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Chemistry for Engineering Students2nd EditionLawrence S. Brown, Thomas A. Holme 945 solutions Chemical Reaction Engineering3rd EditionOctave Levenspiel 228 solutions Manufacturing Engineering and Technology7th EditionSerope Kalpakjian, Steven Schmid 2,011 solutions Teratogeinc (all cetogry X or D drugs, paroxetine, mtx, misoprostol, mifepristine, ribavarin) Carcinogenic ( chemotherapy) genotoxic hormones (contracetpives, estradiol, testosterone) Transplant drugs (mycophenolate, tacrolimus, cyclosproine, everolimus, sirolimus) Others: colchicine, fluconazole, spironolactone, risperidone, raloxefiene, rasagliine, ziprasidone USP 800 Is not enforceable (only informational) It can be enforceable by state boards of pharmacy USP 800= describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. USP 800 includes: all personnel that interact with the medication including those recieving, storing, compounding, dispensing, transporting, administering, and disposing of the medication. Hazardous Drug Process What are hazardous drugs? include those that exhibit one or more of the following SIX characteristics in humans or animals.
National Institute for Occupational Safety and Health NIOSH Drugs are divided into 3 groups: 1. Antineoplastic drugs Common Drugs that are Listed on the NIOSH list: Newly Appproved DRUGS: To evaluate hazardous potential: -check the safety date sheets from the manufacturer Routes of unintentional entry of hazardous drugs into the body include:
-dermal absorption Examples of Exposures Table (1): Examples of Exposures Table (2): Assessment of Risk from Low to High Risk Levels: Drugs on NIOSH list that must follow the requirements of USP 800 include: Any hazardous drug active pharmaceutical ingredient (API) Any antineoplastic requiring manipulation Drugs on the NIOSH list that do NOT have to follow all of the containment requirements of USP 800 if an assessment of risk is performed and implemented include: Final dosage forms that do not require further manipulation other than counting or repackaging Equipment and Facility Requirements: Engineering Controls 1. containment primary engineering controls (C-PECs) 2. containment secondary engineering controls (C-SECs) 3. supplemental engineering controls are adjunct controls to offer additional levels of protection C-PECs rely on high-efficiency particulate air (HEPA) filters C-PECs Sterile Compounding: -must protect the compounder and the product from contamination ex: Class II
Biological safety cabiner (BSC) C-PECs Nonsterile Compounding: -must protect the compounder ex: containment ventilated enclosures (CVE) Containment secondary engineering controls (C-SECs) the room in which the containment primary engineering control (C-PEC) is placed For both sterile and nonsterile compounding, the room must be: C-SECs Sterile compounding: Personal Protective equipment (PPE) PPE requirements ... If there is a risk of spills or splashes when working outside a C-PEC, appropriate eye and face protection must be worn. -goggles (safety glasses not sufficient) If respiratory protection is required, a N95 or more protective respirator is sufficient to protect against airborne particles. Surgical masks offer no protection. Handling Hazardous drugs Receipt of hazardous drugs Compounding of hazardous drugs: Deactivation= render hazardous drug inert or inactive Decontamination= removal of hazardous drug residue from non-disposable surface and transfer it to an absorbent, disposable material such as a towel/wipe Cleaning= removal of organic or inorganic materials Disinfection= inhibits or destroys microorganisms Environmental Quality and Control Medical Surveillance True or false, USP 800 applies to all workers that handle hazardous drugs including workers outside the pharmacy. True (includes but is not limited to pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians) Which of the following is TRUE regarding medications listed on the NIOSH list? a. These medications are all considered chemotherapies. b. These medications must be administered in a hospital-based setting that allows for extensive monitoring of toxicity. c. These medications include only those that require compounding. d. If a facility is using these medications, it requires compliance with USP 800. If a facility is using these medications, it requires compliance with USP 800 The NIOSH list considers drugs hazardous if they exhibit one or more hazardous drug characteristics. Which of the following describe those characteristics? Select all that apply. Carcinogenic Teratogenic Genotoxic Reproductively toxic Similar bioavailability to a known hazardous drug Carcinogenic Which of the following best describes a C-PEC? a. A ventilated device designed to minimize worker and environmental exposure. b. A ventilated room in which an additional engineering control is placed. c. A type of personal protective equipment. A ventilated device designed to minimize worker and environmental exposure. Which of the following is FALSE of a Class II biological safety cabinet? a. It can be used for both sterile and nonsterile compounding of hazardous drugs. b. It protects both the compounder and the product during compounding. c. It provides ISO Class 7 air onto the work surface. It provides ISO Class 7 air onto the work surface. (A Class II BSC provides ISO class 5 air quality) True or false, disposable gowns can be reused within the same day according to USP 800. False (If PPE is disposable, it cannot be reused) Which of the following are TRUE when compounding a non-sterile, hazardous drug? Select all that apply. The C-PEC must be externally ventilated. The C-SEC must be a separate room with negative pressure relative to all adjacent areas. The C-SEC must be externally ventilated. The C-SEC must be a separate room with negative pressure relative to all adjacent areas. The C-SEC must be externally ventilated. True or false, all workers that handle hazardous drugs within a facility must be enrolled in a medical surveillance program according to USP 800. True A compounding pharmacy has access to a compounding aseptic containment isolator (CACI). Which of the following types of compounding can theoretically take place within a CACI? Select all that apply. Sterile, non-hazardous compounding Sterile, hazardous compounding Non-sterile, hazardous compounding ALL apply (A CACI can be used for non-sterile HD compounding but needs to be re-sterilized before any sterile product is compounded in it) Which of the following need to be completed when compounding a non-sterile, hazardous medication? Select all that apply. Deactivation Deactivation The purpose of USP 800 is to describe practice and quality standards related to which type of medications? a. Chemotherapies b. All hazardous drugs c. All medications including both hazardous and non-hazardous drugs All hazardous drugs The practice and quality standards within USP 800 are designed to? a. Promote patient safety, worker safety, and environmental protection b. Minimize medication errors c. Minimize contamination of sterile compounded preparations. Promote patient safety, worker safety, and environmental protection Which setting does USP 800 apply to? a. Compounding pharmacies only All healthcare settings In which of the following scenarios would the drug described be considered as hazardous? Select all that apply. A drug shown to damage the genetic information of a cell within mouse models. A drug known to cause birth defects when exposed to pregnant women. A new drug with a similar structure and toxicity as a well-recognized hazardous drug. A drug shown to be carcinogenic. A drug known to cause cardiac toxicity at low doses. ALL apply Which of the following are ways that a pharmacist can determine if a drug is considered hazardous? Select all that apply. ___ Drugs@FDA NIOSH list What is the full name of the NIOSH list? a. NIOSH List of Hazardous Medications b. NIOSH List of Chemotherapies and Other Hazardous Medications c. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings The NIOSH list divides hazardous drugs into which three classifications? Select all that apply. Antineoplastic drugs Immunosuppressive drugs Drugs that pose reproductive risk Drugs that can easily aerosolize Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug Antineoplastic drugs Drugs that pose reproductive risk Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug True or false, the NIOSH list is updated when new drugs come on the market. False Which of the following are potential scenarios in which a healthcare worker may be exposed to a hazardous drug that could be prevented by procedures noted in USP 800? Select all that apply. Dermal exposure to a hazardous drug from handling a package that contained broken vial of chemotherapy. Inhalation exposure to a hazardous drug for aerosolized particles created during compounding of a sterile preparation. Exposure to HIV from an accidental needle stick from improper sharp disposal. Accidental ingestion of a chemotherapy from contaminated coffee kept in the compounding area. Dermal exposure to a hazardous drug from handling a package that contained broken vial of chemotherapy. Inhalation exposure to a hazardous drug for aerosolized particles created during compounding of a sterile preparation. Accidental ingestion of a chemotherapy from contaminated coffee kept in the compounding area. Which one of the following describe the ventilated devices designed to minimize worker and environmental exposure, which are often described as "hoods"? a. Containment primary engineering controls b. Containment secondary engineering controls c. Supplemental engineering controls Containment primary engineering controls Which of the following is an example of a supplemental engineering control? a. Class I biological safety cabinet b. Powder hood c. Glovebox d. Closed-system drug-transfer device Closed-system drug-transfer device What is the goal of C-PECs when sterile compounding? a. To protect the compounder from hazardous drug exposure b. To protect the compounder from hazardous drug exposure AND to protect the product from contamination c. To act as a type of supplemental engineering control to protect against environmental exposure To protect the compounder from hazardous drug exposure AND to protect the product from contamination Which of the following are C-PECs that are recommended within USP 800 for sterile compounding of hazardous drugs? Select all that apply. ___ Class I Biological safety cabinet (BSC) ___ Class II Biological safety cabinet (BSC) ___ Compounding aseptic isolator (CAI) ___ Compounding aseptic containment isolators (CACI) ___ Horizontal laminar airflow workbench Class II Biological safety cabinet (BSC) Compounding aseptic containment isolators (CACI) Which of the following are C-PECs that are recommended within USP 800 for nonsterile compounding of hazardous drugs? Select all that apply. ___ Compounding aseptic containment isolators (CACI) ___ Class I Biological safety cabinet (BSC) ___ Class II Biological safety cabinet (BSC) ___ Vertical laminar airflow workbench ___ Containment ventilated enclosure (CVE) Compounding aseptic containment isolators (CACI) Class I Biological safety cabinet (BSC) Class II Biological safety cabinet (BSC) Containment ventilated enclosure (CVE) What is the difference between a Class II biological safety cabinet and a compounding aseptic containment isolator? a. A Class II BSC provides external ventilation while the CACI does not. b. A Class II BSC has a shield to protect the compounder while the CACI uses a glovebox design. c. A Class II BSC uses HEPA filters while CACIs do not. A Class II BSC has a shield to protect the compounder while the CACI uses a glovebox design. An image of a type of C-PEC and its airflow is shown to the right. If the air is pulled directly through the shield opening and not through a HEPA filter, what type of engineering control is this? a. Class I Biological safety cabinet (BSC) b. Class II Biological safety cabinet (BSC) c. Horizontal laminar airflow workbench Class I Biological safety cabinet (BSC) Can this PEC be used for sterile compounding? No. It does not protect the product. Which of the following is TRUE of a containment ventilated enclosure? Select all that apply. ___ Abbreviated as CVE ___ Commonly called powder hoods ___ Can be used for non-sterile, hazardous drug compounding ___ Can be used for sterile, hazardous drug compounding Abbreviated as CVE Commonly called powder hoods Can be used for non-sterile, hazardous drug compounding Which of the following are requirements for all C-SECs no matter if for sterile or nonsterile compounding? Select all that apply. __ Must provide ISO Class 7 air Must be a room separated from the rest of the pharmacy Must be externally vented to outside the building Must circulate the air and have a certain number of air changes per hour True or false, parenteral products compounded within a Class II biological safety cabinet that is located within a room without ISO Class 7 air quality will have a shortened beyond-use date. True (this will be considered as a "low risk with 12 hour or less BUD") Which of the following are considered as personal protective equipment that is appropriate for hazardous drug compounding? Select all that apply. ___ A highly permeable, low-lint
gown Head and shoe covers Sleeve covers Goggles Two pairs of chemotherapy gloves True or false, a surgical mask provides sufficient protection against airborne hazardous drug particles. False (Needs to be opened by a trained employee) True or false, many types of hazardous drugs may need to be stored in a specialized hazardous drug storage room that is externally vented and has negative pressure. True Which of the following dosage forms would NOT require storage in a hazardous drug storage room? Use the NIOSH list and USP 800 if necessary. a. Bulk containers of testosterone
powder Tablets of topiramate When completing nonsterile compounding of a hazardous drug, which of the following are required? Select all that apply. ___ The compounder also follows standards listed in USP 797 _X__ Compounding must take place in a C-PEC located within a C-SEC _X__ Equipment used in compounding like balances, beakers, spatulas, etc must be dedicated for use with hazardous drugs only _X__ Environmental wipe sampling of compounding areas Compounding must take place in a C-PEC located within a C-SEC Equipment used in compounding like balances, beakers, spatulas, etc must be dedicated for use with hazardous drugs only Environmental wipe sampling of compounding areas Use of a chemical, heat, UV light, or another agent to transform a hazardous drug into a less hazardous agent is better known as? a. Deactivation Deactivation A pharmacy technician has just finished compounding a hazardous drug. The technician uses an absorbent, disposable cloth to remove hazardous drug residue from the surface of the C-PEC she was utilizing. This is an example of? a. Deactivation Decontamination Which of the following are TRUE regarding cleaning and disinfecting? Select all that apply. _X__ Cleaning is the removal of both organic and inorganic materials from a surface. ___ Cleaning will disinfect a surface. _X__ Disinfection if the inhibition or destruction of microorganisms. ___ Disinfection needs to occur for both sterile and non-sterile hazardous drug compounding. Cleaning is the removal of both organic and inorganic materials from a surface. Disinfection if the inhibition or destruction of microorganisms. SUMMARY TABLE: Deactivation SUMMARY TABLE: Non-hazardous What can make a drug be classified as a hazardous drug select all that apply?The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure ...
Which medication is classified as a hazardous drug quizlet?Hazardous drugs include drugs that are: teratogenic, carcinogenic, genotoxic (damage the DNA and can cause cancer), have reproductive toxicity, and cause organ toxicity at low doses.
Where would you find warnings and special handling for hazardous drugs quizlet?Where would you find warnings and special handling for Hazardous Drugs? On the manufacture's Safety Data Sheet.
Which medication is classified as a hazardous drug?Antineoplastic cytotoxic medications, anesthetic agents, anti-viral agents, and others, have been identified as hazardous. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects.
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In our pharmacy which of the following activities are allowed select all that apply Quizlet
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