Table 1.
Study ID | Methods
|
Results
|
|||
---|---|---|---|---|---|
Method/population | Sample size | Instrument | Knowledge | Attitude/practices | |
Suyagh et al35/Jordan | Cross-sectional/community and hospital pharmacists | 208 (130 community pharmacists; 78 hospital pharmacists) | Questionnaire | Only 19.2% and 67.7% could define PV and ADR correctly, respectively. 68.5% were not aware of the existence of PV center in Jordan and 85.4% did not know about the official ADR reporting form. | Reasons for not reporting: lack of information from patient; ADR form not available; unaware of existence of national PV system; ADR too trivial. |
Mahmoud et al30/Saudi Arabia | Cross-sectional/community pharmacists | 147 | Questionnaire | Only 22.1% were familiar with ADR reporting process in Saudi Arabia and 80% were not aware of the availability of online reporting system. | 87.5% did not report ADR if they encountered one and referred patients to physicians. Unaware of reporting method, ADR reporting being physicians’ responsibility, and ADRs encountered by community pharmacists are usually minor and need not to be reported were the most common reasons cited for not reporting ADRs. |
Khan28/Saudi Arabia | Cross-sectional/community pharmacists | 50 | Questionnaire | 92% could define ADR and 90% were not aware of the existing ADR reporting system available in Saudi. | Major reasons for not reporting included: unavailability of professional ambience to discuss ADR; ADR form not available; reporting form is complicated; it is time consuming. |
Elkalmi et al25/Malaysia | Cross-sectional/community pharmacists | 116 | Questionnaire | Only 11.6% could define PV correctly and 75% were not aware the existence of PV system. 68.3% did not know that ADR reports can be submitted online. | Reasons for not reporting ADRs included: did not know how and where to report; ADR form not available; serious ADR already detected prior registration. |
Al-hazmi and Naylor23/Saudi Arabia | Cross-sectional/community pharmacists | 170 | Face to face interviews | Only 18% were aware of the national ADR reporting system and more than half (56%) of the respondents did not know about the existence of the national PV center. | 38.8% agreed that pharmacists are responsible for reporting ADRs. 94.1% felt that ADR reporting should be made compulsory. ADR form not available, did not care to report, ADR already known, and did not know how to report were the common reasons for not reporting ADRs. |
Qassim et al33/UAE | Cross-sectional/community pharmacists | 223 | Questionnaire | Only 4.9% of the participants had good knowledge score. 44% were not aware about ADRs reporting program in UAE. | 93.7% had a positive attitude toward reporting ADRs. However, only 3.6% of the participants had sent ADR reports to MOH or the pharmaceutical companies at least once. |
Jose et al27/Oman | 93.7% had a positive attitude toward reporting ADRs. However, only 3.6% of the participants had sent ADR reports to MOH or the pharmaceutical companies at least once. | 88.8% of the pharmacists were aware of the national PV program in Oman. However, 20.5% thought that only adverse reactions to a new drug need to be reported. | 90.6% considered it part of their professional obligation of pharmacists. Sixty four percent rejected the notion that ADR reporting would increase unnecessary workload. 91.5% and 86.9% of pharmacists would inform patient regarding important side effects of a medication and regarding actions needed to avoid ADRs, respectively. | ||
Duarte et al24/Portugal | Mixed-methods/community pharmacists | 154 | Questionnaire and qualitative interviews | One-quarter of the respondents were familiar with the new ADR definition. 38.3% had previously reported an ADR. Educational interventions were believed to be the main facilitator. | ADR reporting was considered as very important by 66.9% of the respondent. Unsure of causal association between drug and reactions, lack of time, and ADR already known were commonly cited barriers. |
Yu et al36/South Korea | Cross-sectional/community pharmacists | 1001 | Questionnaire | 95.5% recognized pharmacists’ duty to report ADRs. However, only 77% of the respondents knew about the national PV system in Korea. | 87.1% of the respondent had encountered ADR but only 29.4% had reported an ADR. Among reasons for not reporting ADRs were ADR was not serious; already known ADR; and unsure of causal relationship between drug and reactions. |
Rabba and Mohammad32/Saudi Arabia | Cross-sectional/community pharmacists | 53 | Questionnaire | Only 25% were aware of the existence of the PV system in Saudi Arabia and 74% of the participants did not know where to report ADR if encountered. | 85% considered ADR reporting as pharmacists’ responsibility and 95% believed that PV is important. ADR form not available; confidentiality; and inability to establish causation were the commonly cited reasons for not reporting ADRs. |
Hadi et al26/Malaysia | Cross-sectional/hospital pharmacists | 163 | Questionnaire | 95.0% and 79.1% correctly identify definitions of ADRs and PV, respectively. 97.5% were aware on how to locate an ADR form. 95.0% of the pharmacists involved also knew that ADR should be sent to MADRAC. | All pharmacists agreed that ADR reporting is part of their professional responsibility. Reasons for not reporting ADRs included: lack of information from patient; ADR already well known; minimal feedback received, and too busy to report. |
Liu et al29/People’s Republic of China | Case–control (case – pharmacists who had reported ADR between January 2008 and December 2010; control – pharmacists who had not reported ADR for the same period)/hospital pharmacists | 558 (186 from cases and 372 from controls) | Questionnaire | Pharmacists who had reported an ADR had higher compared to those who had not (p=0.005). More than half were of the availability of phone reporting and e-mail reporting. | Majority agreed that reporting ADR is the professional responsibility of pharmacists. Most of the participants agreed that easier reporting system can increase reporting rate. Top three reasons cited that might affect ADR reporting were seriousness of the reaction, expected reaction to the drug, and lack of mandatory regulation on ADR reporting. |
Obara et al31/Japan | Cross-sectional/community pharmacists | 1795 | Questionnaire | About 77% did not understand the national ADR reporting system and pharmacists’ knowledge was significantly associated with gender, age, level of education, working experience, and number of pharmacists in the hospital. | Reasons for not reporting ADR were well- known reaction, unsure of causal relation between drug and reactions, and did not know how to report and ADR. |
Abbreviations: ADR, adverse drug reaction; PV, pharmacovigilance; MADRAC, Malaysian Adverse Drug Reactions Advisory Committee; MOH, Ministry of Health.