At the time of consultation with a patient regarding OTC drugs, a pharmacist goes through the following five steps. In Step 1 information is collected, including the patient's gender, age, health condition, living situation, etc. In Step 2, upon analyzing and evaluating this collected information, the pharmacist decides whether to recommend that the patient see a medical doctor or whether an OTC drug is sufficient. In Step 3, when an OTC drug is required, the pharmacist suggests the most suitable OTC drug. In Step 4, the pharmacist provides the patient recommendations and information about the selected OTC. In Step 5, sales record entry and aftercare are performed. In these five steps, the pharmacist is making a decision on whether the consultation recommendation is required or optional; the step of making an optimal selection of an OTC drug is distinct from prescription dispensing. In many cases, at the time of OTC drug consultation, since the patient is not consulting a medical doctor, a pharmacist becomes a “first access” health professional. In this instance, the advice of a pharmacist may have a great influence on a patient's prognosis regarding the particular health challenge. Therefore, pharmacists who perform patient consultations regarding OTC drugs are required to have broad medical knowledge and communication skills. The features of consultation and information dissemination about OTC drugs by a pharmacist, and the practice and study of this subject in present-day pharmaceutical education, are described herein.
For appropriate primary care practice corresponding to the various symptoms of a patient, team medicine on that combines the expertise of physicians and other medical staff has been recommended in recent years. It results in (1) higher quality of medical care, (2) lower burden on the physician, (3) better medical safety, and (4) reduced medical expenses. In order to promote team medicine through inter-professional collaboration, the responsibilities of the medical staff need to be reviewed to expand their respective roles. The Ministry of Health, Labour and Welfare designated nine specific medical acts by pharmacists in 2010. Some acts require clinical reasoning (medical interview and physical assessment) in order to manage side effects in patients undergoing drug therapy. The new curriculum introduced in 2015 includes primary care education for pharmacists who see patients before they are seen by a physician. Because such patients are usually seen by the pharmacist on a walk-in basis, medical interview and inspection education is especially important in this situation. However, there is incongruity in the physical assessment education of prospective pharmacists among schools of pharmaceutical sciences in recent years, which tends to focus primarily on vital signs. Moreover, there is currently no consensus among physicians on the optimum range of procedures performed by a pharmacist before the patient is seen by a physician. In this presentation, the practice of primary care by pharmacists is discussed from the following perspectives: (1) target symptoms and patients, (2) clinical reasoning education at pharmaceutical schools, and (3) future issues.
The promotion of self-medication by pharmacies, with the aim of encouraging a patient's self-selection of proper OTC drug, is written about in the national action plan “Japan is Back”. The subject of self-medication has been improved in the 2013 revised edition of “Model Core Curriculum for Pharmaceutical Education”. At Tokyo University of Pharmacy and Life Sciences, the systematic education of self-medication was started from the onset of the six-year course in the third, fourth and fifth grade. We introduce here a new approach in our systematic education of self-medication. In the practice of the fourth grade, groups of around 5-6 students are formed. The pharmacy students assume various roles—of pharmacist, rater, observer, and chairman—and perform role-playing. We prepared a standardized patient (SP) showing various symptoms. The student of the role of pharmacist asks about the SP's symptoms, chooses an OTC drug suitable for the SP, and explains the OTC drug to the SP. After the role-playing, those in the roles of rater, observer, SP, and faculty give feedback to the student who played the role of pharmacist. Because we conduct this role-playing using SPs with a variety of symptoms, we can create a situation similar to a real drugstore.
Japan's Ministry of Health, Labour and Welfare published “the required function and the desired operating form of a pharmacy” and proposed that “a pharmacy should demonstrate a positive role for the promotion of self-medication”. In the future, it will be indispensable to pharmacies that pharmacists play a role not only in dispensing medicine but also in serving a central health-station role in the community, including promoting the self-selection of proper OTC medications for the maintenance of health. My pharmacy in a traditional area in Tokyo carries OTC drugs, health and nursing care goods, medical supplies, etc. besides dispensing medicine by prescription. Moreover, a “sample measurement room” where a person can conduct a blood test by self-puncture was prepared in April of 2014. In addition, my pharmacy has held “health consultation meetings” for patients in collaboration with a registered dietitian, as well as “meetings for briefing sessions on how to better take or administer medicines” for parents of infants, etc. These activities have been useful to local residents in the prevention of lifestyle-related diseases and in promoting a better understanding of medicine. Moreover, on-site student trainees from schools of pharmacy are helping with planning, data collection, and explanation on the days of these meetings. For trainees from schools of pharmacy, participating in these activities is important to becoming a pharmacist trusted at the community level in the future.
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.
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.
A major difference in medical flow between acute and nonacute medical care is the urgency of diagnosis and treatment. In the acute medical setting, diagnosis and treatment sometimes must be done almost simultaneously. Learning clinical management in the acute-care setting can be the basis of drug therapy in other clinical settings. When infusion is performed in emergency medicine, stabilization of blood pH is achieved through kidney and lung functions. At the same time, the oxygen transport capacity is monitored using blood gas analysis. One medical intervention can lead to multiple diagnostic and treatment processes in the emergency medical field. Most pharmacists rarely have the opportunity to learn about the reasoning process in which different body functions are linked together such as heart, lung, and kidney functions when performing infusions in emergency medicine before starting to work in the clinical setting. Learning from emergency medicine can be applied to drug therapy in other clinical settings as it teaches how to link different body functions and understand the relationships between those functions and the results of medical tests. These are considered to be necessary reasoning skills to understand patients' conditions in various clinical situations, including management in intensive care and the treatment of chronic disease. Knowledge of emergency medicine can be the foundation of drug therapy in other clinical settings, for example, the meanings of vital signs.
Pharmacists are in demand not only because of their knowledge of medical therapy but also due to their skills in basic physical assessment and emergency care as medical personnel. Pharmaceutical education has developed using patient simulators in bedside training, seminars in hospital pharmacies, and physical assessment practice at the Kyushu University of Health and Welfare School of Pharmaceutical Sciences. We first explain the outline of the method to confirm basic vital signs with simulators and then demonstrate some simulations to enable the reproduction of drug misadministration/changes in condition. In addition, we check students' knowledge of and skill in the advanced objective structured clinical examination through practical examinations to test their technical ability in physical assessment. Furthermore, we conduct case study exercises in which students perform physical assessments and collect basic information on patient background. The Stan, Heart SIM, and Physico simulators are used. As examples of drug misadministration, the reproduction of asystole from fatal arrhythmia after the rapid intravenous injection of potassium preparations and ventricular fibrillation from tachycardia after an overdose of insulin are presented to student pharmacists utilizing the simulators. The simulation of anaphylactic shock and hyperglycemia is also possible as examples of changes in condition. Overall, pharmaceutical simulation education provides pharmacy students and pharmacists with experience in the types of medical treatment performed by various healthcare professionals, leading to explorations of the new roles of pharmacists in team medical care.
Pharmacists are expected to be active members of the healthcare team in emergency medicine, because many pharmaceuticals are administered to patients with life-threatening conditions. However, adequate education for pharmacists and pharmacy students is not provided. The “Emergency Pharmaceutical Sciences” course was introduced for the first time in Japan by the Department of Pharmacy, Okayama University, to offer advanced education in emergency medicine and research related to critical care. We offer an emergency pharmaceutical training program with high-performance simulators and have succeeded in improving the clinical skills and confidence of pharmacy students. In this review, we introduce our activities intended to mold pharmacy students into emergency pharmacists who can contribute to emergency medicine.
Among private Universities of Pharmacy in Japan, Kyoritsu University of Pharmacy was the first to introduce courses in social pharmacy in 1991. Social pharmacy is a discipline driven by social needs. By studying the relationship between pharmacy and society, particularly through case studies, the impact of drugs and changes in societal expectation of them, as well as through historical background studies and surveys of current trends, this discipline acts to determine the roles of pharmacists and pharmacies expected by society. Social pharmacy requires a basic knowledge of pharmaceutical science, but an understanding from economic viewpoints of the current systems and structures in which healthcare functions is important as well. Once these are understood, the goal is to identify social problems, and to create and apply models for their resolution which connect pharmacy and society. So far, social pharmacy has played an important role in training programs for community-based pharmacists essential for a hyper-aged society, for community pharmacies' health management programs aimed at promoting the health of residents, and educational programs for elementary and middle school children.
Requirements for education on proper use of drugs were included in the junior high school educational guideline in 2012 incorporating pharmaceutical education in the obligatory school curriculum. This move is closely related to the country's new OTC drug marketing system. The amendment of the Pharmaceutical Affairs Law (PAL) in 2013 highlighted the public's own role in “promoting proper use of drugs and other related products and making greater efforts to acquire knowledge and improve understanding of their effective and safe use”. Furthermore, the Law to Amend the PAL and Pharmacists Law enforced in 2014 allowed all OTC drugs to be sold online under appropriate rules. Deregulation of online sale of OTC drugs is expected further to promote self-medication for minor illnesses and require stricter measures to ensure people's safety through their proper use. These legal amendments in recent years have made people's education about proper use of drugs one of the top priorities Japan should pursue at state level. Since 2000, the author has been offering education on drugs to early primary school children as part of their healthcare education program. In the future, dedicated education on drugs will be necessary for people of all ages including not only school children but also their guardians and elderly citizens as well.
Taste disorder is one of the adverse effects of cancer chemotherapy resulting in a loss of appetite, leading to malnutrition and a decrease in the quality of life of the patient. Oxaliplatin, a platinum anticancer drug, has a critical role in colon cancer chemotherapy and is known to induce taste disorder. Here, we evaluated the taste functions in oxaliplatin-administered rats. Among the taste receptors, expression levels of T1R2, one of the sweet receptor subunits, increased in the circumvallate papillae of the oxaliplatin-administered rats. In a brief-access test, i.e., behavioral analysis of the taste response, oxaliplatin-administered rats showed a decreased response to sweet taste. However, we did not detect any differences in the plasma levels of zinc, number of taste cells, or morphology of taste buds between control and oxaliplatin-administered rats. In conclusion, the decreased response to sweet taste by oxaliplatin administration may be due to the upregulation of T1R2 expression.
It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a change in their dosage interval (dose-interval prolongation group). The primary end-point was time to treatment failure (TTF), and the secondary end-points were overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and adverse events. The TTF and OS of the dose reduction group were approximately two times longer than those of the dose-interval prolongation group. In addition, the dose reduction group had significantly improved ORR and CBR, which together indicate an antitumor effect (p=0.013 and 0.002, respectively). Although peripheral neuropathy occurred significantly more frequently in the patients in the dose reduction group (p=0.026), it was grade 1 and controllable in most of the cases. There were no differences in the occurrence of other adverse effects between the two groups. Therefore, we suggest that dose reduction with maintenance of the dosage interval is the preferred treatment approach in cases where Eri dose or schedule modification is necessary.
β-cryptoxanthin is a common carotenoid pigment found in fruit, especially in Satsuma mandarins and in persimmons. After ingestion, β-cryptoxanthin is distributed to and accumulates in organs, such as the liver, lung, and kidney. Recent studies have reported that because of its antioxidant defense, β-cryptoxanthin performs several important functions in the preservation of human health and in the prevention of several diseases, including cancer and osteoporosis. The present study aims to determine whether β-cryptoxanthin has a protective effect on renal glomeruli during acute nephritis. To develop our acute nephritis mouse model, we induced kidney inflammation in mice using lipopolysaccharide. To analyze pathological changes in the renal glomeruli of these mice, tissue sections of the kidney were analyzed by hematoxylin-eosin and periodic acid-Schiff staining. In mice with acute nephritis, we observed a thickening of the basal membrane in the renal glomeruli. By ultrastructural analysis, abnormalities in the foot cells were also identified. In the β-cryptoxanthin-ingested mice, these pathological changes were decreased. Migration of urinal proteins occurred in mice with acute nephritis, but this was decreased in β-cryptoxanthin-ingested mice, such that it correlated with the blood concentration of β-cryptoxanthin. Furthermore, in β-cryptoxanthin-ingested mice, both the accumulation and activation of inflammatory cells were decreased in the renal glomeruli. These results suggest that β-cryptoxanthin ingestion may produce great improvement in acute nephritis. These findings provide new insights into β-cryptoxanthin and its protective effect, and provide a new target for pharmacological therapy in human disease.
In six-year pharmacy education programs, humanistic education is now regarded as more important than ever, and we are working to incorporate active learning methods into a variety of subjects. Because performance evaluations are by their nature subjective, it is difficult to ensure the validity of any given assessment. Fifth-year students at Tohoku Pharmaceutical University learn case and prescription analysis in problem-based learning tutorials. As part of this curriculum, 20 presentation and discussion meetings over the course of 10 weeks are held, with approximately 100 students making presentations two or more times each. With regard to the presentation skills that students are expected to acquire, we instructed them to conduct peer evaluations and analyzed the evaluation results for 863 students conducted between 2012 and 2014. From the results, it was found that peer evaluation scores improved between the first and second evaluations for 70% to 86% of students, and furthermore that students who received lower scores in their first evaluations increased their scores correspondingly in the second. In addition, while 87% of students responded positively in the presentation skill acquisition self-evaluations conducted after the completion of the program, there was no correlation between the results of self-evaluation and peer evaluation. It was suggested that many students were able to cultivate an eye for criticism by evaluating other students and gain confidence by becoming aware of their own growth through repeated presentations.
In 2013, Kobe Pharmaceutical University established “Yakugaku Nyumon”, an interdisciplinary course, which consists of omnibus lectures and problem-based learning (PBL) on topics ranging from basic to clinical subjects. The themes of the PBL were original ones; “Study from package inserts of aspirin”, which aimed to reinforce the contents of the interdisciplinary lectures, and “Let's think about aspirin derivatives (super-aspirin)”, which aimed to engender an interest in studying pharmacy. The PBL featured questions from teachers to help with study and was therefore referred to as “question-led PBL” (Q-PBL). The Q-PBL regarding aspirin derivatives began with preparing answers to the questions for a small group discussion (SGD) as an assignment, followed by a SGD, a presentation, and peer-feedback. From an analysis of the questionnaire survey, it was found that students considered the Q-PBL satisfying and that they had achieved the 4 aims: (1) to increase the motivation to study, (2) to enhance an understanding of the relations and significance of basic and clinical sciences, (3) to comprehend the learning content, and (4) to recognize the importance of communication. The Q-PBL with assignments has two favorable points. One is that the first-year students can challenge difficult and high-level questions when they are given these as assignments. The other is that students, who are unfamiliar with SGD can engage in discussions with other students using the knowledge gained from the assignment. The introduction of omnibus lectures and Q-PBL, along with these improvements in theme, application, and review process, promises increased learning efficacy at the university.
Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events.