China Hospital Pharmacovigilance System-based study of trimetazidine-associated Parkinson's syndrome / 中国基层医药

Objective:To evaluate the active monitoring methods and population characteristics of trimetazidine-associated Parkinson's syndrome.Methods:The clinical data of patients with trimetazidine-associated Parkinson's syndrome who received treatment in Liaocheng People's Hospital from January 2019 to December 2020 were retrospectively analyzed using the China Hospital Pharmacovigilance System (CHPS).Results:In 4 883 patients included in the study,167 patients were alarmed by CHPS, of which 26 patients were confirmed positive by manual rechecks. The rate of positive pre-alarming by CHPS was 15.57%. The actual incidence of trimetazidine-associated Parkinson's syndrome was 0.53%. The average age of the 26 patients with Parkinson's syndrome was (75.08 ± 10.79) years. None of the 26 patients had a past history/family history of idiopathic Parkinson's disease. There were 21 patients (80.77%) aged over 65 years, 19 patients (73.08%) with a history of ischemic encephalopathy, 17 patients (65.38%) with positive symptoms in both limbs, 20 patients (76.92%) with abnormal brain CT or MRI findings, and 21 patients (80.77%) with medication doses of 60-70 mg/d. Among the 26 patients, 18 were female patients (69.23%) and 18 were patients with normal renal function (69.23%). The follow-up results showed that trimetazidine administration was not terminated in 14 patients (53.85%), symptoms were not alleviated or worsened in 8 patients (30.77%), and symptoms were alleviated or disappeared in 18 patients (69.23%).Conclusion:The use of CHPS can timely detect trimetazidine-associated Parkinson's syndrome. CHPS has significant advantages over traditional monitoring modes. Age > 65 years and a previous history of ischemic encephalopathy are risk factors for developing trimetazidine-associated Parkinson's syndrome. No history/family history of idiopathic Parkinson's disease, positive Alzheimer's disease symptoms in both limbs and abnormal brain CT and MRI findings contribute to early diagnosis and differentiation of trimetazidine- associated Parkinson's syndrome. Trimetazidine-associated Parkinson's syndrome is more common in women than in men. Trimetazidine-associated Parkinson's syndrome can also occur in a population with normal renal function or under a normal trimetazidine dose condition. Trimetazidine-associated Parkinson's syndrome is relatively rare. Patients with trimetazidine- associated Parkinson's syndrome have low awareness. Because of the difficult diagnosis and serious consequences, there is a need to strengthen research on trimetazidine-associated Parkinson's syndrome.

Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine / 中国中药杂志

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.

Farmacovigilancia: conocimiento básico de los profesionales de salud del primer nivel de atención / Pharmacovigilance: basic knowledge of health professionals of the first level of care

Se realizó un estudio de tipo observacional descriptivo, de corte transversal con el fin de determinar el grado de conocimiento básico sobre la Farmacovigilancia en los profesionales de salud que trabajan en los establecimientos de salud de primer nivel del área urbana del Municipio de Sucre - Bolivia, en el año 2019. La muestra está representada por 35 establecimientos de salud de primer nivel del área urbana del Municipio de Sucre. El presente estudio se realizó en 2 etapas. La primera etapa donde se desarrolló un cuestionario autoadministrado y en la segunda etapa se realizó la encuesta; donde solo 76 profesionales quisieron participar del estudio. Se descartaron 2 cuestionarios por diversos motivos (información incompleta), quedando así, solo 74 cuestionarios que se incluyeron en el estudio. En las consideraciones éticas se determinó por los investigadores que no era necesario el llenado de un consentimiento informado. De los datos obtenidos se observó que el conocimiento básico sobre Farmacovigilancia de los profesionales de salud que trabajan en los establecimientos de salud de primer nivel del área urbana del Municipio de Sucre, en el año 2019 se ubica en un grado medio.

A descriptive, cross-sectional observational study was carried out in order to determine the degree of basic knowledge about Pharmacovigilance in health professionals working in the first level health establishments of the urban area of the Municipality of Sucre - Bolivia, in the year 2019. The sample is represented by 35 first level health facilities in the urban area of the Municipality of Sucre. The present study was carried out in 2 stages. The first stage where a self-administered questionnaire was developed and in the second stage the survey was conducted; where only 76 professionals wanted to participate in the study. Two questionnaires were discarded for various reasons (incomplete information), leaving only 74 questionnaires that were included in the study. In the ethical considerations it was determined by the researchers that it was not necessary to fill out an informed consent. From the data obtained, it was observed that the basic knowledge about Pharmacovigilance of health professionals working in the first level health establishments of the urban area of the Municipality of Sucre, in 2019 is located in a medium degree.

Análisis del sitema de farmacovigilancia en Venezuela: Aplicación de los indicadores recomendados por la Organización Mundial de la Salud / Analysis of the pharmacovigilance system in Venezuela: Application of the indicators recommended by the World Health Organization

Internacionalmente las actividades de farmacovigilancia han incrementado su presencia, aunque no existe un conceso sobre el óptimo funcionamiento de un sistema de farmacovigilancia diversos países y organizaciones han implementado estrategias para mejorarlos y alcanzar así al uso seguro y racional de los medicamentos. Los elementos utilizados para el desarrollo y evaluación del sistema de farmacovigilancia venezolano podrían ser insuficientes antes las expectativas actuales, por ello, esta investigación pretende evaluarlo a través de los indicadores más recientes sugeridos por la Organización Mundial de la Salud. La evaluación se enfocó en el año 2015, a partir del 2016 fueron revisados los registros, documentos oficiales, normas y leyes relevantes procesando los datos según cada caso y tabulándolos para su presentación. Los resultados sugieren la presencia de un soporte estructural para la vigilancia pasiva con alto compromiso hacia la imputación de los casos y el Programa Internacional de Monitoreo de Medicamentos aunque existen debilidades relacionadas al alcance, vigilancia activa, detección de señales, integración de los Programas de Salud Pública, soporte de un Comité Asesor de Farmacovigilancia, calidad de los reportes, participación de los profesionales de la salud, representatividad de la información de seguridad y compromiso de las compañías farmacéuticas. Se recomienda la incorporación de estos indicadores para una evaluación sistemática del sistema de farmacovigilancia así como para medir el impacto de las intervenciones realizadas, de igual forma es necesario atender las debilidades encontradas

The pharmacovigilance activities have increased their presence internationally, although there is no consensus about the optimum performance of pharmacovigilance systems, several countries and organizations have implemented strategies for improve them and achieve the safety and rational use of medicines. The elements used for the development and evaluation of the venezuelan pharmacovigilance system may be insufficient in the face of currents expectations. Thus, this investigation aims to evaluate it through the most recent indicators suggested by the World Health Organization. The evaluation focused on the year 2015, from march 2016 were reviewed relevant records, official documents, norms and laws processing the data according each case and tabulating it for its presentation. The results suggest the presence of a structural support for the passive surveillance whit a high commitment toward the case imputation and the WHO Programme for International Drug Monitoring although there are weaknesses related to active surveillance, signal detection, Public Health Programme integration, pharmacovigilance advisory committee support, reports quality, health care professionals' participation, safety information representativeness and pharmaceutical companies commitment. It is recommended the incorporation of these indicators for a systematic evaluation of the pharmacovigilance system as well as measure the impact of performed interventions, similarly it is necessary to attend the weakness detected

Research and Application of the Sentinel Hospital Pharmacovigilance System Based on HIS / 中国药房

OBJECTIVE:To introduce the research and application of sentinel hospital pharmacovigilance system,and provide technical reference for hospital pharmacovigilance working in China. METHODS:A sentinel hospital pharmacovigilance system based on hospital information system was established,the architecture and functionality were introduced and its effects were ana-lyzed. RESULTS:The sentinel hospital pharmacovigilance system formed by hospital business information management platform and data center. Its main functions included drug data arrangement,the auxiliary reporting of ADR,active monitoring,pharmaco-vigilance information inquiry,monitoring and warning and statistical analysis,which successfully achieved the rapid reporting and active monitoring of hospital ADR. The system had applied in 20 sentinel hospitals,and the ADR reporting quantity was obviously increased after applying the system. Compared with 2015,ADR reporting in a sample sentinel hospital was increased 120.6％ since it used the system in early 2016. Besides,the system had improved the ADR reporting process,operation and input standard for the ADR reporter,shortened the reporting time and improved the efficiency of the reporting staff. CONCLUSIONS:The establish-ment and application of sentinel hospital pharmacovigilance system has greatly improved the hospital ADR monitoring management level,and it is of great significance to further strengthen the pharmaovigilance in China.

Pharmacovigilance Systems in Europe and US and Its Implication for China / 中国药房

OBJECTIVE:To provide suggestions for the setting-up of the current pharmacovigilance(PV)system.METHODS:The characteristics of the setup of the PV system in both US and France were analyzed and the problems encountered in current monitoring system of adverse drug effects were pointed out.RESULTS & CONCLUSION:Both American and French PV systems have their own advantages and we should learn from it and draw useful experiences from them.In constructing PV system,China should make improvement in organization,communication,financial resource and information technology etc.