The diffusion of a novel therapy into clinical practice: the case of sildenafil.

BACKGROUND: Erectile dysfunction is a common condition, yet in the past most affected men did not seek medical treatment. OBJECTIVE: To examine how sildenafil (Viagra), a new medication for the treatment of erectile dysfunction, has been incorporated into general medical practice. SUBJECTS AND METHODS: The study population consisted of all male members of a group-model Massachusetts health maintenance organization (HMO) whose first prescription for sildenafil was dispensed during the first 24 weeks of its availability through the HMO as a plan benefit (April 24, 1998, through October 8, 1998). Data collected on each member in the study population included age, specialty of the prescribing physician, initial dose, use of prior treatments for erectile dysfunction, receipt of medications known to predispose to impotence, filling of a second prescription for sildenafil, and concomitant medical conditions (including hypertension, ischemic heart disease, hyperlipidemia, diabetes mellitus, and history of radical prostatectomy). Cross tabulations and logistic regression models were constructed to evaluate the potential associations between filling a second prescription for sildenafil and other characteristics of sildenafil users. RESULTS: We identified 899 members who filled a first-time sildenafil prescription in the 24-week period of interest. The majority of sildenafil prescriptions that were filled for the first time (85%) occurred in the first 12 weeks of its availability. Most sildenafil users (84%) were between 45 and 74 years of age (average age, 61 years; age range, 23 to 90 years), and approximately 40% had documentation of prior treatment for erectile dysfunction. Use was highest among those aged 55 to 64 years, with almost 5% of all male HMO members in that age group having received at least 1 sildenafil prescription. Our cohort of sildenafil users was significantly more likely to have hypertension (P<.01), hyperlipidemia (P<.01), and diabetes mellitus (P<.01) than persons who participated in a widely publicized clinical trial of the medication. Prescribing physicians were predominantly primary care physicians (78% were internists, and 11% were family practitioners). More than 60% of sildenafil users filled a second prescription within 3 months of the first prescription; in multivariate analyses, factors associated with filling a second prescription included younger age and prior treatment for erectile dysfunction. CONCLUSIONS: Sildenafil was rapidly adopted into the clinical practice of primary care physicians for the treatment of erectile dysfunction in the managed care setting. The patients for whom the drug was prescribed in the general practice setting differed across many medical characteristics from study subjects who participated in clinical trials of the drug. Arch Intern Med. 2000;160:3401-3405.

Hierarchical relationship development: parents and children.

Child growth and development occur in hierarchical relationships. In our attempt to work more collaboratively, family therapists have neglected to work toward developing theory that guides our work in such hierarchical relationships. This article describes a method for understanding child and relational growth. It builds on Wynne's (1984) epigenetic model of relational systems by integrating his model of family development with Bateson's (1958) concepts of complementarity and symmetry. Wynne's model defines a process for understanding the stages of relationship development, and Bateson articulates the process of change within a relationship. Utilizing principles from both theorists, this paper proposes that parent-child complementary relationships mature through Wynne's developmental stages via symmetrical struggles, and that these symmetrical struggles are necessary ingredients in the development of the relationships as well as of the individuals within those relationships.

Evaluation of a formulary switch from conjugated to esterified estrogens in a managed care setting.

BACKGROUND: Formulary switches between agents in the same therapeutic class have become commonplace in the managed care setting as a strategy to reduce costs. OBJECTIVES: We evaluated the impact of a formulary switch from conjugated to esterified estrogen tablets at the Fallon Community Health Plan, a mixed-model health maintenance organization. DESIGN: A retrospective study was conducted with the use of the automated database of the health plan. SUBJECTS: Study subjects were members of the health plan during the period from May 1, 1995, to December 31, 1997, who were dispensed > or =1 estrogen replacement product. From this population, a cohort of users of conjugated estrogens during the period from May 1, 1995, to October 31, 1995, was selected. MEASURES: The cumulative incidence of switching from conjugated to esterified estrogen tablets and subsequent discontinuations of esterified estrogens was evaluated. The frequencies of ambulatory encounters during the 6 months before and after a switch or discontinuation were compared. RESULTS: During the period after promotion of the formulary switch, 2,149 of 2,984 patients (72%) originally dispensed conjugated estrogen tablets switched to esterified estrogen tablets. Among those patients switching to esterified estrogens, an excess of 20 office visits per 100 patients was noted in the postswitch period (P = 0.005). The risk of switching back to conjugated estrogen tablets was 15% by 2 years. CONCLUSIONS: The findings of this study suggest that plan efforts were successful in switching most users of conjugated estrogens to esterified estrogens. The switch was associated with an increase in utilization of health care services.

Dissecting life with a Jewish scalpel: a qualitative analysis of Jewish-centered family life.

This article highlights findings from a qualitative analysis of the ways in which Jewish families identify how Judaism influences their lives. A theoretical sample of two religious and two cultural families were chosen from a larger sample of 48 Jewish families in Central New York. The qualitative part of this study, which was part of a larger multimethod investigation, was done in order to gather inductively any data that would allow the researchers to build a theory about a particular type of ethnic identity--Jewish identity--and how it affects family dynamics. Eleven categories emerged from this study, which suggest that this particular type of ethnic identity influences many family dynamics, for example, styles of communicating, parenting, values, and family rituals. The participants seem to dissect the world with a "Jewish scalpel." This "scalpel" informs their daily interactions, their parenting styles, and their childrens' self-perceptions.

The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of H2-receptor antagonists.

BACKGROUND: Prescription medications are being switched to over-the-counter (OTC) status with increasing frequency. Information is limited regarding the impact of OTC availability on the use of prescription forms of those products and on the utilization of health care services. OBJECTIVES: To determine the impact of OTC availability of H2-receptor antagonists on medication prescribing patterns and utilization of physician services among a population of chronic users of those agents. DESIGN: A retrospective study was conducted to evaluate changes in the number of prescriptions filled for H2-receptor antagonists and other gastrointestinal agents (proton pump inhibitors, gastric motility agents, and sucralfate), and ambulatory medical encounters with physicians during a one-year period before (July 1, 1994-June 30, 1995) and after OTC availability of H2-receptor antagonists (July 1, 1995-June 30, 1996). Changes in the prescription drug costs for gastrointestinal agents were also estimated. SUBJECTS: Members of the Fallon Community Health Plan, a mixed-model HMO located in Central and Eastern Massachusetts (July 1, 1994-June 30, 1996) who were dispensed at least one H2-receptor antagonist during each quarter for the period between July 1, 1994 through June 30, 1995. MEASURES: Mean absolute differences in the frequencies of drug dispensings and ambulatory encounters and prescription drug costs during the pre-OTC (July 1, 1994-June 30, 1995) and post-OTC switch (July 1, 1995-June 30, 1996) periods were calculated. RESULTS: For the one-year period after OTC availability H2-receptor antagonists, we estimated that the mean absolute number of prescriptions dispensed for H2-receptor antagonists was reduced by 1.5 prescriptions (P < 0.001) and the mean number of prescriptions dispensed for all gastrointestinal agents was reduced by 1.3 prescriptions (P < 0.001) among chronic users of these agents. The number of dispensings of gastrointestinal agents was similarly reduced in the population of chronic users with a diagnosis of gastroesophageal reflux disease (GERD). OTC availability was not associated with an increase in physician visits, overall or for GERD-related conditions. CONCLUSIONS: The findings of this study suggest that the prescription-to-OTC switch of H2-receptor antagonists reduced the number of prescriptions for those agents dispensed among a population of chronic users of those drugs in a managed care setting without increasing physician visits.

Quality of life issues in the management of ovarian cancer.

In patients with ovarian cancer, quality of life is defined by the severity of the disease. In early stage disease, patients focus on the long-term effects of therapy, whereas in late-stage disease, symptom management is paramount. The chemotherapeutic agents used to combat ovarian cancer have a wide range of adverse effects, the management of which is key to ensuring a patient's quality of life. Patient-specific considerations are also important in maintaining quality of life. However, patient preferences are hard to define and harder to predict, so that it is important to assess each patient individually. A large number of assessment tools have been developed, but many are too cumbersome to administer regularly and provide information that cannot be incorporated into patient care plans. The Functional Assessment of Cancer Therapy questionnaire for ovarian cancer (FACT-O) is a notable exception to this group. The FACT-O is a short questionnaire grouped by logical categories that can be completed by most patients without assistance within 5 minutes. Furthermore, the FACT-O allows patients to weight each category of questions based on the categories' perceived importance to the quality of the patients' lives. These two factors allow the FACT-O to be used to institute management decisions on the level of both the individual patient and the institution.

The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of vaginal antifungal products.

OBJECTIVE: We examined the impact of over-the-counter (OTC) availability of vaginal antifungal products, beginning in January 1991, on medication prescribing patterns and utilization of physician services. DATA SOURCES AND STUDY SETTING: Data on utilization of health care services and prescription medications by female members (ages 11 and older) of the Fallon Community Health Plan (FCHP), a group model health maintenance organization and a component of the Fallon Health Care System of central Massachusetts. The census for such individuals increased from 49,551 in January 1990 to 67,365 in December 1992. DESIGN: Time-series analyses were employed to assess changes in prescribing patterns of vaginal antifungal products and physician visits for vaginitis from January 1, 1990 through December 31, 1992. Monthly numbers of prescriptions for vaginal antifungal products and physician visits per 100 members were measured. Monetary savings relating to the prescription-to-OTC switch were also estimated. DATA COLLECTION METHODS: The computerized management information system of FCHP contains records on utilization of all health care services and prescriptions filled, collected as part of routine fiscal activities. We identified all vaginally administered products on the FCHP formulary used for the treatment of vaginal candidiasis and determined the number of prescriptions filled for these agents during each month of the study period. We also identified the number of physician office visits characterized by the ICD-9-CM code 616.10 ("vaginitis and vulvovaginitis, unspecified") occurring during each month of the study period. PRINCIPAL FINDINGS: For the one-year period after OTC availability of vaginal antifungal products (January 1991 through December 1991), we estimated that the number of prescriptions dispensed for these products was reduced by 6.42 per 100 female FCHP members ages 11 and older. Physician visits for vaginitis were reduced by 0.66 per 100 members. Estimated savings to the Fallon Health Care System for the one-year period following OTC availability were $42,528 in medication costs and $12,768 to $25,729 for costs associated with physician visits, depending on use of laboratory testing in patient evaluations. CONCLUSIONS: The findings of this study suggest that the prescription-to-OTC switch of vaginal antifungal treatments reduced health care costs to the insurer in the managed care setting. These favorable effects on costs for the insurer need to be weighed against shifts in medication costs to consumers and potential adverse consequences to the patient relating to errors in self-diagnosis.

Shared parenting in dual-income families.

Dual-income couples who share child care were compared with traditional couples in which the wife takes primary responsibility for the children. Couples who reported that they shared child care were found more likely to have a male first-born, compatible work arrangements, and similar levels of income than were traditional couples. They were also more likely to feel that their relationship was egalitarian and that the division of labor in the household was satisfactory.