Gifu University Hospital moved to new premises in June 2004.It is now equipped with a total medical information system named“SystemGIFU”which utilizes a high-speed optical fiber network.The concept of SystemGIFU is having all hospital information stored in an electronic medical recording system (EMRS) for use in medical examinations and treatment. We developed a pharmacy department information system (PDIS) based on the same concept as SystemGIFU.A component of EMRS,the PDIS comprises of two parts,one for improving the propriety and effectiveness of pharmacy services and the other for recording details of pharmacy services in electronic format in EMRS so that it may be shared with other medical staff.For the part designed to improve the propriety and efficiency of pharmacy services,we developed a prescription checking system that references clinical laboratory data,a preparation checking system for injections that uses order entry system information,and a pharmaceutical care supporting system having 2-way connections with EMRS.For the electronic storage of pharmacy service details in EMRS,we recorded the processes and records for dispensing,pharmaceutical care,and TDM services electronically in observance of the watchwords of“Authenticity”,“Visual Readability”,and“Storability”. An evaluation of this system showed that it raised the accuracy of pharmacy services,aided the proper use of drugs and shortened the times needed for pharmacy services.We therefore conclude that our newly-developed system is useful for improving the services provided by pharmacists overall.
The purpose of this study was to clarify the causality assessment information items necessary to improve the usefulness of individual case safety reports (ICSRs) from medical facilities as adverse drug reaction (ADR) information.To do this,we investigated standard causality assessment items used by pharmaceutical companies.The number of the companies responding was 76,93.8% of all Japan Pharmaceutical Manufacturers Association (JPMA) member companies. We found that the use of algorithms for causality assessment,the grades and expressions used to describe causality,and criteria for determining whether reactions were ADRs or not varied among the companies as well as their divisions (whether they conducted clinical trials or post-marketing surveillance).Having such a variety of assessment criteria is inconvenient for the reporters who have to judge it and also lowers the validity of judgments.It also hampers the overall assessment of ADR information and may cause great differences in ADR frequencies.We therefore feel that it is desirable to agree on international criteria for causality assessment as soon as possible.
In clinical pharmacy training III (bedside training) at the School of Pharmaceutical Sciences,Kyushu University of Health and Welfare,we included vital sign confirmation using vital sign measuring instruments,physical assessment models for this purpose,ACLS trainers,and high-fidelity patient simulators.Students were able to confirm vital signs (such as blood pressure,pulse rate,respiratory rate,and body temperature) afterwards,and on conducting a survey on students’ opinions of the necessity of vital sign confirmation in training and their level of understanding of it,we observed significant increases in scores as regards both necessity and understanding (p <0.01).The measurement of vital signs by pharmacists is important to evaluating drug efficacy and adverse effects and this type of practical training should greatly contribute to pharmacist education and enhancing their skills.
In April 2006,Fukuoka University Hospital started a resident pharmacist system for the postgraduate training of pharmacists.After the completion of the general practice (GP) course which takes 1 year,students choose specialty courses from a list that includes those on cancer chemotherapy and diabetic medicine.The GP course includes practical training (about 1,800 hours),lectures (40 hours),Problem Based Learning (six hours,excluding time for collecting data),role-playing in informed consent training (two hours),and field training at another hospital (one week) and a pharmacy (two days). Six months after the start of the GP course,we conducted a survey of resident pharmacists and staff pharmacists to assess the validity of the program.In the results,training in dispensing was cited as the most useful by the resident pharmacists.Next came TPN (total parenteral nutrition),mixing of injectable anti-cancer drugs and drug counseling for in-patients.However,few of them said that the learning goals set for the program had been achieved,which indicates the necessity of establishing an advanced GP course in the second year so that students can learn more about a wide range of basic pharmacist tasks.Ninety-seven percent of the staff pharmacists responded that the program was beneficial for the pharmacy department,indicating that it could enhance human resources and staff motivation. Our findings show that the resident pharmacist system is instructive and useful for not only in postgraduate education but also for the pharmacy department.
Two lots (3 samples each) of 4 companies’(Shionogi&Co.,Ltd.,Meiji Seika Kaisha,Ltd.,Nichi-iko Pharmaceutical Co.,Ltd.and Merck Pharmaceutical Co.,Ltd.) vancomycin hydrochloride injection products (referred to hereafter as VCM injections) were dissolved in normal saline 100 mL.The solubility of each product was investigated for 3 different dissolution times (5 seconds,10 seconds,30 seconds) using a bioassay method employing Bacillus subtilis ATCC 6633 and a fluorescence polarization immunoassay. The dissolution rate of the Shionogi product increased from 83.9±2.8% at 5 seconds to 99.0±0.7% at 30 seconds which was in proportion to the increase in dissolution time.Further,the dissolution rates for the Meiji Seika Kaisha and Nichi-Iko Pharmaceutical products were 90% or more for a dissolution time of 30 seconds.On the other hand the dissolution rate of the Merck Pharmaceutical product,which was 81.7±2.6% for a dissolution time of 10 seconds,was only 83.1±2.8% for a dissolution time of 30 seconds.These results show that in order to obtain dissolution rates exceeding 90%,at least 30 seconds of dissolution time is required even for the VCM injection products manufactured by Shionogi,Meiji Seika Kaisha and Nichi-Iko Pharmaceutical.Moreover,as there were differences in the solubility of preparations,this should be taken into account when selecting the product.
Constipation frequently occurs as an adverse reaction with many drugs.However,the relative risk of its occurrence with individual drugs had not been clarified. To clarify the relationship between constipation and various drugs,we investigated the defecation frequency and use of -laxatives for 251 inpatients on admission.They were divided into a constipation group (defecation interval>3 days and/or using laxatives,n=73)and non-constipation group (defecation interval<3 days and no laxative use,n=178).A comparison of the patient backgrounds of the 2 groups revealed significant differences in age,gender,numbers of drugs taken regularly,colon cancer,use of non-steroidal anti-inflammatory drugs including low-dose aspirin and use of hypnotics,antidepressants,anti-anxiety drugs,and iron preparations.Multiple logistic regression analysis using these nine factors as autonomous variables showed that female gender (odds ratio[OR]: 2.01 ; 95% confidence interval[CI]: 1.06-3.81 ; P=0.033)and use of hypnotics (OR : 3.98 ; 95% CI : 1.40-11.28 ; P=0.010)were significantly related to constipation.Therefore,as hypnotics appear to more likely to cause constipation than other drugs they should be used with caution.
We present two cases of markedly decreased serum aprindine levels during anti-tuberculous therapy.Case 1 was a 65year-old man with end-stage renal disease (ESRD) on regular dialysis who was being treated for atrial fibrillation with oral aprindine (40 mg/day).In the 6-month period before treatment with anti-tuberculous drugs,the mean serum aprindine concentration had been 1.01 (SD 0.31)μg/mL (n=6).When anti-tuberculous therapy including rifampicin was commenced for intestinal tuberculosis,there was a marked decrease in the serum aprindine concentration to 0.14μg/mL but after it was discontinued,the serum aprindine concentration rose to 0.48μg/mL. Case 2 was a 76-year-old man with ESRD on regular dialysis who was being treated for paroxysmal atrial fibrillation with oral aprindine (30 mg/day).In the 9-month period before anti-tuberculous therapy,the mean serum aprindine concentration had been 0.67 (SD 0.16)μg/mL (n=9).Anti-tuberculous therapy including rifampicin for soft-tissue tuberculosis of the left arm resulted in a marked decrease in the serum aprindine concentration to 0.09μg/mL. Aprindine is known to be metabolized by cytochrome P 450 (CYP) 2D6 and CYP3A4 and rifampicin is a potent inducer of CYP3A4 but has little effect on CYP2D6.Accordingly,the coadministration of rifampicin is assumed to have caused the substantial decreases in serum aprindine concentrations,probably through the induction of CYP3A4.Concomitant administration with rifampicin may therefore result in the failure of aprindine to ameliorate arrhythmia.
Pharmaceutical support is important in ensuring the proper use of drugs.In providing such support,it is necessary for pharmacists to be involved in pharmacotherapy from a different perspective to that of physicians and nurses,to use the tools unique to pharmacists effectively,and discuss individual cases from the pharmacological viewpoint. On conducting an investigation to evaluate the effects of pharmaceutical support in clinical pharmacy practice,we noted that pharmaceutical support provided to physicians resulted in modification of 95.1% of prescriptions with benefits for 43.4 % of the patients.Patients who received pharmaceutical support with the objective of avoiding adverse drug reactions benefited financially since it lowered their medicine expenses by an average of 1,299 yen/day.On the other hand,patients who received pharmaceutical support to assist their pharmacotherapy saw an average increase in their medicine expenses of 2,417 yen/day. These findings suggest that pharmaceutical support provided in clinical pharmacy practice provides greater medical safety and medical economy for patients.
Smoking is a risk factor for pulmonary diseases,cardiovascular diseases and many other morbid conditions but it is difficult to get patients to cease smoking due to the strength of nicotine dependence.As one of our pharmaceutical management and counseling services,we conducted a smoking cessation intervention program for inpatients in which we counseled them on the proper use of nicotine replacement products using a smoking cessation guidebook,and evaluated the usefulness of such counseling. We interviewed 228 patients and from among them enrolled 18 current smokers and 11 people who had stopped smoking during the past 30 days as subjects.The content of the program was evaluated through a questionnaire survey of patients and the success of the counseling by pharmacists was evaluated by smoking cessation status at discharge.Immediately after the program,44.4% of the smokers had ceased smoking and this figure had increased to 83.3% at the time of discharge.All subjects who had stopped smoking during the past 30 days continued to refrain from smoking until discharge. The results of the questionnaire survey showed that the use of a smoking cessation guidebook in the intervention enhanced awareness of the importance of ceasing smoking in 89.7% of the subjects.Though they were frequently made aware of nicotine replacement products,only about 10% had wished to use them. The findings of the questionnaire survey suggest that our smoking cessation intervention program for inpatients involving counseling on the proper use of nicotine replacement products improved patients’awareness of the importance of smoking cessation and reduced the smoking rate.
From April 2009 onwards,the over-the-counter (OTC) drug sales system will be deregulated in accordance with the revised Pharmaceutical Affairs Law.There will be two major changes.As the first one,the risk classification of OTC drugs will comprise 3 classes and as the second,new qualifications for the registration of drug sellers will be established.The aims of this study were to investigate the views of pharmacy students concerning the revision of the OTC drug sales system and to reflect the results obtained in pharmaceutical education programs.To do this,small group discussion (SGD) was included in the college class program for 82 undergraduate students in the 3rd year of a 4-year course at Chiba University and they were given 2 questionnaires-one before the SGD and one after it. The questionnaire found that 95% of the students knew the term“OTC drugs”and 73% thought that such drugs were easy to obtain.Further,while 72% agreed with the new risk classification for OTC drugs,52% opposed the establishment of new qualifications for the registration of drug sellers.Through the SGD,they realized that pharmacists need to acquire a special knowledge of OTC drugs and skill in providing appropriate information on their safe use.Overall,the results suggest that future pharmaceutical education programs need to incorporate training designed to achieve a comprehensive knowledge of drugs and enhance communication skills.
To examine the properties of the rubber stopper of the newly-developed prefilled insulin injector,Lantus® SoloSTAR® (Sanofi Aventis ; hereinafter referred to as SOL),and its structural problems in relation to dose setting and injection accuracy,we performed certain basic testing in which the prefilled insulin pen Levemir® FlexPen® (Novo Nordisk Pharma Ltd.; hereinafter referred to as L-FLX) was used as a control.The testing consisted of measuring the dose setting knob torque,assessing the damage to rubber stoppers,measuring elastic properties,observing the fit of rubber stoppers in insulin cartridges and determining injection resistance patterns.Based on the results,we feel that attention should be drawn to the following points regarding the use of SOL for insulin injection : 1)Since clutch parts will easily wear out if the dose setting knob of SOL is rotated vigorously,the dose setting should be made gently and if patients feel uncomfortable with the torque needed to rotate the dose setting knob,they had better not use this product. 2)Any dripping or leakage from SOL would cause great anxiety in patients,and reduce injection accuracy.So if dripping is experienced,patients should be instructed to stop using this product.