Drugman--a computerized supplement to a hospital's drug information newsletter

A computerized supplement to a hospital's drug information newsletter, called Drugman, is described. The pharmacy department of a 452-bed teaching hospital developed Drugman. The program uses the "Converse" software, which was developed by the hospital's computer medicine department. The program provides information on new drugs recently added to the formulary and updated information on current formulary drugs. It also provides information on investigational drugs. A staff pharmacist is responsible for coordinating the writing and review of each new-drug monograph in the system, as well as the computer entry and up-dating of existing monographs. The program is available to all medical, nursing, and pharmacy personnel via computer terminals located on each nursing unit and in the pharmacy department. Survey questions at the end of the program elicit user response to the program and suggestions for additions or changes. In the initial 14-month period, the general response to Drugman has been favorable. Drugman represents a new method of disseminating drug information via computer in an individual hospital. The program complements traditional drug information sources and has been received positively in our hospital.     

Providing clinical pharmacy services in an AIDS--oncology ambulatory-care clinic

The activities of a pharmacist in an ambulatory-care AIDS-oncology clinic are described. In December 1984, the chief of the AIDS Activities Division of San Francisco General Hospital's Department of Medicine hired a clinical pharmacist to develop the pharmacokinetics sections of investigational drug protocols, provide drug therapy consultations, and supervise the reorganization of the drug storage and inventory system. Since joining the clinic staff, the pharmacist has become active in a variety of clinical, research, and educational activities. The pharmacist conducts weekly medication refill clinics and developed drug information sheets for clinic patients and health-care professionals. The pharmacist also supervises timely collection of blood samples for serum drug concentration determinations and helps to prepare the investigational drugs for dispensing. The pharmacist developed policies and procedures for the safe handling of antineoplastic agents and standardized the accountability procedures for investigational drugs. The pharmacist also serves as a liaison between the clinic and the hospital's department of pharmacy and as a preceptor of pharmacy students and residents. A clinical pharmacist can make an important contribution to the research and patient-care activities in an AIDS-oncology clinic.     

The financial impact of investigational drug services

The pharmacy-based investigational drug service plays an important role in the clinical research process. Investigators and sponsors often rely on the research pharmacist to assure drug accountability and to assist in educating staff about drug studies, reporting adverse reactions, and providing drug information. While many pharmacy departments across the country have established investigational drug services, there is an increasing need to justify these services from a financial perspective. Our pharmacy department currently provides investigational drug services for over 100 protocols. We have established a fee-for-service billing mechanism, but only 61% of our protocols are drug-company or investigator-sponsored, which reimburse for pharmacy services. As a result, we are unable to collect all operating costs through our billing mechanism. Many protocols, however, are sponsored by the National Cancer Institute (NCI), which provides free drugs for cancer protocols. Some NCI drugs are also on the market, so the hospital experiences savings in drug costs when patients are placed on certain NCI protocols. When we combine direct costs recovered through billing with the indirect cost savings from dispensing "free drugs, we find that the total benefit of operating an investigational drug service more than outweighs the cost of operating the service.     

Direct order entry by physicians in a computerized hospital information system

Implementation of a policy encouraging direct order entry by physicians in a computerized hospital information system is described. A fully integrated database system was implemented in this tertiary-care university hospital. Terminals are available in the patient-care areas, order entry is uncomplicated, and typing is not necessary. When entering medication orders, the physician can select screens that display either general-order or specialty-order sets that are similar to preprinted-order sheets. A program was developed by the pharmacy and nursing departments to help the physicians learn to use the computer system and to demonstrate its benefits. Physicians were offered a training program that could be taken in one six-hour session or as six one-hour segments. Pharmacy technicians were trained to assist physicians with order entry in the patient-care areas during the implementation phase. Hospital policy requires that orders not personally entered by the physician must be written by hand in the patient chart and reviewed and entered in the computer system by a pharmacist before being dispensed. The delays inherent in this procedure give physicians an incentive to use the terminals. The policy encouraging direct order entry by physicians has been broadly accepted and has enabled the hospital to standardize drug therapy ordering and encourage adherence to the formulary.     

Documenting pharmacists' interventions on a hospital's mainframe computer system

The development and implementation of a code that enables pharmacists to document their clinical interventions in the hospital's computerized patient records is described. To allow data to be entered in patient records from terminals throughout the hospital that are linked to the mainframe computer, a code was developed to summarize each pharmacist recommendation. The coded information is added to the computer entry for the specific drug requiring intervention. A computer program was developed inhouse for generating daily reports of the pharmacist interventions. During an initial 25-day study period, 300 interventions were documented; house staff physicians accepted the pharmacists' recommendations in 257 (85.7%) of these interventions. An additional 17 (6%) of the interventions resulted from physicians' requests for pharmacists' recommendations. In addition to review of all pharmacist clinical interventions, this system allows review of a specific target drug to determine compliance with institutional drug-use guidelines. Through use of the computer program developed at this hospital, information that documents pharmacists' clinical services can be entered directly into patients' records on the hospital's mainframe computer system and retrieved as useful reports.     

Procedures for emergency or treatment use of investigational drugs

The procedures for obtaining and dispensing investigational drugs for single-patient compassionate use are described, and roles for pharmacists in this process at a university medical center are identified. To obtain an investigational drug, a physician must contact a pharmaceutical-company study monitor to discuss the details of the case. Other responsibilities of the physician include obtaining institutional review board approval; completing FDA form 1572 or 1573, or both; and securing written informed consent from the patient. The responsibilities of the pharmacist are to ensure that informed consent has been obtained; inform nursing, pharmacy, and medical staffs about the use, admixture requirements, and administration of the investigational agent; provide a therapeutic drug monitoring plan; and store, handle, and prepare the medication. The pharmacist also keeps inventory of all shipped drugs and returns all unused drugs to the manufacturer. Pharmacists should be knowledgeable about the proper procedure for obtaining and dispensing investigational drugs on an emergency or treatment basis.     

Computer-assisted investigational drug information and testing mechanism for nurses

The Joint Commission on Accreditation of Healthcare Organizations and the American Society of Hospital Pharmacists state that nurses should not administer investigational drugs to patients unless they can prove knowledge about the medication. Traditionally this obligation was met when the pharmacy provided nurses with investigational drug data sheets or access to computer files containing similar information. Our department of pharmacy was cited at a recent JCAHO inspection as being unable to show that nurses were knowledgeable about the investigational medications they were administering. The reviewer requested testing documents prepared by the pharmacy and completed by nursing staff showing the nurses' proficiency with investigational drug information. In response to the JCAHO inspection, the department of pharmacy proposed a quality assurance mechanism to provide investigational drug information and to determine nurses' comprehension and application of these data before they administer any investigational drug. Use of a hospital mainframe computer system to disseminate investigational drug information and test nurses is described.     

Training the "clinical scientist" through a combined industrial/academic fellowship

A novel two-year fellowship program is described which provides specialized training both in clinical drug research and drug development methodology for pharmacists with previous clinical experience. Pharmaceutical industry, university and hospital research facilities are used as the training laboratories, and collectively offer theoretical as well as practical research skills development. Traditional didactic and laboratory training are provided within university and hospital environments with emphasis in the conduct of clinical trials. Extramural experience with pharmaceutical industry provides a corollary experience which includes exposure to ethical, legal and regulatory issues involving both investigational and marketed drugs. Following successful completion of the fellowship, the pharmacist is expected to have developed the fundamental skills necessary for a career in academia, pharmaceutical industry, or clinical practice.     

Development and funding of a pharmacy-based investigational drug service

The development, implementation, and operation of a pharmacy-based investigational drug service (IDS) at a university medical center are described. Before the IDS was established, pharmacy participation in investigational drug research was limited to the preparation of novel dosage forms. Medication errors, improper storage and labeling, and inadequate inventories of investigational drugs were common problems. Stepped-up enforcement by FDA and the National Cancer Institute (NCI) of guidelines for investigational drug control prompted the formation of a multidisciplinary task force, which recommended that the department of pharmaceutical services expand its support of investigational drug studies to include inventory control, record keeping, and clinical services. The IDS is supported by both the hospital and the school of medicine and currently receives 36% of its funding from principal investigator grants and contracts. The IDS coordinates more than 100 study protocols and dispenses more than 4000 doses of investigational drugs annually. The IDS is staffed by 1.0 full-time equivalent (FTE) clinical pharmacist and 0.5 FTE technician. Inventory control and billing functions are performed by a departmental microcomputer system. The IDS has demonstrated a positive gross margin for each of its first two years of operation. Problems associated with the control and use of investigational drugs at this institution have been successfully corrected by the implementation of a pharmacy-based IDS.     

Pharmacist involvement in a thyroid clinic

The patient-care activities of a pharmacist in a thyroid clinic are described. Since 1978 a pharmacist has been an active member of the staff of a thyroid clinic associated with a 500-bed university hospital. More than 1500 patients are referred to the clinic each year. The pharmacist initiates, maintains, or modifies the drug therapy of selected patients with physician-diagnosed thyroid disorders under the guidance of written protocols approved by the chief endocrinologist. Most patients treated by the pharmacist are receiving thyroid-suppression therapy, antithyroid drugs for Graves' disease, or thyroid hormone supplementation after surgery or after radioactive iodine therapy. The pharmacist assesses patients, prescribes medications, orders laboratory tests, charts visits and therapeutic plans, and educates patients about their conditions. Major changes in thyroid status and drug therapy are always discussed with the chief endocrinologist. The pharmacist also participates in educational programs to influence prescribing by physicians, provides drug information, serves as a preceptor to pharmacy students, and is investigating the equivalence of levothyroxine preparations in vivo and in vitro. An audit of patient outcomes showed that the pharmacist is highly effective in her role as a giver of direct patient care. A pharmacist's role in a thyroid clinic can consist of clinical practice, education, preceptorship, and research.     

Inexpensive microcomputer for intravenous admixture service applications

A microcomputer system for maintaining data on intravenous piggyback (IVPB) admixture use and for generating labels for IVPB admixtures is described. The system was developed in a 558-bed hospital where the pharmacy compounds 500-800 i.v. admixtures daily. The objectives were to (1) provide an electronic profile with quick patient-search capabilities, (2) reduce time spent and errors occurring in labeling, (3) decrease duplication and consequent waste of admixtures, and (4) improve collection of drug-use statistics. Software was developed by the pharmacist to achieve these objectives. When a drug order is entered, files are automatically searched for duplication. Every 24 hours, labels for the entire patient profile are printed and statistics are generated on types of drugs used, number of each type of drug, total number of patients on IVPBs, and total number of IVPBs. A user's manual was developed and staff-training sessions were held before the system was implemented. In the first 24 months of operation, most computer downtime was caused by hardware problems. Four man-hours per day were saved in typing time (+7000 annual cost reduction). Waste of approximately six admixtures daily was prevented (+5000 annual savings). Total software development and implementation cost +5000, and hardware cost +4200. The total cost of the system was thus realized during the first year of operation.     

如何提高医院摆药岗位管理质量

目的探讨如何进一步完善摆药工作,提高摆药的速度,增加摆药的准确性,进而为患者安全用药提供保障。方法引进和完善计算机网络,使摆药工作得到明显的改进,速度取得大幅度的提高。结果药师成为摆药工作的核心,能用心去做,并与病区护士作好沟通,共同为患者安全、准确用药努力。结论严格控制药品质量,保证病区患者安全用药。     

美国药品标签和说明书的法规管理

目的:为我国完善和发展药品标签和说明书的管理提供借鉴。方法:采用非接触性研究中的内容分析方法,主要资料是从美国食品与药品管理局网站上收集的有关美国管理药品标签和说明书的23个法律文件,其中7个法律、1个联邦法规和15个指导准则。结果:美国药品标签和说明书是按处方药和非处方药分类管理,重点是对内容与格式的监管。结论:美国已建立了一套完整的法律体系管理药品标签和说明书,我国应从中得到启示,保证药品标签和说明书的信息全面、客观、准确,确保药品安全、有效地使用。     

Nonprogramming relational database primer: a case study--pharmacist intervention audits

Using a database product has never been easier. The above example may appear to be complicated, but the Alpha Four software program guides you at every step. You have to decide what you wish to accomplish, then set up the program to handle the task. Alpha Four (or any other nonprogrammable relational database) can also be used for formulary management, investigational drug accounting, personnel management, inventory, purchase order requisitions, etc. Some drug distribution systems provide access to the patient records and clinical information. If you learn how to operate a database manager, you can create reports that may not be available from the vendor. Computers have reduced the workload required for drug distribution. The future of pharmacy practice is headed toward a highly automated setting. New roles for the pharmacist may include the provision of information from the point of admission to discharge and possibly continued follow-up. This will all be an automated process with the pharmacist as a key resource person. If you do not learn how to control the computer systems you work with, they will eventually control you. You do not have to be an expert to learn how to use a database application. If computer applications are not already part of your professional responsibilities, they soon will be.     

Computer-Assisted Retrospective Clinical Activities Statistics (CARCAS) Program

Clinical pharmacy services have been demonstrated to have a positive impact on patient care in the hospital setting. Accurate and complete documentation of interventions aimed at improving drug use is essential to assess workload characteristics, determine the impact of pharmacist activities, justify current programs and predict future clinical staffing requirements. The need for an improved system of collecting and analyzing clinical workload statistics led to the development of a Computer-Assisted Retrospective Clinical Activities Statistics (CARCAS) Program in our department. Using a pre-defined clinical activity coding system, pharmacist activities were efficiently documented on a daily basis using an existing distributional computer system. Training requirements and data entry time were minimal. The CARCAS Program appeared to capture more clinical pharmacist activities than the earlier manual system. The flexibility of the CARCAS Program should permit adaptation to other hospitals with similar computer systems regardless of the nature of their clinical programs.     

Computer-based program for identifying medication orders requiring dosage modification based on renal function

A computer-based program that enables staff pharmacists to quickly review medication orders written for renally impaired patients is described. Medication orders requiring dosage modification based on the renal function of the patients for whom they were written were being identified by a medical staff-approved pharmacist intervention program. However, staff pharmacists were unable to assess the orders easily and rapidly because of a lack of readily available patient data. In response, a computer-based intervention program was developed. Specific dosage guidelines for renally eliminated drugs in patients with renal dysfunction were entered into the pharmacy computer. An interface with the laboratory computer enables the pharmacy computer to access creatinine concentration or clearance values, perform calculations if necessary, and alert pharmacists to specific drug orders that may require modification. Such medication orders are flagged by the pharmacy computer during order entry. When a staff pharmacist judges that intervention is needed, he or she telephones the ordering physician or sends a note to the patient's nursing station. Over a two-month period, 1485 orders were identified as being potentially inappropriate. Physicians were contacted about 191 of the flagged orders, and they accepted the pharmacist's recommendation for 141 (74%) of these orders. The interventions resulted in a drug acquisition cost saving of $7082 over the two-month period. A computer-based program enabled staff pharmacists to easily and rapidly identify orders for renally eliminated agents that required modification, reduced the risk of adverse reactions, trimmed costs, and promoted the clinical dimension of pharmacy practice.     

National survey of pharmacy-coordinated investigational drug services

A national survey of 703 pharmacy departments was conducted to obtain information on the status and scope of investigational drug services (IDS). Questionnaires were mailed to the directors of pharmacy departments of general medical and surgical hospitals with 300 or more beds and a university affiliation. The survey consisted of 27 questions that were primarily based on the ASHP guidelines for the use of investigational drugs in institutions. A total of 403 questionnaires were returned, 386 of which could be evaluated, 386 of which could be evaluated. Only 33% of the pharmacy departments adopted a minimal subset (7 of 11) of the recommended procedures based on the ASHP guidelines. All pharmacy departments with more than 40 protocols reported having a research pharmacist or a need for one. Of all of the protocols, 43% were sponsored by the National Institutes of Health, 34% by pharmaceutical companies, 16% by investigators and physicians, and 7% by various other sponsors. Drug information, monetary reimbursement for services,a dn coordination and communication were the most frequently cited areas in need of improvement by the drug sponsors. The most common types of protocols involved cancer research (56%) and infectious disease and cardiovascular studies (12% and 13%, respectively). Directors of pharmacy departments should review their investigational drug policies and procedures for compliance with ASHP guidelines as the first step in developing the IDS concept.