Microcosting method for small-volume injectables

The costs of preparing different small-volume injectables (SVIs) in a centralized i.v. admixture pharmacy in a 650-bed teaching hospital were calculated using a microcosting method. The types of SVIs produced and methods of preparation were identified. Time-and-motion and work-sampling studies were performed to determine the amount of pharmacist and technician time spent in SVI production, auxiliary activities, and nonproductive activities. The costs of material and equipment used were calculated, and waste-cost factors based on percentages of wasted SVIs were determined. To determine the final cost per unit prepared, the calculated costs were added and multiplied by the appropriate waste factors. On the average, it took 5.57 minutes of total personnel time to prepare an SVI. It took an average of 192.4 seconds and 16.6 seconds for the technicians and pharmacists, respectively, to reconstitute a vial of powder and prepare an SVI in a minibag. Bulk prepacked items and admixtures prepared from vials of powder for reconstitution and stored in minibags were, respectively, the least and most expensive SVIs. By using microcosting methods to determine the cost of preparing SVIs, this institution discovered that the cost figures were much higher than it had anticipated. These data can be used to improve productivity and cost efficiency and to compare the costs of in-house and commercially available preparations.     

Bromism caused by mix-formulated analgesic injectables

Bromism, chronic bromide intoxication, can be caused by a variety of medicines, but bromism due to pain-relieving injectable medications has not been reported. In this study, the methods used were internet searching on bromide-containing injectables available in Taiwan and the first case report of bromism due to mixed-formulated injectable medication. Many analgesic/antipyretic and antihistamine injections containing bromides are still being used in Taiwan. They contain sodium bromide up to 1000 mg/ampoule or calcium bromide up to 800 mg/amp. A 25-year-old female suffered from forgetfulness and unstable gait after long-term frequent injections of a preparation to relieve head and neck pain. Blood tests showed hyperchloremia (171 mEq/L) and a negative anion gap (-48.7 mEq/L). Serum bromide measured 2150 mg/L. She recovered completely in 3 days with saline treatment. Many bromide-containing injections are still being used in Taiwan. Clinicians should keep alert on this issue to avoid iatrogenic bromism or making misdiagnoses.     

Aseptic meningitis associated with naproxen

A rare complication of nonsteroidal antiinflammatory drug (NSAID) use, particularly in patients with collagen vascular or autoimmune diseases, is aseptic meningitis. A healthy 21-year-old man receiving naproxen for muscle spasm was admitted with a chief complaint of severe headache. Approximately one week after beginning naproxen, the patient developed headache, fever (T 38.8 degrees C), shaking chills, and nuchal rigidity with occasional nausea and vomiting resulting in a 15-lb weight loss. Findings from a cerebrospinal fluid examination revealed polymorphonuclear pleocytosis and elevated protein, but no evidence of infection with bacteria, fungi, mycobacteria, or viral agents was noted. Within 36 hours of discontinuing naproxen, the meningitis-like symptoms markedly improved. Rechallenge with naproxen was not performed. In patients exhibiting meningitis-like symptoms, a thorough drug history, including that of recent or intermittent NSAID use, should be obtained.     

浅析无菌药品的参数放行

目的:为提高我国无菌药品的质量控制水平提供参考。方法:通过对比传统的无菌检查质量控制方法,参考发达国家的参数放行指南,分析无菌药品参数放行优越性及具体实施方法。结果与结论:对于无菌药品,参数放行能够为最终产品提供更高水平的质量保证,其替代传统的质量控制方法是必然的趋势。     

无菌预灌装培养平皿的质量控制

目的：通过对比3家不同供应商的无菌预灌装培养平皿实验结果,筛选出质量较好的平皿培养基,同时探讨其供应商筛选、进厂检查和使用方法,为无菌药品生产企业进行无菌预灌装培养平皿的质量控制工作提供参考。方法：分别对3家供应商的无菌预灌装培养平皿进行3个批次的模拟使用,培养基无菌性、内层包装袋无菌性、平皿密闭性和培养基适用性检查,筛选适合用于无菌生产区洁净环境微生物监测的平皿培养基。结果：3家供应商的模拟使用、培养基无菌性和内层包装袋无菌性实验结果没有差异,供应商A的平皿密闭性和培养基适用性实验结果较另外两家更好。结论：本实验方法可用于筛选质量较好的无菌预灌装培养平皿。     

一次性无菌过滤器在无菌受控检验中发挥的作用及验证结果考察

目的探讨不同厂家不同规格的一次性无菌过滤器的质量。方法通过采用无菌检查的方法对其进行验证检查,以氟哌叮醇注射液为样品,根据试验结果对一次性无菌过滤器的质量进行分析、比较和评估。结果不同厂家相同规格的一次性无菌过滤器均通过ISO9001质量管理体系及ISO4001环境管理体系的认证,可以满足各类检品无菌试验的检查要求。结论不同厂家相同规格的一次性无菌过滤器按照《中国药典》2010年版无菌检查首选方法,无菌质量控制可满足方法学的验证。     

Aseptic meningitis after intraventricular administration of gentamicin

Infection of the central nervous system (CNS) is a major cause of morbidity in patients with cerebrospinal fluid (CSF) shunts. Intraventricular administration of gentamicin, in combination with systemic antibiotics and shunt removal, may be beneficial in treating these infections. A young child was treated successfully for a ventriculoperitoneal shunt infection while receiving systemic nafcillin and intraventricular gentamicin. During treatment she developed CNS toxicity resembling aseptic meningitis. Based on CSF gentamicin levels and differential white blood cell counts, it was suspected that gentamicin was causing meningeal inflammation. Discontinuation of the drug relieved her symptoms. Rebound CSF leukocytosis associated with lymphocyte increase, despite a negative CSF culture, can indicate aseptic meningitis when drugs are administered intraventricularly. Clinicians should evaluate CSF cell count differentials before concluding treatment failure when administering antibiotics intraventricularly for meningitis.     

Polyester-based long acting injectables: Advancements in molecular dynamics simulation and technological insights

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"Non injectables": methadone syrup and benzodiazepine injection by methadone-maintained clients

To obtain more information about anecdotal reports of injection of methadone syrup and benzodiazepine drugs among injecting drug users, interviews were conducted with 32 subjects as part of a larger study into drug use patterns of clients in methadone maintenance treatment. Subjects were asked about frequency of injection of methadone and benzodiazepines, reasons for injection and methods of preparation for injection. The study found that 78% had injected methadone and 25% had injected benzodiazepines at some time during their drug using careers. Service providers can play an important role in promoting harm minimization strategies, and utilizing behaviour modification techniques.     

呋喃西林溶液的无菌检查方法验证

目的:建立合理的无菌呋喃西林溶液无菌检查方法并进行方法验证。方法:按《中国药典》2005年版附录要求进行试验,通过薄膜过滤法消除无菌呋喃西林溶液中呋喃西林和苯甲酸钠较强的抑菌性,进行方法验证试验并建立无菌呋喃西林溶液无菌检查方法。结果:方法验证试验结果证明此方法适用于无菌呋喃西林溶液的无菌检查。结论:该方法简便易行,结果准确。