Drug Shortages: A Complex Health Care Crisis

National tracking of drug shortages began in 2001. However, a significant increase in the number of shortages began in late 2009, with numbers reaching what many have termed crisis level. The typical drug in short supply is a generic product administered by injection. Common classes of drugs affected by shortages include anesthesia medications, antibiotics, pain medications, nutrition and electrolyte products, and chemotherapy agents. The economic and clinical effects of drug shortages are significant. The financial effect of drug shortages is estimated to be hundreds of millions of dollars annually for health systems across the United States. Clinically, patients have been harmed by the lack of drugs or inferior alternatives, resulting in more than 15 documented deaths. Drug shortages occur for a variety of reasons. Generic injectable drugs are particularly susceptible to drug shortages because there are few manufacturers of these products and all manufacturers are running at full capacity. In addition, some manufacturers have had production problems, resulting in poor quality product. Although many suppliers are working to upgrade facilities and add additional manufacturing lines, these activities take time. A number of stakeholder organizations have been involved in meetings to further determine the causes and effects of drug shortages. A new law was enacted in July 2012 that granted the Food and Drug Administration additional tools to address the drug shortage crisis. The future of drug shortages is unknown, but there are hopeful indications that quality improvements and additional capacity may decrease the number of drug shortages in the years to come.     

Acute disseminated encephalomyelitis following biting by a scolopendra subspinipes mutilans

Abstract

Context. Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs. Objective. To characterize drug shortages affecting the management of poisoned patients. Materials and Methods. Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated. Results. Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76–434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs. Discussion. Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives. Conclusion. Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and implement mitigation strategies to safeguard patient care.     

Safety,risk, and aggression: Health professionals’ experiences of caring for people affected by methamphetamine when presenting for emergency care

The crystalline form of methamphetamine, commonly known as crystal meth (crystal methamphetamine) or ICE, is a highly‐addictive and powerful stimulant. Users of crystal meth often require emergency care, and are associated with a substantial burden of care by emergency care providers. The aim of the present qualitative study was to explore health professionals’ experiences of providing care for patients affected by ICE who presented to the emergency department (ED). Nine semistructured interviews were conducted. The major theme, ‘staying safe’, was revealed, in which participants described their experiences of being exposed to potentially unsafe situations, and their responses to challenging behaviours, including aggression. The findings highlight the need for ED staff to understand the nature of ICE use and its adverse impact on the mental and physical health of users. Furthermore, it is clear that establishing and maintaining safety in the emergency care setting is of utmost importance, and should be a priority for health‐care managers.     

Emergency department approach to QTc prolongation

QTc prolongation has been associated with increased risk of developing ventricular tachydysrhythmias, particularly Torsades de Pointes (TdP). QTc prolongation is influenced by many factors including congenital causes, heart rate, metabolic imbalances, and pharmacotherapy. Several commonly used medications in the emergency department (ED), such as antipsychotics and antiemetics, are known to prolong the QT interval. In addition, ED patients may present with conditions that may predispose them to QTc prolongation, such as drug overdose or hypokalemia, which can further complicate management. ED providers should not only be aware of which medications have these effects, but must also thoroughly investigate any pertinent patient history that may contribute to QTc prolongation. This review discusses commonly encountered medications that are associated with QTc prolongation, the mechanisms by which they prolong the QTc interval, and other factors that may influence ED medication administration and management.     

Drug-associated disease: cytochrome P450 interactions

Critically ill patients generally are older, frequently have organ failure, and commonly receive multiple medications, all of which make them susceptible to adverse effects of drugs. Drug interactions are a common adverse effect, and many are predictable based on understanding the mechanisms that underlie drug interactions. This article identifies commonly used medications in critically ill patients and the associated drug interactions that may occur with emphasis on the cytochrome P450 enzyme system.     

Proper sling selection and application while using patient lifts.

In response to staff shortages, an aging clinical workforce, and research on safe patient handling, manufacturers have provided an extensive array of patient-lifting technology, including ceiling, floor-based, and sit-to-stand lifts as well as slings that are required for their use. Expanded choice, however, may pose challenges to both healthcare facilities and individual clinicians. These challenges, if not successfully resolved, can preclude the consistent, safe, and efficient use of patient-handling devices. This article provides nurses and other direct patient care providers with a heightened awareness of the challenges to appropriate sling and lift use in rehabilitation and other clinical settings. A new way to categorize slings is introduced, and guidelines for safely evaluating and using slings for different patient-handling tasks are offered.     

A Preliminary Report of Knowledge Translation: Lessons From Taking Screening and Brief Intervention Techniques From the Research Setting Into Regional Systems of Care

This article describes a limited statewide dissemination of an evidence‐based technology, screening, brief intervention, and referral to treatment (SBIRT), and evaluation of the effects on emergency department (ED) systems of care, utilizing the knowledge translation framework of reach, effectiveness, adoption, implementation, and maintenance (RE‐AIM), using both quantitative and qualitative data sources. Screening and brief intervention (SBI) can detect high‐risk and dependent alcohol and drug use in the medical setting, provide early intervention, facilitate access to specialty treatment when appropriate, and improve quality of care. Several meta‐analyses demonstrate its effectiveness in primary care, and the federal government has developed a well‐funded campaign to promote physician training and adoption of SBI. In the busy environment of the ED, with its competing priorities, researchers have tested a collaborative approach that relies on peer educators, with substance abuse treatment experience and broad community contact, as physician extenders. The ED‐SBIRT model of care reflects clinician staff time constraints and resource limitations and is designed for the high rates of prevalence and increased acuity typical of ED patients. This report tracks services provided during dissemination of the ED‐SBIRT extender model to seven EDs across a northeastern state, in urban, suburban, and rural community settings. Twelve health promotion advocates (HPAs) were hired, trained, and integrated into seven ED teams. Over an 18‐month start‐up period, HPAs screened 15,383 patients; of those, 4,899 were positive for high risk or dependent drinking and/or drug use. Among the positive screens, 4,035 (82%) received a brief intervention, and 57% of all positives were referred to the substance abuse treatment system and other community resources. Standardized, confidential interviews were conducted by two interviewers external to the program with 24 informants, including HPAs and their supervisors, clinicians, nurse managers, and ED directors across five sites. A detailed semistructured format was followed, and results were coded for thematic material. Barriers, challenges, and successes are described in the respondents’ own words to convey their experience of this demonstration of SBIRT knowledge translation. Five of seven sites were sustained through the second year of the program, despite cutbacks in state funding. The dissemination process provided a number of important lessons for a large rollout. Successful implementation of the ED‐SBIRT HPA model depends on 1) external funding for start‐up; 2) local ED staff acting as champions to support the HPA role, resolve territorial issues, and promote a cultural shift in the ED treatment of drug and alcohol misuse from “treat and street” to prevention, based on a knowledge of the science of addiction; 3) sustainability planning from the beginning involving administrators, the billing and information technology departments, medical records coders, community service providers, and government agencies; and 4) creation and maintenance of a robust referral network to facilitate patient acceptance and access to substance abuse services.     

Drug-drug and drug-disease interactions in the ED: Analysis of a high-risk population

A study was undertaken to determine the potential for adverse drug interactions (ADIs) and drug-disease interactions (DDIs) in a high-risk population of emergency department (ED) patients and to characterize drug-drug and drug-disease interactions in terms of percentage of patients at risk from existing drug regimens, percentage of patients at risk from ED treatment, relation between number of drugs and potential for interactions, types of drugs and diseases posing greatest potential for interaction, and the differences in a general versus community hospital population with respect to these parameters. Records of 205 consecutive patients, 111 from a general hospital teaching facility ED (Facility 1) and 94 from a community hospital ED (Facility 2) were retrospectively reviewed. The records of all patients receiving three or more medications and all patients older than 50 years of age receiving two or more medications were analyzed by two computer programs for the presence of potential drug-drug and drug-disease interactions. A total of 226 potential ADIs were found in 89 patients (47%), with 50% of ADIs being related to ED treatment. A total of 94 potential DDIs were found in 44 patients (21%), with 34% of DDIs being related to ED treatment. The risk of an ADI rose from 13% for patients taking 2 medications to 82% for patients taking 7 or more medications. Eleven medications and four disease categories were identified as having particular potential for interactions. No significant differences were found between the general and the community hospital populations in these respects. ED patients taking three or more medications and patients older than 50 years of age taking two or more medications are at substantial risk for adverse drug-drug and drug-disease interactions. The risk is increased in patients taking particular drugs or having particular disease states.     

Towards IV drug standardization in critical care

Local infusion practice within critical care has evolved over time, and one example of this is the wide variation in concentrations of drug infusions within critical care. While there are many similarities between critical care units, there are also many differences. Often drug infusions are used outside their product licence and, because of the diversity in practice, manufacturers are unlikely to license multiple preparations of even the most commonly used infusions. Critical care nurses spend many hours every day preparing and administering intravenous infusions. Much time could be saved if the infusions were available as a ready-to-use solution. This would also reduce the risk of errors that occur during the preparation and administration of medication infusions. This article describes a national project to achieve consensus on the strengths of drug infusions used within UK critical care units. Having agreed on standard solutions, it is hoped that manufacturers will seek licences for commonly used infusions and work towards mass production of these products. Off the shelf, ready-to-use infusions of commonly used medications could become a reality.     

Should We Use Expired Drugs When Necessary?

BackgroundMedication shortages commonly occur in resource-poor settings. The relatively short expiry dates on many medications exacerbate these shortages, often requiring clinicians to choose between providing needed medications to the patient and violating rules governing drug dispensing.Case ReportA patient presented to an emergency department in a resource-poor setting with an acute anterior myocardial infarction. Standard of care required using thrombolytics due to the unavailability of percutaneous coronary intervention. The only available thrombolytic, streptokinase, was 2 weeks past its labeled expiration date. The physicians faced the ethical dilemma of violating regulations and using the medication vs. failing to provide the patient with the best available therapy.DiscussionThe physicians in this case needed to weigh their obligation to improve the patient's health against the professional danger to themselves, their colleagues, and their institution for violating a health care regulation. The information they needed to make this decision and to provide the patient with factual informed consent requires an understanding of the myths, regulations, and science surrounding drug expiry dates. Two myths about medications pervade both the professional and lay communities—that they are uniformly effective and that medications taken past their expiry dates may be ineffective or even harmful. Scientific studies have demonstrated that both are false.ConclusionsEthically, physicians have a duty to place their patient's welfare above their own self-interest. In a time of increasing medication shortages around the globe, clinicians need to push rule makers to synchronize drug expiry dates with scientific findings.     

Drugs used to treat erectile dysfunction

Knowledge of the drugs currently approved to treat erectile dysfunction (ED) is important for nurses who care for male patients, especially those men of middle age or older and those who have concurrent health problems or are taking medications that may contribute to ED. This article provides a very basic look at ED and the drugs currently approved and used for treatment. Informed nurses can increase patient understanding of ED, make suggestions for necessary referrals, and help patients and their sexual partners understand the appropriate use and cautions associated with drugs used to treat ED. On the surface, one might question why orthopaedic nurses would need knowledge about drugs currently used to treat ED. However, when one considers that a large proportion of patients in any orthopaedic setting are men, the need for knowledge about the use and safety of these medications becomes a valid component of total patient care. This is an especially important subject today, when media advertising has heightened public awareness of the medications used to treat ED but has not provided much toward a basic understanding about ED or the safe use of the advertised therapeutic agents. Nurses who have some knowledge about ED and the medications used to treat ED are better able to serve as a patient resource for education and referral.     

Non‐therapeutic omission of medications in acutely ill patients

Aims and objectives: To examine documentation of medication administration in medical and surgical patients. Study objectives: (1) Determine the point prevalence of non‐therapeutic medication omissions; (2) identify documented reasons for non‐therapeutic medication omissions; (3) examine the relationship between length of stay and medication omissions; and (4) explore the impact of outlier status (e.g. medical patients managed on surgical wards) on medication administration. Background: Acutely ill patients are particularly sensitive to health care errors. We previously identified a 26% rate of non‐therapeutic medication omissions in patients admitted unexpectedly to intensive care unit (ICU) from medical and surgical wards. Design: A point prevalence survey of 162 medical and surgical patients across four sites in the South West of England. Method: Data collected included: all instances of, and reasons for, non‐therapeutic medication omission. We also recorded whether the patient was an ‘outlier’ and examined nursing documentation where no reason for medication omission was given on the drug chart. Results: The number of patients who missed at least one medication was high across all sites (n = 129/162; 79.6%, range 60–88%), with a total of 1077 doses omitted. Patients who were outliers (e.g. surgical patients on a medical ward) were more likely to miss medications (100% versus 74%, p < 0.001). The most common missed medications were analgesia and anti‐inflammatory drugs (28%, 299/1077); 203 of these were due to patient refusal. Conclusions: The extent of medications omitted for non‐therapeutic reasons in medical and surgical patients is of concern. None were recorded as an adverse drug event; however, the extent of omitted or refused medications suggests the need for a review of prescribing and drug administration processes. These findings have important implications for the role of ICU outreach and liaison services, for example, including medication management in the monitoring of patients pre/post‐ICU admission and support/education provided for ward staff. Relevance to clinical practice: Detailed analysis of medication records suggests a number of areas of medication administration that would benefit from review.     

Ce que le réanimateur doit connaître des antirétroviraux

Antiretroviral drugs have dramatically improved the prognosis of human immunodeficiency virus (HIV) infection over the recent decades. Currently, most of the HIV-infected patients in France are receiving antiretroviral therapy. Since admission of HIV-infected patients to the intensive care unit (ICU) is not an infrequent event, ICU physicians may commonly have to manage antiretroviral drugs besides the regular intensive care medications. This review focuses on the general principles of antiretroviral therapy in HIV infection as well as on some important points related to the specific use of antiretroviral agents in the ICU, including optimal starting time, administration regimen, drug toxicities, and drug-drug interactions.     

Geropharmacology: a primer for advanced practice acute care and critical care nurses, part I

Advanced practice nurses' challenge in managing older adults' medication regimens from an evidence base is difficult because older adults are vulnerable to medication errors and adverse drug reactions related to a number of factors. Predicting patients' responses to drugs is compounded during critical illness, adding to the heterogeneity and unpredictability of drug effects that are prevalent premorbidly. In the first part of this 2-part continuing education series, sources of medication errors and older adults' vulnerability are discussed, including normal changes of aging affecting pharmacokinetics and pharmacodynamics, polypharmacy, self-medicating, patient-family noncompliance, and inappropriately prescribed medications. In the second part, drug classes and drugs posing particular problems for older adults and cautions for acute care and critical care nurses who manage the medications of older adults are highlighted.     

Atypical antipsychotics and newer antidepressants

Atypical antipsychotics and newer antidepressants are commonly prescribed medications responsible for tens of thousands of adverse drug exposures each year. The emergency medicine physician should have a basic understanding of the pharmacology and toxicity of these agents. This knowledge is crucial to providing proper care and timely management of patients presenting with adverse drug effects from exposure to atypical antipsychotics and newer antidepressants.     

Preventing potential drug interactions in community pharmacy

With ongoing debate on health care reform including improved pharmaceutical care, there is much current concern about drug interactions and their prevention. Many patients visit more than one doctor for their different diseases and receive more than one drug at a time, and often doctors are unaware of all the medications their patients are taking and the risks to which their patients are exposed when treated with multiple drugs. Pharmacists in the community setting or hospital are the most accessible health care providers able to intervene when faced with potential drug interactions that may occur during patients' multiple drug therapy. A few selected examples of potential drug-drug interactions and interventions instituted are presented in this paper. Possible mechanisms for the drug interactions are also discussed. It is hoped that more documentation of pharmacists' involvement in such interventions will demonstrate the true value of pharmaceutical care.     

Medication-related emergency department visits and hospitalizations among older adults

Objective

To identify medications that have a high risk of adverse drug effects (ADEs) among seniors, using data from publicly available administrative databases.

Design

Cross-sectional study using the Discharge Abstracts Database (DAD) (which contains data on acute care institutions in all provinces and territories except Quebec), the National Ambulatory Care Reporting System (NACRS) (which contains data on emergency department [ED] visits in Ontario), and the IMS Brogan database Canadian CompuScript.

Setting

Canada.

Participants

Adults 65 years of age and older with diagnostic codes for drugs, medicaments, and biologic substances causing adverse effects in therapeutic use.

Main outcome measures

Adverse drug events from 2006 to 2008 associated with hospitalizations and ED visits among adults 65 years of age and older were identified by the DAD and the NACRS. The medications most frequently prescribed by primary care providers in 2008 were identified using data from Canadian CompuScript.

Results

From 2006 to 2008, the DAD identified 92 141 ADEs among older adults, and the NACRS identified 23 845 ADEs among older adults in Ontario EDs, which represented 2.9% of inpatients and 0.8% of ED patients (21.5% of whom were admitted to hospital). Drugs implicated in the DAD ADEs included anticoagulants (15.4%), antineoplastic agents (10.6%), opioids (9.2%), and nonsteroidal anti-inflammatory drugs (6.5%); drugs included in the ADEs of ED visits were anti-infective agents (15.9%), anticoagulants (14.2%), antineoplastic agents (9.6%), and opioids (7.3%).

Conclusion

Among older adults, the drug classes most often associated with causing harm in the hospital setting and occurring out of proportion to the frequency prescribed were anticoagulants, opioids, antibiotics, and cardiovascular drugs. Thus, these drug classes should be the focus of quality improvement efforts in primary care.