Trends of analgesic nephropathy in two high-endemic regions with different legislation.
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Analgesic abuse is related to a specific form of interstitial nephritis, but the exact nature of the causal agent remains controversial and this has resulted in differences in regulation. In Flanders, the free sale of phenacetin was banned, but the consumption of other combined analgesics remained free. In New South Wales, phenacetin was also banned, but 2 yr later the sales of all combined analgesics were also prohibited. This study compared the evolution of end-stage renal disease as a result of analgesic nephropathy (AN) in these two high-endemic regions with different legislation. In both regions, the time trend of the age-specific incidence of end-stage renal disease as a result of AN is similar in the age group 45 to 54 yr. In all age groups combined, the time trend of the percentage of AN among the patients admitted for renal replacement therapy is also similar. This finding does not support the hypothesis that non-phenacetin mixed analgesics play a significant role in the occurrence of AN. (+info)
Antibiotic resistance: consequences of inaction.
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Bacterial resistance presents therapeutic dilemmas to clinicians worldwide. The warnings were there long ago, but too few people heeded them. Thus an emerging problem has grown to a crisis. Resistance is an ecological phenomenon stemming from the response of bacteria to the widespread use of antibiotics and their presence in the environment. While determining the consequences of inaction on the present and future public health, we must work to remedy the lack of action in the past. By improving antibiotic use and decreasing resistance gene frequency at the local levels, we can move towards reversing the resistance problem globally. (+info)
Antimicrobial growth promoter ban and resistance to macrolides and vancomycin in enterococci from pigs.
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Ninety-six enterococcus isolates from fecal samples of pigs receiving tylosin as an antimicrobial growth promoter and 59 isolates obtained in the same farms 5 to 6 months after the ban of antimicrobial growth promoters in Switzerland were tested for susceptibility to nine antimicrobial agents. A clear decrease in resistance to macrolides, lincosamides, and tetracycline was visible after the ban. Vancomycin-resistant Enterococcus faecium belonged to the same clonal lineage as vancomycin-resistant isolates previously isolated from Danish pigs. (+info)
Drugs for neglected diseases: a failure of the market and a public health failure?
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Infectious diseases cause the suffering of hundreds of millions of people, especially in tropical and subtropical areas. Effective, affordable and easy-to-use medicines to fight these diseases are nearly absent. Although science and technology are sufficiently advanced to provide the necessary medicines, very few new drugs are being developed. However, drug discovery is not the major bottleneck. Today's R&D-based pharmaceutical industry is reluctant to invest in the development of drugs to treat the major diseases of the poor, because return on investment cannot be guaranteed. With national and international politics supporting a free market-based world order, financial opportunities rather than global health needs guide the direction of new drug development. Can we accept that the dearth of effective drugs for diseases that mainly affect the poor is simply the sad but inevitable consequence of a global market economy? Or is it a massive public health failure, and a failure to direct economic development for the benefit of society? An urgent reorientation of priorities in drug development and health policy is needed. The pharmaceutical industry must contribute to this effort, but national and international policies need to direct the global economy to address the true health needs of society. This requires political will, a strong commitment to prioritize health considerations over economic interests, and the enforcement of regulations and other mechanisms to stimulate essential drug development. New and creative strategies involving both the public and the private sector are needed to ensure that affordable medicines for today's neglected diseases are developed. Priority action areas include advocating an essential medicines R&D agenda, capacity-building in and technology transfer to developing countries, elaborating an adapted legal and regulatory framework, prioritizing funding for essential drug development and securing availability, accessibility, distribution and rational use of these drugs. (+info)
Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.
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The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). (+info)
Effect of clean indoor air laws on smokers: the clean air module of the SimSmoke computer simulation model.
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OBJECTIVES: To develop a simulation model to examine the effects of clean indoor air laws on prevalence rates and smoking attributable deaths. METHODS: Based on empirical and theoretical research, the effects of clean air laws are modelled by type of law. The model considers clean air laws at the state levels between 1993 and 2000, and projects the number of smokers and smoking attributable deaths in the USA under different scenarios from 2000 onward. RESULTS: The model predicts that comprehensive clean air laws have the potential to reduce substantially the number of smokers and smoking attributable deaths, and these effects are predicted to grow over time. The predicted impact of new worksite laws are reduced when previously implemented private and public worksite restrictions are taken into account. CONCLUSIONS: Clean indoor air laws have the ability to reduce smoking rates substantially and save lives, but their impact is likely to depend on their comprehensiveness and prior private worksite restrictions in place. (+info)
Federal regulations and reimbursement for PET.
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OBJECTIVE: The regulatory and reimbursement environment for PET has changed significantly over the past several years. The Food and Drug Administration's (FDA) findings of the safety and efficacy of key PET drugs have been published, as well as guidelines for the applications to produce PET drugs. In addition, the national Medicare coverage policy for PET has been expanded, most recently with additional indications and coverage restrictions added as of July 2001. The payment rates under the new Hospital Outpatient Prospective Payment System (HOPPS) have been set for PET as well. This communication reviews these recent changes and discusses their impact on the development and operation of a PET center. After reading this article, the nuclear medicine technologist should be able to: (a) state the indications for the use of PET drugs that have been found to be safe and effective by the FDA; (b) detail the general procedures a PET drug production site would have to undertake to be in compliance with FDA regulations; (c) list specific studies that have been approved for payment by Medicare; and (d) describe billing codes used for PET scans. Clarification of regulatory and reimbursement issues is leading to rapid expansion of clinical PET. Keeping abreast of these changes will ensure the successful expansion of any nuclear medicine program to include PET services. (+info)
Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule.
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The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after receiving no public comments on the agency's proposed nonmonograph status of these specific combination drug products, which was issued in the form of a tentative final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA. (+info)