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.

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.

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.

Immune globulin use at a multihospital medical center.

Use of i.v. immune globulin (IVIG) at four hospitals was audited to evaluate the need for therapeutic protocols and identify strategies for reducing drug expenditures. Charts and nursing notes for patients who received IVIG over a six-month period were reviewed retrospectively to obtain the following data: patient demographics, indication for IVIG use, product used, amount administered, and adverse reactions. Indications were categorized as to whether they are included in FDA-approved labeling, recognized in national guidelines, documented in published studies, or not documented. Expenditures were calculated from acquisition costs. At the first hospital (which offers oncology and other specialty services for adult patients), 71 patients received IVIG for 15 indications, with 89.5% of the orders for unlabeled uses. Of all grams reconstituted, 17.8% were wasted. The rate of documented adverse reactions was 11.3%. At the second, a pediatric hospital, 34 patients received IVIG for six indications, with 65% of the orders for unlabeled uses. Of all grams reconstituted, 13% were wasted. At the third hospital (which specializes in emergency trauma and critical care medicine), two patients received IVIG for a labeled indication. At the fourth (a maternity hospital), no patients received IVIG. Three of four hospitals used IVIG during a six-month audit period. In most instances, the drug was used for indications not included in FDA-approved labeling. Audit information may be useful in creating guidelines for appropriate use of IVIG.