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| USP <797> Intent, . Applies to anyone who prepares • Is Enforceable | Prevent harm to pts due to microbial contamination, CSP’s – hospitals, home infusion, physician offices, nursing homes, etc.fines can substantial for failure to meet guidelines
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| Why USP <797> was developed. Practices standards were | Voluntary for many years but pharmacy didn’t follow good technique – many infections and adverse reactions to poorly prepared admixtures
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| guidelines for preparation of sterile products published by the American Soc. of Health Systems Pharmacy (ASHP) | 1970’s NCCLVP
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| 1992 ASHP guidelines | on quality assurance for pharmacy
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| 1994 USP chapter 1206 | (standards with #s > 1000 are recommendations, standards with #s < 1000 are regulations with required compliance)
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| If USP 797 fails, next step would be | to require pharmacies to meet FDA GMP (good manufacturing practice) guidelines which those required of pharmaceutical manufacturers
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| GAP – analysis done by | an organization to determine the areas where they need to improve in order to meet the guidelines
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| • CSP | Compounded sterile preparation
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| • ISO | International Organization for Standardization – sets guidelines for many different processes. In our area, we use ISO standards to describe the number of particles in the air.
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| • BUD | Beyond Use Date – the date beyond which a sterile preparation should not be used
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| • NCCLVP | – National Coordinating Council on Large Volume Parenterals
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| • USP | United States Pharmacopeia – non-governmental, not-for-profit organization that sets official standards for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States
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| Enforceability of USP | no enforcement authority just sets standards
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| FDA exercises “enforcement | discretion” (ie only involved if cmpding in bulk)
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| State board of pharmacy authority | YES, can choose to inspect for compliance
Accrediting bodies, YES (ie JCAHO, CHAP, etc)
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| Important Revisions to USP 797 | Hazardous drug section expanded – covers things like cancer chemo drugs and other potentially toxic drugs, Air, surface and finger tip sampling frequency and methods have changed – more stringent than in the past
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| Important Revisions to USP 797 | Hazardous drug section expanded – covers things like cancer chemo drugs and other potentially toxic drugs
Air, surface and finger tip sampling frequency and methods have changed – more stringent than in the past
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| Important Revisions to USP 797 | Staff that clean/disinfect cleanroom must be validated, Cleaning/disinfection frequency, use of sterile alcohol/gloves – immediate use < 12 hrs category which can be mixed outside a clean room. Extend stability guidelines of med risk prep (TPN) to 9days
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| Key Sections on Hazardous Drugs | Stored in containment of a negative pressure room (air pressure lower in clean room than outside)
When possible closed system vial transfer devices should be used – several special systems are available
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| Key Sections on Hazardous Drugs | Training required and must be documented
If workers have reproductive capability must sign they understand risk (male and female must both sign)
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| CSP (compounded sterile preparations) microbial contamination Risk-levels | Which drugs fit into each Risk level IS NOT assigned by USP 797 – pharmacy must decide which drugs fit each classification in their organization
Risk Level: according to the complexity of the preparation of CSP
High risk requires in add ISO8 anteroom
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| CSP (compounded sterile preparations) microbial contamination Risk-levels | ALL risk levels (except low risk/w 12 hours or less BUD. require use of LAFW (laminar air flow hood) (ISO 5) and clean room of ISO 7. Each risk level builds on the lower one – example Risk Level II must meet or exceed all the Level I + the Level II
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| • Low Risk level | Simple transfers, measuring, mixing w/ sterile closed. Prepared in ISO 5 hood, no more than 3 products being mixed (Annual skills validation required requires anteroom but doesn’t require a wall between anteroom and rest of cleanroom
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| • Low risk level w/12 hour or less BUD | Simple transfers, measuring, mixing w/ sterile closed or sealed packaging systems. Prepared in ISO 5 hood but doesn’t require a cleanroom environment, no more than 3 products being mixed. USED if can’t build clean room.
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| • Medium Risk-level | Multiple individual or small doses combined or pooled to prepare CSP for multiple pts or multiple doses for a single patient. Prepared in ISO 5 hood and ISO 7 cleanroom(Annual skills validation required)
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| Examples of medium risk preparations | TPN, preparing infusion pump cassettes with > 3 drug products
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| • High Risk | Non-sterile ingredients or device used for cmpding, when purity and potency of raw materials is assumed; Involves filtration with 0.2micron filter; must be prepared in ISO 5 hood, ISO 7 cleanroom, and ISO 8 anteroom(Semi Annual skills required)
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| Clean Rooms need | buffer room, is SECONDARY ENGINEERING CONTROL
Contains the PRIMARY ENGINEERING CONTROL DEVICES (Laminar flow hood, glove box isolators, etc)
Have HEPA filters in ceiling, maintain positive pressure
must be free of particulate matter
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| High efficiency particulate air filter(HEPA) | Filters anything larger than 0.2 microns (won’t block viruses)
In clean room and hoods
CAN NOT get filter wet during cleaning – you can carefully clean screen over filter
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| Laminar airflow hoods (LAFH) | Filter room air through pre-filter and HEPA filter May be Horizontal or Vertical Checked (certified) every 6 months by outside inspection company
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| Horizontal flow hoods | For Risk level I and II HEPA filter in back Most common primary engineering device Except for immediate use preps, must be inside clean room
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| Vertical flow hoods | HEPA filter is in top of hood Used to prepare hazardous drugs (chemo) Almost always in separated enclosure in the clean room
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| Compounding Aseptic Isolator(CAI) | “Glove Box” Products enter through airlock chamber Used to cmpd hazardous drugs within clean room or can be used where clean room not possible for making a few CSP’s
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| Syringes Tip types | Luer lock – screws together Luer Slip – forced friction connection Centered Eccentric Irrigation(catheter tip) – usually 60ml size
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| Syringe sizes | Never completely fill syringe Choose the smallest syringe to increase accuracy Sizes .3 to 60 ml, For IV push(bolus) going directly into the patient’s IV access device, DO NOT use less than 10 ml syringe. If running IV line, smaller size is OK.
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| Syringe Calibration Marks | Syringes are accurate to one half the smallest increment marking (ie 10 ml syringe, 0.2ml interval, accurate to 0.1 ml). The larger the syringe, the larger the interval between calibration marks
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| Parts of needle | Shaft: lubricated with silicone coating; Hub: larger end of the needle, connects to syringeBevel: slanted(pointed) part of needle(composed of bevel tip, bevel, and bevel heel)
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| Needle Types | Regular bevel: for most purposes including compounding injections Filter: for removing particles(for amps) Vented: equalizing pressure between vial and environment
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| Filter: for removing particles(for amps and other fluids) | 5 micron: filter large particles – glass shards and sometimes undissolved drug particles 0.2 microns: filters fungi/bacteria not virus 5 micron Filter straw: sometimes used with amps, doesn’t have sharp point
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| Products that must be sterile: | Anything injectable – IV, SQ, IM, intrathecal, epidural, etc Ophthalmic and otic solutions Most irrigation solutions
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| SQ Access | Short needle, inserted under the skin Common Uses: Pain meds or immune globulin infusions, insulin, premature labor Easily learned by pts and caregivers
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| SQ Access | If longer infusion required by us silastic catheter (rather than metal) DO NOT require Flushing because not inserted into vein Most SQ sets last 2-3 days, easily replaced. SQ sets can be single, dual, triple, or quad lumen
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| Peripheral IV | 1. Catheter enters small vein, usually arm or hand with metal introducer used to insert the silastic catheter (soft plastic part that remains in the vein)
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| Peripheral IV 2,3 | 2. Catheter usually replaced every 2-3 days (used mostly in short term therapy)
3. Don’t use for irritating drugs (vesicant chemo, TPN, some Antibiotics)
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| Peripheral IV 4,5 | 4. Require daily flushing with Heparin and Saline, adults and neonates 3-5ml saline and 2-3 ml Heparin 10 units/ml
5. Osmolality should not exceed 600 mOsm/L Try to keep closer to isotonic if infusing large volumes through a peripheral line.
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| Peripheral IV 6,7 | 6. OK to infuse up to 600 mOsm/L for small doses or short periods of time, but over time, > 500 mOsm/L will be irritating to peripheral veins.
7. Keep fluids in pH range of 5 to 9
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| Peripheral IV 8 | 8. Sometimes OK to give vesicant drug through peripheral IF the drug is only given over a few minutes and infusion is observed to be sure it doesn’t infiltrate – no continuous infusion of vesicants through peripheral line
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| Midline Catheter 1-2 | 1. Inserted peripherally into the basilic, cephalic or median cubital veins of either arm. The basilic is preferred. The midline catheter is advanced though the vein only to the mid-clavicular region.
2.No X-ray for placement(can be inserted at home)
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| 3-5 Midline Catheter | 3. Can last several weeks
4. DO NOT use midline for TPN, continuous infusions of irritating drugs, osmolarity of > 500, or pH <5 or >9
5. Require Flushing with heparin 100 units/ml and saline daily or if used
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| Pheresis catheters | Larger and sturdier than Hickman and most CVC, Often used for dialysis bone marrow transplants, stemcell harvestine, Are flushed daily SASH 1000 units/ml
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| Hickmen, Broviac or Leonard Catheters ( Central Tunneled) | Insertion is surgical procedure
Accesses subclavian vein (through chest wall) proximal tip of catheter advanced into superior vena cava
Distal end is tunneled and exits chest near nipple( the tunnel decreases risk of infxn & makes catheter secure)
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| Hickmen, Broviac or Leonard Catheters ( Central Tunneled) | Made of silastic (silicone elastomere), Can be single, double or triple lumen
Lasts months to years if cared for properly, Flushed daily with saline and heparin (100 unit/ml)
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| Implanted Ports | Surgically placed below top layer of skin and fat (chest)
Port accessed with L-shaped needle(Huber needle or port-needle)
Can stay in place for years if cared for properly
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| Implanted Ports | Risk for infxn is smaller than with external catheters
Are central lines
Flushed monthly with heparin and saline if not being used for infusions
Can have single or double lumen ports
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| TPN administration Methods | TPN soln must go through a central line. CAN NOT be infused through peripheral or midline catheters unless the dextrose concentration is < 10%. May infuse through CVC
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| Types of Sterile diluents | SINGLE USE vials: contain no preservatives, discard after one use, may be left in hood for short period of time, but cannot be kept from one day to the next, even if left in hood
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| MULTIPLE USE vials: contain preservatives (Benyzl Alcohol, parabens, phenol, or benzalkonium chloride), can be used | several times and be removed from hood between uses. Due to USP 797 max days of use is 28 days after entering vial for the first time.
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| preservatives are | OK in small amts in adults, DO NOT use preservatives in neonates (toxic esp. benzyl alcohol) – toxic and may be fatal in large quantities
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| Diluent With preservatives – multiple use are | Bacteriostatic water for injection, Bacteriostatic 0.9% sodium chloride for injection
Preservative-free Sterile water for injection, Sterile 0.9% sodium chloride for injection
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| Patient Risks during IV therapy | Infection, Air Embolism, Allergic Rxn, Incompatibilities, Particulate matter, Pyrogens
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| methods of infusion of IV's depend on the | VRD known as volume, rate and duration
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| Clinical rate infusion restriction depend on two things | Manufacturer and the clinical guidelines
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| Location of a patient recieveing IV meds will be located in 4 places | Home, Hospital, Clinic and Nursing Facillity
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| Things to consider when selecting a device for a Pt is | unstable ion balance, staffing available to properly infuse drugs, cost of device, behavior of the IV equiptment and ability of Pt to take own IV meds.
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| Advantages of IV push med are | prepared in syringes, directly given into the IV access, Smaller vol given in shorter time frames.
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| IV push is also advantageous due to | cheap, easy, portable and works for most IV drugs (not all).
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| Disadvantages to IV push is | Head pressure has to be considered, some drugs cant be given fast but need to be infused slowly.
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| Syringe pumps are used for | a controlled rate for smaller IV doses, there is no IV bag
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| Syringe Pumps are advantageous due to | a controlled rate of injection, small and portable, less expensive than IV drip systems, good for younger Pt small infusions
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| Syringe Pumps are hard to | program, you need dedicated tubing and can cost in the range of 500-2000 dollars.
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| Elastomeric devices are used for | smaller volumes that are portable, easy to use, the rate of infusion is based on the size of the bag. To know what device to use for elastomerice use you need size and desired rate.
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| Advantages of elastomeric devices | great for home care, discard when done, easy for the patient to learn and there is no IV pole
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| Disadvantages of ELASTOMERIC devices are | Cant adjust the rate of infusion, may be bulky and takes us lots of space, cost more than an IV push.
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| Gravity infusion medications are | simple, have to be placed on a pole and require tubing, rate is adjusted by a roller clamp. Good for drugs where the rate is not that important and used in simple infusion procesees
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| Advantages to gravity drip is | inexpensive and the infusion rate is flexible
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| Disadvantages to IV gravity infusion are | very hard to control the rate of infusion, height of IV pole/bag can influence the rate of drug infusion.
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| IV gravity infusion rate control is | the rate is monitored by the dial flow meter that is built into the tubing, the IV rate prevents the soln from exceeding the desired amount of IV fluids, accuracy of the IV fluids depends on the Pt pole height and IV access diameter of vein.
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| IV gravity infusion rate control advantage is | inexpensive tubing, good for IVPB over 1-2 hrs, used in home and NF settings,
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| IV gravity infusion rate control disadvantage is | Pole must be at the proper height, just prevents the rate from being to fast and not specific rate.
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| Pole mounted pumps have | pump mounted on the pole, works best for Pt that are bed fast, counts the drops,
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| Pole mounted pumps advantages are | Flex use of pump, wide range of rates that programed and used, pumps may be able to infuse multiple drugs at one time.
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| Pole mounted pumps disadvantages | Not good for uneven floors, large device that is meant to be in one place, requires dedicated tubing
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| Ambulatory pumps are | small and easy to carry, easy to use, secure with lock out properties to prevent Pt from getting hurt, errors are easy to be read.
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| Ambulatory pumps are advantageous use cause they are | flex in uses, good for in home use, battery powered, not position dependant, very accurate
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| Ambulatory pumps are not ideal due to | Need to have dedicated tubing, must carry the soln with you in a bag.
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| NIOSH is in charge of | PPE standards and is part of the CDC, defines chemicals and their nature,
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| Carcinogenicity is | causes cancer
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| Tetragenic is causes | birth defects
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| Organ Toxicity | is toxic to organs i.e the kidney and others.
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| Types of harmful drugs will be | Cytotoxic, antineoplastic, antiviaral, immunosuppr;essive, bioengineered, or any drug that presents a cuasitive level of harm.
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| Employers must follow these guidlines for NIOSH | Written procedures and policies for dealing with hazard chemicals, must address pregnancy, recieving, storage, transport, prep, admin and then disposal of haz drugs.
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| NIOSH also requires the use of | MSDS, PPE available, drug spill managment and monitor compliance.
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| Employees need to follow NIOSH by | training before handling chemicals, correct use of chemicals, knowledge of working policies.
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| IF there is a chemo spill | There should be a chemo pill kit, MSDS available
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| If chemo spills in the work place to clean it up you must first then | remove chemo gown, cleanse with soap and water, flood area with water for 15 min, obtain med attention and document faculty protocol.
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