Evaluation of Specific Administering Devices for Antineoplastic Drugs Compounded in Syringes in Paediatry: Methodology Proposal

Abstract

Purpose

The aims of this study were to propose a simple methodology to assess the rinsing volume of syringe extension sets and to compare several marketed devices.

Methods

A UV-spectrophotometry assay using quinine hydrochloride as drug substitute was developed. Quinine concentration ranged from 20 to 200 µg/ml. The assay was validated with the accuracy profile method and tested on five different assemblies (device+extension sets) with different dead-space volumes (1.28–2.80 ml) and at two different quinine concentrations (0.3 and 8.0 mg/ml). Rinsing was performed stepwise with water for injection until reaching an undetectable quinine concentration. After fitting the data with a Weibull model, assemblies were compared with an ANOVA performed on ranks (GraphPad, La Jolla, USA).

Results

The within-day and between-day precision ranges were 0.39–0.81 and 0.48–0.84%, respectively. The lower limit of quantification was 4.26 µg/ml. The volume required to completely rinse the infusion line was different according to the initial drug concentration and to the device assessed: from 6 to 10 ml for a low quinine concentration and from 7 to 17 ml for a high quinine concentration.

Conclusion

This study shows that a simple, cheap and easy-to-use methodology may be used to assess the rinsing volume of syringe extension sets. The rinsing volume is different according to the tested device.

Keywords

Specific extension sets infusion antineoplastic drugs chemotherapy assessment paediatric

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References

Falck

Gröhn

Sorsa

et al.

Mutagenicity in urine of nurses handling cytostatic drugs. Lancet 1979; 1: 1250–1251.

Occupational Safety and Health Administration. Controlling occupational exposure to hazardous drugs. Occupational safety and health administration. Am J Health-Syst Pharm 1996; 53: 1669–1685.

National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings, www.cdc.gov/niosh/docs/2004-165/default.html (2004, accessed 10 March 2017).

American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm 2006; 63: 1172–1193.

Martin

Larson

. Chemotherapy-handling practices of outpatient and office-based oncology nurses. Oncol Nurs Forum 2003; 30: 575–581.

ISOPP

Standards of practice

. Safe handling of cytotoxics. J Oncol Pharm Pract 2007; 13: 1–81.

GERPAC-Europharmat workgroup. Preparation and administration of drugs at risk for both workers and environment, http://www.euro-pharmat.com/documents/dm_de_preparation/guiderecommandationdm.pdf (2007, accessed 10 March 2017).

Shierl

Herwig

Pfaller

et al.

Surface contamination of antineoplastic drug vials: comparison of unprotected and protected vials. Am J Health-Syst Pharm 2010; 67: 428–429.

Connor

Anderson

Sessink

et al.

Effectiveness of a closed-system device in containing surface contamination with cyclophosphamide and ifosfamide in an i.v. admixture area. Am J Health-Syst Pharm 2002; 59: 68–72.

10.

Wick

Slawson

Jorgenson

et al.

Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health-Syst Pharm 2003; 60: 2314–2320.

11.

Harrison

Peters

Bing

. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health-Syst Pharm 2006; 63: 1736–1744.

12.

Guillemette

Langlois

Voisine

et al.

Impact and appreciation of two methods aiming at reducing hazardous drug environmental contamination: the centralization of the priming of IV tubing in the pharmacy and use of a closed-system transfer device. J Oncol Pharm Pract 2014; 20: 426–432.

13.

Sidikou

Simon

Sergent

et al.

In vitro assessment of a new extension set intended to reduce occupational exposure to antineoplastic drugs during hepatic chemoembolization. Cardiovasc Interv Radiol 2016; 39: 141–143.

14.

Kromhout

Hoek

Uitterhoeve

et al.

Postulating a dermal pathway for exposure to antineoplastic drugs among hospital workers. Applying a conceptual model to the results of three workplace surveys. Ann Occup Hyg 2000; 44: 551–560.

15.

Zaugg

Ackermann

Ziewitz

et al.

[Evaluation de tubulures courtes à connecter aux poches de chimiothérapies] in French. Pharm Hosp 2009; 44: 64–69.

16.

Jorgenson

Spivey

et al.

Contamination comparison of transfer devices intended for handling hazardous drugs. Hosp Pharm 2008; 43: 723–727.

17.

Queruau-Lamerie

Carrez

Décaudin

et al.

Multiple-test assessment of devices to protect healthcare workers when administering cytotoxic drugs to patients. J Oncol Pharm Pract 2012; 18: 191–200.

18.

Nygren

Olofsson

Johansson

. Spill and leakage using a drug preparation system based on double-filter technology. Ann Occup Hyg 2008; 52: 95–98.

19.

Simon

Décaudin

Lannoy

et al.

Technical evaluation of a new sterile medical device to improve anticancer chemotherapy administration. Oncol Nurs Forum 2010; 37: E370–E376.

20.

Kontny

Boos

Würthwein

et al.

Minimization of the preanalytical error in pharmacokinetic analyses and therapeutic drug monitoring: focus on IV drug administration. Ther Drug Monit 2012; 34: 460–466.

21.

Simon

Vasseur

Guillaussier

et al.

Potential impact of infusion technique on drug delivery. Ther Drug Monit 2016; 38: 268–273.

22.

Hubert

Nguyen-Huu

Boulanger

et al.

Harmonization of strategies for the validation of quantitative analytical procedures A SFSTP proposal – part I. J Pharm Biomed Anal 2004; 36: 579–586.

23.

Hubert

Nguyen-Huu

Boulanger

et al.

Harmonization of strategies for the validation of quantitative analytical procedures A SFSTP proposal – part II. J Pharm Biomed Anal 2007; 45: 70–81.

24.

Weibull

. A statistical distribution function of wide applicability. J App Mech 1951; 18: 293–297.

25.

Lannoy

Décaudin

Simon

et al.

The impact of drug mass flow-rate of interrupting and resuming carrier fluid flow: an in vitro study on a very low dead-space volume infusion set. Anest Anal 2012; 114: 328–332.

26.

Contractor

Kumar

Phillip

et al.

Use of phaseal transfer system during chemoembolization to prevent unintentional leakage of chemotherapeutic agents during preparation and delivery. J Vasc Interv Radiol 2015; 26: 137–139.