A Review on The Assessment of Knowledge, Attitude and Practices Regarding Adverse Drug Reactions (ADR) And Its Reporting of Community Pharmacist

Adverse drug reactions (ADRs) represent a worldwide health concern requiring attention due to their significant contribution to patients’ drug-related morbidity and mortality, increasing hospital admission and healthcare expenditure.^[1] Advanced age, comorbidities, poly medication, inappropriate prescribing, and suboptimal monitoring are some of the risk factors for the development of ADRs. Of all hospitalizations, 0.2%–59.6% are attributed to ADRs, and 1.8% are known to be fatal.^[2] A retrospective study evaluating ADRs has reported that systemic antimicrobial agents, drugs acting on the cardiovascular system, alimentary tract and metabolism, and musculoskeletal system were the most common pharmacological groups according to the World Health Organization (WHO)-Anatomical Therapeutic Chemical (ATC) classification implicated in the ADRs. Although every drug undergoes various phases of safety screening during pre-clinical studies and clinical trials, not all ADRs are identified due to clinical trial constraints.^[3] Therefore, it becomes essential that drug products continue to be monitored for safety and efficacy in practice settings even after approval.^[4] Among various methods of reporting ADR, healthcare professionals’ spontaneous reporting system of ADRs is the backbone of PV that will serve as the basis for a robust and comprehensive post-marketing drug safety surveillance program.^[5]  Most countries have joined the WHO’s international drug monitoring program to identify and report the ADRs in clinical practice through PV centres. The United Arab Emirates (UAE) established the national drug surveillance program in 2008 and later in 2013, with the WHO inter-drug monitoring program in collaboration with the Uppsala Monitoring Centre. The Ministry of Health (MOH)/Emirates Health Services, Department of Health (DOH)-Abu Dhabi, and Dubai Health Authority (DHA)-Dubai now governs healthcare in the UAE.^[6]  PV laws and legislation exist following the best standards worldwide. Health regulatory authorities continually work to raise awareness among healthcare practitioners about the necessity of monitoring and reporting ADR in the country; nonetheless, appropriate application remains a challenge. Additionally, the UAE Ministry of Health and Prevention implemented an innovative UAE RADR application in 2019 to facilitate PV activities in the country.^[7]

MATERIALS AND METHODS

Study design, study settings, and study populations

This cross-sectional study was conducted using a validated questionnaire related to KAPs regarding ADRs and its reporting among community pharmacists in Ras Al Khaimah among community pharmacists for 5?months between March and July 2022 in the northern emirate of UAE.

Sample size and sampling method

A convenient sampling technique was involved to collect data from the study participants. The required sample size was calculated using Qualtrics. There are around 90 pharmacies within Ras Al-Khaimah, with at least one pharmacist and one assistant pharmacist in each pharmacy. Considering a total of 180 probable respondents from 90 pharmacies and a response distribution of 50%, the required number of respondents was 123, with a 5% error margin and a 95% confidence interval.

Data collection method

The study investigator met the pharmacist independently at their practice sites, explained the purpose of the study, and asked the pharmacist to fill out the validated structured self-administered questionnaire along with the informed consent provided in hard copy delivered by hand. Participants were informed that the study was optional, and we guaranteed their replies would be anonymous and confidential. Pharmacist ambiguity related to the questionnaire was answered verbally. Sufficient time (approximately 1?week) and reminders were provided to each participating pharmacist working in chain pharmacies and independent pharmacies to complete and submit the questionnaire, and their response was documented. The investigator thoroughly reviewed the submitted questionnaires to verify the integrity of the gathered data and to prevent any missing or inadequate information within the questionnaire.

Questionnaire development and validation

A self-administered questionnaire assessing KAP was developed by consulting relevant literature, recommendations, and similar research. It was subsequently adjusted to suit the requirements of the current investigation. The questionnaires were validated for content and criteria validity. The initial question was forwarded to three academic clinical pharmacists specializing in pharmacovigilance to assess the content validity. The questionnaire underwent a pilot test to evaluate internal consistency and reliability. This test was conducted with a convenient sample of six pharmacists and four assistant pharmacists, who were not included in the final participants of the study. The questionnaire’s Cronbach alpha value, determined using the reliability scale, was 0.697. No other alterations were made to the questionnaire. The responses to the questionnaire section mentioned above were provided as “yes,” “no,” and “I do not know.”

Scoring system

The questionnaire was provided to the study participants in English and did not require language translation. The pharmacist’s response to the structured questionnaire about KAP was categorized as “correct” or “incorrect.” Each correct and positive response received a score of “1,” and the negative and incorrect responses received a score of “0.” Regarding questions related to attitude, participants’ responses, such as “yes,” were considered positive, while “no” and “I do not know” were considered negative. The scoring system helped us understand study participants’ ADR reporting practices.

Data analysis

The questions were encoded, inputted into the Excel spreadsheet, and examined using SPSS version 27 (IBM Corp., Armonk, NY, USA. Question numbers 8, 9, and 15 were negative-worded statements; hence, they were reverse-coded during analysis. Data normality was verified using the one-sample Kolmogorov–Smirnov test. Descriptive statistics were employed to examine the average and variability of continuous variables and the proportions and frequencies of categorical variables to describe the demographic characteristics. The examination of differences between the pharmacist and assistant pharmacist in terms of each question related to KAP was carried out using the Mann–Whitney U test (for two groups) and the Kruskal–Wallis test (for more than two groups).

RESULTS

Demographic characteristics of study participants

In our study, 177 private community pharmacists were approached and given questionnaires. A total of 156 study participants completed the questionnaires with a response rate of 88% and were included for analysis. The majority of the respondents were males (61.53%), in the age group of 21–35?years (71.70%), and pharmacists (75%). In addition, most of the respondents had bachelor’s degrees (54.48%).

Interrelationship of the KAP scores with ADR reporting

The inter-association of the study participants’ KAP scores concerning their ADR reporting was analyzed. There was a significant positive correlation between knowledge and attitude and knowledge and practice, indicating that good knowledge positively imparted their attitude and practice (p?<?0.01). Furthermore, attitude had a significant positive correlation with the practice of study participants concerning ADR reporting (p?<?0.01).  Correlation is significant at the 0.01 level (two-tailed)

Patients reporting ADRs to community pharmacies

Furthermore, it was observed that a majority of the survey participants (61.54%) acknowledged that only 10%–20% of their patients disclose ADRs to the community pharmacy. In contrast, 30.76% of the respondents stated that patients never report any ADRs to the pharmacy. Study participants mean KAP scores in reporting ADRs. A comparison of mean KAP scores on reporting ADRs of study participants was carried out concerning their demographic profiles. A statistically significant association was observed for the variables “designation” and “qualification” concerning the mean knowledge and practice scores among study participants except for age, gender, work experience, and nationality (p?<?0.05). However, no association was observed between mean attitude scores and the study’s demographic variables. The inter-association of the total KAP scores of the study participants was analyzed concerning their demographic profiles: A positive association was observed between the “designation,” “qualification,” and “work experience” with the KAP scores of the respondents, which was found to be statistically significant (p?<?0.05). However, no such association has been found between total scores and the gender, age, and nationality of study participants.