Evaluation of Pharmaceutical Characteristics and Carer Usability of Antiglaucoma Ophthalmic Solutions / 医薬品情報学

Objective: Glaucoma is the most frequent cause of blindness in Japan and is primarily treated using IOP-lowering ophthalmic solutions. Although the patients themselves frequently instill ophthalmic solutions, instillation by caregivers may be necessary for various reasons. Therefore, we evaluated pharmaceutical characteristics of antiglaucoma ophthalmic solutions and their usability from the caregivers' viewpoint.Methods: Five dorzolamide hydrochloride-timolol maleate ophthalmic solutions and 2 travoprost-timolol maleate ophthalmic solutions were evaluated concerning the pharmaceutical characteristics and subjective squeezability rated by adults aged 20 years or above.Results: Among the dorzolamide hydrochloride-timolol maleate compounding ophthalmic solutions, the squeeze force was the lowest in COSOPT® ophthalmic solution (11.8 N), and DORMOLOL® combination ophthalmic solution NITTEN was rated highest, with 68.2% of the subjects placing it within the top 3 levels of a 7-level scale. Of the travoprost-timolol maleate ophthalmic solutions, the squeeze force was 9.8 N, lower than the pioneer drug, in TraTimo® combination ophthalmic solution NITTO, which was also rated in the top 3 levels by 90.3% of the subjects. A strong negative correlation was observed between the squeeze force and squeezability.Conclusion: In instillation by caregivers, the squeeze force was shown to be correlated with subjective squeezability as in instillation by patients themselves. This study provided information concerning the usability of ophthalmic solutions from the caregivers' viewpoint. For the future, it is necessary to select ophthalmic solutions from the caregivers' as well as the patients' viewpoints by utilizing information obtained in this study.

Comparative Evaluation of the Pharmaceutical Properties of Original and Generic Betamethasone Ophthalmic Solution / 医薬品情報学

Objective: In this study, pharmaceutical properties were compared between the original and generic ophthalmic solutions containing betamethasone.Methods: The squeeze force, drop weight, surface tension, pH, kinematic viscosity, and total number of drops were measured. The drop volume was calculated from the drop weight and specific gravity. Information on preservatives contained in each product was collected from package inserts.Results: There was a significant difference in the squeeze force between the original and generic drugs. The pH and kinematic viscosity did not differ between the drugs. The drop volume was in the range of 30.3 to 47.2 μL, and the surface tension ranged between 33.7 and 65.2 mN/N. The total number of drops was approximately 100 in the original drug, being the lowest.Conclusion: The results of this study showed that the squeeze forces of all generic products but RINBETA PF, which was contained in a specific container, were smaller than that of the original product. The drop volumes of 2 generic products were ≥ 15-μL smaller than that of the original product, but they were within the permissible range. The maximum difference in the surface tension was approximately 33 mN/N, suggesting that drug solution relatively frequently overflows from the eyes. The total number of drops for all generic products was greater than that for the original product, suggesting that the former can be used at a higher frequency. Based on these results, pharmacists must select products in accordance with individual patients.

A Survey on the Use of External Medications and Injection Drugs Conducted by Persons Visiting in a Health Insurance Pharmacy / 社会薬学

Since attention is sometimes required with regard to the use and handling of external medications or injection drugs in drug therapy, patients may have a feeling of “inconvenience”. We, therefore, focused on a feeling of “inconvenience when using” external medications and injection drugs, and conducted a questionnaire survey to investigate the level of awareness and current status of using assist devices that can effectively reduce such inconvenience. The survey took place at a pharmacy, and involved interviews using a questionnaire. Of the 197 respondents, valid responses were obtained from 147 individuals (74.6%). As the results, 25.9% of individuals using external medications or injection drugs responded ‘yes’ concerning the feeling of “inconvenience when using” them. In addition, 39.4% of individuals using eye drops and 10.5% of those using insulin similarly responded. However, only 10.9% knew of the availability of assist devices that are expected to reduce the inconvenience. The results revealed that a certain number of people feel the “inconvenience” of external dosage forms investigated in this study, suggesting the need for pharmacists to consider that patients may have problems using their medications, and to recommend and support the use of assist devices that can be operated by patients.

A Survey on the Use of External Medications and Injection Drugs Conducted by Persons Visiting in a Health Insurance Pharmacy / 社会薬学

Since attention is sometimes required with regard to the use and handling of external medications or injection drugs in drug therapy, patients may have a feeling of “inconvenience”. We, therefore, focused on a feeling of “inconvenience when using” external medications and injection drugs, and conducted a questionnaire survey to investigate the level of awareness and current status of using assist devices that can effectively reduce such inconvenience. The survey took place at a pharmacy, and involved interviews using a questionnaire. Of the 197 respondents, valid responses were obtained from 147 individuals (74.6%). As the results, 25.9% of individuals using external medications or injection drugs responded ‘yes’ concerning the feeling of “inconvenience when using” them. In addition, 39.4% of individuals using eye drops and 10.5% of those using insulin similarly responded. However, only 10.9% knew of the availability of assist devices that are expected to reduce the inconvenience. The results revealed that a certain number of people feel the “inconvenience” of external dosage forms investigated in this study, suggesting the need for pharmacists to consider that patients may have problems using their medications, and to recommend and support the use of assist devices that can be operated by patients.

Laparoscopic Resection of a Jejunal Inflammatory Fibroid Polyp that Caused Occult Gastrointestinal Bleeding, Diagnosed via Capsule Endoscopy and Double-Balloon Enteroscopy: A Case Report

An inflammatory fibroid polyp (IFP) is a mesenchymal tumor of the gastrointestinal tract. IFPs in the small intestine are the most frequently detected with symptoms, such as abdominal pain and tarry stool due to intussusception. Accordingly, few studies have reported jejunal IFP as a cause of occult gastrointestinal bleeding (OGIB) diagnosed via both of capsule endoscopy (CE) and double-balloon enteroscopy (DBE). A 68-year-old woman presented with a progression of anemia and a positive fecal occult blood test result. Esophagogastroduodenoscopy and total colonoscopy findings were unremarkable. CE revealed a tumor with bleeding in the jejunum. DBE also revealed a jejunal polypoid tumor. Bleeding from the tumor seemed to have caused anemia. The patient underwent partial laparoscopic resection of the jejunum, including resection of the tumor. The tumor was histopathologically diagnosed as IFP. To our knowledge, this is the first reported case of laparoscopic resection of jejunal IFP with OGIB diagnosed via CE and DBE preoperatively.

Questionnaire Survey on the Level of Awareness of the National Policies and Projects Concerning Dementia Measures among Chain Community Pharmacists / 社会薬学

To smoothly proceed with the national policies and projects concerning dementia measures, it is important that pharmacists who take care of patient in clinical practice sufficiently understand its contents. In this study, we conducted a questionnaire survey involving chain community pharmacists to investigate the level of awareness concerning these policies and projects. Subjects were 446 chain community pharmacists. The questionnaire consisted of 17 items (e.g. the level of awareness regarding the “Comprehensive Strategy to Accelerate Dementia Measures (New Orange Plan)”, “Dementia Supporters Caravan Program (Caravan Program)”, and “Dementia training certified pharmacist program (Certification program)”). The questionnaires were filled out anonymously. The levels of awareness concerning the “New Orange Plan” and “Caravan Program” were 34.7% and 48.9%, respectively. Sixty-one percent of subjects attended a “Dementia Supporter Training Lecture”, 30.4% of whom were wearing the “orange ring”. The levels of awareness and the hope of acquisition concerning the “Certification program” were 47.8% and 79.8%, respectively. To achieve the purpose of “contribution to early detection of dementia by pharmacist” of the “New Orange Plan”, it is necessary to conducting the workshop and to create an opportunity to come in contact with dementia patients. It is also important to recognize that it is necessary to enlighten the meaning of wearing an “orange ring” and to enlarge the circle of dementia supporters. In addition, it is thought that more dementia patients can be supported in the community by increasing the levels of awareness concerning the “Certification program” and giving appropriate advice and response.

Examination Regarding the Simple Suspension Method using Oral Anticancer Drugs / 社会薬学

To administer oral anticancer drugs safely, the simple suspension method has been introduced in many hospitals. Therefore, concerning drugs for which it is unclear whether or not this method is applicable, testing must be able to be conducted at any time. In this study, we investigated 20 oral anticancer drugs to expand information on the application of the simple suspension method. Disintegration/suspension and permeability tests were conducted, as described in the 3rd version of the Tube Administration Handbook for Oral Drugs. All products were disintegrated/suspended after 10 minutes. On permeability tests, there was no residue in any tube for tubal feeding. On the final evaluation, the products were regarded as suitable (grade 1). Bicalutamide tablets (80 mg, TCK and KN), which were analyzed in this study, were regarded as suitable (grade 1) on the final evaluation. On the other hand, the simple suspension method is not applicable for a brand-name drug, Casodex^® tablets (80 mg). This may be related to the different additives. Furthermore, the results suggest that, even when the simple suspension method is not applicable for a brand-name drug, it may become applicable for generic drugs. This may provide a new merit for promoting the use of generic drugs.

Comparison of Usefulness of Switch OTC Eye Drops among Products / 医薬品情報学

<b>Objective: </b>The squeezing force and one-drop weight, suggested to directly influence adherence, were measured in 6 eye drop products containing a switch OTC drug, ketotifen fumarate, to investigate useful information for product selection.<br><b>Methods: </b>The squeeze force, one drop weight, and pH were measured using a digital force gauge, analytical balance, and pH meter, respectively.  Information on additives contained in each product was collected from package inserts.  For the total number of drops, the number per 10 mL was calculated from the obtained value.<br><b>Results: </b>The maximum squeeze force was 14.8 N of Irice AG Guard, and the one drop weight (33.2 mg) of Raferusa®AL was the minimum.  The total number of drops per 10 mL was 215 in Sutto eyes Z, being the minimum.  The pH was in the range of 5.2-5.7.  On comparison of additives among the products, a cooling agent was contained in only 2 products.<br><b>Discussion: </b>Since the squeeze force was in the range of 5.3-14.8 N, it was less likely that the squeeze force reduces usability.  Since the one-drop weights of 2 products were more than 10 mg lower than the weights of the other products, the dose may be insufficient and the effect may not be attained.  The pH was within the acceptable range in all products.  Two products contain a cooling agent as an additive, and this has to be explained beforehand.  Information related to usability, actual feeling of the effect, and sense of the use of the products containing ketotifen fumarate was collected.

Status of Self-Medication with OTC Drugs by International Students / 医薬品情報学

<b>Objective: </b>Along with the globalization of the Japanese economy, the number of international students in Japan has gradually increased.  Under these circumstances, international students to visit pharmacies for self-medication are expected to increase.  Thus, we carried out a questionnaire survey on international students conducting self-medication using non-prescription drugs, and examined its problem.<br><b>Method: </b>To clarify the status of self-medication using OTC drugs by students studying abroad, multiple-choice and free description-style questionnaire sheets written in Japanese or English were distributed to 30 international students based in Kobe City.  The sheets were independently completed by the students, excluding those who had difficulty in sufficiently comprehending the questions and required the researcher’s oral explanations for assistance.<br><b>Result: </b>While 90.0% of the respondents answered that they occasionally use non-prescription drugs in their own countries, only 60.0% answered that they had experience of purchasing the drugs in Japan.  When purchasing OTC drugs, 15.2% faced <difficulty in reading> instructions printed on their packages.  While 30.0% regarded <pharmacists’ advice> as important to purchase appropriate drugs in their home countries, only 23.3% sought such advice in Japan.<br><b>Conclusion: </b>These results revealed a tendency for international students to purchase OTC drugs following pharmacists’ advice less frequently in Japan than in their home countries despite their literacy difficulties.  In the future, we hope to examine issues such as possible active communication by pharmacists and the drugstore structure, so as to promote self-medication through purchasing drugs at Japanese pharmacies.  As a result, we hope to contribute to making Japanese pharmacies more foreign user-friendly in a real sense.

Usability of Auxiliary Devices for Eye Drop Administration / 医薬品情報学

<b>Objective: </b>For pharmacists to select a suitable auxiliary device for eye drop administration for patients who have difficulty in applying eye drops, the pharmacists need to know the characteristics and level of difficulty of using each device.<br><b>Methods: </b>Thus, we compared the characteristics of New Rakuraku Tengan, Rakuraku Tengan III, and an eye-drop self-help device and also conducted a survey involving 40 healthy volunteers on each device’s accessibility and suitability for people with motor disabilities.<br><b>Results: </b>New Rakuraku Tengan received the highest score for “usage was able to easily understand” (70.0% of the respondents answered positively) and “suitability for poor-sighted people” (65.0%).  Rakuraku Tengan III received the highest score for the “effectiveness of photos and illustrations in the manual” (77.5%),but was evaluated to be difficult to use.  The eye-drop self-help device received the highest score for “suitability for people with difficulty raising their shoulders and arms” (75.0%).<br><b>Results: </b>Thus, we observed the need for pharmacists to have thorough knowledge of the products in order to recommend suitable auxiliary devices for eye drop administration for each patient.

Therapy-Related Myelodysplastic Syndromes in an Ovarian Carcinoma Patient Following Treatment with Paclitaxel- and Carboplatin-Based Regimens / 日本農村医学会雑誌

Progress in chemotherapeutic strategy has significantly decreased side effects of the drugs used and greatly added to survival rates for ovarian cancer. On the other hand, the occurrence of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) has been reported after long-term chemotherapy. We encountered a case of therapy-related MDS that developed as a consequence of chemotherapy. A 59-year-old woman (gravida 2, para 2) stage IIIc ovarian cancer received three courses of paclitaxel and carboplatin therapy (TC) prior to primary surgery, and 16 courses of weekly TC as adjuvant chemotherapy. She exhibited pacritaxel-associated hypersensitivity reactions in the last course, so that chemotherapy was discontinued. Following three mouths of remission, a sudden rise in her tumor markers and an increase in the size of her pelvic lymphonode were discovered on PET-CT. She recieved multiple courses of chemotherary of docetaxel/carboplatin, weekly docetaxel, docetaxel/briplatin and Gemcitabin/Irinotecan between four months. In 30 months after diagnosis, complete blood count showed hemoglobin 7.7 g/dl; white cell count 4,310/μl; and platelet 7.9×104/μl. A bone marrow examination revealed MDS. She then decided against further chemotherapy, opting instead for palliative care. Fortunately, up to the present, she has not developed AML.