Avisek Dutta

Pharmaceuticals in the environment have the potential to be hazardous to human beings. With each passing day it is becoming a major source of concern. Due to recent findings showing the availability of pharmaceutical components in the environment, particularly in ground water bodies, pharmaceuticals have gained a growing amount of attention from worldwide health regulatory bodies and have become one of the most significant water pollutants. The aim of this article is to review the environmental hazards of pharmaceuticals that have been reported in various literature sources to promote awareness on safe usage of medicines, to increase pharmaceutical manufacturers’ knowledge on environmental safety aspects and to arrest the attention of pharmacovigilance practitioners to some of the emerging problems caused by medicines. Pharmaceutical waste has been a source of huge concern amongst environmental scientists. Pharmaceutical manufacturers and pharmacovigilance scientists should invest more attention to these increasing environmental concerns caused by medications. Ecopharmacovigilance is defined by the World Health Organization (WHO) as the science and activities concerned with the detection, assessment, understanding, and prevention of adverse events or other related problems caused by pharmaceuticals in the environment that affect people and other animal species. This review is an attempt to compile information on Ecopharmacovilance, with an emphasis on the Indian perspective. Keywords: Pharmacovigilance (PV), Ecopharmacovigilance (EPV), Eco-directed sustainable prescribing (EDSP), Active pharmaceutical ingredients (APIs), Liquid Chromatography-Mass, Spectrometry (LC-MS), Non-steroidal anti-inflammatory drugs (NSAIDs), Environmental Risk Assessment (ERA), Gas Chromatography-Mass, Spectrometry (GC-MS)

The World Health Organization (WHO) defines PV as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems  (WHO 2004). In 1968, during the 16th World Assembly the 16.36 resolution called for “a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use”. This led to the formation of the WHO Programme for International Drug Monitoring (PIDM) in 1968. PV systems should include all entities and resources that protect the public from medicines-related harm (adverse reactions, poor product quality, medication errors, and therapeutic ineffectiveness), whether in personal healthcare or public health services. The PV system safeguards the public through efficient and timely identification, collection, and assessment of medicine-related adverse events and by communicating risks and benefits. The WHO has provided technical and normative leadership on PV since the development of the first voluntary notification scheme in 1961. As of January 2016, 123 countries have joined the WHO PIDM, and in addition 28 associate members are awaiting full membership. WHO has defined norms and guidelines for PV and has allowed information sharing among the participant countries. Another WHO PV-related activity is the work of the Council for International Organizations of Medical Sciences (CIOMS) which was established jointly by WHO and UNESCO in 1949. Starting with the publication of the Suspect Adverse Reaction Report Form (CIOMS Form I) by the CIOMS working group II, other CIOMS publications have greatly shaped the direction of PV. CIOMS publications have also greatly influenced the development of International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use (ICH) E2A-E2F guidelines in drug safety. The standards for the electronic transmission of regulatory information regarding the individual case safety report (ICSR) has been changing over the last decade.  The ICH adopted the E2B (R2) in February 2001 and the E2B (R3) in 2005, is being developed as the proposed harmonized international standards for health products safety reporting. These ICH guidelines have facilitated the adoption of harmonized standards for PV activities. This study contributes to filling the gap in the understanding of the PV systems capacity in Indian and five ASEAN countries namely Malaysia, Singapore, Thailand, Indonesia, and Philippines.  Keywords: PV - Pharmacovigilance, WHO - World Health Organization, ASEAN - Association of Southeast, Asian Nations.

People manager is not a designation or position. It is an attitude to keep an eye on the quality of the mindset of the people. Managing people well is extremely important to achieve goals and objectives at workplace. People management skills can be acquired through experience and observation. Theses kills are positively affected by the attitudes and personalities that the managers develop and apply. This review article presents the essence of people management. While the viewpoints of the human resource management across different levels have been observed, the main skills required for effective people management have also been discussed. The role of social psychology at work is also becoming increasingly important for the people managers especially with the arrivals of the Millennials at workplace and the ongoing new normal where most of the employees worldwide are connected virtually with each other as well as with their leaders. Employees should look up to a people manager as their role model in every aspect at workplace. Keywords: TQP, HR, HRM, FLM, People Manager.

Hemovigilance is defined as the surveillance procedures covering the blood transfusion chain (from the collection of blood and its components to the follow-up of its recipients), intended to collect and assess information on unexpected or undesirable effects. The word hemovigilance is derived from the word pharmacovigilance, which encompasses activities and systems to collect information useful in supervising medicinal products, with particular reference to adverse drug reactions in human beings, and to evaluate such information scientifically. An adverse drug reaction is a response to a drug which is noxious and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. The aim of hemovigilance is to detect and to analyze all untoward effects of blood transfusion in order to correct their cause and to prevent recurrence, and to improve the safety of blood transfusion. Although several reports have been published on adverse events, including transfusion-associated deaths, the relative risk based on the number of actual cases divided by the number of units of blood products issued or transfused, is relatively low. Scope of different hemovigilance systems varies due to differences in spectrum of reporting. Ideally, the hemovigilance system should cover processes throughout the entire transfusion chain, from blood donation, processing, and transfusion to patients for the monitoring, reporting, and investigation of adverse events and reactions and near misses related to blood transfusion. Keywords: Serious Hazards of Transfusion (SHOT), European Hemovigilance Network (EHN), Pharmacovigilance Program of India (PVPI), Hemovigilance Program of India (HvPI), International Hemovigilance Network (IHN).

Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicine which occurs at doses normally used in human being. Pharmacovigilance (PV) is the process to monitor patient safety in practical condition and analyse adverse events during the entire life cycle of a drug beginning from its trial phase to post-marketing of the drug. Before medicines get authorised, they are tested in controlled trial conditions within a smaller population for a limited length of time. Post authorization, drugs are used by a larger population across various geographies without any control in place. So, it is very important to monitor adverse effect caused by these medicines throughout their life cycle in order to identify and minimize risks associated with the use of drug and enhance the knowledge of healthcare professionals. Under reporting is a major obstacle in the PV system. Research shows that the major causes of under reporting are lack of knowledge and awareness among healthcare professionals and also absence of established ADR reporting system in various part of the world. Some other reasons of under-reporting included large number of patients, lower doctor-patient ratio and common practice of self-medication. This article reviews the research done on ADR under-reporting scenario with a focus on the factors leading to this obstacle in PV. Keywords: ADRAdverse Drug Reaction, PVPharmacovigilance, WHOWorld Health Organisation, UMCUppsala Monitoring Centre, AMCADRs Monitoring Centres, AIIMSAll India Institute of Medical, Sciences, CDSCOCentral Drugs Standard, Control Organization, ICSR Individual Case Safety Report, FDA Food and Drug administration, ICH International Conference on  Harmonisation, EMAEuropean Medicines Agency, PRAC Pharmacovigilance Risk, Assessment Committee, PMDA Pharmaceuticals and medical, Device Agency.