowledge of the drug-event association. The total score classifies the causality as definite, probable, possible, or doubtful.
World Health Organization-Uppsala Monitoring Centre (WHO-UMC) Scale:
The WHO-UMC scale is a standardized method for assessing causality in ADRs. It consists of a set of criteria that consider factors such as the time to onset of the event, the response to dechallenge/rechallenge, alternative causes, and the presence of supporting information. Causality is categorized as certain, probable/likely, possible, unlikely, or unclassified.
Bradford Hill Criteria:
The Bradford Hill criteria are a set of nine factors used to assess causality in various fields, including pharmacovigilance. These criteria include strength of association, consistency, specificity, temporality, biological plausibility, coherence, experimental evidence, analogy, and dose-response relationship. These factors are considered collectively to determine the likelihood of a causal relationship.
CIOMS (Council for International Organizations of Medical Sciences) Scale:
The CIOMS scale provides a structured approach to assessing causality by considering factors such as the temporal relationship, the presence of alternative causes, drug dechallenge/rechallenge, and the consistency of the event with the drug's known pharmacology.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Clinical Trials: Types and Design
Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional
Clinical Trial Study Team Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Formulary is an official or authorised publication of an approved list of medicines for use in a hospital, a group of hospitals a society a state or a region a country or a number of countries.
Hospital Formulary is a continually revised compilation of pharmaceuticals dosage agents and their forms that reflects the current clinical view of the medical staff.
Pharamcovigilance of drugs of natural originNiravKumar9
WHO Guidelines on safety monitoring of herbal medicines in Pharmacovigilance system and AYUSHSURAKSHA (Pharmacovigilance of Ayurveda, Unani, Siddha, And Homeopathy) syestem in India.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Clinical Trials: Types and Design
Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional
Clinical Trial Study Team Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Formulary is an official or authorised publication of an approved list of medicines for use in a hospital, a group of hospitals a society a state or a region a country or a number of countries.
Hospital Formulary is a continually revised compilation of pharmaceuticals dosage agents and their forms that reflects the current clinical view of the medical staff.
Pharamcovigilance of drugs of natural originNiravKumar9
WHO Guidelines on safety monitoring of herbal medicines in Pharmacovigilance system and AYUSHSURAKSHA (Pharmacovigilance of Ayurveda, Unani, Siddha, And Homeopathy) syestem in India.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
United Arab Emirates Pharmacists’ Practices and Views on Adverse Drug Reactio...iosrjce
Adverse drug reactions (ADRs) constitute a huge burden on health systems, and medication errors
(MEs) are the most common preventable cause of adverse drug events. In developed countries pharmacists
contribute to a great extent in ADR monitoring and reporting, improving patient quality of care and safety. This
review aims to explore pharmacists’ practices and views on ADR reporting, extent and causes of MEs and other
health professionals expectations of pharmacists in this regards. An extensive literature search was conducted
using pertinent electronic health databases (ProQuest, PubMed, Embase, and International Pharmaceutical
Abstracts, and the Cumulative Index to Nursing & Allied Health Literature). Hand-searching of the references
retrieved was also performed. Very few studies were found, none report the prevalence or severity of MEs.
Under-reporting of ADRs is common place among community pharmacists in the UAE. Overall physicians
expressed positive views about clinical pharmacists’ role in medication reviews to identify and prevent drug
interactions and improve patients’ clinical outcomes. More research is required to enhance ADR reporting and
reduce MEs in the UAE. Training about the process of ADR monitoring and reporting at undergraduate level
across health science disciplines and continued education and development led by pharmacists is vital to
improve patient safety.
An Essential Drug List, also known as a core drug list or medication list, is a carefully selected inventory of medications that are deemed essential for addressing the most prevalent health conditions within a specific population or country. It serves as a key component of national drug policies and pharmaceutical programs, ensuring the availability, accessibility, and affordability of essential medicines. The list is typically developed based on rigorous criteria, taking into consideration the medications' safety, efficacy, cost-effectiveness, and suitability for primary healthcare settings.
Rational Drug Therapy refers to the systematic and evidence-based approach to prescribing medications, aiming to maximize therapeutic benefits while minimizing the risk of adverse effects. It involves following established therapeutic guidelines and clinical protocols to ensure that medications are prescribed in a manner that is appropriate for the patient's condition, taking into account factors such as age, weight, co-existing conditions, drug interactions, and individual response. Rational drug therapy promotes the use of medications based on sound scientific evidence, emphasizing the principles of efficacy, safety, and cost-effectiveness to optimize patient outcomes and improve overall healthcare quality.
A Study on Knowledge of Pharmacist on Risk of Medication Use During Pregnancy...Sunil Vadithya
A Study on Knowledge of Pharmacist on Risk of Medication Use During Pregnancy in India- Study on knowledge of pharmacist, Risk of medication use during pregnancy, Important risk factor during pregnancy, stages of pregnancy, first trimester, second trimester, third trimester, methods for knowledge of pharmacy, results for knowledge of pharmacy in India, case report forms for A Study on Knowledge of Pharmacist on Risk of Medication Use During Pregnancy in India by sunil vadithya
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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2. TITLES
INTRODUCTION
NEED OF PHARMACOVIGILANCE
PURPOSE OF PHARMACOVIGILANCE
PHARMACOVILANCE PROGRAMME OF INDIA
ADRs MONITORING CENTERS
PHARMACOVIGILANCE PROCESS IN HEALTH CARE
SYSTEM
REPORTING OF ADRs, ADRs REPORTING IN INDIA &
SUSPECTED ADRs REPORTING FORM
PHARMACIST- AN ADRs REPORTER
CONCLUSION
REFERENCES
2
Gaurav Chhabra, NRCH, NDLS
3. INTRODUCTION
PHARMACOVIGILANCE
Pharmaco + Vigilance
(Medicines) (To Watch)
According to WHO-:
Science and activities relating to the detection, assessment,
understanding and prevention of adverse effects and any other drug
related problems.
This applies throughout the life cycle of a medicine equally to the
pre-approval stage as to the post approval.
Adverse drug reaction (ADR): “A response to a medicine which is
noxious and unintended, and which occurs at doses normally used in
man”
3
Gaurav Chhabra, NRCH, NDLS
4. Some adverse effects are not predictable from pre-clinical studies (Animal
studies during drug discovery).
Phase I, II, III: limited size of the population,
• Narrow population (age & sex specific – Children, elderly, pregnant are
excluded),
• Short duration of study(Pressure from various groups to reduce time to
approval)
• Participants are closely monitored with clinical supervision
• Detection of rare adverse event is difficult
• Detection of Drug-food interaction and Drug- Drug interaction is not
possible
• Detection of Long term adverse effects are not possible.
•Due to all above problems ADR remain an important cause of
morbidity and mortality
NEED OF
PHARMACOVIGILANCE
4
Gaurav Chhabra, NRCH, NDLS
5. Globally about 5% of all deaths may be caused by pharmaceuticals.
Globally about 6.5% hospital admission were related to ADR’s.
ADR related cost to the country exceeds the cost of medications
themselves.
ADR are preventable in large scale (at least in 50 %) but in some cases
new approaches are needed.
NEED OF
PHARMACOVIGILANCE
(Conti….)
5
Gaurav Chhabra, NRCH, NDLS
6. THE PURPOSE OF
PHARMACOVIGILANCE
The main purpose/ practice of pharmacovigilance in health care
system is to improve the patient’s safety and enhance patient
care in terms of the use medicines, including paramedical
interventions.
Pharmacovigilance also supports public health programs by
providing reliable information for the efficient assessment of the
risk-benefit profile of medicines.
6
Gaurav Chhabra, NRCH, NDLS
7. THE PURPOSE OF
PHARMACOVIGILANCE
(Conti….)
Contribute to the assessment of uses, side-effects, harm,
effectiveness and risk of medicines.
Encouraging the safe, rational and more effective (including
cost-effective) use of various medicines.
Promote education, understanding and clinical training in
pharmacovigilance and its effective availability to the public.
7
Gaurav Chhabra, NRCH, NDLS
8. A nation-wide pharmacovigilance programme was started in July,
2010 by the Central Drugs Standard Control Organisation (CDSCO),
New Delhi, under the aegis of Ministry of Health & Family Welfare
Government of India in AIIMS, New Delhi.
In April, 2011 shifted from AIIMS, New Delhi to the Indian
Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.). (NCC-PvPI)
From July, 2017 IPC, NCC-PvPI became a WHO Collaborating
Centre for Pharmacovigilance in Public Health Programmes &
Regulatory services.
PHARMACOVILANCE
PROGRAMME OF INDIA
8
Gaurav Chhabra, NRCH, NDLS
10. PHARMACOVIGILANCE PROCESS
IN HEALTH CARE SYSTEM
Pharmcovigilance is to be seen as the process of-
1) Collection and reporting of ADRs.
2) Monitoring and causality assessment
3) Researching
4) Evaluating information from heath care providers for the
purposes of understanding and preventing Drug-related
problems.
10
Gaurav Chhabra, NRCH, NDLS
11. REPORTING OF ADRs
ADR reporting can be done by-
Healthcare professionals
Clinician/ Physician/ Doctor
Dentist
Pharmacist
Nurse
Patient
4 Minimum criteria for reporting of ADRs-
1. A Patient / Medicine consumer
2. A suspected ADR
3. A suspected Drug
4. A Reporter
11
Gaurav Chhabra, NRCH, NDLS
17. Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of ADRs)
An Important part of health care system, so the reporting
of ADRs are moral responsibility of a Pharmacist.
Qualified in prescription reading, therefore can monitor
and determine drug related problems; thus maintain safe use
of medicines..
17
Gaurav Chhabra, NRCH, NDLS
18. Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of ADRs)
(Conti…)
Up to date knowledge of side effects and adverse
reactions of different drugs.
Educated and aware of drug dosage and drug-drug
interactions, contraindications.
18
Gaurav Chhabra, NRCH, NDLS
19. Pharmacist–Patient relationship-
A good patient–pharmacist relation allows patients to talk
openly without hesitation about the ADRs with pharmacist
during drug treatment.
Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of
ADRs)
(Conti…)
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Gaurav Chhabra, NRCH, NDLS
20. CONCLUSION
Pharmacovigilance basically targets safety of medicine and
prevent from the irrational use of medicines.
The vision of Pharmacovigilace Programme of India (PVPI) is to
improve patient safety and by reporting and monitoring of drug
safety and thereby reducing the risk associated with the use of
medicines.
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Gaurav Chhabra, NRCH, NDLS
21. CONCLUSION
(Conti…)
Pharmacists play crucial roles in health systems in maintaining
the rational and safe use of medicines by theire contribution in
reporting of ADRs since they are specifically trained in the field of
pharma and health care sector.
Effective use of pharmacist workforce will improve the outcome of
the pharmacotherapy as well as decrease global health costs.
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Gaurav Chhabra, NRCH, NDLS
22. REFERENCES
Gupta SK ”Textbook of Pharmacovigilance” Jaypee brothers medical publishers (P)Ltd, New Delhi
2011.
Mann RD, Andrews EB, Pharmacovigilance John Wiley & Sons Ltd, Chichester, 2002.
Katzung BG (Eds.): Basics and Clinical Pharmacology: 10th edition.: McGraw- Hill, Boston, 2007.
Rang HP, Dale MM, Ritter JM, Moore PK: Pharmacology: 5th edition.: Churchill Livingstone,
Edinburg, 2003.
Biswas P Pharmacovigilance in Asia Journal of Pharmacology and Pharmacotherapeutics |
December 2013 | Vol 4 | Supplement 1.
www.who.int/medicines/areas/quality_safety/safety.../definitions
www.Who-umc.org.
www.fda.gov
www.ich.org/products/guidelines.
www.ema.europa.eu
"Central Drugs Standard Control Organization". Cdsco.nic.in
"Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India".
Ipc.gov.in
dbtbiosafety.nic.in/act/schedule_y.pdf
Hale Z. Toklu1 and Edward Mensah “Why do we need pharmacists in pharmacovigilance systems?”
Online Journal of Public Health Informatics, 2016.
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Gaurav Chhabra, NRCH, NDLS