scholarly journals PHARMACOVIGILANCE: DYNAMICS IN INDIAN PHARMA INDUSTRY

2018 ◽  
Vol 6 (01) ◽  
pp. 30-33
Author(s):  
Shubham Bhardwaj ◽  
Rajeshwar Verma ◽  
Romil Sharma ◽  
Rahul Solakhia
Keyword(s):  
Early Stage ◽  
Safety Issue ◽  
Safety Information ◽  
Safety Monitoring ◽  
Reporting Rate ◽  
Drug Safety Issue ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Marketing Data ◽  
Pharmaceutical Industries

Pharmacovigilance refers to the process of identifying, detecting, and responding to drug safety issue and has witnessed dynamic advancements in pharmaceutical industries throughout the world. The main objective of pharmacovigilance is to extend the safety monitoring and to detect any ADRs that previously got unrecognized in evolution during clinical trial. ADRs monitoring is required for each medicine throughout its lifecycle which includes early stage of drug design, clinical trials, and post marketing surveillance. The emerging trend in pharmacovigilance is to link the pre marketing data with the data collected during post marketing phase that include safety information. India is a vast country with population of over 1.32 Billion with different social economics status, different patterns of disease prevalence it becomes more important to have a standardized and robust pharmacovigilance. Pharmacists, as doctor remark that their involvement may increase the reporting rate and have a greater role to play in the area of pharmacovigilance

Acute Hemolytic Reactions Reported in ITP Patients Treated with Rho (D) Immune Globulin: Symptom Onset and Does Prior Exposure Lessen the Risk?

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4670-4670
Author(s):  
Carmen Muller ◽  
Gregg Little ◽  
Kristen Hess ◽  
Chris Sinclair
Keyword(s):  
Immune Globulin ◽  
Symptom Onset ◽  
Reporting Rate ◽  
Prior Exposure ◽  
Retrospective Evaluation ◽  
Intravascular Hemolysis ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Marketing Data ◽  
Surveillance Database

Abstract Abstract 4670 BACKGROUND: Acute hemolytic reactions (AHR) associated with administration of Rho (D) Immune Globulin (RhIG; WinRho® SDF, Cangene Corporation, Winnipeg, Canada) have been infrequently reported during the previous 16 years. AHR were defined as any case reported with signs of hemolysis (hemoglobin decrease, haptoglobin decrease, LDH increase, elevation of bilirubin, etc.) occurring within hours to a number of days after RhIG administration irrespective of the degree of change from baseline. Intravascular hemolysis (IVH) was defined as a specific type of AHR in which plasma or urinary hemoglobin were positive. The reporting rate of AHR (including IVH) among RhIG-treated patients was previously estimated as 1/946 doses (0.11%), while the estimated reporting rate of IVH was 1/3,271 doses (0.03%).1 Reports surrounding the clinical monitoring of such patients have led to the analysis of AHR post-marketing data. AIMS/PURPOSE: Identify the onset of AHR/IVH symptoms relative to RhIG and determine if prior exposure to RhIG mitigates the risk of such events. METHODS: Retrospective evaluation of AHR (AEs reported with signs of hemolysis; including IVH) from the Cangene post-marketing surveillance database. RESULTS: CONCLUSION: Of the ITP patients who developed IVH, 40% reported an onset of symptoms within 4 hours of RhIG infusion; an additional 10% reported symptoms within 8 hours. The symptom onset was unidentified in 18% of IVH cases. In addition, previous uneventful administration of RhIG did not preclude the possibility of an occurrence of IVH and its complications following subsequent administration of RhIG; however, the majority (approx 84%) of reports of IVH were among RhIG naïve patients. Disclosures: Muller: Cangene: Employment. Little:Cangene: Employment. Hess:Cangene: Employment. Sinclair:Cangene: Employment.

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

FUTURE PERSPECTIVES OF PHARMACOVIGILANCE IN ACCORDANCE WITH CURRENT

2018 ◽  
Vol 5 (01) ◽  
Author(s):  
Rajeshwar Verma ◽  
Shubham Bhardwaj ◽  
Romil Sharma ◽  
Vimal Arora
Keyword(s):  
Spontaneous Reporting ◽  
Adverse Drug Events ◽  
Pv System ◽  
Post Marketing ◽  
Current Scenario ◽  
Regulatory Bodies ◽  
Marketing Data ◽  
Pharmaceutical Industries ◽  
Drug Adverse Effect ◽  
Regular Training

India’s participation in multinational trials has increased in past few years. This review article provides information regarding overview of the Pharmacovigilance (PV) system in India, focusing on the current scenario, its development and the challenges faced shows PV will lead robust of its tremendous effect in upcoming future. PV in India relies mainly upon the spontaneous reporting of adverse drug events and there is an improvement in the number of given reports after regular training and awareness programmes. To increase the post marketing data collection of drug adverse effect pharnacovigilance programme of India has taken an initiative by launching a toll free number for consumers to report. Actually a change in way of thinking is necessary for doctor-Pharmacist, patients, regulatory bodies and pharmaceutical industries. Pharmacovigilance will provide a better and improved future of pharmaceutical industry alongwith carrier opportunities.

scholarly journals A COMPARATIVE STUDY FOR THE QUANTITATIVE DETERMINATION OF DIFFERENT BRANDS OF PARACETAMOL TABLET USING UV-VISIBLE SPECTROPHOTOMETRIC, POTENTIOMETRIC AND TRIMETRIC METHODS.

2019 ◽  
Vol 8 (4) ◽  
Author(s):  
Dr. Tamiru Tilki ◽  
Prof (Dr.) Vijender Singh ◽  
Hema Arya
Keyword(s):  
Quantitative Determination ◽  
Internal Quality ◽  
Weight Variation ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Pharmaceutical Industries ◽  
Uv Visible ◽  
The Government ◽  
Paracetamol Tablet

Paracetamol (acetaminophen) is a widely used over-the-counter analgesic, antipyretic and a mild anti inflammatory drug. In several developing countries some of pharmaceutical industries sale fake, counterfeit and substandard drugs which affect the health of people. The present study investigates the comparison for the quantitative determination of various brands of paracetamol tablet using UV-Visible spectrophotometric, potentiometric and trimetric methods. Four brands (Pacimol, Paracip, Parazest, and Crocin) of paracetamol tablets having 500 mg strength were purchased from various pharmacy shops within Pari chowk and Jagat market in Greater Noida, India. Weight variation test was performed before the assay of paracetamol samples. The result of tablets weight variation (Mean ± S.D) of Crocin, Parazest, Paracip and Pacimol brand was 0.66 ± 0.014, 0.64 ± 0.010, 0.58 ± 0.007 and 0.55 ± 0.009 respectively. All brands showed different mean weight which indicates the use of different excipients in the different brands. The ranges of the amount of paracetamol content (g/tab) for paracetamol samples analyzed using UV-Visible spectrophotometric, potentiometric and trimetric methods were from 0.49195-0.52010, 0.48300-0.52100 and 0.48106-0.50110 respectively. The results indicated that all four brands of paracetamol tablets have sufficient quantity and amount is approximately similar to the company’s recommended or claimed value. Similarly, the ranges of percentage content (assay) of the analyzed samples using UV-Visible spectrophotometric, potentiometric and trimetric methods were from 98.69-104.20%, 96.60-104.20%, and 96.21-100.22% respectively. The assay results indicated that variation among all brands and this may show that different manufacturer formulates the different brands are under the IP specification. However, all of the brands of the tablets under the study were complied with the IP specification and passed for weight variation test and assay conducted on it. Hence, the drug control authority of the government should be continuously monitored the safety, quality, and efficacy of paracetamol tablet through post marketing surveillance practices, and the proper internal quality control of the pharmaceutical companies need to take further necessary steps to ensure the continuity in the establishment of the product quantity and quality. Keywords: Assay, Brands, Comparative, Determination, Paracetamol, Tablets

Hardships of drugs monitoring – Ambiguities in pharmacovigilance (PV) rules 2018 and guidelines 2019 in the Pakistan

2021 ◽  
Author(s):  
Nazish Abbas ◽  
Rawshan Jabeen
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Self Medication ◽  
Over The Counter ◽  
Healthcare Settings ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Pharmaceutical Industries ◽  
The Government ◽  
Very High

Introduction: Pharmacovigilance is the monitoring of drugs in and after post marketing surveillance phase of drug development and clinical trials. The phases in clinical trials is restricted to a certain population size under some conditions therefore all effects of medicine which is under trials is limited to the involved participants and it needs to be monitored through a constant channel later for eliminating the adverse events of drugs, when it is ready to be used by general consumers. In a country like Pakistan where self-medication and over the counter (OTC) medicine rate is already very high 25-75%, the regulations to control this health threat is weak due to the weak regulations. This paper is aimed to address the critical analysis on the pipeline draft of Pharmacovigilance Rules 2018 and Guidelines 2019 of Pakistan. Methodology and Rationale: The qualitative document analysis has been done by using National PV guidelines and Rules 2018 draft of Pakistan. The culture of reporting adverse events of medicines in Pakistan is not followed because of no awareness and no PV training of Pharmacists and Physicians in healthcare settings who could disseminate PV and understand the need of this hence. Pharmaceutical industries also do not adopt and accept this subject properly because of no regulations by the government and regulatory authorities. They do not have proper workforce and departments for PV.  

scholarly journals Safety Profile of Recommended Vaccinations in Adolescents: Data from Surveillance of Adverse Events Following Immunization in Puglia (Italy), 2016–2020

Vaccines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1302
Author(s):  
Antonio Di Lorenzo ◽  
Francesco Paolo Bianchi ◽  
Andrea Martinelli ◽  
Sabrina Lattanzio ◽  
Antonella Carbonara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Causality Assessment ◽  
Real Life ◽  
Study Data ◽  
Reporting Rate ◽  
World Health ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Health Organization

Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization (AEFIs) is recommended by the World Health Organization (WHO) to better understand the safety of these drugs. This report describes AEFIs notified in Puglia (Italy) after recommended vaccinations in adolescents aged 12 to 18 years in 2016–2020 to determine the safety profile of these products in a real-life scenario. This is a retrospective observational study. Data were gathered from the list of AEFIs notified in subjects between 12 and 18 years of age following administration of recommended vaccines in Puglia in 2016–2020. AEFIs were classified according to the WHO’s decisional algorithm, and causality assessment was carried out for serious AEFIs. From 2016 to 2020, 323,627 doses of vaccine were administered to adolescents in Puglia and 50 AEFIs were reported (reporting rate: 15.4 × 100,000 doses). Of these, 17 (34.0%) were classified as serious, and causality assessment identified 13 of them (76.5%) as vaccine related. The most common symptoms were local reactions, fever and neurological symptoms. No deaths were notified. The benefits of immunization in adolescents appear to be greater than the risk of AEFIs for all studied vaccines; in fact, AEFIs occur in less than 0.1‰ of patients and are generally mild and self-limiting.

scholarly journals Role of Pharmacovigilance in India: An overview

2015 ◽  
Vol 7 (2) ◽  
Author(s):  
Sanvidhan G Suke ◽  
Prabhat Kosta ◽  
Harsh Negi
Keyword(s):  
Clinical Trials ◽  
Safety Information ◽  
Collective Responsibility ◽  
Scientific Data ◽  
Biomedical Literature ◽  
Pv System ◽  
Spontaneous Reports ◽  
Post Marketing Surveillance ◽  
Patient Reported ◽  
Post Marketing

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication, ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due  to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, product safety PV helps to the patients get well, and to manage optimally, or ideally avoid, illness is a collective responsibility of industry, drug regulators, and clinicians and other healthcare professionals. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.Keywords: Pharmacovigilance; Adverse drug reaction; Clinical trials; Pharmacogenomics; Data mining; Indian Pharmacopoeia Commission

scholarly journals An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems

2021 ◽  
Vol 12 (4) ◽  
pp. 8
Author(s):  
Manal Mohammed Younus ◽  
Ali Azeez Al-Jumaili
Keyword(s):  
Safety Monitoring ◽  
Vaccine Safety ◽  
Lessons Learned ◽  
Surveillance Systems ◽  
Real World Data ◽  
Post Marketing Surveillance ◽  
The World ◽  
Post Marketing ◽  
Data Surveillance ◽  
Tools And Methods

The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization (AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.

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