| Summary: | 博士 === 高雄醫學大學 === 醫學研究所 === 97 === Background: The functions of pharmacist professional practice have been changed from the traditional compounding and dispensing to providing individual patients with pharmaceutical care and its quality management. Pharmaceutical care includes assessment of the prescription appropriateness, drug effectiveness monitoring and follow-up evaluations. The quality management includes selection of appropriate drugs, management of drug purchase and inventory, preventing and reporting medication error, adverse drug monitoring and reporting. All those services are most likely to improve patients’ drug safety and reduce drug expenditure and health care cost reimbursed by Bureau of National Health Insurance Company (BNHI). In order to cope with the continuously increase of health care expenditure, the application of economic analysis to explore the consumption of pharmaceuticals is part of a larger global trend to maximize the value received for money spent on healthcare services. The aim of this study was to apply the pharmacoeconomic methodologies and principles to pharmaceutical services which included pharmaceutical care quality management, such as the costs of adverse drug monitoring and reporting; pharmacist intervention to educate asthma patients and develop shortened version of quality of life questionnaire (AQLQ), validity and reliability measuring. The evaluation on cost-effectiveness of pharmaceutical care included pharmacist intervention in the use of activated protein C (APC) for the treatment of severe sepsis; evaluation on Trastuzumab for HER-2(+) early breast patients by using systematic review methodology.
Study design: This study included two parts. The first part was pharmacist monitoring on the quality of pharmaceutical care services, two sub-studies were included. The first was the cost evaluation of adverse drug reactions (ADRs) caused hospitalization; the second sub-study was pharmacist intervention in educating asthmatic patients and measuring the validity and reliability of shortened asthma quality of life questionnaire by Rasch model. The second part was to explore the economic effictiveness of pharmaceutical care, included pharmacist intervention in APC therapy for severe sepsis: influence on clinical and economic outcome and the cost-effectiveness ratio of trastuzumab as an adjuvant therapy for early breast cancer.
Study methods: The first sub-study of the first part was an observational study, patients who were admitted into the hospital due to ADRs or experienced ADRs during hospitalization from January 2002 to December 2004 were identified actively through high-intensity ADR monitoring by clinical pharmacists and passively by physicians and nurses told to report ADRs. The WHO definition of ADR severity was adopted, and degrees of probability for each ADR were determined using the Naranjo algorithm. The direct medical cost incurred by ADRs during hospitalization was excluded to calculate because of uneasy identification; therefore, only direct medical cost of ADRs caused admission was calculated. The second sub-study was educating asthma outpatients about the skill of using inhaler and then administered the asthma knowledge questionnaire to measure the improvement of asthma knowledge. In addition, the original 32-item AQLQ was also administered to the patients and evaluate the impact of asthma on their quality of life. The validity and reliability of two versions was assessed using Rasch model. The first sub-study of the second part was a retrospective case-control study. We reviewed the medical records of patients aged 18 years and older who were admitted to research hospital for severe sepsis from Jan 1, 2003 to Dec 31, 2007. The influence of pharmacist intervention on clinical and economic outcomes was evaluated. The second sub-study was using the systematic review methology to analyze the cost-effectiveness ratio of trastuzumab as an adjuvant therapy for early breast cancer by using modeling or clinical trials. The quality and cost-effectiveness reported in studies retrieved were appraised according to the pharmacoeconomic appraisal guideline. By virtue of the search strategy practiced in this study, we anticipate that the experience in searching evidence-based medicine data may extend to search EBM data of cost-effectiveness of other anti-cancer drugs.
Study results: The results indicated that pharmacist intervention in quality monitoring of pharmaceutical care services is cost-effective, including ADRs monitoring and estimated the direct medical cost of ADRs caused hospitalization was US$ 3489.00, which is the direct medical cost to be saved as pharmacist or physician can prevent the occurrence of one ADR. The asthma outpatients’ recognization of asthma allergen and skill of using inhaler showed improvement. The results of this part have already published in Clin Drug Investig. 2004: 24(10):603-9. This study was only assessed the influence on asthma patients’ quality of life. Rasch model was used to assess and shorten the original AQLQ. The preliminiary results showed that there was differential item functioning (DIF) in the original Chinese AQLQ, i.e. some items in Chinese AQLQ exhibited difficulty for asthma patients’ in answering the questionnaire. The constructive validity (infit and outfit MNSQ were 0.5-1.5) and the person separation index (0.92 Conbach’s α) of the simplied version of 5-scale TAQLQ was better than the original AQLQ. The second parts, the first sub-study showed that the pharmaceutical care is cost-effective. The pharmacist intervention in the use of APC for patients with septic shock in ICU can remind physician to use APC earier which resulted in shortened hospital’s length of stay and reduced direct medical cost; pharmacist using systematic review method indicated that the incremental cost-effectiveness ratios threshold for trastuaumab as an adjunvant treatment for HER+2 early breast cancer patients aged below 55 for one year or long term therapy is appropriate. However, it is not cost-effective for HER+2 breast cancer patients aged over 75 and less than 10 year.
Conclusion: The results showed that the application of pharmacoeconomic in clinical pharmacy is not only providing physicians with a cost-effective drug regimen, the function of pharmacist professional practice, including pharmaceutical care and its quality management monitoring are also likely to reduce direct medical cost. We therefore anticipate that the application of pharmacoeconomic methodology in clinical research on cost-effectiveness of pharmaceutical care and quality management will be continued in order to provide the health care decision maker with more evidence-based data for cost containment and physician to select more cost-effective drug regimens. In addition, we also hope that BNHI may consider adjusting the reimbursement of pharmacist service.
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