Earticle

BACKGROUND Re-examination system was post-marketing safety measures for drugs in Korea. The objective of this study was to examine experts’ opinions for post-authorization study and current status of quality control of study in pharmaceutical company to improve the quality of post-authorization study of re-examination. METHODS We conducted mail survey for pharmaceutical company (2014. 9. 15-10. 17) and e-mail survey for experts (2014. 10. 1-10. 17). Questionnaires for 29 pharmaceutical companies and for 19 experts were collected and analyzed. RESULTS More than 80% of experts said that quality control of post-authorization study is needed to improve the study, however, many pharmaceutical companies had a difficulty in conducting study. Seventy two percent of companies pointed out low cooperation of survey sites as difficulty in monitoring of post-authorization study. CONCLUSION Quality control of post-authorization study of re-examination system needs to be improved to provide reliable evidence for drug safety.

Positive list system was introduced in 2007 as a part of DERP (Drug Expenditure Rationalization Plan) in Korea. The purpose of this system is allocation efficiency based on value for money. Value is evaluated by HTA (Health Technology Assessment) focusing on clinical usefulness and cost-effectiveness with proven evidence at the time of launch. This article is prepared to assess current HTA system from industry perspective considering value-based decision making. It seems that current HTA process has several areas to improve since reimbursement decision is too much dependent on launch time evidence which may not reflect true value. The difficulty of showing superior efficacy does not necessarily mean there isn’t any additional value for society. New treatment option brings value of better treatment mixture. Drugs with unquantifiable benefit also have their own value. The issue is that current HTA often fails to capture these values. Current HTA focusing on statistical significance sometimes fails to find clinically significant value. One of big issues is that uncertain evidence of effect is often interpreted as the evidence of no value. ICER dependent decision making may result in unreasonable decision such as non-reimbursement of highly valuable drug for society. HTA methodology needs to be evolved in accordance with advancement of science. The flexible pricing method such as risk-sharing and holistic approach like MCDA (multiple criteria decision analysis) in decision-making is required for better patient access. This decision should incorporate fair assessment for innovativeness, clinical usefulness and equity not only for cost-effectiveness or budget impact.

The sale amounts of pharmaceutical company depends on the salesperson's core competence. The objective of this study is to analyze the impact of salesperson’s perception on pharmaceutical corporate culture and reputation on one’s own core competence. We reviewed a previous study on corporate culture and reputation to develop a questionnaire to investigate corporate culture, reputation and core competence of pharmaceutical company’s salespersons. We conducted a survey for 150 participants in Seoul and Gyeonggi region and the response rate was 93.3%(140/150). We conducted a regression analysis, in which the dependent variable was core competence of salesperson and independent variables were corporate culture and reputation. The correlation between corporate culture and core competence was positive in both communication and organization culture. Also, we suggested that communication culture was more important than organization culture for core competence. In case of reputation, ethical management was the only factor affected core competence positively. On the other hand, societal responsibility and corporate image did not affect core competence significantly. For the sales and management ability of salespersons in pharmaceutical companies, the improvement on factors that directly affect salesperson’s performance, such as communication and organization culture between colleagues and superiors, is preferentially needed rather than the company's societal responsibility, quality of product, ethical management, corporate image and reputation.

OBJECTIVE The purpose of this research is to analyze the prescribing pattern and amount of narcotic analgesics by the presence of cancer or non-cancer patients in Korea. METHODS We identified opioid analgesic prescriptions used by pain patients using National patient sample of Health Insurance Review and Assessment claims data from 2010 to 2013. Prescribed amount of opioid analgesics were calculated using defined daily dose. The dataset included 104,220 pain patients who were prescribed opioid analgesics and 220,296 claims containing narcotic analgesics for 4 years. RESULT Opioid use for non-cancer pain management gradually increased from 24% in 2010 to 40% in 2013. Compound annual growth rate (CAGR) of opioid analgesics was higher in pain patients without cancer (11%) compared to those with cancer (5%). Overall, use of patch formulation dramatically increased from 2% in 2010 to 76% in 2013, while oral formulation decreased from 76% to 20% for non-cancer pain management. The most frequent pharmaceutical ingredient prescribed for cancer patients was oxycodone (37%), followed by morphine (32%) in 2010. For non-cancer pain management, the prevalence of oxycodone, morphine and other opioids (such as codeine) use was 30%, 21% and 37% respectively in 2010. On the other hand, in 2013, the proportion of fentanyl prescription was 76%, showing the most frequent use for both cancer and non-cancer pain management. Approximately 80% of opioid analgesics were prescribed from tertiary hospitals and general hospitals for non-cancer pain management. CONCLUSION Since non-cancer pain market is growing over the year and has a huge market potential, it is necessary to build up different strategies from the cancer pain market. The market analysis using HIRA claim data can help understand market trend and to develop marketing strategies.

Unlike a conventional drug, cell therapy product needs special regulatory track which allows to use cell therapy products that is not yet approved with a certain restriction such as Hospital exemption scheme in Europe and Advanced medicine system in Japan.

BACKGROUNDS Health insurance administrative databases are important sources of information in finding health-related evidence. The objective of this study was to introduce the Korean Health Insurance Review and Assessment Service (HIRA) claims database to perform public health and social pharmacy studies. METHODS This article introduces the contents and characteristics of the HIRA data, describes the data acquisition procedures, provides examples of studies carried out using the data, and discusses several aspects that requires attention in those studies. RESULTS The HIRA claims database contains information on all claims including patients’ diagnoses, treatments, procedures, and prescription drugs for approximately 50 million Koreans. This database can be used for the following analyses: estimation of incidence or prevalence for a variety of specific disease, description of the utilization of health care resources and services, and verification of hypotheses about the health outcomes. This database has advantages including low cost, ease of patient follow-up over long time periods, and absence of reporting bias. There are several limitations of using this database including uncertain or low validity of disease diagnoses, potential discrepancies between physician’s prescriptions and patient’s actual medication intake, and lack of laboratory results and health-related behavioral information. CONCLUSION The HIRA data provide tremendous opportunities to perform large-scale quantitative analyses in the fields of public health and social pharmacy. A better understanding of prescribing practice, health policy, and data structures allows the researchers to use the claim database appropriately.