Objective: To examine the signal of gastrointestinal tract injury induced by aspirin and other drugs, we analyzed the US FDA Adverse Event Reporting System (FAERS).
Methods: After deleting duplicate submissions, we analyzed the reports involving gastrointestinal tract injury associated with aspirin, H2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs), ACE inhibitors, angiotensin II receptor blockers (ARBs), and antiplatelet and antithrombotic drugs.  The reporting odds ratio (ROR), a recognized pharmacovigilance tool, was used for the quantitative detection of signals.
Results: Based on 29,017,485 co-occurrences, i.e., drug-adverse event pairs, found in 1,645,605 reports from 2004 to 2009, the ROR-associated gastrointestinal tract injury for aspirin alone, aspirin with H2RAs, aspirin with PPIs, aspirin with ACE inhibitors, aspirin with ARBs, and aspirin with antiplatelet and antithrombotic drugs were 2.88, 1.42, 1.46, 1.00, 1.05, and 2.98-8.26, respectively.  The following summarizes the types of listed reports: 86 reports described the daily aspirin doses, and 36/86 were between 75 and 100 mg; 343 reports described the periods between the start-date for aspirin and the date when gastrointestinal tract injury occurred, of which 128/343 were within one month while 215/343 were over one month; additionally, 78 reports described the total cumulative doses of aspirin, and 17/78 were between 1 and 5 g.
Conclusion: The data suggest that H2RAs, PPIs, ACE inhibitors, and ARBs may reduce gastrointestinal tract injury associated with aspirin in possibility.

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Objectives: The objectives of this study are to evaluate the current situation of concomitant drug use by community-dwelling elderly dementia patients, and to extract factors influencing the presence of potentially inappropriate medications (PIMs).
Method: The research subjects were patients 65 years of age or older for whom concomitant drugs were prescribed on the same prescription form as donepezil hydrochloride.  One hundred and twenty community pharmacies randomly selected from 28 of the 47 prefectures throughout Japan.  Main research topics were sex, age, the clinical department to which the prescribing physician belonged, daily dosage of donepezil, and concomitant drugs.  Concomitant drugs were evaluated using the Beers Criteria: the Japanese Version. Furthermore, to search factors influencing the presence of PIMs, logistic regression analysis was used.
Results: Data for 335 patients were extracted.  The average number of concomitant drug cases per patient were 4.2 (SD 2.6), and 109 patients (32.5%) were prescribed PIMs.  A logistic regression analysis confirmed that significant factors influencing the presence of PIMs were “the clinical department to which the prescribing physician belonged” (OR 4.80, 95%CI 1.01-22.72), “concomitant drug cases” (OR 1.26, 95%CI 1.13-1.41) and “the presence of concomitant use of central nervous system agents” (OR 5.82, 95%CI 3.35-10.11).
Conclusion: This study revealed that more than a few cases of community-dwelling elderly patients of dementia were using concomitant drugs with potential risks.  It suggested that influencing factors were “the specialty of the prescribing physician” and “the presence of concomitant use of central nervous system agents.”

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Objective: The purpose of this study was to clarify the importance of therapeutic drug monitoring (TDM) at acute care hospitals using Diagnosis Procedure Combination (DPC) data.
Methods: We used DPC data from about 3,500,000 inpatients at about 950 acute care hospitals.  The investigation period was from July 2010 to December 2010.  Patients were divided into 2 groups: TDM intervention (n=22,012); and non-TDM intervention (n=26,400).  We compared the clinical indicators (length of hospital stay, payment based on performance and drug costs) and use of antimicrobials.
Results: TDM intervention was carried out in 45.5% patients for whom an anti-MRSA agent was prescribed.  The duration of anti-MRSA agent administration was significantly longer in the TDM intervention group than in the non-TDM intervention group.  The total daily cost of anti-MRSA agents was significantly lower in the TDM intervention group than in the non-TDM intervention group.
Conclusion: Our results suggest that TDM intervention is often performed for seriously ill patients who require continuous treatment.  TDM intervention may prevent adverse reactions as a result of adjusting the dosage of the anti-MRSA agent.

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