Targeted intervention programs: creating a customized practice model to improve the treatment of allergic rhinitis in a managed care population.

OBJECTIVE: To develop an intervention program to improve health outcomes among patients with allergic rhinitis in a managed care environment. STUDY DESIGN: The Episodes of Care (EOC) team at Lovelace Health Systems selected allergic rhinitis for an intervention program because it was identified as one of the top 10 reasons for visits to primary care clinics. The intervention program was based on a multidisciplinary team process designed to create a customized provider and patient education program to alter inconsistence or deficiencies in the treatment of allergic rhinitis. PATIENTS AND METHODS: The EOC team researched literature and current practices and then identified inconsistencies in diagnostic and treatment patterns. Based on this research, the team developed guidelines and a provider education program. Intervention strategies were structured around decision points in a treatment protocol. More than 500 patients were monitored throughout the allergy season by using written and telephone surveys, symptom diaries, and encounter data. Measurable outcomes were established for provider and patient behavior. Patient outcomes were derived from a preventive behavior index and administrative data reporting usage of 5 classes of medication. RESULTS: Approximately 50% of providers altered their practice patterns as a result of the intervention program. Patient outcomes showed a decrease in the use of rescue medications, particularly antibiotics, and an increase in preventive measures in the treatment group compared with the control group. CONCLUSION: The EOC model resulted in positive changes in provider and patient behavior. The multidisciplinary approach resulted in broad provider participation.

Benign intracranial hypertension in children with growth hormone deficiency treated with growth hormone.

We report 13 cases of benign intracranial hypertension (IH) in children with growth hormone (GH) deficiency treated with GH in the United States. The group consisted of eight boys and five girls, 3 to 16 years of age (median, 9 years). The interval from starting GH therapy to diagnosis of IH was 2 weeks or less in six patients, between 2 and 12 weeks in four, 8 months in one, 5 years in one, and unknown in one. Seven patients were not known to have previously described IH risk factors; the other six had at least one factor each. All patients but one had headache, nausea, vomiting, and visual changes. All had papilledema, and cerebrospinal fluid pressures were elevated (> 250 mm H2O) in all nine patients tested. The GH dosage range was 0.17 to 0.35 mg per kilogram body weight per week (median, 0.30 mg/kg per week) for the 11 patients with dosage data. After discontinuation of GH and treatment with lumbar punctures and/or medications, signs and symptoms resolved in eight children; in two of these children signs and symptoms reappeared when GH therapy was restarted. In four patients signs and symptoms resolved while GH therapy was continued; one child was treated with a ventriculoperitoneal shunt because of an arachnoid cyst, after which GH was restarted without subsequent IH. In the 12 patients with idiopathic GH deficiency the course of IH was benign, with complete resolution of all signs and symptoms. Because doses and scheduling of GH administration have changed since the introduction of recombinant GH, higher doses and increased frequency of administration may be contributing to the development of IH in some patients. We suggest beginning therapy at the lowest recommended dose, with gradual titration to higher doses, and the performance of routine funduscopic examinations during initiation of GH therapy and whenever signs or symptoms of IH develop.

Postmarketing surveillance: curriculum for the clinical pharmacologist. Part II: Clinical and regulatory considerations.

This is the second of a two-part series that develops a curriculum on postmarketing surveillance. With the ongoing emphasis on drug safety and possible earlier marketing of drugs, this becomes an essential element of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a specific drug or drug class, perhaps in the context of clinical trial study design and analysis. This curriculum complements this approach and provides an overview of drug safety surveillance from regulatory and epidemiologic perspectives.

Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process.

This series of two articles on postmarketing safety surveillance has been developed for use in training clinical pharmacologists. It provides a basic overview useful to clinical pharmacologists in a range of occupational functions. These reports can be used as the basis for a lecture or as background reading material for establishing a unit on postmarketing surveillance. For teaching rounds, multiple illustrations and summary tables have been included. These can readily be made into 35-mm slides or transparencies. Table I outlines the curriculum on postmarketing surveillance for the clinical pharmacologist. The first article describes postmarketing surveillance within the continuum of the drug approval process. The relationship of clinical trials to safety surveillance after drug approval are reviewed. The importance of spontaneous adverse drug experience reporting also is discussed. The second article focuses on the regulatory aspects of postmarketing surveillance and discusses the FDA's (Food and Drug Administration) Spontaneous Reporting System. The two types of adverse experience reports in the Spontaneous Reporting System are described: reports voluntarily submitted by health care providers and others, and reports manufacturers are required by regulation to submit. The clinical pharmacologist's role in postmarketing surveillance is defined.

Adverse reaction reporting of interaction between warfarin and fluoroquinolones.

Reports to the Food and Drug Administration's Adverse Drug Reaction Reporting System of prolonged prothrombin time due to a suspected interaction between warfarin sodium and a fluoroquinolone were reviewed. Five reports of patients who experienced this adverse reaction 2 to 16 days after the addition of a fluoroquinolone to their treatment regimen are described. Possible mechanisms of action that are discussed include inhibition of warfarin metabolism by the anti-infective agent and displacement of warfarin's binding to protein. Physicians need to be aware of this interaction and closely monitor prothrombin time in patients concurrently receiving warfarin and a fluoroquinolone.

Labetalol hepatotoxicity.

The Food and Drug Administration has received 11 reports of cases (three fatal) in the United States in which hepatocellular damage was associated with labetalol. The temporal circumstances strongly implicate labetalol; the conditions of nine patients improved after cessation of labetalol therapy, and one patient had a recurrence after therapy was restarted. Follow-up with each reporting physician failed to provide historic or laboratory evidence for other viral, toxic, or drug-induced causes of hepatocellular damage, and the case series did not show the demographic and historic risk factors that would be expected if non-A, non-B hepatitis were the cause. Reports of microscopic liver examinations were available in the 5 cases in which they were done. The reported histologic changes were consistent with hepatocellular necrosis in four instances and chronic active hepatitis in one. The clinical presentation of the cases was most compatible with the mechanism of metabolic idiosyncracy, but other pathogenetic explanations could not be entirely excluded.

Gynecomastia associated with calcium channel blocker therapy.

Gynecomastia is a reaction that is not usually associated with calcium channel blocker therapy. The Division of Epidemiology and Surveillance, within the US Food and Drug Administration (Rockville, Md), has received 31 reports of gynecomastia occurring after the use of these drugs. The underlying mechanism of this reaction is unknown, although two patients did report elevated prolactin levels. Gynecomastia developed in two patients, resulting in the surgical removal of the breast and/or nodules before discontinuation of drug therapy. The possibility of an association between calcium channel blockers and gynecomastia should be considered before an extensive workup or surgical procedure is undertaken.

Food and Drug Administration monitoring of adverse drug reactions.

Food and Drug Administration requirements for reporting adverse drug reactions (ADRs), processing of ADR reports, and actions in response to these reports are described. FDA requires that drug manufacturers report ADRs to the FDA Division of Epidemiology and Surveillance; 90% of the ADR reports received are from manufacturers. Of the remaining 10%, one third are from pharmacists. FDA regulations were revised in 1985 to specifically define reportable ADRs and procedures for reporting; manufacturers are required to report within 15 days reactions that are serious and unlabeled. For newly approved drugs, reports on ADRs must be submitted quarterly for three years; subsequently, annual reporting is required. Any increase in the frequency of serious, labeled reactions must be reported. Serious reactions not listed in the product labeling must be reported for products marketed before 1962 for which new drug applications or abbreviated new drug applications were not filed. ADR information received by FDA is coded into standard terms and entered in a computerized database for evaluation by reviewers. If an important reaction is suspected, the report is entered in a tracking system for further monitoring. ADR reports may result in requirements for changes in product labeling, "Dear Doctor" letters, requirement of further study by the manufacturer, or withdrawal of the product. Information about ADRs is communicated to health-care practitioners in product labeling and in the literature. Pharmacists are encouraged to report suspected serious and unlabeled reactions to FDA so that the medical community and the public can benefit from current information about drug safety.

A teachers' guide to teaching medical interviewing.

Success in teaching a course in medical interviewing requires competence on the part of instructors, who also need training, and have to provide a structured approach. Problems encountered by course coordinators at the Department of Family Medicine, University of Miami School of Medicine, Miami, Florida have been: (1) a shortage of skilled teachers; (2) inadequate motivation of instructors for teaching the course; (3) differences in content, teacher's style, and outcomes from small groups; and (4) ambiguities in structure or guidelines provided for teachers. The development of a teacher's guide, giving specific objectives and step-by-step methods for teaching significantly improved teacher satisfaction and commitment to the course, as well as student learning.

A study of older adults attending a program on human sexuality: a pilot study.

This study attempted to ascertain if significant changes took place in older adults' knowledge and attitudes about human sexuality following a two-session course on the subject. Subjects were volunteers who attended a neighborhood center in Miami, Florida. Information was gathered immediately before the first session and after the second session by use of pencil-and-paper tests. Test items were adapted from the Sex Knowledge and Attitude Test and Attitude and Knowledge Assessment. At the first session, small-group discussions followed a large-group instruction period; the second session consisted of a 20-minute film on human sexuality, followed by group discussion. Of the 30 participants who took the pretest, only four completed the posttest, although most of the 30 attended the second session.

Teaching sex education and counseling for the primary physician.

Today's family physicians are being confronted by increasing numbers of patients who desire and need sex education and counseling. It is suggested that the family and primary physician can approach the multiple sex-related needs of the family by understanding the family life cycle and by using permission-giving, limited information, and specific suggestions with patients as needed and as appropriate. The experience of the University of Miami's Department of Family Medicine in teaching human sexuality to medical students, residents, and faculty of the medical center is cited to help other residency programs include sex counseling and sex education in the armamentarium of residents.