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[Historical study of clinical pharmacy education in Japan (part 2) retrospective evaluation of the roles of the one-year graduate course of clinical pharmacy practice (Yakugaku Senkouka) at Meijo University].

Clinical pharmacy practice education started 30 years ago in Japan. Since 1975, a one-year graduate course, clinical pharmacy practice (Yakugaku Senkouka), has been offered at Meijo University, making it a leading school to raise pharmacists with sufficient experience in hospital settings. This article describes the scope of the course, the development of educational systems to meet public demand for new pharmaceutical skills, and the influences on reforming the Japanese health-care system. The content consists of the following: (1) The process of building up the first curricula of clerkship, (2) requirements for admission, namely including an essay, an interview, school records and an aptitude test, (3) establishing the teaching discipline, (4) achievement goals, (5) learning process modeled on methods used in the United States, (6) establishing the concept of medical ethics, (7) professional status of course graduates, and (8) nationwide influence on the social health-care of the country. The one-year graduate course of clinical pharmacy practice was terminated in 2002 and is to be reintroduced as a two-year graduate school course to cope with the present and future trends in health-care systems.

Education, Pharmacy, Graduate↗

The American Pharmaceutical Association: a lens for viewing pharmacists (from compounders to therapeutic judges).

OBJECTIVE: (1) To document the changes that have occurred in pharmacy in the last century and (2) to investigate the role played by the American Pharmaceutical Association (APhA) during the changes. DATA SOURCES: Journal of the American Pharmaceutical Association (JAPhA). STUDY SELECTION: Sample articles published in JAPhA pertaining to practice and ethical issues. DATA EXTRACTION: Examples of articles at 10-year intervals from 1912 through 1997. DATA SYNTHESIS: Short reviews of the articles are included containing their purpose and topic. Authors' notes are included where appropriate. The research was performed using a qualitative/historical method. CONCLUSION: The changes that have occurred in pharmacy throughout the 20th century are seen through JAPhA. APhA has been a stabilizing social structure over the years, and continues to serve society in this manner.

History, 20th Century↗

1995 National Clinical Pharmacy Services Study.

To determine the extent of hospital-based clinical pharmacy services in 1995, we surveyed 1109 United States acute care, general, medical-surgical, and pediatric hospitals with 50 or more licensed beds. Fifteen clinical pharmacy services were assessed to determine pharmacists' specific patient care responsibilities. The percentage of hospitals offering services grew between 1992 and 1995: pharmacokinetic consultations (16% increase), drug therapy protocol management (15%), drug therapy monitoring (8%), drug counseling (13%), and parenteral-enteral nutrition team (6%). All other services increased 0-5%. Pharmacists conducted clinical research in 14% of hospitals, averaging 6.3+/-22.1 protocols/department annually; total budget $96,219+/-$262,026. Patient-focused care predominated in 20% of hospitals, although most pharmacists reported to directors of pharmacy through traditional pharmacy department channels. Clinical pharmacy services continue to expand, with pharmacists providing higher-level direct patient care activities related to drug therapy management and monitoring.

Ambulatory Care↗

Drug evaluation and registration in Hungary.

In Hungary, the actual drug evaluation and registration system reflects international standards and national traditions. The compulsory drug registration system that was established in 1933 was among the first in Europe. Laboratory control (since 1927), clinical trials (since 1951) and human clinical pharmaceutical experiments (since 1967) are prerequisites for new-drug approval. Applications should be sent to the National Institute of Pharmacy, which has the overall responsibility for the registration of pharmaceutical products. Applications are assessed on the basis of the drug's quality, safety, and efficacy. The procedure follows several steps: evaluation of chemical and pharmaceutical data by the staff of the National Institute of Pharmacy; evaluation of toxicologic and pharmacologic documentation with the help of the Committee on Drug Administration; after consultation with the Committee on Medical Research Ethics (mandatory in cases of original new drugs), authorized clinical pharmacologic investigations are conducted in the units of the Clinical Pharmacological Network, which are supervised by the National Center for Clinical Pharmacology; clinical trials; application for registration (scientific evaluation); and finally, application to the Ministry of Health for a marketing authorization. The process may be facilitated appreciably for preparations already registered in another country. Moreover, Hungary is an active member in the World Health Organization (WHO), Pharmaceutical Inspection Convention of the European Free Trade Association (EFTA PIC), the Council of Mutual Economic Assistance (COMECON), and other international pharmaceutical and clinical pharmaceutical collaborations.

Drug Evaluation↗

[Jan Marian Dobrowolski--botanist and expert in herbalism (1886-1958)].

A botanist by education, Jan M. Dobrowolski devoted his whole life to the advancement of pharmacy. Working at the universities of Warsaw and Poznań, he organized medicinal herbs cultivation projects, for which he developed a theoretical basis. He also gave lectures for students of pharmacy, taking care to provide them with a comprehensive and modern eduction. Some of the less known episodes of his life include his participation in the formation of the scouting movement in Poland, his religious and ethical activity, his journalistic experiences, and his role in organizing mass-scale collection of medicinal herbs in the years of the Second World War. After the war he continued his research as well as organizational and didactic work at the University of Poznań.

Botany↗

Drug use and harm reduction policy: alternative perspectives on the California proposal.

On October, 12, 2003, then California Governor Gray Davis vetoed legislation which would have created a trial period for evaluating nonprescription pharmacy access to needles and syringes for adults in California. An analysis of California Senate Bill 774 provides a case study to examine the struggle for clean syringe and needle access as a component of disease prevention along with the community fear of tacit approval for illicit drug use. Reflecting upon the empirically-supported research and community concerns for this specific type of harm reduction policy is an important step towards forming common political ground. This article underscores the relevance of syringe deregulation and its relevance as an ethical and political issue for social workers.

Adult↗

Pharmacy agenda for change: the time is now.

In the midst of society's debate and focus on patient care and outcome, healthcare providers must articulate their strategic positioning to be part of the collective societal drive. Pharmacy as an integral component of healthcare provided, must also take the opportunity to create its own agenda for change. This agenda revolves around pharmacists agreeing on aspects of pharmaceutical care for which they are legally and ethically responsible. Pharmacists must also strive to gain social and cultural authority for those aspects for which the profession has accepted responsibility. Pharmacist action is needed to ensure appropriate drug therapy to the public.

Drug Utilization↗

Nursing practice in the next decade: the impact on nursing and pharmacy systems.

Nursing practice in the year 2000 will occur within more regulated health care systems, with a much higher focus on the cost and the quality of the service that is delivered. Patients will have more complex illnesses and treatment regimens that will require that nurses have appropriate levels of education, experience, and clinical specialization. The nursing work force will change in its nature, cost, and composition. Nurses will operate in flatter organizations and within productive multiprofessional and technical work groups that operate as flexible, self-directed teams. New clinical practice models will be operational, and they will be adapted to the unique work and environment of each patient care unit. Practice will be restructured to incorporate clinical and nonclinical support. Work redesign and restructured practice environments will be essential to meeting the requirements for the future. Patients with complicated illnesses will continue to move through hospital systems at high speeds. Treatment regimens will be extremely complex. The requirement will be to emphasize high-quality and affordable care, while minimizing errors and complications. Technology will provide new challenges, new excitement, new dilemmas, and new demands. The ethical dimensions of care will become ever more challenging. The pharmacological aspects of treatment will gain in prominence. Mutual respect and mutual support will be the hallmarks of the nursing and pharmacy interface in the year 2000.

Education, Nursing↗

Clinical pharmacy administration.

Clinical pharmacy administration has emerged as a separate discipline, but this new field has not been functionally defined. This article defines clinical pharmacy administration from an academic point of view and provides a framework within which it may be understood. It is an applied field of study that deals with the research, evaluation, and management of the patient, the drug, and the health care practitioner as they all relate to patient care. These entities and relationships are studied at the micro, macro, and global levels from financial, economic, managerial, legal, ethical, social, behavioral, educational, and historical perspectives. It is intended that this paper generate debate and discussion in order to refine and develop the field.

Pharmacy Administration↗

[Consequences for public hospital of the law of December 20th 1988 (Huriet law), concerning the protection of persons used for biomedical researches].

Does the public hospital have the capability of harbouring this research? In any case, it is an important mission entrusted to it by the Huriet law. But even before the law has come into effect (the date of applicability was initially set for January 1st 1990, postponed until June 1st 1990, and then further pushed back to December 31st 1990 due to the lack of publication of corresponding application decrees), its text has prompted many questions and much debate among numerous health sectors. We are limited in the extent to which we may estimate, within the context of the public hospital, the sphere of application and the ramifications of the Huriet law, particularly in the matters of expenses, the responsibility assumed by the hospitals' pharmacy, and the arrangement for the hospitals' management. In effect, while waiting for the expected creation of local committees for the protection of public health, the ethics committees which already exist in many hospitals carry on with their works in the spirit of this new law. The result is an accelerated awareness of the difficulties foreseen in putting this law into effect. It is these difficulties of application that we have tried to analyze.

Clinical Trials as Topic↗

Telemedicine and telepharmacy: current status and future implications.

Uses of telemedicine are described and potential roles for pharmacists are discussed. Telemedicine has been defined as "the use of electronic information and communications technologies to provide and support health care when distance separates the participants." Technologies included in telemedicine are videoconferencing, telephones, computers, the Internet, fax, radio, and television. Telepharmacy has the same basic definition but refers to pharmaceutical care provision. Although the videotelemedicine market is expected to grow considerably, lack of reimbursement and high costs are continuing obstacles. Pharmacy is using video-conferencing for education, training, and management purposes. The telephone has changed from a dial-and-talk instrument to a multimedia access tool. Medical devices are being attached to telephone lines to provide remote monitoring and therapy, and call centers are providing medication counseling, prior authorization, refill authorization, and formulary compliance monitoring. Although the Internet has quickly become a star performer, utilization by health care lags behind that of other industries. The Internet-fueled empowerment of consumers and their expectations for speed, access, and convenience are creating more unmet expectations of the traditional health care system. Pharmacy has both organizational and individual practitioner Web sites, but it is online drugstores that are attracting most attention. Potential benefits of telemedicine include improved access to care, greater efficiency in diagnosis and treatment, higher productivity, and market positioning for the coming century. Telemedicine will tax the economic, regulatory, legal, ethical, and clinical care expertise of the entire health care system. Studies of the effectiveness, cost, and societal implications of telemedicine are needed, along with practice models and standards, training programs, and solutions to regulatory, licensing, and legal questions. Securing reimbursement for cognitive services remains a problem for telemedicine and telepharmacy. Telemedicine presents profound opportunities and challenges to pharmacy and other health care professions.

Accreditation↗

Quality use of medicines (QUM) in critical care: an imperative for best practice.

Quality use of medicines (QUM) as a discrete concept is gaining increasing importance in Australia and is supported by a policy platform which has federal government and health professional support. The QUM movement is also supported by a strong consumer base and this lobby group has been responsible for endorsement as a major health initiative. However, the importance of QUM to achievement of optimal patient outcomes has not achieved sufficient recognition in the critical care literature. Implicit in the discussion of QUM is the rational, ethical, safe and effective use of drugs within a best practice framework. Successful implementation of QUM requires appropriate infrastructure and the commitment and cooperation of medical, nursing and pharmacy staff. Support, education and training provide the prerequisites of knowledge, skills and awareness for quality use of medicines for all groups. An emphasis upon evidence based practice and the prevalence of polypharmacy in contemporary health care systems requires examination of factors that are barriers to best practice. QUM in critical care areas requires appropriately skilled staff who are competent to manage patients with a wide range of selected drugs, often in highly stressful situations. In many situations in critical care, the role of the critical care nurse is one of patient advocate. It is important to note that the delivery of critical care is not limited to a discrete setting and is inclusive of management at the trauma scene, assessment and delivery of care in the emergency department, through to intensive, coronary care and high dependency units. This paper presents a discussion of the concept of QUM and its relevance in the critical care context. Key theoretical, policy and research considerations for establishment of QUM in critical care are reviewed and discussed. This paper seeks to describe key issues in QUM and endorse the need for a research agenda in critical care.

Australia↗

Availability of emergency contraception: a survey of hospital emergency department staff.

STUDY OBJECTIVE: I investigate accessibility of emergency contraception pills at hospital emergency departments and survey staff at Catholic and non-Catholic hospitals across the United States. More specifically, I sought to report the likelihood that a woman calling a hospital and seeking emergency contraception could access the medication; (2) if emergency contraception is not provided, whether hospital staff would provide a referral to another facility; and (3) the outcome of the referral process. METHODS: Using a "mystery client" approach, I telephoned staff at all 597 Catholic hospitals in the United States and at 17% of non-Catholic hospitals (n=615). I used this interviewing method to reflect the experience of a laywoman calling to inquire about the availability of emergency contraception. RESULTS: I found that staff at 42% of non-Catholic hospitals and 55% of Catholic hospitals said that they do not dispense emergency contraception, even in cases of sexual assault. Overall, more respondents at Catholic hospitals (23%) reported that they provide emergency contraception only to victims of sexual assault compared with staff at non-Catholic hospitals (17%). Among staff who said that their hospital does not provide emergency contraception under any circumstances, only about half gave callers a valid referral, and most referrals were ineffective. CONCLUSION: To improve women's access to emergency contraception, hospitals can (1) use collaborative drug-therapy agreements to enable hospital pharmacies to dispense emergency contraception without a prescription, (2) develop and communicate written policies that support provision of emergency contraception, and (3) encourage health care providers who observe religious or ethical guidelines to provide effective referrals for women seeking emergency contraception.

Catholicism↗

Review of five consecutive studies of radiolabeled immunoglobulin therapy in Hodgkin's disease.

Recurrent Hodgkin's Disease (HD) provides unique opportunities to improve radiolabeled immunoglobulin therapy (RIT). Normal tissue toxicity after RIT is limited to bone marrow damage and is well documented and quantified in HD patients. Anti-antibody formation is rare in patients with HD, allowing for multiple RIT cycles. Overall, 134 patients with recurrent HD were treated on five different studies with i.v. antiferritin, labeled with 131I or with 111In for diagnostic purposes and 90Y for therapeutic purposes. Patients with recurrent, end-stage HD obtain a 60% response rate following 90Y-labeled antiferritin. One-half of the therapy responses are complete. Responses are more common in patients with longer disease histories (> 3 years) and smaller tumor volumes (< 30 cm3) and in patients receiving at least 0.4 mCi 90Y-labeled antiferritin/kg body weight. Complete responders survive significantly longer than partial responders (2 years versus 1 year). Partial responders survive longer than patients with progressive disease (1 year versus 4 months). HD in one-third of the patients recurs in new areas. A low protein dose (2-5 mg) and a moderate specific activity (10 mCi/mg) are recommended. Results obtained with 90Y-labeled antiferritin are significantly better than results with 131I-labeled antiferritin. Further translational research in vitro in the radio pharmacy and in vivo with experimental animals is ongoing to improve the therapeutic results of RIT in HD. Obviously, many permutations of RIT cannot be explored in HD patients for ethical, financial, or logistic reasons, and predictive preclinical research is required to achieve further progress. Currently, RIT is a low-toxicity, low-cost outpatient procedure for recurrent HD with a high response rate in a patient population with an unfavorable prognosis.

Animals↗

Confronting the use of placebos for pain.

What do you do when a physician's order conflicts with your role as patient advocate? Here's how one nurse initiated a policy change that put an end to the unethical use of placebos.

Chest Pain↗

Ethical issues arising in pharmacoepidemiologic research in a community hospital in Crete, Greece.

This paper presents the various issues encountered in planning, designing, performing, and reporting pharmacoepidemiologic research. Five hundred and fifty-one indigent patients insured by Social Care visited the Hospital Pharmacy of Chania General Hospital, and were compared with 551 patients insured under Social Security funds who visited three community pharmacies. The study had no external funding. Before we started the study, we officially sought approval from the Scientific Committee of our Hospital and from the local Pharmaceutical Association. We asked also for approval from the Medical School of the University of Crete. Patient privacy was of great concern in the design and performance of the study. The law in Greece, according to the directives of European Union, affects the way we use records in hospitals and protect patient rights. After these studies were completed, we made proposals to the authorities concerning continuous health education for both patients and health workers. Pharmacoepidemiologic research is difficult in hospitals outside universities or institutions, because of the lack of adequate funding and grants to support research staff.

Bioethics↗