Prescription of off-label and unlicensed medication for newborns hospitalized in the Intensive Care Unit / Prescrição de medicamentos off-label e não licenciados para neonatos hospitalizados na Unidade de Terapia Intensiva

ABSTRACT Objective: To analyze the prevalence of off-label and unlicensed prescriptions for a population of neonates admitted to the Neonatal Intensive Care Unit in a hospital in southern Santa Catarina. Methods: Observational study with a cross-sectional design. All neonates admitted to the Intensive Care Unit during the period from March 2020 to March 2021 were included. Data collection was performed through a questionnaire made by the authors and the classification of drugs based on the Electronic Drug Description (Bulário Eletrônico) of the Brazilian Health Regulatory Agency and Drug Dex-Micromedex. Results: Data from 296 neonates were evaluated. The prevalence was 50,7% for prescribing off-label medications and 37,2% for unlicensed medications. The use of drugs was higher in preterm neonates, with low birth weight, 1st minute Apgar between 6-8, 5th minute Apgar between 7-8, and in need of invasive procedures. The most used off-label drugs were ampicillin, gentamicin and fentanyl (92.6, 92.0 and 26.6%, respectively), whereas the most used unlicensed drugs were caffeine, phenobarbital and bromopride (78.1, 16.3 and 10.9%, respectively). Conclusions: This study showed a large percentage of prescriptions made in the off-label (50.7%) and unlicensed (37.2%) form in the Neonatal Intensive Care Unit, corroborating the worrying world scenario. The most exposed neonates were precisely the most vulnerable ones and, among the most commonly prescribed medications, ampicillin and gentamicin stood out in off-label form and caffeine in unlicensed form.

RESUMO Objetivo: Analisar a prevalência de prescrições off-label e não licenciadas uma população de neonatos internados na Unidade de Terapia Intensiva Neonatal em um hospital ao sul de Santa Catarina. Métodos: Estudo observacional com delineamento transversal. Foram incluídos todos os neonatos admitidos na Unidade de Terapia Intensiva durante o período de março de 2020 a março de 2021. A coleta de dados foi realizada a partir de questionário elaborado pelos autores, e a classificação dos medicamentos, com base no Bulário Eletrônico da Agência Nacional de Vigilância Sanitária e no Drug Dex-Micromedex. Resultados: Foram avaliados dados de 296 neonatos. A prevalência foi de 50,7% para prescrição de medicações off-label e 37,2% para medicações não licenciadas. O uso dos fármacos foi maior em neonatos pré-termo, com baixo peso ao nascer, Apgar de 1o minuto entre 6-8, Apgar de 5o minuto entre 7-8, e com necessidade de procedimentos invasivos. Os fármacos off-label mais utilizados foram a ampicilina, gentamicina e fentanil (92,6, 92 e 26,6%, respectivamente), já os fármacos não licenciados mais utilizados foram a cafeína, fenobarbital e bromoprida (78,1, 16,3 e 10,9%, respectivamente). Conclusões: O estudo demonstrou grande porcentagem de prescrições realizadas de forma off-label (50,7%) e não licenciada (37,2%) na Unidade de Terapia Intensiva Neonatal de análise, corroborando o preocupante cenário mundial. Os neonatos mais expostos foram justamente aqueles mais vulneráveis e, entre as medicações mais utilizadas, destacam-se a ampicilina e a gentamicina de modo off-label e a cafeína de modo não licenciado.

Analysis of the punishment on unlicensed medical practice in Jinshan District of Shanghai / 上海预防医学

ObjectiveThis paper analyzed the punishment situation of unlicensed medical practice in recent 7 years in Jinshan District of Shanghai， then suggested the countermeasures to prevent and combat unlicensed medical practice in the future. MethodsA total of 190 cases of unlicensed medical practice from 2016 to 2022 were investigated. The basic situation of the punishment，legal basis，subject distribution，clue source and individual characteristics were analyzed. ResultsThe case-filing number of unlicensed medical practice showed a decreasing trend，but the amount of fines increased obviously. The clues of investigation and punishment of unlicensed medicine practice were mainly found by inspection（32.11%） and transferred from other departments（28.42%）， while the number of complaints and clues reported from grassroots increased year by year. Medical and dental were the two major unlicensed practice，accounting for 35.79% and 33.16%， respectively. In addition， unlicensed medical cosmetology practice was increasing year by year. 78.62% of the unlicensed medical practioners are immigrants， 62.76% of them aged between 31 and 50 years old， among them 70.34% are men， and 62.76% of them have a fixed place. ConclusionThough the prevention and crack-down on unlicensed medical practice has achieved significant achievements，it is still necessary to enhance the responsibility of local administration，strengthen the inspection，investigate and deal with cases jointly by multiple departments，and implement the comprehensive supervision mechanism of the health care industry.

Pattern Of Prescription And Utilization Of Off-Label And Unlicensed Drugs Among Pediatric Patients Attending Outpatients Department Of Tertiary Care Teaching Hospital Of Gujarat State

Objectives: To determine the pattern of prescription and utilization of off-label and unlicensed drugs among pediatric patients attending outpatients department of tertiary care teaching hospital of Gujarat state. AMethods: prospective study was conducted for 6 months among 140 pediatric patients attending outpatient department of Gujarat Medical Education and Research Society Medical College, Dharpur, Patan. The demographic details and complete prescription were noted in predesigned form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classified by using Anatomical Therapeutic Chemical classification. Out of 481Results: drugs prescribed, the pattern of distribution of off-label and unlicensed drugs were 215(44.7%) and 3(0.6%) respectively. Majority (n=151, 70.2%) of off-label drugs prescribed among 1-12 years age group. Most of off-label drugs were prescribed for indication of respiratory system (68%). The findings of this study showed a highConclusion: incidence of off-label prescribing mainly antibiotics for respiratory disease

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos / Off-label and unlicensed drugs in the pediatric field: a descriptive review of the last ten years

A falta de medicamentos contendo bulas prevendo o tratamento de pacientes pediátricos representa um problema frequentemente observado em hospitais, principalmente nos setores de unidade de terapia intensiva (UTI) pediátrica e neonatais. Sabe-se que, para que um tratamento seja considerado seguro e eficaz, uma série de estudos clínicos são necessários, no entanto, relata-se um baixo número dessas pesquisas envolvendo crianças, principalmente devido a questões éticas que dificultam a condução das mesmas. Assim, poucos são os medicamentos que provam ser adequados para o tratamento desses pacientes, tornando necessário recorrer ao uso de medicamentos off-label e não licenciados. Os medicamentos são classificados como off-label quando seu uso se dá de maneira que difere de suas especificações aprovadas, por sua vez, produtos não licenciados são classificados desta forma por não possuírem aprovação para sua comercialização no país ou não possuírem comprovação de segurança e eficácia. O preparo de protocolos de estudo organizados, relato de informações aos pais e à criança de maneira clara e objetiva, aproximação entre pesquisadores e pais para o estabelecimento de uma relação de confiança e a condução das pesquisas em momentos de disponibilidade da família demonstram-se estratégias importantes para facilitar a realização dos ensaios clínicos.

The lack of medicines containing drug information leaflets considering the treatment of pediatric patients is a problem frequently observed in hospitals, especially in the pediatric and neonatal intensive care unit (ICU) sectors. It is known that, for a treatment to be considered safe and effective, a series of clinical studies are necessary; however, a low number of these studies involving children are reported, mainly due to ethical issues that make conducting them difficult. Thus, few drugs prove to be suitable for treating these patients, making it necessary to resort to using off-label and unlicensed drugs. Drugs are classified as off-label when their use differs from their approved specifications, in turn, unlicensed products are classified in this way due to not having approval for marketing in the country or do not have proof of safety and efficacy. Preparation of organized study protocols, reporting information to parents and the child in a clear and objective way, bringing researchers and parents closer to establish a relationship of trust and conducting research at moments when the family is available are important strategies to facilitate conducting clinical trials.

A Descriptive Summary Of Unlicensed Dental Practice

@#Despite the fines and action taken by authorities against illegal dental practise, it could not be eliminated and remain a threat to the public’s oral health. The aim of this study was to gather holistic evidence on unlicensed dental practice by collating news coverage, scientific research publications, and information on social media activities of illegal dental practitioners. Information on news coverage was collated via Google, Yahoo and Bing while information on research publications was obtained through three databases, Scopus, Pubmed and Google Scholar. Public data from Facebook and Instagram were extracted to gain information on illegal dental services actively provided. Out of 195 news reported regarding unlicensed dental practitioner, only 110 news reported on legal actions received with 81 news reports were on financial punishments, and the rest was on jail terms or probation. For scientific publications, only 13 related publications were found, and the majority were case reports. Despite having a law that stated an unlicensed dentist would be punished, there were more than 170 Facebook, and Instagram users with thousands of followers found actively offering illegal dental services to the public. In conclusion, not much attention was paid by the scientific community on illegal dental practice despite it being a significant public health issue and covered quite thoroughly in the news, and services are still actively offered through social media. This descriptive report helps give a holistic perspective on the illegal dental service providers issue, especially in Malaysia.

Unlicensed and Off-labelled Use of Medicines among Adult Patients in Intensive Care Unit, Universiti Kebangsaan Malaysia Medical Centre / Jurnal Sains Kesihatan Malaysia

@#The use of medicines in unlicensed and off-label manner for adults is less common with limited research compared to children. This research was carried out to characterise unlicensed and off-label use of medicines in adult intensive care patients of a hospital in Malaysia. Data on medications prescribed to patients were collected from the patients’ medical records and the unlicensed and off-label status for each medicine were determined. Forty nine (73.1%) and 20 (29.9%) patients from a total of 67 patients received at least one medicine in an unlicensed and off-label manner, respectively. The most common reason for off-label use of medicines was higher than the licensed dosing frequency (29.6%). The most common unlicensed and off-label medicine used was amlodipine tablet (5.8%) and IV metoclopromide (11.1%), respectively. Length of stay in the ICU was a significant predictor for unlicensed use of medicines (OR 1.219; 95% CI 1.022-1.456; p=0.028) and number of medication prescribed was a significant predictor for off-labelled use of medicines (OR 1.130; 95% CI 1.010-1.263; p=0.032). There was substantial prescribing of unlicensed medicines compared to off-label medicines in the adult ICU highlighting the need for more research to be carried out considering the critical condition of the patients.

Dirigir moto ou carro entre adolescentes: inquérito "saúde em Vespasiano", 2015 / Adolescents driving motorcycles or cars: inquiry "health in Vespasiano", 2015

INTRODUÇÃO: Inquérito de base populacional realizado em Vespasiano, Minas Gerais, em 2015/2016. Adolescentes e não habilitados para uso de veículos motorizados, representam maior risco para acidentes no trânsito. OBJETIVOS: Analisar o relato de frequência de dirigir moto e carro alguma vez na vida por adolescentes, bem como fatores associados a esse evento. MÉTODOS: Participaram 424 adolescentes com idades entre 11 e 17 anos, selecionados em amostra aleatória. Foram calculadas as frequências do relato de dirigir moto e carro alguma vez na vida associadas às variáveis explicativas bem como odds ratio, e seu intervalo de confiança a 95% Para análise, foi utilizado o software SPSS, versão 19.0. RESULTADOS: 26,4% dos adolescentes relataram ter dirigido moto e 23,6% ter dirigido carro alguma vez na vida. Na faixa etária de 14 a 17 anos observou-se frequência maior de relato de ter dirigido moto (78,6%) e carro (81,0%) comparados à faixa de 11 a 13 anos (21,4% e 19,0% respectivamente. Adolescentes que ingeriram bebida alcoólica alguma vez na vida apresentaram 2,9 vezes mais chance de relatar ter dirigido moto (IC 95% 1,8 - 4,6) e 2,7 vezes mais chance de relatar ter dirigido carro alguma vez na vida (IC 95% 1,7 - 4,3). 13,9% dos adolescentes relataram ter sofrido acidente de trânsito durante a vida, como motorista, passageiro ou pedestre. CONCLUSÕES: Em Vespasiano, 26,4% dos adolescentes estudados relataram ter dirigido moto e 23,6% carro, o que reforça a necessidade de maior reflexão quanto a estratégias preventivas à ocorrência da transgressão da lei de trânsito pelos adolescentes.(AU)

Introduction: Population based survey conducted in Vespasiano City, Minas Gerais State, Brasil, em 2015/2016. Young unlicensed drivers are more likely to adopt several inappropriate behaviors while driving. Objectives: determine and quantify the association between driving motorcycle and car sometime in life and selected explanatory variables. Methods: 424 teenagers aged 11-17 years were selected in a household random sample of census tracts. The frequency driving a motorcycle and/or car was calculated. Associations were quantified through the odds ratio and its 95% confidence interval. For the analysis we used the software SPSS, 19.0 version. Results: 26.4% of adolescents reported driving motorcycle and 23.6% have driven car sometime in life. The age group 14-17 years reported the a higher frequency of driving motorcycle (78.6%) and car (81%) compared to the age group 11 to 13 years (21.4% and 19%, respectively). Teens who used alcohol in their lifetime were 2.9 (CI 95% 1.8 ­ 4.6) times more likely to ride motorcycle and 2.7 (CI 95% 1.7 ­ 4.3) times more likely to drive a car; 13.9% of adolescents reported having suffered a traffic accident during life as a driver, passanger or pedestrian. Conclusions: In Vespasiano, 26.4% of adolescents reported having driven motorcycle and 23.6% have driven car. This result may contribute to discussion and preventive strategies for health and safety actions related to the occurrence of the violation of the traffic law by adolescents.(AU)

Analysis of off-label use of anti-infective drugs in children / 中国小儿急救医学

Off-label use or unlicensed use of anti-infective drugs is most commonly in children both in the outpatient and inpatient settings. Off-label anti-infective drug use is due to dosage,frequency,patient age,indication,route of administration,or contraindications. Off-label use of drugs does not necessarily mean unsafe use. Off-label drug use should be based on high-quality evidence;use within the context of a formal research proposal and exceptional use.

A Study of the Discussions on Psychiatry of Korea in the 1960s and 1970s: From Mental Hygiene to Modern Psychiatry / 의사학

This study is to review the emergence of new psychiatrists, scientific rationalization, and popular internalization to reorganize the formation process of modern psychological medicine system. Unlike eugenic psychiatry from the Japanese Colonial Era, the social conditions and contexts forming autonomous system of psychiatry of Korea in the 1960s and 1970s have been concentrated. The discussion approach has been tried to secure two perspectives-treatment and criticism-at the same time and to expand the time and scope of study through the extensive texts such as newspapers, magazines, books, advertisements, and others in the 1960s and 1970s. Through formation of subject, rationalization, and popularization, this study has surveyed the characteristics of psychiatry in the 1960s and 1970s to accentuate complicated conditions and kinetic steps to systemize psychiatry as scientific field to promote treatment of patients by deviating from mental hygiene approaching national mental health from cleanliness and removal. The characteristics are summarized as follows. First, as the ethical models of good doctors, medical paternalistic doctors, and non-authoritarian symmetric doctors have been proposed as good psychiatrists by new medical specialists with experience of globality, a new subject emerges. However, there has been illegalization process of unlicensed medical practitioner excluded by the regulatory authority called “clearness.” Second, the rationalization of psychiatry has been accelerated through the dispute of enactment of Mental Hygiene Law, segmentalization of concept of mental illness, and scientific characteristics. Especially, the disputes over enactment of Mental Hygiene Law focused on criminalization of mental patients brought a result to regulate the patients as the target of humanistic treatment and potential criminals at the same time. Third, popularization of psychiatry has embraced invisible mental illness into popular daily life through visual measure called medicine advertisement, and through the discussion about social neurosis, a new paradigm for diagnosis of Korean society has been proposed. Moreover, by focusing on autobiographical works with voices of patients, this article reveals a new doctor-patient relationship.

Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

ABSTRACT This study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) off-label prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The off-label use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns.

Magistral drugs in hospitalized newborns and children / Medicamentos magistrais em recém-nascidos e crianças hospitalizados

Abstract Objective: Study the use of magistral oral solutions and suspensions in infants and children at a university hospital. Methods: This is a descriptive study based on the analysis of the assessed hospital's magistral drug request forms regarding the patients in the neonatal ICU, Obstetrics, Pediatrics and Pediatric Emergency from January 2012 to December 2013. The frequency of drug requests and dispensation was evaluated and the consumption of each active ingredient of the preparations was expressed as number of “infant defined daily dose” (iDDD) and of iDDD/100 bed-days. Results: A total of 657 forms were analyzed - a monthly average of 27 pediatric preparations. The neonatal ICU accounted for 69.6% of these requests. Twenty-one drug items were used, of which the most common were folinic acid (88 requests), sulfadiazine (85) and captopril (73). The consumption of the active principle in these preparations varied in number of iDDD, from 7.5 (hydralazine) to 16,520.0 (folic acid), and in number of iDDD/100 bed-days in the neonatal ICU, from 0.1 (zinc sulfate) to 146.1 (folic acid). Conclusions: The constant consumption of magistral oral solutions and suspensions by newborns and children of the assessed hospital indicates the need for such preparations as a pediatric therapeutic alternative in this hospital.

Resumo Objetivo: Estudar o uso de soluções e suspensões orais magistrais em recém-nascidos e crianças de um hospital universitário. Métodos: Foi feito um estudo descritivo a partir da análise dos formulários de solicitação de manipulação do hospital estudado referentes aos pacientes da UTI-neonatal, obstetrícia, pediatria e emergência pediátrica de janeiro de 2012 a dezembro de 2013. As frequências das solicitações e dispensações desses medicamentos foram avaliadas e o consumo de cada princípio ativo das preparações foram expressos sob a forma de número de infant defined daily dose (iDDD) e de iDDD/100 leitos-dia. Resultados: Foram analisados 657 formulários - média mensal de 27 preparações pediátricas. A UTI-neonatal foi responsável por 69,6% dessas solicitações. Foram usados 21 itens de medicamentos, destacou-se o uso de ácido folínico (88 solicitações), sulfadiazina (85) e captopril (73). O consumo de princípio-ativo nessas preparações variou, em número de iDDD, de 7,5 (hidralazina) a 16.520 (ácido fólico) e em número de iDDD/100 leitos-dia da UTI-neonatal, de 0,1 (sulfato de zinco) a 146,1 (ácido fólico). Conclusões: O consumo constante das soluções e suspensões orais magistrais pelos recém-nascidos e crianças do hospital estudado indica a necessidade dessas preparações como opção terapêutica pediátrica nesse hospital.

Prescripción de Medicaciones no aprobadas (off label y sin licencia) en Recién Nacidos hospitalizados: Estudio multicéntrico en cinco hospitales de Asunción y Gran Asunción / Prescription of Off-label and Unlicensed Drugs in Hospitalized Newborns: a Multicenter Study in Five Hospitals in Greater Asuncion, Paraguay

Introducción: La falta de suficientes estudios clínicos sobre la eficacia y seguridad de las medicaciones en la población neonatal, conduce a la utilización de alternativas con medicaciones no aprobadas. Objetivos: Determinar la prevalencia de la utilización de medicaciones no aprobadas por la Food and Drug Administration (EEUU) en los neonatos hospitalizados en diferentes niveles de atención de cinco hospitales de Asunción y Gran Asunción. Metodología: Estudio observacional, descriptivo con componente analítico, transversal. Se incluyeron recién nacidos de las salas de terapia intensiva, intermedia y cuidados mínimos de cinco hospitales. Variables: Peso de nacimiento, edad gestacional, sexo, vía del parto, edad postnatal al ingreso al estudio, sala de internación, asistencia respiratoria mecánica y tipo y número de medicaciones no aprobadas (MNA) por paciente en el momento de llenarse el cuestionario. Los datos fueron cargados y analizados en SPSS 17 y se expresaron en proporciones y medias. Se utilizó la prueba de chi cuadrado y se consideró un error alfa del 5%. Resultados: Se analizaron 105 pacientes con edad postnatal al ingreso al estudio de 12±8 días y 11±8 días de hospitalización. Recibieron MNA 41 neonatos (39%) con 92 prescripciones no autorizadas, en mayor proporción en la unidad de terapia intensiva (49%), con respecto a las salas de los otros niveles (p=0,01). El número de MNA por neonato fue de 2,29±1,7 (rango1 a 8).Las MNA más frecuentemente utilizadas fueron antibióticos (42%), omeprazol y ranitidina (11%) y los corticoides (9%). Conclusiones: La prevalencia de utilización de medicaciones no aprobadas fue elevada y se demostró asociación con el uso de asistencia respiratoria mecánica y presencia de infecciones.

Introduction: The scarcity of clinical studies on the efficacy and safety of medications in newborns leads to the use of alternative treatment using unapproved drugs. Objectives: To determine the prevalence of the use of drugs not approved by the U.S. Food and Drug Administration in newborns hospitalized at care facilities of various levels in Asuncion and Greater Asuncion. Methodology: We conducted a cross-sectional observational and descriptive study with an analytic component. Included were newborns in intensive care, intermediate care, and minimal care wards of five hospitals. Variables were birth weight, gestational age, gender, route of delivery, postnatal age on inclusion in the study, ward in which hospitalized, mechanically assisted ventilation, and type and number of unapproved drugs (UD) administered to each patient at the time of completing the questionnaire. The data were entered and analyzed using SPSS 17 and expressed as proportions and means. The Chi squared test was used and an Alpha error deemed as 5%. Results: We analyzed 105 patients aged 12±8 days upon inclusion in the study and with 11±8 days of hospitalization. UD were administered to 41 newborns (39%), comprising 92 prescriptions, most commonly (49%) in intensive care wards (p=0.01) compared to other care level wards. The number of UD administered per newborn was 2.29±1.7 (range: 1-8). The UD most commonly used were antibiotics (42%), omeprazol and ranitidine (11%), and corticosteroids (9%). Conclusions: The prevalence of use of unapproved medications was high and demonstrated association with mechanically assisted ventilation and diagnosis of infection.

Prescripción de Medicaciones no aprobadas (off label y sin licencia) en Recién Nacidos hospitalizados. Estudio multicéntrico en cinco hospitales de Asunción y Gran Asunción / Prescription of Off-label and Unlicensed Drugs in Hospitalized Newborns: a Multicenter Study in Five Hospitals in Greater Asuncion, Paraguay

Introducción: La falta de suficientes estudios clínicos sobre la eficacia y seguridad de las medicaciones en la población neonatal, conduce a la utilización de alternativas con medicaciones no aprobadas. Objetivos: Determinar la prevalencia de la utilización de medicaciones no aprobadas por la Food and Drug Administration (EEUU) en los neonatos hospitalizados en diferentes niveles de atención de cinco hospitales de Asunción y Gran Asunción. Metodología: Estudio observacional, descriptivo con componente analítico, transversal. Se incluyeron recién nacidos de las salas de terapia intensiva, intermedia y cuidados mínimos de cinco hospitales. Variables: Peso de nacimiento, edad gestacional, sexo, vía del parto, edad postnatal al ingreso al estudio, sala de internación, asistencia respiratoria mecánica y tipo y número de medicaciones no aprobadas (MNA) por paciente en el momento de llenarse el cuestionario. Los datos fueron cargados y analizados en SPSS 17 y se expresaron en proporciones y medias. Se utilizó la prueba de chi cuadrado y se consideró un error alfa del 5%. Resultados: Se analizaron 105 pacientes con edad postnatal al ingreso al estudio de 12±8 días y 11±8 días de hospitalización. Recibieron MNA 41 neonatos (39%) con 92 prescripciones no autorizadas, en mayor proporción en la unidad de terapia intensiva (49%), con respecto a las salas de los otros niveles (p=0,01). El número de MNA por neonato fue de 2,29±1,7 (rango1 a 8). Las MNA más frecuentemente utilizadas fueron antibióticos (42%), omeprazol y ranitidina (11%) y los corticoides (9%). Conclusiones: La prevalencia de utilización de medicaciones no aprobadas fue elevada y se demostró asociación con el uso de asistencia respiratoria mecánica y presencia de infecciones .

Introduction: The scarcity of clinicalstudies on the efficacy and safety ofmedications in newborns leads tothe use of alternative treatment using unapproved drugs...

Criminal liability of medical professionals

The Medical Service Act and many other laws regulate the actions of medical professionals. Receiving rebates from pharmaceutical companies has been criticized as unethical but not punished until 2011. However, it is now strongly forbidden. Unlicensed acts of medical care, which include providing medical care beyond the scope of the license or giving directions to an unlicensed person to practice medical care, are strictly punished even in the case of licensed medical professionals. It recently became an issue whether a doctor who wrote prescriptions to patients after examining them over the telephone violated the Medical Service Act. In addition, it is necessary to pay special attention to the administration of propofol since it recently became a major controversy. Furthermore, public health doctors are legally forbidden to work outside of a public health institution. The number of regulations on the medical industry is increasing every day. New laws usually toughen up punishment for those violating regulations. There is a legal maxim that says, "Ignorance of law excuses no one." Therefore, it is necessary for medical professionals to steadily study and become familiar with applicable laws and related criminal cases to prevent themselves from becoming criminally liable.

Avaliação da qualidade de saneantes clandestinos comercializados em Belo Horizonte, Minas Gerais / Assessment of the quality of unlicensed home-made sanitizing products sold in Belo Horizonte, Minas Gerais

Os saneantes representam uma variedade de agentes de limpeza, incluindo os desinfetantes. Os saneantes clandestinos não passam por nenhum tipo de avaliação quanto à eficácia e possíveis contaminações, portanto o consumidor não tem segurança ao utilizá-lo. Este trabalho teve por objetivo analisar amostras de saneantes clandestinos comercializadas quanto aos parâmetros de rotulagem, qualidade microbiológica e físico-química e a avaliação da eficácia. A contagem de micro-organismos e a pesquisa de patógenos foram determinadas conforme indicado na Farmacopéia Brasileira. A avaliação da eficácia das amostras foi realizada pela determinação da atividade antimicrobiana de produtos desinfetantes por meio da redução da carga microbiana frente a micro-organismos patogênicos. 91% das amostras apresentaram rótulos em desacordo com a Legislação. O teste de Capacidade Inibitória indicou que, para inibir possíveis contaminações, os saneantes clandestinos possuem maior quantidade de princípio ativo do que o indicado nos rótulos e do que o determinado pela Legislação. Além disso, nove amostras apresentaram como princípio ativo o formaldeído, conservante banido das formulações de desinfetantes. Nove amostras apresentaram contaminação por bactérias e/ou fungos. O teste de eficácia indicou que aproximadamente 50% das amostras não foram eficazes contra micro-organismos testados e que não houve redução da carga microbiana nos tempos testados. As amostras analisadas podem oferecer riscos aos consumidores e fabricantes, uma vez que os resultados indicaram que o processo de produção não segue as Boas Práticas de Fabricação, além de serem importantes para reafirmar as ações preventivas, na conscientização dos fabricantes e consumidores pela busca de produtos de qualidade.

The term sanitizer includes a variety of cleaning agents, including disinfectants. Unlicensed home-made sanitizing products do not undergo any kind of quality control to attest to their effectiveness and lack of contamination, so do not ensure consumer safety. Therefore, the aim of this study was to analyze samples of clandestine home-made sanitizers sold in the local market, to check microbiological and physicochemical quality and labeling and assess their effectiveness. Total viable counts of microorganisms and pathogens were determined as indicated in the Brazilian Pharmacopoeia. Effectiveness was assessed by challenging the product with pathogenic microorganisms and antimicrobialactivity was determined by the reduction of the bacterial load. Results showed that 91% of the samples had labels violating current legislation. The analysis indicated that, to guarantee inhibitory capacity, home-made sanitizers had a higher level of active ingredient than indicated on their labels and than allowed by legislation. In addition, nine samples had formaldehyde as the active ingredient, a preservative banned as a component of disinfectants. Nine samples were contaminated by bacteria and/or fungi. The antimicrobial challenge test showed that approximately 50% of the samples were ineffective against the microorganisms tested, with no reduction in the microbial load. The present study points to home-made sanitizers as risks to consumers and manufacturers. Results indicate that the production process does not follow Good Manufacturing Practice, hence they are very significant in reaffirming preventive practices and making manufacturers and consumers aware of the need to seek products of certified quality.

The allure of the private practitioner: Is this the only alternative for the urban poor in India.

The main objective of the study has been to identify trajectories of health seeking behaviour of the urban poor, particularly their use of the private health sector, with the aim to identify strategies to improve quality of health care for this burgeoning population. This article presents findings from a slum settlement in Delhi where ethnographic sub-studies were carried out over two years among private health providers and selected households alongside a survey of household expenditure patterns. The primary research tools were in-depth interviews with practitioners and key informants as well as observations of clinical interactions. Illness narratives and case studies were documented over two years. The software package q.s.r. Nvivo was used for coding and content analysis. It was found that almost 90% of the respondents exclusively depend on local unlicensed and unregistered practitioners for basic primary health care. Long distances, time-consuming procedures, rude behaviour and, in many cases, bribes that had to be paid to staff in the hospitals were cited as major deterrents to utilising government facilities. Despite the public health consequences of inappropriate treatment protocols and misuse of drugs by these untrained private providers, in the absence of a structured urban primary health care system in the country, they seem to be the only alternative for the burgeoning urban poor in vast metros such as Delhi.

Off-label or Unlicensed Drug Prescriptions in Child and Adolescent Psychiatry

The purpose of licensing system is to ensure that the medicines are examined for safety, efficacy and quality. Nevertheless, off-label or unlicensed drug usages in pediatric practice is widespread in Korea and worldwide. Psychotropics are one of the most commonly used off-label or unlicensed drugs. The most valid approach to face this dilemma will be to have more evidences from pediatric pharmacological studies. Clinicians, in addition, need to monitor closely their off-label or unlicensed drug prescriptions to minimize the trial and error in practice. Researchers should publish their experiences and provide guidelines. Pharmaceutical companies, regulatory authorities, and consumer organizations should endeavor altogether for the children's right to get safe and efficacious drugs as adults do. Here, the definition as well as the current status of off-label and unlicensed drug prescriptions will be introduced. Critical issues regarding the off label drugs are discussed. In addition, I will describe the present condition as to the off-label and unlicensed drugs in child and adolescent psychiatry and the authorization process of off-label drug prescription in Korea. Lastly, direction we should like to take in this field will be mentioned.

State Control of Medicine through Legislation and Revision of the Medical Law : Licensed and Unlicensed Medical Practices in the 1950s - 60s / 의사학

In the 1950s and 1960s, Korea overcame the aftermath of the war and laid the foundations for modernization of economy and professionalization of medicine. The National Medical Services Law, enacted in 1951 was the first medical law to be legislated since the establishment of the Republic of Korea. The law provided a medical system for the traditional Korean medical practitioners, activated opening of hospitals through report-only system and prohibition of interference in medical practice, and facilitated mobilization of the doctors by the government. The Medical Law, legislated in 1962 by the Park Jong-Hee administration contained practice license system, regular practice reporting system and practice designation, thereby strengthening the government control on the medical practitioners, inducing professionalism and high-quality of medical practitioners and abolished unlicensed medical practitioners such as acupuncturists, moxa cauterists and bone setters. The Medical Assistant Law of 1963 was introduced so that medical examination and assistance could be carried out under supervision of professional doctors. To reduce areas without healthcare system, region-specified medical practitioners got licensure and a community doctor system was organized. However, due to expensive medical fees in comparison to economic status and medical needs of patients, shortage of doctors, low accessibility to hospitals led to the prevalence of illegal medical practice by unlicensed practitioners. Absence of national budget or policy on the health care system and the American-style noninterference medical system were other factors causing the situation. Government, Korean Medical Associations and Korean Dental Association tried, without success, to exercise control over the unlicensed medical practice. President Park Jong-Hee had to introduce a special law concerning the health-care related crimes with life sentence as the highest penalty. While the government put modernization before social welfare, operated on a policy of state-controlled medical care system, and doctors achieved specialization system similar to that of the United States, the public had to suffer, being treated by unlicensed medical practitioners. Inevitably, the need for a national medical practitioner supply plan and a policy to support health service was raised.

Considerations on Unlicensed and Off-Label Drug Uses / 中国药房

OBJECTIVE: To provide reference for dealing with the problems arose from unlicensed and off-label drug uses.METHODS: The rationality of unlicensed and off-label drug uses and the possible problems induced by which were analyzed.RESULTS: The existence of unlicensed and off-label drug used has its rationality,and it also in line with the international practices,but it may cause some problems related to policy,laws and regulations and medication safety etc.CONCLUSION: The concerned department and trade association should attach great importance to unlicensed and off-label drug uses and establish a generally accepted principle and strategies to tackle the problems.

Cosmetical Skin Treatment and the Treatment Nature of Skin Cosmetic / 대한피부과학회지

The medical system is turning into a general health care system recently. The change in the system increases the cooperation between the physicians and the non-physicians in reality. So it is inappropriate to punish every cooperative work between the two for unlicensed medical practice control program anymore. In order to readjust the control over the unlicensed medical practice, critically dismantling and reconstructing the concept of medical treatment must be done. The three elements of the concept of medical treatment can be constructed socially in relation to disease. When this is done under social subsystems, the ideological functions of disease and medical treatment concepts can be explained. There are three aspects to the current unlicensed medical practice control program. There is a large gap between the legal judgment and the medical rationality. Moreover, the government unnecessarily has a full control over all dimensions of the medical treatment concept, and the license system only emphasizes the status, not the essence of the medical treatment itself. The dermatologists and cosmeticians' work must be divided but done cooperatively. A way to legislate this is to draw the cosmeticians into the area of medical skin treatment. Rather than solving the problem by giving cosmeticians another status, it is important for them to cooperate functionally with the dermatologists. The government should control the `cooperative division of work' between the two indirectly, so that the civil society can function on its own disciplinary mechanism.