Diretrizes regulatórias aplicáveis à cadeia dos produtos para saúde

A ciência e a tecnologia cada vez mais vêm proporcionando avanços em produtos inovadores. Particularmente na área da saúde nota-se eminente sinergismo entre os materiais utilizados, suas propriedades de biocompatibilidade, biofuncionalidade, processabilidade, esterilidade e a área de aplicabilidade no organismo humano. O setor farmacêutico por apresentar grande complexidade exige conhecimentos multidisciplinares, atualizados e em conformidade às tendências internacionais. A Agência Nacional de Vigilância Sanitária (ANVISA) tem sob sua responsabilidade extensa diversidade de bens, serviços e produtos, dentre eles estão os correlatos, que também compreende os produtos para saúde. Os produtos para saúde são classificados conforme o seu risco, no Brasil podendo apresentar até quatro classes, sendo as classes III e IV as que caracterizam maior risco. Para alguns produtos, devido seu risco sanitário, é compulsório a Certificação de Conformidade pelo Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) previamente a concessão de seu registro sanitário pela ANVISA. Dentre as normas técnicas aplicáveis pelo INMETRO estão as normas da Associação Brasileira de Normas Técnicas (ABNT) e na sua ausência, as normas da International Organization for Standardization (ISO). Outros requisitos técnicos e regulatórios devem ser contemplados com o propósito de comprovação da segurança e eficácia dos produtos. Entretanto, as regulamentações sanitárias inerentes a essa categoria de produtos ainda se encontram incipientes no país. A desenvoltura do setor produtivo nesse segmento pode ser evidenciada pelo aumento de novas solicitações na ANVISA e de seu crescimento na balança comercial. No entanto, observa-se pouco estudo e entendimento do setor regulado e regulador referente à relação mútua entre ANVISA, INMETRO e ABNT e quanto à regulação sanitária aplicável para obtenção da anuência do produto ao consumo. Na conjuntura das demandas apontadas o objetivo deste estudo foi avaliar o processo regulatório aplicável à cadeia produtiva dos produtos para saúde com a finalidade de compreender a relação entre ANVISA, INMETRO e ABNT na garantia da qualidade, segurança e eficácia dos produtos. A metodologia aplicada neste trabalho foi à pesquisa qualitativa. Com o auxílio da pesquisa documental constatou-se que o processo regulatório brasileiro é complexo, específico e robusto e apresenta estrutura e exigências semelhantes dos Estados Unidos e União Europeia. A fiscalização pós-uso é uma tendência internacional e a ANVISA vem adotando com frequência com intuito de acompanhar a qualidade dos produtos comercializados. As três instituições apresentam competências definidas e regulamentadas, bem como mecanismos de inter-relação por meio de conselhos consultivos. O estudo de caso caracterizou que o perfil dos profissionais do setor regulado apresenta em grande percentual formação na área da saúde e nível de pós-graduação, porém o nível de conhecimento dos principais conceitos relativos aos produtos para saúde é parcial, reforçando a necessidade de incentivos de capacitação de recursos humanos em regulação em saúde.

A formação do fisioterapeuta na perspectiva das diretrizes curriculares nacionais e das competências no âmbito da promoção da saúde

Tese (doutorado)—Universidade de Brasília, Instituto de Psicologia, Psicologia Clínica e Cultura, 2016.

Levels of cardiac knowledge and cardiopulmonary resuscitation training among older people in Queensland

Objectives: The current study was conducted to determine levels of cardiac knowledge and cardiopulmonary resuscitation (CPR) training in older people in Queensland, Australia.---------- Methods: A telephone survey of 4490 Queensland adults examined respondents’ knowledge of coronary heart disease (CHD) risk factors, knowledge of heart attack symptoms, knowledge of the local emergency telephone number, as well as respondents’ rates and recency of training in CPR.---------- Results: Older participants, aged 60 years and over, were approximately one and a half times more likely than the 30–39 year-old reference group to have limited knowledge of heart disease risk factors (OR = 1.53), and low knowledge of heart attack symptoms (OR = 1.60). Knowledge of the local emergency telephone number also decreased with age. Older participants had significantly lower rates of training in CPR, with almost three quarters (71.7%) reporting that they had never been trained. Older people who had completed CPR training were significantly less likely to have done so recently.---------- Conclusions: Cardiac knowledge levels and CPR training rates in older Queensland persons were lower than those found in the younger population.

Clinical supervision in four mental health professions : a review of the evidence

Examines a range of theoretical issues and the empirical evidence relating to clinical supervision in 4 mental health professions: clinical psychology, occupational therapy, social work, and speech pathology. There is widespread acceptance of the value of supervision among practitioners and a large quantity of literature on the topic, but there is very little empirical evidence in this area. To date, there is insufficient evidence to demonstrate which styles of supervision are most beneficial for particular types of staff, in terms of their level of experience or learning style. The data suggest that directive forms of supervision, rather than unstructured approaches, are preferred by relatively inexperienced practitioners, and that experienced clinicians also value direct supervision methods when learning new skills or dealing with complex or crisis situations. The available evidence suggests that supervisors typically receive little training in supervision methods. However, there is little information to guide us as to the most effective ways of training supervisors. While acknowledging the urgent need for research, this paper concludes that supervision is likely to form a valuable component of professional development for mental health professionals.

Issues in multidisciplinary training of cognitive-behavioural interventions

Argues that if brief workshop training is used as the primary method of disseminating behavior therapy skills across professions, it will provide an inadequate preparation, especially for higher levels of behavioral practice. In some circumstances, brief training may lead to an overestimation of behavioral skills by the trainees. These issues are discussed in the context of current moves toward providing health professionals with multiple skills. Examples are provided of situations in which generic health professionals received brief workshop training in behavior therapy and attempted to make use of that training in their jobs. There is no substitute for ongoing training and consultation by senior clinical psychologists who are expert in behavior therapy.

Aboriginal public health and education : has it made a difference in practice?

Over the years, public health in relation to Australian Aboriginal people has involved many individuals and groups including health professionals, governments, politicians, special interest groups and corporate organisations. Since colonisation commenced until the1980s, public health relating to Aboriginal and Torres Strait Islander people was not necessarily in the best interests of Aboriginal and Torres Strait Islander people, but rather in the interests of the non-Aboriginal population. The attention that was paid focussed more generally around the subject of reproduction and issues of prostitution, exploitation, abuse and venereal diseases (Kidd, 1997). Since the late 1980s there has been a shift in the broader public health agenda (see Baum, 1998) along with public health in relation to Aboriginal and Torres Strait Islander people (NHMRC, 2003). This has been coupled with increasing calls to develop appropriate tertiary curriculum and to educate, train, and employ more Aboriginal and Torres Strait Islander and non-Aboriginal people in public health (Anderson et al., 2004; Genat, 2007; PHERP, 2008a, 2008b). Aboriginal and Torres Strait Islander people have been engaged in public health in ways in which they are in a position to influence the public health agenda (Anderson 2004; 2008; Anderson et al., 2004; NATSIHC, 2003). There have been numerous projects, programs and strategies that have sought to develop the Aboriginal and Torres Strait Islander Public Health workforce (AHMAC, 2002; Oldenburg et al., 2005; SCATSIH, 2002). In recent times the Aboriginal community controlled health sector has joined forces with other peak bodies and governments to find solutions and strategies to improve the health outcomes of Aboriginal and Torres Strait Islander peoples (NACCHO & Oxfam, 2007). This case study chapter will not address these broader activities. Instead it will explore the activities and roles of staff within the Public Health and Research Unit (PHRU) at the Victorian Aboriginal Community Controlled Health Organisation (VACCHO). It will focus on their experiences with education institutions, their work in public health and their thoughts on gaps and where improvements can be made in public health, research and education. What will be demonstrated is the diversity of education qualifications and experience. What will also be reflected is how people work within public health on a daily basis to enact change for equity in health and contribute to the improvement of future health outcomes of the Victorian Aboriginal community.

Exploring the process of implementing a smoking cessation intervention in pregnancy training program for midwives

The question of how to implement evidence effectively reveals a deficiency in our knowledge and understanding of the compound factors involved in such a process (Kitson, Rycroft-Malone et al. 2008). Although there is some awareness of the complexities of the process, there has been little exploration of the effectiveness of implementing evidence-based programs in health care. Despite public awareness of the dangers of smoking in pregnancy, and widespread public health measures to prevent smoking-related disease, women still continue to smoke in pregnancy (Ananth, Savitz et al. 1997; Laws and Hilder 2008). Evaluation of public health measures concludes that smoking cessation interventions during pregnancy increase quit rates among pregnant women (Melvin, Dolan-Mullen et al. 2000; Albrecht, Maloni et al. 2004; Lumley, Oliver et al. 2007). Notwithstanding the potential for improvement in health outcomes for pregnant women and their unborn babies, smoking interventions are often conducted poorly or not at all. Although midwives understand why women smoke in pregnancy and parenthood and are aware of the risks of smoking to both the pregnancy and the unborn child, they require specific knowledge and skills in the provision of support and advice on smoking for pregnant women (Bull and Whitehead 2006) . Organisational-change research demonstrates the complexity of the process of planned change in professionalised institutions such as health care (Greenhalgh, Robert et al. 2005). Some innovations and interventions are never accepted, and others are poorly supported (Greenhalgh, Robert et al. 2004). Comprehension of the change process around health promotion is crucial to the implementation of new health promotion interventions within health care (Riley, Taylor et al. 2003). This study utilised a case study approach to explore the process of implementing a smoking cessation training program for midwives in Queensland metropolitan and regional clinical areas, who attended a ‘Train-the-Trainer program’. The study draws on the organisational change work of Greenhalgh et al (2004) as the theoretical framework through which situational and structural factors are explored and examined as they inform the implementation of smoking cessation programs. The research data constituted staged interviews with midwives who instituted training programs for midwives, as well as organisational and policy documentation. Analysis of the data identified some areas that were not fully addressed in the theoretical model; these formed the basis of the Discussion and Implications for Future Research.

Feasibility of using health data sources to inform product safety surveillance in Queensland : a report for the Queensland Injury Prevention Council

This report provides an evaluation of the current available evidence-base for identification and surveillance of product-related injuries in children in Queensland. While the focal population was children in Queensland, the identification of information needs and data sources for product safety surveillance has applicability nationally for all age groups. The report firstly summarises the data needs of product safety regulators regarding product-related injury in children, describing the current sources of information informing product safety policy and practice, and documenting the priority product surveillance areas affecting children which have been a focus over recent years in Queensland. Health data sources in Queensland which have the potential to inform product safety surveillance initiatives were evaluated in terms of their ability to address the information needs of product safety regulators. Patterns in product-related injuries in children were analysed using routinely available health data to identify areas for future intervention, and the patterns in product-related injuries in children identified in health data were compared to those identified by product safety regulators. Recommendations were made for information system improvements and improved access to and utilisation of health data for more proactive approaches to product safety surveillance in the future.

Evaluation of the skills for preventing injury in youth program : impact on health risk behaviors, injury and school connectedness

Injury is the leading cause of death among young people, and involvement in health risk behaviors, such as alcohol use and transport-related risks, is related to increased risk for injury. Effective health promotion programs for adolescents focus on multiple levels, including relationships with peers and parents, student knowledge, behavior and attitudes, and school-level factors such as school connectedness. This study describes the pilot evaluation of a comprehensive, multi-level injury prevention program for 13-14 year old adolescents, targeting change in injury associated with transport and alcohol risks. The program, called Skills for Preventing Injury in Youth (SPIY), incorporates two primary elements: an 8-week, teacher delivered attitude and behavior change curriculum with peer protection and first aid messages; and professional development for program teachers focusing on strategies to increase students’ connectedness to school. Five Australian high schools were recruited for the pilot evaluation research, with three being assigned to receive intervention components and two assigned as curriculum-as-usual controls. In the intervention schools, 118 Year 8 students participated in surveys at baseline, with 105 completing surveys at follow up, six months following the intervention. In the control schools, 196 Year 8 students completed surveys at baseline and 207 at follow up. Survey measures included self-reported injury, risk taking behavior and school connectedness. Results showed that students in the control schools were significantly more likely to report riding bikes without helmets, riding with dangerous drivers, having driven cars on the road, and using alcohol six months after the program, while the intervention group showed no such increase in these behaviors. Additionally, students in the control schools were significantly more likely to report having had pedestrian-related injuries at follow up than they were at the baseline measurement, while intervention school students showed no change. There was also a trend observed in terms of a decrease in bicycle related injuries among intervention school students, compared with a slight increasing trend in bicycle injuries among control students. Overall, scores on the school connectedness scale decreased significantly from baseline to follow up for both intervention and control students, however measurement limitations may have impacted on results relating to students’ connectedness. Overall, the SPIY program has shown promising results in regards to prevention of students’ health risk behavior and injuries. Evidence suggests that the curriculum component was important; however there was limited evidence to suggest that teacher training in school connectedness strategies contributed to these promising results. While school connectedness may be an important factor to target in risk and injury prevention programs, programs may need to incorporate whole-of-school strategies or target a broader range of teachers than were selected for the current research.

Is simulation training effective in increasing podiatrists' confidence in foot ulcer management?

Background: Foot ulcers are a frequent reason for diabetes-related hospitalisation. Clinical training is known to have a beneficial impact on foot ulcer outcomes. Clinical training using simulation techniques has rarely been used in the management of diabetes-related foot complications or chronic wounds. Simulation can be defined as a device or environment that attempts to replicate the real world. The few non-web-based foot-related simulation courses have focused solely on training for a single skill or “part task” (for example, practicing ingrown toenail procedures on models). This pilot study aimed to primarily investigate the effect of a training program using multiple methods of simulation on participants’ clinical confidence in the management of foot ulcers. Methods: Sixteen podiatrists participated in a two-day Foot Ulcer Simulation Training (FUST) course. The course included pre-requisite web-based learning modules, practicing individual foot ulcer management part tasks (for example, debriding a model foot ulcer), and participating in replicated clinical consultation scenarios (for example, treating a standardised patient (actor) with a model foot ulcer). The primary outcome measure of the course was participants’ pre- and post completion of confidence surveys, using a five-point Likert scale (1 = Unacceptable-5 = Proficient). Participants’ knowledge, satisfaction and their perception of the relevance and fidelity (realism) of a range of course elements were also investigated. Parametric statistics were used to analyse the data. Pearson’s r was used for correlation, ANOVA for testing the differences between groups, and a paired-sample t-test to determine the significance between pre- and post-workshop scores. A minimum significance level of p < 0.05 was used. Results: An overall 42% improvement in clinical confidence was observed following completion of FUST (mean scores 3.10 compared to 4.40, p < 0.05). The lack of an overall significant change in knowledge scores reflected the participant populations’ high baseline knowledge and pre-requisite completion of web-based modules. Satisfaction, relevance and fidelity of all course elements were rated highly. Conclusions: This pilot study suggests simulation training programs can improve participants’ clinical confidence in the management of foot ulcers. The approach has the potential to enhance clinical training in diabetes-related foot complications and chronic wounds in general.

Enhancing capacity for 'systematic' thinking in public health

The concept of being evidence based or evidence informed is widely acknowledged as an important component of decision-making. It is perhaps most universally referred to in medicine, however has extended into many other disciplines over the past decade, including public health. Evidence-based public health has been defined as the ‘conscientious, explicit and judicious use of current best evidence in making decisions about the care of communities and populations in the domain of health protection, disease prevention, health maintenance and improvement (health promotion)’.1 More recent literature favours the use of the term evidence informed over evidence based to acknowledge the varying influences on decisions in this complex field.2,3 Evidence-informed activities in any discipline require a specific set of skills in critical thinking. These skills include identifying the questions to be resolved, collecting relevant evidence, and assessing, synthesizing and distilling evidence in a way that can inform the set of activities to be undertaken as a result.

Identifying competencies for Australian health professionals working in international health

A profile of the roles performed by Australian health professionals working in international health was constructed to identify the core competencies they require, and the implications for education and training of international health practitioners. The methods used included: literature review and document analysis of available training and education; an analysis of competencies required in job descriptions for international health positions; and consultations with key informants. The international health roles identified were classified in four main groups: Program Directors, Program Managers, Team Leaders and Health Specialists. Thirteen 'core' competencies were identified from the job analysis and key informant/group interviews. Contributing to international health development in resource poor countries requires high level cultural, interpersonal and team-work competencies. Technical expertise in health disciplines is required, with flexibility to adapt to new situations. International health professionals need to combine public health competencies with high level personal maturity to respond to emerging challenges.

The effect of exercise training on sleep quality in heart failure

Background: Heart failure is a serious condition estimated to affect 1.5-2.0% of the Australian population with a point prevalence of approximately 1% in people aged 50-59 years, 10% in people aged 65 years or more and over 50% in people aged 85 years or over (National Heart Foundation of Australian and the Cardiac Society of Australia and New Zealand, 2006). Sleep disturbances are a common complaint of persons with heart failure. Disturbances of sleep can worsen heart failure symptoms, impair independence, reduce quality of life and lead to increased health care utilisation in patients with heart failure. Previous studies have identified exercise as a possible treatment for poor sleep in patients without cardiac disease however there is limited evidence of the effect of this form of treatment in heart failure. Aim: The primary objective of this study was to examine the effect of a supervised, hospital-based exercise training programme on subjective sleep quality in heart failure patients. Secondary objectives were to examine the association between changes in sleep quality and changes in depression, exercise performance and body mass index. Methods: The sample for the study was recruited from metropolitan and regional heart failure services across Brisbane, Queensland. Patients with a recent heart failure related hospital admission who met study inclusion criteria were recruited. Participants were screened by specialist heart failure exercise staff at each site to ensure exercise safety prior to study enrolment. Demographic data, medical history, medications, Pittsburgh Sleep Quality Index score, Geriatric Depression Score, exercise performance (six minute walk test), weight and height were collected at Baseline. Pittsburgh Sleep Quality Index score, Geriatric Depression Score, exercise performance and weight were repeated at 3 months. One hundred and six patients admitted to hospital with heart failure were randomly allocated to a 3-month disease-based management programme of education and self-management support including standard exercise advice (Control) or to the same disease management programme as the Control group with the addition of a tailored physical activity program (Intervention). The intervention consisted of 1 hour of aerobic and resistance exercise twice a week. Programs were designed and supervised by an exercise specialist. The main outcome measure was achievement of a clinically significant change (.3 points) in global Pittsburgh Sleep Quality score. Results: Intervention group participants reported significantly greater clinical improvement in global sleep quality than Control (p=0.016). These patients also exhibited significant improvements in component sleep disturbance (p=0.004), component sleep quality (p=0.015) and global sleep quality (p=0.032) after 3 months of supervised exercise intervention. Improvements in sleep quality correlated with improvements in depression (p<0.001) and six minute walk distance (p=0.04). When study results were examined categorically, with subjects classified as either "poor" or "good" sleepers, subjects in the Control group were significantly more likely to report "poor" sleep at 3 months (p=0.039) while Intervention participants were likely to report "good" sleep at this time (p=0.08). Conclusion: Three months of supervised, hospital based, aerobic and resistance exercise training improved subjective sleep quality in patients with heart failure. This is the first randomised controlled trial to examine the role of aerobic and resistance exercise training in the improvement of sleep quality for patients with this disease. While this study establishes exercise as a therapy for poor sleep quality, further research is needed to investigate the effect of exercise training on objective parameters of sleep in this population.

Effect of exercise training on skeletal muscle cytokine expression in the elderly

Aging is associated with increased circulating pro-inflammatory and lower anti-inflammatory cytokines. Exercise training, in addition to improving muscle function, reduces these circulating pro-inflammatory cytokines. Yet, few studies have evaluated changes in the expression of cytokines within skeletal muscle after exercise training. The aim of the current study was to examine the expression of cytokines both at rest and following a bout of isokinetic exercise performed before and after 12 weeks of resistance exercise training in young (n = 8, 20.3 ± 0.8 yr) and elderly men (n = 8, 66.9 ± 1.6 yr). Protein expression of various cytokines was determined in muscle homogenates. The expression of MCP-1, IL-8 and IL-6 (which are traditionally classified as ‘pro-inflammatory’) increased substantially after acute exercise. By contrast, the expression of the anti-inflammatory cytokines IL-4, IL-10 and IL-13 increased only slightly (or not at all) after acute exercise. These responses were not significantly different between young and elderly men, either before or after 12 weeks of exercise training. However, compared with the young men, the expression of pro-inflammatory cytokines 2 h post exercise tended to be greater in the elderly men prior to training. Training attenuated this difference. These data suggest that the inflammatory response to unaccustomed exercise increases with age. Furthermore, regular exercise training may help to normalize this inflammatory response, which could have important implications for muscle regeneration and adaptation in the elderly.

Pushing cultural competence boundaries in nutrition and dietetics training

A health workforce ready for safe practice is a government priority, and particularly critical to support indigenous communities closing ‘the gap’. Increased pressure exists on dietetic training programs for quality placements, with fewer opportunities for immersion in Aboriginal and Torres Strait Islander communities to demonstrate cultural competence. In 2012, Queensland University of Technology established a partnership with Apunipima Cape York Health Council with 56 weeks of dietetic placement for 8 students provided to achieve these aims. Clinical practice in Community Public Health Nutrition (CPHN) was structured in a standard 6 week placement, with Individual Case Management (ICM) and Foodservice Management (FSM) integrated across 8 weeks (4 each), with an additional 2 weeks ICM prior in a metropolitan indigenous health service. Students transitioned from urban to rural then remote sites, with new web-based technologies used for support. Strong learning opportunities were provided, with CPHN projects in antenatal and child health, FSM on standardisation of procedures in a 22 bed health facility, and ICM exposing students to a variety of cases via hospital in/outpatients, general clinics and remote community outreach. Supervisor focus group evaluation was positive, with CPHN and FSM enhancing capacity of service. Student focus group evaluation revealed placements exceeded expectations, with rating high, and strong confidence in cultural competence described. Students debriefed final and third year cohorts on their experiences, with increased awareness and enthusiasm for work with indigenous communities indicated by groups. With the success of this partnership, placements are continuing 2013, and new boundaries in dietetic training established.