Hospital Pharmacists’ Perspectives on Adverse Drug Reaction Reporting in Developed and Developing Countries: A Comparative Pilot Study
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design, Population, and Study Setting
2.2. Questionnaire Instrument
2.3. Tool Validation
2.4. Data Collection Process
2.5. Data Analysis
3. Results
3.1. Baseline Characteristics
3.2. Knowledge of Hospital Pharmacists Regarding ADR Reporting
3.3. Attitude of Hospital Pharmacists Regarding ADR Reporting
3.4. Perceived Barriers by Hospital Pharmacists Regarding ADR Reporting
3.5. Perceived Facilitators of Reporting ADRs by Hospital Pharmacists
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
ADR | Adverse drug reactions |
US | United States |
PV | Pharmacovigilance |
FDA | Food and Drug Administration |
FAERS | FDA Adverse Event Reporting System |
WHO | World Health Organization |
STROBE | Strengthening the Reporting of Observational Studies in Epidemiology |
KAP | Knowledge, Attitude, and Perception |
SA | Strongly agree |
SD | Strongly disagree |
A | Agree |
N | Neutral |
D | Disagree |
RII | Relative Importance Index |
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Total (n = 151) | US (n = 51) | Pakistan (n = 100) | p-Value | |
---|---|---|---|---|
Sex | ||||
Male | 57 (37.7) | 11 (21.6) | 46 (46.0) | 0.0034 |
Female | 94 (62.3) | 40 (78.4) | 54 (54.0) | |
Age (Years) | ||||
≤28 Years | 55 (36.4) | 13 (25.5) | 42 (42.0) | <0.0001 |
29–35 Years | 58 (38.4) | 11 (21.6) | 47 (47.0) | |
>35 Years | 38 (25.1) | 27 (52.9) | 11 (11.0) | |
Type of hospital | ||||
Government/Public | 86 (56.9) | 32 (62.8) | 54 (54.0) | 0.4887 |
Private | 48 (31.7) | 13 (25.5) | 35 (35.0) | |
Other † | 17 (11.3) | 6 (11.8) | 11 (11.0) | |
Working hours | ||||
Full-time (more than 20 h) | 126 (83.4) | 43 (84.3) | 83 (83.0) | 0.8373 |
Part-time (less than 20 h) | 25 (16.5) | 8 (15.7) | 17 (17.0) | |
Academic degree | ||||
B. Pharm | 29 (19.2) | 10 (19.6) | 19 (19.0) | 0.2536 |
Pharm. D | 75 (49.7) | 21 (41.2) | 54 (54.0) | |
Masters, Ph.D., or similar | 47 (31.1) | 20 (39.2) | 27 (27.0) | |
No. of years practiced | ||||
1–3 Years | 52 (34.4) | 21 (41.2) | 31 (31.0) | 0.2512 |
4–6 Years | 26 (17.2) | 11 (21.6) | 15 (15.0) | |
7–9 Years | 23 (15.2) | 5 (9.8) | 18 (18.0) | |
≥10 Years | 50 (33.1) | 14 (27.5) | 36 (36.0) | |
Have received ADR training/certificate | ||||
No | 107 (70.9) | 33 (64.7) | 74 (74.0) | 0.2346 |
Yes | 44 (29.1) | 18 (35.3) | 26 (26.0) | |
Is there a pharmacovigilance center/ADR reporting center in your hospital? | ||||
No | 66 (43.7) | 25 (49.0) | 41 (41.0) | 0.6237 |
Yes | 70 (46.7) | 21 (41.2) | 49 (49.0) | |
Not sure | 15 (9.93) | 5 (9.8) | 10 (10.0) | |
Is there a drug safety or medication safety officer in your hospital? | ||||
No | 68 (45.0) | 26 (50.9) | 42 (42.0) | 0.3216 |
Yes | 66 (43.7) | 18 (35.3) | 48 (48.0) | |
Not sure | 17 (11.3) | 7 (13.7) | 10 (10.0) | |
Are ADRs actively reported by colleagues and other health professionals in your hospital? | ||||
No | 77 (50.9) | 32 (62.8) | 45 (45.0) | 0.0391 |
Yes | 74 (49.0) | 19 (37.6) | 55 (55.0) | |
Do hospital managers and your colleagues consider your ADR reporting positively? | ||||
No | 43 (28.5) | 19 (37.3) | 24 (24.0) | 0.0878 |
Yes | 108 (71.5) | 32 (62.8) | 76 (76.0) | |
No. of ADRs reported in the last 6 months | ||||
None | 79 (52.3) | 30 (58.8) | 49 (49.0) | 0.2530 |
≥1 ADRs | 72 (47.7) | 21 (41.2) | 51 (51.0) | |
Knowledge * | 5.64 ± 1.28 | 6.02 ± 1.15 | 5.45 ± 1.31 | 0.0085 |
Attitude ** | 32.50 ± 3.30 | 32.49 ± 0.37 | 32.51 ± 0.35 | 0.9697 |
US (n = 51) | Pakistan (n = 100) | Adjusted Difference Between Means * | p-Value 1 | |||
---|---|---|---|---|---|---|
Mean ± SE | 95% CI | Mean ± SE | 95% CI | Mean (95% CI) | ||
Knowledge | 6.03 ± 0.27 | 5.49–6.58 | 5.69 ± 0.25 | 5.19–6.19 | 0.34 (−0.17–0.86) | 0.1937 |
Attitude | 32.02 ± 0.73 | 30.56–33.47 | 32.63 ± 0.67 | 31.30–33.97 | 0.62 (−2.01–0.77) | 0.3797 |
US (n = 51) | Pakistan (n = 100) | p-Value | |
---|---|---|---|
System-Based Barriers | Median (Q1–Q3) | Median (Q1–Q3) | |
Your schedule is too busy to fill out the form. | 4 (3–5) | 4 (3–4) | 0.0166 |
Your practice is too busy to actively look for ADRs. | 4 (2–4) | 3.5 (2–4) | 0.7734 |
Non-availability of a reporting form at the workplace. | 2 (2–4) | 4 (2–4) | 0.0002 |
Complex procedure of ADR reporting. | 4 (2–4) | 3 (2.5–4) | 0.864 |
It’s too difficult to identify ADRs in clinical practice. | 2 (2–4) | 3 (2–4) | 0.4552 |
Fear of legal liability for the reported ADRs. | 3 (2–4) | 3 (2–4) | 0.0269 |
Lack of ADR reporting culture in my hospital. | 3 (2–4) | 4 (2–4) | 0.0052 |
Lack of professional setup/body to discuss ADRs. | 3 (2–4) | 4 (3–5) | <0.0001 |
Individual base barriers | |||
Apprehension about sending inappropriate forms | 3 (2–4) | 3 (3–4) | 0.0291 |
Concern that extra work is required to fill and send the report | 4 (3–4) | 4 (3–4) | 0.1656 |
Insufficient knowledge of pharmacotherapy in detecting ADR | 2 (2–4) | 4 (3–4) | <0.0001 |
I sometimes get confused about what exactly I should report | 2 (2–2) | 2 (2–3) | 0.0084 |
Feeling that reporting of previously known ADR is not required | 3 (2–4) | 3 (2–4) | 0.2634 |
Not knowing how to report ADRs | 2 (2–4) | 3 (2–4) | 0.0287 |
There is fear of retaliation from physicians when ADR is reported for their prescriptions | 2 (2–4) | 4 (3–5) | <0.0001 |
I am sometimes not sure if the drug caused the ADR given | 2 (2–2) | 2 (2–3) | 0.0915 |
Punishment if ADR occurs from your recommendation | 3 (2–4) | 3 (2–4) | 0.7349 |
Feeling that sending a single report of the patient may not contribute a lot of patient care | 2 (2–4) | 3 (2–4) | 0.074 |
US | RII * | Ranking |
Your schedule is too busy to fill out the form | 0.76 | 1 |
Concern that extra work is required to fill and send the report | 0.75 | 2 |
Complex procedure of ADR reporting | 0.67 | 3 |
Your practice is too busy to actively look for ADRs | 0.65 | 4 |
Apprehension about sending inappropriate forms | 0.62 | 5 |
Pakistan | RII * | Ranking |
Insufficient knowledge of pharmacotherapy in detecting ADR | 0.77 | 1 |
Lack of professional setup/body to discuss about ADRs | 0.72 | 2 |
There is fear of retaliation from physicians when ADR is reported for their prescriptions | 0.71 | 3 |
Concern that extra work is required to fill and send the report | 0.70 | 4 |
Apprehension about sending inappropriate forms | 0.69 | 5 |
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Khalid, J.; Temedie-Asogwa, T.; Zakeri, M.; Sansgiry, S.S. Hospital Pharmacists’ Perspectives on Adverse Drug Reaction Reporting in Developed and Developing Countries: A Comparative Pilot Study. Pharmacy 2025, 13, 103. https://doi.org/10.3390/pharmacy13040103
Khalid J, Temedie-Asogwa T, Zakeri M, Sansgiry SS. Hospital Pharmacists’ Perspectives on Adverse Drug Reaction Reporting in Developed and Developing Countries: A Comparative Pilot Study. Pharmacy. 2025; 13(4):103. https://doi.org/10.3390/pharmacy13040103
Chicago/Turabian StyleKhalid, Javeria, Tarilate Temedie-Asogwa, Marjan Zakeri, and Sujit S. Sansgiry. 2025. "Hospital Pharmacists’ Perspectives on Adverse Drug Reaction Reporting in Developed and Developing Countries: A Comparative Pilot Study" Pharmacy 13, no. 4: 103. https://doi.org/10.3390/pharmacy13040103
APA StyleKhalid, J., Temedie-Asogwa, T., Zakeri, M., & Sansgiry, S. S. (2025). Hospital Pharmacists’ Perspectives on Adverse Drug Reaction Reporting in Developed and Developing Countries: A Comparative Pilot Study. Pharmacy, 13(4), 103. https://doi.org/10.3390/pharmacy13040103