Aseptic Dispensing in Hospital Pharmacy a very efficent and easy to understand. Hope u people will get some knowledge from it

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.