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The Annals of Pharmacotherapy Sep 2007To estimate the incidence and describe characteristics of preventable adverse drug events (pADEs) in ambulatory care. (Review)
Review
OBJECTIVE
To estimate the incidence and describe characteristics of preventable adverse drug events (pADEs) in ambulatory care.
DATA SOURCES
Studies were searched in PubMed (1966-March 2007), International Pharmaceutical Abstracts (1970-December 2006), the Cochrane database of systematic reviews (1993-March 2007), EMBASE (1980-February 2007), and Web of Science (1945-March 2007). Key words included medication error, adverse drug reaction, iatrogenic disease, outpatient, ambulatory care, primary health care, general practice, patient admission, hospitalization, observational study, retrospective studies, health services research, and follow-up studies. Additional articles were found in the reference sections of retrieved articles.
STUDY SELECTION AND DATA EXTRACTION
Peer-reviewed articles assessing pADEs in ambulatory care, with detailed descriptions/frequency distributions of (1) ADE/pADE incidence, (2) clinical outcomes, (3) associated drug groups, and/or (4) underlying medication errors were included. Study country, year and design, sample size, follow-up time, ADE/pADE identification method, proportion of ADEs/pADEs and ADEs/pADEs requiring hospital admission, and frequency distribution of adverse outcome, associated drug groups, or medication errors were extracted.
DATA SYNTHESIS
Twenty-nine studies met inclusion criteria: 14 were ambulatory-based and 15 were hospital-based. Seven studies enrolled only elderly patients. The median ADE incidence was 14.9 (range 4.0-91.3) per 1000 person-months, and the pADE incidence was 5.6 per 1000 person-months (1.1-10.1). The median ADE preventability rate was 21% (11-38%). The median incidence of ADEs requiring hospital admission was 0.45 (0.10-13.1) per 1000 person-months, and the median incidence of pADEs requiring hospital admission was 4.5 per 1000 person-months. Cardiovascular drugs, analgesics, and hypoglycemic agents together accounted for 86.5% of pADEs, and 77.2% of pADEs resulted in symptoms of the central nervous system, electrolyte/renal system, and gastrointestinal tract. Medication errors resulting in pADEs occurred in the prescribing and monitoring stages. The most frequent drug therapy problem and error of commission reported in ambulatory-based studies on pADEs was the use of inappropriate drugs (42.7%; 40.4-45%). For pADEs requiring hospital admission, the most frequent drug therapy problem and error of omission reported was inadequate monitoring (45.4%; range 22.2-69.8%). Failure to prescribe prophylaxis to patients taking nonsteroidal antiinflammatory drugs or antiplatelet drugs frequently caused gastrointestinal toxicity, whereas lack of monitoring of diuretic, hypoglycemic, and anticoagulant use caused over- or under-diuresis, hyper- or hypoglycemia, and bleeding.
CONCLUSIONS
ADEs in ambulatory care are common, with many being preventable and many resulting in hospitalization. Quality improvement programs should target errors in prescribing and monitoring, especially for patients using cardiovascular, analgesic, and hypoglycemic agents.
Topics: Ambulatory Care; Drug-Related Side Effects and Adverse Reactions; Hospitalization; Humans; Medication Errors
PubMed: 17666582
DOI: 10.1345/aph.1H658 -
The Cochrane Database of Systematic... Jul 2005Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity and development of tolerance. Continuous infusion has been proposed to avoid these complications and result in greater diuresis, hopefully leading to faster symptom resolution, decrease in morbidity and possibly, mortality.
OBJECTIVES
To compare the effects and adverse effects of continuous intravenous infusion of loop diuretics with those of bolus intravenous administration among patients with congestive heart failure Class III-IV.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003) and the HERDIN database. We also contacted pharmaceutical companies .
SELECTION CRITERIA
Randomized controlled trials comparing the efficacy of continuous intravenous infusion versus bolus intravenous administration of loop diuretics in congestive heart failure were included
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed study eligibility, methodological quality and did data extraction. Included studies were assessed for validity. Authors were contacted when feasible. Adverse effects information was collected from the trials.
MAIN RESULTS
Eight trials involving 254 patients were included. In seven studies which reported on urine output, the output (as measured in cc/24 hours) was noted to be greater in patients given continuous infusion with a weighted mean difference (WMD) of 271 cc/24 hour (95%CI 93.1 to 449; p<0.01). Electrolyte disturbances (hypokalemia, hypomagnesemia) were not significantly different in the two treatment groups with a relative risk (RR) of 1.47 (95%CI 0.52 to 4.15; p=0.5). Less adverse effects (tinnitus and hearing loss) were noted when continuous infusion was given, RR 0.06 (95%CI 0.01 to 0.44; p=0.005). Based on a single study, the duration of hospital stay was significantly shortened by 3.1days with continuous infusion WMD -3.1 (95%CI -4.06 to -2.20; p<0.0001) while cardiac mortality was significantly different in the two treatment groups, RR 0.47 (95% CI 0.33 to 0.69; p<0.0001). Based on two studies, all cause mortality was significantly different in the two treatment groups, RR 0.52 (95%CI 0.38 to 0.71; p<0.0001).
AUTHORS' CONCLUSIONS
Currently available data are insufficient to confidently assess the merits of the two methods of giving intravenous diuretics. Based on small and relatively heterogenous studies, this review showed greater diuresis and a better safety profile when loop diuretics were given as continuous infusion. The existing data still does not allow definitive recommendations for clinical practice and larger studies should be done to more adequately settle this issue.
Topics: Heart Failure; Humans; Infusions, Intravenous; Injections, Intravenous; Randomized Controlled Trials as Topic; Sodium Potassium Chloride Symporter Inhibitors
PubMed: 16034890
DOI: 10.1002/14651858.CD003178.pub3 -
The Cochrane Database of Systematic... 2004Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity... (Review)
Review
BACKGROUND
Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity and development of tolerance. Continuous infusion has been proposed to avoid these complications and result in greater diuresis, hopefully leading to faster symptom resolution, decrease in morbidity and possibly, mortality.
OBJECTIVES
To compare the effects and adverse effects of continuous intravenous infusion of loop diuretics with those of bolus intravenous administration among patients with congestive heart failure Class III-IV.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003) and the HERDIN database. We also contacted pharmaceutical companies.
SELECTION CRITERIA
Randomized controlled trials comparing the efficacy of continuous intravenous infusion versus bolus intravenous administration of loop diuretics in congestive heart failure were included
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed study eligibility, methodological quality and did data extraction. Included studies were assessed for validity. Authors were contacted when feasible. Adverse effects information was collected from the trials.
MAIN RESULTS
Eight trials involving 254 patients were included. In seven studies which reported on urine output, the output (as measured in cc/24 hours) was noted to be greater in patients given continuous infusion with a weighted mean difference (WMD) of 271 cc/24 hour (95%CI 93.1 to 449; p<0.01). Electrolyte disturbances (hypokalemia, hypomagnesemia) were not significantly different in the two treatment groups with a relative risk (RR) of 1.47 (95%CI 0.52 to 4.15; p=0.5). Less adverse effects (tinnitus and hearing loss) were noted when continuous infusion was given, RR 0.06 (95%CI 0.01 to 0.44; p=0.005). Based on a single study, the duration of hospital stay was significantly shortened by 3.1days with continuous infusion WMD -3.1 (95%CI -4.06 to -2.20; p<0.0001) while cardiac mortality was not significantly different in the two treatment groups, RR 0.47 (95% CI 0.33 to 0.69; p<0.0001). Based on two studies, all cause mortality was not significantly different in the two treatment groups, RR 0.52 (95%CI 0.38 to 0.71; p<0.0001).
REVIEWER'S CONCLUSIONS
Currently available data are insufficient to confidently assess the merits of the two methods of giving intravenous diuretics. Based on small and relatively heterogenous studies, this review showed greater diuresis and a better safety profile when loop diuretics were given as continuous infusion. The existing data still does not allow definitive recommendations for clinical practice and larger studies should be done to more adequately settle this issue.
Topics: Diuretics; Heart Failure; Humans; Infusions, Intravenous; Injections, Intravenous; Randomized Controlled Trials as Topic
PubMed: 14974008
DOI: 10.1002/14651858.CD003178.pub2 -
The Cochrane Database of Systematic... 2000Leg oedema from venous insufficiency is not dangerous but it can cause women symptoms such as pain, feelings of heaviness, night cramps and paraesthesiae. Leg oedema can... (Review)
Review
BACKGROUND
Leg oedema from venous insufficiency is not dangerous but it can cause women symptoms such as pain, feelings of heaviness, night cramps and paraesthesiae. Leg oedema can be a sign of pre-eclampsia when associated with raised blood pressure or proteinuria.
OBJECTIVES
The objective of this review was to assess the effects of treatment to relieve the symptoms associated with varicosity in pregnancy and to reduce leg oedema.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group trials register.
SELECTION CRITERIA
Randomised trials of any form of treatment for varicosity or leg oedema in pregnancy.
DATA COLLECTION AND ANALYSIS
Trial quality was assessed and data were extracted independently by two reviewers.
MAIN RESULTS
Three trials of three different treatments were included. A total of 115 women were involved. In one trial, two thirds of women given rutoside capsules in the last three months of pregnancy noted an improvement in symptoms compared with only one third given placebo (odds ratio 0.30, 95% confidence interval 0.12 to 0.77). They had a decrease in ankle circumference at 36 weeks' gestation after eight weeks of treatment, while women given placebo had a small increase. In one trial, women with ankle oedema had a small non-significant reduction in lower leg volume when treated with external pneumatic intermittent compression for 30 minutes. Fifty minutes immersion in water at 32 degrees Celsius resulted in greater diuresis and fall in blood pressure than 50 minutes bedrest.
REVIEWER'S CONCLUSIONS
Rutosides appear to relieve symptoms of venous insufficiency in late pregnancy. However it is not known if the drug is safe in pregnancy. External pneumatic compression appears to reduce ankle swelling. Immersion in water for 50 minutes results in diuresis and fall in blood pressure. It is not known for how long these changes are sustained nor whether they are of any benefit.
Topics: Edema; Female; Humans; Immersion; Leg; Pregnancy; Pregnancy Complications, Cardiovascular; Pressure; Rutin; Varicose Veins; Vasodilator Agents
PubMed: 10796237
DOI: 10.1002/14651858.CD001066