Modernizing the FDA: an incremental revolution.
The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business. (+info)
Pharmaceutical donations by the USA: an assessment of relevance and time-to-expiry.
This paper assesses the relevance and time-to-expiry of pharmaceutical donations by the USA by means of a convenience sample of two private voluntary organizations. Data were collected on 16,566 donations shipped between 1994 and 1997 for the two organizations to a total of 129 countries. For three field study countries (Armenia, Haiti, and the United Republic of Tanzania), between 37% and 65% of donated unique drug products were on the recipient countries' essential drugs lists, and between 50% and 80% were either on these lists or were permissible therapeutic alternatives. Between 10% and 42% were not listed on either the national essential drugs lists or the WHO Model List of Essential Drugs, nor were they permissible therapeutic alternatives. For the worldwide data set, the median times to expiry when shipment by the organizations took place were 599 and 550 days; about 30% of shipment items had a year or less of shelf-life, and about 6% had less than 100 days of shelf-life. Although a majority of the donations fulfilled the criteria of relevance and time-to-expiry, a substantial proportion failed to do so. Actions are proposed with a view to improving the relevance and time-to-expiry of USA pharmaceutical donations. (+info)
Effects of written drug information on patient knowledge and compliance: a literature review.
The prospect of patient-oriented prescription drug labeling has focused increased attention on the effectiveness of written information for the consumer. Studies which have evaluated the effects of written prescription drug information in a patient population are reviewed. Several studies indicate that written information can be effective in improving patient compliance with regimens for antibiotic therapy. However, for drugs used on a long-term basis, written information as a sole intervention has not been shown to be sufficient for improving patient compliance. Patient knowledge of less commonly known information, such as precautions, side effects, or special directions is frequently improved by written information. Listing a drug's side effects has not been shown to increase the reported experience of side effects; however, one study suggests that patients may be more willing to report side effects to a health professional if they are listed in the written information. The trend for recent studies has been to focus on the "milieu" in which written information is provided or to systematically vary structural features of the information in order to improve the quality of drug communications. (+info)
Functional foods: the Food and Drug Administration perspective.
Because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods, the Food and Drug Administration has no authority to establish a formal regulatory category for such foods. The primary determinant of the regulatory status of a food is its intended use, which is determined largely by the label and labeling information accompanying the product. This information includes nutrient information, nutrient content claims, and various types of health claims. In marketing these foods, manufacturers may come under one of several existing regulatory options. The first decision manufacturers will make that will help determine their product's regulatory status is whether the product is a food or a drug. Thus, manufacturers and retailers have a range of legal and regulatory categories in which their products may be classified. This article describes the definitions provided in the FFDCA for a drug and a food, the safety and labeling requirements of various food categories, and types of possible claims for dietary supplements. (+info)
Unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel.
BACKGROUND: Many medications used for children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efficacy. As a result, the majority of children admitted to hospital wards receive medications outside the terms of their license (off-label) or medications that are not specifically licensed for use in children (unlicensed). The extent of unlicensed and off-label medication use in ambulatory children is unknown. OBJECTIVE: To determine the extent of unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel. PATIENTS AND METHODS: We conducted a retrospective analysis of the medical records of 132 outpatient children treated in the General Pediatrics Ambulatory Unit of the Soroka Medical Center, Beer Sheva, in November-December 1998. RESULTS: The children's ages ranged from 1 month to 18 years (mean +/- SD 50 +/- 58 months). Of the 222 prescriptions given to these children, one-third were unlicensed (8%) or unlabeled (26%). Different dose and age were the most common categories of off-label medication use. All 18 cases of unlicensed use were due to modification of licensed drugs (tablets were crushed to prepare suspensions). Altogether, 42% of children received medicines that were off-label and/or unlicensed. CONCLUSIONS: More off-label than unlicensed medications were used. Further investigations are required to establish the extent of unproved drug use in both hospitalized and ambulatory pediatric patients in Israel. Recommendations recently issued by the Ministry of Health's National Council for Child Health and Pediatrics constitute a first step in the Israeli contribution to the international effort demanding testing of medications for children. (+info)
Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation. (+info)
Unlicensed and off label prescribing of drugs in general practice.
AIM: To determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice. METHODS: A retrospective analysis of all prescriptions for one year involving children (aged 12 years or under) from a single suburban general practice in the English Midlands. Prescribed drugs were categorised as licensed, unlicensed (without a product licence), or used in an off label way (outside the terms of their product licence). RESULTS: During 1997 there were 3347 prescription items involving 1175 children and 160 different drugs. A total of 2828 (84. 5%) prescriptions were for licensed medicines used in a licensed way; 10 (0.3%) were for unlicensed medicines; and 351 (10.5%) were licensed medicines used in an off label way. For 158 (4.7%) the information was insufficient to determine licence status. CONCLUSION: This is the first study to show that a significant number of drugs prescribed for children by general practitioners are off label and highlights the anomalies and inadequacies of drug information for prescribers. (+info)
Off label and unlicensed drug use among French office based paediatricians.
AIMS: To determine the extent of off label and unlicensed drug use in French office based paediatric practice. METHODS: A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration. RESULTS: A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions. CONCLUSIONS: Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group. (+info)