جستجوی مقالات مرتبط با کلیدواژه « drug safety » در نشریات گروه « پزشکی »

Pharmacovigilance is definedas “the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions or any other drug-related problems”.The framework of the national pharmacovigilance system illustrates the general pattern of howthe health system approaches the care of health products, defines the philosophy of supervision and policy orientation, and outlines the structure and development priorities of pharmacovigilance. The present study was conducted with the aim of presenting a framework of the national pharmacovigilance system framework for developing countries. The present study is of an applied study that was conducted descriptively in 2023. To present a framework of the national pharmacovigilance system framework, the main components of the national pharmacovigilance system framework were first identified and determined through a review of valid scientific sources and texts and national pharmacovigilance systems of the countries under study, considering the conditions and requirements of these countries. Then, the proposed model was put to the opinion of 65 experts for validation, and the Delphi method was implemented with a three-point scale in two rounds. Based on the results of the present study, the main components of thenational pharmacovigilance system framework include: functions, infrastructure, and network. Each component includes sub-components and related operations and was agreed upon by experts with an average agreement rate of 95%. The framework of the national pharmacovigilance system is essential as a guide for the implementation of the national pharmacovigilance system. This framework enables a comprehensive evaluation of the structures and national and regional institutions affecting pharmacovigilance and canlead to the optimal implementation of the national pharmacovigilance system in developing countries. The national pharmacovigilance system can reduce drug-related problems, and its ultimate result can be a reduction in mortality and morbidity rates.

 Addressing the Coronavirus disease 2019 (COVID-19) pandemic remains a significant challenge for healthcare systems globally. Despite the absence of a proven cure, ivermectin has been proposed as a potentially effective agent against it.

 This study aimed to evaluate the therapeutic effects of ivermectin compared to a placebo group in non-critically ill confirmed COVID-19 patients.

 A double-blind, randomized clinical trial was conducted on 110 patients with moderate-to-severe (non-critical) confirmed COVID-19 infection. The patients were equally divided into two groups, with one group receiving ivermectin tablets (14 mg every 12 hours for three days) and the other group receiving a placebo. The efficacy and safety of ivermectin were assessed in both groups.

 A total of 110 patients, including 62 (56.4%) men and 48 (43.6%) women, with an average age of 53.36 ± 15.10 years, were enrolled in our double-blind, randomized clinical trial. The baseline characteristics of the two groups were similar. The findings demonstrated that ivermectin significantly reduced the need for Intensive Care Unit admission (32.7% vs. 5.5%; P < 0.001), hospitalization duration (six vs. four days; P < 0.001), and median time to symptom resolution period (P < 0.05) in COVID-19 patients compared to the placebo group, without any serious side effects (P > 0.05).

 Ivermectin appears to be a potentially effective and safe medication for COVID-19 patients with moderate disease.

Zoledronic acid (ZLD) is a bisphosphonate drug widely administered against pathological conditions such as hypercalcemia of malignancy, osteoporosis, bone metastases from solid tumors, and multiple myeloma. Unfortunately, renal injury is a serious and dose-limiting adverse effect of ZLD. There is no specific mechanism for ZLD-induced renal damage. The current study aimed to assess the effects of ZLD (10 and 15 mg/kg, i.p., single dose) on the rat kidney. In this regard, several parameters, including oxidative stress biomarkers, serum level of BUN and creatinine, inflammatory cytokines, kidney histopathology, and indices of mitochondrial function were assessed. A significant increase in serum Cr and BUN revealed renal injury. Moreover, kidney histopathological changes, including interstitial inflammation, tissue necrosis, and tubular atrophy, were detected in ZLD-treated rats. Biomarkers of oxidative stress, including a significant increase in reactive oxygen species (ROS), depletion of kidney glutathione (GSH) stores, increased lipid peroxidation, and suppression of the total antioxidant capacity, were detected in ZLD-treated animals. ZLD also significantly increased renal levels of TNF-α, IL-6, and IL-1β. ZLD exposure was also associated with significantly decreased mitochondrial dehydrogenases activity, mitochondrial depolarization, mitochondrial permeabilization, and ATP depletion. These data highlight mitochondrial dysfunction, inflammatory response, and oxidative stress as potential mechanisms in ZLD-induced kidney injury.

Proton Pump Inhibitors (PPIs) are often prescribed inappropriately among hospitalized patients and same is often continued even after their discharge from the hospital. The inappropriate use of PPIs leads to an increased risk of adverse effects, drug interaction, and unnecessary hospital expenditure for such patients. Aim of this study was to determine the appropriateness of PPIs use among hospitalized patients.

A cross sectional observational study was conducted on hospitalized patients in a tertiary care hospital in Northern India. The clinical records of adult patients hospitalized during April- May 2022 were assessed for the prescribing pattern and appropriateness of PPI use as per the National Institute of Health and Care Excellence (NICE) guidelines.

A total of 192 patient’s records were included in this study with the mean age 57 years and 61% of the study participants were males. Overall, 72% (138) of the study participants were prescribed PPIs by intravenous route and only in 28% (54) cases an oral route was preferred. Pantoprazole was the most commonly prescribed PPI in 112 (58%) patients and it was administered by intravenous route among 87 patients (78%) and by oral route in 25 (22%) patients. PPI use was appropriate in 54% of the cases and they were most commonly prescribed for ulcer prophylaxis. This study identified higher use of PPIs was seen in low risk patients for longer duration than indicated.

PPIs are being prescribed inappropriately among hospitalized patient unrelated to their widely accepted clinical indications and are often continued unnecessarily once patient is discharged. These results suggest the need of regular audits on use of PPIs clubbed with educational initiatives to promote rational use of PPIs among hospitalized patients.

Pediatric patients have very different pharmacokinetic and pharmacodynamic profiles compared to adults. A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in pediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. When considering medication for a child or adolescent, one should be cautious about extrapolating from adult studies or practices. Always remember, children are not small adults. Children tend to have higher rates of metabolism and elimination than adults. As a result, children generally require higher weight-adjusted doses of most medications to achieve similar blood levels as adults. As pharmacokinetics is hard to predict in children, and thus a ‘start low and go slow’ approach is important. This review details key pharmacological and practical considerations which a healthcare professional should be aware of to understand consequences of drug use and dose adjustments in infants and children.

The objective of our study is to characterize the knowledge, information sources, and institutional trust of patients regarding medication use in pregnancy.

We conducted a review of three databases: MEDLINE, EMBASE, and CINAHL. We included observational studies and knowledge assessments that examined the knowledge, attitudes, beliefs or information sources of pregnant patients related to medication use during pregnancy. Extraction was completed by two independent reviewers, outcomes were summarized descriptively, and appraisal was conducted.

Of the 1359 search results, 34 studies met inclusion criteria. Thus, our systematic review encompasses the beliefs of 11,757 pregnant participants. In most studies, participants described apprehension regarding potential risks to the fetus and the inadequacy of safety information. Across the 23 knowledge assessments, the majority of studies reported patient misconceptions about prescription medication in pregnancy. The most preferred information source was a healthcare provider. However, many participants expressed frustration, mistrust, and skepticism regarding physician knowledge. A common source of mistrust was due to perceived physician self-interest as well as a lack of education tailored to pregnancy. Consequently, informal sources of information were also popular.

There is a need to improve the health literacy and trust among pregnant patients regarding drug prescribing. There are modifiable risk factors for mistrust that require further attention.

Nowadays, the role of clinical pharmacists has become more prominent by more clinical pharmacists joining the health-care teams. This study was aimed to assess the role of a clinical pharmacist specialist in detecting and managing drug-related problems (DRPs) in the neurology ward of a tertiary care teaching hospital in Iran.

This is a prospective cross-sectional study conducted on 123 hospitalized patients admitted to the neurology ward of a teaching hospital. The clinical pharmacist visited the patients and filled out the designed pharmacotherapy sheet for each patient. Then, the general pharmacist checked the patients’ files and pharmacotherapy sheets and categorized DRPs using modified method of “The Pharmaceutical Care Network Europe classification, Version 5.01.”

A total of 168 errors were found and 346 interventions were done by the clinical pharmacist during the study period. The most common form of errors in our study was “drug choice problems”(57.76%). The acceptance rate of interventions was 41.91% among physicians.

The large number of interventions reported in several studies, as well as this study, revealed that clinical pharmacy services could contribute to a rationalization of drug therapy and may eventually lead to more medication safety

Monoclonal antibodies are increasingly being employed in oncology, toxicology, infectious diseases and rheumatology owing to unmatched efficacy and safety; nevertheless, their usage in developing countries is restricted due to high cost to the exchequer. The newer production line of monoclonal antibodies comes forth with improved efficacy and safety of the current generation monoclonal antibodies and has led to a meteoric growth in their utility. We performed a comparative analysis of consumption pattern of monoclonal antibodies in a sponsored tertiary-care healthcare system during 2013 - 2017. The humanized anti-IgE monoclonal antibody, omalizumab, was compared with various groups of drugs used for the treatment of bronchial asthma such as combination of long-acting β-agonists and inhaled corticosteroids, short-acting β-agonists and anticholinergics, and inhaled corticosteroids and leukotriene receptor antagonists. The consumption pattern revealed a three-fold increase in the number of monoclonal antibodies during 2016 - 2017 compared to the three-year period from 2013 to 2015. Omalizumab incurred the highest cost burden relative to other medicines used in bronchial asthma. The comparative analysis of usage pattern of monoclonal antibodies, immunomodulators, anti-HIV drugs and all insulin preparations demonstrates annually rising cost burden of monoclonal antibodies. The study showed an increasing trend of healthcare costs and proportionately increasing use of monoclonal antibodies, which add to the quality of care through increased efficacy and safety. We need to accept the fact that quality comes with an additional cost burden, and costs can be optimized with economy of scale.

Adverse drug events can cause serious consequences including death. A published report by Lazarou et al in 1998 showed that adverse drug events were the 4th to 6th leading cause of death in the United States. These events may lead to drug safety crises in some issues, which need to take crises management process for solving the problem and/or preventing similar events.
To evaluate nature of drug safety crises based on adverse events reported to Iranian Pharmacovigilance Center from 1999 through 2012. To mention success and failure outcomes of crises management process taken against detected crises.
All adverse drug events received by Iranian Pharmacovigilance Center from 1999 through 2012 were evaluated for reports with fatal outcome. All alerting letters and manuscripts published by the Center during the same period were reviewed for detailed information on detected crises. World Health Organization definition was used for detecting drug safety crises.
Among 42036 registered cases in our database, 463 deaths were recorded. The most frequent suspected drug for adverse events with fatal outcome was ceftriaxone (100 cases). Ten different drug safety crises issues were detected during the study period and their successful or failure outcomes were evaluated. There were 112 issued alerting letters and 17 published manuscript during the same period which was monitored for detailed information.
It is necessary for national pharmacovigilance centers to have prepared programs for crises management. This could be useful for reducing drug related mortality.

Personalized medicine aims is to supply the proper drug to the proper patient within the right dose. Pharmacogenomics (PGx) is to recognize genetic variants that may influence drug efficacy and toxicity. All things considered, the fields cover a wide area, including basic drug discovery researches, the genetic origin of pharmacokinetics and pharmacodynamics, novel drug improvement, patient genetic assessment and clinical patient administration. At last, the objective of Pharmacogenomics is to anticipate a patient’s genetic response to a particular drug as a way of presenting the best possible medical treatment. By predicting the drug response of an individual, it will be possible to increase the success of therapies and decrease the incidence of adverse side effect.

Medication errors and adverse drug events of high alert medication are one of the major problems in therapeutic system. The purpose of the present study was to investigate ýthe effect of clinical supervision model on high alert medication safety in intensive care units nurses.
This was a quasi-experimental study conducted on 32 nurses of intensive care units. The researcher observed the administration of high alert drugs including heparin, warfarin, norepinephrine, dobutamine, and dopamine by nurses and recorded the scores of “the work in preventing medication errors,” “the work in preventing adverse drug events,” and “medication safety.” Then, the researcher performed clinical supervision model and during performance of the model, the researcher reassessed the score of “the work in preventing medication errors”, “The work in preventing adverse drug events” and “medication safety”. Tool of data collection was “action plan of high alert medication safety” checklists (heparin, warfarin, norepinephrine, dobutamine, and dopamine checklists).
The result of the statistical trials showed that before and after applying the clinical supervision model, there was a statistically significant difference between the average scores of medication safety of heparin (15.7 vs 18.73), warfarin (11.08 vs 15.67), norepinephrine (14.60 vs 19.72), dobutamine (13.80 vs 19.30), and dopamine 14.25 vs 19.47).
Based on the results of this study, it seems that administration of clinical supervision model in intensive care units can lead to improving the status of safety of high alert medication.