For over a decade now, the ongoing dilemma on whether to use antipsychotics to manage the behavioral symptoms of dementia is still being discussed because we have yet to come to a consensus of what is best for these patients. The article by Greenblatt and Greenblatt1 exemplifies this dilemma. After nonpharmacological treatments are tried and either failed or provided suboptimal results, what is a nursing home practitioner to do for those numerous patients with behavioral symptoms associated with dementia? The FDA boxed warnings about the increased risk of sudden death associated with the use of antipsychotics in this population is used as “evidence” by attorneys to show how patients are being chemically restrained in nursing homes or are being treated inappropriately.2 As a result, there is substantial information available for clinicians to use on how to mitigate risk when prescribing antipsychotics to dementia patients through the use of consent forms and thorough appropriate documentation. Greenblatt and Greenblatt make a worthy notation in their review. The American Society of Consultant Pharmacists has made an effort to bring a perspective in regard to the FDA boxed warnings because the reality is that most of the nursing home residents will need management beyond nonpharmacological interventions. Many medications, not just antipsychotics, are used off-label every day.3 The review also comments on a sad reality: most nursing homes are not well staffed, and an adequate trial of nonpharmacological treatments requires the intervention of well-trained staff members. Some institutions, specifically adult day care centers, have tried—in many cases successfully—to decrease the burden on the caregiver by structuring their services when they are needed the most: they are open from 7 pm to 7 am, when dementia patients may experience worsening of their behavioral symptoms. Perhaps, that is a schedule that nursing homes should consider because traditionally staffing is decreased during the evening and overnight shifts when dementia symptoms are worse for patients. The efficacy of antipsychotics in managing the agitation, anxiety, aggression, and paranoia of dementia patients is inconclusive, with many remaining questions, as noted by Greenblatt and Greenblatt. Which antipsychotic works best? Neurologists and psychiatrists rely on their own experience in choosing the antipsychotics, based on the patient's comorbidities, the drug's side effect profile, or simply which is the preferred agent based on the institution's drug formulary. The review of the possible mechanisms of increased risk of cardiovascular events by antipsychotics is described in the review. We simply do not know the exact mechanism(s) of toxicity, nor do we know which antipsychotic(s) are most likely to contribute to these toxic events. Almost 11 years have passed since the first FDA warning was issued about the use of antipsychotics in dementia patients and the increased risk of sudden death. We still have inconclusive answers for most of the original questions. However, progress has been made to provide some guidance to practitioners in which a step approach can be used to manage dementia patients, as described in the “Clinical Considerations” section of the review, which is based on the recommendations set forth by the Centers for Medicare and Medicaid Services (1). The “Dementia Care Principles” described in Table 2 in Greenblatt and Greenblatt,1 are a good starting point for nursing homes on what they should be striving to achieve for their dementia patients. The successful management of behavioral symptoms in dementia patients is a great challenge that nursing homes as well as home caregivers continue to face. Even though current literature is inconclusive in regard to the risk of prescribing antipsychotics in this patient population, once nonpharmacological treatments fail, pharmacotherapy is the next best option.
Drug-induced serotonin syndrome is a potentially life-threatening condition. An Ovid MEDLINE, and PubMed search from 1950 to October 2015 revealed one published case report of suspected tapentadol-induced serotonin syndrome. We report a probable case of tapentadol-induced serotonin syndrome after overdose.A 48-year-old male was found unresponsive after a witnessed overdose of medications including tapentadol. After administration of naloxone by emergency medical services, the patient became combative and presented with altered mental status. He was managed with physical and pharmacologic restraints in the emergency department. Other medications that could be implicated in the patient's presentation include duloxetine and amitriptyline. It was suspected that the opioid properties of tapentadol were masking the patient's signs and symptoms of serotonin syndrome. The patient was admitted to the medical intensive care unit, remained stable, and was discharged 2 days later. Currently, there is one published case report of suspected tapentadol-induced serotonin syndrome after an overdose. The manufacturer of tapentadol reported no cases of serotonin syndrome during clinical trials, but there have been postmarketing cases reported with co-administration of other serotonergic drugs.We report a probable case of tapentadol-induced serotonin syndrome after overdose. Further research is needed to better understand the pharmacology and incidence behind this adverse event.
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacology (JCP) for original research, special reviews, commentaries, and case reports on all phases of drug development from absorption, disposition, metabolism, excretion interactions, and preferred uses through post-marketing evaluations.
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacology (JCP) for original research, special reviews, commentaries, and case reports on all phases of drug development from absorption, disposition, metabolism, excretion interactions, and preferred uses through post-marketing evaluations.
The purpose of this study was to compare problem- based learning (PBL) and traditional lecturing (TL) in Pharm.D. students’ performance on pharmacotherapeutic examinations. Fourth-year Pharm.D. students were divided into two groups: Group A (n 5 186), enrolled in Pharmacotherapeutics II (PH210), Fall 1999, were taught hyperlipidemia by PBL and thromboembolic diseases by TL; Group B (n 5 187), enrolled in Fall 2000, were taught thromboembolic diseases by PBL and hyperlipidemia by TL. Student performance was assessed via multiple-choice examinations. For hyperlipidemia examination scores, Group B students performed statistically and academically significantly better (defined as >5% difference) on the total score (78.6 vs. 55.6%, p 0.05) than Group A. For thromboembolic diseases examination scores, Group A did as well as Group B in analytical questions (73.6 vs. 71.3%, p > 0.05), significantly better in total scores (72.2 vs. 69.2%, p 5 0.047) and recall questions (73.8 vs. 63.0%, p 5 0.001). Teaching hyperlipidemia by PBL resulted in statistically and academically significantly lower examination scores; this difference was not noted when thromboembolic diseases was the topic. Limitations include large class size, variations in examination questions and the possibility that certain topics may be more difficult for students to master using PBL. Continuation of long-term data collection will further determine if PBL helps students to develop critical thinking and problem solving skills.
This paper reviews and examines a select category of published abstracts pertaining to social and behavioral pharmacy created by Social and Administrative Science faculty members from 1989 through 1999. Through a search of the names of Social and Administrative Science faculty members in the 1999 AACP member Roster in International Pharmaceutical Abstracts and MEDLINE, 106 abstracts that fit the inclus ion criteria were identified. Based upon categories and subcategories of “who” and “what” was studied, the authors classified each abstract. Independent judges reviewed each abstract to address inter-rater reliability. The findings showed that the majority of publications centered on such topics as attitudes, beliefs and perceptions of patients or pharmacists, as well as medication issues/problems in the elderly. There was little social or behavioral pharmacy intervention research conducted. Divisions of social and administrative sciences seem primed for more research in areas that concentrate on behavioral pharmaceutical care interventions.
Drug‐associated ototoxicity is a potentially irreversible adverse event. Among the several 3‐hydroxy‐3‐methylglutaryl coenzyme A reductase inhibitors (statins) available in the United States, only atorvastatin is associated with tinnitus, but none are associated with any forms of hearing loss. A search of the published literature (1950–August 2011) revealed no published case reports of ototoxicity associated with statins. To our knowledge, we describe the first case of progressive, irreversible hearing loss in a 32‐year‐old man 18 months after starting atorvastatin therapy. He began taking atorvastatin 20 mg every evening for treatment of hypercholesterolemia. Six months later, he complained of occasional episodes of tinnitus, which resolved spontaneously. An audiogram was obtained and was normal. By 18 months, the tinnitus became continuous. Another audiogram revealed bilateral “cookie‐bite” middle‐frequency hearing loss. Atorvastatin was immediately discontinued, and the patient was fitted with hearing aids. Four years after drug discontinuation, his hearing loss had neither progressed nor regressed. Use of the Naranjo adverse drug reaction probability scale indicated a possible (score of 2) temporal and causal relationship between the patient's hearing loss and atorvastatin. Causes of “cookie‐bite” hearing loss include chronic exposure to loud noises, presbycusis, genetic predisposition, and drugs. The manufacturer of atorvastatin has received three unpublished cases of deafness, but claims that causal relationships were not established. Despite these claims by the manufacturer, based on this case report, we recommend that clinicians and patients be aware of the risk of atorvastatin‐associated tinnitus and permanent hearing loss. Further research is needed to better understand the mechanism and frequency of this adverse event.
