Dental Protection is regularly asked about the obligation of the clinician to record the batch number of each local anaesthetic cartridge when providing dental treatment.
The short answer is that there is no legal or regulatory requirement to record individual local anaesthetic batch numbers and members request support from Dental Protection in a challenge the contrary. This briefing document is intended to remove some of the confusion that surrounds this issue.
Why the confusion?
Bodies such as The General Dental Council and The Care Quality Commission (CQC) have stated in the past that it is a “requirement”, implying that there is a statutory duty to keep a note of batch numbers.
The CQC refer to European Regulation 726/2004. The Regulation relates to the manufacturing of medicinal products but makes no mention of the need to record batch numbers of local anaesthetics in the clinical notes.
The phrase ‘’batch numbers should be recorded in clinical records’’ appears to have been taken completely out of context. Post-Shipman, Richard Baker, who held the post of Professor of Quality and Health Care in Leicester, said, “There is now confusion about who is responsible for keeping a check on doctor’s use of controlled drugs such as Diamorphine, which Shipman used to kill his victims… batch numbers should be recorded in clinical records”
Professor Baker had confined his remarks to “controlled drugs”, but it has since been more freely interpreted by various bodies as being a “requirement” for all drugs.
Over 50 million cartridges of local anaesthetic, which is a "prescription only medicine" or POM, are administered in the dental setting in the UK each year. In each case the drug is metabolised and excreted within 3-4 hours. It has been suggested by some that the rationale for recording batch numbers relates to the monitoring of untoward events and drug-related incidents. Complications arising from the administration of local anaesthetic solutions are rare and most of such complications relate to the procedure or technique rather than the anaesthetic solution itself. In any event, such complications become apparent very soon after administration, when the patient is still in the surgery. At that stage the clinical records may not even have been written up, and even if relevant to the situation, the batch number is readily available from the cartridge itself.
It would be perfectly reasonable for a batch number to be recorded after an adverse event or complication. The purported need for the routine recording of this information in all other situations is apocryphal.
Many dental hospitals and centres of excellence for dental education, do not record batch numbers for local anaesthetics. Given that these are also tertiary referral centres and many of their patients are severely medically compromised, it begs the question why should GDPs feel it necessary to record this additional information?
Dental Protection believes that time should be spent either communicating with patients or recording more significant details of the treatment provided, rather than noting details of local anaesthetic solutions.
In Riskwise UK 36, we wrote:
Yet another difficulty that besets guidelines and protocols is that – even within the same set of guidelines – the text alternates between objective, evidence-based fact, and entirely subjective opinion. There is an ever-present danger that such opinion will be subsequently quoted by others as if it were incontrovertible fact. By that stage nobody tends to question the source or scientific basis for the statement, nor stops to consider whether or not the statement is still being made in its original context. One such example is that of the purported ‘requirement’ to record the batch number of local anaesthetic solutions administered in dentistry. Not only is this bizarre expectation starting to appear in checklists used by PCTs and others, and in guidance and ‘best practice’ documents on record keeping, it has even appeared as one of the charges in more than one GDC Fitness to Practise hearing before the Professional Conduct Committee
Dental Protection has been unable to identify a single case where the batch number of a local anaesthetic solution has become an issue of any kind in terms of patient safety or an adverse event – although many confused members (including senior academics) have contacted us to question why they are being criticised by third parties for not recording these details.
In the view of Dental Protection, such requirements are not only unnecessary and unscientific but are also directly contributing to the problems frequently seen in clinical record keeping. While practitioners are being coerced into recording peripheral details such as the batch numbers of local anaesthetic solutions, they are squandering precious time that could and should be put to much better use – either in communicating with patients or in recording more significant details of the treatment provided.
The perversity of this example of ill-conceived guidelines is that the same ‘requirement’ to record batch numbers is not extended to the many other pharmacological agents and materials that are used in every day dentistry – from distilled water, to sodium hypochlorite and the endless range of dental materials. The suggestion simply does not withstand logical scrutiny.