Medicare program; manufacturer submission of manufacturer's average sales price (ASP) data for Medicare Part B drugs and biologicals. Interim final rule with comment period.
(65/355)
This interim final rule with comment period will implement the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) related to the calculation and submission of manufacturer's average sales price (ASP) data on certain Medicare Part B drugs and biologicals to CMS by manufacturers. (+info)
Supplements and other changes to an approved application. Final rule.
(66/355)
The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report. (+info)
Towards targeted prescribing: will the cure for antimicrobial resistance be specific, directed therapy through improved diagnostic testing?
(67/355)
The discovery of antimicrobial agents was one of the major events of the twentieth century. However, with the 'antibiotic era' barely five decades old, we are now faced with the global problem of emerging resistance in virtually all pathogens. Guidelines and admonishments to improve prescribing have had little effect. At this point, in the twenty-first century, we are on the threshold of another era of discovery-that of molecular diagnostics. We postulate that the development and use of new molecular microbiological testing, coupled with an ever-improving understanding of how best to use these precious drugs in the treatment of infection, offers the greatest hope yet for physician prescribing that can retard, or perhaps even reduce, the development of drug resistance in many microbial species. This diagnostic advance could preserve the utility of antimicrobial agents well into the future for the benefit of all people. (+info)
Antidiarrheal drug products for over-the-counter human use; amendment of final monograph. Final rule.
(68/355)
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) antidiarrheal drug products to include relief of travelers' diarrhea as an indication for products containing bismuth subsalicylate. Travelers' diarrhea occurs in travelers and is most commonly caused by an infectious agent. This final rule is part of FDA's ongoing review of OTC drug products. (+info)
Medicare and state health care programs; fraud and abuse: OIG civil money penalties under the Medicare prescription drug discount card program. Interim final rule with comment period.
(69/355)
In accordance with section 1860D-31 of the Social Security Act, this rule sets forth the OIG's new authority for imposing civil money penalties (CMPs) against endorsed sponsors under the Medicare prescription drug discount card program that knowingly engage in false or misleading marketing practices; overcharge program enrollees; or misuse transitional assistance funds. (+info)
Requests for emergency contraception at an accident and emergency department--assessing the impact of a change in legislation.
(70/355)
The aim of this study was to examine the pattern of attendance of patients requesting Emergency Hormonal Contraception (EHC) at an accident and emergency department before and after a government driven change in legislation, which allowed EHC to be sold over-the-counter by trained pharmacists, to women aged 16 years and above. We employed retrospective comparative study using computer records of all accident and emergency attendances coded as requests for emergency contraception for the years 2000 and 2001. The number of patients requesting emergency contraception at the A&E department decreased after over-the-counter sales were introduced, from 196 in the year 2000 to 164 in 2001 (p = 0.037). Despite this, the number of teenagers requesting emergency contraception at the A&E department increased in 2001--from 63 in 2000 to 74 in 2001 (p = 0.0115). Most requests are received outside local pharmacy opening hours--63.77% in 2000 and 62.2% in 2001. This study raises concerns that the government initiative allowing emergency hormonal contraception to be sold in pharmacies is having little impact on teenagers most in need of this service. A&E departments can expect to continue to receive a significant number of requests for emergency contraception. Further measures will be required to reduce the U.K.'s high rate of unplanned pregnancies. (+info)
Ethical issues in using a cocaine vaccine to treat and prevent cocaine abuse and dependence.
(71/355)
A "cocaine vaccine" is a promising immunotherapeutic approach to treating cocaine dependence which induces the immune system to form antibodies that prevent cocaine from crossing the blood brain barrier to act on receptor sites in the brain. Studies in rats show that cocaine antibodies block cocaine from reaching the brain and prevent the reinstatement of cocaine self administration. A successful phase 1 trial of a human cocaine vaccine has been reported. The most promising application of a cocaine vaccine is to prevent relapse to dependence in abstinent users who voluntarily enter treatment. Any use of a vaccine to treat cocaine addicts under legal coercion raises major ethical issues. If this is done at all, it should be carefully trialled first, and only after considerable clinical experience has been obtained in using the vaccine to treat voluntary patients. There will need to be an informed community debate about what role, if any, a cocaine vaccine may have as a way of preventing cocaine addiction in children and adolescents. (+info)
Venetian treacle and the foundation of medicines regulation.
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Mithridatium and the related product Theriac were both regarded from the time of their original formulations in the 2nd Century BC and the 1st Century AD respectively, until the mid 18th Century as universal panaceas. Any failure of these products to achieve the desired therapeutic result was attributed to defective composition or manufacture. As a result measures were introduced to ensure the quality of ingredients used in these products composition, the establishment of standard formulations and assurance of the competence of the manufacturer. Manufacture frequently was required to take place in public. Doubts about the efficacy of these panaceas arose in the mid 18th century and concerns of the adverse nature of interactions between the numerous ingredients surfaced in Heberden's treatise of 1745, as result of which these products disappeared from Editions of The London Pharmacopoeia after 1746. Subsequently, arising from these concerns for safety and efficacy, a call was made in 1799 for the establishment of a Public Committee of eminent physicians to scrutinise all new products prior to their launch to an gullible public. The concepts developed in the history of Mithridatium form the basis of modern medicines regulation. (+info)