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Does educational intervention change knowledge,attitude,and practice regarding pharmacovigilance among nursing officers in Central India?An interventional study

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Journal of Integrative Nursing 2022年第3期4卷 114-119页

作者： Chaitali Ashish CHINDHALORE Ganesh Natthuji DAKHALE Ashish Vijay GUPTA Department of Pharmacology All India Institute of Medical SciencesNagpurMaharashtraIndia

Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing *** and Methods:A pre-and post-single-arm interventional study was conducted at All India Institute of Medical Sciences(AIIMS),Nagpur from May 2021 to October 2021 among 48 nursing *** related to KAP were obtained through validated questionnaires before and after 3 months of educational ***:The mean knowledge score among nursing officers significantly improved from 11.05±3.09 to 16.77±2.07 after training session(P<0.001).The mean score regarding attitude was significantly upgraded from 21.16±5.6 to 23.79±2.97(P<0.001).At baseline,the mean practice score was poor(2.41±2.89),which was improved after training session,but the difference is not ***:Educational intervention had a significant impact on knowledge and attitude toward ADR *** practice of detecting and reporting an ADR to the treating consultant is improved,but it is not transformed into reporting an ADR to the PV center to a significant ***,it is recommended to streamline ADR reporting process by implementing such training modules more frequently.

关键词： Adverse drug reaction attitude knowledge nursing staff pharmacovigilance practice

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in pharmacovigilance

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Chinese Journal of Integrative Medicine 2021年第11期27卷 832-837页

作者： GE Fei-lin NIU Ming HAN Zi-xin CAO Jun-ling WANG Jia-bo BAI Zhao-fang SONG Hai-bo GUO Yu-ming XIAO Xiao-he School of Chinese Materia Medica Beijing University of Chinese MedicineBeijing100029China Department of Hepatology Fifth Medical Center of Chinese PLA General HospitalBeijing100039China Department of Pharmacy Dongfang Hospital Affiliated to Beijing University of Chinese MedicineBeijing100078China Center for Drug Reevaluation National Medical Products AdministrationBeijing100022China

Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce *** A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December *** and general ADRs were analyzed and *** There were 355 cases of hepatobiliary ADR related to *** the amount of cases and the proportion of serious ADR showed an increasing growth by years(P<0.05).It was found that 10.43%of 355 cases may be involved with irrational drug use,including overdose,repeated medication,and combination of multiple *** were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(P<0.05).The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days,and the median latency was 27.5 days,along with the range of cumulative dose(0.45–520.02 g)as well as the daily dose(0.09–2.64 g/d)after the *** Cases of hepatobiliary ADR related to BGZP showed significant individual differences,and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary *** may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.

关键词： drug safety hepatobiliary adverse drug reaction Psoraleae Fructus pharmacovigilance

Familiarity, Knowledge and Practices of Healthcare Professionals Regarding the pharmacovigilance of Biological Medicines in Lusaka, Zambia: A Multi-Facility Cross-Sectional Study

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Pharmacology & Pharmacy 2022年第7期13卷 230-251页

作者： Michelo Banda Katia Verhamme Webrod Mufwambi Steward Mudenda Billy Chabalenge Scott Kaba Matafwali Ronald Kampamba Mutati Christabel Nang’andu Hikaambo Martin Kampamba Lavina Prashar Department of Pharmacy School of Health Sciences University of Zambia Lusaka Zambia Department of Medical Informatics Erasmus MC Rotterdam Netherlands Department of Bioanalysis Ghent University Ottergemsesteenweg Ghent Belgium Department of Medicines Control Zambia Medicines Regulatory Authority Lusaka Zambia Clinical Research Department Faculty of Infectious and Tropical Diseases London School of Hygiene & Tropical Medicine London UK Department of Physiological Sciences School of Medicine University of Zambia Lusaka Zambia

Background: pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines.

关键词： pharmacovigilance Biological Medicines Biosimilars Brand Batch Zambia

Why pharmacovigilance of traditional medicines used as analgesics is important?

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Traditional Medicine Research 2023年第10期8卷 47-55页

作者： Subhransu Dash Neha Bajwa Abinash Choudhury Preet Amol Singh University Institute of Pharma Sciences Chandigarh UniversityMohali 140413India

Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological *** perceived safety has led to the increasing use of herbs by people without *** therapies remain significant in areas with limited access to modern drugs or cultural preferences for traditional *** a long history of use,traditional medicines have been the primary method of pain *** review article explores natural and herb-based analgesics,their origins,and potential benefits,along with the growing scientific evidence supporting their *** have examined their efficacy in treating musculoskeletal pain,neuropathic pain,and *** than being seen as separate therapies,traditional medicines should be considered supplementary or alternative options that can be integrated into comprehensive pain management ***,some studies have reported adverse drug reactions associated with herbal formulations and ***,there is a need for pharmacovigilance in traditional medicine to ensure patient safety and promote evidence-based *** pharmacovigilance in this field is still developing,it faces challenges due to the wide availability of herbal medicines without on-site medical *** paper discusses the complex challenges of herbal pharmacovigilance,provides insights on recent advancements,and offers recommendations for improving the safety monitoring of traditional medications in the future.

关键词： herbal medicine pharmacovigilance regulatory framework traditional medicine

Comparative Perception of pharmacovigilance by Physicians versus Paramedical Professions in Ivory Coast

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Pharmacology & Pharmacy 2019年第10期10卷 416-426页

作者： Balayssac Eric Adon Auguste Tuo Mamadou Ehouman Mocket Clinical Pharmacology Service University Teaching Hospital of Cocody Abidjan Cte d’Ivoire Department of Biochemistry Physiology and Pharmacology Training and Research Unit of the Medical Sciences of Abidjan Felix Houphouet Boigny University Abidjan Cte d’Ivoire Department of General and Digestive Surgery University Teaching Hospital of Treichville Abidjan Cte d’Ivoire Clinical Research Service Olopam Pharma and Research and Development Abidjan Cte d’Ivoire.

Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectional survey has been conducted in 2017 at the University Teaching Hospital of Cocody. This survey involved a sample of healthcare professionals practicing in 17 services who are prescribing medications and gave their oral consent. Results: A response rate of 54.08% (106/196) among physicians versus 43.87% (86/196) for the nurses and 27.61% (21/76) for the mid-wives. 57.94% (62/107) of paramedics versus 94.33% (100/106) of physicians had already heard about pharmacovigilance, during their basic training (40.18% of paramedics versus 73.58% of doctors). However, the main obstacles to the practice of pharmacovigilance were it teaching hours considered insufficient (94.39% of paramedics versus 75.47% of physicians), the lack of knowledge on the location of the pharmacovigilance unit (80.37% of paramedics versus, 40% of physicians) and the reporting of the adverse drug reactions to a hierarchical supervisor (60.60% of paramedics versus 37.25% of physicians). A regular visit of pharmacovigilance monitors in the hospital services (34.57% of paramedics versus 29.24% of physicians) and the availability of reporting forms (30.84% of paramedics versus 27.35% of physicians) could improve the perception of pharmacovigilance by the healthcare professionals. Conclusion: Our investigational survey has highlighted some factors that may influence the perception of pharmacovigilance by the healthcare professionals in Ivory Coast.

关键词： Perception pharmacovigilance Healthcare Professionals Hospital

Enlightenment from WHO pharmacovigilance in Construction of Chinese Materia Medica pharmacovigilance System

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World Journal of Integrated Traditional and Western Medicine 2018年第3期4卷 40-47页

作者：魏瑞丽谢雁鸣王连心 Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the characteristics of traditional Chinese medicine(TCM). A good job of pharmacovigilance of Chinese materia medica not only helps Chinese pharmaceutical companies to control their risks, but also guides them to use drugs safely and rationally. And it is also of great significance to the national drug regulatory work. Based on the monitoring of herbal safety in WHO pharmacovigilance system, the establishment of a Chinese materia medica pharmacovigilance system was explored in order to provide a valuable reference for the risk control of Chinese pharmaceutical companies, the clinical use of Chinese materia medica, and the national drug regulatory work.

关键词： WHO pharmacovigilance Chinese materia medica pharmacovigilance Adverse drug reaction

Perception of pharmacovigilance by Nurses and Midwives of the Cocody University Teaching Hospital in Abidjan

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Pharmacology & Pharmacy 2019年第11期10卷 474-483页

作者： Balayssac Eric Tadjo Jean Adon Auguste Ehouman Mocket Clinical Pharmacology Service University Teaching Hospital of Cocody Abidjan Ivory Coast Department of Biochemistry Physiology and Pharmacology Training and Research Unit of the Medical Sciences of Abidjan Felix Houphouet Boigny University Abidjan Ivory Coast Department of General and Digestive Surgery University Teaching Hospital of Treichville Abidjan Ivory Coast Clinical Research Service Olopam Pharma and Research and Development Abidjan Ivory Coast

Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents’ main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast.

关键词： Perception pharmacovigilance Nurses Midwives Hospital

Analysis of Adverse Reactions Related to Drugs and Vaccines Received at the National Centre for pharmacovigilance from 2009 to 2016 in Togo

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Pharmacology & Pharmacy 2018年第8期9卷 344-356页

作者： Yao Potchoo Mouhoudine Yerima Tante T. Gnandi Mounerou Mounerou Salou Aboudoulatif Diallo Batoyema Bakoma Atani T. Nyansa Mireille Prince-David Département des Sciences Pharmaceutiques Faculté des Sciences de la Santé Université de Lomé Lomé Togo Direction de la Pharmacie du Médicament et des Laboratoires Ministère de la Santé et de la Protection Sociale Lomé Togo Comité de Bioéthique et de la Recherche en Santé Ministère de la Santé et de la Protection Sociale Lomé Togo

Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.

关键词： Medicines Vaccines Routine Health Care Public Health Program Adverse Events Reporting pharmacovigilance

Antibiotics’ Prescribing and pharmacovigilance Attitudes among Pediatricians and Pediatric Residents in Cyprus

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Pharmacology & Pharmacy 2017年第3期8卷 75-84页

作者： Mary Geitona Aikaterini Toska Dimitra Latsou Maria Saridi Andri Evripidou Iliada Evripidou Department of Social & Educational Policy University of Peloponnese Corinth Greece University of Neapolis Pafos Cyprus

Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most commonly prescribed. Methods: A cross-sectional study was conducted in all public pediatric clinics in the Republic of Cyprus, from April to May 2015. A questionnaire was distributed to pediatricians in order to identify the antibiotic prescription practices in common childhood diseases and attitudes towards pharmacovigilance. The SPSS 19.0 was used for the statistical analysis. In total 42 pediatricians and pediatric residents filled out the questionnaire. Results: A significant percentage of the respondents administered empirical therapy for possible group A streptococcus infection (59.5%), they implemented the “watchful waiting” tactic in acute otitis media (66.7%), whereas 11.9% of them administered antibiotics for the prevention of secondary respiratory tract infections. The majority of physicians did not feel diagnostic uncertainty leading to antibiotics prescribing (90.2%) and their prescribing habits were not influenced by parental demand (80.5%). Although 23.1% of physicians observed often/very often Adverse Drug Reactions (ADRs) after antibiotic administration during their clinical practice, however, 47.6% of the pediatricians declared that they did not report them. Conclusion: Health professionals’ continuing education on the use of therapeutic guidelines and protocols and the development of pharmacovigilance programs could significantly contribute to the avoidance of the misuse of antibiotics in hospital care as well as to health professionals’ awareness on rational prescribing.

关键词： Antibiotics’ Prescribing pharmacovigilance Pediatricians Adverse Drug Reactions