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    Post Marketing Surveillance

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    Sonu Thorve
    This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they reach the market to evaluate their safety and efficacy in wider patient populations over longer time periods. It describes the principles and types of PMS, including proactive and reactive approaches. Sources of PMS data are identified as expert user groups, customer surveys, adverse event reports, and medical literature. Benefits of PMS include detecting manufacturing issues, improving devices, verifying risk analyses, and monitoring long-term performance and complications. The conclusion emphasizes the importance of PMS for strengthening safety monitoring.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Post Marketing Surveillance

    Uploaded by

    Sonu Thorve
    30 views16 pages
    This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they reach the market to evaluate their safety and efficacy in wider patient populations over longer time periods. It describes the principles and types of PMS, including proactive and reactive approaches. Sources of PMS data are identified as expert user groups, customer surveys, adverse event reports, and medical literature. Benefits of PMS include detecting manufacturing issues, improving devices, verifying risk analyses, and monitoring long-term performance and complications. The conclusion emphasizes the importance of PMS for strengthening safety monitoring.

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    Summary of post market surveillance

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    post marketing surveillance

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    This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they reach the market to evaluate their safety and efficacy in wider patient populations over longer time periods. It describes the principles and types of PMS, including proactive and reactive approaches. Sources of PMS data are identified as expert user groups, customer surveys, adverse event reports, and medical literature. Benefits of PMS include detecting manufacturing issues, improving devices, verifying risk analyses, and monitoring long-term performance and complications. The conclusion emphasizes the importance of PMS for strengthening safety monitoring.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views16 pages

    Post Marketing Surveillance

    Uploaded by

    Sonu Thorve
    This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they reach the market to evaluate their safety and efficacy in wider patient populations over longer time periods. It describes the principles and types of PMS, including proactive and reactive approaches. Sources of PMS data are identified as expert user groups, customer surveys, adverse event reports, and medical literature. Benefits of PMS include detecting manufacturing issues, improving devices, verifying risk analyses, and monitoring long-term performance and complications. The conclusion emphasizes the importance of PMS for strengthening safety monitoring.

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    © All Rights Reserved
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    of 16

    POST MARKETING

    SURVEILLANCE
    BY
    SHRAVANI MAHESH THORVE

    Course- Diploma in Clinical research and Data management

    Roll no- 45
    INDEX

    Sr. No. Content Page no.


    1. Introduction 4
    2. Principle of post 5
    marketing
    surveillance
    3. Types of pms 7
    4. Sources of pms 11
    5. Benefits of pms 13
    6. Conclusion 14
    7 Reference 15

    2
    3

    Acknowledgement

    I WOULD LIKE TO SAY A SPECIAL THANK YOU


    TO OUR HONOURABLE PRINCIPAL DR. S. K. PATIL
    FOR GIVING ME THIS OPPURTUNITY TO COMPLETE
    MY
    PROJECT, AND I AM ALSO THANKFUL TO OUR
    BIOTECHNOLOGY DEPARTMENT HOD MAM DR. MRS
    SEEMA KOTITKAR AND OUR PROJECT GUIDE MS.
    SHARMILA GHANGALE MAM , WHO GUIDED ME IN
    MY PROJECT ON THE TOPIC POST MARKETING
    SURVEILLANCE.I WOULD ALSO LIKE TO THANK MY
    PARENTS , TEACHERS AND MY FRIENDS FOR
    HELPING ME IN MY PROJECT , WHO SUPPORT AND
    GUIDE ME VERY WELL FOR NOT ONLY COMPLETING
    MY PROJECT BUT ALSO TO GAIN THIS NEW
    EXPERIENCE.
    Post Marketing surveillance
    Introduction

    • Post marketing surveillance refers to the


    monitoring of drugs once they reach the
    market after clinical trials. It evaluates
    drugs taken by individuals under a wide
    range of circumstances over an extended
    period of time.

    It uses a number of approaches to monitor drug


    and device safety, including spontaneous
    reporting databases, prescription event
    monitoring, electronic health records, patient
    registries, and record linkage between health
    databases. These data are reviewed to maintain
    safety of patients.

    4
    Principle of Post Marketing Surveillance
    • It aims to monitor use of medicine to
    identify any adverse effect or unusual
    pattern concerned with it.
    • Carries out risk–benefit analysis for
    medicines and suggesting suitable actions
    when necessary.
    • Providing regular updates to healthcare
    professionals and patients with regard to
    the safe and efficacious use of medicines.

    5
    6
    Types of Post Marketing surveillance

    Post marketing surveillance can be of two


    types proactive and reactive.

    Proactive :Its measures include customer


    surveys, manufacturer sponsored device
    tracking/implant registries, and expert user
    groups. The data is collected from
    manufacturers of complaint with their
    reasons.

    Reactive: Information on quality, safety or


    performance of a device on the market is
    collected reactively through notification by
    users and evaluation by manufacturers of
    complaints, including adverse events. The
    reactive nature of this statement refers to

    7
    the fact that the problem has already
    occurred, and may have affected a clinical
    decision.

    Proactive and reactive post marketing


    surveillance.

    8
    9
    Sources of post marketing surveillance
    Some important sources referred for the
    surveillance are:

    • Expert user group


    • Customer surveys
    • Customer complaints and warranty
    claims
    • Post CE -market clinical trials
    • Literature review
    • Device tracking/implant registeries
    • User reaction during training
    program
    • The media

    10
    11
    12
    Benefits of Post Marketing
    Surveillance
    • Detection of manufacturing problem
    • Improvement of medical device
    • Verification of risk analysis
    • Intelligence of long term
    performance
    • Chronic compilations
    • Performance trends
    • Performance in different user
    populations

    13
    Conclusion

    To strengthen safety monitoring


    and reporting by professionals,
    more awareness among health
    professionals and innovative
    strategies are needed. Recording
    the genetic data of patients can be
    beneficial in predicting adverse
    effects, therefore avoiding them
    and enhancing safe prescribing and
    dispensing by healthcare
    professionals. So post marketing
    surveireports. is important for many
    reasons.

    14
    Reference

    1) https://en.m.wikipedia.org
    /wiki/Postmarketing_surve
    illance#:~:text=Postmark
    eting%20surveillance%20(
    PMS)%2C%20also,of%20t
    he%20science%20of%20
    pharmacovigilance.
    2) https://pubmed.ncbi.nlm.
    n ih.gov/21882120/
    3) https://www.sciencedirect
    .
    com/topics/pharmacologyht
    tps://www.sciencedirect.com/topics/pharmacology-
    toxicology-and-pharmaceutical-science/postmarketing-

    surveillance toxicology-and-
    pharmaceutical-

    15
    science/postmarketinghttps://www.scienc
    edirect.com/topics/pharmacology-toxicology-and-pharmaceutical-

    science/postmarketing-surveillance surveillance
    4) https://accesspharmacy.m
    hmedical.com/content.asp
    x?sectionid=40428529&bo
    okid=438
    5) https://www.sciencedirect
    .
    com/topics/pharmacologyht
    tps://www.sciencedirect.com/topics/pharmacology-
    toxicology-and-pharmaceutical-science/postmarketing-

    toxicology-and-
    surveillance

    pharmaceutical-
    science/postmarketinghttps://www.scienc
    edirect.com/topics/pharmacology-toxicology-and-pharmaceutical-

    science/postmarketing-surveillance surveillance
    6) https://apps.who.int/iris/r
    est/bitstreams/1321284/re
    trieve

    16

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