While the management of safety information obtained from investigational drugs has been much studied up till now, few studies have been done on the management of safety information obtained from post marketing drugs. Through collecting adverse event information from post marketing clinical trials and those for additional indications carried out at our institution, we investigated the situation of adverse event information available after the marketing of drugs, the management of such information and its submission to the IRB. Though there was no appreciable change in the amount of post-marketing information for cancer drugs over a three-year period beginning in April, 2001, for other categories of drugs, a major increase in the amount of information in the last year of our study was noted. Regarding the predictability and seriousness of adverse event information, it was noted that “unexpected non-serious events” were included in the reporting system (3.2% of post-marketing information) and that information on “expected serious events” accounted for 72.2 % of post-marketing information. In 2002, the year that Early Post-marketing Phase Vigilance was introduced on a full scale, major differences in the handling of safety information among individual pharmaceutical companies began to be observed. Through the present study, we were able to determine the current status of the reporting of post-marketing information to medical institutions. In the future, it will be necessary to evaluate the quality of the adverse event information.
In most hospital wards, nurses make the parenteral nutrition (TPN) preparations for patients. In April 1997, pharmacists at Yame General Hospital, started making aseptic TPN preparations in internal medicine wards to further improve pharmaceutical care. In August 2002, this service was expanded to include all wards and the average monthly number of aseptic TPN preparations increased to 818. When we conducted a cost-benefit analysis on the aseptic TPN preparations made by pharmacists, it was found that the return on investment [ROI= (benefit-cost) /cost] was initially-18%. Through the analysis, we pinpointed variable factors affecting materials costs and other expenses arising in the making of aseptic TPN preparations and by managing such costs were able to increase ROI markedly to 39%. Our detailed analysis of costs thus enabled the making of aseptic TPN preparations by pharmacists to make a significant contribution to our hospital, and they also improved the quality of life of patients. It may also be useful to apply cost-benefit analysis to the evaluation of other clinical pharmaceutical services such as TDM and pain management.
Though disease-modifying antirheumatic drugs are now available for the treatment of rheumatoid arthritis, weekly low dose methotrexate (MTX, Rheumatrex®) is the most common treatment. MTX is a cancer chemotherapy agent whose adverse effects include nausea, stomatitis, bone marrow suppression, liver toxicity, and interstitial pneumonia. Since MTX is prescribed for outpatients, the detection and management of adverse effects is not easy. To investigate the occurrence and consequences of adverse effects due to MTX, we conducted a retrospective chart review study of 109 patients who received MTX in the past two years. We also examined the use of folic acid for the prevention and amelioration of adverse effects. Over the period of the study, 95 adverse events occurred in 62 patients and 2 of them were admitted for treatment. However through monthly follow up, it was possible to manage the adverse effects successfully in most of these patients. Concomitant folic acid supplementation not only reduced the toxic effects of MTX but also prevented their occurrence. We therefore feel that pharmacists should advise physicians to use folic acid for patients undergoing long-term therapy with MTX.
Ensuring the proper use of drugs is an important role of pharmacists in the medical team. In the present paper, we describe two support tools for this purpose made for cancer chemotherapy, one of them having the title “Basic Knowledge ofCancer Chemotherapy” and the other “Cancer Chemotherapy Work Sheet”. They are designed to help maintain safety incancer chemotherapy and can be used in many different hospitals. Our objectives in making these tools were to standardizepharmaceutical care and improve its quality, in the process of promoting the proper use of drugs. First, we prepared our Basic Knowledge of Cancer Chemotherapy sheet for 4 types of cancer (stomach cancer, ovary cancer, malignant lymph adenoma, lung cancer) and then g Cancer Chemotherapy Work Sheets for various chemotherapy regimens : Tegafur-gimeraciloteracil+Cisplatin (TS-1+CDDP) (2), Paclitaxel+Carboplatin (TAXOL+CBDCA) (2), Cyclophosphamide+Doxorubicin+Vincristine (CHOP), bi-weekly Cyclophosphamide+Doxorubicin+Vincristine (bi-weeklyCHOP), Gemcitabine+Cisplatin (GEM+CDDP), Weekly-Paclitaxel+Carboplatin (Weekly-TAXOL+CBDCA), Cisplatin+Etoposide (CDDP+VP16). We evaluated the Cancer Chemotherapy Work Sheets through a questionnaire sent to hospital pharmacists. Most pharmacists (91%) responded that the sheets were “useful” and over half (69%) thought that their purpose was “understandable”. In order to expand the use of our sheets among hospital pharmacists, we made them available through an internet website. We believe that these tools will contribute to the standardization of the pharmaceutical care in cancer chemotherapy and raising its quality.
The drug release and swelling characteristics of cataplasms may be evaluated using artificial sweat. In our study, these characteristics were compared among brand name and generic cataplasms containing nonsteroidal anti-inflammatory drugs (NSAIDs ; indomethacin (IM) (8 products), ketoprofen (KP) (7 products) and flurbiprofen (FP) (4 products)) using artificial sweat and the apparatus described in JP 14 Dissolution Test Method 2. For cataplasms containing IM and FP, the degree of swelling of generic products was less than that of brand name products but there was no significant difference in release rate. On the other hand, for KP-containing cataplasms, disintegration of the base material was observed for three of the four generic products tested, and all four had higher release rates than the brand name products. Thus, the drug release testing method used in the present study showed that the release and swelling characteristics differed between brand name and generic cataplasms and we felt that it was a useful way of evaluating their quality.
To help ensure the proper use of nonprescription drugs, we developed a drug information database with a drug interaction checking function. The database was set up by using Microsoft® Access 2002 for Windows. There are a total of eight tables in the database : drug information for nonprescription and prescription drugs, ingredients of nonprescription and prescription drugs, product information for nonprescription drugs, drug interactions, contraindications, and therapeutic categories. All tables have links to each other using the Japanese Article Number (JAN) Code and generic names. The data used for the database were taken from resources such as “Japan Self-Medication Database Center”, “The Medical Information System Development Center”, “Japan Pharmaceutical Information Center”, and “Hansten and Horn's Drug Interactions (Facts and Comparisons)”. Three different levels are assigned to drug interactions : avoid combination (level 1), avoid combination unless benefit outweighs risk (level 2), and monitor (level 3). The database contains data on 14, 496 nonprescription drugs and 18, 159 prescription drugs. A total of 2, 094 drug interactions are recorded, 14 of them assigned level 1, 165 level 2 and 1915 level 3. Five hundred sixty-three ingredients were used for both prescription and nonprescription drugs, 218 ingredients of them having contraindications when used as prescription drugs. The database efficiently retrieves general drug information, information on drug interactions and contraindications for nonprescription drugs when enquiries are made using brand names, generic names, or JAN codes. We consider our database to be a useful tool for ensuring the proper use of drugs and for promoting self-medication.
Faculties of pharmaceutical science in Japan are to start six-year curriculums in 2006 and this reform of the educational system is expected to further improve the quality of pharmaceutical care provided by pharmacists. However, the improvement of education for pharmacists who have already received their license is as important as changing to the six-year curriculum. To obtain ideas for improving education for Japanese pharmacists in the future, we investigated the American Pharmacist Continuing Education System in the state of Ohio. We also sent out a questionnaire on Pharmacist Education to all members of the Ehime Society of Hospital Pharmacists. The questionnaire was based on the results of our investigation of the Ohio State system. Through it, we found that many pharmacists feel dissatisfied with the current pharmacist education system. A particular point of dissatisfaction was that many respondents felt they were too busy time to attend lecture meetings and were therefore interested in education via the Internet. Thus, an important finding of our questionnaire survey was that the establishment of active learning systems using the Internet would meet the needs of Japanese pharmacists who have already received their license.
We investigated 468 inpatients for adverse reactions occurring after they underwent coronary angiography (CAG) according to the specified clinical path in the cardiology department of our hospital. Upon interviewing the patients we noted that about 20% of them had symptoms like headache, nausea, vomiting, and giddiness. Though such symptoms were more prevalent in women and patients who had a history of allergic reactions to medicines, no correlation was found between symptom occurrence rates and age, type of contrast media used or dosage. These adverse effects occurred one hour or more after undergoing CAG. The rate of occurrence for such delayed reactions was 37 % in the patients in whom they were observed and 7.6% for all patients. Although these adverse effects were assumed to be mainly due to contrast media, the possibility of them being due to other drugs could be not be ruled out. However, symptoms were very similar to those for delayed adverse reactions of contrast media reported in the past. Unexpected adverse reactions due to contrast media will continue to occur and may be serious so patients should be carefully observed following CAG.