“Though many of the conceptual objectives contained within the RP regulations are attractive in theory, two and a half years of operational experience has shown that they have failed to achieve these in practice and that they are unlikely to do so in the longer term,” says PDA Chairman Mark Koziol. “Furthermore, independent assessment and real time operational experience has shown that they cause defensive practice and behaviours which are generally damaging to the public interest.”
It is therefore no surprise that virtually all responses to the MHRA consultation on medicines regulation support the long held PDA view that the RP regulations should be repealed. Mr Koziol comments: “These responses are merely a reflection of how poorly thought through the regulations were at the outset and the extent to which objections to them were ignored.”
Mr Koziol continues: “There has not been an example in recent memory of pharmacy regulation that has delivered so many unwelcome and damaging operational consequences and which has attracted so much derision from practising pharmacists.” Even prior to the launch of the regulations in July 2009, more than 6,000 pharmacists signed a petition calling for their launch to be delayed.
“These regulations deliver many disadvantages to those they seek to govern and also the public that they seek to protect,” says Mr Koziol. “They deliver unacceptable levels of red tape, are prone to be used in ways in which they were not intended resulting in many unwelcome consequences, and they introduce entirely disproportionate criminal and professional sanctions.”
There is a worrying lack of a strategic fit between these regulations and the future vision for pharmacy of pharmacists more available to the public, and not less so. The regulations have singularly failed to empower pharmacists through standard operating procedures, forcing them instead to think twice about the risks of making professional decisions that are outside the SOPs. Scrapping the regulations would go some considerable way towards repairing the damage that has already been caused. And an initial return to the concept of personal control would increase public safety and simultaneously cut vast tracts of unnecessary administration and red tape.
“Thereafter we would want to have a debate about where we want pharmacy to go and from that debate it would be possible to agree some models of practice going forward,” says Mr Koziol. “Once that has been done – and ONLY once that has been done – we should revisit the supervision regime and hold a meaningful debate and consultation involving all the stakeholders. If models of practice have been agreed, then together it should be possible (and much easier) to decide upon a new and modernised supervision regime – one that supports future models of practice, that protects the public interest and one that secures the confidence of the profession.”
The Red Tape Challenge on medicines, which covered the RP regulations and the safe management and use of controlled drugs, called for suggestions on, “anything we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, whilst maintaining the necessary safeguards for the public and patients.” A full list of responses can be viewed at: www.redtapechallenge.cabinetoffice.gov.uk/medicines-pharmacy/comment-page-5/#comments.