It is important that laboratory data to be constantly checked according to described package inserts during usage of medicines. However, many hepatic and renal disorders were reported to have strong adverse reactions for prescription drugs. We investigated the necessity of hepatic and renal function checks in package inserts for 3300 prescription drugs. As a result, the number of drugs which recommended checks on hepatic and renal functions were 240 (7.3%) and 209 (6.3%) respectively. The described expression or place regarding checks of hepatic and renal functions on package inserts were various types of unclear information to doctors and pharmacists. We thus found that the present style of package inserts unapprehensive to the necessity of hepatic and neral function checks. So, in our hospital, we decided to provide a list of drugs that required hepatic and renal function checks during administration of drugs.
These findings suggest that the need of hepatic and renal functions monitoring during the administration of drugs by the establishment of a new Clinical Checks item in the package inserts is therefore necessary.

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The cause of coring was researched using a combination of 6 types of injection needles and 5 types of rubber stoppers. The research was carried out by sticking a needle into a rubber stopper 30 times, and observing the core in the vial and also observing the interior of the stopper. As a result, the rubber stopper with the least amount of coring was the newly developed S 2-210N1. However, depending upon the needle used, coring occurred and protrusions and cracks in the rubber were confirmed in the interior of the rubber stopper. The best injection needle was found to be the PenNeedle 31G (PN 31 G needle). However, coring occurred when used with the rubber stoppers PenFill R 300U and HumaCart R300, which are currently sold on the market. The least amount of coring occurred with the combination of the S 2-210N1 and the PN31G. In addition, while an extreme amount of coring occurred with a MicroFine Plus 31G (BD31G needle) cut needle tip, little coring occurred with the non-cut needle tip, and it was discovered that the make-up of the needle tip of the injector is closely related to such coring. The cause of the core occurrence was thus found to be the make-up of the needle tip and the material of the rubber stopper. In addition the affinity of both parties is also related. Therefore, in order to prevent coring it is advisable to change the rubber stoppers of insulin medicine to a rubber that does not cause coring, and to use an injection needle with a make-up close to the PN31G needle. In addition, the rubber stopper and needle combination for such usage needs to be further evaluated.

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There are many medical supplies, which are required to undergo periodical laboratory tests to prevent the occurrence of serious adverse effects. However, it is uncertain as to whether or not such laboratory tests are actually carried out routinely at hospitals. In order to prevent serious adverse effects, it is important to clarify the current performance of the laboratory tests in hospitals and to perform such laboratory tests properly. In this study, we surveyed the current performance of laboratory tests on Flutamide, Ticlopidine, Benzbromarone, Acarbose, and Thiamazole, which have all been recently required to undergo laboratory tests to prevent potential adverse effects.
The present study showed the performance rate of proper laboratory tests, based on package inserts, to be 60, 33.3 and 46.2% for Ticlopidine, Acarbose, and Thiamazole, respectively. Surprisingly, the performance rate of proper laboratory tests for Flutamide was zero, in spite of the fact that it is well known to cause serious liver dysfunction.
Our findings suggest a poor recognition by medical staff members of the importance of laboratory tests in or-der to prevent adverse effects. It is therefore important to promote the implementation of periodical laboratory tests, and pharmacists should play a significant role in appropriately conducting such needed laboratory tests to avoid the occurrence of serious adverse effects.

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A new type of rubber plug reduces leakage in the Lantus^® OptiClick^® 300 insulin pen (Sanofi Aventis K.K. ; n-OPC).In order to evaluate this improvement, using a questionnaire, we asked patients whether they had experienced leakage with the pen having the previous rubber plug (o-OPC) as well as concerning the effect of such leakage. Twenty-seven outpatients with diabetes provided responses.
In Japan, the pre-filled insulin pen product NovoRapid FlexPen^® (Novo Nordisk Pharma K.K. ; FLX) is widely used. As basic testing, we examined the material and structure of its rubber plug, and conducted an insulin injection accuracy test and a puncture resistance test. We also assessed the n-OPC to see how much it prevented the leakage that frequently occurred with the o-OPC. We compared the elasticity of plugs, conducted a puncture resistance test and an accuracy test, and compared how well they fit in the pens.
The responses to the questionnaire indicated that leakage increases patient anxiety and required preventive measures to be taken as early as possible. The results of the basic testing showed that there were no problems with the FLX but the o-OPC had problems with regard to all test parameters. For the n-OPC, while the new plug material helped prevent leakage, there were still various points of the product that required improvement.

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Coring, which is the name for when a piece of rubber is shaved off from the rubber stopper of a vial when the needle punctures it, is herein reported. We investigated whether or not coring could happen with insulin injections, and also whether or not such pieces of rubber could then actually pass through the needle. Vials for syringes and pen type injectors were used with 29, 30 and 31 gauge (G) needles, under cool and room temperature conditions, and at 60/90 degree puncturing angles. The shapes, sizes and number of pieces of rubber were measured at the 10th and 30 th puncturing times. For the passage test, the presence rubber pieces was measured during air venting, as well as in the insulin liquid actually ejected and in the liquid in the vial.
Coring often occurs in vials for syringes under cool conditions. Vials for pen type injectors also show coring under all the above conditions. The rubber pieces which passed through the needle could be found in both air venting and the insulin liquid. Coring was shown in thin hypodermic syringes, such as 29-31 G, and there was evidence that such rubber pieces may be dangerous if they enter the body. Rubber pieces can pass through the needle in a vial for pen type injectors, due to the design of the fixed needle in the injector. Based on our findings a safer injection system which prevents coring should thus be develepoed.
In addition Careful attention should also be paid to patients with rubber allergies.

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糖尿病の自己注射療法は，インスリンやGLP-1受容体作動薬のペン型自己注射用注入器（以下，ペン型注入器とする）に専用の注射針を注射時に嵌合させて使用する製剤によるものが主流になっている．一般に，注射針をゴム栓に穿刺すると，注射針の刃先部とヒール部によってゴム片が削り取られる「コアリング」という現象が生じることがある．今回，数種類のプレフィルド型インスリン注入器と注射針の嵌合部の構造を観察し，コアリングの発生との関連について考察することを目的に試験を行った．方法は，注入器に注射針を嵌合させたとき，後針の穿刺直後と嵌合完了時の状態をマイクロフォーカスX線テレビ透過装置にて投影し，実測値とあわせて解析した．結果は，ソロスターとナノパス以外の組み合わせで，嵌合開始時の後針刃先はゴム栓を貫通していないことが確認され，コアリングが発生しやすい状態であると思われる．また，ランタスXRソロスターとミリオペンでは注射針（後針）の基底部とゴム栓表面に隙間があることから，コアリングによって引き起こされる液漏れを防止するための構造になっていないことが確認された．よって，これらを参考に，注射針と注入器の嵌合部に関する構造的な改良が必要であると考えられる．

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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.

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糖尿病療養指導では患者の簡便性や実践度にも配慮してインスリン製剤の保管に関する留意点として，「原則として使用前は2〜8℃（凍結を避けて冷蔵庫内）保管，使用開始後は（冷蔵庫には入れずに）室温保管」と説明している．しかし，近年，市街地でのヒートアイランド現象や気候変動などにより世界各地の環境温度の上昇が見られ，高温環境下での適正な保管に関した不安から，患者が保管温度に配慮するも品質を維持するために苦慮していることが伺える．基礎試験からは，高温状態でのインスリンの立体構造の変化とそれによる薬理活性を減弱させる恐れが排除できないため，インスリン製剤の保管は可能な限り4℃付近の冷蔵保存が推奨されるべきである．近年，日本各地において30℃以上（真夏日）の日数が増加しており，これからも増加傾向にある．そこで，高温対策のひとつとして，これまで指摘されてきた使用中の注入器を冷蔵庫内に保管した場合の問題点には十分配慮し，室温が30℃を超える場合は，使用中のプレフィルド（キット）型のインスリン製剤は，（注射針を取り外した上で）冷蔵庫に保管し，注射の前には常温（15〜25℃）程度に戻すことを推奨する．

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