The MHRA is consulting on plans to consolidate and review UK medicines legislation to provide a clear, coherent regulatory framework (see here for the consultation details – the deadline is 17 January 2012).
About 200 statutory instruments and much of the Medicines Act 1968 could be replaced with one set of regulations that will be shorter and simpler – much of the existing law is obsolete – and provide a platform for future changes. Some policy changes are also included, with the proposal to remove the need for pharmacists to attempt to contact the prescriber before making certain changes to prescriptions probably attracting the most comment. The aim is to allow pharmacists to optimise the use of medicines – for example by adjusting an antibiotic schedule. At present, pharmacists can only make these changes if they have tried to contact the prescriber but failed. This suggestion has attracted questions about where the legal responsibility lies, whether there is a conflict of interest for the pharmacist as the seller of drugs, and whether adverse events reporting would be compromised.
Another change will remove statutory warnings and replace them with warnings in the relevant marketing authorisation, a speedier and more flexible system. A different proposal will remove some of the current exemptions from the Act that allow health professionals and other people to sell, supply and/or administer medicines, and extend or introduce others, for example about water for injections. The suggestion that the appropriate professional bodies should hold and maintain the list of medicines that can be accessed by their particular professional group, rather than the lists being specified in statutory instruments, with all that implies, is being considered separately.
Finally, what will happen to Patient Group Directions (PGDs)? Well, their current general structure and requirements will be retained, and only registered health professionals will be able to use them. But it is proposed that NHS bodies should be able to supply medicines not from pharmacies according to the directions of independent nurse, pharmacist and optometrist prescribers, as they can currently for doctors and dentists. Other proposals relate to the way independent hospitals, clinics and agencies are registered with the Care Quality Commission, and removing the distinction as far as PGDs are concerned between NHS-funded dental services and others. Unlicensed medicines will continue to be excluded from the scope of PGDs.
ANP Chair, Barbara Stuttle, said, “The law has certainly become confusing – this is a chance for us all to influence the system we work under – and it could produce something we can all work with!”