Development and Face Validity of Explicit indicators of Appropriateness of Long Term Prescribing

Objectives: To develop a set of explicit and operationalisable indicators of appropriate prescribing and assess their face validity using clinical pharmacists practising in secondary and primary care. Method: Appropriateness indicators were derived from the literature, applied to data in the hospital clinical records of all newly prescribed long-term drugs for 50 randomly selected patients, further refined and then applied to another 25 randomly selected patients. A pre-piloted postal questionnaire was sent to 200 hospitals and primary care pharmacists, asking them to assess the indicators as to their importance for the assessment of appropriateness of long-term prescribing initiated in hospitals. Results: Fourteen indicators were developed and piloted. Of the 16 original indicators, 5 were discarded, as they were unable to be operationalised, and 2 were subdivided to reflect the routinely available data. Eighty-six pharmacists with individual patient-focussed clinical duties took part in the assessment of the face validity (response rate 43%). Eleven indicators achieved a median importance rating of 1 (very important), and three indicators a median importance rating of 2 on a 5-point scale. The three most important indicators overall were ‘indication included in discharge summary’, ‘questionable high-risk therapeutic combination’ and ‘hazardous drug-drug combination’. Conclusion: It was possible to develop and operationalise 14 indicators of the appropriateness of long-term prescribing commenced in hospital practice, all of which were considered to have face validity by an expert panel of clinical pharmacists. The development of these explicit indicators highlighted the incompleteness of the patient’s record. Further work is needed to assess their validity and reliability, before their use in research or audit can be recommended.     

Computer-assisted medication review for asthmatic patients as a basis for intervention Constructing and validating an algorithmic computer instrument in pharmacy practice

OBJECTIVE: To construct and validate a computer instrument that identifies asthma patients receiving--theoretically--suboptimal drug therapy in community pharmacies, by the use of patient medication records. This selection enables the pharmacist to assist these patients in using medicines appropriately. METHODS: According to Dutch asthma guidelines which describe a stepwise approach and in order to define correct profiles for the use at each level of these guidelines, the optimum use of drugs in the different levels in asthma treatment was expressed in defined daily doses (DDDs) per pharmacological drug-group during a period of one year. An algorithmic computer instrument was developed to select patients with medication use deviant from these profiles. By using nine different selection profiles, the computer instrument stratified patients according to the medication records filed in the pharmacy computer. Patient medication records in four community pharmacies were investigated to validate the selection profiles as indicators for theoretically suboptimal drug use by asthma patients. The validation was performed by comparing the professional judgement of participating pharmacists with the selections made by the computer. MAIN OUTCOME MEASURE: Positive predictive value and negative predictive value of the selection made by algorithmic computer instrument. Rate of false-positive results. RESULTS: The computer instrument identified asthma patients using theoretically suboptimal drug therapy with approximately 95% predictive value compared with the professional judgement of the pharmacists. The rate of false-positive results was 5%. CONCLUSION: The results of the algorithmic computer instrument and the professional judgement of the pharmacists are in close agreement. The instrument will be utilised in further research in the IPMP study (Interventions on the principle of Pulmonary Medication Profiles) investigating the role of Dutch community pharmacists in counselling patients who are at risk of suboptimal drug use in the treatment of their asthma.     

中药汤剂治疗奥氮平药物副反应的临床经验

目的:分析总结中药汤剂治疗奥氮平药物副反应的临床经验。方法:调查服用奥氮平1月以上的精神病患者,统计服用药物后较常出现的中医证候及舌脉象,类推奥氮平的中医“药毒”特性;将60例受试者随机分为2组,其中奥氮平合并服用中药汤剂的为治疗组,中药汤剂根据辨证论治选用温胆汤、玉女煎、补中益气汤、补脾胃泻阴火升阳汤加减治疗,对照组服用奥氮平合并安慰剂,观察治疗前、治疗1月、2月后中医证候评分及糖脂代谢指标的前后变化及组间差异,对疗效进行评估。结果:服用奥氮平1月前后比较,受试者便秘、纳多、肥胖、口干、脉数、精神疲倦、苔厚腻、肢体乏力、舌红、舌淡、脉滑、舌边齿痕、舌胖大、苔白的中医证候评分较前显著升高,具有统计学差异(P<0.05或P<0.01)。中医辨证分型为痰湿内阻证、胃热伤津证、脾气亏虚证和兼有脾虚、痰湿、胃热证。运用传统中医分析中药药性及功效的方法,类推奥氮平的“药毒”性热,入脾胃经,具有胃热伤津、伤脾生湿的作用。经过2月中药汤剂治疗后,试验组中医证候总分较前显著降低,差异具有统计学意义(P<0.01);试验组与对照组比较治疗后中医证候总分差异有显著性(P<0.01)。治疗后试验组与对照组的空腹血糖、餐后2h血糖、血清胰岛素、总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白、体重、腰围、腰臀比及BMI值差异有显著性(P<0.05)。结论:临床上依据奥氮平“药毒”特性来辨证论治,运用中药汤剂治疗可以显著减少奥氮平所致的药物副反应。     

Prediction of individual response to antidepressants and antipsychotics: an integrated concept

In both clinical trials and daily practice, there can be substantial inter- and even intraindividual variability in response—whether beneficial or adverse—to antidepressants and antipsychotic medications. So far, no tools have become available to predict the outcome of these treatments in specific patients. This is because the causes of such variability are often not known, and when they are, there is no way of predicting the effects of their various potential combinations in an individual. Given this background, this paper presents a conceptual framework for understanding known factors and their combinations so that eventually clinicians can better predict what medication(s) to select and at what dose they can optimize the outcome for a given individual. This framework is flexible enough to be readily adaptable as new information becomes available. The causes of variation in patient response are grouped into four categories: (i) genetics; (ii) age; (iii) disease; and (iv) environment (internal). Four cases of increasing complexity are used to illustrate the applicability of this framework in a clinically relevant way In addition, this paper reviews tools that the clinician can use to assess for and quantify such inter- and intraindividual variability. With the information gained, treatment can be adjusted to compensate for such variability, in order to optimize outcome. Finally, the limitations of existing antidepressant and antipsychotic therapy and the way they reduce current ability to predict response is discussed.     

Rosiglitazone maleate + metformin hydrochloride extend: review of an emerging compound

Clinical practice guidelines from around the world have continued to highlight the importance of glycemic control in the prevention of diabetes complications. Despite the many tools available to achieve these targets, it remains a constant challenge for healthcare providers and patients alike. Rosiglitazone maleate + metformin hydrochloride extend is a new compound that has the advantage of the clinical experience and knowledge about the current version and the added benefit of being a once daily, single pill option. The existing version of rosiglitazone + metformin has been shown to effectively lower hemoglobin A1C, improve insulin sensitivity and minimize weight gain. It is expected that the new compound will also have similar features, with the added benefit of improved patient adherence given its once daily formulation.     

医疗失效模式与效应分析在药物基因实验质量管理的应用与实践

目的 通过应用医疗失效模式与效应分析(healthfailure mode and effect analysis，HFMEA)，预防药物基因实验的风险事件，提高药物基因实验的操作质量。方法 药学实验室成立失效模式与影响分析(failure mode and effect analysis，FMEA)活动小组，采用头脑风暴法，借助HFMEA模式，识别及分析药物基因实验过程前、中、后可能存在的操作、仪器及环境对药物基因实验质控造成的风险事件，同时制定相对应的解决方案。结果 开展HFMEA活动后，预防与补救了药物基因实验前、中、后的风险事件产生，风险系数值由总分值1 375分降至62.36分，降幅为95.47%(P<0.01)；活动小组成员在品管手法、解决问题能力、沟通配合、积极性等方面得到了显著提高。结论 HFMEA活动有助于降低药物基因实验产生风险事件的频次，有效提升实验室的质量管理。