The goal of this research was to determine if the Pharmaceutical Care Services Program (PCSP) significantly changes the utilization and cost of medical services for Medicaid recipients. The University of Maryland Center on Drug and Public Policy (CDPP) has contracted with the Maryland Department of Health and Mental Hygiene (DHMH) to provide pharmaceutical care services for Maryland Medicaid recipients. The main goal of PCSP is to improve the appropriateness and cost-effectiveness of physician prescribing decisions and patient drug use. The program accomplishes this by placing clinical pharmacists in hospital clinics to review drug therapy and provide advice to physicians and counseling to patients. A quasi-experimental pretest and post-test design with three control groups was performed in this study. The subjects who received PCSP and met the study criteria were the study group. The subjects who were Medicaid enrollees and relatively similar to the study subjects in terms of age, sex, hospital, and ACG (ambulatory care group) classification were randomly selected into the control groups by using a multiple computerized matching process. Differences in utilization and cost of medical services between study and control groups were tested for statistical significance. Cost-benefit analyses were then performed from budgetary and societal perspectives by applying a net present value method. The mortality and morbidity productivity loss estimations were specifically addressed as the indirect benefits in this study. Lastly, a sensitivity analysis was performed to test the assumptions (discount rate and wage rate) underlying the analysis. In this study, the utilization and costs comparisons between the PCSP patients and control patients revealed that: (1) PCSP "capped" the total cost of services by holding them constant while the control groups' costs rose sufficiently to create a significant difference between the PCSP and control groups; (2) specialty care physician visits remained stable for PCSP while increasing in the control groups; (3) primary care physician visits remained stable for PCSP recipients while they declined in the control groups; (4) less prescription medication was used in PCSP group than in the control group; (5) while the total cost of prescriptions increased for both groups, the cost of PCSP prescriptions was less than the control group cost; (6) PCSP showed no significant impact on the use of the emergency room and hospitalizations. The cost-benefit analysis illustrates that PCSP saved the Medicaid program $204.32 per patient for the first year intervention and $2,043.20 for the future 10 years from a budgetary perspective. From a societal perspective, PCSP saved society $4,116.01 per patient for the future 10 years period. Theoretically, if PCSP were expanded to serve all Medicaid, adult, non-institutionalized patients receiving drug therapy, the state of Maryland should be able to save as much as $27 million in the next fiscal year from a budgetary perspective. The society should be able to save as much as $259 million in the next fiscal year from both direct and indirect savings.
A novel solid oral dosage form, a tablet which can disintegrate rapidly in water to form homogenous suspension of high viscosity to deliver sustained release medication was developed. Such a system avoids the administration of large doses of drugs at one time and circumvents the stability problems encountered when sustained release coated pellets are incorporated in a suspending vehicle. The key to the dosage form is a rapidly disintegrating tablet followed quickly by the development of a viscous suspension system. By design, the viscous gel does not form until disintegration of the tablet is complete. The system contains a processed swellable material, composed of carbomer produced by extrusion-spheronisation which is able to generate viscosity on contact with water, an active drug substance exhibiting sustained release properties from polymethacrylate copolymer coated beads, and freeze-dried cushioning beads composed of microcrystalline cellulose (MCC) and croscarmellose sodium. The cushioning beads, produced by extrusion-spheronisation, possess certain properties among which are compactibility and the capability of disintegrating rapidly. The incorporation of carbomer as a fine powder impedes the disintegration process due to the networking of the carbomer in the tablet matrix and at the surface which upon hydration results in a voluminous mass. However, processing of the viscosity enhancer into beads produced by either extrusion-spheronisation with microcrystalline cellulose (MCC) using a hydroalcoholic system or powder layering onto sugar spheres using alcoholic PVP as a binder provided a solution to the problem. Freeze-drying the cushioning beads containing MCC and croscarmellose sodium produced beads which possessed high compactibility and the ability to maintain good content uniformity and weight variation (less than 5%) when mixed with the drug-loaded membrane-coated beads. The cushioning beads exhibited initial fragmentation into primary powder particles followed by plastic deformation during compaction with the drug-loaded membrane-coated millispheres. They were able to not only to fill the voids between the drug-loaded millispheres but also to surround them so that the tablet was held together by excipient-excipient contact. Moreover, the compacts formed from those cushioning beads were able to disintegrate rapidly and release intact drug-loaded beads with minimal effect on drug release kinetics. Compression force, percentage of drug-loaded membrane-coated beads and the type of membrane coating were important factors affecting the release profile of the tablet compacts. Unlike ethylcellulose, polymethacrylate copolymer coatings were able to resist the mechanical stresses of compaction with relatively small changes in drug release profiles. The increase in the percentage of drug released from the tablets containing 12.5% sustained release theophylline beads in freeze-dried cushioning beads compacted at a pressure of 332 Kg/cm2 relative to the uncompacted beads was 20, 21, 19, 16, 10, 7, 4 and 2% at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours, respectively. This increase in the drug release was attributed to the fracturing of the membrane-coated beads present at the tablet surface. The formulation of tablets for instantaneous preparation of sustained release suspension was achieved by compressing a blend composed of 8.3% drug-loaded beads coated with polymethacrylates, 16.7% carbomer beads produced by extrusion-spheronisation and the freeze-dried cushioning beads. These tablets disintegrated quickly in water forming a homeogenous suspension after stirring for 1-1.5 minutes.
The intent of this study is to understand the extent to which consumers' are willing to pay to have access to community-based pharmacist services. These services are distinct from the physical skills of dispensing a pharmaceutical product. The contingent valuation method was used to determine consumers' willingness-to-pay (WTP) for these services. Contingent valuation is a survey method that asks individuals to express their WTP for a good or service currently not available and/or not priced in well-functioning markets. A convenience sample of 348 adult, working individuals from four locations around Baltimore city were asked their WTP for five individual pharmacist services and then for a package of all services in hypothetical market scenarios. Consumers were asked their WTP via three payment mechanisms: an out-of-pocket payment, a monthly insurance premium and an annual membership fee payable to a pharmacy of their choice. The survey was administered using a self-administered, computerized interview to obtain WTP bids in dollar terms for community-based pharmacist services. All WTP values for pharmacist services are significantly greater than zero. A two-part estimation model that corrects for the biased estimates of zero dollar bidders, was used to separate WTP bidding behavior into two stages. The first stage separates individuals by their decision to bid for pharmacist services and then a decision about how much to bid conditional on bidding in the first place. The probability of bidding ranged from 0.595 for advice on nonprescription medication to 0.837 for the pharmacists attention to safety when dispensing a prescription medication. Respondents were WTP most to have the pharmacist review the appropriateness of all their medication ($4.76, SD 5.90) and to have all pharmacist services available based on an annual fee ($89.14, SD 161.37). Individuals are more likely to bid if they are non-white and have a positive attitude towards paying and are less likely to bid if they have an income exceeding $50,000/year. Non-whites are WTP significantly more than whites. Tests of starting point bias and the effect of information on WTP bids were not significant. The WTP bids obtained for community-based pharmacist services are subject to rational interpretation.
Disintegrants are substances included in tablet formulations to cause the compressed tablet to break apart and promote drug dissolution when placed in an aqueous environment. In the past two decades, three categories of newer disintegrants have come into widespread use. These substances are chemically modified starch (sodium starch glycolate), chemically modified cellulose (croscarmellose sodium) and a synthetic polymer (crospovidone). Because of their high efficiency at low levels of addition compared to traditional starch, these substances are often called "super disintegrants." One objective of this dissertation was to identify among different sources of disintegrants of each type meeting NF standards, differences in physical properties thought to be related to functionality. A second objective was to develop standard performance tests and use those tests to determine the hypothesized relationship between these physical differences and disintegrant functionality. Dissolution was performed on a model tablet formulation of hydrochlorothiazide using either an insoluble filler (dicalcium phosphate dihydrate) or a soluble filler (spray-dried lactose) and test disintegrants at a 1% level. Disintegrants tested exhibited significant differences in the rate and extent of liquid uptake and in the ability to develop axial and radial disintegrating forces. Lowering the pH altered the rate and extent of liquid uptake of sodium-starch glycolate and croscarmellose sodium. Since there are no ionizable groups in crospovidones, lowering the pH did not affect their liquid uptake performance. Sources of crospovidone containing larger particle size fractions showed greater rate of liquid uptake, however crospovidones with greater porosity showed greater extent of liquid uptake. Liquid uptake study on sieve fractions of crospovidones showed greater rate and extent of uptake for larger sieve cuts, whereas smaller sieve cuts of starch glycolates showed greater rate and extent of liquid uptake. For tablets containing water-insoluble filler dicalcium phosphate, disintegration times for sources of crospovidone containing larger particle size were lower and showed correspondingly faster dissolution rates. The rate of disintegration and dissolution followed the same rank order as the extent of liquid uptake. However, when the filler was changed to spray-dried lactose, although the disintegration of all tablets containing different sources of crospovidone was faster than in the insoluble filler, no significant differences were detected in either the disintegration times or dissolution amongst the disintegrants from different sources. Tablets containing croscarmellose sodium or sodium starch glycolate from different sources, in either filler showed no significant differences in disintegration times and their corresponding rates of dissolution were also not different, indicating that dissolution of hydrochlorothiazide is the rate limiting step. This study indicates that liquid uptake study, particle size and porosity should be included in crospovidone monographs, whereas liquid uptake studies and/or settling volume studies in a low pH medium should be included in compendial monographs for sodium starch glycolate and croscarmellose sodium. (Abstract shortened by UMI.)
Patient drug consumption behavior has an impact on the outcomes, effectiveness, and costs associated with therapy. Patients' beliefs influence their health behaviors and little is known about how patients form beliefs. Therefore, an understanding of belief formation will assist professionals in developing interventions that effectively influence health behaviors. This study used the model of belief processing proposed by Smith, Benson, and Curley (1991) to examine the belief formation used by arthritis patients regarding their medication. Study subjects included arthritis patients from a health maintenance organization population. Forty-six subjects were randomly assigned to four groups. Three groups received different levels of information about a drug and were asked about their beliefs regarding its helpfulness. Subjects in the final group were asked about their beliefs regarding the helpfulness of nabumetone, a drug they were currently taking. Verbal protocols were independently coded by three coders using operational definitions from the literature and constructs in the model. The codes were tallied and the hypotheses were tested using ANOVA and MANOVA. Subjects used more practical reasoning than judgments or calculation to form their beliefs. Most subjects used responses that corresponded with two or more modules of the model. Contrary to expectations, providing more information did not influence the use of practical reasoning or judgments. Amount of information also did not influence subjects' use of most argument types. These findings suggest that (1) patients use practical reasoning rather than formal logical reasoning to form beliefs about the helpfulness of medications; (2) the "expectancy x value" approach is not appropriate in modeling the reasoning patients use to form beliefs about their medications; (3) the Smith, Benson, and Curley model contains constructs used by patients to form beliefs; (4) experience decreases the use of authoritative arguments in forming beliefs; and (5) increased information may influence beliefs, but it does not seem to influence the processing used to form beliefs.
Understanding the pharmacokinetics (PK) and pharmacodynamics (PD) of a new drug in an appropriate animal model provides a scientific framework for efficient and rational drug development. Cardiovascular measurements from small animals are difficult or impossible to obtain. The conventional methods, chemical restraint, physical restraint, cuff blood pressure and tethering used to obtain cardiovascular PD have limitations. These methods affect physiological function of animals and introduce stress artifact into data. Recently, radiotelemetry has been proposed as a new method to obtain cardiovascular PD from small animals. The objective of this research was to investigate the application of radiotelemetry in the pharmacokinetic/pharmacodynamic (PK/PD) modeling of cardiovascular agents in small animals. PD of various cardioactive agents such as procainamide (PA) and its active metabolite, N-acetylaprocainamide (NAPA) were evaluated. Additionally, one of the objectives of this dissertation was to evaluate the effects of exercise training on the pharmacokinetics of a model substrate of N-acetylation reactions (phase II enzymes). PA was chosen as a model drug for these studies. Radiotelemetry avoided the stress associated with animal handling and the use of anesthesia during PD studies, which allowed for the attainment of higher quality and more accurate data. PA displayed a significant increase in QT, QR and QS intervals from the baseline. The QT prolongation has been used as a surrogate marker in PA clinical studies. The PK of PA and NAPA were best described by a one compartment model. An Emax model was able to accurately describe the relationship between PA concentration and the QT interval. Effects of exercise training on the PK as well as PD of PA and NAPA were evaluated using radiotelemetry. Rats were exercised for four weeks by treadmill running. These studies noted that four weeks of exercise training did not alter the PK or PD of PA and NAPA suggesting that exercise training may not have significantly affected N-acetyltransferase. In conclusion, radiotelemetry allows the prediction of the PK/PD relationship observed in clinical studies by conducting such studies in small animals.
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