Management Of Drug Shortages Research Articles

Impact of anti-cancer drugs shortages in oncology and hematology departments in a Moroccan hospital

Drug shortages have been a growing global problem in recent years. Some of them are of vital necessity and importance for the patient, such as those used to treat pathologies in clinical hematology and oncology departments. The objectives of this study are to determine the impact of anti-cancer drugs shortages on both: treatment and patient in the hematology and oncology departments, to describe the actions that have been put in place to manage the shortages and to survey patients about their perspectives and experiences. It was a prospective, observational study, it took place in the oncology and hematology departments. It was carried out with the help of an operating sheet, which contained two parts: patient and treatment data. This sheet was filled out after the interview with the patient and on the basis of the medical file. Of the 101 patients interviewed, 67.3% were impacted by the shortage of drugs. The treated pathology that was most impacted by the rupture was Non-Hodgkin lymphoma (55.8%), vincristine was the drug most responsible for the shortages (34%). Most patients (51.4%) went to a non-local pharmacy to buy the medicine that was in short supply in the hospital. Delayed care was the main impact of the drug shortage (42.6%). As a result of these shortages, the majority of patients (45.6%) were frustrated and anxious about the situation. Drug shortages have a profound impact on patient safety, clinical outcomes, quality of treatment, hospital management and other important factors. In-depth collaboration between different health actors and timely communication strategies are essential elements of an effective drug shortage management plan.

Development and validation of a predictive model to predict and manage drug shortages.

Pharmacy departments across the country are problem-solving the growing issue of drug shortages. We aim to change the drug shortage management strategy from a reactive process to a more proactive approach using predictive data analytics. By doing so, we can drive our decision-making to more efficiently manage drug shortages. Internal purchasing, formulary, and drug shortage data were reviewed to identify drugs subject to a high shortage risk ("shortage drugs") or not subject to a high shortage risk ("nonshortage drugs"). Potential candidate predictors of drug shortage risk were collected from previous literature. The dataset was trained and tested using 2 methods, including k-fold cross-validation and a 70/30 partition into a training dataset and a testing dataset, respectively. A total of 1,517 shortage and nonshortage drugs were included. The following candidate predictors were used to build the dataset: dosage form, therapeutic class, controlled substance schedule (Schedule II or Schedules III-V), orphan drug status, generic versus branded status, and number of manufacturers. Predictors that positively predicted shortages included classification of drugs as intravenous-only, both oral and intravenous, antimicrobials, analgesics, electrolytes, anesthetics, and cardiovascular agents. Predictors that negatively predicted a shortage included classification as an oral-only agent, branded-only agent, antipsychotic, Schedule II agent, or orphan drug, as well as the total number of manufacturers. The calculated sensitivity was 0.71; the specificity, 0.93; the accuracy, 0.87; and the C statistic, 0.93. The study demonstrated the use of predictive analytics to create a drug shortage model using drug characteristics and manufacturing variables.

An application of multi-criteria decision-making approach to sustainable drug shortages management: evidence from a developing country

BackgroundDrug shortage is a significant public health problem, especially for drugs related to life threatening conditions. Almost all countries affected by variety of supply problems and spent a considerable amount of time and resources responding to shortage. The aim of present study is to determine and prioritize strategies to achieve best solutions for these considerable healthcare system challenges and to evaluate this strategies base on practical criteria.MethodsTo achieve the study objectives, the research was conducted in two phases. Determining of the strategies to control drug shortage, and comprehensive assessments of priority of possible strategies. For each phase, a self-design questionnaire was developed. The five main managerial strategies dimensions including: regulatory, financial, supply chain, information system and policy-making were set out. Forty-five alternatives were elicited from literature, and were evaluated and trimmed to 37 strategies based on experts’ opinion. The Multiple criteria decision-making (MCDM) methods were applied in second phase. Five important criteria including cost, time, labor, compliance with law and culture were weighed by Analytic Hierarchy Process (AHP) technique. Then, 37 alternatives have been rated base on the five criteria on the Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) technique.Results“Creating integrated Supply chain information system to manage medicines inventory in the country”, “Creating and using the databases to predict the shortage of medicines”, “Using track and trace system” are alternatives 20th, 24th and 25th, which related to supply chain (SC) and information system (IS) dimensions have higher priority in the experts’ point of view. The results show IS dimension has 100 percentage of priority; following that policy and supply chain have higher priority, respectively.ConclusionHealth systems rely on consistent supplying of pharmaceuticals to support patient care. The results show that information system, policy-making and supply chain are in the top-ranking priorities. Warning system needs to be improved to the advance system via better collaboration with stakeholders, publish precise and explicit national guidelines for drug shortage management, enforce the guidelines, and improve Iran FDA’s pharmaceutical market control capability.

Analysis on the Current Situation of Classified Management of Drug Shortages: Case China

Analysis on the Current Situation of Classified Management of Drug Shortages: Case China

Management of a parenteral opioid shortage using ASHP guidelines.

PurposeManagement of an acute shortage of parenteral opioid products at a large hospital through prescribing interventions and other guideline-recommended actions is described.SummaryIn early 2018, many hospitals were faced with a shortage of parenteral opioids that was predicted to last an entire year. The American Society of Health-System Pharmacists (ASHP) has published guidelines on managing drug product shortages. This article describes the application of these guidelines to manage the parenteral opioid shortage and the impact on opioid dispensing that occurred in 2018. Our approach paralleled that recommended in the ASHP guidelines. Daily dispensing reports generated from automated dispensing cabinets and from the electronic health record were used to capture dispenses of opioid medications. Opioid prescribing and utilization data were converted to morphine milligram equivalents (MME) to allow clinical leaders and hospital administrators to quickly evaluate opioid inventories and consumption. Action steps included utilization of substitute opioid therapies and conversion of opioid patient-controlled analgesia (PCA) and opioid infusions to intravenous bolus dose administration. Parenteral opioid supplies were successfully rationed so that surgical and elective procedures were not canceled or delayed. During the shortage, opioid dispensing decreased in the inpatient care areas from approximately 2.0 million MME to 1.4 million MME and in the operating rooms from 0.56 MME to 0.29 million MME. The combination of electronic health record alerts, increased utilization of intravenous acetaminophen and liposomal bupivacaine, and pharmacist interventions resulted in a 67% decline in PCA use and a 65% decline in opioid infusions.ConclusionA multidisciplinary response is necessary for effective management of drug shortages through implementation of strategies and practices for notifying clinicians of shortages and identifying optimal alternative therapies.

CTSA pharmacies: Contribution to research and public health during the COVID-19 pandemic.

In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators. The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken. Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines. The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.

Overview of the causes and management of drug shortages in the United States and in Hungary

Drug shortages are a multifactorial international concern that is increasingly reported all over the world. A continuously rising number of cases could be observed since 2001, but the issue is particularly significant since 2009. In Hungary, the same increasing tendency was observed; while in 2012 464 shortages occurred, in 2020 1466 cases were reported. According to the Food and Drug Administration, there are three root causes behind the shortages, but several factors can be derived from them. This paper aims at conducting a comprehensive review of literature, exploring these factors in detail and thereby explaining how each of these factors contributes to shortages. Furthermore, it will illustrate how the lack of sufficient information due to an imperfect warning system also contributes to the issue. As the problem affects every stakeholder in the supply chain from patients to Marketing Authorisation Holders, each party should be involved in the development and implementation of mitigating strategies that can provide the basis of policy measures. The article highlights how international trends both in terms of affected therapeutic areas and causes of shortages are reflected in the Hungarian markets; therefore similar approaches could be adapted to tackle the issue domestically and deliver enduring solutions.

How do community pharmacies in Ontario manage drug shortage problems? Results of an exploratory qualitative study.

Pharmacists report spending a considerable amount of time dealing with drug shortages. There is no research in Canada identifying and describing the strategies and resources that pharmacists use to minimize disruption and continuity of care for patients. An exploratory qualitative methodology was used. Community pharmacists and technicians in Ontario were interviewed using a semi-structured protocol. Verbatim transcripts were generated and coded by at least 2 independent reviewers using content analysis methods to identify management strategies. A total of 14 pharmacists and 7 regulated pharmacy technicians participated in this study. The following 5 main strategies for managing drug shortages were identified: (1) using the supplier, (2) generic options, (3) brand options, (4) contacting other pharmacies and (5) switching to a different medication. The strategies identified through this research can provide pharmacists with some guidance in approaching the real-world problem of drug shortages. It also highlights opportunities for organizations, government and manufacturers to provide additional support for pharmacists to minimize disruptions for patients and to ensure current ad hoc practices do not further compound shortage issues. Can Pharm J (Ott) 2020;153:xx-xx.

Rethinking the Drug Distribution and Medication Management Model: How a New York City Hospital Pharmacy Department Responded to COVID-19.

Beginning in March 2020, New York City began the fight against coronavirus disease 2019. Health care workers were faced with a disease that led to significant morbidity and mortality with no proven therapies. As hospitals became inundated with patients and underwent rapid expansion of capacity, resources such as drugs, protective and medical equipment, and hospital staff became limited. Pharmacists played a critical role in the management of clinical care and drug delivery during the pandemic. As members of the department of pharmacy within NewYork‐Presbyterian Hospital, we describe our experiences and processes to overcome challenges faced during the pandemic. Strict inventory management through the use of daily usage reports, frequent communication, and minimization of waste was critical for the management of drug shortages. The creation of guidelines, protocols, and restrictions were not only used to mitigate drug shortages, but also helped educate health care providers and guided medication use. Managing technology through setting up new automatic dispensing cabinets to address hospital expansions and modifying the electronic order entry system to include new protocols and drug shortage information were also vital. Additional key pharmacist functions included provision of investigational drug service support and training of pharmacists, prescribers, nurses, and respiratory therapists to educate and standardize medication use. Through implementation of operational and clinical processes, pharmacists managed critical drug inventory and guided patient treatment. As the pandemic continues, pharmacists will remain vital members of the multidisciplinary team dedicated to the fight against the virus.

Redistribution of short-dated emergency medications as a cost avoidance and drug shortage management strategy.

This study aimed to develop a process to reduce waste through redistribution of short-dated medications in emergency drug boxes and assess associated cost avoidance. Short-dated medication items (defined as those expiring within 4 months) from more than 200 emergency drug boxes located throughout a large academic medical center were collected, sorted, and counted during two 3-month time periods. Medications expiring within 2 weeks were discarded. Remaining short-dated medications were redistributed to satellite pharmacies and the emergency department based on historical utilization patterns. The counts and costs of redistributed medications were collected and totaled. Results were compared between study periods to assess differences in numbers of drugs redistributed and the associated cost avoidance. A total of 4,415 short-dated medication items were collected during the study periods. The medication items associated with the highest cost avoidance were epinephrine 1 mg/mL, 30-mL vial (cost avoidance of $25,764), phenylephrine 10 mg/mL, 1-mL vial (cost avoidance of $8,626), and naloxone 0.4 mg/mL, 1-mL vial (cost avoidance of $5,382). The estimated total annualized cost avoidance was $104,357 for the first period and $144,674 for the second period. Of the 16 unique medications stocked in emergency drug boxes, 12 were in short supply at the institution at the time of the project, and about 67% of the redistributed items were subject to national drug shortages. A process that facilitates appropriate redistribution of short-dated emergency drug box medications can reduce medication waste and lead to substantial cost avoidance.

Preparedness of pharmacists to respond to the emergency of the COVID-19 pandemic in Brazil: a comprehensive overview

The outbreak of COVID-19 in low- and middle-income countries is worrisome due to the social inequalities in these countries, their limited health budgets and the significant burden of other acute and chronic diseases. The leap in the number of cases in Brazil has imposed a huge strain on the healthcare system. We sought to provide a comprehensive overview of the challenges encountered by pharmacy services in responding to the COVID-19 pandemic emergency in Brazil and discuss the role of clinical pharmacists in this context. Pharmaceutical services play a key role in the emergency response to the pandemic. The pharmacy workforce has been actively working to manage drug shortages, redesign workflow, and review drug formularies/protocols to improve safety for patients and healthcare professionals (HCPs). COVID-19 patients may present high risk in the use of medications and clinical pharmacists can contribute substantially as part of a multidisciplinary team to improve outcomes in drug therapy in severe and critical illness. The participation of pharmacists as members of antimicrobial stewardship programs should be enhanced to ensure appropriate and safe use of antibiotics in this context. HCPs should be encouraged to seek improvements in the performance of pharmaceutical services and innovative practices to respond to the pandemic. Further studies are needed to generate knowledge on COVID-19 to improve patient care in vulnerable populations.

Dynamic pharmacy leadership during the COVID-19 crisis: Optimizing patient care through formulary and drug shortage management

DisclaimerIn an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeThe coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for health systems around the world. We describe our approach to adapting the pharmacy leadership structure to address critical medication shortages through innovative data analysis, procurement strategies, and rapid implementation of medication policy.SummaryYale New Haven Health deployed a system incident management command structure to effectively respond to the COVID-19 crisis. System pharmacy services adopted a similar framework to enable efficient communication and quick decision-making in key domains, including drug procurement and policy. By refining a model to project health-system medication needs, we were able to anticipate challenges and devise alternative treatment algorithms. By leveraging big data and creating a system knowledge base, we were able to consolidate reporting and coordinate efforts to ensure system success. Various procurement strategies were employed to ensure adequate supply, including frequent communication with our wholesaler, sourcing direct from suppliers, outsourcing of sterile products compounding to registered 503B outsourcing facilities, and acquisition of active pharmaceutical ingredients for compounding of essential medications. Strategic positioning of pharmacists within the health system’s incident command response teams and rapid adaption of drug use policy governance fueled accelerated response and nimble implementation. Communication was streamlined and executed via multiple outlets to reach a broad audience across the health system.ConclusionWith medication shortages posing a threat to patient care, dynamic pharmacy leadership proved essential to providing patient care at the height of the COVID-19 pandemic. System alignment and the rapid adaption of the existing framework for drug shortage management and medication use policy were crucial to success in crisis response.

Guidance for the management of adult patients with coronavirus disease 2019.

In December 2019, a novel coronavirus was identified in Wuhan City, Hubei Province, China and later the disease was named coronavirus disease 2019 (COVID-19). On March 11, 2020, the World Health Organization (WHO) officially announced that COVID-19 had reached global pandemic status. This article summarized the understanding of the etiology, pathogenesis, epidemiology, clinical characteristics, diagnosis, treatment, rehabilitation, and prevention and control measures of COVID-19 based on the available data and anti-epidemic experience in China.

The Role of Pharmacists in the Fight Against COVID-19

COVID-19 is a respiratory infection caused by SARSCoV-2, a newly identified coronavirus. The disease has quickly spread throughout the world and was declared a pandemic. Older people and those with comorbid conditions carry the highest burden of morbidity and mortality associated with COVID-19. As the most accessible health care professionals, community and ambulatory care pharmacists are well positioned to respond to this public health crisis by testing eligible patients–recently allowed by federal regulation–counseling them on treatment options for symptomatic relief, reinforcing prevention measures, and managing drug shortages. Hospital pharmacists also play an important role by assisting prescribers in selecting the best treatment regimens for patients, evaluating and securing investigational agents, developing criteria for drug use, mitigating drug shortages, and preserving personal protective equipment. In addition, long-term care pharmacists are instrumental in optimizing medication management and developing policies to reduce the risk of COVID-19 transmission among vulnerable residents.

The Role of Pharmacists in the Fight Against COVID-19.

COVID-19 is a respiratory infection caused by SARSCoV-2, a newly identified coronavirus. The disease has quickly spread throughout the world and was declared a pandemic. Older people and those with comorbid conditions carry the highest burden of morbidity and mortality associated with COVID-19. As the most accessible health care professionals, community and ambulatory care pharmacists are well positioned to respond to this public health crisis by testing eligible patients–recently allowed by federal regulation–counseling them on treatment options for symptomatic relief, reinforcing prevention measures, and managing drug shortages. Hospital pharmacists also play an important role by assisting prescribers in selecting the best treatment regimens for patients, evaluating and securing investigational agents, developing criteria for drug use, mitigating drug shortages, and preserving personal protective equipment. In addition, long-term care pharmacists are instrumental in optimizing medication management and developing policies to reduce the risk of COVID-19 transmission among vulnerable residents.

Role of Canadian pharmacists in managing drug shortage concerns amid the COVID-19 pandemic.

Role of Canadian pharmacists in managing drug shortage concerns amid the COVID-19 pandemic.

AN OVERVIEW OF DRUG INFORMATION CENTER – FUNCTIONS AND CHALLENGES IN INDIA

Drug information has been providing data on drugs that are being used in the health-care system. It also bears dosing, adverse drug reactions (ADRs), side effects, pharmacokinetic parameters and educating the health-care professionals and managing drug shortage, identifying alternative treatments, and developing alternative protocols for restrictive use. The Moto of drug information is to contribute genuine, precise, appropriate, impartial drug information to the patients, nursing staff, practicing physician, pharmacist, and other health-care professional. Drug information regularly responds to inquiries from patients, health-care professionals. The drug information center routinely receives queries from hospital staff, patients, and responds to queries regarding ADRs, drug interactions, pharmacokinetic parameters of drugs, and information on new drugs available in the market. Drug information services help in improving patient safety, minimizing drug-related issues to the patient, and rational use of drugs by both physician and patient. Drug information services are providing unambiguous data with a well-trained and registered clinical pharmacist. Most of the developed countries are using this service successfully. In well-developed countries, these centers provide accurate and up to date drug information to health-care professionals within minutes. However, developing countries like India need to pay more attention to the services. Information present in this paper not only enlightens the drug information services but also on the future aspects that need to be taken.

Combating drug shortages in China: surveillance warning and practice standardization.

Like other countries, China has been experiencing drug shortages during the past years, including drugs on the National Essential Medicine List and emergency drugs. Drug shortages have raised public concerns in China and have severe impacts on all stakeholders in the supply chain, especially patients and hospitals. Recently, Chinese governments have ramped up several measures to ensure a steady supply of essential and first-aid drugs. In this commentary, we share our experiences of addressing drug shortages at Hunan Province, central China. We focus on the establishment of a provincial drug shortage monitoring center, and the Center's efforts to standardize practices on the management of drug shortages and identify therapeutic alternatives for drugs in short supply based on international best practices.

USP General Chapter and Its Impact on Nursing Practice.

The Infusion Nurses Society (INS) and the Journal of Infusion Nursing (JIN) editors are pleased to debut Pharmacology Report, a recurring bimonthly column authored by Susan Kleppin, RPh, FASHP. Susan is an accomplished pharmacist in health-system pharmacy with significant experience in infusion therapy. Her column will discuss relevant pharmacology topics, including medications new to market, safe handling for hazardous drugs, and managing drug shortages. INS and JIN extend Susan a warm welcome.

PNS188 ECONOMIC DRUG SHORTAGE MANAGEMENT BURDEN AS MODELLED FOR AN ACUTE-CARE HOSPITAL SYSTEM.

Drug shortages across the US are associated with substantial economic burden to hospital health systems, estimated at $200M annually nationwide. This study assessed the potential economic burden associated with central inpatient pharmacy drug shortage management for an acute-care hospital system. A comprehensive search of PubMed was conducted from 2008-2018 for studies investigating economic or workflow-based outcomes of drug shortages from the perspective of an acute hospital pharmacy setting. A dynamic model was created using data from literature to quantify hours spent per task associated with a shortage, inventory costs associated with shortages, and potential safety impact over 1 year from the health-system pharmacy perspective. Using evidence from literature and ASHP guidelines, 9 discrete management steps related to drug shortages were defined. Drug shortages were weighted by severity and defined both by availability and equivalency of therapeutic alternatives in the market. The model summarized the initial management period of a shortage and subsequent organizational changes with any restrictions necessary during the shortage period through its resolution. Accounting for labor and workflow involved with 50 drug shortages, the total cost associated with shortage management was $708,300. The total number of hours spent with shortage management for a pharmacist were 10,125 and for a technician, 6,300. The analysis estimated the greatest amount of labor was dedicated to reconfiguration of automated dispensing cabinets (ADCs) initially during the shortage, as well as, returning to baseline after shortage resolution, with a total of 3,000 pharmacist hours dedicated to this task. This analysis estimated the least amount of time was spent updating EMR systems due to the shortages, using 375 pharmacist hours total. This modelling framework provided a quantification of economic burden associated with drug shortages for a health systems pharmacy and its impacts on pharmacy workflow and patient safety.