Políticas públicas basadas en evidencia científica: el caso de la seguridad vial infantil / Public policies based on scientific evidence: child road safety

Los accidentes de tránsito son un problema de salud pública global. En América Latina, la tasa de mortalidad por accidentes de tránsito en niños es casi el doble que el promedio mundial. Se presenta nuestra experiencia en la formulación de una política pública de seguridad vial infantil en Panamá, basada en la evidencia científica generada por nuestro grupo de investigación. Además, se propone un modelo para la formulación de políticas públicas que podría usarse en otros países latinoamericanos. Se trata de un vector de formulación que es parte del ciclo de las políticas públicas e incluye la identificación de un problema público, la ejecución de la investigación científica, la publicación y la socialización de los productos científicos para la formulación de la política pública con la participación incluyente de los científicos, la sociedad civil y los tomadores de decisiones cuando estos comparten espacios de diálogo.

Road traffic accidents are a global public health problem. In Latin America, the mortality rate among children due to road traffic accidents almost doubles the global average. We describe our experience formulating a public policy on child road safety in Panama, based on the scientific evidence produced by our research group. Moreover, we propose a model for public policy-making that may be used in other Latin American countries. It is a formulation vector that is part of the public policy-making cycle and entails identifying a public problem, conducting scientific research, publishing and disseminating scientific products for public policy-making with the participation of scientists, the civil society, and decision-makers by sharing spaces for dialog.

Por uma sociedade sem hospitais de custódia e tratamento psiquiátrico / For a society without secure psychiatric hospitals

Resumo O artigo indaga sobre a possibilidade de defesa de uma sociedade sem hospitais de custódia e tratamento psiquiátrico (HCTP) no Brasil. A base da sustentação dos HCTP tem sido os paradigmas jurídico-psiquiátricos persistentes – a medida de segurança e a periculosidade – vinculados às circunstâncias sócio-históricas específicas que, apesar das concepções ultrapassadas, mantêm em comum a franca repressão de populações consideradas “perigosas”, em nome do princípio da defesa social. O direito e a psiquiatria construíram conjuntamente os lugares de saberes-poderes nessa engrenagem de controle social. Pensar em uma abordagem do tema no campo transdisciplinar da memória social implica indicar lutas e jogos desses saberes-poderes específicos produzidos em tensão permanente.

Abstract The article explores the possibility of defending a society without secure psychiatric hospitals in Brazil. These hospitals have been sustained by persistent legal and psychiatric paradigms, including the notions “safety measure” and “dangerousness,” in conjunction with particular social and historical circumstances. The open repression of so-called dangerous individuals is still practiced in the name of the principle of social defense, outdated concepts notwithstanding. Together, law and psychiatry constructed spaces of power/knowledge within these workings of social control. Addressing this topic from the transdisciplinary field of social memory means identifying the struggles within particular power/knowledge arrangements, which play out in a state of ongoing tension.

Medida de Segurança: a violação do direito à saúde a partir do conceito de periculosidade / Safety Measure: the violation of the right to health from the concept of dangerousness

La relación entre los fenómenos de la locura y del crimen fue un punto estratégico para la constitución de la medicina mental y para la formación de las instituciones de control, castigo y regeneración. El propósito de este artículo es cuestionar si este modelo de intervención psiquiátrica-penal garantiza al loco infractor el respeto a su derecho a la salud, o si es un mecanismo para garantizar el orden social a partir de la clasificación de los individuos considerados peligrosos. La hipóthesis del trabajo es que la peligrosidad es un concepto no científico, marcado por conceptos morales que identifican a la locura como una manifestación de peligro en sí misma. Este estudio es de carácter descriptivo y cualitativo, basado en la revisión bibliográfica y análisis de los datos recogidos por la investigación "La custodia y el tratamiento psiquiátrico en Brasil: Censo 2011?. Se puede concluir que la medida de seguridad se justifica por un dispositivo frágil del punto de vista psiquiátrico y penal - la peligrosidad del individuo - que no es basada en una identificación o cuantificación de factores objetivos, lo que indica una tendencia a adoptar un modelo punitivo centrado en la defensa social a expensas de la rehabilitación del loco delincuente.

: The relationship between the phenomena of insanity and criminality was a strategic point for the constitution of mental medicine ­ psychiatry ­ and for the establishment of institutions of control, punishment and regeneration. The purpose of this paper is to question whether this model of criminal-psychiatric intervention ensures to the insane criminal offender the respect to his/her right to health, or if it is a mechanism for ensuring social order by isolating individuals considered dangerous. The paper's hypothesis is that dangerousness s a nonscientific concept, marked by moral concepts that identify madness as a manifestation of danger in itself. It is a descriptive and qualitative research, based on literature review and analysis of data collected by the survey "The Custody and Psychiatric Treatment in Brazil: 2011 Census?. It is concluded that the security measure is justified by a fragile psychiatric and criminal concept - the dangerousness of the individual ­ which does not provide identification and quantification purposes elements, indicating a tendency to adopt a punitive model focused on social defense at the expense of rehabilitation of the insane criminal offender

<b>1. The Feature and Implementation Process of Japanese RMP from the Regulatory Authority's Viewpoint </b> / 薬剤疫学

ICH-E2E guideline was published on November 18, 2004. In Japan, it has been notified on September 16, 2005 as “Pharmacovigilance Planning”. Then, in parallel with the system development of PMDA is advanced, Ministry of Health, Labour and Welfare revised the notification, it was announced the “Risk Management Plan Guideline” on April 2012. Based on this Guideline, Marketing Authorization Holder creates a whole plan of post-marketing safety measures. This plan is the Japanese RMP (J-RMP). “Risk Management Plan Guideline” are created by the reference to REMS in US and EU-RMP, and modified in consideration of the real situation in Japan. Then, GVP Ordinance and GPSP Ordinance were revised on March 11, 2013. As the result, since October 2014, implementation and creation of the RMP was mandated. At the end of November 2014, 65 RMPs has already been published on Website of PMDA. J-RMP has been positioned as an important system for strengthening of post-marketing safety measures. Published versions of J-RMPs are summarized in compact an overall picture of the post-marketing safety measuresfor respective new drugs. It is also including planned time-line of post-marketing surveillance or post-marketing clinical study. By all stakeholders get a better understanding, it is expected thatthe J-RMP is steadily perform.

<b>Utilization of SS-MIX in Electronic Medical Record Networking Project in Japan </b> / 薬剤疫学

An adverse drug reaction report system has played an important role to obtain safety information and to consider safety measures in Japan. However, there are some limitations in the system; for example, the number of prescribed patients cannot be found; it is difficult to differentiate between disease symptoms and adverse drug reactions; and no information can be grasped without a report from a health care professional. Therefore, Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) started an electronic medical information networking project since FY2011 in order to develop a new method to consider safety measures. In this project, MHLW/PMDA plan to establish medical information databases in 10 hospitals and a data analysis system in PMDA. The first database prepared by the University of Tokyo Hospital and the data analysis system in PMDA are almost available, and discussions for rules to utilize electronic medical records are ongoing. After the development of the rules, MHLW/PMDA will experimentally run the system in PMDA, support accumulating data from electronic medical records in the 10 hospitals and create analytical methods where the databases in these hospitals are leveraged. (Jpn J Pharmacoepidemiol 2013；18(1)：15-21)

Pharmacovigilance based on ICH E2E / 薬剤疫学

Implementation of the ICH E2E Guideline is based on the Notification dated September 16, 2005 concerning pharmacovigilance planning. The E2E Guideline requires post-marketing safety measures, observational studies, and clinical trials to be performed according to the profile of a particular drug.<br> Development of specific pharmacovigilance plans has remained incomplete because of the limited available experience on which planning can be based.<br> Examples of safety measures taken, observational studies, and clinical trials conducted with the anticancer drug TS-1 are explained from the view point of the E2E Guideline.<br> Important risks identified after the market launch of TS-1 include a significant difference from similar drugs in adverse drug reaction profile, contraindication of concomitant medication with 5-FU-containing drugs due to interactions, and an increase in side effects resulting from renal disorders. Examples of missing information include lack of data on concomitant medication with other anticancer drugs and on the efficacy and safety of post-operative medication. Data on long-term medication were also lacking. How these issues were addressed will be explained.<br> Plans for post-marketing safety measures, observational studies, and clinical trials cannot be standardized; risks and other specific factors for each particular drug need to be taken into consideration.

Aspectos psicopatológicos e forenses de mulheres homicidas com diagnóstico de transtornos psicóticos primários: estudo de série de casos / Psychopatologic and forensic features of female murderes with a diagnosis of primary psycchotic disorders – a case series

Objetivo: Avaliar amostra de todas as mulheres com diagnóstico de transtorno psicótico primário que receberam medida de segurança e estavam em hospital de custódia e tratamentopsiquiátrico em regime de internação (n = 8), em virtude de homicídio ou tentativa de homicídio (artigo 121 do Código Penal Brasileiro). Métodos: Trata-se de um estudo de série de casos. Foi realizado o levantamento retrospectivo de dados por meio de registros periciais e pareceres de equipes de assistência. O diagnóstico psiquiátrico final foi realizado com base na entrevista psiquiátrica e observação dos registros, utilizando-se os critériosdiagnósticos do DSM-IV-TR. Houve aplicação de questionário padronizado e escala das síndromes positiva e negativa (PANSS). Resultados: Sete pacientes receberam diagnóstico de esquizofrenia e uma de transtorno esquizoafetivo. A maioria das vítimas (n = 6, 60%) era membro familiar das pacientes. Foi encontrado que 37,5% (n = 3) das pacientes tinham história prévia de comportamento violento. De acordo com a avaliação da perícia psiquiátrica inicial, cinco (62,5%) pacientes da amostra total presentavam sintomatologia psicótica no momento desta avaliação. As alucinações auditivas foram os sintomas psicóticos mais comuns. Conclusão: O estudo de fatores motivadores do comportamento homicida pode fornecer conhecimentos para o estabelecimento de intervenções terapêuticas em mulheres com transtornos mentais que apresentem risco para este ou outros comportamentos violentos.

Objective: Evaluate a sample of women with primary psychotic disorders who received a safety measure and were admitted to inpatient forensic psychiatric care (n=8), due to homicide or attempted homicide (article 121 from the Brazilian Penal Code). Method: This is a serial cases study. The case records of all the women were retrospectively examined, including technical files andthe evaluations of clinical experts. The final psychiatric diagnosis was obtained with a psychiatric evaluation of the patients and the examination of their records, using the diagnostic criteriaof DSM-IV-TR. A standardized interview and positive and negative syndrome scale (PANSS) were also applied. Results: Seven patients received a diagnosis of schizophrenia and one a diagnosis of schizoaffective disorder. Most victims (n=10; 60%) were family members of the patients. We found that 37.5% (n=3) of the patients had previous history of violent behavior. According to the initial psychiatric forensic evaluation, five (62.5%) of the patients from the sample had psychoticsymptoms. Auditory hallucinations were the most common psychotic symptoms. Conclusion: The study of motivational factors for homicidal behavior may provide further knowledge for theimplantation of therapeutic interventions in women with mental disorders and an increased risk for homicidal or other violent behaviors.

Influence on Individual Finger Stalls in Pain during Acupuncture Operation / 全日本鍼灸学会雑誌

[Objective] In this study, the pain of receiving acupuncture was evaluated with or without individual finger stalls.<BR>[Design] In a randomized, subject- and operating person-blind, controlled study.<BR>[Methods] Sixteen acupuncturists and same number of normal volunteers participated in this study. Two needles were inserted into each side of the lumbar muscles. The trials were carried out twice using finger stalls and with bare fingers. These trials were performed in random order. Right after the insertion of needles and at the beginning of electrical stimulation, the subjects were asked to answer a questionnaire about the severity and quality of pain on receiving acupuncture. Durations of procedures were measured. We asked the acupuncturists whether they felt any difficulty in performing acupuncture using finger stalls.<BR>[Result] The majority of acupuncturists reported that using the finger stalls during treatment was inconvenient. Although the severity of pain of acupuncture did not significantly differ between that with and that without finger stalls, the average value was slightly higher with finger stalls. The qualities of pain on receiving acupuncture did not significantly differ between the two methods, however, the numbers of selected words differed on some items. The subjects could not recognize the use of individual finger stalls. The use of finger stalls did not influence the duration of the procedure.<BR>[Conclusion] In this study, the qualities of pain on receiving acupuncture did not significantly differ between that with and that without finger stalls. The subjects could not recognize the use of individual finger stalls.

Revison of Pharmaceutical Regulation / 日本東洋医学雑誌

Research and development based on bio-genomic technologies have been developed recently in pharmaceutical sector. New types of product have come out, applying various state of art industrial and scientific technology in medical devices sector. International harmonisation will be more emphasised while information technology (IT) development enhances further international expansion of our daily life and industrial activities as well as governmental administration.<br>Thorough revision of Pharmaceutical Affairs Lan has been requested since it experienced several minor revisions throughout the time from the time of the first enforcement. The present major revision plan under preparation will provide three major items: safety measure of medical devices, comprehensive measures for biological products and revision of approval system in response to the needs of the 21st century.