Oral anticoagulation: improving the risk-benefit ratio.

For four decades, warfarin has been used extensively to treat thromboembolic disorders. Major advances in monitoring have been achieved through recognition of thromboplastin variability and implementation of the international normalized ratio (INR). Recommended INR ranges have shifted to lower intensity, and new clinical information has led to the potential for increased use of warfarin to prevent venous thromboembolism, to treat patients with prosthetic heart valves, to prevent stroke in patients with atrial fibrillation, and to prevent death and recurrent events after myocardial infarction. Optimal management of the patient who requires a drug that has a narrow therapeutic index, such as warfarin, remains challenging. Strategies to enhance patient outcomes with these drugs attempt to improve the risk-benefit ratio of such therapies, which requires optimizing the agent's effectiveness, improving its safety profile, or both.

Unit dose pharmacy workload forecasting: validation of the pharmacy service unit model.

Departmental efficiency is a priority issue for hospital administration as third party payers maintain or reduce the level of reimbursement. This study validates the PHASU (PHArmacy Service Unit) model, which predicts the workload and productivity of a unit dose pharmacy. A PHASU equivalency system enabled the authors to develop a comparative standard for all pharmacy procedures. The procedure most reflective of workload is unit dose orders. Predicted productivity and staff requirements compare favorably to management engineering determinations. The PHASU model represents a reliable workload forecasting instrument that pharmacy managers can prospectively incorporate in the support of current and future pharmacy services.

Development of a model for predicting pharmacy personnel requirements.

The purpose of this study was to adjust current staffing based on productivity measurement and analysis of the unit dose and sterile products area of the pharmacy, and to develop a model for predicting pharmacy personnel requirements based on Pharmacy Staffing Units (PHASUs). Time measurements of the specific pharmacy procedures were performed to define baseline procedure data. A PHASU equivalency system was developed to allow comparison of all pharmacy procedures. This system was based on the time required to complete a specific procedure divided by the time required to complete the procedure most reflective of workload, a single medication order. Pharmacy personnel requirements were forecasted using the number of unit dose orders and the number of miscellaneous sterile preparations in the sterile products area. A software package used by management engineering to predict patient days and number of admissions was used to forecast workload. The PHASU system provides a means for forecasting workload and addressing personnel requirements for the next fiscal year. Pharmacy administrative personnel must adopt a contemporary business approach to meet the challenge that pharmacy will encounter in the new health care environment.

The development of a computerized LAN-based investigational drug information database.

A computerized LAN-based investigational drug information database, IRxBase, was developed at the University of Pittsburgh Medical Center to facilitate healthcare professionals' access to investigational drug information. Healthcare professionals at the medical center were surveyed to identify current problems in accessing investigational drug information. The survey reflected that before the implementation of the database, the medical center lacked a systematic approach to providing protocol-specific investigational drug information. Although investigational drug information software programs are commercially available, they provide limited information and few are protocol-specific. IRxBase offers an efficient means for the widespread provision of investigational drug information with advantages of accessibility, ongoing data entry, and preservation of confidentiality.

Outpatient management of venous thromboembolism.

Low molecular weight heparins (LMWHs) have provided the necessary pharmacologic tool to facilitate the outpatient management of selected patients presenting with acute venous thromboembolism. A growing collection of clinical trial results supports the safety and efficacy of this cost-efficient management strategy. However, this approach requires careful patient selection and meticulous care planning. Several randomized multicenter trials have compared a primarily outpatient approach to treating uncomplicated proximal venous thrombosis with a LMWH administered subcutaneously once or twice daily to the inpatient use of unfractionated heparin (UFH). The results have been very encouraging and suggest that the use of subcutaneous LMWH in highly selected, uncomplicated venous thrombosis patients is as safe and effective as intravenous UFH, and that most patients can be treated as outpatient or be discharged early. Irrespective of parenteral anticoagulant approach, warfarin therapy was commenced on day 1 and continued for 3 months. A recent publication by Dedden and colleagues describes a 1-year experience with a pharmacy-managed program for the home treatment of patients presenting with proximal deep vein thrombosis. A plan for coordinated patient care was implemented which included a process for patient referrals, standardized protocol orders, a plan for holding area processing and home healthcare agency follow-up, and subsequent oral anticoagulation management. Results of the program demonstrate a significant healthcare savings (as compared with standard inpatient management) with no significant compromise in patient outcomes. Recently published trials by the Columbus Investigators and Simonneau and colleagues have looked beyond uncomplicated proximal venous thromboembolism to include patients presenting with recurrent venous thrombosis and pulmonary embolism. Results suggest the subcutaneous use of LMWH is as safe and effective as intravenous UFH. Such data begin to lay the scientific foundation for the expanded clinical base of patients who may be candidates for an outpatient management approach. In today's cost-conscience environment, managing the treatment of select venous thromboembolism patients with LMWH(s) and warfarin therapy in an outpatient environment represents an evolving approach that is economically logical, does not compromise patient outcomes, but requires considerable planning to address a myriad of logistical issues.

Exaggerated warfarin sensitivity: a case report.

A 64-y-old male was hospitalized because of significant bleeding and a prolonged prothrombin time (PT) (greater than 200 sec) following an inadvertent doubling of his anticoagulant dose. He was previously well controlled on 2.5 mg warfarin every fourth day. Treatment included vitamin K, fresh frozen plasma, and packed red blood cells. Warfarin plasma concentrations, clotting factor analysis (CFA) and PTs were analyzed to evaluate this patient. Following hospitalization, the patient was followed by the Anticoagulation Clinic and his dose was stabilized at 0.5 mg daily. He experienced no further bleeding episodes and his PT ratio was maintained at 1.5 times control. The response to a dose of warfarin varies greatly from patient to patient. Previous reports of abnormal responses to warfarin can be categorized as either warfarin "resistant" or "sensitive." The preponderance of reports are compliance or hereditary warfarin resistance. This patient represents a case of exaggerated warfarin sensitivity that cannot be easily explained. There was no evidence of a drug interaction, warfarin concentrations were not excessive, and CFA was reflective of a moderate warfarin effect. Extreme tissue sensitivity to warfarin is a plausible explanation for this abnormal response.

Warfarin and the international normalized ratio: reducing interlaboratory effects.

In North America, the dose of warfarin has been unintentionally increased during the past two decades because of failure to recognize the effect on the anticoagulation test of less sensitive tissue thromboplastins. Although there still is some controversy, the suggested dose of warfarin has now been adjusted downward to reduce the risk of bleeding. These revised dosing recommendations incorporate the international normalized ratio (INR), which takes into account the source of thromboplastin. However, there is considerable variability in the sensitivities of thromboplastin from manufacturer to manufacturer and lot to lot. Therefore, prothrombin times (PTs) are not comparable from laboratory to laboratory without knowing the sensitivity of the thromboplastin. Unless laboratories adopt a standardized tissue thromboplastin, the PT should be reported as an INR.

Natural products and the athlete: facts and folklore.

OBJECTIVE: To contrast scientific facts with suggested manufacturers' claims regarding food supplements (natural products) marketed for enhanced athletic prowess. DATA SOURCES: A MEDLINE search was performed to obtain documentation supporting the claims of natural-product manufacturers. In addition, several references pertaining to pharmacognosy, natural products, herbs, pharmacy practice, and sports medicine were reviewed. Claims were obtained from promotional advertisements in bodybuilding magazines, product labels, and fact sheets for sales representatives in nutrition and health-food stores. DATA EXTRACTION: We reviewed all of the clinical trials, published between 1966 and 1992, relative to the manufacturers' claims regarding these products. DATA SYNTHESIS: Pertinent human and/or animal studies supporting each natural product were compared with the manufacturers' claims. CONCLUSIONS: We found that there was no published scientific evidence to support the promotional claims for a large proportion of the products (8/19, 42 percent). Only 4 of 19 products (21 percent) were associated with any documented human clinical trials supporting their promotional claims. Six of 19 agents (32 percent) had some scientific documentation to support their promotional claims; however, these products were judged to be marketed in a misleading manner.

Survey and evaluation of newsletters marketed to family physicians.

BACKGROUND: Newsletters are marketed to physicians to provide a concise, accurate, and timely overview of the medical literature. The goal of these newsletters seems to be to present information that can be a suitable substitute for reading the original article. The purpose of this paper is to describe and evaluate newsletters pertinent to family physicians. METHODS: Newsletters appropriate for family physicians were selected by collecting newsletter advertisements and by searching newsletter directories. A 3-month sample and pertinent data were collected from the publishers. Evaluation criteria included accuracy and completeness of the abstracts, scope of coverage of the medical literature, and relevance of article sources. RESULTS: Eight newsletters were collected and evaluated. Accuracy was high for the evaluated abstracts. Abstract completeness averaged only 70 percent (range 55 percent to 92 percent). The type and source of abstracted articles varied widely among the newsletters. CONCLUSION: Newsletters available to family physicians vary widely; personal evaluation should supplement the results of the evaluation.

Characterization of rash with indinavir in a national patient cohort.

OBJECTIVE: To characterize indinavir-associated rash using systematic data collection through postmarketing surveillance in a sample of HIV/AIDS patients. DESIGN: HIV-infected patients identified through a medication counseling line who reported onset of a rash following initiation of indinavir therapy were included in this case series analysis. Pertinent information regarding onset, description, and management of rash; other medications initiated within two weeks of indinavir or rash onset; and medication allergy history was obtained through follow-up telephone contact. Patients were contacted weekly until the rash resolved or indinavir was discontinued. SETTING: Stadtlanders Drug Distribution Company, located in Pittsburgh, PA. RESULTS: Of the 110 patients identified and followed, 67% reported rash onset within two weeks of initiating indinavir therapy. The rash was initially localized in all 110 patients and subsequently spread to other areas of the body in 77% of the patients. The rash spread to the full body in 44% (49) of the patients. The rash was accompanied by pruritus in 86% of the patients, and the majority of patients (87%) were afebrile. Eighty-one patients received treatment with medications such as antihistamines or oral or topical corticosteroids. Fifty percent of patients receiving treatment for the rash reported that these medications were helpful in relieving rash symptoms. Fifty-nine percent of the patients continued indinavir therapy despite the occurrence of rash. CONCLUSIONS: Results from this study suggest that indinavir-associated rash occurs within two weeks of initiation of therapy for the majority of patients. Typically, the rash is localized with subsequent spread and is associated with pruritus. The majority of patients are able to continue indinavir therapy despite the occurrence of rash.

Applying scientific criteria to therapeutic interchange: a balanced analysis of low-molecular-weight heparins.

Under pressure to provide cost-effective healthcare, many healthcare systems have adopted Therapeutic Interchange (TI) programs-the interchange of therapeutically equivalent but chemically unique drugs-to reduce the total cost of therapy without compromising patient care. To be appropriate and feasible, a TI program for any class of drugs must meet certain rigorous criteria and undergo medical, financial, tactical, and legal reviews. Moreover, once a TI program is implemented, a process to monitor its success should be established. Application of the TI criteria to low-molecular-weight heparins (LMWHs) reveals that a blanket TI program for LMWHs does not appear advisable at this time.

The future of medication information practice: a consensus.

OBJECTIVE: To analyze the current practice of drug information and develop a strategic plan for a "valued" specialty of medication information practice. DATA SOURCES: The Consortium for the Advancement of Medication Information, Policy, and Research (CAMIPR) met in June 1994 to initiate a strategic plan for a future of medication information practice. A multidimensional situation analysis and strategic planning process was conducted and the results are discussed. RECOMMENDATIONS: Trends in health care (e.g., healthcare reform, managed care) will impact the future of medication information practice, and the medication information specialist must evolve with society's values. Medication information practice must transform and attention will likely focus on medication policy research/ development and information systems. However, new skills, resources, and relationships must be developed to facilitate this evolution. In addition, interest in the practice of drug information has declined. Strategies are presented to enhance the "value" and "image" of future medication information practice.