Research and Education Needs for Complex Generics.

Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e. complex generics) are an important element of the United States (U.S.) Food and Drug Administration's (FDA's) Generic Drug User Fee Amendments (GDUFA) II Commitment Letter. The Center for Research on Complex Generics (CRCG) was formed by a grant from the FDA to address challenges associated with the development of complex generics. To understand these challenges, the CRCG conducted a "Survey of Scientific Challenges in the Development of Complex Generics". The three main areas of questioning were directed toward which (types of) complex products, which methods of analysis to support a demonstration of bioequivalence, and which educational topics the CRCG should prioritize. The survey was open to the public on a website maintained by the CRCG. Regarding complex products, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and inhalation and nasal products. Regarding methods of analysis, the top three selections were locally-acting physiologically-based pharmacokinetic modeling; oral absorption models and bioequivalence; and data analytics and machine learning. Regarding educational topics, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and data analytics, including quantitative methods and modeling & simulation. These survey results will help prioritize the CRCG's initial research and educational initiatives.

Oral biopharmaceutics tools: recent progress from partnership through the Pharmaceutical Education and Research with Regulatory Links collaboration.

OBJECTIVES: To summarise key contributions of the Pharmaceutical Education and Research with Regulatory Links (PEARRL) project (2016-2020) to the optimisation of existing and the development of new biopharmaceutics tools for evaluating the in vivo performance of oral drug products during the development of new drugs and at the regulatory level. KEY FINDINGS: Optimised biopharmaceutics tools: Based on new clinical data, the composition of biorelevant media for simulating the fed state conditions in the stomach was simplified. Strategies on how to incorporate biorelevant in vitro data of bio-enabling drug products into physiologically based pharmacokinetic (PBPK) modelling were proposed. Novel in vitro biopharmaceutics tools: Small-scale two-stage biphasic dissolution and dissolution-permeation setups were developed to facilitate understanding of the supersaturation effects and precipitation risks of orally administered drugs. A porcine fasted state simulated intestinal fluid was developed to improve predictions and interpretation of preclinical results using in vitro dissolution studies. Based on new clinical data, recommendations on the design of in vitro methodologies for evaluating the GI drug transfer process in the fed state were suggested. The optimized design of in vivo studies for investigating food effects: A food effect study protocol in the pig model was established which successfully predicted the food-dependent bioavailability of two model compounds. The effect of simulated infant fed state conditions in healthy adults on the oral absorption of model drugs was evaluated versus the fasted state and the fed state conditions, as defined by regulatory agencies for adults. Using PBPK modelling, the extrapolated fasted and infant fed conditions data appeared to be more useful to describe early drug exposure in infants, while extrapolation of data collected under fed state conditions, as defined by regulators for adults, failed to capture in vivo infant drug absorption. SUMMARY: Substantial progress has been made in developing an advanced suite of biopharmaceutics tools for streamlining drug formulation screening and supporting regulatory applications. These advances in biopharmaceutics were achieved through networking opportunities and research collaborations provided under the H2020 funded PEARRL project.

[Global Standards for Pharmaceutical Education].

The environment surrounding clinical pharmacy practices has changed greatly in the past thirty-some years, basically since the end of the 1980s. During this period, the separation ratio between pharmacists' dispensing and prescribing functions has increased, from 12% to 74%. The three big events in this timeline include the beginning of pharmaceutical care for inpatients by hospital pharmacists in 1988; the transition of pharmacy schools to a six-year educational program in 2006; and the revision of Pharmaceutical Affairs Law, as well as its name change, in 2014. In concert with these events, the central role of the pharmacist has changed from being dispensing-centric to an active participation in patient treatment via medication as a member of the medical care team. As a key participant in these changes, the author helped to improve the operations of hospital pharmacists, strengthened their role with advanced information and communication technology (ICT) support, and established a baseline for clinical pharmacy research and education. Accordingly, in this paper, the history of this development will be reviewed, and the future of a global standard for pharmaceutical education will be discussed.

Student confidence with oncology pharmacy competencies.

OBJECTIVE: The purpose of this study was to assess the change in student confidence to perform oncology pharmacy competencies before and after completing oncology didactic instruction using a flipped classroom approach. METHODS: First year doctor of pharmacy students completed a survey prior to the Applied Science and Therapeutics (AST) oncology module (pre-survey) and the same survey following the completion of the oncology module (post-survey). The survey consisted of questions addressing prior oncology pharmacy experience related to employment (research or patient care) and education, level of interest in oncology pharmacy, and level of confidence to perform thirteen oncology pharmacy competencies. RESULTS: One-hundred sixteen students completed the pre-survey and 35 completed the post-survey. Students completing both surveys reported greater confidence in all oncology pharmacy competencies (p < 0.0001) after instruction. The greatest increases in student confidence were related to chemotherapy dose calculations, patient education, and drug-drug interactions. CONCLUSIONS: The delivery of oncology content using flipped classroom instruction in the AST course successfully increased student confidence in ability to perform oncology pharmacy competencies. Cancer screening, cancer risk factors, and the preparation and dispensing of chemotherapy were competencies identified as needing greater emphasis in classroom instruction. Future studies are needed to assess student's knowledge and application of oncology pharmacy competencies in both the experiential and classroom settings.

The Need for Palliative Care in Pharmacy Education.

There is a growing need for palliative care pharmacists in the United States. There is also a gap in the education of palliative care for pharmacy students. To address both, pharmacy schools must develop and disseminate palliative care-focused experiences, including traditional didactic lectures, problem-based learning, interactive skills, laboratory- and web-based experiences. This commentary presents the need for palliative care-focused experiences in the Doctor of Pharmacy (PharmD) degree program, and how schools can take smaller steps to tackle this issue.

A Hospital-based Pharmacy Internship Program in Jordan.

Objective. To develop a hospital-based pharmacy internship program in a comprehensive cancer care center in Jordan and review its outcomes over a 10-year period.Methods. King Hussein Cancer Center developed a two-year internship program for pharmacy students in Jordanian universities. The program included training in operational and clinical settings during the academic year and school holidays. In addition, the students completed rotation-related assignments and met weekly with the program director. During the rotations and at the end of the program, interns were asked to assess their level of satisfaction with the program and to comment on its content and structure. Results. From a pilot phase with only three interns and a simple training structure, the two-year internship program has become more structured now training six interns annually. During the first 10 years of the program, 51 students from four universities in Jordan enrolled in the program, with six current interns, 34 graduates, and 11 withdrawals. Graduates reported improved academic performance and satisfaction with the program's structure and the skills obtained. Their main challenge was time management during the academic year. Conclusion. A hospital-based pharmacy internship program is feasible and sustainable. Participation in the program improves interns' academic performance and clinical and professional skills, despite the challenges of highly demanding conditions on both the hospital and the students.

Palliative and end of life care content within common pharmacy textbooks.

INTRODUCTION: This study compared the end-of-life care (EOLC) content in pharmacy-related textbooks to textbooks evaluated in a comparable 2003 study. METHODS: Six common pharmacy-related textbooks were reviewed for content relating to EOLC. Five of the textbooks were the newest editions of the same texts reviewed in a similar 2003 study, and one focused primarily on clinical ethics, a topic that was underrepresented in the previous study. The six texts were searched for a list of 33 keywords or phrases pertaining to EOLC. Entries containing any of these 33 keywords were assigned a domain and scored using a simple scoring system of one if minimally helpful content was present or two if helpful content was present. The total number of entries and their average scores were compared to the results of the previous study. RESULTS: The average number of entries per textbook was 154, which represents an increase from the 110.1 average number of entries in the 2003 study. However, one of the textbooks had a total of 470 entries alone. Of a total number of 78 possible domains, 40 had either zero or one entries. The average ratings for each book ranged from 0.5 to 1.6, whereas they ranged from 0.9 to 1.6 in 2003. Four of six books in this study had average rating of less than 0.9. CONCLUSION: Although certain texts have made strides to include more EOLC content, overall, EOLC content in pharmacy textbooks may still be improved.

Reflections on 500 Call-in Radio Shows.

Pharmacy educators, whether in didactic classes, laboratory settings, or experiential opportunities, search for ways to incorporate "real life" patient questions and concerns into the educational process. This practice not only enhances the educational opportunities for students, it also prepares them for questions and concerns that they will inevitably face as practicing professionals. This commentary describes listener calls from 500, live, call-in radio shows. There is no accurate way to directly assess information that patients do not know or understand. The author suggests using commonly asked pharmacy-based questions, directly from the public, as a proxy to identify the information most desired by patients. The author assumes that radio callers are not calling to ask questions when they already know the answers. Thus, having identified the information most desired by radio-show callers, pharmacist educators, no matter the setting, can be provided with a ready-made resource that lists the most common concerns from over 6,000 radio callers. The author recommends educators use this resource and apply real patient questions and concerns during the educational process, furthermore, opportunities to use this resource are provided.

The Shrinking of Formalized Nutrition Education in Health Professions Curricula and Postgraduate Training.

The quantity of formalized nutrition education is shrinking in curricula of health professions, such as physicians, nurses, dietitians, and pharmacists. The current nutrition education being taught in U.S. schools of healthcare professionals does not appropriately prepare students for identification of patients at nutrition risk or management of undernourished hospitalized patients with specialized nutrition therapies. In U.S. schools of pharmacy, parenteral nutrition is considered a highly specialized and advanced practice so little time is devoted to this area and more attention is focused on chronic disease state management (ie, hypertension, diabetes mellitus, and congestive heart failure). Nutrition support fellowships for physicians and nutrition support residency programs for pharmacists have dwindled in number over the years so that only a handful of these healthcare professionals are produced each year from the remaining formalized programs. Physicians, nurses, pharmacists, and dietitians can positively affect patient care, but each profession must first determine how best to integrate basic and applied nutrition concepts into their professional curricula and training programs. There must also be consensus among the healthcare professions as to the depth of nutrition education and the stage of training at which these integrations should occur. Only by having these crucial conversations among all disciplines will we be able to develop new strategies to expand nutrition education in the training of future medical practitioners.

The prevalence of exercise prescription-related course offerings in United States pharmacy school curricula: Exercise is Medicine.

Exercise training has proven to be beneficial in the prevention of disease. In addition, exercise can improve the pathogenesis and symptoms associated with a variety of chronic disease states and can attenuate drug-induced adverse effects. Exercise is a drug-free polypill. Because the benefits of exercise are clear and profound, Exercise is Medicine, a joint initiative between the American Medical Association and American College of Sports Medicine, was launched in 2007 to call on all health care providers to counsel patients and prescribe exercise in the prevention and treatment of chronic disease states. Pharmacists play an increasing role in direct patient care and are the most accessible health care providers in the community. Thus, pharmacists should be knowledgeable in counseling patients on the frequency, intensity, time, and type of exercise that is appropriate for various conditions and disease states. The aim of the present study was to determine the prevalence of didactic course offerings in United States pharmacy school curricula regarding training in exercise prescription. School websites were accessed for information regarding course offerings in PharmD programs. No United States pharmacy schools offered courses that were dedicted to the role of exercise in disease prevention or exercise prescription in disease management. Ninety percent of pharmacy schools did not offer courses with the keywords "exercise," "fitness, or "physical activity" in the title or description. The data suggest that student pharmacists are not adequately trained to counsel patients on the benefits of exercise or exercise prescription.

Using Simulation to Improve First-Year Pharmacy Students' Ability to Identify Medication Errors Involving the Top 100 Prescription Medications.

Objective. To evaluate first-year pharmacy students' ability to identify medication errors involving the top 100 prescription medications. Design. In the first quarter of a 3-quarter pharmacy self-care course, a didactic lecture on the most common prescribing and dispensing prescription errors was presented to first-year pharmacy students (P1) in preparation for a prescription review simulation done individually and as a group. In the following quarter, they were given a formal prescription review workshop before a second simulation involving individual and group review of a different set of prescriptions. Students were evaluated based on the number of correctly checked prescriptions and a self-assessment of their confidence in reviewing prescriptions. Assessment. All 63 P1 students completed the prescription review simulations. The individual scores did not significantly change, but group scores improved from 79 (16.2%) in the fall quarter to 98.6 (4.7%) in the winter quarter. Students perceived improvement of their prescription checking skills, specifically in their ability to fill a prescription on their own, identify prescribing and dispensing errors, and perform pharmaceutical calculations. Conclusion. A prescription review module consisting of a didactic lecture, workshop and simulation-based methods to teach prescription analysis was successful at improving first year pharmacy students' knowledge, confidence, and application of these skills.

Issues and Prospects from the OTC Industry vis a vis Pharmaceutical Education and OTC Medicines.

In the amendment of the Pharmaceutical Affairs Law in 2013, a new category, Pharmacist Intervention Required Medicines (PIRM), was introduced, and other OTC medicines, which were classified after the 2006 amendment, were allowed to be sold via the Internet. Regarding PIRM, Japan's Ministry for Health, Labour and Welfare designates medicines which require special intervention by a pharmacist who explains their proper use to a patient through a face-to-face consultation, wherein the pharmacist provides guidance based on pharmaceutical knowledge and experience. This encourages consumers to approach their longer term personal healthcare with a rational knowledge of medicines, and dovetails with the direction described in "Japan is Back". Along with the 2006 amendment, an upgraded 6-year curriculum for the study of pharmacy in preparation for becoming a pharmacist was introduced. This allows student pharmacists to have more experience working in community pharmacies, thus supporting and providing pharmacists with the knowledge they need to better help the consumer to rationally use OTC medicines and self-select proper OTC medications. And this is not only restricted to OTC medicines, as there are many items sold in local pharmacies available to be utilized by the consumer with reasonable support by pharmacists. There is an expectation that the pharmacist be prepared to assist the consumer not only with prescriptions, but also with OTC medications, supplements, medical accessories, etc. using their knowledge and experience.

Involvement of Pharmacists in Medical Care in Emergency and Critical Care Centers.

Emergency and critical care centers provide multidisciplinary therapy for critically ill patients by centralizing the expertise and technology of many medical professionals. Because the patients' conditions vary, different drug treatments are administered along with surgery. Therefore, the role of pharmacists is important. Critically ill patients who receive high-level invasive treatment undergo physiological changes differing from their normal condition along with variable therapeutic effects and pharmacokinetics. Pharmacists are responsible for recommending the appropriate drug therapy using their knowledge of pharmacology and pharmacokinetics. Further, pharmacists need to determine the general condition of patients by understanding vital signs, blood gas analysis results, etc. It is therefore necessary to conduct consultations with physicians and nurses. The knowledge required for emergency medical treatment is not provided during systematic training in pharmaceutical education, meaning that pharmacists acquire it in the clinical setting through trial and error. To disseminate the knowledge of emergency medical care to pharmacy students, emergency care training has been started in a few facilities. I believe that medical facilities and universities need to conduct joint educational sessions on emergency medical care. Moreover, compared with other medical fields, there are fewer studies on emergency medical care. Research-oriented pharmacists must resolve this issue. This review introduces the work conducted by pharmacists for clinical student education and clinical research at the Emergency and Critical Care Center of Nihon University Itabashi Hospital and discusses future prospects.

[Education Program of Kampo-medicine for Undergraduates in Preparation for Clinical Setting].

Kampo-medicine has become popular in Japanese medical practice combined with western medicine. For example, Daikenchu-To for intestinal obstruction after surgical operation, Shakuyakukanzo-To and Goshajinki-Gan for anti-cancer agents-induced neuropathy, and Yokkan-San for behavioral psychological symptoms of dementia are alternatively used in addition to conventional treatments in Japan. However, combined use of Kampo-medicine and western medicine may cause unexpected adverse events including undesirable drug-drug interactions because Kampo-medicine was not originally developed to be used with western medicine. Although adverse effects of Kampo-medicine are rare compared with those of western medicine, severe events such as liver dysfunction and interstitial pneumonia have been reported in increasing trends. Medical staff including pharmacists, therefore, should be aware of the onset of adverse events before the patients' symptoms become severe. Several adverse effects are caused by chemical constituents such as glycyrrhizin in licorice for pseudoaldosteronism and geniposide in Gardeniae fructus for mesenteric phlebosclerosis. To understand the adverse effects of Kampo-medicine, pharmacists should learn trends in current medication as well as pharmacology and toxicology of the chemical constituents in pharmacognosy. These issues should also be addressed in educational materials for students of clinical pharmacy and pharmacy practice.

[Kampo Medicine in the New Model Core Curriculum of Pharmaceutical Education].

What should we educate for Kampo medicine in the model core curriculum of pharmaceutical education? The curricular core should be discussed considering the points mentioned below. (1) Positioning of Kampo medicine in the Japanese medical care system. Kampo medicine is an authorized medical care category in the National Health Insurance (NHI) program in Japan. The NHI drug price list carries 148 Kampo formulations. According to the report of the Japan Kampo Medicines Manufacturers Association in 2011, approximately 90% of Japanese physicians prescribe Kampo medicines. (2) Differences between Kampo medicine and western medicine: In Kampo medicine, the most suitable formula among various Kampo formulas to normalize the psychophysical state of individual patients is selected. In other words, if there is a complaint, there are always some treatments. (3) A strong point of Kampo medicine: Kampo medicine enables physicians to deal with difficult-to-treat conditions by western medicine alone. Also, by using the scale of Kampo medicine, each patient can grasp his or her own systemic state and improve their lifestyle. To extend healthy life expectancy, a basic knowledge of Kampo medicine may play a significant role in integrated health care. "The guide book of the approval standards for OTC Kampo products", "the pharmaceutical advanced educational guideline", and "the manual of the exam questions preparation for registered sales clerks" should also be consulted before selecting the area and contents that should be covered.

A new lexicon for polypharmacy: Implications for research, practice, and education.

Previous research suggests that polypharmacy is a significant challenge for health care systems. However, polypharmacy has been defined in at least 24 distinct ways, which has understandably caused confusion among researchers, educators, and students in health care. Previous definitions of polypharmacy capture what could be both inappropriate therapy, i.e. too many medications, as well as evidence-based therapy that is appropriate. Previous research has tried to focus on the number of medications a patient is prescribed to define polypharmacy; however only focusing on the number of medications a patient is taking may be of limited value in determining whether that patient will experience an adverse event. This paper proposes a lexicon change for polypharmacy. It suggests that in future research, polypharmacy be defined as patients going to more than one pharmacy for their prescriptions. The authors also proffer a new term, 'extraordinary prescribing,' to define patients who are taking medications that are either grossly excessive or not beneficial for that patient. This definition is different than the current use of polypharmacy because the number of medications a patient is taking is irrelevant, especially if that patient has multiple chronic diseases. This paper is meant to start a dialog within the health services research community to inform future research that examines why inefficient prescribing may harm patients and the broader health care system.

Is there a need to teach pharmacogenetics?

Pharmacogenetics/pharmacogenomics has been subject to considerable development during the past 10 years and seems likely to advance even more rapidly in the next decade. Several surveys suggest that initial training for health-care professionals-particularly physicians and pharmacists-frequently includes education in this area, but equipping these professions more generally to deal with ongoing development of the field and to make best use of new knowledge remains an important challenge.

Pharmacist credentialing in pain management and palliative care.

A credential is documented evidence of a pharmacist's qualifications; while credentialing is the method used to acquire, confirm, determine, and document a pharmacist's qualifications to practice. Voluntary credentials are important in clinical pharmacy specialties to ensure proficiency in caring for patients with complex pharmacotherapy needs. This article discusses current and future pharmacy pain management and palliative care credentialing opportunities. Pharmacists wishing to pursue voluntary pain management and palliative care credentialing may elect to take a multidisciplinary pain credentialing exam offered by the American Society of Pain Educators (ASPE) or American Academy of Pain Management (AAPM) and/or complete an American Society of Health System Pharmacists (ASHP) Postgraduate Year 2 (PGY2) pain management and palliative care pharmacy residency. A palliative care credentialing exam is not currently available to pharmacists. Efforts are underway within the pharmacy profession to standardize the board certification process, design a pain and palliative certificate program, and create a specialty pain management and palliative care board certification examination.

[Regulatory science: modern trends in science and education for pharmaceutical products].

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

Educational opportunities and anti-doping roles and responsibilities for pharmacists.

Drug use and abuse by athletes has become a common problem. Pharmacists can assist by managing the legitimate medication needs of athletes to prevent them from accidentally using a banned substance. Pharmacists can also educate athletes and the public about the health consequences of using performance-enhancing substances. Pharmacists can play a variety of roles to assist with anti-doping. Such roles include educating, advising, dispensing and monitoring medications and supplements; and working with anti-doping agencies. There are few established educational opportunities for pharmacists and pharmacy students. Educational programs in sports pharmacy and doping control need to be developed for instruction in the classroom, for post-graduate training and for experiential programs. Classroom instruction should include information about performance-enhancing substances and general principles of doping control. Student activities for an established advanced pharmacy practice experience include education on performance-enhancing substances and assay technologies, preparing and providing presentations to athletes and others regarding these substances, performing literature research on drugs and dietary supplements used to improve athletic performance, writing a monograph on these substances, and participating in doping control programs.