Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility

Parenteral products must be compounded using an aseptic technique to ensure sterility of the medicine. We compared the effect of three clinical environments as compounding areas as well as different aseptic techniques on the sterility of the compounded parenteral product. Clinical pharmacists and pediatric nurses compounded 220 samples in total in three clinical environments: a patient room, a medicine room and biological safety cabinet. The study combined four methods: observation, environmental monitoring (settle plates), monitoring of personnel (finger dab plates) and sterility testing (membrane filtration). Of the compounded samples, 99% were sterile and no significant differences emerged between the clinical environments. Based on the settle plates, the biological safety cabinet was the only area that fulfilled the requirements for eliminating microbial contamination. Most of the steps on the observation form for aseptic techniques were followed. All participants disinfected their hands, wore gloves and disinfected the septum of the vial. Non-contaminated finger dab plates were mostly detected after compounding in the biological safety cabinet. Aseptic techniques were followed relatively well in all environments. However, these results emphasize the importance of good aseptic techniques and support the recommendation of compounding parenteral products in biological safety cabinets in clinical environments.

Retention of Sterile Compounding Knowledge Among Pharmacy Technicians

Background: Patient safety is in jeopardy due to a rise in the preparation of adulterated parenteral products with poor technique identified as a significant contributing factor. Pharmacy technicians perform an overwhelming majority of aseptic compounding practices; however, this group’s progressive loss of aseptic technique knowledge has not been documented. Objective: The purpose of this correlational research study was to investigate the association between sterile compounding knowledge and years in the field controlling for formal training in sterile compounding techniques. Methods: An assessment tool of fundamental sterile compounding content was electronically distributed to sterile compounding technician members of pharmacy organizations in the southeastern United States. A multiple regression was conducted to predict sterile compounding knowledge from number of years in the field and prior years of formal compounding training. Results: Sixty-eight assessments were returned complete. The overall model was significant ( P < .0005), explaining 22% of the variance in knowledge retention. Years in the field was the only significant predictor ( P < .001). Each additional year of work experience was associated with a 0.18 drop in the assessment score. Conclusions: The longer pharmacy technicians remain in the field, the more aseptic technique knowledge they will lose. Modeling of poor sterile compounding techniques in the workplace may promote loss of competency of the skill. As a result, a plan to address continuing education for pharmacy technician sterile compounders is necessary to ensure patient safety.

Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).

A survey about label enhancement methods for parenteral medication in European hospital pharmacies

Purpose Unclear labeling has been recognized as an important cause of look-alike medication errors. Little is known about which labeling practices are currently used in European hospitals. The aim of this article is to obtain an overview of the labeling practices for parenteral medications, in relation to national guidelines, in the Netherlands, Germany, and the UK. Methods An online survey was conducted using the Qualtrics® software. The survey was distributed to hospital pharmacists in the Netherlands, Germany, and the UK. The results were downloaded from Qualtrics and exported to Microsoft Excel. Data were categorized into groups and analyzed descriptively. Results In total, 104 responses were received. The response rate was 63% (n = 48) in the Netherlands and 11% (n = 41) for Germany; for the UK, 15 responses were received. In general almost 90% of the respondents followed the National guidelines concerning labeling of pharmacy-prepared parenteral products. The use of label enhancement techniques was relatively low in all countries. On average, the use of “Tall Man” lettering was 19%, the use of color coding was 29%, and the use of a barcode on the label was 27%. Conclusion Label-enhancement methods for parenteral medication in hospital pharmacies do not seem to be widely implemented and acknowledged in European hospitals, but response rates were limited for two countries. Greater standardization in conjunction with research for evidence-based enhancement techniques is needed to guide improvement in labeling practices across Europe.

Incidence of Adverse Reactions to Parenteral Thiamine in the Treatment of Wernicke’s Encephalopathy, and Recommendations

Aim To offer an estimate of the incidence of anaphylactic reactions to parenteral products containing thiamine used in the treatment of Wernicke’s encephalopathy (WE) and make recommendations. Method Review of previously released data on some older products and parenteral thiamine use in some other countries; analysis of sales and adverse incident data on anaphylaxis for a contemporary parenteral product used in the UK, Pabrinex. Results It was difficult to estimate the incidence of related anaphylactic reactions to Pabrinex in the UK because the number of doses given is unknown. Sales data are only an approximation to doses given because for products with a limited shelf life not all product sold is administered. However, available data indicate that there have been 10 anaphylactic reactions to Pabrinex from between 5,431,235–6,651,947 patient-days (14,880–16,080 years) of treatment. Conclusion It is reasonable to assume that the risk of anaphylaxis is low, and lower than for many other drugs. The risk-benefit ratio for administration is favourable given the potential severity of brain damage in Wernicke–Korsakoff (WK) syndrome. There is a need for international agreement on the reporting of anaphylaxis and on the optimum thiamine therapy for the treatment of WK syndrome. We make recommendations on how this might be achieved.

Development of Guidelines for Accurate Measurement of Small Volume Parenteral Products Using Syringes

Background: Syringes are commonly used in pharmacy compounding for the measurement of small volumes, especially in the preparation of sterile products for injection and infusion. However, there are no current official guidelines for the proper use of syringes in measuring small volumes. Objective: The purpose of this project was to determine the accuracy and precision of commercially available syringes in measuring small volumes during sterile product preparation to make recommendations for syringe size selection. Methods: To assess precision and accuracy of syringes, 3 separate investigators measured 5%, 10%, or 20% (n = 30 each) of the volume of a 1-, 3-, 5-, 10-, or 20-mL syringe with an attached 18G, 1½” needle by drawing sterile water for injection from a vial. Delivered volumes were measured gravimetrically using an electronic balance and converted to volume using the specific gravity of water (1.0). Accuracy is represented as the mean and standard deviation, while precision is represented as percent relative standard deviation. Differences were assessed using a 1-way analysis of variance with Bonferroni adjustments and significance set at P < .05. Results: Precision and accuracy were highly variable and often significantly ( P < .05) different compared to the theoretical volume delivered both within and between investigators. An increased likelihood of unacceptable error (>5%) was observed when less than 20% of the labeled capacity of a syringe was measured. Mean percent error ranged from 1.4% to 18.6%, despite manufacturer specification of ±5% accuracy, suggesting proper technique as a major factor in small-volume measurements. Conclusion: In addition to proper, validated training of syringe users, we recommend that users measure no less than 20% of the indicated volume of the syringe while choosing syringes as close as possible to the desired measurement. When possible, very small volumes should be diluted to meet the minimum volume of the smallest syringe available. Implementation of these recommendations will improve accurate dosing and, ultimately, patient safety.