Owing to the large infusion resistance of insulin injectors, instruction on self injection is sometimes difficult for diabetes mellitus patients who are elderly or have disability in their fingers. This is considered to be due to the structure of the injector and the thin injection needle used. In this regard, 4 types of injection needles were attached to each of 8 types of commercialized injectors and the changes in the infusion resistance were determined for the purpose of investigating the important points in instructing patients. As for the method, the infusion resistance after infusion of 20 units of insulin in 10 seconds was determined using an autograph, and the infusion resistance curve, maximum infusion resistance and area under infusion resistance curve (AUIRC) were obtained in order to investigate the characteristics of each injector and the difference in infusion resistance in combination with the injection needles. The results showed that there were differences in the infusion resistance curve, maximum infusion resistance and AUIRC among the different types of injector. Infusion curves were classified into a “regular type” that has a regular amplitude and an “irregular type” that does not have a regular amplitude. For the former, the amplitude was large in some and small in others and for the latter, a marked increase in infusion resistance was observed. The InnoLet® and HumaPen® Luxura injectors had a smaller maximum infusion resistance than the AUIRC OptiPen®Pro 1 and OptiClik® injectors. In consideration of cautions that have to be observed in instructing patients on the injection technique, InnoLet was thought to be the most suitable for elderly patients and those having decreased grip strength due to hemiplegia, etc., since its infusion resistance was the smallest and it does not require to be assembled (prefilled preparation). In the case of the irregular types Humacart®Kit and OptiPen®Pro 1, and OptiClik®, it is important to check whether the patient can keep pushing the infusion button until the injection procedure has been completed.
We conducted a pharmacoeconomic analysis on the treatment of knee osteoarthritis (K-OA) in which we compared the use of Boiogito and oral NSAIDs. The outcome criterion used for the analysis was the numbers (and %) of patients achieving the endpoint for K-OA treatment. The probability of effectiveness was predicted by calculating the number of patients achieving the endpoint or treatment goal for each treatment group, (TJ-20 (Boiogito, Tsumura) group, TJ 20 plus NSAIDs group and NSAIDs group). We conducted the analysis from the point of view of the payer. The cost of each treatment regimen was calculated for an eight-week period using cost effectiveness models based on medical service fee scores (revised in April, 2004). By calculating costs in this way, we obtained the numbers of patients achieving the treatment goals and probability of effectiveness in the three treatment groups. The probability of effectiveness for the TJ-20, TJ 20 plus NSAIDs, and NSAIDs groups were 17 of 31 patients (54.8%), 21 of 33 patients (63.6%) and 10 of 20 patients (50.0%) respectively, showing that the highest probability of effectiveness was in the TJ 20 plus NSAIDs group. The results of the cost effectiveness analysis showed that the treatment costs necessary for one patient to achieve the treatment goal for K-OA with TJ-20, TJ 20 plus NSAIDs, and NSAIDs were ¥22,002, ¥29,248 and ¥23,610, respectively. Treatment using TJ-20 alone was thus the most inexpensive.
Enteral nutrition is essential to the treatment of inflammatory bowel disease. However, diarrhea and abdominal pain may occur if microbial contamination occurs through inappropriate handling of enteral nutrition solutions. This frequently happens when patients receive enteral nutrition using the specified self administration device (Portermate®) since there is no particular method for cleaning and sterilizing the device. On monitoring enteral nutrients prepared by patients, we found that microbial contamination frequently occurred. It was therefore necessary to devise an easy and effective method for the prevention of microbial contamination of enteral nutrient preparations through sterilization of the device, and to instruct patients on how to do this. In this regard, we found sterilization of the device using sodium hypochlorite was more effective in reducing the degree of microbial contamination than boiling water or conventional washing procedures. The above findings suggest that the use of sodium hypochlorite for sterilizing the Portermate® device by patients using enteral nutrient preparations would be a simple and effective way of avoiding the complications associated with contamination.
Cases of intervention in pharmacotherapy by pharmacists in the ophthalmology ward were collected and analyzed and the drug information obtained by doing this was provided to ophthalmologists and nurses at a study meeting. This significantly changed the writing of prescriptions by ophthalmologists and helped avoid medication problems. For each case of intervention by pharmacists in pharmacotherapy, we prepared a “PREAVOID report” and submitted 39 of them to the Japanese Society of Hospital Pharmacists. They were classified according to “pharmaceutical management” and “medicines involved in medication errors”. As for the former, 16 cases (41.0%) came under the heading of drug interactions and duplicate medications and for the latter, 13 cases (33.3%) came under “pre-admission medications”, 15 cases (38.5%) under “medications prescribed by ophthalmologist” and 11 cases (28.2%) under “concomitant use of preadmission medications and those prescribed on-admission”. Thus 24 cases (61.5%) concerned “pre-admission medications”. The study meeting held by pharmacists for ophthalmologists and nurses focused on these medication errors, and was held twice. Afterwards, the frequency of errors significantly decreased-from 13.7×10-4 (cases/patient/month) before the meetings to 6.8×10-4 after the meetings (p<0.05). There was a particularly great improvement as regards the frequency of drug interactions between the antibiotic cefdinir prescribed by ophthalmologists and metal cation medicines included in “pre-admission medications”. The reason for this was discovered by examining the prescribing tendency for metal cation medicines and that of cefdinir for both before and after the meetings. While there was no significant change for metal cation medicines between before and after the meetings (p=0.443), there was a significant decrease in cefdinir prescriptions (p<0.05).
It is widely known that lipid-soluble injections (e.g. Paclitaxel) elute di (2-ethylhexyl) phthalate (DEHP), a plasticizer used in polyvinyl chloride (PVC) administration sets. A survey of the current situation in medical facilities revealed that 50% did not take adequate measures against this and in most of them, pharmacists were not involved in selecting administration sets. In the case of Kobe Teishin Hospital, the Medical Treatment Safety Management Committee decided to provide Paclitaxel and other injections together with PVC administration sets containing tris (2-ethylhexyl) trimellitate (TOTM), a plasticizer, which is less easily eluted than DEHP, in accordance with doctors' instructions. A questionnaire survey of hospital nurses conducted to compare the situation between before and after providing the TOTM sets revealed that their provision had eliminated the confusion nurses felt when administering injections and reduced the stock of administration sets. In conclusion, our findings show that it is necessary for pharmacists be involved in the selection of medical equipment for administering drugs to help ensure safety, that drugs are used properly, and economic use of resources.
The number of medical facilities conducting outpatient chemotherapy is increasing, and it is becoming quite normal for pharmacists to prepare anti-cancer admixtures. However, it is not only important for pharmacists to help ensure safety and confidence in treatments by preparing admixtures, they should also keep a check on the situation at the bedside. With this in mind, a questionnaire survey of patients was conducted to determine the effect of conducting chemotherapy in the outpatient situation. The questionnaire used multiple choice answers with regard to “length of time under intravenous drip”, “how patients spent the time they were receiving drips”, “things they wanted to know” and “requests and opinions”. Responses were received from 53 patients over a period of 2 months The results revealed that half of patients slept during chemotherapy, but there were some who read books or magazines or listened to music. Some felt dissatisfied with the inconvenience. Many respondents mentioned adverse effects and anxiety concerning treatment and some said that they welcomed the visit of the pharmacist. Thus the survey revealed the anxiety that patients felt on receiving chemotherapy in the outpatient setting and we felt that it was necessary to provide an atmosphere in which they could feel at ease during treatment. Moreover, it let us clearly see that the pharmacist's mission is to ensure safety and a feeling of confidence in outpatient chemotherapy.
It has been reported that the pharmacokinetics and pharmacodynamics of carvedilol vary between the S- and R- enantiomers. The aim of this study was to evaluate the pharmacokinetic characteristics of carvedilol for each enantiomer and apply this in clinical practice. Serum stereoselective concentrations of carvedilol were monitored in 60 Japanese inpatients who received a fixed dose of carvedilol. The concentrations were determined by high performance liquid chromatography (HPLC). Serum carvedilol concentration/dose of administered carvedilol ratios were determined for each enantiomer (R/D, S/D). The means±SD for R/D and S/D were 85.8±264.0 (10-3kg/L) and 29.0±78.2 (10-3kg/L), respectively. The mean for R/D tended to be larger than that for S/D (p=0.11), and the dispersion of R/D was significantly greater than that of S/D (p<0.01). Although a significant positive correlation was observed between R/D and S/D, a remarkable difference was observed in a few inpatients. These results suggest that the pharmacokinetics of carvedilol are different for each enantiomer. The monitoring of the stereoselective pharmacokinetics of carvedilol is therefore necessary to ensure proper use.
Cancer pain has a number of physical and psychological components. It is usually defined as a subjective phenomenon since only the sufferer experiences it and because of this, cancer pain is difficult to evaluate. Many cancer patients suffer from their pain, and an important part of relieving it is determining the intensity and characteristics of such pain through pain assessment. We considered that the words chosen by patients to describe their pain were useful for its assessment and had potential value as a diagnostic adjunct. We evaluated methods of pain assessment for cancer patients with regard to the following objectives : 1) To find an adequate pain assessment instrument for cancer patients for clinical use and to develop the Aichi Prefectural Society of Hospital Pharmacists Pain Questionnaire (APQ) based on the McGill Pain Questionnaire (MPQ), 2) To investigate the relationship between the etiology of pain and words related to pain using APQ and 3) To analyze the relationship between the etiology of pain and the words related to pain by collecting seventy clinical cases. We predicted whether morphine would be effective or not based on the relationship between changes in morphine doses and changes in verbal pain descriptions made by patients. Our findings indicated that pain assessment by APQ is useful means of selecting adequate therapeutics for pain relief.
Pain assessment is important in treating the pain of cancer patients and choosing adequate analgesics for this purpose. Though pain is defined as a subjective phenomenon, it is necessary to evaluate the words chosen by cancer patients to describe their pain objectively. In our previous study (part 1), We developed the Aichi Prefectural Society of Hospital Pharmacists Pain Questionnaire (APQ) based on the McGill Pain Questionnaire (MPQ), a tool for measuring pain based on words used to describe pain. In order to evaluate pain in thirty-one cancer patients in ten hospitals using the APQ, we investigated the relationship between the words used by patients to describe pain and pain quality (equivalent to the subclasses in APQ) and opioid responsiveness. In addition, we tried to select adequate adjuvant analgesics based on the words for pain in the APQ through a search of the literature. Words used to describe pain and pain quality for pain that is responsive or non-responsive to opioids could be inferred from the seventy-eight pain words in the APQ. These findings suggest that we can choose adequate medication based on an evaluation of the patient's pain using the APQ and relieve cancer pain successfully.
The guideline on the dosing of Epoprostenol sodium (PGI2) was established based on data for adults. In order to study the dosing regimen in children in Japan, we followed-up 7 patients under 16 years old with primary pulmonary hypertension (PPH) who received PGI2 and analyzed their doses, hemodynamic parameters and brain natriuretic peptide (BNP) levels. The mean initial dose of PGI2 was 2.0±0.7 ng/kg/min and increases in the PGI2 dosage occurred mostly within 2 weeks of the start of administration. Up to 28 days after starting administration, the mean interval between dose increases was 2.9±3.3 days and the mean dosage increase increment was 0.8±0.4 ng/kg/min. Up to 3 months after starting administration, there was no statistically significant difference in doses between adults and children. Among severe adverse effects reported in acute dose-ranging in Japan, 7 of 18 cases were in children and the initial doses in 4 of them were over 2 ng/kg/min. Based on these findings, appropriate dosing of PGI2 in children is considered to be as follows : 1) The initial dose should be 0.5 ng/kg/min, 2) The dosage increase interval should be over 2 days and the dosage increase increment between 0.5 and 1 ng/kg/min, 3) Up to 3 months, the dose in children may be increased to the same extent as in adults.
We have identified a discrepancy in the regulations on ophthalmic solutions and suspensions in the Japanese Pharmacopoeia (JP). The JP regulations specify that there should be no visible particles of foreign matter in any ophthalmic drug product. The JP further specifies that there may not be more than 1 particle of foreign matter of 300μm in size in 1 mL of solution. However, we determined that particles of 50μm in size are visible to the naked eye suggesting that the JP regulations concerning ophthalmic products are contradictory and should be revised.
We conducted an investigation of inquiries on prescriptions for ambulatory cancer chemotherapy with the aim of using the results in future operational auditing. In the investigation, which was carried out from January to December 2004, we examined the content of the inquiries in detail and classified them into 3 classes which were further broken down into 12 subclasses. Among 3,279 prescriptions, there were 991 inquiries, as the result of which 189 prescriptions were changed. The inquiries prevented potential adverse events in 60 cases. Our study showed that with prescriptions for ambulatory cancer chemotherapy, it is important to : 1) Check prescriptions against the protocol, 2) Check prescriptions with regard to medication history management and efficacy, 3) Check prescriptions based on pharmacists' expertise and 4) Check prescriptions with respect to 12 points that we specified based on our analysis. We felt that the check in 2) above was particularly important. Furthermore, seeing the findings of our study as very important, we made arrangements to continue checking ambulatory cancer chemotherapy prescriptions.
We operate a quality management system for pharmacy practice whose aims are to achieve effective and safe pharmacotherapy for patients. ISO 9001 certification was obtained for the system in October 2003. In the following, we describe the measures against dispensing errors and the evaluation of their effectiveness. We divided dispensing errors into those noted by pharmacists other than those who did the dispensing and what we called “incidents”, which were dispensing errors discovered after medicines were given to patients. When incidents involved giving the wrong medication to patients, a report on corrective action was required. We also analyzed the factors in the occurrence of dispensing errors, devised actions to prevent them, and evaluated their effectiveness after they had been implemented. The corrective actions lead to the prevention of similar incidents. Corrective actions in the form of visual aids on the dispensary shelves and supporting information reduced dispensing errors involving names and dosage forms of medicines. Though errors regarding the quantities of medicines were not decreased by these actions, they were significantly reduced by implementation of an error reporting system and preparation of a list of medicines giving details of their package sizes (i.e. number of tablets in a package). While the prevention of dispensing errors is not easy, our efforts suggested that the practice of the PDCA cycle using an ISO 9001 certified quality management system is useful in this regard.
We examined the current status of cancer chemotherapy in outpatients at Takarazuka Municipal Hospital and the associated problems between June, 2002 and May, 2004. The number of patients receiving cancer chemotherapy during this period was 201 and the number of cancer chemotherapy sessions was 2,489. The rate of prescription changes due to a pharmacist's check was 1.6%, and these checks confirmed the usefulness of cooperation between doctors and pharmacists. The average mixing time per chemotherapy mixture was 6.7 minutes, and the mixing time tended to be correlated with the number of vials or ampoules needed for each mixture. The rate of cancellations was 13.0%. Patient complaints such as poor physical condition accounted for a higher proportion of cancellations than abnormal laboratory tests such as a decrease in white blood cell count. These findings suggest that it is necessary for the oncology pharmacist or other medical staff to keep a careful watch on cancer chemotherapy.
The size and the shape of tablets and capsules may influence the taking of medicines and compliance in elderly patients may be negatively affected by physical disabilities and/or swallowing difficulties. In order to develop medicines that are easy for patients to grasp and swallow, we conducted a sensory test regarding the size and shape of tablets and capsule size, in which our subjects were elderly people (average age : 71.9) and students (average age 22.3). Eighteen white imitation tablets of different shapes (circular, oval, rectangular) and varying from 5.0-13.0 mm in size, and six different imitation capsules were prepared for the test and the subjects' feelings about them were determined through interviews. The subjects took the tablets in the pre-assigned order and evaluated them according to 3 levels concerning ease of grasping and ease of swallowing. Based on the overall results for the elderly subjects and students, the easy-to-grasp, easy-to-swallow size was determined to be 7-8 mm in diameter for circular tablets, 9 mm in the longer axis for oval tablets, 9-10 mm in the longer axis for rectangular tablets, and the No. 3 size for capsules. Thus, among prescription drugs available in Japan, easy-to-grasp, easy to swallow circular tablets account for 35% of the total, 16% of the total for oval tablets, 9% of the total for rectangular tablets, and 32% of the total for capsules. Our findings suggest that more effort should be put into the design of medications regarding their size and shape in order to improve patient compliance.
We prepared a chemotherapy information leaflet that helped to enhance patients' understanding of chemotherapy and to reduce their anxiety about its adverse reactions. The aim of the present study was to evaluate pharmaceutical services with regard to the management of adverse reactions, length of hospital stay and the medical costs for women with gynecologic cancer who received chemotherapy. We carried out a retrospective chart survey of 28 ovarian cancer patients to clarify the effects of pharmaceutical care on their chemotherapy. Half of the patients were given chemotherapy information verbally and were assigned to Group A, and the other half were supplied with an information leaflet and a self-check list for adverse reactions and assigned to Group B. There were no significant differences between the two groups regarding the occurrence of adverse events, except for fatigue and insomnia. However, 50% (7/14) of the patients in Group A stayed longer in hospital to be free from adverse reactions, especially myelosuppression. The mean hospital days per cycle of chemotherapy in Group B (2.76±0.80 days) was significantly shorter than that in Group A (7.28±3.97 days, p<0.001). Thus, our pharmaceutical care using chemotherapy information leaflets had a favorable effect in terms of shortening the length of hospital stay.