VYMNQHPF7R « Non-Sterile Compounding for Pharmacy Technicians

International journal of pharmaceutical compounding

Journal of managed care & specialty pharmacy, 2014

Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal infections outbreak. Contaminated injectable methylprednisolone led to the diagnosis of fungal infections in 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed into law November 27, 2013, to improve regulation of compounding pharmacies. To (a) review the literature regarding clinical, legal, and regulatory implications of pharmacy compounding for patient safety during the 2012-2013 fungal infections outbreak and (b) discuss strategies that managed care organizations (MCOs) can use to promote safe compounding practices. A literature search was conducted via PubMed for original articles on fungal infections related to drug compounding published October 2012 to March 2014. Specifi...

The Canadian Journal of Hospital Pharmacy, 2010

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2003

The compliance of hospitals' quality assurance practices for pharmacy-compounded sterile preparations with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products was studied. A survey based on the 2000 ASHP guidelines was developed to determine current practices for compounding sterile preparations in hospital pharmacies. Practices were compared with those identified in a 1995 ASHP survey. The survey was mailed in July 2002 to a stratified random sample of 600 hospital pharmacy directors. There were a total of 182 usable responses, for a net response rate of 30.3%. Quality assurance practices for some quality domains showed low compliance with the 2000 ASHP guidelines. Only 5.2% of pharmacies that compounded risk level 1 preparations were compliant with garb requirements. Only 4.7% of pharmacies compounding risk level 3 preparations were compliant with recommendations for documentation. Compliance with guid...

IP Innovative Publication Pvt. Ltd., 2018

Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. 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. 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 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. Purpose of the Study: The article aims to physico-chemical and economic considerations before compounding; factors and quality control issues; compounding support, training, chemical supplies, types of compounding (specially in hospital and ambulatory care compounding). It should aid to practice the extemporaneous preparation of basic and advanced formulations including pharmacopoeial and non-pharmacopoeial formulations encountered in pharmacy practice, together with requisite documentation, labeling, packaging and counseling requirements. Along with this, they have to study the analysis of formulations and their components and relate these to the clinical performance of medicines. This will help them to investigate, evaluate and report the physical characteristics of formulations including release kinetics and relate these to quality control and preformulation requirements; relate the application of quality control, quality assurance and the principles of good manufacturing practice to regulation of medicine production in home and abroad. Outline: Background; Introduction; Compounding Factors; Types of Compounding; Identifying Errors and Cause; Types of Compounding; Risk Management Keywords: Pharmacy Practice; Drugs; Dosage Forms; Compounding; Equipment; Pharmacopeia.

2000

11:32 AM Ben -After the last TSBP meeting you asked me to do a 'straw poll' on what our members thought about the sterile gloves and alcohol issue.

Journal of Pharmacy & Pharmacognosy Research, 2022

Context: Compounding sterile preparations in hospitals requires special attention because the process is more complex. Errors that occur when compounding sterile preparations can cause contamination of the prepared preparations. Aims: To evaluate the compounding of sterile preparations in a referral hospital. Methods: This research was conducted by observing nine critical aspects in the compounding of sterile preparations. The research instrument used was a checklist, as regulated in USP <797> Guidelines and Basic Guidelines for Dispensing Sterile Preparations. After that, the most mixed preparations were tested for sterility using a fluid thioglycollate medium and soybean casein digest medium. Results: Of the 36 compounding sterile preparations, discrepancies were found in the aspects of compounding personnel (100%), building (100%), equipment (100%), aseptic procedures (100%), packaging (0%), labels (100%), storage (2.78%), distribution (2.78%) and quality assurance (100%). Furthermore, sterile preparations prepared in the cleanroom in this referral hospital indicate the occurrence of microbial contamination. Conclusions: Most of the critical aspects in compounding sterile preparations at this referral hospital have not met the recommendations of the USP <797> Guidelines and the Basic Guidelines for the Dispensing of Sterile Preparations, except for the packaging aspect. Improvements in several critical aspects need to be made to ensure the quality of the prepared preparations from microbial contamination.

The Canadian Journal of Hospital Pharmacy, 2009

Background: The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. Objectives: To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. Methods: An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. Results: A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement. Conclusion: This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice. RÉSUMÉ Contexte : Les Lignes directrices sur la préparation des produits stériles dans les pharmacies de la Société canadienne des pharmaciens d'hôpitaux (SCPH) publiées en 1996 représentent la norme actuelle de pratique en matière de préparation de produits stériles au Canada. En revanche, ces lignes directrices sont des recommandations en matière de pratique et non pas des normes coercitives. Des sondages menés sur la préparation des produits stériles ont révélé une non-observance marquée de ces recommandations de pratique à conformité volontaire. En 2004, la United States Pharmacopeia (USP) publiait son « General Chapter <797> Pharmaceutical Compounding-Sterile Preparations », qui met de l'avant une norme plus rigoureuse et coercitive en matière de préparation des produits stériles aux États-Unis. Objectifs : Évaluer les pratiques de préparation des produits stériles dans les pharmacies hospitalières canadiennes et les comparer aux recommandations actuelles de la SCPH et aux normes du chapitre <797> de l'USP. Méthodes : Un sondage en ligne fondé sur des études antérieures des pratiques en matière de préparation des produits stériles, les lignes directrices de la SCPH et les normes du chapitre <797> a été créé et distribué à 193 pharmacies hospitalières au Canada. Résultats : Un total de 133 pharmacies ont répondu au sondage, soit un taux de réponse de 68,9 %. Tous les répondants ont déclaré préparer des produits stériles. Divers degrés de non-observance ont été notés dans presque toutes les sphères des lignes directrices de la SCPH et des normes de l'USP. Un faible taux d'observance était particulièrement remarquable en matière d'installations et d'équipement, de validation de la procédure et de contrôle des produits. L'accès à une salle blanche de classe 8 ou supérieure selon l'Organisation internationale de normalisation (ISO) dans la pharmacie centrale est une exigence du chapitre <797>, mais plus de 40 % des répondants ont déclaré ne pas disposer d'une telle salle. De meilleurs taux d'observance ont été notés au chapitre des politiques et procédures, des vêtements de protection, des techniques aseptiques et de la manipulation des produits dangereux. La première partie de cette série décrit la méthodologie du sondage et les résultats concernant les politiques, le personnel, les matières premières, l'entreposage et la manipulation, les installations et l'équipement, et les vêtements. La deuxième partie traitera des résultats portant sur la préparation des produits aseptiques, l'attribution de la date de péremption, l'étiquetage, la validation de la procédure, le contrôle et la délivrance des produits, les registres, et l'élimination des produits pharmaceutiques dangereux. Elle soulignera aussi certains des domaines clés qui méritent une attention considérable.

European Journal of Hospital Pharmacy, 2016

Objectives To evaluate implementation of safety standards of compounded sterile preparations in different hospitals. Methods This cross-sectional study included 124 hospitals from 19 countries. A survey was developed based on the guidelines and safety practices of the Institute for Safe Medication Practices (ISMP) for sterile preparations compounding, and was sent to the members of the Intravenous and Parenteral Nutrition experts' network (IV PN experts' network) in the Gulf region and beyond using SurveyMonkey software. Results 124 pharmacists were invited to participate in this study. Only 39 (31.5%) pharmacists from seven countries responded: 16 (41%) of the participants were pharmacy supervisors, and 23 (59%) had >10 years of work experience. However, a majority, 27 (69%), of the respondents were from Saudi Arabia. Written policies and procedures for sterile preparations compounding were available in 37 (95%) hospitals. The concentrated electrolytes were removed from all patient care areas in 28 (72%) hospitals, and 30 (77%) hospitals clearly labelled those as high-alert medications. The use of advanced technologies, such as bar code verification or IV robotics, for compounding sterile preparations were not implemented in 27 (69%) hospitals. Conclusions Minimum standards and best practice recommendations to ensure safety of sterile preparation compounding were implemented in many hospitals of different countries. However, advanced technologies were not implemented by the majority of the hospitals.

Sterile facility is required for Realizing the crucial importance of quality, safety and efficacy of sterile pharmaceutical preparations such as eye drops, intravenous admixtures, parenteral nutrition and cytotoxic drug reconstitutions (CDR) in hospitals. There is an urgent need for better clean room facilities, water supply system and sterilization facilities in new as well as existing hospitals. To assist those in the planning and development of such facilities, the FDA, WHO, ISO and Good Manufacturing Practices has established the " Guides to the Development of Sterile Pharmaceutical Preparation Facilities for Healthcare Establishments ". This document addresses several important aspects including policies, design, layout and specifi cations, management and quality control as well as storage, distribution and ancillary areas. It also provides recommendations for the layout of CDR and non-CDR preparation facilities and also lays down the specific requirements during the construction process of such facilities. To ensure quality, safety and efficacy of products and also protect personnel, the document is intended to promote awareness amongst healthcare planners and developers of the stringent regulatory requirements for such facilities. It is our fervent hope that relevant stakeholders involved will find this guide useful and applicable. Finally, I would like to honor and thank each and every one of you that have played important role and made remarkable contributions towards the success of the project of this guideline.