Pharmacovigilance – The science in public welfare
Pharmacovigilance defined as the process or activities relating to the detection, assessment, understanding, and prevention of adverse effects and responding to drug- safety related problems. Pharmacovigilance is related to a number of scientific disciplines, the most important being clinical medicine, clinical and pre-clinical pharmacology, immunology, toxicology and epidemiology. Different countries and regions across the globe witness varied patterns in drug effects and reactions. This forms an essential system for adverse event monitoring of the newly marketed & existing pharmaceutical products. It is practiced to ensure the quality of medicines is maintained and to safeguard public interest to prevent any harm to the Patients. This occurs due to differences in diseases, genetics, diet, prescribing practice, local traditions and drug manufacturing process impacting its quality. Few of these effects are untoward and noxious termed as adverse events. Such events are unwelcomed not only for patients but also for manufactures. Since, regulatory authorities keep a close eye on these occurrences even after the marketing approval of a drug and may take preventive steps to ensure public safety which might even include withdrawal of drug from market.
Pharmacovigilance is practiced under the regulatory norms lay down by authorities’ viz European Medicines Agency, in Europe, MHRA in UK and FDA in United States. In India, the pharmacovigilance efforts are in progress as instituted by the CDSCO. Pharmacovigilance is a vast process dealing with health aspects and companies opt for outsourcing in order to ensure safety of the patient.
All medicinal products to be authorized for marketing by any regulatory body are subject to a strict testing of quality, efficacy and safety before being marketing approval. Once approved for marketing, drugs continued to be monitored in order to detect any factor which could impact the safety profile of a medicine, which if detected and assessed, the necessary measures are taken to ensure public safety.
Pharmacovigilance involves collection and management of safety data, screening the data to detect any new or changing safety issue, evaluating the data and making decisions with regard to safety issues. The aims of pharmacovigilance within the industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. It also involves communicating with and informing stakeholders and the public about the outcomes of action taken and of the key processes involved. The key element of entire monitoring system is reporting. Reporters involve, patients, healthcare professionals, regulatory authorities responsible for monitoring the safety of medicines, pharmaceutical companies and importing or distributing companies. Adverse event reporting, the activity which consumes most of the time and resources of regulatory authorities or marketing authority involves the receipt, triage, data entering, assessment, distribution, reporting, and archiving of AE data and documentation. Spontaneous AE reports come from healthcare professionals or patients; solicited reports come from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media; and those reported to regulatory authorities are also sources of AE reports.
WorkSure® is a Medpharma outsourcing company which offers impeccable services in pharmacovigilance with profound experience of the team. Our team consists of dedicated, skilled, and experienced physicians, life science professionals, and other clinical professionals experienced in drug safety. We bridge the gap between industry and regulatory bodies to meet the desired requirements economically, within timelines with best owed knowledge.
We offer wide range of services in pharmacovigilance like adverse event and serious adverse event data collection, signal detection & data mining, maintenance of trial data, patient data along with preparing Individual Case Study Report, Periodic Safety Update Report, Periodic Adverse Drug Experience Report, in accordance with the regulatory requirements. Broadly categorized, our services encompass safety management, regulatory reporting, and post-marketing surveillance, as well as technology support.