Type of PN Formulation 3in1 versus 2in1

O PN admixtures can be prepared by mixing all components into one bag, or instead, IV lipid emulsion may be infused separately (via a Y-site infusion or through a separate IV catheter or lumen). When all components are mixed together, this is re ferred to as a 3-in-1 admixture or a TNA. When dextrose, amino acids, and all other PN components are mixed together without IV lipid emulsion, this is referred to as a 2-in-1 PN admixture. With a 2-in-1 PN admixture, IV lipid emulsion can be infused separately on a daily or intermittent basis. When lipid emulsion is mixed in the PN, the TNA becomes an emulsion with its physical and chemical characteristics. There are various advantages and disadvantages to using either 3-in-1 or 2-in-1 PN (Table 100-5).

A primary concern when administering PN is safety. The FDA published a safety alert in 1994 in response to two deaths associated with TNA infusion.15 Autopsy reports from these patients revealed diffuse microvascular pulmonary emboli containing calcium-phosphate precipitates. The FDA provided recommendations for safe infusion of PN admixtures containing calcium and phosphate:

Table 100-5 Advantages and Disadvantages of Using 3-in-1 (TNA) or 2-in-1 PN Admixtures

¿Tinrt {TNA]

Mn-1

Advantages

^¡mpNfcd regimen tor patleri

Improved siabllity tompaied to fMA

hbiMd ^Kknt tOmpii jno.-J! home

Inciejwd number 0< cc*Hpa(iHe

(Jpf leai^d libof (lev; nursing time)

mediations

Dctiemcd costs (lewer supptcs and equipment needed)

Decreaiod bdcteilal gtomh ftn dentrose/

DKieiWSd ris* of (Oil! JKlirtOliCHn (Jut In Irti nVinipuUtiOa Ji

jnfcino j;.ld tt^npOnCnrh ¿Oni|>|fWJ

rompcmw .lseptkraJly compounded)

loTMA

hhibitcd bjntcH ul ^owllh m. separate IV lipid cmublon

Easier visual Inspection

Minimi^ ililuvt " I n-lilii i Ii* tiOfii fiom IV lipid <?filliK>:Xii <lrn!

CniHAÎÏitHion fc*neiiai woeniioft

pmntjly Improved lipid t leaianfe (If mftiifd mer mote thin hours)

(Hter

Dcuejsed winiipilation (es-prcidly with FPHO

Cost «wings if unusud lie, rioi ip.lmj oi oceri«ii (v lip« «nuHon tan b* wuted

Disadvantages

Dec leased stabi ny compared to 2 ln-1 PN

Increased labor and coats (if IV lipid

Cjnrita use 0.Ï2 micron tuclcrijl letemitji filter. must

emulsion intuscd separately)

ys^ 1 J-m'cnon filter

liï «HHd uein iiiii.iKju. i.ily if PPN

fctioaiscd bacleful aiowth compared to 2-in 1 PN

Ë not coin'usfd uilh IV lipid emulsion

W>iAil ini0e(tiOn cWtkuH

1 imnHJioni|Vs!il)iliiy ■AnM mediations

'('hi peripheral parenieral mm mort TNA, total nuricra admitiine

'('hi peripheral parenieral mm mort TNA, total nuricra admitiine

• A 0.22-micron air-eliminating in-line filter should be used for infusion of nonlipid-containing PN.

• A 1.2-micron in-line filter should be used for the infusion of 3-in-1 PN (i.e., a TNA)

because it can remove large and unstable lipid droplets and also particulate mat-

23 ter.23

Another concern is the coinfusion of IV medications with PN admixtures. Many IV medications have limited compatibility with 3-in-1 formulations but may be coin-fused with a 2-in-1 formulation.2 ,25 Some medications can be coinfused at the Y-site, few medications can be mixed directly into the PN admixture or coinfused with IV

24 25

lipid emulsion, and some cannot be mixed or coinfused with the PN admixture. Always consult compatibility data before adding a medication to a PN admixture or coinfusing it with PN. Medications that are compatible should be added to PN only if it is reasonable and safe (i.e., based on toxicity profile, pharmacokinetic/pharmaco-dynamic considerations).

The United States Pharmacopeia, Chapter 797 (USP 797) is a document that provides guidelines and best practices for pharmaceutical compounding of sterile products. 6 These guidelines address many aspects of compounded sterile preparations (CSPs), including (but not limited to) appropriate training of personnel; appropriate environments for compounding; appropriate storage, handling and labeling of ingredients and final products; and quality assurance. The purpose of USP 797 is to prevent patient harm from CSPs as a result of contamination (including physical, chemical, and bacterial or fungal pathogens), inappropriate ingredients (variability in strength or quality), or inappropriate preparation, compounding, handling, transportation or storage. CSPs are classified as either low-risk level, medium-risk level, high-risk level, or immediate use. CSPs are also assigned an appropriate beyond-use date (BUD), which is the date or time after which a CSP shall not be stored or transported, and it is determined from the date or time the CSP is compounded. PN admixtures are usually classified as medium-risk products, and they are assigned a BUD of 30 hours at controlled room temperature or 9 days at a cold (refrigerated) temperature. The full details of USP 797 are beyond the scope of this chapter. Pharmacists and other health care professionals involved in the preparation of CSPs should review this document along with institutional policies and procedures regarding CSPs.

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