Identification and International Comparison of Drugs Contraindicated for Pregnant Women in the Package Inserts / 医薬品情報学

Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.

Mucosal and Submucosal Thickening of Esophageal Wall Is a Promising Factor in the Development of Symptoms in Eosinophilic Esophagitis

Background/Aims@#Asymptomatic esophageal eosinophilia (aEE) is considered to be a potential precursor of eosinophilic esophagitis (EoE). However, there are few clinical parameters that can be used to evaluate the disease. Therefore, we aimed to clarify the factors involved in the symptoms of EoE by examining the clinicopathological differences between aEE and EoE. @*Methods@#We reviewed 41 patients with esophageal eosinophilia who underwent endoscopic ultrasonography and high-resolution manometry. They were divided into the aEE group (n=16) and the EoE group (n=25) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score. The patients’ clinicopathological findings were collected and examined. @*Results@#The median Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score was 3.0 in the aEE group and 10.0 in the EoE group. There was no significant difference in patient characteristics, endoscopic findings and pathological findings. The cutoff value for wall thickening was 3.13 mm for the total esophageal wall thickness and 2.30 mm for the thickness from the surface to the muscular layer (total esophageal wall thickness: 84.0% sensitivity, 75.0% specificity; thickness from the surface to the muscular layer: 84.0% sensitivity, 68.7% specificity).The high-resolution manometry study was abnormal in seven patients (43.8%) in the aEE group and in 12 (48.0%) in the EoE group. The contractile front velocity was slower in the EoE group (p=0.026). @*Conclusions@#The esophageal wall thickening in the lower portion of the esophagus is an important clinical factors related to the symptoms in patients with EoE.

Long-term Outcome of Asymptomatic Esophageal Eosinophilia

Background/Aims@#Asymptomatic esophageal eosinophilia (aEE), characterized by eosinophil infiltration in the esophagus without clinical symptoms, has been reported as a precursor of eosinophilic esophagitis (EoE). Nevertheless, no report exists on the long-term clinical course of the disease. Therefore, this study aimed to investigate the long-term clinical course of aEE over 5 years, including the symptomatic conversion rate and the effect of treatments. @*Methods@#We reviewed 28 patients with aEE who had been followed up for over 5 years with endoscopic monitoring. The basal characteristics of patients were compared with those of 58 patients diagnosed with EoE during the same period. Patients’ clinicopathological findings were collected and examined. @*Results@#No significant differences in basal characteristics and histopathological findings were observed between the patients with aEE and those with EoE. The median follow-up duration was 64 months. Among the 28 patients with aEE, seven were treated with proton pump inhibitor or potassium-competitive acid blocker and the remaining 21 opted for follow-up with no medication.Among the treated patients, six (85.7%) exhibited endoscopic and pathologic improvements.Among the cases followed up without medication, the findings worsened in two (9.5%), improved spontaneously in seven (33.3%), and were unchanged in 12 (57.1%), and three (14.3%) developed symptoms at a mean time of 40 months. Symptoms developed in cases where endoscopic and pathologic findings remained unchanged or worsened during follow-up. @*Conclusions@#Some patients with aEE had improved findings without treatment, whereas others developed symptoms, emphasizing the importance of long-term monitoring and individualized treatment decisions.

An Approach for Providing Drug Information to Primary Care Physicians of Patients Undergoing Nephrectomy Using Information Forms Created by Urologists and Pharmacists / 日本プライマリ・ケア連合学会誌

Tohoku Medical and Pharmaceutical University Hospital uses an information form created by doctors and pharmacists to provide postoperative information to patients who undergo nephrectomy at the Department of Urology. The form recommends that patients' physicians change prescriptions and adjust medication doses considering post-nephrectomy deterioration of renal function in patients with a single remaining kidney. Of the 7 patients who used this information form, prescription changes were made in 4 patients. An information form jointly created by a physician and pharmacist may affect prescription changes.

The Usage of Acetylsalicylic Acid for Lenalidomide Medication in Patients with Multiple Myeloma / 医薬品情報学

Lenalidomide (LD) was reported to increase the risk of thromboembolism when it was used along with dexamethasone (DEX). Prophylactic administration of antithrombotic drugs against thromboembolism has been recommended for proper use of LD, but none of the recommendation is stated in the package insert. The purpose of this study was to elucidate the usage of acetylsalicylic acid (ASA) for lenalidomide medication in patients withmultiple myeloma. We used the MDV analyzer to investigate clinical data retrospectively. The investigation period was from October 1, 2016 to September 30, 2017. Subjects were outpatients aged 20 years or older who were recorded in clinical data as multiple myeloma. There were 7,590 outpatients with multiple myeloma. They were divided into 4 groups by the combined use situation of LD and DEX: LD/DEX non-use group (n＝5,462), DEX alone group (n＝632),LD alone group (n＝203), and LD/DEX together group (n＝1,293), respectively. The prevalence rate of thromboembolism was 7.3% in the DEX alone group and 16.9% in the LD/DEX together group (p＜0.0001). Among the LD/DEX together group, ASA was prescribed at 63.6% in the group without thromboembolism (n＝1,074). The prevalence rate of thromboembolism was higher in the LD/DEX combined group than in the DEX alone group. Considering these findings, risk management for thromboembolism caused by administration of antithrombotic drugs should be considered. It is necessary to create more evidence concerning the necessity of administration of antithrombotic drug in combination with LD/DEX medication.

Gastrointestinal Endoscopy-Assisted Minimally Invasive Surgery for Superficial Cancer of the Uvula

Previous studies reported that endoscopic resection is effective for the treatment of superficial pharyngeal cancers, as for digestive tract cancers. However, the optimal treatment for superficial cancer of the uvula has not been established because of the rarity of this condition. We present two male patients in their 70s with superficial cancer of the uvula, detected with upper gastrointestinal endoscopy. Both patients underwent surgical resection of the uvula under general anesthesia. The extent of the lesions was determined by means of gastrointestinal endoscopy by using magnifying observation with narrow-band imaging, enabling the performance of minimally invasive surgery. Endoscopic submucosal dissection was performed to achieve en bloc resection of the intramucosal carcinoma that had infiltrated the area adjacent to the uvula. Gastrointestinal endoscopists should carefully examine the laryngopharynx to avoid missing superficial cancers. Our minimally invasive treatment for superficial cancer of the uvula had favorable postoperative outcomes, and prevented postoperative loss of breathing, swallowing, and articulation functions.

Acute hemorrhagic rectal ulcer in a patient with lung cancer

<b>Purpose</b>: Acute hemorrhagic rectal ulcer (AHRU) commonly occurs in elderly who are bedridden for long time due to severe underlying diseases such as cerebral and myocardial infarction and their complications. However, it is uncommon in end-stage cancer patients receiving palliative care. We report a rare AHRU case in his forties who had lung cancer with paraplegia due to tumor invasion. <b>Case</b>: A male lung cancer patientwas admitted to our hospital for new-onset paraplegia caused by spinal cord invasion. On 25th day after admission, he suffered from a little rectal bleeding. From that day, a painless rectal bleeding becomes gradually increased. On 37th day, a massive bleeding was occurred. Endoscopy showed that there was no active bleeding but an exposed vessel and partial circumferential ulcer in the lower part of rectum, which was compatible with the finding of AHRU. The lesion was successfully treated by clipping and no re-bleeding was observed after clipping. He was discharge on 103rd day. <b>Conclusion</b>: AHRU should be considered in the differential diagnosis of a massive melena in end-stage cancer patients. Prompt diagnosis and therapy is important because this disease is curable even in the terminal stage to improve their quality of life. Palliat Care Res 2011; 6(1): 308-312