A Framework for Engaging Healthcare Professional Trainees as Continuing Education Activity Planners and Speakers.

Health professional education and post-graduate training programs, including residencies, fellowships, and other post-graduate training experiences, may encourage or require trainee participation in continuing education (CE) activity planning and development. Providers of CE should ensure appropriate mentorship and faculty guidance during development of the activity and provide direction on the expectations of adult learning principles (e.g. identification of an educational gap; development of measurable learning objectives; inclusion of independent, balanced, and evidenced-based content; use of active learning techniques; and incorporation of learning assessment methods). Nonetheless, there is no established best practice or approach for how CE providers should ensure trainees are prepared to serve as CE activity faculty. New practitioners provided with an opportunity to participate may be unsure of where to begin and may be hesitant to engage in this new activity. In this manuscript, authors delineate key principles to incorporate when introducing trainees to CE activity development and share outcomes associated with a comparison of trainee- vs. faculty-developed and delivered CE.

Evaluation of temperature excursions from USP <659> recommendations during mail transit.

BACKGROUND: Patients use mail delivery as a convenient alternative to acquiring medications in person. Federal laws require nonspecialty oral medications to be stored at controlled room temperature during distribution; however, no laws or regulations govern temperature requirements for medication transport among patients, which may expose medications to harmful temperature excursions. OBJECTIVE: The purpose of this study was to evaluate temperature excursions during mail transit based on the shipment method, carrier, and season. METHODS: This prospective study monitored temperature fluctuations during simulated mail transit between New Jersey, California, and Tennessee over winter (December 2019-February 2020) and summer (August-September 2020) time frames. Packages with data-logging thermometers were shipped to 3 U.S. destinations via 3 common mail carriers and 2 popular shipping methods. Three packages were mailed for each combination of season, carrier, and shipping method, representing 36 individual packages. The primary end point was percent of transit time out of range (OOR) based on the United States Pharmacopeia <659> recommended range, 68°F to 77°F. Additional end points include package transit durations and extreme temperatures. RESULTS: Evaluated packages spent an average of 68.3% of transit time OOR. In winter, 3-day and next business day packages spent similar time OOR (80.1% vs. 78%). In summer, 3-day packages spent more time OOR compared with next business day shipping (43.1% vs. 13.6%). Mean transit time was statistically significantly longer for 3-day packages (406.6 hours vs. 303.1 hours; P < 0.0001). Mean winter transit time was statistically significantly longer than summer (475.7 hours vs. 233.9 hours; P < 0.001) regardless of the shipping method. The minimum and maximum temperatures recorded were 5.1°F and 102.3°F, respectively. CONCLUSION: Package temperatures were outside of the recommended range for most of the transit time regardless of the shipping method, carrier, or season.

Opioid abuse risk among student pharmacists.

OBJECTIVE: To benchmark opioid abuse risk among student pharmacists attending three northeast pharmacy schools utilizing the opioid risk tool (ORT). DESIGN: A cross-sectional, anonymous risk assessment questionnaire. SETTING: Three pharmacy schools in the northeast United States. PARTICIPANTS: Professional year 1 (P1) through professional year 3 (P3) student pharmacists. METHODS: ORT was collected and scored by investigators and inputted into an electronic format for analysis. Students voluntarily participated, and 812 surveys were completed during one course meeting time and day at each school. RESULTS: The majority of students were in the low-risk category (n = 581, 71.6 percent). Additionally, 137 (16.9 percent) patients were categorized as moderate risk and 94 (11.6 percent) as high risk. No statistically significant differences existed when comparing risk groups across the first through third professional year student pharmacist cohorts. There were no statistically significant differences in the proportion of risk groups among the three pharmacy cohorts between low-risk versus the high-risk groups. When comparing risk groups by gender, males were found to have a statistically significant higher proportion of being classified as moderate or high risk. CONCLUSIONS: The results of this study demonstrate that there may be some student pharmacists with an increased risk for opioid abuse potential. There is potential need for education regarding opioid risk awareness and abuse prevention, which may serve as a call to action for professional school students and practitioners to understand baseline opioid abuse risk if they require chronic pain therapy.

Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials.

BACKGROUND: Melanoma is a skin cancer with a rising worldwide incidence of just over 280,000 individuals with the greatest burden of illness in European, New Zealander, and Australian populations. Patients are diagnosed with melanoma with the mean and median ages being 65 and 59 years old, respectively. Phase 3 trials not only provide a wide representation of the target population but also study the efficacy for a certain intervention. OBJECTIVE: The objective of this literature review is to analyze patient demographics of phase 3 trials for melanoma and identify if there is a true disparity between the clinical trial age demographics and the natural epidemiological age demographics. DATA SOURCES: The authors conducted a search on clinicaltrials.gov, a publicly available resource that lists clinical trials and their data. The reported mean and median ages for each trial were extracted after determining if each trial meets our inclusion criteria. Weighted mean and median ages were calculated using an online calculator. Data from 35 trials were evaluated with 30 trials reporting a weighted mean age of 55.85 years and 5 trials reporting a weighted median age of 55.14 years. CONCLUSION: Based on the results, melanoma clinical trials enroll patients who are younger than the epidemiological mean and median ages. Due to this underrepresentation of the elderly patients with melanoma, clinical trials may provide limited application for the use of their results.

Pharmacists' Perceptions and Drivers of Immunization Practices for COVID-19 Vaccines: Results of a Nationwide Survey Prior to COVID-19 Vaccine Emergency Use Authorization.

BACKGROUND: Pharmacists play a vital role in recommending and providing vaccines to improve public health and are on the front line of mass immunization efforts. AIM: The objective of this study is to evaluate pharmacists' perceptions on COVID-19 vaccines prior to emergency use authorization (EUA) amid a global pandemic. METHODS: A voluntary, anonymous, cross-sectional survey was conducted between September and November 2020. Survey respondents included a convenience sample of licensed pharmacists in the United States. The primary outcomes were pharmacists' willingness to receive and recommend hypothetical COVID-19 vaccines. Covariates assessed in the survey included COVID-19 exposure or personal experience, primary pharmacy practice setting, background in training, geographic region, and prioritization of clinical data. The data were analyzed using descriptive and inferential statistics. RESULTS: This study surveyed 763 pharmacists and results from 632 participants were included in final analysis. Overall, 67.1% of the pharmacists were willing to receive a COVID-19 vaccine and 63.4% of the pharmacists were willing to recommend a COVID-19 vaccine at ≤1 year from the time of vaccine approval. At >1 year after vaccine approval, 78% of the pharmacists were willing to receive a COVID-19 vaccine and 81.2% of the pharmacists were willing to recommend a COVID-19 vaccine. CONCLUSIONS: Survey findings suggest that, while a majority of pharmacists surveyed indicate acceptance of hypothetical COVID-19 vaccines, there remains to be hesitancy among pharmacists to receive or recommend vaccination.

Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials.

The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results.

Opinions and Trends of Healthcare Providers Concerning Scientific/Standard Response Documents.

BACKGROUND: One of the main roles of the medical information (MI) department within a pharmaceutical company is to develop scientific/standard response documents (SRDs) to provide comprehensive medical information to healthcare providers (HCPs). This study seeks to gain HCP feedback on the various elements in the format of an SRD. METHODS: This study surveyed 400 healthcare providers (200 physicians, 100 pharmacists, and 100 nurse practitioners/advanced practice nurses and physician assistants) regarding their opinions and preferences on the structure, content, layout, and delivery options of SRDs. The survey also included questions assessing where HCPs access their medical information, their trust in the medical information they receive from MI Departments, and alternative methods for receiving medical information. RESULTS: HCPs often self-search for medical information via an electronic device, which allows for SRDs to serve as a key resource. HCPs, who had prior contact with a pharmaceutical company's MI department, have a high degree of trust in the SRDs that they had received. However, perception of bias can have an impact on their level of trust. HCPs prefer all relevant data such as real-world evidence, adverse drug reactions, and clinical trial data, while abstracts and data on file may not be needed, but the overall length should only be three to five pages. HCPs find value in various SRD formatting characteristics, such as charts, tables, and infographics. CONCLUSIONS: Overall, HCPs seek medical information resources, such as SRDs, to aid in the delivery of personalized patient care. HCPs prefer SRDs to be concise, but include comprehensive, unbiased medical information. Through HCP feedback, MI Departments of pharmaceutical companies can continue to develop and update their SRDs to increase uptake and potentially impact clinical practice.

Sentiment of Media Coverage and Reputation of the Pharmaceutical Industry.

BACKGROUND: Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 and 2016 and investigate the potential relationship to the public perception of the select pharmaceutical companies. METHODS: Reputation Institute's RepTrak System report was used for selection of 5 highly rated pharmaceutical companies (A-E). Electronic newspapers were selected based on US circulation within the selected time period. Lexalytics sentiment analysis software was used for analysis of relevant articles appearing in the selected newspapers. RESULTS: A total of 797 articles were analyzed; 63% were assessed as neutral, 24% as negative, and 14% as positive. The overall median sentiment scores (scale ranging from -2 through [Formula: see text]2) for companies A through E across all newspapers were determined to be [Formula: see text]0.026, [Formula: see text]0.03, [Formula: see text]0.028, [Formula: see text]0.034, and [Formula: see text]0.033, respectively. The most frequent topics were merger/acquisition/ re-structuring, finances/stocks/profits, and other, which included topics such as transparency of pharmaceutical industry data, lack of drug efficacy, and innovation. CONCLUSION: Overall, pharmaceutical companies were represented similarly across newspapers and most articles were assessed as neutral. However, on analysis of all nonneutral articles, all categories were assessed as negative with the exception of finances/stocks/profits.

Telepharmacy: A New Paradigm for Our Profession.

Telepharmacy is a rapidly growing area of communication within pharmaceutical care delivery, especially in rural areas. The purpose of this literature review is to determine how telepharmacy is currently being practiced within community and ambulatory pharmacy settings, its effectiveness, and how it is being regulated across the United States. A literature review was performed using PubMed, Ovid MEDLINE, and the Google search engine. State-specific rules were researched using board of pharmacy and legislative online resources. Telepharmacy has been successfully implemented within community pharmacy settings through the creation of remote dispensing sites. The increasing focus of state regulations on telepharmacy services and practices shows the growth and acceptance of this modality of pharmacy practice. There is wide variation among state regulations pertaining to the setup and operation of telepharmacies. Trends in telemedicine show that telepharmaceutical care is likely to continue to expand as it allows for a better allocation of resources and access to more patients. However, research needs to be conducted to specifically analyze the value and place for telepharmacy services.

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

BACKGROUND: The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. METHODS: The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. RESULTS: An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. CONCLUSION: Lack of consistency exists between risks versus benefit proportions among different drug products.

Sleep Health and Appropriate Use of OTC Sleep Aids in Older Adults-Recommendations of a Gerontological Society of America Workgroup.

Getting a good night's sleep can be challenging for older adults with chronic medical conditions, which often interfere with sleep. As a result, many older adults turn to over-the-counter (OTC) sleep aids, that is, products with diphenhydramine or doxylamine. However, these products are indicated only for occasional difficulty with sleep, not for chronic use; and their safety and efficacy has not been well established in general and in older adults specifically. To engage national stakeholders in a discussion of OTC sleep aids in older adults, the Gerontological Society of America (GSA) convened a multidisciplinary workgroup. The Workgroup examined differences between younger and older adults in sleep health and use of OTC sleep aids using data from the National Health and Wellness Survey; assessed the pharmacologic properties and medication effects of OTC sleep aids; and worked with stakeholders to promote strategies for safe and effective use. Older adults are more likely to take diphenhydramine or doxylamine products 15 or more days in a month, an indicator of inappropriate use. The Workgroup recommends research to investigate the ways older people use OTC sleep aids. The goal should be reduction in inappropriate use and associated risks, such as daytime sedation, compromised cognitive function, and falls. In addition, the Workgroup recommends a greater role for community pharmacists in counseling older adults on appropriate use of OTC sleep aids.

The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry.

The first dual-degree program combining both the doctor of pharmacy (PharmD) and the doctor of medicine (MD) degrees was designed and launched by Rutgers, The State University of New Jersey, in academic year 2013-2014. This joint effort was led by the Ernest Mario School of Pharmacy (EMSOP) and the Robert Wood Johnson Medical School (RWJMS) to combine expertise in both diagnostic and treatment facets of health care and to prepare graduates for leadership roles in providing and managing comprehensive patient care in a variety of settings. One area of potential value of these skill sets is the drug development industry. A survey was conducted among pharmaceutical executive stakeholders associated with a postdoctoral training program to assess the perceived value of this new dual-degree skill set and to identify particular functions where the combined training has its best fit. Results indicate that the combined nature of this training is highly valued in this setting, especially in the areas of clinical pharmacology, drug safety and pharmacovigilance, medical affairs/strategy, and medical science liaisons. Future monitoring of graduates will further define the value of this dual degree in this and other health care settings.

Clinical and Economic Impact of Empirical Extended-Infusion Piperacillin-Tazobactam in a Community Medical Center.

BACKGROUND: Current medical center practice allows for the automatic conversion of all piperacillin/tazobactam orders from intermittent to extended infusion (EI). OBJECTIVE: To compare the clinical and cost impact of empirical extended-infusion piperacillin/tazobactam. METHODS: All consecutive patients treated with piperacillin/tazobactam for >48 hours were reviewed for inclusion. Patients were stratified into 2 groups: (1) traditional infusion (TI), preprotocol implementation, and (2) EI, postprotocol implementation. Patient demographics and primary and secondary diagnoses were extracted from the hospital discharge database. All patients were assessed for the primary end point of all cause 14-day in-hospital mortality. Secondary outcomes included length of hospital stay, duration of antibiotic therapy, cost per treatment course, and occurrence of Clostridium difficile infection. RESULTS: A total of 2150 patients were included (EI = 632; TI = 1518). After adjusting for comorbidity, length of stay, and age, 14-day in-hospital mortality was similar between groups (odds ratio = 1.16; 95% CI = 0.85-1.58; P = 0.37). Length of stay was similar between the EI group versus TI (mean ± SD: 12.5 ± 9.58 days vs 11.8 ± 9.58 days, respectively; P = 0.10) after adjusting for age and Chalson-Deyo comorbidity index. Total cost per treatment course was reduced in the EI group by 13% compared with the TI group ($565.90 ± $257.70 vs $648.30 ± $349.20, respectively; P < 0.0001). CONCLUSION: Automatic substitution of EI for TI piperacillin/tazobactam is safe and associated with significant cost savings. EI piperacillin/tazobactam was not associated with a reduction in mortality or length of stay.

Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like".

BACKGROUND: The way in which pharmaceutical companies are using social media is vitally important in staying competitive, but the way social media users respond is equally if not more important. This study aimed to evaluate the use of social media by the top 20 pharmaceutical companies and to determine how much consumers interacted with these posts. RESULTS: The top 20 pharmaceutical companies included in this study were present in varying degrees on Twitter, YouTube, and Facebook (90%, 70%, and 50%, respectively). A linear regression analysis between pharmaceutical company interactions and corresponding consumer interactions for each social media platform did not find a statistically significant association ( r2 = 0.44, 0.49, and 0.22, respectively). CONCLUSION: In a descriptive review of the social media posts analyzed, this study found pharmaceutical company posts to relate to disease state awareness, business updates, and community outreach projects.

Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products.

Compared with single-entity treatments, multientity or combination products have the potential to provide enhanced therapeutic utility. Because they involve components that would normally be overseen by different branches of health authorities (eg, different FDA centers), they raise numerous scientific, regulatory, policy, and review management challenges. This article summarizes the current status of the evolving combination product development landscape and potential options to address key challenges facing combination product developers. Continued collaboration and transparency among regulators, combination product developers, and other stakeholders is essential to streamlining the global combination product development and review process to ensure the availability of high-quality new products that are being used in a way that is safe and effective.

Current Trends in Personalized Medicine and Companion Diagnostics: A Summary From the DIA Meeting on Personalized Medicine and Companion Diagnostics.

Personalized medicine has reached the mainstream, accounting for more new drug approvals and a promising pipeline of candidate therapeutics. Recent advances in genomics, computational biology, medical imaging, diagnostic technologies, and translational medicine are creating the possibility for scientists to develop diagnostic tools and new treatments for cancer, genetic disorders, and infectious diseases that may be particularly effective in biomarker-defined subpopulations. Drug development under this model creates new challenges that will require the need for increased regulatory flexibility, novel clinical trial designs, and translational science development. In this review, the authors highlight key developmental and regulatory challenges in the advancement of personalized medicines and their associated companion diagnostics with the need for innovative clinical trial designs to support drug/diagnostic development and registration. Further, the clinical complexities of implementing new technologies are considered, such as high-throughput next-generation sequencing in personalized medicine, and offer a glimpse of the regulatory and policy considerations shaping this methodology in multimarker diagnostic development.

Risk evaluation mitigation strategies: the evolution of risk management policy.

The United States Food and Drug Administration (FDA) has the primary regulatory responsibility to ensure that medications are safe and effective both prior to drug approval and while the medication is being actively marketed by manufacturers. The responsibility for safe medications prior to marketing was signed into law in 1938 under the Federal Food, Drug, and Cosmetic Act; however, a significant risk management evolution has taken place since 1938. Additional federal rules, entitled the Food and Drug Administration Amendments Act, were established in 2007 and extended the government's oversight through the addition of a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. REMS is a mandated strategy to manage a known or potentially serious risk associated with a medication or biological product. Reasons for this extension of oversight were driven primarily by the FDA's movement to ensure that patients and providers are better informed of drug therapies and their specific benefits and risks prior to initiation. This article provides an historical perspective of the evolution of medication risk management policy and includes a review of REMS programs, an assessment of the positive and negative aspects of REMS, and provides suggestions for planning and measuring outcomes. In particular, this publication presents an overview of the evolution of the REMS program and its implications.

Meeting the challenges and burdens associated with hereditary angioedema.

PURPOSE: Because little is known about the burden of illness associated with hereditary angioedema (HAE), this article reviews the challenges in identifying and managing this rare disease and its humanistic and economic burdens. DESIGN: We identified studies examining the burdens associated with HAE. Conducting larger studies using claims analyses for HAE is particularly challenging, owing to the rarity of the disease in health plans and to diagnostic/coding challenges. Because the data have been limited, larger surveys of patients have been conducted. They are explored here. METHODOLOGY: We searched for studies addressing attack characterization, acute treatment, chronic disease management, adverse events, psychosocial burden, effect on work, and patient costs. PRINCIPAL FINDINGS: HAE may result in physical and/or psychological disability because of the lack of effective treatments and the unpredictability of symptom severity. The reported average annual total costs per patient are approximately $42,000, ranging from approximately $14,000 for mild cases to approximately $96,000 for severe disease. It is not known how much of this is paid by the patients, although it can be assumed that it is substantial for some. CONCLUSION: The appropriate use of disease-specific treatments for HAE may improve patients' quality of life and reduce HAE-associated morbidity and mortality while also reducing costs associated with hospitalizations and other interventions. Future cost-effectiveness studies are needed to examine these issues. Disease-specific agents are expected to significantly change the HAE treatment paradigm in the United States and dramatically improve the efficacy of medical care for these patients.

The biologic finance and access council 2nd annual biologics healthcare survey: views from key healthcare stakeholders.

Although biologics are a growing area of interest, payers, purchasers, and providers understand surprisingly little about their overall costs or benefits coverage.

The biologic finance and access council 2nd annual biologics healthcare survey: views from key healthcare stakeholders, part 2.

Part 2 of BFAC's survey reveals a range of understanding among providers, purchasers, and payers about the management of biologics and the implications of their use.