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Monitoring and management of bone status in patients on chronic glucocorticoid treatment--the Medscheme experience.

OBJECTIVE: Review of administrative databases to gain insight into the investigation, management and sequelae of bone disease in patients on long-term glucocorticoid treatment. DESIGN: Retrospective analysis of 1998 pharmaceutical and clinical claims data for +/- 2 million lives administered by Medscheme. Data were extracted for members registered with the chronic medication programme as eligible for chronic glucocorticoid treatment. Those identified were subjected to further review for evidence of osteoporosis and/or hip fracture. Subgroup analysis of peri- and postmenopausal women was carried out and compared against a control group. MAIN OUTCOME MEASURES: Osteoporosis investigation and treatment rates in males and females; frequency of hip fractures; prescribing profiles; role of underlying disease, glucocorticoid route, gender and age in development of osteoporosis. RESULTS: A total of 1,614 subjects (54% females) was registered for chronic glucocorticoid treatment. Osteoporosis was diagnosed in 14.1% of females and 5.9% of males across a broad age range. Hip fractures were recorded for one female and three males. The subgroup analysis showed that osteoporosis was +/- 1.5 times more common in women receiving glucocorticoids than in peri- and postmenopausal controls, and that there was greater use of vitamin D and calcium supplementation and bisphosphonates in those exposed to glucocorticoids. Multivariate analysis showed overall that female gender, increasing age and oral glucocorticoids were significantly related to osteoporosis. CONCLUSION: Reference to UK and US data suggests that while local practitioners are aware of the effect of glucocorticoids on bone, the level of awareness is probably suboptimal, especially with regard to male patients.

Administration, Inhalation↗

Comparison of indicators assessing the quality of drug prescribing for asthma.

OBJECTIVE: To compare different indicators for assessing the quality of drug prescribing and establish their agreement in identifying doctors who may not adhere to treatment guidelines. DATA SOURCES/STUDY SETTING: Data from 181 general practitioners (GPs) from The Netherlands. The case of asthma is used as an example because, in this area, different quality indicators exist whose validity is questioned. The study is part of the European Drug Education Project. STUDY DESIGN: Spearman rank correlations were assessed among the GPs' scores on self-report instruments, aggregated prescribing indicators, and individualized prescribing indicators. Kappa values were calculated as agreement measures for identifying low adherence to the guidelines. DATA COLLECTION: Prescribing data from GPs were collected through pharmacies, public health insurance companies, or computerized GP databases. Two self-report instruments were mailed to the GPs. The GPs first received a questionnaire assessing their competence regarding the treatment of asthma patients. Three months later they received a series of 16 written asthma cases asking for their intended treatment for each case. PRINCIPAL FINDINGS: Correlations between scores based on self-report instruments and indicators based on actual prescribing data were mostly nonsignificant and varied between 0 and 0.21. GPs identified as not adhering to the guidelines by the prescribing indicators often had high scores on the self-report instruments. Correlations between 0.20 and 0.55 were observed among indicators based on aggregated prescribing data and those based on individualized data. The agreement for identifying low adherence was small, with kappa values ranging from 0.19 to 0.30. CONCLUSIONS: Indicators based on self-report instruments seem to overestimate guideline adherence. Indicators assessing prescribing quality at an aggregated level give clearly different results, as compared to indicators evaluating prescribing data on an individual patient level. Caution is needed when using such prescribing indicators to identify low adherence to guidelines. Further validation studies using a gold standard comparison are needed to define the best possible indicator.

Administration, Inhalation↗

[Bases of safe substance levels for unified sanitary standards].

The study was undertaken to detect substances whose threshold and safe levels cannot be used without their correction in order to provide unified sanitary standardization. The criteria for choosing the substances were their high stability, capacity of bioaccumulation, the presence of mutagenic and/or carcinogenic properties and great discrepancy between the values of chronic toxicity of a substance and structure-activity relationships, which are typical of the structural series it belongs to. The use of these criteria may identify 155 substances standardized in water and 126 in the ambient air, whose threshold and safe levels in their oral and inhaled administrations are to be clarified.

Carcinogenicity Tests↗

The acute toxicity and primary irritancy of glutaraldehyde solutions.

Glutaraldehyde (GA, CAS Number 110-30-8), an aliphatic dialdehyde, has a wide range of industrial, scientific, and medical applications. It is available in aqueous solutions, whose concentrations vary up to 50% (w/w) and from which there is a potential during use for skin and eye contact and exposure to the vapor. The acute toxicity and primary irritancy of a wide range of GA concentrations were investigated to determine the differential hazards for such solutions. The acute peroral toxicity in the rat, expressed as ml of solution dosed, was moderate for solutions of 5% and above (LD50 range 0.88-3.25 ml/kg) and generally varied little for solutions up to 50%. Solutions less than 5% GA were of slight toxicity (LD50 range 3.34-12.30 ml/kg for 1 and 2% solutions). When lethality was expressed as absolute amount of GA dosed (mg GA/kg), there was a reciprocal relationship between the concentration of GA solution dosed and LD50. This was confirmed in the mouse, which is more susceptible than the rat to acute peroral toxicity. The acute percutaneous toxicity of GA solutions to rabbits (24 h occlusion) was moderate (LD50 range 1.59-2.71 ml/kg) for 46 and 50% solutions, and slight for 25% GA solutions (8.80-16.00 ml/kg). At 15% and less, 16.0 ml/kg was not lethal. Exposures (4-8 h) of rats to saturated vapor atmospheres of GA generated dynamically or statistically at ambient temperature (17-25 C) produced only transient peripheral sensory irritant effects to the eyes and respiratory tract. In contrast, vapor atmosphere generated dynamically at elevated temperature (60 or 65 C) produce severe effects, including mortality (4-h LC50 range 23.5-44.3 ppm). Histopathology in rats that died included exposure concentration-related acute inflammation and necrosis in the nasal mucosa, larynx, trachea, and bronchi. Standard primary skin irritation tests in the rabbit indicated severe skin irritation and necrosis at 45 and 50% GA; necrosis occurred with 1 and 4 h contact at 50% and at 4 h with 45%. Inflammation was moderate at 25%, slight to moderate with 5 and 10% GA, minor at 2%, and threshold at 1%. Standard primary eye irritation tests showed 45% GA to produce severe conjunctival and corneal injury, which was persistent. At 2% GA corneal injury was mild, and at 5% marked. The lowest concentration producing corneal injury was 1.0%, and the no-effects concentration was 0.5%. The threshold for conjunctival effects was 0.2%, and the no-effects concentration 0.1%. At 1% GA, conjunctival hyperemia and chemosis were moderate to marked, and became more severe with higher GA concentrations. The results suggest potential acute handling hazards with various concentrations of GA solutions and indicate industrial hygiene considerations.

Administration, Cutaneous↗

Comparing the safety, efficacy and recovery of intranasal midazolam vs. oral chloral hydrate and promethazine.

PURPOSE: The purpose of this study was to compare the safety, efficacy and recovery time of intranasal midazolam spray administered using an atomizer to orally administered chloral hydrate and promethazine for the sedation of pediatric dental patients. METHODS: A randomized double-blind crossover study design was utilized in which 31 patients (mean age 41.8 months, range 26-58 months) underwent two restorative dental appointments. At one appointment, subjects received 0.2 mg/kg intranasal midazolam; at the other appointment subjects received 62.5 mg/kg chloral hydrate with 12.5 mg promethazine. Administered at each appointment was 25%-50% N(2)0/0(2). Physiologic parameters (heart rate, blood pressure, respiratory rate, oxygen saturation) and behavior assessments (crying, movement, sleep) using the Houpt Sedation Rating Scale were recorded at baseline and every five minutes during treatment. Overall behavior was assessed at baseline and at the end of treatment. Following treatment, a modified Vancouver Recovery Scale was used to determine the length of time it took each subject to meet established discharge criteria. RESULTS: There were no clinically significant differences in physiologic parameters, however a statistically significant decrease in systolic and diastolic blood pressure was observed in patients sedated with chloral hydrate/promethazine. There were no significant differences in behavior between groups. Patients sedated with intranasal midazolam slept less and recovered quicker than patients sedated with oral chloral hydrate/promethazine. CONCLUSIONS: Intranasal midazolam administered using an atomizer is as safe (as assessed by physiologic parameters) and effective (as assessed by behavior ratings) as oral chloral hydrate/promethazine for conscious sedation of pediatric dental patients.

Administration, Inhalation↗

Patient preferences and satisfaction with prescribed nasal steroids for allergic rhinitis.

A telephone survey of 503 patients with seasonal and perennial allergic rhinitis was performed to assess satisfaction with their nasal steroid therapy and their reasons for preferences for particular products. Product attributes such as efficacy and various sensory features (e.g., nasal irritation, odor, and taste) were evaluated. Although patients generally are satisfied with their nasal steroid preparations, they do show clear preferences for the sensory attributes of different products. Patients are willing to switch on their physicians' recommendations and clearly prefer products with no odor and no taste.

Administration, Inhalation↗

[Treatment of nicotine addiction. Drug therapy for smoking cessation].

Most Danish smokers are addicted to nicotine. Treatment with nicotine replacement therapy or bupropion doubles the one-year success rate after cessation of smoking. Pregnant smokers who are unable to stop smoking without medical treatment can safely be offered nicotine replacement therapy. The health risk of smoking is particularly high in patients with cardiovascular disease. Reluctance to use nicotine products for patients with heart disease is not supported by scientific evidence, and either bupropion or nicotine products can safely be administered to them.

Administration, Inhalation↗

Special delivery.

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Administration, Cutaneous↗

Influenza.

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Acetamides↗

Asthma in primary care.

Asthma is a chronic disease that cannot be cured but can be effectively controlled. Control is achieved through education of the patient, monitoring of symptoms and pulmonary functions, environmental modification and pharmacologic therapy. The latter should aim at providing control with the least amount of medications. Any form of asthma more severe than mild intermittent requires the use of long term anti-inflammatory medications.

Administration, Inhalation↗

[Effectiveness of mometasone furoate nasal spray in seasonal allergic rhinitis. First experiences in practice after the introduction of the drug in Hungary].

INTRODUCTION: The authors appraised the clinical efficacy of mometasone furoate in patients with seasonal allergic rhinitis and rhinoconjunctivitis. PATIENTS AND METHODS: An open, two-week trial was conducted in 89 patients between 1 July and 15 September 2001. A baseline oto-rhinolaryngological examination was performed. Nasal obstruction, rhinorrhea, sneezing, and itching as well as ocular, throat and ear clinical signs and general symptoms including cough and dyspnea were characterized using a symptom score. Mometasone furoate was administered intranasally in 100 micrograms doses into both nostrils. Depending on the severity of symptoms, antiallergic eye drops and systemic antihistamines were also allowed. After two weeks of treatment, a follow-up physical examination was performed and the symptom score was re-evaluated. Potential adverse events that had occurred during the treatment period were recorded. RESULTS: Mometasone furoate nasal spray alleviated all four nasal symptoms promptly and effectively. In particular, treatment resulted in a 93 percent decrease of overall symptom score. None of the participants discontinued treatment due to the occurrence of adverse effects. CONCLUSION: These results demonstrate that mometasone furoate nasal spray is a safe and effective intranasal corticosteroid for the therapy of SAR/SARC seasonal allergic rhinitis and rhinoconjunctivitis.

Administration, Inhalation↗