Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Setting
2.2.1. General Setting
2.2.2. Specific Setting
2.3. Study Population and Period
2.4. Data Source, Collection, and Validation
2.5. Statistical Analysis
3. Results
3.1. Trends in Reporting of ICSRs and ADRs
3.2. Timeliness and Completeness of Reporting
3.3. Seriousness and Actions Taken for Antimicrobial-Related ADRs
3.4. Types of Antimicrobial-Related ADRs
3.5. Patient Outcomes Stratified by Antimicrobial Drug Classes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
References
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Characteristics | n | (%) |
---|---|---|
Total | 566 | |
Time to reporting (in days) 1 | ||
<30 | 56 | (9.9) |
30–180 | 289 | (51.1) |
≥180 | 221 | (39.0) |
Completeness score 2 | ||
0–25% | 2 | (0.4) |
26–50% | 28 | (4.9) |
51–75% | 221 | (39.0) |
76–99% | 21 | (3.7) |
100% | 240 | (42.4) |
Not recorded | 54 | (9.5) |
Reported by | ||
Pharmacists | 364 | (64.3) |
Nurses and allied health workers 3 | 129 | (22.8) |
Physicians | 3 | (0.5) |
Consumers or non-health professionals | 17 | (3.1) |
Not recorded | 53 | (9.4) |
Characteristics | n | (%) |
---|---|---|
Total | 566 | |
Serious reaction 1 | ||
Yes | 10 | (1.8) |
No | 501 | (88.5) |
Not recorded | 55 | (9.7) |
Action taken 2 | ||
Drug withdrawn | 18 | (3.2) |
Dose increased | 1 | (0.2) |
Dose reduced | 2 | (0.4) |
Unknown | 56 | (9.9) |
Dose not changed | 4 | (0.7) |
Not applicable | 277 | (48.9) |
Not recorded | 208 | (36.7) |
Adverse Drug Reactions | n | (%) 1 |
---|---|---|
Gastrointestinal disorders | 337 | (59.5) |
Diarrhea | 143 | (25.3) |
Abdominal pain | 93 | (16.4) |
Vomiting | 61 | (10.8) |
Nausea | 30 | (5.3) |
Others (loss of appetite, dysphagia, loss of taste, increased appetite, and dyspepsia) | 10 | (1.8) |
Nervous system disorders | 167 | (29.5) |
Headache | 101 | (17.8) |
Dizziness | 62 | (11.0) |
Seizure | 3 | (0.5) |
Peripheral neuropathy | 1 | (0.2) |
General disorders and administration site conditions | 130 | (23) |
Asthenia/Malaise/Fatigue | 62 | (11) |
Generalized, pelvic, and musculoskeletal pain | 30 | (5.3) |
Fever | 26 | (4.6) |
Pedal edema/Facial edema/Periorbital edema | 12 | (2.1) |
Skin and subcutaneous tissue disorders | 98 | (17.3) |
Pruritus | 72 | (12.7) |
Skin rashes | 21 | (3.7) |
Others (Increased sweating, erythema, and urticaria) | 5 | (0.9) |
Psychiatric disorders (insomnia, confusion, somnolence, anorexia, abnormal gait, hallucination, and nightmares) | 29 | (5.1) |
Musculoskeletal and connective tissue disorders (arthralgia, muscle pain, and muscle weakness) | 16 | (2.8) |
Ear and labyrinth disorders (tinnitus, hearing impairment, and others) | 16 | (2.8) |
Eye disorders (blurred vision, conjunctivitis, and others) | 11 | (1.9) |
Renal and urinary disorders (polyuria, urinary urgency, and acute renal injury) | 8 | (1.4) |
Cardiac disorders (palpitations and orthostatic hypotension) | 7 | (1.2) |
Respiratory, thoracic, and mediastinal disorders (coughing, chest discomfort, and dyspnea) | 7 | (1.2) |
Immune system disorders (allergy and hypersensitivity) | 6 | (1.1) |
Reproductive system and breast disorders (menorrhagia, erectile dysfunction, and others) | 6 | (1.1) |
Blood and lymphatic system disorders (bleeding and anemia) | 4 | (0.7) |
Antimicrobial Class | Recovered | Recovering | Not Recovered | Death | Unknown | Total | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | N | |
Antiparasitics | 313 | (62.5) | 180 | (35.4) | 4 | (0.8) | 1 | (0.2) | 16 | (2.2) | 514 |
Antibiotics | 21 | (47.8) | 17 | (38.6) | 3 | (6.8) | 0 | (0) | 3 | (6.8) | 44 |
Access | 8 | 10 | 0 | 0 | 2 | 20 | |||||
Watch | 12 | 6 | 2 | 0 | 1 | 21 | |||||
Reserve | 1 | 1 | 1 | 0 | 0 | 3 | |||||
Antiviral | 3 | (42.9) | 4 | (57.1) | 0 | (0) | 0 | (0) | 0 | (0) | 7 |
Antifungals | 0 | (0) | 0 | (0) | 1 | (10.0) | 0 | (0) | 0 | (0) | 1 |
Total | 337 | (59.5) | 201 | (35.5) | 8 | (1.4) | 1 | (0.2) | 19 | (3.4) | 566 |
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Thomas, F.; Abiri, O.T.; Komeh, J.P.; Conteh, T.A.; Bah, A.J.; Kanu, J.S.; Terry, R.; Abrahamyan, A.; Thekkur, P.; Zachariah, R. Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting. Int. J. Environ. Res. Public Health 2022, 19, 3264. https://doi.org/10.3390/ijerph19063264
Thomas F, Abiri OT, Komeh JP, Conteh TA, Bah AJ, Kanu JS, Terry R, Abrahamyan A, Thekkur P, Zachariah R. Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting. International Journal of Environmental Research and Public Health. 2022; 19(6):3264. https://doi.org/10.3390/ijerph19063264
Chicago/Turabian StyleThomas, Fawzi, Onome T. Abiri, James P. Komeh, Thomas A. Conteh, Abdulai Jawo Bah, Joseph Sam Kanu, Robert Terry, Arpine Abrahamyan, Pruthu Thekkur, and Rony Zachariah. 2022. "Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting" International Journal of Environmental Research and Public Health 19, no. 6: 3264. https://doi.org/10.3390/ijerph19063264