Table 4 Practice of the hospital pharmacists concerning pharmacovigilance
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 |