The PDA has responded to the Pharmaceutical Society of Northern Ireland’s (PSNI’s) consultation, which ran from 2nd October to 27th November 2017, on proposed new premises standards for registered pharmacies.

The PDA challenged both the format and content of the new premises standards, saying that they appear to be a ‘significant retrograde step’ and that the PSNI’s proposed new approach appeared similar to that taken by the GPhC in Great Britain. It highlighted the findings of a recent response to an FOI request – that the GPhC has not taken any punitive action against pharmacy owners in connection with pharmacy premises standards since its inception in 2010, despite significant concerns being raised by its pharmacist members.

The PDA went on to say, ‘While we do agree with a regulatory approach involving in part the inspection and monitoring of patient outcomes, it is not appropriate to monitor outcomes alone, particularly in the context of the substantial corporatisation of community pharmacy. There are various issues with monitoring outcomes alone, without monitoring more prescriptive requirements.’

The organisation went on to set out the issues, which included:

  • The outcomes could be delivered by any means necessary, which may result in inappropriate approaches from some pharmacy owners
  • In being less prescriptive, the outcomes could be subject to wide interpretation and issues affecting patient safety may be masked or undetected
  • The PSNI might risk inadvertently becoming subject to regulatory capture through spending a lot of time working with corporate businesses during its inspection process
  • The PDA called a provision in the standards for MUR targeting by employers ‘extraordinary’, not least because it comes at a time when other authorities have taken steps to prevent such behaviour, but also because the  draft standards suggest incorrectly that the number of MURs is a patient outcome.
  • The PDA also asked the PSNI to clarify whether the new powers it will soon gain – courtesy of legislation produced through the work of the Rebalancing Medicines Legislation and Pharmacy Regulation programme board – will allow it to hold superintendents to account for a breach of the pharmacy premises standards.
  • It said, ‘It may only be possible for the PSNI to apply sanctions in relation to breaches of premises standards where the fitness to practise committee or statutory committee is satisfied that the pharmacy owner is unfit to carry on the relevant business safely and effectively. The only sanction available will be the removal of the pharmacy from the register.’
  • The standards were in parts written as if they were setting additional requirements for employee and locum pharmacists to adhere to, where the stated intention was that they would be for owners and superintendents to uphold.