Pharmacy
Topic Collection
February 2, 2022
Topic Collection: Pharmacy
Prescription medications are a critical part of effective healthcare. Shortages can arise from manufacturing or distribution issues, an increase in demand, or, in a disaster situation, lack of available distribution locations, lack of refrigeration, or a patient’s inability to access their medications. Medication shortages can cause inadequate treatment, and may require triage and crisis care strategies. These situations are occurring more frequently in non-disaster situations due to production and inventory factors. Hospitals and retail pharmacies face numerous challenges when attempting to prepare for these shortages, particularly during emergency situations.
Community members with acute or chronic conditions may face challenges obtaining their medicine before, during, and after disasters due to insurance or access issues. These barriers can exacerbate their medical conditions, which can also increase the vulnerability of a population and the number of preventable medical care and emergency room visits.
The resources in this Topic Collection can help pharmacists and healthcare providers prepare for and respond to shortages and other pharmaceutical-related challenges that may arise during and after a disaster, as well as during non-disaster situations requiring resource allocation and crisis care strategies. This Collection also includes resources related to the role of pharmacists in disaster response, and strategies for partnerships between pharmacists/pharmacies and public health for public health emergency response.
Additional related resources may be found in the following ASPR TRACIE Topic Collections: Bioterrorism and High Consequence Biological Threats; Chemical Hazards; Emergency Operations Plans/ Emergency Management Program; Epidemic/ Pandemic Flu; Mass Distribution and Dispensing of Medical Countermeasures; and Radiological and Nuclear.
Each resource in this Topic Collection is placed into one or more of the following categories (click on the category name to be taken directly to that set of resources). Resources marked with an asterisk (*) appear in more than one category.
Must Reads
The Emergency Prescription Assistance Program (EPAP) is funded by the Stafford Act and designed to help disaster survivors access prescription medicines. EPAP can also be activated by the Public Health Service Act under the authority of the National Disaster Medical System (NDMS). The program utilizes normal business operations (e.g., electronic prescription claims processing, utilization of the normal pharmaceutical supply chain for distribution and dispensing) to pay for prescription medications for eligible persons.
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This calculator allows hospitals to estimate whether they have adequate supplies of medications for a disaster in stock. The user inputs facility details and based on the medication category and type, the calculator compares the amount of medications available to an estimate of those needed for 48 hours per patient and determines whether the hospital has a surplus or deficit in specific categories. The password required to work with the tool is "password1." (For a 508 compliant version of this tool, copy and paste this link into your browser: https://files.asprtracie.hhs.gov/documents/aspr-tracie-hospital-disaster-pharmacy-calculator-pdf.pdf)
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This guidance provides background into the scope and issues surrounding medication shortages and encourages use of a conventional, contingency, and crisis framework, which may be applied in disaster and non-disaster situations. It provides practical recommendations for hospital pharmacies and other stakeholders affected by medication shortages.
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This resource addresses legal issues, including the legal barriers faced by state and territorial health departments, pharmacists, and physicians that continue to hinder the expansion and inclusion of pharmacist vaccinators during routine and pandemic influenza seasons.
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This document provides guidance and templates for state and territorial health agencies charged with creating memoranda of understanding with pharmacies in response to influenza pandemics and other public health emergencies.
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The objective of this article is to provide healthcare system pharmacy leaders with a practical approach in developing an emergency operations plan (EOP) that can be activated and help meet patient-centered needs in the event of a disaster. The authors address how pharmacy leaders should: 1) review government and community disaster responses and understand the movement of drug supply for each response; 2) create a pharmacy disaster plan; 3) list the essential medications and determine their inventory levels; and 4) establish a staff training program to enhance understanding and implementation of the EOP.
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The authors of this study provide the first step in an evidence-based approach to inform the planning, periodic review, and revision of repositories of chronic disease medications, which would be helpful for rapid response to public health emergencies. The article identifies the most-prescribed medication classes of drugs as a start to outpatient planning.
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This training course addresses the changing role of pharmacists in the public health system, and their specific roles during a public health emergency response. The presenters also discuss experiences of the pharmacy community during the aftermath of Hurricane Katrina.
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The authors of this study discuss the imbalance between the high proportion of chronically ill Americans who depend on prescription medications and their lack of medication reserves for disaster preparedness. They examined barriers that Los Angeles County residents with chronic illness experience within the prescription drug procurement system to achieve recommended medication reserves.
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This fact sheet is intended for Medicare patients and provides information about: how to see doctors and other providers; get prescription drugs and extended day supplies; pay Medicare premiums; and receive dialysis or chemotherapy in a disaster or emergency area. It also describes how to replace a Medicare card, or lost or damaged durable medical equipment or supplies that Medicare paid for.
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Healthcare Ready (formerly Rx Response). (2019).
Rx Open.
This website helps emergency management teams and the general public locate operating pharmacies in areas affected by natural disasters or public health emergencies. The tool provides maps to identify the location of open and closed pharmacies using Google Maps. The website is free to the public when activated at the request of state or federal officials.
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The authors of this article discuss the how Jefferson County (AL) Department of Health worked with a local school of pharmacy to develop a novel pharmacy plan to address gaps in service for evacuees after Hurricane Katrina. This plan may serve as a model for other municipalities and/or states interested in preparing a pharmacy response to future natural disasters.
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The authors of this study assess the relationship between actual medication demands and medical relief pharmaceutical supplies in a population of 18,000 evacuees relocated to San Antonio, TX after Hurricane Katrina struck the Gulf Coast in August 2005.
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This report encourages building public-private partnerships between health departments and pharmacies to help distribute and dispense critical medications or vaccines during a public health emergency. It offers actionable steps for pharmacists and public health professionals to begin laying the foundation of long-lasting, mutually beneficial partnerships. It also provides information about the benefits of partnership, partnership best practices, and a checklist for building partnerships.
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This document offers eight recommendations for local health departments on collaborating with pharmacy partners for public health emergency preparedness and response. It discusses how strong relationships between local health departments and pharmacy partners can increase the safe, fast, effective, and equitable distribution of medical countermeasures during a public health emergency, and are crucial to effective public health emergency response.
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The authors describe the various roles pharmacists could have in disaster readiness and divide them into two categories: "clinical" and "other." Clinical roles would primarily be fulfilled by ambulatory care readiness pharmacists, pharmacotherapy readiness pharmacists, and critical care readiness pharmacists. The "other" category includes specialized clinical roles and nonclinical activities carried out by weapons of mass destruction/pandemic readiness pharmacists, pharmacy readiness logisticians, and pharmacist readiness managers.
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Drug Shortages
This article includes suggestions made by attendees of a September 2018 summit focused on the issue of drug shortages as a matter of national security. The non-consensus recommendations include those pertaining to policy and marketplace changes to prevent and mitigate drug shortages.
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This article details discussions held at a November 2017 roundtable on drug shortages organized by the American Society of Health-Systems Pharmacists. Topics included: the role of the Food and Drug Administration in addressing shortages; drug shortage trends and causes; compounding outsourcing facilities regulated under Section 503B of the Food, Drug, and Cosmetics Act; and recommendations for preventing and mitigating shortages.
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This fact sheet “summarizes the status of the current acute shortage of small-volume parenteral solutions and provides an outline of potential actions for organizations to consider in managing the shortage.” Included are strategies to assist physicians with conserving resources; inventory control strategies; pharmacy operational strategies; informatics strategies; and safety information.
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This factsheet supplements the Pharmacy Topic Collection and includes recent resources that provide an overview of the situation and how it can worsen during emergencies. These resources can help healthcare providers prepare for and respond to shortages and other pharmaceutical-related challenges that may arise during and after a disaster using crisis standards of care principles.
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Webinar speakers respond to questions received during "Clinicians and Coalitions: A Conversation about Finding Solutions for Medication Shortages."
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The speakers in this webinar: provided an overview of the medication shortages and their clinical impact; described coping strategies for scarce resources; and discussed the decision- making strategies states, coalitions, and healthcare facilities have used based on crisis standards of care principles.
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This guidance provides background into the scope and issues surrounding medication shortages and encourages use of a conventional, contingency, and crisis framework, which may be applied in disaster and non-disaster situations. It provides practical recommendations for hospital pharmacies and other stakeholders affected by medication shortages.
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The author describes a process to manage drug shortages in healthcare facilities including having a plan, implementing structured communications, and asking the right questions.
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This fact sheet can help healthcare planners and providers understand the acute shortage of certain large-volume intravenous solutions that occurred in 2014. It includes a list of potential actions that can be taken to conserve such solutions and manage their shortage.
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This webpage includes links to the agenda, speaker biographies, and presentation slides from a 1-day seminar held in November 2018 focused on drug shortages. Topics included: federal efforts to address drug shortages; economics of drug shortages; health impacts of drug shortages; manufacturing and supply challenges; drug purchasing and demand challenges; and strategies to reduce clinical and economic consequences of drug shortages.
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The author highlights strategies offered by hospital pharmacists for managing drug shortages. These include: working closely with pharmacy buyers to manage inventory; securing as much product as possible for each hospital within a network and then reallocating supply across hospitals as needed; using a Drug Use Policy team of pharmacists who review all of the literature and prepare pharmacy and therapeutic drug reviews to identify alternatives; triaging available supplies; and having pharmacists work closely with physicians on the floors to ensure available clinical data supports decision-making for use of alternative options.
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This document addresses the Food and Drug Administration’s plan for identifying, preventing, and mitigating drug shortages.
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This page shows the status of past and current shortages of drugs available in the United States.
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This article provides an overview of the causes of drug shortages, and the effects that they have on clinical care. The authors call drug shortages “a form of health care rationing,” and note multiple examples of medication errors that have resulted from drug shortages.
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The authors share a case study of a patient treated with a sodium acetate (SA) continuous IV infusion after the hospital ran out of sodium bicarbonate. This approach may be considered by other healthcare facilities experiencing similar shortages.
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This article describes managing critical resource shortages through an incident management system and utilizing the key stewardship components of the Institute of Medicine’s standards of care guidelines for catastrophic emergencies.
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This document summarizes a conference held in 2017 in response to a shortage of intravenous saline solution (made worse during that year's hurricane season) during which experts discussed predicting, preventing, and responding to drug shortages.
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This webpage includes links to a technical report issued in 2014, “Risk-Based Approach for Prevention and Management of Drug Shortages.” Included with the report is a template for a Drug Shortage Prevention and Response Plan.
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This interview of drug shortage staff from the Food and Drug Administration, addresses the 2014 saline shortage. It provides recommendations for substitution of normal saline with other solutions and alternatives for mixing and administering medications.
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The authors share the results of a descriptive study with the primary outcome of characterizing the impact of drug shortages on institutional cost and patient safety events among Veterans Health Administration facilities.
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The Committee shares the benefits, problems, gaps, challenges, best practices, and the ongoing efforts to strengthen the supply chain for donated product.
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These meeting proceedings highlight how the shortage of emergency care drugs relates to the longer- term national drug shortage issue.
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This webpage provides links to a video and written transcript addressing the U.S. Food and Drug Administration (FDA) Safety and Innovation Act. The Act was passed by Congress in 2012, and provides new authorities for the FDA to manage drug shortages. In the video, FDA Drug Info Rounds pharmacists discuss the management of drug shortages and how the FDA’s role has changed in recent years.
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This article reviews the causes of drug shortages, drugs most susceptible to shortages, the impacts of drug shortages, and strategies for managing drug shortages. In addition, recommendations from a drug shortage summit in November 2010 attended by representatives of pharmaceutical manufacturers, wholesalers, group-purchasing organizations, health care providers, trade groups, and the federal government, are also included.
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Education and Training
This training course addresses the changing role of pharmacists in the public health system, and their specific roles during a public health emergency response. The presenters also discuss experiences of the pharmacy community during the aftermath of Hurricane Katrina.
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This 3-hour online continuing education course reviews basic emergency preparedness information; personal and business preparedness; the legal framework for pharmacists to respond within Oregon; and specific ways pharmacists can help their communities during emergencies/disasters.
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This webpage includes links to the agenda, speaker biographies, and presentation slides from a 1-day seminar held in November 2018 focused on drug shortages. Topics included: federal efforts to address drug shortages; economics of drug shortages; health impacts of drug shortages; manufacturing and supply challenges; drug purchasing and demand challenges; and strategies to reduce clinical and economic consequences of drug shortages.
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This presentation, developed for pharmacists in Illinois, includes an overview of the potential roles pharmacists may play in emergency/disaster response; key actions to take in developing a response plan; and how pharmacists can work with public health authorities on planning and response. A Memorandum of Understanding (MOU) between pharmacists and public health agencies in Illinois is also discussed, and may be referenced by other jurisdictions for development of similar agreements.
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In this video, FDA Drug Info Rounds pharmacists discuss the importance of being prepared for emergency situations and discuss the resources that pharmacists can rely on when advising their patients about keeping medications safe during emergencies and disasters.
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This course familiarizes pharmacists and pharmacy technicians with the basic components of public health emergency preparedness and the role pharmacists play in disaster events. It addresses basic policies and directives related to public health emergencies, and reviews the federal and state resources available, with a specific look at the organizations involved in responding to a public health event in Mississippi.
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Electronic and Novel Prescribing, and Pharmacy Information Sharing
This report describes how KatrinaHealth, an online service developed to help Hurricane Katrina survivors, worked with healthcare providers to grant them access to evacuees’ records of medications (including dosages). The authors also share successes and challenges of the program and recommendations for the future.
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Emergency Prescription Assistance Program (EPAP) Resources
This fact sheet provides a summary of the EPAP data collected and analyzed following Hurricane Gustav from September 2, 2008 to October 31, 2008.
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This fact sheet provides a summary of the EPAP data collected and analyzed following Hurricane Ike from September 12, 2008 to December 15, 2008.
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The Emergency Prescription Assistance Program (EPAP) is funded by the Stafford Act and designed to help disaster survivors access prescription medicines. EPAP can also be activated by the Public Health Service Act under the authority of the National Disaster Medical System (NDMS). The program utilizes normal business operations (e.g., electronic prescription claims processing, utilization of the normal pharmaceutical supply chain for distribution and dispensing) to pay for prescription medications for eligible persons.
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This fact sheet provides a summary of the EPAP data collected and analyzed following Superstorm Sandy for New Jersey and New York through October 30, 2013.
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This fact sheet provides a summary of the EPAP data collected and analyzed following the Louisiana flooding from August 19, 2016 to September 20, 2016.
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This fact sheet provides a summary of the EPAP data collected and analyzed following Hurricanes Irma and Maria for Puerto Rico only from November 2, 2017 to May 18, 2018.
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This fact sheet provides a summary of the EPAP data collected and analyzed following Hurricanes Irma and Maria for the U.S. Virgin Islands only from November 2, 2017 to September 15, 2018.
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This document provides a summary of the EPAP data collected and analyzed for the following natural disasters in 2018: Hurricanes Irma and Maria, U.S. Virgin Islands; Hurricane Michael, Florida; Typhoon Mangkhut and Yutu, Mariana Islands; and California Wildfires.
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The purpose of the EPAP is to perform the activities related to processing claims for prescription medications, vaccines, specific medical supplies and certain durable medical equipment for designated eligible individuals in a Federally-identified disaster area. The activation of EPAP is requested through the states' department of health in their emergency management agency. The program can then provide a 30-day supply of covered drugs and medical supplies that can be renewed every 30 days for as long as EPAP is active.
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Evaluation and Studies: General
The authors conducted a literature review to characterize pharmacists' disaster preparedness and response experiences. They identified key activities that must be performed, and developed a classification scheme for pharmacy personnel “to enable pharmacy personnel working in diverse practice settings to identify and undertake essential actions that are necessary to ensure an effective emergency response.”
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The authors of this study provide the first step in an evidence-based approach to inform the planning, periodic review, and revision of repositories of chronic disease medications, which would be helpful for rapid response to public health emergencies. The article identifies the most-prescribed medication classes of drugs as a start to outpatient planning.
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The authors of this study discuss the imbalance between the high proportion of chronically ill Americans who depend on prescription medications and their lack of medication reserves for disaster preparedness. They examined barriers that Los Angeles County residents with chronic illness experience within the prescription drug procurement system to achieve recommended medication reserves.
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The objective of this study was to develop a model that can help determine supply requirements for the National Disaster Medical System, Disaster Medical Assistance Teams, or other responding disaster medical teams in a civilian environment. Results proved that the model predicted the proportion of patient complaints and, therefore, the medicine and supplies needed for the management of these patients.
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The authors conducted a study to identify the kinds of medications that might be needed during and after a disaster. They analyzed national ambulatory hospital data on the prescription medication needs of patients who visited emergency departments in non-disaster circumstances. Their findings can help pharmacies plan and stockpile medication.
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This article addresses the issues associated with the prescribing abilities of mental health providers after a disaster and the implications for acute and chronic management of behavioral health issues.
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Evaluation and Studies: Pandemic
The Institute of Medicine, with technical assistance from the Centers for Disease Control and Prevention (CDC), convened public engagement events in three demographically and geographically diverse communities to assess public perception of the alternative strategies for prescribing, distributing, and dispensing antivirals and disseminating information about influenza and its treatment. Participants at all three locations expressed high levels of acceptance for each of the proposed strategies, including pharmacists prescribing under Collaborative Practice Agreements (CPAs) with sponsoring physicians. Key findings from these sessions are discussed further in this article.
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The authors analyzed reporting data from immunization and public health preparedness programs to assess their pandemic planning with pharmacies. They found that most jurisdictions include pharmacies in their pandemic vaccine distribution plans, nearly half have a process to recruit pharmacists as vaccinators, and nearly a third have formal relationships established with pharmacies.
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Following the detection of a novel influenza strain A (H7N9), the authors modeled the use of antiviral treatment in the U.S. to mitigate severe disease across a range of hypothetical pandemic scenarios. The model included estimates of attack rate, healthcare-seeking behavior, prescription rates, and other related data. Based on these inputs, the total antiviral regimens estimated to be available in the U.S. (as of April 2013) were deemed sufficient to meet treatment needs for the scenarios considered.
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Rubin, S.E., Schulman, R.M., Roszak, A.R., et al. (2014).
Leveraging Partnerships among Community Pharmacists, Pharmacies, and Health Departments to Improve Pandemic Influenza Response.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 12(2):76-84.
This article provides recommendations on how local health departments can most effectively develop and maintain relationships with community pharmacies. It also addresses how pharmacists can help provide a more coordinated and resourceful public health response to emergencies, specifically to pandemic influenza outbreaks.
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The authors developed a model to estimate the effects of vaccine administration in retail pharmacies. They estimated that nationwide capacity to administer vaccines would increase to 25 million doses per week when retail pharmacies were included and that the time to achieve 80% nationwide vaccination coverage could be reduced by seven weeks.
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Guidelines and Protocols: General
This document provides guidance and templates for state and territorial health agencies charged with creating memoranda of understanding with pharmacies in response to influenza pandemics and other public health emergencies.
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This fact sheet is intended for Medicare patients and provides information about: how to see doctors and other providers; get prescription drugs and extended day supplies; pay Medicare premiums; and receive dialysis or chemotherapy in a disaster or emergency area. It also describes how to replace a Medicare card, or lost or damaged durable medical equipment or supplies that Medicare paid for.
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The authors present guidelines “to provide a framework for healthcare teams in patient care settings that can be used to develop policies and procedures that minimize the effects of drug shortages on quality of care.”
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This guidance document was developed for the Boards of Pharmacy to assist them with developing robust emergency and disaster plans that complement local efforts. It also includes several appendices, which contain guidance information and templates for issues such as emergency planning, maintaining operations, and communications.
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This report encourages building public-private partnerships between health departments and pharmacies to help distribute and dispense critical medications or vaccines during a public health emergency. It offers actionable steps for pharmacists and public health professionals to begin laying the foundation of long-lasting, mutually beneficial partnerships. It also provides information about the benefits of partnership, partnership best practices, and a checklist for building partnerships.
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This document offers eight recommendations for local health departments on collaborating with pharmacy partners for public health emergency preparedness and response. It discusses how strong relationships between local health departments and pharmacy partners can increase the safe, fast, effective, and equitable distribution of medical countermeasures during a public health emergency, and are crucial to effective public health emergency response.
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The authors describe the various roles pharmacists could have in disaster readiness and divide them into two categories: "clinical" and "other." Clinical roles would primarily be fulfilled by ambulatory care readiness pharmacists, pharmacotherapy readiness pharmacists, and critical care readiness pharmacists. The "other" category includes specialized clinical roles and nonclinical activities carried out by weapons of mass destruction/pandemic readiness pharmacists, pharmacy readiness logisticians, and pharmacist readiness managers.
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The authors conducted a literature review and outline best practices and recommendations regarding maintaining and sustaining a local or regional stockpile. Recommendations include timing and procedures for assessing, inventorying, storing, managing, tracking, and deploying materials stockpiled on site, in a trailer, or in a warehouse. The authors also provide an overview of alternative approaches for maintaining a local or regional cache. Healthcare facilities, coalitions, and related entities can use the findings to develop their own stockpile management protocols and policies.
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This chart details the stability of the most commonly dispensed refrigerated drug products (based on the U.S. top 200 prescription medications in 2014), and over-the-counter insulin products. The chart includes proper storage data, allowable temperature excursions and the length of time such excursions are permitted, and contact information for product manufacturers.
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Facilities that have controlled substances in supply often need increased security during a disaster to prevent theft or provide crowd control, which may not be available due to the competing response demands on security and law enforcement. DEA advises DEA registrants to reach out to law enforcement in order to check-in and provide security. Pharmacies may also partner with local law enforcement or the local DEA field office to secure controlled substances.
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The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration offers information on the use of drugs that have been potentially affected by fire, flooding or unsafe water, and the use of temperature-sensitive drug products when refrigeration is temporarily unavailable.
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This resource provides tips on checking medical devices for contamination and disposing of contaminated products in order to help pharmacies return to business as soon as possible following flooding or loss of power.
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During a disasters, studies may be disrupted, subjects and study staff dispersed, and records damaged or lost. This webpage provides information on where to direct questions related to clinical investigations affected by natural disasters.
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Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient's usual insulin. After a disaster, patients in the affected area may not have access to refrigeration. This website provides information for patients and providers regarding those issues.
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Legal/Regulatory Resources
This fact sheet discusses the mechanisms used by states to modify healthcare worker scope of practice during emergencies and analyzes the types of activities and control measures associated with modified scope of practice. It provides an example of how prescription authority was expanded to include pharmacists and EMS providers during the H1N1 epidemic.
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This Florida statute, which may be referenced by other jurisdictions to develop a similar statute, states: “In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication.” However, in areas or counties included in an emergency order or proclamation of a state of emergency declared by the Governor, the pharmacist may dispense up to a 30-day supply given certain circumstances as indicated in this statute.
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This four-page fact sheet provides information about controlled substances in emergencies and the 2017 Protecting Patient Access to Emergency Medications Act (PPAEMA). It discusses how PPAEMA applies to Emergency Medical Services (EMS) Agencies, and Pharmacists and Patients, including how a pharmacist may dispense controlled substances during emergencies upon receipt of “oral authorization from a prescribing individual practitioner.”
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This webpage highlights the process associated with and benefits of developing collaborative practice agreements between pharmacists and prescribers. Links to related resources are included.
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This webpage provides links to resources that can help emergency planners understand the mechanisms by which states authorize pharmacists’ prescriptive authority (i.e., collaborative prescribing and autonomous prescribing). It focuses on autonomous prescribing, which primarily consists of statewide protocols (“conditions under which pharmacists are authorized to prescribe a specified medication or category of medications when providing a clinical service”).
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This document may serve as a reference for other jurisdictions in the development of guidance for pharmacists asked to fill refills for disaster evacuees from other states.
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This article addresses the issues associated with the prescribing abilities of mental health providers after a disaster and the implications for acute and chronic management of behavioral health issues.
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This document describes the federal regulations standards opioid treatment programs must adhere to (e.g., “have current valid accreditation status, SAMHSA certification, and Drug Enforcement Administration registration prior to administering or dispensing opioid drugs for the treatment of opioid addiction”).
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This process allows physicians and other medical professionals to dispense or prescribe medications that are traditionally administered in the context of an opioid treatment program.
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This document describes the law, and rules/protocol that allowed pharmacists in Texas to dispense 30-day emergency supplies of medications (other than controlled substances) following Hurricane Harvey in 2017.
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This webpage includes links to new and renewal applications and registration tools and resources for various pharmacies and providers (e.g., retail pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners).
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The Controlled Substances Act passed in 1970 directs DEA in the development of rules and regulations that must be followed when prescribing, dispensing, administering, transporting, and storing controlled substances.
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This webpage provides links to a video and written transcript addressing the U.S. Food and Drug Administration (FDA) Safety and Innovation Act. The Act was passed by Congress in 2012, and provides new authorities for the FDA to manage drug shortages. In the video, FDA Drug Info Rounds pharmacists discuss the management of drug shortages and how the FDA’s role has changed in recent years.
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This guidance describes how reporting of drug sample known thefts and possible/known diversion remain subject to the investigative, reporting, and timeframe requirements of federal regulations.
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This Act allows individual practitioners to administer narcotic controlled substances in schedules III – V for the purpose of narcotic addiction treatment, outside of an opioid treatment practice. Qualifying physicians may treat up to thirty or one hundred patients, as determined by their individual authorization from the Center for Substance Abuse Treatment (CSAT).
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This Act authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the prescription opioid abuse and heroin use crisis, and for other purposes. It also extends buprenorphine waiver privileges to qualifying nurse practitioners and physician assistants until October 1, 2021.
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Part of this Act allows emergency medical services agencies to receive DEA registration in order to administer controlled substances (II-IV) “outside the physical presence of a medical director or authorizing medical professional.”
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While state-specific, this example of codified law shows how the state board of pharmacy may issue a waiver during declared emergencies waiving certain requirements of the Drug Control Act and the Board’s regulations governing the practice of pharmacy. The law also explicitly states that it does not authorize the “administering or dispensing of controlled substances by persons whose scope of practice does not include such authority.”
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Lessons Learned
This report summarizes a 2016 meeting focused on building partnerships between pharmacy professionals and public health to support pandemic influenza preparedness and response. Included are lessons learned from several states that piloted the Memorandum of Understanding (MOU) prior to the meeting. The final toolkit appears in this Topic Collection under Plans, Tools, and Templates.
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This article highlights lessons learned by pharmacists and pharmacy technicians after the Pulse nightclub shooting. Links to related resources are provided throughout.
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This article reviews steps pharmacists can take to support their patients during a natural disaster, as well as key elements of business continuity that should be considered. Lessons learned from Texas-based pharmacists during Hurricane Harvey are also discussed.
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The authors advocate for the inclusion of pharmacists into post-disaster patient care teams, noting that pharmacists can provide care without an appointment; have been shown to be able to successfully manage chronic disease patients in the community; and can use their knowledge of alternative therapies to help facilitate patient care in resource-limited settings. Some specific experiences of pharmacists in North Carolina after Hurricane Matthew are shared.
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The authors of this article discuss the how Jefferson County (AL) Department of Health worked with a local school of pharmacy to develop a novel pharmacy plan to address gaps in service for evacuees after Hurricane Katrina. This plan may serve as a model for other municipalities and/or states interested in preparing a pharmacy response to future natural disasters.
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The authors note the strides that have been made in providers’ ability to manage patients with chronic disease during and after disasters, and describe challenges experienced during the 2017 hurricanes in Texas, Florida, and Puerto Rico to illustrate the need for enhanced preparedness to meet “noncommunicable disease essential needs.” Recommendations for reducing demand among individuals with chronic disease (e.g., improved availability of health information sharing and personal preparedness), as well as increasing system capacity (e.g., better access to pharmaceuticals and durable medical goods, and more special needs shelters), are offered.
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The authors examined associations between patient characteristics, chief complaints, final diagnoses, and medications prescribed at a post-Katrina clinic to better inform strategic planning for post-disaster healthcare delivery (e.g., charitable donations of medications and medical supplies). Results of the study indicated donations of certain classes of medications were more useful than others.
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The authors of this study assess the relationship between actual medication demands and medical relief pharmaceutical supplies in a population of 18,000 evacuees relocated to San Antonio, TX after Hurricane Katrina struck the Gulf Coast in August 2005.
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The author of this article (and webcast) discusses the medical issues that some Superstorm Sandy survivors experienced after the storm. The storm caused many pharmacies to close, kept home healthcare aides from getting to their patients, and flooded many of the clinics people rely on. The article also describes one doctor’s mission to get medicine to people who did not have access to their doctors or could not get out of their homes.
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The authors analyzed retail pharmacy data from June-August 2017 to project what medications would be needed in Puerto Rico following Hurricane Maria. They found that the top categories of drugs prescribed were for cardiovascular (average = 21% of prescriptions filled), psychiatric (12%), and analgesic (10%) drugs. They note that their analysis could be improved by the inclusion of drug sales data to hospitals, clinics, and nursing homes, as well as information provided by third-party claims adjudication data.
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This case study describes the collaboration between the Palm Beach County (FL) Health Department and the medical and hospital community, responding partners, and community pharmacies that facilitated a mass influenza vaccination campaign during the H1N1 influenza outbreak in 2009. The partnership enabled information and vaccines to flow from the health department to hundreds of area supermarkets and community pharmacies and their in-store health clinics, ensuring the public had access to credible and timely influenza information.
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The authors examine the "Return to Open Pharmacy Operations" in Puerto Rico after Hurricane Maria and compare it to pharmacy recovery in Florida after Hurricane Irma.
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In this article, the CEO of a pharmacy with locations across Texas shares lessons learned from his organization’s experience during Hurricane Harvey. Key lessons learned include: contacting patients in advance of a storm and ensuring that they have sufficient supplies of medications to last more than just a few days; tracking down patients after a storm using social media; using courier services to send medications to patients who cannot get to the stores; and using a wholesaler with robust back-up power and monitoring capabilities to store temperature-controlled medications.
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The author of this essay describes how she, as a pharmacy faculty member in a family medicine residency, helped with relief efforts in Hoboken, NJ after Hurricane Sandy. She recounts her experiences with managing the medication needs of community residents in the hurricane’s aftermath and some of the challenges figuring out what medications seniors were taking.
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The authors of this study surveyed healthcare providers (e.g., traditional vaccine providers, pharmacists, and healthcare providers in correctional facilities) in Washington State to examine: differences in experiences administering H1N1 vaccine during a public health emergency, participation in preparedness activities, and communication with public health agencies. Pharmacists reported higher patient volumes and higher patient-to-practitioner ratios, and said that they rely on federal sources for public health information (versus local health departments). Pharmacists were also less likely to have participated in training, actual emergency response, or surge capacity initiatives.
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The authors (from a tertiary academic medical center) discuss the pharmaceutical response to the Boston Marathon bombing, which focused on staffing, supplies, and communication.
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In July 2006, a flash flood affected more than 3,000 households in southwest Japan. The authors conducted a study to describe the prevalence of the interruption of medication among the outpatients in the flood-affected area and to determine associated risk and preventive factors. They found that among the evacuated, the elderly and those receiving long-term care services were at high risk for interruption of medication. They also discovered that “preparing to go out with medication” had a preventive effect.
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Pharmacist’s/Pharmacies’ Role in Response
The objective of this article is to provide healthcare system pharmacy leaders with a practical approach in developing an emergency operations plan (EOP) that can be activated and help meet patient-centered needs in the event of a disaster. The authors address how pharmacy leaders should: 1) review government and community disaster responses and understand the movement of drug supply for each response; 2) create a pharmacy disaster plan; 3) list the essential medications and determine their inventory levels; and 4) establish a staff training program to enhance understanding and implementation of the EOP.
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In this article, a pharmacist describes how his experience during Hurricane Andrew in 1992 inspired him to get involved with emergency preparedness and response within his community. Considerations for ensuring pharmacy preparedness for disasters are also discussed, including security of the facility and the need to maintain temperature control to avoid financial and time losses.
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This guidance document was developed for the Boards of Pharmacy to assist them with developing robust emergency and disaster plans that complement local efforts. It also includes several appendices, which contain guidance information and templates for issues such as emergency planning, maintaining operations, and communications.
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Pharmacy Emergency Preparedness
This guidance provides background into the scope and issues surrounding medication shortages and encourages use of a conventional, contingency, and crisis framework, which may be applied in disaster and non-disaster situations. It provides practical recommendations for hospital pharmacies and other stakeholders affected by medication shortages.
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This document provides guidance and templates for state and territorial health agencies charged with creating memoranda of understanding with pharmacies in response to influenza pandemics and other public health emergencies.
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This brief article provides guidance for hospital pharmacists to help facilities prepare for emergencies. Pharmacists are encouraged to learn how to work within the Incident Command System; be part of the Emergency Management Committee; and prepare in advance by knowing what to order, in what quantities to order medications, and how extra medications will be stored.
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These slides are from a presentation on the potential emergency response roles of pharmacists in public health emergencies and mass casualty incidents, medications needed during such events, and steps that should be taken to prepare for such events. Though it includes some New Mexico-specific information, much of the content is generalizable to other hospital pharmacy departments.
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This issue highlights new/existing challenges pharmacy stakeholders face during emergencies; shares a "high-level landscape" of collaborations and resources that have been created to safeguard access to medications and medical supplies during emergencies; and features practices that can increase healthcare resilience. Links to helpful toolkits and templates are provided throughout the document.
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Plans, Tools, and Templates
This calculator allows hospitals to estimate whether they have adequate supplies of medications for a disaster in stock. The user inputs facility details and based on the medication category and type, the calculator compares the amount of medications available to an estimate of those needed for 48 hours per patient and determines whether the hospital has a surplus or deficit in specific categories. The password required to work with the tool is "password1." (For a 508 compliant version of this tool, copy and paste this link into your browser: https://files.asprtracie.hhs.gov/documents/aspr-tracie-hospital-disaster-pharmacy-calculator-pdf.pdf)
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This resource addresses legal issues, including the legal barriers faced by state and territorial health departments, pharmacists, and physicians that continue to hinder the expansion and inclusion of pharmacist vaccinators during routine and pandemic influenza seasons.
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This document provides guidance and templates for state and territorial health agencies charged with creating memoranda of understanding with pharmacies in response to influenza pandemics and other public health emergencies.
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The authors synthesized comments from a series of expert panel meetings on identifying innovative strategies hospitals could adopt to address terrorism-related surge issues. Surge Action Template 9 (Drugs and Pharmaceutical Supplies) addresses required resources and action steps to mobilize within 4 hours of an explosion “appropriate and adequate drugs and pharmaceutical supplies to treat 300 injured patients for up to 72 hours.”
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Prescription Drug Monitoring Programs (PDMPs) offer a potential resource for prescribers and pharmacists to view patients’ controlled substance prescription dispensing histories in near-real time, post-disaster. The PDMP is a statewide electronic database – updated in real time – that collects and stores data on controlled substances dispensed within the state and allows certified providers to view the electronic prescriptions of controlled substances in their state.
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This post provides quick tips and recommendations on how individuals can manage preparations for chronic medications when planning for severe weather emergencies.
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This issue highlights new/existing challenges pharmacy stakeholders face during emergencies; shares a "high-level landscape" of collaborations and resources that have been created to safeguard access to medications and medical supplies during emergencies; and features practices that can increase healthcare resilience. Links to helpful toolkits and templates are provided throughout the document.
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This online tool can be used by the general public and enables users to print a personalized medication wallet card that documents prescriptions, dosages, and other important medical information. These cards can help people access their medical records or refill prescriptions after a disaster or public health emergency.
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Healthcare Ready (formerly Rx Response). (2019).
Rx Open.
This website helps emergency management teams and the general public locate operating pharmacies in areas affected by natural disasters or public health emergencies. The tool provides maps to identify the location of open and closed pharmacies using Google Maps. The website is free to the public when activated at the request of state or federal officials.
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This webpage includes preparedness steps to be taken to protect pharmacy assets during a disaster and ensure that operations may begin again as soon as possible after an incident. The legal/regulatory guidance referenced is primarily for the State of Florida, but could be useful in prompting pharmacists in other locations to think about such issues when developing their plans.
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This webpage highlights the process associated with and benefits of developing collaborative practice agreements between pharmacists and prescribers. Links to related resources are included.
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This guidance document was developed for the Boards of Pharmacy to assist them with developing robust emergency and disaster plans that complement local efforts. It also includes several appendices, which contain guidance information and templates for issues such as emergency planning, maintaining operations, and communications.
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This webpage includes links to state boards of pharmacy. These boards may issue waivers that are activated after an emergency declaration has been made. These may include blanket waivers allowing pharmacists to refill a prescription without the original prescription, assuming the pharmacist exercises reasonable judgment. These waivers do not override federal regulations, including those of the DEA.
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This webpage includes links to an outreach toolkit, operational guidance, and Memorandum of Understanding (MOU) template for use by local public health departments to enter into agreements with pharmacies under a “framework for timely, effective pharmacy response to public health incidents.”
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This webpage includes links to a technical report issued in 2014, “Risk-Based Approach for Prevention and Management of Drug Shortages.” Included with the report is a template for a Drug Shortage Prevention and Response Plan.
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This Memorandum of Agreement (MOA) was created for the Pennsylvania Department of Health to enter into agreements with pharmacies to coordinate influenza vaccine distribution during a public health emergency. It may be used as a reference for other jurisdictions wishing to create similar MOAs.
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This chart details the stability of the most commonly dispensed refrigerated drug products (based on the U.S. top 200 prescription medications in 2014), and over-the-counter insulin products. The chart includes proper storage data, allowable temperature excursions and the length of time such excursions are permitted, and contact information for product manufacturers.
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This glossary can help pharmacy technicians and other healthcare workers become more familiar with terminology and prescription abbreviations.
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The author of this editorial discusses the importance of assuring access to essential medications for chronic disease management during disasters. Included in the commentary is a table showing potential disaster-related medication access problems, showing risks of medication withdrawal by condition.
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This webpage includes contact information for requesting DEA assistance in the aftermath of a disaster and links to state board assistance information for recent events.
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Yale New Haven Health System, Center for Emergency Preparedness and Disaster Response. (n.d.).
Pre-Storm Checklist.
This checklist provides hospital emergency planners with guidance on preparing to withstand the effects of a storm. Actions to be taken 72 hours, 48 hours, and 24 hours prior to the storm is included for the following departments: Administrative, Clinical Laboratory, Clinical Services, Facilities, Food and Nutrition, IT/MIS, Pharmacy, Materials Management, Respiratory Care, and Safety and Security.
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Agencies and Organizations
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This website provides information about current and previous (resolved) drug shortages, discontinued drugs and preparations not commercially available. An API allows the feed to be embedded on your own website.
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This webpage includes links to state boards of pharmacy. These boards may issue waivers that are activated after an emergency declaration has been made. These may include blanket waivers allowing pharmacists to refill a prescription without the original prescription, assuming the pharmacist exercises reasonable judgment. These waivers do not override federal regulations, including those of the DEA.
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