Comparison of Tertiary Drug Information Resources With the CDC Guideline for Oxycodone Dosing: Are Patients at Risk?

Background: Inappropriate prescribing of opioids is thought to play a central role in the ongoing opioid health crisis. Tertiary information resources are commonly used by clinicians for obtaining opioid dosing information. To assist health care providers in pain management, the Centers for Disease Control and Prevention (CDC) developed a guideline for prescribing opioids. Objective: To identify discrepancies for dosing information on oxycodone between commonly used tertiary drug information resources and the CDC Guideline. Methods: Searches of the tertiary drug information resources were conducted in the following order: Facts and Comparisons, Lexicomp, Medscape, and Micromedex. The term "oxycodone" was entered in the search box in the tertiary resources' applications. Drug information items retrieved were organized in tabular format. In the Google Chrome version 106.0.5249.119 search box, the term "CDC guideline for opioid dosing" was entered to retrieve current information on the CDC Guideline. Results: Searches produced drug information on oxycodone for available formulations, dosing regimens, recommended dosing, and maximum daily dose (MDD). Searches revealed discrepancies in dosing recommendations for oxycodone among tertiary drug resources and between tertiary drug resources and the CDC Guideline. Conclusions: When considering maximum daily dosing information for oxycodone from the selected tertiary drug information resources, the potential exists for patients to be at risk of addiction, overdose, and perhaps death. Improving the way opioids are prescribed through the CDC Clinical Practice Guideline can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse or overdose from inappropriate dosing information.

Pharmacy students' perceptions and attitudes toward face-to-face vs. virtual team-based learning (TBL) in the didactic curriculum: A mixed-methods study.

INTRODUCTION: Virtual TBL is an online adaptation of the team-based learning (TBL) instructional strategy, emphasizing collaborative learning and problem-solving. The emergency shift to virtual TBL during the COVID-19 pandemic presented unique challenges. This study aims to 1) compare overall pharmacy students' perceptions and attitudes toward face-to-face (FTF) TBL vs. virtual TBL in the didactic curriculum and stratify their perceptions and attitudes by various students' characteristics; 2) evaluate students' perceptions of the strengths and weaknesses of virtual TBL. METHODS: This mixed-methods, pre-post, cross-sectional study utilized an anonymous survey to collect the data. Pharmacy students completed a survey to compare their perceptions and attitudes toward learning, class experience, learning outcomes achieved, and satisfaction with FTF TBL vs. virtual TBL using a 5-point Likert-type scale. Additionally, the survey included two open-ended questions to gather students' perceptions of the strengths and weaknesses of virtual TBL. Quantitative survey data were analyzed using the Wilcoxon matched-pairs signed rank exact test, while qualitative survey data were analyzed using thematic analysis. RESULTS: A total of 117 students (response rate of 59.4%) completed the study survey. Pharmacy students perceived FTF TBL to be superior to virtual TBL in their attitudes toward learning, class experience, learning outcomes achieved, and overall satisfaction across various students' characteristics. While the students identified some unique strengths of using virtual TBL, they also highlighted several weaknesses of using this learning modality compared to FTF TBL. CONCLUSIONS: Pharmacy students perceived FTF TBL to be superior to virtual TBL across various students' characteristics. These findings can be helpful to pharmacy programs considering the implementation of virtual TBL in their didactic curricula. Future research should explore whether a purposefully designed virtual TBL environment, as opposed to the pandemic-driven emergency TBL planning, can influence students' perceptions and attitudes toward virtual TBL.

Tricyclic Antidepressants in Nociceptive and Neuropathic Pain: A Review of Their Analgesic Properties in Combination With Opioids.

Objectives: To determine the efficacy and safety of commonly prescribed tricyclic antidepressants (TCAs) as analgesics for nociceptive and neuropathic pain in combination with opioids. Data Sources: A comprehensive literature review was conducted with the assistance of a medical reference librarian on PubMed, MEDLINE, Scopus, and Web of Science using the following search terminology: "Amitriptyline" OR "Doxepin" OR "Desipramine" OR "Imipramine" OR "Nortriptyline" OR "Clomipramine" OR "Trimipramine" AND "Analgesia." Reports of adult patients who received any TCA as an adjunctive analgesic to opioids were included. Study Selection and Data Extraction: A total of 293 results were obtained from the initial database inquiries, following which exclusion criteria were applied and 6 articles were included in this review. Three of the reports detailed the use of TCAs in the perioperative setting, whereas the remaining 3 evaluated their effect on different etiologies of neuropathic pain. Data Synthesis: Tricyclic antidepressants were found to have modest, yet not insignificant, independent analgesic properties, although the ability to provide pain relief was relegated to a select few agents. Desipramine has the most data available for use in nociceptive, postoperative pain through its ability to potentiate and prolong the analgesic effects of opioids and was not associated with adverse drug effects. Conclusions: The efficacy of TCAs for neuropathic pain was not corroborated by this review, and the anticholinergic adverse effects associated with this drug class were found to be significant. Further research is needed to quantify the efficacy of TCAs in the management of nociceptive pain.

Muscle relaxants as adjunctive analgesics in the perioperative setting: A review of the literature.

Patients undergoing surgical procedures are one of the few populations that still require substantial doses of opioid medications to provide analgesia, despite the best efforts of clinicians to integrate non-opioid adjunctive analgesics into practice. While many options exist with varying degrees of evidence, one drug class that deserves renewed consideration are muscle relaxants. Although these medications have differing mechanisms of action and require a more thorough evaluation of patient parameters prior to administration as opposed to other adjunctive analgesics, it is readily apparent by the results of this review that these agents may be able to mitigate pain and limit opioid usage. The objective of this review was to determine the efficacy and safety of adjunctive muscle relaxers for the purposes of analgesia in the perioperative setting.

An Atypical Case of Extreme Polypharmacy.

A commonly reported definition of polypharmacy is the numerical definition of 5 or more medications daily, and definitions have ranged from 2 or more to 11 or more medications. In this case report, an extreme case of polypharmacy is presented, highlighted by the inordinate number of drugs used over time throughout the patient's care. A 48-year-old African American female with multiple comorbidities experienced a serious adverse drug event (ADE) prompting reporting to MedWatch, the US Food and Drug Administration's adverse drug event reporting system. The patient's concomitant medications included 146 drug entities, across 82 therapeutic drug categories. It is apparent that the greatest influence on the occurrence of polypharmacy was the presence of multiple comorbidities, and treatment centered around addressing each morbidity with drug therapy. This case illustrates the insidious nature of polypharmacy and raises questions as to the appropriate progression and limits on the use of multiple medications.

Remdesivir and Coronavirus Disease 2019 (COVID-19): Essential Questions and Answers for Pharmacists and Pharmacy Technicians.

Objective: To conduct a review of the investigational drug remdesivir and its therapeutic potential for treatment of COVID-19, in the form of a series of questions and answers. The purpose of the review is to narrow gaps in knowledge, clarify concepts, and to investigate research advancements for health care professionals. Data Sources: From June 2020 to August 2020, we conducted comprehensive searches of MEDLINE-PubMed, Scopus, and Google Scholar databases with no time limitations. Search terms were included that contained the terms "remdesivir," "COVID-19," "novel coronavirus" and "evidence," "therapy," "safety," "effectiveness," "efficacy," "clinical trial." Study Selection and Data Extraction: The sources of information include all publicly available data from previously published research reports. Reports must have at least one reference to remdesivir as a treatment modality for COVID-19 with no specified outcomes. Data Synthesis: Major research findings on the efficacy and safety of remdesivir are summarized in tabular format and presented in chronological order. Results of this review reveal remdesivir to be an effective therapy in specific clinical contexts; however, in several areas, available data are insufficient to support evidence-based guidance for remdesivir in the treatment of COVID-19. Conclusions: Clinical trials on remdesivir are ongoing, yet questions remain and further research is needed as to the selection of patients, effectiveness, and duration of treatment in the use of remdesivir for treatment of COVID-19.

A Comparison of Tertiary Drug Resources' Consistency Regarding Drug-Drug Interactions of Adjunctive Analgesics.

Background: Health care providers routinely rely on tertiary drug information resources to affirm knowledge or proactively verify the safety and efficacy of medications. Though all patient care areas are affected, the reliability of these resources is perhaps nowhere as poignant as it is in high-acuity settings, including the emergency department and the intensive care unit. As providers seek to identify adjunctive analgesics for acute pain in these areas, they must be able to rely on the integrity to whichever resource their institution has granted access. Objective: To determine the congruency of drug-drug interaction information found on 3 tertiary drug resources. Methods: A drug-drug interaction analysis was conducted on Micromedex, Lexicomp, and Medscape. Adjunctive analgesics included dexmedetomidine and ketamine, which were compared with the intravenous opioid products morphine, fentanyl, and hydromorphone. Results: Significant discrepancies were appreciated with regard to the severity of drug-drug interactions. In addition, the heterogeneity in which reaction severity and likelihood are described by each respective resource makes direct comparisons difficult. Interaction warnings for dexmedetomidine and fentanyl included a "major interaction" from Micromedex, whereas Lexicomp did not identify a risk and Medscape only recommended increased monitoring on the grounds of respiratory and central nervous system depression. Conclusions: Health care providers must remain vigilant when reviewing tertiary drug information resources. Pharmacists possess the training and skills necessary to assist interdisciplinary medical teams in providing optimal patient care through evaluating and applying the information gleaned from these resources.

Efficacy and Safety Considerations With Second-Generation Antipsychotics as Adjunctive Analgesics: A Review of Literature.

Objective: To determine the efficacy and safety of second-generation antipsychotics (SGAs) as adjunctive analgesics. Data Sources: A comprehensive literature review was conducted between August 2020 and January 2021 on PubMed, Scopus, and ProQuest Central. Study Selection and Data Extraction: Keyword and Boolean phrase searches using the following terminology were conducted: "Quetiapine" OR "Risperidone" OR "Olanzapine" OR "Ziprasidone" AND "Analgesia" NOT "Psychosis" NOT "Psych." Articles that involved human adult patients who received any of the SGAs mentioned in the searching filter with an opioid were included. Articles that described pediatrics, pregnant women, patients who received any of these agents for treatment of psychosis and articles that were not in English, or readily translatable to English, were excluded. Data Synthesis: Three articles were selected for inclusion in this review, with 2 articles detailing reports with olanzapine and 1 article describing a randomized, controlled trial with extended-release quetiapine. Both olanzapine and quetiapine were able to decrease pain scores on the numeric rating scale, indicating a reduction pain experienced, and additionally reduced opioid craving behavior in patients. Depression scores and quality-of-life indicators improved with quetiapine, though those metrics were not studied with olanzapine. Conclusions: Select SGAs, specifically extended-release quetiapine and olanzapine, may serve as an appropriate adjunctive analgesic choice in select patients. Further research is required in a clinical setting to determine the exact role of this drug class in pain management.

The Irony of MedWatch and the FAERS Database: An Assessment of Data Input Errors and Potential Consequences.

Health care delivery revolves around accurate documentation, with data management free from error. A seemingly insignificant typographical error can cause short- and long-term problems that may lead to inaccurate records and misinformation. This report presents an overview of input errors in the US Food and Drug Administration Adverse Event Reporting System (FAERS). The focus is on errors and inconsistencies in reporting of drug names in the FAERS database, initiated through input of the MedWatch reporting system. The consequences from erroneous data input-in this case, drug names-can have an impact on data integrity, research, and patient safety.

Opioids and frequency counts in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database: a quantitative view of the epidemic.

BACKGROUND: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database. METHODS: Drug data were obtained from the DRUG and OUTCOME files in the database. Drugs identified included: morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin. Frequency counts and concomitant deaths of opioid drug names were determined via the MySQL database management system. RESULTS: Fifteen different opioid drugs identified in the FAERS database were associated with ADEs, including death, and 3 drugs (oxycodone, hydrocodone, fentanyl) accounted for more than half of the reports. The highest frequency count value was 158,181 for oxycodone, which represents approximately 20.2% of the frequency counts for the opioids. The lowest frequency count value was 2,161 for dextromethorphan, which represents approximately 0.3% of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%). CONCLUSION: The FAERS database represents an important source for detection and reporting of adverse drug events (ADEs), in particular the opioids and related drugs. It remains a challenge to estimate the true incidence of ADEs for this class of drugs in the general population.

Association of Hospitalization With First-Line Antidepressant Polypharmacy Among Veterans of Iraq and Afghanistan With Post-Traumatic Stress Disorder: Examining the Influence of Methodological Approaches.

OBJECTIVE: To compare the influence of various statistical analysis approaches while assessing the marginal effect of polypharmacy (prescription of multiple psychotropics including a first-line antidepressant) on all-cause hospital admission among veterans diagnosed with post-traumatic stress disorder. METHODS: Data were obtained on 398 Iraq/Afghanistan veterans being followed in a southwestern U.S. health care system from October 2005 through September 2009, diagnosed with post-traumatic stress disorder and receiving first-line antidepressants (serotonin selective or serotonin norepinephrine reuptake inhibitors). High-dimensional propensity score (hd-PS) approaches were considered, examining both covariate adjustment per PS deciles and propensity weighting, with results compared to those of standard multivariable logistic regression. RESULTS: Veterans prescribed polypharmacy did not appear to have increased odds of admission in either the decile-adjusted hd-PS model (odds ratio [OR] = 2.1; 95% confidence interval [CI]: 0.9-4.9, not significant [ns]) or traditional covariate-adjusted logistic model (OR = 2.1; 0.9-5.0, ns). Inverse probability of treatment (OR = 2.1; 1.3-3.3) and standardized-morbidity-ratio-weighted (OR = 2.2; 1.3-3.6) hd-PS models estimated similar odds of admission with narrower CIs. CONCLUSIONS: Future research should incorporate alternate analytical methods for observational data and investigate their respective biases relative to clinician treatment decision-making. For several analytical approaches, greater risk of admission among patients prescribed antidepressant-related polypharmacy was observed despite recommended guidelines, suggesting the need to investigate why clinicians may deviate from guidelines.

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet.

BACKGROUND: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. OBJECTIVE: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. METHODS: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. RESULTS: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. CONCLUSIONS: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet.

Attrition of Canadian Internet pharmacy websites: what are the implications?

BACKGROUND: The unavailability of Internet pharmacy websites may impact a consumer's drug purchases and health care. OBJECTIVE: To address the issue of attrition, a defined set of Canadian Internet pharmacy websites was examined at three separate time intervals. METHODS: In February to March 2006, 117 distinct, fully functional "Canadian Internet pharmacy" websites were located using the advanced search options of Google and the uniform resource locator (URL) for each website was recorded. To determine website attrition, each of the 117 websites obtained and recorded from the previous study was revisited at two later periods of time within a 4-year period. RESULTS: After approximately 4 years and 5 months, only 59 (50.4%) sites were found in the original state. Thirty-four sites (29.1%) had moved to a new URL address and were not functioning as the original Internet pharmacy. For 24 sites (20.5%) the viewer was redirected to another Canadian Internet pharmacy site. CONCLUSION: Of concern for patients if Internet pharmacy sites were suddenly inaccessible would be the disruption of continuity of care.

Full circle-old drugs prove more beneficial than newer agents for schizophrenia: a case report.

A 55-year-old female with a diagnosis of schizophrenia currently resides in an assisted living facility in a large metropolitan suburb. For approximately 25 years, the patient was relegated to a life of poor symptom control and social adjustment, largely due to nonadherence, relapse, and rehospitalization. The patient experienced a trial-and-error approach to drug therapy, which resulted in reliance on the older or first generation agents for symptom improvement. This case supports the assertion that the second-generation or atypical antipsychotics used to treat schizophrenia are no better than older drugs in terms of efficacy or tolerability.

Pharmacy cases in Second Life: an elective course.

Interactive pharmacy case studies are an essential component of the pharmacy curriculum. We recently developed an elective course at the Rangel College of Pharmacy in pharmacy case studies for second- and third-year Doctor of Pharmacy students using Second Life® (SL), an interactive three-dimensional virtual environment that simulates the real world. This course explored the use of SL for education and training in pharmacy, emphasizing a case-based approach. Virtual worlds such as SL promote inquiry-based learning and conceptual understanding, and can potentially develop problem-solving skills in pharmacy students. Students were presented ten case scenarios that primarily focused on drug safety and effective communication with patients. Avatars, representing instructors and students, reviewed case scenarios during sessions in a virtual classroom. Individually and in teams, students participated in active-learning activities modeling both the pharmacist's and patient's roles. Student performance and learning were assessed based on SL class participation, activities, assignments, and two formal, essay-type online exams in Blackboard 9. Student course-evaluation results indicated favorable perceptions of content and delivery. Student comments included an enhanced appreciation of practical issues in pharmacy practice, flexibility of attendance, and an increased ability to focus on course content. Excellent student participation and performance in weekly active-learning activities translated into positive performance on subsequent formal assessments. Students were actively engaged and exposed to topics pertinent to pharmacy practice that were not covered in the required pharmacy curriculum. The multiple active-learning assignments were successful in increasing students' knowledge, and provided additional practice in building the communication skills beneficial for students preparing for experiential clinical rotations.

Open-access publishing for pharmacy-focused journals.

PURPOSE: Pharmacy-focused journals that are available in open-access (OA), freely accessible, hybrid, or traditional formats were identified. METHODS: Relevant journals were accessed from PubMed, International Pharmaceutical Abstracts, EMBASE, and the Pharmacology and Pharmacy category of Thomson Scientific Journal Citation Reports. Criteria were established to select journals that satisfied the definition of pharmacy focused. Journals were assessed based on accessibility, copyright transfer requirements, and restrictions. If tracked, the journal's impact factor (IF) was identified according to classification, and medians were calculated for each journal category. RESULTS: A total of 317 pharmacy-focused journals were identified. The majority of pharmacy-focused journals identified were traditional/non-OA (n = 240). A smaller number of journals were freely accessible/ non-OA (n = 37), freely accessible/non-OA with content restrictions (n = 20), or freely available/non-OA with date restrictions (n = 18). The fewest number of journals were completely OA (n = 2). The median IF for the 185 journals whose IF was tracked was 2.029. The median IF for freely accessible and hybrid journals (n = 42) was 2.550, whereas the median IF for traditional journals (n = 143) was 1.900. CONCLUSION: A very small number of pharmacy-focused journals adhere to the OA paradigm of access. However, journals that adopt some elements of the OA model, chiefly free accessibility, may be more likely to be cited than traditional journals. Pharmacy practitioners, educators, and researchers could benefit from the advantages that OA offers but should understand its financial disadvantages.

Comparison of simvastatin tablets from the US and international markets obtained via the Internet.

BACKGROUND: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. OBJECTIVE: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. METHODS: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pharmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. RESULTS: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. CONCLUSIONS: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

"Insight" into drug quality: comparison of simvastatin tablets from the US and Canada obtained via the Internet.

BACKGROUND: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US. OBJECTIVE: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. METHODS: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis. Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets' internal structures. RESULTS: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. CONCLUSIONS: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.