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• W2014281871 abstract "Pharmaceutical shortages threaten clinical care outcomes and third-party payer, government, and personal finances, yet these shortages are not routinely considered in pharmacoeconomic analyses.A recent summit noted multiple causes for drug shortages: regulatory and legislative factors, including limited authority by the US Food and Drug Administration (FDA) to compel notification of drug shortages; raw materials, manufacturing, and Good Manufacturing Practices adherence; market factors, such as merger of firms and modification of product lines; and supply chain factors.1American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists, and the Institute for Safe Medication PracticesDrug Shortages Summit Report, November 5, 2010.http://www.ashp.org/drugshortages/summitreportGoogle Scholar This complexity almost assures that drug shortages will not be resolved in the near—or possibly even the foreseeable—future. It becomes a reality that pharmacoeconomics must address.From 2006 to 2010, drug shortages in the United States have increased 306% and are on track to exceed this growth in 2011(Figure).2US Government Accountability OfficeDrug Shortages: FDA's Ability to Respond Should Be Strengthened GAO-12-116, November 2011.http://www.gao.gov/assets/590/586999.pdfGoogle Scholar The shortages include life-saving antineoplastic medications, chronic care pharmaceuticals, and important but more routine products. The worsening trend led to Presidential Executive Order #13588 directing the FDA to prioritize streamlining regulatory actions for the development of early warning and prevention strategies and the Department of Justice to investigate possible market pathologies (eg, stockpiling, collusion).3President Barack Obama Executive Order 13588—Reducing Prescription Drug Shortages, October 31, 2011.http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortagesGoogle ScholarSenator Amy Klobuchar (D-Minn) introduced the Preserving Access to Life-Saving Medications Act of 2011.4S.296 - Preserving Access to Life-Saving Medications Act.http://thomas.loc.gov/home/thomas.phpGoogle Scholar This bipartisan legislation would give the FDA greater authority to obtain earlier warnings and thus possibly avert actual shortages. The FDA has also acted, expanding the requirement for sole source manufacturers to report potential shortage of “medically necessary” medication rather than only the previously more stringent standard of “lifesaving” medication. Current discussions also include having the FDA require, before granting marketing authorization, that manufacturers have backup plans for continuity of supply should there be a disruption in the primary manufacturing plan.As prices for some products in short supply have risen, Senator Charles Schumer (D-NY) is proposing legislation that would establish “price gouging” for such drugs as a category of federal crime.5Senator Charles Schumer Schumer: Shortages of Life-Saving Medications Hitting Syracuse-Area Hospitals—Pushes Three-Point Plan To Ensure Patients Get The Medicine They Need.http://schumer.senate.gov/Newsroom/record.cfm?id=335252Google Scholar In the other chamber, Rep. Elijah E. Cummings (D-MD) has launched an inquiry into pricing for shortage products, while other legislators are joining the probe.6US House of Representatives. Committee on Oversight and Government ReformCummings Investigates Potential Prescription Drug Price Gouging, October 5, 2011.http://democrats.oversight.house.gov/index.php?option=com_content&view=article&id=5445:gray-market&catid=146:democratic-agenda&Itemid=107Google ScholarThese developments form the context within which pharmacoeconomic analyses are generated, published, and used to establish the value of particular agents to treat specific conditions. The analyses take an economic rather than an accounting approach to quantification, and consider the clinical and economic consequences of conditions treated under guideline scenarios. Value, as a product of these determinations, is a probabilistic statement based on distributional and risk assumptions. Supply risk—or, more correctly, the risk of a supply shortage—is seldom explicitly included in the model. Recent experiences suggest that this may need to change.It is well accepted that a strong rationale must be provided for the conversion factor(s) from efficacy to effectiveness in a pharmacoeconomic analysis. Similarly, supply chain risk increases from essentially zero in randomized clinical trial settings to nonzero in usual community practice. Not including this factor in the quantification and sensitivity analyses potentially represents a type of omitted variable bias. Economic costs in this instance are not just the price rise of the product in short supply, although that is a material consideration, but the full stream of consequences due to disrupted supply.Moving from small to large molecules, current strategic plans by manufacturers regarding biosimilars may be most relevant not for the cost savings due to competition, which are likely to be much more modest than those for small molecules, but for the assurance of a larger and more resilient supply. For example, Amgen and Watson Pharmaceuticals, and Biogen Idec Inc. and Samsung Biologics Inc., separately announced collaborations to develop, manufacture, and market biosimilars. However, for each, the partnerships will only develop and market biosimilars of the other company's products7Pollack A. Amgen Plans to Team Up With Watson on Generics. The New York Times, December 20, 2011http://www.nytimes.com/2011/12/20/health/research/amgen-and-watson-to-work-together-on-generic-drugs.html?scp=1&sq=biosimilars%20&st=cseGoogle Scholar and not their own, expanding the supply for similar therapeutic products.Where there is evidence of supply disruption, or the meaningful possibility of supply disruption, this risk should be an element of value analysis. Sensitivity analyses should assess the range and likely outcomes from variations in the certainty of supply and consequences of disruption. For pharmacoeconomic results to have practical value for decision makers, the analyses must encompass the priority concerns decision makers actually confront. Pharmaceutical shortages threaten clinical care outcomes and third-party payer, government, and personal finances, yet these shortages are not routinely considered in pharmacoeconomic analyses. A recent summit noted multiple causes for drug shortages: regulatory and legislative factors, including limited authority by the US Food and Drug Administration (FDA) to compel notification of drug shortages; raw materials, manufacturing, and Good Manufacturing Practices adherence; market factors, such as merger of firms and modification of product lines; and supply chain factors.1American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists, and the Institute for Safe Medication PracticesDrug Shortages Summit Report, November 5, 2010.http://www.ashp.org/drugshortages/summitreportGoogle Scholar This complexity almost assures that drug shortages will not be resolved in the near—or possibly even the foreseeable—future. It becomes a reality that pharmacoeconomics must address. From 2006 to 2010, drug shortages in the United States have increased 306% and are on track to exceed this growth in 2011(Figure).2US Government Accountability OfficeDrug Shortages: FDA's Ability to Respond Should Be Strengthened GAO-12-116, November 2011.http://www.gao.gov/assets/590/586999.pdfGoogle Scholar The shortages include life-saving antineoplastic medications, chronic care pharmaceuticals, and important but more routine products. The worsening trend led to Presidential Executive Order #13588 directing the FDA to prioritize streamlining regulatory actions for the development of early warning and prevention strategies and the Department of Justice to investigate possible market pathologies (eg, stockpiling, collusion).3President Barack Obama Executive Order 13588—Reducing Prescription Drug Shortages, October 31, 2011.http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortagesGoogle Scholar Senator Amy Klobuchar (D-Minn) introduced the Preserving Access to Life-Saving Medications Act of 2011.4S.296 - Preserving Access to Life-Saving Medications Act.http://thomas.loc.gov/home/thomas.phpGoogle Scholar This bipartisan legislation would give the FDA greater authority to obtain earlier warnings and thus possibly avert actual shortages. The FDA has also acted, expanding the requirement for sole source manufacturers to report potential shortage of “medically necessary” medication rather than only the previously more stringent standard of “lifesaving” medication. Current discussions also include having the FDA require, before granting marketing authorization, that manufacturers have backup plans for continuity of supply should there be a disruption in the primary manufacturing plan. As prices for some products in short supply have risen, Senator Charles Schumer (D-NY) is proposing legislation that would establish “price gouging” for such drugs as a category of federal crime.5Senator Charles Schumer Schumer: Shortages of Life-Saving Medications Hitting Syracuse-Area Hospitals—Pushes Three-Point Plan To Ensure Patients Get The Medicine They Need.http://schumer.senate.gov/Newsroom/record.cfm?id=335252Google Scholar In the other chamber, Rep. Elijah E. Cummings (D-MD) has launched an inquiry into pricing for shortage products, while other legislators are joining the probe.6US House of Representatives. Committee on Oversight and Government ReformCummings Investigates Potential Prescription Drug Price Gouging, October 5, 2011.http://democrats.oversight.house.gov/index.php?option=com_content&view=article&id=5445:gray-market&catid=146:democratic-agenda&Itemid=107Google Scholar These developments form the context within which pharmacoeconomic analyses are generated, published, and used to establish the value of particular agents to treat specific conditions. The analyses take an economic rather than an accounting approach to quantification, and consider the clinical and economic consequences of conditions treated under guideline scenarios. Value, as a product of these determinations, is a probabilistic statement based on distributional and risk assumptions. Supply risk—or, more correctly, the risk of a supply shortage—is seldom explicitly included in the model. Recent experiences suggest that this may need to change. It is well accepted that a strong rationale must be provided for the conversion factor(s) from efficacy to effectiveness in a pharmacoeconomic analysis. Similarly, supply chain risk increases from essentially zero in randomized clinical trial settings to nonzero in usual community practice. Not including this factor in the quantification and sensitivity analyses potentially represents a type of omitted variable bias. Economic costs in this instance are not just the price rise of the product in short supply, although that is a material consideration, but the full stream of consequences due to disrupted supply. Moving from small to large molecules, current strategic plans by manufacturers regarding biosimilars may be most relevant not for the cost savings due to competition, which are likely to be much more modest than those for small molecules, but for the assurance of a larger and more resilient supply. For example, Amgen and Watson Pharmaceuticals, and Biogen Idec Inc. and Samsung Biologics Inc., separately announced collaborations to develop, manufacture, and market biosimilars. However, for each, the partnerships will only develop and market biosimilars of the other company's products7Pollack A. Amgen Plans to Team Up With Watson on Generics. The New York Times, December 20, 2011http://www.nytimes.com/2011/12/20/health/research/amgen-and-watson-to-work-together-on-generic-drugs.html?scp=1&sq=biosimilars%20&st=cseGoogle Scholar and not their own, expanding the supply for similar therapeutic products. Where there is evidence of supply disruption, or the meaningful possibility of supply disruption, this risk should be an element of value analysis. Sensitivity analyses should assess the range and likely outcomes from variations in the certainty of supply and consequences of disruption. For pharmacoeconomic results to have practical value for decision makers, the analyses must encompass the priority concerns decision makers actually confront." @default.
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• W2014281871 title "Price and Value: The Pharmacoeconomics of Scarcity" @default.
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