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Results for “Drug Labeling”

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At least 37 records · Page 2Linked to original sources
PubMed1995

Off-label drug prescribing on a state university obstetric service.

Off-label drug use occurs when physicians prescribe a drug recommended for indications other than those listed on the prescription labeling. The purpose of the present investigation was to describe patterns of off-label drug use during pregnancy, including the types of drugs and their timing of use. All study pregnancies had to receive prenatal care at our state university clinics before 14 weeks' gestation and deliver at our institution during a five-month period. Prenatal records were reviewed, and subjects were interviewed after delivery. A total of 165 (22.6%) of the 731 eligible subjects took > or = 1 (average 1.7, 95% confidence interval 1.3-3.8) drugs for off-label indications. Nearly all drugs were taken for a short term during the third trimester. The primary purposes were to avoid an obstetric complication (premature labor and delivery, preeclampsia/eclampsia) or improve the capacity for eventual postnatal adaptation. Despite discussions with patients, on no occasion was it recorded on the chart that the patient was informed that the drug was recommended for an off-label indication. Results from this study should help drug manufacturers, insurance companies and federal regulatory agencies understand the common use of recommending certain drugs for off-label indications during pregnancy.

Drug Labeling↗
PubMed2004

Dose individualisation in patients with renal insufficiency: does drug labelling support optimal management?

OBJECTIVE: An important information source for pharmacotherapy in populations at risk is drug labelling. We compared the recommendations for patients with renal insufficiency included in German drug labellings with evidence from the literature. METHODS: From the 120 drugs with the highest turnover in a large university hospital, all drugs with pharmacokinetics independent of renal function (n=48) and those with substantial accumulation in renal failure (n=28) were identified. For both groups of compounds, pharmacokinetic and pharmacodynamic aspects relevant for dose individualisation in those with renal insufficiency were extracted from the literature and compared with the information given in the German drug labelling. RESULTS: Over half of the labellings (15 of 26) of non-accumulating drugs without renal adverse drug reactions contained no dose recommendation for patients with renal insufficiency. The labelling of nephrotoxic compounds that do not accumulate included more frequently a recommendation to adapt the dose or to monitor than the labelling of drugs without nephrotoxic potential (15 of 22 versus 5 of 26, P=0.002). For over half of accumulating drugs (16 of 28), the dose given in the labelling depends primarily on creatinine clearance. The ratio between the labelling dose and the dose based on the pharmacokinetic concept to achieve identical plasma concentrations (Q0 concept) differed widely (0.4-2). CONCLUSIONS: When renal failure had no impact on dosing, information was often missing. Such information is however important to differentiate, whether no dose adaptation is necessary or no information is available. If dose adjustment is required, application of a uniform concept is desirable.

Creatinine↗
PubMed2002

Standardized colour coding for syringe drug labels: a national survey.

A standardised colour code for user-applied syringe labels for anaesthetic drugs exists in the USA, Australia, New Zealand and Canada. In the UK, there is none. Consequently, an assortment of colour codes for syringe labels is available in the UK. We conducted a postal survey of the 285 College Tutors of the Royal College of Anaesthetists to establish their local syringe drug labelling system and their views on a national, standardised colour code. We found that that 96% of departments currently use coloured syringe drug labels. Of these, 98% use the 'Medilabel' scheme. The College Tutors felt that a standardised colour code for labels is required (94%), that the Association of Anaesthetists or the Royal College of Anaesthetists should be involved in the choice of scheme (76%) and that the scheme chosen should be international (65%). There was a majority feeling that the opinions expressed were representative of other members of the College Tutors' departments. We conclude that a national standard for drug labels is required and that a choice will have to be made between the 'international' scheme and the currently dominant Medilabel scheme.

Anesthesiology↗
PubMed2001

Off-label drug use in WOC nursing: issues related to use of mafenide acetate to treat infected chronic wounds.

It is not unusual for practitioners to prescribe off-label drugs for their patients--that is, drugs that have not yet been approved by the Food and Drug Administration to treat the patient's particular condition. The decision to use off-label drugs should be based on a clear understanding of the risks and benefits to the patient. This issue is pertinent to WOC nurses because they may work with physicians who prescribe off-label drugs for their wound care patients. In addition, WOC nurses who are also nurse practitioners and have prescribing privileges may be intimately involved in the decision to prescribe off-label drugs. A review of the literature related to off-label drug use and mafenide acetate was conducted. This article presents the issues related to off-label use of mafenide acetate (Sulfamylon) and possible implications for patients with chronic infected wounds.

Anti-Infective Agents, Local↗