A vigilancia farmacológica no cenário brasileiro do sáculo 21 / Pharmacological surveillance in the Brazilian scenario of the 21st century / La vigilancia farmacológica en el escenario brasileño del siglo XXI

Resumo Os estudos em vigilancia farmacológica e ecofarmacológicas possibilitam o monitoramento, identificagao e minimi-zagao de efeitos nocivos advindos do uso de medicamentos. Diante disso, o presente estudo teve como objetivo descrever o cenário atual da farmacoepidemiologia e ecofarmacovigilancia no Brasil, no que se refere a produgao, registro, comerciali-zagao e uso de medicamentos. Foi realizado um levantamento sistemático, através dos bancos de dados PubMed/Medline, Lilacs e SciELO, cuja temática envolveu pesquisas em farmacoeconomia, farmacovigilancia, ecofarmacovigilancia e estudo da utilizagao de medicamentos no Brasil de 2001 a 2019. As publicagóes distribuíram-se de forma desigual entre as regióes brasileiras. Pacientes hipertensos, oncológicos e as gestantes foram os grupos de risco mais citados e os antimicrobianos, psicotrópicos e antineoplásicos os grupos farmacológicos mais discutidos. Custo de cuidados em saúde foi a temática mais abordada no contexto da farmacoeconomia e grande parte dos trabalhos destinou-se a análise e obtengao de dados referentes ao uso de medicamentos e suas reagóes adversas. Em relagao a ecofarmacovigilancia nao foram encontradas publicagóes no Brasil que contemplem essa área. Apesar dos avangos da legislagao farmacoepidemiológica e melhorias nos processos de fiscalizagao, no que tange a vigilancia da produgao, registro, comercializagao e uso de medicamentos, ainda permanecem carencias, quanto ao aporte de uma visao científica direcionada, sobretudo ao gerenciamento e diferentes usos dos recursos terapéuticos, e económicos do sistema de saúde brasileiro, bem como uma visao ambiental referente ao uso de medicamentos.

Abstract Studies in pharmacological and ecopharmacological surveillance make it possible to monitor, identify and minimize harmful effects arising from the use of drugs. Therefore, the present study aimed to describe the current scenario of pharmacoepidemiology and ecopharmacovigilance in Brazil, about the production, registration, marketing, and use of medicines. A systematic survey was carried out through the PubMed/Medline, Lilacs, and SciELO databases, whose theme involved research in pharmacoeconomics, pharmacovigilance, ecopharmacovigilance, and the study of drug use in Brazil from 2001 to 2019. Publications were unevenly distributed between Brazilian regions. Hypertensive patients, cancer patients, and pregnant women were the most cited risk groups, and antimicrobials, psychotropics, and antineoplastics were the most discussed pharmacological groups. Cost of health care was the most discussed topic in the context of pharmacoeconomics and most of the work was aimed at analyzing and obtaining data regarding the use of drugs and their adverse reactions. Regarding ecopharmacovigilance, no publications were found in Brazil covering this area. Despite advances in pharmacoepidemiological legislation and improvements in inspection processes, regarding the surveillance of the production, registration, commercialization, and use of medicines, there are still gaps regarding the contribution of a directed scientific vision, especially to the management and different uses of resources. therapeutic and economic aspects of the Brazilian health system, as well as an environmental vision regarding the use of medicines.

Resumen Los estudios de vigilancia farmacológica y ecofarmacológica permiten controlar, identificar y minimizar los efectos nocivos derivados del uso de los medicamentos. Ante esto, el presente estudio tuvo como objetivo describir el escenario actual de la farmacoepidemiología y la ecofarmacovigilancia en Brasil, en relación con la producción, el registro, la comercialización y el uso de los medicamentos. Se realizó una encuesta sistemática, a través de las bases de datos PubMed/Medline, Lilacs y SciELO, cuya temática involucró investigaciones sobre farmacoepidemiología, farmacovigilancia, ecofarmacovigilancia y estudio del uso de medicamentos en Brasil desde 2001 hasta 2019. Las publicaciones se distribuyeron de forma desigual entre las regiones brasileñas. Los pacientes hipertensos, los pacientes oncológicos y las mujeres embarazadas fueron los grupos de riesgo más citados y los antimicrobianos, los psicotrópicos y los antineoplásicos fueron los grupos farmacológicos más discutidos. El coste de la asistencia sanitaria fue el tema más abordado en el contexto de la farmacoeconomía y la mayoría de los trabajos estaban dirigidos a analizar y obtener datos sobre el uso de los medicamentos y sus reacciones adversas. En cuanto a la ecofarmacovigilancia, no se encontraron publicaciones en Brasil que aborden esta área. A pesar de los avances en la legislación farmacoepidemiológica y de las mejoras en los procesos de inspección, en lo que respecta a la vigilancia de la producción, registro, comercialización y uso de los medicamentos, todavía falta una visión científica dirigida, sobre todo, a la gestión y a los diferentes usos de los recursos terapéuticos y económicos del sistema de salud brasileño, así como una visión ambiental en cuanto al uso de los medicamentos.

A study to assess the knowledge and awareness regarding safe disposal of pharmaceutical wastes among 2nd year medical and para-medical students in a tertiary care teaching hospital in North India

Background: The use of pharmaceutical products in our day to day life is escalating and one cannot deny their presence in every household. Unfortunately not all the medicines that reach our homes get consumed. Unused, unwanted and expired drugs get accumulated over time and are generally disposed along with other household trash thus contributing to environmental pollution. This turns our attention towards the significance of eco-pharmacovigilance. Assessing the level of knowledge and awareness of students under training as health care professionals regarding safe disposal of pharmaceutical wastes can help us to partly assess the magnitude of the problem of inappropriate disposal methods and help us to plan and initiate steps to prevent the hazards caused by improper disposal of these items.Methods: A questionnaire based cross-sectional study was conducted among medical and paramedical students of a tertiary care teaching hospital using a pre-validated questionnaire from previous studies.Results: Majority of the participants were not aware of the possible hazards of improper disposal of pharmaceutical wastes. They expressed the need for awareness programs regarding the subject.Conclusions: The study revealed the practice of drug accumulation at home. The disposal methods opted by the participants were not the recommended methods. There is a need to address this issue through awareness programs at various levels.

A study on awareness regarding disposal of unused medicines among consumers at a tertiary care teaching hospital of North India

Background: In the recent years, large number of human pharmaceuticals have been introduced to the environment by landfill when household medications are thrown to trash and liquid medications gain access to the environment via liquid drainage systems. There is lack of knowledge and awareness in the general public regarding the safe disposal of unused and expired medicines. The objective was to assess the awareness regarding disposal of unused medicines among consumers at a tertiary care teaching hospital of north IndiaMethods: It was a cross-sectional observational questionnaire-based study carried out on 220 consumers in medicine outpatient department (OPD) of a tertiary care teaching hospital in North India for 3 months. All the participants were provided the pre-validated self-administered questionnaire. The final questionnaire consisted of twelve questions to assess participants’ knowledge and attitude towards disposal of the medicines. The data was analyzed with the help of descriptive statistics.Results: It is quite evident from the present study that majority of participants 56.36% stated 1-5 drugs were left-over drugs at their homes. Most of the leftover medicines were analgesics in 59.1% followed by antibiotics in 51.36%. Most common dosage form of these leftover medicines were tablets in 85.9% of respondents. Majority of the respondents (55.9%) were not aware of the adverse outcomes of the pharmaceuticals in the environment. The most common method followed by majority of the participants for disposing of the solid, semi-solid and liquid dosage forms was garbage in 95%, 91.4% and 76.4% of consumers respectively. About 9.31% of the participants were in favour of initiating a program to collect unused medications from home.Conclusions: It can be concluded from the present study that the consumers had poor knowledge regarding the safe drug disposal techniques. Therefore, efforts need to be done by the health care professionals to make people educate regarding the safe drug disposal techniques.

Environmental pharmacology: an emerging science

With continuous rapid expansion of the human population there is escalating demand for resources, including human and veterinary pharmaceuticals. This has lead to rapid development of global pharmaceutical industry and with that increase in issues caused by pharmaceutical products. In recent years a great concern has been expressed over the occurrence and persistence of pharmaceutical products in the environment and their potential impact on environment. Owing to this the new branch of science called environmental pharmacology has sprouted. Environmental pharmacology deals with dispersion and impact of pharmaceutical products on environment. Solutions need to be suggested to save this only liveable planet from ill effects of these pharmaceutical products. This has given birth to the science of Ecopharmacovigilance (EPV).