The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs

Bonan, Brigitte; Martelli, Nicolas; Berhoune, Malik; Maestroni, Marie-Laure; Havard, Laurent; Prognon, Patrice

doi:10.1093/intqhc/mzn052

Cited by 32 publications

(25 citation statements)

References 20 publications

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“…Intravenous antineoplastic agents present additional safety challenges. [1][2][3][4] In addition to patient safety concerns, antineoplastic preparation and administration create significant staff risks. [5][6][7][8][9] The medication use system includes several stages that are vulnerable to opportunities for potentially harmful medication errors (MEs), such as incorrect drug, dose, concentration, or storage.…”

Section: Introductionmentioning

confidence: 99%

Impact of Robotic Antineoplastic Preparation on Safety, Workflow, and Costs

Seger

Churchill

Keohane

et al. 2012

JOP

103

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Purpose: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. Methods:We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/ manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time.Results: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P ϭ .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P ϭ .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P Ͻ .001). Mean drug preparation time increased by 47% when using the robot (P ϭ .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P Ͻ .001). Conclusion:Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations.

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Section: Introductionmentioning

confidence: 99%

Impact of Robotic Antineoplastic Preparation on Safety, Workflow, and Costs

Seger

Churchill

Keohane

et al. 2012

JOP

103

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“…-Pendeskripsian produk serta penyusunan bagan alir dan konfirmasi bagan alir di lapangan (Bonan et al, 2009). -Pengambilan contoh uji pada setiap tahapan, yaitu pada bahan baku yang terdiri atas air baku, kacang kedelai, susu sapi segar, pada tahap pengolahan yang terdiri atas kedelai giling dan sari kedelai, serta pada produk akhir yang terdiri atas tahu susu putih dan tahu susu kuning.…”

Section: Metodologiunclassified

Jurnal Teknik Lingkungan

Fithri¹,

Oginawati

Santoso

2011

j.tl

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“…Eleven of these control points were of high importance and carried a high-risk index: prescription errors, computerized prescription system errors, drug storeroom temperature conditions, compounding sheet errors, commercial product defects, microbial contamination, needle-stick injuries, analytical nonconformities, chemical contamination, differences between prescription and preparation, and packaging nonconformities. 30 Capacity planning Optimal allocation of resources within the tight budgetary constraints of most aseptic units can be challenging. Capacity planning involves estimating the workload arising from meeting these demands within given timeframes.…”

Section: Guidelines For Preparation Of Cytotoxic Agentsmentioning

confidence: 99%