|Year : 2018 | Volume
| Issue : 1 | Page : 29-34
Knowledge and attitude of health-care professionals toward adverse drug reactions reporting at King Saud Medical City
Ali2, Amal Qadri Al-Aqqad1, Sara Osama Salem1, Maram Abdullah Al-Dossari1, Abdullah Mohammad Ananzeh1, Jaffer
1 King Saud Medical City, Ministry of Health, Riyadh, Saudi Arabia
2 Institute of Biomedicine, University of Eastern , Kuopio, Finland
3 University of Karachi, Karachi, Pakistan
|Date of Web Publication||20-Mar-2018|
King Saud Medical City, Ministry of Health, Riyadh 12746, Saudi Arabia.
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Health-care professionals across the globe are obligated to report adverse drug reactions (ADRs). The knowledge of ADRs and attitude of health-care professionals toward ADRs reporting is vital for patient safety. This study intends to investigate the knowledge of ADRs and attitude of health-care professionals toward ADRs reporting. Materials and Methods: A cross-sectional study using an anonymous questionnaire was conducted over a period of 3 months (September 2016 to November 2016) at King Saud Medical City, Riyadh, Saudi Arabia. This study included 399 questionnaires submitted by health-care professionals. Results: A total of 399 questionnaires were submitted by health-care professionals, of which only 14.8% knew the term “ADR” and 55.1% of the respondents reported ADRs during their practice. A total of 93.8% of the respondents agreed that ADR reporting should be made mandatory for health-care professionals, and 94.5% agreed that it improves the patient safety. Conclusion: The findings generally indicate that health-care professionals in a tertiary care setting have low awareness regarding the term “ADR.” Lack of pharmacovigilance training, amount of workload, and legal liabilities are the main causes of underreporting. More than half of the respondents agreed that ADR reporting eventually improves patient safety.
Keywords: ADRs, health-care professionals, pharmacovigilance, reporting, safety
|How to cite this article:|
, Ali S
, Al-Aqqad AQ, Salem SO, Al-Dossari MA, Ananzeh AM, Baqar J
. Knowledge and attitude of health-care professionals toward adverse drug reactions reporting at King Saud Medical City. J Pharm Bioall Sci 2018;10:29-34
|How to cite this URL:|
, Ali S
, Al-Aqqad AQ, Salem SO, Al-Dossari MA, Ananzeh AM, Baqar J
. Knowledge and attitude of health-care professionals toward adverse drug reactions reporting at King Saud Medical City. J Pharm Bioall Sci [serial online] 2018 [cited 2018 Jul 20];10:29-34. Available from: http://www.jpbsonline.org/text.asp?2018/10/1/29/227679
| Introduction|| |
Adverse drug reaction (ADR) is defined as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” Preclinical and clinical trials do not reveal all the serious and latent ADRs of experimental drugs, which necessitate the need for post-marketing monitoring of all drugs. Most of the ADRs are reported after the consumption of prescribed drugs by a heterogeneous population group. The reporting of ADRs is itself regarded as an important source of information for health-care professionals, and the quality of collected ADR reports mostly depend on their reported data.,
The World Health Organization (WHO) defines pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” With a population approaching 30 million and huge annual health-care expenses, the funding of health-care services in the Kingdom of Saudi Arabia (KSA) is quite challenging for the Ministry of Health., Health-care services in the KSA are provided free of cost in the public hospitals, whereas several initiatives have been taken by Saudi Food and Drug Authority (SFDA) to promote patient safety and encourage health-care professionals to report ADRs. SFDA established National Pharmacovigilance Center (NPC), which plays a vital role by receiving ADR reports from consumers and health-care professionals, and urged the need to promote awareness about these reporting centers. As per the recommendations of the WHO, 200 or more ADR reports are optimally required to be submitted per million inhabitants per year to the Uppsala Monitoring Centre. ADR reporting is regarded as an ethical and professional obligation of the health-care professionals, which could save millions of lives worldwide. ADRs were found to be the sixth leading cause of death in the United States, whereas 16% of hospital admissions in the United Kingdom were recorded due to these incidents.
NPC in the KSA accepts both electronic and paper ADR reports from consumers and health-care professionals. On the contrary, underreporting of ADRs is still prevalent despite NPC’s endeavors for promoting ADR reporting in the KSA. A descriptive study in the Eastern Province of the KSA revealed that health-care professionals occasionally contacted drug information centers for ADR-related queries. The aim of this study was to investigate the knowledge of ADRs and attitude of health-care professionals toward ADR reporting. The study findings will facilitate Medication Safety Unit for designing and implementing customized ADR training programs for health-care professionals, thus improving hospital’s PV process.
| Materials and Methods|| |
It was a cross-sectional study conducted during September 2016 to November 2016 at King Saud Medical City (KSMC), which is a large tertiary care Ministry of Health hospital with a 1400-bed capacity in Riyadh, KSA. This hospital serves a wide range of patients drawn from a large population, many of whom present with complex medical comorbidities and are referred from different regions of the KSA. Health-care professionals in KSMC report ADRs to the Medication Safety Unit. Moreover, this unit disseminates collected ADR reports to the NPC, which later transfers all individual case safety reports by ICH-E2B format to the database of WHO-Uppsala Monitoring Centre in Sweden.
A self-administered and anonymous printed questionnaire was distributed to 450 health-care professionals (doctors, pharmacists, nurses, dentists, and technicians) working at different departments of KSMC. The study questionnaire was adapted from similar studies conducted earlier with some minor modifications to suit the KSA’s environment. All health-care professionals were briefed about the objective of the study and were also provided study information sheet; waiver of informed consent was granted by the ethics committee of KSMC as there was no risk involved. Health-care professionals were asked 29 open-ended and structured questions and given 1-week time for self-completion. The questionnaire comprised three sections such as demographic characteristics of participants, knowledge of health-care professionals about ADR reporting, and their attitude toward ADR reporting.
The sample size was calculated by an online sample size calculator with the selection of 5% margin of error and 95% confidence interval, which provided a sample of 362 participants. Data analysis was performed using Statistical Package of Social Sciences Software, Version 21.0 (IBM, Armonk, NY). Descriptive statistics were applied to the categorical variables and represented as frequency and percentages. The influence of gender and nationality differences on the responses of knowledge and attitude questions was also evaluated by performing χ2 test. A P-value of <0.05 was taken as the level of significance between responses. This study was commenced after the approval (reference number: H1RI-11-Aug) from Institutional Review Board of KSMC.
| Results|| |
A total of 399 questionnaires were returned by the health-care professionals, and the response rate was 88.6%. Majority of the respondents were female, whereas majority (34.3%) of the respondents belonged to the age group of 26–30 years. More than two-third of the respondents were international employees; 301 (75.4%) were nurses, 52 (13%) were doctors, whereas pharmacists and dentists were 36 (9%). Majority of the health-care professionals had 1–5 years of working experience (236, 59.1%). The respondents were asked whether they had ever received training or lecture on ADR; 25.3% received training at KSMC, 26.8% received training in their previous hospital services, and 39.3% attended a lecture during their graduation period. When asked about the best source of ADR information, the respondents answered standard textbooks (49.9%), US Food and Drug Administration (44.1%), Saudi National Formulary (15.1%), and British National Formulary (7.8%) [Table 1].
|Table 1: Demographic characteristics of health-care professionals (n = 399)|
Click here to view
Of the 399 respondents, only 14.8% knew the term “ADR,” which was significantly associated with the nationality (P < 0.001). Overall 71.2% witnessed ADRs, and they thought the likely causes of these ADRs were drug–drug interactions (39.4%), medication errors (18.3%), idiosyncratic reactions (5.6%), and other causes (36.6%). The reported outcomes from witnessed ADRs were short hospitalization (24.6%), prolonged hospitalization (35.2%), morbidity (3.5%), and death (4.2%). When asked whether ADRs are avoidable, 75.9% answered “yes,” which was statistically significant with the nationality (P = 0.040). A total of 55.1% respondents reported the ADRs; of these, 50% reported to Medical Safety Unit of KSMC, 30.9% to their head of department, 4.5% to SFDA, and 14.5% to other means. When asked about the medium of ADR reporting, 71.4% answered ADR form, 6% telephone, 2.5% e-mail, whereas 17.3% did not know where to report. The medium of reporting was associated with gender (P = 0.003) and nationality (P = 0.001). Interestingly, 70.2% answered that everyone is responsible to report ADRs, whereas 14.8%, 5.2%, 4.1%, and 3.3% thought ADR reporting is only the responsibility of nurses, doctors, clinical pharmacists, and pharmacists, respectively. The gender (P < 0.001) and nationality (P = 0.035) of the respondents were associated with the responsibility of ADR reporting. Majority (92%) of the respondents answered that all types of ADRs should be reported, whereas 4.3% thought only serious ADRs should be reported. Type of ADRs reporting was associated with gender (P = 0.006) [Table 2]. When respondents were asked the reasons for not reporting ADRs, 34.8% were uncertain of how to report, 25.1% said lack of time, 18% said lack of feedback, 8.3% said forgetfulness, and 7.3% said unavailability of ADR form [Figure 1].
|Table 2: Knowledge of health-care professional regarding ADR reporting (n = 399)|
Click here to view
|Figure 1: Percentage responses regarding reasons for not reporting ADRs (n = 399)|
Click here to view
In the last section of survey where respondents’ attitude toward ADR reporting was asked, 93.8% agreed that ADR reporting should be mandatory for health-care professionals and 94.5% agreed that it improves the patient safety (nationality; P = 0.041). Majority (95%) of respondents agreed that all ADRs should be reported (nationality; P = 0.011). When asked whether ADR reporting increases workload, 51.1% agreed to it (gender, P = 0.002; nationality, P < 0.001). Only 17.8% agreed that ADR reporting is not important for health-care system (gender, P < 0.001; nationality, P < 0.001). Approximately 35.1% agreed that ADR reporting affects the patient’s confidentiality issue (nationality, P = 0.001), 34.6% agreed that ADR reporting brings no difference (nationality, P = 0.017), and 58.4% agreed that legal liability issues affect the ADR reporting (nationality, P = 0.048) [Table 3].
|Table 3: Health-care professional’s attitude toward ADR reporting (n = 399)|
Click here to view
| Discussion|| |
To the best of our knowledge, this is the first study that explored the knowledge and attitude of health-care professionals regarding ADR reporting in a large tertiary care hospital in the KSA. This study revealed several important findings about the awareness and attitude of health-care professionals toward ADR reporting. Nurses outnumbered other professional categories in this study and showed more interest in the submission of study questionnaires as they usually spend more time in the administration of drugs. Consistent to this notion, other health-care professionals are not generally in the same number of size than nurses at a tertiary care setting.
On the basis of the results obtained, majority of the health-care professionals were not familiar with the term “ADR,” which shows their lack of knowledge regarding PV; this is in line with the findings of a study conducted in Northern Cyprus. On the contrary, 55% of the health-care professionals reported ADR during their practice in spite of having difficulty in understanding the term “ADR.” It has been observed from practical experience that the words “side effect” and “ADR” are often used interchangeably at a health-care setting, which might be a reason that majority of the participants were not familiar with the term “ADR.”
Majority of the ADRs were reported to hospitals’ Medication Safety Unit, and the reporting interest toward NPC was found to be low as the concept of PV in the KSA is still in its inceptive phase. An earlier study revealed that more than two-third of the respondents were unaware of the existence of NPC in the KSA. The lack of awareness regarding the existence of NPC among the health-care professionals also exists in Kuwait and Malaysia., The most commonly reported patient outcome was prolonged hospitalization, whereas a significant proportion of health-care professionals held the belief that ADRs are mostly avoidable, which accords well with the prospective analysis of 18,820 subjects in the United Kingdom. The study findings demonstrate that the knowledge about ADRs and their reporting is suboptimal, which can be improved by conducting lectures and training programs for health-care professionals. A systemic review that included 37 studies of 12 countries concluded that underreporting of ADRs to spontaneous reporting systems is prevalent. More than 70% of health-care professionals were aware of ADR-reporting forms and merely 17% did not know the medium of ADR reporting at hospital and national level.
Approximately 70% of the respondents felt that ADR reporting is a part of health-care workers’ professional obligations, which corroborates the findings of a survey conducted in Malaysia. In contrast, John et al.
 found that merely 40% of health-care professionals felt exactly the same way. In this study, the foremost barriers to underreporting were uncertainty among health care professionals about reporting procedures and lack of time, which replicate the findings of an exploratory study conducted in a teaching hospital in the United Arab Emirates.
Participants in this study had positive attitude toward ADR reporting, as 93.8% believed that ADR reporting should be mandatory for all health-care professionals, which is similar to the findings of an earlier study. Consistent to this notion, a very high proportion of participants considered ADR reporting as a means of improving patient safety. The findings also revealed that more than half of the health-care professionals felt legal liability issue as one of the reasons for underreporting, which was reported in a range of 46%–87% in the earlier studies., Majority of the health-care professionals in Malaysia suggested the provision of education and training regarding ADR detection and reporting to avoid underreporting of ADRs. There is a need to promote nonpunitive culture for ADR reporting at a tertiary care setting, which will boost the confidence of health-care professionals, thereby improving patient safety.
There are some limitations to this study. This study was conducted in a single tertiary care institution in the KSA; hence, the results cannot be generalized to the whole population. A large number of responses were received from the nurses, whereas questionnaire submission rate from other health-care professionals was found to be low. There is also the possibility of response bias as some questions, such as have you ever witnessed ADRs and did you report ADRs, were dependent on the respondents’ ability to recall information. Moreover, a causal relationship cannot be established through cross-sectional studies. Therefore, it is imperative to conduct a multicenter longitudinal study across the health-care settings of the KSA to validate the findings of a large tertiary care setting in the KSA.
| Conclusion|| |
The findings generally indicate that health-care professionals in a tertiary care setting have low awareness regarding the term “ADR.” Lack of PV training, amount of workload, and legal liabilities are the main causes of underreporting. More than half of the respondents agreed that ADR reporting eventually improves patient safety. It is evident that PV-awareness programs for the health-care professionals should be regularly along with the continuous medical education accreditation. However, a large-scale multicenter study would help the ministry to formulate an effective strategy to encourage ADR reporting among health-care professionals.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interests.
| References|| |
The importance of pharmacovigilance: Safety monitoring of medicinal products. World Health Organization. Available from: http://apps.who.int/iris/bitstream/10665/42493/1/a75646.pdf. [Last accessed on 2018 Jan 22].
Reporting adverse drug reactions: Definitions of terms and criteria for their use. Council for International Organizations of Medical Sciences (CIOMS). Available from: https://cioms.ch/wp-content/uploads/2017/01/reporting_adverse_drug.pdf. [Last accessed on 2018 Jan 22].
Almalki M, Fitzgerald G, Clark M. Health care system in Saudi Arabia: An overview. East Mediterr Health J 2011;17: 784-93.
Ali S, Alghamdi MA, Alzhrani JA, Devol EB. Magnitude and characteristics of clinical trials in the Kingdom of Saudi Arabia: A cross-sectional analysis. Contem Clin Trials Commun 2017;7:126-9.
. Uppsala Monitoring Centre. Available from: https://www.who-umc.org/safer-use-of-medicines/uppsala-reports. [Last accessed on 2018 Jan 22].
Safety of Medicines: A guide to detecting and reporting adverse drug reactions—Why health professionals need to take action. World Health Organization. Available from: http://apps.who.int/medicinedocs/en/d/Jh2992e. [Last accessed on 2018 Jan 22].
Alshammari TM, Alshakka M, Aljadhey H. Pharmacovigilance system in Saudi Arabia. Saudi Pharm J 2017;25:299-305.
Alamri SA, Aljaizani RA, Naqvi AA, Ghamdi MSA. Assessment of drug information service in public and private sector tertiary care hospitals in the Eastern Province of Saudi Arabia. Pharmacy (Basel) 2017;5:37.
Necho W, Worku A. Assessment of knowledge, attitude and practice of health professionals towards adverse drug reaction reporting and factors associated with reporting. J Pharmacovigilance 2014;2:135.
Sample size calculator. Raosoft. Available from: http://www.raosoft.com/samplesize.html. [Last accessed on 2018 Jan 22].
Physical and human resources. World Health Organization. Available from: http://www.wpro.who.int/asia_pacific_observatory/ hits/series/Hits_MYS_4_resources.pdf?ua=1. [Last accessed on 2017 Sep 15].
Toklu HZ, Soyalan M, Gültekin O, Özpolat M, Aydın MD, Gunay AC, et al
. The knowledge and attitude of the healthcare professionals towards pharmacovigilance and adverse drug reaction reporting in Northern Cyprus. J Pharmacovigilance 2016;4:193.
Sales I, Aljadhey H, Albogami Y, Mahmoud MA. Public awareness and perception toward adverse drug reactions reporting in Riyadh, Saudi Arabia. Saudi Pharm J 2017;25:868-72.
Alsaleh FM, Lemay J, Aldhafeeri RR, Alajmi S, Abahussain EA, Bayoud T. Adverse drug reaction reporting among physicians working in private and government hospitals in Kuwait. Saudi Pharm J 2017;25:1184-93.
Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007;16:223-8.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al
. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18,820 patients. BMJ 2004;329:15-9.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006;29:385-96.
Hadi, MA, Helwani R, Long CM. Facilitators and barriers towards adverse drug reaction reporting: Perspective of Malaysian hospital pharmacists. J Pharm Health Serv Res 2013;4:155-8.
John LJ, Arifulla M, Cheriathu JJ, Sreedharan J. Reporting of adverse drug reactions: An exploratory study among nurses in a teaching hospital, Ajman, United Arab Emirates. Daru 2012;20:44.
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.
Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012;17:21-5.
Hamedivafa F, Peiravian F. A survey of knowledge, attitude and practice of nurses towards pharmacovigilance in teaching hospital, Qazvin-Iran. Res Pharm Sci 2012;7:S863.
[Table 1], [Table 2], [Table 3]