Evidence of prescription of antidepressants for non-psychiatric conditions in primary care: an analysis of guidelines and systematic reviews.
ABSTRACT: BACKGROUND: Antidepressants (ADs) are commonly prescribed in primary care and are mostly indicated for depression. According to the literature, they are now more frequently prescribed for health conditions other than psychiatric ones. Due to their many indications in a wide range of medical fields, assessing the appropriateness of AD prescription seems to be a challenge for GPs. The aim of this study was to review evidence from guidelines for antidepressant prescription for non-psychiatric conditions in Primary Care (PC) settings. METHODS: Data were retrieved from French, English and US guideline databases. Guidelines or reviews were eligible if keywords regarding 44 non-psychiatric conditions related to GPs' prescription of ADs were encountered. After excluding psychiatric and non-primary care conditions, the guidelines were checked for keywords related to AD use. The latest updated version of the guidelines was kept. Recent data was searched in the Cochrane Database of Systematic Reviews and in PubMed for updated reviews and randomized control trials (RCTs). RESULTS: Seventy-eight documents were retrieved and were used to assess the level of evidence of a potential benefit to prescribing an AD. For 15 conditions, there was a consensus that prescribing an AD was beneficial. For 5 others, ADs were seen as potentially beneficial. No proof of benefit was found for 15 conditions and proof of no benefit was found for the last 9. There were higher levels of evidence for pain conditions, (neuropathic pain, diabetic painful neuropathy, central neuropathic pain, migraine, tension-type headaches, and fibromyalgia) incontinence and irritable bowel syndrome. There were difficulties in summarizing the data, due to a lack of information on the level of evidence, and due to variations in efficacy between and among the various classes of ADs. CONCLUSIONS: Prescription of ADs was found to be beneficial for many non-psychiatric health conditions regularly encountered in PC settings. On the whole, the guidelines were heterogeneous, seemingly due to a lack of trials assessing the role of ADs in treatment strategies.
Project description:BACKGROUND:Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. METHODS:All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. RESULTS:Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. CONCLUSIONS:Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
Project description:The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements.This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media.A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information.Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented.In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.
Project description:INTRODUCTION:Factors that influence antidepressant (AD) prescription and use during pregnancy are multiple including, in particular, the balance between the potential risk of untreated depression and the potential risk of AD treatment. Surveillance of temporal trends of AD use might identify areas requiring further research. We studied the use of ADs before, during, and after pregnancy using national data across two decades in Denmark. METHODS:We included 1,232,233 pregnancies leading to live birth in Denmark between 1 January 1997 and 31 December 2016. Information on redemption of AD prescriptions was obtained from the Danish National Prescription Register. RESULTS:We identified 29,504 (2.4%) pregnancies having at least one AD prescription (96,232 AD prescriptions) during pregnancy. The majority redeemed more than one prescription (69.7%) often for a single kind of AD (83.5%), and in 94% of the AD-exposed pregnancies, the estimated duration of treatment was 1 month or longer. Prescription of ADs during pregnancy increased steadily from 0.4% in 1997 to 4.6% in 2011, but decreased thereafter to 3.1% in 2016. The proportion of pregnancies with ADs in 2011 was 6.05-fold higher than that in 1997. The temporal trends in AD prescription in the years before and after pregnancy were similar to the trend during pregnancy. The decreasing use of ADs during pregnancy after 2011 was mainly driven by a decrease in the use of selective serotonin reuptake inhibitors (SSRIs), especially citalopram, the main type of SSRIs used in Denmark. CONCLUSION:Prescription of ADs during pregnancy in Denmark increased steadily from 1997 to 2011 but decreased sharply thereafter. More research is needed to show whether the same trend exists in other populations, like women of reproductive age, men of reproductive age, and old people, and other countries. We also need to find explanation for the decreasing trend in recent years and potential risk for untreated depression.
Project description:OBJECTIVES:To improve the effectiveness of alcohol harm reduction mass media campaigns, this study aimed to (1) identify existing advertisements (ads) with greatest potential to motivate reduced alcohol consumption, (2) assess consistency across audience subgroups in ad effectiveness and (3) identify ad features associated with effectiveness. DESIGN:Cross-sectional online ad response study with random assignment to view ads. PARTICIPANTS:2174 Australian adult weekly drinkers recruited from an online panel. PROCEDURE:Participants were randomly assigned to view three of 83 English-language alcohol harm reduction ads. Each ad was viewed and rated by a mean of 79 participants. OUTCOME MEASURE:After viewing each ad, participants reported the extent to which they felt motivated to reduce their drinking. Ads were ranked from most to least motivating using predicted means adjusted for demographic characteristics and alcohol consumption. We compared the characteristics of the top-ranked 15% of ads (most motivating) with the middle 70% and bottom 15%. RESULTS:An ad about the link between alcohol and cancer ('Spread') was most motivating, whereas an ad that encouraged drinking water instead of beer ('Add nothing') was least motivating. Top-ranked ads were more likely than other ads to feature a 'why change' message and less likely to carry a 'how to change' message; more likely to address long-term harms; more likely to be aimed at the general adult drinking population and more likely to include drinking guidelines. There was substantial overlap in top-ranked ads for younger versus older adults, men versus women and high-risk versus low-risk drinker subgroups. CONCLUSIONS:The effectiveness of alcohol harm reduction campaigns may be improved by directly communicating alcohol's long-term harms to the general adult population of drinkers along with drinking guidelines. By doing so, campaigns can also efficiently influence high-risk drinkers and key demographic subgroups.
Project description:Background: The steady increase in type 2 diabetes prevalence and the availability of new antidiabetic drugs (AD) have risen the use of these drugs with a change in the patterns of specific drug utilization. The complexity of this treatment is due to successive treatment initiation, switching and addition in order to maintain glycaemic control. The aim of this study was to describe the utilization patterns of ADs at initiation, treatment addition, and switching profiles and to measure factors influencing persistence to therapy. Methods: Retrospective observational study. Data were retrieved from the Campania Regional Database for Medication Consumption. Population consisted of patients receiving at least one prescription of ADs between January 1 and December 31, 2016. We calculated time to treatment switching or add-on as median number of days and interquartile range (IQR). Persistence rates were estimated using the Kaplan-Meier method. We used Cox regression models to estimate the likelihood of non-persistence over 1 year of follow-up. Hazard ratios and 95% confidence intervals were calculated. Results: Of 14,679 patients, 86.9% started with monotherapy and 13.1% with combination therapy. Most common initial treatment was metformin in both monotherapy and combination therapy. First-line prescription of sulfonylurea was observed in 6.9% of patients aged 60-79 years and in 10.8% of patients aged ?80 years. Patients starting with metformin showed fewer treatment modifications (10.4%) compared to patients initiating with sulfonylureas (35.2%). Newer ADs were utilized during treatment progression. Patients who initiated with sulfonylurea were approximately 70% more likely to discontinue treatment compared to those initiated on metformin. Oldest age group (?80?years) was more likely to be non-persistent, and likelihood of non-persistence was highest in polymedicated patients. Patients changing therapy were more likely to be persistent. Conclusions: Our results show that treatment of T2D in Italy is consistent with clinical guidelines. Even if newer ADs were utilized during disease progression, they seem not to be preferred in patients with a higher comorbidity score, although these patients could benefit from this kind of treatment. Our study highlights patients' characteristics that might help identify those who would benefit from counselling from their health-care practitioner on better AD usage.
Project description:<h4>Background</h4>Previous studies in general practice and hospital settings have identified that prescribing of non-insulin diabetes medications may be sub-optimal in people with type 2 diabetes (T2D) and renal impairment. Since these publications, a number of new medications have become available for the management of T2D. Study aims were to, in a cohort of Australians with T2D and renal impairment attending general practice, (1) investigate whether the prescribing of non-insulin diabetes medications is consistent with dosing adjustments recommended within current Australian Diabetes Society (ADS) guidelines; and (2) identify patient socio-demographic and clinical factors associated with at least one prescription of a non-insulin diabetes medication inconsistent with current ADS guidelines for medication doses.<h4>Methods</h4>Cross-sectional study using data from the MedicineInsight general practice database managed by NPS MedicineWise. Patients with T2D who were aged 18?years and over, with an average eGFR<?60?ml/min/1.73m<sup>2</sup> and at least one prescription of a non-insulin diabetes medication between 1st January 2015 and 30th June 2017 were included. Descriptive statistics were used to summarise patient characteristics and medication use. Marginal logistic regression models were used to estimate associations between sociodemographic and clinical factors and prescribing of ?1non-insulin diabetes medicine not consistent with ADS guidelines.<h4>Results</h4>The majority of the 3505 patients included (90.4%) had an average eGFR of 30-59?ml/min/1.73m<sup>2</sup>. In terms of absolute numbers, metformin was the medication most frequently prescribed at a dose not consistent with current ADS guidelines for dosing in renal impairment (n =?1601 patients), followed by DPP4 inhibitors (n =?611) and sulphonylureas (n =?278). The drug classes with the highest proportion of prescriptions with dosage not consistent with ADS guidelines were SGLT2 inhibitors (83%), followed by biguanides (58%) and DPP4 inhibitors (46%). Higher HbA1c, longer known diabetes duration and diagnosis of retinopathy were associated with receiving ?1prescription with a dosage not consistent with guidelines.<h4>Conclusions</h4>Prescribing of non-insulin diabetes medications at doses inconsistent with current ADS guideline recommendations for dosing adjustments for people with renal impairment was common. Further research is needed to understand how general practitioners access, interpret and apply the ADS guidelines and the impact this may have on patient outcomes.
Project description:This article evaluates the additive effects of children's comorbid conditions with attention-deficit/hyperactivity disorder (ADHD) in relation to caregivers' distress, in a clinical trial conducted through telemental health (TMH).The Children's ADHD Telemental Health Treatment Study (CATTS) is examining the effectiveness of treatment delivered via TMH for children with ADHD who are living in underserved communities. The CATTS trial recruited 223 children (?=9.53±2.06 years) and their caregivers. Diagnoses of ADHD and comorbid oppositional defiant disorder (ODD) and anxiety disorders (ADs) were established with the Child Behavior Checklist and the Computerized Diagnostic Interview Schedule for Children. We took advantage of rich baseline data from the CATTS trial to investigate associations between caregivers' distress and children's comorbid mental health conditions. Caregivers' distress was assessed with the Patient Health Questionnaire-9, Parenting Stress Index, and Caregiver Strain Questionnaire. ANOVAs were used to compare children with ADHD alone with children having one comorbid condition (ODD or ADs) and children having two comorbid conditions (ODD and ADs).Three quarters (75.3%) of participants met criteria for ODD and/or AD comorbid with ADHD: 24.7% had neither comorbidity; 47.5% had ODD or AD; and 27.8% had both ODD and AD comorbidities. The parents of children with multiple comorbid conditions experienced the highest levels of depression, stress, and burden of care.The CATTS sample that was recruited from underserved communities provided evidence of additive effects of child psychiatric comorbidities with caregivers' distress, echoing earlier findings from the Multi-modal Treatment of ADHD (MTA) study that was conducted with a metropolitan sample of youth. Results indicate that caregivers' distress should be addressed in developing treatment models for children with ADHD.http://clinicaltrials.gov/show/NCT00830700 .
Project description:Antidepressants are prescribed for the treatment of a number of psychiatric disorders in children and adolescents, however there is still controversy about whether they should be used in this population. This meta-review aimed to assess the effects of antidepressants for the acute treatment of attention-deficit/hyperactivity disorder (ADHD), anxiety disorders (ADs), autistic spectrum disorder (ASD), enuresis, major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD) in children and adolescents. Efficacy was measured as response to treatment (either as mean overall change in symptoms or as a dichotomous outcome) and tolerability was measured as the proportion of patients discontinuing treatment due to adverse events. Suicidality was measured as suicidal ideation, behavior (including suicide attempts) and completed suicide. PubMed, EMBASE, and Web of Science were systematically searched (until 31 October 2019) for existing systematic reviews and/or meta-analyses of double-blind randomized controlled trials. The quality of the included reviews was appraised using AMSTAR-2. Our meta-review included nine systematic reviews/meta-analyses (2 on ADHD; 1 on AD; 2 on ASD; 1 on enuresis; 1 on MDD, 1 on OCD and 1 on PTSD). In terms of efficacy this review found that, compared to placebo: fluoxetine was more efficacious in the treatment of MDD, fluvoxamine and paroxetine were better in the treatment of AD; fluoxetine and sertraline were more efficacious in the treatment of OCD; bupropion and desipramine improved clinician and teacher-rated ADHD symptoms; clomipramine and tianeptine were superior on some of the core symptoms of ASD; and no antidepressant was more efficacious for PTSD and enuresis. With regard to tolerability: imipramine, venlafaxine, and duloxetine were less well tolerated in MDD; no differences were found for any of the antidepressants in the treatment of anxiety disorders (ADs), ADHD, and PTSD; tianeptine and citalopram, but not clomipramine, were less well tolerated in children and adolescents with ASD. For suicidal behavior/ideation, venlafaxine (in MDD) and paroxetine (in AD) were associated with a significantly increased risk; by contrast, sertraline (in AD) was associated with a reduced risk. The majority of included systematic reviews/meta-analyses were rated as being of high or moderate in quality by the AMSTAR-2 critical appraisal tool (one and five, respectively). One included study was of low quality and two were of critically low quality. Compared to placebo, selected antidepressants can be efficacious in the acute treatment of some common psychiatric disorders, although statistically significant differences do not always translate into clinically significant results. Little information was available about tolerability of antidepressants in RCTs of OCD and in the treatment of ADHD, ASD, MDD, and PTSD. There is a paucity of data on suicidal ideation/behavior, but paroxetine may increase the risk of suicidality in the treatment of AD and venlafaxine for MDD. Findings from this review must be considered in light of potential limitations, such as the lack of comparative information about many antidepressants, the short-term outcomes and the quality of the available evidence.
Project description:BACKGROUND:Deaths due to prescription opioid overdoses have increased dramatically. High-quality guidelines could help clinicians mitigate risks associated with opioid therapy. PURPOSE:To evaluate the quality and content of guidelines on the use of opioids for chronic pain. DATA SOURCES:MEDLINE, National Guideline Clearinghouse, specialty society Web sites, and international guideline clearinghouses (searched in July 2013). STUDY SELECTION:Guidelines published between January 2007 and July 2013 addressing the use of opioids for chronic pain in adults were selected. Guidelines on specific settings, populations, and conditions were excluded. DATA EXTRACTION:Guidelines and associated systematic reviews were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument and A Measurement Tool to Assess Systematic Reviews (AMSTAR), respectively, and recommendations for mitigating opioid-related risks were compared. DATA SYNTHESIS:Thirteen guidelines met selection criteria. Overall AGREE II scores were 3.00 to 6.20 (on a scale of 1 to 7). The AMSTAR ratings were poor to fair for 10 guidelines. Two received high AGREE II and AMSTAR scores. Most guidelines recommend that clinicians avoid doses greater than 90 to 200 mg of morphine equivalents per day, have additional knowledge to prescribe methadone, recognize risks of fentanyl patches, titrate cautiously, and reduce doses by at least 25% to 50% when switching opioids. Guidelines also agree that opioid risk assessment tools, written treatment agreements, and urine drug testing can mitigate risks. Most recommendations are supported by observational data or expert consensus. LIMITATION:Exclusion of non-English-language guidelines and reliance on published information. CONCLUSION:Despite limited evidence and variable development methods, recent guidelines on chronic pain agree on several opioid risk mitigation strategies, including upper dosing thresholds; cautions with certain medications; attention to drug-drug and drug-disease interactions; and use of risk assessment tools, treatment agreements, and urine drug testing. Future research should directly examine the effectiveness of opioid risk mitigation strategies. PRIMARY FUNDING SOURCE:California Department of Industrial Relations and California Commission on Health and Safety and Workers' Compensation.
Project description:BACKGROUND: False and misleading advertising for drugs can harm consumers and the healthcare system, and previous research has demonstrated that physician-targeted drug advertisements may be misleading. However, there is a dearth of research comparing consumer-targeted drug advertising to evidence to evaluate whether misleading or false information is being presented in these ads. OBJECTIVE: To compare claims in consumer-targeted television drug advertising to evidence, in order to evaluate the frequency of false or misleading television drug advertising targeted to consumers. DESIGN: A content analysis of a cross-section of television advertisements for prescription and nonprescription drugs aired from 2008 through 2010. We analyzed commercial segments containing prescription and nonprescription drug advertisements randomly selected from the Vanderbilt Television News Archive, a census of national news broadcasts. MAIN MEASURES: For each advertisement, the most-emphasized claim in each ad was identified based on claim iteration, mode of communication, duration and placement. This claim was then compared to evidence by trained coders, and categorized as being objectively true, potentially misleading, or false. Potentially misleading claims omitted important information, exaggerated information, made lifestyle associations, or expressed opinions. False claims were factually false or unsubstantiated. KEY RESULTS: Of the most emphasized claims in prescription (n?=?84) and nonprescription (n?=?84) drug advertisements, 33 % were objectively true, 57 % were potentially misleading and 10 % were false. In prescription drug ads, there were more objectively true claims (43 %) and fewer false claims (2 %) than in nonprescription drug ads (23 % objectively true, 7 % false). There were similar numbers of potentially misleading claims in prescription (55 %) and nonprescription (61 %) drug ads. CONCLUSIONS: Potentially misleading claims are prevalent throughout consumer-targeted prescription and nonprescription drug advertising on television. These results are in conflict with proponents who argue the social value of drug advertising is found in informing consumers about drugs.