Pharmacy preparations and compounding

Schors, Tjalling van der; Amann, Steffen; Makridaki, D; Kohl, Stephanie

doi:10.1136/ejhpharm-2020-002559

Cited by 6 publications

(3 citation statements)

References 3 publications

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“…Many previous studies reported that standard guidelines and procedures, such as the quality control of extemporaneous products, were also required. 2,3,12,20,28,29,31 Overall, the survey findings shed light on the extent of variation in extemporaneous preparations among Thai hospitals, identify common formulas used in extemporaneous preparations, and reveal opportunities for standardization and improvement in extemporaneous preparation practices. These findings provide valuable insights for healthcare professionals, policymakers, and stakeholders to enhance the quality, safety, and efficiency of extemporaneous preparations.…”

Section: Opportunities For Standardization and Improvement In Extempo...mentioning

confidence: 88%

“…11 Evaluating the compounding practices employed in hospitals helps identify improvement areas and ensure quality control. 12 This evaluation encompasses the assessment of compounding techniques, adherence to standard operating procedures, utilization of compounding equipment, and training provided to the healthcare professionals involved in the compounding process. 13 The Professional Pharmacy Standards for Thai Hospitals, specifically Domain 4 concerning the procurement, distribution, and control of medicines, mandates that the preparation or compounding of medications that are not commercially available but essential for patients (extemporaneous compounding preparations) must be conducted by welltrained pharmacists or personnel.…”

Section: Introductionmentioning

confidence: 99%

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Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations

Sadira Supapaan,

Jamlongpeng,

Yangyuen

et al. 2024

PHARMPRACT

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Objective: This study aimed to assess the diversity of extemporaneous preparations, identify the prevalent formulations, and highlight the challenges and opportunities for standardization and improvement of extemporaneous preparation practices. Methods: A survey was conducted among 88 Thai hospitals representing the public and private sectors. The questionnaire gathered information on general hospital characteristics, detailed aspects of extemporaneous compounding, and the specific extemporaneous formulations used. Results: The survey revealed significant variations in extemporaneous preparations among Thai hospitals, with oral liquids, semisolids, and eye preparations commonly employed. The primary oral liquid formulations used were suspensions, syrups, and solutions. Specific medications frequently used in extemporaneous preparations were also identified. The challenges encompassed space, personnel, skills, raw materials, equipment, standardized formula information, preparation process information, funding, and other factors. Conclusion: A survey among Thai hospitals revealed significant variations in extemporaneous preparations in 88 participating hospitals. Common formulations used in extemporaneous compounding include oral liquid preparations, such as suspensions, syrups, solutions, semisolid preparations, and eye preparations. Stakeholder involvement, implementation of standardized operating procedures, resource allocation, comprehensive training programs, and collaboration among hospitals, pharmaceutical companies, and regulatory agencies are recommended to enhance extemporaneous compounding practices.

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Section: Opportunities For Standardization and Improvement In Extempo...mentioning

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations

Sadira Supapaan,

Jamlongpeng,

Yangyuen

et al. 2024

PHARMPRACT

View full text Add to dashboard Cite

show abstract

“…In summary, it would be better to consume the more diluted formulations in a shorter period of time, considering that they are administered to the more vulnerable patients. The shifts towards personalized medicines on the one hand and the pressure on national health budgets and the shortage of medicines on the other have increased more and more, compounding the activity of the hospital pharmacy [34]. Among the procedures carried out by the pharmacists, the reconstitution of intravenous medicines, such as anti-infectives, analgesics, and anti-emetics represent one of the most frequent activities.…”

Section: In Vitro Toxicity Evaluation Of Amb Formulationsmentioning

confidence: 99%

AmBisome® Formulations for Pediatrics: Stability, Cytotoxicity, and Cost-Effectiveness Studies

Zuccari,

Villa,

Iurilli

et al. 2024

Pharmaceutics

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Liposomal amphotericin B (Ambisome®) is the gold standard for the treatment and prevention of fungal infections both in the adult and pediatric populations. The lyophilized dosage form has to be reconstituted and diluted by hospital staff, but its management can be challenging due to the spontaneous tendency of amphotericin B to form aggregates with different biological activity. In this study, the colloidal stability of the liposomes and the chemical stability of amphotericin B were investigated over time at storage conditions. Three liposomal formulations of amphotericin B at 4.0 mg/mL, 2.0 mg/mL, and 0.2 mg/mL were prepared and assayed for changes regarding the dimensional distribution, zeta potential, drug aggregation state, and onset of by-products. Our analyses highlighted that the most diluted formulation, kept at room temperature, showed the greatest changes in the aggregation state of the drug and accordingly the highest cytotoxicity. These findings are clinically relevant since the lower dosages are addressed to the more vulnerable patients. Therefore, the centralization of the dilution of AmBisome® at the pharmacy is of fundamental importance for assuring patient safety, and at the same time for reducing medication waste, as we demonstrated using the cost-saving analysis of drug expense per therapy carried out at the G. Gaslini children hospital.

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Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022

Dmour

2022

J Pharm Innov

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Purpose Assessment of the US FDA-issued WLs content is an educational tool that can be used in the continuous training program of community pharmacists in compounding pharmacies. The study was designed to critically assess FDA warning letters (WLs) issued to compounding pharmacies in 2017–2022 for violations of Current Good Manufacturing Practices (cGMP). Methods Content analysis was used to evaluate WLs issued concerning (1) type of violations; (2) frequency of violations mentioned in the WLs; (3) specific evaluations of the deviations related to compounded sterile products, and (4) evaluation of corrective measures requested by the US FDA. Results A total of 141 WLs were evaluated. The main observed violations in the analyzed WLs were adulterated drug products (130), misbranded drugs (103), unapproved new drug products (42), failure to report adverse events (22), and failure to report drugs (11). Other violations were evaluated related to sterile product compounding with emphasis on personnel qualifications, quality control procedures, equipment, etc. Conclusion The continuous issuance of WLs by the FDA indicates the need for compounding pharmacies become more vigilant to reduce the recurrence of the addressed violations through establishing adequate training/retraining programs. The analysis of issued WLs can serve as a learning tool to help improve compounding procedures, reduce the recurrence of these violations, and enhance patient safeguards. Supplementary Information The online version contains supplementary material available at 10.1007/s12247-022-09692-4.

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Pharmacy preparations and compounding

Cited by 6 publications

References 3 publications

Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations

Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations

AmBisome® Formulations for Pediatrics: Stability, Cytotoxicity, and Cost-Effectiveness Studies

Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022

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