Pharmacovigilance & Healthcare Revolution with Era of Internet of Things
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
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Risk management plans
A risk management plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug and/or the FDA, EMA)).
The overall goal of an RMP is to assure a positive risk-benefit profile once the drug is (has been) marketed. The document is required to be submitted, in a specified format, with all new market authorization requests within the European Union (EU). Although not necessarily required, RMPs may also be submitted in countries outside the EU.
Rising Incidences of Adverse Drug Reactions (ADRs)
Adverse drug reactions (ADRs) is an important public health problem, signifying an important cause of illness and death. Because all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. According to the Agency for Healthcare Research and Quality 2018, In the US, 3% to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur from 10% to 20% of admissions; about 10% to 20% of these ADRs are severe.
These statistics do not include the number of ADRs that occur in ambulatory and nursing home patients. Although the exact number of ADRs is not specified, ADRs represent a significant public health problem that is, for the most part, preventable. In 2016, 1,238,178 reports related to suspected adverse reactions were collected and managed in EudraVigilance, 339,544 of which originate from the European Economic Area (EEA).
European database for adverse drug reaction reports, which Member State and the Agency use for monitoring the safety of authorized medicines on the EU market. EudraVigilance now holds 10.8 million reports referring to 6.7 million cases and therefore is one of the most significant adverse drug reaction databases in the world.
Adverse drug reactions (ADRs) reported by a patient or healthcare professional adds to safety monitoring and thus to the safe and effective use of medicines. The increasing amount of data generated through adverse drug reaction report needs to be handled and stored carefully. All these data come in different forms, language, location, etc. To arrange these uniformly the automation systems/software are helpful.