Signal Detection - An Imperative Activity of Pharmacovigilance

The Professional Medical Journal

The solution for safe and rational medication use to improve patient care aswell as to enhance public health status is Pharmacovigilance (PV). Optimal care of patientand appropriate medication utilization in secure way with respect to various conditions is animperative function of pharmacovigilance system. PV mainly involves in the adverse drugreactions (ADRs) identification, system of reporting, scrutinizes the effectiveness of treatment,reduces the adverse consequences to utmost level and guarantees the patient wellbeing.The safety of drug is highly essential factor when it comes from the healthcare provider to thepatient. For a drug to be successful in market, it is crucial for it to be efficacious as well as safeand secure for the patients. Hence, adherence toward pharmacovigilance activities and systemis now based on a paradigm change from care to safety.

Journal of Drug Delivery and Therapeutics

Pharmacovigilance outlined by the globe Health Organization (WHO) because the science and series of activities about the detection, evaluation, understanding rejection of adverse impact or Associate in Nursing different drug connected problem’ and a clinical test could be an analysis study in human volunteers to answer specific health queries. Fastidiously conducted clinical trials square measure quickest and safest thanks to realizing treatment that employment in individuals and thanks to improving health. Play a crucial role in guaranteeing that patient to be provided the safe drug. The Pharmacovigilance has been recognizing to play a crucial role in the rational use of the drug by providing data concerning the adverse impact possess by drug normally population. The information of drug Adverse Drug Reaction (ADRs) are often increased by numerous suggests that such information studies, intensive observation, spontaneous reportage and different new method at dictatorial and scienti...

Medicines cannot be claimed as absolutely safe for all people, in all places & at all times.Adverse drug reactions are one of he major cause of death in a hospital. Clinical Research without ensuring patient safety is unethical. Various studies suggest that irrational use of traditional medicines and procedures may lead to negative or dangerous effects. The drugs were studied in ancient days according to their Properties, Uses, Dose, Drug Reactions / Side Effects, their Management, Compatibilities & Incompatibilities; Interactions etc.The Pharmacovigilance system is prevalent from ancient days. Validation with suitable documentation is the need of the hour. Adverse Drug Reactions are the integral part of drug Pharmacology. Traditional Medicine is presumed to be Natural, Safe even in Long term usage..Pharmacovigilance includes drug and Therapeutic procedures (Varmam & Thokkanam, Karanool, Detoxification procedures in Siddha).

International Journal of Advanced Research, 2020

Pharmacovigilance, defined by the World Health Organization as ‘the science and series of activities relating to the detection, evaluation, understanding and avoidance of adverse effects or any other drug-related problem’ plays an important role in ensuring that patients be given safe drugs. The knowledge of a drug’s Adverse Drug Reactions (ADRs) can be augmented by various means such database studies, intensive monitoring, spontaneous reporting, and other new processes at dictatorial and a scientific level are being developed with the intention of escalation pharmacovigilance. On dictatorial level, these include risk management plans and conditional approval and on scientific level, increased patient involvement and transparency are two vital elements. The main objective of review is to unfold various aspects of pharmacovigilance including new methodological developments.

Indian journal of pharmacology

Pharmacovigilance programmes monitor and help safeguarding the use of medicines which is grave to the success of public health programmes. Identifying new possible risks and developing risk minimization action plans to prevent or ease these risks is at the heart of all pharmacovigilance activities throughout the product lifecycle. In this paper we examine the use of data mining algorithms to identify signals from adverse events reported. The capabilities include screening, data mining and frequency tabulation for potential signals, including signal estimation using established statistical signal detection methods. We have standard processes, algorithms and follow current requirements for signal detection and risk management activities.

… and drug safety, 2007

Objectives To applies three different methods of signal detection to the registered adverse events in Iranian Pharmacovigilance database over the period of 1998-2005. Methods All adverse drug reactions (ADRs) reported to Iranian Pharmacovigilance Center (IPC) from March 1998 through January 2005, were used for the analysis. The data were analysed based on three different signal detection methods including reporting odds ratios (RORs), information component (IC) and proportional reporting ratios (PRRs). The signals detected were categorised based on the number of reports per drug-adverse event combination, severity of the event and labelled or unlabelled ADRs. Results During the study period, 6353 cases of ADR reports describing 11 130 reactions were received by IPC. The dataset involved 4975 drug-adverse event combinations. The count of drug-event combinations was 1, 2 and 3 or more for 3470, 726 and 779 combinations, respectively. According to PRRs, there were 2838, 872 and 488 drug-event combinations known as a signal for the pairs with the reporting frequency of 1, 2 and 3 reports, respectively. The results of estimating RORs showed that 2722, 862 and 481 drug-adverse event combinations were detected to be signal for the pairs with the reporting frequency of 1, 2 and 3 reports, respectively, while measuring IC and IC-2SD detected 1120, 378 and 235 for the same reporting frequencies. Diclofenac-induced paralysis and tramadol-induced severe reactions were the most important signals. Conclusion Applying quantitative signal detection methods to the database of national pharmacovigilance centres is necessary to early detection of drug safety alerts.

Clinical Pharmacology & Therapeutics, 2010

The detection and reporting of serious adverse drug reactions (SADRs) have become important components of monitoring and evaluation activities performed in hospitals. We present the implementation of a prospective pharmacovigilance program based on automatic laboratory signals (ALSs) at a hospital. We also report the general findings after the first year of operation of the program, which involved ALSs that indicate various SADRs: agranulocytosis, aplastic anemia, liver injury, thrombocytopenia, hyponatremia, and rhabdomyolysis. The number of hospitalizations during the year was 54,525, and 1,732 patients experienced at least one ALS. The review of electronic medical records (EMRs) showed that no alternative cause (i.e., no non-SADR explanation) for the ALS was identified in 520 (30%) of the patients. After the individual ALS-patient evaluation, a total of 110 SADRs (6.35% of those identified after reviewing EMRs and 21.15% of those requiring individual patient evaluations) were identified. In other words, in order to identify a single SADR, we had to review the electronic records of approximately 16 patients and personally visit 5 patients.

International Journal of Basic & Clinical Pharmacology, 2018

Background: Pharmacovigilance is of core importance for the prevention of adverse effect by signal generation. It developed as a science and Practice. Central database collecting international reports helpful in generating signals, improving safety profile, prevention of future adverse effects, thus provide a key data to national drug regulatory to make regulation. It is not only a science but act as a law and regulation. Underreporting of ADRs by healthcare professionals remains a major problem. Clinician’s collaboration is needed to come up with the challenges of underreporting. Spontaneous reporting plays a cardinal role in Pharmacovigilance practice.Methods: Cross Sectional, questioner-based study, 56- postgraduates, 42- first year,60- Second year, 35- Third year students of Institute of Medical Sciences were included with prior consent and Ethical committee permission. Structured pre-test questioner on, Knowledge-10, Attitude-02, Practice-06 were asked. Seminar was conducted on...