scholarly journals Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist

2020 ◽  
Vol 11 ◽  
pp. 204209862093374
Author(s):  
Paulo Henrique Santos Andrade ◽  
Amanda Carvalho Barreiros de Almeida ◽  
Ana Keilla Santana dos Santos ◽  
Iza Maria Fraga Lobo ◽  
Francilene Amaral da Silva ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Professional Training ◽  
Hospital Pharmacist ◽  
Plain Language ◽  
Cross Sectional ◽  
Hospital Pharmacists ◽  
The Social ◽  
Qualitative Variables ◽  
Cross Sectional Design

Aims: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. Methods: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform ‘Google forms’. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. Results: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% ( n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category ‘people involved’ (45.1%) stood out from the others. Conclusion: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. Plain language Summary Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.

Impacto de la comunicación de la responsabilidad social universitaria en la selección de universidad y efecto mediador de la reputación

2020 ◽  
Author(s):  
Lucy Erazo-Coronado ◽  
Sergio Llano-Arristizábal ◽  
Miguel Garcés-Prettel ◽  
Ana-María Erazo-Coronado
Keyword(s):  
Social Responsibility ◽  
Professional Training ◽  
Research Work ◽  
Community Support ◽  
Human Beings ◽  
Cross Sectional ◽  
Public And Private ◽  
University Selection ◽  
Cross Sectional Design ◽  
Institutional Websites

The emerging concept of university social responsibility (USR) consists in the fulfillment of the mission of the university in terms of ethical standards, community support, respect for human beings, and respect for the environment. Thus, universities must not only provide professional training but also instill ethical principles in students to allow them to behave as good citizens and help solve community problems. On the other hand, competition for students requires efficient management of university reputation and communication with their stakeholders, to demonstrate the accomplishment of the university’s mission and attract potential students. The objective of this paper is thus to explain the causal relationship between communication about university social responsibility (USR) activities through institutional websites and university selection, as well as the role of reputation. Research work was carried out based on an explanatory cross-sectional design, with a sample of 356 subjects from a population of 11th-grade students from public and private schools in the City of Barranquilla (Colombia). The results revealed that USR communication through institutional websites has a significant influence on university selection, not only directly but also indirectly, through reputation as a mediating variable. These findings contribute at a theoretical level by providing empirical evidence to understand and explain the analyzed topic. Furthermore, the results provide useful information to evaluate USR disclosure and implement strategies to make progress on USR issues. Resumen El naciente concepto de responsabilidad social universitaria (RSU) consiste en el cumplimiento de la misión de la universidad dentro de unos estándares éticos, de apoyo a la comunidad, respeto al ser humano y al medio ambiente. Así, pues, la universidad no sólo debe impartir formación profesional, sino inculcar a sus estudiantes principios éticos que les permitan comportarse como buenos ciudadanos y contribuir a la solución de los problemas de la comunidad. Por otra parte, la competencia entre universidades exige una gestión eficiente de su reputación y de la comunicación con sus distintos stakeholders, para demostrar a la sociedad el cumplimiento de su misión social, y para atraer estudiantes potenciales hacia la institución. Por lo tanto, este artículo tiene como objetivo explicar la relación de causalidad entre la comunicación de las prácticas de RSU en los sitios web institucionales y la selección de universidad, y el papel mediador de la reputación en esta relación. Para lograrlo, se llevó a cabo una investigación cuantitativa de nivel explicativo experimental y diseño transversal, con una muestra conformada por 356 sujetos, de una población de estudiantes de grado 11º de colegios públicos y privados de la ciudad de Barranquilla (Colombia). Los resultados revelan que la comunicación de las prácticas de RSU en los sitios web institucionales ejerce una influencia significativa directa en la intención de selección de universidad, e indirecta, a través de la reputación como variable mediadora. La evidencia empírica aportada representa un avance teórico en la comprensión y explicación del fenómeno estudiado, e igualmente servirá para que las universidades evalúen si están comunicando adecuadamente su responsabilidad social y adopten estrategias para avanzar en este aspecto.

scholarly journals Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

2016 ◽  
Vol 72 (5) ◽  
pp. 605-614 ◽  
Author(s):  
A. C. B. van Orten-Luiten ◽  
A. Janse ◽  
R. A. M. Dhonukshe-Rutten ◽  
R. F. Witkamp
Keyword(s):  
Vitamin D ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Vitamin D Deficiency ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional

scholarly journals Adverse Drug Reaction Policy in a Tertiary Care Hospital

2015 ◽  
Vol 3 (1) ◽  
pp. 41-47
Author(s):  
V Aggarwal ◽  
Shakti Kumar Gupta ◽  
DK Sharma ◽  
S Arya ◽  
S Singh
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Cross Sectional ◽  
Study Population ◽  
Personnel Paramédical

ABSTRACT Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to the incidence of adverse events, resulting in increased healthcare costs. Healthcare providers need to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs. The purpose of this study is to provide guidelines regarding the procedure of reporting ADRs to hospital authority. It was a descriptive cross-sectional study carried out between April and August 2013. The study population included doctors, nursing personnel, paramedical staff and quality managers of tertiary care hospital from one public and two private hospitals. Interaction was done with study population against the back drop of the checklist and ADR policy was formulated. How to cite this article Singh S, Gupta SK, Arya S, Sharma DK, Aggarwal V. Adverse Drug Reaction Policy in a Tertiary Care Hospital. Int J Res Foundation Hosp Healthc Adm 2015; 3(1):41-47.

Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals

Drug Safety ◽  
2017 ◽  
Vol 40 (7) ◽  
pp. 597-606 ◽  
Author(s):  
Nibu Parameswaran Nair ◽  
Leanne Chalmers ◽  
Bonnie J. Bereznicki ◽  
Colin Curtain ◽  
Gregory M. Peterson ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional

Feasibility Study of Surveying the Adverse Drug Reaction Surveillance Systems in a Large Community of Hospitals

1992 ◽  
Vol 26 (3) ◽  
pp. 384-391 ◽  
Author(s):  
Abraham G. Hartzema ◽  
Miquel S. Porta ◽  
Hugh H. Tilson ◽  
Carlos R. Herrera ◽  
Jeffrey T. Moss ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Surveillance System ◽  
Large Scale ◽  
Surveillance Systems ◽  
Harris County ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Uniform Definition ◽  
Definition Of

OBJECTIVE: To determine the feasibility of accurately assessing the types of hospital adverse drug reaction (ADR) surveillance systems. DESIGN: Cross-sectional survey by mailed, self-administered questionnaire followed by selected verification interviews. SETTING: Harris County, Texas. PARTICIPANTS: All hospitals in the county with different pharmacy directors. MAIN OUTCOME MEASURE: Self description of surveillance system and number of ADRs reported. RESULTS: Forty-nine of 61 hospitals (80 percent) responded to a questionnaire. Forty-seven (96 percent) of the responding hospitals collected information on ADRs with 11 (22 percent) describing their surveillance system as active. Those individuals most often cited as responsible for ADR surveillance included pharmacists, quality assurance personnel, and nurses. Data were verified by personal interviews for 10 hospitals. The number of ADRs reported during the interviews was significantly lower than that reported in the questionnaires. Overall, the reporting of fatal and severe ADRs were more reliable than the reporting of moderate ADRs. These differences were the result of inadequate documentation and the lack of a uniform definition of ADRs. CONCLUSIONS: These data suggest that a large-scale ongoing survey of surveillance systems and reported adverse event rates has limitations and the reliability of data derived from a questionnaire should be verified. To improve the accuracy of surveys used to monitor hospital ADR surveillance systems, it is essential to develop reliable definitions for classifying ADRs and surveillance methods, as well as accurate measures of ADR documentation procedures.

scholarly journals Adverse Drug Reaction with Hyoscine and Valethamate for Cervical Dilation during Labour

2019 ◽  
Vol 21 (2) ◽  
pp. 128-133
Author(s):  
Lujaw Ratna Tuladhar ◽  
A. Shrestha ◽  
R.K. Shrestha
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Statistical Significance ◽  
Cross Sectional Study ◽  
Cervical Dilation ◽  
Blurred Vision ◽  
Cross Sectional ◽  
Hyoscine Butylbromide ◽  
Birth Canal ◽  
Life Threatening

 Adverse drug reaction (ADR) is an injury caused by taking medication. ADR may occur following single dose or prolong administration of drug or combination of two or more drugs. While major advancements of discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries. Labour is characterised by forceful and painful uterine contraction that result in cervical dilation and foetus decent from the birth canal. Anti-spasmodic drugs like hyoscine butylbromide and valethamate bromide have been used to accelerate cervical dilation and thus reduce the labor duration. The objective was to observe ADR with hyoscine and valethamate for cervical dilation during labor. It was a hospital based cross sectional study. Investigation was carried out in the form of questionnaire. All the consecutive patients who were in active stage of labor were included in the study. They were given Intravenous (IV) valethamate bromide 8mg and hyoscine butylbromide 20mg, 3 doses half an hour apart. After administration of the drug, the progress of labor was monitored and management was done as per protocol in obstetrics and gynaecology department. ADR reported were blurred vision in 47.7% of the patients, followed by dry mouth (36.9%) and tachycardia (19.2%). Other ADRs were nausea (6.2%), dizziness (3.8%), flushing (2.3%), vomiting (1.5%), fever (1.5%) and constipation (1.5%). No statistical significance was found when ADR was compared between the age group of 18-25 years and 26-35 years. Therefore, ADR reported were irrespective of the age of the patients and no life threatening or severe forms of ADR were seen with hyoscine and valethamate during cervical dilation.

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