Labeling requirements for systemic antibacterial drug products intended for human use. Final rule. (25/341)

The Food and Drug Administration (FDA) is amending its regulations to require that the labeling for all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use include certain statements about using antibiotics in a way that will reduce the development of drug-resistant bacterial strains. The final rule reflects a growing concern in FDA and the medical community that unnecessary use of systemic antibacterials has contributed to a dramatic increase in recent years in the prevalence of drug-resistant bacterial infections. The final rule is intended to encourage physicians to prescribe systemic antibacterial drugs only when clinically necessary. The final rule is also intended to encourage physicians to counsel their patients about the proper use of such drugs and the importance of taking them exactly as directed.  (+info)

Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. (26/341)

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.  (+info)

Medicines and elderly people: a general practice survey. (27/341)

All 151 patients of 75 years and over in one practice were visited at home to survey their health and how they managed their medicines. Altogehter 87% were on regular treatment, 34% taking three or four different drugs each day. Most were responsible for their own drugs and managed them well, but many left their drugs in exposed places and were uncertain about how to dispose of unwanted medicines. Overall they were prescribed about three times the number of drugs prescribed for the general population, and women took twice as many drugs regularly as men. Although many drugs were obtained directly from a pharmacist, his advice was rarely sought. Most were labelled, but more explicit instructions about indications for taking the drug would have been helpful, and information about hoarded drugs would have been enhanced by dispensing and expiry dates. Treatment was facilitated when patients brought their drugs to the consultation and careful records were made of repeat prescriptions. As so many patients take three or more different types of drugs each day a container in which a day's supply could be laid out would be useful.  (+info)

Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK. (28/341)

BACKGROUND: Use of unlicensed and off-label medications is common in hospital based paediatric practice. Whilst inpatient prescription can be closely monitored within the hospital setting, it is subspecialties like paediatric gastroenterology, caring for chronically ill children on an outpatient basis that require administration of regular medications in the community. Local practitioners rely on available paediatric formularies or information provided by the tertiary unit for monitoring and dispensing further prescriptions. AIM: To assess the proportion of unlicensed and off-label medications prescribed in a paediatric gastroenterology unit to children discharged to the community and assess adequacy of information about these medications in commonly used British formularies. METHODS: All prescriptions prescribed over a six-month period (Jan-Jul 2002) either in the paediatric gastroenterology outpatient department or for children discharged home after an inpatient stay, were retrieved from the pharmacy database. The main outcome measures were to assess the proportion of medications prescribed for unlicensed or off-label use. RESULTS: 308 patients received 777 prescriptions of which 384 (49%) were for unlicensed or off-label use. Of these 291 (76%) were off-label; 208 in relation to indication and 83 to child's age. 93 of the prescribed medications were unlicensed; 37 were due to manipulation of formulation. Of the commonly used formularies in the UK, only 'Medication for Children(R)' contained dosage information on more than half (9/13) of the most often prescribed off-label/unlicensed medications in paediatric gastroenterology. CONCLUSIONS: Use of unlicensed and off-label medications remains a problem in paediatric practice. Until licensing laws change and more drugs are licensed in children, paediatric gastroenterologists remain responsible for provision of information to families, local practitioners, nurses and pharmacists. Of the commonly used formularies, 'Medicines for Children' is the most detailed and comprehensive, and should be available to all general practitioners and pharmacists in the UK. Clear communication between specialist units and local practitioners is imperative to ensure safe and effective prescribing to children.  (+info)

Labeling for oral and rectal over-the-counter drug products containing aspirin and nonaspirin salicylates; Reye's Syndrome warning. Final rule. (29/341)

The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations to revise the Reye's syndrome warning required for oral and rectal over-the-counter (OTC) human drug products containing aspirin and to require a warning on OTC drug products containing nonaspirin salicylates as active ingredients. The revised warning will inform consumers of the symptoms of Reye's syndrome and advise that aspirin and nonaspirin salicylate drug products should not be given to children or teenagers who have or are recovering from chicken pox or flu-like symptoms. This final rule also finalizes FDA's notice of proposed rulemaking to require a Reye's syndrome warning for orally administered OTC drug products for relief of symptoms associated with overindulgence in food and drink (overindulgence drug products) that contain bismuth subsalicylate that published in the Federal Register of May 5, 1993 (58 FR 26886). FDA is issuing this final rule after considering public comment on the agency's notices of proposed rulemaking and all relevant data and information that have come to the agency's attention.  (+info)

Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience. (30/341)

BACKGROUND: While the off-label use of oncology interventions is widespread, the factors influencing off-label use and the resultant influence on oncology drug expenditures are not well understood. STUDY DESIGN: To assess the indications for rituximab use, a retrospective review was undertaken at a single academic center between September 1998 and June 2001. METHODS: Patient diagnoses were linked to pharmacy records, and each administration of rituximab was classified as either on-label or off-label as defined by FDA-approved indications. The resultant utilization patterns were the foundation for a conceptual model designed to identify factors that influence off-label use of oncology-related therapeutics and forecast the effect of off-label use on aggregate oncology drug expenditures. RESULTS: One hundred one patients received a total of 428 rituximab administrations during the study period. Most (320, 75%) of the administrations were for off-label indications. Although the extent of off-label and on-label use grew at a similar rate initially, off-label utilization increased nearly exponentially over time as on-label uses lessened. A conceptual model that describes factors that promote, inhibit, or have a mixed influence on off-label use may help predict future patterns of off-label utilization and allow better forecasting of oncology drug expenditures. CONCLUSIONS: The off-label use of rituximab is substantial. Projections of oncology-related patterns of care and drug expenditures must account for the potential for off-label use.  (+info)

Interaction of science, consumer practices and policy: calcium and bone health as a case study. (31/341)

Data to support a relationship between calcium and bone health are a major part of the body of evidence that underlie calcium-related policy in the United States. Examples of these policies include dietary intake recommendations, health claims for calcium and osteoporosis on food labels and an objective to improve calcium intake of the U.S. population in Healthy People 2010. Median calcium intakes among females fall below recommended levels after childhood even when supplemental calcium intakes are included. This is a concern in light of data that support a positive relationship between calcium and bone health. Most of the studies on the calcium-bone relationship have focused on older women, and several have used fracture as the endpoint; a meta-analysis of their results suggests that increased calcium intake is associated with approximately 30% decrease in fracture risk. Studies in children, adolescents and premenopausal women have focused on the relationship between calcium and bone mineral density rather than fracture; most of these also support a positive relationship between calcium intake and skeletal health although some data gaps remain. Calcium appears to be a threshold nutrient (e.g., intakes above a certain level do not result in further benefit to bone). The effect of increased calcium intake on bone density does not appear to persist unless the higher intakes are sustained. There are certain conditions, such as lactation, during which calcium intake does not appear to influence bone. Other factors that may influence the effect of calcium on bone include bone-specific genotypes and physical activity.  (+info)

Skin protectant drug products for over-the-counter human use; final monograph. Final rule. (32/341)

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of the ongoing review of OTC drug products conducted by FDA. The final monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on skin protectant drug products for these specific uses that have come to the agency's attention. This final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC skin protectant ingredients that have been found to be not generally recognized as safe and effective. This final rule also lifts the stay of 21 CFR part 352 (published at 66 FR 67485, December 31, 2001) to amend the final monograph for OTC sunscreen drug products to include sunscreen-skin protectant combination drug products, and then stays Sec. 347.20(d) (21 CFR 347.20(d)) and part 352 until further notice in the Federal Register.  (+info)