Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey.
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ABSTRACT:
SUBMITTER: Sullivan HW
PROVIDER: S-EPMC7325631 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Publications
Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey.
Sullivan Helen W HW Aikin Kathryn J KJ David Kathleen T KT Berktold Jennifer J Stein Karen L KL Hoverman Victoria J VJ
Pharmacoepidemiology and drug safety 20191212 2
<h4>Purpose</h4>Misperceptions of how the US Food and Drug Administration (FDA) regulates prescription drugs may affect how consumers assess the safety and efficacy of prescription drugs. The study objective was to survey the public on their knowledge of FDA oversight regarding prescription drug approval and advertising.<h4>Methods</h4>In 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults.<h4>Results</h4>Although most respondents (86%) knew that FDA appro ...[more]
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Project description:OBJECTIVES:The factors determining individuals' self-reported behavioural responses to direct to consumer advertising of prescription drugs were explored with an emphasis on 'at-risk' individuals' responses. DESIGN:Nationally representative cross-sectional survey. SETTING:Community living adults in New Zealand. PARTICIPANTS:2057 adults (51% women). PRIMARY OUTCOME MEASURES:Self-reported behavioural responses to drug advertising (asking a physician for a prescription, asking a physician for more information about an illness, searching the internet for more information regarding an illness and asking a pharmacist for more information about a drug). METHODS:Multivariate logistic regressions determined whether participants' self-reported behavioural responses to drug advertising were predicted by attitudes towards advertising and drug advertising, judgements about safety and effectiveness of advertised drugs, self-reported health status, materialism, online search behaviour as well as demographic variables. RESULTS:Identifying as Indian and to a less extent Chinese, Māori and 'other' ethnicities were the strongest predictors of one or more self-reported responses (ORs 1.76-5.00, Ps<0.05). Poorer self-reported health status (ORs 0.90-0.94, all Ps<0.05), favourable attitude towards drug advertising (ORs 1.34-1.61, all Ps<0.001) and searching for medical information online (ORs 1.32-2.35, all Ps<0.01) predicted all self-reported behavioural outcomes. Older age (ORs 1.01-1.02, Ps<0.01), less education (OR 0.89, P<0.01), lower income (ORs 0.89-0.91, Ps<0.05) and higher materialism (ORs 1.02-1.03, Ps<0.01) also predicted one or more self-reported responses. CONCLUSIONS:Taken together, the findings suggest individuals, especially those who are 'at-risk' (ie, with poorer self-reported health status, older, less educated, lower income and ethnic minorities), may be more vulnerable to drug advertising and may make uninformed decisions accordingly. The outcomes raise significant concerns relating to the ethicality of drug advertising and suggest a need for stricter guidelines to ensure that drug advertisements provided by pharmaceutical companies are ethical.
| S-EPMC5728274 | biostudies-literature
Project description:BackgroundWHO estimates that about 170,000 deaths by suicide occur in India every year, but few epidemiological studies of suicide have been done in the country. We aimed to quantify suicide mortality in India in 2010.MethodsThe Registrar General of India implemented a nationally representative mortality survey to determine the cause of deaths occurring between 2001 and 2003 in 1·1 million homes in 6671 small areas chosen randomly from all parts of India. As part of this survey, fieldworkers obtained information about cause of death and risk factors for suicide from close associates or relatives of the deceased individual. Two of 140 trained physicians were randomly allocated (stratified only by their ability to read the local language in which each survey was done) to independently and anonymously assign a cause to each death on the basis of electronic field reports. We then applied the age-specific and sex-specific proportion of suicide deaths in this survey to the 2010 UN estimates of absolute numbers of deaths in India to estimate the number of suicide deaths in India in 2010.FindingsAbout 3% of the surveyed deaths (2684 of 95,335) in individuals aged 15 years or older were due to suicide, corresponding to about 187,000 suicide deaths in India in 2010 at these ages (115,000 men and 72,000 women; age-standardised rates per 100,000 people aged 15 years or older of 26·3 for men and 17·5 for women). For suicide deaths at ages 15 years or older, 40% of suicide deaths in men (45,100 of 114,800) and 56% of suicide deaths in women (40,500 of 72,100) occurred at ages 15-29 years. A 15-year-old individual in India had a cumulative risk of about 1·3% of dying before the age of 80 years by suicide; men had a higher risk (1·7%) than did women (1·0%), with especially high risks in south India (3·5% in men and 1·8% in women). About half of suicide deaths were due to poisoning (mainly ingestions of pesticides).InterpretationSuicide death rates in India are among the highest in the world. A large proportion of adult suicide deaths occur between the ages of 15 years and 29 years, especially in women. Public health interventions such as restrictions in access to pesticides might prevent many suicide deaths in India.FundingUS National Institutes of Health.
| S-EPMC4247159 | biostudies-literature
Project description:National malaria death rates are difficult to assess because reliably diagnosed malaria is likely to be cured, and deaths in the community from undiagnosed malaria could be misattributed in retrospective enquiries to other febrile causes of death, or vice-versa. We aimed to estimate plausible ranges of malaria mortality in India, the most populous country where the disease remains common.Full-time non-medical field workers interviewed families or other respondents about each of 122,000 deaths during 2001-03 in 6671 randomly selected areas of India, obtaining a half-page narrative plus answers to specific questions about the severity and course of any fevers. Each field report was sent to two of 130 trained physicians, who independently coded underlying causes, with discrepancies resolved either via anonymous reconciliation or adjudication.Of all coded deaths at ages 1 month to 70 years, 2681 (3·6%) of 75,342 were attributed to malaria. Of these, 2419 (90%) were in rural areas and 2311 (86%) were not in any health-care facility. Death rates attributed to malaria correlated geographically with local malaria transmission ratesderived independently from the Indian malaria control programme. The adjudicated results show 205,000 malaria deaths per year in India before age 70 years (55,000 in early childhood, 30,000 at ages 5-14 years, 120,000 at ages 15-69 years); 1·8% cumulative probability of death from malaria before age 70 years. Plausible lower and upper bounds (on the basis of only the initial coding) were 125,000-277,000. Malaria accounted for a substantial minority of about 1·3 million unattended rural fever deaths attributed to infectious diseases in people younger than 70 years.Despite uncertainty as to which unattended febrile deaths are from malaria, even the lower bound greatly exceeds the WHO estimate of only 15,000 malaria deaths per year in India (5000 early childhood, 10?000 thereafter). This low estimate should be reconsidered, as should the low WHO estimate of adult malaria deaths worldwide.US National Institutes of Health, Canadian Institute of Health Research, Li Ka Shing Knowledge Institute.
| S-EPMC3021416 | biostudies-other
Project description:BackgroundProviders are uniquely positioned to encourage health-promoting behaviors, particularly among cancer survivors where patients develop trust in providers.MethodsWe utilized the National Health Interview Survey to identify adults who reported a visit to a provider in the prior year (44,385 individuals with no cancer history and 4,792 cancer survivors), and reported prevalence of provider discussions on weight loss, physical activity, diet, and smoking. We used generalized linear mixed models to examine predicted prevalence of provider lifestyle discussions by cancer history overall, and among those who do not meet body mass index (BMI), activity, or smoking guidelines.ResultsAmong those with a BMI of 25-<60 kg/m2, 9.2% of those with a cancer history and 11.6% of those without a cancer history reported being told to participate in a weight loss program (P < 0.001). Overall, 31.7% of cancer survivors and 35.3% of those with no cancer history were told to increase their physical activity (P < 0.001). Only 27.6% of cancer survivors and 32.2% of those with no cancer history reported having a general discussion of diet (P < 0.001). Among smokers, 67.3% of cancer survivors and 69.9% of those with no cancer history reported counseling on smoking (P = 0.309).ConclusionsFewer cancer survivors, who are at increased risk for health complications, are reporting provider discussions about critical lifestyle issues than those with no cancer history.ImpactOur nationally representative results suggest that providers are missing an opportunity for influencing patient lifestyle factors, which could lead to mitigation of late and long-term effects of treatment.
| S-EPMC7867611 | biostudies-literature
Project description:Evidence of an association between added sugars (AS) and the risk of obesity has triggered public health bodies to develop strategies enabling consumers to manage their AS intake. The World Health Organisation (WHO) has strongly recommended a reduction of free sugars to 10% of total dietary energy (TE) and conditionally recommended a reduction to 5% TE to achieve health benefits. Despite food labelling being a policy tool of choice in many countries, there is no consensus on the mandatory addition of AS to the nutrition panel of food labels. An online survey was conducted to explore consumer ability to identify AS on food labels and to investigate consumer awareness of the WHO guidelines in relation to sugar intakes. The questionnaire was tested for participant comprehension using face-to-face interviews prior to conducting the online study. The online survey was conducted in Northern Ireland during May 2015 and was completed by a convenient sample of 445 subjects. Results showed that just 4% of respondents correctly classified 10 or more ingredients from a presented list of 13 items, while 65% of participants were unaware of the WHO guidelines for sugar intake. It may be timely to reopen dialogue on inclusion of AS on food product nutrition panels.
| S-EPMC5295081 | biostudies-other
Project description:BackgroundMore than 2·3 million children died in India in 2005; however, the major causes of death have not been measured in the country. We investigated the causes of neonatal and child mortality in India and their differences by sex and region.MethodsThe Registrar General of India surveyed all deaths occurring in 2001-03 in 1·1 million nationally representative homes. Field staff interviewed household members and completed standard questions about events that preceded the death. Two of 130 physicians then independently assigned a cause to each death. Cause-specific mortality rates for 2005 were calculated nationally and for the six regions by combining the recorded proportions for each cause in the neonatal deaths and deaths at ages 1-59 months in the study with population and death totals from the United Nations.FindingsThere were 10,892 deaths in neonates and 12,260 in children aged 1-59 months in the study. When these details were projected nationally, three causes accounted for 78% (0·79 million of 1·01 million) of all neonatal deaths: prematurity and low birthweight (0·33 million, 99% CI 0·31 million to 0·35 million), neonatal infections (0·27 million, 0·25 million to 0·29 million), and birth asphyxia and birth trauma (0·19 million, 0·18 million to 0·21 million). Two causes accounted for 50% (0·67 million of 1·34 million) of all deaths at 1-59 months: pneumonia (0·37 million, 0·35 million to 0·39 million) and diarrhoeal diseases (0·30 million, 0·28 million to 0·32 million). In children aged 1-59 months, girls in central India had a five-times higher mortality rate (per 1000 livebirths) from pneumonia (20·9, 19·4-22·6) than did boys in south India (4·1, 3·0-5·6) and four-times higher mortality rate from diarrhoeal disease (17·7, 16·2-19·3) than did boys in west India (4·1, 3·0-5·5).InterpretationFive avoidable causes accounted for nearly 1·5 million child deaths in India in 2005, with substantial differences between regions and sexes. Expanded neonatal and intrapartum care, case management of diarrhoea and pneumonia, and addition of new vaccines to immunisation programmes could substantially reduce child deaths in India.FundingUS National Institutes of Health, International Development Research Centre, Canadian Institutes of Health Research, Li Ka Shing Knowledge Institute, and US Fund for UNICEF.
| S-EPMC3042727 | biostudies-literature
Project description:BackgroundIt is estimated that India has more deaths from rabies than any other country. However, existing estimates are indirect and rely on non-representative studies.Methods and principal findingsWe examined rabies deaths in the ongoing Million Death Study (MDS), a representative survey of over 122,000 deaths in India that uses enhanced types of verbal autopsy. We estimated the age-specific mortality rates of symptomatically identifiable furious rabies and its geographic and demographic distributions. A total of 140 deaths in our sample were caused by rabies, suggesting that in 2005 there were 12,700 (99% CI 10,000 to 15,500) symptomatically identifiable furious rabies deaths in India. Most rabies deaths were in males (62%), in rural areas (91%), and in children below the age of 15 years (50%). The overall rabies mortality rate was 1.1 deaths per 100,000 population (99%CI 0.9 to 1.4). One third of the national rabies deaths were found in Uttar Pradesh (4,300) and nearly three quarters (8,900) were in 7 central and south-eastern states: Chhattisgarh, Uttar Pradesh, Odisha, Andhra Pradesh, Bihar, Assam, and Madhya Pradesh.Conclusions and significanceRabies remains an avoidable cause of death in India. As verbal autopsy is not likely to identify atypical or paralytic forms of rabies, our figure of 12,700 deaths due to classic and clinically identifiable furious rabies underestimates the total number of deaths due to this virus. The concentrated geographic distribution of rabies in India suggests that a significant reduction in the number of deaths or potentially even elimination of rabies deaths is possible.
| S-EPMC3464588 | biostudies-literature
Project description:Optimal breastfeeding practices can ensure healthy growth and development of infants, which in the long term can impact the country's economic development. Nevertheless, Myanmar has yet to achieve the WHO's target of 70% for early initiation of breastfeeding, and the country's target of 90% for exclusive breastfeeding. The purpose of this study was to assess the associations between early initiation of breastfeeding and exclusive breastfeeding and bio-demographic, socio-economic and behavioral factors in Myanmar. Using the 2015-2016 Myanmar Demographic and Health Survey, the analysis of early initiation of breastfeeding was based on a sample of 1,506 under-2 children and the analysis of exclusive breastfeeding was based on a sample of 376 children aged 0-5 months. Multiple logistic modeling, with heteroskedasticity-adjusted standard errors, was used. The prevalence rates of early initiation of breastfeeding and exclusive breastfeeding in the study were 67.9% and 52.2% respectively. Having a vaginal delivery (AOR = 2.5; 95% CI = 1.7-3.7) and having frequent (≥ 4) antenatal visits (AOR = 2.4; 95% CI = 1.5-3.8) were associated with higher odds of early initiation of breastfeeding. Having a postnatal checkup (AOR = 0.5; 95% CI = 0.3-0.9) and having an infant that was perceived to be small at birth (AOR = 2.5; 95% CI = 1.1-5.7, for infants perceived to be large at birth) were significantly associated with decreased odds of exclusive breastfeeding. In order to promote optimal breastfeeding practices, this study suggested that delivery and quality of health services during pregnancy need to be strengthened in Myanmar.
| S-EPMC7514058 | biostudies-literature
Project description:OBJECTIVE:Sexual minority adolescents (SMA) may be at disproportionate risk for misusing prescription psychotropic medications compared to their heterosexual peers. However, generalizable studies specific to this age group are lacking. The current study aimed to describe the prevalence of sexual orientation disparities in prescription drug misuse among a nationally representative sample of adolescents as well as to examine key correlates of misuse. METHOD:Using data from the National Youth Risk Behavior Survey, we conducted stepwise multivariable weighted logistic regressions, sequentially controlling for demographics, experiences of victimization, mental health, and other illicit substance use. RESULTS:Adjusting for grade and race/ethnicity, female SMA and gay and unsure males had significantly elevated odds of ever misusing a prescription drug compared to heterosexual adolescents (ORs from 1.7-2.5). Most sexual orientation disparities among females remained significant with the addition of victimization and mental health covariates but attenuated completely after controlling for other illicit drug use. The effect for unsure males attenuated when victimization variables were included, but the effect for gay males remained significant through the final model. Controlling for other illicit drug use, mental health variables remained significant correlates for females whereas only forced sex was significant for males. CONCLUSION:These results suggest experiences of victimization and mental health partially account for the disparities in prescription drug misuse between SMA and heterosexual adolescents, and their effects may differ by sex. A combination of structural, individual coping, and universal drug prevention approaches should be used to make the largest impact on reducing these disparities.
| S-EPMC5701833 | biostudies-literature
Project description:To estimate the prevalence of gross hematuria and urinary retention among men in Sierra Leone and report on barriers to care and associated disability. Gross hematuria and urinary retention are classic urologic complaints that require medical attention for significant underlying pathology, but their burden has not been quantified in a developing country.A cluster randomized, cross-sectional household survey was administered in Sierra Leone using the Surgeons OverSeas Assessment of Surgical need tool as a verbal head-to-toe examination. A total of 2 respondents in each of 25 households in 75 clusters were surveyed to assess surgical needs. Data on questions related to blood from the penis and the inability to urinate for men>12 years were included in the present analysis to determine the period and point prevalence of hematuria and urinary retention.From 3645 total respondents, 1054 (28.9%) were men>12 years included in the analysis. Period and point prevalence of gross hematuria were 21.8 per 1000 (95% confidence interval [CI] 13.0-30.7) and 12.3 per 1000 (95% CI 5.7-19.0), respectively, and for urinary retention, they were 19.9 per 1000 (95% CI 11.5-28.4) and 4.7 per 1000 (95% CI 0.5-8.9), respectively. Lack of financial resources was the major barrier to care. Disability assessment showed 19.1% were not able to work as a result of urinary retention, and 34.8% felt ashamed of their gross hematuria.The results provide a prevalence estimate of gross hematuria and urinary retention for men in Sierra Leone. Accessible medical and surgical care will be critical for early intervention and management.
| S-EPMC4037342 | biostudies-other