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B33CAN - ROGO Prep > Aseptic Preparation and Safe Handling > Flashcards

Aseptic Preparation and Safe Handling Flashcards

1
Q

What are some examples of sterile pharmaceutical products?

A
  • Chemotherapy drugs and antibody preparations
  • Total parenteral nutrition (TPN)
  • Intravenous additives
  • Eye products e.g. intravitreal use (injection to the eye)
  • Drugs used in clinical trials
  • Some ‘medicated’ dressings
    > Where an IV route is preferable
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2
Q

What are the potential contaminants of a sterile pharmaceutical product, and how could these occur?

A
  • Microorganisms (fungi and bacteria)
  • Particulate matter (skin, hair, fibres, condensate)
  • Pyrogens (endotoxin produced from G-ve bacteria)
    > From ingress during preparation or administration.
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3
Q

What are the purposes of patient safety alerts?

Give examples.

A

To seek to understand and address errors w/injectable medicines.

  • Breckenridge report (1976); CIVA services
  • Farwell report (1995); Aseptic preparation
  • NPSA Alert (2007); safer use of injectables
  • NHS Alert (2016); restrict use of open systems
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4
Q

How did the Breckenridge Report (1976) arise, and what did it recommend?

A
  • Accidental infusion of potassium that was incorrectly mixed on the ward; KCL denser than H2O, precipitated at bottom = ‘bolus dose’ of strong conc KCL administered leading to cardiac arrest.
  • Lead to development of CIVAS; Hospital Centralised IV Additive Services = additions to infusions to be made by the manufacturer or by the hospital pharmacy department.
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5
Q

What did the Farewell report (1995) and the 2007 NPSA Alert recommended?

A
  • Farwell; set out requirements for aseptic dispensing in NHS patients.
  • NPSA; promoted safer use of injectable medicines, requiring all healthcare organisations to perform new risk assessments. Came about after 800 errors w/injectables; 25 fatalities.
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6
Q

What legislation governs the preparation and supply of medicines?
What do these specify?

A
  • Medicines Act 1968 and various statutory amendments, now part of the Human Medicines Regulations 2012.
  • Marketing Authorisation (MA) required with any medicinal product sold or marketed; liability of product defects lies with manufacturer.
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7
Q

What guidance is availible for the preparation and supply of medicines?

A
  • Orange Guide (MHRA); Good Manufacturing Practice (GMP)

- Yellow Guide; Quality Assurance of Aseptic Preparation Services.

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8
Q

What does The Yellow Guide entail, and what regulation does it include?

A
  • Provides guidance on GMP for aseptic dispensing e.g. procedures, competencies, responsibilities, control of materials, provision/maintenance/monitoring of facilities and equipment
  • EL(97)52 Regulation/Farwell report; guidance on aseptic dispensing contained within The Yellow Guide.
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9
Q

What does the Crown (Parliamentary) Section 10 Exemption entail?
Where does liability lie?

A
  • Allows medicines to be prepared ‘manufactured’ under the supervision of a Pharmacist, against a written Rx, for subsequent administration to a named patient.
  • Includes manipulation of raw materials incl. licensed medicines e.g. addition to a syringe/infusion bag.
    > Liability for defects lies with the Pharmacist, company or NHS Hospitals Trust.
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10
Q

How do rules for manufacturing medicines vary in the Orange Guide to Section 10 Exemption preparation by a pharmacist, and why is this so?

A
  • Rules and regulations much more stringent for large-scale batch manufacturing than Section 10 dispensing for an individual patient (whether a small batch or single)
  • Potential to harm many more people w/mass manufacturing opposed to tailored preparation
  • Medicines made in manufacturing have to be put to market; sold and distributed.
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11
Q

Why is there a need for a Special Manufacturer’s Licence (Specials), and what rules are they governed by?

A
  • Used where there is no suitable commercially availible product, often in small hospital production units
  • Does not require a full MA; meets ‘special’ need.
  • Rules similar to medicines prepared under a Manufacturer’s Product License (MA) (not as lax as Section 10 Dispensing)
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12
Q

List and compare aspects of manufacturing (via specials manufacturing licence) and dispensing (under section 10 exemption).

A

Manufacturing:

  • Preparation by suitably trained person (not necessarily qualified pharmacy technicians)
  • Extended expiry (stability); longer shelf lives and less waste (provided stability data supporting)
  • Batch prepared for stock
  • Final product check and batch release done by separate people (pharmacy technician former, registered and degree-qualified person latter e.g. pharmacist, scientist, Qualified Person)
  • Inspected by MHRA on risk-based approach (more frequently if more risks identified)

Dispensing:

  • Prepared or directly supervised by a pharmacist (pharmacy technicians prepare product ‘under supervision’)
  • Max 7 day expiry (stability allowing)
  • Prepared against Rx (though small batches up to 10 items can be infrequently prepared in anticipation of a prescription; subject to limited shelf life and full dispensing requirements e.g. labels)
  • Final check and release together by suitably qualified pharmacist
  • Regional audit under EL(97)52 QA on 1-3 year cycle
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13
Q

What is the PQS?

A

Pharmaceutical Quality System; overall system of quality management, providing assurance of product quality as a result of the systems and processes in place.

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14
Q

What is the Beaney (2016) definition for Quality management/assurance?

A

“The sum total of organised arrangements with objective of ensuring that medicinal products are of the quality required for their intended use.”

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15
Q

What does quality assurance cover?

A

All aspects of manufacturing process:

  • Product design
  • Clean room environment
  • SOPs
  • Training
  • Documentation
  • Internal audit
  • Final release of product
  • Product recall and complaints
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16
Q

What documentation might be involved in PQS?

A
  • Policy and procedures
  • Worksheets
  • Labels
  • Computer systems
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17
Q

What roles and responsibilities for staff may be defined in PQS?

A
  • Standards of hygiene
  • Changing into clean room protective clothing
  • Training
  • Assessment
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18
Q

What are the differences in roles and responsibilities of the Chief, Accountable, Authorised and Suitably Qualified Pharmacists in a PQS? (Section 10 Exemption)

A
  • Chief; overall boss man.
  • Accountable; also an Authorised Pharmacist, responsible for all aspects of aseptic preparation unit.
  • Authorised; supervises the aseptic process and release of products inc. Rx verification for each product, ensures clinical check has been carried out by a Suitably Qualified Pharmacist.
  • SQ Pharmacist; Clinical checks, but not specifically authorised to supervise or oversee routine aseptic preparation activities (Authorised Pharmacist).
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19
Q

What is the role of the Chief Pharmacist in a PQS?

A

Overall responsibility and accountability for the PQS and safe supply of medicines.

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20
Q

What is the role of the Accountable Pharmacist in a PQS?

A

The named Pharmacist responsible for all aspects of the aseptic preparation unit e.g. approval of work systems.

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21
Q

What is the role of the Authorised Pharmacist in a PQS?

A
  • Specifically designated to routinely supervise the aseptic process and release of products for use.
  • Including prescription verification at an individual product level.
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22
Q

What is the role of a Suitably Qualified Pharmacist in a PQS?

A

Any registered pharmacist e.g. a clinical pharmacist, performs clinical checks.

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23
Q

How is the Sterile environment designed?

A
  • Legislation and guidance govern design around workflow, health & safety, cleaning and ongoing maintenance.
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24
Q

What system maintains a sterile environment, to what controls?

A
  • Maintained by air flow and pressure from highest to lowest
  • Creates a positive pressure drop (10 - 15 Pa) carrying contaminants from sterile (cleanest) to non-sterile (dirtiest) environment.
  • Achieved by careful design, use of air handling unit, laminar air flow and extraction between rooms.
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25
Q

How many air changes per hour are desirable in a sterile environment?

A

A minimum of 20-30 complete air changes per hour.

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26
Q

What are the typical configuration of clean zones? (EU GMP Grading)

A
  • Grade A - Sterile; Laminar air flow (LAF) cabinets and isolators i.e. point of fill.
  • Grade B - the aseptic preparation room (where LAFCs are housed)
  • Grade C - Change areas or inner support room (where materials are assembled)
  • Grade D - Outer support rooms
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27
Q

Which zone is aseptic manipulation carried out in?

A

In critical zone EU GMP Grade A (EC 2015).

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28
Q

Where are Grade A isolators installed?

A

Can be installed in Grades B-D rooms.

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29
Q

What is meant by the Validation Master Plan?

A
  • Includes all documentation and testing of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
  • Rigorous procedures and processes to ensure aseptic sterility are maintained before, during and after use.
  • There is an essential requirement for commissioning facility and ongoing audit and inspection.
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30
Q

What equipment is required for sterile pharmaceutical production?

A
  • Laminar airflow cabinets (open)
  • Isolator devices (closed)
  • Clothing and PPE
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31
Q

What variants of LAFC and isolator devices are there for aseptic manipulation?

A
  • Horizontal or vertical LAFCs
  • Class II safety cabinets
  • Cytotoxic cabinets
  • Negative and positive pressure isolators
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32
Q

How are different clean zones connected?

A
  • Interlocking hatches and doors
  • Allow time for decontamination and audible alarms if breach of environment or malfunction (e.g. needle through isolator sleeve, failure in Air Handling Unit, AHU).
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33
Q

Where are washing facilities and changing facilities located in an aseptic manufacturing unit?

A
  • Washing facilities; on way into facility only (never in clean zones)
  • Changing facilities; at entrance and between rooms when required e.g. Grade C inner support room to Grade B clean room with LAFC.
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34
Q

What is deemed a hazardous material in relation to manipulation by the operator?

A
  • Cytotoxic chemotherapy
  • Monoclonal antibodies
  • Penicillin antibodies
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35
Q

Are hazardous materials prepared in the same space as non-hazardous preparations?

A

No; they must be prepared in separate work zones/rooms/equipment.

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36
Q

How and where is cytotoxic chemotherapy prepared?

Why is this the case?

A

It must only be prepared in a safety cabinet (like in chemistry/ceutics lab) or negative pressure isolator, to maximise operator protection.

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37
Q

Do procedures for hazardous materials also apply for the preparation of licensed and unlicensed products?

A

Yes; in that preparation of licensed and unlicensed products must be clearly separated.

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38
Q

What clothing/PPE is required for a Grade D outer support room?

A
  • Non-shedding protective coat
  • Overshoes
  • Covered hair/facial hair
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39
Q

What clothing/PPE is required for a Grade B aseptic preparation room?

A
  • Single piece clean room garment
  • Boots
  • Non shedding headgear
  • Facemask
  • Non-powder sterile gloves
  • Armlets
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40
Q

What is the role of PPE?

A

Minimises risk of exposure via inhalation/absorption of hazardous substances

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41
Q

What are the PPE requirements when handling cytotoxic chemotherapy?

A
  • Full-length suit w/sleeve protection
  • Gauntlets (outer hench gloves)
  • Double gloving w/inner thin layer latex gloves and nitrile cytotoxic-grade outer gloves
  • Balances operator protection with ability to manipulate product safely (using syringes and needles etc.)
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42
Q

What are the PPE/clothing requirements when preparing products outside of a closed containment system?

A
  • Full length suits
  • Gloves
  • Eye protection
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43
Q

In what activities is eye/respiratory protection required on top of gloves and gowns?

A
  • Raw materials, Setting up, Preparation = G&G OG
  • Administration (eye)
  • Waste disposal (eye & respiration)
  • Spillage (eye & respiration)
44
Q

Define: cleaning.

A

The removal of dirt.

schedule & approach accordingly

45
Q

Define: decontamination.

A

Removal of a chemical (or microbiological) contaminant e.g. in cytotoxic

46
Q

Define: disinfection.

A

Process of reducing number of viable micro-organisms.

47
Q

What is an effective cleaning schedule?

A
  • Ceilings and walls monthly
  • Floors and benches daily
  • Critical zones before/after each session
48
Q

What is the best cleaning approach?

A
  • To clean from least to most contaminated; from Grade A to D.
  • Wipe down walls to push down particles
  • Wipe cabinets from back to front in overlapping strokes using clean wipe for each surface (walls, bench etc.)
  • Clean slowly (to avoid generating particles)
  • Methodically (to cover all areas)
49
Q

What is the minimum contact time required for disinfectants to work?

A

At least 2 minutes

50
Q

What cloths are used to wipe down surfaces, and what process follows?

A
  • Lint-free, non-shedding sterile cloths

- Disinfect w/freshly diluted products afterwards

51
Q

What is the standard disinfectant product used for critical zones?

A

70% w/v IMS (industrial methylated spirits)

52
Q

What are the ideal attributes for a disinfection/sanitisation agent?

A 
- Bactericidal (must)
Ideally:
- Fungicidal
- Virucidal
- Sporicidal
53
Q

How do alcohols compare with aldehydes/hydrogen peroxide for disinfection agent activity?

A
  • Alcohols have good BFV (bacterio-fungal-virucidal) activity, but lack sporicidal
  • Aldehyde and hydrogen peroxide are sporicidal, but hazardous.
54
Q

What are the different ways to monitor cleaning/sanitation?

A
  • Environmental
  • Microbiological
  • Physical
55
Q

What does environmental monitoring entail, and why is it required?

A
  • Alarm panels (e.g. temperatures/pressures of AHU) and gauges
  • To ensure facility and equipment are performing correctly, within controlled limits, and SOPs being followed.
  • Involves physical, microbiological and chemical testing.
56
Q

What does microbiological monitoring entail?

A
  • Settle plates
  • Contact plates
  • Swabs
  • Finger dabs
  • Active air samples (onto agar strips)
  • Plates exposed during working sessions then incubated.
57
Q

What are some examples of physical monitoring of sanitation?

A
  • Airflow; anemometer
  • HEPA filter integrity; dispersed oil particulate (DOP)
  • Particle counter (at rest and during activity)
  • Differential pressures; isolator/glove ‘leak tests’ for pressure decay
58
Q

What does chemical monitoring of sanitation entail?

A
  • Residue swabs

- Surface wipes

59
Q

How often are quality assurance reports reviewed for cleaning/sanitation?

A

Monthly.

60
Q

Define: ANTT.

A
  • Aseptic non-touch technique; to avoid any contact with any surface which will be in contact with the sterile fluid path.
  • Preparation and administration of injectables
61
Q

Where is ANTT used?

A
  • Near-patient (wards, patient home)

- Aseptic environments (aseptic units, operating theatres etc.)

62
Q

What is a ‘closed procedure’ w/reference to ANTT?

A

‘Transfer of sterile ingredients or solutions to a pre-sterilised sealed container, directly or using a sterile transfer device, without exposing the solution to the external environment’

  • Must be within an EU GMP Grade A (EC 2015) environment.
  • Used in pharmacy aseptic areas
63
Q

Is a single withdrawal from a sterile ampoule, using a sterile syringe and needle a closed procedure?

A

Yes

64
Q

What needs to be considered w/regards to ANTT approach to safe aseptic technique in near patient areas?
(6 step approach)

A
  • Risk assess
  • Manage environment
  • Decontaminate and protect (product + patient)
  • Use aseptic fields
  • NTT
  • Prevent cross-infection
65
Q

What are some examples of critical surfaces?

A
  • Walls
  • Bench
  • Syringe hub
  • Syringe needle
66
Q

Why is needle safety important?

A
  • Reduce risk of needlestick/sharp injury
  • Risk of exposure to blood borne infections e.g. HIV, Hep C
  • Risk of contamination w/concentrated cytotoxics and other drugs
67
Q

What regulations govern needle safety and what do they specify?

A
  • Health and Safety (Sharps Instruments in Healthcare) Regulations 2013 (May 2013)
  • Requires all employers to risk assess use of sharps, introduce controls to avoid unnecessary use, to utilise needle-safe or needle-free equipment, ensure sharps bins are availible in all relevant areas, and that all sharps-related incidents continue to be acted on and reported.
68
Q

What is meant by needle-safe equipment?

A
  • Blunt needles
  • Protection mechanisms
  • Re-sheathing of needles using single-handed re-sheathing devices e.g. needle block; re-sheathing usually not advised as increases risk of needlestick injury (dispose of after use immediately) but required for containment/asepsis to avoid cross-contamination e.g. infusion bags in the confined space
69
Q

What is meant by needle-free devices?

A
  • Devices designed to reduce risk of needle-stick injury
  • Incorporate closed systems to reduce exposure to hazardous drugs
  • E.g. Tevadaptor, Braun OnGuard and Phaseal.
70
Q

What are the COSHH regulations (2002)?

A
  • Control of Substances Hazardous to Health Regulations (2002)
  • Chemicals, biological agents etc.
  • NOT radioactive substances.
71
Q

Where do carcinogens appear in COSHH, and what are the guidelines?

A
  • Appendix 1 approved code of practice
  • Require risk assessment and safety data sheets to cover products, covering control measures (e.g. PPE and health surveillance)
72
Q

What is a safety data sheet?

A

Required for carcinogens as per COSHH:

  • Raw materials
  • Control measures
73
Q

What organisation cover/manage COSHH?

A

The UK Health and Safety Executive (part of NHS Public Health)

74
Q

What are the 5 steps to risk assessment with COSHH?

A
  • Identify hazard
  • Who is at risk of being harmed and how (attention to high risk employees e.g. pregnant women)
  • Adequacy of existing control measures (frequency of use, previous incident records)
  • Documented risk assessment
  • Review date
75
Q

What regulations other than COSHH govern the safe handling of chemicals/biologicals etc?

A
  • Health and Safety at Work Act 1974

- Management of Health and Safety Work Regulations 1999

76
Q

What is safe storage of cytotoxics?

A
  • Secure storage at bench height (heavy objects near the floor)
  • Clearly labelled areas
77
Q

Which organisation provides guidelines on the safe transport of cytotoxic drugs from manufacturer to pharmacy?

What do these entail?

A
  • The International Society of Oncology Pharmacy Practitioners (ISOPP)
  • Using manufacturer’s that meet recognised standards e.g. oncotainers (plastic sheath around glass vials to prevent smashing)
  • Transport documentation
  • Damage check
  • Certification containers are not contaminated
78
Q

How must chemotherapy be supplied from the manufacturer?

A

Containers must be:

  • Secure
  • Sealed
  • Clearly labelled
  • Spill-proof

Cytotoxic bag (clear) with product double wrapped, transported in person or within secure transport box.

79
Q

What is the procedure for dealing with cytotoxic spillages?

A
  • Act immediately
  • Cordon off area
  • Collect spill kit
  • PPE (double glove, disposable gown, goggles, mask, overshoes)
  • Lay down ‘chemosorb’ pads over liquid spillage
  • Use absorbent towel to clean from uncontaminated outer to centre of spillage
  • Wash down contaminated area with copious water
  • Dry w/absorbent towels
  • Double bag all waste in cytotoxic waste bag
  • Complete incident form
  • Replace spillage kit
80
Q

What is a spill kit?

A
  • Protects personnel and contains the spillage
    Should include:
  • PPE
  • Hazard signs
  • Absorbent materials (e.g. chemosorb pads/granules)
  • Scoop/scraper
  • Container for safe disposal and subsequent high temperature waste incineration
81
Q

Where are spill kits located?

A

Every area with chemotherapy is stored, manipulated, administered or disposed.

82
Q

What regulations cover the spillage of chemotherapy?

A
  • European Waste framework Directive 2008/98/EC
  • UK Health Technical Memorandum
  • Hazardous Waste Regulations
  • UK Health and Safety Legislation
83
Q

What is defined as product waste, and how is it disposed?

A
  • Empty vials
  • Consumables
  • Contaminated administration equipment

> Disposed of in designated sharps bins w/purple lids
Sealed, double bagged and disposed of by high temperature incineration

84
Q

How is cytotoxic/cytostatic medicinal waste classified?

A
  • H6 = toxic
  • H7 = carcinogenic
  • H10 = toxic for reproduction
  • H11 = mutagenic
85
Q

What is the significance of a purple-lidded sharps bin?

A
  • For cytotoxics

- Sent with authorised consignment note for high temperature incineration in a licensed facility

86
Q

What are the dangers of patient waste, and how should it be discarded?

A
  • Potentially hazardous metabolites excreted in urine and faeces
  • Contaminated linen and clothing may be treated as infected clinical waste
  • Heavily contaminated to be disposed by incineration
87
Q

What factors influence the duration that a patient excretes hazardous waste?
Give examples.

A
  • Drug
  • Dose
  • Route
  • Patient factors (e.g. hepatic-renal function)

> Cisplatin excreted largely unchanged in urine for 7 days
Methotrexate in urine for 3 days, 7 days in faeces

88
Q

Define: aseptic processing.

A

The manipulation of sterile starting materials and components in such a way that they remain sterile and uncontaminated whilst being prepared for presentation in a form suitable for administration to patients.

89
Q

What is included in the process design of aseptic processing?

A
  • Entry/exit from sterile facility
  • Choice of clothing/PPE
  • Choice of equipment/materials
  • Adoption of principles of good aseptic practice (e.g. sanitisation of all starting materials, correct choice and use of equipment)
  • Product segregation
  • In-progress checks
90
Q

Where can hazards arise during aseptic manipulation, and how can they be minimised?

A
  • In constitution due to use of wrong equipment/technique; positive pressure in a vial results in liquid aerosols/vapours escaping, contaminating equipment and transferred by operators
  • Validated operator checks to check for contamination and decontamination of surfaces (e.g. w/fluorescein)
91
Q

What size needles are most preferable during aseptic processing?

A
  • Wide range of sterile needles availible
  • 16-20 gauge (13 largest bore to 27 finest)
  • Use smallest bore to reduce risk of coring rubber septum on vials/ports
92
Q

What syringes are availible for aseptic processing/manipulation?

A
  • Luer-slip (septic manipulation)
  • Luer-loc (as final container)
    > 1-50 mL size
93
Q

What is the purpose of using aseptic transfer devices?

A
  • Maintain closed procedure
  • Minimise manipulations and connections
  • Phaseal; equalises pressures in vials without need for push/pull technique.
94
Q

What are the three stages of aseptic processing?

A
  • Pre-production; worksheet selection, preparation, labels, assembly of tray, record batch numbers, sanitise, transfer to aseptic room
  • Preparation; aseptic manipulation of raw materials into final container, in-process checks, reconciliation, decontamination
  • Post-production; labeling, reconciliation of materials/consumables used, check final product, pack for supply, final release.
95
Q

What are the steps involved in product check and release?

A
  • Verification
  • Inspection
  • Reconciliation (HELP)
  • Final product checks
  • Product approval (Release)
96
Q

What does the Verification process involve?

A

Checking something is correct:

  • Clinical; against Rx by suitably qualified pharmacist (ensure product appropriate for patient)
  • Aseptic services; to check clinical check has been undertaken, the prescibed components are compatible, formulation stable and product presentation appropriate for intended use (route), by an authorised pharmacist
97
Q

What does the Inspection process involve?

A

Occurs at various stages:

  • Initial visual examination of starting materials (correct, signs of degradation/colour change/particles/leaks/label defects)
  • Consumables; visually checked before sanitisation and transfer to aseptic room.
  • Documentation; inspected to ensure it is correct
  • In-process checks; products well-mixed, volumes accurately measured, no physical signs of discolouration or precipitation on assembly
98
Q

What does the process of Reconciliation involve?

A

Accounting for materials, consumables, labels:

  • No. of drug containers (vials/ampoules) compared w/quantity expected on worksheet
  • Labels checked against worksheet before affixing to pre-filled syringe/infusion bag etc.
99
Q

How does the acronym (HELP) aid the process of reconciliation?

A

H - how many? (check worksheet)
E - expiry date
L - label (details of patient & product)
P - product (drug, strength, final volume, diluent)

100
Q

What does the final product check entail? Who does it?

A
  • Reconciliation of product and labels
  • Visual inspection, sign off worksheets
    > Only carried out by fully trained competent staff e.g. senior PTs routinely involved
101
Q

What is involved with product approval/release?

Who does it?

A
  • A formal, recorded decision of release after all checks have been completed and documented.
    > Suitably qualified person, under Section 10 dispensing under supervision of a pharmacist
102
Q

What is a Laminar Air Flow Cabinet (LAFC), and what does it protect?

A
  • Continuous, unidirectional flow of sterile air

- Protects the product, but not the worker

103
Q

What are the dos and don’ts of using a LAFC?

A

Do:

  • Work behind the red line
  • Use the needle safe tool

Don’t:

  • Obstruct air flow
  • Pass hands over product
  • Lean into the LAFC
  • Talk
104
Q

What does HEPA stand for, and how small a particle can they remove?

A
  • High Efficiency Particulate Air Filter

- Removes at least 99.997% of airborne particles down to 0.3 micrometres in diameter

105
Q

How must the product record sheet be completed with regards to weights/volumes/trailing zeroes/corrections/units?

A
  • Weights = three d.p., with 0.001 tolerance
  • Volumes = 1 d.p.
  • Zeroes = 0.5g instead of 0.500g
  • Corrections; initialled
  • Units; include

B33CAN - ROGO Prep (2 decks)

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