scholarly journals Methodological framework to identify possible adverse drug reactions using population-based administrative data

F1000Research ◽  
2014 ◽  
Vol 3 ◽  
pp. 258
Author(s):  
Brian C. Sauer ◽  
Jonathan Nebeker ◽  
Shuying Shen ◽  
Randall Rupper ◽  
Suzanne West ◽  
...  

Purpose: We present a framework for detecting possible adverse drug reactions (ADRs) using the Utah Medicaid administrative data. We examined four classes of ADRs associated with treatment of dementia by acetylcholinesterase inhibitors (AChEIs): known reactions (gastrointestinal, psychological disturbances), potential reactions (respiratory disturbance), novel reactions (hepatic, hematological disturbances), and death.Methods: Our cohort design linked drug utilization data to medical claims from Utah Medicaid recipients. We restricted the analysis to 50 years-old and older beneficiaries diagnosed with dementia-related diseases. We compared patients treated with AChEI to patients untreated with anti-dementia medication therapy. We attempted to remove confounding by establishing propensity-score-matched cohorts for each outcome investigated; we then evaluated the effects of drug treatment by conditional multivariable Cox-proportional-hazard regression. Acute and transient effects were evaluated by a crossover design using conditional logistic regression.Results: Propensity-matched analysis of expected reactions revealed that AChEI treatment was associated with gastrointestinal episodes (Hazard Ratio [HR]: 2.02; 95%CI: 1.28-3.2), but not psychological episodes, respiratory disturbance, or death. Among the unexpected reactions, the risk of hematological episodes was higher (HR: 2.32; 95%CI: 1.47-3.6) in patients exposed to AChEI. AChEI exposure was not associated with an increase in hepatic episodes. We also noted a trend, identified in the case-crossover design, toward increase odds of experiencing acute hematological events during AChEI exposure (Odds Ratio: 3.0; 95% CI: 0.97 - 9.3).Conclusions: We observed an expected association between AChEIs treatment and gastrointestinal disturbances and detected a signal of possible hematological ADR after treatment with AChEIs in this pilot study. Using this analytic framework may raise awareness of potential ADEs and generate hypotheses for future investigations. Early findings, or signal detection, are considered hypothesis generating since confirmatory studies must be designed to determine if the signal represents a true drug safety problem.

2019 ◽  
Vol 7 (4) ◽  
pp. 190-199
Author(s):  
A. P. Pereverzev ◽  
O. D. Ostroumova ◽  
O. N. Tkacheva ◽  
Y. V. Kotovskaya

For the treatment of dementia and Alzheimer’s disease, acetylcholinesterase inhibitors (donepezil, rivastigmine, galantamine) and/or the non-competitive inhibitor of N-methyl-D-aspartate receptors (NMDA receptors) memantine are currently used. The administration of these drugs can help temporarily improve or stabilize memory impairments and other cognitive functions, regress behavioral disorders, reduce the patient’s dependence on others, but at the same time can lead to the development of adverse drug reactions. The aim of this study was to analyze the information on the safety of acetylcholinesterase inhibitors (donepezil, rivastigmine, galantamine) and the non-competitive inhibitor of NMDA receptors used to treat dementia. It was shown that stimulation of cholinergic receptors can lead to adverse drug reactions as contraction and narrowing of the pupil (miosis), an increase in lens curvature, accommodation spasm (visual impairment and an increased risk of falls), a decrease in heart rate (bradycardia) and inhibition of conduction of impulses through the conducting system heart, increased tone of the bronchi, gastrointestinal tract, gall and bladder, decreased tone of the sphincters of the digestive tract and bladder, increased secretion of exocrine and glands of the stomach, agitation, confusion. Blockade of NMDA receptors due to impairment of glutamate metabolism in the central nervous system may be the cause of neurotoxicity of NMDA receptor antagonists, and also causes dizziness, feeling of tiredness, hallucinations, drowsiness, and confusion. In case of development of adverse reactions, if possible, it is necessary to stop using the drug or reduce its dose, in case of an overdose or other need, prescribe symptomatic therapy. Information on the safety of cholinesterase inhibitors and NMDA receptor antagonists presented in the article is of practical importance for healthcare professionals, as it allows them to assess the possible risks associated with the use of drugs of these groups more accurately. In addition, the information can be used to optimize and individualize the pharmacotherapy regimens for patients with dementia, including the development of domestic protocols for the deprescribing of drugs (evidence-based practice of withdrawal, replacement or gradual dose reduction) in the elderly. 


2020 ◽  
Vol 11 ◽  
Author(s):  
Gina Mejía ◽  
Miriam Saiz-Rodríguez ◽  
Beatriz Gómez de Olea ◽  
Dolores Ochoa ◽  
Francisco Abad-Santos

2015 ◽  
Vol 71 (12) ◽  
pp. 1525-1533 ◽  
Author(s):  
Khedidja Hedna ◽  
Katja M. Hakkarainen ◽  
Hanna Gyllensten ◽  
Anna K. Jönsson ◽  
Max Petzold ◽  
...  

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 745-750
Author(s):  
Bushan Kumar GG ◽  
Jyothi Singamsetty ◽  
Rajasekhar K V ◽  
Sahitya Meda

Clinical pharmacy services are the services provided by the pharmacists to promote patient care, optimizes medication therapy, promote health and disease prevention. This prospective cross sectional study was conducted in tertiary care hospital over a period of 6 months. This collected data is checked for their appropriateness of any prescription related errors and DRPs were identified. Results obtained were assessed to determine the influence of Clinical pharmacist services. Majority of the prescriptions were with 5-9(62.5%) drugs. The majority of co-morbidities among 125 enrolled patients in age group of 60-70, 55 patients were with 3-4 co-morbidities. Among 125 prescriptions around 12 prescriptions were identified with 622 drug interactions. Among 125 patients 2 (0.277) adverse drug reactions were observed and according to Naranjo's probability assessment scale these adverse drug reactions were mild and 15(2.08%) dispensing errors, 10(1.386%) prescription errors where majority of prescription errors are due to missed written frequencies in the prescriptions. 5(0.693%) administration errors, 5 (0.693%)untreated indications were observed. Presence of clinical pharmacist in hospital settings can reduce drug related problems and they can assist other staff in improving patient care.


2013 ◽  
Vol 22 (12) ◽  
pp. 1317-1325 ◽  
Author(s):  
Khedidja Hedna ◽  
Staffan Hägg ◽  
Karolina Andersson Sundell ◽  
Max Petzold ◽  
Katja M. Hakkarainen

2008 ◽  
Vol 65 (4) ◽  
pp. 573-579 ◽  
Author(s):  
Karin Wester ◽  
Anna K. Jönsson ◽  
Olav Spigset ◽  
Henrik Druid ◽  
Staffan Hägg

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243714
Author(s):  
Sara Iasmin Vieira Cunha Lima ◽  
Rand Randall Martins ◽  
Valdjane Saldanha ◽  
Vivian Nogueira Silbiger ◽  
Isabelle Cristina Clemente dos Santos ◽  
...  

Objective Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. Methodology Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution’s research ethics committee. Results In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. Conclusion We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.


2017 ◽  
Vol 33 (3) ◽  
pp. 83-86 ◽  
Author(s):  
Milena M. McLaughlin ◽  
Jenny Lin ◽  
Rosie Nguyen ◽  
Pratixa Patel ◽  
Erin R. Fox

Drug shortages create significant challenges for patients and health care providers. Pharmacists play important roles in managing medication therapy during drug shortages. The management of drug shortages by the community pharmacist is an expanding role. Adverse drug reactions and delayed treatments are highlighted in the literature as some of the consequences of outpatient drug shortages; it is likely these harms are underreported. This commentary reviews examples and opportunities for the management of outpatient drug shortages.


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