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YAKUGAKU ZASSHI, 123(3),77-89, 2003
Risk management in the medical field is said to be entering into the third generation. By definition, the first generation covers the period until some 10 years ago when medical errors themselves used to be regarded as inconceivable and therefore as something of a taboo. The second generation is a period in which those concerned with medical treatment grappled squarely with this issue of medical errors and compiled manuals of “near miss” cases in an effort to prevent errors. After that, such an idea has come into existence that even the deepest carefulness threatens errors that could develop into the disputes among those involved. The thought of this kind has resulted in the deepening of understanding of the importance of risk management. As a result, the point of view on this issue has been getting broader to cover not only prevention of errors but also prevention of disputes. This type is called third-generation risk management. In this sense jurisprudent pharmacy or legal pharmacy, which is a kind of pharmacy that constitutes medical pharmacy, is aimed at feeding back the lessons learned from litigations to pharmacy to improve and develop it as a practical science and contributing to the realization of “patient-centered medical science.”
Key words--jurisprudent pharmacy; third generation risk management; alternative resolution; patient-centered medical science
YAKUGAKU ZASSHI, 123(3),91-106, 2003
The Japanese Pharmaceutical Law was revised at the end of July 2002. The important features of this revision are the postmarketing safety scheme, especially for biological products, and reconstruction of the legislation for effective pharmaceutical development. This is based on the national policy to foster life sciences such as genetic research and regenerative medicine for both healthcare improvement and industrial promotion. Such research requires study participants who donate human tissue including abandoned embryos or aborted fetuses, which may touch the human dignity. In particular, fetal stem cell research appears to have unpredictable risks not only to women who undergo abortions but also to societal epistemology. The authors conducted risk-benefit assessment of fetal stem cell research, reviewing the scientific, ethical, legal, and social aspects, including a case study of critical appraisal on a report of the double-blind, sham surgery-controlled trial of implantation of fetal tissues in patients with Parkinson's disease conducted in the USA. It is concluded that risk-benefit assessment with a wide, profound perspective is necessary for advanced biotechnology. Some types of research should not be assessed based only on such utilitarian viewpoints as risk and benefit. Conscientious reflection is necessary to reach a public consensus on which types of human material can be utilized as research or pharmaceutical resources.
Key words--pharmaceutical law; regenerative medicine; aborted fetus; bioethics; risk-enefit assessment; biotechnology
YAKUGAKU ZASSHI, 123(3),107-119, 2003
This article provides an overview of the use of human materials and information (human subject) in the new phase of pharmacological research and development in the current context, especially as it relates to the progress of the human genome project. In a sense, humanity has been drastically reduced to an array of DNA sequences that can be universally used in comparing living things. Pharmacological studies now acquire a unique status in bridging chemical substances to human body function. To perform the full activity of the nature of pharmacology, it requires both genotype and personal information, i.e. medical records and life style information, as research resources. In the UK, the Medical Research Council, the Wellcome Trust, and the Department of Health had started to plan UK Biobank for promoting and supporting the new stage of medical and pharmacological research and development. UK Biobank will collect DNA samples, medical records, and life style information of 500,000 people between the age range of 45 to 69 years old. It will follow the changes in health status of the participants for more than 10 years. The Biobank will provide researchers chances to correlate the genotypic traits to phenotypic ones, i.e. common diseases. In relation to the secondary use of medical records in health research, National Health Service (NHS) initiated a new strategy on the governance of patient information. These movements clearly demonstrated the indispensable nature of infrastructures for promoting and supporting pharmacological and medical research. We discuss on the necessary policies in constructing the Japanese infrastructure.
Key words--genome research; medical records; human subject; ELSI (ethical, legal, and social issues); nature of science
YAKUGAKU ZASSHI, 123(3),121-132, 2003
By October 2002, the separation of prescribing and dispensing in Japan had already been implemented for 28 years since the system was inaugurated in 1974. Although the separation rate reached 44.5% in 2001, the questions, “Is the separation necessary in Japan?” or “Has the system been working successfully?” are often heard. These questions are raised because people have not noted the advantages of the system yet, and because the separation itself has many problems or shortcomings. These questions are not only from pharmacists, but also from physicians, patients, or medical and educational institutions. If the problem concerns pharmacists, it is assumed to stem from their lack of ability required for the separation. A breakthrough for an early solution of the problem will be found in a change in education, which includes a range of clinical subjects and long-term clinical practices.
Key words--problems of separation; separation of prescribing and dispensing; ability required for separation; long-term clinical practices
YAKUGAKU ZASSHI, 123(3),133-142, 2003
The pharmacoeconomics is relatively new field in pharmaceutical science. In August, Pharmaceutical Society of Japan published “model core curriculums for pharmacy education” and pharmacoeconomics is included in it. As the Japanese health insurance system is composed of fee for service system and small patients' co-payment, physicians as well as patients have not needed pharmacoeconomic analysis. However the recent economic squeeze begin to direct their attention to the pharmacoeconomics research. The pharmacoeconomic analysis is intended to show alternatives to the decision maker for their consideration. The analyst should not impose his of her conclusion on the decision maker. The analysis must reflect the actual medical practice under the circumstances where the decision-making will be done. Pharmacists in hospitals are expected to conduct pharmacoeconomic analysis for themselves, using their hospital's data, for their decision maker, hospital manager. This article introduces some pharmacoeconomic analysis and outlines analytical measures for the economic evaluation such as cost utility analysis and cost benefit analysis.
Key words--pharmacoeconomics; cost utility analysis; cost benefit analysis; willingness to pay
YAKUGAKU ZASSHI, 123(3),143-150, 2003
In Japanese pharmaceutical community, there seems to be a lack of “Science of Science” and “Research on Research” which are to utilize unit sciences and research for the benefit of human being. In other words, pharmaceutical people in Japan should have much more pharmaceutical philosophy. The late Professor Komei Miyaki, founder Editor-in-Chief of FARUMASHIA, the monthly membership magazine of Pharmaceutical Society of Japan, under whom I worked as one of editorial board members, taught me that scientists should have their own philosophy of their sciences. Such a pharmaceutical philosophy as mentioned above should be established on the basis of complete separation of medical profession between doctors and pharmacists, which form the most important and necessary issue in safety assurance for patients with the complete zero defect (ZD action), as there is a long history for that in Europe since the separation was completed by King Friedrich II in 1240. Therefore, we have to learn the social status of European/American pharmacist practitioners who are the great No. 1 among all the professions. European pharmacists guarantee the safety of every chemical used for human body and pets, such as medicines, cosmetics, foods, tooth stuffs and so on. Regarding the pharmaceutical sciences in Japan also there seems to be a lack of pharmaceutical philosophy, as pharmaceutical scientists have no identity in research object that may be similar to basic scientists who are non-pharmacy graduates. Japanese sciences generally have developed along the lines of the Western model, reaching the current high level. We now not only should receive profits from the outside but also should embark on a mission to support pharmaceutical sciences throughout the world, especially Asian courtiers. At the present, we do not seem to be fulfilling our mission to do that, even though general activity includes significant international exchange. We have to make much more effort for international contribution/participation. For that, the most important and necessary issue is to make change in fundamental sense in Japanese pharmaceutical community, though an internationalization of technological issues is usually taken into consideration. In this connection, regarding the new drug development, we must have a change in the sense to establish pharmaceutical philosophy and jump up in conception from the existing one. Based on the above mentioned pharmaceutical philosophy, seven star pharmacists should be educated as described in 2000 FIP Statement of Policy: Good Pharmacy Education Practice, who could be a (3) care giver; (2) decision maker; (3) communicator; (4)leader; (5) manager; (6) life-long learner; (7)teacher.
Key words--pharmaceutical philosophy; science of science; research on research; professional separation between medical doctors and pharmacists; creation of new pharmaceutical science; seven star pharmacists
YAKUGAKU ZASSHI, 123(3),151-155, 2003
We performed an investigation of medication notebook utilization among patients in Iwai City and conducted a questionnaire survey of physicians to evaluate its usefulness. The patients who used our insurance pharmacies for dispensing prescriptions were queried about six items, i.e., age, types of acute or chronic disease, possession of a medication notebook, efficient use of a medication notebook, consultation at two or more medical institutions, and efficient use of the medication notebook at the other medical institutions. The medication notebook possession rates were 73.1% and 94.6% among those aged 69 yeas or younger and among those aged 70 yeas or older, respectively. Furthermore, one patients who unified their drug information from two or more medical institutions into one medication notebook accounted for 55.4% and 73.2% of patients with chronic diseases aged 69 years or younger and those aged 70 years or older, respectively. As a result of the questionnaire survey, 92.3%, 76.9%, and 69.2% of physicians evaluated the medication notebook favorably in preventing duplicate prescriptions, avoiding drug interactions, and deferminins side effects due to prescriptions from other medical institutions, respectively. To increase the effective use of the medication notebook in patients with chronic diseases aged 69 years or younger, we need to promote an educational campaign instructing them in its clinical usefulness.
Key words--medication notebook; pharmacy; questionnairesurver; usefulness; chronic disease
YAKUGAKU ZASSHI, 123(3),157-162, 2003
Low-dose oral contraceptives (OCs) were approved by the Japanese Ministry of Health, Labor and Welfare in 1999. However, few women use low-dose OCs (married 1.9%, unmarried 0.7%). A survey of pharmacies was conducted to determine the current status of OC transactions. Of the 449 pharmacies randomly selected from each prefecture in Japan, 408 agreed to be interviewed. The survey results indicated that few pharmacies (15.1% of the total) stocked low-dose OCs. Even among pharmacies where they were available, only a few (13.5%) offered a wide variety of low-dose OCs for immediate dispensing. The price of low-dose OCs varied widely (¥1,167-¥7,000). In many pharmacies, the amount of space and interior structure were not adequate for users to seek advice on and receive low-dose OCs. The survey revealed that the current environment of many pharmacies is not adequate for users to visit, consult on OC use, and receive their prescriptions. To promote wider use of low-dose OCs, the facilities of pharmacies as well as the behavior of pharmacists need to be improved to safeguard the privacy of users.
Key words--low dose pill; pharmacy; stock; price; privacy
YAKUGAKU ZASSHI, 123(3),163-171, 2003
With recent advances in the separation of dispensing and prescribing drugs (Bungyo), the social role of community pharmacists has expanded. Therefore we carried out a questionnaire survey on the “image of community pharmacists” among patients/the public, physicians, and community pharmacists. The understanding of their role by community pharmacists differed slightly from that by patients/the public or physicians. Better mutual understanding among the three parties is necessary for smooth communication. Dispensing and handing over drugs to patients are not the only tasks required of community pharmacists. Evaluation of records of telephone drug counseling by the Japan Pharmaceutical Association revealed that many callers desired not only drug information but also the opinions and judgments of pharmacists. Providing drug information is an important task for community pharmacists. In addition, counseling on anxiety and worries about health may be necessary. Bungyo has also affected drug distribution. In this field, the role of community pharmacists in providing drug information may markedly change in the future.
Key words--Bungyo; community pharmacist; image of community pharmacists; telephone drug counseling; correspondence analysis
YAKUGAKU ZASSHI, 123(3),173-178, 2003
In recent years, a pharmacist's work has changed in terms of therapeutic management and counseling of patients. Generally, a pharmacist has to provide pharmaceutical care in cooperation with a doctor. In the present study, a questionnaire survey on what a doctor expects of a pharmacist was conducted, and directors of hospital were interviewed on what they expect of a pharmacist. Eighty-two doctors participated in the survey. As results, doctors consider that a pharmacist's work is dispensing of drugs (41%), and highly evaluated the works of a pharmacist in advising doctors regarding pharmacotherapy (29%), checking the prescription (28%), providing patient compliance instructions (27%) and providing drug information (26%). Five directors of hospital expect the pharmacists to carry out risk managements and prescription checks, provide drug information, and consultation on drug costs. In addition, doctors want pharmacists to have more knowledge on pharmacotherapy. These results clearly show what doctors expect of a pharmacist's work.
Key words--pharmacist; doctor; work; questionnaire; dispensing; pharmacotherapy
YAKUGAKU ZASSHI, 123(3),179-183, 2003
Separation of medical practice from pharmaceutical dispensing had been a system with just the notation without the reality even after Showa era, although its concept was brought into Japan along with European medicine in Meiji era. Since 1970's, its concept has been prevailing gradually, and the so-called separation rate currently has reached to 47 percent. Increasingly keen attention has been paid recently by the public toward medicine in general. Taking into consideration these facts, a questionnaire survey was conducted for dispensing pharmacists in order to find out where pharmacists stand at present. Most of pharmacists (98.3%) answered that they practice patient counseling either by documents or by verbal communication, and that they take patient profiles. They said that patients could enjoy a proper medical treatment (32.9%) as well as a rational prescribing (14.3%). For a question asking what pharmacists should do to promote the separation of medical practice from pharmaceutical dispensing, 40.3% of them answered that they should make progress in their knowledge on drug therapy.
Key words--separation of medicine from pharmacy; patient counseting; pharmaceutical care
YAKUGAKU ZASSHI, 123(3),185-190, 2003
In recent years, the system for the separation of dispensing and prescribing functions (SDP) has progressed in Japan. However, because of the failure of the healthcare system, it is difficult to estimate how the system of SDP contributes to the improvement of patient utility and welfare. In this paper, I try to evaluate the SDP by analyzing the strategic behavior of dispensing pharmacies, employing some economic models under imperfect information. In these models, quality is characterized as a strategic variable in monopolistic or duopolistic competition. As a result, I show that competition among dispensing pharmacies in the SDP raises the quality of pharmaceutical services, but there is some possibility of “excess entry” with free entry.
Key words--strategic behavior; dispensing pharmacy; separation of dispensing and prescribing functions
YAKUGAKU ZASSHI, 123(3),191-200, 2003
We developed the WAKASHIO Pharmacotherapeusis Network system. This system electronically links physicians' offices with pharmacies to share clinical records and offers the means for real time bi-directional information input. The system is equipped with individual signature (handwriting) recognition protocols to ensure strict enforcement of security and privacy. The network enables front-line pharmacists to access to pertinent clinical records. We performed a series of tests (a “shakedown cruise”) of the system and examined the role of the pharmacist as a counselor for patient compliance with prescribed therapeutic regimens. The results indicated the following: 1) This system provides an unequivocal means of communication between physicians and pharmacists. 2) This system is useful for judicious resolution of potential problems arising from separation of the domains of prescriber and dispenser. 3) A noteworthy finding was that community pharmacists devote substantial time/effort to counseling patients concerning their pharmacotherapeutic regimens. 4) Over 80% of patients responded with statements such as “Now I understand my medicines better,” and “I am free of anxiety over my medication now.” Thus the system provides a powerful tool to promote patient compliance based on pharmacological knowledge. Our future plans for the system include: 1) implementation of an inquiry/response protocol to enhance risk management; 2) online prescription issuance; and 3) expansion of the database used for patient counseling and improvement of the counseling method. Finally, physician-pharmacist collaboration through the system will contribute to a clear redefinition of their respective roles in community medical care services.
Key words--Electronic Pharmacotherapeusis Network; clinical data exchange; online resource for patient counseling; redefinition of the roles of physicians and pharmacists
YAKUGAKU ZASSHI, 123(3),201-209, 2003
To promote the appropriate use of pharmaceuticals and to prevent side effects, physicians need package inserts on medicinal drugs as soon as possible. A medicinal drug information service system was established for electronic medical records to speed up and increase the efficiency of package insert communications within a medical institution. Development of this system facilitates access to package inserts by, for example, physicians. The time required to maintain files of package inserts was shortened, and the efficiency of the drug information service increased. As a source of package inserts for this system, package inserts using a standard generalized markup language (SGML) form were used, which are accessible to the public on the homepage of the Organization for Pharmaceutical Safety and Research (OPSR). This study found that a delay occurred in communicating revised package inserts from pharmaceutical companies to the OPSR. Therefore a pharmaceutical department page was set up as part of the homepage of the medical institution for electronic medical records to shorten the delay in the revision of package inserts posted on the medicinal drug information service homepage of the OPSR. The usefulness of this package insert service system for electronic medical records is clear. For more effective use of this system based on the OPSR homepage pharmaceutical companies have been requested to provide quicker updating of package inserts.
Key words--drug information service; package inserts; electronic medical records
YAKUGAKU ZASSHI, 123(3),211-215, 2003
We investigated the correlation of peak inspiratory flow (PIF) with peak expiratory flow (PEF) in 29 bronchial asthma patients, and the improvement of inhalation technique with a dry powder inhaler (DIP) before and after medical consultation in 3 patients. There was a significant positive correlation (R=0.772, p<0.001) between PIF and PEF in asthmatics. Furthermore, PIF and PEF the values were low in elderly women with combined complications of emphysema. Two of 3 patients who had experienced the problem of residual medicine improved their inhalation technique after the medical consultation compared with before. These results indicate that the clinical examination of PIF and PEF and medical consultation on inhaled steroid use in bronchial asthma patients could be important.
Key words--bronchial asthma; inhaled steroids; medical consultation; peak inspiratory flow; peak expiratory flow