pharmacovigilance: an umbrella word for drug safety
DESCRIPTION
In this PPT All type of information regarding pharmacovigilance is to be given. i hope this will give your answers regarding p'covigilance.TRANSCRIPT
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A Pharmacovigilance: A A Pharmacovigilance: A worldwide master key for drug worldwide master key for drug
monitoringmonitoring
A Pharmacovigilance: A A Pharmacovigilance: A worldwide master key for drug worldwide master key for drug
monitoringmonitoring
Presented by:Presented by:
Maninder kaurManinder kaur
M.Pharm (Pharmacology)M.Pharm (Pharmacology)
Assistant professor at DVIPM, Assistant professor at DVIPM, karnalkarnal
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Pharmacovigilance:• Pharmacovigilance (PV) also called as
drug safety. Pharmakon (in Greek) :Drug Vigilare (in Latin) : to keep
watch
• It is the umbrella word for ADR’s monitoring.
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Definition• Accon to WHO “It is pharmacological
science relating to the detection , assessment, understanding and prevention of adverse effects”
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AIM• To improve patient care and safety. • To contribute to the assessment of benefit,
harm ,effectiveness and risk of medicines.• To promote education and clinical training. • To promote rational and safe use of
medicines.
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Need of Pharmacovigilance
• Humanitarian Concern.• Safe use of medicines.• ADR’s are expensive.• Promoting rational use of
medicines.• Ensuring public confidence.
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Reason :1
Humanitarian concern:Insufficient evidence of safety from clinicaltrials, Animal experiments & Phase 1 – 3
studiesprior to marketing authorization.
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Reason:2
Medicines are supposed to save lives: Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable.
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Reason :3ADRs are expensive !! ADR’s as cause of admission to hospital; analysis of 18820 patients.•6.5% admission due to ADR’s•ADR related cost to the country exceeds the cost of medications themselves.
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Reason: 4
Promoting rational use of medicines and adherence Reason :
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Reason:5 & 6
5) Ensuring public confidence Reason
6) Ethics :To know of something that is harmful to another person who does not know, and not telling, is unethical
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Function:
• Receive and manage ADR data.• Develop tools. • Analyse. • Signal detection :Identification of
previously unknown drug reactions.• Communicate.
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Pharmacovigilance system
• Records medication related errors• Analyses those errors • Implements interventions• Promotes patient safety• Prevent 'preventable errors‘
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Preventable Errors
• Handwriting of prescriptions• Drug interactions.• Similar-sounding and look-alike names and
packages of medication.• Level of stress on workplace.• Unclear records in information system• Disruptions in information availability and flow
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How to prevent errors• Introduction of advanced medical
information systems– Electronic Health Record (EHR) – Automatic checks for dose, interactions,
allergies, resistance.– Personalized prescription (on base of
pharmacogenetic data).• Analyze all errors, research what enabled
them. • Try to design uncomplicated processes.
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Historical background
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Historical background
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INDIA in this Duration:
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Historical background(Pharmacovigilance in India)
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System of Safety Data Gathering
Patients
HealthcareProfessionals
PharmaceuticalCompanies
National RegulatoryAuthority
Clinical Trials
International SafetyDatabases
Pre-Approval
Post-Approval
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National scenario
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International scenario:
WHO HQ + 6regional
offices
WHO Collaborating
centre, Uppsala
National centers
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Collaboration with WHO-UMC
• Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC) WHO and UMC work with and provide technical support to more than 94 countries worldwide. The long term objective of the Pvpi is to establish a ‘ Centre of Excellence ’ for Pharmacovigilance in India. To achieve this objective, the Pvpi National Coordinating Centre will collaborate with the WHO Collaborating Centre - Uppsala Monitoring Centre (UMC) based in Sweden.
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Partners in Pharmacovigilance:
• The pharmaceutical industry
• Regulatory authorities
• WHO collaborating centre for international drug monitoring
• CIOMS(Council for International Organization of Medical Sciences )
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Role of clinical pharmacist in Pharmacovigilance:
• Provide medical history.• Create database.• Monitoring patient.• Improving patient compliance • Documentation of case for future reference.• Follow up of patients to assess outcomes.• Encouraging health professional and patients.• Patient and health care professional education.
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Drugs Banned
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Four Drugs banned in all countries but not in india
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Special Cases for PharmacovigilanceSome groups of medicinal products are not required
todocument their safety – natural medicines,
homeopathicPreparations.1. Natural (herbal) medicines :• Exact composition is often not known, efficacy nor
safety is usually not documented• 37 ADR reports in Australia related to Echinacea
use in allergy.
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Special Cases for Pharmacovigilance2. Homeopathic preparations:• Zycam Cold Remedy case – unusual dilution
resulted in permanent loss of smell in several subjects and 340 filed.
• Content of alcohol in some preparations for children is higher than allowed in allopathic medicines.
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Summary & ConclusionTo minimize the harm, medicines should
be good:
In all, Pharmacovigilance will promote: • Systematic and rational use of medicines.• Boost confidence for safety.
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Institute offering Pharmacovigilance courses
• Clinwellkriger training & research institute , Bangalore.
• Bioinformatics institute in India, Noida.• Empower school of health,Kalkaji, Delhi.• Indian institute of pharmaceutical
marketing (IIPM), Lucknow . • New York university, New York, USA. • Yale university, Chicago, USA.
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Scope of Pharmacovigilance in india
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References • WHO Policy Perspectives on Medicines- Pharmacovigilance :
Ensuring the safe use of Medicines, Geneva .(2004). • Safety of medicines-A guide to detecting and reporting
adverse drug reactions, WHO Geneva (2002).• National Pharmacovigilance Protocol , Ministry of Health &
Family Welfare, Government of India, March 2003. • Central Drugs Standard Control Organization
http://cdsco.nic.in/html/Drugsbanned.html • Adverse reactions, post marketing surveillance and
pharmacoepidemiology by Judith K. Jones & Juhana E. Idanpaan-Heikkila in Pharma . Medicine by Denis M. Burley.
• Guidelines for Good Pharmacoepidemiology Practices (GPP), International Society for Pharmacoepidemiology , August 2004.
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“People who are vigilant do not die; people who are negligent are as if dead”