Frequency Of Adverse Drug Events Research Articles

An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury.

The recent rise in acute kidney injury (AKI) incidence, with approximately 30% attributed to potentially preventable adverse drug events (ADEs), poses challenges in evaluating drug-induced AKI due to polypharmacy and other risk factors. This study seeks to consolidate knowledge on the drugs with AKI potential from four distinct sources: (i) bio(medical) peer-reviewed journals; (ii) spontaneous reporting systems (SRS); (iii) drug information databases (DIDs); and (iv) NephroTox website. By harnessing the potential of these underutilised sources, our objective is to bridge gaps and enhance the understanding of drug-induced AKI. By searching Medline, studies with lists of drugs with AKI potential established through consensus amongst medical experts were selected. A final list of 63 drugs was generated aggregating the original studies. For these 63 drugs, the AKI reporting odds ratios (RORs) using three SRS databases, the average frequency of ADEs from four different DIDs and the number of published studies identified via NephroTox was reported. Drugs belonging to the antivirals, antibacterials, and non-steroidal anti-inflammatory pharmacological classes exhibit substantial consensus on AKI potential, which was also reflected in strong ROR signals, frequent to very frequent AKI-related ADEs and a high number of published studies reporting adverse kidney events as identified via NephroTox. Renin-angiotensin aldosterone system inhibitors and diuretics also display comparable signal strengths, but this can be attributed to expected haemodynamic changes. More variability is noted for proton-pump inhibitors. By integrating four disjointed sources of knowledge, we have created a novel, comprehensive resource on drugs with AKI potential, contributing to kidney safety improvement efforts.

Implementation of a pharmacovigilance system to detect adverse events and improve medication appropriateness in a hospital in Indonesia

Background: The growing elderly population has led to an increased occurrence of adverse drug reactions (ADRs) due to the various drugs they are prescribed, posing the problem of potential drug interactions. The application of causality instruments combined with trigger tools and the competency of healthcare professionals has yielded better results in detecting ADRs. Objective: To evaluate the implementation of a pharmacovigilance system to detect ADRs, potentially inappropriate medications, and potential prescription omissions. Methods: An observational, descriptive, prospective study was conducted over six weeks at one of the largest hospitals in Indonesia. The pharmacist and the physicians collaborated in reviewing patient medication records using the pharmacovigilance system. Results: The study enrolled 144 patients. The 163 positive triggers identified helped detect 28 Adverse Drug Events (ADEs) caused by at least one high-alert medication. These ADEs occurred in 25 patients. Additionally, 62 potentially inappropriate medications and 41 potential prescription omissions were detected. Conclusion: The pharmacovigilance system could reduce the frequency of ADEs caused by medications used in elderly patients.

Adverse drug events in Chinese elder inpatients: a retrospective review for evaluating the efficiency of the Global Trigger Tool.

Elderly patients frequently experience a high incidence of adverse drug events (ADEs) due to the coexistence of multiple diseases, the combination of various medications, poor medication compliance, and other factors. Global Trigger Tool (GTT) is a new method for identifying ADEs, introducing the concept of a trigger, that is, clues including abnormal laboratory values, reversal drugs, and clinical symptoms that may suggest ADEs, and specifically locating information related to ADEs in the medical record to identify ADEs. The aim of this study was to establish a GTT-based trigger tool for adverse medication events in elderly patients and to investigate the risk variables associated with such events. The triggers were identified by reviewing the frequency of ADEs in elderly patients in Sichuan, China, retrieving relevant literature, and consulting experts. A retrospective analysis was carried out to identify adverse medication occurrences among 480 elderly inpatients in Sichuan People's Hospital. A total of 56 ADEs were detected in 51 patients (10.62%), 13.04 per 1,000 patient days, and 11.67 per 100 admissions. The overall positive predictive value (PPV) of the triggers was 23.84, and 94.64% of ADEs caused temporary injury. Gastrointestinal system injury (27.87%) and metabolic and nutritional disorders (24.53%) were the primary organ-systems affected by ADEs. The majority of ADEs were caused by drugs used to treat cardiovascular diseases. 71.43% of ADE occurred within 2 days of administration and the risk factor analysis of ADE revealed that the number of medicines had a significant correlation. This study demonstrated GTT's value as a tool for ADEs detection in elderly inpatients in China. It enhances the level of medication management and comprehensively reflects the situation of ADE of the elderly.

Efficacy and safety profile of Minolexin in patients with urogenital chlamydia infection: results of an open randomized comparative clinical trial

Background. Urogenital chlamydia infections is a widespread STI: 131 million people are infected every year. Scientists are studying the issue of reducing the sensitivity of the pathogen to traditionally used drugs and are investigating the effectiveness of antibacterial drugs active against C. trachomatis.
 Aims: to study the efficacy and safety of the minocycline in the treatment of urogenital chlamydia infection in comparison with the doxycycline.
 Methods: an open randomized comparative clinical trial included 100 patients: group 1 50 patients who received minocycline 100 mg 2 times a day for 7 days, group 2 50 patients who received doxycycline 100 mg 2 times a day in within 7 days. The diagnosis was confirmed by the detection of C. trachomatis by PCR. The parameter of the effectiveness of therapy was the eradication of C. trachomatis and the absence of clinical symptoms 4 weeks after therapy.
 Results: 1 week after therapy, clinical symptoms were registered in 20;40.8% patients of group 1 and 28;57.1% patients of group 2 (p=0.106), 4 weeks later in 4;8.2% and 7;18.4% patients (p=0.524). In group 1, the absence of most subjective clinical symptoms was recorded in a shorter time than in the comparison group. 100% of patients had achieved eradication C. trachomatis, laboratory signs of an inflammatory reaction were recorded in 2;5.0% patients of group 1 and 3;7.3% patients of group 2 (p=1,000). According to the frequency of adverse drug events, there were also no significant differences between the groups, however, in group 2 patients, adverse drug events that had a high probability of being associated with taking the drug were recorded more often than in the group 1.
 Conclusions. The results of the study demonstrated the comparable effectiveness of minocycline and doxycycline in the treatment of urogenital chlamydia infection and a similar safety profile of these drugs.

Drug Allergy Alert System in a Spanish University Hospital: Description and Dynamics of Use

Introduction: The drug allergy alert system reduces the frequency of adverse drug events, although it is subjected to collateral effects, since 80–90% of alerts are not real, and a large percentage of alerts are overridden (46.2–96.2%). We reviewed how the alert system is used at University Hospital Fundación Alcorcon (HUFA). Methods: Data were obtained from the drug allergy alert and the alert overriding notification forms (both in the period 2011–20). We also recorded drug allergy diagnoses at HUFA, drug consumption in primary care in 2016. We calculated the incidence of drug allergy alert activation, temporal trends in use, and correlations between the number of drugs in several datasets. Results: We collected 15,535 alerts. NSAIDs and penicillins were the drugs with the highest number of drug allergy alerts (36.55% and 26.91%, respectively). A correlation was found between the number of drug alerts and the type of drug allergy in HUFA in 2016. Only 6.83% of the alerts were removed, and, of these, 21.77% were reactivated. Approximately 100 overrides were recorded per year from 2016 (6.8% of 8,434 activated alerts during 2014–2020). Conclusions: The number of drug allergy alerts recorded via the drug allergy alert system of HUFA correlates with the distribution of drug allergy diagnoses in the hospital, although many of the alerts could be false positives (as per current published evidence). We detected a very low frequency of removed alerts (6.83%), a relevant frequency of reactivations (one quarter), and a very low frequency of overrides (6.8%).

Safety of purified Vero cell rabies vaccine manufactured in Pakistan: A comparative analysis of intradermal and intramuscular routes

Background Rabies vaccines are conventionally given via the intramuscular (IM) route; however, switching the route of administration from IM to intradermal (ID) without affecting efficacy can be advantageous in terms of cost, dosing, and time. Hence, it is indispensable to evaluate its safety along different routes. This study was carried out to ascertain the frequency of adverse drug events (ADEs) and associated factors, as well as to compare safety based on the IM and ID routes. Methods A prospective observational study was carried out on 184 individuals with rabies exposure. The vaccination schedules for post-exposure prophylaxis (PEP) included 0.2 milliliter (ml) of purified Vero cell rabies vaccine (PVRV) administered ID at two different sites with 0.1ml each on days 0, 3, and 7 in first group (3-dose regimen ID) and 0.5 ml administered IM on days 0, 3, 7, 14, and 28 in the second group (5-dose regimen IM). The safety of the vaccines was determined by reviewing ADEs during physical examinations and follow-up. ADEs were characterized by local and systemic effects. Results Of the total, 99 (53.80%) patients reported ADEs. Those who reported local and systemic ADEs were 80 (43.48%) and 59 (32.06%), respectively, while simultaneous occurrence was reported in 40 (40.40%) patients. The most frequent local ADE 76 (41.30%) reported was pain followed by erythema 18 (9.78%). Additionally, fever was in highest proportion 25 (13.59%) for systemic effects, followed by headache 15 (8.15%). The patients reported with ADEs by the IM and ID routes was comparable (p > 0.05). Similarly, both local and systemic effects were also comparable (p > 0.05). Conclusion Half of the study participants reported ADEs. Almost similar proportions of local and systemic effects were observed. Likewise, the ADEs recorded were comparable for both routes. PVRV carries very low safety concerns with either route for administration.

Update of triggers for detection of adverse drug events in hematologic patients

The use of triggers for the active search and detection of adverse drug events (ADEs) has been gaining ground within pharmacovigilance services. Thus, the main objective of the study was to propose a new list of triggers to be used in a center specialized in hematology in Rio de Janeiro, Brazil. The update of the list of triggers consisted of revising the current list, with the exclusion and inclusion of new triggers. To verify the performance of the new list of triggers, a cross-sectional study was conducted in which the new triggers were used to investigate the occurrence of ADEs in patients attended in the emergency unit or hospitalized from January to March 2022. For each suspected ADEs, the patient's profile and adverse drug reactions (ADRs) were characterized regarding causality and severity. The performance of the triggers and their ability to capture ADEs were estimated using the following indicators: frequency of the trigger per 100 medical records, frequency of ADEs per 100 records, and positive predictive value (PPV). To evaluate the overall performance of the proposed new list, the PPV was estimated. A total of 374 prescriptions for triggers were identified in 186 medical records. The most efficient in the detection of possible ADEs were: lidocaine, loperamide, bisacodyl, filgrastim and glycerin clyster. The overall PPV of the new suggested list was 48% versus 10% of the previous list. This study demonstrated the importance of an updated list of triggers for the monitoring of ADEs and improvement of the care provided.

Antimicrobial Stewardship in Cystic Fibrosis.

The chronic airway infection and inflammation characteristic of cystic fibrosis (CF) ultimately leads to progressive lung disease, the primary cause of death in persons with CF (pwCF). Despite many recent advances in CF clinical care, efforts to preserve lung function in many pwCF still necessitate frequent antimicrobial use. Incorporating antimicrobial stewardship (AMS) principles into management of pulmonary exacerbations (PEx) would facilitate development of best practices for antimicrobial utilization at CF care centers. However, AMS can be challenging in CF given the unique aspects of chronic, polymicrobial infection in the CF airways, lack of evidence-based guidelines for managing PEx, limited utility for antimicrobial susceptibility testing, and increased frequency of adverse drug events in pwCF. This article describes current evidence-based antimicrobial treatment strategies for pwCF, highlights the potential for AMS to beneficially impact CF care, and provides practical strategies for integrating AMS programs into the management of PEx in pwCF.

A snapshot of the adverse effects of companion animal ectoparasiticides

The burden of ectoparasitic infestations is aggravated by the lack of vaccines and the inability to prevent the most serious vector-borne infections. This makes the administration of effective and safe ectoparasiticide drugs vital for prevention and treatment. However, adverse clinical consequences of treatment with ectoparasiticides affect many companion animals in the UK each year. In this study, information about the frequency of adverse drug events associated with the use of some ectoparasiticides in dogs and cats was collected, from data obtained from The National Office of Animal Health compendium datasheets and data available from published studies. Different ectoparasiticides were associated with different prevalences and types of adverse dermatological, gastrointestinal and neurological events. The heterogeneity between studies and the lack of field safety data for some products precludes head-to-head comparison of adverse events associated with ectoparasiticide treatment between studies. Therefore, caution should be exercised about making any conclusions when comparing ectoparasiticides. However, the data indicated an association between ectoparasiticide treatment and adverse events and demonstrated that this association can vary across different drug administration routes and classes. The low number of observations of the adverse drug events, relative to the number of administered doses, confirms that the health benefits of ectoparasiticides far outweigh the potential risks associated with their use. Further research is required on how adverse drug events can be predicted and prevented.

The Continuity of Chronic Medications in Multimorbid Patients during Perioperative Period: Retrospective Analysis

Background. Failure of continuity at care transitions results in 50% of all medication errors and up to 20% of adverse drug events (ADEs). In surgical patients medication errors occur more often than in medical patients due to perioperative corrections of medications and greater number of in-hospital transitions. The frequency of ADE in surgical patients varies from 2.3 to 27.7%.
 Aims to determine the prevalence and structure of unintentional discrepancies (UDs) in medications at admission to and discharge from surgery departments, report their potential clinical impact and analyse possible risk factors.
 Methods. Retrospective observational study was conducted in a general hospital in Russia. The study included patients hospitalized for elective surgery in Surgical Departments from January to June 2019. The pre-admission Best Possible Medication History (BPMH) for every patient was obtained. The BPMHs were compared with admission medication orders and hospital discharge prescriptions to identify UDs. Detected UDs were analysed for potential ADE with severity evaluation.
 Results. 206 patients were included, 55.83% were female, mean age 63.85 (9.38), median of chronic medications was 3 drugs. At least one UD was detected in 70.87% of patients at admission and in 92.72% at discharge, respectively, with averages of 1.30 and 2.81 discrepancies per patient. Cardiovascular drugs were the most frequent class involved at both admission (72.2%) and discharge (68.05%) in UDs. The most often UDs at both admission (51.68%) and discharge (94.65%) were omissions, incorrect dose (22.47% and 2.25%), and additional medications (11.6% and 1.55%). UDs had the potential to cause significant ADEs in 81.27%, serious ADEs in 18.35% of cases. Only 0.37% of UDs could contribute to life-threatening ADEs. The relative risk of discrepancies in patients of 60 years and older was 1.292-fold higher; three and more chronic medications increase risk 1.565-fold; diabetic or thyroid medications increase risk 1.932-fold.
 Conclusions. We reported on the first study of medication discrepancies conducted in Russian hospital. Estimated frequency, structure and risk factors of UDs in medications at admission to and discharge from surgery departments are similar to those from other countries. To decrease UDs in medications, implementation of medication reconciliation is needed.

A Survey of Neonatal Nurses on Mydriatic Regimens Used in Neonatal Retinopathy of Prematurity Eye Examinations.

This study was aimed to determine mydriatic regimen(s) used in neonatal units in Aotearoa, New Zealand (NZ), and Australia and to estimate the frequency of adverse drug events following mydriatic administration in preterm neonates. A cross-sectional survey was sent to neonatal nursing staff listed in the Australian and New Zealand Neonatal Network contact list. Participants were asked to state what mydriatic regimen they use, and to estimate the frequency of adverse drug events when eye drops were administered for retinopathy of prematurity eye examinations (ROPEE). Thirteen different mydriatic regimens were identified; phenylephrine 2.5% and cyclopentolate 0.5% (1 standard drop of each) was the most commonly used regimen. Two of the regimens exceeded adult doses and five regimens included a mydriatic that is equivalent to an adult dose. Following mydriatic instillation, the three most common adverse effects were apnea, tachycardia, and periorbital pallor. Low-concentration single-microdrop regimens are currently in use and resulting in successful ROPEE, yet doses exceeding adult doses are in use throughout Aotearoa, NZ, and Australian units. We know from this dataset that neonates are experiencing unwanted and potentially preventable, adverse effects associated with mydriatics, and every effort should be made to minimize this risk. · Thirteen different regimens are in use in Aotearoa, NZ, and Australia.. · Three regimens use doses in excess of adult doses.. · Phenylephrine 2.5% and cyclopentolate 0.5% (one standard drop of each) is the most common regimen.

Adverse drug events: description of an active search process in a teaching hospital of the Sentinela Network

Objective: To describe the implementation of an active search service for adverse drug events (ADE) in a teaching hospital in the Midwest region of Brazil. Method: Observational sectional study conducted at the Pharmacovigilance Service in a University hospital in the Midwest Region of Brazil, from March to August/2019. All patients admitted to a medical clinic unit were included and those who did not find medical records were excluded. A work process structured in six stages was elaborated: 1) elaboration of a list of triggers through literature review; 2) elaboration of a list of patients whose previously selected triggers appeared; 3) visiting the wards and reviewing medical records; 4) validation of ADE; 5) notification of ADE to Agência Nacional de Vigilância Sanitária; 6) registration of information in databases. Results: The Positive Predictive Value (PPV) of each tracker was calculated individually and globally. The relative and absolute frequency of ADE was calculated as to the type, description and the drug involved. A total of 479 searches were made in the period and the frequency of ADE was 7.48%. The global triggers PPV was 0.04. The trigger with the best performance was promethazine (1.00), followed by the Activated Partial Thromboplastin Time (0.67). Regarding the identified ADE, it was observed that most of the time, 24.14% were related to infusion reactions. It was observed that 53.85% of the drugs involved in ADE were high alert medications. Conclusion: It was observed that the implementation of an active search service for ADE in hospitals that do not have the support of an electronic medical record system is feasible to be performed. It was also observed a high frequency of ADE and that the active search guided by triggers allows to identify events that otherwise could not be identified.

Effect of bromhexine in hospitalized patients with COVID-19

BackgroundBromhexine is a potent inhibitor of transmembrane serine protease 2 and appears to have an antiviral effect in controlling influenza and parainfluenza infection; however, its efficacy in COVID-19 is controversial.MethodsA...

Non-medical switching from reference to biosimilar etanercept - no evidence for nocebo effect: a retrospective analysis of real-life data.

To evaluate the effectiveness and safety of non-medical switching from reference to biosimilar etanercept in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) using different information strategies before switching. Data of adult patients with RA, PsA or axSpA who had received reference etanercept were retrospectively analysed. Whether or not patients were informed about the switch from reference to biosimilar etanercept was left to the discretion of the treating rheumatologist. Disease activity and function were regularly assessed in two consecutive visits (week 12 and 24). The scores documented at week 12 week after the switch were defined as primary outcome. Adverse drug events (ADE) were documented. Data of 84 patients were available (44 RA, 25 axSpA and 15 PsA patients), of whom 24 had been informed about the planned switch (28.5%). The scores at week 12 of disease activity and function remained rather unchanged. Neither outcomes nor frequency of ADE were influenced by information strategy. The retention rate was high (96.4% at week 12, 87.6% at week 24). Seven patients were lost to follow-up, and six patients discontinued due to inefficacy or ADE. 18 ADEs were reported in 10 patients (12%). In 3 patients (3.6%) who had 5 ADEs in the first 12 weeks the reference etanercept was successfully readministered. Systematic switch from reference to biosimilar etanercept was not associated with changes in disease activity or function in. This was independent of information on the switch transmitted to the patients.

Comparison of dalbavancin to standard-of-care for outpatient treatment of invasive Gram-positive infections

Objective: To assess the efficacy and safety of dalbavancin compared to standard-of-care (SOC) or vancomycin and daptomycin in invasive infections due to suspected or confirmed Gram-positive organisms.Methods: Retrospective cohort of adults who received dalbavancin or SOC on discharge or as an outpatient from 12/2016 to 11/2019. Indications were osteoarticular infection (OAI), infective endocarditis (IE), or other bloodstream infection (BSI). Primary endpoint was 90-day infection-related readmission (IRR); secondary endpoints included time-to-IRR, frequency of adverse drug events (ADEs), and all-cause readmission and mortality.Results: 215 patients were included: 70 (33%) receiving dalbavancin, and 145 (67%) receiving SOC. Indications were OAI (47%), IE (27%), and other BSI (26%). OAI was more common in patients on dalbavancin compared with those receiving SOC (70% vs. 37%, P<0.001). Dalbavancin patients had shorter median (interquartile range [IQR]) length of stay (LOS) prior to drug initiation compared with those receiving SOC (10 [7-17] vs. 13 [9-19], P=0.021). IRR incidence was 17% for dalbavancin patients and 28% for SOC patients. Dalbavancin use was independently associated with lower IRR (adjusted odds ratio [adjOR], 0.10; 95% confidence interval [CI], 0.04-0.31). There was longer median (IQR) time-to-IRR in the dalbavancin group (43 [30-87] vs. 23 [11-63] days, P=0.039), but no differences in all-cause readmission or mortality. Treatment-related ADE incidence was 3% and 14% for the dalbavancin and SOC groups, respectively (P=0.013). Infusion reactions (1/2) and catheter-related complications (1/2) were the most common dalbavancin ADEs; catheter-related complications (14/21), nephrotoxicity (3/21), rhabdomyolysis (2/21), and rash (2/21) were the most common SOC ADEs.Conclusions: Dalbavancin use was associated with lower 90-day IRR, a shorter hospital LOS prior to therapy, and longer time-to-IRR compared with SOC.

Prevalence of Adverse Drug Events in Severely Obese Adults and Associated Factors: Clinical Trial Baseline Results

Drugs are the most widely used therapeutic tool for treatment of diseases. However, misuse can lead to an adverse drug event (ADE) in susceptible individuals such as those that are severely obese. This study aimed to describe the frequency of ADEs, the associations of ADEs with anatomical therapeutic chemical classes and their respective frequency, estimate the prevalence of ADEs, and analyse factors associated with ADE in adults with severe obesity. Cross-sectional analysis of baseline data from a randomized clinical trial in the central-western region of Brazil. A total of 150 individuals aged 18–65 years with a Body Mass Index of 35 kg/m2 were included. The outcome variable was the presence of ADE and the explanatory variables were socio-demographic factors, lifestyle, health, and medication use. ADEs were associated with use of drugs for the digestive tract and metabolism (p &lt; 0.001) and the cardiovascular system (p &lt; 0.001). The prevalence of ADEs was 32.67% (n = 49) and associated with the age range 40 to 49 years (p = 0.033), diabetes (p = 0.004), multimorbidities ≥ 4 (p = 0.009), self-medication (0.031), and presence of potential drug interactions (0.017). The prevalence of ADEs was high and was associated with drugs commonly used in treatment of obesity-related morbidities and self-medication. The introduction of a pharmacist to multi-professional teams can improve medication safety for severely obese patients.

In-hospital adverse drug events: analysis of trend in Portuguese public hospitals.

The objectives of this study were to analyze in-hospital adverse drug events (ADEs) in Portuguese public hospitals, and their association with mortality and the duration of hospitalization. We analyzed an administrative database containing the registration of all hospitalizations occurring in Portuguese public hospitals in 2013-2015. ADEs were identified using the codes E850-858.9 and E930-949.9 from ICD-9-CM. We identified all episodes with registration of in-hospital ADE and we compared them with a random sample of an equal number of episodes with no events recorded. A total of 3,041,443 cases were analyzed, 60,521 presented at least one ADE from which 17,213 occurred in hospital context. The most frequent drug classes associated with ADE were the antineoplastics/immunosuppressant drugs, antibiotics and steroids. Patient characteristics associated with a greater occurrence of in-hospital ADEs (all with p < 0.001) were medical admissions (OR = 1.29), the diagnosis - myeloid leukaemia (OR = 18.63), nephrotic syndrome (OR = 15.75), pneumonia (OR = 1.33) -, a higher number of secondary diagnoses (OR = 1.27), and increased duration of hospital stay (OR = 1.06). Hospitalizations with records of in-hospital ADEs presented a significantly higher mortality (9.6% vs. 4.5) and duration of hospitalization (22.6 vs. 6.4 days). ADEs were shown to be directly associated with an increase in the duration of hospital stay of 8.18 days. This study adds some interesting insights related to the most frequent drug classes and patient characteristics that can influence the frequency of ADEs in Portuguese public hospitals and also the burden of injury resulting from them.

Impact of training and structured medication review on medication appropriateness and patient-related outcomes in nursing homes: results from the interventional study InTherAKT

BackgroundUncoordinated interprofessional communication in nursing homes increases the risk of polypharmacy and inappropriate medication use. This may lead to augmented frequency of adverse drug events, hospitalizations and mortality. The aims of this study were (1) to improve interprofessional communication and medication safety using a combined intervention and thus, (2) to improve medication appropriateness and health-related outcomes of the included residents.MethodsThe single-arm interventional study (2014–2017) was conducted in Muenster, Germany and involved healthcare professionals and residents of nursing homes.The intervention consisted of systematic education of participating healthcare professionals and of a structured interprofessional medication review which was performed via an online communication platform.The primary endpoint was assessed using the Medication Appropriateness Index MAI. Secondary endpoints were: cognitive performance, delirium, agitation, mobility, number of drugs, number of severe drug-drug interactions and appropriateness of analgesics.Outcomes were measured before, during and after the intervention. Data were analyzed using descriptive and inference-statistical methods.ResultsFourteen general practitioners, 11 pharmacists, 9 nursing homes and 120 residents (n = 83 at all testing times) participated.Overall MAI sum-score decreased significantly over time (mean reduction: -7.1, CI95% -11.4 – − 2.8; median = − 3.0; dCohen = 0.39), especially in cases with baseline sum-score ≥ 24 points (mean reduction: -17.4, CI95% -27.6 – − 7.2; median = − 15.0; dCohen = 0.86).MAI sum-score of analgesics also decreased (dCohen = 0.45). Mean number of severe drug-drug interactions rose slightly over time (dCohen = 0.17). The proportion of residents showing agitated behavior diminished from 83.9 to 67.8%. Remaining secondary outcomes were without substantial change.ConclusionMedication appropriateness increased particularly in residents with high baseline MAI sum-scores. Cognitive decline of participating residents was seemingly decelerated when compared with epidemiologic studies. A controlled trial is required to confirm these effects. Interprofessional interaction was structured and performance of medication reviews was facilitated as the online communication platform provided unlimited and consistent access to all relevant and updated information.Trial registrationDRKS Data Management, ID: DRKS00007900, date of registration: 2015-09-02 (retrospectively registered i.e. 6 weeks after commencement of the first data collection).

Pill-count and the arithmetic of risk: Evidence that polypharmacy is a health status marker rather than a predictive surrogate for the risk of adverse drug events.

With advancing age there is an increase in the disease burden and thus in the number of drugs prescribed to this patient group. It is often assumed that an increase in pill count is associated per se with an increase in the number of medication errors (e.g., potentially inappropriate prescribing, PIP) and the frequency of adverse drug events (ADE). However, prescribing more drugs can also mean more successful treatment, making it important to critically assess the benefit/risk balance of the medications prescribed in each patient. Whether a prescribed medication is appropriate depends on the clinical state of the patient (diagnoses), treatment goals, comedication/drug interactions, patient preferences, whether the patient tolerates the drug, a measure of how frail the patient is, etc. It is often argued that the number of prescribed drugs should be restricted, but we hold the view that this should only be done after careful consideration of the factors mentioned above. In our study, we remodeled the findings of two large cohort studies investigating the association between the number of drugs prescribed and clinical endpoints. The graphic illustrations obtained confirmed that targeting pill count, as a measure to reduce ADEs and mortality, fails to impact patient well-being because the number of drugs prescribed is likely determined by patient characteristics affecting drug response, namely, disease burden, patient functionality, and specific patient needs, all of which must be taken into account in order to reduce the risk of PIMs and the occurrence ADEs. .

Bedaquiline: A New Hope for Shorter and Better Anti-Tuberculosis Regimens.

In 2014, an estimated 1.8 million people died from Mycobacterium tuberculosis (MTB); moreover, 680,000 people developed multidrug-resistant TB (MDRTB). Currently available anti-MDR and XDR regimens are long-lasting and expensive, need high adherence and are undermined by a high frequency of adverse drug events, thus leading to a low success rate; furthermore, in the last 50 years only two new molecules, bedaquiline (BDQ) and delamanid, have been approved and released for the treatment of MDR-TB. BDQ, patent number US 7,498,343B2, is a diarylquinoline anti-mycobacterial drug, active regardless of the state of MTB; in fact, its efficacy is conserved against replicating and non-replicating bacilli, despite extracellular or intracellular location. BDQ has been approved by the Food and Drug Administration (FDA) only for combination treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB), in adult patients, when an effective treatment cannot be provided otherwise due to resistance or poor tolerability; however, due to high bactericidal activity, BDQ may be used in future to treat extrapulmonary tuberculosis and Mycobacterium other than tuberculosis (MOTT) infection. BDQ may play a major role to get closer to TB eradication and to ensure higher retention in care, even in fully susceptible MTB strains and against non-replicating mycobacteria in latent-TB, providing an alternative to standard regimen.