Effect of an intervention on the features of adverse drug reactions spontaneously reported in a hospital

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

doi:10.1007/s00228-010-0856-8

Cited by 24 publications

(29 citation statements)

References 20 publications

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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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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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“…In addition, a multifaced intervention aimed to improve spontaneous reporting was initiated in our hospital in 2003. [5][6] This intervention consists of economic incentives and educational activities. Since 2003 a framework agreement between hospital managers and clinical services included different commitments linked to economic incentives.…”

Section: 2mentioning

confidence: 99%

“…5 Furthermore, no signals were recognized during the period previous the intervention, however, two signals and one additional safety concern were identified during the period with intervention. 6 Nevertheless, under-reporting continues being a problem in hospitals. A closer relationship between doctors and the pharmacovigilance centre and the feedback of the pharmacovigilance activities in the hospital may be a way to improve this problem.…”

mentioning

confidence: 99%

Invited Speaker Abstracts

2012

Basic Clin Pharma Tox

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The immense potential of translating pharmacogenetics into clinical practice in pain medicine coexists with many questions and challenges, due to the complexity of pain multifaceted phenotype nature. What we have witnessed in the past decade, however, is a breathtaking acceleration in understanding human genetic diversity as the result of a technological revolution. The sequencing of genome and other technological advances have revealed the extent of diversity and the relative contribution to predict drug outcomes and adverse effects, of genetic and nongenetic factors, including age, concomitant therapy or drug interactions. Overall, there are now several examples in which interindividual differences in opioid pharmacologic effect and safety, are due to sequence variants in genes involved with pharmacokinetics and dynamics response that encoding drug targets (mu-opioid receptor, MOR-1), transporters (substrates of P-glycoprotein, ABCB1) or cytochrome P450 enzymes (ultrarapid and poor metabolism, CYP2D6). Genomic variants of CYP2C9 and CYP2C8 genes influence NSAIDs' blood concentrations and side effect profile. Overall, the level of evidence linking genetic variability to codeine, tramadol, hydrocodone, oxycodone and tricyclic antidepressants response and metabolic profiles is strong; however, this information is probably of limited use to most physicians and patients. On the other hand, predicting analgesic response to morphine based on pharmacogenetic testing continue being more complex; probably phenotypes are also affected by rare SNPs, structural variants or epigenetic mechanisms modifying genes expression including covalent DNA modifications (methylation), DNA-packaging histones (e.g., deacetylation or phosphorylation) or regulatory non-coding RNA molecules (microRNAs). Opportunities (knowledge networks, electronic health record (HER) database and biobanks, drug developments, therapeutic decision support tools) and challenges (understanding probabilities, managing expectations, involvements of stakeholders, cost) are greats. Thus, the transition to a new era of genome informed medical care will need a team approach incorporating medical and genetics professionals, ethicists, and health-care delivery organisations because requires an oversight system that ensures the accuracy and discriminatory use of genetic information. References: 1. Ashley, E, Butte A, Wheeler M et al. Clinical assessment incorporating a personal genome.

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“…Continuous intervention of spontaneous reporting systems within a hospital resulted in very high number of ADR reports. A study conducted in Spain showed that ADR reports increased from 2 reports to 236 reports which required hospitalization, and 99 reports to 277 reports of ADRs among hospital in-patient 26 .…”

Section: Recommendationsmentioning

confidence: 99%

“…Intervention through education is the most effective way to improve the rate and quality of ADR reporting among healthcare professionals 23,24,25,26 . Inclusion of drug safety issues in the secondary level curriculum may cultivate concern about the drug and ADRs.…”

Section: Recommendationsmentioning

confidence: 99%

Strengthening the Pharmacovigilance Programme in Nepal

Tragulpiankit

Gorsanam

et al. 2013

Nepal J Epidemiology

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The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharmacovigilance programme in Nepal is a recent development. The Department of Drug Administration (DDA) took the initiative to set up a pharmacovigilance program in 2002; however, it was initiated systematically only after two years. DDA acts as the National Pharmacovigilance Centre (NPC). It collects ADR case reports from the Regional Pharmacovigilance Centre (RPC). Currently there are six RPCs operating in the country. The current reporting trends suggest high under-reporting of suspected ADRs. This paper is a review of those studies which are focused on pharmacovigilance and healthcare professionals' perspectives on ADR reporting in Nepal. It also recommends the possible ways to improve the ADR reporting based on the context of Nepal.

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Effect of an intervention on the features of adverse drug reactions spontaneously reported in a hospital

Cited by 24 publications

References 20 publications

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

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

Invited Speaker Abstracts

Strengthening the Pharmacovigilance Programme in Nepal

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