Recently, the high mortality rate resulting from the reactivation of hepatitis B virus (HBV) through the use of immunosuppressive therapy or chemotherapy for fulminant hepatitis patients has been recognized as one of the most critical medical issues.
On May 19, 2014, we started a collaborative drug therapy management (HBV-CDTM) project to establish a preventive procedure that can be used to avoid HBV reactivation. Before starting the project, the project protocol developed by the commission of chemotherapy was approved by the Director of Iwakuni Clinical Center. We decided to manage the HBV screening demonstrated in the hepatitis B treatment guidelines in collaboration with pharmacists, doctors and medical technologists. To fill in clinical records when conducting HBV-CDTM, we used the “eXChart” of the electronic clinical record system “HOPE/EGMAIN-GX” to simplify tasks, information sharing among medical staff members with different duties and collection of electronic clinical data.
From May 19, 2014 to January 31, 2015, we applied HBV-CDTM to 211 patients in total, and found three patients (1.4%) were hepatitis B surface antigen (HBsAg)-positive, and 75 patients (35.5%) were hepatitis B core antibody positive and/or hepatitis B surface antibody-positive despite being HBsAg-negative. We extracted 78 high-risk patients of HBV reactivation through HBV-CDTM. In addition, the operation rate of HBV screening examination after the introduction of HBV-CDTM rose to 98.6% from that of 3.2% before introduction.
Through the HBV-CDTM project, we concluded that the introduction of HBV-CDTM enabled reduction of doctors' loads and enhanced the preventive procedure against HBV reactivation.
Hand-foot skin reaction (HFSR) caused by regorafenib deteriorates the quality of life (QOL) of patients. Risk factors of HFSR by regorafenib in the Japanese population have not been clarified. We conducted a retrospective survey to clarify the risk factors of HFSR by regorafenib in 45 patients with unresectable advanced or recurrent colorectal cancer. The initial dose of regorafenib was reduced in 19 (42.2%) patients. The median time to treatment failure (TTF) was 42 days, and median relative dose intensity (RDI) was 50% over the entire treatment period. HFSR was developed in 31 patients (68.9%), and 22 of them (48.9%) were assessed as Grade 2 or higher.
In the Cox proportional hazards regression analysis, significantly prolonged factors of TTF by regorafenib were a history of three or more chemotherapy regimens (hazard ratio 0.484, 95% confidence interval: 0.247-0.948; P = 0.034) and HFSR assessed as Grade 2 or higher (hazard ratio 0.378, 95% confidence interval: 0.163-0.620; P = 0.001). In the multivariable logistic regression analysis, significant risk factors of severe HFSR assessed as Grade 2 or higher were under 65 years old (odds ratio 4.755, 95% confidence interval: 1.215-18.616; P = 0.025) and hypoalbuminemia (odds ratio 4.738, 95% confidence interval: 1.208-18.582; P = 0.026).
The patient was receiving hormone treatment with a bone resorption inhibitor, zoledronic acid, a gonadotropin-releasing hormone agonist, goserelin acetate, and an estrogen agonist to treat castration-resistant prostate cancer with bone metastasis. There was a slight increase in the prostate-specific antigen (PSA) level, and ethinylestradiol (EE) was switched to estramustine phosphate sodium (EMP). Subsequently, the PSA level again increased, and the regimen was switched to enzalutamide. Thoracic pain suddenly occurred 2 weeks after EMP discontinuation. Under a tentative diagnosis of ischemic heart disease (IHD), the patient was admitted to the ward of the Department of Cardiology. In the left anterior descending branch, stenosis was observed. Percutaneous coronary intervention was performed. Estrogen agonists exhibit coagulation actions. On the product labeling of EE and EMP, myocardial infarction and angina are reported. In this patient, there had been no clinical findings suggesting ischemia, and there was no history of hypertension, diabetes mellitus, or dyslipidemia. The influence of estrogen-containing drugs must be considered even after discontinuation. Therefore, we considered that IHD was associated with EE or EMP in the present case. In addition, it was possible that the new antiandrogen drug enzalutamide caused IHD. It may be necessary to recognize that IHD may occur during the period of hormone treatment.
Use of a closed system drug transfer device is effective in decreasing the exposure of medical staff to anti-cancer drugs. However, the exposure of a syringe plunger to anti-cancer drugs during preparation has not been validated. Therefore, we conducted a study to examine the drug pollution of the syringe plunger after cyclophosphamide (CPA) preparation. In the present study, CPA were detected in all syringe plungers that had been used in CPA preparation (median: 2.97 ng, range: 0.681-68.2 ng). Therefore, using the same syringe for administering two or more injections could increase the risk of CPA exposure for the medical staff.
Because of the large volume of medical information used in medical settings, we conducted a study on the sources that pharmacies in Chiba Prefecture, Japan, utilize to obtain drug and patient information. We also looked at the status of dispensing devices in pharmacies for functions such as patient information management. We investigated the information sources for acquiring patient information and prescription questions, and the status of books and journals used for acquiring drug information. With respect to dispensing devices, we investigated the equipment used for patient information management and drug preparation. The most common means for obtaining patient information were drug profile books (95.5%), patient communication (95.1%) and medication histories (91.0%). Compared to 2004, these results showed a significant rise in the use of drug profile books and medication histories to obtain information (P < 0.01). The top method for confirmation when there was a question about a prescription being taken was patient communication (86.7%), followed by contacting healthcare institutions such as by telephone or fax (81.2%), and medication histories (80.0%). Of the pharmacies polled, 96.2% had a computerized medical fee receipt management system and 50.3% had an electronic drug history system. While a mere 1.7% of the pharmacies had no reference books, the rate rose to 54.4% for pharmacies without academic or technical journals. Although pharmacies utilize drug profile books and medication histories to collect information, the penetration rate of electronic drug history systems is inadequate. In addition, measures that will increase the low rate of journal subscriptions must be studied.
Seven products, currently on the market as acetaminophen suppository 100 mg, are commonly used for pyrexia in children, and yet there have been no reports on their solubility and divisibility. We examined the hourly solubility rate of each suppository using a dissolution tester for suppositories. In addition, we conducted a hardness test using the EZ-test, a questionnaire-based investigation on the accuracy and divisibility when the suppositories were divided. There was a significant difference between each suppository (P < 0.01). While 4 types dissolved completely within 60 minutes, one type took 120 minutes to dissolve completely. Another two had only 51 and 67%, respectively, at 180 minutes. The bases are hard fat in all suppositories. The types and additives of hard fat may have had an influence on solubility. The hardest suppository was assessed as showing marked differences in the weight ratio and solubility between the distal and tail portions when divided in half, due to which division was considered inappropriate, and there were differences in accuracy and divisibility among suppositories.
From the above, it was suggested that the acetaminophen suppository 100 mg products may show differences in the solubility, time to action onset, and duration of the action. In addition, we should instruct physicians on important points of caution regarding the characteristics of each preparation when dividing the suppositories so that they can be given safely to infants.
Currently, there are several problems associated with the dispensation of pharmaceuticals. Among these, issues related to dispensing techniques when splitting tablets in half or misreading orders for half tablets are reported“. Splitting tablets in half” possesses elements of risk leading to dispensing error in various aspects of the dispensing process. A small group discussion (SGD) using the KJ method was held to identify issues related to dispensing half tablets, and to develop appropriate medical safety training measures for pharmacists working at chain drug retailers. The discussion revealed several factors affecting the dispensation of half tablets, such as “incorrect assumption about prescription,” “dispensing technique was insufficient,” “dosage/administration was not checked,” and “miscalculation.”
Based on the discussion, precautionary measures were established and put into practice for a certain period. A survey among the participants to evaluate the effects of the workshop revealed that the participants were more conscious of the issues after the SGD. In addition, an evaluation of the measures discussed in the SGD was performed 1.5 years after the workshop. These evaluations showed that the measures discussed were still being followed at many pharmacies. Therefore, we suggest that medical safety training workshops be conducted for pharmacists working at chain drug retailers.
In patients with chronic kidney disease (CKD), cautious drug dose adjustment is required as adverse effects including drug-induced acute kidney injury or drug intoxication may occur when an inappropriate dose of medicine is administered. We herein performed family-pharmacy based trials for drug dose adjustment in which pharmacists evaluate renal function of the patients using a hearing survey. In our group it was revealed that 50.3% of the outpatients have impaired renal function as their average eGFR was below 60 mL/min / 1.73 m2, and suggested that we need to confirm the degree of their renal insufficiency in the dispensing work. The ratio of inquiry for prescribed medicine from pharmacists to doctors was 3.3%, and 53.2% of these inquired prescriptions was readjusted, indicating this inquiry system potentially contributed to appropriate medication. The role of family pharmacies is considered to be important in the inspection of prescribed drugs for the patients with impaired renal function who visit multiple clinics, and is expected to be the last bastion as the inspector for safe administration of drugs.
Decontamination of antineoplastic drugs in safety cabinets by guideline-recommended swabbing using sodium hydroxide (NaOH) is difficult. Studies on decontamination of antineoplastic drugs are lacking. On the flooring of our chemotherapy center, we evaluated the decontamination effect of ozone water (OW) and sodium hypochlorite (NaClO). Cyclophosphamide (CP), 5-Fluorouracil (5-FU) and gemcitabine (GEM) were the antineoplastic drugs used as indicators of this evaluation. Wipe tests were conducted before and after immersion decontamination of flooring using 0.3 M NaOH, OW and 0.1% NaClO, as well as before and after immersion decontamination or swabbing decontamination using OW and NaClO. Wipe tests were also conducted after immersion decontamination or wipe decontamination using NaClO after OW and OW after NaClO. Flooring that was contaminated at the first wipe test was not decontaminated by immersion decontamination using NaOH. However, it was decontaminated using immersion decontamination by employing OW and NaClO continuously after using NaOH. Flooring contaminated by CP, 5-FU and GEM was decontaminated largely by immersion decontamination using OW or NaClO. When the immersion decontamination was conducted by using OW continuously after using NaClO, or by using NaClO continuously after using OW, contamination was hardly detected. In the case of swabbing decontamination, similar results were found. Variation in effectiveness between immersion decontamination and swabbing decontamination was not shown. These results suggest that decontamination of antineoplastic drugs is possible using 0.3 M NaOH, OW, and 0.1% NaClO. Furthermore, antineoplastic drugs could be decontaminated by swabbing using OW and 0.1% NaClO.
Osteoporosis is more common in elderly people and oral bisphosphonates are widely used for the treatment of osteoporosis throughout the world. It is generally considered that elderly people decline in physical function with age and find the taking of drugs to be problematic. We conducted this survey to clarify potential problems in osteoporotic patients during treatment with oral bisphosphonates. The survey of an 8-item questionnaire was performed in 32 pharmacies in Hiroshima prefecture. A total of 684 patients were enrolled in the survey, 637 patients were analyzed and 47 patients with protocol violation were excluded from the survey. Baseline characteristics were as follows: gender (female, 581; male, 56), age (< 70 years old, 26%; 70 years old ≤, 74%), administration interval (daily, 42; weekly, 313; monthly, 282). The patients with dry mouth accounted for 14% of total patients and those with experience of discomfort during swallowing accounted for 11%. Moreover, 40% of total patients had experience of forgetting to take bisphosphonates. Our survey demonstrated that osteoporotic patients taking bisphosphonates experienced several hurdles and did not complain directly to pharmacists about it. We need to communicate better with osteoporotic patients and collaborate closely with physicians, nurses and others.
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