Aseptic Dispensing PDF

ASEPTIC DISPENSING LECTURE BY DR. SAIQUA LASHARI LECTURER DEPARTMENT OF PHARMACY ASEPTIC DISPENSING Preparation and supply of sterile medical products, which requires manipulation before administration Q.1. Who can prepare? Q.2. Which products are prepared?...

ASEPTIC DISPENSING LECTURE BY DR. SAIQUA LASHARI LECTURER DEPARTMENT OF PHARMACY ASEPTIC DISPENSING Preparation and supply of sterile medical products, which requires manipulation before administration Q.1. Who can prepare? Q.2. Which products are prepared? IV Admixtures  I/V Admixtures OR I/V additive solutions 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. Used in: A. Correction of disturbances in electrolyte balance B. Correction of disturbances in body fluids (fluid replacement) C. Vehicles for other drug substances Examples Dextrose: Dextrose 5%, 10%Injection NaCl Injection: 0.9%, 0.45% Preparation 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 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. 5. Once drug is added – new seal crimped on container. Seal color 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 TPN / HYPERALIMENTATION IV administration of sufficient nutrients above usual basal requirements to achieve; Tissue synthesis Positive nitrogen balance & Anabolism Used for patients – unable in enteral feeding. Also known –TPN 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  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 preparing TPN. Facility & environment TPN – require aseptic environment. So LFH are used. Personnel & training Trained personnel – should carry out aseptic preparation of TPN. Should know about patient requirements & product use. Documentation Work sheet – should be designed for TPN dispensing & maintained. Work sheet contain information about: Materials, patient name, label details etc. Manufacturing procedures Should be developed jointly by production & quality control staff. On receiving request for TPN Feasibility & stability is checked within normal clinical limits of requested combinations. Information is then transferred to dispensing work sheet. 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. Materials – placed well within LFH. Organized in manner which will facilitate systematic steps. And cause minimum disruption of air flow. Labelling Charging of TPN(Billing) Label should contain: TPN compounding service – costly for Patient name/number pharmacy dept. Ward Amino acids & lipids itself – costly items. Product constituents Pricing of TPN requires – identification of Batch no. materials cost & labour costs etc. Expiry date All factors considered – before deciding Storage conditions etc. inhouse mfg; or obtain product from other hospital or manufacture supply. Storage TPN – stored at 2-6 °C. To protect it from microbiological & chemical degradation. Packaging Quality of packaging systems – should comply QC standards & To maintain product temp. during transfer. Insulated polystyrene containers – most useful. CYTOTOIXC DISPENSING Cytotoxic drugs – can kill cells. So used in treatment of cancer & to destroy tumor & neoplastic cells. Most cytotoxic injectables – available in powdered form.  Require reconstitution. 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. 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, leukemia, Infertility So if proper precautions & procedures are followed then: possible direct exposure, inhalation of aerosolized drugs or ingestion – can be eliminated. 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( ENTRY OF EXTERNAL AIR).  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. 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 clothing & gloves – protect skin. Latex gloves used commonly. 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.