Patient centered Pharmacovigilance .. .

Welcome
PATIENT CENTERED
PHARMACOVIGILANCE
ANJANA A
B PHARMACY
014/022024
10/18/2022
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@clinosolresearch
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INDEX
Introduction
Definition,importance and benefits
Current practices in pharmacovigilance
Challenges and limitations
Patient contribution to pharmacovigilance
Importance of collaboration between patient,health professionals and
regulatory bodies
Case studies
Recommendations for implementing successful patient centered
pharmacovigilance
Conclusion
Reference
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INTRODUCTION
 Pharmacovigilance is the science and activities with detection,assessment,prevention of adverse
events and drug related risk.
 Nowadays, the patients perspectives were incorporated into pharmacovigilance activities
including adverse drug reaction reporting ,evaluation,medication error assessment,benefit risk
assessment and risk communication.
 Rare,unexpected and new adverse drug reactions are discovered when drugs are used in different
population .
 It involves actively engaging patients in reporting and monitoring adverse drug reactions .
 There are many challenges and oppourtunities associated with involving patients in
pharmacovigilance.
 Through this we are going to examine which all ways patient can be involed in
Pharmacovigilance.
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DEFINITION
Patient centered pharmacovigilance is defined as “An proactive approach to drug safety that
emphasizes the active involvement of patients in reporting and monitoring adverse drug reactions”.
IMPORTANCE
• To detect,access,understand and prevent the adverse effects of medications.
• Consumers often much better able to articulate non-clinical aspects of their adverse events.
• Identification of product quality issues and tampering.
• Builds trust in Australian regulatory system and health system.
• Patients may report different adverse drug reactions than healthcare professionals.
• Patient empowerment.
BENEFITS
• Enhanced data quality
• Input can lead to the early detection of adverse events that might have otherwise gone unnoticed.
• Enhanced medication adherence.
• Improved communication between patient and healthcare providers.
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CURRENT PRACTICES
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CURRENT PRACTICES IN
PHARMACOVIGILENCE
Use of patient report
outcomes
Digital health
technologies
Patient reporting
systems
Patient support
groups
Patient education
And awareness
Patient engagement
in clinical trials

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CHALLENGES AND LIMITATIONS
1)Ensuring data accuracy and quality
• Under reporting:
Patients hesitate to report ADRs due to lack of awareness,fear of being a burden,or
difficulty identifying and associating synptoms with medication.
• Over reporting:
Certain dempgraphics like older adults ,might pver-report unrelated events,requiring
additional resources for verification.
• Data bias:
specific patient groups like with limited health literacy or access to technology lead
to biased data.
2)Resource constraints
• Limited infrastructure:
These includes training healthcare professionals and establishing reporting
platform,requires significant investment in infrastructure and personnrl.
• Data processing and analysis:
Effectively managing and analysing the influx of patient reported data necessities
robust data management systems and trained personnel.

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3)Privacy and ethical concerns
• Informed consent:
Ensuring patients understand how their data will be used and obtaining their consent
throughout the process is essential.
• Maintaining patient confidentiality:
Balancing the need for comprehensive data collection with data protection is crucial.
4)Communication and collabration
• Effective communication:
clear and effective consistent communication channels are crucial for informing
patients about patient centered pharmacovigilance,addressing their concerns and providing
feedback on reported ADRs.
• collaboration:
Effective collaboration among patients,healthcare professionals,regulatory agencies
and pharmaceutical companies is essential for implementation of patient centered
pharmacovigilance.

PATIENT CONTRIBUTION TO
PHARMACOVIGILANCE
Patient play a crucial role in pharmacovigilance ,the science and practice of monitoring the
effects of medications.some of them are;
Reporting Adverse event(ADRs):Patients are often the first to experience and notice side
effects,known as adverse drug reactions(ADRs).
• Many countries have dedicated systems for patients to directly report ADRs to regulatory
Bodies or pharmaceutical companies.
Raising awareness:Patient can raise awareness about pharmacovigilance by sharing their
experiences.
• This encourage others to report ADRs and improve safety and effectiveness of medications
for everyone.
Participating in research:Patients can actively join in studies that evaluate the safety and
efficay of medications.
• This can involve completing surveys,participating in focus groups or using mobile apps to
track their experiences.
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Providing real-world data:
• Patients offer valuable insights into the effectiveness and tolerability of medications in real-
world settings,which can differ from controlled clinical trial.
• This information can help identify rare or long-term side effects,assess the impact of medications
on daily life,and inform treatment decisions
Advocating for patient-centric care:
• By this done by ensuring their perspectives and experience are considerered when making
decisions about medication safety.
• This can involve participating in patient advisory boards,engaging with regulatory agencies,and
collaborating with healthcare professionals.
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Examples of patient reported adverse drug reactions
A patient reports experiencing severe nausea and vomiting after taking a prescribed
medication.
A patient experiences dizziness and lightheadedness after taking a particular drug.
A patient notices a rash and itching on their skin after taking a new medication.
A patient reports feeling fatigued and having difficulty concentrating after taking a
medication.
A patient notices unusual swelling in their hands and feet after starting a new medication.

IMPORTANCE OF COLLABORATION BETWEEN PATIENTS,HELATHCARE
PROVIDERS AND REGULATORY BODIES
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STAKEHOLDER IMPORTANCE OF COLLABORATION
Patient o Improved patient centered care:
shared decision making leads to care plans that align with individual needs and
preferences.
o Enhanced cliniclal research:
Patient participation in research trials improves the design,relevance,and
effectiveness of new treatments and therapies.
o Empowered advocacy:
Collaboration allows patients to contribute their lived experience to inform
policy and regulatory decisions.
Healthcare professionals o Informed consent:
Acess to patient insights and experiences helps healthcare professionals tailor
teratments and adress individual concerns.
o Improved patient education:
Enable healthcare professionals to develop clear and effective communication
strategies for patients.
o Enhanced innovation:
This lead to the development of new and effective healthcare solutiions.

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Regulatory bodies o Regulaions:
Collaborations ensures regulations reflect the needs and
perspectives of patients,promoting safer and effective
products .
o Evidence based decision making:
Patient reported data informs safety,efficacy,and acess
to new treatments and technologies.
STRATEGIES FOR PROMOTING COLLABORATIONS
Addressing ethical considerations
Leveraging technology and data sharing
Facilitating patient engagement
Collaborative platforms and initiatives
Building trust and communication

CASE STUDIES
Real life situations of successful patient centered pharmacovigilance initiatives are;
1)The sentinel initiatives by the FDA:
• It is a large scale program by the US Food and Drug Administration(FDA)that leverages electronic
healthcare records(EHRs)to sactively monitor the safety of drugs and medical devices in real world
settings.
• This program allows for the identification of potential safety issues ,enabling FDA to take quicker action
to protect public health.
• Identified several safety signals for the increased heart attack associated with a particular type of
diabetes medication.
2)The European Medicines Agency’s(EMA)Pateint Reporting Suspected Adverse Event (PASS):
• It is an online prlatform that allows patients and healthcare professionals across Europe to directly report
suspected adverse reactions to medicines.
• It also collects valuable data on safety of medicines in the real world which improves safety profile of
many medicines.
• Helpful in identifying the increased risk of blood clots associated with a particular type of hormonal
contraception.
3)The patientLikeMe platform:
• It is a patient centered research network that allows patients to share their health information
• It is used to collect data on the safety and effectiveness of a variety of medicines including
investigational drugs and new drugs.
• Helpful in identifying rare but serious side effects of medications difficult to detect through traditional
method
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RESULTS AND OUTCOMES:
• Improved patient safety
• Early detection of safety signals
• Empowered patients
• Identification of rare side effects
• Enhanced drug development and use
• Informed labelling and risk management
• Informed drug policy decisions
• Improved medication adherence
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RECOMMENDATIONS FOR IMPLEMENTING SUCCESSFUL
PATIENT CENTERED PHARMACOVIGILANCE
Training and education:
Ensure that all involved parties such as healthcare professionals,patients and
pharmacovigilance staff,receive proper training and education.
 communication and trasparency:
clear and open communication with patients provide regular upadates on the use of their data
and impact of their contributions.
Multiple reporting channels:
offer various reporting options through online platforms,mobile applications,phone hotlines and
paper forms to clear to individual preferences and accessibility needs.
Patient education and awareness:
Raise awareness among people about the importance of reporting the adverse drug reactions and
provide resources for education and support .
 Data quality assurance:
Implement strategies to ensure data quality and address challenges like missing information
and potential bias
Monitoring program effectiveness:
Regularly assess the effectiveness of the patient centered program,evaluating reporting
rates,data quality,and impact on drug safety decisions.
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CONCLUSION
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Patient centered pharmacovigilance is a crucial component of ensuring drug safety and improving
healthcare outcomes.
By actively invloving patients in monitoring and reporting adverse drug reactions,we can enhance
the detection and management of medication related risks.
There are challenges in implementing patient centered pharmacovigilance and these obstacles can
be addressed through effective communication strategies and robust data porotection measures.
Moving forward,it is essential for all stakeholders to commit to a patient centric approach to
pharmacovigilance recogonizing invaluable role that patients play in promoting drug safety and
quality
By working together and empowering patients to actively participate in monitoring their own
health outcomes,can achieve safer and more effective medication practices that ultimately benefit
society.

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REFERENCE
1.https://www.slideshare.net/drhagerali/patientcentered- pharmacovigilance
2.https://www.slideshare.net/TherapeuticGoodsAdministration/presentation-the-role-of-the-patient-in-pharmacovigilance
3. Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM. Attitudinal survey of patients, doctors and pharmacists towards the use of patient
reporting to improve pharmacovigilance. Br J Clin Pharmacol. 2011 Mar;71(3):405-18. doi: 10.1111/j.1365-2125.2010.03777.x. PMID:
21395652; PMCID: PMC3047126.
4. https://www.clinskill.com/patient-centric-approaches-in-
pharmacovigilance/#:~:text=Patient%2Dcentric%20pharmacovigilance%20can%20be,the%20drug%20safety%20monitoring%20process.
4. Smith MY, Benattia I, Evans K, Patel K. Patient-centered pharmacovigilance: a review of recent developments and future perspectives.
Ther Adv Drug Saf. 2016 Oct;7(5):203-14. doi: 10.1177/2042098616664020. PMID: 27660725; PMCID: PMC5023163.
5. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf.
2009;32(1):19-31. doi: 10.2165/00002018-200932010-00002. PMID: 19132804.
6. https://vial.com/blog/articles/patient-centric-care-the-impact-of-pharmacovigilance/?https://vial.com/blog/articles/patient-centric-care-the-
impact-of-pharmacovigilance/?utm_source=organic

Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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