Evolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância Sanitária

Mota, Daniel Marques; Vigo, Álvaro; Kuchenbecker, Ricardo de Souza

doi:10.1590/0102-311x00000218

Cited by 12 publications

(23 citation statements)

References 22 publications

(39 reference statements)

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“…Training for this network was carried out by Anvisa, and it considers the elements described above, including the seriousness and causality assessment of ADRs. SADRs are investigated in health services by patient safety teams before being reported to Notivisa (Brazil, 2011;Brazil, 2015;Teixeira et al, 2017;Mota et al, 2018;Brazil, 2019a).…”

Section: Methodsmentioning

confidence: 99%

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study

et al. 2020

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Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs 'imipenen/cilastatin-pneumonia' and 'laronidase-respiratory insufficiency') should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.

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Section: Methodsmentioning

confidence: 99%

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study

et al. 2020

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“…Pharmacovigilance in Brazil has a history of evolution and strengthening of its legislation . In this sense, ANVISA as a regulatory agency regulates pharmacovigilance in the country through ordinances and legislation with the purpose of preventing and mitigating possible damages to the health of the population by means of effective and timely identification of problems associated with the use of medication…”

Section: Introductionmentioning

confidence: 99%

Thirteen years of medication alerts issued by the Brazilian Health Regulatory Agency (ANVISA): What is the profile?

Ferreira

Baldoni

2019

Evaluation Clinical Practice

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Rationale, aims, and objectives: As a pharmacovigilance measure, the Brazilian Health Regulatory Agency (ANVISA) monitors the postmarketing events of medication and issues alerts on actions to be taken and information updates. The present study has the objective of analysing the profile of all the alerts on medication issued by ANVISA between 2006 and 2018.Methods: A descriptive documentary analysis was carried out through the ANVISA website and double checked with two researchers in order to avoid discrepancies in data collection and interpretation of information.Results: A total of 79 alerts available in the period were analysed, the mean being 6.07 alerts/year and standard deviation of 3.81. The medications most cited in the alerts were antivirals (9.7%), followed by antidiabetics (7.3%) and contraceptives (7.3%). The main problems identified were adverse reactions (50%) and other problems related to safety (15%). The main actions directed by ANVISA were generation of a new contraindication (37.3%) and alteration in the package insert (22.3%). Conclusion:Alerts are an important means of communicating new information to health professionals and to society. However, they need better standardization in order to facilitate understanding, dissemination in order to broaden access to information, and studies to corroborate the current literature and improve current pharmacovigilance.

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“…However, it was not until the late 1990s that the pharmacovigilance field was strengthened with the creation of the Brazilian Health Surveillance Agency (ANVISA). 8,10 From this period to date, pharmacovigilance in Brazil has focused on notification; 10 however, it has not been proved to have a direct impact on patient care yet. 18 Although there is a surveillance network for medicine and a small production and dissemination of information to healthcare professionals about the health risk for some medicines, there is no effective monitoring of the notified events at national level or any responses that may directly impact the patient involved.…”

Section: Discussionmentioning

confidence: 99%

“…3,8,9 In this context, hospitals seem to be the driving force of pharmacovigilance in Brazil, representing the main centers for reporting ADRs. 10 In particular, sentinel hospitals set up an ADR reporting network that strengthens the pharmacovigilance. Furthermore, safety programs in the use of medicines ascribe responsibility to the pharmacist towards drug safety indicators.…”

Section: Introductionmentioning

confidence: 99%

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

Andrade

Almeida

Santos³

et al. 2020

Therapeutic Advances in Drug Safety

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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.

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Evolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância Sanitária

Cited by 12 publications

References 22 publications

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study

Thirteen years of medication alerts issued by the Brazilian Health Regulatory Agency (ANVISA): What is the profile?

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

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