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Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

ABSTRACT: OBJECTIVES:New specialty drugs such as biologics are now available in record numbers, presenting increased safety risks for people with immune-mediated diseases. However, comprehensive assessments of patient safety for these drugs are lacking. We examined performance on key patient safety measures, such as screening for latent tuberculosis (LTBI), hepatitis B virus (HBV), and hepatitis C virus (HCV), for new users of a broad group of specialty medications. METHODS:Data were extracted via electronic health record data warehouses of a large university health system using structured queries, and extensive chart review was performed to confirm measure elements. We included all new users of immunosuppressive specialty drugs between 2013 and 2017. We assessed screening for LTBI, HBV, and HCV from 12?months before through 60?days after medication initiation, and calculated performance on a composite measure that required screening for all three infections. Multivariable logistic regression was used to assess differences in screening across specialties, adjusting for patient race, sex, age, and comorbidities. RESULTS:Among 2027 patients, the most common drugs prescribed were adalimumab (32%), etanercept (24%), infliximab (19%), and ustekinumab (9%). Overall, 62% of patients were screened for LTBI, 42% for HBV, and 33% for HCV. Only 26% of patients were screened appropriately for all three infections. Screening patterns differed significantly according to treating specialty. CONCLUSIONS:We found gaps in ambulatory safety for patients treated with immunosuppressive specialty drugs for diverse inflammatory conditions across all relevant treating specialties. More robust safety protocols are urgently needed to prevent serious patient safety events in this high-risk population.

SUBMITTER: Patterson S

PROVIDER: S-EPMC7433663 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

Patterson Sarah S Schmajuk Gabriela G Evans Michael M Aggarwal Ishita I Izadi Zara Z Gianfrancesco Milena M Yazdany Jinoos J

Joint Commission journal on quality and patient safety 20190125 5

<h4>Objectives</h4>New specialty drugs such as biologics are now available in record numbers, presenting increased safety risks for people with immune-mediated diseases. However, comprehensive assessments of patient safety for these drugs are lacking. We examined performance on key patient safety measures, such as screening for latent tuberculosis (LTBI), hepatitis B virus (HBV), and hepatitis C virus (HCV), for new users of a broad group of specialty medications.<h4>Methods</h4>Data were extrac ...[more]

PMID: 30686706

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Project description:ImportanceThe coronavirus disease 2019 (COVID-19) pandemic has required a shift in health care delivery platforms, necessitating a new reliance on telemedicine.ObjectiveTo evaluate whether inequities are present in telemedicine use and video visit use for telemedicine visits during the COVID-19 pandemic.Design, setting, and participantsIn this cohort study, a retrospective medical record review was conducted from March 16 to May 11, 2020, of all patients scheduled for telemedicine visits in primary care and specialty ambulatory clinics at a large academic health system. Age, race/ethnicity, sex, language, median household income, and insurance type were all identified from the electronic medical record.Main outcomes and measuresA successfully completed telemedicine visit and video (vs telephone) visit for a telemedicine encounter. Multivariable models were used to assess the association between sociodemographic factors, including sex, race/ethnicity, socioeconomic status, and language, and the use of telemedicine visits, as well as video use specifically.ResultsA total of 148 402 unique patients (86 055 women [58.0%]; mean [SD] age, 56.5 [17.7] years) had scheduled telemedicine visits during the study period; 80 780 patients (54.4%) completed visits. Of 78 539 patients with completed visits in which visit modality was specified, 35 824 (45.6%) were conducted via video, whereas 24 025 (56.9%) had a telephone visit. In multivariable models, older age (adjusted odds ratio [aOR], 0.85 [95% CI, 0.83-0.88] for those aged 55-64 years; aOR, 0.75 [95% CI, 0.72-0.78] for those aged 65-74 years; aOR, 0.67 [95% CI, 0.64-0.70] for those aged ≥75 years), Asian race (aOR, 0.69 [95% CI, 0.66-0.73]), non-English language as the patient's preferred language (aOR, 0.84 [95% CI, 0.78-0.90]), and Medicaid insurance (aOR, 0.93 [95% CI, 0.89-0.97]) were independently associated with fewer completed telemedicine visits. Older age (aOR, 0.79 [95% CI, 0.76-0.82] for those aged 55-64 years; aOR, 0.78 [95% CI, 0.74-0.83] for those aged 65-74 years; aOR, 0.49 [95% CI, 0.46-0.53] for those aged ≥75 years), female sex (aOR, 0.92 [95% CI, 0.90-0.95]), Black race (aOR, 0.65 [95% CI, 0.62-0.68]), Latinx ethnicity (aOR, 0.90 [95% CI, 0.83-0.97]), and lower household income (aOR, 0.57 [95% CI, 0.54-0.60] for income <$50 000; aOR, 0.89 [95% CI, 0.85-0.92], for $50 000-$100 000) were associated with less video use for telemedicine visits. These results were similar across medical specialties.Conclusions and relevanceIn this cohort study of patients scheduled for primary care and medical specialty ambulatory telemedicine visits at a large academic health system during the early phase of the COVID-19 pandemic, older patients, Asian patients, and non-English-speaking patients had lower rates of telemedicine use, while older patients, female patients, Black, Latinx, and poorer patients had less video use. Inequities in accessing telemedicine care are present, which warrant further attention.

Project description:ObjectiveRoutine measurement of patient safety from the patients' perspective receives increasing attention as an important component of safety measurement systems. The aim of this study was to examine patients' experience with patient safety in ambulatory care and the results' implications for routine patient safety measurement in ambulatory care.DesignCross-sectional mixed-mode survey.SettingGeneral practitioner and specialist practices.ParticipantsPatients aged >18 years seeking care in ambulatory care practices between February and June 2020.MethodsA 22-item-questionnaire was completed in the practice or at home either on paper or online. Multivariate logistic regression was used to analyse the influence of survey mode and patient characteristics on patient experience with patient safety.ResultsThe overall response rate was 71.1%. Most patients completed the questionnaire on site (76.6%) and on paper (96.1%). Between 30.1% to 68.5% of the respondents report the most positive option for patient experience with the main domains of patient safety. A total of 2.9% of patients reported having experienced a patient-safety event (PSE) during the last 12 months. Patients who filled in the questionnaire off site were more likely to report negative experiences for the scales communication & information (OR 1.2, 95% CI 1.0-1.5), rapport & participation (OR 1.4, 95% CI 1.1-1.7) and access (OR 1.3, 95% CI 0.9-1.4) than those who completed it on site. Those who chose a paper questionnaire were more likely to report negative experiences for all five scales compared to web responders.ConclusionRoutine measurement of patient experience with factors contributing to the occurrence of PSEs can achieve high response rates by offering flexible participation options. Results gained from mixed-mode surveys need to take mode-effects into account when interpreting and using the results. Further research is needed in how to adequately assess number and type of experienced events in routine measurements.

Project description:Background: In the counseling process, a multi-cultural competence of dispenser is among the key factors affecting his/her successful communication with patients for achieving optimal use of medications. For patients to use dispensed drugs appropriately, it is a must for them to understand the medication related information provided by the dispenser. Hence, the objective of this study was to identify parameters that likely affect ambulatory patients' knowledge of medication(s) provided at the exit of outpatient pharmacy of Federal Harar Police Hospital, Eastern Ethiopia. Methods: Cross-sectional study design was employed to conduct this study. An interview of patients was made at the exit of hospital pharmacy using a semi-structured questionnaire. The interview tool primarily assessed the knowledge of the patients for a maximum of three medications provided. Statistical Package for Social Sciences (SPSS), Version 20.0, was employed for analysis of the data. Chi-squared test was done to retain parameters with potential to have association; and the retained parameters were adjusted by performing bivariate and multivariate logistic regression analyses. Results: The result showed that only 37.2, 33.4 and 28.7% of the patients were able to recall the name of the drug(s), common side effects, and actions to be taken for missed doses, respectively. The likelihood of patients' knowledge for dispensed medications was high among patients aged 19-39 years (adjusted odds ratio [AOR]: 5.0; 95% CI: 1.04-24.2) and who thought their communication with dispenser had been polite (AOR: 4.62; 95% CI: 1.48-14.4). However, the knowledge status was found low among patients who were Afan Oromo speakers (AOR: 0.58; 95% CI: 0.35-0.95) and who came from rural residence (AOR: 0.48; 95% CI: 0.25-0.90). Conclusion: A high proportion of patients were unable to recall the drug (s) name, associated common toxicities, and actions to be taken in case of missed dose. In addition, patients who were at early adulthood and who were positive for the politeness of dispenser had better exit-knowledge of their medication. Therefore, for the patients' clear understanding of medications provided, it is mandatory to optimize patient-dispenser communication possibly by adapting multi-cultural communication skills and by providing focused training for dispensers to address factors that likely affect patient-dispenser interactions.

Project description:Rationale: Immunosuppression was associated with adverse events for patients with idiopathic pulmonary fibrosis (IPF) in the PANTHER-IPF (Evaluating the Effectiveness of Prednisone, Azathioprine and N-Acetylcysteine in Patients with IPF) clinical trial. The reason why some patients with IPF experience harm is unknown.Objectives: To determine whether age-adjusted leukocyte telomere length (LTL) was associated with the harmful effect of immunosuppression in patients with IPF.Methods: LTL was measured from available DNA samples from PANTHER-IPF (interim analysis, n = 79; final analysis, n = 118). Replication cohorts included ACE-IPF (Anticoagulant Effectiveness in Idiopathic Pulmonary Fibrosis) (n = 101) and an independent observational cohort (University of Texas Southwestern Medical Center-IPF, n = 170). LTL-stratified and medication-stratified survival analyses were performed using multivariable Cox regression models for composite endpoint-free survival.Measurements and Main Results: Of the subjects enrolled in the PANTHER-IPF and ACE-IPF, 62% (49/79) and 56% (28/50) had an LTL less than the 10th percentile of normal, respectively. In PANTHER-IPF, exposure to prednisone/azathioprine/N-acetylcysteine was associated with a higher composite endpoint of death, lung transplantation, hospitalization, or FVC decline for those with an LTL less than the 10th percentile (hazard ratio, 2.84; 95% confidence interval, 1.02-7.87; P = 0.045). This finding was replicated in the placebo arm of ACE-IPF for those exposed to immunosuppression (hazard ratio, 7.18; 95% confidence interval, 1.52-33.84; P = 0.013). A propensity-matched University of Texas Southwestern Medical Center IPF cohort showed a similar association between immunosuppression and composite endpoints (death, lung transplantation, or FVC decline) for those with an LTL less than the 10th percentile (hazard ratio, 3.79; 95% confidence interval, 1.73-8.30; P = 0.00085). An interaction was found between immunosuppression and LTL for the combined PANTHER-IPF and ACE-IPF clinical trials (Pinteraction = 0.048), and the University of Texas Southwestern Medical Center IPF cohort (Pinteraction = 0.00049).Conclusions: LTL is a biomarker that may identify patients with IPF at risk for poor outcomes when exposed to immunosuppression.

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Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

Publications

Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

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