W9 General Principles Of SACT preparation and Manufacture Flashcards

1
Q

What is the definition of a cytotoxic agent?

A

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.

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2
Q

Define Systemic Anti-Cancer Therapy (SACT).

A

All anti-cancer drug treatment including chemotherapy and immunotherapy.

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3
Q

What is chemotherapy?
What are the methods of chemotherapy administration?

A

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.

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4
Q

True or False: Chemotherapy is a high-risk drug.

A

True.

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5
Q

How are SACT prepared?

A

Aseptic unit
▪ Isolators
▪ Clean rooms

Positive and negative pressure within aseptic unit
▪ protect operator (- pressure isolator)
▪ protect the product (+ pressure isolator)

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6
Q

What is Good Manufacturing Practice (GMP)?

A

The minimum standard that a medicines manufacturer must meet in their production processes.

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7
Q

List the requirements for GMP compliance. (3)

A
  • Be of consistent high quality
  • Be appropriate to their intended use
  • Meet the requirements of the marketing authorisation or product specification.
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8
Q

What organizations must comply with GMP? (4)

A
  • Manufacturer licence holders
  • Wholesale dealer licence holders
  • Blood establishment authorisation holders
  • Non-UK sites employed by UK MA holders.
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9
Q

Flow of work through an aseptic unit? (8)

A
  1. Prescription printed by coordinating technician/ATO
  2. Technician prints worksheets
  3. Pharmacist clinically checks prescription & worksheet
  4. Dispensed from worksheet by technician
  5. ACPT technician checks worksheet and ingredients tray
  6. Chemotherapy made by technician/ATO
  7. Volume check by ATO
  8. Final release check by pharmacist
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10
Q

What does COSHH stand for?
What is it?

A

Control of Substances Hazardous to Health Regulations. (A law that requires employers to control substances that are hazardous to health).

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11
Q

What are the main principles of COSHH?

A
  • 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.
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12
Q

SACT dosing:

A

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

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13
Q

What are the factors affecting the storage and stability of chemotherapy?

A
  • Certain diluents with certain drugs (e.g., carboplatin and glucose)
  • Licensed vs. non-licensed aseptic units.
  • Section 10 MHRA.
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14
Q

What is the purpose of dose banding in chemotherapy?

A
  • To round calculated doses of chemotherapy drugs to pre-determined standard doses.
  • Will not affect toxicity or clinical outcomes.
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15
Q

What is the maximum variation allowed between prescribed and banded doses?

A

≤5%.

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16
Q

What are the 2 methods of dose banding?

A
  • 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
17
Q

Fill in the blank: The _______ equation is used for calculating doses of Carboplatin.

A

Calvert.

18
Q

What are the benefits of SACT dose banding?

A
  • 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
19
Q

Safe handling of chemotherapy

A
  • 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
20
Q

What is required when managing a cytotoxic spillage?

A

▪ 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

21
Q

Factors affecting stability of
chemotherapy and how this is
managed:

A

▪ 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

22
Q

Safe disposal of chemotherapy:
What types of waste are considered cytotoxic waste? (6)

A
  • 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))

23
Q

Reasoning for SACT manufacturing
processes:
What is intrathecal administration?

A

Treatment with drugs that are injected into the fluid surrounding the brain and spinal cord (CSF)

24
Q

What is Good Clinical Practice (GCP)?
What should all follow GCP?

A
  • The agreed international standard for conducting clinical research.
  • Clinical trials
25
Q

What is the significance of the UK Policy Framework for Health and Social Care Research?

A

It sets out principles of good practice in the management and conduct of health and social care research in the UK.

26
Q

What does the term ‘aseptic preparation’ refer to?

A

A critical activity undertaken according to national quality standards for preparing injectable medicines.

27
Q

What is the role of the Medicines and Healthcare products Regulatory Agency (MHRA)?

A

To carry out inspections to check if manufacturing complies with GMP.

28
Q

What does the term ‘dose banding’ refer to?

A

The practice of rounding chemotherapy doses to standard predetermined amounts.

29
Q

What is the purpose of protective personal equipment (PPE) when handling cytotoxic drugs?

A

To protect healthcare workers from direct exposure to hazardous substances.