White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access,medication safety,and impact on the health care system

ObjectiveTo convene a group of expert stakeholders to develop recommendations for standardizing systems for the implementation of risk evaluation and mitigation strategies (REMS).Data sourcesOn July 15, 2009, the American Pharmacists Association convened an expert panel of stakeholders to explore standardized solutions to REMS development and implementation. Meeting participants included pharmacists from various practice settings, physicians, researchers, patient advocates, and a nursing delegate, and the meeting was observed by a U.S. Food and Drug Administration representative. The stakeholders’ recommendations were combined with themes arising from discussion of their experiences with existing REMS, and a review of the literature on REMS and risk management was performed by the author.SummaryA systematic, standardized REMS process that balances the need to control the risks of medications with the need to minimize the impact on patient access is required. A standardized REMS system could address various aspects of development and implementation, including the creation of specific REMS “levels,” centralized systems for data management and program structure, public education, individualized patient education, provider education, access to medications, pilot testing, outcomes monitoring, and quality of care.ConclusionSeveral strategies to streamline the development and implementation of a REMS system are feasible. Incorporating such strategies is necessary to manage the rapidly growing number of individual and diverse REMS programs that patients and health care providers must navigate. Furthermore, a standardized REMS system could be used to improve quality of care and support patient education and empowerment.     

The impact of maternal experience of violence and common mental disorders on neonatal outcomes: a survey of adolescent mothers in Sao Paulo,Brazil

Background  

Both violence and depression during pregnancy have been linked to adverse neonatal outcomes, particularly low birth weight. The aim of this study was to investigate the independent and interactive effects of these maternal exposures upon neonatal outcomes among pregnant adolescents in a disadvantaged population from Sao Paulo, Brazil.     

Must Macrosomic Fetuses be Delivered by a Caesarean Section? A Review of Outcome for 786 Babies ≥ 4,500 g

Because difficult vaginal delivery is more frequent with macrosomic fetuses, some writers recommend routine Caesarean section for the delivery of fetuses greater than or equal to 4,500 g. The purpose of this study was to evaluate the appropriateness of this recommendation. A retrospective review was undertaken to determine how many fetuses born in our hospital weighing greater than or equal to 4,500 g died or were permanently damaged as a consequence of mechanical difficulties at delivery. During a 10-year period, 590 (75%) of 786 cephalic babies weighing greater than or equal to 4,500 g and alive at the start of labour were born vaginally. No baby died or was permanently damaged as a consequence of mechanical difficulties at delivery. Routine Caesarean section for macrosomic fetuses to prevent death or damage from difficult delivery is not warranted by our results.     

Comparison of an elemental with a hydrolysed whey formula in intolerance to cows' milk

In a double blind study, 40 infants with cows' milk intolerance of various causes were randomised to receive a nutritionally complete formula in which nitrogen was supplied either as whey hydrolysate or amino acids. The median age of infants was 10 weeks (range 36 weeks' gestation to 108 weeks' postnatal age). After a median follow up period of 25 weeks there was no significant difference in dietary intake between the formulas. Twenty four weeks after entry, weight and weight for length improved equally on both formulas. Plasma albumin improved significantly on the hydrolysed whey formula but not in the amino acid group. Both milks were palatable and normal intakes of formula were maintained. Biochemical and haematological indices remained within normal limits. There was no difference in stool frequency and vomiting between the two formulas. Two infants developed a probable allergic colitis while receiving hydrolysed whey. Amino acid formula may have a role in the management of atopic infants with severe cows' milk intolerance who have already reacted to whey or casein hydrolysate formula.     

The Significance of Mild Squamous Atypia on Cytology

Summary: Between January, 1991 and February, 1993 inclusive, 396 Papanicolaou smears were reported to show Mild Squamous Atypia with or without Human Papilloma Virus (MSA ± HPV). All women with MSA ± HPV smears were routinely recalled for colposcopy. To determine the significance of MSA ± HPV on routine smear screening, the records of all patients were reviewed.
Three hundred and thirty-seven women (85.1%) attended the colposcopy clinic and are the subjects analyzed for this report. The remaining 59 (14.9%) failed to attend. Intraepithelial neoplasia was found in 61 patients (18.1%), of whom 27 (8.0%) had a high grade lesion (CIN 2 or 3 or GIN 2). No patient had invasive cancer of the cervix. Only 1 of the 45 pregnant women had a significant lesion.
It is concluded that all asymptomatic women with MSA ± HPV on cervical smear may be managed in accordance with the current NH and MRC recommendations (1) and have a repeat smear in 6 months and colposcopy if the abnormality persists at 12 months.     

Evaluation of a self-management programme for congestive heart failure patients: design of a randomised controlled trial

Background  

Congestive heart failure (CHF) has a substantial impact on care utilisation and quality of life. It is crucial for patients to cope with CHF adequately, if they are to live an acceptable life. Self-management may play an important role in this regard. Previous studies have shown the effectiveness of the 'Chronic Disease Self-Management Program' (CDSMP), a group-based cognitive behavioural programme for patients with various chronic conditions. However, the programme's effectiveness has not yet been studied specifically among CHF patients. This paper presents the design of a randomised controlled trial to evaluate the effects of the CDSMP on psychosocial attributes, health behaviour, quality of life, and health care utilisation of CHF patients.     

Localized muscular mucormycosis in a child with acute leukemia

Mucormycosis is a rare fungal infection of childhood, occurring mainly in patients with chronic illnesses such as diabetes and malignancies. The fungus seldom grows in culture and confirmation of the diagnosis depends on histologic examination of infected tissues. To date, the reported natural history of the disease has been rapid progression and a fatal outcome. Therefore, the importance of early diagnosis by tissue biopsy and early treatment with surgical debridement and systemic antifungal therapy cannot be overemphasized. The pulmonary system is the most common site for mucormycosis in patients with leukemia. We report what we believe to be the first successfully treated case of isolated muscular mucormycosis occurring in a child with biphenotypic acute leukemia. The diagnosis was made promptly by tissue examination at the time of surgical debridement. The patient was also given systemic amphotericin-B therapy.      

Metabolic effects of growth hormone treatment: an early predictor of growth response?

Fourteen children receiving one year of recombinant human growth hormone (rhGH) treatment underwent measurement of serial changes in body composition (measured by skinfold thickness, bioelectrical impedance, and H2(18)O dilution), resting energy expenditure (REE, estimated by ventilated hood indirect calorimetry), and total free living daily energy expenditure (TEE, measured by the doubly labelled water technique). Mean height velocity increased from 4.9 to 8.6 cm/year after six months of treatment. Fat free mass (FFM) increased more during the first six weeks (24.4 g/day) than from six to 26 weeks of treatment (6.8 g/day); fat mass decreased by 7.2 g/day and 1.1 g/day respectively. The six week increase in REE (kJ/day) was maintained after six months of treatment, though expressed per kilogram FFM (kJ/kgFFM/day), returned to pretreatment values by three months. Height velocity increases at six months correlated with six week changes in fat mass measured by skinfold thickness and REE, though use of this relationship to predict growth response in individuals is limited by the wide 95% prediction intervals. No significant changes in growth, body composition, or energy expenditure were observed between six and 12 months of treatment, in either patients who had initially responded well to treatment or those who were poor initial responders to treatment and who had their dose of rhGH doubled after six months.     

Effects of a few food diet in attention deficit disorder

Seventy-eight children, referred to a diet clinic because of hyperactive behaviour, were placed on a 'few foods' elimination diet. Fifty nine improved in behaviour during this open trial. For 19 of these children it was possible to disguise foods or additives, or both, that reliably provoked behavioural problems by mixing them with other tolerated foods and to test their effect in a placebo controlled double blind challenge protocol. The results of a crossover trial on these 19 children showed a significant effect for the provoking foods to worsen ratings of behaviour and to impair psychological test performance. This study shows that observations of change in behaviour associated with diet made by parents and other people with a role in the child's care can be reproduced using double blind methodology and objective assessments. Clinicians should give weight to the accounts of parents and consider this treatment in selected children with a suggestive medical history.