Psychometric evaluation of measures of organizational commitment and intention to quit among pharmaceutical scientists.

This study utilized different statistical techniques to evaluate the reliability (internal consistency) and the discriminant validity of the most widely used measures of organizational commitment and intention to quit (the employing organization). Data were obtained from a national mail survey of members of the American Association of Pharmaceutical Scientists (AAPS) working in the pharmaceutical industry. Both instruments had high Cronbach alpha values in this sample of pharmaceutical scientists. There was a substantial correlation between the scale designed to measure organizational commitment and that for intention to quit. Factor analysis revealed that there was only one common factor underlying the 20 items that were originally designed to measure two distinct constructs. The findings in this study suggested that the most widely used instruments designed to measure organizational commitment and intention to quit may be actually measuring one construct, or the theoretical constructs named as organizational commitment and intention to quit may not be empirically distinct.

Prescribing for unlabeled indications.

Little is known about the practice of physicians prescribing drugs for unlabeled (off-label) indications (prescribing approved drugs for indications not listed/approved in the FDA New Drug Application). In order to learn more about this practice, a 17-item questionnaire was administered to 251 physicians, many of whom practiced in some form of managed care setting. Respondents were asked for which of several indications they would prescribe five specific drugs. Some of these indications were labeled (approved by the FDA) while others were not. In addition, respondents were asked to list drugs they thought were commonly used for unlabeled indications. Results indicated that 88% of the physicians used drugs for unlabeled indications. Nearly 25% prescribed off-label daily. Correlations between demographics and prescribing practices were conducted, and descriptive data on sources of information used for new drug uses are described. Efficacy and payment considerations make this subject important for policy and practice decisions.

Prescribing for unlabeled conditions: patient benefit or therapeutic roulette?

There is ample evidence that prescribed medications are employed for uses far broader than the approved label indications in the U.S. An enormous research agenda thus exists that should be addressed in the not-too-distant future. In fact, it seems essential that operation of the Medicare Catastrophic Drug Benefit program be designed with the best available knowledge in this area. Perhaps it might be appropriate for several universities, the U.S. Pharmacopeial Convention, and/or the FDA to establish a center to study this question. This model has been applied with clinical/surgical registries, with adverse reaction reporting, and with device failures. We need a rational, science-compatible, and uniform policy free of political and emotional arguments to address the issue of handling, monitoring, and regulating the use of drugs for unlabeled conditions. Comprehensive data should be provided for policy makers, regulators, payers, and clinicians in their evaluating the use of different drug products. Even a brief glance at any page from the National Disease and Therapeutic Index shows intended use that would cause most experts to react in disbelief. Further, there seem to be relatively few instances in which the use of a given pharmaceutical for an unlabeled indication would qualify as a drug of choice in the first place. The therapeutic and economic consequences of the use of legend drugs for unlabeled indications are difficult to document. We do know that a significant proportion of hospital admissions and days can be traced to the inappropriate use of pharmaceutical products but the net impact of our subject on institution cost has not been established.(ABSTRACT TRUNCATED AT 250 WORDS)

Drug utilization study methodologies: national and international perspectives.

This paper in the series on pharmacoepidemiology describes the history, development, and present status of drug utilization activities. The various methodologies employed in drug utilization studies are evaluated and presented along with a listing of the principal drug databases available for drug utilization research. An analysis is presented comparing the validity of drug consumption rates based on individual patient usage or drug cost data as adopted in North America and the defined daily dose unit as developed in Europe. Drug utilization derives its importance in pharmacoepidemiology from the fact that it provides the methodological rigor for defining the denominator data needed in pharmacoepidemiological research.

Cisplatin alone or in combination with adriamycin in the treatment of patients with head and neck cancer relapsed after radiotherapy and/or surgery.

37 evaluable patients with relapsed head and neck cancer received as treatment Cisplatin alone (18 patients) or Cisplatin + Adriamycin (19 patients). Both regimens consisted of three-weeks-interval courses. Cisplatin was administered at a dose of 100 mg/m2 as an i.v. infusion with prehydration, posthydration, mannitol and furosemide. Cisplatin + Adriamycin combination was administered at doses of 50 mg/m2 Cisplatin and 50 mg/m2 Adriamycin, both drugs the same day. Clinical toxicity was mild with both regimens. Overall hematologic toxicity was moderate but it was severe with regard to red cells. Some cases of renal toxicity were observed with Cisplatin regimen while no case was noticed with Cisplatin + Adriamycin combination. An overall response rate of 44% (4 CR + 4 PR) was achieved with Cisplatin protocol. The mean duration of response was 5,5 months. An overall response rate of 53% (3 CR + 7 PR) was achieved with Cisplatin + Adriamycin protocol. The mean duration of response was 2,75 months.

Balanced translocation (10;13) in a father, ascertained through the study of meiosis in semen, and partial trisomy 10q in his son. Characterization of the region responsible for the partial trisomy 10q syndrome.

We describe a reciprocal translocation (10;13) in a man, ascertained through the study of meiosis in semen, and a partial trisomy 10q in his abnormal son. The phenotypic anomalies of the partial 10q trisomy syndrome are probably due to the presence in triplicate of the region q25 = to qter of chromosome 10.