Effect of various factors on the amount of plasticizer in intravenous solutions packaged in flexible bags

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Abstract
The effects of administration time, hydrogen ion concentration, ethanol content and agitation on the amount of di-2-ethylhexyl phthalate (DEHP) delivered in polyvinylchloride bags containiiig five different intravenous solutions were studied. The five solutions (1-liter bags) were: 0.9% sodium chloride injection; 5% dextrose injection; Ringer's injection; sodium lactate injection; and sterile water for irrigation. All solutions were packaged in polyvinylchloride bags. Nonagitated bags were stored at room temperature for two months. Agitated bags were mechanically shaken at room temperature for a 24-hour period prior to use. Five different hydrogen ion concentrations were used: pH 3, 4, 5.5-6.5, 8 and 11. The concentrations of ethanol studied were: 0, 5, 10, 40 and 70%. The administration times tested were 6,8,12 and 24 hours. The length of administration time and the hydrogen ion concentration had no effect on the amount of DEHP delivered. Agitation increased the amount of DEHP delivered as compared to nonagitated solutions. The type of agitated solution also had an effect on the amount of DEHP delivered, with 0.9% sodium chloride injection and Ringer's injection delivering less DEHP. The concentration of ethanol was the controlling element of those factors studied in determining the amount of DEHP delivered from the solutions when ethanol was present in concentrations of from 0 to 70%. It would seem appropriate to include a warning on the container or package insert not to compound ethanol solutions in plastic bags because of a possible increase in the amount of DEHP the patient may be exposed to. The results of this study indicate that the pharmacist can lower plastlcizer levels by: (1) storing freshly transported solutions for a period of one to two months to allow the level of DEHP particles to decrease; (2) using the salt solutions 0.9% sodium chloride injection and Ringer's injection where possible; (3) mixing additives thoroughly but with a minimum of agitetion; and (4) using caution that ethanol not be extemporaneously compounded in these containers.

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