| Literature DB >> 32493307 |
Sunil Shrestha1, Sabina Sharma2, Ramesh Bhasima2, Puskar Kunwor3, Baburam Adhikari2, Binaya Sapkota4.
Abstract
BACKGROUND: Pharmacovigilance (PV) knowledge and attitudes among health care professionals (HCPs) directly affect the practice of PV and reporting of adverse drug reactions (ADRs) in a hospital. The main aim of the study was to assess the impact of an education intervention on the knowledge and attitude of HCPs attached to the regional PV center in an oncology based hospital of Nepal.Entities:
Keywords: Adverse drug reactions; Drug safety; Educational intervention; Healthcare professionals; Nepal; Nurses; Pharmacists; Pharmacovigilance
Mesh:
Year: 2020 PMID: 32493307 PMCID: PMC7268292 DOI: 10.1186/s12909-020-02084-7
Source DB: PubMed Journal: BMC Med Educ ISSN: 1472-6920 Impact factor: 2.463
Demographic characteristics of the participants
| Study variables | Frequency (n) | Percentage (%) |
|---|---|---|
| Age (in years): (25.88 ± 4.131) (Range: 20–46) | ||
| < = 20 | 4 | 4.5 |
| 21–30 | 78 | 87.6 |
| 31–40 | 5 | 5.6 |
| 41+ | 2 | 2.2 |
| Total | 89 | 100.0 |
| Gender | ||
| Male | 13 | 14.6 |
| Female | 76 | 85.4 |
| Total | 89 | 100.0 |
| Professional Status | ||
| Staff nurse | 55 | 61.8 |
| Nurse | 12 | 13.5 |
| Assistant pharmacist | 15 | 16.9 |
| Pharmacist | 5 | 5.6 |
| Clinical Pharmacist | 2 | 2.2 |
| Total | 89 | 100.0 |
| Department | ||
| Nursing | 66 | 74.2 |
| Pharmacy and Clinical Pharmacy | 23 | 25.8 |
| Total | 89 | 100.0 |
| Qualifications of the participants | ||
| Diploma Degree | 48 | 53.9 |
| Undergraduate | 36 | 40.4 |
| Graduate | 5 | 5.6 |
| Total | 89 | 100.0 |
| < = 0.1 | 1 | 1.1 |
| 0.2–5.1 | 80 | 89.9 |
| 5.2–10.1 | 5 | 5.6 |
| 10.2–15.1 | 2 | 2.2 |
| 15.2+ | 1 | 1.1 |
| Total | 89 | 100.0 |
Practice related statements regarding pharmacovigilance without any educational intervention
| Practice questions | Yes (n, %) |
|---|---|
| Experienced ADR in a patient during the profession | 47 (52.8) |
| Seen ADR reporting form | 30 (33.7) |
| Reported ADR to PV center | 11 (12.45) |
| Trained on how to report ADR | 20 (22.5) |
| PV committee in the Institute | 35 (39.3) |
| Keeping records of ADR | 56 (62.9) |
| Visited any ADR Monitoring Center | 19 (21.3) |
| Will report ADR if occurs in future | 70 (78.7) |
| Read an article on prevention of ADR | 38 (42.7) |
Comparison of responses before and after the training on pharmacovigilance regarding knowledge and attitude related questions
| Knowledge related questions | Healthcare professionals (n, %) | ||
|---|---|---|---|
| Pre-survey correct response (n, %) | Post-survey correct response (n, %) | ||
| Adverse Drug Reaction (ADR) definition | 56 (62.9) | 89 (100) | < 0.001 |
| Pharmacovigilance (PV) definition | 56 (62.9) | 84 (94.4) | < 0.001 |
| Most important purpose of Pharmacovigilance | 47 (52.8) | 86 (96.6) | < 0.001 |
| A serious adverse event in Nepal that should be reported to a regulatory body within | 20 (22.5) | 79 (88.8) | < 0.001 |
| Rare Adverse Drug Reactions can be identified in the following phase of the clinical trial | 32 (36) | 78 (87.6) | < 0.001 |
| Which of the following methods is commonly employed by pharmaceutical companies to monitor? | 55 (61.8) | 79 (88.8) | < 0.001 |
| Do you think ADR reporting is professional responsibility for you | 78 (87.6) | 89 (100) | < 0.001 |
| The healthcare professionals responsible for reporting ADR in a hospital is/are | 82 (92.1) | 87 (97.8) | < 0.001 |
| Do you know about the existence of a National PV program in Nepal | 39 (43.8) | 88 (98.9) | < 0.001 |
| In Nepal, which regulatory body is responsible for monitoring ADR | 39 (4.8) | 82 (96.1) | < 0.001 |
| Where the international center for ADR monitoring is located | 40 (44.9) | 86 (96.6) | < 0.001 |
| One of the following agencies in the USA involved in drug safety issues | 50 (56.2) | 84 (94.4) | < 0.001 |
| Reporting of ADRs as the exploration of mistakes of health professionals | 21 (23.6%) | 59 (66.3%) | < 0.001 |
| Reporting of adverse drug reaction is necessary | 31 (34.8%) | 89 (100%) | < 0.001 |
| Establishing ADR monitoring center in every hospital | 69 (77.5%) | 84 (94.4%) | 0.001 |
| Reporting ADR will increase patient safety | 39 (43.8%) | 89 (100%) | < 0.001 |
Assessment of knowledge and attitude mean scores before and after the educational intervention (n = 89)
| Mean ± S.D | Range | |||
|---|---|---|---|---|
| Total score before educational intervention | 6.90 ± 2.527 | (1–12) | < 0.001 | |
| Total score after the educational intervention | 11.36 ± 1.189 | (6–12) | ||
| Total score before educational intervention | 1.80 ± 0.932 | (0–4) | < 0.001 | |
| Total score after the educational intervention | 3.61 ± 0.556 | (2–4) |
Fig. 1Factors discouraging reporting of ADRs
Recommendations for improving adverse drug reactions (ADRs) reporting
| Recommendations for improving ADRs reporting | Frequency (n) | Percentage (%) |
|---|---|---|
| Frequent pharmacovigilance awareness via continuing medical education (CME) / workshop | 21 | 23.6 |
| Frequent SMS / Email about ADR reporting / Provide toll-free number | 3 | 3.4 |
| Make online reporting of ADRs through software | 2 | 2.2 |
| Keep ADR register in all the wards and Out-patients Department (OPD) | 32 | 36.0 |
| Include ADR forms along with case sheet | 11 | 12.4 |
| Make ADR reporting mandatory | 1 | 1.1 |
| Include ADR column in a medical case sheet | 2 | 2.2 |
| Develop mobile apps for ADR reporting | 2 | 2.2 |
| Discuss ADR cases every month during PV meeting | 1 | 1.1 |
| Make a standardized protocol for reporting ADR | 9 | 10.1 |
| Include ADR reporting in the resident logbook | 5 | 5.6 |