An Intervention to Improve Spontaneous Adverse Drug Reaction Reporting by Hospital Physicians

Pedrós, Consuelo; Vallano, Antonio; Cereza, Glòria; Mendoza-Aran, Gemma; Agustí, Antònia; Aguilera, Cristina; Danés, Imma; Vidal, Xavier; Arnau, Josep Maria

doi:10.2165/00002018-200932010-00007

Cited by 73 publications

(63 citation statements)

References 23 publications

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“…But, only 5(2.3%) of those who diagnosed adverse drug reactions reported them to reporting centers. The considerable numbers of Nurses in the present study never reported an adverse drug reaction that is comparable with other studies (18)(19)(20).…”

Section: Discussionsupporting

confidence: 91%

“…Results of a study performed in a tertiary teaching hospital in Barcelona/ Spain are similar to our study, and lack of time to report an adverse drug reaction due to the workload of clinical practitioners was detected as the most important reason to adverse drug reaction underreporting (19). Other causes of not reporting in that study were lack of information about the spontaneous reporting system, unavailability of yellow cards, doubt of adverse drug reaction causality assessment and lack of patient confidentiality (33).…”

Section: Discussionsupporting

confidence: 83%

“…These included is through training 106(49.5%). Several studies also agreed (24,29,(44)(45)(46), continuing education on pharmacovigillance 61(28.5%), incentives 15(7.0%) studies supported were (19,47). Apart from the fact that the use of incentives have not been widely accepted and practiced, it raises the possibility of overreporting by some health care workers in a bid to obtain financial rewards.…”

Section: Discussionmentioning

confidence: 74%

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Predictors of Nurses Reporting Practice Related to Adverse Drug Reaction at Felegehiwot Referral Hospital and Felegehiwot Referral Hospital and University of Gondar Teaching Hospital, Northwest Ethiopia

Adimasu¹

2014

AJHR

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Abstract:Background: Prevention, monitoring and reporting of adverse drug reactions is still a challenge among Nurses.Objective: to assess predictors of Nurses' practice related to adverse drug reaction reporting at Felegehiwot Referral Hospital and University of Gondar Teaching Hospital, Northwest Ethiopia. Method: Hospital based cross sectional study was conducted at Felegehiwot Referral Hospital and University of Gondar Teaching Hospital from March 11, 2013 to April 12, 2013. A total number of 214 Nurses involved in this study. Self-administered pre-tested questionnaire was used. Stratified random sampling technique was used to select study participants. Bivariate analysis and multivariable logistic regression analyses were employed for identifying not reporting practice regarding adverse drug reaction. Results: Mean age of the respondents 21.8 years (SD = 7.01). One hundred twenty two (57.0%) of the respondents were females, 152(71.7%) participants' level of education were bachelor of Nurse. The participants mean of experience were 1.64 (SD = 4.7) years. Participants who took training/seminar on Pharmacovigilance had 0.29 times more likely to have adequate knowledge (AOR = 0.29, 95% CI = 0.226-0.004, P=0.001) Conclusions and recommendation: Even though most Nurses had encountered adverse drug reaction, most of them were not reporting regarding adverse drug reaction. So Food, Medicine, Health Care Administration and Control Authority of Ethiopia should prepare training and continual education related to adverse drug reaction reporting for Nurses.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 74%

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Predictors of Nurses Reporting Practice Related to Adverse Drug Reaction at Felegehiwot Referral Hospital and Felegehiwot Referral Hospital and University of Gondar Teaching Hospital, Northwest Ethiopia

Adimasu¹

2014

AJHR

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“…Despite the positive and promising outcomes, the vast majority of these studies have been carried out with limited objectives and short follow-up periods. In addition, the majority of these studies was suffering from a limited number of participants, as they were mainly regional surveys and lacked the representation of all healthcare providers on the national level [9][10][11][12][13]. This leads us to raise an important question: Do healthcare professionals suffer from the problem of resistance to change and what are the possible strategies that could be adapted to mitigate this problem?…”

Section: Problem Backgroundmentioning

confidence: 99%

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Elkalmi¹,

lela²

2016

J Pharmacovigilance

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Spontaneous Adverse Drug Reactions (ADRs) reporting system is considered the back-bone for any pharmacovigilance system. Within this context, active Involvement of healthcare professionals is very crucial to improve the rate and quality of ADRs reporting. Despite the various techniques that have been adopted in order to improve the rate and quality of ADR reporting, there is a decline in the rate of ADRs notification. Under-reporting of ADRs is well-recognized phenomena associated with the almost all of pharmacovigilance systems around the world. Many logistic and personal barriers to ADRs reporting among healthcare professionals including resistance to change have been reported. This commentary focuses on the problem of resistance to change towards ADR reporting and the possibility of applying theory of Force Field Analysis (FFA) to overcome the problem of underreporting among these professionals.

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“…Several studies have shown that implementing simple strategies such as increasing the availability of more yellow cards in health centres, including a hyperlink to an online ADR reporting form in hospitals' electronic patient records, regular visits by a clinical expert, or educational measures as well as small financial incentives can increase the reporting of ADRs [36][37][38][39][40][41][42]. ADRs are still discovered by spontaneous reporting systems in hospitals, but electronic hospital information systems and the implementation of pharmacoepidemiological approaches increase the possibilities and the value of ADR detection in hospitals [17].…”

Section: Discussionmentioning

confidence: 99%

Hospital DoctorsÂ’ Views and Concerns about Pharmacovigilance

PF¹

2015

J Pharmacovigil

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IntroductionAdverse drug reactions (ADRs) are a relevant problem in health care, and particularly in the hospital setting [1][2][3]. Unfortunately, ADRs are underreported in general [4], and particularly in hospitals [5]. Knowledge and attitudes of health professionals appear to be strongly associated with underreporting in a high proportion of studies [6]. Therefore, it is important to know the opinions, perceptions and attitudes of hospital doctors with respect to ADRs because their knowledge can help to improve the spontaneous reporting of ADRs. Several studies have assessed the knowledge, behaviour and attitudes of physicians regarding ADRs and their reporting to the pharmacovigilance systems [7][8][9][10][11][12][13][14]. Nevertheless, those studies have not evaluated specifically the doubts, uncertainties, misunderstandings and misconceptions that medical doctors may have about ADRs and pharmacovigilance systems, which are barriers to the development of pharmacovigilance activities. Thus, the objective of our study was to analyze the opinions and doubts that hospital doctors have about ADRs and pharmacovigilance activities. MethodsA survey was carried out in a tertiary university hospital. The design of the study was qualitative because this type of methodological research allows us to understand the perceptions of doctors adequately. The qualitative technique used in the study was the focus group discussion methodology [15]. Participants were selected using a theoretical sampling model. Focus group discussions were carried out among physicians (house staff and residents in training) from different medical specialties. The groups were naturally occurring using pre-existing groups of people who worked together in the same medical department of the hospital. Thirteen focus group nonstructured discussions were conducted and 296 physicians (each focus group had approximately 22 participants) from the following medical specialities participated: Anaesthesiology, Cardiology, Dermatology, Endocrinology, Gastroenterology, Infectious diseases, Internal medicine, Intensive care medicine, Nephrology, Pneumology, Neurology, Psychiatry, and Rheumatology.Focus groups were held from January 2008 to December 2013, and the running of the groups took place in the annual pharmacovigilance sessions in each of the departments of the medical specialities described above. These sessions lasted from 45 to 60 minutes in which the pharmacovigilance program of the hospital was introduced. In the first part of the sessions, the global results of the program and the specific results relating to each medical department were presented by a clinical pharmacologist specialised in pharmacovigilance. News and other topics to do with pharmacovigilance were also introduced. In the second part of the sessions, the participants were encouraged to share their points of view and doubts about the different aspects of ADRs and pharmacovigilance activities, and an open discussion was held. The participants were told that the purpose of the sessions ...

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An Intervention to Improve Spontaneous Adverse Drug Reaction Reporting by Hospital Physicians

Abstract: A continuous intervention based on healthcare management agreements with economic incentives and educational activities is associated with a quantitative and qualitative improvement of spontaneous reporting of ADRs by hospital physicians.

Cited by 73 publications

References 23 publications

Predictors of Nurses Reporting Practice Related to Adverse Drug Reaction at Felegehiwot Referral Hospital and Felegehiwot Referral Hospital and University of Gondar Teaching Hospital, Northwest Ethiopia

Predictors of Nurses Reporting Practice Related to Adverse Drug Reaction at Felegehiwot Referral Hospital and Felegehiwot Referral Hospital and University of Gondar Teaching Hospital, Northwest Ethiopia

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Hospital DoctorsÂ’ Views and Concerns about Pharmacovigilance

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