Physician’s Practice of Adverse Drug Reaction in Saudi Arabia

Yousef Ahmed Alomi* , BSc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, CDE Critical Care Clinical Pharmacists, TPN clinical pharmacist, Freelancer Business Planner, Content Editor and Data Analyst Riyadh, Riyadh, SAUDI ARABIA. Nouf Hassan Alamoudi, PharmD, Umm Al-Qura University, Makkah, SAUDI ARABIA. Sabah Alanazi, B.D.S. Prince Sultan Medical Military City, Riyadh, SAUDI ARABIA. Abeer Hussin Almasoudi, BSc.Pharm Director, Administration of research and studies, Ministry of Health, Tabuk, SAUDI ARABIA.


INTRODUCTION
The clinical pharmacy activity was well recognized in the Kingdom of Saudi Arabia for more than forty years. [1,2] The drug information services included among clinical pharmacy services. 2 The drug information activities are well established, and adverse drug reaction reporting system comprised among those activities. [1,3] The reporting of the ADR reporting system recognized altogether with drug information services. [4] The ADR was recognized by drug information pharmacists and reported to the medication's registration department at the Ministry of Health and recently reported to the Saudi Food and Drug Authority (SFDA). [4] The ADR reporting system encompassed a medication safety program in the past pharmacy strategic plan and the new plan with a new vision in 2030. [5][6][7] The ADR reporting required from all healthcare professionals, including physicians, pharmacists and nurses. [8] The knowledge and insight of healthcare professionals have an important role in ADR reporting practice, lack of knowledge and perception lead to ADR's under-reporting. As a result, variously reported the poor practice of ADR reporting system among physicians. Multiple inquiries found the insufficient practice of physician's knowledge, perception and practice the ADR reporting system among Saudi Arabia and some Arabic countries world-wide.  The reporting of ADR by physicians was found 5-34% only from 15 studies world-wide. More than 80 % did not get a training program about ADR and reporting system. [9,12,13,15,19,[21][22][23][24]26,[28][29][30][31][32] In Saudi Arabia, the number of studies showed to assess practice toward ADR reporting or pharmacovigilance between healthcare professionals, in Dammam city, 135 participants (17 physicians of participants) designated 88.22% of the participants did not report ADRs. In contrast, 57.7% have skilled ADRs during their professional. [14] In Al-Khobar at King Fahd Hospital of the University, 331 participants (161 physicians of participants), a result specified to 88.8% had never reported, submitted, or identified any ADR reports. [13] In Jeddah city, 337 hospital physicians contributed; a result showed that 57.6% of physicians had come across ADRs in practice, but only 21.7% reported these reactions. [12] All previous studies did not debate the factors affecting the physician's practice of ADR with gender or age, qualifications and experiences. Also, most of the studies did usage authenticated methods of the cross-sectional survey. The current study with explore the physician's practice of the ADR reporting system and factoring the physician's practice in the Kingdom of Saudi Arabia.

METHODS
It is a descriptive analysis of a cross-sectional study of physicians' practice of the adverse drug reaction & reporting system in Saudi Arabia. It was a self-administered electronic investigation for all physicians and dentists who worked in Saudi Arabia. All physicians' qualifications or types of specialties will be comprised in the study. All students will be omitted from the study. The survey comprised of two sections. The first part contained respondents' demographic data, comprising geographic location, gender, age, qualifications, specialties, the position held and working experiences. The second part had selected practice rudiments of the ADR system responsible for reporting ADR, the number of ADR reporting and the methods of ADR reporting system from previous literature. [9,12,13,15,19,[21][22][23][24]26,[28][29][30][31][32][33][34][35] The 5-point Likert response scale system was employed with closed-ended questions. The sample calculated as crosssectional study according previous literature with the confidence level 95% with z score of 1.96, margin of error (5-6.5%), unlimited populations size, populations' percentage (50%) and drop-out rate (10%). As results, the sample size will equal to 251 to 432 with power of study of 80%. [36][37][38] The response rate required of calculated sample size at least 60-70 % and above. [38,39] The survey was dispersed through social media whatsapp and telegram of physician's groups. Reminders message sent every 1-2 weeks. The survey was authenticated through the revision of expert reviewers and pilot testing. Besides, various tests of reliability McDonald's ω, Cronbach alpha, Guttmann's λ2 and Guttmann's λ6 had been completed with the study. The survey analysis through monkey survey system, the statistical package of social sciences (SPSS), Jeffery's Amazing Statistics Pro (JASP) and Microsoft excel sheet version 16 with description and frequency analysis, good of fitness analysis, correlation analysis and inferential analysis of factors affects physician's knowledge of adverse drug reaction & reporting system. The STROBE (Strengthening the reporting of observational studies in epidemiology statement: guidelines for reporting observational studies) showed the reporting of the current study. [40,41]

The Practice of ADR Reporting
In this study, only 52 (35.68%) had stated ADR reactions before with important difference with non-reported before of ADR, or they do not know (p<0.05). The average number of ADR was per patient. Despite that; the majority of responders thought ADR reporting is critical 138 (92.62%) with a statistically important difference from other answers (p<0.05) and responders had ADR reporting forms 60 (40.27%) with a statistically significant alteration with outstanding answers (p<0.05) ( Table 3) The patients infrequently report ADR a few times per year or once a month, 57 (38.51%) and 37 (25.%), respectively. The first action of most of the responders exposed to severe ADR they contact with treating physician 67 (47.18%), then direct the patients to the emergency room 65 (45.77%) and document the ADR on patients profile 64 (45.07%) ( Table 4). The average scores of rudiments of ADR reporting practice were (2.59) with a statistically significant difference among answers within each constituent (p<0.05). The highest score element was ADR's prevailing policy and procedures (2.67) and implemented the ADR reporting system and quality management regulations (2.66). In contrast, the ADR reporting system's lowest score elements were the yearly plan of ADR (2.49) and the ADR reporting system (2.55). The average scores of the physician's perception of ADR responsibility were (4.10) with statistically significant differences within answers of each element (p<0.05). The physicians stated that's doctors and pharmacists (4.46) and (4.5) respectively should be accountable for the ADR reporting system ( Table 5 and 6). The reliability test of McDonald's ω (0.875), Cronbach alpha (0.808), Guttmann's λ2 (0.870) and Guttmann's λ6 (0. 870). There is not any statically significant relationship between factors (location, gender, age, qualifications, positions, years of experiences, physicians specialties and dentists specialisms) and all items for Adverse drug reaction (ADR) employment at the institution; physician's perception of reporting adverse drug reactions (to authorities) is the accountability, and some questions related of experiences of ADR reporting, ADR reporting practice for instance number of ADR pragmatic daily, number of a patient exposed to ADR daily and the importance of ADR reporting system (p>0.05). Factors Affecting the Practice of ADR Reporting

Gender and Age
There is a noteworthy difference between males and females in the practice of ADR with higher males than females in the mission of reporting ADR, the yearly plan of reporting ADR, policy, and procedures of reporting ADR, and writing capability ADR and writing capability ADR (p<0.05) ( Table 7). There is no momentous difference among all age groups in all rudiments of ADR practice (p>0.05).

Qualifications and Specialty
There is no substantial difference between practice elements and physician's qualifications (residents, specialist and consultant) except consultant more reporting of ADR than residents (p<0.06). Also, the consultant is more alert of the availability of ADR's policy and procedures, yearly plan of ADR more than residents (p<0.05

Position and Experiences
There is no noteworthy difference between physician positions (director of medical units, assistant director of the medical department, medical director and physician staff) and practice of adverse drug reaction (p >0.05).
There are no important differences among the majority of ADE practice basics between all types of experiences except for the lower experience (1-3 years) had more applied of the strategic plan of ADR, and the yearly plan of reporting ADR than high experience (>9 years).

DISCUSSION
The medications' phases comprised of various steps that have encompassed procurement, prescribing, preparation, dispensing and monitoring. [42] The last steps, monitoring medications, need several tools to influence the defined outcome of drug therapy, such as medication errors or adverse drug reaction prevention and documentation. [5,43] The adverse drug reaction reporting chiefly was under-reporting by healthcare that is related to knowledge reasons or practice and insight reasons for healthcare providers, highlighting physicians. The current study reconnoitered the practice physicians of the ADR reporting system. The study had three quarters or responders were physicians, and one quarter were dentists. Many responders were young residents, physicians with various experiences, which imitate the high response of electronic surveys with fitting knowledge of using electronic devices. In the study, the results presented that only one-third of responders reported ADR. At the same time, the majority  did not even send any ADR during their practice period despite the ADR reporting system's vital opinions, which reliable with previous studies. [9,10,13,14,18,19,[21][22][23]25,26,32,33,[44][45][46][47][48][49] Further, it might be the ADR not readily obtainable at the front medical disk or nursing station at the wards or clinics. The ADR reporting system was incompetently implemented with most practice elements related to inadequate knowledge of physicians of the practice or not practice or seldom doing the exercise of ADR reporting system and contained with another study. [22,25,45] Few physicians familiar with ADR policy & procedures implementation and might practice it like aforementioned studies. [46] The inadequacy of education and training or inadequate practice at their organization facilities contributes like previous studies. [22,26,29,30,48] The physicians thought the accountability of ADR was supposed to be physicians or pharmacists and less likely with nurses or pharmacy technicians because of more knowledge than physicians of pharmacovigilance system. [10,13,23,27,31,49] To progress practice physicians to ADR reporting system, we propose transferring the full time activity to the pharmacist and may aid the physicians and facilitates the ADR reporting system with collaboration with physicians and other healthcare providers. It wants fulltime employees (FTE) to implement the ADR reporting system and displays it daily. Because the pharmacist more familiar with the design and required quality management standards to follow up and document ADR. Also, the physicians do not need wide-ranging courses and extra work of follow-up by pharmacist or quality management services for ADR reporting system that will protect time and effectors. Besides, the patients hardly report ADR reporting to physicians, and it will not occur except for patients to do the job of ADR reporting. The pharmacist can contact patients to text ADR and prevent any ADR sequence risk for patients. The physicians will deal with severe ADR unsuitable way, and that had been from trained physicians or dentists. As a result, the physicians can call the pharmacist to help him in emergency ADR and solve the glitches, and document all sever ADR related issues. The ADR reporting practice will not be pretentious by several variables, comprising location, age, qualifications, positions, years of experience, physicians' specialties and dentists' specialties, which varies from the earlier study. [30] However, the male were more knowledgeable and perception than female about adverse drug reaction reporting. The difference of the preceding research might be related to a well-established system of ADR and occasionally education and training about the ADR reporting system. [30] There was not any association between them. Some factors found might make some difference in ADR reporting, for example, gender without clear aims. Also, the consultant or higher qualifications or   many years of experience had more practice with some ADR reporting system which look like former studies). [9,50] Other factors will not make any difference, for instance, age levels, physician's qualifications, or positions.

Limitations
The current study was showed in detail about ADR's practice and related issues, with a authorized survey from expert reviewers and various reliability test applications. The study also deliberated the factors that exaggerated physician's or dentists' practice in the ADR reporting system. However, the study had various boundaries, including the sample sized not optimal, which could not signify the total number of participants, either physicians or dentists. The study does not have an equal number of type participants, physicians and dentists; most responders were physicians, making it stimulating to liken physicians and dentists. Many responders were young with fewer experiences and qualifications that is main the findings express that young category of physicians and dentists. The future study with a high number of samples and an equal number of physicians and dentists or choose one of them, and an equal number of qualifications and experiences are documented to explain all study limitations.

CONCLUSION
This study was steered among physicians and dentists about the physician's practice of the ADR reporting system. The self-administered questionnaire was authenticated through various methods and multiple biostatistics reliability tests. The outcomes showed that the ADR system was incompetently implemented and poor reporting of ADR look like the previous studies. That is related to insufficient knowledge and missing of ADR education and training. There were various challenges of physicians practicing the ADR system. The pharmacist should be more conversant and practice than all healthcare professionals. It will improve ADR reporting system by transferring complete accountability from all healthcare providers to pharmacists through full documentation of ADR and following up all ADR reporting matters in Saudi Arabia.