Presence Of Adverse Drug Reactions Research Articles

Analgesic effectiveness of prophylactic therapy and continued therapy with naproxen sodium post simple extraction.

Objective: To compare the effectiveness of prophylactic therapy and continued therapy with naproxen sodium post simple extraction. Material and methods: Prospective randomized, parallel, single-blind clinical assay, was developed in the Clinica Estomatologica of Universidad Alas Peruanas Filial Trujillo (Peru). Patients who required a simple extraction by dental caries, were randomized into three groups: 30 received naproxen sodium 550 mg preoperatively and then every 12 hours, 30 received naproxen sodium 550 mg postoperatively and then every 12 hours, and 30, ibuprofen (control group) 400 mg postoperatively and then every 8 hours, according to the established criteria. The procedure was standardized and the analgesic efficacy assessed by visual analog scale, and the presence of adverse drug reactions. Data were analyzed by IBM SPSS Statistics 22, using ANOVA and Duncan test, considering a significance level of 5%. Result: continued therapy with naproxen sodium showed higher analgesic effectiveness at 1, 8 and 24 hours (p<0,05) post simple extraction. Conclusion: continued therapy with naproxen sodium showed greater effectiveness than prophylactic therapy post simple extraction.

A comparative study of intravenous paracetamol and intravenous tramadol for postoperative analgesia in laparotomies.

Background:Pain in the perioperative setting or thereafter plays a significant role in delaying an otherwise successful recovery. Hence, mitigation of such postoperative pain assumes importance. Among the various agents employed for such mitigation, opioids and non-steroidal anti-inflammatory drugs have for some time taken center stage. However, alas they are not without their share of adverse effects. This study was undertaken with the purpose of elucidating the efficacy of intravenous (IV) paracetamol as compared to IV tramadol in mitigating postoperative pain while observing its effect on hemodynamic stability and the presence of adverse drug reactions, if any.Materials and Methods:A total of 60 randomized cases aged ranges from 20 to 60 years of both sexes divided into two groups (each for paracetamol and tramadol) scheduled for laparotomies were administered IV paracetamol and tramadol for postoperative pain relief and assessed with visual analog scale (VAS) score and variations in vital parameters to ascertain extent of pain relief and post-operative nausea vomiting (PONV).Results:Data so collected was statistically interpreted, and observations extrapolated. Save for a perceptible decline in PONV with paracetamol group compared with tramadol group with a statistically significant P < 0.001, nothing statistically significant was observed in any other parameter, including VAS scores between either group.Conclusion:IV paracetamol is a safer alternative to tramadol with lesser PONV in the postoperative period translates into the lesser duration of hospitalization and hence earlier discharge.

Adverse drug reactions in older patients during hospitalisation: are they predictable?

adverse drug reactions (ADRs) are a major cause of morbidity and healthcare utilisation in older people. The GerontoNet ADR risk score aims to identify older people at risk of ADRs during hospitalisation. We aimed to assess the clinical applicability of this score and identify other variables that predict ADRs in hospitalised older people. we prospectively studied 513 acutely ill patients aged ≥65 years. The GerontoNet ADR risk score was calculated for all patients. ADRs were identified through patient and physician consultation together with analysis of case notes. Receiver operator characteristic (ROC) curves were constructed to test the ability of the GerontoNet risk score to predict ADRs. Multivariate logistic regression examined the influence of individual variables on the presence of ADRs. in-hospital ADRs were identified in 135 patients (26%). The area under the ROC curve was 0.62 (95% CI: 0.57-0.68). Variables which increased ADR risk include (i) renal failure (OR: 1.81, 95% CI: 1.12-2.92), (ii) increasing number of medications (OR: 1.09, 95% CI: 1.02-1.17) (iii) inappropriate medications (OR: 2.40, 95% CI: 1.26-4.50) and (iv) age ≥75 years (OR: 2.12, 95% CI: 1.23-3.70). the GerontoNet ADR risk score incorrectly classified 38% of patients as low risk. Inappropriate medications and increasing age also contribute to ADR risk.

Efficacy and safety of tafluprost in normal-tension glaucoma with intraocular pressure of 16 mmHg or less

To evaluate the intraocular pressure (IOP)-reducing effects and safety of 0.0015% tafluprost ophthalmic solution (tafluprost) in normal-tension glaucoma (NTG) patients with an IOP of 16 mmHg or less. NTG patients with a baseline IOP of 16 mmHg or less were enrolled for a one-eye study in which tafluprost was applied once daily for 12 weeks. The presence of adverse drug reactions and the cumulative incidence of adverse events were also investigated. Among the 44 enrolled patients, 41/44 (93.2%) eyes completed the study. The baseline IOP was 13.2 ± 1.3 mmHg in the study eyes and 13.0 ± 1.3 mmHg in the fellow eyes, which was not statistically significant (P = 0.9173, Student's t test). The values obtained for IOP in the study eyes versus fellow eyes were 10.2 ± 1.6 versus 12.1 ± 1.5 mmHg at week 12. The IOP difference between the study eyes and the fellow eyes was statistically significant (P < 0.0001, Student's t test). The cumulative incidence of adverse events was 58.5% by week 12. Ocular itching was the most frequently observed adverse event (29.3%). All adverse events were clinically tolerable. Tafluprost induced significant IOP reductions in NTG patients with a baseline IOP of 16 mmHg or less without raising any safety concerns.

Utilization of Pharmacogenomics and Therapeutic Drug monitoring for Opioid Pain Management

The use of medication in pain management currently involves empirical adjustment based on observed clinical outcome and the presence of adverse drug reactions. In this study, pharmacogenomics and therapeutic drug monitoring were used to evaluate the clinical effectiveness of genotyping chronic pain patients on analgesic therapy. It was hypothesized that patients who have inherited polymorphisms in CYP2D6 that make them poor or intermediate metabolizers of opioid medications would have higher steady-state concentrations of those opioids and may be more likely to experience adverse drug reactions. In an attempt to investigate the relationship between the polymorphic enzymes, steady-state drug concentrations, therapeutic effects and side effects, 61 patients were clinically evaluated and genotyped, and drug concentrations were measured and outcomes analyzed. Samples were collected and DNA extracted from whole blood using a Puregene DNA isolation kit. CYP2D6 genotyping (*3, *4, *5, *6, *7, *8 and gene duplication) were carried out using Pyrosequencing. Steady-state plasma concentrations of methadone, oxycodone, hydrocodone and tramadol were determined by HPLC tandem mass spectrometry. The results demonstrated the prevalence of CYP2D6 polymorphisms in the population undergoing pain management was not statistically different from the general population. The majority of the pain patients (54%) were extensive metabolizers; 41% were intermediate metabolizers and 5% poor metabolizers. Poor metabolizers in general tended to have the highest steady-state drug concentrations compared with extensive metabolizers (poor metabolizers > intermediate metabolizers > extensive metabolizers) although this wasn't statistically significant. Also, a relationship between oxycodone steady-state drug concentrations and pain relief was found. A total of 80% of patients reporting adverse drug reactions also had impaired CYP2D6 metabolism. The remaining 20% with adverse drug reactions had other cofactors (i.e., drug-drug interactions) that could explain the toxicity. These results suggest that patient care may be improved by genotyping and following therapeutic drug concentrations. Benefits include increased efficiency in proper drug selection, dose optimization and minimization of adverse drug reactions to improve patient outcome and safety. In addition, this study clearly demonstrated a relationship between oxycodone steady-state drug concentrations and pain relief. Future large-scale prospective studies are needed to confirm the clinical value of using genetic information to guide pain management therapy.

Do older hospital patients recognize adverse drug reactions?

To establish the relationship between subjective complaints of side effects of drugs and the objective presence of adverse drug reactions in older patients. Observational cross-sectional study. Five medical wards at the University Hospital Rotterdam Dijkzigt. Patients aged 70 and over admitted to the general medical wards over a 3-month period. Statistical comparison and Kramer's algorithm. Of 106 patients, 102 used medication, and 93 of these were able to report whether they believed they were experiencing drug side effects. Thirty-six [39% (95% confidence interval 28.8-48.6)] believed that they were experiencing side effects and the number of diagnoses per patient and the proportion of patients with chronic obstructive pulmonary disease was higher in these 36 'complainers' than in the group of the 'non-complainers'. We found a correct opinion (true positive and negative) about the objective presence or absence of mild or severe adverse drug reactions in 79% (95% confidence interval 70.2-86.8). Asking the patient about side effects of drugs had a sensitivity of 0.70 and a specificity of 0.85 patients. The severe adverse drug reactions in 21 patients were not recognized by 14 of them. At hospital admission, older patients should be asked about drug side effects because they are often correct in recognizing them. However, severe adverse drug reactions are not easily recognized.

Adverse drug reaction monitoring--cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions.

In an era of health care cost containment it is of particular interest to identify measures that reduce costs and at the same time improve health care quality. One of these cost cutting measures might be the reduction of the frequency of Adverse Drug Reactions (ADR). The objective of this paper is to summarize all original work on ADR frequencies at hospital admission and to come up with a valid estimate for the actual frequency of ADR-related hospital admissions. Additionally, we compared established concepts of ADR monitoring with respect to their utility for drug safety monitoring and pharmacoepidemiologic research. We reviewed 25 studies from the past 25 years. Analysing the effect of methodological characteristics showed that variation of reported ADR frequency mainly depends on differing study bases and the concepts of ADR monitoring. Investigations that thoroughly screened all members of the study population for the presence of adverse drug reactions (comprehensive ADR monitoring) generally yielded highest ADR proportions. Studies that concentrated screening on selected high-risk patients (preselective ADR monitoring) and those applying spontaneous or intensified spontaneous reporting detected lower ADR proportions (2.9% and 2.5%). The ADR proportion among admissions to departments of internal medicine was higher than among mixed hospital populations including surgical patients. In conclusion 4.2-6.0% (lower and upper quartile) and in median 5.8% of all admissions to medical departments are caused by adverse drug reactions. A two-step preselective ADR monitoring appears to be appropriate and efficient for both signal generation and signal validation as compared to spontaneous reporting and comprehensive monitoring. In conclusion, adverse drug reactions are a common cause of hospital admissions. As hospital care is expensive, attempts to prevent ADR and thus hospital admission need active encouragement.

Pharmacist impact on drug use in an institution for the mentally retarded

Pharmacist involvement on a team developed to monitor drug use in an institution for the mentally retarded is described, and the results of the team's efforts are reported. The behavioral review committee consisted of a physician, pharmacist(s), nurses, psychologists, sociologists and therapists. The pharmacists reviewed the patients' charts and pharmacy records to compile a complete drug history on a special "drug calender" form. The pharmacist visited the patient to determine current problems, the effectiveness of therapy and the presence of adverse drug reactions. Recommendations were than made to the committee. During the two-year study period, the use of antipsychotic drugs was reduced 18%; antianxiety-antidepressant drugs, 50%; sedative-hypnotics, 58%; and miscellaneous agents, 65%. The net savings in drug expenditures was more than $10,000 per year, Maladaptive behaviorial test results implied that the decreased drug use did not change behavior significantly. The study shows that the pharmacist, through a team approach, can help reduce the overuse of medications in institutions for the mentally retarded.