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4.
BMJ Qual Saf ; 2019 Dec 13.
Artigo em Inglês | MEDLINE | ID: mdl-31836627

RESUMO

BACKGROUND AND OBJECTIVE: Prescriptions for psychotropic medications to children have risen dramatically in recent years despite few regulatory approvals and growing concerns about side effects. Government policy and numerous programmes are attempting to curb this problem. However, the perspectives of practising clinicians have not been explored. To characterise the perspectives and experiences of paediatric primary care clinicians and mental health specialists regarding overprescribing and deprescribing psychotropic medications in children. METHODS: We conducted 24 semistructured interviews with clinicians representing diverse geographic regions and practice settings in the USA. Interview questions focused on clinician perspectives surrounding overprescribing and experiences with deprescribing. We transcribed audio files verbatim and verified them for accuracy. We analysed transcripts using a grounded theory approach, identifying emergent themes and developing a conceptual model using axial coding. RESULTS: Analysis yielded themes within four domains: social and clinical contextual factors contributing to overprescribing, opportunities for deprescribing, and facilitators and barriers to deprescribing in paediatric outpatient settings. Most participants recognised the problem of overprescribing, and they described complex clinical and social contextual factors, as well as internal and external pressures, that contribute to overprescribing. Opportunities for deprescribing included identification of high-risk medications, routine reassessment of medication needs and recognition of the broader social needs of vulnerable children. Facilitators and barriers to deprescribing were both internal (eg, providing psychoeducation to families) and external (eg, parent and child preferences) to clinicians. CONCLUSION: Our findings highlight a discrepancy between clinicians' concerns about overprescribing and a lack of resources to support deprescribing in outpatient paediatric settings. To successfully initiate deprescribing, clinicians will need practical tools and organisational supports, as well as social resources for vulnerable families.

5.
Circ Cardiovasc Qual Outcomes ; 12(11): e006073, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31707825

RESUMO

BACKGROUND: Recent court decisions have thrown into question the Food and Drug Administration's rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians' beliefs about drug efficacy. METHODS AND RESULTS: In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%, P<0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]). CONCLUSIONS: Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.

7.
Med Decis Making ; 39(2): 100-107, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30632890

RESUMO

BACKGROUND: People often overestimate their risk of developing cancer, which can cause undue worry and unwarranted risk-reducing actions. Standard counseling has a limited and short-lived effect on correcting these misperceptions. We conducted a randomized study to evaluate whether incorporation of visual depictions of risk improves the efficacy and durability of cancer risk counseling. METHODS: Sixty-six individuals seen in the Familial Cancer Program were randomized to receive standard counseling or counseling supplemented with 2 interactive visual representations of their 10-year risk of developing the cancer type of greatest concern (enhanced counseling). The primary outcome was accuracy of self-perceived risk (ratio of perceived to objective risk) 2 weeks and 6 months after counseling. RESULTS: Prior to counseling, 80% of participants overestimated their risk. Improvement in self-perception of risk was greater among those individuals randomized to receive enhanced counseling. At the 2-week follow-up, the percentage of participants who continued to overestimate their risk by 5-fold or more was 3 to 4 times lower in those who received enhanced counseling, compared to the standard counseling group. At the 6-month follow-up, sustained improvement in risk perception was most evident among those exposed to visual depictions of their risk. Statistical significance was achieved in chi-square analysis at P < 0.05, grouping participants' risk estimate as approximately accurate (<2-fold) or different from objective risk to varying degrees. CONCLUSIONS: Overestimation of cancer risk among people with a family history of cancer is common. Counseling can improve risk perception, but individuals tend to revert back to their prior misperception 6 months after counseling. By including visual representations of risk during counseling, correction of risk perception was of greater magnitude and more durable.


Assuntos
Aconselhamento/métodos , Conhecimentos, Atitudes e Prática em Saúde , Neoplasias/psicologia , Adulto , Ansiedade/prevenção & controle , Autoavaliação Diagnóstica , Família , Feminino , Aconselhamento Genético , Humanos , Masculino , Pessoa de Meia-Idade , Percepção , Risco , Medição de Risco , Fatores de Risco , Pensamento
8.
JAMA ; 321(1): 80-96, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30620375

RESUMO

Importance: Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions. Objective: To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). Evidence: Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars. Findings: From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center. Conclusions and Relevance: Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited.


Assuntos
Publicidade Direta ao Consumidor/tendências , Doações , Regulamentação Governamental , Marketing de Serviços de Saúde/tendências , /economia , Técnicas de Laboratório Clínico , Publicidade Direta ao Consumidor/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Conhecimentos, Atitudes e Prática em Saúde , Serviços de Saúde , Marketing de Serviços de Saúde/economia , Marketing de Serviços de Saúde/legislação & jurisprudência , Medicamentos sob Prescrição , Estados Unidos , United States Federal Trade Commission , United States Food and Drug Administration
12.
J Gen Intern Med ; 33(11): 1905-1912, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30066118

RESUMO

BACKGROUND: Decades of persuasive messages have reinforced the importance of traditional screening mammography at regular intervals. A potential new paradigm, risk-based screening, adjusts mammography frequency based on a woman's estimated breast cancer risk in order to maximize mortality reduction while minimizing false positives and overdiagnosis. Women's views of risk-based screening are unknown. OBJECTIVE: To explore women's views and personal acceptability of a potential risk-based mammography screening paradigm. DESIGN: Four semi-structured focus group discussions about screening mammography and surveys before provision of information about risk-based screening. We analyzed coded focus group transcripts using a mixed deductive (content analysis) and inductive (grounded theory) approach. PARTICIPANTS: Convenience sample of 29 women (40-74 years old) with no personal history of breast cancer recruited by print and online media in New Hampshire and Vermont. RESULTS: Twenty-seven out of 29 women reported having undergone mammography screening. All participants were white and most were highly educated. Some women accepted the idea that early cancer detection with traditional screening was beneficial-although many also reported hearing inconsistent recommendations from clinicians and mixed messages from media reports about mammography. Some women were familiar with a risk-based screening paradigm (primarily related to cervical cancer, n = 8) and thought matching screening mammography frequency to personal risk made sense (n = 8). Personal acceptability of risk-based screening was mixed. Some believed risk-based screening could reduce the harms of false positives and overdiagnosis (n = 7). Others thought screening less often might result in missing a dangerous diagnosis (n = 14). Many (n = 18) expressed concerns about the feasibility of risk-based screening and questioned whether breast cancer risk estimates could be accurate. Some suspected that risk-based mammography was motivated by a desire to save money (n = 6). CONCLUSION: Some women thought risk-based screening made sense. Willingness to abandon traditional screening for the new paradigm was mixed. Broad acceptability of risk-based screening will require clearer communication about its rationale and feasibility and consistent messages from the health care team.


Assuntos
Neoplasias da Mama/psicologia , Detecção Precoce de Câncer/psicologia , Grupos Focais , Mamografia/psicologia , Sobremedicalização/prevenção & controle , Pesquisa Qualitativa , Adulto , Idoso , Neoplasias da Mama/diagnóstico por imagem , Detecção Precoce de Câncer/métodos , Reações Falso-Positivas , Feminino , Grupos Focais/métodos , Humanos , Mamografia/métodos , Pessoa de Meia-Idade
15.
BMJ ; 361: k2031, 2018 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-29794072

RESUMO

OBJECTIVES: To characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials. DESIGN: Cross sectional analysis. SETTING: Postmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017. MAIN OUTCOME MEASURES: Postmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials. RESULTS: Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline. CONCLUSIONS: Postmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated.


Assuntos
Vigilância de Produtos Comercializados/estatística & dados numéricos , United States Food and Drug Administration , Animais , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos Transversais , Humanos , Publicações/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration/estatística & dados numéricos
16.
Expert Opin Pharmacother ; 19(6): 547-560, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29596008

RESUMO

INTRODUCTION: At least 20% of children in the U.S. are highly vulnerable because they lack healthcare and protection. Several factors produce vulnerability: trauma, disruptions of parenting, poverty, involvement in the juvenile justice and/or child welfare systems, residence in restrictive settings, and problems related to developmental disabilities. These children receive psychotropic medications at high rates, raising numerous concerns. AREAS COVERED: The authors begin this review with a description of the population of highly vulnerable children. They then follow this with a review of the effectiveness and side effects of psychotropic medications for their most common diagnoses, using the highest-quality systematic reviews identified by multiple database searches. EXPERT OPINION: Highly vulnerable children receive numerous psychotropic medications with high rates of polypharmacy, off-label use, and long-term use, typically in the absence of adjunctive psychosocial interventions. The current evidence contravenes these trends. Future studies of psychotropic medications in vulnerable children should include long-term effectiveness trials and polypharmacy in conjunction with evidence-based, family-centered, psychosocial treatments.


Assuntos
Psicotrópicos/uso terapêutico , Populações Vulneráveis/psicologia , Adolescente , Criança , Feminino , Humanos , Masculino , Uso Off-Label , Polimedicação , Psicotrópicos/farmacologia
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