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PubMed2006

Pharmacological treatment of acute mania in psychiatric in-patients between 1994 and 2004.

BACKGROUND: In a cross-section approach we investigated prescription practice in acute mania in 63 German, Swiss and Austrian hospitals between 1994 and 2004. METHODS: Our data were gathered from a large drug safety program (AMSP) within which on two reference days each year all administered drugs are recorded. For the present study, all cases with a primary diagnosis of acute euphoric mania (n=1291) or mixed-state mania (n=143) were identified. Prescription rates from two periods, 1994 to 1999 and 2000 to 2004, were compared. RESULTS: In euphoric mania, prescription of lithium decreased by about one-fifth (43.3% to 34.5%, p<0.01), while prescription of anticonvulsants increased by one-half (from 40.0% to 60.7%, p<0.001). Administration of atypical antipsychotics more than doubled (18.5% to 43.9%, p<0.001), while use of typical antipsychotics decreased significantly (56.9% to 27.8%, p<0.001). Overall prescription rates of antipsychotics (79.6% vs. 81.6%) and antidepressants (14.0% vs. 15.5%) remained stable, while administration of tranquilizers increased significantly (26.3% to 34.3%, p<0.01). In mixed-state mania, similar trends over time to those seen in euphoric mania were observed for lithium (43.2% to 33.3%), anticonvulsants (50.0% to 69.7%, p<0.05) and tranquilizers (22.7% to 40.4%). Prescription rates of antipsychotics slightly increased (63.6% to 72.7%), while prescription of antidepressants slightly decreased (54.5% to 46.5%). Polypharmacy was a common phenomenon: patients with euphoric mania were treated with a mean number of 2.9+/-1.2 psychotropic agents, and patients with mixed-state mania with 3.3+/-1.5 psychotropic agents. Both groups showed a significant increase over time. Second-generation atypical antipsychotics were adopted quite rapidly for the treatment of acute mania considering the availability of the scientific evidence at that time. Off-label use was a common phenomenon. Deviations from recommended guidelines were found mainly in the use of antidepressant and antipsychotic drugs both in mixed-state and euphoric mania. CONCLUSIONS: Naturalistic prescription studies like this may encourage a critical scrutiny of clinical treatment habits and may also drive further research thus moderating potential differences between evidence-based knowledge and everyday clinical practice.

Acute Disease↗

PubMed2005

Developing quality indicators for elderly patients undergoing abdominal operations.

BACKGROUND: Although the expanding and aging population will likely increase demand for surgical services, surgeons and other providers must develop strategies to optimize care. We sought to develop process-based quality indicators for elderly patients undergoing abdominal operations to identify necessary and meaningful ways to improve care in this cohort. STUDY DESIGN: Through structured interviews with thought leaders and systematic reviews of the literature, we identified candidate quality indicators addressing perioperative care in elderly patients undergoing abdominal operations. Using a modification of the RAND/UCLA Appropriateness Methodology, an expert panel of physicians in surgery, geriatrics, anesthesia, internal, and rehabilitation medicine formally rated and discussed the indicators. RESULTS: Eighty-nine candidate indicators were identified and categorized into seven domains: comorbidity assessment (eg, cardiopulmonary disease), elderly issues (eg, cognition), medication use (eg, polypharmacy), patient-to-provider discussions (eg, life-sustaining preferences), intraoperative care (eg, preventing hypothermia), postoperative management (eg, preventing delirium), and discharge planning (eg, home health care). Of the 89 candidate indicators, 76 were rated as valid by the expert panel. Importantly, the majority of indicators rated as valid address processes of care not routinely performed in younger surgical populations. CONCLUSIONS: Attention to the quality of surgical care in elderly patients is of great importance because of the increasing numbers of elderly undergoing operations. This project used a validated methodology to identify and rate process measures to achieve high-quality perioperative care for elderly surgical patients. This is the first time quality indicators have been developed in this regard.

Aged↗

PubMed2005

The Aging Game: improving medical students' attitudes toward caring for the elderly.

OBJECTIVES: The objective of this study was to evaluate the effectiveness of a modified aging game to enhance medical students' attitudes toward caring for elderly patients, enhance empathy for elderly patients, and improve general attitudes toward the elderly. DESIGN: Preintervention and postintervention study PARTICIPANTS AND SETTING: All 84 students from 2 first-year medical school classes INTERVENTION: The aging game takes place over a period of 3 hours with a group of 10 to 12 students and 5 to 6 facilitators, and includes experiential learning about polypharmacy, medication cost, loss of functional status, semi-independent living, and living in a long-term care facility. MEASUREMENTS: Scores obtained through a modified Maxwell and Sullivan questionnaire, and the Aging Semantic Differential (ASD). RESULTS: There was a statistically significant improvement in 6 of the 8 attitudes toward caring for elderly and a statistically significant increase in empathy towards elderly patients following the aging game. There was a statistically significant change on 23 out of 32 ASD questions. There was no evidence of differences in the scores from pre-course to post-course by gender age group, interest in Family/Internal Medicine, or prior geriatric experience. Following the game, 77 (93%) of the students said they would take the course if not mandatory (P = .0001). A majority stated the aging game added significantly (61.5%) or moderately (37.3%) to their knowledge and skills in patient care for the elderly. CONCLUSION: A simulation experience like the aging game is an effective method of increasing the empathy and attitudes toward caring for the elderly early in the medical school curriculum. Longitudinal assessment of the effect of the aging game in maintaining the positive effect on empathy and attitudes toward caring for the elderly and especially in clinical practice needs to be done.

Activities of Daily Living↗

PubMed2006

Psychotherapy in long-term care: A review.

Psychological distress in long-term care (LTC) settings is highly prevalent and crosses many conventional psychiatric diagnostic boundaries. Mental health professionals who consult in LTC facilities have experienced firsthand the impact of a variety of nonpharmacological therapeutic approaches on individual residents, yet these are rarely investigated in a systematic fashion, and even less commonly reported in the literature. The present report summarizes the state-of-evidence of "talk therapies" for depression and psychological well-being in LTC facilities by reviewing controlled trials of psychotherapy for LTC residents published in English-language peer-reviewed journals. We excluded studies of nonpharmacological approaches designed primarily to curb behavioral disturbances of dementia, and those psychosocial interventions using an approach other than "talk therapy" in individual or group format since they have been reviewed in detail elsewhere. A majority of the 18 studies that met our inclusion criteria reported significant short- and, in some cases, longer-term benefits on instruments measuring depression, hopelessness, self-esteem, perceived control, and a host of other psychological variables. However, these findings must be interpreted within the severe methodological limitations of many studies, including small sample sizes, variable study entry criteria, short duration of trials, heterogeneous outcome assessment methods, and lack of detail on intervention methods. Nevertheless, the positive efficacy of these approaches, when understood within the framework of potential serious complications of pharmacotherapy for frail elders with multiple comorbidities, polypharmacy, and a narrow therapeutic index, suggests a strong need for methodologically rigorous trials of psychotherapy in the LTC setting, especially in combination with pharmacotherapy.

Aged↗

PubMed2006

HPLC analysis of the second-generation antidepressant sertraline and its main metabolite N-desmethylsertraline in human plasma.

A liquid chromatographic method with ultraviolet detection was developed for the analysis of the recent antidepressant sertraline and its main metabolite N-desmethylsertraline in human plasma. The analytes were separated on a C8 reversed phase column, using a mobile phase composed of acetonitrile and a 12.3 mM, pH 3.0 phosphate buffer containing 0.1% triethylamine (35:65, v/v). Clomipramine was used as the Internal Standard. Using a solid phase extraction procedure with C2 cartridges high extraction yields (>94%) and good purification from matrix interference were obtained. Good linearity was obtained in the 7.5-250.0 ng mL(-1) range for sertraline and in the 10-500 ng mL(-1) range for N-desmethylsertraline. The analytical method was validated in terms of precision, extraction yield and accuracy. These assays gave R.S.D.% values for precision always lower than 3.9% and mean accuracy higher than 90%. Thanks to its good selectivity, the method proved to be suitable for the analysis of plasma samples from patients treated with sertraline as either monotherapy or polypharmacy.

Chromatography, High Pressure Liquid↗

PubMed2006

Simultaneous determination of fluvoxamine isomers and quetiapine in human plasma by means of high-performance liquid chromatography.

An original HPLC-UV method has been developed for the simultaneous determination of the atypical antipsychotic quetiapine and the geometric isomers of the second-generation antidepressant fluvoxamine. The analytes were separated on a reversed-phase C8 column (150 mm x 4.6mm i.d., 5 microm) using a mobile phase composed of acetonitrile (30%) and a 10.5mM, pH 3.5 phosphate buffer containing 0.12% triethylamine (70%). The flow rate was 1.2 mL min(-1) and the detection wavelength was 245 nm. Sample pretreatment was carried out by an original solid-phase extraction procedure using mixed-mode cation exchange (DSC-MCAX) cartridges; only 300 microL of plasma were needed for one analysis. Citalopram was used as the internal standard. The method was validated in terms of linearity, extraction yield, precision and accuracy. Good linearity was obtained in plasma over the 5.0-160.0 ng mL(-1) concentration range for each fluvoxamine isomer and over the 2.5-400.0 ng mL(-1) concentration range for quetiapine. Extraction yield values were always higher than 93%, with precision (expressed as relative standard deviation values) better than 4.0%. The method was successfully applied to human plasma samples drawn from patients undergoing polypharmacy with the two drugs. Satisfactory accuracy values were obtained, with mean recovery higher than 94%.

Chromatography, High Pressure Liquid↗

PubMed2006

Simultaneous determination of the antipsychotic drugs levomepromazine and clozapine and their main metabolites in human plasma by a HPLC-UV method with solid-phase extraction.

A HPLC method with UV detection has been developed for the simultaneous determination of levomepromazine, clozapine and their main metabolites: N-desmethyl-levomepromazine, levomepromazine sulphoxide, O-desmethyl-levomepromazine, N-desmethylclozapine and clozapine N-oxide. The analytes were separated on a C8 reversed-phase column using a mobile phase composed of acetonitrile and a pH 2.0, 34 mM phosphate buffer containing 0.3% triethylamine (29:71, v/v). Loxapine was used as the internal standard. A reliable biological sample pre-treatment procedure by means of solid-phase extraction on C1 cartridges was implemented, which allows to obtain good extraction yields (>91%) for all analytes and appropriate sample purification from endogenous interference. The method was validated in terms of extraction yield, precision and accuracy. These assays gave RSD% values for precision always lower than 4.9% and mean accuracy values higher than 92%. The method is suitable for the therapeutic drug monitoring (TDM) of patients undergoing polypharmacy with levomepromazine and clozapine.

Antipsychotic Agents↗

PubMed2006

Burden of illness in painful diabetic peripheral neuropathy: the patients' perspectives.

UNLABELLED: Our goal was to assess the patient-level burden among subjects with painful diabetic peripheral neuropathy (DPN). Community-based physicians recruited patients with painful DPN (N = 255) between April and October 2003. Patients completed a survey on pain experience (Brief Pain Inventory-DPN [BPI-DPN]), health status (EuroQoL [EQ-5D]), healthcare utilization (consults, prescription [Rx], and over-the-counter [OTC] medications), and work productivity/functioning. Patients were 61 +/- 12.8 years old and had diabetes for 12 +/- 10.3 years and painful DPN for 6.4 +/- 6.4 years; 25.5 and 62.7% had other neuropathic and musculoskeletal pain conditions. Average and worst pain scores (BPI-DPN, 0-10 scales) were 5.0 +/- 2.5 and 5.6 +/- 2.8. The mean EQ-5D utility was .5 +/- .3 (range = -.594-1). A majority (87.4%) took pain medications (Rx/OTC) in the preceding week: an average of 3.8 +/- 3.9 Rx and 2.1 +/- 1.3 OTC medications. Nearly half (46.7%) received NSAIDs. Other frequently reported medications were short/long-acting opioids (43.1%), anticonvulsants (27.1%), selective serotonin reuptake inhibitors/selective norepinephrine reuptake inhibitors (18%), and tricyclic antidepressants (11.4%). During the preceding 3 months, 59.6% had >or=2 health professional consults; 59% reported decreased home productivity; 85.5% reported activity limitations; and 64.4% of patients who worked (N = 73) reported missing work/decreased work productivity due to painful DPN. Our results underscore a substantial patient-level burden among subjects with painful DPN. PERSPECTIVE: Information on the patient-level burden among painful DPN sufferers in the U.S. was previously lacking. Our results suggest that this burden is significant, evidenced by moderate-to-high pain levels, polypharmacy, health resource use, and work/activity limitations. Results also suggest suboptimal pain management and low levels of satisfaction with treatments.

Aged↗

PubMed2005

Factors in choosing atypical antipsychotics: toward understanding the bases of physicians' prescribing decisions.

OBJECTIVE: Off-label prescribing of medications, polypharmacy, and other questionable prescribing practices have led investigators to examine a large VA pharmacy database to determine if physician prescribing decisions appear reasonable. METHOD: The current study addresses the question of physician prescribing of atypical antipsychotics in 34,925 veterans with schizophrenia, using a series of signal detection analyses. RESULTS: These results suggest that only three factors (hospital size, age, and secondary diagnosis) allow classification of patients prescribed atypicals into three groups with frequencies of use of atypicals ranging from 43% to 79%, and that these results are consistent with reasonable clinical practice. CONCLUSIONS: Results of two-stage signal detection analyses are readily interpretable by clinicians and administrators who are faced with the task of evaluating how physicians prescribe medications in clinical practice. Physicians' decisions to prescribe atypical antipsychotics are based on both patient and fiscal considerations. This likely reflects a combination of clinical judgment and institutional guidelines.

Antipsychotic Agents↗

PubMed2004

The relationship between oral health and nutrition in older people.

The oral health of older people is changing with reducing numbers of people relying on complete dentures for function, and retaining some natural teeth. Despite this there are substantial numbers of older people whose ability to chew foods is compromised by their oral health status, either because they have few or no natural teeth. This alteration results in individuals selecting a diet that they can chew in comfort. Such diets are low in fruits and vegetables intake with associated reduction in both non-starch polysaccharide and micronutrient intakes. There is also a trend for reduced dietary intake overall. Salivary flow and function may have an impact in relation to the ability to chew and swallow. Whilst there are few differences in salivary function in fit healthy unmedicated subjects, disease resulting in reduced salivary flow and particularly polypharmacy, with xerostomia as a side effect, are likely to have a role in older people. This paper explores the relationships between oral health status and food's choice and discusses the potential consequences for the individual of such dietary change.

Aged↗

PubMed2007

Physical medicine rehabilitation approach to pain.

A physical medicine and rehabilitation approach to acute and chronic pain syndromes includes a wide spectrum of treatment focus. Whether assessing or treating acute or chronic pain syndromes, management should include a biopsychosocial approach. Assessment may include a focused joint and functional examination including more global areas of impairment (ie, gait, balance, and endurance) and disability. More complicated multidimensional chronic pain conditions may require the use of a more collaborative continuum of multidisciplinary and interdisciplinary treatment approaches. Regardless of the scope of care that each individual patient requires, treatment options may include active physical therapy, rational polypharmacy, CBT, and the use of passive modalities. Treatment goals generally emphasize achieving analgesia, improving psychosocial functioning, and reintegration of recreational or leisure pursuits (ie, community activities and sports). Progress in all therapies necessitates close monitoring by the health care provider and necessitates ongoing communication between members of the treatment team. Although this article focuses on diagnoses related to acute and chronic low back pain, OA, and musculoskeletal disorders, assessment and treatment recommendations may be generalized to most other pain conditions.

Humans↗

PubMedDate not supplied

Fixed-drug combinations as first-line treatment for hypertension.

As combinations of drugs from different classes that have synergistic or additive effect and properties to cancel out each others' untoward hemodynamic and metabolic effects become more and more widely used, their use as first-line therapy for the treatment of newly diagnosed hypertensive patients is growing in popularity as well. The possibility to begin therapy with a fixed 2-drug combination may be preferable to starting with monotherapy followed by upward titration and addition of other agents. More and more combinations are coming out on the market and proving their effectiveness in randomized controlled trials and in large multicenter studies. One suggestion is the "polypill," a fixed combination of multiple agents that address various components of the metabolic syndrome and coexisting common risk factors in both high-risk patients with conditions requiring polypharmacy, and in healthy asymptomatic individuals.

Antihypertensive Agents↗

PubMed2004

Cloxazolam treatment for patients with intractable epilepsy.

We examined the antiepileptic effect of cloxazolam on seizures in 23 patients with intractable epilepsy. Most of the patients had central nervous system complications, as well as frequent seizures, and were being treated with polypharmacy. Cloxazolam was administered 1 to 5 mg/day (0.05 to 0.14 mg/kg) at initiation, in two divided doses daily, and gradually increased (1 to 4 mg/day; 0.05 to 0.15 mg/kg) every month at the outpatient clinic. Plasma levels of the main active metabolite, chloro-N-desmethyldiazepam, were measured in 13 patients. Four of 23 patients (17%) became seizure-free, and nine patients (39%) manifested a good response. Both patients with generalized and partial epilepsy manifested a good response. The spectrum of cloxazolam as an antiepileptic was wide. Effective doses were 0.07 to 0.56 mg/kg, and plasma effective levels of chloro-N-desmethyldiazepam were 12.3-115.1 ng/mL. Cloxazolam may be an effective and safe antiepileptic for intractable epilepsy, and should be used as an adjunct to other antiepileptic drugs or administered after other agents.

Adolescent↗

PubMed2006

Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital.

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.

Adolescent↗

PubMed2003

Half a century of antipsychotics and still a central role for dopamine D2 receptors.

A review of the history of antipsychotics reveals that while the therapeutic effects of chlorpromazine and reserpine were discovered and actively researched almost concurrently, subsequent drug development has been restricted to drugs acting on postsynaptic receptors rather than modulation of dopamine release. The fundamental property of atypical antipsychotics is their ability to produce an antipsychotic effect in the absence of extrapyramidal side effects (EPS) or prolactin elevation. Modulation of the dopamine D2 receptor remains both necessary and sufficient for antipsychotic drug action, with affinity to the D2-receptor being the single most important discriminator between a typical and atypical drug profile. Most antipsychotics, including atypical antipsychotics, show a dose-dependent threshold of D2 receptor occupancy for their therapeutic effects, although the precise threshold is different for different drugs. Some atypical antipsychotics do not appear to reach the threshold for EPS and prolactin elevation, possibly accounting for their atypical nature. To link the biological theories of antipsychotics to their psychological effects, a hypothesis is proposed wherein psychosis is a state of aberrant salience of stimuli and ideas, and antipsychotics, via modulation of the mesolimbic dopamine system, dampen the salience of these symptoms. Thus, antipsychotics do not excise psychosis: they provide the neurochemical platform for the resolution of symptoms. Future generations of antipsychotics may need to move away from a "one-size-fits-all polypharmacy-in-a-pill" approach to treat all the different aspects of schizophrenia. At least in theory a preferred approach would be the development of specific treatments for the different dimensions of schizophrenia (e.g., positive, negative, cognitive, and affective) that can be flexibly used and titrated in the service of patients' presenting psychopathology.

Animals↗

PubMed2004

Comparison of risperidone and olanzapine as used under "real-world" conditions in a state psychiatric hospital.

As a follow-up to our previous study of clozapine, medical records of a state psychiatric hospital were reviewed for patients who were prescribed an atypical antipsychotic. From that sample, demographic and clinical data were obtained for individuals with an initial score of 35 or greater on the Brief Psychiatric Rating Scale (BPRS), and at least two additional successive monthly BPRS ratings. A total of 100 patients met the criteria. Most received either olanzapine (46%) or risperidone (36%), with few administered quetiapine (11%) or clozapine (7%). Most also received adjunctive medications, including conventional antipsychotics, anticonvulsants/mood stabilizers, antidepressants, and antiparkinsonian agents. The number of patients whose BPRS total scores decreased by 20% or more from baseline was significantly greater for those who received olanzapine than those who received risperidone. However, there was no difference between the two antipsychotics in the number of patients who maintained that degree of improvement, in the average latency to achieve that decrease (1.67 and 1.47 months, respectively), or the average length of stay (LOS; 332 and 376 days, respectively). These results indicate a modest therapeutic advantage of olanzapine compared to risperidone, and a substantial degree of polypharmacy in the use of atypical antipsychotics. This uncontrolled "real-world" evaluation supports data from controlled clinical trials, showing that either risperidone or olanzapine would be a reasonable first choice in patients with treatment-resistant schizophrenia, with the decision based on the least adverse side effect profile and economic constraints. When compared to our previous clozapine study, we confirm a slight advantage for the effectiveness of clozapine in the treatment of this refractory population.

Adult↗

PubMed2004

Encephalopathy and myoclonus triggered by valproic acid.

In recent years, the use of valproic acid (VPA) as a mood-stabilizing agent has continuously increased. Although VPA usually is well tolerated, its use in combination with other psychotropic compounds might bear an elevated risk of adverse reactions. Here, we present the case of a 42-year-old male suffering from treatment-resistant psychotic depression, who was prescribed VPA additionally to lithium, clomipramine, flupentixol and risperidone. By doing so, he developed myoclonus, tremor and encephalopathy with sedation and marked EEG background slowing. Most notably, these side effects occurred in the presence of normal VPA and ammonia serum concentrations. On VPA discontinuation, all symptoms vanished and EEG normalized. We thus suggest that direct VPA-induced encephalopathy in the absence of ammonemia does exist, in this case probably facilitated by psychotropic polypharmacy.

Adult↗

PubMed2006

Possible levomepromazine-clozapine interaction: two case reports.

OBJECTIVE: To report and comment upon two cases of suspected pharmacological interaction between the "classical" neuroleptic levomepromazine (LMP) and the "atypical" antipsychotic clozapine (CLZ). CASE SUMMARY: The patients who simultaneously took the two drugs had unusually low plasma levels of CLZ and its metabolites, even though they took high doses of CLZ. The patients were considered "non-responders" to the treatment by the psychiatrist. When LMP was withdrawn from the therapy, plasma concentrations of CLZ returned to therapeutic levels and one of the two patients experienced the anticipated therapeutic response. DISCUSSION: No information can be found in the literature regarding possible interactions between LMP and CLZ. However, the results of the two cases reported herein point out to a possible lack of therapeutic efficacy of CLZ therapy during this kind of polypharmacy. CONCLUSION: While two cases are too few to draw any conclusion, it would be prudent on the part of psychiatrists to consider a possible drug interaction in patients receiving both CLZ and LMP who fail to respond to the therapy.

Adolescent↗