International Public Health Forum
Vol.1 No.4
December 2014
ISSN: xxxx-xxxx (Print) ISSN: xxxx-xxxx (Online) http://www.researchpub.org/journal/iphf/iphf.html
Adverse Drug Reactions Reporting, Knowledge, Attitude and Practice of Physicians towards it in El Minia University Hospitals Nashwa N. Kamal1*,MD, Emad G. Kamel1 and Eman M. Mahfouz1
annually. The rate of hospitalizations due to ADRs in different countries is about 10% 2,3. In addition to the increased morbidity and mortality, treatment of ADRs is also a financial burden for the public, some countries spend up to 15-20% of their healthcare budget for treatment of drug-related problems 4 . Despite this, about 95% incidences of ADR go undocumented worldwide 5. However there is a lack of information on ADR burden in developing countries like Egypt 6 . In fact, less than 27% of lower middle income and low income economies have national pharmacovigilance systems registered with the WHO program, compared with 96% of the high income countries in the Organization for Economic Co-operation and Development. The main reasons for this are lack of resources, infrastructure, and expertise. Thus, although access to medicines is increasing in developing countries, there is a danger that their risk benefit profiles in some populations will not be fully monitored and acted upon 7. Physicians have a very important role in ADRs reporting 8, however the number of reports received is insufficient, and occurred less frequently for serious and unexpected reactions9. Studies from different settings indicate inadequate knowledge about pharmacovigilance among healthcare professionals as well as attitudes that are associated with a high degree of underreporting 10-12. Pharmacovigilance is still in its infancy in Egypt and the Egyptian national pharmacovigilance program lacks continuity due to lack of awareness and inadequate training about drug safety monitoring among Egyptian healthcare professionals 13. Assessment of awareness of pharmacovigilance among the healthcare professionals is very important due to underreporting of adverse drug reactions. This study aimed at assessing the knowledge, attitude and practice of physicians from various fields in Minia University hospital, towards adverse drug reactions reporting, and to get an in-sight into the causes of under-reporting of ADRs and suggest possible ways of improving method of reporting.
Abstract— Objectives: This study was designed to assess physicians’ knowledge and attitude towards adverse drug reporting (ADR), identify the reasons for underreporting, and to suggest possible ways of improving reporting. Methods: A cross sectional study was done by survey using a self-administered structured questionnaire. A total of 211 doctors working at El Minia University Hospital were included. The questionnaire was structured to obtain the demographics of the doctors, information about their knowledge of ADR reporting, attitudes, factors that may influence reporting, and their training on ADR reporting. Results: Only 14 (16.1%) of the GPs were aware of the existence of a pharmacovigilance centre in Egypt and only 6 (6.9%) of them had reported ADRs to it, compared to 26 (22.8%) and 17 (15.9%) of the specialists. Backward Multivariable logistic regression showed that only qualification and average years of experience were associated with satisfactory knowledge among physicians. Average years of experience were associated also with satisfactory attitude among physicians, as those with more than 10 years of experience were 1.7(1.1-2.6) times more likely to have satisfactory attitude compared to less experience physicians. Conclusion: The knowledge of ADRs and how to report them are inadequate among physicians working in El Minia University hospital. Keywords: attitude, adverse drug reaction, Egypt, knowledge, physicians, practice, reporting.
I. INTRODUCTION
A
dverse drug reactions (ADRs) are important public health
problem and one of the leading causes of morbidity and mortality. The World Health Organization defines ADRs as 'a reaction which is harmful and unintended and which occurs at doses normally used in humans for prevention, diagnosis or therapy of disease, or for the modification of physiological functions '1 . Serious ADRs are the 6th leading cause of death in the USA, and they cause the death of several thousand patients
II. METHODS Study setting: This study was carried out at El Minia University hospital which are providing medical, dental and super-specialty services. Study design and population: A cross sectional study was done by survey using a self-administered structured questionnaire. A total of 211 doctors working at El Minia University Hospital were included. Sampling: During the study period (from 1st May 2014 to 1st July 2014), physicians and dentists working in Minia
Received on 10./10/2014, accepted on 18/11/2014. 1 Department of Public health, Faculty of Medicine El-Minia Governorate, Egypt. *Corresponding author:
[email protected]
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International Public Health Forum
Vol.1 No.4
December 2014
ISSN: xxxx-xxxx (Print) ISSN: xxxx-xxxx (Online) http://www.researchpub.org/journal/iphf/iphf.html
University hospitals were invited and recruited to participate in this study. The questionnaire were distributed to those who gave an approval, there were 221. A total of 211 filled the questionnaire were received back, where 10 physicians declined to participate. Inclusion and exclusion criteria: Physicians worked in El Minia University hospital during the study period. Physicians who were not willing to participate in the study and the ones who were on leave were excluded. They were 32 and the response rate was 86.8%. Research tool: A self-administered questionnaire was used to assess the awareness of reporting of ADRs among physicians. The questionnaire was structured to obtain the demographics of the doctors, information about their knowledge of ADR reporting, attitudes to reporting, factors that may influence reporting, and their training on ADR reporting. The questionnaire included both open-ended and close-ended questions. Face validity was done by University professors and experts. Pilot study was done to examine the survey reliability, determine the time needed for data collection and to revise and finalize the questionnaire. Data collection: The questionnaire was validated through a pilot study of 20 randomly selected doctors (both medical and dental) from the same hospital and they were included in the study. The approval from the ethics committee of El Minia Faculty of Medicine was obtained before starting the study. After obtaining the consent from the doctor the questionnaire was distributed to them. The doctors were given enough time to respond to the questions. The filled in questionnaire was collected back immediately. Statistical analysis Data analysis was performed using SPSS version 20. Descriptive statistics was used. Results are presented as mean ± standard deviation, numbers with percentages and graphic presentations. The association between variables was determined using chi-square test. p value
