Adverse drug events in an intensive care unit of a university hospital

Purpose  

Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated.     

Evaluation of adverse drug reactions in medical intensive care units

Purpose

Patterns of adverse drug reactions (ADRs) in the medical intensive care unit (MICU) were analysed, and signals for detecting ADRs were developed from the analysis.

Method

A retrospective study was conducted in MICU wards at a tertiary care teaching hospital in Seoul, Korea. The areas included one general MICU and one cancer centre MICU. Two pharmacists evaluated ADRs in terms of length of stay, causality, severity, preventability, types, related organs, and incidence. Differences in ADR perception rates between physicians and pharmacists were also evaluated. ADR cases detected through the evaluation were reviewed to develop specific alerting signals for ICU ADRs.

Results

The study group included 346 patients admitted to the ICU over 4 months. The overall incidence of ADRs was 32%. ICU length of stay is closely related to ADRs (p?=?0.014). Most ADR cases were mild, temporary, and harmful to the patient. Twenty percent of ADRs were preventable, and 74% were type A. Of the ADRs, 70% were noted by physicians; 80% required intervention. The most commonly implicated drug was amphotericin B, and the clinical presentation was a haematologic reaction. Data on the time required for pharmacists to identify ADRs indicated that they were not slower than physicians. Six signals for early detection of the ADRs were developed.

Conclusions

The overall ADR incidence in the MICU was about one-third, and the length of stay of the ADR group was longer than that of those without this experience. Automated signal generation was developed. It seemed to be a valuable tool for faster and more efficient patient management, and possibly prevention of ADRs. A future study should scientifically evaluate the clinical relevance of this tool.     

药学监护中的药品不良反应监察

药学监护（ＰｈａｒｍａｃｅｕｔｉｃａｌＣａｒｅ）这一概念是１９８８年国际药学会议上提出来的，药学监护第一个受益者是病人。而药品不良反应（ＡＤＲｓ）则是临床治疗中必须予以重视的问题，因而在药学监护涉及的众多的内容中，首先被指出的就是规定要对药物引起的不良反应进行监护。本文结合临床药学工作实践，就药学监护中有关ＡＤＲｓ监察的问题提出讨论。     

Patterns of drug utilization in a neonatal intensive care unit

The objective of this study was to determine drug use in newborns at an inborn tertiary care neonatal intensive care unit, serving a predominantly African American population, to identify educational/research priorities in neonatal drug therapy. Data on demographics and exposure rates to all drugs from 6839 neonates born between January 1997 and June 2004 were analyzed. Number of drugs used was correlated with race, gender, gestational age, birthweight, and survival status. The contribution of these factors to mean drug use was predicted by multivariate regression analysis. In this population of 80% African Americans, mean drug use was 3.6/infant, with the highest use in the 24- to 27-week gestational age group (11.7/infant). Ampicillin and cefotaxime had the highest exposure rates. Premature infants had high use of surfactant, pressor agents, and diuretics. Caucasians, males, gestational age<28 weeks, and birthweight<1000 g were the risk factors for higher drug exposure. Future research/education must emphasize these therapeutic areas with priority assigned to low-birthweight infants.     

Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines

1 We have retrospectively analysed data collected by a local adverse drug reactions reporting scheme in an acute hospital medical setting and have determined the numbers and types of reactions that would have merited notification as yellow card reports according to the guidelines of the Committee on Safety of Medicines.
2 The data related to 20 695 consecutive acute general medical admissions on seven general medical wards (140 beds) and were collected over 3 years, from April 1990 to March 1993.
3 Over 3 years there were 1420 reports of suspected adverse drug reactions, a rate of 68.7 per 1000 admissions.
4 If the guidelines for reporting issued by the Committee on Safety of Medicines had been strictly followed, 477 yellow cards would have been sent (23.1 per 1000 admissions). In 357 of these reports (74.8%), the reaction had caused admission to hospital. Only 31 of the 477 potential cards (6.5%) involved black triangle drugs and 10 of these were for minor reactions.
5 Only 30 of the 477 potential yellow cards (6.3%) were known to have been sent. The majority of those reactions not reported were for drug-related admissions, most of which were for well-known reactions to established drugs.
6 We have confirmed and quantified the extent of under-reporting of serious suspected adverse drug reactions to the Committee on Safety of Medicines from our hospital medical unit.     

Adverse drug reactions in an emergency medical dispatching centre

Purpose

The purpose of this study is to assess the incidence of adverse drug reactions (ADR) leading to call an emergency medical dispatching centre.

Methods

A prospective, observational, monocentric clinical study performed over a 2-year period (2011–2012) in a French prehospital emergency dispatching centre, the Service d'Aide Médicale Urgente (SAMU) covering 1,156,000 inhabitants. All adult patients (age?≥?18) who called for any cause were included. We created an electronic trigger ‘iatrogenic event’ implemented by the dispatching physician for each suspected case of ADR, then we completed the analyses of all the cases with a chief complain represented in more than 1 % of the triggered cases. The primary outcome variable was the occurrence of any possible ADR. We then used the French method of causal relationship assessment.

Results

The SAMU dispatched 339,915 calls during the study. In total, 1,467 ADRs were identified, representing 0.95 % (CI 95 % 0.90–1.00 %) of cases. ADRs were as serious (SADR) in 51.06 % (CI 95 % 48.45–53.67 %) of cases. The major ADR observed was haemorrhage, (42.81 % (CI 95 % 40.62–45.00 %), n?=?628) followed by allergy, hypoglycaemia, vomiting, dizziness and drowsiness. The class of drugs most frequently involved was antithrombotic (43.69 % (CI 95 % 41.45–45.93 %), n?=?641), followed by insulin (17.98 % (CI 95 %:17.06–18.90 %), n?=?264).

Conclusions

Emergency calls concerning ADRs were estimated as 9/1,000, and one out of two is serious.     

Use of dexmedetomidine in the pediatric intensive care unit

STUDY OBJECTIVE: To determine the safety, effectiveness, and dosing of dexmedetomidine in intensive care infants and children who require sedation, and the rationale for patient selection. DESIGN: Prospective observational study. SETTING: Eleven-bed pediatric intensive care unit in a university-affiliated children's hospital. PATIENTS: Seventeen infants and children who received dexmedetomidine consecutively between May 4, 2005, and May 4, 2006. MEASUREMENTS AND MAIN RESULTS: Data were collected on demographics, blood pressure and heart rate measurements, and adverse effects. The rationale for dexmedetomidine use, its dosing, use of other sedatives, and treatment duration were also recorded. Twenty treatment courses in 17 patients (median age 5 mo, range 1 mo-17 yrs) were evaluated. Ten patients (59%) had chronic neurologic impairments (including Down syndrome in nine [53%]). Thirteen (76%) had undergone cardiac surgery, two (12%) had respiratory failure, one (6%) had endocarditis, and one (6%) had undergone scoliosis repair. In 15 (75%) of 20 cases, dexmedetomidine was started to minimize the use of midazolam before extubation; in 13 (87%) of these cases, the patients were extubated within 24 hours. The remaining patients could not tolerate midazolam, and dexmedetomidine was used as an alternative. No loading doses were given. The mean +/- SD starting dose was 0.2 +/- 0.2 microg/kg/hour, with a maximum of 0.5 +/- 0.2 microg/kg/hour. Mean +/- SD duration was 32 +/- 21 hours (range 3-75 hrs); 10 courses exceeded 24 hours. Mean arterial pressures before and after starting treatment were not significantly different (p=0.76), nor were values at discontinuation (p=0.31) or 12 hours later (p=0.29). No significant differences were noted in heart rate at the start (p=0.09), at discontinuation (p=0.06), or 12 hours later (p=0.17). One patient (6%) developed hypotension; no other adverse effects were noted. CONCLUSION: With careful patient selection and a conservative approach to dosing, dexmedetomidine was a useful sedative in children requiring mechanical ventilation. It allowed for a reduction or elimination of other sedatives, and it was particularly useful in children with chronic neurologic impairments. Dexmedetomidine was well tolerated, with no clinically significant effects on blood pressure or heart rate.     

内科监护病房的感染分析

目的了解本院内科监护病房的感染和细菌耐药情况.方法按<全国临床检验操作规程>进行分离培养,细菌用法国梅里埃公司VITEK-60自动细菌鉴定仪鉴定菌种,药敏试验采用K-B法.真菌用梅里埃公司API 20C AUX鉴定条和ATB FUNGUS药敏条进行鉴定和药敏试验.结果革兰阴性杆菌感染占36.3%,革兰阳性球菌占27.4%,真菌占36.3%.革兰阴性杆菌对不同的抗生素敏感性不一,革兰阳性球菌对万古霉素、替考拉宁敏感性高,真菌对5-氟胞嘧啶、两性毒素B等抗真菌药物敏感.结论多数细菌呈多重耐药性,完善消毒制度和合理使用抗生素对降低感染率和控制耐药菌株的传播具有重要意义.     

内科监护病房的感染分析

目的:了解本院内科监护病房的感染和细菌耐药情况.方法:按<全国临床检验操作规程>进行分离培养,细菌用法国梅里埃公司VITEK-60自动细菌鉴定仪鉴定菌种,药敏试验采用K-B法.真菌用梅里埃公司API 20C AUX鉴定条和ATB FUNGUS药敏条进行鉴定和药敏试验.结果:革兰阴性杆菌感染占36.3%,革兰阳性球菌占27.4%,真菌占36.3%.革兰阴性杆菌对不同的抗生素敏感性不一,革兰阳性球菌对万古霉素、替考拉宁敏感性高,真菌对5-氟胞嘧啶、两性毒素B等抗真菌药物敏感.结论:多数细菌呈多重耐药性,完善消毒制度和合理使用抗生素对降低感染率和控制耐药菌株的传播具有重要意义.     

Adverse drug reactions

Our ability to understand fully the characteristics of clinically important adverse drug reactions is hindered by a lack of emphasis on biological mechanisms, patient susceptibility factors and long-term outcomes. Assessment of drug safety needs to move beyond industry and regulatory perspectives, towards a greater focus on evidence-based preventive and management strategies that will allow patients and physicians to deal with adverse drug reactions at the bedside. This would ideally involve close collaboration between clinical pharmacologists and pharmacoepidemiologists skilled at interrogating the increasingly sophisticated electronic healthcare databases. In light of the myriad safety scares that are constantly emerging, patients and physicians would be best served by a centrally funded independent network of rapid-response drug safety researchers who can use techniques of teleoanalysis to describe fully the magnitude of risk, the potential biological mechanisms and patients' susceptibility factors.