Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PHA111 > Principles of Extemporaneous dispensing and 'Specials' > Flashcards

Principles of Extemporaneous dispensing and 'Specials' Flashcards

1
Q

What is extemporaneous dispensing?

A

Preparation of a single medicinal product tailor made to the patient’s requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are specials?

A
  • Anything which does not have a UK marketing authorisation (MA)
  • Imported items licensed in another country
  • Extemporaneous preparations
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

List Regulation 167 of human medicines regualtion 2012

A
  • Exemption from requirement of marketing authorisation

- Need to fulfil the stated conditions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

List the guidance note 14 - MHRA

A
  • Guidance note on procurement of specials
  • Maximum 30 day shelf life if no formal stability data of your own
  • Can download document from MHRA website
  • Prescriber awareness of unlicensed status & liability
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

List the 5 steps for the procurement and supply of specials

A
  • Establish a clinical need
  • Understand the patient experience
  • Identify a preperation and supplier
  • Ensure effective governance
  • Monitor and review
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

List the facility requirements

A
  • Space
  • Work bench with cleanable surfaces
  • Somewhere to store clean equipment
  • Raw materials’ storage
  • Control of cross contamination
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

List the equipment requirements

A
  • Government stamped measures
  • Balances
  • Mortar and pestle (avoid wood)
  • Stirring rod
  • Spatulas
  • Tiles
  • Method of heating
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

List facts about an unguator

A
  • closed system
  • good operator protection
  • hygienic
  • set mixing speeds/times
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

List the documentations requirements

A
  • Reference materials
  • Standard operating procedures
  • Worksheet
  • Labelling systems
  • Certificates of analysis for raw materials
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

List microbial contamination

A

Bacteria or fungi

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

List physical contamination

A

Particle

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

List chemical contamination

A

Residues/particles of another drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

List the risk analysis - twofold exercise

A
  • Risk to patient: error, cross contamination, nil/little formal stability data, no clinical trials, excipient suitability
  • Risk to dispenser: control of COSHH, PPE available, risk to other employees
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

List what happened in the peppermint water case

A
  • Death of a 3 week old baby due to incorrect dilution of chloroform water concentrate
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

List the basic approach to risk analysis

A
  • Consequences to patient?
  • How likely error to occur?
  • Pharmacist/patient able to detect error?
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

List common problems with specials prescriptions

A
  • If short dated, will patient use?
  • Cost of specials company
  • Lack of details on prescriptions
  • Computer generated prescriptions
  • Finding a formula
  • Regional differences with non-compendial formula
17
Q

List common ‘specials’ script enquiries

A
  • Ingredients of creams/ointments expressed as % but not add up to 100%
  • Readily available licensed medicine written generically
  • Licensed medicine should be dispensed wherever possible
18
Q

List sources of formulae

A
  • Compendia
  • Hospital-often continuation
  • GP’s own
  • Published literatures/journal articles on internet
19
Q

List the availability of raw materials

A
  • Need to obtain pharmaceutical grade BP
  • Laboratory grades
  • Difficult to obtain small quantities of pure drug powders
  • Need to consider TSE
  • Good practice to obtain a cert of analysis
  • May need to use another unlicensed medicine
20
Q

What is TSE?

A

Transmissible Spongiform Encephalopathy

21
Q

List microbial considerations in formulation

A
  • Preservative in formula?
  • Product prone to microbial growth?
  • Traditional single strength chloroform water
  • cold water soluble salts available but raise pH of product which is undesirable
  • Ester soluble at 80 degrees > little effect on pH
22
Q

List the general formulation problems

A
  • Physical: cracking, caking
  • Chemical degradation: pH dependent
  • BP limits for actives usually 95-105%
  • Microbial preservative system
23
Q

List common requested non sterile dosage forms

A
  • For application to the skin, e.g. creams, ointments

- For oral ingestion-liquids, e.g. solutions, linctus

24
Q

List less common dosage forms (non sterile)

A
  • Capsules & powders
  • Lozenges/pastilles
  • Bars of soap
  • Reefers (cigarettes injected with drug)
25
Q

List the steps of making a suspension from tablets to give a homogenous product

A
  • Crushing, grinding

- Wetting and pasting

26
Q

List the importance of calculation skills

A
  • Full understanding of what is required to prevent dispensing errors
  • Ensure correct clinical interpretation of prescription
  • Overdose/ sub-therapeutic dose
27
Q

Beware of ______ as a pharmacist

A

complacency

28
Q

List compliance with other regulations

A
  • Employment law
  • Weights & measures
  • Health & safety
  • Waste disposal & enviromental issues
29
Q

List what the orange guide is

A
  • Rules & guidance for pharmaceutical manufacturers and distributos
  • Introduces the concepts of QA system & GMP
30
Q

List what the green guide is

A
  • Rules & guidance for pharmaceutical distributors
31
Q

List the two key personnel in specials manufacturing

A
  • Head of production

- Head of quality control

32
Q

List extemporaneous dispensing in industry

A
  • Cleanrooms
  • MHRA licences
  • Full GMP compliance
  • Validation system
  • Full audit trail
  • Develop best practice
33
Q

When scaling up, what is required?

A
  • Change from crushing tablets to using powder (API)
  • Need to QC test
  • Need TSE compliance certificate
  • Shelf life extension/ stability testing
  • Full set of processing equipment
  • Bulk storage > quarantine & released
  • and more
34
Q

List some patients that require specials

A
  • Paediatric, geriatric, terminally ill, drug misusers, special needs, tube fed, allergies

PHA111 (23 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions