Cost-effectiveness of medication reconciliation performed by a pharmacist in pediatrics of a hospital: A randomized clinical trial protocol linked to a pharmacoeconomic study

IntroductionEach patient admitted to the hospital is subject to one medication error per day, since the occurrence of this one with the potential to cause harm is three times more common in pediatric hospitalized patients than in adults. These harms can result from inaccurate or incomplete drug use histories when patients undergo a clinical evaluation, which jeopardizes patient safety and compromises hospitalization costs. Thus, medication reconciliation (MC) emerges as a possible solution to avoid the occurrence of these in pediatric patients and directly contributes to reducing costs in the hospital environment and increasing quality of life). Therefore, this study proposes to determine whether pharmacist-led medication reconciliation is a cost-effective strategy to improve health outcomes in pediatric patients.MethodsA randomized clinical trial will be carried out, over eight months, to carry out the cost analysis. Micro-costing pharmacoeconomic model through a questionnaire and clinical interview to collect the variables necessary for the study and comparison of the control and intervention groups. Participants in this study will be children aged 0 days to 12 years, admitted to the hospital. The perspective adopted will be that of the hospital. To assess the economic outcomes of MC, the cost-effect pairs will be categorized and visually represented in the cost-effectiveness plan to compare the intervention and control groups. Monte Carlo simulation and univariate sensitivity analysis will be performed to test the robustness of the findings.Ethics and disseminationThe clinical trial was approved by the Research Ethics Committee of the Federal University of Sergipe (CAAE: 19625319.6.0000.5546 and opinion number: 3,630,579). This protocol fully adhered to the recommendations of the 2010 CONSORT Declaration and was registered in the Brazilian Registry of Clinical Trials (ReBEC): RBR-25dnqsk.     

Analysis of medication information exchange at discharge from a Dutch hospital

Background At hospitalisation and discharge the risk of errors in medication information transfer is high. Objective To study the routes by which medication information is transferred during discharge from Deventer Hospital, and to improve medication information transfer. Setting Eight hospital wards of the Deventer Hospital. Method From December 6 to 17th 2010, the following data was recorded across eight hospital wards: the identification number of discharged patients, the date of discharge and the route by which medication information was transferred. The possible route categories recorded were the Pharmacy Service Point, the hospital??s public pharmacy, and ??other?? routes (which had to be specified). Validation of the data was performed by cross-checking the information collected by the hospital??s Admission Office, the Pharmacy Service Point and the hospital??s public pharmacy, in addition to electronic patient files, interviews with ward staff and, where necessary, interviews with the concerned patients. Main outcome measure Route of medication information transfer at discharge in all discharged patients. Results A total of 629 patients were included in the study. The routes of transfer were: Pharmacy Service Point 281 patients (44?%), the hospital??s public pharmacy 54 patients (9?%), and other routes 44 patients (7?%). Other routes were most recorded at the children??s ward, the short stay and cardiology ward. In 250 patients (40?%), there was no transfer of information by the Pharmacy Service Point because they were registered as using no medication or as experiencing no medication changes during hospitalisation. Conclusion Medication information was transferred for 53 % of the discharged patients, which is close to the maximum achievable result. Further improvement of medication transfer in Deventer Hospital can be made by adjusting the current procedure and by educating the ward staff about the importance and the clinical practice of this procedure.     

伊托必利治疗功能性消化不良的随机双盲对照试验104例

目的:观察国产伊托必利片治疗功能性消化不良的疗效和药物安全性。方法:将209例功能性消化不良病人,采用随机双盲、阳性药物对照试验方法,随机分为2组,伊托必利(受试)组给伊托必利50mg,餐前口服,每日3次;多潘立酮(对照)组给多潘立酮10mg,餐前口服,每日3次。疗程均为2或4wk。结果:伊托必利组治疗功能性消化不良总有效率为89%,与对照组多潘立酮(89%)相比无差异(P>0.05);明显改善病人消化不良临床症状和体征,显著改善胃排空功能(P<0.01),与对照组相比无差异。伊托必利组不良反应发生率为4%,与多潘立酮组(5.9%)比较无统计学差异。结论:伊托必利治疗功能性消化不良是安全、有效。     

Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial

Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.     

尿促卵泡素诱发排卵的多中心随机对照试验

目的:验证国产尿促卵泡素(uFSH)对不孕症病人诱发排卵治疗的临床有效性与安全性。方法:对144例WHOⅡ类无排卵或黄体功能不全的不孕症病人进行多中心、随机、阳性对照研究。试验组使用国产uFSH,对照组使用进口uFSH,月经d 3～5始,每日肌内注射uFSH 75 IU,监测卵泡发育、宫颈黏液、有无排卵及妊娠,并观察不良反应。结果:试验组9对照组均入选72例,完成试验分别为66例和69例。试验组和对照组的有效率、排卵率、妊娠率、不良反应的发生率分别为96％(63／66)和99％(68／69),97％(61／63)和94％(64／68),14％(9／63)和15％(10／68),2％(1／68)和1％(1／70),2组比较无显著差异(P>0．05)。结论:国产uFSH用于不孕症病人诱发排卵是有效和安全的,效果与进口制剂相当。     

西酞普兰对恶性肿瘤患者抑郁症状的随机双盲对照研究

目的以随机双盲对照研究明确西酞普兰在肿瘤患者伴随抑郁症的疗效和安全性。方法188例恶性肿瘤伴随抑郁症患者随机分为两组,分别给以西酞普兰和安慰剂治疗6周。采用汉密尔顿抑郁量表（HAMD一17）,汉密尔顿焦虑量表（HAMA）于治疗前和治疗1、2、4、6周末分别评定疗效。结果西酞普兰组总有效率62．22％,治疗后HAMD和HAMA评分均较治疗前下降,同安慰剂对照组相比差异有显著性（p〈0．05）。两组不良反应发生率轻微,比较差异无显著性（p〉0．05）。结论西酞普兰治疗肿瘤患者伴随抑郁症疗效确切,不良反应轻微。     

洛美利嗪治疗偏头痛随机双盲多中心对照研究

目的:评价国产洛美利嗪胶囊治疗偏头痛的疗效及安全性。方法:采用多中心、随机、双盲、氟桂利嗪阳性药平行对照研究,为期56 d,洛美利嗪组(试验组)服用洛美利嗪(5 mg,bid),共105例,氟桂利嗪组 (对照组)服用氟桂利嗪(5 mg,qn),共99例。结果:治疗28,56 d,试验组病人在头痛综合评分、病人自觉头痛评分,综合临床疗效自身前后比较差异均有统计学意义(P<0．01),治疗28 d时试验组有效率(79．1％)略高于对照组(74％),试验组在短时间内疗效更明显;不良反应轻微,试验组发生率(5．6％)略低于对照组(8．8％), 均不影响继续用药。结论:洛美利嗪是一种不良反应较少、安全有效治疗偏头痛发作的药物。     

The effect of inpatient pharmaceutical care on nephrotic syndrome patients after discharge: a randomized controlled trial

International Journal of Clinical Pharmacy - Background Clinical pharmacists can play an important role in chronic diseases management, but&nbsp;limited attention has been given to the...     

Cost-effectiveness of interventions to enhance medication adherence in psychiatric patients: a systematic review

It was conducted a systematic review of economic evaluations that assessed the cost-effectiveness of interventions to enhance the medication adherence in psychiatric patients. Several bibliographic databases were searched: MEDLINE, MEDLINE in process, PSYCINFO, EMBASE, Cochrane Controlled Trials Register, CINAHL, CRD, EconLit, Science Citation Index and Social Science Citation Index. Full economic evaluations which assessed interventions to enhance the adherence to drug therapy in adult patients with a mental illness were included. Data were extracted and the methodological quality of selected studies was assessed. The information was synthesized through narrative procedures. Four clinical trials and two ongoing studies fulfilled the selection criteria. Two studies did not find significant differences in adherence between the interventions (a compliance-enhancing program, a therapeutic drug monitoring and a pharmacy-based intervention) and the control groups; one study found that a compliance program was more effective than a non-specific counselling intervention over 18 months in psychotic patients; another study found better results in terms of adherence among high-severity depressed patients receiving a stepped collaborative care during 12 months in comparison to a control group; in moderate-severity patients the differences disappeared after the first 6 months. None of the four studies found significant differences in costs between groups because of the low statistical power. In summary, adherence enhancing programs could be cost-effective in psychiatric patients although this statement is based on few studies with limited methodological quality. It is necessary more and better research on the cost-effectiveness of interventions in the field of mental health.     

利扎曲普坦治疗偏头痛随机双盲多中心对照研究

目的:评价利扎曲普坦片对偏头痛急性发作的有效性和安全性。方法:共入组偏头痛病例115例。其中先给利扎曲普坦后给安慰剂 57例,先给安慰剂后给利扎曲普坦 58例。治疗前 2组的一般资料、临床评价和实验室指标无显著差异。结果:利扎曲普坦组和安慰剂组的 2h内头痛消失率分别为(57±s5)%和 (37±4)% (P<0. 01)。利扎曲普坦组 2h内头痛缓解率为 (67±4)%,安慰剂组 2h内头痛缓解率为(50±5)% (P<0. 01)。治疗中,仅1例出现一过性的血小板减少,无肝、肾功能等影响。结论:利扎曲普坦治疗偏头痛安全性好,可作为治疗偏头痛急性发作的有效药物。     

Effect of clinical pharmacist intervention on medication discrepancies following hospital discharge

Background Medication discrepancies may occur at transitions in care and negatively impact patient outcomes. Objective To determine if involving clinical pharmacists in hospital care, medication reconciliation and discharge medication plan communication can reduce medication discrepancies with a prospective, randomized, blinded, controlled trial. Setting A large, tertiary care, academic medical center. Method The intervention consisted of clinical pharmacist medication reconciliation, patient education and improved communication of the discharge medication plan, as devised by the hospital physician and care team, to primary care physicians and community pharmacists. Medication discrepancies were identified by blinded research pharmacists who reviewed primary care physician and pharmacy records at discharge through 90 days post-discharge to create 30- and 90-day medication lists. Main outcome measure Rate of medication discrepancies compared across groups. Results A total of 592 subjects from internal medicine, family medicine, cardiology and orthopedic services were evaluated for this study. Clinically important medication discrepancies in the primary care physician record were different between groups 30 days after hospital discharge following a clinical pharmacist’s intervention. The mean number of medication discrepancies per patient for the enhanced group being nearly half the number in the control group. However, this effect did not persist to 90 days post-discharge and did not extend to community pharmacy records. Conclusion The present study demonstrates the involvement of pharmacists in hospital care, medication reconciliation and discharge medication plan communication may affect the quality of the outpatient medical record.     

Atenolol and chlorthalidone in combination in the management of older hypertensive patients: a randomized clinical trial

In a double-blind, crossover study in 100 elderly hypertensive patients, the hypotensive effect of a fixed combination of atenolol (50 mg) with chlorthalidone (12.5 mg) was compared with that of each of its component drugs given alone. Patients were allocated at random into two groups: one group received treatment for 4 weeks with either the combination or atenolol alone before being crossed over to the alternative medication for a further 4 weeks; the other group received either the combination or chlorthalidone alone and followed the same treatment pattern. Dosage was a single tablet per day given in the morning. Blood pressure and pulse rate were measured approximately 24 hours after dosing at the end of each treatment period. The results showed that significantly lower blood pressures were achieved, both in the standing and lying positions, with the combination than with either atenolol or chlorthalidone used alone. Combination treatment was well tolerated, few side-effects being reported and there was no significant disturbance of plasma electrolytes.