Pharmacovigilance or drug safety in lay man language. Pharmacovigilance is the science that connects to the detection, collection, monitoring, assessment, and prevention of the negative effects of pharmaceutical products. Pharmaceutical vigilance mainly involves the evaluation of information and facts provided by the health care providers. Pharmacovigilance excessively focuses on the adverse reactions of drugs, defined as the response to an unintended and noxious drug. It also includes the inefficiency of the drug. Errors like abuse and overdose of the medication and drug exposure during pregnancy despite the lack of an adverse effect are considered to result in an adverse drug reaction.
Pharmacovigilance is extremely important to determine the usability and the effects of any drug. Any pharmacovigilance service centre undergoes special clinical research training through several clinical research course. This is one of the major departments of any pharmaceutical company. Any pharmacovigilance process mainly consists of four stages.
These stages include:
Pharmacovigilance Detection Process: This is the first stage in the vigilance process of any drug. It begins with the safety information that comes from several sources, which may be either solicited or unsolicited. Those that are received as a result of the targeted data collection form the solicited data sources. These include clinical trials with one or three phases and post-marketing, including interventional and non-interventional studies and research. Solicited sources also include organized systems that have a well-defined public health purpose and a scientific and clinical purpose. Solicited sources also include personalized programs forum-registered drug administration. Unsolicited sources are spontaneous and those which are received without any form of request. These sources generally include regulatory authorities, literature reports, patients and healthcare providers, license providers, internet, journal, books, and other resources.
Pharmacovigilance Assessment Process: After the initial collection of all the required data, ICSR assessment is conducted. This assessment mainly includes:
1. Triage: This phase of potential adverse event report involves the major function of establishing the validity of an ICSR. Any valid ICSR should mainly possess an identifiable patient, an identifiable reporter, suspect drug, and an adverse event.
2. Data Entry: Any pharmaceutical company maintains its own suitable database. After validation, the drug parameters are entered into this safe database. The further steps in data entry include determining seriousness, coding the adverse events, assessing causality, assessing labeling, and concise and legible narrative writing.
3. Questioning Process: Any clarifications and additions discrepancies are raised and cleared during this phase of the assessment.
4. Reviewing: Physicians and other professionals review the safety regulations that emphasize the seriousness, causality, labeling, etc.
5. Closure of the case: The completed report, including all the parameters, is submitted to the required authorities. . Learn Best Clinical Research Course.
Understanding and Analysing the Drug safety profile: The data collected is reviewed and analyzed to understand the safety profile of the drug using a periodic benefit-risk evaluation report which includes data collected from all forms of clinical trials and spontaneous trials for which a risk-benefit analysis is conducted. Particular adverse reaction follow-up queries are used to get structured information on reported suspected adverse reactions. A risk management plan and development safety update report is also made. Signal analysis is also conducted.
Prevention of the negative effects: This phase is the final stage of pharmacovigilance. Performing minimization of risk activities in order to update the summary of the product description, a leaflet of patient information, labeling and packaging, and legal status of the medication is done in this phase. This stage also includes the monitoring of this minimization of risk activities.
Collaboration in the field of pharmacovigilance forms the foundation of the WHO program for international drug monitoring. These reports are generally analyzed locally and could lead to action within the country itself. The WHO program membership of any country helps them keep up with similar researches and reports that are made worldwide. When there are multiple reports of a particular drug, this process may lead to a detection of a signal which could be hazardous to the human body.
Ecopharmocovigilance: Procedures for monitoring the drug concentrations and the ill effects of these drugs on the environment lack despite the FDA. A concept including environmental pharmacology and pharmacovigilance focuses on this domain. The activities of ecopharmacovigilance include increasing the facts available on the environmental effects on the drug, use of environmental risk management plans, tracking new data on the exposure to the environment, risk identification, etc. There are several pharmacovigilance courses that focus on this aspect of the field.