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%.
What are the 2 methods of dose banding?
-
BSA Centred Dose Banding - Bands are set in increments of BSA,
e.g. patient’s BSA is rounded up or down to one decimal place and a set dose band given for that BSA, e.g. doxorubicin 50mg/m2 for patient of 1.73 m2 , the BSA is rounded to 1.7 and a
dose of 85mg given - Drug Centred Dose Banding (or ‘Target Dose’ Banding) - The patient’s dose prescribed using BSA and then rounded up or down to the nearest band e.g. doxorubicin 50mg/m2 for patient of 1.73 m2, the calculated dose is 86.5mg. This falls in the 82.6mg to 87.5mg range for which a dose of 85mg is given
Fill in the blank: The _______ equation is used for calculating doses of Carboplatin.
Calvert.
What are the benefits of SACT dose banding?
- Reduced waiting times for patients
- Increased pharmacy capacity/workload
- Reduced medicine waste by avoiding incomplete usage of a vial/ampoule for individual doses
- Reduced waste when treatments are deferred- can reuse
- Inc pharmacy capacity/workload
- Facilitates pharmacy skill mix
Safe handling of chemotherapy
- Direct exposure - inhalation, ingestion or absorption
▪ The health risk of any procedure involving chemotherapy depends on the toxicity of the drug and the extent of exposure to health care
workers/patients
▪ Staff trained on the handling of cytotoxic drugs and on the management of cytotoxic spillages at induction/ yearly update
▪ Staff who are pregnant/ planning to conceive - seek advice from the Occupational Health department & line manager before handling chemo (limited evidence)
▪ Protective Personal Equipment (PPE) is necessary when handling cytotoxic drugs and cytotoxic waste
What is required when managing a cytotoxic spillage?
▪ Immediate action:
* Restrict access to the spillage area
* Alert other staff and inform a senior member
* If you have been injured or contaminated, another member of staff must
deal with the spillage while you receive attention
▪ New and expectant mothers should not have direct involvement in the
management of a cytotoxic spillage
▪ Turn off all fans
▪ Open a cytotoxic spill kit
▪ If protective clothing contaminated during the spillage, remove the
contaminated items and put on fresh protective clothing from the spillage
kit. Place all contaminated items in the designated cytotoxic waste bin
▪ Follow the procedure as outlined in the cytotoxic spill kit
Factors affecting stability of
chemotherapy and how this is
managed:
▪ Certain diluent with certain drugs e.g. carboplatin and glucose because sodium interferes with platinum chemotherapy
▪ Licensed and non-licensed aseptic unit – difference in length of expiry on products
▪ Medusa
▪ Section 10 MHRA
Safe disposal of chemotherapy:
What types of waste are considered cytotoxic waste? (6)
- Equipment and materials used for cytotoxic spillage
- Frank chemotherapy not administered (e.g. syringe, infusion set, bags of cytotoxic chemotherapy)
- PPE.
▪ Empty syringes.
▪ Nappies
▪ All equipment and materials used to prepare
chemotherapy
(Hazardous waste regulations 2005 (England & Wales))
Reasoning for SACT manufacturing
processes:
What is intrathecal administration?
Treatment with drugs that are injected into the fluid surrounding the brain and spinal cord (CSF)
What is Good Clinical Practice (GCP)?
What should all follow GCP?
- The agreed international standard for conducting clinical research.
- Clinical trials
