Self-reported Adverse Drug Events Research Articles

Effectiveness of Jena DM® Herbal Formulation as Complementary Therapy to Conventional Oral Hypoglycemic Agents in Type-2 Diabetes Mellitus: A Quasi-experimental Study.

There is vast preclinical evidence that indicates that extracts from several Artemisia plant species have significant antidiabetic benefits. However, clinical evidence is limited to this effect. We sought to evaluate the effectiveness ofJena DM® (anArtemisia annua-based poly-herbal formulation) on glycemic control (Hb A1C) and insulin metabolism (HOMA), when administered as a complementary therapy in type-2 diabetes mellitus (T2DM). This study was supported by a research grant (JRD005) from Jena Herbals (U) Ltd, which is a local herbal medicines manufacturing facility in Uganda. We conducted a 12-week quasi-experimental study, involving 118 patients under routine follow-up at a diabetes and endocrinology clinic. Random assignment to either conventional or experimental study groups was done using a random number generator (Microsoft Excel version 16.0). Participant sociodemographic and clinical data as well as whole blood samples (3-5 mL) were obtained at scheduled clinic visits. Medication adherence was assessed using the Hill-Bone Scale, and adverse drug events (ADEs) using the Naranjo causality and the National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) scales. Group differences in glycemic control (HbA1C), fasting serum insulin (FSI) indices (% HOMA2-B, HOMA-IR), and other cardiometabolic parameters were assessed using independent samples t-test, and Pearson chi-square statistical tests were used. A p-value <0.05 was considered statistically significant. Ethical approvals were obtained before the study commencement. 12-week daily complementary therapy withJena DM® showed no significant effect on Hb A1C reduction (0.1 (95% CI: -0.56, 0.80) %;p=0.798); however, we observed a significant reduction in total body weight (2.0 (95% CI: 0.73, 3.28) kg;p=0.002). The overall frequency of self-reported ADEs including dizziness was significantly higher among patients that usedJena DM® (p=0.001).Epigastric pain was the most severe ADE necessitating clinical management. There was no significant difference in the homeostatic model assessment for insulin resistance (HOMA2-IR) between study groups. In contrast to a few studies that previously showed significanthypoglycemic effects ofArtemisia-basedextracts, this study did not show a statistically significant reduction on HbA1C during a 12-week complementary use ofJena DM® in patients withT2DM. Based on the findings of this study, future research should evaluate the long-term effects ofJena DM® on body weight, overall insulin metabolism, and the subsequent effect on glycemic control in T2DM.

A population-based study of self-reported adverse drug events among Lebanese outpatients

There is a limited number of studies assessing the epidemiology of Adverse Drug Events (ADEs) in the outpatient setting, especially those that do not result in healthcare use. The primary objective of this study was to assess the prevalence and determinants of self-reported ADEs among Lebanese outpatients. It was a cross-sectional observational study performed among Lebanese outpatients visiting community pharmacies across Lebanon. A questionnaire was designed to elicit patients’ relevant information. The association between categorical variables were evaluated using Pearson χ2 test or Fisher's exact test. Binary logistic regression was performed to identify factors that affect the experience of self-reported ADEs. The study comprised 3148 patients. Around 37% of patients reported experiencing an ADE in the previous year. When ADEs occur, 70.5% of the respondents reported informing their physicians. Increasing number of medications per patient, use of injectable medication, and inquiring about potential drug-drug interactions were associated with higher experience of ADEs (p = 0.049; p = 0.003; and p = 0.009 respectively). Patients who received hospital discharge counseling reported experiencing less ADEs (p = 0.002). Our study showed prevalence of ADEs among Lebanese outpatients especially patients with polypharmacy, and highlighted the need to educate patients about the importance of reporting ADEs to their physicians.

Disability and self-reported adverse drug events among patients with chronic diseases

Very few studies have examined the association between self-reported adverse drug events (ADEs) and the presence of disability in patients with chronic diseases. The purpose of this study was to investigate the relationship between disability and self-reported ADEs in a population with chronic diseases in the community setting in Korea. Data were obtained from the Korean Health Panel from 2014 to 2016, from which 5382 adults aged ≥ 30 years who received any drug to treat a chronic disease were selected. The dependent variable was defined as a self-reported ADE related to a chronic-disease drug. Disability was measured by self-reported vision problems, hearing problems, cognitive impairment, chewing problems, and activity limitation. The data were analyzed using panel logistic regression. In 2016, 5.07% of participants self-reported an ADE related to a chronic-disease drug. The likelihood of a patient self-reporting an ADE depended on various sociodemographic factors, health status including disabilities, and polypharmacy. Specific risk factors for ADEs included age, vision problems, chewing problems, activity limitations, and polypharmacy. Subgroup analyses showed that the risk factors of hypertension, diabetes, and hyperlipidemia had slightly different effects on self-reporting of ADEs. Disabilities, such as vision problems, chewing problems, and activity limitation, were significantly related to self-reported ADEs in chronic-disease patients in the community setting.

Medication Therapy Management and Complex Patients With Disability

Drug therapy problems, adverse drug events (ADEs), and symptom burden are high among adults with disabilities. To compare the effects of a modified medication therapy management (MTM) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations. Three-group randomized controlled trial among adults (age 40 and older) with self-reported activity limitations in community practice. 8 weekly Living Well With a Disability (LWD) 2-hour workshop sessions with and without a collaborative medication management (CMM) module. mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms. Process measures: changes in medication regimens and self-reported ADEs. general linear mixed models (continuous outcomes) and generalized estimating equations (categorical outcomes). Participants had high symptom burden, low physical health, and took many medications. There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups (Study group × Time P = .014), and there were significantly more changes in medication regimens in the LWD + CMM group (P = .013 LWD only vs LWD + CMM). The oldest third of participants had significantly fewer mean symptoms but received more intense CMM. There was no difference between the LWD-only, LWD + CMM, and usual care groups in symptom burden over time. Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations.

Prevalence and Perceived Preventability of Self-Reported Adverse Drug Events – A Population-Based Survey of 7099 Adults

PurposeAdverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs).MethodsIn this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18–44, 45–64, or ≥65 years) were compared.ResultsOf 7099 respondents (response rate 51.0%), ADEs were reported by 19.4% (95% confidence interval, 18.5–20.3%), and the prevalence did not differ by age group (p>0.05). The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2–8.4%), 7.6% (7.0–8.2%) and 8.1% (7.5–8.7%), respectively. The prevalence of self-reported drug dependence was 2.2% (1.9–2.6%), and drug intoxications 0.2% (0.1–0.3%). The respondents considered 19.2% (14.8–23.6%) of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar.ConclusionsOne-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs from widely used drugs across care settings supports redesigning a safer healthcare system to adequately tackle the problem.

Cost of illness of patient-reported adverse drug events: a population-based cross-sectional survey

ObjectivesTo estimate the cost of illness (COI) of individuals with self-reported adverse drug events (ADEs) from a societal perspective and to compare these estimates with the COI for individuals without...

Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients: A cross-sectional survey

Background Identifying patients with heart failure (HF) who are at risk of experiencing symptomatic adverse drug events (ADEs) is important for improving patient care and quality of life. Several demographic and clinical variables have been identified as potential risk factors for ADEs but limited knowledge is available on the impact of HF patients’ beliefs and perceptions on their experience of ADEs. Objective The purpose of the study was to identify the relationship between HF patients’ illness perception and medication beliefs and self-reported ADEs. Design A cross-sectional survey was performed between November 2008 and March 2009. Settings One university medical centre, two regional hospitals and 20 general practitioners in the Netherlands participated in the study. Participants 495 patients with HF were included. Methods Patients completed the validated Revised Illness Perception Questionnaire (IPQ-R) and the Beliefs about Medication Questionnaire (BMQ) which collected data on their illness perception and medication beliefs. In addition, data on ADEs as experienced in the previous four weeks were collected through an open-ended question and a symptom checklist. Multivariate logistic regression was performed to identify factors associated with these ADEs. Results In total, 332 (67%) patients had experienced ADEs in the previous four weeks, of whom 28% reported dry mouth, 27% dizziness and 19% itchiness as the most prevalent. In the adjusted multivariate analysis, disease-related symptoms (illness identity) (OR for 1–5 symptoms 3.57; 95% CI 2.22–5.75, OR for >5 symptoms 7.37; 95% CI 3.44–15.8), and general beliefs about medication overuse (OR 1.07; 95% CI 1.01–1.13) were independently associated with experiencing ADEs, whereas none of the demographic or clinical factors were significant. Conclusions HF patients who perceive a high number of disease symptoms and have negative medication beliefs are at higher risk of experiencing self-reported ADEs. We suggest that future studies and interventions to improve ADE management should focus on negative medication beliefs and assisting patients in differentiating disease symptoms from ADEs.

Association of adverse drug reactions with drug–drug and drug–disease interactions in frail older outpatients

SIR—The most common type of medication-related adverse events in older adults is Type A (‘augmented’) adverse drug reactions (ADRs) [1–3]. Type A reactions are an exaggeration of the expected pharmacologic effect of a drug. These ADRs are more predictable, dose dependent and potentially preventable than Type B (‘bizarre’) ADRs (i.e. allergic reactions) [3, 4]. The relationship of different elements of suboptimal prescribing to ADRs in older outpatients has not been adequately explored. Recently, Chrischilles et al. [5] examined the association between multiple aspects of potentially inappropriate prescribing (defined by explicit criteria for drugs-to-avoid, drug–disease interactions, drug–drug interactions and therapeutic duplication) with self-reported adverse drug events (ADEs). A recent study used a modified weighting system for the medication appropriateness index (MAI), a validated measure that employs a standardised implicit approach to determining prescribing appropriateness, to examine the association of potentially inappropriate prescribing with self-reported ADEs [6, 7]. Neither of the above studies, however, had a specific focus on Type A ADRs. Given this background, the objective of this study was to determine whether incorrect dosage, incorrect directions, drug–drug interactions and drug–disease interactions, as measured by the MAI, are associated with the Type A ADRs among frail older veterans transitioning from the hospital to the community.

Concerns and beliefs about medicines and inappropriate medications: An internet-based survey on risk factors for self-reported adverse drug events among older adults

Background: Adverse drug events (ADEs), which can be especially problematic in older adults, often can be prevented by detecting potential risk factors. Sociopsychological factors such as concerns and beliefs about medicines (patients' anxieties about the harmful effects of prescribed medications) may also be risk factors related to self-reported ADEs, even when considering clinical variables such as receiving an inappropriate medication. Objectives: This study was designed to quantify the use of inappropriate medications among older adult outpatients and to determine whether an association exists between the use of inappropriate medications, concerns and beliefs about medicines, and self-reported ADEs. Methods: This cross-sectional, Internet-based survey of Medicare beneficiaries was conducted in 2007. Harris Interactive®, a New York-based marketing research firm, invited participants from their online panel who were ≥65 years of age, residents of the United States, and enrolled in the Medicare health plan to participate in the survey. The updated Beers criteria and a modified version of the Assessing Care of Vulnerable Elders quality indicators were used to determine the appropriateness of medications. Respondents' concerns about their medicines were assessed using items from a validated scale such as “Having to take medicines worries me” and “I sometimes worry about the long-term effects of my medicines.” To establish self-reported ADEs, respondents were asked, “Did you see a doctor about any side effects, unwanted reactions, or other problems from medicines you were taking in the past year?” Results: Of the 1024 panelists who responded to the survey, 874 provided all of the information required for analysis. The respondents who were included in the analyses ranged in age from 65 to 94 years; 56.6% were female, 94.4% were white, and 20.3% self-reported an ADE. The frequency of patients receiving either an inappropriate medication or a medication that failed a quality indicator was 45.8%. Stronger concerns and beliefs about medicines (odds ratio [OR] = 1.57; 95% CI, 1.02–2.39; P = 0.04) and having more symptoms (OR = 2.26; 95% CI, 1.22–4.22; P = 0.01) were significantly related to self-reporting of ADEs, whereas receiving an inappropriate medication (OR = 1.03; 95% CI, 0.65–1.64) and the number of medications received (OR = 1.28; 95% CI, 0.52–3.13) were not. Conclusions: Stronger concerns and beliefs about medicines and having more symptoms were significantly related to self-reporting of ADEs. Receiving an inappropriate medication and the number of medicines received were not significantly related.

What Types of Inappropriate Prescribing Predict Adverse Drug Reactions in Older Adults?

Adverse drug events happen all too often in older adults, but we still do not have a clear understanding of potentially modifiable risk factors, with the exception of polypharmacy. This paper critiques the article in this issue of The Annals entitled, "Inappropriate Prescribing Predicts Adverse Drug Events in Older Adults." A validated measure for self-reported adverse drug events was used, along with a modified measure for inappropriate prescribing that we developed nearly 2 decades ago (ie, Medication Appropriateness Index). Besides discussing the strengths and weaknesses of this article, we also recommend future research directions in this area.

Risk factors of self-reported adverse drug events among Medicare enrollees before and after Medicare Part D.

Quantify risk factors for self-reported adverse drug events (ADEs) after the implementation of Medicare Part D, quantify self-reported ADEs before and after Medicare Part D and quantify the association between self-reported ADEs and increased use of prescription medication. The design was a longitudinal study including an internet survey before Medicare Part D in 2005 (n=1220) and a follow-up survey in 2007 (n=1024), with n=436 responding to both surveys. Harris Interactive® invited individuals in their online panel to participate in this study. Individuals who were 65 or older, English speakers, US residents and enrolled in Medicare were included. Data collected and used in analysis included self-reported ADE, socio-demographics, self-rated health, number of medications, symptoms experienced, concern and necessity beliefs about medicines, number of pharmacies, and whether doses were skipped or stopped to save money. In 2007, reporting an ADE was related to concern beliefs, symptoms experienced and age. ADEs were experienced by 18% of respondents in 2005 and 20.4% in 2007. The average number of medications increased from 3.82 (SD=2.82) in 2005 to 4.32 (SD=3.20) in 2007 (t= -5.77, p<0.001). Among respondents who answered both surveys (n=436), 18.4% reported an ADE in 2005 while 24.3% reported an ADE in 2007. The increase in self-reported ADE was related to concern beliefs (OR=1.12, 95%CI=1.05, 1.19) and symptoms experienced (OR= 3.27, 95%CI=1.60, 6.69), not number of medications (OR=1.04, 95%CI=0.77, 1.41). Discussing elderly patients' beliefs about their medicines may affect their medication expectations, symptom interpretation and attributions and future medication attributions.

Risk Factors for Self-Reported Adverse Drug Events Among Medicare Enrollees

Adverse drug events (ADEs) occur in older adults. ADEs occur in up to 6.5% of all hospitalized patients and outpatients, and about 28% of these events are preventable. The proportion of outpatients with an ADE ranges from 5% to 35%, depending on the exact definition used. There is a critical need to examine the risk factors associated with having an ADE to increase awareness about medication safety among older adults. To quantify the association between risk factors such as the number of pharmacies used by patients and their concern and necessity beliefs about medicines, and self-reported ADEs. A cross-sectional Internet survey was administered by Harris Interactive. Harris Interactive asked individuals from their online panel who were 65 years of age or older, US residents, and enrolled in Medicare to complete the survey. A convenience sample of 1220 anonymous surveys was obtained. Multiple logistic regression analysis was performed. The dependent variable was self-reported ADEs, defined as the patient's visiting a physician to report an unwanted reaction or medicine problem in the past year. Independent variables included sociodemographics, self-rated health, number of medications, sum of symptoms experienced, concern and necessity beliefs about medicines, number of pharmacies, and whether subjects skipped doses of their medications to save money or stopped taking the drugs due to cost. Eighteen percent of respondents reported an ADE. ADEs were related to being female (OR 1.56; 95% CI 1.05 to 2.33), number of pharmacies (OR 3.40; 95% CI 1.56 to 7.41), number of symptoms experienced (OR 3.39; 95% CI 1.87 to 6.14), concern beliefs about medicines (OR 1.14; 95% CI 1.08 to 1.20), and having a graduate academic degree (OR 2.17; 95% CI 1.41 to 3.36). The number of pharmacies, concern beliefs about medicines, and number of symptoms experienced in the past month were associated with self-reported ADEs. Discussing patients' beliefs about their drug therapy with them is likely to affect their expectations and interpretation of symptoms, as well as future attributions regarding drug therapy.

Is the number of prescribing physicians an independent risk factor for adverse drug events in an elderly outpatient population?

Background: Studies indicate that adverse drug events (ADEs) are common and costly. It appears that the elderly are at greater risk of ADEs because they use more medications, have less specific presentations, and have more chronic conditions than younger populations. Objective: The goal of this study was to determine if the number of physicians prescribing medications to an elderly patient was associated with that patient's likelihood of reporting an ADE. Methods: This cohort study was a secondary analysis of data collected from a previous survey of Medicare managed care enrollees aged ≥65 years at the time of enrollment. A telephone survey of residents in the Philadelphia, Pennsylvania, area was conducted. Data included self-reported information on the number of prescribing physicians, chronic conditions, medications, ADEs, and general health status. Results: A total of 405 patients (mean [SD] age, 74 [5.1 ] years) were included in the study. Enrollees had a mean (SD) of 2.9 (1.3) prescribing physicians, and 98 (24%) patients reported having experienced an ADE in the previous 6 months. The mean (SD) number of self-reported chronic medical conditions and number of prescription medications was 4.7 (2.4) and 4.0 (2.8), respectively. In a multivariable logistic regression model, each additional provider prescribing medications increased the odds of reporting an ADE by 29% (odds ratio [OR], 1.3; 95% CI, 1.0–1.6). The number of chronic health conditions was also associated with ADEs. Having 4 or 5 self-reported chronic conditions doubled a person's odds of experiencing an ADE (OR, 2.1; 95% CI, 1.0–4.1) and having ≥6 conditions tripled the likelihood of experiencing an ADE (OR, 3.4; 95% CI, 1.6–6.9). The number of prescription medications or taking a potentially contraindicated medication was not significantly associated with self-reported ADEs. Conclusions: In this study population, the number of prescribing physicians was an independent risk factor for patients self-reporting an ADE. More research is needed to confirm and explain this finding. One possibility is poor communication between multiple providers. Physicians should work to ensure more effective coordination of care between providers and communicate information about all medications prescribed to their patients with their colleagues.

Risk Factors for Adverse Drug Events in Older Adults with Mobility Limitations in the Community Setting

To investigate risk factors for self-reported adverse drug events (ADEs) in a cohort of annually surveyed Iowa Medicare beneficiaries with mobility limitations. Prospective cohort study with baseline and two annual follow-up questionnaires. Population-based sample of Iowa Medicare beneficiaries with mobility limitations. Members of the cohort with complete follow-up questionnaires and prescription dispensing data (N=689). The questionnaires asked about self-reported ADEs in the previous 12 months, sociodemographic data, smoking, alcohol use, number of mobility limitations, and history of chronic disease. Pharmacy dispensing records were the source of number and classes of prescription drug use. Linked Medicare claims provided additional comorbidity data. Of the 689 subjects, 151 (21.9%) reported an ADE, 83% of which resulted in physician contact and 56% of which resulted in discontinuing the medication. Number of different medications dispensed during the prior year was an independent predictor of a self-reported ADE. Neither age, extent of mobility limitation, nor number of chronic conditions was independently associated with reporting an ADE. Excess ADE risk observed with increasing mobility limitations is mediated through greater medication use.

Adverse drug events in elderly patients receiving home health services following hospital discharge.

To assess incidence, healthcare consequences, and identify risk factors for adverse drug events (ADEs) in elderly patients receiving home health services during the month following hospital discharge. This was a prospective cohort study of three home health agencies in Madison, Wisconsin, and its surrounding area. The sample consisted of 256 participants aged > or =65 years who were hospitalized for medical illness, received home nursing after discharge, and completed the one-month interview. The main outcome measure was self-reported ADEs (possible, probable, or definite) during the month following hospital discharge. Incidence of ADEs was 20%. Fifty-two participants (20.3%) reported 64 ADEs: 23 possible, 37 probable, and four definite. The most common ADEs involved the gastrointestinal tract (31.3%) and the central nervous system (31.3%). Of 53 ADEs reported to providers, 59% of the drugs were discontinued or altered. One ADE resulted in hospitalization. In logistic regression, female gender (OR = 2.26; 95% CI 1.06 to 4.77) and the interaction between number of new medications and cognition were significantly associated with ADEs. The risk of an event increased with the number of new medications at discharge; however, risk was elevated primarily for participants with lower cognition. ADEs were common during the month following hospital discharge, were more frequent in women, and often resulted in medication changes. Individuals at particular risk were those with lower cognition who were discharged with several new medications.