Lec 5- Aspectics

Question 1

Outcome

Answer 1

• The farwell report (UK 1995)
• Aseptic dispensing for NHS patients
• Identified need to ensure standards of practice are in place in pharmacy aseptic units
• Regular audits
• We learnt from mistakes and the Manchester incident (1994) which resulted in the death of more than one child produced a new respect for aseptic dispensing

Question 2

Aseptic vs sterile

Answer 2

• Sterile
  
  • Sterile is defined in the BP
  • As a substance capable of passing the BP sterility test- takes 12 hours
  • This does not mean it is appropriate for use in a dispensed IV item
  • May be able to give oral but not IV
• Aseptic
  
  • Aseptic is defined in the BP also
  • Here it is defined as the process of maintaining sterility
  • Aseptic manufacture is the process required to keep appropriate formulations sterile

Question 3

Do you have time?

Answer 3

• 12 hours to perform the sterile BP test
• IV medication may be required to be administered before the test can be carried out
• You don’t have time, so you conduct and aseptic procedure, which you hope produces a sterile products
• By working ‘aseptically’ you minimise the risk of sterile starting products becoming infected during combination
• The Manchester case highlighted several problems when working Aseptically most notably the regulatory framework surrounding pharmacists consisted if only the medicines act

Question 4

Additional regulation since 1994

Answer 4

• Aseptic dispensing for NHS patients
• EL96(95) and EL97(52)
• MCA (now MRHA) visits unlicensed units
• EU regulation
• Human medicines regulations 2012- revision of 1968 medicines act
  
  • Need to no sections 9-11- recent to pharmacists

Question 5

But

Answer 5

• Pharmacist have not had the section 10 restriction removed
• What makes a pharmacist different to everybody else running around the pharmacy is that when needed you know these exemptions
  
  • Pharmacist have large legal powers, Use them.
  • BUT make sure your always within the law

Question 6

The human medicines regulation 2012

Answer 6

• MRHA issues two licenses to make medicinal products
  
  • Manufactures (Full products) license
    
    • Normally to the large multi-nationals
    • To make specific named forms/strengths of a drug- 250mg/mL paracetamol elixir
  • Manufactures special license
    
    • Lists product types e.g. injectables, tablets
    • When we need strange doses etc
    • DOES NOT allow licensed product manufacture
    • Hospital pharmacy units

Question 7

[Manufactures special license

Answer 7

• The specials license
• The most common license for hospitals to hold
• You can advertise your service
• Have longer shelf life (with valid data)
• Manufacture in batches (keep for stock)
• No need for prescription

Question 8

Manufactures license

Answer 8

• The full license
• Specials manufactures can’t compete with you. They MUST buy from you
• Very specific product form and strength you are allowed to use
• Much higher regulation of quality assurance and limits

Question 9

Make sure you know

Answer 9

• When to use the term “this is sterile” and when to use “this was produced aseptically”
• When part 10 can be used to manufacture a product without a license
  
  • Have to be a registered pharmacist, in registered premises
  • Has to be for a named patient (i.e. on prescription)
• When a manufactures special license can be used and when you must let a product licence holder make the item
• Manufacturer license = PL
• Specials = MS

Question 10

So what is GMP (Good Manufacturing Practice) for aseptics

Answer 10

• If you are not able to prove product quality you must assure the process, in the hope the product can never be made wrong
• We have already seen
  
  • Designed environments to work in
  • Worksheets to perform tasks
  • Trained staff
• These are all very broad categories covering GMP

Question 11

Aseptic suite documentation

Answer 11

1. Standard operating procedures (SOP)
2. Product specifications
3. Dispensing and preparation records
4. Site record
5. Site master file (SMF)- required for Licensed manufacturing sites

Question 12

SOP rules

Answer 12

1. Designed and prepared (author) and date
2. Approved by and date
3. Orderly and easy to check
4. Reproduction of master must be error free
5. Typed
6. Traceable- Need the SOP number
7. Prevents use of superseded document
8. Regular review- e.g. 1 year and state who will review it
9. Pearsons capable or (trained) for operation

Question 13

Best practice

Answer 13

• An easy read (layout)
• Totally unambiguous
• Plain language
• Don’t miss the obvious
• Builds on existing practice
• One activity only
• High-level endorsement

Question 14

Product specification

Answer 14

• Replacements are not allowed by the SOP- if a specific brand it must be used
• Product specifications do at least allow a supplier to vary the item (in a limited way)

Question 15

Dispensing and preparation record (work order)

Answer 15

1. Name and formula
2. Batch number
3. Expiry date
4. Date of preparation
5. Copy of label- ensure accuracy, written trail if an error
6. Batch and supplier name for medicinal products- incase of recalls
7. Written protocol- e.g. say dont combine calcium and phosphate= precipitate
8. Reconciliation procedure for labels
9. Signature of initials of technical staff
10. Pharmacist supervising signature
11. Signature for final check
12. Patient name
13. Comment section

Question 16

Site records

Answer 16

• Consists of a batch record book. Which is now normally computerised
  
  • Batch number (number manufactured, batch size, date prepared)
  • Product code
  • Product name, strength and quantity
  • Container
  • Label reference (ward- patient name + consultant; prepared and checked by)
  • Expiry date
• Note how this is almost the same as the dispensing record
• If you have a manufacturing license or manufacturing specials license you require a site master file

Question 17

Site master file

General summary

Answer 17