A Qualitative Evaluation of Adverse Drug Reaction Reporting System in Pakistan: Findings from the Nurses' Perspective.
ABSTRACT: The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient's response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.
Project description:BACKGROUND:Higher incidence of adverse drug reactions (ADRs) is a global health problem requiring attention of all stakeholders regardless of the practice settings. This study therefore aimed to evaluate awareness, knowledge, attitude and practice of ADR reporting among health workers and patients in 10 primary healthcare centres (PHCs) in Ibadan, southwestern Nigeria. METHODS:Questionnaire-guided cross-sectional survey among 80 health workers and 360 patients enrolled from the selected PHCs between October and December 2018. The semi-structured questionnaires generally comprised open-ended and closed-ended questions to explore general knowledge and awareness of ADRs and pharmacovigilance, while other question-items evaluated attitude towards ADR reporting and ADR reporting practice. Overall percent score in the knowledge and attitude domains for the health workers was developed into binary categories of >?80 versus ?80% for "adequate" and "inadequate" knowledge, as well as "positive" and "negative" attitude, respectively. Data were summarised using descriptive statistics, while Chi-square test was used to evaluate categorical variables at p?<?0.05. RESULTS:Overall, 58(72.5%) health workers had heard of pharmacovigilance, but only 3(5.2%) correctly understood the pharmacovigilance concept. Twelve (15.0%) showed adequate knowledge of ADRs, while 37(46.2%) demonstrated positive attitude towards ADR reporting. Thirty (37.5%) health workers had come across ADR reporting form, while 79(98.8%) expressed willingness to report all ADRs encountered. Of the patients, 31(8.6%) had heard of pharmacovigilance, 143(39.7%) correctly cited ADR definition, while 67(18.6%) reported the previously experienced ADRs. Informing healthcare professional (38; 38.8%) was the most common measure taken by patients when they experienced reaction(s). Nurses significantly had adequate knowledge of ADRs (p?<?0.001) compared to other cadres. CONCLUSIONS:Health workers in the selected PHCs were largely aware of pharmacovigilance but show low level of knowledge about ADRs and pharmacovigilance concept, with moderately positive attitude towards ADR reporting. Patients on the other hand demonstrate low level of awareness of pharmacovigilance and ADR reporting, with less than one-fifth who reported the previously experienced ADRs. This perhaps underscores a need for regular mandatory education and training on ADRs/pharmacovigilance concept among the PHC health workers, while continuous public enlightenment and awareness campaign on spontaneous reporting of ADRs is advocated in order to enhance reporting rate.
Project description:Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist's role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians' and other healthcare professionals' communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.
Project description:In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were "serious" according to CIOMS criteria. In five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%) and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.
Project description:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme.In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme.From May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p < 0.05). After participation in the programme, the students intended to report serious ADRs in their future practice, and their knowledge of pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding.The student-run pharmacovigilance programme is a win-win venture. It offers students a valuable 'pharmacovigilance experience', creates awareness in future doctors, and has the potential to increase pharmacovigilance skills and knowledge.
Project description:BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting. METHODS: A total of 120 doctors working at the Lagos State University Teaching Hospital (LASUTH), in Nigeria were evaluated with a questionnaire for their knowledge and attitudes to ADR reporting. The questionnaire sought the demographics of the doctors, their knowledge and attitudes to ADR reporting, the factors that they perceived may influence ADR reporting, and their levels of education and training on ADR reporting. Provision was also made for suggestions on the possible ways to improve ADR reporting. RESULTS: The response rate was 82.5%. A majority of the respondents (89, 89.9%) considered doctors as the most qualified health professionals to report ADRs. Forty (40.4%) of the respondents knew about the existence of National Pharmacovigilance Centre (NPC) in Nigeria. Thirty-two (32.3%) respondents were aware of the Yellow Card reporting scheme but only two had ever reported ADRs to the NPC. About half (48.5%) of the respondents felt that all serious ADRs could be identified after drug marketing. There was a significant difference between the proportion of respondents who felt that ADR reporting should be either compulsory or voluntary (chi2 = 38.9, P < 0.001). ADR reporting was encouraged if the reaction was serious (77, 77.8%) and unusual (70, 70.7%). Education and training was the most recognised means of improving ADR reporting. CONCLUSION: The knowledge of ADRs and how to report them are inadequate among doctors working in a teaching hospital in Lagos, Nigeria. More awareness should be created on the Yellow Card reporting scheme. Continuous medical education, training and integration of ADR reporting into the clinical activities of the doctors would likely improve reporting.
Project description:Pharmacovigilance education is essential since adverse drug reactions (ADRs) are a serious health problem and contribute to unnecessary patient burden and hospital admissions. Healthcare professionals have little awareness of pharmacovigilance and ADR reporting, and only few educational interventions had durable effects on this awareness. Our future healthcare providers should therefore acquire an adequate set of pharmacovigilance competencies to rationally prescribe, distribute, and monitor drugs. We investigated the pharmacovigilance and ADR-reporting competencies of healthcare students to identify educational interventions that are effective in promoting pharmacovigilance.The PubMed, EMBASE, Cochrane, CINAHL, PsycINFO, and ERIC databases were searched using the terms "pharmacovigilance," "students," and "education.".Twenty-five cross-sectional and 14 intervention studies describing mostly medical and pharmacy students were included. Intentions and attitudes on ADR reporting were overall positive, although most students felt inadequately prepared, missed the training on this topic, and lacked basic knowledge. Although nearly all students observed ADRs during clinical rounds, only a few had actually been involved in reporting an ADR. Educational interventions were predominately lectures, sometimes accompanied by small interactive working groups. Most interventions resulted in a direct increase in knowledge with an unknown long-term effect. Real-life learning initiatives have shown that healthcare students are capable of contributing to patient care while increasing their ADR-reporting skills and knowledge.There is an urgent need to improve and innovate current pharmacovigilance education for undergraduate healthcare students. By offering real-life pharmacovigilance training, students will increase their knowledge and awareness but can also assist current healthcare professionals to meet their pharmacovigilance obligations.
Project description:BACKGROUND:Medication safety and pharmacovigilance (PV) remains as an important discipline worldwide. However, there is a significant lack of knowledge of PV and adverse drug reaction (ADR) reporting among students in the healthcare field. Thus, this study is aimed to measure knowledge, attitude, and perceptions and compares it between healthcare students (i.e., medicine, dentistry, and nursing). METHODS:A cross-sectional study involving 710 undergraduate healthcare students from different universities in Saudi Arabia was conducted. A validated structured pilot-tested questionnaire was administered to the participants to assess their knowledge, attitude, and perceptions towards PV and ADRs reporting. Descriptive statistics were used to describe the study findings. Data were analyzed using SPSS version 21. RESULTS:Overall, the study found that 60.8 and 40.0% of healthcare students correctly defined PV and ADRs respectively. Most students showed positive attitudes and perceptions towards PV and ADRs reporting. PV knowledge, attitude, and perceptions towards PV were significantly higher among pharmacy students as compared to other healthcare students. Only 39% of healthcare students revealed that they have received any form of PV education and 49% of them indicated that PV is well covered in their school curriculum. Pharmacy students are more trained in their schools to report and have performed ADRs reporting in their school as compared to other healthcare students. CONCLUSIONS:Pharmacy students have better knowledge, attitude, and perception towards PV and ADR reporting in comparison to other healthcare students. The study clearly describes the need for integrating pharmacovigilance education in Saudi healthcare schools' curriculums to prepare them for real-world practices and workplaces.
Project description:Background:Our aim in this study was to evaluate the effect of a combined educational intervention and year-long monthly text message reinforcements via the Short Messaging System (SMS) on the knowledge, attitude and practice (KAP) of healthcare professionals (HCPs) towards pharmacovigilance. Methods:Six randomly selected teaching hospitals in the South-South zone of Nigeria were randomized in 1:1 ratio into intervention and control groups. The educational intervention consisted of delivering a seminar followed by sending monthly texts message reinforcements via SMS over 12?months. Then a semi-structured questionnaire regarding the KAP of pharmacovigilance was completed by HCPs working in the hospitals after the intervention. Data was analysed descriptively and inferentially. Results:A total of 931 HCPs participated in the post intervention study (596 in the intervention and 335 in the control). The M:F ratio was 1:1.5. According to the KAP questionnaire, a significant difference was observed between the intervention and control groups, regarding knowledge of the types of adverse drug reactions (ADRs). ADR resulting from pharmacological action of the drug (85.6% versus 77%, p = 0.001), the fact that ADRs can persist for a long time; (60.1% versus 53.4%, p = 0.024) and a higher awareness of the ADR reporting form (48.7% versus 18.8%, p < 0.001). Most respondents in the intervention group (68.5% versus 60.6%, p = 0.001) believed they should report ADRs even if they were unsure an ADR has occurred, a greater proportion of HCPs from the intervention group had significantly observed an ADR (82% versus 73.4%, p = 0.001). Furthermore, of the 188 who had ever reported an ADR, 41% from the intervention group used the national ADR reporting form compared with 19.8% from the controls (p < 0.001). Conclusion:This educational intervention and the use of SMS as a reinforcement tool appeared to have positively impacted on the knowledge and practice of pharmacovigilance in South-South Nigeria with a less-than-impressive change in attitude. Continuous medical education may be required to effect long-lasting changes.
Project description:Knowledge, attitude, practice (KAP)-based educational intervention is an important tool to reduce underreporting of adverse drug reactions (ADRs). Hence, this study aimed to assess the KAP of doctors and nurses working in medicine and allied departments of Jawaharlal Institute of Postgraduate Medical Education and Research on spontaneous reporting of ADRs, following an educational intervention. The study also compared the quantity of ADRs reported before and after 1 year of introducing the educational intervention.The study was a cross-sectional questionnaire-based study involving doctors and nurses working in a tertiary care hospital in South India. A predesigned structured questionnaire was prepared to suit our ADR monitoring center, validated and then distributed to doctors and nurses working in medicine and allied departments of the institute. The study participants were asked to fill KAP pretest questionnaire followed by interactive educational intervention and post-test questionnaire related to KAP after 1 year. The impact of educational intervention among doctors and nurses was evaluated by their response to the post-test questionnaire and the number of ADR reported after intervention. The appropriate statistical analysis was used through Graph Pad InStat version 3.0.A total of 235 health-care professionals were involved in the pre-KAP questionnaire, an educational intervention, and post-KAP questionnaire. Among them, doctors were 39%, and nurses were 61%. The overall response rate among doctors and nurses following educational intervention was statistically significant (P < 0.0001). Following the educational intervention, the quantity of ADR reported became double compared to pre-intervention.The KAP of health-care professionals improved following educational interventional program on pharmacovigilance. Continued educational intervention may inculcate ADR reporting culture among health-care professionals.
Project description:<h4>Purpose</h4>The goal of this study was to compare the knowledge and attitudes of pharmacy and medical students regarding adverse drug reactions (ADRs), as well as their perceptions of barriers to ADR reporting, in a Higher Education Commission-recognised Pakistani university.<h4>Methods</h4>A cross-sectional study was conducted among final-year pharmacy (n=91) and medical (n=108) students in Pakistan from June 1 to July 31, 2014. A self-administered questionnaire was used to collect the data. The responses of pharmacy students were compared to those of medical students.<h4>Results</h4>Pharmacy students had a significantly better knowledge of ADRs than medical students (mean±SD, 5.61±1.78 vs. 3.23±1.60; P<0.001). Gender showed a significant relationship to knowledge about ADRs, and male participants were apparently more knowledgeable than their female counterparts (P<0.001). The attitudes of pharmacy students regarding their capability to handle and report ADRs were significantly more positive than those of medical students (P<0.05). In comparison to pharmacy students, a lack of knowledge of where and how to report ADRs was the main barrier that medical students perceived to ADR reporting (P=0.001).<h4>Conclusion</h4>Final-year pharmacy students exhibited more knowledge about ADRs and showed more positive attitudes regarding their capacity to handle and report ADRs than final-year medical students.