الفهرس 
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Abstract
Recently, pharmacovigilance has developed importance for its vital role in detection and prevention of Adverse Drug Reactions (ADRs), eliminating people suffering, improving health and enhancing quality of life. Pharmacovigilance is defined by The World Health Organization (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions or any other drug-related problem”. The term pharmacovigilance is derived from the Greek word “pharmakon” which means drug and the Latin word “vigilare” which means to keep watch.(WHO, 2002a)
The benefits of pharmacovigilance as stated by WHO are: early detection of unknown ADRs and drug interactions, identification of possible mechanisms by which a drug produces ADRs plus the risk factors that increase the probability of having such events, ensuring the rational and safe use of drugs by continuous assessment of the benefits and risks of drugs, encouraging effective communication between healthcare providers and the public, education and spreading of all information with regard to drugs for regulators, pharmaceutical companies, health professionals and patients to improve the prescription, administration and regulation of medicines. (Aronson J. K., 2011,WHO, 2006)
The World Health Organization (WHO) defines ADR as “any response that is noxious and unintended, and that occurs at doses normally used in humans for the prophylaxis, diagnosis, therapy of disease, or for modification of physiological function”.(WHO, 2002a)
ADRs are between the fourth and sixth direct cause of death in hospitalized patients in the United States (US), and caused elevation of hospital costs from $1.56 to $4 billion in year1998.(Lazarou J. et al., 1998) The rate of ADRs has been increased by 76.8 % annually and the mortality rate increased by 10 %.(Wu T. Y. et al., 2010)
Knowledge about pharmacovigilance is defined as the capacity to acquire, retain and to perceive the concept and purpose of pharmacovigilance.(Badran I. G., 1995)The knowledge about pharmacovigilance is still in its early stage especially in Arabian countries. Recent researches have shown that healthcare professionals‟ attitude to ADRs reporting is positive.(Bakhsh T. M. A. et al., 2016,Khan T. M., 2013)Despite this, there is still a need to improve the practice of ADR reporting.(Said A. S. A. & Hussain N., 2017)
In Alexandria hospitals in Egypt, very few data are known about healthcare professionals‟ knowledge, attitude and practice towards pharmacovigilance, the extent of their awareness to report ADRs, barriers to report and the additional support to incorporate pharmacovigilance into everyday healthcare practice.
Aim of the work
The aim of this work is to assess the knowledge, attitude and practice of healthcare professionals towards pharmacovigilance in Alexandria, Egypt.
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Materials and method
This study was a cross sectional study. We used a simple random sampling approach to select a representative hospital from each of university, ministry of health and health insurance hospitals then we randomly selected physicians and pharmacists from different departments with proportional allocation according to their size in each hospital. A self-administered questionnaire was distributed to healthcare professionals with different: scientific degrees, years of experience and both sexes were included.
A pilot study was conducted and some modifications were done after consulting three experts in pharmacovigilance to reinforce the content validity. Reliability of the questionnaire was calculated using Cronbach‟s alpha, yielding a value of 0.69. Those who refused to complete the questionnaire were excluded; and other randomly selected participants were included. The total minimum required sample size was 547 from physicians and pharmacists.
Data was collected, coded, introduced into SPSS program version 20.
Each item of knowledge questions was recoded into either (incorrect= 0 or correct= 1). We assumed that the cut off points dividing the scores into high and low values for knowledge, attitude and practice were 8, 4, 5 respectively based on that if respondents answered more than 66.0% of knowledge, attitude or practice questions (considering that it is a new science and it was recently established in Egypt).
Chi square test was performed to test for the presence of statistical significant difference in pharmacovigilance knowledge, attitude, practice and barriers towards reporting adverse drug reactions between: physicians and pharmacists, different health sectors, different scientific degrees (Bachelor, Diploma, master, Fellowship, PhD) and attendance of trainings. In case of invalid Chi square test, Fisher‟s Exact test was used for 2×2 tables and MonteCarlo test for r×c tables.
Mann-Whitney test was used to test for the presence of statistical significant difference in the knowledge, attitude and practice scores between physicians and pharmacists and between attendants and non-attendants of pharmacovigilance trainings. Kruskal-Wallis test was used to test for the presence of statistical significant difference in the knowledge, attitude and practice scores between different hospitals and between different scientific degrees.
Bivariate analysis for high and low scores was done using Chi square test.
Pareto chart was done to assess the most contributing barriers for reporting ADRs.
We conducted a multivariate stepwise backward logistic regression analysis after bivariate analysis to estimate the adjusted magnitude of association between each predictor and knowledge, attitude and practice towards pharmacovigilance. The initially included independent variables were profession, different health sectors‟ hospitals, training effect, years of experience and scientific degrees. For scientific degrees we combined bachelor degree and diploma and this was considered the reference category and those with fellowship, master or PhD degree was considered as the category with high scientific degrees. For health sectors the university hospital was considered the reference category.
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Odds ratios (OR) and respective 95 % confidence intervals were calculated. The predicted probability then was calculated from the following equation:
ln (p/1-p) =a + b1x
Predicted probability = e ln (odds)/(1+e ln (odds))
Significance was judged at the 5% level and quoted as two-tailed probabilities.
Hosmer–Lemeshow goodness-of-fit test was employed to test the agreement between observed and predicted knowledge, attitude and practice within quintiles of their scores. It signifies how well the model predicts both high score and low score across subcategories of independent variables. Acceptable prediction is evidenced by a p value ≥0.05. Nagelkerke R2 was calculated to explain the amount of variance in outcome accounted by the model.
The most important findings in the current study were
Healthcare professionals had poor knowledge about pharmacovigilance. Knowledge score was calculated with maximum score 12. The mean knowledge score was 4.4 ± 2.4, and the median was 4 ranging from 0-12.
Response rate of healthcare professionals in this study was promising and expressed a favorable desire to learn more about pharmacovigilance. The mean attitude score was 5.1±1 out of 6 and the median was 5 ranging from 1-6.
The most common barrier for reporting ADRs was lack of time. The second barrier was the difficulty in deciding whether the ADR had occurred or not. The belief that a single unreported case may not affect ADR database was the third barrier. Minority of healthcare professionals considered that absence of money compensation is a barrier towards ADR reporting. Pareto chart illustrated that 66 % of the barriers stated by healthcare professionals were attributed to lack of time to report and difficulty in deciding whether ADR has occurred or not.
Practicing the reporting of ADRs was poor among healthcare professionals. Less than half of participants have been exposed to at least one ADR during their practice, nearly one quarter of them reported it to EPVC. They declared that they are always reporting ADRs when the reaction is serious, or is to a new product, or is not reported before, or is unusual or when it is well recognized for a particular drug. The mean practice score was 2.8 ±1.7 out of 7 and the median was 3 ranging from 0-7.
There was a statistical significant difference between the percent of pharmacists who got high knowledge score 16.5% compared to 2.2% of physicians. Also, comparing the total high attitude score revealed that there was a statistical significant difference between the percent of high score in pharmacists 98.1% and physicians 90.1%. Similarly, the comparison of the percent of high practice score between physicians and pharmacists showed that there was a statistical significant difference between pharmacists 17.8% and physicians 9.9%.
Comparison between different health sectors revealed that there was no statistical significant difference between the percent of high knowledge score in the university hospital 10.9%, ministry of health hospital 9.1% and health insurance hospital 7.7%. The
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entire study sample in health insurance hospital had high positive attitude score, in ministry of health hospital the score was 97.0%, while in university hospital the percent was 93.9% and these differences were not statistically significant. Also, the percent of high practice score was not statistically significantly different between university hospital 14.0%, ministry of health hospital 13.6% and health insurance 20.5%.
There was a statistical significant difference between the percent of trained healthcare professionals who got high knowledge score 20.7 % and non-trained 3.4%. Also, the difference in the percent of high attitude score between trained 98.2 % and non-trained 92.3 % was statistically significant. Although the percent of high practice score was very low among healthcare professionals who received training 19.4 % and those who did not 11.1 % but this difference was statistically significant.
Considering different years of experience there was no statistical significant difference in the percent of high knowledge or high attitude. However, the percent of high practice was statistically significant between healthcare professionals with more than ten years‟ experience 20.8%, those with 5years or more and less than 10 years 14.8% and those with less than 5 years of experience 11.0%.
Healthcare professionals who held bachelor or diploma did not show statistical significant difference in the percent of high knowledge 10.8% compared to 9.6 % of those with higher degrees as fellowship, master or PhD, however there was a statistical difference in the percent of high positive attitude 96.7%, 90.4 % respectively. Even though, the good practice score was high among healthcare professionals who held fellowship, master or PhD degree 18.0 % than among those with bachelor or diploma degree 12.7% but this difference was not statistically significant.
Results of the multivariate logistic regression model testing for factors influencing healthcare professionals‟ knowledge about pharmacovigilance revealed that the odds of high knowledge was nearly 7 times more among pharmacists than physicians, twice more in healthcare professionals with high scientific degrees as fellowship, master or PhD than that among those with lower degrees as bachelor or diploma. Also, it was 4.5 times more among trained professionals in comparison to than the odds among non-trained.
Regarding factors influencing healthcare professionals‟ attitude towards pharmacovigilance, the odds of high attitude was nearly 6 times more among pharmacists than physicians.
For factors influencing healthcare professionals‟ practice, the odds of high practice was about 3 times more among pharmacists than that among physicians. Likewise, it was among healthcare professionals with high scientific degrees as fellowship, master or PhD than that among those with lower degrees as bachelor or diploma. Also, it was 1.6 times more among trained professionals in comparison to non-trained. However, in health insurance sector it was nearly 3 times more than the odds in university sector.
Knowledge, attitude and practice of healthcare professionals towards pharmacovigilance in Egypt were similar to that in Arab countries but the practice is less than European countries.