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Results for “Drug Labeling”

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At least 73 records · Page 4Linked to original sources
PubMed2003

Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children.

BACKGROUND: The need to use unlicensed and off label drugs in children due to the lack of suitable, licensed formulations with appropriate prescribing information creates many problems on an everyday basis for healthcare professionals, carers and children. PATIENTS AND METHODS: This prospective study was designed to examine the incidence and nature of unlicensed and off label prescribing, in paediatric oncology patients with acute lymphoblastic leukaemia and other malignancies. Inpatient and outpatient prescriptions were analysed for a 4-week period. RESULTS: All patients received at least one unlicensed or off label drug. Fifty-five per cent of prescriptions were licensed, 19% were unlicensed and 26% were licensed drugs used in an off label manner. Unlicensed preparations were used in 40% of prescriptions for cytotoxic agents, due to a lack of commercially available formulations suitable for the paediatric patient. These drugs included mercaptopurine and methotrexate which have been used in the treatment of paediatric leukaemia for many years, their efficacy having been demonstrated by on-going Medical Research Council trials. CONCLUSIONS: It is disappointing that drugs, which are the mainstay of therapy for paediatric leukaemia and other malignancies, are unavailable in appropriate licensed formulations to facilitate their administration to children. This needs to be urgently addressed.

Adolescent↗
PubMed2005

[Off label drug use in adult patients treated by anticancer chemotherapy].

Off-label drug use is supposed to be widespread in chemotherapy but very few studies have determined its extent in clinical practice. This prospective study evaluates the proportion of off-label anticancer drug use in terms of indications in a French teaching hospital. Adult ambulatory patient prescriptions were analysed by pharmacists in the year 2002. Data concerning the type of cancer and the indication of the antitumor agent were collected and compared with the official Summary of Product Characteristics in France. In the year 2002, 6,168 chemotherapy cycles (prescriptions) were administered to 1,206 patients. Four hundred and fifteen (6.7%) prescriptions presented a drug used in an off-label manner. Off label prescriptions were common in patients with hormone-refractory prostate cancer (57.6% of the courses for this type of tumor) and in patients with bladder cancer (37.6%). No off-label use was observed in patients with colorectal cancer. The drugs most commonly used in an off-label indication were docetaxel (29.1% of the off label prescriptions) and oxaliplatin (23.6%). Overall, in our hospital, the proportion of off-label use of anticancer agents in terms of indications in adult patients appears low.

Adult↗
PubMed2004

Drug labeling; orally ingested over-the-counter drug products containing calcium, magnesium, and potassium. Final rule.

The Food and Drug Administration (FDA) is amending the general labeling provisions for over-the-counter (OTC) drug products to require that the labeling of all OTC drug products intended for oral ingestion include: The calcium content per dosage unit when the product contains 20 milligrams (mg) or more per single dose; a warning statement that persons with kidney stones and persons on a calcium-restricted diet should ask a doctor before using when the product contains more than 3.2 grams (g) of calcium in the labeled maximum daily dose; the magnesium content per dosage unit when the product contains 8 mg or more per single dose; a warning statement that persons with kidney disease and persons on a magnesium-restricted diet should ask a doctor before using if the product contains more than 600 mg magnesium in the labeled maximum daily dose; the potassium content per dosage unit when the product contains 5 mg or more per single dose; and a warning statement that persons with kidney disease and persons on a potassium restricted diet should ask a doctor before using if the product contains more than 975 mg potassium in the labeled maximum daily dose. FDA is issuing this final rule in order to provide uniform calcium, magnesium, and potassium content and warning labeling for all OTC drug products intended for oral ingestion whether marketed under an OTC drug monograph, the ongoing OTC drug review, a new drug application (NDA) or abbreviated new drug application (ANDA), or no application.

Administration, Oral↗
PubMed1992

Hospital pharmacies watch prescriptions as debate rages over 'off-label' drug use.

Hospital pharmacies are closely monitoring physicians' prescribing practices in an effort to restrain drug expenditures by ensuring that drugs are used appropriately. But controversy continues over whether the increasingly common practice of using drugs for non-FDA-approved applications is appropriate and whether those uses should be allowed and covered by health insurers.

Cost Control↗