Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (<80% agreement among all participants) regarding 'Clinical Pharmacy' activities, whether non-pharmacists could provide 'Clinical Pharmacy' services, and whether such services could be provided in non-hospital settings. There was disagreement (<80% agreement among those linking items to Clinical Pharmacy) as to whether Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists accepting responsibility for drug therapy outcomes.

Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs) in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

Estudos de farmacovigilância são imprescindíveis em oncologia, pois os antineoplásicos possuem alta toxicidade e estreita janela terapêutica. Os objetivos deste estudo foram analisar o perfil das notificações espontâneas de reações adversas a medicamentos (RAM) em pacientes oncológicos e a incidência de RAM ao tratamento antineoplásico em um hospital terciário e universitário. Para compor o perfil de RAM, revisaram-se os formulários de notificação de reações em pacientes oncológicos do ano de 2010 e classificaram-se as reações conforme o medicamento envolvido, mecanismo, causalidade e gravidade. Para avaliar a incidência de reações, aplicou-se um questionário no momento da quimioterapia e a gravidade foi classificada pelos Critérios Comuns de Toxicidade. Apenas 10 reações foram notificadas ao Setor de Farmacovigilância, cujo perfil encontrado foi tipo B, grave, possível, e foram principalmente relacionadas aos compostos de platina e taxanos. Na análise da incidência das reações, observou-se que náusea, alopecia, fadiga, diarreia e distúrbio do paladar foram as reações mais frequentes relatadas por pacientes oncológicos, e as reações grau 3 e 4 não foram notificadas. De acordo com essas análises, propõe-se que os profissionais da saúde sejam treinados quanto às notificações e que farmacêuticos clínicos sejam cada vez mais inseridos neste contexto para redução da subnotificação de RAM.

Development and reliability testing of the clinical pharmacist recommendation taxonomy.

STUDY OBJECTIVE: To evaluate the reliability of a newly developed taxonomy--the Clinical Pharmacist Recommendation (CPR) taxonomy--to classify clinical pharmacy interventions. DESIGN: The CPR taxonomy was developed and refined in three phases. In each phase, reviewers independently reviewed recommendations made by a clinical pharmacist-physician team and categorized them into mutually exclusive categories: priority, problem, and response. Interrater reliability was assessed for all categories during each development phase. SETTING: Primary care clinics of a Veterans Affairs Medical Center. PATIENTS: Fifty-three patients enrolled in the Veterans Affairs Enhanced Pharmacy Outpatient Clinic (EPOC) trial. MEASUREMENTS AND MAIN RESULTS: Interrater reliability was assessed using the kappa statistic. A total of 423 recommendations were evaluated during the three testing phases. In the final testing phase, agreement was moderate for pharmacotherapy problem subcategories (kappa = 0.57), substantial for pharmacotherapy problem primary categories (kappa = 0.64), and almost perfect for response categories (kappa = 0.85). Taxonomy completion time/patient averaged 4.6 minutes (range 1-11 min). CONCLUSION: The CPR taxonomy provides a reliable method to systematically evaluate clinical pharmacy recommendations based on the therapeutic problem identified and specific action recommended to resolve the problem.

Futuro de la selección de medicamentos en el hospital / The future of the selection of medicines in the hospital

Los Servicios de Farmacia hospitalaria han tenido y tienen un papel clave en la implantación y desarrollo de los procesos de selección de medicamentos, desarrollando sistemas y procedimientos de evaluación y selección. En este artículo se analiza el estado de la cuestión apuntando estrategias para la buena selección y dispensación de medicamentos en el hospital (AU)

The hospital pharmacy services have had and continue to have a key role in the introduction and development of medicine selection processes, developing evaluation and selection system and procedures. This article analyses the state of the question, indicating strategies for the good selection and dispensing of medicines in the hospital (AU)

Reflexiones sobre la relación dirección gerencia- Servicio de Farmacia / Reflections about the relation between the general management and pharmacy services

En este artículo se analiza la relación actual y la deseada entre la Gerencia y el Servicio de Farmacia de un hospital, transmitiendo la necesidad de interactuar y establecer una buena comunicación con el objetivo de conseguir una óptima gestión de los medicamentos en el hospital (AU)

This article analyses the present relation and that desired between General Management and the Pharmacy Service of a hospital, transmitting the need to interact and establish good communication with a view to achieving optimum management of medicines in the hospital (AU)

Findings from the ISMP Medication Safety Self-Assessment for hospitals.

BACKGROUND: Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. DESIGN: A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. METHOD: A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. RESULTS: The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. CONCLUSIONS: Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.

Hospital and pharmacy characteristics associated with mortality rates in United States hospitals.

We attempted to determine hospital and pharmacy characteristics associated with mortality rates in 4864 United States hospitals. Data were obtained from the Health Care Financing Administration, the American Hospital Association, and the National Clinical Pharmacy Services survey. Univariate and multivariate regression models were used to determine which hospital characteristics were associated with mortality. A similar regression analysis was performed on 718 hospitals for which detailed pharmacy information was available. In a multivariate regression model, some characteristics of 4864 hospitals associated with reduced mortality rates were high-technology index (R2 = 0.09, p < 0.001), severity of illness (R2 = 0.048, p < 0.001), number of hospital beds (R2 = 0.016, p < 0.001), and medical personnel (R2 = 0.012, p < 0.001). This analysis accounted for 41% of the mortality rate variance. For the 718 hospitals and pharmacies, some of these characteristics were high-technology index (R2 = 0.157, p < 0.001), severity of illness (R2 = 0.07, p < 0.001), number of pharmacists/average daily census (R2 = 0.021, p < 0.001), and combined hospitalwide clinical pharmacy services (R2 = 0.016, p < 0.01). The results of this analysis were similar to those in the only other large study in this area, but that excluded pharmacy characteristics. This is the first study to show a statistically significant association between pharmacist and pharmacy variables and reduced hospital mortality rates.

Physician perceptions of clinical pharmacy encounters in a family practice clinic.

The purpose of this study was to classify pharmacist-physician encounters in a family medicine center into three progressive levels of service in order to determine the physician's perception of the relative value of each level. The three levels of service were drug information, pharmacy consultation individualized to the patient, and pharmaceutical care-consultation with follow-up to monitor patient outcome. Physicians received a questionnaire with each encounter and were asked to rank questions regarding the quality of the information provided, the impact they perceived that the information had on patient care, and to assign a monetary value for each encounter. A total of 106 of 141 (75 percent) questionnaires suitable for analysis were stratified into drug information (25.5 percent), pharmacy consultation (49 percent), and pharmaceutical care (25.5 percent). Physicians' perceptions toward the quality, impact, and value of pharmacy services were favorable overall, but they perceived a significantly higher quality, impact, and value to pharmaceutical care encounters than for drug information and pharmacy consultation (p < 0.05).

1992 National Clinical Pharmacy Services Study.

STUDY OBJECTIVE: To determine the extent of hospital-based clinical pharmacy services in 1992. DESIGN: National survey with trend comparison to 1989. SETTING: All 1597 United States acute care, general medical-surgical and pediatric hospitals with 50 or more licensed beds and one or more full-time pharmacists (43% of all U.S. hospitals). MEASUREMENTS AND MAIN RESULTS: Fourteen clinical pharmacy services, carefully defined to indicate pharmacist proactive or concurrent patient care provision, were assessed to determine pharmacists' specific patient care responsibilities. The percentage of hospitals offering each of the services increased from 1989 to 1992, with greatest growth in management of adverse drug reactions (22% increase), pharmacokinetic consultations (14%), and drug therapy protocols (12%). The mean percentage of patients actually receiving clinical pharmacy services ranged from 0.2% for pharmacist participation on the cardiac arrest team to 36.1% for daily monitoring of drug therapy. Pharmacists conducted clinical research in 13% of all hospitals, averaging 3.9 +/- 4.3 protocols per year with a total budget of $79,765 +/- $128,641. CONCLUSIONS: Clinical pharmacy services continue to expand; however, even the most common direct patient care service is provided to a small number of inpatients.

ASHP national survey of hospital-based pharmaceutical services--1992.

The results of a national mail survey of pharmaceutical services in community hospitals conducted by ASHP during summer 1992 are reported and compared with the results of earlier ASHP surveys. A simple random sample of community hospitals (short-term, nonfederal) was selected from community hospitals registered by the American Hospital Association. Questionnaires were mailed to each director of pharmacy. The adjusted gross sample size was 889. The net response rate was 58% (518 usable replies). The average number of hours of pharmacy operation per week was 105. Complete unit dose drug distribution was offered by 90% of the respondents, and 67% offered complete, comprehensive i.v. admixture programs. A total of 73% of the hospitals had centralized pharmaceutical services. Some 83% provided services to ambulatory-care patients, including clinic patients, emergency room patients, patients being discharged, employees, home care patients, and the general public. A computerized pharmacy system was present in 75% of the departments, and 86% had at least one microcomputer. More than 90% participated in adverse drug reaction, drug-use evaluation, drug therapy monitoring, and medication error management programs. Two thirds of the respondents regularly provided written documentation of pharmacist interventions in patients' medical records, and the same proportion provided patient education or counseling. One third provided drug management of medical emergencies. One fifth provided drug therapy management planning, and 17% provided written histories. Pharmacokinetic consultations were provided by 57% and nutritional support consultations by 37%; three fourths of pharmacist recommendations were adopted by prescribers. A well-controlled formulary system was in place in 51% of the hospitals; therapeutic interchange was practiced by 69%. A total of 99% participated in group purchasing, and 95% used a prime vendor. The 1992 ASHP survey revealed a continuation of the changes in many hospital-based pharmaceutical services documented in earlier surveys (e.g., growth in clinical services, ambulatory-care services, computerization) and identified static areas that merit the attention of pharmacy leaders (e.g., provision of complete, comprehensive i.v. services).

An examination of adverse drug event monitoring practices in U.S. hospitals.

Unfortunately, the reasons for respondents' negative attitudes and perceptions toward ADE monitoring are not entirely clear because they generally are not related to time or staff constraints. There was some indication that poor medical record documentation was a contributing factor; however, this problem can be addressed through education of physicians and nurses as to the importance of capturing and reporting ADE data. Other research has demonstrated that substantial effort and diligence are required on the part of all members of the health care team to capture ADEs consistently. Fortunately or unfortunately--depending on the perspective--the motivation and at least the initial energy to establish and maintain an effective ADE monitoring program have to come from the pharmacy department. The greatest fear is that many pharmacists simply will be apathetic to the issue and not devote the time and energy necessary to capture and process ADE information effectively.

Pharmacist career ladder with clinical privilege categories.

The development of a career ladder program for staff pharmacists at a Department of Veterans Affairs (VA) medical center is recounted. Center policy required the establishment of clinical privileges for all pharmacists with direct patient contact and specified three VA privilege categories with increasing degrees of autonomy. The pharmacy department supported the need for all pharmacists to incorporate clinical activities into their daily practice but faced several problems, including inadequate instruction, insufficient incentives, fragmentation of clinical services, and subjectivity of measures of competence. In response, a pharmacy credentialing committee created a career ladder with three levels based on the established system of clinical privileges. Level A integrated basic clinical pharmacy knowledge with dispensing activities. Level B increased the number of clinical skills required and allowed the pharmacist to act as a therapeutic consultant. Level C incorporated the skills necessary for specialty practice. Instructors were designated for each clinical service area, readings and sample problems were assigned, and staff development presentations were improved. Objective tests of skills were designed. Combining the three levels on the career ladder with the three categories of clinical privileges formed a matrix of nine options for advancement. Pharmacists applying for advancement must master all requisite skills and submit relevant documentation. Each level carries a pay increase of 2%. A total of 53% of the staff pharmacists have participated in the program, which has had a favorable impact on staff retention. By combining nationally established categories of clinical privileges with an institution-specific career ladder, a pharmacy department helped ensure the consistency of services and promote the development of clinical practitioners.

Multidimensional work sampling to study the activities of decentralized clinical pharmacists.

Self-reported multidimensional work sampling (MDWS) was used to study the activities of decentralized clinical pharmacists at six hospitals in Portland, Oregon, and Seattle-Tacoma, Washington, in March through June 1989. A community hospital, a university hospital, and a hospital associated with a health maintenance association were selected in each city, and pharmacists at each site who provided clinical services were recruited. Each pharmacist wore a random reminder device and recorded the activity during which the device sounded by writing on a card numbers assigned to describe work activity, contact, location, and function. Of 6609 classifiable observations, 34.5% (2280) were of clinical activities and 35.8% distributive activities. Pharmacists spent 28.6% of their clinical time reviewing and assessing patients' charts, 17.1% on clinical rounds, 15.9% on activities related to therapeutic drug monitoring, 10.2% providing drug information, 11.6% attending or giving formal education, 6.1% doing research, and 2.6% attending meetings. The average pharmacist spent less than 10 minutes each day with patients but spent a substantial portion of time providing clinical services to other health professionals. Self-reported, multidimensional work sampling appears to be a valuable method for describing and monitoring decentralized pharmacists' work activities at multiple sites and work settings.

ASHP national survey of hospital pharmaceutical services--1987.

The results of a fall 1987 national mail survey of pharmaceutical services in short-term hospitals are reported and compared with similar surveys conducted in 1975, 1978, 1982, and 1985. A sample of 875 hospitals was selected randomly from among the estimated 5600 U.S. short-term hospitals that employ a pharmacist on at least a part-time basis. The survey had a 71.1% response rate (617 usable replies). Nearly three-fourths of the respondents had complete unit dose drug distribution services (UDD), 68% reported complete i.v. admixture services (IVA), and 57% reported both complete UDD and complete IVA. Nearly 5% of respondents offered five specified clinical services (up from 1.8% in 1985); 24% reported having no clinical services (versus 38% in 1985). Nineteen percent said their departments had one or more clinical specialists. Overall, about one-third of pharmacy technicians had completed formal training. The number of respondents with programs to contain drug costs increased about 10% since 1985. Weekly hours of pharmacy operation averaged 102; 36.7% of respondents had pharmacy service around the clock. The percentage of hospitals with computerized drug distribution systems increased from 32% in 1985 to 52% in 1987. Prime vendors were used by 94.6% of respondents, and only 2% reported that they did not use a purchasing group. National expenditures for drugs and fluids for community hospitals were projected at $4.7 billion, personnel costs at $1.8 billion, and other pharmacy expenditures at $0.4 billion. The projected numbers of open positions nationally for pharmacists in community hospitals was 1950. The survey also collected data on the use of personal computers, inventory turnover, quality assurance, continuing-education philosophy, revenue-generating programs, and outpatient services. Drug control in community hospitals is improving, and clinical services are more widespread. Twenty percent of respondents had comprehensive pharmaceutical services, defined as complete UDD and complete IVA plus three or more clinical services.