Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 16 de 16
Filter
1.
JAMA Health Forum ; 5(6.9): e241939, 2024 Jun 30.
Article in English | MEDLINE | ID: mdl-38944763

ABSTRACT

Importance: In the US, the COVID-19 pandemic led to a significant rise in unemployment and economic loss that disproportionately impacted low-income individuals. It is unknown how health care and prescription medication affordability changed among low-income adults during the COVID-19 pandemic overall and compared with their higher-income counterparts. Objective: To evaluate changes in health care affordability and prescription medication affordability during the COVID-19 pandemic (2021 and 2022) compared with pre-COVID-19 pandemic levels (2019) and whether income-based inequities changed. Design, Setting, and Participants: This retrospective cross-sectional study included adults 18 years and older participating in the National Health Interview Survey (NHIS) in 2019, 2021, and 2022. Low-income adults were defined as having a household income of 200% or less of the federal poverty level (FPL); middle-income adults, 201% to 400% of the FPL; and high-income adults, more than 400% of the FPL. Data were analyzed from June to November 2023. Main Outcomes and Measures: Measures of health care affordability and prescription medication affordability. Results: The study population included 89 130 US adults. Among the weighted population, 51.6% (95% CI, 51.2-52.0) were female, and the mean (SD) age was 48.0 (0.12) years. Compared with prepandemic levels, during the COVID-19 pandemic, low-income adults were less likely to delay medical care (2022: 11.2%; 95% CI, 10.3-12.1; 2019: 15.4%; 95% CI, 14.3-16.4; adjusted relative risk [aRR], 0.73; 95% CI, 0.66-0.81) or avoid care (2022: 10.7%; 95% CI, 9.7-11.6; 2019: 14.9%; 95% CI, 13.8-15.9; aRR, 0.72; 95% CI, 0.64-0.80) due to cost, while high-income adults experienced no change, resulting in a significant improvement in income-based disparities. Low-income and high-income adults were less likely to experience problems paying medical bills but experienced no change in worrying about medical bills during the COVID-19 pandemic compared with prepandemic levels. Across measures of prescription medication affordability, low-income adults were less likely to delay medications (2022: 9.4%; 95% CI, 8.4-10.4; 2019: 12.7%; 95% CI, 11.6-13.9; aRR, 0.74; 95% CI, 0.65-0.84), not fill medications (2022: 8.9%; 95% CI, 8.1-9.8; 2019: 12.0%; 95% CI, 11.1-12.9; aRR, 0.75; 95% CI, 0.66-0.83), skip medications (2022: 6.7%; 95% CI, 5.9-7.6; 2019: 10.1%; 95% CI, 9.1-11.1; aRR, 0.67; 95% CI, 0.57-0.77), or take less medications (2022: 7.3%; 95% CI, 6.4-8.1; 2019: 11.2%; 95% CI, 10.%-12.2; aRR, 0.65; 95% CI, 0.56-0.74) due to costs, and these patterns were largely similar among high-income adults. Improvements in measures of health care and prescription medication affordability persisted even after accounting for changes in health insurance coverage and health care use. These patterns were similar when comparing measures of affordability in 2021 with 2019. Conclusions and Relevance: Health care affordability improved for low-income adults during the COVID-19 pandemic, resulting in a narrowing of income-based disparities, while prescription medication affordability improved for all income groups. These findings suggest that the recent unwinding of COVID-19 pandemic-related safety-net policies may worsen health care affordability and widen existing income-based inequities.


Subject(s)
COVID-19 , Poverty , Prescription Drugs , Humans , COVID-19/epidemiology , Cross-Sectional Studies , United States/epidemiology , Male , Female , Middle Aged , Retrospective Studies , Adult , Prescription Drugs/economics , Prescription Drugs/therapeutic use , Income , Aged , Health Services Accessibility/economics , Health Services Accessibility/statistics & numerical data , Health Services Accessibility/trends , Young Adult , Adolescent , Pandemics
2.
POCUS J ; 8(2): 175-183, 2023.
Article in English | MEDLINE | ID: mdl-38099168

ABSTRACT

Background: Chest imaging, including chest X-ray (CXR) and computed tomography (CT), can be a helpful adjunct to nucleic acid test (NAT) in the diagnosis and management of Coronavirus Disease 2019 (COVID-19). Lung point of care ultrasound (POCUS), particularly with handheld devices, is an imaging alternative that is rapid, highly portable, and more accessible in low-resource settings. A standardized POCUS scanning protocol has been proposed to assess the severity of COVID-19 pneumonia, but it has not been sufficiently validated to assess diagnostic accuracy for COVID-19 pneumonia. Purpose: To assess the diagnostic performance of a standardized lung POCUS protocol using a handheld POCUS device to detect patients with either a positive NAT or a COVID-19-typical pattern on CT scan. Methods: Adult inpatients with confirmed or suspected COVID-19 and a recent CT were recruited from April to July 2020. Twelve lung zones were scanned with a handheld POCUS machine. Images were reviewed independently by blinded experts and scored according to the proposed protocol. Patients were divided into low, intermediate, and high suspicion based on their POCUS score. Results: Of 79 subjects, 26.6% had a positive NAT and 31.6% had a typical CT pattern. The receiver operator curve for POCUS had an area under the curve (AUC) of 0.787 for positive NAT and 0.820 for a typical CT. Using a two-point cutoff system, POCUS had a sensitivity of 0.90 and 1.00 compared to NAT and typical CT pattern, respectively, at the lower cutoff; it had a specificity of 0.90 and 0.89 compared to NAT and typical CT pattern at the higher cutoff, respectively. Conclusions: The proposed lung POCUS protocol with a handheld device showed reasonable diagnostic performance to detect inpatients with a positive NAT or typical CT pattern for COVID-19. Particularly in low-resource settings, POCUS with handheld devices may serve as a helpful adjunct for persons under investigation for COVID-19 pneumonia.

3.
Circ Cardiovasc Qual Outcomes ; 16(12): e010516, 2023 12.
Article in English | MEDLINE | ID: mdl-37929572

ABSTRACT

BACKGROUND: Low-income working-age US adults disproportionately experienced health care disruptions at the onset of the coronavirus disease 2019 pandemic. Little is known about how health care access and cardiovascular risk factor management changed as the pandemic went on or if patterns differed by state Medicaid expansion status. METHODS: Cross-sectional data from the behavioral risk factor surveillance system were used to compare self-reported measures of health care access and cardiovascular risk factor management among US adults aged 18 to 64 years in 2021 (pandemic) to 2019 (prepandemic) using multivariable Poisson regression models. We assessed differential changes between low-income (<138% federal poverty level) and high-income (>400% federal poverty level) working-age adults by including an interaction term for income group and year. We then evaluated changes among low-income adults in Medicaid expansion versus nonexpansion states using a similar approach. RESULTS: The unweighted study population included 80 767 low-income and 184 136 high-income adults. Low-income adults experienced improvements in insurance coverage (relative risk [RR], 1.10 [95% CI, 1.08-1.12]), access to a provider (RR, 1.12 [95% CI, 1.09-1.14]), and ability to afford care (RR, 1.07 [95% CI, 1.05-1.09]) in 2021 compared with 2019. While these measures also improved for high-income adults, gains in coverage and ability to afford care were more pronounced among low-income adults. However, routine visits (RR, 0.96 [95% CI, 0.94-0.98]) and cholesterol testing (RR, 0.93 [95% CI, 0.91-0.96]) decreased for low-income adults, while diabetes screening (RR, 1.01 [95% CI, 0.95-1.08]) remained stable. Treatment for hypertension (RR, 1.05 [95% CI, 1.02-1.08]) increased, and diabetes-focused visits and insulin use remained stable. These patterns were similar for high-income adults. Across most outcomes, there were no differential changes between low-income adults residing in Medicaid expansion versus nonexpansion states. CONCLUSIONS: In this national study of working-age adults in the United States, measures of health care access improved for low- and high-income adults in 2021. However, routine outpatient visits and cardiovascular risk factor screening did not return to prepandemic levels, while risk factor treatment remained stable. As many coronavirus disease-era safety net policies come to an end, targeted strategies are needed to protect health care access and improve cardiovascular risk factor screening for working-age adults.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus , Adult , Humans , United States/epidemiology , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Patient Protection and Affordable Care Act , Pandemics , Cross-Sectional Studies , Risk Factors , Medicaid , Health Services Accessibility , Insurance Coverage , Heart Disease Risk Factors
4.
J Thorac Cardiovasc Surg ; 166(2): 457-464.e1, 2023 Aug.
Article in English | MEDLINE | ID: mdl-34872761

ABSTRACT

OBJECTIVES: Drug use-associated infective endocarditis is a rapidly growing clinical problem. Although operative outcomes are generally satisfactory, reinfection secondary to recurrent substance use is distressingly common, negatively affects long-term survival, generates practical and ethical challenges, and creates potential conflict among care team members. We established a Drug Use Endocarditis Treatment team including surgeons, infectious disease, and addiction medicine experts specifically focused on the unique complexities of drug use-associated infective endocarditis. METHODS: We reviewed the impact of Drug Use Endocarditis Treatment team involvement on quantitative measures of quality of care, including length of stay, time to addiction medicine consultation, time to surgery, and discharge on appropriate medications for opioid use disorder, as well as operative mortality. Standard statistical tests were used, including the Fisher exact test, t test, and Wilcoxon rank-sum test. Qualitative assessment was made of the impact on clinicians, including communication and mutual understanding. RESULTS: Comparing the pre-Drug Use Endocarditis Treatment cohort with the post-Drug Use Endocarditis Treatment cohort, patients in the post-Drug Use Endocarditis Treatment cohort who underwent surgery had a significantly lower time from admission to addiction medicine consultation (3.8 vs 1.0 days P < .001) and clinically relevant increase in discharge on medications for opioid use disorder (48% vs 67% P = .35). Additionally, involved members of the team thought communication was improved. CONCLUSIONS: The Drug Use Endocarditis Treatment team improved engagement with addiction medicine consultation and appropriate discharge care. Given the impact of relapse of injection drug use on long-term outcomes, interventions such as this offer potentially powerful tools for the treatment of this complex patient population.


Subject(s)
Endocarditis, Bacterial , Endocarditis , Substance-Related Disorders , Humans , Neoplasm Recurrence, Local , Endocarditis, Bacterial/diagnosis , Endocarditis, Bacterial/surgery , Endocarditis/diagnosis , Endocarditis/surgery , Substance-Related Disorders/complications , Patient Care Team
5.
Open Forum Infect Dis ; 9(3): ofac047, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35252467

ABSTRACT

BACKGROUND: Consensus guidelines recommend multidisciplinary models to manage infective endocarditis, yet often do not address the unique challenges of treating people with drug use-associated infective endocarditis (DUA-IE). Our center is among the first to convene a Drug Use Endocarditis Treatment (DUET) team composed of specialists from Infectious Disease, Cardiothoracic Surgery, Cardiology, and Addiction Medicine. METHODS: The objective of this study was to describe the demographics, infectious characteristics, and clinical outcomes of the first cohort of patients cared for by the DUET team. This was a retrospective chart review of patients referred to the DUET team between August 2018 and May 2020 with DUA-IE. RESULTS: Fifty-seven patients were presented to the DUET team between August 2018 and May 2020. The cohort was young, with a median age of 35, and injected primarily opioids (82.5% heroin/fentanyl), cocaine (52.6%), and methamphetamine (15.8%). Overall, 14 individuals (24.6%) received cardiac surgery, and the remainder (75.4%) were managed with antimicrobial therapy alone. Nearly 65% of individuals were discharged on medication for opioid use disorder, though less than half (36.8%) were discharged with naloxone and only 1 patient was initiated on HIV pre-exposure prophylaxis. Overall, the cohort had a high rate of readmission (42.1%) within 90 days of discharge. CONCLUSIONS: Multidisciplinary care models such as the DUET team can help integrate nuanced decision-making from numerous subspecialties. They can also increase the uptake of addiction medicine and harm reduction tools, but further efforts are needed to integrate harm reduction strategies and improve follow-up in future iterations of the DUET team model.

6.
R Soc Open Sci ; 8(9): 210699, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34527275

ABSTRACT

Dynamic models are used to assess the impact of three types of face masks (cloth masks, surgical/procedure masks and respirators) in controlling the COVID-19 pandemic in the USA. We showed that the pandemic would have failed to establish in the USA if a nationwide mask mandate, based on using respirators with moderately high compliance, had been implemented during the first two months of the pandemic. The other mask types would fail to prevent the pandemic from becoming established. When mask usage compliance is low to moderate, respirators are far more effective in reducing disease burden. Using data from the third wave, we showed that the epidemic could be eliminated in the USA if at least 40% of the population consistently wore respirators in public. Surgical masks can also lead to elimination, but requires compliance of at least 55%. Daily COVID-19 mortality could be eliminated in the USA by June or July 2021 if 95% of the population opted for either respirators or surgical masks from the beginning of the third wave. We showed that the prospect of effective control or elimination of the pandemic using mask-based strategy is greatly enhanced if combined with other non-pharmaceutical interventions (NPIs) that significantly reduce the baseline community transmission. By slightly modifying the model to include the effect of a vaccine against COVID-19 and waning vaccine-derived and natural immunity, this study shows that the waning of such immunity could trigger multiple new waves of the pandemic in the USA. The number, severity and duration of the projected waves depend on the quality of mask type used and the level of increase in the baseline levels of other NPIs used in the community during the onset of the third wave of the pandemic in the USA. Specifically, no severe fourth or subsequent wave of the pandemic will be recorded in the USA if surgical masks or respirators are used, particularly if the mask use strategy is combined with an increase in the baseline levels of other NPIs. This study further emphasizes the role of human behaviour towards masking on COVID-19 burden, and highlights the urgent need to maintain a healthy stockpile of highly effective respiratory protection, particularly respirators, to be made available to the general public in times of future outbreaks or pandemics of respiratory diseases that inflict severe public health and socio-economic burden on the population.

7.
J Card Surg ; 36(7): 2300-2307, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33797800

ABSTRACT

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (ECPR) has emerged as a rescue strategy for nonresponders to conventional CPR (CCPR) in cardiac arrest. Definitive guidelines for ECPR deployment do not exist. Prior studies suggest that arrest rhythm and cardiac origin of arrest may be variables used to assess candidacy for ECPR. AIM: To describe a single-center experience with ECPR and to assess associations between survival and physician-adjudicated origin of arrest and arrest rhythm. METHODS: A retrospective review of all patients who underwent ECPR at a quaternary care center over a 7-year period was performed. Demographic and clinical characteristics were extracted from the medical record and used to adjudicate the origin of cardiac arrest, etiology, rhythm, survival, and outcomes. Univariate analysis was performed to determine the association of patient and arrest characteristics with survival. RESULTS: Between 2010 and 2017, 47 cardiac arrest patients were initiated on extracorporeal membrane oxygenation (ECMO) at the time of active CPR. ECPR patient survival to hospital discharge was 25.5% (n = 12). Twenty-six patients died on ECMO (55.3%) while nine patients (19.1%) survived decannulation but died before discharge. Neither physician-adjudicated arrest rhythm nor underlying origin were significantly associated with survival to discharge, either alone or in combination. Younger age was significantly associated with survival. Nearly all survivors experienced myocardial recovery and left the hospital with a good neurological status. CONCLUSIONS: Arrest rhythm and etiology may be insufficient predictors of survival in ECPR utilization. Further multiinstitutional studies are needed to determine evidenced-based criteria for ECPR deployment.


Subject(s)
Cardiopulmonary Resuscitation , Extracorporeal Membrane Oxygenation , Heart Arrest , Heart Arrest/therapy , Humans , Retrospective Studies , Survival Rate
11.
JAMA Intern Med ; 175(2): 218-26, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25506771

ABSTRACT

IMPORTANCE: Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers. OBJECTIVE: To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers. DESIGN, SETTING, AND PARTICIPANTS: This prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n = 399; control group, n = 308). INTERVENTIONS: We analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system. MAIN OUTCOMES AND MEASURES: Self-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff. RESULTS: The intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P < .001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P < .001). CONCLUSIONS AND RELEVANCE: Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01156610.


Subject(s)
Poverty , Primary Health Care , Smoking Cessation/statistics & numerical data , Adult , Aged , Aged, 80 and over , Community-Institutional Relations , Female , Humans , Male , Middle Aged , Prospective Studies , Smoking Cessation/methods , Young Adult
12.
J Gen Intern Med ; 30(6): 719-23, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25527336

ABSTRACT

BACKGROUND: Collection of data on race, ethnicity, and language preference is required as part of the "meaningful use" of electronic health records (EHRs). These data serve as a foundation for interventions to reduce health disparities. OBJECTIVE: Our aim was to compare the accuracy of EHR-recorded data on race, ethnicity, and language preference to that reported directly by patients. DESIGN/SUBJECTS/MAIN MEASURES: Data collected as part of a tobacco cessation intervention for minority and low-income smokers across a network of 13 primary care clinics (n = 569). KEY RESULTS: Patients were more likely to self-report Hispanic ethnicity (19.6 % vs. 16.6 %, p < 0.001) and African American race (27.0 % vs. 20.4 %, p < 0.001) than was reported in the EHR. Conversely, patients were less likely to complete the survey in Spanish than the language preference noted in the EHR suggested (5.1 % vs. 6.3 %, p < 0.001). Thirty percent of whites self-reported identification with at least one other racial or ethnic group, as did 37.0 % of Hispanics, and 41.0 % of African Americans. Over one-third of EHR-documented Spanish speakers elected to take the survey in English. One-fifth of individuals who took the survey in Spanish were recorded in the EHR as English-speaking. CONCLUSION: We demonstrate important inaccuracies and the need for better processes to document race/ ethnicity and language preference in EHRs.


Subject(s)
Documentation/standards , Electronic Health Records/standards , Ethnicity/statistics & numerical data , Language , Racial Groups/statistics & numerical data , Smoking Cessation/ethnology , Adult , Aged , Female , Health Status Disparities , Humans , Male , Middle Aged , Self Report , Young Adult
13.
Prev Chronic Dis ; 10: E84, 2013 May 23.
Article in English | MEDLINE | ID: mdl-23701721

ABSTRACT

INTRODUCTION: Practice-Based Research Networks (PBRNs) and health systems may provide timely, reliable data to guide the development and distribution of public health resources to promote healthy behaviors, such as quitting smoking. The objective of this study was to determine if PBRN data could be used to make neighborhood-level estimates of smoking prevalence. METHODS: We estimated the smoking prevalence in 32 greater Boston neighborhoods (population = 877,943 adults) by using the electronic health record data of adults who in 2009 visited one of 26 Partners Primary Care PBRN practices (n = 77,529). We compared PBRN-derived estimates to population-based estimates derived from 1999-2009 Behavioral Risk Factor Surveillance System (BRFSS) data (n = 20,475). RESULTS: The PBRN estimates of neighborhood smoking status ranged from 5% to 22% and averaged 11%. The 2009 neighborhood-level smoking prevalence estimates derived from the BRFSS ranged from 5% to 26% and averaged 13%. The difference in smoking prevalence between the PBRN and the BRFSS averaged -2 percentage points (standard deviation, 3 percentage points). CONCLUSION: Health behavior data collected during routine clinical care by PBRNs and health systems could supplement or be an alternative to using traditional sources of public health data.


Subject(s)
Smoking/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Behavioral Risk Factor Surveillance System , Boston/epidemiology , Female , Health Services Research , Humans , Male , Middle Aged , Prevalence , Residence Characteristics/statistics & numerical data , Young Adult
14.
J Gen Intern Med ; 28(12): 1558-64, 2013 Dec.
Article in English | MEDLINE | ID: mdl-23588670

ABSTRACT

BACKGROUND: There is growing interest in developing systems to overcome barriers for acquiring and interpreting family health histories in primary care. OBJECTIVE: To examine the capacity of three different electronic portals to collect family history from patients and deposit valid data in an electronic health record (EHR). DESIGN: Pilot trial. PARTICIPANTS, INTERVENTION: Patients were enrolled from four primary care practices and were asked to collect family health history before a physical exam using either telephone-based interactive voice response (IVR) technology, a secure Internet portal, or a waiting room laptop computer, with portal assigned by practice. Intervention practices were compared to a "usual care" practice, where there was no standard workflow to document family history (663 participants in the three intervention arms were compared to 296 participants from the control practice). MAIN MEASURES: New documentation of any family history in a coded EHR field within 30 days of the visit. Secondary outcomes included participation rates and validity. KEY RESULTS: Demographics varied by clinic. Documentation of new family history data was significantly higher, but modest, in each of the three intervention clinics (7.5 % for IVR clinic, 20.3 % for laptop clinic, and 23.1 % for patient portal clinic) versus the control clinic (1.7 %). Patient-entered data on common conditions in first degree relatives was confirmed as valid by a genetic counselor for the majority of cases (ranging from 64 to 82 % in the different arms). CONCLUSIONS: Within primary care practices, valid patient entered family health history data can be obtained electronically at higher rates than a standard of care that depends on provider-entered data. Further research is needed to determine how best to match different portals to individual patient preference, how the tools can best be integrated with provider workflow, and to assess how they impact the use of screening and prevention.


Subject(s)
Electronic Health Records/standards , Family Health/standards , Health Records, Personal , Patient Participation , Primary Health Care/standards , Electronic Health Records/trends , Family Health/trends , Female , Humans , Longitudinal Studies , Male , Middle Aged , Patient Participation/trends , Pilot Projects , Primary Health Care/trends , Reproducibility of Results
15.
Am J Manag Care ; 18(11): e423-8, 2012 11 01.
Article in English | MEDLINE | ID: mdl-23198749

ABSTRACT

OBJECTIVES: While active surveillance for adverse drug events using electronic medical records (EMRs) and claims data is expanding, these data do not fully capture patient experiences with medication-related symptoms. Our objective was to describe adherence and outcomes associated with an automated pharmacovigilance call. STUDY DESIGN/METHODS: Prospective cohort of patients receiving a prescription for a target medication at a participating primary care clinic were eligible for an automated phone pharmacovigilance call. Outcomes, compared for participants who completed (n = 1184) versus did not complete the call (n = 407), included EMR documentation during the 6 months following the call that the patient had: stopped the medication, used acute care services or died, or received a specialty or primary care visit. RESULTS: Compared with those who agreed to participate but did not complete the pharmacovigilance call, subjects who completed the call had greater rates of EMR-documented medication cessation (3.9% vs 1.0%, adjusted P value = .007), and use of primary or specialty care (32.8% vs 18.7%, P value <.0001), but similar use of acute care services or death (12.2% vs 9.8%, P = .38). Of participants, 50.2% reported >1 symptom; of these, 22.0% thought the symptom was medication-related. In contrast to the low rates of EMR-documented medication cessation, 21.2% of participants said that they were no longer taking the medication; 69% said that their doctor did not know that they had stopped. CONCLUSIONS: Automated phone pharmacovigilance provides important information about adherence, and was associated with greater EMR-documented medication cessation and planned service use.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Pharmacovigilance , Telephone , Electronic Health Records , Female , Humans , Male , Medication Adherence , Middle Aged , Prospective Studies
16.
Drug Saf ; 35(8): 623-8, 2012 Aug 01.
Article in English | MEDLINE | ID: mdl-22764754

ABSTRACT

BACKGROUND: While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. OBJECTIVE: The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. METHODS: English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. MAIN OUTCOME MEASURES: The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. RESULTS: Compared with the package insert, patients taking zolpidem were significantly (p < 0.001) more likely to report fatigue (9.0% vs 1.0%), itching (4.5% vs 1.0%) and muscle aches (5.6% vs 1.0%). Elicited rates of depression and hallucination were similar to those reported in the package insert. Patients taking varenicline were significantly more likely to report confusion (1.7% vs 0.1%), depression (3.4% vs 0.1%), fatigue (6.0% vs 1.0%), hallucinations (1.7% vs 0.1%), muscle aches (6.0% vs 1.0%) and sexual dysfunction (4.3% vs 0.1%). CONCLUSIONS: Automated phone pharmacovigilance can provide estimates of possible ADEs in clinical practice. In the case of varenicline, these data support some of the safety concerns that have come to light postmarketing, while others such as depression and hallucination related to zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.


Subject(s)
Adverse Drug Reaction Reporting Systems , Benzazepines/adverse effects , Hypnotics and Sedatives/adverse effects , Nicotinic Agonists/adverse effects , Product Labeling , Pyridines/adverse effects , Quinoxalines/adverse effects , Telephone , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Patients/psychology , Pharmacovigilance , Primary Health Care , Varenicline , Young Adult , Zolpidem
SELECTION OF CITATIONS
SEARCH DETAIL
...