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Table 4 Practice of the hospital pharmacists concerning pharmacovigilance

From: Medication safety knowledge, attitude, and practice among hospital pharmacists in tertiary care hospitals in Saudi Arabia: a multi-center study

Questions n (%) 95% CI
1. Concerning the national accreditation Pharmacy chapter, are all medication safety-related standards applied in your hospital?
a. Yes 216 (74.7) 0.69–0.80
b. No 73 (25.3) 0.20–0.31
2. Does your hospital have written policies and procedures on safe medication practice?
a) Yes 289 (100) 1
b) No 0
3. Has your hospital established a defined system for adverse events reporting?
a) Yes 216 (74.7) 0.69–0.80
b) No 73 (25.3) 0.20–0.31
4. Is there a “Medication Safety” or a “Safety Committee/Department” in your hospital?
a) Yes 279 (96.5) 0.94–0.98
b) No 10 (3.5) 0.02–0.06
5. If yes, Is the pharmacist a member of the committee/department?
a. Yes 278 (99.6) 0.94–0.98
6. If yes, does the pharmacist chair/oversee that committee/department?
a. Yes 278 (99.6) 0.94–0.98
7. In your hospital, is there a standardized form for reporting ADRs?
a. Yes 289 (100) 1
b. No 0
8. Is the reporting form available at your Pharmacy?
a. Yes 279 (96.5) 0.94–0.98
b. No 10 (3.5) 0.02–0.06
9. Does your workplace encourage you to report any ADR?
a. Yes 220 (76.1) 0.71–.081
b. No 69 (23.9) 0.19–0.29
10. Have you ever come across an ADR?
a. Yes 150 (51.9) 0.46–0.58
b. No 139 (48.1) 0.42–0.54
11. In your hospital, ADRs are reported only when they are: (check all that apply)
a. Serious and life-threatening 279 (96.5) 0.94–0.98
b. Severe and cause disability 279 (96.5) 0.94–0.98
c. Mild and cause less inconvenience 282 (97.6) 0.95–0.99
12. When an ADR is encountered in your hospital, it is reported to:
a. Patient 21 (7.3) 0.05–0.11
b. Prescriber 3 (1) 0.002–0.30
c. Drug Company 12 (4.2) 0.22–0.07
d. MOH 40 (13.8) 0.10–0.18
e. Saudi FDA 279 (96.5) 0.94–0.98
13. How do you prefer to report ADRs to drug companies? (check all that apply)
a. Verbally inform the representative of the drug company on routine visits 2 (0.7) 0.01–0.02
b. Formal email/letter. 201 (69.6) 0.63–0.75
c. Phone call. 0
d. Via a National Pharmacovigilance Center. 279 (96.5) 0.94–0.98
14. Have you attended any congress/ seminar on continuing educational program on safe medication practice issues in the last year?
a. Yes 49 (17) 0.13–0.22
b. No 240 (83) 0.78–0.87
15. Have you ever had a course/attended a workshop about pharmacovigilance?
a. Yes 145 (50.2) 0.44–0.56
b. No 144 (49.8) 0.44–0.56
16. Have you anytime read any article on prevention of ADRs?
a. Yes 250 (86.5) 0.82–0.90
b. No 39 (13.5) 0.10–0.18
17. Have you ever been trained on how to report ADRs?
a. Yes 200 (69.2) 0.64–0.74
b. No 89 (30.8) 0.26–0.36
18. Do you think Pharmacovigilance should be taught in detail to healthcare professionals?
a. Yes 280 (96.9) 0.94–0.98
b. No 9 (3.1) 0.01–0.06
19. Do you think medication safety (ADR) programs should be included in the actual Pharmacy curriculum?
a. Yes 283 (97.9) 0.96–0.99
b. No 6 (3.1) 0.01–0.04
20. Which of the following medication safety preventive measures are applied in your Pharmacy? (check all that apply)
a. Unit dose labeling 200 (69.2) 0.63–0.74
b. Unit dose labeling per patient 200 (69.2) 0.63–0.74
c. Look-A-Like / Sound-A-Like labeling 289 (100) 1
d. High Alert Medication labeling 279 (96.5) 0.94–0.98
e. Use of TALLman letters Avoidance of ambiguous nomenclature (abbreviations, trailing zeroes) 289 (100) 1
f. Bar-coding 189 (65.4) 0.60–0.71
g. Temperature monitoring 220 (76.1) 0.71–0.81
21. In your Pharmacy, are there any staff educational sessions on medication safety best practices?
a. Yes 220 (76.1) 0.71–0.81
b. No 69 (23.9) 0.19–0.29
22. When ADRs are reported, which of the following assessment methods are implemented in your hospital:
a. Root Cause Analyses (RCA) 0
b. Failure Mode and Effects Analysis 0
c. Causality Assessment tools 10 (3.5) 0.02–0.06
d. Severity Assessment tools 10 (3.5) 0.02–0.06
e. Classification Tools 9 (3.1) 0.01–0.06
f. All of the above 259 (89.6) 0.86–0.93
g. None of the above 1 (0.3) 0.0001–0.02
23. Are analysis results reported to the Pharmacy & Therapeutics committee?
a. Yes 260 (90) 0.86–0.93
b. No 29 (10) 0.07–0.14
24. How often are ADRs reported?
a. More than once a week 201 (70) 0.64–0.75
b. Once Month 70 (24.2) 0.19–0.30
c. A few times a year 16 (5.5) 0.03–0.09
d. Never 2 (0.7) 0.01–0.02
e. No answer 0
25. Whether electronic and/or paper-based, are ADRs documented in the patient medical record?
a. Yes 189 (65.4) 0.60–0.71
b. No 100 (34.6) 0.29–0.40
26. If yes, is there an alerting system, such as pop-up alerts and/or colorful labeling, on the electronic or paper-based patient’s medical record, preventing future events from occurring with the same me …
a. Yes 180 (62.3) 0.56–0.68
b. No 109 (37.7) 0.32–0.44
27. Which activities in the field of safe medication practice are implemented in your hospital on a regular basis (more than 50%)? (check all that apply)
a. Unit dose dispensing 280 (96.9) 0.94–0.99
b. Centralized cytotoxic preparation 220 (76.1) 0.71–0.81
c. Centralized intravenous administration service 220 (76.1) 0.71–0.81
d. Therapeutic drug monitoring 220 (76.1) 0.71–0.81
e. Drug information 260 (90) 0.86–0.93
f. Pharmacists round with physicians 140 (48.4) 0.43–0.54
g. Pharmacists round independent of physicians 80 (27.7) 0.22–0.33
h. Patient Counseling at Discharge 268 (92.7) 0.89–0.95
i. Medication reconciliation 260 (90) 0.86–0.93
j. ADEs reporting 260 (90) 0.86–0.93
k. SBAR communication 2 (0.7) 0.01–0.02
l. None of the above 1 (0.3) 0.01–0.02
28. Which of the following medication incidents are encountered in your hospital? (check all that apply)
a. Wrong /unclear dose of strength of frequency 289 (100) 1
b. Wrong Dosage Form 53 (18.3) 0.14–0.23
c. Wrong medication 80 (27.7) 0.22–0.33
d. Wrong Route 99 (34.3) 0.29–0.40
e. Omitted/delayed medication 90 (31.1) 0.25–0.37
f. Wrong label 60 (20.8) 0.16–0.26
g. Wrong storage 84 (29.1) 0.24–0.35
h. Wrong Method Preparation 60 (20.8) 0.16–0.25
i. Passed expiry date 82 (28.4) 0.23–0.34
j. Contraindicated medication 70 (24.2) 0.19–0.30
k. Allergy to medication 90 (31.1) 0.25–0.37
l. Mismatching patients 70 (24.2) 0.19–0.30
29. Which of the following causes have been behind medication incidents in your hospital? (check all that apply)
a. Breakdown or communication at transfer and hand-offs 30 (10.3) 0.07–0.14
b. Poor/improper documentation 60 (20.8) 0.16–0.26
c. Inaccurate dosage calculations 30 (10.3) 0.07–0.14
d. Unavailability of electronic system 40 (13.8) 0.10–0.18
e. No Written Policies and procedures 20 (6.9) 0.04–0.10
f. No/Insufficient trainings 30 (10.3) 0.07–0.14
g. High Workload Pressures 289 (100) 1
h. Insufficient Human Resources 20 (6.9) 0.04–0.10
i. Lapse in individual performance 30 (10.3) 0.07–0.14