2 Aseptic Technique“Aseptic technique is the term used for all procedures and techniques performed to keep a sterile product from becoming contaminated.”
3 Parenteral Drug Administration Basic Intravenous Therapy- Intravenous (IV) route of administrations is the mostcommon route that parenteral dose are administeredtoday.- Other parenteral dosage forms are:1. intramuscular (IM)2. subcutaneous (SubQ)3. intradermal (ID)4. epidural- IV fluid is in a large-volume parenteral (LVP), usuallymore than 100 mL
4 Basic IV Therapy cont…- Hang on an IV pole approximately 36 inches higher thanthe patient’s bed.- The LVP is usually a simple solution of dilute dextrose,sodium chloride or both.- Solution is infused continually to keep blood from clottingin the catheter and plugging the line.
5 Basic IV Therapy cont…- Primary IV set – attaches to the LVP. Most IV sets thatflow by the force of gravity have several common features:1. Drip chambers are typically classified as macrodripor minidrip based on the size of the drop that isformed in the drip chamber.a. Macrodrip – deliver 10 to 20 drops/mLb. Minidrop or Microdrip – deliver 60 drops/mL2. Electronic infusion devices are usually used in fluidrestricted patients or when the LVP contains a drugthat must be administered at a precise rate thatcannot be monitored by using the gravity method.
6 Continued… - Secondary IV sets – drugs that are routinely delivered through the same basic IV setup are usually attached toa “secondary IV set” connected to the primary set.- Catheters – typically inserted into a peripheral vein (arm,leg, or hand) or a central vein (in the chest near theheart).1. Where the catheter is inserted depends on thecontents of the IV2. Peripheral insertion is more common than centralinsertion3. The central catheter is more complicated and riskierto insert and maintain, but has fewer restrictions withrespect to type and rate of administration
7 Continued… 4. Types of peripheral catheters: a. Plastic – most common b. Steel – commonly referred to as a scalp vein orbutterfly. Used in patients that require IV therapywho are still capable of eating and drinking, do notrequire supplemental fluids, and might be ambulatory.5. Central catheters can be temporary; used for days or weeks(such as during a hospital stay) or permanent, when usedfor months or years (such as home care or cancer patients)
8 Continued…6. The central catheter gives direct access into a vein thatthat has a high flow of blood.7. Peripheral inserted central catheter (PICC) offers some ofthe benefits of both central and peripheral catheters.Inserted peripherally it is a long flexible catheter thattravels through the vein and its tip ends near the heartwhere there is a high volume of blood flow.
9 Risks of Intravenous Therapy Infection – results if a product contaminated with bacteria is infused into a patient.- human touch contamination continues to be the mostcommon source of IV related contamination.Air embolus – incidence is low, because many solutions are administered using infusion pumps equipped with an alarm that sound when air is in the IV line. These are called air-in-line alarms.- in adults it takes 150 or 200 mL of air (much less ininfants or pediatric patient) given quickly to result inharm.
10 Risks continued…Bleeding – when the IV catheter is removed, bleeding may occur around the catheter site.Allergic reaction – when a patient has an allergic reaction to a substance given parenterally the reaction is usually more severe than if the same substance was given by another route (e.g. mouth, topically, or rectally)- one reason for this is that substances given parenterallycannot be retrieved like substances given by other routes.Incompatibilities – if an incompatibility exists, the drug might precipitate, be inactivated, or adhere to the container. Incompatible solutions should not be administered to patients.
11 Risks continued…Extravasation – occurs when the catheter punctures and exits the vein under the skin, causing drugs to infuse or infiltrate into the tissue.Particulate matter – refers to particles present in parenteral products. When injected into the bloodstream can cause adverse effects to the patient. Examples:- microscopic glass fragments- hair- lint or cotton fibers- cardboard fragments- undissolved drug particles- fragments of rubber stoppers
12 Risks continued…Pyrogens – the by-products or remnants of bacteria, can cause reactions (e.g. fever and chills) if injected in large enough amounts.Phlebitis – Irritation of the vein. Caused by:- the drug being administered (due to it chemical propertiesor its concentration)- the location of the IV site- a fast rate of administration- the presence of particulate matter- the patient usually feels pain or discomfort along the pathof the vein (often severe) and red streaking may alsooccur
13 Aseptic Preparation of Parenteral Products Aseptic Technique- Programs designed to ensure the aseptic preparation ofsterile products.- The main elements these programs focus on are:1. the development and maintenance of good aseptictechnique in the personnel who prepare andadminister sterile products.2. Development and maintenance of a sterilecompounding are complete with sterilized equipmentand supplies.3. Development and maintenance of the skills needed toproperly use a laminar flood hood (LAH).
14 Aseptic Technique continued… Aseptic technique is a means of manipulating sterile products without contaminating them.Proper use of a LAH and strict aseptic technique are the most important factors in preventing the contamination of sterile products.
15 Sterile Compounding Area Sterile parenteral solutions must be free of living microorganisms and relatively free of particles and pyrogens.A sterile compounding area should be cleaned daily and segregated from normal pharmacy operations, patient specimens, nonessential equipment, and other materials that produce particles. Examples:- cardboard into the clean environment should be avoided.- traffic flow should be minimized.- floors should be disinfected periodically.- trash should be removed frequently and regularly.
16 Compounding Area continued… Sterile products should be prepared in a Class 100 environment, which contains no more than 100 particles per cubic foot that are 0.5 micron or larger in size.LAHs are frequently used to achieve a Class 100 environment.
17 Laminar Airflow Hoods (LAH) Underlying principle of LAHs is that twice-filtered layers of aseptic air continuously sweep the work area inside the hood to prevent the entry of contaminated room air.Two common types:- Horizontal LAH – sweeps filtered air from the back of thehood to the front.1. use an electrical blower to draw contaminated roomair through a prefilter.2. The prefilter, which is similar to a furnace filter, onlyremoves gross contaminants and needs to be cleanedor replaced on a regular basis.3. The high efficiency particulate air or (HEPA) filterremoves 99.9% of particles that are 0.3 micron orlarger.
18 Laminar Airflow Hoods continued… Vertical LAH – HEPA filtered air emerges from the top and passes downward through the work area.- used for antineoplastic (anticancer) drugs.- the risk of exposure to airborne drug particulates isminimized.- the type of vertical LAH used for the preparation ofantioneoplastics contains airflow within the hood and arereferred to as biological safety cabinets (BSCs).The critical principle of using LAHs is that nothing interrupts the flow of air between the HEPA filter and the sterile object. The space between the HEPA filter and the sterile object is known as the critical area.
19 Hoods continued…To maintain sterility, nothing should pass behind a sterile object in a horizontal flow hood or above a sterile object in a vertical flow hood.Materials placed within the laminar flow hood disturb the patterned flow of air blowing from the HEPA filter. This “zone of turbulence” created behind an object could potentially extend outside the hood pulling or allowing contaminated room air into the aseptic working area.It is advisable to work with objects at least six inches from the sides and front edge of the hood without blocking air vents, so that unobstructed airflow is maintained between the HEPA filter and sterile objects.
20 Hoods continued…The following are general principles for operating LAHs properly:- A LAH should be positioned away from excess traffic,doors, air vents, or anything that could produce air currents.- If turned off, it should be allowed to run for minutesbefore use.- Before use, all interior working surfaces of the laminarflow hood should be cleaned with 70% isopropyl alcohol orother appropriated disinfecting agent and a clean, lint-freecloth. Cleaning should be performed from the HEPA filtertoward the front of the LAH (in a horizontal LAH) so thatcontaminants are moved out of the hood.
21 Hood Criteria continued… Nothing should be permitted to come in contact with the HEPA filter. This includes cleaning solution, aspirate from syringes, or glass from ampules. Ampules should not be opened directly toward the filter.Do not put paper, pens, labels, or trays into the hood.Jewelry should not be worn on the hands or wrists when working in the LAH since it may introduce bacteria or particles into the clean work area.Actions such as talking and coughing should be directed away from the LAH working area, and any unnecessary motion within the hood should be avoided to minimize the turbulence of air flow.
22 Hood Criteria continued… Smoking, eating or drinking are prohibited in the aseptic environment.All aseptic manipulations should be performed at least six inches within the hood to prevent the possibility of potential contamination caused by the closeness of the worker’s body and backwash contamination resulting from turbulent air patterns developing where LAH air meets room air.LAHs should be tested by qualified personnel every six months, whenever the hood is moved, or if filter damage is suspected.
23 Personal AttireThe first component of good aseptic technique is proper personal attire.Clean garments, which are relatively particulate free, should be worn when preparing sterile products.Many facilities provide clean scrub suits or gowns for this purpose.Hair covers and shoe covers help reduce particulate or bacterial contamination, and some experts claim that the use of surgical masks and gloves is warranted as well.
24 USP 797 – New StandardsThe primary structure of the new USP standards is based on 3 risk levels classified according to the potential for:- Microbial contamination(microorganisms and endotoxins)- Physical contamination(particulate contaminants: from cotton garments,cardboard cartons, pencils, paper towels, chewing gumand electronic equipment)- Chemical contamination(solid or liquid matter from precipitates)
25 Standards continued… There are specific standards for each risk level. Standards regarding personnel training, environmental quality and control, verification of compounding accuracy, packing and transport, adverse event reporting, storage, and beyond-use dating.
26 Risk Levels: Low Risk - All aseptic manipulations Definition: within class 100environment using onlysterile ingredients anddevices- Only single transfersused- Measuring/mixing no morethan 3 productsExamples:- Single patient doses- Single patient syringe w/oadditives- Batch syringes withpreservatives- Sterile solution withdrawnfrom an amp and filtered toremove glass particles- Manually prepared TPNwith three ingredients
27 Risk Levels: Medium Risk Definition:- No Broad Spectrumantibacterial presentdespite administration overseveral days- Complex asepticmanipulations- Multiple doses in onecontainer for multiplepatients or one patient onmultiple occasionsExamples:- Batch reconstitutedantibiotics withoutpreservatives- Batch syringes w/opreservative- Filling reservoirs withmultiple sterile products andevacuating air foradministration over severaldays at room temperature- TPN prepared by acompounder
28 Risk Levels: High Risk Definition: - Sterile products compounded from nonsterile ingredients oruse of a nonsterile deviceprior to terminalsterilization- Sterile ingredients,components, or devicesexposed to air quality <class 100 if opened orpartially used and notadequately preservedExamples:- Mixing or measuring innonsterile devices- Assuming 95% purity ofingredients- Injections made fromnonsterile powder that willbe terminally sterilized- Compounded bladderirrigations- TPN for terminal sterilizationby final filtration
29 Environmental Quality Control Work bench area: where compounding is completedBuffer area = clean room: area immediately surrounding the work bench. Should not contain any drains or sinks.Ante area: Space beyond the buffer area where hand sanitizing and gowning occurs.- includes hands free faucets and air dryers or low-sheddingtowels.- Supplies are unpacked and disinfected for storage in theante room.
30 Environmental Quality Control General Requirements:- Must limit tasks performed in the buffer area to thosedirectly related to compounding.- 2 stainless steel carts with cleanable castors;1. one for buffer area2. collecting medications solutions and supplies thatare cleaned and sanitized before being transferredto the buffer cart for compounding.
31 Environmental Quality and Control Compounding personnel must be properly garbed in clean roomFYI: A motionless person sheds 100,000 particles every 60seconds…Skin flakes, hair, salt, oils, moisture droplets,even deodorant.For all risk levels:Hair covers, shoe covers, knee-length coats or coveralls withSnug writs and front closures face masks, and gloves
32 Training and Performance Documentation for Tech trainingPrior to commencing any compounding, perform a thorough didactic instruction in the theory and practice of sterile preparations, with evaluation of technique- annually for low and medium risk levels- semiannually for high risk levelsCompounder evaluations should include a formal written exam and practical evaluation of aseptic technique using growth media
33 HandwashingTouching sterile products while compounding is the most common source of contamination of pharmacy prepared sterile products.Scrub your hands, nails, wrists, and forearms thoroughly for at least 30 seconds with a brush, warm water, and appropriate bactericidal soap before performing aseptic manipulations. Wash your hands frequently and every time you re-enter the sterile compounding area.Workers who have open sores on their hands or have an upper respiratory tract infection should inform their supervisor and/or consult the institutions quality assurance procedures. Wear sterile gloves and mask is needed.
34 Equipment and Supplies Another important factor in aseptic preparation of sterile products is the correct use of appropriate sterile equipment and supplies, including syringes and needles.Syringes:- made of either glass or plastic- most drugs are more stable in glass, so glass syringesare most often used when medication is to be stored inthe syringe for an extended period of time.- Composed of a barrel and plunger. To maintain sterilityof the product, do not touch the syringe tip or plunger.Many syringes have a locking mechanism at the tip:Leur-lock, which secures the needle within a threadedring.
35 Syringes continued…Available in numerous sizes ranging from 0.5 to 60 mL. Usually the larger the syringe capacity, the larger the interval between calibration lines.Ideally, the volume of solution should only take up ½ to 2/3 of the syringe capacity. This avoids inadvertent touch contamination caused when the syringe plunger is pulled all the way back.When measuring with a syringe, lineup the final edge (closest to the tip of the syringe) of the plunger piston, which comes in contact with the syringe barrel, to the calibration mark on the barrel which corresponds to the volume desired.
36 Syringes continued…The syringe package should be opened within the laminar flow hood in order to maintain sterility.The wrapper should be peeled apart and not ripped or torn.To minimize particulate contamination, do not lay discarded packaging on the LAH work surface.The syringe tip protector should be left in place until it is time to attach the needle.
37 Needles Sizes are described by two numbers: - Gauge: corresponds to the diameter of its bore, which isthe diameter of the inside of the shaft. The larger thegauge the smaller the needle bore.Ex: the smallest needles have a gauge of 27, thelargest needles have a gauge of 13.- Length: the needle shaft is measured in inches andusually ranges from 3/8 to 3 ½ inches.
38 Needles continued… Components of a simple needle: - Hub: attached the needle to the syringe and is oftencolor-coded to correspond to a specific gauge.- Shaft: the tip of the needle shaft is slanted to form apoint. The slant is called the bevel, the point is called thebevel tip. The opposite end of the slant is termed thebevel heel.No part of the needle itself should be touched. Needles should be manipulated by their over-wrap and protective covers only. The protective cover should be left in place until the needle and/or syringe are ready to be used.
39 Needles continued…A needle shaft is usually metal and is lubricated with a sterile silicone coating.- For this reason, needles should never be swabbed withalcohol.Some needles have built in filters and are meant to be used with products requiring frequent such as drugs removed from a glass ampule.
40 Drug Additive Containers Ampules- Composed entirely of glass and once broken (opened)become open-system containers- Since air or fluid may now pass freely in and out of thecontainer, it is not necessary to replace the volume orfluid to be withdrawn with air.- Before an ampule is opened, any solution visible in thetop portion (head) should be moved to the bottom (body)by swirling the ampule in an upright position, tapping theampule with your finger or inverting the ampule and thenquickly swinging it into an upright position.
41 Ampule continued…To break an ampule properly, the head must be broken from the body of the ampule. To make the break properly, the ampule neck is cleansed with an alcohol swab and the swab should be left in place.To withdraw medication from an ampule, the ampule should be tilted and the bevel of the needle placed in the corner space (or shoulder) near the opening.To withdraw the solution, either use a flter needle and change to a regular needle BEFORE expelling the contents. Either way, the filter needle must not be used for both withdrawing from the ampule and expelling from the syringe, because doing so would nullify the filtering effort.
42 Ampules continued…Usually the medication is withdrawn from the ampule with a regular needle and then the needle is changed to a filter needle before pushing drug out of the syringe.
43 VialsIs a glass or plastic container with a rubber stopper secured to its top, usually by an aluminum cover.They are used to hold powders and liquids.The rubber stopper is usually protected by a flip-top cap or aluminum cover.Most protective covers do not guarantee sterility of the rubber stopper; therefore, before the stopper is penetrated, it must be swabbed with 70% isopropyl alcohol and allowed to dry.
44 Vials continued… Swabbing helps achieve sterility in two ways: - the alcohol acts as a disinfecting agent- the physical act of swabbing in one direction removesparticles.When piercing vials with needles, avoid coring fragments out of the rubber stopper with the needle.- a core is carved out of the rubber stopper when thebevel tip and the bevel heel do not penetrate the stopperat the same point.Vials are closed-system containers since air or fluid cannot pass freely in or out of them.
45 Vials continued…In most cases, air pressure inside the vial is similar to that of room air.In order to prevent the formation of a vacuum inside the vial (less pressure inside the vial than room air) the used should normalize pressure by first injecting into the vial a volume of air equal to the volume of fluid that is going to be withdrawn.If the drug is in powdered form, it has to be reconstituted. Inject the desired volume of sterile diluting solution (the diluent), such as sterile water for injection, into the vial containing the powdered drug.
46 Vials continued…An equal volume of air must be removed in order to prevent a positive pressure from developing inside the vial.Vials with drugs in solution are classified as multiple-dose (also called multiple use) or single-dose.Multiple-dose vials contain a small amount of a preservative agent, added to retard the growth of bacteria or other organisms that inadvertently contaminate a product.Single-dose vials have no preservative and are intended to be used one time only. Once a vial is entered with a needle, it should be discarded.
47 Pre-filled SyringesDrugs commonly given IM or IV are packaged this way to make them convenient for the health care provider.It is also done if the drug is commonly used in emergency situations because a pre-filled syringe saves time.
48 Preparation of Intravenous Admixtures Before compounding – assemble all materials and visually inspect vials, ampules, and IV solution containers for signs of cloudiness, particulate matter, cracks and punctures, expiration dates, and anything else that may indicate that the product is defective.
49 Preparation continued… Next, disinfect all injection surfaces and allow them to dry.- Flexible plastic bag – made of polyvinyl chloride (PVC)are frequently used.- Easier to store, less breakable than glass bottles, andeliminates the need to vent the container whenremoving fluid.- The protective overwrap should not be removed froma PVC bag until it is ready to be used.- To minimize air turbulence in the critical area, positionthe injection port of a PVC bag, which is covered by anoutside latex tip diaphragm, toward the HEPA filterwhen preparing an IV admixture.
50 Disposal of SuppliesSyringes and uncapped needles should be discarded according to institutional policy.Never recap a needle. Lay the syringe horizontally and slide the cap onto the needle. Or place the syringe vertically and drop the cap onto the needle.In some institutions supplies are discarded in puncture-resistant, sealable containers often called sharps containers.
51 Labeling Properly label the IV with the following information: - Patient name, ID number and room number (if inpatient)- Bottle or bag sequence number, when appropriate- Name and amount of drugs(s) added- Name and volume of admixture solution- Auxiliary labeling- Approximate final total volume of the admixture, whenapplicable- Prescribed flow rate (in mLs per hour)- Date and time of scheduled administration- Date and time of preparation- Expiration date- Initials of person who prepared and person who checkedthe IV admixture- Auxiliary labeling – supplemental instructions and precautions- Typically drugs are considered stable as long as they arewithin 10% of their labeled potency.
52 Administration Systems for Parenteral Products Continuous Infusions- More effective and less toxic than when givenintermittently.- Includes:1. Basic fluid and electrolyte therapy2. Blood products3. Specific drugs that require tight administrationcontrol to minimize adverse effects
53 Parenteral Systems continued… Intermittent Injections- Used to administer medications that work better wheninfused at defined time intervals rather than when infusedcontinuously.- Examples of drugs commonly given intermittently are:1. antibiotics2. drugs used to treat or prevent gastrointestinalulcers
54 Intermittent Injections continued… - Types of systems for intermittent injections:1. Large Volume Parenterals (PVC)a. Usually defined as those IV solutions containingmore than 100 mLb. Usually infused as solutions of dilute dextroseand/or sodium chloride as continuous infusionswith or without additives, but they can be usedfor intermittent infusions as well.- Commercially Available1. Preparations with additives are used in standardconcentrations, are stable in solution for long periods oftime.2. Available in a variety of sizes and containers3. Ready-to-use products are advantageous because they reducehandling by the pharmacy, - the potential for contamination.
55 Intermittent Injections continued… - Pharmacy Prepared1. Made in the pharmacy to meet the specific needs ofpatients2. Prepared in different volumes and different containersSyringe Systems- Most common drug delivery systems that use syringes are:1. syringe pumps2. volume control chambers3. gravity feed4. intravenous push systems- Require that the pharmacy fill syringes with drugs and label them.- Stability may differ from the stability of the same drug in otherdosage forms because of concentration differences.
56 Intermittent Injections continued… Syringe Pumps1. Used to administer drugs by means of a speciallydesigned syringe pump and tubing set.2. Pumps are either operated by a battery or acompressing spring.3. Pumps are also available to administer a single doseper setup or a 12 or 24 hour supply at preprogrammedintervals.Volume Control Chambers (Buretrol or Volutrol)1. The drug is injected through a port on top of thechamber, and solution is added from the primary LVP.2. With this system, minimal amounts of fluid can be given perdose, a method that may be beneficial in fluid-restricted orpediatric patients.
57 Intermittent Injections continued… Gravity Feed1. Tubing set has an air vent through which air entersthe syringe as fluid is pulled out by gravity.2. The system is relatively inexpensive and requires noother special equipment.Intravenous Push1. Drugs given by IV push are injected directly into theIV tubing and pushed into the patient quickly.2. Injected into an injection port, a Y-site on the IV tubing,or an injection flashball.3. Disadvantage – difficult to control the rate of drugdelivery with a syringe and many drugs cause thepatient to experience adverse effects when given tooquickly.
58 Intermittent Injections continued… Small Volume Parenterals (“Piggyback” Systems)1. Common method for drug additives to a smallvolume parenteral or piggyback (< 100 mL)2. The piggyback is placed higher than the primary IV(usually an LVP) so that gravity causes the drugsolution to run into the patient’s vein before theprimary fluid.3. The back-check valve at the proximal Y-site closesoff while the piggyback is being administered, thuspreventing the piggyback solution from entering theprimary IV.
59 Intermittent Injections continued… Add-Vantage – specially designed bag and a vialVial Spike System – similar in concept to the Add-Vantage system – not activated until just before administration.Premixed Solutions – often frozen and thawed by the pharmacy hours or days before administration.Bags/bottles containing powder for reconstitution – requires to be added to a bottle of 20 to 100 mL of solution – piggyback systemControlled-release infusion system (CRIS) – delivers medication directly form the vial to the primary IV solution.
60 Patient Controlled Analgesia (PCA) A method of drug administration usually used with injectable pain medications, which is very effective in managing pain.Two advantages of PCAs:- they eliminate the need for painful IM injections- reduce patients’ anxiety about controlling their painGoals of PCA – to relieve pain as soon as the patient recognizes a need for it.- may also reduce nursing time associated with painmedication administration.
61 PCA continued… Used with either a stationary or a portable pump. The pump releases a programmed amount of the pain medication into the IV tubing when the patient pushes a button.The pump is programmed to release an amount of pain medication that is specific for the patient’s weight and condition.The pump is also programmed to limit how often the patient may push the button and receive pain medication.
62 PCA continued…The pump may be programmed to allow a patient to receive a maximum of 1 mg of drug every 15 minutes. When the patient pushed the button, the pump injects 1 mg. If the patient pushes the button again in 10 minutes, the pump does not release the drug. If the patient pushes the button at least 5 minutes later (15 minutes since the last injection), the pump again administers 1 mg. This is often referred to as a 15-minute lock-out period.Differs from most other products in two ways:- if the patient does not have other means of pain control,there might be an urgency to initiate therapy.- these doses usually contain enough medication to last atleast 8 hours and often up to 24 hours or more.
63 Total Parenteral Nutrition Solutions Definition:- Total parenteral nutrition (also known as hyperalimentation,hyperal or TPN) is the IV administration of nutrients neededto sustain life: carbohydrates, protein, fats, water,electrolytes, vitamins, and trace elements.- Usually initiated in patients who cannot meet theirnutritional needs from other sources for an extended periodof time.- TPN is used for patients who cannot eat (e.g. head & neck surgery,comatose, or before or after surgery), who will not eat (e.g.patients with esophageal obstruction or inflammatory boweldisease or who cannot eat enough (e.g. patients with cancer,burns or trauma).
64 Components of Parenteral Nutrition Solutions Contain base components and additives- Base components are usually mixed first and make upmuch of the volume of the TPN. Composed of dextrose(carbohydrates) and amino acids (protein) and mayinclude fat and water.- Additives are usually mixed with the base componentsand include life-sustaining nutrients, electrolytes, vitamins,trace elements as well as heparin, insulin and H2antagonists.
65 Additives continued…Carbohydrates – usually administered in the form of dextrose because of its low cost and easy availability. Usually a 50 – 70% solution is used in TPN preparation, and the final dextrose concentration in the TPN is usually around 25% for solutions administered via central vein.Protein – required for tissue synthesis and repair, transport of body nutrients and waste, and maintenance of immune function. These solutions are available in concentrated form, such as 8.5 – 10% and diluted in the compounding process.
66 TPN continued…Fats – (lipids) are usually administered as fat emulsions. Administered as a source of calories. Available as 10 to 20% emulsions dispensed in a separate container given through a peripheral IV line. Fats can be added to the TPN solution (3-in-1 solution or total nutrient admixture). Considered a third base component along with dextrose and amino acids.Water – in all preparations and is usually derived from the components used in the preparation. The purpose of adding water is to offset normal bodily losses and prevent dehydration.
67 TPN continued…Electrolytes – needed to meet daily metabolic needs and correct deficiencies. Usually include sodium, potassium, chloride, acetate, phosphate, magnesium, and calcium.Vitamins – usually administered in a standard formulation o fat and water-soluble vitamins and are often abbreviated as “MVI.” When vitamin K (phytonadione) is needed it is usually given separately as an IM injection.Trace elements – required for proper enzymatic reations and for use of energy sources in the body. Typical elements administered are copper, zinc. Chromium, manganese, selenium and iron.
68 TPN continued… The proper order of mixing is: - add the fats first (adding concentrated dextrose may “oilout” or crack the emulsion)- the amino acid second- the dextrose last- remember the acronym “FAD” fats, amino acids, dextrose- this mixing order dilutes and buffers the fat emulsion withamino acids before the highly concentrated and acidicdextrose is added.
69 Automated Compounding Three primary pieces of equipment are used, sometimes together and sometimes individually.- An automated compounder prepares the base componentsdextrose, amino acids, and possibly fat emulsion & H20- A second automated compounder adds most or all of theadditives or other components- A computer with software maintains the orders of theingredients and controls the two compounders.
70 Compounding continued… The base compounder accounts for the specific gravity of the solutions being used and actually weighs the amount pumped into the final container.The additives compounder weights the solution to ensure proper volumes and flushes the line between injections to avoid incompatibility problems. The additives compounder must be used with the computer and cannot be programmed alone.
71 AdministrationMost TPN solutions are made for administration through a central line.This route is used because it results in immediate dilution of the solution being administered and therefore a very concentrated solution can be administered.Administering a concentrated solution often allows the medical team to completely meet an adult patient’s daily nutritional needs with 2000 to 3000 mL of TPN solution.Occasionally, TPNs are administered through a peripheral IV line – can contain same ingredient, but diluted to a lower osmolarity. Since the solution is more dilute, they do not meet al the patient’s nutritional needs. May need supplements for caloric intake.
72 Pediatric Parenteral Drug Administration Standardization of doses is not as common in pediatric patients as it is in adults.Their doses are usually calculated based on their body weight, resulting in much smaller dose than most adults receive.The volume of solution also is limited since their blood volume is considerably less than that of an adult.Intermittent doses are usually given by syringe through a volume control chamber or by using a syringe pump.
73 Quality Assurance Program The ASHP technical assistance bulletin describes three different levels of risk for products.Products are classified into one of the three risk levels based on:- How they are prepared- How long they can be stored- whether they are prepared for a single patient or as partof a batch, whether they are from a sterile or non-sterilesource.
74 Characteristics of Risk Levels - Sterile products w/o preservatives for individual patientsor batch prepared with preservatives for multiple patients.- These are sterile products transferred into a sterilecontainer (e.g. syringe, IV bag or bottle).- Storage time for these products, including administrationtime, should not exceed 28 hours at room temperature,7 days under refrigeration, or 30 days if frozen.
75 Characteristics continued… Risk Level II- These products are batch-prepared w/o preservatives formultiple patients.- These include products that require multiple sterile ingredientsthat are combined in a sterile container through a closed systemtransfer that are then subdivided into multiple parts.- Storage time for these products, including administration time,can exceed 28 hours at room temperature, 7 days underrefrigeration, or 30 day frozen.
76 Characteristics continued… Risk Level III- These products are compounded from nonsterileingredients, containers or equipment or prepared fromsterile or nonsterile ingredients in an open system.The pharmacist is likely to be responsible for ensuring compliance with the guidelines and other standards of practice.Areas of the document that affect the technician include training, policies and procedures, garb, aseptic technique, process validation, and end-product evaluation.
77 Process ValidationMeans procedures that ensure that the processes used in sterile product preparation consistently result in sterile products of acceptable quality.For most aseptic processes, validation is actually a method for evaluating the aseptic technique of personnel.Validation may be accomplished through process simulation.Process simulation is carried out just like a normal sterile product preparation process except that a microbial growth medium is substituted fro the products that would normally be used.
78 Process Validation continued… Once the sterile product is prepared, the growth medium is incubated and evaluated for microbial growth over a period of time.No microbial growth indicates that the person performing the preparation did not contaminated the product.Individuals should complete a process validation program before being allowed to prepare sterile products, and technique should be re-evaluated regularly.
79 End-Product Evaluation End-product evaluation is the final inspection made by the pharmacist before the product is allowed to leave the pharmacy.It includes an inspection for leaks, cloudiness, particulate matter, color, solution volume, and container integrity.The pharmacist also verifies compounding accuracy with respect to the correct ingredients and quantities.This check of the technician’s work is an important step in ensuring that only quality products are sent for patient use.