Five-year trends in acetaminophen use exceeding the recommended daily maximum dose.

Temporal patterns of acetaminophen use exceeding the recommended daily maximum dosage of 4 g over a 5-year period (4/1/2011-3/31/2016) were evaluated in an online 1-week diary study of 14 434 adult acetaminophen users who also reported acetaminophen use in the previous month. Specific medications taken were identified by list-based prompting; respondents were not required to know their medications contained acetaminophen. Details of use were recorded daily; total daily dosage was determined programmatically. Prevalence of >4 g use over time was modelled and tested for linear changes. The overall prevalence of >4 g use (6.3% of users and 3.7% of usage days) did not change over the 5 years: odds ratio (OR) persons, 1.02 (95% CI, 0.98-1.09); OR days, 0.98 (0.92-1.05). Deviations from label directions were largely unchanged, though concomitant use increased slightly. Thus, over a recent 5-year period, there was no evidence of change in how often acetaminophen use exceeded the labelled maximum daily dose.

Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge.

Introduction: Nicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information). Methods: A randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days). Results: Abstinence rates did not differ significantly between snus and the nicotine lozenge-continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups. Conclusions: Smoking cessation rates were comparable between snus and a nicotine lozenge, but success rates in this trial were low. Implications: This randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.

Exceeding the maximum daily dose of acetaminophen with use of different single-ingredient OTC formulations.

OBJECTIVES: To assess whether there are differences in the likelihood of exceeding the daily limit of 4 grams of acetaminophen when using different formulations (325 mg, 500 mg, 650 mg) of OTC single-ingredient (SI) acetaminophen medications. DESIGN AND SETTING: Multiyear observational study of acetaminophen use via daily online acetaminophen-usage diaries completed for 7 days. PARTICIPANTS: A total of 7579 U.S. adults from online research panels who used acetaminophen in the month preceding enrollment and used an OTC SI acetaminophen medication during the study. OUTCOME MEASURE: Exceeding the daily dose. RESULTS: On days when 325-mg or 500-mg OTC SI formulations were taken, users were not significantly more likely to exceed 4 grams than on days when OTC SI formulations were not used. On days when 650-mg extended-release (ER) formulations were taken, exceeding 4 grams was significantly more likely (8.9% of days vs. 4.4%; P < 0.0001; median on those days was 5.2 g) than on days with 325- or 500-mg OTC SI formulations. Users of 650-mg ER formulations were significantly less likely to know their dosing interval of 8 hours (33% vs. 49%; P < 0.0001) and more likely to redose too soon (26% vs. 10%; P < 0.0001) and to use other acetaminophen medications concomitantly (14% vs. 7%; P < 0.0001). These patterns were strongest among 650-mg ER products that did not include "8-Hour" in the product name. CONCLUSION: Usage of 500-mg OTC SI acetaminophen formulations does not contribute differently to exceeding dosage compared with other OTC SI acetaminophen formulations. Exceeding 4 grams is more likely when 650-mg ER formulations are used. Improved consumer information on the packages and counseling from pharmacists may help to reduce practices that contribute to exceeding the labeled daily limit of these medications.

Knowledge of dosing directions among current users of acetaminophen-containing medications.

OBJECTIVES: Users should know the active ingredients and dosing directions to optimize the safe use of acetaminophen-containing medications. The aim of this work was to examine knowledge of acetaminophen-containing medication directions among current users. DESIGN, SETTING, AND PARTICIPANTS: An Internet panel diary study (2012-2016) of 1-week usage of acetaminophen medications (over-the-counter [OTC] and prescription), recorded daily; 9629 participants. Users were asked about ingredients of medications taken; specific dosing instructions were asked for each OTC medication taken. Subjects were considered to be correct only if an accurate response was provided for all of the medications they used. OUTCOME MEASURES: Analyses examined prevalence of several aspects of knowledge and their relation to the corresponding deviations from directions. Knowledge that acetaminophen was an ingredient was compared between medication types. RESULTS: Two-thirds of 5161 participants who used only 1 acetaminophen medication knew the ingredient; the proportion was almost halved in 4468 users of 2 or more. Ingredient knowledge was highest for single-ingredient medications (74%); for combination medications it ranged from 39% (cough or cold) to 61% (sleep or other non-pain). About one-third knew the prohibition against concomitant use of multiple acetaminophen medications; 85% knew the maximum one-time OTC dose, but only 47% knew the minimum interval between doses. Correct knowledge was inversely associated with violating the relevant label directions; in particular, knowing the one-time dose decreased the odds of taking too much at one time fivefold. Knowing both the ingredient and the concomitant use prohibition decreased the odds of concomitant use by 50%. CONCLUSIONS: Knowledge of directions for safe use of acetaminophen-containing medications is poor, and its deficiency is associated with corresponding deviations from label instructions. This study demonstrates a need for education about safe use of acetaminophen-containing medications, particularly for combination products.

Prevalence of exceeding maximum daily dose of paracetamol, and seasonal variations in cold-flu season.

AIMS: To estimate prevalence of excess intake of paracetamol and investigate seasonal variations therein. METHODS: Between 2011 and 2016, 14 481 US adults who used paracetamol in the preceding 30 days were sampled from national online panels and completed a detailed online daily diary of paracetamol medication use for 7 days. Respondents were not told that the study concerned paracetamol. Cold/flu season (CFS), identified using Google Trends data, was contrasted to off-season in symptoms, use of paracetamol medications, and consumption exceeding 4 g (the recommended daily maximum). RESULTS: Overall, 6.3% [95% confidence interval: 5.9-6.7%] of users exceeded 4 g on at least one day; 3.7% [3.5-3.8%] of usage days exceeded 4 g. Cold/flu symptoms were more likely to be experienced and treated with paracetamol in CFS than off-season. Paracetamol users were more likely to exceed 4 g during CFS (6.5% vs. 5.3%; odds ratio = 1.24, 1.04-1.48); days exceeding 4 g also increased (3.9% vs. 2.8%; odds ratio = 1.37, 1.11-1.69). This was not due to differences in characteristics of individuals using paracetamol in CFS, but primarily to increased use of over-the-counter combination medications designed to treat upper respiratory cold/flu symptoms (33.2% of usage days in CFS vs. 24.8% in off-season; odds ratio = 1.58, 1.46-1.72). When such medications were omitted, there was no statistically significant seasonal variation in exceeding 4 g. CONCLUSIONS: Paracetamol use and over-dosing increases in CFS, primarily due to increased use of over-the-counter combinations treating upper respiratory cold/flu symptoms. Pharmacists should warn users to follow labelled dosing directions, especially during CFS.

Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users.

PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective and very commonly used, but also have side effects. We determined prevalence of NSAID dosing exceeding the daily limit (EDL) and identified related user characteristics and dosing patterns among current ibuprofen users. METHODS: Online 1-week diary study of 1326 ibuprofen users. NSAIDs were identified by list-based prompting; respondents were not required to know their medications were NSAIDs. Details of hourly use were recorded by respondents daily. Deviations from dosing directions were programmatically determined afterwards. An exit survey obtained information on demographics, medical history, physical and mental health status, attitudes regarding label reading and dosing behavior, and knowledge of product label instructions. RESULTS: Most diary users (90%) took over-the-counter ibuprofen during the week; 37% also took non-ibuprofen NSAIDs. Most did not recognize all products taken as NSAIDs. EDL occurred among 11% of users for ibuprofen, 4% of users for other NSAIDs, and on 9.1% of NSAID usage days. EDL was associated with deviations from detailed dosing directions, particularly exceeding the 1-time dose, which occurred more often with medications with 1-pill doses. Personal characteristics associated with EDL included male sex, ongoing pain, poor physical function, daily smoking, having the attitudes of "choosing my own dose" and not starting with the lowest dose, and poor knowledge of the recommended 1-time and 24-hour doses. CONCLUSIONS: The prevalence of EDL among NSAID users is nontrivial, and it is associated with potentially modifiable factors. Educating consumers about NSAIDs and their dosing directions could reduce excess dosing.

Relation of Health Literacy to Exceeding the Labeled Maximum Daily Dose of Acetaminophen.

INTRODUCTION: Acetaminophen is a commonly used analgesic/antipyretic; overdoses can lead to liver damage. Little is known about the relationship of health literacy to exceeding the recommended maximum daily dose (4 g). METHODS: Subjects were recruited at 23 U.S. malls in 2011. Health literacy was measured by Rapid Estimate of Adult Literacy in Medicine (REALM), classified as very low (VLL, score <45); low (LL, 45-60); or adequate (AL, >60). Participants completed a 7-day acetaminophen use diary by daily telephone interview; an exit interview covered demographics, physical/mental health, medical history, medication label reading, and medication-taking knowledge/attitudes. Acetaminophen products were identified from a comprehensive list; subjects were not required to know their medications contained acetaminophen. Seven hundred fifty-six subjects aged ≥18 years had taken acetaminophen in the past 30 days and completed 7 diary days with ≥1 day of acetaminophen use, plus the exit survey. Analysis was conducted in 2012-2014. RESULTS: VLL were more likely than AL individuals to exceed 4 g on ≥1 day (OR [95% CI]=3.8 [1.5, 9.6]; 4.0 [1.3, 12] after controlling for five REALM score-related factors). On usage days, VLL individuals were also more likely to exceed 4 g (3.3 [1.1, 10], by generalized estimating equations; 2.4 [0.9, 6.6], direct effect after accounting for mediation by other deviations from label recommendations). CONCLUSIONS: VLL individuals exceed the recommended maximum acetaminophen dose more often than AL individuals. Other identified characteristics related to health literacy do not explain this, but it is partly mediated by increased frequency of other label deviations.

Impact of oppositional defiant disorder dimensions on the temporal ordering of conduct problems and depression across childhood and adolescence in girls.

BACKGROUND: Little is known about the role of oppositional defiant disorder (ODD) dimensions on the temporal unfolding of conduct disorder (CD) and depression in girls between childhood and adolescence. METHOD: The year-to-year associations between CD and depressive symptomatology were examined using nine waves of annually collected data (ages 8 through 16 years) from 1215 participants of the Pittsburgh Girls Study. A series of autoregressive path models were tested that included ODD-Emotion Dysregulation (ODD-ED) and ODD-Defiance, as time-varying covariates on CD predicting depression severity in the following year, and vice versa. RESULTS: Conduct problems, depression, and ODD dimensions were relatively stable throughout childhood and adolescence, and a moderate degree of covariance was observed between these variables. Path analyses showed that CD often preceded depression across this developmental period, although the effect sizes were small. There was less consistent prediction from depression to CD. The overlap between ODD-ED and CD partially explained the prospective relations from CD to depression, whereas these paths were fully explained by the overlap between ODD-ED and depression. The overlap between ODD-Defiance and CD did not account for the prospective relations from CD to depression. In contrast, the overlap between ODD-Defiance and depression accounted for virtually all paths from CD to depression. Accounting for the overlap between ODD dimensions and both CD and depression eliminated all significant predictive paths. CONCLUSIONS: Symptoms of CD tend to precede depression in girls during childhood and adolescence. However, covariance between depression and both ODD-ED and ODD-Defiance accounts for these prospective relations. ODD dimensions should be assessed when evaluating risk for comorbid depression in girls with conduct problems, and emotion dysregulation and defiance aspects of ODD should be identified as targets for treatment in order to prevent depression in the future.

Primary care patients' personal illness models for depression: relationship to coping behavior and functional disability.

OBJECTIVE: The applicability and clinical utility of Leventhal et al.'s model of illness cognition were evaluated in depressed primary care patients. The intercorrelations of illness beliefs and the mediational effects of coping behavior on these beliefs were also evaluated. Moderating effects of coping behaviors were explored. METHODS: Baseline evaluations of demographic information, depression diagnoses, depressive symptom severity, self-reported psychosocial and physical functioning, medical comorbidity, illness beliefs and depression coping strategies were obtained from 191 primary care patients receiving antidepressant medication for the treatment of depression. RESULTS: Patients' beliefs about depressive symptoms, causes, duration as well as controllability and the consequences of these symptoms are described. Leventhal et al.'s mediational model was partially supported for the outcome of psychosocial functioning. Coping behavior did not mediate the relationship between illness beliefs and physical functioning. The relationships between participants' beliefs about the cause, controllability and duration of depressive symptoms were mediated by the use of behavioral disengagement, venting or self-blame as a strategy to cope with depression. In addition, use of acceptance, religious coping or behavioral disengagement moderated the relationship between beliefs about the cause of depression (i.e., environment or chance or medical illness) and psychosocial functioning. CONCLUSIONS: Illness models for depression are important determinants of functioning in depressed primary care patients. These beliefs and coping behaviors are potentially modifiable and could be the target of interventions to decrease functional impairment in depressed patients.

The relationship between beliefs about depression and coping strategies: gender differences.

OBJECTIVE: Leventhal's common-sense model of illness representation provides a conceptual framework for exploring the relationship between beliefs about depressive illness and use of coping strategies. We explored this relationship among depressed patients both across genders and in terms of gender differences. DESIGN: Depressed primary care patients prescribed antidepressants provided self-report measures of beliefs about depression, emotional reaction to depression, beliefs about medications and coping strategies used. Baseline data from a longitudinal study is presented. METHOD: Primary data analyses were conducted using canonical correlation analysis, a multivariate statistical method akin to principal component and regression analyses. It allows for parsimonious description of the association between two multivariate sets of variables (in this case, beliefs about depression and coping strategies) by identifying pairs of linear combinations that account for the majority of the between association from the two sets of variables. RESULTS: The sample consisted of 189 depressed primary care patients (70.4% female). Results indicated that emotional reaction to depression is a major factor in determining coping strategies. Greater emotional reaction to depression was associated with maladaptive coping for men and women, while women showed additional relationships between greater perceived control over depression and more adaptive coping techniques as well as between perception of consequences of depression and problem solving. CONCLUSIONS: The present research provides preliminary evidence that beliefs about depression are related to coping styles. Further, men and women may differ in the way in which their perceptions about depression influence coping styles adopted.

Beliefs about antidepressant medications in primary care patients: relationship to self-reported adherence.

BACKGROUND: Adherence to medication is unacceptably low in both medical and psychiatric disorders. Explanatory models of illness beliefs and behaviors suggest that an individual's beliefs about a disorder and its treatment will influence their adherence. Given that beliefs about medications may influence adherence to antidepressants, we examined beliefs about medications in relation to antidepressant adherence in a primary care sample. OBJECTIVE: The purpose of this report is to 1) describe beliefs about medication in primary care patients prescribed antidepressants for depression; 2) examine the factor structure of the Beliefs about Medicines Questionnaire (BMQ) and compare it with the previously reported factor structure of the BMQ in medical conditions; and 3) examine the association of medication beliefs with self-reported medication adherence. RESULTS: Factor analysis indicates that the BMQ is valid in a sample of primary care patients receiving treatment for depression and has a similar factor structure to that obtained in samples of patients with chronic medical conditions. Beliefs about medications are significantly associated with self-reported adherence. Severity of depressive symptoms and specific concerns about antidepressants are significantly associated with self-reported medication-taking behavior. Findings suggest that in addition to telling patients how to take their medications, primary care physicians should also educate patients about the short- and long-term effects of the medication, how the medication works, and that antidepressants are not addictive.