Introduction: Pancreatic cancer often recurs as local recurrence or peritoneal dissemination, causing severe abdominal and back pain. We report a case of postoperative skull metastasis of pancreatic cancer that caused headache and was treated effectively with radiotherapy. Case: A 67-year-old woman underwent surgery for pancreatic cancer. She had epigastric pain due to local recurrence and peritoneal dissemination, which was controlled with loxoprofen and fentanyl transdermal patch. She had right-sided headache, which gradually increased in intensity, but lacked intracranial hypertension and focal neurological symptoms. Acetaminophen and Goreisan did not provide adequate pain relief. Although CT showed no brain or bone metastasis, MRI showed metastasis in the right frontal bone. Palliative radiotherapy was administered. Subsequently, headache decreased from 7–8/10 to 2–3/10 on the Numerical Rating Scale. Conclusion: Skull metastases in cancer patients may be diagnosed using MRI, even when they remain undetectable by CT.

In Japan, the National Health Insurance (NHI) prices of new drugs are set according to the NHI Drug Price Standard (NHI Price Standard).　The NHI Price Standard was notified by the Ministry of Health, Labour, and Welfare based on the ”Drug Price Calculation Criteria” proposed by the Central Social Insurance Medical Council (Chuikyo) in Japan.　The NHI Price Standard affects the research and development strategy of pharmaceutical companies.　In order to discover undetected relationships, the factors influencing the ”drug price” were evaluated through the association rule mining technique.　We surveyed the Chuikyo‐documents about NHI price listing over the period October 27, 2006 to February 8, 2007.　The number of approved new drugs was 874, while that of drugs completed (”drug price per day”) was 314.　The numbers of new compounds corresponding to a drug price per day of ”below 200 yen,” ”between 200 yen and 1,000 yen,” ”between 1,000 and 10,000 yen,” and ”above or equal to 10,000 yen” were 87 (27.7%), 91 (29.0%), 79 (25.2%), and 57 (18.2%), respectively.　In the association rule mining method, we observed high lift values of the combined items ”above or equal to 30,000 patients expected to be administrated” and ”drugs affecting sensory organs” in the group of drug price per day below 200 yen.　The lift values of the combinations of ”biological preparations” and ”similar efficacy comparison‐based price setting (Ⅱ)” or ”below 30,000 patients expected to be administrated” and ”antineoplastic drug” in the group of ”above or equal to 10,000 yen of drug price per day” were high.　These results provide a basis for the development and application of new drugs in Japan.

In Japan, a re-examination system was introduced in the 1970s, and Post-marketing surveillance (PMS) has been conducted in many cases after the launch of new drugs or the approval of new indications for existing drugs. The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2018, and more scientific approach has been required for PMS. The survey aims to identify what kinds of change occurred in the PMS planned after r-GPSP enacted. As for the study method, after confirming the review report of each product, Risk Management Plan (RMP), and the package insert, and extracting necessary items, tabulation and analysis were performed. As a result of analysis, Drug Use Investigations (DUI) still accounted for more than 60％ of the total in PMS. Regarding the target number of DUI, Fifty-eight out of 90 had a sample size of 500 or fewer, only 3 studies exceeded 3,000. Regarding the newly introduced Post-marketing database surveillance (DB study) after r-GPSP enacted, 13 products and 18 surveillances were confirmed, although the number was not as large as the number of DUI. The most used database was Medical Data Vision Co., Ltd. (MDV), which were used in twelve DB studies, and cardiovascular disease and interstitial pneumonia were set as survey targets for safety considerations in multiple studies. There was no Drug Use Comparative Investigation. Furthermore, there were two products which were approved on the condition with re-examination period but did not required additional Pharmacovigilance activities. In terms of sample size calculation, 88 out of 135 studies mentioned rationales for setting the number of samples. Of which, 58 studies had statistical rationales. In many studies, the sample size calculation method that was commonly used in conventional PMSs, called ‘Rule of three’ was described as the statistical rational. After r-GPSP enacted, newly introduced Post-marketing surveillance, including DB surveys, and the scientific approach recommended by PMDA have been adopted in companies gradually. In the future, in order to further promote the scientific approach, it is necessary to further improve the capability of human resources of companies involved in PMS.