National medicines policies – a review of the evolution and development processes

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved

Caracterización de atención primaria de salud en tres municipios de Minas Gerais, Brasil : un analisis de los casos

Este trabalho teve como objetivo estudar como se caracteriza a atenção básica em três municípios do Estado de Minas Gerais, Brasil. Buscou-se compreender o contexto local, a estrutura e a gestão da atenção básica nos municípios pesquisados. As técnicas utilizadas para a coleta dos dados foram a pesquisa documental e a entrevista com os gestores locais. Os dados coletados foram analisados de acordo com a legislação brasileira para desenvolvimento da atenção básica. Foi identificado que os municípios assumem a atenção básica de forma diferenciada. A característica da política e da administração local foi considerada um ponto que parece permear tanto o contexto de desenvolvimento da atenção básica quanto sua forma de estruturação e da gestão. _______________________________________________________________________________________ ABSTRACTThis work aimed to study how primary health care is characterized in three municipalities in the state of Minas Gerais, Brazil, concerning the local context, structure, and management of primary health care. The techniques used for data collection were the documentary research and the interview with the local managers. The collected data were analyzed according to the Brazilian legislation for development of primary health care. It was identified that municipalities deal with primary health care differently. The characteristic of politics and local government was considered a point that seems to permeate both the context of development of primary health care as their means of structuring and management. _______________________________________________________________________________________ RESUMENEste trabajo tuvo como objetivo estudiar la forma en que la atención primaria de salud se caracteriza en tres municipios de Minas Gerais, Brasil. Hemos tratado de comprender el contexto local, la estructura y la gestión de la atención primaria en los municipios pesquisados. Las técnicas utilizadas para la colecta de datos fueron la investigación documental y la entrevista con los gestores locales. Los datos obtenidos fueron analizados de acuerdo con la legislación brasileña para el desarrollo de la atención primaria. Se identificó que los municipios asumen la atención primaria de salud de manera distinta. La característica de la política y del gobierno local fue considerada un punto que parece permear tanto en el contexto del desarrollo de la atención primaria como su forma de estructuración y gestión

AS DIFICULDADES DO PERSONAL TRAINER EM SE MANTER NO MERCADO COMPETITIVO

The present study aimed to observe what professional skills Personal Trainers find to remain in the competitive market, from their point of view. The data were obtained through a semi-structured interview. The survey is classified as bibliographic, field and qualitative. It can be seen that the demand for professionals in this area is great, and that they constantly seek professional improvement and that Personal Marketing strategies have been the key point for the professional to remain in the market, in addition to professional commitment, aiming at good service and the quality of the service provided to your client, keeping you loyal.O presente estudo teve por objetivo identificar as estratégias de fidelização do Personal Trainer com o cliente. Os dados foram obtidos através de uma entrevista semiestruturada, aplicada a três Personais Treiners. A pesquisa se classifica como bibliográfica, de campo e de cunho qualitativo. Pode ser constatado que a demanda de profissionais dessa área é grande, e que buscam o aperfeiçoamento profissional constantemente e que as estratégias de marketing pessoal tem sido o ponto chave para que o profissional permanecer no mercado, além também do comprometimento profissional, visando o bom atendimento e a qualidade no serviço prestado ao seu cliente, o mantendo fidelizado

Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance

Funding: This work was supported by the European Union Horizon 2020 Research and Innovation Program (grant number 965246) and was part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project.Objectives Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.Design A three-round Delphi panel.Setting A task within the Coordinating Research and Evidence for Medical Devices project.Participants 101 experts in the medical device community (healthcare professionals, methodologists, registry experts, regulators, and assessors from notified bodies) were invited.Interventions Based on a literature review and expert advice, 27 items relating to the quality of registry data and the analysis of medical device safety and performance were selected. In round 1, participants selected which items were required for a minimum checklist. They could also propose new items. Items selected by ≥70% of participants indicated consensus. Remaining items were discussed in round 2, resulting in a final checklist that was ranked by participants for importance (round 3).Main outcome measures Consensus of items to be included in the minimum checklist.Results 51 experts participated in round 1, achieving consensus on 18 (67%) items and suggesting 12 items. After discussion in round 2, 5 additional items were selected, resulting in a final set of 15 data quality items and 8 data analysis items. The most important items were ‘completeness of procedures’ (data quality) and ‘definition of outcome analyzed’” (quality of analysis).Conclusions Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.Peer reviewe

Chronicity of sleep problems in children with chronic illness: a longitudinal population-based study

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to examine the chronicity of sleep problems in children with chronic illness, and potential predictors of sleep problems.</p> <p>Methods</p> <p>Using data from a longitudinal total population study in Norway, The Bergen Child Study, data on sleep problems, chronic illness and potential confounders were assessed at ages 79 and 1113.</p> <p>Results</p> <p>295 of 4025 (7.3%) children had a chronic illness, and the prevalence of chronic sleep problems was significantly higher in this group compared to children without chronic illness (6.8% versus 3.6%). Sleep problems at the first wave increased the risk of sleep problems at the second wave, also when adjusting for potential confounders (odds-ratio = 5.41). Hyperactivity and emotional problems were also independent risk factors for later sleep problems.</p> <p>Conclusion</p> <p>These findings call for increased awareness and development of treatment strategies of sleep problems in children with chronic illness.</p

Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia

OBJECTIVES: To establish whether long-term use of melatonin influences pubertal development, sleep quality and mental health development in children as compared with the normal Dutch population of the same age. METHODS: This follow-up research study was conducted in children included in a previous melatonin dose-finding trial. Outcomes were measured using questionnaires (Strength and Difficulties Questionnaire (SDQ), Children's Sleep Habits Questionnaire (CSHQ) and Tanner Stages) adopted for Dutch children. Mean duration of therapy, persistence of effect, adverse events and (other) reasons leading to cessation of therapy were additional objectives of this study. RESULTS: Mean years of usage (n = 51) was 3.1 years (min 1.0 year, max 4.6 years), mean dose 2.69 mg (min 0.3 mg, max 10 mg). Mean SDQ score, mean CSHQ score and Tanner Stages standard deviation scores did not differ in a statistically significant way from published scores of the general Dutch population of the same age and sex. CONCLUSIONS: This follow-up study demonstrates that melatonin treatment in children can be sustained over a long period of time without substantial deviation of the development of children with respect to sleep quality, puberty development and mental health scores, as compared with the general Dutch population

Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT

Contains fulltext : 86695.pdf (publisher's version ) (Open Access)Rationale Pharmacokinetics of melatonin in children might differ from that in adults. Objectives This study aims to establish a dose–response relationship for melatonin in advancing dim light melatonin onset (DLMO), sleep onset (SO), and reducing sleep onset latency (SOL) in children between 6 and 12 years with chronic sleep onset insomnia (CSOI). Methods The method used for this study is the randomized, placebo-controlled double-blind trial. Children with CSOI (n=72) received either melatonin 0.05, 0.1, and 0.15 mg/kg or placebo during 1 week. Sleep was assessed with log and actigraphy during this week and the week before. Outcomes were the shifts in DLMO, SO, and SOL. Results Treatment with melatonin significantly advanced SO and DLMO by approximately 1 h and decreased SOL by 35 min. Within the three melatonin groups, effect size was not different, but the circadian time of administration (TOA) correlated significantly with treatment effect on DLMO (rs=-0.33, p=0.022) and SO (rs=-0.38, p=0.004), whereas clock TOA was correlated with SO shift (r=-0.35, p=0.006) and not with DLMO shift. Conclusions No dose–response relationship of melatonin with SO, SOL, and DLMO is found within a dosage range of 0.05–0.15 mg/kg. The effect of exogenous melatonin on SO, SOL, and DLMO increases with an earlier circadian TOA. The soporific effects of melatonin enhance the SO shift. This study demonstrates that melatonin for treatment of CSOI in children is effective in a dosage of 0.05 mg/kg given at least 1 to 2 h before DLMO and before desired bedtime.13 p