Pharmacist's Perception of Pharmacovigilance and Reporting of Adverse Drug Reactions in Saudi Arabia

Background: Pharmacists’ perception toward their role in reporting of Adverse Drug Reactions (ADRs) and their understanding of the importance of reporting ADRs are essential keys to be assessed and studied in order to determine the factors that may predispose to underreporting of ADRs in Saudi Arabia. Therefore, in this study, we aimed to asses and compare the perception of community and hospital pharmacists toward reporting of ADRs in different regions of Saudi Arabia. Method: A structured, validated questionnaire was used to conduct a cross-sectional study. A total of 263 pharmacists were enrolled. The questionnaire included the demographic data of the pharmacists and 11 questions to measure pharmacists’ perceptions of ADRs reporting of reporting ADRs. All statistical analysis done by using Statistical Package for the Social Sciences (SPSS) version 21 and Survey Monkey system. Result: the result shows that community and hospital pharmacists strongly agree about that reporting of ADRs allow to measure the incidence of ADRs 29 (55.77%), 121 (58.45) and to identify previously unrecognized ADRs 30 (57.69%), 116 (56.59%) and enable safe drugs to be identified 39 (70.91%), 129 (62.32%), respectively with no significant difference (p>0.05). Besides, both hospital pharmacists 116 (55.77%) and community pharmacists 31 (60.78%) strongly agree about their important role in the pharmacovigilance system. However, only 67 (32.52%) of hospital pharmacists strongly agreed about the physician’s responsibility in reporting ADRs compared to community pharmacists 29 (52.73%) with a significant difference between groups (p<0.05). However, 37 (17.87%) of hospital pharmacists were uncertain about drug companies’ role in pharmacovigilance system with a significant difference between community pharmacists with (p<0.05). Conclusion: The result of this study demonstrated that both community and hospital pharmacists among Saudi Arabia had a very goods of perception about the importance of ADRs reporting and their role in reporting ADRs.


INTRODUCTION
Drug safety is an aim we look for a healthcare provider for our patient to reduce morbidity and mortality, it could be hard to achieve because there is no medication without side effects, but it is not impossible.One way to make it possible achieving this goal is by practicing pharmacovigilance system by keeping an eye on an every ADRs and report it by using spontaneous reporting of ADRs as it is the cornerstone of pharmacovigilance practice.[3] Reporting of ADRs is the responsibility of doctors, pharmacists, nurses and even the patients (anyone deals with the medications). [4]etween all these specialties pharmacists are located at the better place to identify ADRs because they are the expert regarding medications; in addition to that, they represent the link between the prescriber and the patient and they tend to be involved in preventing diseases and improving the outcome of the treatment by counseling the patients. [5]Therefore, their significant role cannot be denied in this vital process.[11] One of the reasons for under-reporting is the low awareness of pharmacists regarding pharmacovigilance another reason is the pharmacist's perceptions and understanding the importance of ADRs reporting.Most of the professionals agreed about the importance of ADRs reporting and it is the leading role of pharmacists. [8]Unfortunately, some of the community pharmacists believe in that reporting of ADRs is the duty of physicians and hospital pharmacists, therefore, they do not take the responsibility of reporting ADRs seriously which consider one of the significant barriers as documented in one of the previous studies done in Saudi Arabia specifically in Riyadh city. [6]This perception of community pharmacists is not only seen in Saudi Arabia but also, in United Arab Emirate where the community pharmacists agreed about their technical role, but less to their clinical role and they are not ready to change to take more responsibility. [12][15] However, hospital pharmacists believe in their role in reporting ADRs as part of their professional obligations. [5,10]This study aimed to asses and compared pharmacist's perception of ADRs reporting between hospital and community pharmacists among different regions in Saudi Arabia.

Methods
This is a cross-sectional study was conducted from January 2016 to March 2016 in Al-Sharqyiah, Riyadh, Jeddah and another region in Saudi Arabia.A total of 263 pharmacists (both hospital and community pharmacists) enrolled in this study and with the approval of health research center in the eastern region, the questionnaire was distributed among hospital pharmacists (both public and private) and community pharmacists (chain and independent pharmacies).Pharmacists completed the validated, structured questionnaire and the questionnaires were delivered by hand or the Internet, depending on accessibility.Informed consent was obtained; all participants were informed that all their information was private and the results would be presented anonymously.A questionnaire was prepared and adapted from. [16]The questionnaire included the demographic data of the pharmacists and 11 questions to measure pharmacists' perceptions of ADRs reporting and their attitude and impression about the importance of reporting ADRs.All statistical analysis done by using SPSS version 21 and survey monkey system.The chi-squared test for categorical variables calculated P value.Mean and standard deviation (SD) were used for continuous variables, whereas percentage was used for qualitative variables.

RESULTS
In this study, a total 263 pharmacists responded to the survey; of them, 208 (79.09%) responded from hospital pharmacy sites and 55 (20.91%) from community pharmacy.Most community pharmacies were from Al-Sharqyiah (43 (78.18%)), whereas the highest percentage of hospital pharmacies (78 (37.68%)) were from Al-Riyadh and 73 (35.27%) from Al-Sharqyiah.The number of responders statistically significant between most of the cities (p<0.05).The majority of pharmacists were male 173 (65.78%) with statistically significant hospital pharmacies with more female where community pharmacy higher in male gender (p<0.05).Most of the pharmacists participated in this study were in the age group (24-35) years old without any statistically significant among groups of ages between hospital or community pharmacies (p>0.05).The BSc in pharmacy was the most common educational level between groups (88.89% community pharmacist and 52.88% hospital pharmacists) without statistically significant among all educational levels (p<0.05)except in the Ph.D. degree; the number hospital pharmacists more that community pharmacist (p<0.05).However, the majority of pharmacists had (1-3) and more than nine years of experience.The more common in community pharmacists' group (p>0.05) while one to three years of experience was common in hospital pharmacists' group (p<0.05)(Table 1).
Pharmacists were asked about of the importance of reporting ADRs.The result shows that community and hospital pharmacists strongly agreed that reporting of ADRs enable safe drugs to be identified 39 (70.91%), 129 (62.32%), to measure the incidence of ADRs 29 (55.77%),121 (58.45) and to identify previously unrecognized ADRs 30 (57.69%), 116 (56.59%), respectively with no significant difference (p>0.05).In addition, community and hospital pharmacists agreed that reporting of ADRs help to identify factors that might predispose to an ADR 22 (42.31%),72 (34.78%) and to compare ADRs for drugs in similar therapeutic classes 24 (46.15%),92 (44.44%) or same drug from different drug companies 26 (50%), 84 (40.98%), respectively with no significant difference between groups (p>0.05).As a result, all pharmacists clearly understood the vital importance of reporting ADRs (Table 2).Pharmacists were asked about their level of agreement regarding their duties in reporting ADRs and what they thought about the responsibilities of physicians, nurses, drug companies and patients in the reporting process.To determine their beliefs about their role in the reporting and pharmacovigilance system, the scale consisted of four levels: (strongly agree, agree, disagree and strongly disagree); community pharmacists 31 (60.78%) and hospital pharmacists 116 (55.77%) strongly agreed about their essential role in the pharmacovigilance system with no significant difference between groups (p>0.05).Hospital pharmacists 30 (14.56%) were uncertain of the doctor responsibility in reporting ADRs and only 67 (32.52%) of them strongly agreed compared to community pharmacists 29 (52.73%) with a significant difference between groups (p<0.05).The majority of the community and hospital pharmacists agreed about that nurses and patients have a responsibility in reporting ADRs with no significant difference between groups (p>0.05).However, 37 (17.87%) of hospital pharmacists were uncertain about the responsibility of drug companies in the pharmacovigilance system with a significant difference between community Pharmacists with (p<0.05)(Table 3).

DISCUSSION
The role of pharmacists has been expanding and started to shift from being product oriented to be more patientoriented. [17]This expansion in the pharmacy profession in the last years allow pharmacists to be a significant member in the medical team reducing healthcare costs, detecting and preventing ADRs.This growth and increase in responsibilities are mostly experienced with hospital pharmacists as the nature of their work.
However, the community pharmacists are less to be involved with other healthcare providers but this.It is not an excuse to not practice the patient-oriented approach, getting involved with the patient asking the right questions and taking the responsibility of the patient health by trying to build the communication with patient's physician as necessary, can make a huge difference in the community pharmacy practice environment.So, the pharmacists' perception about their role and the importance of ADRs reporting is very significant.In this study both community and hospital pharmacists strongly agreed about the importance of ADRs reporting in measuring the incidence of ADRs, to identify previously unrecognized ADRs and identifying factors that may predispose to an ADRs as consistent with a previous study. [10]Besides, both community and hospital pharmacists participated in this study strongly agreed about the importance of their role in reporting of ADRs.[20] Unlike one study was done in Riyadh pharmacists refuse to take the responsibility of reporting ADRs was one of the significant barriers was found in that study. [6]In this study also, community pharmacists strongly agreed about the doctor responsibility in reporting ADRs as seen in the result of the previous study. [6]Physicians also requested to report ADRs no doubt in this, but that does not mean that community pharmacists should retract and give up one of their primary responsibility and delivered it to the physicians.Unlike community pharmacists, the majority of hospital pharmacists in this study were uncertain about that reporting the ADRs is the responsibility of the doctor and drug companies. [4]Therefore, it is imperative to clear this concept for them as pharmacovigilance and reporting of ADRs is collaborative teamwork.

Study limitation
We are aware of some weakness in the methodology of our study.Part of the questionnaire was in electronic form, which could have contributed to some bias and some paper questionnaires were not collected at the same time because some of the pharmacists were busy.Besides, they might have felt forced to complete the survey or were not willing to reveal their practice deficiencies.

CONCLUSION
Both community and hospital pharmacists in Saudi Arabia participated in this study were aware of their essential role in reporting ADRs as well as they genuinely understand the purpose of reporting ADRs.

ACKNOWLEDGEMENT
We wish to thank health research center in eastern region for distributing the questionnaire among hospitals

CONFLICT OF INTEREST
None.

ADRs:
Adverse Drug Reactions; FDA: Food and Drug Administration; SFDA: Saudi Food and Drug Authority; MOH: Ministry of Health; BSC: Bachelor of Science; SPSS: Statistical Package for the Social Sciences.