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Search results for "United States of America"

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Book/Report

Drug Shortages: Certain Factors Are Strongly Associated With This Persistent Public Health Challenge.

Washington, DC: United States Government Accountability Office; July 7, 2016. Publication GAO-16-595.

Despite the reduction of drug shortages in recent years, access to certain types of drugs, such as generic sterile injectable medications, remains limited. Analyzing data on drug shortages in the United States, this government report identifies factors that contribute to shortages and suggests prioritizing efforts to address the most pressing problems including suppliers that fail to comply with standards.

Journal Article > Study

Despite federal legislation, shortages of drugs used in acute care settings remain persistent and prolonged.

Chen SI, Fox ER, Hall MK, et al. Health Aff (Millwood). 2016;35:798-804.

Drug shortages have been a persistent problem for several years and have been shown to affect patient safety. The Food and Drug Administration Safety and Innovation Act of 2012 was intended to address these shortages. This analysis found that while shortages have decreased since the act was passed, problems with drug supply for acute care facilities remain.

Journal Article > Review

The impact of drug shortages on patients with cardiovascular disease: causes, consequences, and a call to action.

Reed BN, Fox ER, Konig M, et al. Am Heart J. 2016;175:130-141.

Patients hospitalized with cardiovascular conditions are particularly vulnerable to medication errors. This review explains how drug shortages associated with cardiovascular medications pose risks to patients and provides recommendations for clinicians, policymakers, and manufacturers to address this problem.

Newspaper/Magazine Article

Drug shortages forcing hard decisions on rationing treatments.

Fink S. New York Times. January 29, 2016.

Drug shortages have become a routine challenge in medicine. Reporting on the impact of medication shortages on care delivery and decision making, this newspaper article discusses processes in place to manage patient care as safely as possible and ethical dilemmas health care providers have faced in light of the reduced availability of medications.

Journal Article > Study

Longitudinal trends in U.S. drug shortages for medications used in emergency departments (2001–2014).

Hawley KL, Mazer-Amirshahi M, Zocchi MS, Fox ER, Pines JM. Acad Emerg Med. 2016;23:63-69.

This analysis of medication shortages in the emergency department revealed that there have been shortages of high-acuity medications for which no substitute is available. This suggests further investigation into patient safety implications of drug shortages is needed.

Journal Article > Study

Impact of a drug shortage on medication errors and clinical outcomes in the pediatric intensive care unit.

Hughes KM, Goswami ES, Morris JL. J Pediatr Pharmacol Ther. 2015;20:453-461.

Drug shortages can result in safety consequences, as studies have shown a higher rate of treatment failure and increased adverse events associated with unavailability of first-line therapies. However, this study did not find any change in adverse events in pediatric intensive care unit patients during a shortage of commonly used sedatives and injectable opioid pain medications. The authors note that advance warning of the shortage and development of standardized algorithms for drug substitution may have mitigated the potential safety hazards.

Journal Article > Study

Evaluation of parenteral nutrition errors in an era of drug shortages.

Storey MA, Weber RJ, Besco K, Beatty S, Aizawa K, Mirtallo JM. Nutr Clin Pract. 2016;31:211-217.

Parenteral nutrition (PN) can result in patient harm if prepared or administered improperly. Recent shortages of PN ingredients have forced pharmacies to deviate from guidelines for safe PN preparation, but this study found that the incidence of errors has not increased.

Newspaper/Magazine Article

The US has a drug shortage—and people are dying.

Koba M. Fortune. January 6, 2015.

National drug shortages are a persisting and serious patient safety issue in the United States. Reporting on the drug shortage problem, this magazine article explores underlying causes, economic factors involved, and how shortages threaten the safety and timeliness of patients receiving treatment.

Newspaper/Magazine Article

Drug shortages: the scary reality of a world without meds.

Eban K. Reader's Digest. June 2014.

Reporting on the persisting issue of medication shortages in the United States, this magazine article describes how it has affected patients, underlying causes, and strategies regulators, clinicians, and patients have used to work around or address the problem.

Journal Article > Review

Drug shortages: a complex health care crisis.

Fox ER, Sweet BV, Jensen V. Mayo Clin Proc. 2014;89:361-373.

National drug shortages in the United States have become a serious patient safety concern. Spotlighting the impact of drug shortages on the economy and health care, this review reveals underlying issues contributing to the problem and highlights the persisting need for solutions to address them.

Book/Report

Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability.

Washington, DC: United States Government Accountability Office; February 10, 2014. Publication GAO-14-194.

Reporting on the current state of the drug shortage problem and its causes, this publication examines FDA efforts to proactively identify potential shortages and recommends enhanced policies and procedures for data management to augment this work.

Legislation/Regulation > Organizational Policy/Guidelines

Chemotherapy drug shortages in pediatric oncology: a consensus statement.

DeCamp M, Joffe S, Fernandez CV, Faden RR, Unguru Y; Working Group on Chemotherapy Drug Shortages in Pediatric Oncology. Pediatrics. 2014;133:e716-e724.

Shortages of medications pose ethical, efficiency, and safety challenges for prescribers. This consensus statement makes recommendations to help guide policy development and promote proactive response to reduce the potential for pediatric chemotherapy drug shortages.

Newspaper/Magazine Article

Drug shortages persist in US, harming care.

Thomas K. New York Times. November 17, 2012:A1.

This newspaper article reports on the concerns of patients and health care workers associated with the continuing drug shortages in the United States.

Book/Report

Strategic Plan for Preventing and Mitigating Drug Shortages.

Silver Spring, MD: Food and Drug Administration; October 2013.

This report outlines the FDA's plans to address drug shortages, including streamlining tracking processes and developing early warning signals to identify potential shortages.

Newspaper/Magazine Article

Drug shortages still at crisis levels.

Talsma J. Drug Topics. June 15, 2013.

Discussing the current state of and efforts to address drug shortages, this news article notes a reduction in chemotherapy delays and reveals persistent barriers to improvement.

Book/Report

Report on the ISPE Drug Shortages Survey.

Tampa, FL: International Society for Pharmaceutical Engineering; June 2013.

This worldwide survey determined root causes and underlying issues contributing to drug shortages and provides recommendations for industry and regulators to drive improvement.

Journal Article > Review

Clinical dilemmas and a review of strategies to manage drug shortages.

Rider AE, Templet DJ, Daley MJ, Shuman C, Smith LV. J Pharm Pract. 2013;26:183-191.

Drug shortages have been shown to have serious clinical consequences for affected patients. This review article outlines a systematic approach for managing drug shortages.

Journal Article > Study

National survey on the effect of oncology drug shortages on cancer care.

McBride A, Holle LM, Westendorf C, et al. Am J Health Syst Pharm. 2013;70:609-617.

National drug shortages in the United States have become a serious patient safety concern. These shortages reached record levels in 2011, resulting in documented patient harm, longer stays, and increased costs. This survey of US oncology pharmacists reveals that cancer drug shortages were common during the first half of 2011 and resulted in delays and changes in chemotherapy. Use of less familiar alternatives also led to increased risk of medication errors and adverse outcomes. Near misses were reported by 16% of respondents, and 6% documented medication errors. A previous article discussed how hospitals and health care leaders might address this "patient safety crisis."

Newspaper/Magazine Article

Management of drug shortages in the perioperative setting.

Murray C, Rycek W, Johnson D, Sifuentes-Tovar F. Pharm Purch Prod. January 2013;10:12.

This magazine article details how one academic medical center used a collaborative approach and implemented policies and procedures to address perioperative drug shortages.

Journal Article > Study

The impact of drug shortages on children with cancer—the example of mechlorethamine.

Metzger ML, Billett A, Link MP. N Engl J Med. 2012;367:2461-2463.

The nationwide unavailability of certain prescription medications has posed a potential patient safety problem, as these shortages have been increasingly common over the past few years. This study shows clear evidence that drug shortages can result in patient harm. In 2009, a shortage of mechlorethamine (a standard component of chemotherapy regimens for childhood leukemia) forced oncologists to treat patients with an alternative agent, cyclophosphamide (which was thought to be equally effective). This article demonstrates that children who received cyclophosphamide clearly had a higher rate of treatment failure, resulting in the need for further chemotherapy and bone marrow transplantation. This finding adds to other recent studies documenting clinical consequences directly related to drug shortages.

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