Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Sample Size and Sampling Technique
2.3. Survey Design
2.4. Statistical Analysis
2.5. Ethical Considerations
3. Results
3.1. Baseline Characteristics
3.2. Knowledge
3.3. Attitude
3.4. Practice
3.5. Barriers
3.6. Associations Between Demographic Characteristics and PV Aspects
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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N | N% | |
---|---|---|
Current Position | ||
In the sales department | 377 | 94.3% |
In the marketing department | 23 | 5.8% |
Region | ||
Eastern Region | 72 | 18% |
Central Region | 229 | 57.3% |
Western Region | 58 | 14.5% |
Northern Border Region | 1 | 0.3% |
Southern Region | 40 | 10% |
Age Group (years) | ||
18–24 | 6 | 1.5% |
25–34 | 370 | 92.5% |
35–44 | 22 | 5.5% |
45–54 | 2 | 0.5% |
Gender | ||
Male | 229 | 57.3% |
Female | 171 | 42.8% |
Nationality | ||
Saudi | 394 | 98.5% |
Non-Saudi | 6 | 1.5% |
Academic Qualification | ||
A degree in pharmacy (Bachelor, Diploma, ….) | 391 | 97.8% |
A degree in a related field (e.g., biology, chemistry, business administration) | 9 | 2.3% |
Years of Experience in Pharmaceutical Field | ||
Less than 2 years | 74 | 18.5% |
2–4 years | 149 | 37.3% |
4–6 years | 121 | 30.3% |
6–8 years | 38 | 9.5% |
More than 8 years | 18 | 4.5% |
Type of Company | ||
Multinational company | 252 | 63% |
Local company (including Arab companies) + Distributor (Agent) | 148 | 37% |
Frequency of Interaction with Healthcare Professionals (HCPs) | ||
Daily or almost daily | 344 | 86% |
2–3 times per week | 27 | 6.8% |
1–2 times per week | 13 | 3.3% |
Less than once per week | 7 | 1.8% |
1–2 times per month | 6 | 1.5% |
Less than once per month | 3 | 0.8% |
What is Pharmacovigilance (PV)? | ||||
The science of monitoring adverse drug reactions (ADRs) occurring in a hospital | 94 | 23.5% | ||
The process of improving the safety of drugs | 15 | 3.8% | ||
The detection, assessment, understanding, and prevention of adverse effects | 176 | 44% | ||
The science of detecting the type and incidence of adverse drug reactions (ADRs) marketing | 110 | 27.5% | ||
None of the above | 5 | 1.3% | ||
What is the primary purpose of pharmacovigilance activities? | ||||
To identify predisposing factors to adverse drug reactions (ADRs) | 59 | 14.8% | ||
To identify unrecognized adverse drug reactions (ADRs) | 98 | 24.5% | ||
To calculate the incidence of adverse drug reactions (ADRs) | 43 | 10.8% | ||
To enhance patient safety in relation to the use of drugs | 195 | 48.8% | ||
None of the above | 5 | 1.3% | ||
Which of the following best defines an adverse drug reaction (ADR)? | ||||
Any noxious or undesired effect of a drug occurring at normal doses, during normal use | 298 | 74.5% | ||
Adverse health outcomes associated with inappropriate drug use | 35 | 8.8% | ||
Harm resulting from the use of substandard/counterfeit drugs | 22 | 5.5% | ||
Harm caused by drug overdose | 2 | 0.5% | ||
Adverse outcomes associated with drug impurity | 25 | 6.3% | ||
Other health problems associated with drug use | 18 | 4.5% | ||
Who may report ADRs at a pharmaceutical company? | ||||
Only Sales and Marketing team | 19 | 4.8% | ||
Only Pharmacovigilance team | 54 | 13.5% | ||
Only Medical team | 9 | 2.3% | ||
Every single employee at the company | 318 | 79.5% | ||
Any adverse drug reaction (ADR) is considered serious if it: | ||||
Results in death | 15 | 3.8% | ||
Life-threatening | 10 | 2.5% | ||
Leads to hospitalization or prolongs existing hospitalization | 15 | 3.8% | ||
Causes significant disability/incapacity | 2 | 0.5% | ||
Leads to congenital anomaly (birth defect) | 2 | 0.5% | ||
Requires intervention to prevent permanent impairment or damage | 5 | 1.3% | ||
All of the above | 351 | 87.8% | ||
Should only serious adverse drug reactions be reported? | ||||
Yes | 68 | 17% | ||
No | 321 | 80.3% | ||
Don’t Know | 11 | 2.8% | ||
Should common and well-known adverse drug reaction (ADR) be reported? | ||||
Yes | 291 | 72.8% | ||
No | 92 | 23% | ||
Don’t Know | 17 | 4.3% | ||
Which regulatory agency is responsible for pharmacovigilance activities in Saudi Arabia? | ||||
National Pharmacovigilance Centre (NPC) | 270 | 67.5% | ||
Saudi Commission for Health Specialties | 50 | 12.5% | ||
Ministry of Health (MOH) | 80 | 20% | ||
Is the following information essential to include in an adverse drug reaction (ADR) report to make it valid (Identified Patient, Suspected drug, Description of the ADR, Reporter’s contact | ||||
Yes | 367 | 91.8% | ||
No | 12 | 3% | ||
Don’t Know | 21 | 5.3% | ||
Knowledge groups | ||||
Good | 228 | 57% | ||
Poor | 172 | 43% |
Is Adverse Drug Reactions (ADRs) Reporting Necessary for Patient Safety? | ||||
Yes | 388 | 97% | ||
No | 9 | 2.3% | ||
Don’t Know | 3 | 0.8% | ||
Is Adverse drug reactions (ADRs) reporting a professional obligation for healthcare professionals? | ||||
Yes | 350 | 87.5% | ||
No | 26 | 6.5% | ||
Don’t Know | 24 | 6% | ||
Is Adverse drug reactions (ADRs) reporting form complex to fill out? | ||||
Yes | 129 | 32.3% | ||
No | 207 | 51.8% | ||
Don’t Know | 64 | 16% | ||
Do you think pharmacovigilance should be taught in detail to healthcare professionals? | ||||
Yes | 324 | 81% | ||
No | 50 | 12.5% | ||
Don’t Know | 26 | 6.5% | ||
Attitude groups | ||||
Positive | 334 | 83.5% | ||
Negative | 66 | 16.5% |
Where do you Typically Report Adverse Drug Reactions (ADRs) in Your Organization? | ||||
Online reporting system | 97 | 24.3% | ||
Directly to the manager or supervisor | 36 | 9% | ||
To the Saudi Food and Drug Authority (SFDA) | 39 | 9.8% | ||
To the Ministry of Health (MOH) | 6 | 1.5% | ||
To the Regulatory Affairs department (RA) | 16 | 4% | ||
To the Pharmacovigilance team | 206 | 51.5% | ||
Have you ever reported an Adverse Drug Reaction (ADR) to your company’s pharmacovigilance department? | ||||
Yes | 241 | 60.3% | ||
No | 159 | 39.8% | ||
Have you reported an Adverse Drug Reaction (ADR) in the last 12 months? | ||||
Yes | 163 | 40.8% | ||
No | 237 | 59.3% | ||
Are you familiar with the different sections of an Adverse Drug Reaction (ADR) report form (e.g., patient demographics, adverse event details, Drug information)? | ||||
Yes | 314 | 78.5% | ||
No | 86 | 21.5% | ||
Have you received any training on pharmacovigilance principles and the use of ADR report forms? | ||||
Yes | 358 | 89.5% | ||
No | 42 | 10.5% | ||
When do you typically report an Adverse Drug Reaction (ADR) in your organization? | ||||
Within 1 business day | 267 | 66.8% | ||
Within 5 business days | 41 | 10.3% | ||
At the end of the week | 10 | 2.5% | ||
At the end of the month | 6 | 1.5% | ||
No specific time frame | 76 | 19% | ||
What is the first step you take when you have a valid Adverse Drug Reaction (ADR) report? | ||||
Contact the Pharmacovigilance team (via email, web, phone, etc.) | 331 | 82.8% | ||
Hand it over to your direct supervisor | 46 | 11.5% | ||
Contact the SFDA to submit the report | 16 | 4% | ||
Notify other HCPs about the ADR | 7 | 1.8% | ||
Do you discuss Adverse Drug Reactions (ADRs) with healthcare professionals during your visits? | ||||
Yes | 332 | 83% | ||
No | 68 | 17% | ||
Practice groups | ||||
Good | 244 | 61% | ||
Poor | 156 | 39% |
Do you feel you lack sufficient time to complete ADR reports? | ||||
Yes | 179 | 44.8% | ||
No | 221 | 55.3% | ||
Do you believe that ADR reporting is not part of your job role? | ||||
Yes | 90 | 22.5% | ||
No | 310 | 77.5% | ||
Are you aware of the national ADR reporting system and how to use it? | ||||
Yes | 212 | 53% | ||
No | 188 | 47% | ||
Have you received adequate training on ADR reporting? | ||||
Yes | 309 | 77.3% | ||
No | 91 | 22.8% | ||
Do you feel confident in discussing ADRs with healthcare providers? | ||||
Yes | 342 | 85.5% | ||
No | 58 | 14.5% | ||
Do you always have enough patient’s information to complete an ADR report? | ||||
Yes | 189 | 47.3% | ||
No | 211 | 52.8% | ||
Do you always feel confident in determining whether an event is an ADR worth reporting? | ||||
Yes | 298 | 74.5% | ||
No | 102 | 25.5% | ||
Do you feel your ADR reports make a significant difference in patient safety? | ||||
Yes | 373 | 93.3% | ||
No | 27 | 6.8% | ||
Do you have concerns that your ADR reports could be incorrect or incomplete? | ||||
Yes | 223 | 55.8% | ||
No | 177 | 44.3% | ||
Do you feel that reporting ADRs creates additional, unnecessary work for you? | ||||
Yes | 130 | 32.5% | ||
No | 270 | 67.5% | ||
Do you believe that most ADRs are already well-documented before a drug is marketed? | ||||
Yes | 215 | 53.8% | ||
No | 185 | 46.3% | ||
Is it always easy to contact the QPPV or relevant personnel for assistance with ADR reporting? | ||||
Yes | 323 | 80.8% | ||
No | 77 | 19.3% | ||
Do you have concerns about patient privacy that may hinder your willingness to report ADRs? | ||||
Yes | 207 | 51.8% | ||
No | 193 | 48.3% | ||
Does your company culture encourage open reporting of ADRs? | ||||
Yes | 343 | 85.8% | ||
No | 57 | 14.3% | ||
Does your company provide adequate support and resources for ADR reporting? | ||||
Yes | 335 | 83.8% | ||
No | 65 | 16.3% | ||
Are the ADR reporting systems and processes easy to use and understand? | ||||
Yes | 340 | 85% | ||
No | 60 | 15% | ||
Do you feel that your manager or other supervisors encourage you to report ADRs? | ||||
Yes | 313 | 78.3% | ||
No | 87 | 21.8% | ||
Do you feel that your career progression or job security could be negatively impacted by reporting ADRs? | ||||
Yes | 152 | 38% | ||
No | 248 | 62% | ||
Barriers groups | ||||
Challenging | 29 | 7.2% | ||
Non-challenging | 371 | 92.8% |
PV Aspect | Poor Knowledge | Poor Attitude | Poor Practice | Challenging Work Environment | |
---|---|---|---|---|---|
Demographic | |||||
Marketing department | 0.009 * | 1.00 | 0.082 | 0.075 | |
Non-central region | 0.001 * | 1.00 | 0.097 | 0.334 | |
Non-pharmacy degree | 0.043 * | 0.366 | 0.320 | 0.002 * | |
<4 years of experience | 0.360 | 0.498 | 0.024 * | 0.700 | |
Local company | 0.021 * | 0.331 | 0.001 * | 0.231 | |
Non-daily interaction with HCPs | 0.005 * | 0.846 | 0.141 | 0.782 |
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Share and Cite
Alsalloum, M.A.; Almutairi, M.A.; Alsahali, S.M.; Altowayan, W.M. Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study. Pharmacy 2025, 13, 145. https://doi.org/10.3390/pharmacy13050145
Alsalloum MA, Almutairi MA, Alsahali SM, Altowayan WM. Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study. Pharmacy. 2025; 13(5):145. https://doi.org/10.3390/pharmacy13050145
Chicago/Turabian StyleAlsalloum, Muath A., Mohammed A. Almutairi, Saud M. Alsahali, and Waleed M. Altowayan. 2025. "Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study" Pharmacy 13, no. 5: 145. https://doi.org/10.3390/pharmacy13050145
APA StyleAlsalloum, M. A., Almutairi, M. A., Alsahali, S. M., & Altowayan, W. M. (2025). Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study. Pharmacy, 13(5), 145. https://doi.org/10.3390/pharmacy13050145