Good record keeping

The MHRA has specific requirements around record keeping for all ‘Specials’ including those that are imported and it is recommended that pharmacists maintain the following records:

To be kept for a minimum of 5 years*

  • A record of the purchase and supply of a Special and the specification of the product agreed with the supplier should be documented and kept on file in the pharmacy for at least five years
  • Documentation to verify the specifications i.e. a certificate of analysis or a certificate of conformity from the manufacturer, should be obtained on delivery and must include the batch number and expiry details of the product, kept on file in the pharmacy
  • Patient details, such as name and address linked to the Special should also be maintained to provide an adequate audit trail.
  • The source of the product i.e. manufacturer’s details
  • The quantity of each sale or supply
  • The batch number and expiry date of the product (listed on certificate of analysis or certificate of conformity)
  • If the product is in response to a prescription, the records must also include the patient’s details, prescription details and the date of dispensing
  • The date the product was supplied (as may differ from the date of manufacture)

*The MHRA requires a minimum of 5 years, but as pharmacies are accountable for the quality, and claims under the Consumer Protection Act may be brought after many years, pharmacists could decide to retain records for longer periods.

Where a patient receives prescriptions on a continuing basis, the pharmacist is advised to periodically reconfirm with the prescriber that the ongoing use of an unlicensed product is appropriate, having regard to any circumstance that might suggest that a licensed product may become more suitable. It is also recommended that any discussions between the prescriber and pharmacist in relation to the unlicensed nature of the product and its suitability should be documented. The urgency of the patient’s need for the medicine should also be noted and reasonable steps taken to ensure timely supply.

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  • Prescribing ‘Specials’ – Five guiding principles for prescribers. NPC.
  • Dealing with ‘Specials’. RPSGB.
  • Information and guidance on the prescribing and use of unlicensed pharmaceutical specials. East of England NHS Collaborative Procurement Hub.
  • Association of Pharmaceutical Specials Manufacturers
  • Manufacturer’s and wholesale dealer’s licences. MHRA.
  • Introduction of a 'Specials' tariff. NHS Prescription Services.