Pharmacovigilanve And Its Importance

PHARMACOVIGILANCE AND ITS IMPORTANCE

UNDER GUIDANCE OF – DEEP SHIKHA

BY- SHUBHAM KUMAR SINHA M. PHARMACY (QA)

REG- 11600914

CONTENTS

• INTRODUCTION • OBJECTIVES• RESPONSIBILITY • NEED OF PHARMACOVIGILANCE • GOVERNING BODIES • METHOD OF PHARMACOVIGILANCE • ADVERSE DRUG REACTIONS• SCOPE OF PHARMACOVIGILANCE • REFERENCE

INTRODUCTIONPharmacovigilance (PV) also called as drug safetyPharmakon --- in Greek -- drugVigilance --- in Latin -- to keep watch

The science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems

:

OBJECTIVES

• To improve patient care and safety • To improve public health 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 • Tracking any drastic effects of drugs

RESPONSIBILITIES

• Time to time collection of data, recording and notification

• Appropriate assessments (data completeness, seriousness)

• Expedited and periodic reporting • Creates appropriate structures for

communication

WHY PHARMACOVIGILANCE IS NEEDED

NEED OF PHARMACOVIGILANCE

1. Humanitarian concern • Animal toxicology is often not a good predictor for human effects• Evidence of safety from clinical trials is insufficient due to some

limitations

2. Safe use of medicines Dying from a disease is sometimes unavoidable; dying from a

medicine is unacceptable - Lepakhin V. Geneva 2005 • It has been suggested that ADRs may cause 5700 deaths

per year in UK • ADRs were 4th-6th commonest cause of death in the US in 1994

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3. To reduce healthcare expenses - ADRs are huge burden

4. Ensuring the public confidence 5. Ethical concern • To know something which is harmful to

another person who does not know, and not telling is unethical

GOVERNING BODIES

• The pharmaceutical industry

• Regulatory authorities

• WHO collaborating centre for international drug

monitoring

• CIOMS(Council for International

Organization of Medical Sciences )

METHOD OF PHARMACOVIGILANCE

1. Individual case safety reports2. Clinical review of case reports 3. Cohort event monitoring 4. Longitudinal electronic patient records 5. Periodic Safety Update Reports (PSUR)6. Expedited report7. Record linkage

Individual case safety reports

• Like Yellow card system which is used in UK in pharmacovigilance

• By this scheme they collect information on suspected ADRs to medicines & the scheme allow the safety to the medicines & vaccines that are on the market to be monitored

YELLOW CARD SCHEME

• This scheme was founded in 1964 after the thalidomide disaster was developed & also run by medicines and healthcare product regulatory agency (MHRA) or the commission of human medicines

• It also include all herbal preparation or these ADRs can be reported by pharmacist, doctor, nurse or even patients also

CLINICAL REVIEW OF CASE REPORT

• The quality of report is variable through nation to nation or international organization collect hundreds or thousands of report each year and this is not possible to review all report by the available experts

• Even if each report could be reviewed, important reporting pattern would be missed

COHORT EVENT MONITORING

Cohort Event Monitoring (CEM) systems for intensified follow up of selected medicinal products The main limitations are its restriction to small subset of medicinal products, the relatively small fraction of the population covered

LONGITUDINAL ELECTRONIC PATIENT RECORDS

• It is extremely valuable but still in used

• They cover large population, provide detailed information on both exposed and unexposed patients

• Information is extracted directly from the computer systems in which physicians store patient’s data

PERIODIC SAFETY UPDATE REPORTS (PSUR)

• Pre marketing clinical trials may not be sufficient to reflect the product safety profile • Therefore medically advanced countries impose the “post marketing drug safety monitoring period ” on new drugs

• License holders shall proactively collect post marketing safety data, prepare PSUR and submit them to the health authority

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•According to the “regulation of medical products under safety monitoring”, if pharmaceutical companies fail to submit PSUR as required, then the health authority may consider the safety of the concerned product

• The last PSUR should be submitted before the expiration of the drug safety monitoring period

•The “summary bridging report” provides summarized information of the PSURs

EXPEDITED REPORT

• If there has been spontaneous reporting of a suspected ADR to a pharmaceutical company, there are legal obligations on the company to report serious reactions within a specified time frame to the regulatory authority

• Based on the results of drug safety assessment, license holders shall report to the health authorities in an expedited manner

ADVERSE DRUG REACTIONS• In year 1932 it was

introduced for treatment of streptococcal infections in a elixir or syrup dosages form

• But, in year 1937 sulphanilamide is withdrawal from market because it was responsible for death of 105 individuals

THALIDOMIDE DISASTERS

• In year 1957 thalidomide was introduced in market for treatment of morning sickness & nausea

• And in year 1961 it was withdrawal from the market due to massive pressure from press and public

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• ADVERSE Drug Events- ADE, harm caused by the drug (ADR & overdoses) and harm from the use of the drug (including dose reductions & discontinuations of drug therapy)

• ADVERSE Drug Reactions- are response to the drug which is noxious & unintended which occurs due to doses normally used in man for the prophylaxis, diagnosis or therapy of disease. There is causal link between a drug & an adverse drug reaction

Continue..•Side effects

undesirable and unavoidable effects of drugs due to their

pharmacological property at recommended doses

Ex-dry mouth from atropine therapy

•Toxic effect

It is a pharmacological action due to over dosage or prolonged

usage.

Ex-coma with barbiturates

Scope of Pharmacovigilance

• Improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions

• Improve public health and safety in relation to the use of medicines

• Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use

• Promote understanding, education and clinical training in pharmacovigilance and its effective communication with the public

REFERENCE https://www.google.co.in/search?q=cerivastatin+drug+or+dosages

https://www.linkedin.com/pulse/all-pharmacovigilance-must-read-garima-srivastava

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/

https://www.google.co.in/#q=pharmacovigilance+from+medicine.net

www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/

who-umc.org/Graphics/24729.pdf

www.who-umc.org/graphics/28550