The document outlines procedures for the aseptic dispensing of intravenous admixtures, TPN, and cytotoxic drugs, detailing the preparation steps, necessary equipment, and personnel training required to ensure the safety and efficacy of these sterile products. It emphasizes the importance of labeling, documentation, inspection, and proper storage conditions to maintain product integrity and mitigate risks during handling. Additionally, it discusses the potential hazards of cytotoxic agents and the precautions necessary for safe preparation and administration.

1. Chapter# 3

2.  ASEPTIC DISPENSINGOF:
 I/V Admixtures OR I/V additive solutions
 TPN OR Hyperailimentation
 Cytotoxic Dispensing
 Semi-sterile Dispensing (Eye drops, Ear drops)

3.  Sterile product produced when one or more
drugs are added to the IV solutions/fluids.
 Additive – drug added to IV solution
 IV fluids
 Large volume parenteral to be administered by
intravenous infusion.
 Group of sterile products referred to as large-
volume parenteral
 Prepared withWater for Injection, USP

4.  Used in:
 Correction of disturbances in electrolyte balance
 Correction of disturbances in body fluids (fluid
replacement)
 Vehicles for other drug substances
 Examples
 Dextrose 5%, 10% Injection
 NaCl Injection (0.9%, 0.45%)
 Dextrose and NaCl Injection

5. Steps
1. Receipt of physician order.
 Pharmacist work from physician’s order sheet.
2. Prepare the label.
 Label provide information:
▪ Patient identification with location.
▪ Physician’s name
▪ Drugs with quantities
▪ Date of compounding
▪ Expiry date
▪ Pharmacist name

6. 3. If necessary – prepare additional label.
 Positioned in upside down – to facilitate when
container is hung from pole on patient’s bed.
4. Preparation of IV solution – always in LFH.
 Using sterile needles, syringes etc.

7. 5. Once drug is added – new seal crimped on
container.
 Seal colour should be different – warn that drug
has been added.
6. Before supplying – final inspection by
pharmacist.
 Like label, clarity of solution and calculations of
preparation

8.  IV administration of sufficient nutrients
above usual basal requirements to achieve;
 Tissue synthesis
 Positive nitrogen balance &
 Anabolism
 Used for specific patients – unable in enteral
feeding.
 Also known -TPN

9.  TPN – part of total patient care.
 Simple procedures for its preparation.
 But require appropriate facilities & equipments.
 Such as LFH – provide controlled environmental
conditions.
 Pharmacist – should know about:
 Preparation methods
 Stability & compatibility
 Facilities
 Equipments
▪ Required for this program.

10. Stability & compatibility
 TPN – consists of various ingredients.
 i.e., complex pharmaceutical system
 Possibility of interactions & incompatibility
between entities present.
 So increase risk of its toxicity to patients.
 Pharmacist – thorough understanding of
stability & compatibility issues.
 Should consult available literature before
preparingTPN.

11. Facility & environment
 TPN – require aseptic environment.
 So LFH are used.
Personnel & training
 Trained personnel – should carry out aseptic
preparation ofTPN.
 Should know about patient requirements &
product use.

12. Documentation
 Work sheet – should be designed for TPN
dispensing & maintained.
 Work sheet contain information about:
 Materials, patient name, label details etc.

13. Manufacturing procedures
 Should be developed jointly by production &
quality control staff.
 On receiving request forTPN
 Feasibility & stability is checked within normal
clinical limits of requested combinations.
 Information is then transferred to dispensing work
sheet.

14. Collection of materials & preparation
 In this case – first step is identification &
collection of all materials required.
 Pharmacist – check these against the work
sheet & then sign it.
 When more than one TPNs are processed –
care necessary to avoid intermixes of source
materials, labels etc.

15.  Materials – placed well within LFH.
 Organized in manner which will facilitate
systematic steps.
 And cause minimum disruption of air flow.
Inspection
 TPN bag – inspected for integrity of;
 All ports
 Leaks
 Particulate materials
 TPN – should meet criteria for limit test of
particulate material.

16. Labelling
 Label should contain:
 Patient name/number
 Ward
 Product constituents
 Batch no.
 Expiry date
 Storage conditions etc.

17. Storage
 TPN – stored at 2-6 °C.
 to protect it from microbiological & chemical
degradation.

18. Packaging
 Quality of packaging systems – should
comply QC standards &
 To maintain product temp. during transfer.
 Insulated polystyrene containers – most
useful.

19. Dispensing
 TPNs – dispensed according to above
mentioned procedure.
 In addition – pharmacist in ward should check
thatTPN is administered correctly.

20. Charging ofTPN
 TPN compounding service – costly for
pharmacy dept.
 Amino acids & lipids itself – costly items.
 Pricing of TPN requires – identification of
materials cost & labour costs etc.
 All factors considered – before deciding in-
house mfg; or obtain product from other
hospital or manufacture supply.

21.  Cytotoxic drugs – can kill cells.
 So used in treatment of cancer & to destroy
tumour & neoplastic cells.
 Most cytotoxic injectables – available in
powdered form.
 Require reconstitution.

22.  Pharmacist – can provide cytotoxic
reconstitution service.
 Because of knowledge in pharmaceutics,
pharmacology, pharmaceutical chemistry &
pharmacokinetics.
▪ Knowledge necessary for understanding:
pharmacological action of cytotoxic drug &
 their stability in solution.

23. AREA OF SKILLS NEEDED FOR PHARMACIST
Safe handling
 Cytotoxic agents – non-selective so far & can
destroy some healthy tissue as well.
 So precautions necessary for personnel handling
them.
 Exposure to cytotoxic agents may cause:
 Irritation of mucous membranes, eyes, skin
 Light-headedness, nausea, headache
 Allergic reactions
 Risk of malignancy, teratogenesis, leukaemia,
infertility

24.  So if proper precautions & procedures are
followed then:
 possible direct exposure,
 inhalation of aerosolized drugs or
 ingestion – can be eliminated.

25. Preparation areas
 LAF cyctotoxic cabinet used for preparation.
 Provides;
▪ Product protection
▪ Worker protection
 Cytotoxic cabinet – reserved only for
cytotoxic drugs.
 Ventilation of area – should be adequate.
 But doors & windows – closed to prevent
draughts.

26.  Working area – non-porous.
 So can be easily cleaned.
 Equipments & drugs – arranged in orderly
manner.
 To avoid accidents.
 Neutralizing solutions – close to hands.
 To neutralize effects of spills.
 Horizontal LAF – never be used.

27. Techniques & precautions
 Prior to dispensing – product reconstituted.
 But maintaining sterility of product &
 Ensuring maximum protection to operator.
 Eating, smoking, drinking – prohibited in work
area.
 Suitable protective clothings & gloves – protect
skin.
 Latex gloves used commonly.

28.  Surgical face masks – to prevent inhalation.
 Goggles – protect eyes.
 Should be washed after use.
 Reconstitution – carried out on solid surface.
 Cleaned easily.
 Broad edge tray – suitable when LFH surface
is perforated.