Extemporaneous preparation of rifampicin granules from capsules to improve usability

2021 ◽  
pp. ejhpharm-2021-002866
Author(s):  
Yasunori Miyazaki ◽  
Tomonobu Uchino ◽  
Yoshiyuki Kagawa
2016 ◽  
Vol 10 (2) ◽  
pp. 84-87
Author(s):  
Sylva Klovrzová ◽  
Soňa Brtnová ◽  
Lada Novotná

1985 ◽  
Vol 821 (1) ◽  
pp. 79-84 ◽  
Author(s):  
J.R. Philippot ◽  
S. Mutaftschiev ◽  
J.P. Liautard

2018 ◽  
Vol 549 (1-2) ◽  
pp. 150-160 ◽  
Author(s):  
Rampurna P. Gullapalli ◽  
Carolyn L. Mazzitelli ◽  
Christina M. Charriez ◽  
David J. Carpenter ◽  
Rebecca D. Crean ◽  
...  

Medicina ◽  
2019 ◽  
Vol 55 (9) ◽  
pp. 531 ◽  
Author(s):  
Olga Kiseļova ◽  
Baiba Mauriņa ◽  
Venta Šidlovska ◽  
Jānis Zvejnieks

Background and objectives: Extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, but also high-risk products accompanied by doubts regarding their safety and quality. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries. This problem is partially resolved by Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. In order to understand the relevance of extemporaneous compounding in Latvia and the fulfillment of the abovementioned resolution’s requirements, it is essential to get information about the volume and breakdown of sales of extemporaneous medicinal products in community pharmacies. The purpose of this survey is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. Materials and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions. In order to compare the regulatory framework in Latvia with the resolution, the Latvian Pharmaceutical Law and the Cabinet of Ministers Regulations regulating prescription, compounding and control of extemporaneous preparations in community pharmacies were analyzed. Results: Only 280 of 384 pharmacies submitted a report of sales of extemporaneous preparations for 2017 to the SAM. These pharmacies represented all Latvian statistical regions. Extemporaneous preparations were mostly sold in Riga (78.93%). The Latvian regulation does not include all paragraphs of the resolution. Most of the paragraphs of the resolution are described in Latvian regulatory enactments only partially. Conclusions: The total number of compounding pharmacies evidence that the service is needed. Latvian example highlights a necessity for European Union countries to compare their national legislation with the requirements of the resolution’s last version and, if necessary, implement relevant amendments.


2019 ◽  
Vol 9 (1) ◽  
pp. 252-264 ◽  
Author(s):  
AK Mohiuddin*

Pharmacists are only knowledgeable and skilled healthcare professionals dedicated to compounding and preparing medications to meet the unique needs of patients. The safe and effective extemporaneous compounding of prescription products for patients require in special care is fundamental to the pharmacy profession. But there are much to do for secundum artem. It is not at all economical for a pharmaceutical company to marketize a product in 10 different probable doses or in 5 different dosage forms to meet the needs of the entire range of individuals receiving therapy. 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


2020 ◽  
pp. 107815522096798
Author(s):  
Romain-Pacôme Desmaris ◽  
Elisabeth Bermudez ◽  
Maxime Annereau ◽  
François Lemare ◽  
Florian Slimano

Objective The development of oncology day-hospital activities contributes to increase quality of life of patients and consequently have changed their perception about waiting. The extemporaneous preparation of antineoplastic has become difficult to achieve given the increasing activity, and hospital pharmacists have taken up the challenge by the implementation of the antineoplastic preparation in anticipation. Because anticipation can lead to an important number of preparations to be discarded, we also develop a recycled process for other patients to limit these waste extra costs. We aim to demonstrate the positive balance of anticipated preparation in this 4-year study report. Data sources: This prospective study was conducted in a major European oncology day-hospital from January, 2012 to December, 2015. The data were extracted from our software WinSimbad™ and updated as needed. The number and cost-associated of preparation ungiven chemotherapy doses (recycled or discarded) were compared to the global drug budget of our hospital in order to not exceed 2%. Data summary: 303,100 antineoplastic have been prepared. Approximately 35% of them were anticipated with an average of 5,431±984 that were finally ungiven. Two-third was recycled and the cost of the ungiven preparations finally discarded represents 1.7±0.15% of the global drug budget. Conclusions This study assesses the drug wastage and its associated cost of this concept through a prospective study and discusses the cost of ungiven antineoplastic preparations. With prior consideration of the need to define the acceptable rate of discarded ungiven preparation, the hospitals with an high oncology day-hospital activity should implement this approach.


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