The Drug Shortage Era: A Scoping Review of the Literature 2001–2019

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.

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“…It would be cost-effective to measure such impact severity using the same method in all member states at the same time [73].…”

Section: Future Perspectives and Possible Solutionsmentioning

confidence: 99%

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

Turbucz

Hankó

2020

APH

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“…According to the US FDA, medication shortages are defined as a "period when the command or projected demand for the drug is more than the supply of the drug" [1][2][3][4]. The American Society of Health-System Pharmacists (ASHP) defines shortage as "A supply issue that affects how pharmacies formulate and distribute a drugs or that impacts patient care when prescribers necessary to find an alternative treatment because of supply issues" [5].…”

Section: Introductionmentioning

confidence: 99%

A Ripple Effect of Covid-19 Pandemic on Shortage of Medicinal Products and Its Impact on Patient Care

et al. 2021

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Objective: Shortages of medicinal products are complex global problems. Drug shortages remain a significant public health issue. Global shortages of medical products have a potential effect on patient health and total healthcare costs. Countries worldwide, especially those affected by Coronavirus disease 2019 (COVID-19), is experiencing a rapid increase in drug shortage, which causes several complications for physicians, health care provider, patients, health institutes and health regulatory bodies. Methods: To carry out the study of shortages, several efforts have been taken by the regulators and industries. Prominent amongst these include FDA's research the needs and the reforms made in the regulations about shortages. We also searched for electronic databases (PubMed, Science direct, Web of Science) using the terms (COVID-19 and shortage) or (medicine and COVID-19) for articles in periods of 2019 to 2021. Results: On assessment based on the report, the number of shortage drugs in 2020 is 835; Anesthesia drugs are highest during the COVID-19 outbreak data indicate the number of shortages is 143 in USA. It was found that generic products were mostly in short supply, with antimicrobial agents (63%) topping the list of therapeutic categories of medicines with interrupted supply, followed by oncology medicines (47%) and then anesthetic agents (38%) during COVID-19 pandemic. Conclusion: Many steps have been taken to reduce the impact of a shortage of health care. Agencies like the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) has established guidelines and works with manufacturers and other partners to help prevent shortages. This article aims to the analysis the root cause of medicinal product shortages, their effects on the patient outcome, medication error, which occurs due to the substitution safe and effective therapies with alternative treatments, identify possible solutions and policies established to manage medicinal product shortages.

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“…The number of drug shortages has risen steadily in the United States (US) since 2005 [1,2]. Drug shortages are a significant ongoing threat to patient safety by increasing patient morbidity and mortality [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

“…Prior studies assessed overall trends of pharmaceutical shortages in the US for specific drug classes including antimicrobials, cancer chemotherapy, and cardiovascular and neurologic drugs [1,2,4,8,11]. Despite its high prevalence and incidence, little is known about the characteristics of shortages of opioid analgesics.…”

Section: Introductionmentioning

confidence: 99%

Predictors of shortages of opioid analgesics in the US: Are the characteristics of the drug company the missing puzzle piece?

2021

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Background Shortages of opioid analgesics are increasingly common, interfere with patient care and increase healthcare cost. This study characterized the incidence of shortages of opioid analgesics in the period 2015–2019 and evaluated potential predictors to forecast the risk of shortages. Methods This was an observational retrospective study using the US Food and Drug Administration (FDA) drug shortages data. All FDA approved opioids were included in the study. Opioid analgesics were identified using the FDA National Drug Codes (NDC) and classified according to the Drug Enforcement Administration (DEA) schedule. We conducted Least Absolute Shrinkage and Selection Operator logistic regression analysis to assess direction of the association between risk of shortage and potential predictors. We used multivariable penalized logistic regression analysis to model predictors of shortages. We split the dataset into training and validation sets to evaluate the performance of the model. Findings The FDA approved 8,207 unique NDCs for opioid analgesics; 3,017 (36.8%) were in the market as of April 30, 2019 and 91(3.0%) of them were listed as in shortage by the FDA. All NDCs in shortage were schedule II opioids; 86 (94.5%) were injectable and 84 (92.3%) generics. There were 418 companies with at least one opioid NDC listed by the FDA. Three companies accounted for more than 4 in 5 of the schedule II active injectable opioids. For each unit increase in the number of prior instances of shortages of a company, the likelihood of an NDC shortage for that company increased by 3.4%. For each unit increase in number of NDCs marketed by a company, the odds of an NDC shortage for that company decreased by 1%. Conclusions In the period 2015–2019, shortages of opioid analgesics disproportionally impacted schedule II and injectable opioids. The risk of shortage of opioid analgesics significantly increased with the incidence of previous instances of shortages of a manufacturing company and decreased with the number of NDCs marketed by a company. The characteristics of the manufacturing company, rather than the number of companies, might be the missing piece to the complex puzzle of drug shortages in the US.

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The Drug Shortage Era: A Scoping Review of the Literature 2001–2019

Cited by 47 publications

References 31 publications

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

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

A Ripple Effect of Covid-19 Pandemic on Shortage of Medicinal Products and Its Impact on Patient Care

Predictors of shortages of opioid analgesics in the US: Are the characteristics of the drug company the missing puzzle piece?

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