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Introduction to Pharmacovigilance PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Introduction to Pharmacovigilance".

This medical PowerPoint presentation is about pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is a critical component of drug development, marketing, and post-marketing surveillance, as it helps to identify and monitor the safety of drugs and other medical products.

The primary goal of pharmacovigilance is to ensure that medicines are safe and effective for the patients who use them. It involves collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems, such as medication errors, interactions, and misuse. The information collected through pharmacovigilance activities is used to improve the safety and efficacy of medicines and to provide reliable information to healthcare professionals and patients.

Pharmacovigilance activities are carried out by various stakeholders, including pharmaceutical companies, regulatory agencies, healthcare professionals, and patients. It involves the systematic collection, analysis, and dissemination of information about the safety of medicines, which helps to identify potential risks and benefits associated with their use.

In summary, pharmacovigilance is essential for ensuring the safety and effectiveness of medicines and improving public health.

Tags : pharmacovigilance, drug development, drug marketing, drug post-marketing surveillance, adverse drug reactions, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 3084 | Downloads : 3

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Slide 1-

Introduction to Pharmacovigilance
Slide 2-

Outlines of the presentation Smooth orientation to pharmacovi gilance Why do we need pharmacovi gilance? WHO programme for drug monitoring Pharmacovi gilance in Egypt Important terminologie s in pharmacovi gilance Yellow Card & Blue Card Workshop
Slide 3-

Medicine Safety To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine Molière
Slide 4-

Risk/Benefit Balance of medications Medicines are safe! (X) Approved medicines are safe! (X) No medicine is safe! (X) No medicine is without risk (√)
Slide 5-

Risk/Benefit Balance of medications Acceptable Unacceptable
Slide 6-

What is Pharmacovigilance?
Slide 7-

WHO definition of pharmacovigilance Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
Slide 8-

Pharmacovigilance prevention of adverse effects Assessment &Understand ing Detection
Slide 9-

Learning from History Thalidomide Disaster: Tranquilizer launched - 1957 First reports of birth defects - 1959 13 reports of birth defects - 1961 •Withdrawn shortly afterward 10000 infants affected by Phocomelia. No teratogenicity detected in testis during clinical trials and prior to launch.
Slide 10-

Why do we need Pharmacovigilance?
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Reason 1: Humanitarian concern Insufficient evidence of safety from clinical trials, Animal experiments & Phase 1 – 3 studies prior to marketing authorization
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Limitations of clinical trials •Small number of patients studied •Restricted populations (age, sex, ethnicity) •Narrow indications •Short duration of drug exposure
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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. Lepakhin V. Geneva 2005
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ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998 USA It has been suggested that ADRs may cause 5700 deaths per year in UK. Pirmohamed et al, 2004 UK
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Reason 3: ADRs are expensive !! Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc). ADR related cost to the country exceeds the cost of the medications themselves.
Slide 17-

Reason 4: Promoting rational use of medicines and adherence Reason 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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Pharmacovigilance is needed in every country because of differences in: Drug production Distribution and use ( e.g. indications, dose, availability) Genetics, diet, traditions of the people (e.g. use of herbal remedies, etc.) Pharmaceutical quality and composition (active/inactive ingredients )
Slide 19-

Who program for international drug monitoring
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Who program for international drug monitoring Started 1968 Located in Uppsala, Sweden Collaborating centre for maintaining global ADR database - Vigibase
Slide 21-

Roles of WHO Collaborating Centre Identify early warning signals of serious adverse reactions to medicines Evaluate the hazard Undertake research into the mechanisms of action to aid the development of safer and more effective medicines
Slide 22-

Important Terminologies in Pharmacovigilance
Slide 23-

Side Effect (SE) Vs Adverse Drug Reaction (ADR) Vs Adverse Event (AE) SE Response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease. AE Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. ADR Response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect.
Slide 24-

Adverse Drug Reaction (ADR) Vs Adverse Event (AE)
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Medication Errors (ME) They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreading or miswriting a prescription. Medication errors are more common than adverse events, but result in harm less than 1% of the time. About 25% of adverse events are due to medication errors. Not all medication errors lead to adverse outcomes.
Slide 26-

Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors (ME)
Slide 27-

Seriousness of Adverse drug reactions Serious ADR Life-Threatening Hospitalization (initial or prolonged) Disability Death Congenital Anomaly Medically important event or reaction Cause Cancer OTHER WISE ADR IS NON-SERIOUS
Slide 28-

Serious reports should be submitted in expedited manner i.e. as soon as possible & no later than 15 calendar days. Thus they best submitted Online Email or Fax
Slide 29-

We are almost there
Slide 30-

A VALID REPORT CONSISTS OF:- Identifiable patient Identifiable drug (pharmaceutical product) Identifiable reaction Identifiable reporter
Slide 31-

Who should report? Healthcare Professionals Marketing authorization holder (MAH) Patients & their relatives Nurses Pharmacists
Slide 32-

Reports Journey Reporter QPPV Data entry RA
Slide 33-

Thank you