Aseptic Technique and Sterile Compounding

Transcription

1 Aseptic Technique and Sterile Compounding Chapter 12 1 Introduction Hospital technician crucial responsibility: Proper preparation of parenteral products Contamination must be reduced when preparing parenterals Only use proper manipulation of materials within a special hood Bacteria and contaminants could affect the drug and the patient What are some possible contaminants? (Contaminants can come from workers clothing, hands, noses, and mouths. Environmental contaminants include dust and other airborne particles. Cross-contamination between medications can occur if needles and syringes are improperly used, or if work areas are not properly cleaned between preparation sessions.) Sterile and aseptic mean the same thing: free from all pathogens (biological contamination). Aseptic technique involves procedures used to eliminate the possibility of a drug becoming contaminated with microbes or other unwanted particles. The pharmacy technician may prepare CSPs in pharmacy settings such as home health services and long-term care facilities, as well as hospital pharmacies. 2 Terminology Used in Pharmacy Solutions, medications, and supplies needed Written doctor s orders contain symbols and abbreviations Understanding terminology is important in filling stock Attention must be paid to strength, form, dosage timing, route of administration 3

2 Standard Precautions of a Health Care Worker Nurses and doctors follow these procedures in order to protect the patient and the health care worker. Hospitals usually require an employee to receive both TB testing and an annual flu shot Standard Precautions (i.e., Universal Precautions): All blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents 4 Standard Precautions of a Health Care Worker (Cont.) Injectable drugs and other sterile products must be made in a clean room under laminar flow hoods Laminar flow hoods are recertified every 6 months by an independent contractor Routine cleaning of the hoods includes cleaning all work surfaces and prefilters All inspections are to be kept on file Injectable drugs enter the body via the veins and bypass the natural defenses of the gastrointestinal (GI) system. They have to be sterile. The IV hoods must be certified and verified every 6 months or whenever moved to ensure their ability to filter contaminants. 5 Commonly Used Supplies for IV Room 70% isopropyl alcohol Alcohol pads Amp breaker Filter needles Filter straws Filters Male/female adapter IV rooms also contain sharps containers for disposal of needles and syringes. An amp breaker is a disposable collar or a reusable device that helps prevent cuts. When using disposable amp breakers, leave the tip inside the breaker and dispose of it in the hazardous waste container. Products that have been tested and shown to cause adverse or toxic effects in humans are classified as hazardous. Examples of these types of medications include chemotherapeutic agents, radioactive compounds, and various hazardous chemicals such as phenol and glacial acetic acid. A filter needle may only be used for one draw (push or pull); either it can be replaced by a regular needle before the drug is pushed into a piggyback container or a regular needle can be used to withdraw the solution and then a filter needle can be used to push the filtered solution into the piggyback container; otherwise, the glass that is trapped in the filter needle will be pushed into the final solution. 6

3 Commonly Used Supplies for IV Room Can you think of any other supplies and equipment not listed on the slide? (Students might mention cleaning materials; protective clothing such as gloves, gowns, and goggles; and labeling supplies.) Syringe needles, syringe caps, syringes Transfer needles Tubing for pumps Tubing transfer sets Mini spike Forceps 7 Syringes Eight basic sizes: 0.5, 1, 3, 5, 10, 20, 30, 60 ml Two types of syringes: Tension: 1 ml (for withdrawing insulin and other medications 1 ml) Luer-Lok: Hold needles in place by a lock mechanism Plastic syringes: Disposed after one use Glass syringes: Can be sterilized and reused Tubex or Caruject: Can hold variety of medications and come in many volumes As the size of a syringe increases, the accuracy of measurement decreases. Tension-type syringes have needles held on by friction; these cannot be used for chemotherapy preparations because of the risk of the needle coming off. Luer-Loks ensure a safe seal. The bottom of the syringe is screwed into the Tubex holder, which can dispense 0.5-mL to 3-mL volumes. A tension-type syringe has a 1-mL volume. In this case, the needle is attached by friction only. This type of syringe can be used for withdrawing insulin and other medications that require volumes equal to or less than 1 ml. 8 Two Types of Syringe Tips The hub (colored part of a needle) is a critical site and cannot be touched by hands during aseptic manipulation. From Potter PA, Perry AG: Fundamentals of nursing, ed 8, St Louis, 2013, Mosby. 9

4 Tubex Holder with Cartridge Inserted Tubex holders are reusable. An example is prefilled injectable heparin. 10 Needles Needles in the pharmacy are used to draw solutions into a syringe, not to administer medications. It is more important for a technician to choose an appropriate-size syringe than to worry about the correct needle gauge. Aluminum or stainless steel Different gauges (sizes) and lengths Most are used by nurses to administer injections Used to draw solutions into a syringe 11 Needles Rule in sizing: Gauge number of a needle is inversely proportional to the needle s bore size Bore size increases as gauge decreases 25 G needle smaller opening than 19 G Most common sizes: 19 G, 18 G, 16 G Length will be determined by the type of injection; for example, IM needs to go into a muscle. The gauge (size) number of a needle is inversely proportional to the bore (opening) size of the needle. The bore size refers to the circumference of the needle opening. 12

5 Needles (Cont.) Length: Can be 1 to 1½ inches Coring increases as bore size increases Bevel up: Avoids coring Filter needle used if coring occurs No part of the needle below the hub should be touched when preparing medications What are the advantages and disadvantages of larger bore sizes (that is, of smaller gauges) for the pharmacy technician? (Even though less effort and time are required to draw liquids into smaller-gauge needles, there is a greater chance of coring the stopper. Nurses who administer medications with syringes and needles must also factor in patient comfort.) When a vial stopper is cored by a needle, a chunk of rubber is dislodged and can fall into the vial. The bore size refers to the circumference of the needle opening; as the bore size increases so does the probability of coring or cutting out a piece of rubber from the vial's rubber stopper. 13 The smaller the gauge, the larger the needle. Anatomy of a Needle 14 Filters Smallest: 0.22 microns; removes unwanted particles larger than 0.22 microns from solution Filter straw is a straw-like needle used to remove any fine particles of glass from an ampule Some medications cannot ever be filtered If use of a filter needle is necessary, the technician must follow the manufacturer s guidelines regarding filter needles suggested for the specific medication. A regular needle is used first to pull the solution into the syringe, the needle is then replaced with a filter needle and the solution is pushed into the IV container. 15

6 Stock Levels IV medications, syringe and needle supplies, and hood-cleaning supplies must be kept in stock. Each box of IVs in the freezer must be marked with the expiration date and, once thawed, must be marked with the new expiration date. IV room: Stock kept at minimum level at all times IV technician: Stocks IV room before and after each shift Central supply: Area of hospital where IV supplies can be obtained Technicians make extra IVs or batches to be used all week; some IVs can be frozen Large temperature-controlled refrigerators used to store IVs and recycle medications Multiple-dose vials stored in refrigerator for days 16 Routes of Administration Medications are given different ways and can be added to a bag or left in a syringe, depending on the route to be given. Understanding the routes of administration is important as the solutions prepared differ in their volumes and/or concentrations The label must note the route of administration 17 Medication Delivery Systems Parenteral medications normally are administered via a syringe or an automated delivery system. Containers: Many types are used to dispense medication They are stable and easy to use Medication: When reconstituted, it must be used within certain time or it expires and money is lost 18

7 Piggyback Containers Piggyback containers are containers that are attached to a system, such as a pump, to dispense medication. Flexible bags and bottles: Two main types of piggyback containers They are purchased prefilled with solutions or empty for use in preparing custom IV Sizes range from 50 ml to 250 ml Insulin cannot be placed in bags; put in glass containers 19 Piggyback Containers (Cont.) Pumps are used to maintain a certain rate of infusion and can be ambulatory or fixed. Specialized containers: Large- and smallvolume drips Buretrol systems Continuous analgesic delivery systems Patient-controlled analgesia syringe system Patient-controlled analgesia cassette system 20 Large- and Small-Volume Drips Some IVs are mixed in large bags and given over several hours as continuous. Large-volume Viaflex bags in four sizes: 500 ml, 1 L, 2 L, 3 L Deliver a variety of fluids, including parenteral nutrition Parenteral nutrition: Combination of essential nutrients administered over several hours 21

8 Continuous Analgesic Delivery Systems Some analgesics (pain medications) are aimed at relieving extreme pain and can be provided with a programmable ambulatory pump. Most are small and portable. Analgesics required after surgery and for hospice patients Morphine: Prepared by pharmacy technician for patients who require it Ambulatory or portable pumps can be programmed for delivery of medication These pumps can be set for short or long durations to deliver medication, not to exceed a 24-hour period Especially effective for those patients who require constant pain control 22 PCA Syringe System Cassettes are small enough for the patient to wear. Patient-controlled analgesia (PCA) is a method of administration that allows the patient to control the rate at which the drug is delivered for the relief of pain. Patient-controlled analgesia (PCA) device used to administer controlled substances Regulated by a computerized device that automatically dispenses the medication Bolus: Preset amount of drug administered to patient when pain intensifies; prevents patient from overdosing Used mainly in hospitals 23 PCA Cassette System Special plastic containers are used as bags when preparing the medications for the pumps. PCA cassette system can be used at home Pumps are preset for dosage administration Priming the line (tubing) is required after the cassette is filled 24

9 History of USP <797> Dramatic increase in nosocomial infection led to guidelines for parenteral medications Other organizations established standards for pharmacists and technicians in parenteral preparation Standards and guidelines weren't enforced in 1990s 2004: USP <797> standards were enforceable 2008: USP guidelines updated 25 Nosocomial infections, or health care-associated infections (HAIs), are infections that originate in a hospital. These organizations included the American Society of Health-System Pharmacists (ASHP), the National Association of Boards of Pharmacy (NABP), and the United States Pharmacopeial Convention (USP). For example, most pharmacies did not perform quality assurance checks or solution tests on a regular basis for prepared parenterals, and many did not provide education and training for personnel on a periodic basis. Pharmacies and other areas that prepare compounded sterile preparations must research, create, and document their standard operating procedures (SOPs) for meeting USP <797> regulations. Nosocomial infections, or health care-associated infections (HAI), are infections that originate in an institutional setting. In 2008, the USP regulations were updated. The risk categories of CSPs were revised and a new low-risk, 12-hour BUD category was added. New guidelines were given concerning the use of single-dose and multi-dose vials. Specifics about the minimum frequency of cleaning and disinfecting the clean room were outlined. USP specifically deals with sterile products. The USP standards are to be met by all practice settings where sterile products are compounded, including any medications prepared by nurses, physicians, or other practitioners that are intended for patient administration. As a result of the enormous expense required to create these new areas, many hospitals now contract out the preparation of compounded sterile preparations to specialized pharmacies. USP <797> Chapter 797 is specific for the requirements and procedures for aseptic technique. Gives guidelines for the preparation of parenteral and other sterile medications Three major sections Responsibilities of personnel Verification Training 26 Risk Levels USP <797> has identified three risk levels: Low: Medications that are prepared from sterile products Medium: Bulk compounding High: Products susceptible to contamination due to the preparation of non-sterile products and/or delayed sterilization The technique must require only minimal manipulations within the hood. This is the most common type of IV preparation performed. A hyperalimentation is an IV nutritional product prepared for individuals who are unable to take in food through the alimentary tract. Many manipulations must be performed while in the hood. Technicians must demonstrate that they can prepare such a product and ensure its sterility. 27

10 USP 797 guidelines determine the requirements for aseptic preparation. Requirements for Compounding All personnel who prepare parenteral medications must be trained and monitored for compliance with techniques Products must be stored according to manufacturer guidelines or other scientific findings 28 IV Environment The ante room is often referred to as the gowning or garbing room. The clean room is where aseptic technique actually takes place inside the hood. The anteroom is adjacent to the clean or buffer room. Refrigeration should be 2º to 8 C or 36º to 46 F. Anteroom: Room adjacent to the buffer room Clean room: Room where aseptic technique takes place inside a controlled airflow area, such as a LAFW or BSC (hood) Must meet stringent minimums pertaining to air particulates at all times 29 Hood Cleaning and Maintenance Types of hoods: Horizontal (LAFW) Vertical (BSC) In a laminar airflow workbench (LAFW), a technician must work 6 inches from the sides and front of the hood because the sides create a disruption of airflow. BSC = biological safety cabinet. The hands cannot move behind the vial, needle, or IV bag in a horizontal flow hood or airflow will be blocked and aseptic technique will be broken. Critical areas such as vial tops or needle hubs cannot be touched as well. 30

11 LAFW HEPA filters are high-efficiency particulate air filters. When cleaning a laminar flow hood, do not allow alcohol to make contact with the filter because it breaks down the filter. Laminar flow airflow workbench (LAFW): Airflow flows from back to front through an HEPA filter that traps all particles larger than 0.22 microns Space items to ensure no disruption in airflow Stay within 6 inches of edge or opening of hood 31 Barrier Hoods Totally enclosed and referred to as glove box or barrier isolator Reduces risk of contamination by using HEPA filter and additional airflow system These systems have outer areas to stage your materials and a door to enter the main space. Hoods must be inspected every six months and every time the hood is moved. Glove boxes are closed systems that use a high-efficiency particulate air (HEPA) filter and a sophisticated venting system, which provide the greatest amount of safety to the preparer because of the containment ability. 32 Cleaning Hoods and Preparing them for Use Use proper cleaning and solvent methods Clean before compounding Horizontal laminar flow hood: Clean all inner surfaces with lint-free wipes; inspect surfaces for crystalized solutions; disinfect all surfaces of hood and work area Vertical laminar flow hood: Clean all inner surfaces with lint-free wipes; inspect surfaces for crystalized solutions; disinfect all surfaces of hood and work area For cleaning the horizontal laminar flow hood, you'll need lint free wipes/ gauze, sterile water, and 70% sterile alcohol. Use a new wipe for each section of the hood. For chemotherapeutic agents, a vertical flow hood can be used because of the direction of the airflow and the specifications of the hood. A biological safety cabinet (BSC) protects the person preparing the chemotherapeutic agent, because these medications can be harmful if inhaled or contacted by the skin. 33

12 Aseptic Technique Used to prepare all parenterals Goes hand-in-hand with universal precautions Universal precautions used by all healthcare workers when dealing with fluids body produces Aseptic technique is used to keep contamination from occurring by a product or to a product Contaminated medication causes serious infection, death Aseptic technique begins with thoroughly washing the hands and arms up to the elbows, which is followed by putting on gloves and a gown, if necessary. Only then can the technician approach the work area to clean the hood and prepare medication. 34 Hand Placement In a vertical flow hood, the hands should not move over the top of any vial, needle, or IV bag. Placement of hands is important aspect when preparing sterile medications Do not block the airflow Do not overload the hood with drugs and supplies 35 Use of Ampules to Prepare Medications IM examples: Antibiotic like Rocephin. IV push: Pain medication or Pitocin from inducing labor. Technicians prepare these for delivery in syringes with tamper-proof caps. Intravenous push or intramuscular (IM): Prepared by nurse at nursing station or at patient s bedside Pharmacies prepare some IV push and IM medications Agents placed in syringe and sealed with syringe cap 36

13 Use of Ampules to Prepare Medications There are seven procedures to follow when preparing syringes from ampules Other injectables are premade from manufacturer, including Tubex ampules Remember to use a filter needle when transferring drug from an ampule because small pieces may break off and fall into the solution Liquid must be untrapped from the tip of an ampule before a syringe can be prepared. A filter needle must be used to remove microscopic pieces of glass from a broken ampule. A label must be placed on a syringe without covering the calibrations. 37 Vials When an MDV solution is used, the date the vial was opened must be written on the label, along with the initials of the person who opened the vial. Single dose: For immediate use Multidose: Used more than once ADD Vantage System: Placed on a small piggyback via an adaptor Controlled release infusion system: Solution mixed but not added to piggyback 38 Drawing Medication from a Vial Using alcohol, swipe the top of the vials and the ports on the IV bags from back to front (move around the vial and bag rather than over or behind) Place the needle bevel side up and push it into the vial s rubber stopper Preload the syringe with the necessary amount of air to replace solution Invert the vial and syringe 180 degrees Push in the air from the syringe and pull out the solution 39

14 Drawing Medication from a Vial (Cont.) After removing the syringe from the vial, insert the needle into the IV bag and inject the medication using a steady hand After injecting the IV bag with the medication, immediately flip the bag over Never recap the used needles; instead, throw away each syringe in a sharps container along with the uncapped needle after use Syringes cannot be reused when changing from one drug to another This decreases the chance of drug-to-drug contamination 40 Parenteral Antibiotics and Solutions For examples of suggested dosing times, solutions, and appropriate volumes Guidelines are determined by the manufacturer and are determined by which microbe is being attacked. Antibiotics: Guidelines for dosing regimen Pharmacies: Instructional chart as to amount of diluent needed, normal dosing time, expiration date, how to prepare, and how long powder takes to dissolve in diluent When adding a diluent to a vial, an equal amount of air must be removed from the vial or a positive pressure is created Using the see-saw method lets some fluid into the syringe while replacing the same amount with air 41 Hyperalimentation Trauma patients are also candidates. Regardless of how many milliliters run per hour, the hyperalimentation solution must be changed at least every 24 hours to ensure sterility. Also known as hyperals Large volumes of parenteral nutritional solutions made for persons who cannot take nutrition orally Reasons: Stomach or intestinal surgery, conditions that affect GI system, coma 42

15 Hyperalimentation (Cont.) Two main types: Total parenteral nutrition (TPN) Peripheral parenteral nutrition (PPN) Home health clinics, hospitals: Prepare 1 week s worth of hyperals Electrolytes tested weekly instead of daily In a hospital, electrolyte levels are tested daily so that hyperals can be altered to compensate for any changes. All TPNs contains dextrose and amino acids; both ingredients help nourish the body. The metabolism of dextrose (i.e., sugar) provides calories and a quick energy source for the body, whereas amino acids are the essential components that the body uses to synthesize protein, needed enzymes, and other important molecules. 43 Hyperalimentation (Cont.) Preparation: Different protocols Large volumes come premixed; electrolytes and other medications added TPN: 50% dextrose, 10% AA, 20% fat PPN: 25% dextrose, 10% AA, 10% fat Hyperals are prepared for neonates, children, and adults Neonatal and pediatric additives differ in concentration from adult formulas The premixed solutions for TPN normally contain 50% dextrose, 10% amino acids, and 20% fat. PPNs normally contain 25% dextrose, 10% amino acids, and 10% fat. Each TPN is custom made for the patient based on calories and electrolyte values. 44 Hyperalimentation (Cont.) TPNs: Given IV via subclavian vein and superior vena cava (high concentration of nutrients) PPNs: Given via large peripheral vein Typical volume: 2 L to 3 L Where are the subclavian vein and the superior vena cava? (The subclavian vein and the superior vena cava are large veins just above the heart that carry blood from the head, neck, chest, and arms. IV and catheter lines that are placed in these veins are often called central lines.) PPNs are given via the back of the hand or another peripheral area in the upper extremity 45

16 Electrolytes and Additives All TPNs contain dextrose and amino acids Lipids commonly added Other medications: Ranitidine, cimetidine, famotidine, insulin (regular) Dextrose provides quick energy, amino acids allow the body to build needed enzymes and other molecules, and lipids are needed for metabolizing important cell components. What class of drugs are ranitidine, cimetidine, and famotidine? (They are all antacids [more specifically, H2 antagonists]). Medications such as ranitidine, cimetidine, or famotidine (all histamine-2 antagonists) that help patients with gastrointestinal (GI) problems can be added to hyperalimentation preparations. Insulin is often added in quantities up to 100 units per bag. Only regular insulin is added to hyperalimentation preparations, because regular insulin is the only insulin product that may be administered intravenously. Electrolytes are also added to TPNs. Sharps containers are to be replaced when two-thirds full and must be picked up or delivered to an approved red bag or medical waste treatment site. Normally, a 7-gallon size is used and is located outside the horizontal flow hood. When cleaning a vertical flow hood, needles, syringes, and vials are discarded in a small sharps container placed inside the hood area. All materials used in the BSC, including disposable needles and syringes, must be placed in appropriate sharps disposal containers and discarded as infectious waste. This is contained inside the hood area. 46 Compatibility Considerations of Parenteral Medications The Handbook on Injectable Drugs is a good reference for compatibility of parenteral medications. Different types of medications prepared in IV room Some protected from light Some kept in bottles Reference books available 47 Components of an IV Label In a hospital setting, labels must contain the patient s full name, medical record number, room number, name of drug, strength of medication, the name of the solution with which the medication was mixed, the rate of infusion, and the expiration date. Final step is application of label Label is checked against medication and doctor s orders Pharmacist checks, along with vial used for preparation Delivery takes place 48

17 This is an example of an IV label. IV Medication Label 49 Disposal and Spills Most sharps containers are made of heavy-duty plastic; they have a separate lid that can be locked into place on top of the container and a one-way opening in the lid for the disposal of needles and other sharps. If a small spill occurs in a BSC, wipe up the spill with a disinfectant-soaked paper towel, and then clean the surface with 70% isopropyl alcohol. All unused materials or used products should be discarded in designated containers after use of hood Last step: Hood countertop must be wiped down Dispose of needles in a sharps container If a spill occurs in a horizontal flow hood, it may be cleaned using a gauze pad and 70% isopropyl alcohol If a small spill occurs in a vertical flow hood, it should be cleaned up with sterile gauze 50