Compounding III Flashcards
1
Q
What are two very important records that each compounded product must have?
A
The master formula record and the compounding record
2
Q
What is the master formula record?
A
The master formula record is the recipe that is followed to compound a preparation
*What you SHOULD do
3
Q
What is the compounding log or record?
A
The compounding log or record is the log book of all products made at the pharmacy
*What you DID
4
Q
What is the requirement for documentation in the compounding log?
A
The documentation in the compounding log must be detailed enough that another trained person can replicate the steps involved in the preparation, evaluate if the procedure was correct and trace the origin of all components
5
Q
What must the pharmacy keep with regards to documentation of compounds?
A
The pharmacy must keep records of steps and processes that relate to the compounder product, such as equipment cleaning, calibration and maintenance, temperature logs for the refrigerator, freezer and room air, and the records of chemicals, bulk drugs and drug products
6
Q
What must pharmacist do prior to preparing a compound?
A
The pharmacist will need to evaluate the prescription and determine if it is appropriate for the patient, and whether the proposed formulation is reasonable
7
Q
When ready to compound, what are some examples of initial steps?
A
Calibrating equipment and weighing ingredients
8
Q
What are some common final steps of compounding non-sterile preparations?
A
Packaging and performing quality control (QC)
9
Q
What documentation must be reviewed prior to compounding?
A
Always review the Safety Data Sheets for each bulk ingredient to determine safety procedures for the staff who will compound the preparation, including the recommended the personal protective equipment (PPE)
10
Q
What should be included in a master formula?
A
- Compound’s Official or Assigned Name, Strength, Dosage Form
- Calculations
- Ingredients, with quantities
- Stability & Compatibility data, with references
- Equipment
- Preparation/Mixing instructions
- Labeling information
- Packaging/Storage requirements
- Quality Control (QC) procedures, with expected results
- BUD, recommended
- Description of final product
11
Q
What should be included in a compounding record or log?
A
- Compound’s official name or assigned name, reference # for Master Formula, Strength, Dosage Form
- Specific to this preparation: Ingredients (including manufacturers/sources, lot numbers & expiration dates), Steps followed, QC results, BUD, actual (assigned), Description of final product, The product’s assigned lot or prescription number (a duplicate prescription label can be attached to the log)
- Staff involved with the preparation: compounder, person who did QC, RPh who approved final product, with dates
12
Q
Where should non-sterile hazardous drugs be compounded?
A
Preferably in a containment primary engineering control
*Efforts must be made to protect the staff with techniques to reduce exposure and all equipment used for HDs, including counting trays and spatulas, must be dedicated for HDs only, and sanitized after use
13
Q
Where should final formulations of non-sterile HDs be placed?
A
The final formulations, when possible, should be placed into unit-dose sealed packaging, and placed into a plastic bag with a hazardous label
14
Q
What should the minimal amount of PPE include?
A
Minimally, PPE should include a clean lab coat and gloves when preparing non-sterile, non-hazardous preparations
15
Q
What are the typical initial steps for compounding non-sterile HDs?
A
1) Calculate the quantities needed for each component
2) Gather all the components and the equipment needed
3) Wash equipment, if needed, and calibrate
4) Perform hand hygiene and garb
16
Q
What are typical completion steps of compounding non-sterile HDs?
A
1) Package the product and apply the container label and any needed auxiliary labels. A duplicate container label can be placed on the compounding record
2) Perform QC: validate the weight, check the product for mixing adequacy, color, clarity, odor, consistency and pH. Enter the measurements and observations in the compounding record
3) Counsel the patient, and if any subsequent ADRs are reported, add them to the compounding record
17
Q
What is comminution?
A
Comminution means to reduce particle size by grinding, crushing, milling, vibrating or other processes (manual or mechanical)
18
Q
What would be a suggested process of comminution?
A
The compounder likely starts off with coarse granules or broken tablet pieces. Powders will be finely ground into particles that range in size from 0.1-10 microns. After the powder has been ground, it is placed into a sieve
19
Q
What are the purpose of sieves?
A
Sieves, which are sifters, are used to ensure that the particle size is uniform. The powder is put into the sieve and sifted through the mesh. Once placed into the sieve, the powder is stirred with a sieve brush or a plastic spatula to force the particles through the mesh
20
Q
What determines the sieve number?
A
The sieve number is based on the number of holes per inch
*A high mesh size has many wires that make many holes, and only a fine powder will get through the mesh
21
Q
What are three methods of comminution?
A
Trituration, Levigation and Spatulation, Pulverization
22
Q
What is trituration?
A
A general term used to mean “mix thoroughly” (or make the product homogenous). Pharmacists most commonly associate trituration with grinding tablets with a mortar and pestle until a fine powder is achieved, but the term can describe liquids
23
Q
What is levigation?
A
Levigation involves triturating the powder with a mortar and pestle and incorporating a small amount of liquid (called a levigating agent or wetting agent). This helps with the grinding process and creates a uniform paste
24
Q
What is spatulation?
A
Spatulation is similar to levigation, but performed on an ointment slab with a spatula (not with a mortar and pestle)
25
What is pulverization by intervention?
Pulverization by intervention is used for crystalline powders that will not crush easily. The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates. When the powder recrystallizes, the particles are finer
26
What is geometric dilution?
Geometric dilution is a method of mixing ingredients to ensure that ingredients are evenly distributed in a diluent or delivery vehicle
27
Describe the process of geometric dilution
A small amount of the drug is mixed into an equal amount of the diluent. After the initial small amount is thoroughly mixed, another equal amount of the ingredients is mixed in. This is repeated until all the ingredients are mixed together
*Geometric dilution can be used with dry powder ingredients alone, or when making a paste
28
What should be done if multiple ingredients are required for geometric dilution?
When using multiple ingredients, begin with the ingredient that has the smallest quantity, followed by the ingredient with the next smallest quantity, and up until each has been added. With each addition, the amount should be roughly doubled
29
What is a solution?
A solution is a solute dissolved in a solvent. Solutions are homogenous and if the solution concentration is too high, it can lead to unwanted precipitation. Solutions are usually for oral use
30
What are different types of solutions?
Syrups, elixirs, tinctures, spirits
31
What are syrups?
Syrups are oral solutions with sucrose, other sugars or artificial sugars
32
What are elixirs?
Elixirs are sweet hydroalcoholic solutions used for drugs that would be insoluble in a purely aqueous formulation (hydroalcohol is a mixture of alcohol and water)
33
What are tinctures?
Tinctures are plant or animal extracts dissolved in alcohol or hydroalcohol
34
What are spirits?
Spirits are alcohols or hydroalcohols of volatile, aromatic compounds, such as camphor. Volatile means the compound vaporizes (evaporates) easily
35
What is a suspension?
A suspension is a solid dispersed in a liquid. It is a two-phase heterogenous mixture
36
What is a wetting agent/levigating agent?
A wetting agent/levigating agent is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension
37
What is considered a desirable suspension?
A desirable suspension does not have rapid precipitation of the solids; particles can be redispersed easily by shaking
38
What is an emulsion?
An emulsion is a liquid dispersed in a liquid. It is a two-phase heterogenous mixture. Emulsions are oil-in-water (oil droplets in an aqueous vehicle) or water-in-oil
39
What is an emulsifier?
An emulsifier is a type of surfactant that is used to reduce the surface tension between two liquids. The emulsifier allows the two phases to come closer together
*to make the emulsion, the emulsifier will need to be carefully chosen, according to the hydrophilic-lipophilic balance (HLB) number
40
What is precipitation/sedimentation?
Precipitation/sedimentation is when the dispersed phase settles (clumps) together. The process of a solid settling on the bottom of a container is sedimentation. This can happen with suspensions and emulsions, and less commonly with solutions. Shake or gently roll to re-disperse
41
What are the steps to prepare solutions?
Prepare the ingredients, and reduce the particle size of the drug/s to form a fine powder. This initial step in preparing any solution will be to determine if the solute will dissolve in the solution. The drug should remain soluble at different temperatures that may be encountered. Determine if the solution will be stable at the desired temperature. Flavorings, sweeteners and coloring agents can be added. Package the solution and apply appropriate auxiliary labels
42
How is dissolution rate calculated?
The dissolution rate is calculated using Fick's First Law of Diffusion. A larger surface area, stirring the preparation and using heat will incease the dissolution rate
43
What are the steps to preparing suspensions?
Prepare the ingredients and reduce the particle size of the drug/s to form a fine powder. Wet the powder, and levigate to form a paste. continue to add liquid in portions. Add a surfactant to help keep the suspension dispersed. Transfer the mixture into a conical graduate or the container in which it will be dispensed and QS to the final volume. Package the suspension and apply a BUD
44
How do you prepare emulsions?
Emulsions can be made by either the Continental or English gum method; mixing oil, water and an emulsifier gum in a 4:2:1 ratio (4 parts oil, 2 parts water, 1 part gum)
45
Describe the steps of Continental (dry gum) method
1) Levigate the gum with oil
2) Add the water all at once
3) Triturate by shaking in a bottle or mixing in a mortar until a cracking sound is heard and mixture is creamy white
4) Add other ingredients by dissolving them first in solution and adding a quantity of water sufficient to make (QS) up to the final volume
5) Homogenize (with a homogenizer machine)
46
Describe the steps of the English (wet gum) method
1) Triturate the gum with water to form a mucilage (thick and sticky like mucus)
2) Add oil slowly while shaking or mixing
3) Add other ingredients as in the dry gum method
47
What are powders used for?
Powders are used to prepare tablets, capsules, inhalations, suspensions, ointments, creams and other topical treatments. Powders often include excipients
48
What is a glidant/lubricant?
Glidant/lubricant to improve the flowability of a powder: magnesium stearate
49
What is a surfactant?
Surfactant to neutralize the static charge and keep the powder from floating away: sodium lauryl sulfate
50
Describe the steps to prepare powders
Reduce the size of the powder. This may require breaking down tablets with a grinder, followed by trituration or levigation. Sift the powder through a sieve onto glassine paper. If the amount of powder per dose is very small, it will be necessary to add an inert filler (diluent). A filler could also be needed to provide a minimum weighable quantity if using a torsion balance
51
What is the order of melting ingredients?
For any formulation, if melting ingredients, melt the ingredient with the highest melting point prior to adding the ingredient/s with lower melting points. Line up the ingredients by the melting temperature, and melt in that order, starting with the highest melting point
52
What is a eutectic mixture?
A eutectic mixture means that the combination of the ingredients will melt at a lower temperature than either of the individual component's melting temperatures. The lower melting point of the eutectic mixture allows it to penetrate the skin more easily than the individual components
53
Why can eutectic mixtures create difficult during compounding?
- If a pharmacist is not aware that the components for a eutectic mixture, the temperature on the hot plate can be set too high and the mixture can burn
- If the components are solid powders at room temperature, the mixture of the powders can melt and turn the mixture of the powders can melt and turn the mixture into a sticky mess, ruining the dry preparation. An adsorbent powder (magnesium oxide, magnesium carbonate or kaolin) can be used to keep the powder dry
54
What are capsules?
Capsules are soluble shells of gelatin or hypromellose, which are filled with the active drug, diluents and any other excipients
55
What are the most commonly used capsules in compounding?
Hard-shell capsules are used most commonly in compounding, and are filled with powders
56
What are soft-shell capsules used for?
Used mostly for oils
57
What is the purpose of glycerol and sorbitol?
Glycerol and sorbitol are used as plasticizers to make the capsules less brittle and more flexible
58
Describe the steps to prepare capsules
Capsules are made by first triturating the dry ingredients and geometrically mixing with the fillers/other excipients. the powder is put into the capsules by either hand filling or by using a capsule-filling machine
59
What is the hand-filling method?
To begin, the powder is placed on powder paper or on an ointment slab. The pile of powder is smoothed with a spatula to a height about a third of the length of the capsule. The open end of the capsule is repeatedly "punched" into the pile of powder until the capsule is filled. When the base is filled, it is fitted with the cap
60
What is the manual capsule-filling machine?
These are small devices that help the pharmacist quickly load 50, 100 or 300 capsules. Plates help sort the capsule bodies and hold them upright and in place. The powder is put above the capsules on to a plastic sheet where a plastic spreader is used to move the powder into capsules. A comb or tamper and a spreader are used repeatedly until the powder is packed into the capsules. Then, the caps are put over the capsule bodies
61
What are common capsule sizes?
Common capsule sizes range from largest (size 000, ~ 1 inch long) to smallest (size 5, ~0.4 inches long)
62
What are different types of tablets?
There are many types of tablets, including molded tablets, sublingual tablets, buccal tablets, orally disintegrating tablets, chewable tablets, effervescent tablets and compressed tablets
63
What is the most common type of table made in compounding and manufacturing?
The molded tablet is the most common tablet type made in compounding, and the compressed tablet is the most common type made in manufacturing
64
Describe the steps to prepare molded tablets
The first step to compound a molded tablet is to triturate the dry ingredients and mix by geometric dilution. Alcohol and/or water is added to moisten the powder. The powder mixture should have a pasty consistency, which can be molded into tablets (using tablet molds), and allowed to dry. Coloring and a coating may be added
65
What are lozenges?
Lozenges can be hard or soft tablets that slowly dissolve in the mouth, or chewable tablets that are easily chewed and swallowed. Lozenges/troches are generally used to deliver a medication that acts locally in the mouth
66
What do lozenges contain?
A lozenge contains the active drug in a base of sucrose or syrup for hard lozenges, PEG for soft lozenges and glycerin or gelatin for chewable lozenges. the base is melted, mixed with the API and excipients, placed into a mold and allowed to cool back into a solid
67
What are creams?
Creams are semi-solid formulations intended for topical use. They contain more than 20% water and up to 50% oil. They spread easily and are reasonably hydrating
68
What are lotions?
Lotions contain the most water, are more fluid than creams and can be poured. They are easy to spread on the skin and they absorb quickly
69
What are ointments?
Ointments contain the least water; 0-20%, with the remainder composed of oil-based product/s. Ointments are a good delivery vehicle to provide a barrier to exposure and prevent moisture loss which helps burn and scar healing
70
Describe the steps to prepare ointments
Powders should be triturated well, using a levigating agent. The levigating agent must be miscible with the base, which means they can mix together well. The powder will be mixed into the ointment base, using geometric dilution. Certain ointments will require heat in order to mix the components together well (fusion method). Always use the lowest temperature possible. First, melt the ingredients with the highest melting point, then add the others, according to their decreasing melting points. A water bath used to heat the ointment components will help prevent over-heating
71
What are pastes?
Similar to ointments but are made thicker by adding more solid ingredients
72
What are gels?
Gels are semisolids interpenetrated by a liquid. Gels serve as a versatile drug delivery system for various routes of administration
73
What are examples of oil-soluble suppository bases?
Cocoa butter and hydrogenated vegetable oils
74
What are examples of water soluble suppository bases?
Polyethylene glycol (PEG) polymers and glycerinated gelatin. If a drug powder is added to abase, the powder should be triturate to a fine consistency
75
What happens if the suppository melts easily?
If the preparation softens or melts easily, the molds will need to be stored in the refrigerator. Storing it in the refrigerator will make the suppository hard, and easier to insert. Storing it in the mold in which it was formed would be preferable
76
What is needed to calculate the amount of base displaced?
The density factor
*If the drug has the same density as the base, it will displace an equal amount of volume. If the density is greater, it will displace less, and if it is lower, it will displace more
77
How do you calculate density factor?
Density factor = B / (A - C + B)
- A = weight of the suppository blank
- B = weight of medication per suppository
- C = weight of medicated suppository
78
What are three methods to prepare a suppository?
Hand molding, fusion molding, compression molding
79
Describe the process of hand molding
Hand molding can be used when only a few suppositories are to be prepared, using a cocoa butter base. The cocoa butter is not melted, but it is grated and then mixed with the drug/s in a mortar and pestle or on a pill tile with a spatula. The mass is tolled into a cylinder, which is cut into suppository-size pieces. A tip is formed on one end to make insertion easier
80
Describe the process of fusion molding
The base is gently heated, the ingredients are added, the mixture is poured into room temperature molds, and left to harden. If the base is poured into a cold mold, it can cause the suppository to crack and split. If the suppository does not harden, the molds can be refrigerated. Disposable plastic molds can be used for molding
81
Describe the process of compression molding
In the compression molding method, the pharmacist will need to know the weight of each mold, and the drug's density factor. The amount of base required to fill each mold is calculated, the base is grated, mixed with drug and put into a cold compression mold
82
What is the purpose of using lubricants in making a suppository?
Lubricants can be applied to the mold so the suppositories can be removed more easily. If a lubricant is used it must be opposite of the suppository base in terms of solubility. The goal is to reduce friction
83
What is the purpose of vaginal suppositories?
Vaginal suppositories are used to treat conditions inside the vagina, such as a Candida infection, or conditions related to the female reproductive system
84
What is the purpose of rectal suppositories?
Rectal suppositories are used either to treat a local condition, such as hemorrhoids or distal ulcerative colitis, or to treat a systemic condition, such as pain and fever in a patient who cannot take oral medication
85
What is the beyond-use-date?
The beyond-use-date is the date or time after which the compounded product should not be used
86
How must non-sterile compounded preparations be packaged according to USP 795?
In tight, light-resistant containers
87
What is the BUD of a nonaqueous formulation according to USP 795?
Not later than 6 months. Store at room temperature
88
What is the BUD of water-containing oral formulations according to USP 795?
Not later than 14 days when stored at controlled cold temperatures. Store in refrigerator
89
What is the BUD of water-containing topical/dermal and mucosal liquid and semisolid formulations (such as a cream or lotion)?
Not later than 30 days. Store at room temperature.
90
When does USP specify refrigeration?
USP specifies refrigeration for water-containing oral formulations only
91
What are exceptions to the BUD stated in USP 795?
- if any ingredient expires before the BUD, use the earlier expiration date
- BUDs can be extended if stability data is obtained that determines the drug is stable for a longer period
92
What is a unit-dose?
A unit-dose refers to a small package that contains one dose of a medication. Unit dose preparations can come from the manufacturer or a repackaging company, or a pharmacy can repackage multi-dose containers into unit-dose packages
93
What are some commonalities that unit-dose repacking shares with compounding?
Assignment of BUD and safety requirements if repackaging HDs
94
What should be the BUD for repackaged drugs?
BUDs for repackaged drugs should be the manufacturer's expiration date from the original container or 6 months from the repackaging date, whichever is earlier
95
What does a quality insurance plan include?
A quality assurance (QA) plan outlines the steps and actions that ensure proper standards are maintained. It includes the Standard Operating Procedures (SOPs,), which are itemized steps on how to perform routine and expected tabsks
96
What should a QA program include?
The QA program should include periodic testing of the finished compounded preparations
97
What do QA records need to include?
QA records need to include the names of the compounding staff, including their job orientation and training records
98
What should labeling of all compounded products include?
The labeling of all compounded products must include the BUD and storage and handling information. There should be a label indicating that it is a compounded product
99
What auxiliary labels should be included on compounded products?
- Topical products: For External Use Only
- Emulsions, suspensions: Shake Well
- Suppositories, some troches, some suspensions: Refrigerate
100
What should be done if a patient experiences an ADR from a compounded products?
ADRs resulting from a compounded product should be reported to the pharmacy, and the pharmacist will need to record the ADR in the compounding record
101
What is a requirement of sterile preparations with regards to osmotic pressure?
Most sterile preparations should be isotonic to human blood and contain a similar number of particles in solution of ~285 mOsm/L which prevents fluid transfer across biological semipermeable membranes
102
What should the pH of sterile preparations be?
The pH of sterile preparations should be close to neutral
103
What should be used with IV medications?
Non-PVC bags should be used for IV medications that have leaching or sorption issues. The IV tubing must be sterile and nonpyrogenic
104
What is an ampule and how is it used?
Ampules are small, sealed glass containers with a long neck that contain liquid medication. The ampule is broken by snapping the neck at the narrowest part. A filter needle or filter straw will be required to remove the glass
105
Describe how to use vials that contain liquids
A volume of drug from the vial is drawn up in a syringe, which can then be added to an IV bag. The compounder will inject a volume of air equal to the volume of drug that is withdrawn to equalize the pressure. A different process if used for hazardous drugs due to risk of exposure to the personnel
106
Describe how to use vials that contain lyophilized or freeze-dried powder
The powder needs to be reconstituted by adding sterile water for injection, bacteriostatic water for injection or a diluent supplied by the manufacturer. Drugs may be commercially available as powders because they are unstable as a solution
107
What is a small volume parenteral (SVP)?
SVPs are IV bags or syringes that contain a small volume (100 mL or less) of fluid. CVPs can contain plain fluid, such as NS or D5W, that can be sent to the patient care area for floor stock or labeled for a specific patient. SVPs can also contain a drug with or without a diluent
108
What is a large volume parenteral (LVP)?
LVPs are IV containers that contain more than 100 mL. 1 liter bags are commonly used to provide fluids and are available in a variety of formulation.
109
What are ready-to-use medications (RTUs)?
Available as prepared IV bags or prefilled syringes. The pharmacy staff opens the outer container and applies the patient label. These do not have a CSP risk level, as they are not compounded. The expiration date is provided by the manufacturer
110
What are ready-to-use vial/bag systems?
Vials and bags are supplied together where the vial can be attached to the bags at the bedside by the nurse for immediate use. If the vial is attached in the pharmacy cleanroom, it can be saved for an extended period of time as indicated by the manufacturer. All involve an activation step of releasing IV fluid into the drug vial and then returning the reconstituted drug back into the bag
111
Describe the workflow for CSP preparation
- Pharmacist review the order
- Gather and inspect all materials
- Clean hood. Place only needed items in the hood
- Prepare CSPs with aseptic technique
- Properly dispose of syringes and needles into the sharps container
- Visually inspect all finished CSPs
- If high-risk, complete terminal sterilization
112
What are the steps to set up items in the sterile hood?
- Only required items can be placed in the hood. No paper, pens, labels, calculators or trays
- All work must be done within the sterile hood at least 6 inches from the front to prevent the hood air (ISO 5) and buffer room air (ISO 7) from mingling
- Place all items in the sterile hood side by side. Items should not be closer than 6 inches from the back of the hood
- Nothing should be between the sterile object and the HEPA filter in a horizontal airflow hood or above a sterile object in a vertical airflow hood
- Do not tear open components. Open along the seal within the hood. Do not touch the syringe tip or plunger, even with gloved hands
113
What should be used for greatest accuracy in transferring solutions?
For greatest accuracy, use the smallest syringe that can hold the desired amount of solution. The syringe should not be larger than twice the volume to be measured
114
How are powders reconstituted?
Powders are reconstituted by introducing a diluent such as sterile water for injection, bacteriostatic water for injection (which is sterile) or a diluent provided by the manufacturer
115
What are the steps to transfer solutions and injecting into IV bags?
1) Swab the rubber top of the vial with 70% IPA, and wait for it to air-dry; do not blow on or wave over it to dry faster
2) Prior to withdrawing any liquid from a vial, inject a volume of air equal to the volume of air equal to the volume of fluid to be removed (exception: do not inject air prior to removing hazardous drugs from vials. the negative-pressure technique or closed-system transfer device should be used
3) Puncture the rubber top of the vial with the needle, bevel up and at a 45 degree angle. Then bring the syringe and needle straight up to a 90 degree angle while penetrating the stopper. Depress the plunger of the syringe, emptying the air into the vial. Invert the vial with the attached syringe. Draw up the amount of liquid required. Withdraw the needle from the vial
4) The volume of solution drawn into a syringe is measured at the point of contact between the rubber piston and the side of the syringe barrel
116
What is the purpose of closed-system transfer device?
As part of their mechanism, CSTDs equalize the pressure in the vial which eliminates the need to inject air
117
What is coring?
Coring occurs when a small piece of rubber from the stopper is aspirated into the needle, and is put into the solution in the vial. The rubber piece can get injected int a patient. Look for small cored pieces floating near the top of the solution during the visual inspection of the CSPWha
117
What is coring?
Coring occurs when a small piece of rubber from the stopper is aspirated into the needle, and is put into the solution in the vial. The rubber piece can get injected int a patient. Look for small cored pieces floating near the top of the solution during the visual inspection of the CSP
118
What is the process of transferring solutions into IV bags if the medication is in a glass ampule?
If the medication is in a glass ampule, open the ampule by snapping the neck away from you. Tilt the ampule, then withdraw the fluid using a filter straw or filter needle to remove any glass particles that may have fallen into the ampule. The needle must be changed before injecting the syringe contents into an IV bag to avoid introducing glass or particles into the bag. A standard needle could be used to withdraw the drug from the ampule, as long as it is then replaced with a filer device before the drug is pushed out of the syringe
119
Describe the negative-pressure technique
1) Pull the plunger back to fill the syringe with a volume of air equal to the volume of drug to be removed
2) Inset the needle into the vial, invert the vial and pull on the plunger which will create a vacuum that pulls the drug out of the vial and into the syringe (this should be done in small increments, pausing to allow the air to move out of the syringe and into the vial, until the desired volume of drug has been drawn up)
120
What steps should be included in the visual inspection of a product?
- Should verify that the correct volume of product is in the syringe before compounding continues
- Finished CSPs are visually inspected immediately after preparation, against a dark background, for particulates, cored pieces, precipitates and cloudiness. The container should be lightly squeezed to check for leakage
121
What is the "syringe pull-back method"?
When the pharmacist verifies the volume in an empty syringe after the compounding is done; the technician pulls back the plunger of the syringe to the volume of product that was added into the IV admixture and places the empty syringe next to the vial
122
What is terminal sterilization and when is it used?
Terminal sterilization is required for high-risk CSPs. Terminal sterilization methods include steam sterilization (with an autoclave), dry-heat sterilization (depyrogenation), gas sterilization, ionizing radiation and unidirectional aseptic processing
123
How can CSPs that are heat labile be sterilized?
CSPs that are heat-labile can be sterilized with filtration using a 0.22 micron filter. The filter will remove microorganisms larger than 0.22 microns, including bacteria, viruses, yeast and fungi
124
What is the bubble-point test?
This test uses pressure to force liquid to "bubble" out of the filter to test the filter integrity
125
What must the labels of CSPs have?
The names and amounts or concentrations of ingredients, the total volume, the BUD, the route of administration, the storage requirements and other information for safe use
126
What kind of label must hazardous preparations have?
All hazardous preparations must have a label that reads "Chemotherapy - dispose of properly" or something similar
127
When should auxiliary labels be placed on CSPs?
Auxiliary labels should be placed on CSPs that require special handling
128
What are high alert medications?
High alert medications are drugs that have a high risk of causing significant patient harm when used incorrectly
129
What produces endotoxins?
Gram-positive and gram-negative bacteria
*Endotoxins from gram-negative bacteria are more potent and represent a serious threat to patient safety
130
Where can pyrogens come from?
Pyrogens can come from using equipment washed with tap water
131
How can you avoid the issue of pyrogens?
To avoid this issue, glassware and utensils should be rinsed with sterile water and depyrogenated using dry-heat (steam) sterilization with an autoclave
132
What is the reagent for the bacterial endotoxins test (BET)?
The Limulus Amebocyte Lysate (LAI)
133
What is risk of contamination based on?
Based on the compounding area, ingredients and equipment used, and the complexity of the preparation. The risk levels are low, medium and high
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What are the two other special categories of risk of contamination?
Low with less than 12 hour BUD and immediate use. these risk levels are used to determine an appropriate BUD
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What is low-risk sterile compounding?
Low-risk sterile compounding uses 1 to 3 components (including diluent) that are supplied as sterile from the manufacturer. Typically, the sterile additives come in solution and are ready to be withdrawn from the vial and used
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What is the contamination risk of low-risk sterile drugs?
Low-risk sterile drugs have the lowest contamination risk, and the longest BUD
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When is a CSP considered medium risk?
The contamination risk increases each time the bag is entered. If more than 3 sterile components are needed, the CSP is medium-risk
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What are examples of CSPs with medium-risk?
Parenteral nutrition and making a batch of drugs
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What are examples of CSPs with medium-risk?
Parenteral nutrition and making a batch of drugs
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What is high risk sterile compounding?
High-risk sterile compounding uses non-sterile ingredients and equipment, including some of the equipment that is normally used for non-sterile compounding. The end product will need to be sterilized prior to use
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What is the contamination risk of high-risk sterile drugs?
High-risk sterile drugs have the highest contamination risk, and the shortest BUD, with the exception of immediate-use CSPs. These are CSPs prepared in emergency situations in which there is adequate time to prepare the CSP aseptically
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What CSPs require sterility training?
Certain high risk CSPs and CSPs intended for use beyond the recommended BUD must have sterility testing
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What should be used for sterility testing?
The sterility testing should use either tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endotoxin (pyrogen) testing prior to use
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How is BUD of a CSP determined?
The BUD is determined by USP 797 standards and the stability/expiration date of the individual ingredients, whichever is shorter. The highest the CSP risk level, the short the BUD and the colder the storage temperature, the longer the BUD
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What is the BUD of low CSP risk level?
- Room temp BUD: 48 hours
- Refrigerated BUD: 14 days
- Frozen BUD: 45 days
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What is the BUD of medium CSP risk level?
- Room temp: 30 hours
- Refrigerated: 9 days
- Frozen: 45 days
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What is the BUD of high CSP risk level?
- Room temp: 24 hours
- Refrigerated: 3 days
- Frozen: 45 days
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What is the BUD of low-risk CSP prepared in an ISO 5 PEC or C-PEC in an SCA or C-SCA (not in a cleanroom)?
12 hours in room temperature and refrigerated
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What is the BUD of an immediate-use CSP?
1 hour in room temperature
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What is the BUD of a single dose container outside an ISO 5 environment?
1 hour from the time of puncture or opening
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What is the BUD of a single dose container inside an ISO 5 environment?
Up to 6 hours from the time of puncture or opening
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What is the BUD of a single dose container (ampule) inside or outside an ISO 5 environment?
An unused contents left in the ampule cannot be stored and must be discarded
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What is the BUD of a multi dose container?
Up to 28 days from the time of puncture or opening, unless otherwise specified by the manufacturer
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What should a CSP quality insurance plan minimally include?
Personnel training and assessment, environmental monitoring, equipment calibration and maintenance
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What should be done at each part of the QA plan?
Each part of the QA plan must be documented and the follow-up actions identified must have assigned personnel responsible for each item, with expected dates of completion
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What should be done when high-risk level CSPs are dispensed before receiving the results of their sterility tests?
There must be a written procedure requiring daily observation of the incubating test specimens and immediate recall of the dispensed CSPs if there is evidence of microbial growth. All patients and physicians who received the recalled CSPs are notified of the potential risk
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What should be done if sterility results come back positive?
If sterility test results come back positive, there should be an investigation of aseptic technique, environmental control and other sterility assurance measures to determine the source of contamination and improve the methods or processes
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What is a class I recall?
A situation in which there is a reasonable probability that the use or exposure will cause serious adverse health consequences or death
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What is a class II recall?
A situation in which use or exposure can cause temporary or reversible adverse health consequences or where the probability of harm is remote
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What is a class III recall?
A situation in which use or exposure is not likely to cause adverse health consequences
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What is the difference between osmolarity and tonicity?
Osmolarity includes all solutes and tonicity includes only the solutes that do not cross the vasculature
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What is considered hypertonic?
Saline concentrations greater than 0.9% are referred to as hypertonic
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What is hypertonic saline used for?
Hypertonic saline is used for various indications in the acute care setting, such as treating hyponatremia (3%) and for use in preparing parenteral nutrition (23.4%)
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What happens when hypertonic saline is administered into a peripheral vein?
The high concentration of solutes relative to the concentration in the blood will cause water to move out of the red blood cells (RBCs) in an attempt to dilute the solute concentration. This will cause the RBCs to become shriveled and dysfunctional
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What is hypertonic saline restricted to?
Hypertonic saline is often restricted to the pharmacy and only dispense for administration in areas of the hospital where safety can be monitored
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What is the highest osmolarity acceptable for IV administration?
~ 900 mOsmol/L
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Where should solutions with a higher osmolarity be administered?
Solutions with higher osmolarity should be administered via a central line to avoid damaging the vein. The central line delivers IV medications and fluids into a larger blood volume, which quickly dilutes the solution
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What can happen when a preparation has lower osmolarity than blood?
The RBCs will absorb fluid. This can cause hemolysis, which can be fatal
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What is the lowest osmolarity that should be administered intravenously alone?
1/2NS (0.45%), which has an osmolarity of 154 mOsm/L, is the lowest osmolarity of saline that should be administered intravenously alone
*Lower concentrations of saline can be administered if combined with other fluids, which will increase the total osmolarity of the fluid
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What happens when pH rises in the body?
When the pH rises, the blood becomes more basic. Hydrogen ions will be released from carbonic acid, which causes the pH of the blood to lower. The blood becomes more acidic
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What happens when the pH falls?
When the pH falls, the blood becomes more acidic. Hydrogen ions get picked up (more bicarbonate binds with protons), which causes the pH of the blood to rise. The blood becomes more basic
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What must be done with preparations that are administered in sensitive tissue?
It must be formulation to keep the pH within a narrow range to avoid damaging the tissue and causing pain
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What is needed for compounding preparations that require a narrow pH range?
A buffer system that can resist changes in pH which consists of an acid and its salt
