Principles of Extemporaneous dispensing and 'Specials' Flashcards
What is extemporaneous dispensing?
Preparation of a single medicinal product tailor made to the patient’s requirements
What are specials?
- Anything which does not have a UK marketing authorisation (MA)
- Imported items licensed in another country
- Extemporaneous preparations
List Regulation 167 of human medicines regualtion 2012
- Exemption from requirement of marketing authorisation
- Need to fulfil the stated conditions
List the guidance note 14 - MHRA
- 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
List the 5 steps for the procurement and supply of specials
- Establish a clinical need
- Understand the patient experience
- Identify a preperation and supplier
- Ensure effective governance
- Monitor and review
List the facility requirements
- Space
- Work bench with cleanable surfaces
- Somewhere to store clean equipment
- Raw materials’ storage
- Control of cross contamination
List the equipment requirements
- Government stamped measures
- Balances
- Mortar and pestle (avoid wood)
- Stirring rod
- Spatulas
- Tiles
- Method of heating
List facts about an unguator
- closed system
- good operator protection
- hygienic
- set mixing speeds/times
List the documentations requirements
- Reference materials
- Standard operating procedures
- Worksheet
- Labelling systems
- Certificates of analysis for raw materials
List microbial contamination
Bacteria or fungi
List physical contamination
Particle
List chemical contamination
Residues/particles of another drug
List the risk analysis - twofold exercise
- 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
List what happened in the peppermint water case
- Death of a 3 week old baby due to incorrect dilution of chloroform water concentrate
List the basic approach to risk analysis
- Consequences to patient?
- How likely error to occur?
- Pharmacist/patient able to detect error?
List common problems with specials prescriptions
- 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
List common ‘specials’ script enquiries
- 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
List sources of formulae
- Compendia
- Hospital-often continuation
- GP’s own
- Published literatures/journal articles on internet
List the availability of raw materials
- 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
What is TSE?
Transmissible Spongiform Encephalopathy
List microbial considerations in formulation
- 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
List the general formulation problems
- Physical: cracking, caking
- Chemical degradation: pH dependent
- BP limits for actives usually 95-105%
- Microbial preservative system
List common requested non sterile dosage forms
- For application to the skin, e.g. creams, ointments
- For oral ingestion-liquids, e.g. solutions, linctus
List less common dosage forms (non sterile)
- Capsules & powders
- Lozenges/pastilles
- Bars of soap
- Reefers (cigarettes injected with drug)
