PubMed · 11637112
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H C Silberman. 1998. [Not Available].. https://pubmed.ncbi.nlm.nih.gov/11637112/
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Opioids have demonstrated efficacy and often are drugs of choice in the management of postoperative pain. However, their use is often limited by adverse drug events (ADEs). The objective of this study was to determine the ADE rate in adult surgical patients who received opioids and the impact of opioid ADEs on length of stay (LOS), costs, and mortality. A hospital-based computerized system detected potential ADEs. Adult patients were selected if they received at least one dose of opioid medication during a surgical hospitalization between 1 January 1990 and 31 December 1999. Control patients were matched based on matching length of stay ([LOS] at least as long as time to ADE), age (within 10 years), sex, admission year, major disease category (MDC), and without an ADE. Linear regression models were used to determine the predictors of increased LOS, total hospital costs, and log-transformed total hospital costs. 60,722 patients received opioid medication during their surgical hospitalization and 2.7% experienced an opioid-related ADE. The most common clinical manifestations were nausea and vomiting (67%), and rash, hives, or itching (33.5%). No statistically significant difference was seen in mortality between ADE/non-ADE patients. ADE patients had statistically significant increases in LOS (0.53 days) and in log-transformed cost (16%). The estimated log cost difference of 16%, if applied to the median cost patient in the non-ADE group, averaged US$ 840. Opioid-related ADEs are common in hospitalized patients and increase LOS and total hospital costs.
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The advent of simultaneous global clinical trials and drug registration strategies has increased the demand for global pharmacoeconomic strategies. Outcomes researchers in pharmaceutical companies are faced with the challenge of assessing at a strategic level what pharmacoeconomic data are most useful in Japan and when, and then deciding at a tactical level what type of study designs are feasible. This paper is written mainly for the benefit of researchers working outside of Japan in the pharmaceutical/medical device industry or academia who are interested in conducting research in Japan. We reviewed the existing pharmacoeconomic literature in Japan, and found that the number of studies per year has been steadily increasing. The majority of studies have been cost-effectiveness and cost-consequence analyses. Typical data sources available in Japan are somewhat limited compared with other Western countries. However, charge data can be easily accessed through the national uniform reimbursement fee system and these data are particularly relevant for pharmaceutical pricing negotiations with the Ministry of Health, Labor and Welfare (MHLW). The present use of pharmacoeconomic data by pharmaceutical companies is mainly for pricing negotiations but recent reforms make certain types of data useful for marketing strategies too. The demand for pharmacoeconomic data may increase because of upcoming MHLW pharmaceutical pricing and/or recent health insurance system reforms. Economic evaluation of medical technologies in Japan, though lagging behind North America, Australia and Europe, has the potential to rapidly gather momentum as increasing cost-escalation worries contribute to a growing interest in pharmacoeconomic data.