Study site and study period
The study was conducted from August 2014 to June 2015 among community pharmacists in Lalitpur district, one of the seventy-five districts of Nepal. The district, with Patan as its headquarters, covers an area of 385 km2 and is one of the three districts in the Kathmandu Valley, along with Kathmandu and Bhaktapur. Its population was 466,784 in the initial 2011 census tabulation [7]. Lalitpur District has two medical colleges, various other colleges and other institutions of higher learning [7].
Study design
The design was cross sectional conducted at three points in time, before, immediately after and 6 weeks following an educational intervention and the study population was community pharmacists registered with the Nepal Chemist and Druggist Association (NCDA) at Lalitpur district [24].
Sampling method
The pharmacy shops were selected using systematic sampling with a sampling interval of three where the first pharmacy was selected randomly between one and three. The sampling interval was three as we were selecting 75 pharmacies from the 204 registered community pharmacies in the district.
Sample size calculation
For sample size calculation, we assumed that the knowledge would be about 40% in our population of community pharmacists. This was obtained from the results of the pilot test and also from the literature review [25].
$$ {\text{Knowledge}} =40\%\,{\text{p}} = 0.4, {\text{q}} = 1-{\text{p}} = 0.6 $$
$$ {\text{N}}= [{\text{Z}}\alpha^{2}\,\times\,{\text{p}}\,\times\,{\text{q}}/({\text{M.E}}.)^{2}] $$
where Zα = 1.645 from normal table, two tailed at 10% alpha or 90% confidence interval, P = Population proportion, M.E = Margin of error = 10%, So, n = (1.645)2 × (0.4) × (0.6)/(0.1)2 = 65
Non response rate = 10%
Total sample size required after provision for drop outs from the study = 65 + 10% of 65 = 71
Development of the questionnaire
The questionnaire included questions framed based on knowledge and attitude studies about pharmacovigilance and consumer pharmacovigilance conducted among community pharmacists in other countries. Manuscripts and published papers describing similar research and methodological issues were also studied [4, 27,28,29,30]. In the questionnaire, the issues addressed were the origin of pharmacovigilance in Nepal, progress and status of pharmacovigilance and the present system of pharmacovigilance in the country. Information about reporting ADRs, who can report ADRs, location and functions of the national pharmacovigilance center were also covered. Processing of ADRs and information about the scales used to analyze ADRs were also addressed in the questionnaire.
Translation of the questionnaire
Additional file 1 shows the questionnaire developed in English. This questionnaire was translated into the Nepali language by two independent translators fluent in both languages and not associated with the study. The questionnaire was then back translated into English by two different individuals and the back translated version was compared with the original.
Pretesting of the questionnaire
The questionnaire was tested for readability and ease of understanding among ten CPs (four rural and six urban). The data obtained was not included in the study. Face validation of the questionnaire was conducted by colleagues in the department. Then the questionnaire was sent to faculties of other departments for their inputs regarding readability and grammatical errors. Content validation was done by sending the questionnaire to content experts of pharmacovigilance within the country. Internal consistency was measured by calculating Cronbach’s alpha value, which was 0.67 indicating good reliability.
Demographics
Gender, age, work experience, educational qualification and the location of the pharmacy were noted. Participant’s knowledge and attitude about pharmacovigilance and consumer pharmacovigilance was measured by noting his/her agreement with a set of 21 statements using a Likert-type scale.
Information about the pharmacy
Information about the year of registration, number of patients visiting the pharmacy daily, number of books available for reference in the pharmacy, number of dispensers and total number of brands of medicines in the pharmacy were noted from the respondents.
Scoring system
The scoring system used was: 5 = strongly agree with the statement, 4 = agree, 3 = neutral, 2 = disagree and 1 = strongly disagree with the statement using a Likert scale. There were twelve statements for assessing knowledge (maximum possible score of 60), and nine statements for attitude (maximum possible score of 45). The maximum possible overall score obtained by adding the ‘knowledge’, and ‘attitude’ scores was 105. The median and interquartile range were calculated for the ‘knowledge’, ‘attitude’ and “overall” scores.
Conduct of the study
The questionnaire was administered personally by one of the investigator (RBP) visiting pharmacies in the study area. The community pharmacists were requested to complete the questionnaire in the presence of the investigator who could take back the completed questionnaire for analysis. This was used for collecting the baseline or pre intervention data. For the post intervention data, the questionnaire were administered to the participants immediately after the intervention session. Retention data were collected by visiting the participants individually in the same pharmacies 6 weeks after the educational intervention and employing the same procedure as that used for the pre-intervention data. Baseline knowledge and attitude of CPs was studied so that strengths and deficiencies could be noted and appropriate educational interventions planned. Knowledge and attitude was measured immediately after the educational intervention, and retention of information was tested 6 weeks post intervention.
Educational intervention
The intervention included a session about pharmacovigilance and consumer pharmacovigilance. They were also asked to share their views and opinions about the adverse drug reaction reporting form designed for community pharmacists. Informative posters were also displayed for information sharing about ADRs. Participants also learned about the existing pharmacovigilance system in Nepal and the importance of involving consumers in the existing system. The duration of the session was 2 h. The teaching learning aids used were power point presentation, posters and leaflets about ADRs. The session was interactive and the participants designed an adverse drug reaction reporting form to be used by community pharmacists in the Nepali language.
Statistical analysis
The knowledge, attitude and overall scores were tested for normality of distribution using Shapiro–Wilk test. The samples were noted not to follow a normal distribution so median and interquartile range and Wilcoxon Signed Rank Tests for Repeated Samples (non-parametric test) were used for comparing pre, post and retention scores. A p value less than 0.05 was taken as statistically significant. As the sample size was small KAP scores at the three points in time were compared only among a limited number of subgroups. The scores were compared among respondents grouped according to gender, location and qualifications as we felt these were the most important characteristics and there was enough number of respondents in each subgroup. The collected data was analyzed using SPSS version 20.0 for Windows.
Ethical considerations
The study was approved by the Institutional Research Committee of KIST Medical College. All CPs were informed and explained about the aims and objectives of the study and invited to participate. Written informed consent was obtained from all participants.