Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation.

This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.

Compliance to Online Retail of Electronic Nicotine Delivery Systems (ENDS) in India before and after the 2018 Ban Order of the Government of India.

Since their launch globally in 2012, electronic nicotine delivery systems (ENDS) were positioned as a harm reduction strategy and cessation device but it is yet to be proven to have clinical safety or public health benefits. Instead, recent reports suggest that the tobacco industry targeted youth and sponsored research whose evidence was used to mislead policymaking. On August 28, 2018, Ministry of Health & Family Welfare's advisory banned the sale, purchase, and trade of ENDS. A survey was done in two waves. The first survey was done between August 10 and 25 2018 all websites which sold ENDS product were mapped and documented. The survey was repeated (November 30, 2018) were after the restriction to trade on ENDS was proposed by the Department of Customs. The two waves of survey found that no website, whether comprehensive e-commerce portals or dedicated ENDS marketing platforms fully complied with government orders. National and states government enforcement agencies are currently unaware of internet-based sale of ENDS. Although some states have given specific directions to stop the sale and delivery of ENDS within the state through e-commerce, there is limited monitoring and legal compliance by seller. Public health advocates need to stay vigilant and monitor the online sale and point of sale retail of ENDS to ensure strict compliance of national and state regulations.

County-Level Recreational Marijuana Policies and Local Policy Changes in Colorado and Washington State (2012-2019).

Policy Points In 2012, Colorado and Washington were the first states to legalize recreational marijuana through voter-initiated ballots. In these states, counties could restrict or ban local marijuana facilities through a variety of regulatory methods such as ordinances and zoning. County-level recreational marijuana policies in Washington and Colorado vary substantially, with 69.2% of Washington counties and 23.4% of Colorado counties allowing all types of recreational marijuana facilities as of April 1, 2019. After Colorado and Washington legalized recreational marijuana, many counties modified their marijuana policies over time, with shifts in county policy often preceded by advocacy and information-seeking activities. CONTEXT: In 2012, Colorado and Washington were the first states to legalize recreational marijuana. Both allowed local governments to further regulate the availability of marijuana facilities in their jurisdictions. As early adopters, these states are important quasi-natural experiments to examine local marijuana policy and policy change processes, including key stakeholders and arguments. METHODS: We conducted a policy scan of county-level recreational marijuana ordinances and regulations in Colorado and Washington. Data collected included policy documents from counties in both states and newspaper articles. We used a mixed-methods approach to describe the types of county-level recreational marijuana policies enacted by April 1, 2019; identify key policy stakeholders involved in local policy debates; and explore arguments used in support or opposition of county policies. We also selected four counties that represent three county policy environments (all marijuana facility types allowed, some marijuana facility types allowed, all marijuana facility types prohibited) and described the policy changes within these counties since recreational marijuana was legalized. FINDINGS: By April 1, 2019, Colorado counties were less likely than Washington counties to allow marijuana facilities-48.4% of Colorado counties prohibited recreational marijuana facilities in their jurisdiction compared to 23.1% of Washington counties. Since state legalization, several counties in both states have made substantial marijuana facility policy modifications, often preceded by information-seeking activities. Primary stakeholders involved in policy debates included elected officials, law enforcement, individual growers/farmers, marijuana business license applicants, parents, and residents. Proponents referenced local economic gain, reduced crime, and potential health benefits of marijuana as arguments in favor of permitting local facilities, whereas opponents pointed to economic loss, negative health and public health issues, public safety concerns, and existing federal law. Both sides referenced local public opinion data to support their position. CONCLUSIONS: By early 2019, a patchwork of local marijuana policies was in place in Colorado and Washington. We identify key areas of policy and public health research needed to inform future local marijuana policy decisions, including the impact of legalization on public health outcomes (particularly for youth) and public safety.

Compliance With Cannabis Act Regulations Regarding Online Promotion Among Canadian Commercial Cannabis-Licensed Firms.

Importance: As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media. Objectives: To evaluate compliance among licensed firms with the Cannabis Act and analyze trends among violations regarding promotional material. Design, Setting, and Participants: This cross-sectional study evaluated cannabis-licensed firms after cannabis legalization. Data were extracted from online public platforms, including company websites, Facebook, Instagram, and Twitter, from October 1, 2019, to March 31, 2020. Descriptive statistics, Poisson regression, and logistic regression were used to analyze the associations of covariates with promotion violations. Main Outcomes and Measures: The primary outcome was characterization of type and prevalence of promotion violations. Secondary outcomes were the role of various covariates (namely, licensed firm characteristics and online platforms) in the frequency and probability of violations. Hypotheses were formulated before data collection. Results: Among 261 licensed firms, 211 (80.8%) had an online platform, including 204 (96.7%) with websites, 128 (60.7%) with Facebook, 123 (58.3%) with Instagram, and 123 (58.3%) with Twitter. Of all licensed firms with an online platform, 182 (86.3%) had at least 1 violation. Compared with websites, the risk of violations was significantly higher on Facebook (rate ratio [RR], 1.24; 95% CI, 1.11-1.39) and Instagram (RR, 1.19; 95% CI, 1.05-1.34). The most common violations included lack of age restrictions, brand glamorization, and omission of risk information. With websites as the reference group, lack of age restrictions was approximately 15 times more likely to occur on Facebook (odds ratio [OR], 14.76; 95% CI, 8.06-27.05); the odds of an age restriction violation were also higher on Instagram (OR, 2.48; 95% CI, 1.43-4.32) and Twitter (OR, 4.03; 95% CI, 2.29-7.09). For unsubstantiated claims, the odds of violations were significantly decreased on Facebook (OR, 0.23; 95% CI, 0.11-0.48) and Instagram (OR, 0.28; 95% CI, 0.14-0.57). The odds of glamorization were associated with an increase on Instagram (OR, 2.90; 95% CI, 1.72-4.88). Conclusions and Relevance: In this cross-sectional study, widespread violations were observed in online Canadian cannabis promotion. To protect public health and safety amid legalization, decision-makers should make explicit federal regulation and enforcement regarding promotional activities of cannabis retailers. These results suggest that policy and enforcement of cannabis promotion in Canada would have an international impact, from ease of access to online media and downstream consequences of unregulated promotion.

Looking back from 2020, how cannabis use and related behaviours changed in Canada.

BACKGROUND: The Canadian government legalized non-medical cannabis use by adults in October 2018 to minimize associated harms and redirect profits from criminals. In October 2019, a wider array of products, including edibles, was legalized, with entry into the legal market beginning in December. DATA AND METHODS: Three quarters (the first quarters of 2018 and 2019 and the fourth quarter of 2020) of the National Cannabis Survey were used to examine changes in cannabis use (overall use and daily or almost daily (DAD) use), consumption methods, products and sources. RESULTS: Cannabis use in the past three months was higher in late 2020 (20.0%) than in 2019 (17.5%) and 2018 (14.0%), and this was particularly the case among: females (for whom rates rose to equal male rates for the first time), adults aged 25 and older, and some provinces. Similarly, DAD use, at 7.9% also increased. Higher percentages of Canadians reported getting at least some of their cannabis from legal sources or growing it, and fewer were relying on friends and family or illegal sources in 2020. DISCUSSION: This study spans three years-from before legalization to about two years after. It provides a more complete picture of the law's impact on cannabis use and related behaviours, given the more established legal cannabis industry better equipped to compete with the black market on price, convenience and selection. Findings demonstrate that change is continuing, and, as before, some cautions and assurances remain. The impact of the COVID-19 pandemic on cannabis use continues to be difficult to measure. Monitoring remains important, given the ever-changing provincial retail landscapes; the introduction of new products; and the pressure by the industry to remove or adjust potency limits, and allow widespread delivery, farm-gate sales and cannabis lounges.

Why are certain age bands used for children in paediatric studies of medicines?

Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands.

General characteristics, economic burden, causative drugs and medical errors associated with medical damage litigation involving severe cutaneous adverse drug reactions in China.

WHAT IS KNOWN AND OBJECTIVE: To investigate the general characteristics, economic burden, causative drugs and medical errors associated with litigation involving severe cutaneous adverse drug reactions (SCADRs) in China, with the aims of improving rational medication use and reducing the extent of damage from SCADRs. METHODS: This study analysed 150 lawsuit judgements involving SCADRs from 2005 to 2019, collected from China Judgments Online. RESULTS AND DISCUSSION: In total, 50% of lawsuits stemmed from SCADRs occurring in general hospitals. The average time elapsed from the date of occurrence of the SCADRs to the end of litigation procedures was 1055 days. Of the patients involved, 51% were female and more than two thirds (69%) were under 60 years old. The most common outcome of SCADRs was death (39%), followed by disabilities (30%). The average responsibility of the medical provider was 48 ± 29%. The average amount of compensation was $43 424. Of the cases studied, 51% of SCADRs were Stevens-Johnson syndrome or toxic epidermal necrolysis, which together accounted for 75% of cases with known clinical subtype. The overall average economic burden of SCADRs was $99 178, of which indirect costs made up the largest proportion (more than 60%). The most common causative drug groups were antimicrobial drugs (49%), Chinese patent medicine and Chinese herbal medicine (17%), and antipyretic analgesics (16%). Finally, 61% of medical errors were found to stem from violation of duty of care, 20% from violation of informed consent and 18% from violations related to the medical record writing and management system. WHAT IS NEW AND CONCLUSION: Severe cutaneous adverse drug reactions not only severely affect patient survival and quality of life, but also impose a heavy economic burden in terms of health care and societal costs. Medical providers should be better educated on strategies to reduce risk to patients and establish mechanisms of risk sharing and management.

Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee.

This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data-UK, IQVIA Medical Research Data-France, IQVIA Medical Research Data-Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing.

The Promotion of Policy Changes Restricting Access to Codeine Medicines on Twitter: What do National Pain Organizations Say?

Codeine is one of the most common opioid medicines for treating pain. Australia introduced policy changes in February 2018 to up-schedule codeine to prescription-only medicine due to concerns of adverse effects, opioid dependency, and overdose-related mortality. This study investigated the frequency and content of messages promoted on Twitter by 4 Australian peak pain organizations, pre- and postpolicy implementation. A time series analysis examined frequency of Twitter posts over a 48-week period. Text analysis via Leximancer examined message content. Results showed that promotion and education of the pending policy change dominated the Twitter feed prior to up-scheduling. However, immediately following policy change, there was a shift in content towards promoting conferences and research, and a significant decrease in the frequency of codeine-related posts, compared to opioid-related non-codeine posts. The findings suggest that pain organizations can provide timely and educational policy dissemination in the online environment. They have implications for individuals with chronic pain who use the Internet for health information and the degree to which they can trust these sources, as well as health professionals. Further research is required to determine if public health campaigns can be targeted to prevent opioid-related harm and improve pain care via this increasingly used medium. PERSPECTIVE: This study presents a first look at what information is being communicated by influential pain organizations that have an online Twitter presence and how messages were delivered during a major policy change restricting access to codeine medicines. Insights could drive targeted future online health campaigns for improved pain management.

Motor vehicle crash fatalaties and undercompensated care associated with legalization of marijuana.

BACKGROUND: Half of the US states have legalized medical cannabis (marijuana), some allow recreational use. The economic and public health effects of these policies are still being evaluated. We hypothesized that cannabis legalization was associated with an increase in the proportion of motor vehicle crash fatalities involving cannabis-positive drivers, and that cannabis use is associated with high-risk behavior and poor insurance status. METHODS: Hawaii legalized cannabis in 2000. Fatality Analysis Reporting System data were analyzed before (1993-2000) and after (2001-2015) legalization. The presence of cannabis (THC), methamphetamine, and alcohol in fatally injured drivers was compared. Data from the state's highest level trauma center were reviewed for THC status from 1997 to 2013. State Trauma Registry data from 2011 to 2015 were reviewed to evaluate association between cannabis, helmet/seatbelt use, and payor mix. RESULTS: THC positivity among driver fatalities increased since legalization, with a threefold increase from 1993-2000 to 2001-2015. Methamphetamine, which has remained illegal, and alcohol positivity were not significantly different before versus after 2000. THC-positive fatalities were younger, and more likely, single-vehicle accidents, nighttime crashes, and speeding. They were less likely to have used a seatbelt or helmet. THC positivity among all injured patients tested at our highest level trauma center increased from 11% before to 20% after legalization. From 2011 to 2015, THC-positive patients were significantly less likely to wear a seatbelt or helmet (33% vs 56%). They were twice as likely to have Medicaid insurance (28% vs 14%). CONCLUSION: Since the legalization of cannabis, THC positivity among MVC fatalities has tripled statewide, and THC positivity among patients presenting to the highest level trauma center has doubled. THC-positive patients are less likely to use protective devices and more likely to rely on publically funded medical insurance. These findings have implications nationally and underscore the need for further research and policy development to address the public health effects and the costs of cannabis-related trauma. LEVEL OF EVIDENCE: Prognostic, level III.

Judicial demand of medications through the Federal Justice of the State of Paraná.

OBJECTIVE: To describe the profile of lawsuits related to drug requests filled at the Federal Justice of the State of Paraná. METHODS: A cross-sectional study, and the data were obtained through consulting the lawsuits at the online system of the Federal Justice of Paraná. RESULTS: Out of 347 lawsuits included in the study, 55% of plaintiffs were women, with a median age of 56 years. Oncology was the field with more requests (23.6%), and the highest mean costs. A wide variety of diseases and broad variety of requested drugs were found in the lawsuits. Approximately two-thirds of them were requested by the brand name, and the most often requested drugs were palivizumab and tiotropium bromide. Only 14.5% of the requested medicines were registered in the National Medication Register. The Public Defender's Office filled actions in 89.6% of cases and all lawsuits had an interim relief. The mean time for approval was 35 days and 70% of requests were granted. CONCLUSION: Oncology was the field with the highest demand for medicines at the Federal Justice of Paraná in 2014. A great variety of medications was requested. The Public Defender´s Office represented most lawsuits. All demands had an interim relief, and the majority of requests were granted, within an average of 35 days. OBJETIVO: Descrever o perfil das ações que solicitam medicamentos ajuizadas na Justiça Federal do Paraná. MÉTODOS: Estudo transversal descritivo, cujos dados foram obtidos por meio de consulta aos processos no sistema on-line da Justiça Federal do Paraná. RESULTADOS: Dentre os 347 processos incluídos no estudo, 55% dos autores eram mulheres, com mediana da idade de 56 anos, sendo a área mais procurada a oncologia (23,6%). A área oncológica também foi a que apresentou maiores custos médios. Foi ampla a variedade de doenças geradoras das ações e também foi consequentemente grande a variedade de medicamentos solicitados. Cerca de dois terços dos fármacos foram solicitados pelo nome comercial, e os mais requeridos foram o palivizumabe e brometo de tiotrópio. Apenas 14,5% dos medicamentos solicitados estavam cadastrados no Registro Nacional de Medicamentos. A Defensoria Pública impetrou as ações em 89,6% dos casos. Todos os processos pediam antecipação de tutela do medicamento. O tempo médio para deferimento foi de 35 dias, sendo que 70% dos pedidos foram deferidos. CONCLUSÃO: A área com maior número de casos de demanda de medicamentos na Justiça Federal do Paraná no ano de 2014 foi de Oncologia. Observou-se grande variedade de medicamentos solicitados. A maioria das ações foi impetrada pela Defensoria Pública. Todas as demandas exigiram antecipação de tutela, sendo que a maioria dos pedidos foram deferidos, num prazo médio de 35 dias.

Judicial demand of medications through the Federal Justice of the State of Paraná / Demanda judicial de medicamentos na Justiça Federal do Estado do Paraná

ABSTRACT Objective To describe the profile of lawsuits related to drug requests filled at the Federal Justice of the State of Paraná. Methods A cross-sectional study, and the data were obtained through consulting the lawsuits at the online system of the Federal Justice of Paraná. Results Out of 347 lawsuits included in the study, 55% of plaintiffs were women, with a median age of 56 years. Oncology was the field with more requests (23.6%), and the highest mean costs. A wide variety of diseases and broad variety of requested drugs were found in the lawsuits. Approximately two-thirds of them were requested by the brand name, and the most often requested drugs were palivizumab and tiotropium bromide. Only 14.5% of the requested medicines were registered in the National Medication Register. The Public Defender’s Office filled actions in 89.6% of cases and all lawsuits had an interim relief. The mean time for approval was 35 days and 70% of requests were granted. Conclusion Oncology was the field with the highest demand for medicines at the Federal Justice of Paraná in 2014. A great variety of medications was requested. The Public Defender´s Office represented most lawsuits. All demands had an interim relief, and the majority of requests were granted, within an average of 35 days.

RESUMO Objetivo Descrever o perfil das ações que solicitam medicamentos ajuizadas na Justiça Federal do Paraná. Métodos Estudo transversal descritivo, cujos dados foram obtidos por meio de consulta aos processos no sistema on-line da Justiça Federal do Paraná. Resultados Dentre os 347 processos incluídos no estudo, 55% dos autores eram mulheres, com mediana da idade de 56 anos, sendo a área mais procurada a oncologia (23,6%). A área oncológica também foi a que apresentou maiores custos médios. Foi ampla a variedade de doenças geradoras das ações e também foi consequentemente grande a variedade de medicamentos solicitados. Cerca de dois terços dos fármacos foram solicitados pelo nome comercial, e os mais requeridos foram o palivizumabe e brometo de tiotrópio. Apenas 14,5% dos medicamentos solicitados estavam cadastrados no Registro Nacional de Medicamentos. A Defensoria Pública impetrou as ações em 89,6% dos casos. Todos os processos pediam antecipação de tutela do medicamento. O tempo médio para deferimento foi de 35 dias, sendo que 70% dos pedidos foram deferidos. Conclusão A área com maior número de casos de demanda de medicamentos na Justiça Federal do Paraná no ano de 2014 foi de Oncologia. Observou-se grande variedade de medicamentos solicitados. A maioria das ações foi impetrada pela Defensoria Pública. Todas as demandas exigiram antecipação de tutela, sendo que a maioria dos pedidos foram deferidos, num prazo médio de 35 dias.

Public support for mandated nicotine reduction in cigarettes.

OBJECTIVES: We assessed public support for a potential Food and Drug Administration (FDA)-mandated reduction in cigarette nicotine content. METHODS: We used nationally representative data from a June 2010 cross-sectional survey of US adults (n = 2649) to obtain weighted point estimates and correlates of support for mandated nicotine reduction. We also assessed the potential role of political ideology in support of FDA regulation of nicotine. RESULTS: Nearly 50% of the public supported mandated cigarette nicotine reduction, with another 28% having no strong opinion concerning this potential FDA regulation. Support for nicotine reduction was highest among Hispanics, African Americans, and those with less than a high school education. Among smokers, the odds of supporting FDA nicotine regulation were 2.77 times higher among smokers who intended to quit in the next 6 months than among those with no plans to quit. CONCLUSIONS: Mandating nicotine reduction in cigarettes to nonaddictive levels may reduce youth initiation and facilitate adult cessation. The reasons behind nicotine regulation need to be communicated to the public to preempt tobacco industry efforts to impede such a regulation.

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

BACKGROUND: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. OBJECTIVE: The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. METHODS: HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. RESULTS: For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our analysis (DHPCs related to contamination/medication error). Six 'index' drugs were paired, each with one to six 'follow-on' drugs. Three concerned drug-drug interactions (DDIs); the other three were intracranial haemorrhage, neuromuscular weakness and severe skin/hepatic reactions. All but one 'follow-on' drug had information in the EPAR on that specific ADR (i.e. attention was paid to the ADR). The DDIs were addressed in pre-marketing studies and/or the SmPC. Two of the other ADRs were addressed by postmarketing surveillance commitments; intracranial haemorrhage was not addressed. Three safety issues for two 'index' drugs could not be paired with a 'follow-on' drug as no drug in the same class was approved after the corresponding DHPCs were issued. Five of the nine safety issues were added to at least one of the current SmPCs for the 'older' drugs already on the market at the time of DHPC issue. Two safety issues were already in the SmPC of the 'older' drugs at time of market approval and two were not introduced into the SmPC of 'older' drugs. Population size to assess short-term safety complied with the guidelines for four 'index', seven 'follow-on' and three 'older' drugs; population size to assess long-term safety complied for one, three and two drugs, respectively. For five drugs, EPARs did not provide adequate information on population size. No statistically significant difference in development time between 'index' and 'follow-on' drugs was found. CONCLUSION: Generally, safety issues were taken into account in the approval process of other drugs in the class. The approaches were different and determined by the nature of the ADR. Taking safety issues into account in the approval process did not seem to impact on the time taken to perform the pre-approval clinical programme.

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population-based study.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * The antiobesity drugs sibutramine and orlistat are not licensed for use in children and adolescents in the UK or USA. * Clinical trials suggest antiobesity drugs are effective and well-tolerated in obese adolescents. WHAT THIS STUDY ADDS: * Prescribing of unlicensed antiobesity drugs in children and adolescents has increased significantly in the past 8 years. * Most prescribed antiobesity drugs in children and adolescents are rapidly discontinued before patients can see clinical benefit, suggesting they are poorly tolerated or poorly efficacious. AIMS: The international childhood obesity epidemic has driven increased use of unlicensed antiobesity drugs, whose efficacy and safety are poorly studied in children and adolescents. We investigated the use of unlicensed antiobesity drugs (orlistat, sibutramine and rimonabant) in children and adolescents (0-18 years) in the UK. METHODS: Population-based prescribing data from the UK General Practice Research Database between 1 January 1999 and 31 December 2006. RESULTS: A total of 452 subjects received 1334 prescriptions during the study period. The annual prevalence of antiobesity drug prescriptions rose significantly from 0.006 per 1000 [95% confidence interval (CI) 0.0007, 0.0113] in 1999 to 0.091 per 1000 (95% CI 0.07, 0.11) in 2006, a 15-fold increase, with similar increases seen in both genders. The majority of prescriptions were made to those >or=14 years old, although 25 prescriptions were made for children <12 years old. Orlistat accounted for 78.4% of all prescriptions; only one patient was prescribed rimonabant. However, approximately 45% of the patients ceased orlistat and 25% ceased sibutramine after only 1 month. The estimated mean treatment durations for orlistat and sibutramine were 3 and 4 months, respectively. CONCLUSIONS: Prescribing of unlicensed antiobesity drugs in children and adolescents has dramatically increased in the past 8 years. The majority are rapidly discontinued before patients can see weight benefit, suggesting they are poorly tolerated or poorly efficacious when used in the general population. Further research into the effectiveness and safety of antiobesity drugs in clinical populations of children and adolescents is needed.

Ethics, law, and pain management as a patient right.

Ethical and legal considerations in pain management typically relate to 2 issues. The first refers to pain management as a human right. The second involves the nature of the patient-physician relationship as it relates to pain management. Although pain physicians often like to think of pain management as a human right, it remains difficult to support this position as a point of law or as a matter of ethics. Medical organizations generally do not define pain management as a specific duty of the physician, apart from the provision of competent medical care. To date, neither law nor ethics creates a duty of care outside of the traditional patient-physician relationship. Absent a universal duty, no universal right exists. Pursuing pain management as a fundamental human right, although laudable, may place the power of the government in the middle of the patient-physician relationship. Despite apparent altruistic motives, attempts to define pain management as a basic human right could have unintended consequences, such as nationalization of medicine to ensure provision of pain management for all patients.

National drug control policy and prescription drug abuse: facts and fallacies.

In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects, addiction and abuse. The multiple reasons for continued escalation of prescription drug abuse and overuse are lack of education among all segments including physicians, pharmacists, and the public; ineffective and incoherent prescription monitoring programs with lack of funding for a national prescription monitoring program NASPER; and a reactive approach on behalf of numerous agencies. This review focuses on the problem of prescription drug abuse with a discussion of facts and fallacies, along with proposed solutions.

The EU-regulation on medicinal products for paediatric use: impacts on child and adolescent psychiatry and clinical research with minors.

BACKGROUND: At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe. METHOD: The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors. RESULTS: The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.