黑龙江省2004年抗菌药品不良反应报告调查分析

目的 分析黑龙江省抗菌药品不良反应(ADR)报告,对抗菌药品的安全性进行再评价.方法 回顾性调查2004年黑龙江省呈报的ADR报告,选择抗菌药品ADR报告,对抗菌药品不良反应类别、临床症状、转归、合理用药等进行分析.按我国药品不良反应因果关系评估方法,对ADR因果关系进行初评.结果 570例ADR报告中274例为抗菌药品,占48.07%.因果关系评估:肯定32例,很可能91例,可能151例.转归:治愈218例,好转56例,没有死亡病例.结论 加强抗菌药品ADR监测,促进临床合理用药.     

Rational use of medicines – an important issue in pharmaceutical policy

In this article the authors deal with issues of drug utilisation from a clinical and policy perspective. They address the difficulties of managing drug therapy on a population level, which is known among professionals, as the problem of rational use of medicines. Various definitions and interpretations are presented and compared. This is followed by a presentation of the concerns associated with pharmaceutical marketing from a policy perspective, including the fear that the dominance of information produced by industry may lead to irrational drug use. Next, the authors review the tools for policy making including educational, managerial, and regulatory interventions. The (often overlapping) concepts of medicines management, clinical pharmacy and pharmaceutical care are then discussed to show how professionals, sometimes in collaboration with policymakers, have tackled the problem of nonrational use of medicines. The authors address the question as to whether the rational use of medicines a universal concept, whether it can be and whether it should be? They argue that, as with most concepts, the rational use of medicines must always be viewed in context. They conclude that pharmacy needs to adapt its way of thinking to include the issue of context. They point out that clinical pharmacists today already adapt their decisons to each patient and patient group. Policymakers are encouraged to adopt a similar approach because populations as well as particular market situations vary and therefore policy solutions cannot be considered universal.*This article is the second in a series of articles on this topic that will appear in Pharmacy World & Science during 2005.     

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.     

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。