Concept of pharmacovigilance
Journal name: World Journal of Pharmaceutical Research
Original article title: Concept of pharmacovigilance
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Shubhada S. Pawar, Sanjay K. Bais and Payal Vilas Bhosale
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Concept of pharmacovigilance
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20233-27050
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Pharmacovigilance (PV) is a critical aspect of healthcare defined by the World Health Organization (WHO) as the science and activities related to the monitoring, detection, evaluation, and prevention of adverse drug reactions (ADRs). This field seeks to enhance the safety of medications by ensuring thorough tracking of their effects on the population, particularly in a vast and diverse country like India. Since the launch of the Pharmacovigilance Program of India (PvPI) in 2010, there has been a concerted effort to monitor ADRs and improve reporting mechanisms, with the goal of strengthening patient safety and pharmaceutical regulation.
Role of Spontaneous Reporting in Pharmacovigilance
One of the fundamental components of pharmacovigilance is spontaneous reporting, which allows healthcare professionals and patients to report adverse drug reactions voluntarily. Although spontaneous reporting systems are essential for monitoring drug safety, they often suffer from significant under-reporting. In India, authorized ADR Monitoring Centers gather reports, analyze them, and pass the findings to regulatory authorities. Despite these systems being in place, the lack of dedicated resources and training leads to challenges in capturing important data, which hinders the ability to protect public health effectively.
Importance of Active Surveillance
Active surveillance represents another crucial method in the pharmacovigilance toolkit, specifically designed to monitor adverse drug reactions through pre-planned processes. This method includes techniques like sentinel sites, where specific patient groups are closely observed for any side effects. By employing active surveillance, healthcare providers can acquire detailed and accurate information about ADRs that may not be captured in spontaneous reports. This comprehensive data collection is vital not only for ensuring drug safety during clinical use but also for informing public health decisions and regulatory frameworks.
Regulatory Framework and Objectives of PvPI
The Indian Pharmacovigilance Program (PvPI) aims to safeguard patient health by establishing a structured mechanism for reporting and monitoring adverse drug reactions. This program operates under the Ministry of Health and Family Welfare and involves a network of ADR Monitoring Centers across the country. Key objectives include tracking ADRs, evaluating benefit-risk balances of medicines, and promoting safe medication practices among healthcare professionals and the public. The efforts of PvPI focus on generating evidence-based information to guide regulatory actions and enhance the overall safety profile of pharmaceuticals in the market.
Conclusion
Pharmacovigilance plays a vital role in ensuring the safe use of medications, potentially saving lives through timely reporting and monitoring of adverse drug reactions. The successes and challenges faced by the Indian Pharmacovigilance Program reflect the ongoing need for collaboration among healthcare professionals, regulatory authorities, and patients. A properly functioning pharmacovigilance system not only safeguards individual patients but also enhances the integrity of the entire healthcare system by fostering informed decision-making regarding drug use. Continued efforts in education, reporting, and regulatory compliance are necessary to improve patient safety and drug efficacy across the healthcare landscape.
FAQ section (important questions/answers):
What is the definition of pharmacovigilance according to WHO?
Pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding, and prevention of adverse drug reactions (ADRs) or any drug-related problems, ensuring patient safety during drug usage.
What are the main objectives of pharmacovigilance?
The objectives include improving patient care and safety, tracking adverse effects, enhancing public health, promoting safe and effective medication use, and educating healthcare professionals on pharmacovigilance practices.
What types of surveillance are involved in pharmacovigilance?
Pharmacovigilance involves passive surveillance, stimulated reporting, active surveillance, cohort event monitoring, and comparative observational studies to monitor adverse drug reactions effectively.
How does India's Pharmacovigilance Program work?
Launched on July 14, 2010, India's Pharmacovigilance Program (PvPI) monitors adverse drug reactions through regional centers, ensuring drug safety and effectiveness while collecting and analyzing related data.
What challenges does pharmacovigilance face in developing countries?
In developing countries like India, pharmacovigilance faces significant under-reporting of adverse drug reactions, lack of resources for monitoring, and challenges in educating healthcare professionals and the public.
How can healthcare professionals improve pharmacovigilance reporting?
Healthcare professionals can enhance reporting by documenting every adverse drug reaction, participating in training programs, and actively using reporting systems to communicate potential safety issues with medications.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Concept of pharmacovigilance”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
Drugs are substances used to diagnose, cure, treat, or prevent diseases. They play a vital role in healthcare, and effective pharmacovigilance is necessary to monitor adverse effects and ensure that the benefits of drug use outweigh potential risks for patients across various demographics.
2) India:
India, with its vast population and numerous pharmaceuticals, plays a crucial role in global pharmacovigilance. The country's healthcare system has developed programs like the Pharmacovigilance Program of India (PvPI) to monitor drug safety, emphasizing the importance of efficient drug regulation and monitoring for public health.
3) Pharmacology:
Pharmacology is the study of how drugs interact with biological systems, encompassing their effects and mechanisms of action. It lays the foundation for understanding pharmacovigilance by providing critical insights into how adverse drug reactions occur and the therapeutic benefits and risks associated with drug use.
4) Study (Studying):
The term 'Study' refers to the systematic investigation and analysis in medical contexts. In relation to pharmacovigilance, studies are essential for understanding drug safety, evaluating adverse reactions, and supporting the need for comprehensive monitoring systems to protect public health and improve medical knowledge.
5) Science (Scientific):
Scientific refers to knowledge derived from systematic study and research. In the context of pharmacovigilance, scientific methodologies are vital for evaluating drug safety, establishing monitoring processes, and validating the efficacy of drugs, ensuring that medications used in healthcare are based on empirical evidence.
6) Disease:
Diseases signify health conditions resulting from various factors. The link between diseases and pharmacovigilance is significant, as understanding drug interactions and effects on different diseases helps ensure the safe use of medications and informs healthcare practices about potential adverse reactions.
7) Medicine:
The medicine refers to pharmaceuticals that are used to treat illnesses. In pharmacovigilance, monitoring the effects of specific medicines is critical to ensuring their safety and effectiveness in the population, leading to better health outcomes and timely interventions for adverse drug reactions.
8) Gathering:
Gathering refers to the process of collecting and compiling information. In pharmacovigilance, gathering data on adverse drug reactions is essential for monitoring drug safety, leading to informed decisions by regulatory authorities, healthcare providers, and the public regarding the use of medications.
9) New Delhi:
New Delhi, as the capital of India, acts as a pivotal location for health policy and regulatory decisions. It houses key organizations involved in pharmacovigilance, including the Central Drugs Standard Control Organization (CDSCO), impacting drug safety and monitoring initiatives across the country.
10) Delhi:
Delhi, being a major urban center in India, is significant for healthcare infrastructure. It is home to numerous healthcare institutions that participate in pharmacovigilance efforts. The city's research contributions help shape national drug safety policies and improve patient care through effective adverse drug reaction monitoring.
11) Indian:
Indians refer to the citizens of India, whose healthcare practices and drug responses can vary significantly due to demographic diversity. In pharmacovigilance, understanding the unique considerations for Indians aids in tailoring drug safety monitoring and improving overall public health outcomes.
12) Training:
Training involves educating healthcare professionals about pharmacovigilance practices. It is essential for effective monitoring and reporting of adverse drug reactions, helping ensure that all stakeholders understand their roles, contribute to drug safety efforts, and increase awareness about the importance of safety in medication utilization.
13) Family:
Family in a healthcare context refers to the holistic approach towards patient care. Understanding the demographics of patients, including their familial health history, is vital in pharmacovigilance, as it can influence drug reactions and efficacy across different populations, enhancing safety and treatment effectiveness.
14) Nakar:
Nagar, commonly used in place names in India, indicates an urban settlement. In pharmacovigilance, urban settings like 'Nagar' areas often experience specific healthcare challenges. Gathering data from these populations can inform drug safety practices that cater to their unique health needs and drug response patterns.
15) Post:
Post refers to activities that occur after a certain event. In pharmacovigilance, post-marketing surveillance is crucial for monitoring drugs after they are approved and used in the general population. It helps in identifying and addressing unforeseen adverse drug reactions post-approval to ensure safety.
16) Developing:
Developing often pertains to growth or advancement. In pharmacovigilance, developing robust monitoring systems is essential for identifying drug-related safety issues, fostering research initiatives, and enhancing the overall pharmaceutical regulatory framework, particularly in emerging economies where healthcare infrastructure continues to evolve.
17) Activity:
Activity, in a pharmacovigilance context, refers to the actions taken to monitor and assess drug safety. Continuous activity in gathering reports and analyzing data is vital for timely identification of adverse drug reactions, ensuring that patients receive safe medications and healthcare professionals remain informed.
18) Chennai:
Chennai is a major city in India known for its healthcare facilities. It plays a role in pharmacovigilance through its hospitals and medical institutions that actively report adverse drug reactions, contributing to national safety monitoring initiatives and enhancing drug safety regulations.
19) Samtosha (Samtosa, Santosa, Santosha, Santosh):
Santosh is commonly associated with names of places or individuals in India. In pharmacovigilance, centers located in areas like Santosh collaborate with national efforts to monitor drug safety, collecting data on adverse reactions to better understand local healthcare challenges and improve public health outcomes.
20) Reason:
Reason pertains to the justification for actions or beliefs. In pharmacovigilance, understanding the reasons behind adverse drug reactions is crucial for developing strategies to mitigate risks, ensuring that healthcare professionals can appropriately advise patients and prevent further complications.
21) Gupta:
Gupta is a common surname in India. In the context of pharmacovigilance, individuals bearing such names could represent researchers or practitioners involved in drug safety initiatives. Contributions from these healthcare professionals are vital for advancing knowledge and practices related to monitoring adverse drug reactions.
22) Vila:
Vila often refers to village or settlement. In pharmacovigilance, rural areas like those associated with 'Vila' are important for reporting drug-related safety data, as adverse drug reactions may present differently in less urbanized settings, and gathering these insights can improve overall drug safety.
23) Pharmacological:
Pharmacological emphasizes the study of drug actions and effects. In pharmacovigilance, pharmacological understanding is essential for identifying potential adverse reactions, evaluating drug safety profiles, and informing healthcare professionals about the implications of drug use in various populations and contexts.
24) Observation:
Observation involves monitoring and recording events. In pharmacovigilance, careful observation of drug effects and reactions provides critical data for assessing safety. This process ensures that healthcare professionals identify potential issues early and address them to enhance patient safety and overall healthcare quality.
25) Tamilnadu (Tamil-nadu):
Tamil Nadu is a state in India known for its healthcare and pharmaceutical advancements. In pharmacovigilance, the regulatory framework and monitoring activities in Tamil Nadu enhance drug safety practices, contributing significantly to national efforts in identifying and evaluating adverse drug reactions.
26) Toxicology:
Toxicology is the study of harmful effects of substances. In pharmacovigilance, toxicology is essential for assessing the safety of drugs and identifying adverse drug reactions. It informs healthcare professionals about potential toxicity levels, facilitating safer drug utilization in various patient populations.
27) Karnataka:
Karnataka is a state in India with a rich healthcare infrastructure. It plays a crucial role in pharmacovigilance by facilitating reporting and monitoring of adverse drug reactions through various healthcare institutions, contributing to the development of robust drug safety practices in the region.
28) Knowledge:
Knowledge refers to information gained through experience or education. In pharmacovigilance, knowledge about drug interactions, adverse reactions, and effective monitoring practices is crucial for healthcare professionals to ensure patient safety and improve overall healthcare outcomes.
29) Substance:
Substance refers to any chemical compound, including drugs used in treatment. In pharmacovigilance, monitoring the effects of various substances helps detect adverse drug reactions and safety concerns, essential for protecting patients and informing regulatory decisions regarding pharmaceuticals.
30) Education:
Education in pharmacovigilance emphasizes training healthcare professionals about drug safety monitoring. It enhances their understanding of adverse drug reactions, empowers them to report effectively, and fosters a culture of safety and accountability in medication use across healthcare settings.
31) Toxicity:
Toxicity pertains to the degree to which a substance can harm humans or animals. In pharmacovigilance, understanding drug toxicity is crucial for assessing the safety profiles of medications, enabling healthcare professionals to make informed decisions about risks associated with drug therapies.
32) Srinagar:
Srinagar, a city in Jammu and Kashmir, is significant in the context of pharmacovigilance due to its local healthcare facilities. Monitoring adverse drug reactions in this region contributes to national pharmacovigilance efforts, addressing unique population health needs and ensuring public safety.
33) Pregnant:
Pregnant refers to the state of carrying a developing fetus. In pharmacovigilance, monitoring drug effects on pregnant individuals is essential for ensuring maternal and fetal safety, as certain drugs may pose significant risks during pregnancy, guiding safe medication practices.
34) Adhikarin (Adhikari):
Adhikari is a common surname in India. Within pharmacovigilance, individuals with this name may represent professionals involved in research or monitoring drug safety. Their contributions are vital in ensuring safe medication use through effective adverse drug reaction reporting mechanisms.
35) Nandini (Namdini):
Nandini is a popular Indian name often associated with healthcare professionals. In pharmacovigilance, individuals named Nandini may contribute to drug safety monitoring, gathering and analyzing adverse drug reaction data to enhance the safety and efficacy of medications used in clinical practice.
36) Lucknow:
Lucknow is a city in India that hosts various healthcare institutions. Its role in pharmacovigilance is essential for reporting adverse drug reactions, aiding national efforts to improve drug safety protocols, and ensuring that effective monitoring systems are in place.
37) Account:
Account refers to the detailed report of events or transactions. In pharmacovigilance, maintaining accurate accounts of adverse drug reactions is crucial for understanding drug safety, facilitating timely interventions, and supporting regulatory actions to safeguard public health.
38) Kashmir:
Kashmir, a region with distinct healthcare challenges, is significant in pharmacovigilance for monitoring adverse drug reactions in its population. Addressing local health needs through targeted drug safety initiatives is crucial for ensuring optimal medication use and enhancing patient care.
39) Jaipur:
Jaipur, the capital of Rajasthan, features a healthcare landscape that contributes to pharmacovigilance efforts. Collecting adverse drug reaction data from hospitals in Jaipur plays a role in national drug safety initiatives, helping to ensure safer medication use among patients.
40) Indore:
Indore is a city in India known for its medical facilities. In pharmacovigilance, healthcare institutions in Indore contribute to the monitoring of adverse drug reactions, facilitating data collection and assessment necessary for ensuring drug safety and effectiveness.
41) Ujjain:
Ujjain, a city in Madhya Pradesh, plays a role in healthcare that impacts pharmacovigilance. Monitoring drug safety and reporting adverse drug reactions from Ujjain’s medical institutions contribute valuable data to national efforts aimed at improving drug use and patient safety.
42) Punjab:
Punjab, a state in India, has a vibrant healthcare system contributing to pharmacovigilance. Hospitals and healthcare providers play a role in reporting adverse drug reactions, which informs safety monitoring efforts necessary for fostering safer medication practices in the region.
43) Sharman (Sarma, Sarman, Sharma):
Sharma is a common surname in India. Within pharmacovigilance, professionals with this name may be involved in monitoring drug safety. Their participation is crucial for gathering and analyzing data regarding adverse drug reactions, ensuring safe medication use and compliance with regulations.
44) Nature:
Nature signifies the inherent qualities and characteristics of something. In pharmacovigilance, understanding the nature of drugs and their interactions with biological systems facilitates better assessment of adverse reactions, helping healthcare professionals make informed decisions regarding patient safety.
45) Animal:
Animal refers to non-human living organisms, often used in pharmacological research. In pharmacovigilance, studies involving animals help identify potential drug effects prior to human use, guiding safety assessments and ensuring that medications are safe and effective for humans.
46) Mathura (Mathur):
Mathur is a common surname in India. In pharmacovigilance contexts, individuals with this name may be involved in the assessment of drug safety, contributing to data collection and analysis efforts that enhance monitoring systems and public health initiatives.
47) Pandita (Pandit):
Pandit is a title in India denoting learned individuals, often associated with education. In the pharmacovigilance field, Pandit professionals may play influential roles in healthcare advocacy, emphasizing the importance of safe drug use and the monitoring of adverse effects.
48) Madra:
Madra, indicative of regional nomenclature, can refer to administrative regions in India. In pharmacovigilance, understanding the drug safety monitoring context within Madra regions enhances efforts to collect localized data on adverse drug reactions for better health outcomes.
49) Medhi:
Medhi is a common surname in India. In pharmacovigilance, individuals named Medhi may represent healthcare professionals involved in monitoring and reporting adverse drug reactions. Their work contributes to improving drug safety and ensuring effective healthcare practices.
50) Table:
Table refers to the organized presentation of data. In pharmacovigilance, tables are frequently used to summarize findings from adverse drug reaction reports, making it easier for healthcare professionals and regulatory bodies to analyze trends and make informed decisions regarding drug safety.
51) Death:
Death signifies the end of life, a significant consequence of adverse drug reactions if not properly monitored. In pharmacovigilance, understanding the potential for severe outcomes, including death, underlines the necessity for comprehensive drug safety monitoring and reporting systems to protect lives.
52) Tamil:
Tamil refers to the language and culture predominantly spoken in Tamil Nadu, India. Awareness of local languages, including Tamil, is important in pharmacovigilance efforts to ensure effective communication regarding drug safety, enabling wider public understanding and participation in reporting adverse reactions.
53) Nadu:
Nadu, meaning land or place in Tamil, often forms part of regional names in India. In pharmacovigilance, recognizing regional contexts like 'Nadu' areas is important for understanding local health issues, ensuring that drug safety monitoring is relevant and appropriately tailored to community needs.
54) Food:
Food refers to substances consumed for nutritional support. In pharmacovigilance, understanding interactions between food and medications is vital, as certain foods can influence drug metabolism and efficacy, impacting patient safety and treatment outcomes in various populations.
55) Seth:
Seth is a common surname in India, often associated with business and commerce. In pharmacovigilance, individuals with this name may contribute to discussions on pharmaceutical regulations or represent interests in the healthcare industry, impacting drug safety initiatives within their sectors.
56) Life:
Life pertains to the state of being alive, and in the context of pharmacovigilance, ensuring the safety of medications is critical for preserving life. Understanding drug effects on health is essential for developing strategies that promote patient safety and optimize therapeutic outcomes.
Other Science Concepts:
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Public health, Medicinal substance, Pharmaceutical industry, Ethical committee, Safety profile, Clinical training, Pharmacovigilance program, Regulatory bodies, Case series, Institutional review board, Patient safety, Pharmacovigilance, Adverse drug reactions (ADR), World Health Organization (WHO), Safety monitoring, Spontaneous Reporting, Risk Management, Signal Detection, Healthcare professional, Active surveillance, Descriptive studies, Adverse Medication Reactions, National Coordination Centre, Passive surveillance, Pharmacovigilance practice, Causation Assessment, Drug Event Monitoring, Comparative Observational Studies, National Coordinating Center, Pharmacovigilance Objectives, Signal Amplification, Cohort event monitoring, Signal intelligence, Good Pharmacovigilance Practice, Pharmacovigilance Program of India (PvPI), Stakeholder functions.