Search

Importance: Current draft guidelines set forth by the US Food and Drug Administration for compounded or repackaged medications would greatly limit the availability and use of bevacizumab by ophthalmologists across the country. Little evidence beyond highly publicized case reports exists for or against the need for additional regulation of compounded bevacizumab., Objective: To determine whether the distribution of bevacizumab through compounding pharmacies increases the risk for endophthalmitis compared with the distribution of single-use vials of ranibizumab from the manufacturer., Design, Setting, and Participants: A retrospective cohort study using medical claims data from ambulatory care centers across the United States that were submitted to a large, national US insurer. Cohorts were created using information on 530 382 intravitreal injections administered from January 1, 2005, through December 31, 2012. Any individual from this data set who received an intravitreal injection of bevacizumab or ranibizumab (n=383 810) and had at least 6 months of data before and 1 month after the injection was eligible. After exclusions (any previous diagnosis of endophthalmitis, multiple injected drugs given on the index day, or intraocular surgery within 15 days of the injection or between the injection and a diagnosis of endophthalmitis), our analysis involved 383 810 intravitreal injections given to 58 612 patients. Data collection and analysis occurred from February 16 through April 7, 2015., Main Outcomes and Measures: The odds of developing endophthalmitis after an intravitreal injection of bevacizumab compared with ranibizumab., Results: In total, 296 565 injections of bevacizumab were given to 51 116 patients and 87 245 injections of ranibizumab were given to 7496 patients. We found 71 cases of endophthalmitis (49 in the bevacizumab cohort and 22 in the ranibizumab cohort) for an endophthalmitis rate of 0.017% (95% CI, 0.012%-0.021%; 1 case per 6061 injections) for bevacizumab and 0.025% (95% CI, 0.015%-0.036%; 1 case per 3968 injections) for ranibizumab. After controlling for age, race, sex, injection-related diagnosis, and year of injection, we found no significant association with development of endophthalmitis after a bevacizumab injection compared with ranibizumab (odds ratio, 0.66 [95% CI, 0.39-1.09]; P = .11)., Conclusions and Relevance: The results of this study suggest bevacizumab as currently used across the United States does not increase the risk for endophthalmitis; therefore, additional regulations on the use of repackaged bevacizumab may be unnecessary.

Importance: Intracameral injection of cefuroxime sodium (1 mg/0.1 mL) has been reported to reduce the risk of endophthalmitis following cataract surgery. In the United States it must be compounded, which is subject to dilution error. We describe a series of 13 eyes that received intracameral injection of cefuroxime sodium, 9 mg/0.1 mL, intraoperatively., Observations: On postoperative day 1, 6 of 13 eyes (46%; 95% CI, 19%-75%) had visual acuity of 20/70 or worse and macular edema. Spectral-domain optical coherence tomography of 2 eyes revealed central subfield thicknesses of 909 and 873 µm. On postoperative day 4, the mean (SD) central subfield thickness was 309 (78) µm in the 6 eyes with diagnosed macular edema, 279 (23) µm in the fellow eyes, and 271 (38) µm in the 7 exposed eyes without macular edema. The mean (SD) time to resolution of macular edema was 5.2 (1.3) days; the final central subfield thickness ranged from 193 to 293 µm. All eyes, except 2 with preexisting ocular comorbidity, had a best-corrected final visual acuity at 1 month of 20/30 or better. Significant corneal edema was not observed., Conclusions and Relevance: Intracameral injection of cefuroxime sodium at a dose of 9 mg/0.1 mL was associated with transient macular edema and diminished visual acuity in 6 of 13 exposed eyes (46%), resolving largely within 1 week.

Purpose: The aim of this study was to report the clinical features and management of patients with ocular surface damage during methamphetamine production accidents., Methods: This is a retrospective noncomparative interventional case series of 5 patients with methamphetamine production-related ocular injuries referred to the Cincinnati Eye Institute between 1999 and 2014., Results: Four of 5 cases were white young men with severe bilateral ocular injury and extremely poor vision. All except 1 eye (9 of 10) were diagnosed with total or near-total ocular surface failure. Limbal stem cell transplantation was performed in 8 of 10 eyes. Keratolimbal allograft was followed by penetrating keratoplasty in 7 of 10 eyes. Ocular surface stability was achieved in 7 of 10 eyes after keratolimabl allograft. Postoperative visual acuity was better than 20/200 in 4 of 10 of eyes. Keratolimbal graft rejection occurred in 3 of 10 eyes; the rate of rejection of penetrating keratoplasty was also 3 out of 10 eyes., Conclusions: Methamphetamine-related accidents can lead to severe bilateral ocular injuries. Although stem cell transplantation procedure success is guarded in most of these patients because of severe conjunctival inflammation and accompanying ocular comorbidities, as well as personality issues, compliant patients can achieve good visual function with ocular surface transplantation and subsequent keratoplasty.

Environmental contamination, product contamination and technicians exposure were measured following preparation of iv bags with cyclophosphamide using the robotic system CytoCare. Wipe samples were taken inside CytoCare, in the clean room environment, from vials, and prepared iv bags including ports and analysed for contamination with cyclophosphamide. Contamination with cyclophosphamide was also measured in environmental air and on the technicians hands and gloves used for handling the drugs. Exposure of the technicians to cyclophosphamide was measured by analysis of cyclophosphamide in urine. Contamination with cyclophosphamide was mainly observed inside CytoCare, before preparation, after preparation and after daily routine cleaning. Contamination outside CytoCare was incidentally found. All vials with reconstituted cyclophosphamide entering CytoCare were contaminated on the outside but vials with powdered cyclophosphamide were not contaminated on the outside. Contaminated bags entering CytoCare were also contaminated after preparation but non-contaminated bags were not contaminated after preparation. Cyclophosphamide was detected on the ports of all prepared bags. Almost all outer pairs of gloves used for preparation and daily routine cleaning were contaminated with cyclophosphamide. Cyclophosphamide was not found on the inner pairs of gloves and on the hands of the technicians. Cyclophosphamide was not detected in the stationary and personal air samples and in the urine samples of the technicians. CytoCare enables the preparation of cyclophosphamide with low levels of environmental contamination and product contamination and no measurable exposure of the technicians., (© The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Background: Omeprazole is a proton pump inhibitor for the treatment of gastric acid-related disorders. In recent years, reports of dermatitis upon exposure to omeprazole during manufacture have been noted., Objective: To present diagnostic findings in workers who reported suspected hypersensitivity reactions resulting from occupational exposure to omeprazole., Methods: Ninety-six workers exposed to omeprazole during the manufacturing process underwent investigation by the AstraZeneca Occupational Health Centre (Södertälje, Sweden) for suspected allergy. All subjects underwent a lymphocyte transformation test (LTT) and a skin test within 6 months of the clinical reaction. Predictive tests on guinea-pigs were conducted to establish omeprazole's sensitizing potential., Results: Thirty-one subjects with clinical symptoms had a positive LTT result. Twenty-eight subjects had positive patch test results; of these, 23 also had a positive LTT result (sensitivity of the LTT: 82%). Fifty-six subjects had negative patch test results; 46 of these had a negative LTT result (specificity: 82%). All subjects who underwent prick testing (n = 18) had negative results. Delayed contact hypersensitivity was observed in 18 of 20 test animals., Conclusions: These findings confirm the risk of sensitization to omeprazole from occupational exposure. They are of importance for the development of new formulations of omeprazole, or its enantiomers, in light of the potential for inducing skin allergy., (© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

After the publication of the Women's Health Initiative, attitudes towards management of menopausal symptoms changed dramatically. One alternative that has received much media attention is the use of bioidentical hormone therapy (BHT). The media and celebrity endorsements have promoted a number of misconceptions about the risks and benefits associated with the various forms of BHT. This article will review the available evidence regarding the safety and efficacy of BHT in comparison to conventional hormone therapy. We will also review several cases seen in our midlife women's referral clinics, which demonstrate concerns for the safety and efficacy of BHT, including unexplained endometrial cancer in otherwise healthy BHT users. Due to the lack of sufficient data to support the efficacy or safety of BHT, we recommend the use of United States Food and Drug Administration-approved regimens in the management of menopausal symptoms.

Objective: To provide an overview of the regulation issues surrounding compounding pharmacy that allowed the United States fungal meningitis outbreak to occur and the changes in regulation that ensued., Summary: In September 2012, a single case report sparked an investigation into a nationwide outbreak of fungal meningitis due to contaminated injectable drugs. The source of the contamination, New England Compounding Center (NECC), was in violation of several state and federal laws and had a history of such violations. The regulation of compounding pharmacies has historically been left to the states, while manufacturing fell under the jurisdiction of the Food and Drug Administration. However, as more compounders took part in large-scale interstate distribution of drugs, the current state-based regulatory system became less equipped to provide oversight. The lack of a clear definition of "compounding pharmacy" further obscures proper oversight and regulation. Congress and several states have taken steps to build safeguards against large-scale compounding by increasing inspections, adopting stricter licensing requirements, and enacting the Drug Quality and Security Act of 2013., Conclusion: While the current compounding regulation changes are a necessary step forward, it remains to be seen how effective they will be in safeguarding the public.

Complications resulting from the use of compounded medications have become a troubling trend nationwide. There is a significant potential for patients to suffer serious harm from the use of substandard medications prepared by compounding pharmacies, and the reality of this problem has been demonstrated in several well-publicized incidences of serious medical complications, including patient deaths, that directly resulted from the use of medications prepared at compounding pharmacies. Unlike US Food and Drug Administration (FDA)-approved drugs, compounded products are not required to meet evidentiary standards for establishing safety and efficacy. Moreover, these products are not held to Good Manufacturing Practices, which require regular inspections, quality control testing, and rejection of material not meeting specifications. Physicians, as well as other prescribers, need to be aware that when a patient suffers harm from using a compounded medication, those injured patients may bring negligence and malpractice claims, not only against the pharmacy and the pharmacist responsible for preparing the medication, but also against the prescribing physician and the physician’s practice. Consequently, the best way for physicians to manage professional risk and avoid both litigation and potential negative patient outcomes related to compounded pharmaceuticals is to not use these products if there is an FDA-approved product available. However, if the use of a compounded medication is medically necessary, then physicians should adhere to the FDA guidance concerning traditional compounding. Moreover, it would be prudent for any physician who intends to either resell or participate in the distribution of compounded products beyond the direct treatment of their patients to consider obtaining the appropriate insurance coverage for this activity.

Objective: To determine the degree in variation of oral liquid pediatric compounding practices in Michigan pharmacies., Design: Cross-sectional survey study., Setting: All types of inpatient and outpatient pharmacies across the state of Michigan, excluding nuclear pharmacies and long-term care facilities., Participants: 244 Michigan pharmacies., Intervention: An online survey tool was used to assess the current compounding practices of 147 oral liquid pediatric medications. The survey was e-mailed or faxed to hospitals, chain pharmacies, and independent pharmacies. Pharmacists were also mailed a follow-up postcard, and the Michigan Pharmacists Association publicized the project through its journal and annual meeting., Main Outcome Measures: Pharmacy demographics; number of compounding pharmacies; number of medications compounded; awareness of compounding errors; results of compounding errors; and number of concentrations compounded per medication., Results: The majority of respondents were from outpatient pharmacies, but inpatient and other types of pharmacies were also represented. The majority of participating pharmacies compound fewer than five oral liquid medications per week. Awareness of errors was low overall, with no errors believed to result in permanent harm or death. The number of concentrations compounded per medication ranged from 1 to 9, with the majority of pharmacies compounding more than 3 concentrations per medication., Conclusion: There is a considerable degree of variation in current oral pediatric liquid compounding practices in Michigan pharmacies. This variability poses a significant risk to patient safety.

Purpose: We wanted to identify modifiable risk factors for intensive care unit (ICU)-acquired hypernatremia., Materials and Methods: We retrospectively studied sodium and fluid loads and balances up to 7 days prior to the development of hypernatremia (first serum sodium concentration, [Na+], >150 mmol/L; H) vs control (maximum [Na+] ≤150 mmol/L; N), in consecutive patients admitted into the ICU with a normal serum sodium (<145 mmol/L) and without cerebral disease, within a period of 8 months., Results: There were 57 H and 150 N patients. Severity of disease and organ failure was greater, and length of stay and mechanical ventilation in the ICU were longer in H (P<.001), with a mortality rate of 28% vs 16% in N (P=.002). Sodium input was higher in H than in N, particularly from 0.9% saline to dissolve drugs for infusion and to keep catheters open during the week prior to the first day of hypernatremia (P<.001). Fluid balances were positive and did not differ from N on most days in the presence of slightly higher plasma creatinine and more frequent administration of furosemide, at higher doses, in H than in N., Conclusions: High sodium input by 0.9% saline used to dilute drugs and keep catheters open is a modifiable risk factor for ICU-acquired H. Dissolving drugs in dextrose 5% may partially prevent potentially harmful sodium overloading and H., (Copyright © 2014 Elsevier Inc. All rights reserved.)

This is an ongoing discussion and analysis of powder-handling safety in the compounding pharmacy laboratory that started in the November/December 2013 issue of the International Journal of Pharmaceutical Compounding. In the previous technical article, we established that most chemical powders handled during compounding procedures have an established occupational exposure limits and that powders are micronized during manipulation. All micronized powders handled on an open bench create health hazards to the technicians and create a potential for cross-contamination to the lab environment. Proper identification of the chemical hazard and established standard operating procedures in direct correlation to Good Lab Practices when working inside a powder hood will positively improve the compounding pharmacy's work environment.

Purpose: To assess the overall risk of needlestick injuries (NSIs) associated with intravitreal injection, and more specifically related to the practice of compounding pharmacies of applying informational adhesive stickers to repackaged bevacizumab injection syringes., Methods: This cross-sectional study involved an online survey of retina specialists in the United States., Results: Of the 717 invited retina specialists, 158 (22%) responded to the online survey. The respondents reported using 1 pair of gloves (51%), no gloves (46%), or 2 pairs of gloves (3%) during intravitreal injection. Repackaged bevacizumab syringes distributed by compounding pharmacy were used by 89% of the respondents, and 63% reported that the adhesive sticker was applied directly to the syringe. Unintentional adhesion between the sticker and hand or glove was experienced by 9% of respondents. At least 1 NSI during intravitreal injection was experienced by 8% of respondents, and sticker-related injury was reported by 3%. The sticker was perceived to increase risk for NSI by 33% of respondents., Conclusion: This survey showed that 8% of the responding physicians surveyed have experienced at least one NSI during intravitreal injections, of which approximately one third was attributed to the adhesive sticker. Direct application of misfitting stickers to repackaged syringes by compounding pharmacies may be a practice that can aggravate the risk of NSI.

Background: Healthcare workers (or relatives) crushing drug tablets for patients with difficulties in swallowing are at risk of developing sensitization via airborne exposure. Tetrazepam, in particular, is increasingly being described as an important occupational allergen in this regard, although other drugs are also involved., Objectives: To identify the allergenic culprits in 4 patients, namely 2 nurses, 1 pharmacy assistant, and 1 spouse, who all regularly crushed tablets of systemic drugs and presented with severe airborne dermatitis., Methods: The patients were patch tested with all of the drugs that they handled, as well as with potential cross-sensitizing molecules., Results: All 4 patients reacted to tetrazepam and other benzodiazepines, some of which they had not previously come into contact with, which favours cross-reactivity rather than concomitant sensitization. These patients also had positive reactions to several other non-structurally related drugs for which, in some cases, there was no history of exposure., Conclusions: Subjects having to crush drugs, in either an occupational or a non-occupational context, and who present with dermatitis suspected of being airborne-induced, should be patch tested with all contacted medicaments, as well as with possible cross-reacting molecules. Prevention by the use of crushing devices and protective measures (gloves and masks) when medications are handled should be advised., (© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Posology concerns science and system of dosage. Conventionally the dosage systems of measurement are the apothecaries' and metric systems and the dosage calculation for each individual patient has been suggested according to several available methods, namely Clark's Rule, Fried's Rule, Young's Rule, body surface area, or mg/kg, etc. There are many factors affect the availability of a drug to its site of action in the body, and their relation to the time course of drug action and variation in each drug response with or without the other drugs taken simultaneously. The correct dosage requires meticulous and accurate calculation. In busy offices, some may feel the dosage calculation is tedious. This article reviews the conventional methods of dosage calculations and the allergy tests, followed by describing a simple way to determine the proper dosage for each patient by simplifying the Clark's concept based on the body weight and verify the optimum dosage with Bi-Digital O-Ring Test minimize the adverse drug reactions and to increase safety for drug administration.

A quick and reliable system is described to quantify risk assessment for compounded sterile pharmaceuticals, which are "compounded in anticipation" for hospitals and clinics, having shelf lives assessed on documented literature and other criteria. These shelf lives are well in excess of the recommendations of the United States Pharmacopeia without placing patients at risk due to inadequate safety, quality, or efficacy.

Purpose: The evolution of sterile compounding in the context of hospital patient care, the evolution of related technology, past incidents of morbidity and mortality associated with preparations compounded in various settings, and efforts over the years to improve compounding practices are reviewed., Summary: Tightened United States Pharmacopeial Convention standards (since 2004) for sterile compounding made it difficult for hospitals to achieve all of the sterile compounding necessary for patient care. Shortages of manufactured injections added to the need for compounding. Non-hospital-based compounding pharmacies increased sterile compounding to meet the needs. Gaps in federal and state laws and regulations about compounding pharmacies led to deficiencies in their regulation. Lapses in sterility led to injuries and deaths. Perspectives offered include potential actions, including changes in practitioner education, better surveillance of sterile compounding, regulatory reforms, reexamination of the causes of drug shortages, and the development of new technologies., Conclusion: Over the years, there have been numerous exhortations for voluntary better performance in sterile compounding. In addition, professional leadership has been vigorous and extensive in the form of guidance, publications, education, enforceable standards, and development of various associations and organizations dealing with safe compounding practices. Yet problems continue to occur. We must engage in diligent learning from the injuries and tragedies that have occurred. Assuming that we are already doing all we can to avoid problems would be an abdication of the professional mission of pharmacists. It would be wrong thinking to assume that the recent problems in large-scale compounding pharmacies are the only problems that warrant attention. It is time for a systematic assessment of the nature and the dimensions of the problems in every type of setting where sterile compounding occurs. It also is time for some innovative thinking about ensuring safety in sterile compounding.

Purpose: Outbreaks of health-care-associated infections related to compounding pharmacies from 2000 through 2012 are described., Methods: PubMed and the websites for the Centers for Disease Control and Prevention and the Food and Drug Administration were searched to identify infectious outbreaks associated with compounding pharmacies outside the hospital setting between January 2000 and November 2012., Results: Between January 2000 and before the 2012 fungal meningitis outbreak, 11 outbreaks were identified, involving 207 infected patients and 17 deaths after exposure to contaminated compounded drugs. The 2012 meningitis outbreak had a similar mortality rate but increased these totals almost fivefold. Half of the outbreaks involved patients in more than one state. Three outbreaks involved ophthalmic drugs. The remaining outbreaks involved corticosteroids, heparin flush solutions, cardioplegia solution, i.v. magnesium sulfate, total parenteral nutrition, and fentanyl. The outbreaks were caused by pathogens commonly associated with health-care-associated infections, common skin commensals, and organisms that rarely cause infection. Morbidity was substantial, including vision loss. Half the outbreaks resulted in recall of all sterile drugs from the pharmacy due to systemic problems with sterile procedures., Conclusion: Before the nationwide 2012 fungal meningitis outbreak, drugs produced by compounding pharmacies were associated with 11 other smaller, but equally serious, outbreaks that occurred sporadically over the past 12 years. Lapses in sterile compounding procedures led to contamination of compounded drugs, exposure to patients, and a threat to public health in these outbreaks. Recognition and subsequent public health investigation were usually triggered by the occurrence of illness among multiple patients in a single health care setting.

In cell culture were compared the different release rates of anthocyanins from a bilberry pomace extract encapsulated either in food grade whey protein-based matrix capsules (WPC) or in pectin amid-based hollow spherical capsules (PHS). The impact of the formulations on typical anthocyanin-associated biological end points such as inhibition of the epidermal growth factor receptor (EGFR) and suppression of cell growth in HT29 colon carcinoma cells was assessed. The purpose was to find whether the release rates are sufficient to maintain biological activity and whether encapsulation affected EGFR inhibitory and growth suppressive properties of the extract. Even though anthocyanin release from extract-loaded capsules was proven under cell culture conditions, the inhibitory potential toward the EGFR was diminished. However, nonencapsulated extract as well as both extract-loaded encapsulation systems diminished the growth of HT29 cells to a comparable extent. The loss of EGFR inhibitory properties by encapsulation despite anthocyanin release indicates substantial contribution of other further constituents not monitored so far. Taken together, both applied encapsulation strategies allowed anthocyanin release and maintained biological activity with respect to growth inhibitory properties. However, the loss of EGFR inhibitory effects emphasizes the need for biological profiling to estimate process-induced changes of plant constituent's beneficial potencies.

Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations (GMPs), which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent. Unlike FDA-approved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy. In addition, compounded preparations do not have standard product labeling or prescribing information with instructions for safe use. Compounding pharmacies are not required to report adverse events to the FDA, which is mandatory for manufacturers of FDA-regulated medications. Some pharmacies engage in activities that extend beyond the boundaries of traditional pharmacy compounding, such as large-scale production of compounded medications without individual patient prescriptions, compounding drugs that have not been approved for use in the US, and creating copies of FDA-approved drugs. Compounding drugs in the absence of GMPs increases the potential for preparation errors. When compounding is performed on a large scale, such errors may adversely affect many patients. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly 'sterile' steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The most recent 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Patients and healthcare practitioners need to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit.

Two cases that involve drug compounding errors are described. One dog exhibited increased seizure activity due to a compounded, flavored phenobarbital solution that deteriorated before the expiration date provided by the compounder. The other dog developed clinical signs of hyperkalemia and bromine toxicity following a 5-fold compounding error in the concentration of potassium bromide (KBr).

This study analysed the total number of consumed vials of chemotherapy drugs during the year 2007 to determine workloads, and investigated the effects of using the Spike medical device in contrast to the use of traditional needles on oncology pharmacists' dispensing time, muscle soreness, work-related burnout and fatigue symptoms. Work-related burnout and physiological symptoms were measured using the Copenhagen Burnout Inventory (CBI) and a visual analogue pain scale. The Spike device significantly reduced the time spent in drawing up fluorouracil (39.46 ± 9.43 s vs. 57.13 ± 13.47 s) or cisplatin (29.65 ± 11.22 s vs. 60.93 ± 20.54 s) compared with traditional needles (P < 0.001). The CBI burnout score improved significantly with the Spike device (53.21 ± 8.58 vs. 73.21 ± 5.42; P = 0.007) because finger and palm muscle soreness complaints and subjective fatigue symptoms for eye tiredness and shoulder-wrist pain were significantly reduced (P < 0.05). Practitioner Summary The pharmacist needs to exert hand strength to counter the vial back-suction pressure to draw out the medical liquid, and confirm the volume during the drawing antineoplastic drug procedure. This study aimed to determine the effects of using a medical device, instead of a needle, on pharmacists' work-related musculoskeletal complaints and burnouts.

Malpractice in preparation and administration of intravenous (IV) medications has been reported frequently. Inadequate knowledge of nurses has been reported as a cause of such errors. We aimed to evaluate the role of nurses' education via installation of wall posters and giving informative pamphlets in reducing the errors in preparation and administration of intravenous drugs in 2 wards (ICU and surgery) of a teaching hospital in Tehran, Iran. A trained observer stationed in 2 wards in different work shifts. He recorded the nurses' practice regarding the preparation and administration of IV drugs and scored them before and after the education process. 400 observations were evaluated. Of them, 200 were related to before education and 200 were related to after education. On a 0-10 quality scale, mean ± SD scores of before and after education were determined. Mean ± SD scores of before and after education at the 2 wards were 4.51 (± 1.24) and 6.15 (± 1.23) respectively. There was a significant difference between the scores before and after intervention in ICU (P<0.001), surgery (P<0.001), and total two wards (P<0.001). Nurses' education by using wall poster and informative pamphlets regarding the correct preparation and administration of IV drugs can reduce the number of errors.

Purpose: To review ocular injuries resulting from "shake and bake" methamphetamine labs., Method: Retrospective case series of 4 patients with ocular injuries sustained from "shake and bake" lab explosions., Results: Four men ages 20-39 underwent complete ophthalmologic examination after an injury from a "shake and bake" methamphetamine lab explosion.The mechanism of injury was initially misrepresented in each case; the physical findings were suggestive of thermal and alkali injury. Visual acuity ranged widely from 20/20 to light perception only. Treatment in the acute setting included irrigation, pH monitoring, and intraocular pressure lowering., Conclusion: Methamphetamine production by means of the"shake and bake" method can result in combined thermal and alkali ocular injury. Patients who sustain this type of injury may not accurately report the mechanism of exposure. Increased awareness of this type of ocular injury may increase the rapidity of diagnosis, avoid early misdiagnosis, and ultimately improve outcomes.

Purpose: To compare the concentration conformity of infusion solutions manually prepared on intensive care units (ICU) with solutions from pharmacy-based, automated production., Methods: A prospective observational study conducted in a university hospital in Germany. Drug concentrations of 100 standardised infusion solutions manually prepared in the ICU and 100 matching solutions from automated production containing amiodarone, noradrenaline or hydrocortisone were measured by high-performance liquid chromatography analysis. Deviations from stated concentrations were calculated, and the quality of achieved concentration conformity of the two production methods was compared., Results: Actual concentrations of 53% of the manually prepared and 16% of the machine-made solutions deviated by >5% above or below the stated concentration. A deviation of >10% was measured in 22% of the manually prepared samples and in 5% of samples from automated production. Of the manually prepared solutions, 15% deviated by >15% above or below the intended concentration. The mean concentration of the manually prepared solutions was 97.2% (SD 12.7%, range 45-129%) and of the machine-made solutions was 101.1% (SD 4.3%, range 90-114%) of the target concentration (p < 0.01)., Conclusions: In this preliminary study, ward-based, manually prepared infusion solutions showed clinically relevant deviations in concentration conformity significantly more often than pharmacy-prepared, machine-made solutions. Centralised, automated preparation of standardised infusion solutions may be an effective means to reduce this type of medication error. Further confirmatory studies in larger settings and under conditions of routine automated production are required.

Background: Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies., Methods: This was an observational cohort study of women between the ages of 18-89 who received a compounded BHRT product from January 1, 2003 to April 30, 2010 in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events. Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test., Results: Women (n = 296) receiving BHRT at Oakdell Pharmacy had a mean (standard deviation) age of 52 (9) years. The most common BHRT dosage forms utilized were topical (71%) and oral (43%). Compounded BHRT regimens were generally initiated at low doses regardless of route. Women experienced a 25% decrease in emotional lability (p < 0.01), a 25% decrease in irritability (p < 0.01), and a 22% reduction in anxiety (p = 0.01) within 3 to 6 months. These women also experienced a 14% reduction in night sweats (p = 0.09) and a 6% reduction in hot flashes (p = 0.50)., Conclusions: This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.

Objective: Many Chinese herbs contain aristolochic acids (ALAs) which are nephrotoxic and carcinogenic. The objective of this study was to identify whether exposure to herbs containing ALAs increased the risk of kidney disease among Chinese herbalists., Methods: A nested case-control study was carried out on 6538 Chinese herbalists registered between 1985 and 1998. All incident cases of chronic renal failure reported to the Database of Catastrophic Illness of the National Health Insurance Bureau between 1995 and 2000 were defined as the case group. Up to four controls without renal failure were randomly matched to each case by sex and year of birth. A structured questionnaire survey was administered between November and December 2002. The Mantel-Haenszel method and conditional logistic regression were used to estimate the risks., Results: 40 cases and 98 matched controls were included in the final analysis. After adjusting for age, frequent analgesic use, and habitual consumption of alcohol, fermented or smoked food, we found manufacturing and selling Chinese herbal medicine (OR 3.43, 95% CI 1.16 to 10.19), processing, selling or dispensing herbal medicines containing Fangji (OR 4.17, 95% CI 1.36 to 12.81), living in the workplace (OR 3.14, 95% CI 1.11 to 8.84) and a history of taking of herbal medicines containing Fangji (frequently or occasionally) (OR 5.42, 95% CI 1.18 to 24.96) were significantly associated with renal failure., Conclusion: Occupational exposure to and consumption of herbs containing ALAs increases the risk of renal failure in Chinese herbalists.

Liposome-encapsulated hemoglobin (LEH) based on a novel, synthetic, non-phospholipid was developed, and evaluated for cerebral energy metabolism in a 40% hemorrhage rat model. The markers of tissue energetics were monitored by (1)H- and (31)P-magnetic resonance spectroscopy (MRS). After hemorrhage, (1)H-MRS showed an increase in the levels of lactate and pyruvate. These markers returned to baseline values following LEH resuscitation. Both LEH and saline were able to exert a neuron-protective effect as indicated by the recovery of N-acetylaspartate. (31)P MRS showed a fall in phosphocreatine after hemorrhage, which upon LEH or saline resuscitation returned to the baseline values. Similarly, inorganic phosphate increased after bleeding, but returned to normal after resuscitation. LEH resuscitation also recovered beta-ATP levels, but saline resuscitation provided only a modest recovery. The results indicate the utility of MRS to monitor cerebral metabolism in hemorrhage/resuscitation. The data is also supportive of the new LEH formulation as an oxygen carrier.

The objective of this study was to develop a preservation method for canine sperm using microencapsulation. Pooled ejaculates from three beagles (Canis familiaris) were extended in egg yolk Tris extender and were encapsulated in gel (alginate only) or polycation (poly-L-lysine membrane bound) microcapsules at 0.75% and 1.0% alginate concentration. In Experiment 1, characteristics of microcapsule and microencapsulated sperm were evaluated during chilling storage for 48 h. Gel microcapsules at 0.75% alginate concentration had a teardrop-like structure with fragility, whereas those at 1.0% alginate had a solid spherical structure. In all groups, diameter of the microcapsules increased with duration of storage (P<0.05). Alginate concentration did not affect the sperm recovery rate from microcapsules. Total average recovery rate of sperm from polycation microcapsules was lower than that of gel microcapsules (P<0.05). Progressive motility of polycation microencapsulated sperm and unencapsulated sperm (control) was higher than that of the gel microencapsulated sperm, both at 0.75% and 1.0% alginate concentration (P<0.05), although viability of sperm was similar among the three groups. In Experiment 2, to evaluate the sperm longevity after chilling storage, sperm were microencapsulated in polycation microcapsules at 1.0% alginate concentration, stored at 4 degrees C for 0, 1, 4, and 7 d, and then cultured at 38.5 degrees C for 0, 6, and 24h. Progressive motility and viability of microencapsulated sperm were higher than those of unencapsulated spermatozoa at 0 to 24h of culture after 4 and 7 d of chilling storage (P<0.05). In conclusion, polycation microencapsulation at 1.0% alginate concentration can be successfully applied for chilling storage of canine sperm by maintaining motility and viability for up to 7 d., (Copyright 2010 Elsevier Inc. All rights reserved.)

Background: Levothyroxine (l-thyroxine) intoxication may arise from intentional or accidental ingestion of excessive doses of the hormone and may cause symptoms equivalent to thyroid storm. We report a case of massive accidental l-thyroxine intoxication resulting from an error in the preparation of capsules to treat goiter., Summary: A 61-year-old woman was admitted showing high levels of thyroid hormones, with serum-free l-thyroxine level of 955.90 nmol/L (74.1 ng/mL) (normal values: 11.61-27.09 nmol/L or 0.9-2.1 ng/mL). It was discovered that she had ingested 50 mg instead of 50 microg/day of l-thyroxine during 9 days. Following charcoal hemoperfusion, the levels of total thyroxine, serum-free l-thyroxine, and triiodothyronine declined dramatically, with a reproducible pattern of reduction in hormone levels observed after each of the three sessions. The patient recovered from her stuporous mental state, atrial fibrillation, and acute respiratory failure., Conclusion: The use of hemoperfusion with a charcoal filter appears to be a very important therapeutic tool for the treatment of acute and severe forms of thyrotoxicosis due to l-thyroxine intoxication.

To develop a treatment strategy for peritoneal carcinomatosis using a combination of extended peritoneal resections, local destructive procedures and hyperthermic intraperitoneal chemotherapy creates great concern between healthcare workers involved in these procedures. New professional risks exist: risk of exposure to cytotoxic drugs, environmental risks (inhalation of smoke, aerosolization of chemotherapy agents). Information, education and training of healthcare workers is mandatory in order to ensure proper evaluation, prevention, and management of professional exposure risks in coordination with the occupational health office.