Clinical Impact of the Implementation Strategies Used to Apply the 2013 Pain, Agitation/Sedation, Delirium or 2018 Pain, Agitation/Sedation, Delirium, Immobility, Sleep Disruption Guideline Recommendations: A Systematic Review and Meta-Analysis.

OBJECTIVES: To summarize the effectiveness of implementation strategies for ICU execution of recommendations from the 2013 Pain, Agitation/Sedation, Delirium (PAD) or 2018 PAD, Immobility, Sleep Disruption (PADIS) guidelines. DATA SOURCES: PubMed, CINAHL, Scopus, and Web of Science were searched from January 2012 to August 2023. The protocol was registered with PROSPERO (CRD42020175268). STUDY SELECTION: Articles were included if: 1) design was randomized or cohort, 2) adult population evaluated, 3) employed recommendations from greater than or equal to two PAD/PADIS domains, and 4) evaluated greater than or equal to 1 of the following outcome(s): short-term mortality, delirium occurrence, mechanical ventilation (MV) duration, or ICU length of stay (LOS). DATA EXTRACTION: Two authors independently reviewed articles for eligibility, number of PAD/PADIS domains, quality according to National Heart, Lung, and Blood Institute assessment tools, implementation strategy use (including Assess, prevent, and manage pain; Both SAT and SBT; Choice of analgesia and sedation; Delirium: assess, prevent, and manage; Early mobility and exercise; Family engagement and empowerment [ABCDEF] bundle) by Cochrane Effective Practice and Organization of Care (EPOC) category, and clinical outcomes. Certainty of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation. DATA SYNTHESIS: Among the 25 of 243 (10.3%) full-text articles included ( n = 23,215 patients), risk of bias was high in 13 (52%). Most studies were cohort ( n = 22, 88%). A median of 5 (interquartile range [IQR] 4-7) EPOC strategies were used to implement recommendations from two (IQR 2-3) PAD/PADIS domains. Cohort and randomized studies were pooled separately. In the cohort studies, use of EPOC strategies was not associated with a change in mortality (risk ratio [RR] 1.01; 95% CI, 0.9-1.12), or delirium (RR 0.92; 95% CI, 0.82-1.03), but was associated with a reduction in MV duration (weighted mean difference [WMD] -0.84 d; 95% CI, -1.25 to -0.43) and ICU LOS (WMD -0.77 d; 95% CI, -1.51 to 0.04). For randomized studies, EPOC strategy use was associated with reduced mortality and MV duration but not delirium or ICU LOS. CONCLUSIONS: Using multiple implementation strategies to adopt PAD/PADIS guideline recommendations may reduce mortality, duration of MV, and ICU LOS. Further prospective, controlled studies are needed to identify the most effective strategies to implement PAD/PADIS recommendations.

Case presentations of medication management for patients at risk for drug-associated acute kidney injury identified with a CDS system and a novel biomarker.

PURPOSE: Traditional methods used to evaluate changes in kidney function to identify acute kidney injury (AKI) have significant limitations. Damage biomarkers can identify patients at risk for AKI prior to changes in kidney function. While clinical trials have shown that biomarker-guided treatment can improve outcomes, whether these biomarkers can influence providers' choice of treatment strategy for risk prediction, surveillance, or diagnostic evaluation in clinical practice is uncertain. SUMMARY: This case series describes 4 patients at an academic medical center whose care was informed by kidney biomarker utilization in conjunction with a clinical decision support system (CDSS). Though each patient's clinical presentation was unique, kidney biomarkers were successfully employed as clinical tools in evaluating the risks and benefits of nephrotoxic medications. CONCLUSION: This case series demonstrates 4 scenarios in which a kidney injury biomarker used in conjunction with CDSS and consideration of the patients' clinical presentation informed treatment strategies with the intent to prevent AKI.

Interventions, Barriers, and Proposed Solutions Associated With the Implementation of a Protocol That Uses Clinical Decision Support and a Stress Biomarker Test to Identify ICU Patients at High-Risk for Drug Associated Acute Kidney Injury.

BACKGROUND: Damage biomarkers are helpful in early identification of patients who are at risk of developing acute kidney injury (AKI). Investigations are ongoing to identify the optimal role of stress/damage biomarkers in clinical practice regarding AKI risk prediction, surveillance, diagnosis, and prognosis. OBJECTIVE: To determine the impact of utilizing a clinical decision support system (CDSS) to guide stress biomarker testing in intensive care unit (ICU) patients at risk for drug-induced acute kidney injury (D-AKI). METHODS: A protocol was designed utilizing a clinical decision support system (CDSS) alert to identify patients that were ordered 3 or more potentially nephrotoxic medications, suggesting risk for progressing to AKI from nephrotoxic burden. Once alerted to these high-risk patients, the pharmacist determined if action was needed by ordering a stress biomarker test, tissue inhibitor of metalloproteinase-2-insulin-like growth factor-binding protein 7 (TIMP-2•IGFBP7). If the biomarker test result was elevated, the pharmacist provided nephrotoxin stewardship recommendations to the team. Pharmacists recorded the response to the clinical decision support alert, ordering, and interpreting the TIMP-2•IGFBP7, and information regarding clinical interventions. An alert in conjunction with TIMP-2•IGFBP7 as a strategy for AKI risk prediction and stimulant for patient care management was assessed. In addition, barriers and solutions to protocol implementation were evaluated. RESULTS: There were 394 total activities recorded by pharmacists for 345 unique patients. Ninety-three (93/394; 23.6%) actionable alerts resulted in a TIMP-2•IGFBP7 test being ordered. Thirty-one TIMP-2•IGFBP7 results were >0.3 (31/81; 38.3%), suggesting a high-risk of progression to AKI, which prompted 191 pharmacist/team interventions. On average, there were 1.64 interventions per patient in the low-risk patients, 3.43 in high-risk patients, and 3.75 in the highest-risk patients. CONCLUSION AND RELEVANCE: Stress biomarkers can be used in conjunction with CDSS alerts to affect therapeutic decisions in ICU patients at high-risk for D-AKI.

Interinstitutional simulation of patients with COVID-19 during a remote acute-care advanced pharmacy practice experience.

Introduction: Faculty and staff from Duquesne University and the University of Pittsburgh Schools of Pharmacy created a simulation activity focused on the care of critically ill patients with coronavirus disease 2019 (COVID-19). Students on remote, short-term-care advanced pharmacy practice experiences (APPE) rotations from both universities worked in comingled teams and completed two educational electronic health record reviews, complex simulation sessions, and debriefs. Individually, students completed two educational electronic health record reviews and verbal patient presentations before and after the simulation sessions. Objectives: Evaluate the effects of a simulation activity during a remote short-term-care APPE on student confidence and knowledge surrounding the care of a critically ill patient with COVID-19. Methods: Student knowledge surrounding COVID-19 short-term-care treatment principles was assessed through pre-/postcase-based multiple-choice examinations and an intermittent clinical examination (ICE). Student confidence and perceptions were gathered through anonymous pre-/postsurveys. The written examination and patient presentation recordings were compared from baseline to the final assessment using the Wilcoxon signed-rank test. Results: In total, 92 students participated in the activity. There was a statistically significant improvement from baseline to the final assessment (preassessment median [interquartile range (IQR)]: 55.3% [50%-60.5%]; postassessment median [IQR]: 68.4 [60.5%-73.7%]; P < .001) on the written examination. ICE total scores improved from baseline (preassessment median [range]: 33 [28-36] vs postassessment median [range]: 36.5 [29.5-43.52]; P = .004) as well as the objective (P < .001), plan (P < .001), and monitoring (P < .001) subdomain scores. Student confidence reported on surveys improved from baseline in all domains. Conclusion: Remote simulation sessions improve student knowledge and confidence and provide an opportunity for students to experience caring for patients with COVID-19 in a safe environment. Collaboration between schools of pharmacy can be successfully employed to leverage resources and expertise to expand opportunities for students.

Choosing Wisely For Critical Care: The Next Five.

OBJECTIVES: To formulate new "Choosing Wisely" for Critical Care recommendations that identify best practices to avoid waste and promote value while providing critical care. DATA SOURCES: Semistructured narrative literature review and quantitative survey assessments. STUDY SELECTION: English language publications that examined critical care practices in relation to reducing cost or waste. DATA EXTRACTION: Practices assessed to add no value to critical care were grouped by category. Taskforce assessment, modified Delphi consensus building, and quantitative survey analysis identified eight novel recommendations to avoid wasteful critical care practices. These were submitted to the Society of Critical Care Medicine membership for evaluation and ranking. DATA SYNTHESIS: Results from the quantitative Society of Critical Care Medicine membership survey identified the top scoring five of eight recommendations. These five highest ranked recommendations established Society of Critical Care Medicine's Next Five "Choosing" Wisely for Critical Care practices. CONCLUSIONS: Five new recommendations to reduce waste and enhance value in the practice of critical care address invasive devices, proactive liberation from mechanical ventilation, antibiotic stewardship, early mobilization, and providing goal-concordant care. These recommendations supplement the initial critical care recommendations from the "Choosing Wisely" campaign.

Pharmacy Personnel's Involvement in Transitions of Care of Intensive Care Unit Patients: A Systematic Review.

OBJECTIVE: Do pharmacy personnel- (ie, pharmacist or pharmacy technician) driven interventions at transitions of care into or out of the intensive care unit (ICU) improve medication safety measures compared to interventions made by other health-care team members or no intervention? DATA SOURCES: A literature search of MEDLINE and Embase limited to English language and humans was performed (from 1969 until January 2019). Bibliographies of included investigations were reviewed for additional citations. METHODS: Investigations were selected if they described a pharmacy-driven intervention at any point of transfer into or out of an ICU setting. Ten investigations were included. Five described interventions relevant to the entire ICU population, and 5 described interventions targeted to specific medications or disease. RESULTS: A variety of interventions were utilized in the 10 included investigations. A significant improvement was demonstrated with pharmacy-driven intervention in all 4 studies that evaluated the entire ICU patient population. Interventions specific to certain medication and disease improved medication safety measures but were not always statistically significant. Medication error rates are high in patients transferred into and out of the ICU, and limited data exist to address this concern. This review compares and evaluates the current literature to guide future interventions and research in this area. CONCLUSIONS: Although pharmacy-driven interventions demonstrated some benefit in various medication safety measures in the majority of studies, additional randomized and prospective trials with patient-centered outcomes that assess morbidity and mortality are needed.

Dexmedetomidine for Facilitating Mechanical Ventilation Extubation in Difficult-to-Wean ICU Patients: Systematic Review and Meta-Analysis of Clinical Trials.

BACKGROUND: Agitation and delirium are common in mechanically ventilated adult intensive care unit (ICU) patients and may contribute to delayed extubation times. Difficult-to-wean ICU patients have been associated with an increased risk of longer ICU length of stays and mortality. The purpose of this systematic review and meta-analysis is to evaluate the evidence of dexmedetomidine facilitating successful mechanical ventilation extubation in difficult-to-wean ICU patients and clinical outcomes. METHODS: A literature search was conducted using MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Global Health, Cochrane Central Register of Controlled Trials, Clinical Trial Registries, and the Health Technology Assessment Database from inception to December 5, 2019. Randomized controlled trials evaluating dexmedetomidine with the intended purpose to facilitate mechanical ventilation liberation in adult ICU patients (≥18 years) experiencing extubation failure were included. The primary outcome of time to extubation was evaluated using the weighted mean difference (WMD), with a random effects model. Secondary analyses included hospital and ICU length of stay, in-hospital mortality, hypotension, and bradycardia. RESULTS: A total of 6 trials (n = 306 patients) were included. Dexmedetomidine significantly reduced the time to extubation (WMD: -11.61 hours, 95% CI: -16.5 to -6.7, P = .005) and ICU length of stay (WMD: -3.04 days; 95% CI: -4.66 to -1.43). Hypotension risk was increased with dexmedetomidine (risk ratio [RR]: 1.62, 95% CI: 1.05-2.51), but there was no difference in bradycardia risk (RR: 3.98, 95% CI: 0.70-22.78). No differences were observed in mortality rates (RR: 1.30, 95% CI: 0.45-3.75) or hospital length of stay (WMD: -2.67 days; 95% CI: -7.73 to 2.39). CONCLUSIONS: Dexmedetomidine was associated with a significant reduction in the time to extubation and shorter ICU stay in difficult-to-wean ICU patients. Although hypotension risk was increased with dexmedetomidine, no differences in other clinical outcomes were observed.

Benefits of Patient/Caregiver Engagement in Adverse Drug Reaction Reporting Compared With Other Sources of Reporting in the Inpatient Setting: A Systematic Review.

OBJECTIVES: Clinicians learn from prior adverse events through pharmacovigilance allowing for improved medication safety in the medication use process; therefore, adverse drug reaction (ADR) reporting needs to be maximized. This systematic review was conducted to determine whether engaging patients/caregivers in ADR reporting during a patient's hospitalization provides further information about ADRs not obtained from traditional sources of reporting (i.e., voluntary reporting, medical record review). METHODS: This review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A literature search was conducted from January 2018 to June 2019 in PubMed, CINAHL, and Embase. Studies were included if they were (i) conducted in the inpatient setting, (ii) surveyed patients/caregivers, (iii) compared patient/caregiver reporting with another source of reporting, and (iv) evaluated ADRs. Studies completed in an outpatient setting or nursing home were excluded. RESULTS: A total of 11 studies were included. Sources of ADR information from patient/caregiver were obtained through interviews, surveys, questionnaires, or open-ended responses. Patient reporting was compared with medical record reports (7 articles) and health care professional reporting (4 articles). Approximately 11% to 35% of ADRs reported from patients were not identified through voluntary reporting by health care professionals, and 5.6% to 66% of ADRs obtained from patient reporting were not provided in the medical record. CONCLUSIONS: Patients/caregivers are important sources of safety information to improve system and practice of medication use that may not be recorded by other surveillance methods. Administrators and clinicians need to determine the best approach to integrate patients/caregivers into routine reporting for optimal engagement.

A Quality Improvement Evaluation of a Primary As-Needed Light Sedation Protocol in Mechanically Ventilated Adults.

OBJECTIVES: First, to implement successfully a light-sedation protocol, favoring initial as-needed (prioritizing as-needed) boluses over continuous infusion sedation, and second, to evaluate if this protocol was associated with differences in patient-level sedative requirements, clinical outcomes, and unit-level longitudinal changes in pharmacy charges for sedative medications. DESIGN: Retrospective review comparing patients who received the prioritizing as-needed sedation protocol to similar patients eligible for the prioritizing as-needed protocol but treated initially with continuous infusion sedation. SETTING: Thirty-two bed medical ICUs in a large academic medical center. PATIENTS: A total of 254 mechanical ventilated patients with a target Riker Sedation-Agitation Scale goal of 3 or 4 were evaluated over a 2-year period. Of the evaluable patients, 114 received the prioritizing as-needed sedation protocol and 140 received a primary continuous infusion approach. INTERVENTIONS: A multidisciplinary leadership team created and implemented a light-sedation protocol, focusing on avoiding initiation of continuous sedative infusions and prioritizing prioritizing as-needed sedation. MEASUREMENTS AND MAIN RESULTS: Overall, 42% of patients in the prioritizing as-needed group never received continuous infusion sedation. Compared with the continuous infusion sedation group, patients treated with the prioritizing as-needed protocol received significantly less opioid, propofol, and benzodiazepine. Patients in the prioritizing as-needed group experienced less delirium, shorter duration of mechanical ventilation, and shorter ICU length of stay. Adverse events were similar between the two groups. At the unit level, protocol implementation was associated with reductions in the use of continuous infusion sedative medications. CONCLUSIONS: Implementation and use of a prioritizing as-needed protocol targeting light sedation appear to be safe and effective. These single-ICU retrospective findings require wider, prospective validation.

Use of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7 [TIMP2]•[IGFBP7] as an AKI risk screening tool to manage patients in the real-world setting.

PURPOSE: To determine the application of various components of the Kidney Disease Improving Global Outcomes (KDIGO) bundle in managing patients at high-risk for AKI progression ([TIMP2]•[IGFBP7] >0.3) in the real-world setting. METHODS: Patients with a [TIMP2]•[IGFBP7] test ordered between 5/23/16-2/28/18 were evaluated. We reviewed the medical record for evidence of implementation of the KDIGO bundle in response to biomarker test results. Evidence including explicit documentation in physicians' note discussing [TIMP2]•[IGFBP7] results and implicit evidence from review of dose adjusted medications, discontinued nephrotoxins and therapeutic drug monitoring. RESULTS: 105 [TIMP2]•[IGFBP7] tests were conducted in 100 patients (54% female; mean age 55.4 ± 16.8; 89% in the ICU). Sixty-one patients had a value of >0.3 and 46 (75.4%) of these patients received at least one management strategy consistent with KDIGO. By contrast, nine patients (23.1%) with [TIMP2]•[IGFBP7] ≤0.3 received one or more components of the KDIGO bundle (p < .001). CONCLUSION: In a real-world setting the use of urinary [TIMP2]•[IGFBP7] as an AKI risk screening tool resulted in differential application of various components of the KDIGO bundle for patient management for those with a positive test result.

Pharmacologic Management of Delirium in the ICU: A Review of the Literature.

PURPOSE: Conflicting data exists on the pharmacologic management of intensive care unit (ICU) delirium. This review appraises the current evidence of pharmacologic management of ICU delirium. MATERIALS AND METHODS: A systematic literature search of MEDLINE and Embase was conducted to answer the population, intervention, comparison, and outcome (PICO) question of: "Does the use of a pharmacologic agent compared to standard of care or placebo improve ICU delirium in a critically ill patient population?" RESULTS: After application of the PICO question and the inclusion and exclusion criteria, 13 articles were included. Of these articles, 7 were prospective randomized controlled trials, 1 was a prospective nonrandomized controlled trial, and 5 were retrospective investigations. The included articles differed in the agents evaluated, primary outcome, and method of identifying delirium. CONCLUSION: The variability of outcomes illustrates the need for a large-scale investigation to further evaluate the role of pharmacologic management of ICU delirium.

Sufentanil Sublingual Tablet: A New Option for Acute Pain Management.

Objective: The purpose of this article is to review the safety and efficacy of sufentanil sublingual tablet (SST) and suggest its place in therapy for managing acute pain in patients requiring intravenous (IV) opioids. Data Sources: A MEDLINE/PubMed search was performed (2010 to April 2019) using the following keywords: sufentanil sublingual tablet, sufentanil, opioid, moderate to severe acute pain. Study Selection and Data Extraction Quantification: We included English language articles evaluating SST pharmacology, pharmacokinetics, efficacy, and safety in humans for the treatment of acute pain. Data Synthesis: SST is Food and Drug Administration approved and considered safe and effective for the treatment of acute pain in Risk Evaluation and Mitigation Strategy-certified and medically supervised health care settings. Phase III clinical trials showed a statistically significant decrease in summed pain intensity score when SST was compared with placebo. Relevance to Patient Care and Clinical Practice: SST can be a useful option in patients requiring a parenteral opioid who do not have IV access, or it may be unnecessary or difficult to obtain. Because of its quick onset and sustained analgesia, SST may also be useful for procedural pain in the critically ill, to expedite discharges for outpatient procedures, in emergency departments (EDs), and in the battlefield. Conclusions: SST can satisfy an unmet need in patients with acute pain, who require parenteral opioids, and either have no IV access or require prolonged time to achieve IV access such as patients in outpatient surgical centers, EDs, and the battlefield. During periods of parenteral opioid shortage, SST may provide another option for adequate analgesia.

Evaluation of Potential Drug-Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis.

INTRODUCTION: There is an increased risk of potential drug-drug interactions (pDDIs) in critically ill patients based on the number of drugs received. The occurrence of pDDIs and clinical significance is not well described. OBJECTIVE: The aim was to provide insight into important clinical issues and offer guidance on drug-drug interaction (DDI) surveillance through the performance of a systematic review. METHODS: Five targeted objectives were developed, a priori, which guided study selection and data abstraction. Two independent reviewers extracted the definition, frequency, type, and clinical significance of pDDIs. A meta-analysis was performed to evaluate the proportion of patients exposed to a pDDI. Three data sources (PubMed, Embase, and Scopus) were utilized for the search to include studies that evaluated pDDIs in adult critically ill patients. Included studies in the systematic review and meta-analysis were required to be full text. RESULTS: A total of 39 studies met inclusion criteria. Definitions of pDDIs were diverse. Frequency of pDDIs varied by study, but was most commonly between one and five pDDIs per patient. Fifty-eight percent of patients were exposed to at least one pDDI during their intensive care unit admission. Types of pDDIs identified were numerous, with aspirin being the most common drug involved. As expected, not all pDDIs were clinically significant. Clinical significance was determined by varied definitions and sources. CONCLUSIONS: Improving the understanding of clinically significant pDDIs and alerts that clinicians encounter may guide better development of surveillance through clinical decision support and decrease alert fatigue.

Pharmacologic Considerations Surrounding Sedation, Delirium, and Sleep in Critically Ill Adults: A Narrative Review.

INTRODUCTION: Agitation, delirium, and sleep dysfunction in the intensive care unit (ICU) are common occurrences that result in negative patient outcomes. With the recent publication of the 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PAD-IS), several areas are of particular interest due to emerging literature or conflicting results of research. OBJECTIVE: To highlight areas where emerging literature or variable study results exist and to provide the clinician with recommendations regarding patient management. METHODS: The 2018 PAD-IS guidelines were reviewed, and areas of emerging literature or lack of consensus of included investigations surrounding pharmacologic management of sedation, delirium, and sleep in the ICU were identified. A review and appraisal of the literature was conducted specifically to address the identified areas. Prospective, randomized trials were included in this narrative review. RESULTS: Four areas with emerging data or conflicting evidence were identified and included: use of propofol or dexmedetomidine for sedation, pharmacologic prevention of delirium, treatment of delirium, and pharmacologic strategies to improve sleep. CONCLUSION: A comprehensive approach to the prevention and management of delirium, sedation, and sleep in the ICU is necessary to optimize patient outcomes.

Catecholamine Vasopressor Support Sparing Strategies in Vasodilatory Shock.

Shock syndromes are associated with unacceptably high rates of mortality in critically ill patients despite advances in therapeutic options. Vasodilatory shock is the most common type encountered in the intensive care unit. It is manifested by cardiovascular failure, peripheral vasodilatation, and arterial hypotension leading to tissue hypoperfusion and organ failure. Hemodynamic support is typically initiated with fluid resuscitation strategies and administration of adrenergic vasopressor agents in nonresponsive patients to restore arterial pressure with subsequent adequate organ reperfusion. Unfortunately, high catecholamine dosing requirements may be necessary to achieve targeted hemodynamic goals that may increase the risk of vasopressor-induced adverse events. The purpose of this article is to review the clinical efficacy and safety data and potential role in therapy for catecholamine-sparing agents in vasodilatory shock. Adjunctive therapeutic options to reduce vasoactive support requirements without compromising arterial pressure include arginine vasopressin and analogs, corticosteroids, midodrine, methylene blue, and angiotensin II. Although concomitant vasopressin and corticosteroids have a more defined role in evidence-based guidelines for managing shock, clinicians may consider other potential catecholamine-sparing agents.

Evaluation of medical marijuana topics in the PharmD curriculum: A national survey of schools and colleges of pharmacy.

INTRODUCTION: To summarize the status of medical marijuana instruction in the PharmD curriculum and capture future plans for the incorporation of medical marijuana content. METHODS: One hundred and forty United States schools and colleges of pharmacy were contacted to complete an anonymous survey regarding inclusion of medical marijuana topics in their curriculum, future plans for inclusion, and evaluation of perceived importance of specific topics. RESULTS: Forty nine percent (68/140) of schools and colleges completed the survey and 62% (44/68) include medical marijuana content in their curriculum. Of the schools and colleges that do not include it, 23% (6/26) plan to incorporate medical marijuana topics within the next 12 months. In regards to perceived importance of specific topics related to medical marijuana, all topics received a median score of three on a scale of one to five, with one being of high importance. CONCLUSION: With more states legalizing medical marijuana, schools and colleges of pharmacy need to evaluate inclusion of medical marijuana topics in their curriculum to prepare student pharmacists to effectively care for patients using this product.

Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults.

OBJECTIVE: Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting System in three subpopulations of older adults (ages 55-64, 65-74, 75+) receiving psychotropic medications. METHODS: Almost 12 years of ADR reports were compiled for adults over 55 years of age receiving psychotropic medications with known side effect profiles. A comparison of the frequency of ADRs reported, odds ratios (ORs), and 95% confidence intervals (CIs) between subpopulations to the whole population of patients aged 55+ was conducted. RESULTS: ADRs reported in three subpopulations of older adults differed significantly when receiving the same psychotropic medications. For example, reports of increased blood glucose (OR, 1.8, CI, 1.4-2.2) were all significantly increased in the youngest population (55-64). CONCLUSION: Current classification of age greater than 65 years when evaluating likely ADRs in older adults using psychotropic medications may be inadequate and require further assessment by subpopulations of older adults.

Predictors of resistant alcohol withdrawal (RAW): A retrospective case-control study.

BACKGROUND: Benzodiazepine-resistant alcohol withdrawal (RAW), defined by a requirement of ≥ 40 mg of diazepam in 1 h, represents a severe form of withdrawal without predictive parameters. This study was designed to identify risk factors associated with RAW versus withdrawal without benzodiazepine resistance (nRAW). METHODS: A retrospective cohort of adults with severe alcohol withdrawal were screened. Demographic and clinical variables, collected through chart review, underwent logistic regression to select the subset that predicst RAW. RESULTS: 736 patients (515 nRAW, 221 RAW) were analyzed. RAW patients were younger (P < 0.001), male (P = 0.008) Caucasians (P = 0.037) with histories of psychiatric illness (P < 0.001), higher serum ethanol concentrations (P < 0.007), and abnormal liver enzymes (P = 0.01). RAW patients had significantly lower platelets (P < 0.001), chloride (P = 0.02), and potassium (P = 0.01) levels; severity of illness (SAPSII) (P < 0.001) and comorbidity scores (P < 0.001). Caucasian race and male gender were found to be 3.6 and 2.6 times more likely to be RAW. For every 1-unit increase in comorbidity and severity of illness scores, patients were 22% [OR(95% CI) 0.78 (0.66-0.90)] and 4% [0.96 (0.93-0.98)] less likely to be RAW. Patients with a psychiatric history or thrombocytopenia were 2 times more likely [2.02 (1.24-3.30); 2.13 (1.31-3.50), respectively] to be RAW. CONCLUSION: These data demonstrate the predictive ability of a history of psychiatric illness, thrombocytopenia, gender, race, baseline severity of illness and comorbidity scores for developing RAW. Considering these characteristics in early withdrawal management may prevent progression to RAW outcomes.