Effective antibiotic conservation by emergency antimicrobial stewardship during a drug shortage

We present the first description of an antimicrobial stewardship program (ASP) used to successfully manage a multi-antimicrobial drug shortage. Without resorting to formulary restriction, meropenem utilization decreased by 69% and piperacillin-tazobactam by 73%. During the shortage period, hospital mortality decreased (P=.03), while hospital length of stay remained unchanged.Infect Control Hosp Epidemiol 2017;38:356–359</jats:p

The Drugs Stop Here: A Public Health Framework to Address the Drug Shortage Crisis

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon

The Drugs Stop Here: A Public Health Framework to Address the Drug Shortage Crisis

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon

Impact of Antibiotic Shortage on H. Pylori Treatment: A Step-Wise Approach for Pharmacist Management

The current drug shortage crisis involving multiple oral antibiotics has significantly impacted preferred therapeutic options for treatment of H.pylori infection. Pharmacists may help alleviate the impact of this shortage through a proposed step-wise approach which includes proper inventory management, verification of indication, evaluation of regimen, therapeutic monitoring, and communication with patients and providers regarding alternative therapy or symptomatic relief

Evaluating Fda Generic Approval After 2017 Agency Initiatives

Importance: Generic drugs play an essential role in the US healthcare system, providing less costly alternatives to branded drugs that are equally effective and safe. The US Food and Drug Administration (FDA) regulatory policies influence the standards for generic drug approval. In 2017, the FDA instituted several initiatives to promote generic drug approval, particularly focused on those with limited competition. Objective: To determine whether the initiatives begun by FDA in 2017 were associated with greater numbers of approvals of generic drugs with limited generic competition and histories of drug shortage. Study Sample and Design: We conducted a cross-sectional study of new drug applications (ANDA) approved by FDA during two one-year periods: July 1st, 2016 to June 30th, 2017 (before the initiatives) and January 1st, 2018 to December 31st, 2018 (after the initiatives). ANDAs were also characterized on the basis of their initial approval year, priority review status and orphan designation status for the original new drug, World Health Organization (WHO) essential medicine status, therapeutic area, drug complexity. Main outcomes and measures: We determined (1) generic competition at the time of ANDA approval; (2) history of drug shortage during the five years before ANDA approval. Results: A total of 1,410 ANDAs were identified, 661 prior to the FDA’s initiatives, 749 afterwards. Overall, there were 336 (23.8%) ANDAs originally approved with priority review status, 183 (13.0%) ANDAs previously approved with orphan drugs status. 262 (18.6%) ANDAs were listed as essential medicine by WHO, and 265 (18.8%) generic approvals were categorized as complex generic drugs. In the pre-period, 234 (35.4%) of the ANDAs approved were determined to have limited competition (≤3 ANDAs), as compared to 237 (31.6%) afterwards (p=0.14). Similarly, 242 (36.6%) of the ANDAs approved in the pre-period had been in shortage during the five years before ANDA approval, as compared to 282 (37.7%) afterwards (p=0.69). In multivariate analysis, approval of generics with limited competition was significantly less likely during the period after the FDA’s initiatives when compared to before (OR=0.76; 95% CI, 0.60-0.97; p=0.02), but there was no significant difference in the approval of generics with histories of drug shortage (OR=1.09; 95% CI, 0.86-1.38; p=0.46). Conclusion and relevance: The FDA’s initiatives in 2017 to promote generic drug approvals had limited impact on the approval of ANDAs for drugs that lacked generic competition and had histories of drug shortage. Additional efforts are needed to promote approval of generic drugs with limited competition

Drug shortage management in Alabama hospital pharmacies

Purpose: The purpose of this study is to identify effective strategies used by Alabama hospitals to manage drug shortages. Moreover, this study aims to determine if there are any relationships among hospital size, utilization of a standard policy for drug shortage management and perceived usefulness of standard procedures for drug shortages. Methods: A paper survey was mailed to 129 hospital pharmacies in Alabama (per the Alabama Hospital Association directory). The survey consisted of 5 demographic questions, questions involving perception of current medication shortages, sources of information about shorted drugs, and frequency of discussion at P&amp;T committee meetings. Most importantly, the survey contained questions about the use of a standard policy for handling drug shortages, the effectiveness of the policy if one is used, and an open-ended question asking the recipient to describe the policy being used. Results: A response rate of 55% was achieved as 71 surveys were completed and returned. Approximately 70% of the survey respondents described the current drug shortage issue as a top priority in their pharmacy department. The pharmacy distributor served as the primary source of information regarding drug shortages for 45% of the facilities. There is a direct relationship between size of hospital and likelihood of utilization of a standard policy or procedure for drug shortage management among the sample. The smaller facilities of the sample perceived their management strategies as effective more frequently than the larger hospitals. Conclusion: Common components of effective management strategies included extensive communication of shortage details and the ability to locate alternative products. The use of portable technology (e.g., Smart phones and tablets) along with mobile applications may emerge as popular means for communicating drug product shortage news and updates within a facility or healthcare system. &nbsp; Type:&nbsp;Original Researc

Too Sick to Be Executed: Shocking Punishment and the Brain

Capital punishment, to be lawfully delivered, must occur without needless cruelty. Cruelty, defined in the setting of punishment, will naturally evolve with the maturation of civil society. Cruel punishment will always be a relative standard, and punishment cannot exceed what is morally shocking. In the setting of public executions, observers and victims share an aspect of the experience of punishment. The inmate has little opportunity to evaluate and report back on cruelty in the moments before death. Once dead, the inmate is necessarily silent on the matter. Empathy allows observers to evaluate punishment as cruel or not. Attempts by the state to block unfettered observation of all aspects of an execution deny Eighth Amendment protection, which stipulates that inflicted punishment shall not be cruel and unusual. Observation necessarily involves more than what a casual observer can surmise. Execution, as a form of killing, is a technical matter and, as such, requires more than casual knowledge of the details of that killing. Lethal injection is now the standard method of execution and while never a medical act, co-opts the tools of the medical trade and engenders comment. Ethically, professional medical societies, including the American Medical Association and the American Board of Anesthesiology, object to physician participation in lethal injection. As a consequence, physicians find themselves caught on the horns of a dilemma: How can the balance be struck between the benefit of some sort of technical evaluation that would reduce cruelty in executions, while refraining from instructing the state on how to kill without cruelty

A mail survey to assess the incidence and impact of drug shortages within Texas Non - Government Acute Care Hospitals

textA Mail Survey to Assess the Incidence and Impact of Drug Shortages within Texas Non – Government Acute Care Hospitals Tawfik Rajab Rajab, M.S.Phr. The University of Texas at Austin, 2013 Supervisor: Marvin D. Shepherd The objective of this study was to explore the incidence and impact of drug shortages within Texas Non-Government Acute Care Hospitals. A self-administered mail survey instrument was used to collect data. A convenience sample of 321 pharmacy directors of non-government acute care hospitals in the state of Texas was selected from the Texas Department of State Health Services (DSHS) Hospital List for 2012. A total of 125 completed surveys were received by mail and 8 surveys were returned as undelivered, resulting in a response rate of 39.84% (125/313). A total of 56 (45.5%) respondents reported 11 or more drug shortages for the month of April 2013. There was a significant association between the number of drug shortages experienced and hospital size (p = 0.003), inpatient medication budget (p = 0.001) and hospital location (p=0.015). Of the 124 respondents, 78 (62.9%) spent four to 12 hours a week on managing drug shortage situations. There was a significant association between the number of hours spent per week by hospital pharmacy personnel when managing drug shortages controlling for hospital size (p < 0.001), number of drug shortages experienced (p < 0.001), number of pharmacist FTEs (p < 0.001), and number of pharmacy technician FTEs (p < 0.001). A total of 107 (85.6%) reported that grey market vendors have contacted hospital pharmacy personnel in the month of April, 2013. A total of 96 (76.8%) ‘strongly agreed’ that grey market vendors are more likely to contact health care facility when drug shortage exists, 110 (88%) ‘strongly agreed’ that grey market vendors sell drugs in short supply at inflated prices and 70 (56%) ‘strongly agreed’ that the practice of buying drug products from grey market vendors should be eliminated. In summary, all surveyed hospitals experienced at least one drug shortage for the month of April 2013, pharmacy personnel devoted a significant amount of time managing drug shortages and the majority of the hospitals were contacted by grey market vendors with the aim of selling drugs in short supply.Pharmac