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1.
BMC Public Health ; 24(1): 422, 2024 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-38336621

RESUMO

BACKGROUND: Eye examinations and eyeglasses acquisition are typically integrated into a cohesive procedure in China. We conducted a randomized controlled trial using incognito standardized patient (SP) approach to evaluate the impact of separating eyeglasses sales on the accuracy of final prescription. METHODS: 52 SPs were trained to provide standardized responses during eye examinations, and undergoing refraction by a senior ophthalmologist at a national-level clinical center. SPs subsequently received eye examinations at 226 private optical shops and public hospitals in Shaanxi, northwestern China. The visits were randomly assigned to either control group, where SPs would typically purchase eyeglasses after refraction, or treatment group, where SPs made an advance declaration not to purchase eyeglasses prior to refraction. The dioptric difference between the final prescriptions provided by local refractionists and expert in the better-seeing eye was determined using the Vector Diopteric Distance method, and the completeness of exams was assessed against national standards. Multiple regressions were conducted to estimate the impact of no eyeglasses sales on the accuracy of the final prescription of local refractionists, as well as the completeness of examinations. RESULTS: Among 226 eye exams (73 in public hospitals, 153 in private optical shops), 133 (58.8%) were randomized to control group and 93 (41.2%) to no eyeglasses sales group. The inaccuracy rate of final prescriptions provided by local refractionists (≥ 1.0 D, experts' final prescription as the reference) was 25.6% in control group, while 36.6% in no-sale group (P = 0.077). The likelihood of providing inaccurate final prescriptions was significantly higher in no-sale group compared to control group (OR = 1.607; 95% CI: 1.030 to 2.508; P = 0.037). This was particularly evident in private optical shops (OR = 2.433; 95% CI: 1.386 to 4.309; P = 0.002). In terms of process quality, the no-sale group performed significantly less subjective refraction (OR = 0.488; 95% CI: 0.253 to 0.940; P = 0.032) and less testing SP's own eyeglasses (OR = 0.424; 95% CI: 0.201 to 0.897; P = 0.025). The duration of eye exams was 3.917 min shorter (95% CI: -6.798 to -1.036; P = 0.008) in no-sale group. CONCLUSIONS: Separating eyeglasses sales from optical care could lead to worse quality of eye care. Policy makers should carefully consider the role of economic incentives in healthcare reform.


Assuntos
Erros de Refração , Humanos , Erros de Refração/diagnóstico , Erros de Refração/terapia , Acuidade Visual , Óculos , Refração Ocular , China
2.
Int J Equity Health ; 20(1): 12, 2021 01 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407503

RESUMO

BACKGROUND: Since 2015, all pilot cities of public hospital reform in China have allowed the zero-markup drug policy and implemented the policy of Separating of Hospital Revenue from Drug Sales (SHRDS). The objective of this study is to evaluate whether SHRDS policy reduces the burden on patients, and to identify the mechanism through which SHRDS policy affects healthcare expenditure. METHODS: In this study, we use large sample data of urban employee's healthcare insurance in Chengdu, and adopt the difference in difference model (DID) to estimate the impact of the SHRDS policy on total healthcare expenditures and drug expenditure of patients, and to provide empirical evidence for deepening medical and health system reform in China. RESULTS: After the SHRDS policy's implementation, the total healthcare expenditure kept growing, but the growth rate slowed down between 2014 to 2015. The total healthcare expenditure of patients decreased by only 0.6%, the actual reimbursement expenditure of patients decreased by 4.1%, the reimbursement ratio decreased by 2.6%. and the drugs expenditure dropped by 14.4%. However, the examinations expenditure increased by 18.2%, material expenditure increased significantly by 38.5%, and nursing expenditure increased by 12.7%. CONCLUSIONS: After implementing the SHRDS policy, the significant reduction in drug expenditure led to more physicians inducing patients' healthcare service needs, and the increased social healthcare burden was partially transferred to the patients' personal economic burden through the decline in the reimbursement ratio. The SHRDS policy is not an effective way to control healthcare expenditure.


Assuntos
Custos de Medicamentos/estatística & dados numéricos , Reforma dos Serviços de Saúde/economia , Reforma dos Serviços de Saúde/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Assistência Médica/economia , Preparações Farmacêuticas/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , China , Feminino , Programas Governamentais/economia , Programas Governamentais/estatística & dados numéricos , Política de Saúde , Hospitais Públicos/economia , Hospitais Públicos/estatística & dados numéricos , Humanos , Masculino , Assistência Médica/estatística & dados numéricos , Pessoa de Meia-Idade
3.
Pharmacoepidemiol Drug Saf ; 27(6): 638-644, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29655296

RESUMO

The consumption of medication, especially over-the-counter drugs, can reflect environmental exposure with a lesser degree of severity in terms of morbidity. The non-linear effects of maximum and minimum apparent temperature on respiratory drug sales in A Coruña from 2006 to 2010 were examined using a distributed lag nonlinear model. In particular, low apparent temperatures proved to be associated with increased sales of respiratory drugs. The strongest consistent risk estimates were found for minimum apparent temperatures in respiratory drug sales with an increase of 33.4% (95% CI, 12.5%-58.0%) when the temperature changed from 2.8°C to -1.4 °C. These findings may serve to guide the planning of public health interventions to predict and manage the health effects of exposure to the thermal environment for lower degrees of morbidity. More precisely, significant increases in the use of measured over-the-counter medication could be used to identify and anticipate influenza outbreaks due to a more sensitive degree of the data source.


Assuntos
Revisão de Uso de Medicamentos/estatística & dados numéricos , Exposição Ambiental/efeitos adversos , Influenza Humana/tratamento farmacológico , Medicamentos sem Prescrição/uso terapêutico , Estações do Ano , Idoso , Temperatura Baixa , Surtos de Doenças/prevenção & controle , Temperatura Alta , Humanos , Influenza Humana/epidemiologia , Influenza Humana/etiologia , Pessoa de Meia-Idade , Dinâmica não Linear , Fatores de Risco , Espanha/epidemiologia , Fatores de Tempo
4.
Int J Legal Med ; 130(5): 1209-16, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26987318

RESUMO

The fatal toxicity index (FTI) is the absolute number of fatal poisonings caused by a particular drug divided by its consumption figure. Consequently, it is a useful measure in evaluating toxicity of the drug and its relevance in fatal poisonings. In this study, we assessed the FTI of medicinal drugs in 3 years (2005, 2009, and 2013) in Finland. As the measure of drug consumption, we used the number of defined daily doses (DDD) per population in each year. There were 70 medicinal drugs in Finland for which the mean FTI expressed as the number of deaths per million DDD over the three study years was higher or equal to 0.1. The Anatomical Therapeutic Chemical (ATC) classification system was used for the classification of the active ingredients of medicinal drugs according to the organ or system which they act on. Of these 70 drugs, 55 drugs (78.6 %) acted on the nervous system (denoted by ATC code N), 11 (15.7 %) on the cardiovascular system (C), three (4.3 %) on the alimentary tract and metabolism (A), and one (1.4 %) on the musculoskeletal system (M). The nervous system drugs consisted of 20 psycholeptics, (ATC code N05), 20 psychoanaleptics (N06), eight analgesics (N02), six antiepileptics (N03), and one other nervous system drug (N07). The highest individual FTIs were associated with the opioids methadone, dextropropoxyphene, oxycodone, tramadol, and morphine; the antipsychotics levomepromazine and chlorprothixene; and the antidepressants doxepin, amitriptyline, trimipramine, and bupropion. Buprenorphine was not included in the study, because most of the fatal buprenorphine poisonings were due to smuggled tablets. A clearly increasing trend in FTI was observed with pregabalin and possibly with bupropion, both drugs emerging as abused substances.


Assuntos
Intoxicação/mortalidade , Acidentes/mortalidade , Bases de Dados de Produtos Farmacêuticos , Uso de Medicamentos/estatística & dados numéricos , Finlândia/epidemiologia , Toxicologia Forense , Humanos , Preparações Farmacêuticas , Suicídio/estatística & dados numéricos
5.
Subst Use Misuse ; 50(6): 721-32, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25774919

RESUMO

We examine gender and meanings of risk in interviews (2007-2010) with gang-involved young men and women (n = 253) engaged in illicit drug sales in San Francisco, California. The in-depth interviews from this NIDA-funded study were coded using the software NVivo to identify patterns and themes. We examine their interpretations of the risks of drug-selling and their narratives about gender differences in these risks. We find distinct discourses regarding the role of femininities and masculinities and male and female bodies in shaping risk as well as the nexus between gender, family, and risk for female drug sellers.


Assuntos
Comportamento do Adolescente , Comércio , Drogas Ilícitas , Delinquência Juvenil , Adolescente , Adulto , Feminino , Identidade de Gênero , Humanos , Entrevistas como Assunto , Masculino , Pesquisa Qualitativa , Medição de Risco , São Francisco , Fatores Sexuais , Meio Social , Adulto Jovem
6.
Ther Innov Regul Sci ; 58(5): 855-862, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38773058

RESUMO

Two frequently cited figures by clinical research insiders and observers - the cost of missing a day to generate prescription drug sales and the cost of a day to conduct a clinical trial - are outdated and based on anecdotal evidence. In late 2023, the Tufts Center for the Study of Drug Development conducted empirical research to gather more accurate and granular estimates and to test whether average sales per day have changed over time. 645 drugs launched since 2000, and 409 clinical trial budgets were drawn from commercially available and proprietary data sets and analyzed. The results indicate that a single day equals approximately $500,000 in lost prescription drug or biologic sales, with daily prescription sales for infectious, hematologic, cardiovascular, and gastrointestinal diseases among the highest. The results also show that each year, the average sales per day of prescription drugs and biologics has decreased by approximately $80,000-$100,000. The estimated direct daily cost to conduct a clinical trial is approximately $40,000 per day for phase II and III clinical trials, with those in respiratory, rheumatology, and dermatology having the highest relative daily direct costs.


Assuntos
Desenvolvimento de Medicamentos , Desenvolvimento de Medicamentos/economia , Humanos , Ensaios Clínicos como Assunto/economia , Medicamentos sob Prescrição/economia , Fatores de Tempo , Comércio/economia
7.
Artigo em Inglês | MEDLINE | ID: mdl-36554903

RESUMO

The market of over-the-counter drugs, so-called OTC drugs, is a dynamically developing market driven primarily by self-medication. Their use does not require consultation with a physician, and the patients themselves decide to take them. The distribution of OTC medications in the pharmaceutical market in Poland is diversified. These drugs could be purchased at a pharmacy but also at a supermarket, gas station, or via the internet. The low involvement of public funds in spending on drugs, a relatively small percentage of pharmacy sales of reimbursable prescription drugs, and the difficult access to physicians or general consent to drug advertising all create ideal conditions for creating demand for these drugs. Among the European countries, Poland also has the largest share of OTC drugs in the entire pharmaceutical market, and the percentage of OTCs (without supplements) in the whole drug market in Poland continues to grow. Unfortunately, the non-pharmacy market for the sale of OTC drugs is not adequately controlled in practice, and Polish legal regulations regarding the sale of medicines outside pharmacies are among the most liberal in the European Union. However, this does not change the general attitude of consumers toward purchasing OTC drugs. In fact, further growth of the OTC drug market is forecast. Self-medication will undoubtedly play an important role in the trends which may shape this market in the coming years.


Assuntos
Medicamentos sem Prescrição , Assistência Farmacêutica , Humanos , Polônia , Medicamentos sem Prescrição/efeitos adversos , Automedicação , Comércio
8.
Indian J Tuberc ; 68(1): 51-58, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33641851

RESUMO

BACKGROUND: No Indian studies have assessed the implementation of recent policy on pharmacy based surveillance and its contribution in TB notification. So, this study was conducted with objectives to describe: a) pharmacy based TB surveillance and TB notification, and b) experiences of pharmacy based surveillance implementation from the programme managers and pharmacists perspective. METHODS: A mixed methods study-quantitative (cross-sectional) and qualitative (in-depth interviews) in two selected districts Dharmapuri and Salem districts of Tamil Nadu State, India. RESULTS: In 2018, 45 (11%) of 397 pharmacies in Dharmapuri and 90 (6%) of 1457 pharmacies in Salem districts reported sale of anti-TB drugs to 1307 and 1673 persons respectively. Upon validation through direct patient contact 942 (72%) persons in Dharmapuri and 863 (52%) persons were identified as previously 'un-notified' TB patients. These patients constituted 20% and 29% of the total TB cases notified in Dharmapuri and Salem respectively. The enablers for implementing this activity were: understanding the importance of notification, availability of resources (manpower, computers) to record, report and validate the patient data, repeated trainings and partnerships. The barriers were: patients' hesitancy to share their details to pharmacists (confidentiality), cumbersome recording and reporting process, difficulties in recording patient details during high workload busy business hours. CONCLUSION: This process contributed about one-fourth of the TB patients notified in these districts. Its implementation needs to be strengthened and should be scaled up in other parts of the country.


Assuntos
Avaliação de Resultados em Cuidados de Saúde , Assistência Farmacêutica , Vigilância da População , Tuberculose Pulmonar/epidemiologia , Antituberculosos/economia , Antituberculosos/uso terapêutico , Comércio/estatística & dados numéricos , Estudos Transversais , Humanos , Índia/epidemiologia , Entrevistas como Assunto , Programas Nacionais de Saúde , Tuberculose Pulmonar/tratamento farmacológico
9.
Int J Drug Policy ; 91: 102969, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33041184

RESUMO

BACKGROUND: Illicit drugs are increasingly sold on cryptomarkets and on social media. Buyers and sellers perceive these online transactions as less risky than conventional street-level exchanges. Following the Risks & Prices framework, law enforcement is the largest cost component of illicit drug distribution. We examine whether prices on cryptomarkets are lower than prices on social media and prices reported by law enforcement on primarily offline markets. METHODS: Data consists of online advertisements for illicit drugs in Sweden in 2018, scraped from the cryptomarket Flugsvamp 2.0 (n = 826) and collected with digital ethnography on Facebook (n = 446). Observations are advertisements for herbal cannabis (n = 421), cannabis resin, hash (n = 594), and cocaine (n = 257) from 156 sellers. Prices are compared with estimates from Swedish police districts (n = 53). Three multilevel linear regression models are estimated, one for each drug type, comparing price levels and discount elasticities for each platform and between sellers on each platform. RESULTS: Price levels are similar on the two online platforms, but cocaine is slightly more expensive on social media. There are quantity discounts for all three drug types on both platforms with coefficients between -0.10 and -0.21. Despite the higher competition between sellers on cryptomarkets, prices are not lower compared to social media. Online price levels for hash and cocaine are similar to those reported by police at the 1 g level. CONCLUSION: Mean prices and quantity discounts are similar in the two online markets. This provides support for the notion that research on cryptomarkets can also inform drug market analysis in a broader sense. Online advertisements for drugs constitute a new detailed transaction-level data source for supply-side price information for research.


Assuntos
Tráfico de Drogas , Drogas Ilícitas , Mídias Sociais , Comércio , Humanos , Polícia , Suécia
10.
Ther Innov Regul Sci ; 54(3): 544-551, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-33301139

RESUMO

BACKGROUND: Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies-the cost calculation method- refers extensively to the prediction of drug sales in establishing drug prices. Deviations from predicted sales can induce disproportionate drug prices and unexpected pharmaceutical expenditures. This study aimed to estimate the upward deviation of actual sales from predicted sales and to explore the predictors of such upward deviation. METHODS: Estimates of upward deviation in 2015 were produced for new molecular entities (NMEs) approved in 2006-2015. To identify the predictors associated with upward deviation through binary logistic regression analyses, sales within 3 years of launch and in the predicted year in which peak sales would be reached were used. RESULTS: Estimated upward deviation was more than 1220 billion yen in 2015 for the targeted drugs. Drugs priced by the cost calculation method or by obtaining additional indications were significantly more likely to show an upward deviation from predicted peak sales. CONCLUSIONS: There is substantial upward deviation between actual and predicted drug sales in Japan. So long as drug sales predictions are used in drug price calculations, a flexible repricing system is needed to buffer unexpected pharmaceutical expenditures.


Assuntos
Custos de Medicamentos , Preparações Farmacêuticas , Custos e Análise de Custo , Gastos em Saúde , Japão
11.
Ther Innov Regul Sci ; : 2168479019860123, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-31311310

RESUMO

BACKGROUND: Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies-the cost calculation method- refers extensively to the prediction of drug sales in establishing drug prices. Deviations from predicted sales can induce disproportionate drug prices and unexpected pharmaceutical expenditures. This study aimed to estimate the upward deviation of actual sales from predicted sales and to explore the predictors of such upward deviation. METHODS: Estimates of upward deviation in 2015 were produced for new molecular entities (NMEs) approved in 2006-2015. To identify the predictors associated with upward deviation through binary logistic regression analyses, sales within 3 years of launch and in the predicted year in which peak sales would be reached were used. RESULTS: Estimated upward deviation was more than 1220 billion yen in 2015 for the targeted drugs. Drugs priced by the cost calculation method or by obtaining additional indications were significantly more likely to show an upward deviation from predicted peak sales. CONCLUSION: There is substantial upward deviation between actual and predicted drug sales in Japan. So long as drug sales predictions are used in drug price calculations, a flexible repricing system is needed to buffer unexpected pharmaceutical expenditures.

12.
Int J Drug Policy ; 58: 113-120, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29908515

RESUMO

BACKGROUND: Many efforts have been undertaken to construct an overview of various aspects of illicit drug distribution in the United Kingdom. Yet given that national, regional, and local differences can be profound, this has proven difficult, to the extent that Scotland has been largely excluded from the conversation. In addition, the level of supply being examined, the drug type, and the actors involved only add to confusion and vast differences between some findings. METHOD: The current study aims to provide a holistic account, as best as possible considering variations of illegal drug supply in illicit networks, by focusing in on a particular geographical context (Scotland) and addressing drug supply at all levels. It is informed by in-depth interviews with 42 offenders involved in drug distribution from retail to wholesale/middle market to importation levels. RESULTS: Findings indicate Scotland's importation and distribution is evolving owing to increasingly adaptive risk mitigation by importers and distributors, and market diversification of both product and demand. While a hierarchical model still dominates the market, commuting or 'county lines' and increasing demand for drugs such as cannabis, but also anabolic steroids and psychoactive substances, means that home growing, online purchasing, and street-level dealership is common. CONCLUSION: The findings have the capacity to further inform police and practitioners about the diverse and evolving nature of drug distribution in Scotland (with a particular focus on the west of the country), so that they may become more effective in improving the safety and wellbeing of people, places and communities.


Assuntos
Comércio/métodos , Tráfico de Drogas/economia , Tráfico de Drogas/tendências , Drogas Ilícitas/economia , Drogas Ilícitas/provisão & distribuição , Humanos , Escócia
13.
Int J Drug Policy ; 54: 68-76, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29414488

RESUMO

In the US, prescription stimulants are prescribed for a variety of conditions including attention deficit hyperactivity disorder (ADHD) and narcolepsy. Over the last two decades, dramatic increases in stimulant prescriptions have led to greater availability and increased risk for diversion and nonmedical use. Our own and other investigators' findings indicate that many drug "suppliers" do not fit into the traditional image of drug "dealers." These suppliers typically do not identify themselves as "dealers," but instead understand their drug distribution as sharing with people they know. Coomber and colleagues' (2007; 2013) concept of "social supply" raises the question: When friends supply or facilitate supply of drugs to friends, is this really dealing? Further, if dealing and supplying are distinct kinds of social transactions, should different types of criminal justice approaches be applied? Social supply extends our understanding of drug dealing as a complex social activity. In this article, we examine the issue of social supply among nonmedical users of prescription stimulants. We conducted a 36-month National Institute on Drug Abuse-funded project to conduct a qualitative, mixed methods study of 150 adult nonmedical prescription stimulant users in the San Francisco Bay Area. We explore intersecting factors, including life stage and social location, that contribute to decisions to use prescription stimulants nonmedically, motivations to use, knowledge about risks and benefits of prescription stimulant use, any adverse health or social consequences experienced, availability, acquisition and diversion of prescription stimulants, and differences in attitudes and behaviours. For this analysis, we rely on participants' narratives concerning prescription stimulant acquisition practices and how they understood these interactions, purchases, and exchanges with the suppliers of prescription stimulants in their social networks. The authors argue that acknowledging the distinction between social supply and "proper" drug dealing would redress the disparity between drug sharing and profiteering particularly regarding criminal sentencing.


Assuntos
Estimulantes do Sistema Nervoso Central/efeitos adversos , Tráfico de Drogas/psicologia , Usuários de Drogas/psicologia , Uso Indevido de Medicamentos sob Prescrição/psicologia , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , São Francisco , Adulto Jovem
14.
J Addict Res Ther ; 7(2)2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27274903

RESUMO

Household space allocation by women who consume drugs in New York and North Florida is depicted to demonstrate the complex character of household space and social relations. Some parents attempt to hide their drug consumption through the allocation space in the household for drug use. Women allocation of space for drug use within their households and the impact of this on the household are relevant issues with implications for therapy and prevention. OBJECTIVE: The use of household space has not been a focus of social scientists. Middle class households have been used by decoration literature to specify space utilization. Modest literature pay attention to the utilization of household space among drug focused households. Analysis herein looks at the lived social relations of drug users to their children through controlling household space. METHODS: Data presented comes from two studies, New York and Florida. The studies involved a total of 158 participants in 72 families from New York and 26 participants in 23 families in North Florida. Both researches used an ethnographic methodology focusing on a variety of behavior patterns and conduct norms occurring within drug abusing households. Repeated interviews and observations took place in households which were visited at different times and days of the week. Florida study was conducted over a 2-year period; New York study took place over a 5-year period. RESULTS: Data suggest parents attempted to conceal their drug use from their offspring by using various strategies. Mental, social, and physical were tied together in space allocation. Household space acquired a different meaning and arose from use practice. CONCLUSION: In urban and rural settings a pattern of household allocation space and drug consumption is emerging. Although drug consumption is still prominent, it is not all consuming or the primary focus in the lives of women who use drugs. These women may have learned to integrate their consumption into their daily household/family life through the reallocation of space in their homes.

15.
Iran J Pharm Res ; 14(2): 651-6, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25901174

RESUMO

Prescribing behavior of physicians affected by many factors. The present study is aimed at discovering the simultaneous effects of the evaluated factors (including: price, promotion and demographic characteristics of physicians) and quantification of these effects. In order to estimate these effects, Fluvoxamine (an antidepressant drug) was selected and the model was figured out by panel data method in econometrics. We found that insurance and advertisement respectively are the most effective on increasing the frequency of prescribing, whilst negative correlation was observed between price and the frequency of prescribing a drug. Also brand type is more sensitive to negative effect of price than to generic. Furthermore, demand for a prescription drug is related with physician demographics (age and sex). According to the results of this study, pharmaceutical companies should pay more attention to the demographic characteristics of physicians (age and sex) and their advertisement and pricing strategies.

16.
Pediatrics ; 134(2): e512-8, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25022732

RESUMO

BACKGROUND: Besides vaccines and otitis media medicines, most products prescribed for children have not been studied in the pediatric population. To remedy this, Congress enacted legislation in 1997, known as pediatric exclusivity (PE), which provides 6 months of additional market protection to drug sponsors in exchange for studying their products in children. METHODS: We reviewed requests for pediatric studies and subsequent labeling for drugs granted PE from 1998 through 2012. Regression analysis estimates the probability of demonstrating efficacy in PE trials. Variables include therapeutic group, year of exclusivity, product sales, initiation process, and small disease population. RESULTS: From 1998 through 2012, the US Food and Drug Administration issued 401 pediatric study requests. For 189 drugs, studies were completed and granted exclusivity. A total of 173 drugs (92%) received new pediatric labeling, with 108 (57%) receiving a new or expanded pediatric indication. Three drugs had non-efficacy trials. Efficacy was not established for 78 drugs. Oncology, cardiovascular, and endocrine drugs were less likely to demonstrate efficacy (P < .01) compared with gastrointestinal and pain/anesthesia drugs. Drugs studied later in the program were less likely to demonstrate efficacy (P < .05). Sales, initiation process, and small disease population were not significant predictors. CONCLUSIONS: Most drugs (173; 92%) granted exclusivity added pediatric information to their labeling as a result of PE, with 108 (57%) receiving a new or expanded pediatric indication. Therapeutic area and year of exclusivity influenced the likelihood of obtaining a pediatric indication. Positive and negative outcomes continue to inform the construct of future pediatric trials.


Assuntos
Indústria Farmacêutica/economia , Rotulagem de Medicamentos , Tratamento Farmacológico , Marketing , Seleção de Pacientes , Sujeitos da Pesquisa , Ensaios Clínicos como Assunto , Aprovação de Drogas , Humanos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
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