Study: Low-dose aspirin lowers the occurrence of new venous blood clots
SYDNEY — Low-dose aspirin lowers the occurrence of new venous blood clots — and represents a reasonable treatment option for patients who are not candidates for long-term anticoagulant drugs, such as warfarin, according to a new study published in Monday's issue of Circulation.
"The study provides clear, consistent evidence that low-dose aspirin can help to prevent new venous blood clots and other cardiovascular events among people who are at risk because they have already suffered a blood clot," stated the study's lead author, University of Sydney professor John Simes. "The treatment effect of aspirin is less than can be achieved with warfarin or other new generation direct thrombin inhibitors, which can achieve more than an 80% reduction in adverse circulatory and cardiopulmonary events," he said. "However, aspirin represents a useful treatment option for patients who are not candidates for anticoagulant drugs because of the expense or the increased risk of bleeding associated with anticoagulants."
Compared to placebo patients, those who took 100 mg daily of aspirin had a one-third reduction in the risk of:
- Thromboembolism, which is the obstruction of a blood vessel by a clot that has dislodged from another site in the circulation;
- Deep vein thrombosis, which is the formation of a blood clot in a deep vein, predominantly in the legs;
- Pulmonary embolism, which is a blood clot affecting the arteries that supply blood to the lungs; and
- Myocardial infarction (heart attack), stroke or cardiovascular death.
Most people who have had a blood clot in a leg vein (i.e., deep-vein thrombosis) or an embolism (i.e., where the clot blocks the blood flow) have anticoagulant drug treatment (e.g., warfarin) for at least six months, first to dissolve the clot and then to prevent it happening again.
However, long-term anticoagulant drugs are expensive and inconvenient, requiring frequent regular blood tests and adjustments to the dosage. Further, there is an elevated risk that the treatment could cause bleeding in some patients. For people who are not able to cope with this, the viable alternative of taking regular aspirin will be a great benefit, Simes noted.
"The study provides evidence that after a first venous thrombosis or embolism, daily aspirin reduces the risk of another event, without causing undue bleeding. This treatment is an alternative to long-term anticoagulation and will be especially useful for patients who do not want the inconvenience of close medical monitoring or the risk of bleeding," Simes said. "Aspirin will be ideal in the many countries where prolonged anticoagulant treatment is too expensive. A major benefit of this treatment is its cost-effectiveness. Aspirin is cheap, but it will save the treatment costs of the many recurrent clots that are prevented. This could mean a saving of millions of healthcare dollars worldwide."
CHPA names new CFO
WASHINGTON — The Consumer Healthcare Products Association on Monday announced that Brian Green will join CHPA as VP finance and operations and CFO. Green will begin his duties on Sept. 2, 2014.
Reporting to CHPA president and CEO Scott Melville, Green will direct CHPA’s finance management, human resources, information technology, meetings and administration functions. He also will serve as a member of the association’s senior management team.
“I’m delighted Brian will be joining CHPA in a senior leadership role,” Melville said. “He brings a strong track record in financial and operations management that will help to strengthen and grow our association.”
A graduate of University of Northern Iowa, Green is a certified public accountant who served as CFO, VP for the Building Owners and Managers Association International for nearly a decade, where he directed all finance, administration, information technology, research activities of the association, as well as administered one of the major member programs.
International Society for Pharmaceutical Engineering releases preview of its Drug Shortages Prevention Plan
TAMPA, Fla. — The International Society for Pharmaceutical Engineering on Wednesday announced that it has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a reliable supply of medications.
"Our goal is that the pharmaceutical industry will use the plan not only to help them look holistically across the supply chain, but also as a roadmap to use in challenging their current processes, systems and practices and to identify potential gaps and risks," stated ISPE CEO and president, Nancy Berg. "Having the input of regulatory authorities has been invaluable to the effort because it helps to clarify what expectations regulators have regarding necessary steps toward drug shortage prevention and mitigation."
ISPE's Drug Shortages Prevention Plan was reviewed by regulators from the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency, with further regulatory review anticipated.
The plan was developed by ISPE and its pharmaceutical and biopharmaceutical industry members, and describes how industry can best prevent drug shortages from occurring by discovering root causes and through creating and sustaining organizational cultures supported by leadership, business processes and quality systems that will ensure a resilient and reliable supply of medications.
The plan was organized around a "six dimension" framework comprised of: corporate quality culture; robust quality systems; metrics; business continuity planning; communication with authorities; and building capability. In each chapter, the plan provides answers to questions posed within each of the six dimensions, and also offers "real world" case studies that illustrate how best practices can be established.
Examples of the questions answered within each framework include:
- Corporate quality culture – How can organizations foster practices, values and a philosophy that require employees at all levels to subscribe to quality?;
- Robust quality systems – What triggers can affect production and the integrity of the supply chain and potentially lead to a drug shortage? How can those triggers be identified and eliminated?;
- Metrics – How can metrics be tailored to help identify risks and mitigate them?;
- Business continuity planning – At a time when supply chains are more global and complex, how can quality and competence be assured in production, factories, materials, machines, equipment and expertise?;
- Communication with authorities – How can rapid and comprehensive communication with health authorities help to prevent potential shortages before they occur, or mitigate with expedience shortages that do materialize?; and
- Building capability – How can capability be built to identify the true root causes of drug shortages, train employees, improve knowledge and knowledge management, as well as strengthen employee commitment to quality?
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