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Genetically engineered human insulin received federal approval nearly 10 years ago, but the pace of federal approval for new biotechnology drugs remains painstakingly slow. In any case, hospitals will soon face a multitude of financial, ethical and procedural issues surrounding these drugs.
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OBJECTIVE: To describe how developments in the pharmacy profession in The Netherlands converged into the current movement toward pharmaceutical care. SETTING: Dutch community pharmacy. DESCRIPTION: Literature was reviewed for key elements of pharmacists' professional development over the last 40 years--the pharmacist-physician relationship, the pharmacist-patient relationship, the education of the pharmacist, provision of information to patients, medication surveillance, clinical pharmacy, and social pharmacy. Consideration was given to how, when and if these elements interacted and contributed to the movement toward pharmaceutical care. RESULTS: During the early years of the 20th century the professional role of the pharmacist, based on preparing medications, declined because of the increased industrial production of drugs. In The Netherlands, a number of developments, starting around 1995, led to a "reprofessionalization" movement in pharmacy, characterized by pharmacists' increased awareness of social and ethical responsibilities with respect to drugs and patients. These developments included an improved relationship between pharmacists and physicians, the implementation of clinical pharmacy and medical surveillance in daily community pharmacy practice in the 1970s and 1980s, and the increased awareness of the rights of patients to quality drug information and counseling in the 1980s and 1990s. By the end of 1980 these trends had coalesced into a professional movement supporting the need for a pharmaceutical care model of practice. CONCLUSION: Dutch pharmacy is gradually implementing pharmaceutical care in daily community practice. However, a proactive attitude, not only from the "front runners," but from all pharmacists, is desirable if pharmaceutical care is to be incorporated into routine community practice.
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PURPOSE: U.S. and Canadian health-system pharmacists' perceptions of the importance of managerial skills and self-ratings of skills were studied. METHODS: A questionnaire asking recipients to rate the importance of 61 pharmacy management skills and to rate their own skill levels was prepared. The instrument was mailed in 2000 to pharmacy managers in Canada. Participants in the Leadership in Healthcare Administration for Pharmacists conference in Phoenix, Arizona, received the survey at the end of the 2001 and 2002 conferences. Participants in the 2002 Department of Veterans Affairs pharmacists' conference in Memphis, Tennessee, received the survey eight weeks before the conference. RESULTS: The net response rates for the Canadian, Arizona, and Tennessee surveys were 52.7%, 56.9%, and 38.4%, respectively. The five skills rated most important in each of the three surveys were all practice foundation skills and tended to be required by all health care managers. Skills rated least important were also generally similar among the surveys. Only five skills demonstrated a significant mean difference in perceived importance among the surveys. In all three surveys, demonstrating ethical conduct was rated the most important skill and was judged by participants to be their greatest strength. Using an organized system for staying current with managerial literature was cited as the greatest weakness by the Tennessee sample and the second greatest weakness by the Canadian sample. CONCLUSION: Surveys in the United States and Canada found differences and similarities in pharmacy managers' opinions of the importance of managerial skills and in self-rated managerial strengths. Also identified were gaps in training.
OBJECTIVE: Pharmacy availability of emergency contraception (EC) is necessary for timely access to this important contraceptive method. This is especially important in rural areas where pharmacies are fewer and further apart. STUDY DESIGN: This study was conducted using a telephone survey of 186 pharmacies located in the northeast region of Pennsylvania. RESULTS: Only 32% of the pharmacies had EC in stock, which did not differ by rural or urban location. Pharmacies that stocked EC in rural counties were less likely to have evening store hours compared with urban counties (p=.01). Pharmacies that did not stock EC most frequently cited lack of perceived need as the reason (61%). CONCLUSION: Emergency contraception availability in pharmacies is uniformly low in this region of Pennsylvania, creating a significant access barrier. Although there were no significant differences in EC availability between rural and urban pharmacies, additional barriers in rural settings could impede timely access to EC for rural women.
OBJECTIVES: To identify challenges that current and future pharmacy executives are facing or will face in the future and to define what skills, knowledge, and abilities (SKAs) are required to successfully negotiate these challenges. DESIGN: Delphi method for executive decision making. SETTING: Civilian pharmacy profession. PARTICIPANTS: 110 pharmacists who graduated from the GlaxoSmithKline Executive Management Program for Pharmacy Leaders. INTERVENTIONS: Two iterations of the Delphi method for executive decision making separated by an expert panel content analysis. MAIN OUTCOME MEASURES: Round 1--participants were asked to identify five major issues they believed to be of greatest importance to pharmacy leaders in the next 5-10 years and name specific SKAs that might be needed by future leaders to successfully deal with those issues. An expert panel reviewed the issues, classified issues into specific domains, and titled each domain. Round 2-participants rated the SKAs on a 7-point scale according to their individual assessment of importance in each domain. RESULTS: For Delphi rounds 1 and 2, response rates were 21.8% and 18.2%, respectively. More than 100 total issue statements were identified. The expert panel sorted the issues into five domains: management and development of the pharmacy workforce, pharmacy finance, total quality management of work-flow systems, influences on the practice of pharmacy, and professional pharmacy leadership. Five of the top 15 SKAs-and all four highest ranked items--came from the professional pharmacy leadership domain, including ability to see the big picture, ability to demonstrate the value of pharmacy services, ability to lead and manage in an ethical manner, and skills for influencing an organization's senior leadership. CONCLUSION: Through successful integration of communication skills, critical thinking, and problem solving techniques, future public-sector pharmacy executives will be better equipped to effectively position their organizations and the profession for the challenges that lie ahead.
OBJECTIVE: To propose adoption of practice standards for pharmacists based on the principles of pharmaceutical care that are parallel to internationally accepted ethical precepts governing clinical research. DATA SOURCES: Relevant literature selected by the authors. SUMMARY: Pharmaceutical care practice standards can create a continuum of high quality care for patients from research through practice and are presented as a rational solution to managing the benefits and risks of medication use. By implementing these practice standards, patients are empowered to become active participants in the treatment process, knowledge of drug effectiveness and safety is increased, and the pharmaceutical care practitioner's responsibilities are delineated. More than a quarter century ago, the research community adopted the ethical principles of respect for persons, beneficence, and justice, as outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Under these guidelines, research subjects are considered participants, knowledge of medication efficacy and safety has increased, and investigator responsibilities have been defined. However, these guidelines only apply to the life cycle of a drug before approval by the Food and Drug Administration. Once the product is released for general use, fewer standards are applied. Pharmacy has the opportunity to establish parallel standards for the clinical use of medications in patients by establishing patient care practices in consonance with pharmaceutical care practice. CONCLUSION: Pharmaceutical care practitioners need to apply new practice standards that allow them to contribute meaningfully to appropriate, effective, safe, and convenient drug therapy for all patients. Such pharmaceutical care practice standards could ensure consistent vigilance throughout the life cycle of the drug product and result in rational, appropriate, effective, safe, and convenient drug therapy for all patients.
OBJECTIVE: To determine the number of professional associations and boards of pharmacy in the United States that have adopted or are considering to adopt a conscience clause as part of their codes of ethics, rules, laws or regulations. BACKGROUND: Pharmacists are often exposed to ethical dilemmas in their day-to-day practice and their response depends on a number of factors, including the personal beliefs and values of those involved. This has lead some professional associations to address whether their members have the right to refuse to participate in procedures which are contrary to their conscience or moral convictions. The outcome of these discussions is usually the development and adoption of a conscience clause. METHODS: A one-page self-administered questionnaire was sent by Fax to the highest ranking officer of 108 pharmacy organizations in the United States. RESULTS: Thirty-five completed questionnaires were received for a 32.4% response rate. In general, it was found that there is a lack of knowledge as to what a conscience clause is. Only two state associations and one board of pharmacy responded that they have a conscience clause as part of their code of ethics or regulations. Reasons given for not having a conscience clause included lack of interest and low priority. Nevertheless, four state associations, one national association and one board of pharmacy responded that they are considering developing a pharmacist conscience clause. More professional associations than boards of pharmacy expressed interest to obtain information about conscience clauses. CONCLUSION: Although many state associations and boards of pharmacy that responded do not have a conscience clause as part of their codes of ethics, laws or regulations, this survey shows an increasing interest to learn about it. This is expected as the pharmacist assumes increasing responsibility in patient care.
The importance of interdependence in the future of the pharmacy profession is discussed. In politics, economics, business, and health care, the pursuit of individual independence is giving way to the realization that interdependence is necessary for future success. Communication technology and the accelerated growth of new knowledge foster interdependence. When one sector of society creates large and interdependent structures, other sectors with which it interacts must do likewise to retain a balance of power or influence. Interdependence--sharing ideas and information--has helped institutional pharmacists to gain influence in health care; with this influence have come responsibilities and risks. Pharmacists' contribution to clinical research is increasingly respected and needed by the pharmaceutical industry. However, compromised ethical standards are at risk when drug companies reward pharmacists for research or presentations involving their products or for influencing prescribing of these products. Industry is also dependent on pharmacists making purchasing decisions. Biotechnology products in particular set the stage for potential conflict of interest. Pharmacy should formulate guidelines defining standards of conduct; ASHP is encouraged to establish a commission on ethics. Guidelines might require (1) that pharmacy and therapeutics committee members fully disclose any relationship with manufacturers of drugs considered for the formulary and (2) that pharmacists' publications in industry-sponsored literature and presentations at industry-supported educational programs be objective and scientifically sound. Successful organizational leadership will require the ability to identify opportunities for interdependence.
A 1998 incident in which patients' prescription information was used to advertise a new drug exemplifies the importance of confidentiality in the era of managed care and computers. The ethical concerns voiced about this incident can also apply to pharmacy benefits management programs. The use of personal health information in pharmacy benefits management is particularly important because of increased pressures to control rising drug costs. Specific confidentiality concerns include whether the goal of benefiting patients will be achieved and whether the means are appropriate. The means may be problematic because of financial conflicts of interest, lack of patient authorization, inappropriate access to information by third parties, and inadequate safeguards for confidentiality. Policies should be crafted that protect confidentiality while allowing appropriate use of personal health information in pharmacy benefits management. Sound policies should require clear evidence of benefit to patients, an oversight committee, patient authorization, disclosure or prohibition of conflicts of interest, additional safeguards for sensitive medical conditions, strong confidentiality protections, and restrictions on advertising.
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The Arden Syntax for Medical Logic Modules standard language for knowledge-based computer systems is described. Knowledge systems can use computerized patient data in decision-making. Although they have the potential to reduce adverse drug events and infection rates, improve drug dosing, and decrease the cost of care, knowledge systems have not yet reached the average patient. Arden Syntax for Medical Logic Modules is the standard language for defining clinical decision rules that drive alerts, reminders, clinical guidelines, and data interpretations. Each medical logic module (MLM) in an Arden Syntax knowledge base is designed to make one type of decision. MLMs usually represent either rules that can be encoded, such as generating a warning that the potassium concentration is decreasing in a patient taking digoxin, or complex decision trees for individual patient care plans and clinical protocols. An MLM contains maintenance slots (title, file name, version, originating institution, author, date, specialist, validation information), library slots (stating the MLM's purpose and providing keywords for searching), and knowledge slots (containing the "essence" of the MLM). Arden Syntax is receiving growing support from the medical and information systems communities as the standard language for medical knowledge systems, but legal, ethical, regulatory, and ownership issues remain. If pharmacy is to grow and prosper as a knowledge profession, it should adopt an accepted standard language for representing active, applied knowledge in computer systems.
Current concepts in gene transfer and its application to the treatment of human genetic disorders, cancer, and other diseases are discussed. Gene therapy is a technique in which a functioning gene is inserted into a human cell to correct a genetic error or to introduce a new function to the cell. Many methods, including retroviral vectors, have been developed for ex vivo and in vivo gene insertion into cells. Some pharmacists have likened gene therapy to a sophisticated form of drug delivery and have envisioned an active role for the pharmacy profession. There are several safety and ethical issues related to manipulating the human genome that need to be understood. Current gene therapy efforts focus on gene insertion into somatic (nongerminal) cells only. Gene therapy has the potential to revolutionize the treatment of genetic disorders, diseases associated with a genetic component (e.g., cystic fibrosis), cancer, AIDS, and many other diseases. Gene transfer may also be used to better understand the biology of disease processes, such as the source of relapse in bone marrow transplant patients. The human genome project will undoubtedly lead to the identification, characterization, and understanding of genes that are responsible for many human diseases, and gene therapy trials are sure to expand accordingly. To date, over 40 clinical trials have been approved and more than 110 patients have been entered in gene therapy studies. There are still many technical obstacles to overcome before gene therapy can have widespread application. Injectable vectors need to be developed to simplify foreign gene administration. Perhaps the biggest problem to overcome will be engineering the target cells to be able to regulate gene expression according to physiologic needs. Pharmacists should become knowledgeable about gene transfer techniques and possible clinical applications of gene therapy to keep abreast of the newest trends in medicine.
This paper examines the obligations of pharmacy licensees and pharmacists in the context of conscience-based objections to filling lawful prescriptions for certain types of medications--e.g., standard and emergency contraceptives. Claims of conscience are analyzed as means to preserve or maintain an individual's moral integrity. It is argued that pharmacy licensees have an obligation to dispense prescription medications that satisfy the health needs of the populations they serve, and this obligation can override claims of conscience. Although efforts should be made to respect the moral integrity of pharmacists and accommodate their claims of conscience, it is argued that the health needs of patients and the professional obligations of pharmacists limit the extent to which pharmacists may refuse to assist patients who have lawful prescriptions for medically indicated drugs.
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A regional summer internship program for pharmacy students that was coordinated by seven hospitals is described. Recruiting for the Mid-Missouri Summer Intern Program began during the winter of 1987-88. Students were recruited from pharmacy schools throughout the Midwest and were provided with housing and financial compensation while in the program. Each participating hospital agreed to hire at least one intern and appointed a preceptor or coordinating pharmacist, who met with the intern regularly. Students got most of their training and work experience at their home hospital; however, they also rotated to the other participating hospital pharmacy departments. Students had to keep a daily diary of their activities and to complete individual special projects. At the end of the summer, students and preceptors completed a written evaluation of the program. Students indicated that the program provided a valuable and unique educational experience. Preceptors thought that fourth-year and fifth-year students were best suited for the program. The hospital pharmacy directors agreed that the opportunity to evaluate a student's work ethic and professional capabilities before offering a position was a benefit. A regional summer internship program was successful in introducing pharmacy students to institutional pharmacy practice.