Educational Intervention in Pharmacovigilance for Hospital Health Professionals

NCT02134587 | Completed Results

• 1 other identifier: E015/10
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the causality assessment of adverse drug events (ADE). Therefore, the present study aimed to validate an educational intervention (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact on the knowledge, skill and attitude in ADE reporting. Investigators proposed a multifaceted EI which will be developed in four meetings with one hour each. The following activities will be carried out: application of a questionnaire to assess the knowledge, skill and attitude before and after EI; lecture; practical class and education material distribution. The answers of questionnaire are going to be analyzed using content analysis technique. The definitions of World Health Organization and the minimum and desired criteria to fill the ADE form, according to the Pan American Health Organization, are going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney test for paired samples will be applied, in order to assess the impact of educational intervention on behavior of health professionals (ADE reporting). With the present study, the following hypotheses will be tested: H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before and after the educational intervention. H1= The numbers of ADE reported before and after the educational intervention are different.

Conditions

Adverse Drug Reaction

Keywords

Health knowledge, attitudes, practices.; Adverse drug reaction reporting systems.; Pharmacovigilance. Product Surveillance, Postmarketing.; Drug-related side effects and adverse reactions.

Outcome Measures

Primary Outcomes (1)

• Absolute Number of ADE Reporting (Change Behavior of Health Professionals)

  Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.

  12 months

Secondary Outcomes (2)

• Knowledge (Awareness) Regarding Pharmacovigilance

  Two days

• Quality of ADE Reports

  Two days

Study Arms (1)

Subjects post educational intervention

OTHER

Multifaceted educational intervention in pharmacovigilance

Other: Multifaceted educational intervention

Interventions

Multifaceted educational intervention OTHER

1. Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2. Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3. Distribution of educational material 4. Practical class to explain the correct fill of adverse drug events form 5. Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.

Subjects post educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All health professionals (physicians, pharmacists, nurses, auxiliaries of nurses and pharmacists, as well as the multidisciplinary team - social assistants, physiotherapists, audiologists, nutritionists, psychologists, occupational therapists and administrative officers), with employment link at the hospital under study who agree to participate by signing an informed consent form are going to be enrolled.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Hospital Estadual Américo Brasiliense

Américo Brasiliense, São Paulo, 14820-000, Brazil

Location

Related Publications (10)

• Figueiras A, Tato F, Fontainas J, Gestal-Otero JJ. Influence of physicians' attitudes on reporting adverse drug events: a case-control study. Med Care. 1999 Aug;37(8):809-14. doi: 10.1097/00005650-199908000-00010.

  PMID: 10448723 BACKGROUND

• Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Physicians' attitudes and adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2005;28(9):825-33. doi: 10.2165/00002018-200528090-00007.

  PMID: 16119975 BACKGROUND

• Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Influence of pharmacists' attitudes on adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2006;29(4):331-40. doi: 10.2165/00002018-200629040-00004.

  PMID: 16569082 BACKGROUND

• Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van Puijenbroek E. Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods. Drug Saf. 2011 Sep 1;34(9):755-62. doi: 10.2165/11592800-000000000-00000.

  PMID: 21830837 BACKGROUND

• Pedros C, Vallano A, Cereza G, Mendoza-Aran G, Agusti A, Aguilera C, Danes I, Vidal X, Arnau JM. An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians: a time series analysis in Spain. Drug Saf. 2009;32(1):77-83. doi: 10.2165/00002018-200932010-00007.

  PMID: 19132807 BACKGROUND

• Figueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA. 2006 Sep 6;296(9):1086-93. doi: 10.1001/jama.296.9.1086.

  PMID: 16954488 BACKGROUND

• Herdeiro MT, Ribeiro-Vaz I, Ferreira M, Polonia J, Falcao A, Figueiras A. Workshop- and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal. Drug Saf. 2012 Aug 1;35(8):655-65. doi: 10.1007/BF03261962.

  PMID: 22788235 BACKGROUND

• Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal. Drug Saf. 2008;31(4):335-44. doi: 10.2165/00002018-200831040-00007.

  PMID: 18366244 BACKGROUND

• Ribeiro-Vaz I, Herdeiro MT, Polonia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica. 2011 Feb;45(1):129-35. doi: 10.1590/s0034-89102010005000050. Epub 2010 Nov 12. English, Portuguese.

  PMID: 21085884 BACKGROUND

• Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013 Feb;69(2):237-44. doi: 10.1007/s00228-012-1321-7. Epub 2012 Jun 17.

  PMID: 22706618 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

• Title: Fabiana Rossi Varallo
• Organization: School of Pharmaceutical Scientes of Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara, SP (Brazil)

varallo.f.r@gmail.com

5516997629496

Study Officials

• Patricia C Mastroianni, PhD

  School of Pharmaceutical Sciences of Unesp

  STUDY CHAIR

• Fabiana R Varallo, Master

  School of Pharmaceutical Sciences of Unesp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist and PhD student

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 9, 2014
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 5, 2023
• Results First Posted: August 20, 2015

Record last verified: 2023-06

Locations

BR (1)