Adverse drug effects Dotaz Zobrazit nápovědu
BACKGROUND: The study aimed to evaluate the agreement of prescribed drug dosages with renal dosing recommendations and describe adverse drug events (ADEs) contributing to hospital admissions of patients with chronic kidney disease (CKD). METHODS: This cross-sectional study focused on CKD patients admitted to University Hospital Hradec Králové, with an estimated glomerular filtration rate below 60 ml/min. The necessity for renal dosage adjustments was determined using the Summary of Product Characteristics (SmPC). For medications requiring renal dosage adjustment according to SmPC, agreement between the prescribed and recommended renal dosage was assessed. ADEs were adjudicated using the OPERAM drug-related hospital admissions adjudication guide. RESULTS: Of 375 CKD patients, 112 (30%, 95% CI 25-34) were prescribed drug dosages in disagreement with SmPC renal dosage recommendations. Perindopril, metformin, and ramipril were most frequently dosed in disagreement with SmPC. ADE-related hospital admissions occurred in 20% (95% CI 16-24) of CKD patients. CONCLUSION: CKD patients are often prescribed medication dosages in disagreement with SmPC renal dosing recommendations. Besides explicit factors, treatment goals, feasibility of monitoring and alternative treatment must be weighed when assessing drug and dosage appropriateness. Gastrointestinal bleeding was the most frequent ADE that contributed to hospital admissions of CKD patients.
- Klíčová slova
- Adverse drug event, adverse drug reaction, chronic kidney disease, hospitalization, medication error,
- MeSH
- chronická renální insuficience * komplikace MeSH
- hodnoty glomerulární filtrace MeSH
- ledviny MeSH
- lidé MeSH
- nemocnice MeSH
- nežádoucí účinky léčiv * epidemiologie etiologie MeSH
- průřezové studie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: The aim of this study was to assess the situation regarding spontaneous adverse drug reaction reporting in the Czech Republic during a 5-year period (2005-2009). SETTING: Descriptive study was conducted using the data from the Czech State Institute for Drug Control pharmacovigilance database. METHODS: The data referring to all spontaneous adverse drug reaction reports received, by the pharmacovigilance department of the Czech State Institute for Drug Control during 2005-2009 were collected, analysed and compared with data from the Slovak Republic, Denmark, and the United Kingdom. MAIN OUTCOME MEASURES: The number of received spontaneous adverse drug reactions reports by year per 10,000 inhabitants, the seriousness and outcome of reactions, the reporting groups, and the top ten molecules which contributed to the highest number of reports. RESULTS: During the study period 2005-2009, the pharmacovigilance department of the State Institute for Drug Control received 7,708 spontaneous adverse drug reactions reports of which 73.6% were serious and 2.1% resulted in death. The number of spontaneous adverse drug reactions reports per 10,000 inhabitants ranged from 1.3 to 1.7, which was lower when compared with the number of reports from three other EU countries. The healthcare professionals contributed to 64.2% of the adverse drug reactions reports, whilst marketing authorization holders provided 35.5%, and finally patients with 0.3%. Vaccines, ketoprofen, amoxicillin, statins, and estradiol were amongst the top ten molecules that gave the highest number of spontaneous adverse drug reactions reports. CONCLUSIONS: Our assessment of adverse drug reactions spontaneous reports received by the Czech Institute for Drug Control during 2005-2009 showed that the reporting rate is relatively low and remains constant over the 5 year period. More emphasis on academic/professional training is needed to educate all potential reporters on the mechanism of reporting of adverse drug reactions and to also emphasize the importance of the whole pharmacovigilance process.
- MeSH
- databáze faktografické normy trendy MeSH
- lidé MeSH
- nežádoucí účinky léčiv diagnóza epidemiologie MeSH
- systémy pro sběr zpráv o nežádoucích účincích léků normy trendy MeSH
- zdravotnický personál normy trendy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- MeSH
- informační systémy MeSH
- lidé MeSH
- nežádoucí účinky léčiv * MeSH
- počítače * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Identification of real-time adverse drug reactions [ADRs] (as opposed to the risk of ADRs) in older poly-medicated people in primary care is a challenging task, often undertaken without an explicit strategy. This systematic review aims to evaluate replicable instruments and methods for identifying and addressing ADRs. METHODS: A systematic search was conducted in Medline, CINAHL, Scopus, Web of Science and Cochrane library, using controlled vocabulary (MeSH) and free-text terms. Randomised controlled trials (RCTs) implementing strategies to identify or resolve ADRs experienced by patients in primary care were included. Two reviewers independently screened studies, extracted data, and assessed the risk of bias using the Cochrane Risk of Bias tool. Discrepancies were resolved by discussion. RESULTS: From 2,182 unique records, 49 studies were identified for full review. Eight papers reporting results from 6 RCTs were included. All six trials utilised a list of medicine-related unwanted symptoms to identify ADRs. Two of three studies using adverse drug reaction questionnaires reported statistically significant increased rates of ADR reporting. Two of three studies that combined symptom questionnaires with prescriber consultations reported reductions in the number of health problems. Overall, results suggest that the three studies that described multidisciplinary collaborations using lists of ADRs plus prescriber reviews enhanced patient safety. However, the RCTs were unblinded and reported suboptimal retention. When considered as a whole, findings are equivocal and the data are too heterogenous to warrant any firm conclusions, beyond the need for more research to optimise strategies to safeguard patient wellbeing. IMPLICATIONS: Adaptable and scalable instruments with decision support are needed in primary care to identify and mitigate medicine-related harm in older poly-medicated people. The effectiveness of adverse drug reaction identification instruments, the value of comprehensive instruments, and the optimum method of delivery should be explored in multicentre trials.
Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70-13.32; p < 0.001]. Along with the increasing utilization of direct oral anticoagulants, the reporting rate gradually declined over time, especially for rivaroxaban and apixaban. Fatal outcomes were reported in 7%, mostly for dabigatran. Hemorrhagic reactions were the most frequently reported adverse drug reactions (37% associated with dabigatran, 28% with apixaban, 24% with warfarin, and 23% with rivaroxaban), and compared to warfarin, they were significantly more often associated with direct oral anticoagulants (ROR: 14.36; CI: 9.57-21.54; p < 0.001). Conclusion The number of adverse drug reaction reports related to oral anticoagulants in the Czech Republic was relatively low, compared to other studies, but 96% of the cases were serious. Data from spontaneous adverse drug reactions reporting should be further analyzed in order to obtain additional information on the safety profile of oral anticoagulants.
- Klíčová slova
- Adverse drug reaction reporting systems, Czech Republic, Direct oral anticoagulants, Pharmacovigilance, Warfarin,
- MeSH
- antikoagulancia škodlivé účinky MeSH
- aplikace orální MeSH
- cévní mozková příhoda * farmakoterapie MeSH
- dabigatran škodlivé účinky MeSH
- fibrilace síní * farmakoterapie MeSH
- lidé MeSH
- nežádoucí účinky léčiv * diagnóza epidemiologie MeSH
- retrospektivní studie MeSH
- warfarin terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Názvy látek
- antikoagulancia MeSH
- dabigatran MeSH
- warfarin MeSH
Background Geriatric patients represent a vulnerable population in terms of adverse drug events (ADEs). Objective The aims of this study were to determine the prevalence and preventability of hospital admissions to a geriatric ward related to ADEs, to identify medications involved in these ADEs and to describe potential preventability aspects of ADE-related admissions. Setting University Hospital Hradec Králové, Czech Republic. Methods This cross-sectional study evaluated acute hospital admissions to the geriatric ward of University Hospital Hradec Králové over a period of nine months (April-December 2017). Medication reviews were performed in order to identify ADE-related hospital admissions. Causality was assessed using the World Health Organization-Uppsala Monitoring Centre criteria. Modified Schumock-Thornton algorithm was used to assess the preventability of ADEs. Main outcome measure 9-month-prevalence of ADE-related hospital admissions. Results A total of 366 hospital admissions were included. The 9-month-prevalence of ADE-related hospital admissions was 11.75% [95% confidence interval 8.45-15.05]. Antithrombotic agents and diuretics represented the most common medication classes associated with ADEs (30.2% each). Electrolyte disturbances and gastrointestinal haemorrhages and ulcerations were the most frequently observed ADEs associated with hospital admission. Out of 43 ADE-related hospitalisations, 23 (53.5%) were considered potentially preventable. Conclusion The contribution of ADEs to hospital admission to the geriatric ward was not negligible. Our results also suggest that 53.5% of identified ADE-related admissions could be potentially prevented. This finding demonstrates just how important the research on the preventability of medication-related hospitalisations is. Further studies and implementations are still needed aiming to minimize the risk of medication-related harm.
- Klíčová slova
- Aged, Czech republic, Drug-related side effects and adverse reactions, Hospitalization, Pharmacoepidemiology,
- MeSH
- hospitalizace MeSH
- lidé MeSH
- nemocnice MeSH
- nežádoucí účinky léčiv * epidemiologie prevence a kontrola MeSH
- průřezové studie MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
Adverse drug reactions represent a common clinical problem. They are partly induced by a large variability in drug response, which results from the complex interplay between pharmacokinetics, pharmacodynamics and other disease-associated factors. The review describes metabolic changes caused by polymorphism in the cytochrome P450 and gives examples of induction and inhibition of this enzyme system in relation to adverse drug interaction. From the clinical point of view, attention should be paid especially to antidiabetics, anticoagulants and phenytoin. Therapeutic drug monitoring and genetic-based individualization of the therapy with polymorphically metabolized drugs with narrow therapeutic range can contribute to the decreased incidence of adverse drug reactions.
- MeSH
- lékové interakce * genetika MeSH
- lidé MeSH
- nežádoucí účinky léčiv * MeSH
- systém (enzymů) cytochromů P-450 genetika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- systém (enzymů) cytochromů P-450 MeSH
Immunotherapy based on immune checkpoint inhibitors (ICIs) represents a novel anticancer treatment strategy. Monoclonal antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA4), programmed cell death-1 receptor (PD1) and programmed cell death-1 ligand (PD-L1) have shown efficacy and safety in the treatment of various malignancies. Some of them have recently found their place in a routine clinical practice, while others are at different phases of clinical trials. Treatment with ICIs may be accompanied by undesirable impairment of immunotolerance to non-tumoural tissues, leading to a specific side-effect also called immune-related adverse events (irAE). There is an increasing body of evidence that the development of irAEs is associated with a beneficial effect of immunotherapy, thus it has become a hot topic in the field of clinical oncology. This review is focused on data from recently published studies evaluating the association between irAEs and outcome of patients with cancer treated with ICIs.
- Klíčová slova
- Immunotherapy, adverse effects, checkpoint inhibitor, efficacy, outcome, review,
- MeSH
- antigeny CD279 antagonisté a inhibitory MeSH
- imunoterapie metody MeSH
- lidé MeSH
- nádory farmakoterapie MeSH
- nežádoucí účinky léčiv farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Názvy látek
- antigeny CD279 MeSH
INTRODUCTION: Collecting information about drugs in clinical practice is essential for ongoing riskbenefit analysis of the drug use. Medical literature is an important source of new information on drug safety, in particular for the signal assessment. A signal is an information about a new potentially causal association, or a new aspect of a known association (e.g. change in frequency or severity of the reaction) between a drug and an adverse event (AE). AIM OF THE STUDY: To verify the effectiveness of the identification of adverse drug reaction (ADR) reports published in the local medical literature using MEDLINE and Embase, versus manual full text review of journals. MATERIAL AND METHODS: The study was performed for 20 randomly selected drugs and 84 Polish medical journals and covers a review of 1,576 individual journal issues with 20,146 articles. Retrospective analysis of literature reports collected during manual full text review was performed and compared to the outcome of database search. RESULTS: ADRs for analyzed drugs were identified only in 17 out of 84 journals, as a result of which 66 reports were analyzed. The majority of reports (55%) were found in local non-indexed journals. Three reports originated from journals indexed in MEDLINE and 9 reports from journals indexed in Embase were not found in these databases because databases do not fully cover conference abstracts and journal supplements. Moreover, while using databases for ADR report search there is a risk of missing up to 30% of ADR reports. The average gap between article publication date and database entry was 119 days. CONCLUSIONS: We verified that the effectiveness of the identification of ADR reports published in the local medical literature is more accurate based on manual full text review than by searching in bibliographic databases.
- Klíčová slova
- drug safety evaluation, medical literature monitoring, risk-benefit analysis, signal management,
- MeSH
- lidé MeSH
- MEDLINE MeSH
- nežádoucí účinky léčiv * MeSH
- periodika jako téma * MeSH
- retrospektivní studie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Polsko MeSH
- MeSH
- lidé MeSH
- monitorování fyziologických funkcí MeSH
- nežádoucí účinky léčiv * MeSH
- těhotenství MeSH
- toxikologie MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
