Pharmacists may be allowed to change prescriptions without consulting prescriberBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d7067 (Published 31 October 2011) Cite this as: BMJ 2011;343:d7067
The UK Medicines and Healthcare Regulatory Agency has announced a 12 week formal public consultation on the consolidation of UK drug legislation.
The agency says that current legislation is “outdated and fragmented” and that a simplified version is needed to replace the roughly 200 statutory instruments currently contained within the 850 pages of the Human Medicines Act 1968.
The consultation proposes policy changes “to ensure that medicines legislation remains fit for purpose and reflects modern practice.” Other drivers for the consultation include the government, which the agency has said “has made it a priority to minimise regulatory burdens in order to boost enterprise and free growth . . . We believe that the consolidation is consistent with these principles.”
The agency says that consolidation will lead to better regulation of drugs, as the current complexity, fragmentation, and number of obsolete clauses causes unneeded confusion.
Among the proposed changes is the suggestion that pharmacists be allowed to make changes to a prescription without, as is currently the case, attempting to contact the prescriber.
The new set of regulations that the agency wishes to form is aimed at reducing the burden on business but also “safeguarding public health.” Clinical trials legislation is not being consolidated and will be retained in current form; the agency says that this is because it is currently being negotiated at a European level.
Statutory warnings on drugs will be removed with the intention that more useful language can be used and that additions and changes can be made to warnings more rapidly, without the need for new public consultation each time.
There are specific provisions for applications for homoeopathic substances. Herbal medicines can still be registered if “traditional use of the produce is not harmful” and is plausible on the basis of “longstanding use and experience.” The consultation states that an aim of the reformed legislation is “ensuring that the public has continuing access to unlicensed herbal medications supplied by practitioners but strengthening the current limited safeguards for the public.”
The legislation also contains provision for review of the pharmaceutical supply chain, through new obligations on wholesale dealers. Additionally the practice of importing drugs into the United Kingdom with the express aim of exporting them on will be subject to regulatory controls.
Other proposed changes include a redefinition of pharmaceutical advertising to include “anything designed to promote the prescription, sale, or use” of a prescription product. The agency says that this is not designed to create a change in current practice but that it may potentially affect disease awareness campaigns run by drug companies.
Changes are also proposed to allow paramedics to use parenteral ondansetron and paracetamol and to allow holders of the advanced life support qualification to use adrenaline (epinephrine) and amiodarone in cardiac emergencies.
There will be formal allowance for NHS bodies to supply drugs at written request from non-medical independent prescribers.
The deadline for responses is 17 January 2012.
Cite this as: BMJ 2011;343:d7067