Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

The drug supply chain in hospital composed of successive steps: drug prescription is a medical task; preparation and dispensation are pharmaceutical ones, whereas drug administration belongs to nurses. Potential errors such as wrong dosage, solvent?s errors, wrong labeling or, in some exceptional cases, chemotherapeutic active substances? errors can occur, leading to potential risks of morbidity and mortality for patients. Recommendations and quality assurance processes have since been applied to ensure safety at each stage of the drug supply chain. The pharmacist is responsible for procurement, distribution, surveillance, and control of all drugs used in the hospital. Drug preparation and quality control are also mandatory activities for a hospital pharmacy. By allowing the identification of qualitative and quantitative preparation non-conformity, verification of the finished product contributes to ensuring drug supply chain safety. However, these quality controls were rare in the hospital pharmacy setting. In 2002, a study showed that only 4.7% of American pharmacies compounding cytotoxic preparations performed these controls and were thus compliant with 2000 ASHP guidelines on quality assurance for pharmacy-prepared sterile products. Since 1998, our clinical pharmacy department has been equipped with an analytical platform using high performance thin-layer chromatography (HPTLC), high performance liquid chromatography (HPLC) and spectrophotometry (IRTF-UV) to ensure post-production quality control of chemotherapeutic preparations, both qualitatively (identification) and quantitatively (concentration). In 2003, a sampling plan was defined to reduce the number of chemotherapy quality controls while preserving the same level of quality. Recent qualitative and quantitative changes led us to define a second sampling plan supplemented by an economic evaluation to determine the cost and cost-savings of quality control. The study considers preparation produced during four semesters classified into three groups. The first one includes drugs produced below 200 batches a semester. Group 2, those for which the lot of preparation lots would have been rejected twice among these four semesters. Group 3, those would have been accepted). A single sampling plan by attributes was applied with an acceptance quality level of 1.65% and a lot tolerance percent defective below 5%. A micro-costing study was conducted on quality control, from the sampling to the validation of the results. Among 39 cytotoxic drugs, 11 were sampled which enabled to avoid a mean of 17,512 control assays per year. Each batch of the 28 non-sampled drugs was however analyzed. Costs were estimated at 4USD and 7USD for control assays depending of the analytical method.

Biography

Angelo Paci graduated in 1990; obtained his PharmD in 1999 and his PhD in Medicinal chemistry- Pharmacology in 2000 from the University of Paris V, France. He integrated the Clinical Pharmacy Department in 2001 and then as senior Pharmacologist the Biology and Pathology Department since 2009, at Institut Gustave Roussy. He developed his research since 2003 in the laboratory of Pharmacology and new anticancer treatments UPRES 3535 Paris Sud University and since 2010 in the laboratory of Vectorology and Anticancer Therapeutics UMR 8203 at Institut Gustave Roussy in the field of nanodrug delivery. He has developed a clinical pharmacology activity dedicated to patients with onco-hematological malignancies since 2006 including therapeutic drug monitoring and pharmacokinetics studies of anticancer drugs. Beside his clinical and scientific activities, he validated in 2012 a Master in Management and Health Economy at ESSEC Business School in Paris.