Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal
12 Dec 2011-Pharmacy Practice (internet) (Centro de investigaciones y Publicaciones Farmacéuticas)-Vol. 9, Iss: 4, pp 228-235
TL;DR: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals.
Abstract: Pharmacovigilance can be helpful in protecting consumers from harmful effects of medicines. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In Nepal, pharmacovigilance activities were initiated in 2004.Objectives: The present study evaluated the knowledge, attitude and practices (KAP) of the healthcare professionals towards ADRs and pharmacovigilance in Manipal Teaching Hospital (MTH), a tertiary care teaching hospital attached to the regional pharmacovigilance center in western Nepal.Methods: A cross-sectional study was carried out in 2007 using a pretested (Cronbach alpha=0.72) questionnaire having 25 questions (15 questions on knowledge, 5 on attitude and 5 on practice). The correct/positive responses were given a score of ‘2’ and the wrong/negative responses ‘1’, maximum possible score of ‘50’.Results: A total of 131 responses were obtained among which 42 were incomplete and remaining 89 [females 49 (55.1%)] were analyzed. Of the 89 professionals, 29 (32.6%) were doctors, 46 (51.8) nurses and 14 (15.7%) pharmacists. The mean age was 28.32 (SD=8.46) years and the median (interquartile range) of duration of the service 14.5 (6-36) months. The total KAP scores was 40.06 (SD=3.51) for doctors, 38.92 (SD=4.83) for pharmacists, and 35.82 (SD=3.75) for nurses. Among the 89 professionals, 59 (62.3%) had not reported even a single ADR to the pharmacovigilance center.Conclusion: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals. Keywords: Adverse Drug Reaction Reporting Systems. Attitude of Health Personnel. Nepal.
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TL;DR: The results of the study strongly point out the need for interventional program among nurses focusing on the importance of ADR reporting and reporting procedure to encourage their active, voluntary participation in drug safety surveillance.
Abstract: Background and the purpose of the study
Adverse drug reactions (ADRs) are important public health problem associated with morbidity, mortality and financial burden on the society. Nurses play important role in medication safety surveillance through the spontaneous voluntary reporting of ADRs. Nurses’ knowledge, attitude and practice towards ADR reporting and factors affecting reporting was assessed in the study.
64 citations
Cites background from "Health professionals' knowledge, at..."
...Several studies carried out to assess the knowledge, attitude, and practice among nurses have documented that the knowledge of ADR reporting procedure are inadequate among nurses [11,13-17]....
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...noted low scores for both knowledge and attitude components of ADR reporting among the nurses [15]....
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TL;DR: Poor knowledge and practice regardingADR reporting is revealed, however, most of the respondents have shown a positive attitude towards ADR reporting.
Abstract: Adverse Drug Reactions (ADRs) underreporting is a great challenge to pharmacovigilance. Healthcare professionals should consider ADR reporting as their professional obligation because the effective system of ADR reporting is important to improve patient care and safety. This study was designed to assess the knowledge, attitude, practice and factors associated with ADR reporting by healthcare professionals (physicians and pharmacists) in secondary and tertiary hospitals of Islamabad. A pretested questionnaire comprising of 27 questions (knowledge 12, attitude 4, practice 9 and factors influencing ADR reporting 2) was administered to 384 physicians and pharmacists in public and private hospitals. Respondents were evaluated for their knowledge, attitude and practice related to ADR reporting. Additionally, the factors which encourage and discourage respondents to report ADRs were also determined. The data was analysed by using SPSS statistical software. Among 384 respondents, 367 provided responses to questionnaire, giving a response rate of 95.5%. The mean age was 28.3 (SD = 6.7). Most of the respondents indicated poor ADR reporting knowledge (83.1%). The majority of respondents (78.2%) presented a positive attitude towards ADR reporting and only a few (12.3%) hospitals have good ADR reporting practice. The seriousness of ADR, unusualness of reaction, new drug involvement and confidence in the diagnosis of ADR are the factors which encourage respondents to report ADR whereas lack of knowledge regarding where and how to report ADR, lack of access to ADR reporting form, managing patient is more important than reporting ADR legal liability issues were the major factors which discourage respondents to report ADR. The study reveals poor knowledge and practice regarding ADR reporting. However, most of the respondents have shown a positive attitude towards ADR reporting. There is a serious need for educational training as well as sincere and sustained efforts should be made by Government and Hospital Authorities to ensure proper implementation of ADR reporting system in all of the hospitals.
62 citations
Cites background from "Health professionals' knowledge, at..."
...A recent study in Nepal showed that knowledge regarding ADR reporting shall be increased through educational intervention (Palaian et al., 2011)....
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TL;DR: Overall this study shows that hospital pharmacists in Kuwait had good knowledge and positive attitude toward PV and ADR reporting, however, the majority of them have never reported ADRs.
Abstract: Introduction: Pharmacovigilance (PV) is essential to detect and prevent adverse drug reactions (ADR) after a drug is marketed. However, ADRs are significantly underreported worldwide. Objective: The aims of this study were to document the knowledge, attitude and practices (KAP) of pharmacists toward PV and ADR reporting and to explore the barriers to implementing a fully functional PV program in Kuwait. Material and methods: Pharmacists working at governmental hospitals were asked to complete a paper-based 25-item questionnaire. Results: A total of 414 pharmacists received the questionnaire and 342 agreed to participate, giving a response rate of 82.6%. Most pharmacists were knowledgeable about the concepts of PV (61.5%) and ADRs (72.6%) and the majority (88.6%) was willing to implement ADR reporting in their clinical practice. Despite this positive attitude, only 26.8% of participants had previously reported an ADR and the main reason for underreporting was stated as not knowing how to report (68.9%). Barriers that hinder the implementation of a PV center included lack of cooperation and communication by healthcare professionals and patients (n = 62), lack of time and proper management (n = 57), lack of awareness of staff and patients (n = 48) and no qualified person to report ADRs (n = 35). Conclusions: Overall this study shows that hospital pharmacists in Kuwait had good knowledge and positive attitude toward PV and ADRs reporting. However, the majority of them have never reported ADRs. These results suggest that targeted educational interventions and a well-defined policy for ADR reporting may help increase ADR reporting and support the implementation of a fully functional independent PV center in Kuwait.
54 citations
Cites background or methods or result from "Health professionals' knowledge, at..."
...…of questions included in previous local and international studies that examined the KAP of HCP, including pharmacists (Toklu and Uysal, 2008; Palaian et al., 2011; Rajesh et al., 2011; Chinenye and Michael, 2012; Ahmad et al., 2013; Isfahani et al., 2013; Khan, 2013; Santosh et al., 2013;…...
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...…published studies reported similar constraints and in addition, they reported concerns with regard to accuracy and importance of the identified ADRs, which was also associated with underreporting (Elkalmi et al., 2011; Palaian et al., 2011; Wilbur, 2013b; Jose et al., 2014; Suyagh et al., 2015)....
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...Previously published studies reported similar constraints and in addition, they reported concerns with regard to accuracy and importance of the identified ADRs, which was also associated with underreporting (Elkalmi et al., 2011; Palaian et al., 2011; Wilbur, 2013b; Jose et al., 2014; Suyagh et al., 2015)....
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...…Toklu and Uysal, 2008; Nichols et al., 2009; Vessal et al., 2009; Gavaza et al., 2010; Su et al., 2010; Elkalmi et al., 2011; Fadare et al., 2011; Palaian et al., 2011; Pérez García and Figueras, 2011; Rajesh et al., 2011; Chinenye and Michael, 2012; Ahmad et al., 2013; Irujo et al., 2013;…...
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...The questionnaire consisted of questions included in previous local and international studies that examined the KAP of HCP, including pharmacists (Toklu and Uysal, 2008; Palaian et al., 2011; Rajesh et al., 2011; Chinenye and Michael, 2012; Ahmad et al., 2013; Isfahani et al., 2013; Khan, 2013; Santosh et al., 2013; Abidi et al., 2014; Jose et al., 2014; Mahmoud et al., 2014; Khan et al., 2015; Suyagh et al., 2015)....
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TL;DR: There was a limited knowledge of pharmacovigilance that could have affected reporting incidence and educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacov Vigilance and drug safety culture in Saudi Arabia.
Abstract: Background Drug safety has major implications for patients’ lives. However, this concept is still considered new to some healthcare professionals. Objective This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). Methods A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. Results Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. Conclusions There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.
36 citations
Cites background from "Health professionals' knowledge, at..."
...In many countries pharmacists play an important role in maintaining and monitoring the ongoing PV programme [12, 13] Besides their educational responsibility towards other health-care professionals regarding the importance of detecting and reporting ADR, physicians and nurses are considered to be the key persons for observing and pinpointing ADR during a patient’s stay in hospital [12, 14]....
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TL;DR: A significant lack of knowledge, positive attitudes, and practices regarding ADRs and reporting was observed in hospital HCPs, and urgent action is needed to promote drug safety and pharmacovigilance in this region.
Abstract: Introduction Adverse drug reactions (ADRs) are a major global clinical problem, causing substantial mortality and morbidity especially in hospitals. Healthcare professionals (HCPs) knowledges’, attitude and practices are crucial points to evaluate the hospital safety environment. Objective of the study was to investigate the knowledge, attitudes, and practices of HCPs regarding the ADRs reporting system. Methods A cross-sectional survey was conducted between January and February of 2013 in nine tertiary care hospitals (governmental and private) that provide highly specialized medical services in Riyadh, Qassim, and the Eastern region of the Kingdom of Saudi Arabia. A validated questionnaire was used to assess the knowledge, attitudes, and practices of HCPs regarding the ADR reporting system. All statistical analyses were performed using SAS version 9.2. Results In total, 480 questionnaires were distributed, and the response rate was 70% (n = 336). Only 33% of the participants were aware of the National Pharmacovigilance Centre (NPC). Of those HCPs who were familiar with the NPC and their responsibility to report ADRs, most (50%) were pharmacists, followed by physicians (24%) and nurses (16%), and these differences were statistically significant (p Conclusions A significant lack of knowledge, positive attitudes, and practices regarding ADRs and reporting was observed in hospital HCPs. This finding represents an international concern, and urgent action is needed to promote drug safety and pharmacovigilance in this region.
36 citations
References
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TL;DR: It was shown that the ADR probability scale has consensual, content, and concurrent validity and may be applicable to postmarketing drug surveillance.
Abstract: The estimation of the probability that a drug caused an adverse clinical event is usually based on clinical judgment. Lack of a method for establishing causality generates large between-raters and within-raters variability in assessment. Using the conventional categories and definitions of definite, probable, possible, and doubtful adverse drug reactions (ADRs), the between-raters agreement of two physicians and four pharmacists who independently assessed 63 randomly selected alleged ADRs was 38% to 63%, kappa (k, a chance-corrected index of agreement) varied from 0.21 to 0.40, and the intraclass correlation coefficient of reliability (R[est]) was 0.49. Six (testing) and 22 wk (retesting) later the same observers independently reanalyzed the 63 cases by assigning a weighted score (ADR probability scale) to each of the components that must be considered in establishing causal associations between drug(s) and adverse events (e.g., temporal sequence). The cases were randomized to minimize the influence of learning. The event was assigned a probability category from the total score. The between-raters reliability (range: percent agreement = 83% to 92%; κ = 0.69 to 0.86; r = 0.91 to 0.95; R(est) = 0.92) and within-raters reliability (range: percent agreement = 80% to 97%; κ = 0.64 to 0.95; r = 0.91 to 0.98) improved (p < 0.001). The between-raters reliability was maintained on retesting (range: r = 0.84 to 0.94; R(est) = 0.87). The between-raters reliability of three attending physicians who independently assessed 28 other prospectively collected cases of alleged ADRs was very high (range: r = 0.76 to 0.87; R(est) = 0.80). It was also shown that the ADR probability scale has consensual, content, and concurrent validity. This systematic method offers a sensitive way to monitor ADRs and may be applicable to postmarketing drug surveillance.
Clinical Pharmacology and Therapeutics (1981) 30, 239–245; doi:10.1038/clpt.1981.154
9,840 citations
"Health professionals' knowledge, at..." refers background in this paper
...La media de edad era de 28,32 años (DE=8,46) y la media (rango intercuartílico) de la duración en el servicio fue 14,5 meses (6-36)....
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TL;DR: The incidence of serious and fatal adverse drug reactions in US hospitals was found to be extremely high, and data suggest that ADRs represent an important clinical issue.
Abstract: Objective.—To estimate the incidence of serious and fatal adverse drug reactions
(ADR) in hospital patients.Data Sources.—Four electronic databases were searched from 1966 to 1996.Study Selection.—Of 153, we selected 39 prospective studies from US hospitals.Data Extraction.—Data extracted independently by 2 investigators were analyzed by a random-effects
model. To obtain the overall incidence of ADRs in hospitalized patients, we
combined the incidence of ADRs occurring while in the hospital plus the incidence
of ADRs causing admission to hospital. We excluded errors in drug administration,
noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs.
Serious ADRs were defined as those that required hospitalization, were permanently
disabling, or resulted in death.Data Synthesis.—The overall incidence of serious ADRs was 6.7% (95% confidence interval
[CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized
patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized
patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making
these reactions between the fourth and sixth leading cause of death.Conclusions.—The incidence of serious and fatal ADRs in US hospitals was found to
be extremely high. While our results must be viewed with circumspection because
of heterogeneity among studies and small biases in the samples, these data
nevertheless suggest that ADRs represent an important clinical issue.
4,764 citations
TL;DR: The attributable lengths of stay and costs of hospitalization for ADEs are substantial and an ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.
Abstract: Objective. —To determine the excess length of stay, extra costs, and mortality attributable to adverse drug events (ADEs) in hospitalized patients. Design. —Matched case-control study. Setting. —The LDS Hospital, a tertiary care health care institution. Patients. —All patients admitted to LDS Hospital from January 1, 1990, to December 31,1993, were eligible. Cases were defined as patients with ADEs that occurred during hospitalization; controls were selected according to matching variables in a stepwise fashion. Methods. —Controls were matched to cases on primary discharge diagnosis related group (DRG), age, sex, acuity, and year of admission; varying numbers of controls were matched to each case. Matching was successful for 71% of the cases, leading to 1580 cases and 20197 controls. Main Outcome Measures. —Crude and attributable mortality, crude and attributable length of stay, and cost of hospitalization. Results. —ADEs complicated 2.43 per 100 admissions to the LDS Hospital during the study period. The crude mortality rates for the cases and matched controls were 3.5% and 1.05%, respectively (P Conclusion. —The attributable lengths of stay and costs of hospitalization for ADEs are substantial. An ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.
1,622 citations
TL;DR: Evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs is provided.
Abstract: The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%. This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals.
1,485 citations
TL;DR: The attributable lengths of stay and costs of hospitalization for ADEs are substantial and an ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.
Abstract: OBJECTIVE
To determine the excess length of stay, extra costs, and mortality attributable to adverse drug events (ADEs) in hospitalized patients.
DESIGN
Matched case-control study.
SETTING
The LDS Hospital, a tertiary care health care institution.
PATIENTS
All patients admitted to LDS Hospital from January 1, 1990, to December 31, 1993, were eligible. Cases were defined as patients with ADEs that occurred during hospitalization; controls were selected according to matching variables in a stepwise fashion.
METHODS
Controls were matched to cases on primary discharge diagnosis related group (DRG), age, sex, acuity, and year of admission; varying numbers of controls were matched to each case. Matching was successful for 71% of the cases, leading to 1580 cases and 20,197 controls.
MAIN OUTCOME MEASURES
Crude and attributable mortality, crude and attributable length of stay, and cost of hospitalization.
RESULTS
ADEs complicated 2.43 per 100 admissions to the LDS Hospital during the study period. The crude mortality rates for the cases and matched controls were 3.5% and 1.05%, respectively (P<.001). The mean length of hospital stay significantly differed between the cases and matched controls (7.69 vs 4.46 days; P<.001) as did the mean cost of hospitalization ($10,010 vs $5355; P<.001). The extra length of hospital stay attributable to an ADE was 1.74 days (P<.001). The excess cost of hospitalization attributable to an ADE was $2013 (P<.001). A linear regression analysis for length of stay and cost controlling for all matching variables revealed that the occurrence of an ADE was associated with increased length of stay of 1.91 days and an increased cost of $2262 (P<.001). In a similar logistic regression analysis for mortality, the increased risk of death among patients experiencing an ADE was 1.88 (95% confidence interval, 1.54-2.22; P<.001).
CONCLUSION
The attributable lengths of stay and costs of hospitalization for ADEs are substantial. An ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death.
911 citations