At the Niigata Pharmacy, there were 3, 402 inquiries about prescriptions during the period from April 2001 to March 2002, and 1, 055 of these inquiries were safety-related, equivalent to 31.0% of all inquiries and 1.60% of all prescriptions. Among these safety-related inquiries, there were 566 adverse effect-related cases (16.6% of all inquiries) and 489 were symptom aggravation-related cases (14.4% of all inquiries). The breakdown of the safety-related inquiries was 30.7% for prescription errors, 46.0% for prescription omissions and 23.3% for pharmacological problems. The frequency of pharmacological problems was significantly higher for adverse effect-related cases as compared with symptom aggravation-related cases (p< 0.0001, X2-test). On the other hand, symptom aggravation-related cases had a significantly higher frequency of prescription omissions (p< 0.0001, X2-test) as compared with the adverse effect-related cases. As for the source of the inquiries, 37.7% stemmed from reviews of the patient's drug history, 46.1 % from patient complaints and 16.2% from examination of prescriptions. Among the safety-related cases, the rate for changing prescription content was 81.4%, for which rates were 75.6% for adverse effect-related cases and 88.1% for symptom aggravation-related cases when further broken down. When analyzed, the rate for the symptom aggravation-related cases was significantly higher than that for adverse effect-related cases (p< 0.0001, X2-test). Our findings indicate that pharmacists must practice proper risk management to prevent symptom aggravation and adverse effects in patients. Also, to ensure the safety of the patient, pharmacists must examine prescriptions for errors, review the drug history of the patient, and listen to patient complaints.
Cerebrospinal fluid (CSF) concentrations of quinolone antibiotics in humans, which may be related to CNS adverse effects and quinolone antibiotic-induced convulsions, were predicted from parameters for penetration into the CSF (CSF-to-unbound plasma concentration ratio : Kpu) of rats and dogs. There was good linear correlation between the Kpu values for rats and dogs (r=0.94), and the relative magnitude of Kpu values among the quinolone antibiotics examined was not affected by the species difference. The CSF concentrations (CCSF, Pred) in humans that were predicted from the Kpu values in rats and dogs were well correlated with the CSF concentrations (CCSF, Obs) actually observed in humans (r=0.86 and 0.91, respectively). These results suggest that for clinical doses, CSF quinolone concentrations in humans can be predicted from Kpu values in animals. The CSF concentrations of UFX (an active metabolite of a prodrug, prulifloxacin), norfloxacin, and ciprofloxacin were lower than those of other quinolone antibiotics.
The aim of this study was to identify the most favorable H2RA (H2 receptor antagonist) for the treatment of upper gastrointestinal hemorrhage (non-phlebeurysm). A decision tree was constructed to evaluate cost-effectiveness among an existing treatment (control), roxatidine, famotidine and ranitidine from the viewpoints of the payer and the medical facility. Clinical parameters used as transition probabilities were obtained from the results of the domestic RCT (Randomized Controlled Trial) of each drug. The cost items consisted of the direct medical cost, capital cost, and medical staff (doctors and nurses) personnel costs. The time horizon was set at 12.3 days on average and there was therefore no discount. Of the three drugs, at approximately 140, 000 yen less than the control, ranitidine was estimated to be most cost-saving for the payer. In percentage terms, ranitidine had the highest earnings rate among the H2RAs of 46.0% and roxatidine had the highest earnings in money terms among the H2RAs of approximately 120, 000 yen. A one-way sensitivity analysis used for investigating extra periods of hospitalization showed that this had no impact on the base case. A two-way analysis showed that ranitidine had the highest efficiency of about 55 % for the cases analyzed. When a threshold analysis was conducted, it was found that, while there would be no change in the hemostatic rate in substitutive plans, the hemostatic rate of 0.60 for famotidine (ceiling total cost : 375, 801 yen) and that of 0.61 for ranitidine (ceiling total cost : 406, 271 yen) were the thresholds affecting the results of analysis. It is therefore likely that selecting ranitidine first in preference to roxatidine or famotidine would be more cost-effective.
At present, not only psychotherapeutic hospitals but also general hospitals and pharmacies are involved in the treatment of outpatients with psychiatric problems. Because of this, it is important for pharmacy students to experience the pharmaceutical care of psychotic patients during their hospital practical training. However, many psychotherapeutic hospitals are not suitable for training because the number of pharmacists is less than in general hospitals and there is insufficient equipment. To study these problems, we sent out a questionnaire regarding practical training to the pharmacists of 95 psychotherapeutic hospitals in Fukuoka Prefecture. The twenty-two hospitals responding that it would be possible to provide practical training had 1.6 full-time pharmacists per 100 beds who provided pharmaceutical care to 44% of their inpatients. The pharmacists of 16 of these hospitals wanted such training be limited to dispensing and pharmaceutical care and the period to 1 or 2 weeks at maximum. It seemed that in many psychotherapeutic hospitals, there would be fewer opportunities for administering injections and providing drug information to outpatients and doctors than in general hospitals. Also, very few students would be able to learn about drug therapy for inpatients undergoing surgery in psychotherapeutic hospitals. In view of the increasing importance of pharmacists knowing about the pharmaceutical care of psychotic patients, it is considered that the grouping together of psychotherapeutic and general hospitals would be useful as a means of providing practical training opportunities for undergraduate students in their pharmacy departments.
Fluid therapy is a fundamental treatment for almost all inpatients, and nutritional therapy is the most important type of such therapy. Currently, total parenteral nutrition (TPN) is widely used to provide complete nutritional support but 30-40% of TPN recipients are considered to in a malnourished state due to inappropriate TPN prescriptions. Computer-assisted TPN prescription systems are thought to be useful to clinical professionals in solving this problem because they can perform complicated calculations that make it easy to draw up correct TPN prescriptions. So, we made a prototype system for aiding the preparation of TPN prescriptions based on Microsoft® EXCEL and it was tested by physicians, pharmacists, dietitians and nurses engaged in TPN therapy at Tokushima University Hospital. We also had them fill out a questionnaire on the system in which they rated it for ease of operation and usefulness according to a scoring system in which 5 indicated full marks. Our Computer-Assisted TPN Prescription System was improved on the basis of the questionnaire results and is now being effectively used by the nutrition support team (NST) in Tokushima University Hospital.
In our hospital, blood preparations are also controlled by the pharmacy department since they are considered as medicines. Preoperative autologous blood donation was started in 1998, but in the case that patients did not meet the blood donation conditions of the Japanese Red Cross Society or other requirements, the amount of blood needed could not be completely collected. For this purpose, we chose a thinner needle (18 G) for blood sampling and have been actively using it since 2001. As a result, the execution rate for autologous blood donation requests had risen to about 95 % in 2003. Further, instances of deviating from the clinical path decreased, and the rate of being able to supply the needs of an operation only through autologous blood donation increased.
A medication notebook was prepared by the Yamagata Pharmaceutical Association in cooperation with the Hospital Pharmacy Association, Medical Association and Dental Association, and distributed to registered health insurance pharmacies and medical institutions, including those operated by individual medical practitioners, for the purpose of sharing pharmaceutical information on patients in Yamagata Prefecture. In addition, a questionnaire concerning the usage rate of the medication notebook and its usefulness was sent to the 411 health insurance pharmacies registered with the Yamagata Pharmaceutical Association. Responses were obtained from 192 pharmacies (response rate 46.7%). More than 40% of these pharmacies had distributed the Yamagata Pharmacy Association medication notebook to patients. Through the use of the medication notebooks, patients were able to avoid duplication of medication and drug interactions. It was therefore useful in promoting the proper use of medicines by patients. Among pharmacies staffed by only one pharmacist, a large number had not given out the medication notebook to patients, but there were also many that were using it effectively. Pharmacies that used the medication notebook more frequently had higher rates for avoiding the improper use of medication. It is thus necessary to further educate pharmacists on the value of using the medication notebook in promoting the proper use of medicines, since this will help to avoid duplicated prescriptions, drug interactions and adverse effects in patients.
The use of Tris (2-ethylhexyl) trimellitate (TOTM) as an alternative to di (2-ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC) medical devices is steadily increasing. Four types of administration sets are available : general-type sets made of PVC using DEHP (DEHP-PVC) or TOTM (TOTM-PVC) as a plasticizer, pump-type sets made of DEHP-PVC, and those made of polybutadiene (PB). Since the elution of plasticizer from administration sets when specific drugs are passed though them is a matter of concern, in the present study, we compared the amounts of plasticizer eluted from these 4 types of administration sets after passing fat emulsion through them, for different drip rate. The concentrations of plasticizer eluted were lowest for the TOTM-PVC administration set, followed in ascending order by the general-type DEHP-PVC and pump-type DEHP-PVC sets. Neither DEHP nor TOTM was detected for the PB set. For the general-type administration set, the maximum concentrations of TOTM and DEHP eluted were obtained with a drip rate of 10 mL/hr, which were 0.38μg/mL for TOTM and 10.32μg/mL for DEHP, respectively. At a drip rate of 80 mL/hr, the maximum concentration of DEHP was 0.97μg/mL but TOTM was not detected. These results indicate that TOTM is less easily eluted than DEHP and that TOTM-PVC is an excellent material for administration sets in view of its low elution characteristics, though care needs to be taken with regard to drug adsorption.
The Outpatient Oncology Unit of Kyoto University Hospital was established in October, 2003 with the aim of conducting chemotherapy for outpatients more safely and effectively. The unit comprises 4 doctors and 3 nurses and 2 pharmacists are always on hand to prepare all the injections used for chemotherapy, which include anticancer drugs. When the Outpatient Oncology Unit was established, 63 regimens were selected from among those which had been used for outpatient chemotherapy in various departments. These regimens are used as the basis for prescribing anticancer drugs. The day before chemotherapy, all drugs are placed in a separate box for each patient and then pharmacists check the prescriptions to see whether the dosage and administration interval are correct based on the regimen. When there are any doubts, prescriptions are checked with the doctors of the Outpatient Oncology Unit. In October 2003, 457 patients were treated in the Outpatient Oncology Unit, and we prepared 1, 765 injections, which included 764 anti-cancer drugs. We feel that it is important for pharmacists to participate in outpatient chemotherapy and communicate with the doctors and nurses involved to improve risk management.
It has been pointed out that adverse effects due to influenza vaccine recorded in clinical on-site reports differ from those mentioned in package inserts. While there have been many studies on the effects of vaccines to date, there have been few detailed studies on adverse effects. Their clinical symptoms resemble those of SARS. Also, while rare serious adverse effects have been a source of concern, slight or moderate adverse effects have drawn little attention. Against this background, we conducted an investigation of adverse effects following the inoculation of our hospital staff (361 males, 908 females) with influenza vaccine. The occurrence rate of local reactions was 45.1% and that of systemic reactions 20.8%, which were higher than the rates stated in the package inserts. Also, on checking the results of the previous year's vaccination, we found that rates had increased. While the occurrence rate was significantly higher in females than in males, the rate in elderly subjects of 60 or older was significantly lower than that in younger subjects. We also determined the impact of various independent factors using a multiple logistics model. In conclusion, actual occurrence rates for adverse effects do not necessarily agree with those stated in package inserts, which may be because rates are affected by vaccination history and various other factors. Our findings will aid the prediction and management of adverse effects.
We investigated the situation of early post-marketing phase vigilance reports prepared by pharmaceutical companies for medical institutions. To do this we collected reports prepared by pharmaceutical companies for this purpose and investigated their contents during the period October 2001 to April, 2003. The number of medicines targeted by our investigation was 51. We found that most pharmaceutical companies were preparing final reports for medical institutions a few months after the early post-marketing phase vigilance was over. However, reports differed greatly regarding such aspects as contents, items reported and analysis methods and information on important adverse effects was difficult to understand. We thus feel that there is a need to standardize the format of early post-marketing phase vigilance reports to make the information in them more useful.
We report on the development and introduction of our original SOAP (Pharmacy-oriented SOAP : P-SOAP) form, an expanded version of the conventional SOAP form, which is highly suited to community pharmacies. In P-SOAP, patient follow-up items and pharmaceutical care planning actions have been added. We conducted a questionnaire survey of 13 newly graduated pharmacists who had been educated on the use of the conventional SOAP for about half a year to ascertain their opinions of P-SOAP. They felt that the conventional SOAP had unclear assessment (A) and planning (P) definitions, and that actual medication instructions did not fit in with the SOAP form. However, they thought that P-SOAP enabled them to easily acquire detailed patient information and prepare patient records in a relatively short time. In conclusion, P-SOAP should be a useful tool for recording medication history in an optimal manner for the community pharmacy, and contribute to raising the quality of patient care.