W9 General Principles Of SACT preparation and Manufacture Flashcards
What is the definition of a cytotoxic agent?
A substance that kills cells, including cancer cells.
Cytotoxic agents may stop cancer cells from dividing and growing and may cause tumors to shrink in size.
Define Systemic Anti-Cancer Therapy (SACT).
All anti-cancer drug treatment including chemotherapy and immunotherapy.
What is chemotherapy?
What are the methods of chemotherapy administration?
A treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
By mouth, injection, infusion, or on the skin.
True or False: Chemotherapy is a high-risk drug.
True.
How are SACT prepared?
Aseptic unit
▪ Isolators
▪ Clean rooms
Positive and negative pressure within aseptic unit
▪ protect operator (- pressure isolator)
▪ protect the product (+ pressure isolator)
What is Good Manufacturing Practice (GMP)?
The minimum standard that a medicines manufacturer must meet in their production processes.
List the requirements for GMP compliance. (3)
- Be of consistent high quality
- Be appropriate to their intended use
- Meet the requirements of the marketing authorisation or product specification.
What organizations must comply with GMP? (4)
- Manufacturer licence holders
- Wholesale dealer licence holders
- Blood establishment authorisation holders
- Non-UK sites employed by UK MA holders.
Flow of work through an aseptic unit? (8)
- Prescription printed by coordinating technician/ATO
- Technician prints worksheets
- Pharmacist clinically checks prescription & worksheet
- Dispensed from worksheet by technician
- ACPT technician checks worksheet and ingredients tray
- Chemotherapy made by technician/ATO
- Volume check by ATO
- Final release check by pharmacist
What does COSHH stand for?
What is it?
Control of Substances Hazardous to Health Regulations. (A law that requires employers to control substances that are hazardous to health).
What are the main principles of COSHH?
- Finding out what the health hazards are
- Deciding how to prevent harm to health
- Providing control measures to reduce harm to health
- making sure they are used ;
- Keeping all control measures in good working order.
- providing information, instruction and training for employees and others;
- providing monitoring and health surveillance in appropriate cases;
- planning for emergencies.
SACT dosing:
Adapted to the individual
▪ Body Surface area (BSA)
▪ Weight
▪ N.B. Carboplatin Calvert equation:
▪ Dose in mg = (25 + GFR ) x AUC
Nearest measurable dose
▪ 5% for chemo
▪ 10% for immunotherapy
What are the factors affecting the storage and stability of chemotherapy?
- Certain diluents with certain drugs (e.g., carboplatin and glucose)
- Licensed vs. non-licensed aseptic units.
- Section 10 MHRA.
What is the purpose of dose banding in chemotherapy?
- To round calculated doses of chemotherapy drugs to pre-determined standard doses.
- Will not affect toxicity or clinical outcomes.
What is the maximum variation allowed between prescribed and banded doses?
≤5%.