Medical Legal Implications When Providing Emergency Care on a Commercial Flight.

INTRODUCTION: U.S. airlines often request a healthcare professional to volunteer to assist an ill passenger. Litigation from a Good Samaritans care of an in-flight medical emergency (IME) is considered improbable. The 1998 Aviation Medical Assistance Act (AMAA) encourages health care professionals to volunteer with indemnity for standard and good medical care. It does not offer legal or financial assistance. Our review explored the legal support malpractice companies and U.S. airlines provide if litigation is initiated for IME care. Malpractice insurance policies can differ on IME coverage. We found most private practice physicians policies include IME. Medical institutions may have policies restricting their physicians coverage to the institutions location. Those without malpractice coverage will need to retain and pay for a legal defense to demonstrate no gross negligence and no willful misconduct. The physicians, airline crews, and on-ground IME documentation support should be retained by the Good Samaritan especially for a pediatric or adolescent ill passenger. U.S. airlines consider a Good Samaritan medical volunteer as a passenger and do not extend legal assistance. This contrasts with some foreign airlines that do provide liability protection. Knowledge of the malpractice policy IME coverage is essential prior to traveling by air. After completing care for an ill passenger, physicians should generate their medical documentation and request the IME documentation generated by the airline and on-ground medical expert. We also believe U.S. airlines should assume responsibility to provide legal assistance to a Good Samaritan physician in the event of IME litigation.de Caprariis PJ, Di Maio A. Medical legal implications when providing emergency care on a commercial flight. Aerosp Med Hum Perform. 2021; 92(7):588592.

Discussing Advance Care Planning and Directives in the General Population.

The concept of end-of-life planning, along with medical and legal issues, has been discussed and has evolved over several years. The 1990 Patient Self-Determination Act and individual states' Department of Health Advance Directive forms helped overcome past problems. Patients with terminal and chronic illness are now able to have their wishes recognized for their future care. Any healthy individual's decision during an advance care planning (ACP) discussion can be adversely affected by various factors; however, multiple barriers-religion, culture, education, and family dynamics-can influence the process. Healthcare professionals' reluctance to initiate the conversation may result from limited training during medical school and residency programs. These limitations hinder both the initiation and productiveness of an ACP conversation. We explored ACP issues to provide guidance to healthcare professionals on how best to address this planning process with a healthy adult.

Advance directives and HIV: a current trend in the inner city.

Throughout the 1980's, HIV antiretroviral therapy was non-existent or insufficient, and patients admitted to hospitals were frequently terminal. In 1988 we evaluated the HIV related hospitalizations at the Lutheran Medical Center in Brooklyn, New York, and found that only 1.3 % of the patients had an advanced directive/living will. Fifty percent of the patients expired during their hospitalization. To assist health care professionals during this serious illness, medical decisions were needed from the patients and, at other times, from family members and/or significant others. Subsequently, patients were approached to discuss advance directives (AD). With the introduction of the Highly Active Antiretroviral Therapy, medical management has decreased HIV mortality. Patients may have started having different perceptions on the need for an AD. The study design was submitted to the Institutional Review Board (IRB), and the IRB granted a HIPPA waiver because this was a retrospective study which delinked the study data from any identification of the patient. The chart reviews were conducted to ascertain the existence of an AD for all patients admitted at the Lutheran Medical Center, Brooklyn, NY from 2004 to 2011. One hundred eighty-two patients were identified from their discharge codes for HIV or AIDS. The median age was 47 years (range 22-85 years). Median time since HIV diagnosis was 9.5 years (range 0-28 years). Ninety-two percent lacked an AD on admission. From the thirty patients that were older than 54 years of age, only four of them had an AD prior to admission. During hospitalization only 11 patients out of 187 enacted a new AD, which decreased the overall percentage of patients lacking an AD to 86.3 % (pre and during admission). The majority of HIV infected patients hospitalized lacked an AD. Our data did not indicate a greater predominance of ADs from a private practice or clinic setting. ADs did not increase with increasing age. Moreover, with longer years with an HIV diagnosis, the number of ADs did not increase. Our results would indicate that a different approach is necessary to adequately address ADs with this specific population, especially as their longevity increases.

Onset of symptom resolution in adults with acute bacterial rhinosinusitis treated with a single dose of azithromycin extended release compared with 10 days of levofloxacin: a retrospective analysis of a randomized, double-blind, double-dummy trial.

BACKGROUND: A previous study found that a single 2-g dose of azithromycin extended release (AZ-ER) was as efficacious as 10 days of levofloxacin (LFX) 500 mg QD in adults with acute bacterial rhinosinusitis (ABRS). The speed with which patients experience resolution of ABRS symptoms has not been reported. OBJECTIVE: The purpose of this study was to evaluate the resolution of ABRS symptoms after a single 2-g dose of AZ-ER compared with 10 days of LFX. METHODS: This was a retrospective analysis of data from a published international, randomized, double-blind, double-dummy clinical trial conducted between January 21, 2003, and February 20, 2004, that included 534 adult (age >or=18 years) outpatients with ABRS. All patients entering the study were required to have purulent nasal discharge, purulent drainage in the posterior pharynx, or purulent discharge from the maxillary sinus orifice and at least 1 of 3 other protocol-defined cardinal symptoms of ABRS (sinus pain, pressure, or tenderness) for >or=7 days. In addition, they were required to have at least 2 of the following 6 noncardinal symptoms at baseline: cough, fever, headache, nasal congestion, postnasal discharge, and leukocytosis. All patients who received medication were assessed for the occurrence of adverse events at study visits during and after therapy. At the ontreatment visit (between days 3 and 5), baseline symptoms were reassessed as resolved, improved, same, new, or worse. Resolution of symptoms was calculated as the proportion of patients with 3 or 4 cardinal symptoms either resolved (if present at baseline) or not new (if absent at baseline). Concomitant medications other than antibiotics were allowed as needed for symptomatic treatment. RESULTS: Demographic characteristics were similar at baseline between the AZ-ER and LFX treatment arms (mean age, 38.4 and 39.5 years, respectively), although more women were randomized to receive LFX (62.9%) than AZ-ER (53.3%) (P = 0.025). More than 90% of patients in both arms had >or=3 ABRS symptoms at baseline. At the on-treatment visit, resolution of >or=3 ABRS symptoms was achieved in 88 of 270 AZ-ER patients (32.6%) and 61 of 261 LFX patients (23.4%) (P = 0.018). Resolution of individual symptoms in the AZ-ER and LFX groups at 3 to 5 days was as follows: sinus pain (92/253[36.4%] and 77/251 [30.7%]; P = NS), sinus pressure (97/243 [39.9%] and 68/244 [27.9%]; P = 0.005), sinus tenderness (83/218 [38.1%] and 73/214 [34.1%]; P = NS), and nasal discharge (57/270 [21.0%] and 49/264 [18.6%]; P = NS). Treatment-related adverse events were reported by 63 of 270 AZ-ER patients (23.3%) and 41 of 268 LFX patients (15.3%). Gastrointestinal disturbances were the most common adverse events, including nausea (4.4% and 3.4%) and abdominal pain (2.6% and 0.4%).

A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media.

BACKGROUND: High dose amoxicillin is recommended for the initial treatment of children with acute otitis media (AOM), particularly patients at risk for having drug-resistant Streptococcus pneumoniae. Single dose azithromycin (30 mg/kg) is considered an alternative agent for the treatment of AOM. OBJECTIVE: To compare the clinical efficacy and safety of single dose azithromycin with that of high dose amoxicillin among children with uncomplicated AOM. METHODS: This was a double blind, double dummy, multinational, clinical trial in which children (6-30 months of age) with AOM were randomized to treatment with single dose azithromycin (30 mg/kg) or high dose amoxicillin (90 mg/kg/d, in 2 divided doses) for 10 days. Tympanocentesis was performed at baseline and clinical responses were assessed at days 12-14 (end of therapy) and at days 25-28 (end of study). RESULTS: The study enrolled 313 patients, and 83% of the patients were < or =2 years of age. A total of 158 patients in the azithromycin group and 154 in the amoxicillin group were considered clinical modified intent-to-treat patients. A middle ear pathogen was detected for 212 patients (68%). Haemophilus influenzae was the most common pathogen (isolated for 96 patients), followed by S. pneumoniae (92 patients), Moraxella catarrhalis (23 patients) and Streptococcus pyogenes (23 patients). beta-Lactamase production was observed for 17% of H. influenzae isolates and 100% of M. catarrhalis isolates. Thirty-five (38%) S. pneumoniae isolates were penicillin-nonsusceptible and 24 (26%) isolates were macrolide-resistant. At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84 and 84%, respectively) and for children < or =2 years of age (82 and 82%, respectively). At the end of therapy and end of study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (P = 0.064). Diarrhea was more common in the amoxicillin group than in the azithromycin group (17.5 and 8.2%, respectively) (P = 0.017). Compliance, defined as completion of > or =80% of the study medication, was higher in the azithromycin group (100%) than in the amoxicillin group (90%) (P = 0.001). CONCLUSIONS: In this study, single dose azithromycin was as effective as high dose amoxicillin for the treatment of children with AOM, whereas rates of adverse events were lower and compliance improved with the simplified single dose regimen.

Comparative efficacies and tolerabilities of intravenous azithromycin plus ceftriaxone and intravenous levofloxacin with step-down oral therapy for hospitalized patients with moderate to severe community-acquired pneumonia.

OBJECTIVE: To compare the efficacy and tolerability of ceftriaxone plus azithromycin with those of levofloxacin in the treatment of hospitalized patients with moderate to severe community-acquired pneumonia (CAP). DESIGN: Randomized, open-label multicenter trial with 1 : 1 treatment allocation in an inpatient setting. PATIENTS: 212 male or female inpatients with a clinical diagnosis of CAP were included in the study. In each treatment group >50% of patients had a pneumonia severity index of IV or V. INTERVENTIONS: Open-label treatment with either intravenous (IV) ceftriaxone 1g and IV azithromycin 500 mg daily or IV levofloxacin 500 mg daily. Patients who improved clinically were switched to oral follow-on therapy with either azithromycin 500 mg/day or levofloxacin 500 mg/day. At the clinician's discretion, oral cefuroxime axetil was added to the treatment regimen of patients who received oral azithromycin if a macrolide resistant pneumococcal isolate was documented. RESULTS: Overall, both study treatments were well tolerated. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 91.5% of patients treated with ceftriaxone plus azithromycin and 89.3% (95% CI -7.1%, 11.4%) of patients treated with levofloxacin at the end of therapy visit and in 89.2% and 85.1% (95% CI -6.7%, 14.8%) patients, respectively, at the end of study visit. Bacteriological eradication rates for both treatments were equivalent with the exception of Streptococcus pneumoniae; 44% of isolates were eradicated with levofloxacin compared with 100% of isolates with ceftriaxone plus azithromycin. CONCLUSIONS: As acknowledged by international CAP treatment guidelines, the combination of a third-generation cephalosporin and a macrolide is at least as efficacious as monotherapy with a fluoroquinolone with enhanced anti-pneumococcal activity, for hospitalized patients with moderate to severe CAP. Combined medication with a macrolide and third-generation cephalosporin may be preferred over fluoroquinolones as first-line therapy of hospitalized patients with CAP to minimize the development of multiresistant nosocomial Gram-negative bacilli.

The effects of once-daily saquinavir/minidose ritonavir on the pharmacokinetics of methadone.

Twelve methadone-maintained HIV-negative subjects were given saquinavir/ritonavir (SQV/rtv) 1600 mg/100 mg once daily for 14 days. Pharmacokinetic evaluations of total and unbound methadone enantiomers (R and S) were conducted before and after SQV/rtv. SQV/rtv was well tolerated, with no ACTG Grade 3-4 adverse events, no evidence of sedation, and no changes in methadone dose. For R-methadone (active isomer), C(max), AUC(0-24 h), and C(min) were unchanged, but percent unbound 4 hours after dosing was reduced by 12%. For S-methadone, no differences in pharmacokinetic parameters of total drug were seen, but unbound concentrations were reduced by 15% and 21% at 4 and 24 hours after dosing, respectively. SQV trough concentrations exceeded the anticipated EC(50) (50 ng/mL) in 10/12 subjects, persisting for at least 6 hours after the final dose in 4/6 subjects. Once-daily SQV/rtv in methadone-maintained subjects is safe and not associated with any clinically significant interaction with methadone during 14 days of concomitant administration.

High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media.

Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged < or =2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged < or =2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged < or =2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.