Pharmacology Department MET institute of D Pharmacy, Adgaon.
India established a system for tracking adverse drug reactions in 1986 and joined the WHO Programme for International Drug Monitoring in 1998. The National Programme of Pharmacovigilance was renamed the Pharmacovigilance Programme of India (PvPI) in 2010, aiming to protect the Indian population’s health.Pharmacovigilance is the science of preventing harmful effects of pharmaceutical medicines, involving pharmacists. It’s crucial in healthcare, identifying potential drugs, analyzing drug interactions, and monitoring adverse effects. This study examines drug store students’ perspectives on pharmacovigilance and ADR announcements during undergraduate education. Pharmacovigilance (PV) is crucial in healthcare for monitoring drug interactions and adverse drug reactions (ADRs) throughout a drug’s life cycle. It involves pharmacogenomics and pharmacogenomics, focusing on detecting, understanding, and preventing these risks, ensuring medication safety. The PV system team collects data to enhance the scientific material in initial reports, promoting strict monitoring of adverse effects and efficient medication approval regulations. PV systems’ proximity to the population and public health professionals allows for easy communication with reporters, highlighting the joint responsibility of pharmaceutical businesses, drug regulators, and physicians.
Assessing the risk of adverse events for patients taking medication is the aim of pharmacovigilance. Keep in mind that no medication is 100% safe, neither during the period Along with informing the public and healthcare professionals about dangers, the Pharmacovigilance Program of India aims to gather, compile, and evaluate data in order to draw conclusions and suggest regulatory solutions (1). This article discusses possible reform topics for Indian pharmacovigilance and offers suggestions for developing a strong clinical research safety reporting system.of time it is approved for sale nor after. Pharmacovigilance is vital for clinical results and patient safety, but for some disease states, timely, accurate, and thorough reporting is crucial. Therapy for cancer—highly toxic The importance of pharmacovigilance in the healthcare system has been acknowledged globally in recent years, since its growth has been substantial. To ensure the safety of medications, a number of important challenges must be resolved. The World Health Organization (WHO) defines Pharmacovigilance, sometimes referred to as “drug safety,” as the science and activity concerned with the identification, evaluation, and avoidance of adverse drug reactions.(1)Pharmacovigilance (PV) was first introduced in December 1961 when an Australian doctor named W. McBride published a case report in the Lancet, raising the possibility that thalidomide, a medication used during pregnancy, and serious fetal deformities (phocomelia) could be linkeThe “Programme for International Drug Monitoring,” a pilot effort launched by the World Health Organization (WHO) in 1968, sought to centralize global data on adverse drug reactions (ADRs). Finding the earliest PV indications was specifically the “WHO Programmer’s” primary goal. A French group of pharmacologists and toxicologists coined the word PV in the middle of the 1970s to describe the initiatives supporting “The assessment of theis especially concerned with adverse drug reactions (ADRs), which are unpleasant and unexpected medication reactions that happen at levels typically used for disease prophylaxis, diagnosis, or treatment, or for modifying physiological function . To optimize benefits and reduce dangers, it is imperative to continuously monitor pharmacological effects, side effects, contraindications, and overtly adverse effects that could result in a significant degree of morbidity, and in some circumstances, even mortality. When a drug is sold and prescribed to huge populations both inside and outside the country, no amount of caution and care throughout the pre-clinical and clinical testing stages can guarantee absolute safety. Due to the fact that clinical studies might involve hundreds of individuals, ADRs and less prevalent side effects are frequently unknown at the (2 India’s Pharmacovigilance Program (PvPI) In India, pharmacovigilance is still in its infancy, and very little is known about the field. Although the field of pharmacy has made significant strides in Western nations, India has not seen as much progress. However, there is a pressing need to comprehend the significance of pharmacovigilance and how it affects the product life cycle, given the increasing number of clinical trials and other clinical research activities being carried out in India. This will make it possible to incorporate best practices in pharmacovigilance into the processes and procedures in order to improve clinical trial safety, post-marketing surveillance, and regulatory compliance The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Pharmacovigilance and associated concerns(3)When a new medication is introduced without first undergoing extensive safety testing, it may not be able to be marketed as therapeutically safe and effective and may even have detrimental or fatal side effects. A few decades ago, the long-term use of a medicine was the basis for evaluating its safety in India. However, this procedure proved unreliable and could not guarantee total safety . In light of this, numerous Indian organizations and research funding agencies began sponsoring the development of fresh products and individual medication research. New information frequently surfaces after a product is produced, information that could have a favorable or negative effect on the product’s risk-benefit profile. To protect the public, a thorough analysis or evaluation of freshly created information using a PV system is necessary. (4)
Aim of pharmacovigilance RMA Covigil
Overview provides a general understanding of clinical trials and their phases. The reader is able to comprehend the significance of the clinical trial in India. This document describes the many government entities that are involved in the trial and the regulations that regulate trials in India. Preclinical research provided a good assessment of medication safety, but it offered little information about how drugs interacted with the human body or how they worked as a whole on people. Drug effects on the human body can be studied through clinical research; to do this, researchers create a clinical study design that includes a number of tasks. Phases of clinical research are involved in this, and the investigational new drug process is started. Here’s the action that(5)
• To find fresh information regarding the risks connected to medications
• To shield the patients from injury. The aim is to enhance patient care and safety concerning medication usage and all related medical and paramedical procedures.
• To promote public health and safety in regard to the Use of medications.
• Checking in with reporters to get further information. Regarding a case report;
• Offering healthcare professionals and patients information about product safety; (6)
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(7) pharma Covigilance future challenges and opportunities
Pharmacovigilance has evolved and will continue to evolve in response to unique requirements and in accordance with the unique strengths of participants in the WHO program and other initiatives. Such active impact should be supported and nurtured, as it has greatly influenced global practice and standards and is a source of vitality and uniqueness. Physician and scientist interest in pharmacovigilance is growing as more and more medication recall tales appear in the world’s mainstream media. Less common side effects and adverse drug reactions (ADRs) are frequently unknown at the time a drug enters the market because clinical trials typically involve several thousand people at most. Due to tiny study populations, even highly serious ADRs, such liver damage, are frequently missed. Pharmacovigilance after marketing makes use of instruments such (8)
Herbal medicine in India
Phenolic Substances The primary function of phenols, which are secondary natural metabolites of plants, is to provide protection from stress. Phenolics are aromatic benzene ring molecules with one or more hydroxyl groups. Many bioactive molecules, including polyphenols, alkaloids, steroids, sapponins, tannins, estragole, catechols, terpenes, limonene, and cadinene, are present in piper betel leaf extract (. These molecules exhibit a variety of pharmacological actions. The Ames test shows that the two main phenolic constituents, hydroxychavicol (HC) and eugenol extracted from betel leaves, have antimutagenic properties against the mutagen dimethylbenzanthracene (DMBA).), HC balances the carcinogenic and anticarcinogenic properties of the components in betel quid and reverses the mutagenic and carcinogenic properties of tobacco. Another significant bioactive molecule, i.e. allyl- pyrocatechol, is Additionally, it is used to treat endoparasites, skin conditions, ENT (ear, nose, and throat) disorders, and disorders of physiological function. Betel leaves are utilized for a variety of therapeutic and preventative purposes because they have cooling and analgesic qualities. Certain components found in betel leaves have been shown to benefit individuals with diabetes and various forms of glycosuria A brief summary of betel leaf’s health advantages is provided by C. It also has antimicrobial, anticariogenic, antiprotozoal, anti-allergic, anti-diabetic, hepatoprotective, cardioprotective, antitumor, and respiratory antidepressant properties. (9)
Clinical trials in India
A clinical trial is defined as a prospective investigation that compares the efficacy and utility of an intervention (or interventions) in humans to a control group. A clinical study is not retrospective; rather, it is prospective. Participants in the study must be tracked down on time. They don’t all have to start on the same day of the calendar. In actuality, this won’t happen very often. But each participant needs to be tracked starting at a specific moment in time, which serves as their study’s time zero or baseline. In comparison, a case-control study is a kind of retrospective observational research where subjects are chosen based on whether an event or condition of interest occurs or not. Such a study is not a clinical trial by definition. The "effectiveness" and "efficacy" of an intervention are not always interchangeable, according to the number of individuals. Additionally, they speak of trials that are “explanatory” as opposed to “pragmatic” or “practical.” The intervention’s effectiveness, also known as explanatory trials, is measured in the best-case scenario. A “intention-to-treat” analysis is not always justified by using this phrase. That provides insufficient justification, as • Phase 3: Phase 3 clinical studies assess the safety and efficacy of new medicines against current standard treatments. Phase 3 trials collect safety and efficacy data from hundreds to thousands of voluntary participants. Positive results from FDA approval, with 25-30% of medications moving on to the next level. • Phase IV: Following FDA approval, Phase 4 trials involve thousands of participants to investigate long-term safety, efficacy, and potential adverse effects.covered in Chapters 8 and 18. When discussing an intervention’s effectiveness or pragmatic trials, one must consider its practical application, accounting for participants who might not follow the protocol exactly or who might not respond to the intervention for other reasons. Trials of both kinds should be conducted correctly and may address pertinent issues. Thus, we do not take into consideration(10)
1)Phase I
2)Phase II
3Phase III
4) Phase IV(11)
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12) clinical trials
Pharma Covigilance program in India
During the 1980s and 1990s, numerous medications were linked to major side effects. 1996: India began a global standard clinical study. In 1997, India joined the ADR Monitoring Program. In 1998, PV activities began in India. In 2002, India launched its 67th National Pharmacovigilance Centre. 2005: India began performing structured clinical trials. 2009–2010: India’s PV strategy was launched and implemented. Scope of PV PV is a rapidly growing field that includes chemical, botanical, and biological therapies, as well as medical devices . Healthcare practitioners and patients provide tie information about questionable products to detect and avoid related problems Therefore PV addresses adverse effects of drugs, polypharmacy, paradoxical reactions, and extreme adverse events. It addresses immunization failure, irrational use, lack of efficacy, drug interactions, toxicity, and overdose. IN light of this, a large number of Indian institutions or research funds Monitoring Centers (AMCs). Individual Case Safety Reports (ICSRs) are gathered by Tiese AMCs, who then analyze and submit the results to the relevant regulatory body . Under PvPI, 250 AMCs—both government and non-government—had been founded as of January 2017. For the purpose of spontaneous ADR reporting, roughly 20 Anti- Retroviral Tierapy (ART) and 17 Revised National Tuberculosis Program (RNTCP) centers were constructed ]. An authorized individual is the medical sciences technical associate at Banaras Hindu University, who is responsible for gathering ICSRs, following up on them, and entering them into the Vigi-Flow software online database. ADR reports are sent to the regional center by each primary health care center (PHC) and community health center (CHC). It was thought that using natural therapies was safe and(4)
• Establish a national patient safety reporting system
• Determine and evaluate novel indicators from the documented cases
• Examine the benefit-risk ratio of marketed medications
• Produce evidence-based data regarding the safety of pharmaceuticals
• Assist regulatory bodies in their decision-making
• To become a national center of excellence for pharmacovigilance activities;
• To work with other national centers for the exchange of information and data management;
• To provide training and consulting support to other national pharmacovigilance centers across the globe;
• To promote the rational use of medicines.(13)
Numerous research that rely on simulations or retrospective analyses have shown the benefits of automated data-mining techniques for pharmacovigilance signal detection. As highlighted by Ahmed et al., defining the reference signals is closely linked to the evaluation of these approaches. A study revealed that, in terms of both the quantity of signals discovered and the time it takes to identify them, Bayesian approaches perform worldwide better than frequentist methods . Furthermore, pharmacovigilance signals and cases may be difficult to evaluate due to a number of biases A bias is defined as a systematic error that arises from the difference between the parameter value in the population and the parameter estimation on a sample (e.g., prevalence, incidence, relative risk, odds ratio, etc.).It is important to separate bias from random mistakes, or fluctuations in sampling.(14
Future prospects of pharma Covigilance
The new regulation aims to increase transparency and improve communication. AIFA’s web portal provides the public with the following information:
• Public assessment reports and summaries;
• Product characteristics and package leaflets;
• Risk management plans;
• List of medicinal products under additional monitoring;
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16) pharma Covigilance service
Drug specialists can save expensive medical care expenses by using pharmacovigilance frameworks linked to electronic health records to monitor the prescriptions they fill and identify adverse pharmaceutical responses more quickly than non-drug specialists. In developing countries with shaky prescription quality control, pharmacovigilance data structures managed by drug specialists can identify adverse pharmaceutical responses. Despite having been using their prescription medications for a while, reports suggested that individuals lacked knowledge about them. 73% of drug experts are employed at drugstores or medical clinics, where they can deal with situations involving adverse drug reactions or other medication-related problems. They play a crucial role in pharmacovigilance frameworks. One accomplishment in the development of electronic data frameworks (17) In the current investigation, the drug-related risk for a specific ADR has been captured using a sensitive and quantitative method based on the disproportional reporting rate, such as ROR. Our results are in line with other research showing that steroids including fluorometholone, betamethasone sodium phosphate, triamcinolone acetonide, and prednisolone were linked to glaucoma. Steroids can be used topically, intravitreally, or systemically to create open angle eye pressure.It is conceivable for reports of “glaucoma” to contain “open-angle glaucoma” in our database. According to our findings, pregabalin caused glaucoma. This is in line with a nested case-control research that found a correlation between the incidence of glaucoma and pregabalin use. Pregabalin has been shown in animal studies to lower intraocular pressure; the underlying mechanisms are believed to be that pregabalin binds to CACNA2D1, which results in the α1(18)
Limitation of pharma Covigilance
There were certain restrictions on our investigation. A tiny percentage of parents of children who encounter ADRs are represented by the parents who submitted Yellow Cards. The majority were either health professionals or had personal ties to them.As a result, they knew more about medications, how to report adverse drug reactions, and why to report them than the majority of parents. The Yellow Card Scheme’s low level of public awareness has led to comparable problems in earlier research on direct patient reporting under pharmaceutical covigilance programs. Our sample of parents who had a child with a suspected ADR but had not utilized the Yellow Card Scheme is especially significant in this regard. Although the opinions of these groups have not been well studied, they are essential in determining how public involvement in pharmacovigilance weight be advertised. Our use of both telephone and in-person interviews raises concerns regarding the data’s comparability, namely whether telephone interviewees were more circumspect than in-person interviewees. Nonetheless, consistent with earlier findings , we did not discover any proof that the interviewing medium affected the participants’ statements.(19)Eleven questions to RELIS and ADR reports illustrated a pregabalin drug safety issue that was later reported globally.. This contrasts with the finding that pregabalin is safe, which is supported by patient reports and clinical study results Among doctors, pregabalin has also generated controversy. Pharmacovigilance centers and medicine-information centers are familiar with the use of qualitative analysis of individual ICSRs and inquiries regarding ADRs on suspicion of drug-safety issues, as mentioned below. Additionally, systematic methodologies can be used to study databases with ICSRs. The current explanation concentrated on how the RELIS network, which includes shared electronic resources, makes it easier to communicate about adverse drug reactions (ADRs) and can identify new drug safety issues using a haphazard approach based on a small set of questions and ADR reports.(20)FAERS is unable to demonstrate a causal link between a medication and an ADR. Because ADRs are reported voluntarily and spontaneously, there may be significant bias. Media coverage and the recent release of an ADR in the literature may have an impact on reporting practices. Concomitant medications and comorbid disorders complicate the reporting relationship between a medication and an ADR. There is no definition of AKI in FAERS, and the reporter may not have distinguished between AKI, acute renal disease, and chronic kidney disease. The data analysis was limited to the principal and secondary suspect prescription medicines. Information that is missing from FAERS includes the route of administration; if this information was not provided, the report was excluded from the data analysis. (21 )
Examples of Adverse drug event from post marketing data leading to action
Drug safety and adverse events have gained public awareness as post-marketing pharmacovigilance has developed further. The popular press has reported on cases when safety signals derived from post-market safety data have revealed safety issues not previously recognized in clinical trials, resulting in modifications to a product or occasionally its removal from the market. There are numerous instances in renal practice when modifications or drug withdrawals have resulted from post-marketing safety data. Icodextrin and the device A PD solution called ExtranealTM (icodextrin) (Baxter Healthcare Corporation) contains the colloid osmotic agent icodextrin.a starch-derived, water-soluble glucose polymer. Extraneal was rigorously monitored and examined during clinical trials, but an unexpected and unusual side effect was not discovered until it was used by a larger population. Icodextrin, the osmotic agent in Extraneal, is converted into oligosaccharides like maltose and other high-molecular-weight compounds. Some glucometers monitor not only glucose but also compounds like maltose, making them “nonspecific”. Maltose can cause falsely increased glucose readings, leading to unnecessary insulin administration in individuals using these glucometers . Excess insulin can cause hypoglycemia, which can result in loss of consciousness, coma, neurologic impairment, and even death. Furthermore, artificially increased blood glucose readings due toExamples of adverse events from post-marketing data resulting from icodextrin medication. This issue was discovered after Baxter received reports of artificially increased glucose levels after the product’s launch, not during the Extraneal clinical studies. A case report of a 59-year-old patient with Extraneal who was admitted for an elective operation exemplifies this potentially fatal condition.14 During the preoperative stage, she informed HCPs that she needed a particular glucometer for her extraneal use. Unfortunately, the patient’s post-operative transfer to the intensive care unit (ICU) did not include this notification. The nonspecific glucose portable monitors in the ICU overestimated the glucose levels. (22,)
CONCLUSION
our work used the FAERS database to undertake a thorough analysis of the signals related with Sunitinib’s. This investigation found common adverse events that were consistent with the manufacturer’s labeling and clinic studies. Unexpected adverse events (AEs) included generalized melanocytic growth and thyroid dysfunction. This article’s assertions are exclusively those of the writers and may not reflect those of connected organizations, publishers, editors, or reviewers. The publication does not guarantee or support any product or manufacturer’s claims mentioned in this article.(23)From the viewpoint of the patient, all parties involved must always show consideration for their
• Roles and regulatory awareness: stakeholders need to understand them in practice.
• Clinical trials: patients need to be better informed about possible safety occurrences and how to report them
.• Data: To improve the scientific and statistical validity of the identification and analysis of possible risks and hazards, cooperation from all stakeholders is necessary.
• Pharmacovigilance and recalls: manufacturers, health care professionals, and regulators must reaffirm their commitment to better fulfilling their obligations
.•Reliable sources, such as patient organizations, must adhere to the strictest guidelines for timeliness, transparency, alignment, and accessibility.
• Patient-friendly: All therapies must have patient-friendly safety information.
• Before an emergency occurs, communication lines, protocols, and infrastructure must be examined and enhanced to maximize information transmission.
• Outreach and communication tactics: social media and associated opportunities should be used to their fullest potential in order ( 24.)
Drug -Drug interaction
This study assesses current methods for detecting and managing drug-drug interactions and finds ways to improve prevention and lower adverse events among primary care physicians brought on by polypharmacy and aging populations. Drug-drug interactions (DDIs) are a major cause of medical expenses and over 770,000 fatalities worldwide. The elderly, polypharmacy, and the use of nutritional supplements are the main causes of DDIs, which make about 20% of adverse events in the US. An 80% chance of developing DDI is linked to polypharmacy, which involves taking many medications. You run the risk of harm if you use supplements with prescription medications.
Food – drug interactions
Differ in impact as a result of interactions with other medications, foods, drinks, dietary supplements, or illnesses. Inappropriate usage or ignorance of the active components may result in these side effects. Drug-food interactions can result in major side effects or change how the body uses the medication. The parent drug may be impacted by changes made to the drug product. For optimal benefit, patients should adhere to their doctor’s prescription in order to reduce food-drug interactions. Physicians and pharmacists can prescribe drugs and give healthy diet with the aid of data mining. Medications are necessary to address medical conditions, but their safety and efficacy depend on their appropriate administration. The best medications should be linear, non-toxic, specific, predictable, and only need one dose to provide long-lasting effect. Substances that alter activity are known as drug interactions. Safety, effectiveness, and patient nutritional status can all be adversely affected by g-drug interactions. Patients should dis)cuss diet and nutritional items with their doctors and pharmacists to avoid this effect. Pharmaceutical foods may interfere with over-the-counter or prescription pharmaceuticals since they have not been thoroughly evaluated. Avoiding this interaction is crucial.
Design and conduct of investigation
Epidemiological designs, another name for observational study designs, assess possible causal linkages for the impact of preventative and social benefit. They include cross-sectional, case-control, case-crossover, prospective cohorts, and sustainable design. The benefits and drawbacks of diagnosis that impact epidemiology standards, procedures, and analysis are assessed by diagnostic research design. Interventional and Observational Studies Two main categories of research are surveys and observation; in this case, observational research examines the connection between events and results, whereas diagnostic research belongs to a separate category. Retrospective research designs are possible; prospective studies follow participants throughout time and offer compelling proof of cause and effect, whereas retrospective studies record past data and are less biased. (25)
REFERENCES
Ghuge V.*, Aher R, Bairagi P., Pawar P., Raut H., Shaikh M. R. N., Pharmacovigilance in India: A Review of ADR Monitoring, Education and Systemic Advancement, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 4, 2396-2407 https://doi.org/10.5281/zenodo.15245702
10.5281/zenodo.15245702
