Adverse Drug Reaction
Conditions
Keywords
Health knowledge, attitudes, practices., Adverse drug reaction reporting systems., Pharmacovigilance. Product Surveillance, Postmarketing., Drug-related side effects and adverse reactions.
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.
Detailed description
A quasi-experimental study with health professionals who acted in a general and public hospital of medium complexity with 104 beds will be performed. Investigators proposed an educational intervention, with the development of lecture and practical class, application of questionnaire before and after EI and the distribution of educational material. Activities will be developed in four meetings of one hour each one. In the first meeting, questionnaire will be applied, in order to assess knowledge, skills and attitudes in pharmacovigilance prior to EI. The instrument was elaborated based on previous studies. Second meeting will be comprise a lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material, whose content includes the same issues of presentation. In the third meeting, a practical class will be performed to promote a discussion of a fictitious case of adverse drug reaction (ADR), in order to elucidate the correct fill of ADE form. In the fourth meeting, will be repeated the application of questionnaire, in order to assess the impact of EI. With the aim to verify change behavior of health professionals regarding pharmacovigilance activities, the number of ADE reports made prior and after intervention will be compared.
Interventions
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.
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Number of ADE Reporting (Change Behavior of Health Professionals) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge (Awareness) Regarding Pharmacovigilance | Two days | Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals. |
| Quality of ADE Reports | Two days | Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Post Educational Intervention Multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 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. | 173 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not completed all meetings | 30 |
Baseline characteristics
| Characteristic | Subjects Post Educational Intervention |
|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment Brazil | 173 participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Post Educational Intervention | Absolute Number of ADE Reporting (Change Behavior of Health Professionals) | 215 absolute number of adverse drug events |
| Subjects Prior to Educational Intervention | Absolute Number of ADE Reporting (Change Behavior of Health Professionals) | 3 absolute number of adverse drug events |
Secondary
Knowledge (Awareness) Regarding Pharmacovigilance
Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.
Time frame: Two days
Population: The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Post Educational Intervention | Knowledge (Awareness) Regarding Pharmacovigilance | 5.2 percentage of right answers |
| Subjects Prior to Educational Intervention | Knowledge (Awareness) Regarding Pharmacovigilance | 2.3 percentage of right answers |
p-value: 0.00001Wilcoxon (Mann-Whitney)
Secondary
Quality of ADE Reports
Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.
Time frame: Two days
Population: The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Post Educational Intervention | Quality of ADE Reports | 5.2 percent of correctly filled forms |
| Subjects Prior to Educational Intervention | Quality of ADE Reports | 3.9 percent of correctly filled forms |
p-value: <0.0001Wilcoxon (Mann-Whitney)