Compounding & Hazardous Drugs

Type of excipient: - Binder

- Adhesive material to hold powders together - Example: acacia (gum)

Type of excipient: - Magnesium oxide/carbonate - Kaolin

- Adsorbent - Keeps powers dry

Type of excipient: - Simethicone

- Anti-foaming agent - Breaks up and inhibits the formation of foams

Type of excipient: - Ascorbic acid

- Antioxidant - Prevents oxidatin

Type of excipient: - Buffer

- Buffers maintain the formulation within the acceptable pH range

When a surfactant is used to reduce the surface tension between oil and water it is referred to as a(n) ________.

- Emulsifier

Type of excipient: - Emollient

- Provides a barrier, acts as a vehicle for drug delivery - Example: Petroleum jelly (petrolatum)

When a surfactant is used to reduce the surface tension between a solid and a liquid, it is referred to as a(n) _______ or _______.

- Wetting agent - Levigating agent "they call me levigator 'cause I am a wetting agent"

Continental/dry gum method

1. levigate gum with oil 2. add water all at once 3. triturate until "cracking" sound is heard

English/wet gum method

1. triturate gum & water 2. add oil SLOWLY

If you have a mixture that combines 70% HLB 15 with 30% HLB 4.3, what is the HLB of the final mixture?

11.78 Just do the percentages times the HLB's and add them. Super easy. 70% x 15 = 10.5 30% x 4.3 = 1.29 10.5 + 1.29 = 11.78

Emulsion ratio

4 parts oil 2 parts water 1 part emulsifier

What is the sensitivity requirement of a torsion balance?

6 mg

BUD for non-aqueous formulations not for PO use

6 months OR no later than the time remaining until the earliest expiration date of any active ingredient, whichever comes first

Hydrophilic-lipophilic balance (HLB)

< 10 = are more lipid soluble > 10 = more water soluble

The technician will be cleaning underneath the work surface (the undertray) of the biological safety cabinet. The biological safety cabinet is used to prepare chemotherapy IV admixtures. According to USP 800, which respirators are appropriate for this activity? (Select ALL that apply.)

A full-facepiece, chemical cartridge-type respirator AND Powered air-purifying respirator Explanation: An appropriate full-facepiece, chemical cartridge-type respirator or powered air-purifying respirator (PAPR) should be worn when there is a risk of respiratory exposure to HDs, including when: • Attending to HD spills larger than what can be contained with a spill kit • Deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC • There is a known or suspected airborne exposure to powders or vapors

According to USP 800, which of the following activities requires the use of a closed system transfer device?

A nurse administers intravenous fluorouracil to a male patient. Explanation: CSTDs are recommended (but not required) when compounding HDs (compounding is usually performed by the pharmacy staff) and required when administering antineoplastics (administration is primarily by the nursing staff), when the dosage form allows. Fluorouracil is an intravenous antineoplastic drug and a CSTD is required for administration. Armidex (anastrozole) is an oral chemotherapy drug, there are no CSTDs for administering PO formulations.

A drug wholesaler delivers a plastic tote containing chemotherapy drugs to the pharmacy. Upon opening the tote, the technician discovers that the drugs are not wrapped in plastic. There are no signs of breakage or leakage. What personnel protective grab should the technician wear when unpacking this tote? (Select ALL that apply.)

An elastomeric half-mask with a muti-gas cartridghe and P100-filter AND one pair of chemo gloves Explanation: One pair of chemotherapy gloves should be worn when unpacking HDs. An elastomeric half-mask with a muti-gas cartridghe and P100-filter should be used when unpacking HDs not wrapped in plastic.

A hospital technician will be spending his entire 12-hour work shift preparing chemotherapy IV admixtures. The manufacturer of the chemotherapy gown has not provided any information on how often the gown must be changed. At a minimum, how many gowns will the hospital technician use during his shift?

At least 4 Explanation Gowns must be changed as often as directed according to the manufacturer's information. If no information is provided, change them every 2-3 hours or immediately after a spill or splash. Since the technician is working a 12-hour shift and the gown must be changed at least every 3 hours, the technician will used at least 4 gowns during his shift.

What type of hood/isolator can be used to prepare the tretinoin solution? (Select ALL that apply.)

Class I biological safety cabinet AND Containment ventilated enclosure Explanation: Tretinoin is a hazardous drug which must be handled in negative pressure ventilated device. A hood with positive pressure airflow would blow hazardous drug residue towards the compounding staff.

The City of Hope oncology hospital has expanded its services and is anticipating that more chemotherapy drugs will need to be compounded. Which containment primary engineering controls can be ordered to prepare hazardous drugs? (Select ALL that apply.)

Class II biological safety cabinet Compounding aseptic containment isolators

After compounding a preparation, documentation is done in the _____.

Compounding log/record

A specialty compounding pharmacy makes many different types of compounded preparations. Which of the following compounded preparations must be prepared in a negative pressure hood, such as a containment ventilated enclosure?

Cyclophosphamide oral suspension

When a surfactant is used to reduce the surface tension between an oil and water, it is referred to as a(n) _______.

Emulsifier

How often should the pharmacist-in-charge perform a wipe sampling to determine the amount of hazardous drug residue in the class II biological safety cabinet?

Every 6 months The surfaces of the HD handling area and patient administration areas should be tested for HD contamination. A moistened wipe is used to wipe the surface and this wipe is then analyzed for any HD residue. This is called environmental wipe sampling and should be performed routinely (e.g., initially as a benchmark and at least every 6 months).

coloring agents

FD&C red No.3, yellow No 6., caramel, ferric oxide (red)

What type of mortar is preferred for mixing liquids (suspension and solutions) and for compounds that are oily or can stain?

Glass

Common Plasticizers

Glycerin, Propylene glycol or sorbitol

What type of surfactant would you use for an Oil-in-Water (o/w) emulsion?

HYDROPHILIC: Tweens HLB Value > 10 - PEG 400 (11.4) - Tween 85 (11) - polysorbate HLB: "ow = tOWer" (high) Tweens love water Hy-drophilics are "high"

The cyclophosphamide oral suspension cannot be prepared in a horizontal airflow workbench for the following primary reason:

Hazardous drugs are not prepared in a horizontal airflow workbench because the air will blow towards the compounder, exposing the compounder to the hazardous drug. Horizontal airflow workbenches can only be used to prepare non-hazardous preparations.

A hospital has the following layout for their sterile compounding area. There is a separate room for preparing sterile, non-hazardous drugs and a separate area for preparing sterile, hazardous drugs (mostly chemotherapy drugs). These two rooms share an ante-room. What is the minimum ISO requirement for the ante-room?

ISO 7 The ante-room must be at least ISO 8 if it opens into a positive pressure buffer area, or must be at least ISO 7 if it opens into a negative pressure buffer area. Since the ante-room opens up to both a positive pressure room and a negative pressure room, the ante-room must be at least ISO 7.

When should a compound not be made?

If it is commercially available, or it has been withdrawn from the market for safety reasons.

Carmustine vials must be stored at 2°C to 8°C (36°F to 46°F). Where can the carmustine vials be stored?

In a dedicated refrigerator that only contains antineoplastic drugs. The refrigerator is located in the negative pressure buffer room. Explanation Refrigerated antineoplastics must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH (e.g., storage room, buffer room, or containment segregated compounding area). The ante room is a positive pressure room.

What type of surfactant would you use for a Water-in-Oil (w/o) emulsion?

LIPOPHILIC: Spans HLB Value < 10 - Glyceryl monostearate (3.8) - Span 65 (2.1) HLB: "wo = lo" Span.. like "Pam" - loves oil, lipophilic

The ifosfamide IV admixture is prepared in a class II biological safety cabinet with an ISO 7 buffer room and ante room. What is the risk level of this preparation?

Low Risk The preparation is made by injecting the contents of one vial into a diluent bag. This is considered a low risk compounded sterile preparation.

Minimum weighable quantity (MWQ)

MWQ= 6mg/acceptable error rate

The __________ is the cookbook for compounds (with ingredients and preparation instructions)

Master formulation record

The pharmacist will use a needle and syringe (with no closed system transfer device) to withdraw the reconstituted Herceptin solution from the vial. What technique should be used to ensure this happens safely?

Negative Pressure Technique Herceptin is a chemotherapy drug. If a closed system transfer device is not used, the negative pressure technique should be used to prevent the drug solution from accidentally spraying out around the needle or vial.

BUD for water-containing oral formulations

Not later than 14 days when stored at controlled cold temperatures (store in fridge)

Hydrophobic solvent

Oils: borage, canola, coconut Fats: omega-3, omega-6

A closed system transfer device (e.g., Phaseal, Equashield) should be used when compounding hazardous drugs, if the dosage form allows this type of drug transfer. Which of the following activities cannot be performed with a closed system transfer device?

Opening a glass ampule and withdrawing solution from the ampule. Explanation: Glass ampules are opened by breaking the neck and the solution is withdrawn with a needle. At this time, there is no transfer device that can accomplish this activity within a "closed system;" the contents must be filtered due to the risk of having glass particles in the solution from the ampule that came off when the neck of the ampule was snapped open.

Hydrophilic solvent

PEG, alcohols

An outpatient pharmacy has two rooms for technicians to compound drugs. One room has neutral air pressure and the other room has negative air pressure. Which of the following compounded preparations can be safely compounded in the room with neutral air pressure?

Pilocarpine lollipop

An oncology nurse accidentally drops a vial of reconstituted carmustine solution, which resulted in a 2-foot wide spill on the floor. Which of the following products can be used to decontaminate the area?

Sodium hypochloride Sodium hypochloride (bleach) is used commonly to decontaminate surfaces areas that have been exposed to hazardous drugs.

What is used to determine the type of surfactant needed for an emulsion?

The HLB number (Hydrophilic-Lipophilic Balance) - Hydrophilics are "Hy" water soluble surfactants ex: tweens - Lipophilics are "L"ow lipid soluble surfactants ex: spans

The HLB range is from ___ to ___, with ___ as the midpoint.

The HLB range is from 0 to 20, with 10 as the midpoint. > 10 = hydrophilic, or water soluble (tweens) < 10 = lipophilic, or lipid-soluble (spans)

The pharmacist-in-charge is currently working with an architect to renovate the hospital's compounding suite. Which of the following rooms need at least 30 air changes per hour?

The buffer room used to prepare sterile hazardous drugs.

The technician has finished preparing all the Herceptin IV admixtures and will be leaving the compounding area for a lunch break. The compounding area has a buffer room and an ante room. Where and when should the technician throw away his garb?

The chemotherapy gown and outer shoe cover must be taken off immediately before exiting the buffer room and thrown away in the trace chemotherapy waste bin. Explanation: The outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the C-PEC or put in a sealable bag if discarding outside the C-PEC. Remove the outer glove before handling and labeling the compounded preparation. The chemotherapy gown and outer shoe cover must be taken off before exiting the buffer room and thrown away in the yellow trace chemotherapy waste bin. The rest of the garb is removed when leaving the ante room.

A hospital technician will be spending his entire work shift preparing chemotherapy IV admixtures. After donning the first pair of gloves, how many times should the technician change his gloves within a 12-hour shift?

The gloves must be changed at least 23 times during the shift. Explanation: The gloves need to be changed every 30 minutes and if it is torn, punctured, or contaminated. After donning on the initial pair of gloves, the technician needs to change his gloves 23 more times within the 12-hour shift

What is the purpose of garbing?

To protect the compounder from the drug and to protect the drug from the compounder

A nurse is administering intravenous busulfan to a patient. What personal protective equipment should the nurse wear during administration? (Select ALL that apply.)

Two pairs of chemotherapy gloves AND a chemo gown Explanation: Busulfan is indicated for chronic myeloid leukemia. Two pairs of chemotherapy gloves are required when administering antineoplastics. Chemotherapy gowns are required when administering injectable antineoplastics and recommended when administering other HDs that are not in tablet or capsule form.

What personal protective equipment (garb) should pharmacists and technicians wear when preparing the isotretinoin oral suspension in a containment primary engineering control? (Select ALL that apply.)

Two pairs of shoe covers AND Two pairs of ASTM D6978 (chemotherapy-rated) gloves AND Disposable chemotherapy gown Explanation: According to USP 800: "Appropriate personal protective equipment (PPE) shall be worn when compounding in a BSC or CACI and when using CSTD devices. PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes and double gloving with sterile chemo-type gloves." An N95 respirator is only required when working outside of a control device (e.g., BSC/CACI).

A specialty oncology pharmacy has several rooms in the compounding suite. In one room, a technician is preparing Blincyto IV admixture for infusion. In another room, a technician is crushing mercaptopurine tablets to compound a 5 mg/mL oral suspension. What USP standards apply to both of these activities?

USP 800 is about handling hazardous drugs. This applies to both non-sterile hazardous drugs (mercaptopurine oral solution) and sterile hazardous drugs (Blincyto). Both compounded preparations are used to treat acute lymphoblastic leukemia.

A nurse will be administering an oral chemotherapy drug through the patient's feeding tube. The nurse will need to crush the tablet at the patient's bedside. What precaution must the nurse take when crushing the tablet?

Use a plastic pouch to crush the tablet

What is a surfactant used to do?

Used to help two ingredients (or phases) that resist each other to move closer together by reducing surface tension between them

What type of mortar is preferred for grinding dry crystals and hard powders due to their ROUGHER surface?

Wedgewood

A qualified certifier is visiting the Westside Compounding Pharmacy to certify the air quality of the compounding area. When does the ante-room need to be at least ISO 7?

When the ante-room opens into a negative pressure buffer room Explanation: For hazardous drug preparation, the ante-room must be at least ISO 7 when it opens into a negative pressure buffer room.

After the pharmacy technician has finished preparing the tretinoin oral suspension, what color waste bin should the technician use to throw away the disposable mortar and pestle?

Yellow Tretinoin is a chemotherapy drug used to treat leukemia. An oral suspension is often prepared for pediatric patients. Trace chemotherapy waste (i.e., empty vials, empty syringes, empty IV bags, IV tubes, used gloves, used gowns, used pads) are items that contain trace amounts of chemotherapy. These are thrown away in yellow containers, which will be destroyed by incineration (burning) at a waste facility

binders

acadia, starch paste, sucrose syrup

thickening agents

agar, gums (xantham,acacia) gelatin, carbomer, cellulose, starches

disintegrints

alginic acid, polacrilin potassium, cellulose products and starches

antioxidants

ascorbic acid

Porcelain mortars are used for

blending powders and pulverizing gummy consistencies

amphilic

both hydrophilic and hydrophobic

enteric-coating

cellulose acetate phthalate, shellac

Suppository base

cocoa butter, hydrogenated vegetable oils, gelatin

The P&T committee is currently reviewing the hospital drug formulary to identify hazardous drugs (HDs) that may require special handling to prevent dangerous exposure to healthcare workers. HDs are drugs that can cause skin rashes, infertility, miscarriages, birth defects, gene toxicity, organ toxicity, and cancer. Which of the following drugs are considered hazardous? (Select ALL that apply.)

colchicine Tacrolimus Estradiol Mifeprex

glidants

colloidal silica, magnesium stearate

2 types of balances to weigh ingredients?

electronic balanace (analytical balance) or a class III torsion balance (grade A balance)

common powder excipients?

glidant/lubricant and surfactant

what is the purpose of a surfactant?

helps to ingredients move closer together by reducing their surface tension

purpose of a glidant/lubricant

improves the flowability of a powder ie) magnesium stearate

Master Formulation Record (MFR)

is hte "recipe" that provides the ingredients and instructions in how to prepare the compounded product

What is a compounding log?

is the log book of all products made at the pharmacy and includes components with source lot &exp, BUD, rx label, RPh signature/date, etc.

purpose of a surfactant

is to neutralize the static charge and keep the powder from floating away ie) sodium lauryl sulfate

What is an emulsion?

liquid dispersed in a liquid - which are not able to be blended together (immiscible) Either: 1. Oil-in-Water (o/w) 2. Water-in-Oil (w/o) Examples: propofol or mayonnaise

Glass mortars are used for

liquids (suspensions, solutions) Oily compounds

adsorbant powders for eutectic mixtures?

magnesium oxide, magnesium carbonate or kaolin

Lubricant Agents

magnesium stearate

2 important documents that each compounded product must have?

master formulation record and compounding record

Levigating (wetting) agent

mineral oil, glycerin, glycols, PEG, propylene glycol

eutectic mixtures

mixture of components that will melt at a lower temperature than either of the two individual products MP's alone

BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations

no later than 30 days, store at room temperature

preservative agents

opth:EDTA, sodium benzoate, benzoic acid, benzalkonium chloride, thimerosal topical: chlorhexidine

emollients

petrolatum, aquaphor, polybase, cetaphil

buffers

potassium phosphate, sodium acetate/citrate

Wedgwood Mortar and Pestle

preferred for grinding dry crystals & hard powders

Goal room/fridge and freezer temperatures in F and C

room: 68 to77 F; 20 to 25 C fridge: 36 to 46 F; 2 to 8 C freezer: -13 to 14 F;-25 to -10 C

coating agents

shellac, gelatin, glutin

Antifoaming agents

simethicone, dimethicone

What is minimally required for non-sterile compounding?

sink (for washing hands/equipment), hot &cold water, soap, and an air dryer/single use towels

What is a suspension?

solid dispersed in a liquid

What are capsules made of?

soluable shells of gelatin (animal product) or hypromellose (vegetable product)

What is a solution?

solute dissolved in a solvent

diluents (fillers)

starches, calcium salts, lactose, mannitol, sorbitol, cellulose

sweetener

sugar free: aspartame, saccharin glycerin, dextrose, lactose, mannitol, sorbitol, phenylalanine, stevia, xylitol

What equipment is the most accurate at measuring small volumes?

syringes

How does surfactants work?

they form a micelle structure which can turn inside out

fusion method

using heat in order to mix components together well (first melt the components with highest MP, then add others according to there decreasing MP's)

Can an emulsion be given IV?

yes