Look-alike medications: a formula for possible morbidity and mortality in the long-term care facility

Medication errors remain an important cause of patient morbidity and mortality. Although all medications have the potential to induce unwanted adverse effects, data on the actual incidence and overall severity of preventable adverse drug reactions remains unknown. An Institute of Medicine report (Institute of Medicine. Preventing medication errors: Quality chasm series. Washington DC, National Academies Press. 2007-06-15) estimated that 1.5 million preventable adverse drug events occur annually in the US and that from 44,000 to 98,000 individuals die in hospitals annually from preventable medication errors. The types of medication errors of clinical relevance leading to moderate to severe outcomes are unfortunately numerous. Such errors would include wrong drug, wrong dose / wrong dose interval and represent the more serious form of a medication error. Institutionalized patients and those patients cared for in long-term care facilities appear to be at heightened risk for a medication error. These patients often receive multiple medications and suffer from variable degrees of cognitive impairment which complicates or negates patient-caregiver communication, one of the most important means to prevent medication errors. Moreover, the increasing financial constraints placed upon treatment facilities encourage the use of generic, rather than name brand medications by their pharmacy provider. While the use of bioequivalent generic medications is completely appropriate and can be very cost-effective, generic drug manufacturers are less often manufacturing their generic medications to look like the name brand drug. Rather, more and more generic medications are plain appearing with no resemblance whatsoever to the name brand product. This difference in drug appearance between the generic and the brand name product as well as differences in drug appearance between different generic drug manufacturers for the same medication represents another, important means by which patients may experience moderate to serious consequences from a medication error. We report such an experience where a patient in a long-term care facility received multi-day, excessive dosing of glipizide rather than her anti-spasticity medication, baclofen.     

Remodeling pharmaceutical care in Sub‐Saharan Africa (SSA) amidst human resources challenges and the HIV/AIDS pandemic

Pharmaceutical care, meant to complement a proper drug supply system, is a key component of a robust health care system and is the direct, responsible provision of medication‐related care designed to achieve definite outcomes that improve a patient's quality of life. Beyond simply dispensing medicine, pharmaceutical care promotes adherence to therapeutic regimens and addresses problems such as overdosage, sub‐therapeutic dosage, adverse drug reactions, medication errors, and untreated indications. The dearth of health care workers trained in pharmaceutical care coupled with inadequate access to medications creates multiple disease management challenges in Sub‐Saharan Africa (SSA), which has 25% of the world's disease burden but only 1.3% of the world's health workforce. To prevent and treat HIV/AIDS, TB, malaria, and other maladies, the need is urgent to train and integrate the contributions of current workers who handle medications for major and minor health problems, especially those in licensed pharmacies and drug shops. On the aggregate in SSA, pharmaceutical care is in a nascent stage in most countries but needs to grow as a discipline as well as be tailored to specific country needs. The SSA solution lies in establishing health care system components where cadres of workers engage in pharmaceutical care practices, as well as store and distribute medications. Curriculum changes in pre‐service education, more continuing education for the health workforce in place, and training pharmacists to supervise a lower cadre of assistants and others are among the elements in a pharmaceutical care paradigm shift which is the focus of this article. Copyright © 2009 John Wiley & Sons, Ltd.     

Verbesserung der Arzneimitteltherapiesicherheit

Drug treatment is beneficial in most patients but can also cause adverse events and death. Since preventable adverse drug events are a relevant cause of morbidity and mortality, strategies for improving medication safety are warranted. Studies demonstrate that system failure is the most relevant cause of preventable adverse drug events, with prescribing errors being the most relevant. Lack of information either about the patient, the functioning of a patient’s organs and concurrent medications, or about the prescribed drug, its correct dosing, contraindications and drug interactions often lead to preventable adverse drug events. International studies show that medication errors result in more people dying than from traffic accidents. Therefore, in addition to the safety of the drug, it is necessary that the safety of the process of drug treatment must be taken care of. This is called medicine safety. In order to improve medicine safety, it is necessary to consider the organization of the medication process, instead of looking for an individual to blame. The goal of the “Action Plan for Medication Safety in Germany” (“Aktionsplan Arzneimitteltherapiesicherheit für Deutschland”) from the Federal Ministry of Health is to optimize patient safety in drug treatment by the joint efforts of physicians, pharmacists, patients, and politicians.     

Adverse drug events and medication problems in “Hospital at Home” patients

“Hospital at Home(HaH)” programs provide an alternative to traditional hospitalization. However, the incidence of adverse drug events in these programs is unknown. This study describes adverse drug events and potential adverse drug events in a new HaH program. We examined the charts of the first 50 patients admitted. We found 45 potential adverse drug events and 14 adverse drug events from admission to 30 days after HaH discharge. None of the adverse drug events were severe. Some events, like problems with medication administration, may be unique to the hospital at home setting. Monitoring for adverse drug events is feasible and important for hospital at home programs.     

Examining nurses' decision process for medication management in home care

BACKGROUND: The process of medication management within home care agencies was prospectively described, with a focus on the nurse's role and critical points in the process. The process the nurse must follow includes preparing, checking, and administering medications; updating knowledge of medications; monitoring the effectiveness of treatment; reporting adverse reactions; and teaching patients about their drugs. PROCESSES FOR MEDICATION MANAGEMENT IN HOME HEALTH CARE: The steps that home health nurses (HHNs) go through with families and the system changes that could be developed to decrease errors were identified. The approach was based on Failure Mode and Effects Analysis-a method to identify and prevent process problems before they occur. The medication management process was divided into drug utilization review (DUR) for duplicative and harmful interactions; drug administration by the patient, family member, and/or caregiver; and side effects. Failure modes were developed for a DUR for duplicative and harmful interactions. DISCUSSION: Home health agencies should analyze the medication management process in their own agencies and identify system solutions. The difficulty encountered by HHNs in contacting physicians to discuss changes to the drug regimen following the assessment of potential drug interactions or duplications is an ongoing problem. Careful monitoring by HHNs could decrease the impact of adverse drug effects.     

Spline‐based self‐controlled case series method

The self‐controlled case series (SCCS) method is an alternative to study designs such as cohort and case control methods and is used to investigate potential associations between the timing of vaccine or other drug exposures and adverse events. It requires information only on cases, individuals who have experienced the adverse event at least once, and automatically controls all fixed confounding variables that could modify the true association between exposure and adverse event. Time‐varying confounders such as age, on the other hand, are not automatically controlled and must be allowed for explicitly. The original SCCS method used step functions to represent risk periods (windows of exposed time) and age effects. Hence, exposure risk periods and/or age groups have to be prespecified a priori, but a poor choice of group boundaries may lead to biased estimates. In this paper, we propose a nonparametric SCCS method in which both age and exposure effects are represented by spline functions at the same time. To avoid a numerical integration of the product of these two spline functions in the likelihood function of the SCCS method, we defined the first, second, and third integrals of I‐splines based on the definition of integrals of M‐splines. Simulation studies showed that the new method performs well. This new method is applied to data on pediatric vaccines. Copyright © 2017 John Wiley & Sons, Ltd.     

Techniques for Measuring Medication Adherence in Hypertensive Patients in Outpatient Settings

Lack of adherence to prescribed antihypertensive regimens constitutes a barrier to adequate blood pressure control and prevention of cardiovascular events. Various means of measuring adherence to antihypertensive medications are currently available for use in clinical practice. The choice of the specific measure used in clinical practice depends on the intended use of the information, the resources available to the provider, as well as patient acceptance and convenience of the method. This article presents an overview of the advantages and limitations of the methods used to measure medication adherence that are currently available for use in outpatient settings, it also outlines provider strategies for addressing adherence issues related to antihypertensive medications.Indirect methods used to measure adherence in the outpatient setting include self report, electronic adherence monitoring (e.g. medication event monitoring system), pharmacy refill rates, and pill counts. Direct methods include the use of bioassays or biomarkers, which involve laboratory detection of the drug or a metabolic product of the drug in a biologic fluid, or laboratory detection of a biologic marker. Direct observation of the patient taking the medication is also another direct method; however, it is impractical in the outpatient setting, especially for long-term treatment. Each of these methods has advantages and disadvantages; perhaps using a combination of methods may provide the most accurate assessment of adherence.The information gained from measurement of adherence can help to formulate recommendations for individual patients regarding necessary adjustments to their medication-taking behavior to achieve the optimum outcome. Part of the difficulty associated with achieving better medication adherence lies in the inherent complexity of medication-taking decisions and behavior and of relationships between patients, their healthcare providers, and often others involved in the patient’s care, such as family members. Poor medication adherence and ultimately, adverse cardiovascular outcomes, is related to a variety of factors: quality of life; complexity of medication regimens; costs of medications; adverse effects of medications; demographic, behavioral, treatment and clinical variables; knowledge of hypertension and healthcare system issues; and use of non-conventional therapies. To be effective, strategies employed in clinical practice to overcome nonadherence need to take into account patients’ individual characteristics. Frequently, more than one strategy is necessary to bring about the desired level of adherence. The benefits of proven medical treatments are only available to patients who actively use them; thus, patient adherence to healthcare provider recommendations is the key mediator between medical practice and health outcomes.     

Adjusting for unmeasured confounders in pharmacoepidemiologic claims data using external information: the example of COX2 inhibitors and myocardial infarction

BACKGROUND: Large health care utilization datasets are frequently used to analyze the incidence of rare adverse events from medications. However, possible confounders are typically not measured in such datasets. We show how to assess the impact of confounding by factors not measured in Medicare claims data in a study of the association between selective COX2 inhibitors and acute myocardial infarction (MI). METHODS: Using the Medicare Current Beneficiary Survey, we assessed the association between use of selective COX2 inhibitors and 5 potential confounders not measured in Medicare claims data: body-mass index, aspirin use, smoking, income, and educational attainment. For 8,785 participants > or =65 years, we estimated the prevalence of selective COX2 inhibitor use and also of each confounder, as well as the association between drug exposure and confounders. Estimates of the confounder-disease associations from the medical literature were used to calculate the extent of residual confounding bias for each potential confounder. RESULTS: Selective COX2 inhibitor users were less likely to be smokers (8% versus 10%) than nonselective NSAID users, while the prevalence of obesity was comparable (24%). Aspirin use was also balanced among all drug exposure categories. Failure to adjust for 5 potential confounders led to a small underestimation of the association between selective COX2 inhibitors and MI; comparing selective COX2 inhibitors with NSAIDs, the net bias was estimated to be -1.0% of the unknown true effect size (maximum range: -6% to 0%). CONCLUSIONS: In this example of the relationship between selective COX2 inhibitors and MI, not adjusting for 5 potential confounders in Medicare claims data analyses tended to slightly underestimate the association, but is unlikely to cause important bias.     

Polypharmacy and possible drug-drug interactions among diabetic patients receiving home health care services

OBJECTIVES: In this study, we examined the drug regimens of diabetic patients receiving home health care services to measure the prevalence of polypharmacy and to assess the likelihood of drug-drug interactions, a consequence of polypharmacy. DESIGN: The sample consisted of 139 diabetic patients who received home health care services from one home health agency in a large mid-Atlantic city. The data were collected from March 1, 1998 to September 30, 1999. Information regarding medications was collected by the home health nurse during the initial home visit and was recorded on the medication sheet in the patient's clinical record. Any changes in medications were noted on the medication sheets. METHODS: We identified all systemic medications prescribed for 139 home health patients. To assess drug-drug interactions, we used Micromedex formulary DRUG-REAX System. OUTCOMES: We calculated (1) the number of systemic medications taken, and (2) the number of possible severe, moderate, and mild drug-drug interactions. Results: We found that the average number of medications taken was 8.9 (SD 3.4) prescribed medications per day. Our results show that 38.8% of the patients in the sample could potentially be subject to at least one severe drug-drug interaction. Nearly all of the patients (92.8%) were at risk for moderate drug-drug interactions, and 70.5% could have mild drug- drug interactions. CONCLUSION: We conclude that polypharmacy is a concern for home health care patients with diabetes and the potential for drug-drug interactions is substantial. Our results indicate that the drug regimens of diabetic patients should be monitored systematically to avoid adverse events such as hospitalization. Family practitioners and home health care takers are in a unique position to identify polypharmacy and to modify drug regimens.     

The long-term management of obesity with continuing pharmacotherapy

OBJECTIVE: Long-term, possibly lifetime, use of medications for the management of obesity may be thought to be similar to the use of pharmacotherapy for other chronic diseases such as hypertension or diabetes. Because there have been no systematic studies of this extended use, the experience of eight patients who have used obesity medications in a sustaining manner was studied. RESEARCH METHODS AND PROCEDURES: The clinical characteristics of eight adult patients, each of whom has experience with long-term (more than 10 years) use of medications for weight loss and weight maintenance, were studied. RESULTS: The clinical experience of these eight patients was analyzed. Each chose to sustain the use of weight management medications for more than 10 years because of perceived benefit, comfort, and the absence of significant side effects. There has been no evidence of the development of tolerance, addiction, or misuse and no adverse events related to the medication. The beneficial effects of the medication have not diminished with time. DISCUSSION: The clinical characteristics of eight patients, each of whom has used obesity pharmacotherapy for more than 10 years, are described. The experience of these eight individuals cannot be generalized to the entire population of overweight or obese patients. It does suggest, however, that some patients respond successfully to this form of therapy and that they will derive value from it for the management of this disease. Efforts should be made to identify these patients, and consideration should be given to the use of chronic medications for the continuing management of obesity.     

Safety surveillance and the estimation of risk in select populations: Flexible methods to control for confounding while targeting marginal comparisons via standardization

We consider the critical problem of pharmacosurveillance for adverse events once a drug or medical product is incorporated into routine clinical care. When making inference on comparative safety using large-scale electronic health records, we often encounter an extremely rare binary adverse outcome with a large number of potential confounders. In this context, it is challenging to offer flexible methods to adjust for high-dimensional confounders, whereas use of the propensity score (PS) can help address this challenge by providing both confounding control and dimension reduction. Among PS methods, regression adjustment using the PS as a covariate in an outcome model has been incompletely studied and potentially misused. Previous studies have suggested that simple linear adjustment may not provide sufficient control of confounding. Moreover, no formal representation of the statistical procedure and associated inference has been detailed. In this paper, we characterize a three-step procedure, which performs flexible regression adjustment of the estimated PS followed by standardization to estimate the causal effect in a select population. We also propose a simple variance estimation method for performing inference. Through a realistic simulation mimicking data from the Food and Drugs Administration's Sentinel Initiative comparing the effect of angiotensin-converting enzyme inhibitors and beta blockers on incidence of angioedema, we show that flexible regression on the PS resulted in less bias without loss of efficiency, and can outperform other methods when the PS model is correctly specified. In addition, the direct variance estimation method is a computationally fast and reliable approach for inference.     

Improving the lives of patients with chronic diseases: pharmacists as a solution

Positive health outcomes hinge on the effective use of medications especially among vulnerable, chronically ill, and aging populations. Yet, increasingly powerful and complex drug combinations are used to treat patients with chronic diseases and multiple health conditions. As treatment complexity increases the potential grows for non-adherence to medications due to side-effects, drug-disease interactions, costs, and patient confusion about medicines. Pharmacists are the medication experts on a health care team. Working in collaboration with the patient and the prescriber, pharmacists offer solutions that foster medication adherence, improve clinical outcomes and decrease drug-related adverse events. Their accessibility, extensive knowledge of drug therapy, and trustworthiness in the minds of consumers open many opportunities for pharmacists to expand their reach in preventing drug-related problems in patients with chronic diseases.     

A conditional sequential sampling procedure for drug safety surveillance

We propose a practical group sequential method, a conditional sequential sampling procedure, to test if a drug of interest (D) leads to an elevated risk for an adverse event E compared with a comparison drug C. The method is designed for prospective drug safety surveillance studies, in which, for each considered drug, a summary table with the exposed person‐times and the associated numbers of adverse events summed by strata defined by several potential confounders, is collected and updated periodically using the health plans' administrative claims data. This new approach can be applied to test for elevated relative risk whenever the data are updated. Our approach adjusts for multiple testing to preserve the overall type I error with any specified α‐spending function. Furthermore, it automatically adjusts for temporal trend and population heterogeneity across strata by conditioning on the numbers of adverse events within each stratum during each time period. Therefore, this approach is very flexible and applies to a wide class of settings. We conduct a simulation study to evaluate its performance under various scenarios. The approach is also applied to an example to examine if Rofecoxib leads to an increased relative risk for acute myocardial infraction (AMI) compared with its two counterparts Diclofenac and Naproxen, respectively. We end with discussions. Copyright © 2009 John Wiley & Sons, Ltd.     

EHR‐related medication errors in two ICUs

The objective of this study was to describe the frequency, potential harm, and nature of electronic health record (EHR)‐related medication errors in intensive care units (ICUs). Using a secondary data analysis of a large database of medication safety events collected in a study on EHR technology in ICUs, we assessed the EHR relatedness of a total of 1622 potential preventable adverse drug events (ADEs) identified in a sample of 624 patients in 2 ICUs of a medical center. Thirty‐four percent of the medication events were found to be EHR related. The EHR‐related medication events had greater potential for more serious patient harm and occurred more frequently at the ordering stage as compared to non–EHR‐related events. Examples of EHR‐related events included orders with omitted information and duplicate orders. The list of EHR‐related medication errors can be used by health care delivery organizations to monitor implementation and use of the technology and its impact on patient safety. Health information technology (IT) vendors can use the list to examine whether their technology can mitigate or reduce EHR‐related medication errors.