Clinical pharmacology.
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The authors studied the relative bioequivalence and bioavailability of two oral polyamino-acid formulations (packet and flacon), based on 4 amino acids (L-glutamine, L-phosphoserine, L-phosphothreonine and L-arginine) in association with vitamin B12 (Bio-logos, Sigma Tau Pharma S.A). Open-trial testing was carried out after intensive treatment and on the attainment of sustained levels. 50 healthy volunteers (27 males, 23 females), ranging in age from 23 to 32 years, were included in the study. The pharmacokinetic behaviour of the various active ingredients was examined at a haematic level. Possible undesirable side-effects, resulting from treatment, were also examined during the study. The mean pharmacokinetic constants considered (Ke1, Cmax and t1/2) generated an almost overlapping AUC (area under the curves) for all homologous components contained in both pharmaceutical forms. This indicates almost complete bioequivalence. The mean index for the rate of relative bioavailability was, in fact, estimated to be 106.3 +/- 12.4%. Repeated treatment did not appear to disturb the absorption mechanisms of the active ingredients contained in either of the two formulations examined, maintaining the relative bioavailability relationship within a negligible range, with a statistically non-significant difference (Student's t test for coupled data). A few episodes, characterized by slight increases in excitability, were reported for both preparations in two patients (4%).
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The Central Pharmacy of Presbyterian Medical Services (PMS) a nonprofit corporation operating a rural comprehensive health care system in New Mexico, is discussed. PMS Central Pharmacy provides pharmaceutical services to a 34-bed acute care hospital and 24 widely scattered clinics for ambulatory patients. The financial base, administration, development of a formulatory, purchasing, prepackaging of medications, and consulting services of the PMS Central Pharmacy are described. Central Pharmacy acts as a drug wholesaler for PMS; the gross margin between acquisition cost and average wholesale price covers 90% of the cost of the pharmacy operation. In addition, the clinics pay a fee and travel expenses for pharmacist consultation. Seven clinics employ drug technicians who are trained and supervised by Central Pharmacy. It is concluded that this system may serve as a model for the development of pharmaceutical services in other rural areas or in poverty-stricken urban areas.
OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22.
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Concerns over pharmaceutical costs and appropriateness of medication use have led state Medicaid programs to restrict drug reimbursement. This article critically reviews 20 years of research on cost sharing, drug reimbursement limits, and administrative limitations on access to particular drugs via formularies, category exclusions, or prior authorization requirements; evaluates their methodological rigor; summarizes the state of current knowledge; and proposes future research directions. Drug reimbursement caps and modest cost sharing can reduce the use of both essential and less important drugs in Medicaid populations; severe reimbursement caps may precipitate serious unintended effects. Limitations on access to particular drugs can cause both rational and irrational drug substitution effects; it is unclear whether such limits reduce expenditures either for drugs or for overall health care.
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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.
A modification of the spectral abbreviation technique originally described by Hites and Biemann is proposed for identifying compounds through a coding of mass spectral data. Data from 2 closely related compounds (trimethadione and paramethadione), acquired by using 3 instruments, are presented. The technique appears to overcome observed differences in low resolution spectra when the same compound is analyzed by electron impact on mass spectrometers differing in design, manufacturer, principle of ion separation,, and operator. A list of spectra coded by this technique could constitute a rapid manual system of reproducing mass spectral data, using the significant high mass ions of low abundance as well as the frequently more abundant lower mass ions. This system is compared with existing systems.
In Storstrøm county an investigation was carried out concerning certificates in connection with sickness benefit during a period of two months, and the general practitioners and the social-workers were asked about their opinion of and attitude to sickness-certificates. A total of 420 sickness benefit certificates were collected consecutively, and all the social-workers and 85% of the general practitioners participated. About half of the certificates were not completely filled out and only one fifth supplied constructive supplementary information. Forty-five percent of the social-workers and 33% of the general practitioners regarded the certificates as useless when dealing with social medical cases. A systematic followup of patients with long-term sickness is an important task in primary health care, and should be carried out in co-operation with other health- and social-workers.
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