Drug Safety
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The frequency of fluoroquinolone-associated anaphylaxis has been estimated to be 1.8-23 per 10 million days of treatment based on spontaneous reports. It is unknown whether there are differences between the reporting rates of anaphylaxis with individual fluoroquinolones. According to pathophysiology, anaphylaxis may be immune mediated (anaphylactic) or not (anaphylactoid). The latter may occur after first-ever intake since no sensitisation phase is necessary. ⋯ Anaphylaxis appears to be associated with the fluoroquinolone class of antibacterials. Observed differences in reporting rates should be further investigated. Fluoroquinolone-associated anaphylaxis may occur after first-ever intake of the agent.
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Review
The safety profile of sustained release paracetamol during therapeutic use and following overdose.
Sustained release (SR) formulations of paracetamol (acetaminophen) have been introduced in several countries to provide lasting pain relief and reduced risk of rebound pain. However, few studies have evaluated the safety of paracetamol SR formulations. To assess the available published safety data regarding SR formulations of paracetamol, the EMBASE and MEDLINE databases were searched from 1980 to June 2003 for published worldwide human experience with paracetamol SR formulations. ⋯ The number of human exposure cases has increased since introduction of the SR formulation; however, sales of the SR formulation amounted to 7.5% of all paracetamol sales but accounted for 2.5% of the cases reported to poison centres. There were two deaths recorded in the TESS database: both were the result of multiple drug ingestion. No cases of death or unusual types of toxicity have been described from an overdose of paracetamol SR alone.
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Comparative Study
Comparison of reporting of Stevens-Johnson syndrome and toxic epidermal necrolysis in association with selective COX-2 inhibitors.
Stevens-Johnson syndrome and toxic epidermal necrolysis are closely related severe acute life-threatening, drug-induced skin disorders. The US FDA Adverse Events Reporting System (AERS) has received reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of the recently introduced selective cyclo-oxygenase (COX)-2 inhibitor NSAIDs, two of which are also sulfonamides. ⋯ There is a strong association between Stevens-Johnson syndrome/toxic epidermal necrolysis and the use of the sulfonamide COX-2 inhibitors, particularly valdecoxib. Physicians should be aware of the possibility of this serious life-threatening event when prescribing these drugs and advise patients to discontinue use at the earliest possible sign or symptom.
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Medication errors are an important cause of hospital-based morbidity and mortality. However, only a few medication error studies have been conducted in children. These have mainly quantified errors in the inpatient setting; there is very little data available on paediatric outpatient and emergency department medication errors and none on discharge medication. This deficiency is of concern because medication errors are more common in children and it has been suggested that the risk of an adverse drug event as a consequence of a medication error is higher in children than in adults. ⋯ Medication error, especially underdose, is common in outpatient, emergency department and discharge prescriptions. Computer calculated doses can significantly reduce errors, but other risk factors have to be concurrently addressed to achieve maximum benefit.
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In hospitals where computerised physician order entry systems will not be available in the near future, there is a need to explore other ways of reducing medication errors that occur in the drug ordering and delivery system. One of these ways is the use of a computerised medication chart that is updated daily. The aim of this study was to evaluate the frequency, types and potential clinical significance of drug prescription and administration errors by comparing a traditional medication distribution system (where the transcription of handwritten into printed medication orders takes 3-5 days and the transfer of medication orders was not complete) with the use of a computerised medication chart (which was updated daily by pharmacy assistants on the ward). ⋯ This observational study shows a significant reduction in clinically relevant, administration and (therapeutic) prescription error rates when applying a system using computerised and daily updated medication charts compared with a system using traditional medication charts. Therefore, the use of computerised and daily updated medication charts has the potential to improve the quality of the medication distribution process in hospitals waiting for the implementation of a computerised physician order entry system.