EP: Equipment and Techniques

• Extemporaneous Preparations


  Medicines prepared in response to the needs of the moment, as there is no appropriate commercially available medicinal product for the treatment of a patient
• Medicines Legislation


  The Human Medicines Regulations 2012 and previously the Medicines Act 1968 requires that medicinal products are licensed before they are marketed in the UK
• Medicines and Healthcare Products Regulatory Agency (MHRA)


  A government agency which directly approves medicines and issues Marketing Authorisation (MA) to the manufacturer. They are the main regulators for medicines in the UK.
• Licensed medicine


  • Assessed for efficacy, safety (shouldn't have adverse side effects/affect patients in a negative way), and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling.
• Specials


  Unlicensed creams and ointments containing ingredients like tars, dithranol, salicylic acid, steroids and other active constituents in a range of concentrations and bases, prescribed when the range of appropriate licensed medicines is limited
• Extemporaneous Dispensing


  The mixing together of ingredients of a prescription or drug formula and generally refers to a manual process performed for individual orders by a dispenser or pharmacist
• Organising Work Environment and Cleanliness


  • Be organised
  • Avoid contamination of final product
  • Bench, all equipment, utensils, container for final product must all be thoroughly cleaned and dry prior to use
  • Keep dispensing area tidy & clear of unnecessary items
  • Do not leave lids off stock bottles, replace immediately
  • Do not return material to stock containers once removed
  • Do not leave weighed and unmeasured items unlabelled on the work surface
  • Do not allow raw material or the final product to come in contact with the hands (wear gloves)
  • All weights and volumes to be checked by a colleague
  • Ensure balances kept clean - i.e. clear any spillages immediately
  • Place weighing boats, measuring cylinders on of labelled paper
  • Clean & dry all equipment and your working area before leaving
  • Personal hygiene: hands washed, any open cuts covered, long hair tied up, clean white coat, safety glasses, gloves
  • Appropriate work area, e.g. suitable, lighting, mains water supply, ventilation
  • Label preparation before starting the product
• Weighing and measuring procedures


  1. Strict control

  2. Documenting procedures and results - keep comprehensive records in methodical way. e.g. calculations, quantities used, procedures
• Techniques in Dispensing

  1. Mixing — to ensure an even distribution of all the ingredients

  2. Mixing of two or more liquids — simple stirring or shaking

  3. Mixing solids with liquids — know the solubility of the solid. Particle size reduction is important

  4. Mixing solids with solids — remember the correct use of mortar and pestle

  5. Mixing semi-solids — as in preparation of ointments and creams

  6. Mixing by Trituration — powder (or liquid ingredient) is incorporated into a base
• Equipment


  • Measuring conical — used to measure liquids and they come in different sizes
  • Beakers — used to transfer the liquid formulations, but aren't as accurate as measuring conicals
  • Mortar and pestle — used for mixing
  • Syringe — used to measure liquids
  • Glass rod — used to mix solids with liquids in a beaker or measuring conicals/cylinders
  • Glass slab and spatula — used in preparations of semi-solids such as ointments and creams
• Containers


  Amber glass bottle/fluted bottle/ointment jar: Amber glass protects the containers from light, so the drug is remains stable; some drugs would be affected by UV radiation and this will break down the drug molecule, making it more susceptible to degradation
• Expiry Dates — Solutions and Suspensions


  • Freshly prepared: Must be made not more than 24 hours before it is issued for use. No preservative, so has a two week expiry
  • Recently prepared: Deterioration is likely if the preparation is stored for longer than about 4 weeks at 15°C to 25°C. Preservative, so has a four week expiry
• Quality Assurance of Final Product

  • Alternatives
  • Production staff
  • Raw materials — obtain from a genuine supplier
  • Manufacturing unit
  • Documentation
  • Compounding
  • Labelling
  • Final check
• Record Keeping

  • Formula
  • Ingredients and quantities
  • Source of ingredients (i.e. Manufacturer)
  • Batch numbers and expiry dates of all ingredients where in existence
  • Use by date of prepared product
• Summary


  • Licensed Medicines
  • Specials
  • Extemporaneous Preparations
• Batch size


  • Large batches (licensed medicines)
  • Small batches (specials)
  • Single packs (EP)
• Safety/efficacy


  • Rigorously tested for quality, safety and efficacy (licensed medicines)
  • Tested for quality but not for safety or efficacy (specials)
  • Not tested (EP)
• Price


  • Cheap (licensed medicines)
  • Expensive (specials)
  • Very expensive (extemporaneous prep)