Good record keeping

Regulation 170 of The Human Medicines Regulations 2012 lays down a number of obligations for people who sell or supply ‘Specials’. Any person selling or supplying a ‘Special’ must keep the following records for at least 5 years:

  • The source from which and the date on which the person obtained the product;
  • The person to whom and the date on which the sale or supply was made;
  • The quantity of the sale or supply;
  • The batch number of the batch of that product from which the sale or supply was made; and
  • Details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

These records should be made available for inspection by the Licensing Authority.

For patients receiving regular prescriptions for continuing treatment, pharmacists and prescribers should work together to periodically review the choice of medicines with the patient and/or carer to confirm whether there is a better alternative. For example, whether the medicine is still required, a newly licensed medicine has become available, there is a licensed medicine in a similar class or an alternative ‘Special’97.

Unlike licensed medicines, the quality, safety and efficacy of ‘Specials’ will not have been formally assessed by the MHRA therefore there may be an increased likelihood of adverse events or treatment failure. Where the pharmacist and prescriber feel it necessary, treatment with ‘Specials’ should be monitored more closely. Any adverse reactions are to be reported to the MHRA via the yellow card scheme along with suspected product defects stating the manufacturer and indicating that the product is unlicensed. Reporting to manufacturers is also encouraged97.