During the Scottish Dental Practice Committee (SDPC) meeting held on 15 March 2017 it was noted and discussed that there had been a large increase in the cost of purchasing emergency drug kits as a result of new guidance issued by The British National Formulary (BNF). The new guidance now advises that the formulation of Midazolam oromucosal solution by buccal administration, repeated after 10 minutes if necessary and the recommended dosages are listed at Section 2. The key change facing general dental practitioners GDPs is that historically the BNF stated that midazolam (in the liquid ampoule format) could be given buccally and to children. This was the format included in the box provided by Tayside Pharmaceuticals until recently. The current BNF guidelines, no longer allows this option and the guidance states that the only licensed orobuccal format is Buccolam which comes in a range of pre-filled syringes. In order to follow the guidelines Tayside Pharmaceuticals were required to change their box contents.
Tayside Pharmaceuticals then issued a letter to GDPs informing them of the change and that the BDA has been in agreement with this. BDA Scotland had not been consulted on the matter and Tayside Pharmaceuticals subsequently apologised to BDA Scotland and re- issued a letter to all GDPs in Scotland retracting their earlier statement that BDA Scotland had been involved in the process.
SDPC was outraged that GDPs were experiencing a 53% rise in cost for emergency drug kits provided by Tayside Pharmaceuticals as a result of the BNF guidance change and agreed that the matter of seeking funding for the emergency kits would be raised by the SDPC Executive Sub-Committee when they met with the Chief Dental Officer (Scotland) (CDO) in March 2017. The CDO reported that Scottish Government had looked at cheaper unlicensed alternatives, but that the Chief Pharmaceutical Officer’s advice was that unlicensed alternatives could not be recommended. CDO also suggested that this expenditure should be recorded by dentists in future as an example of an increased cost.
• Licensed Buccolam Oromucosal Solution and recommended dosages
Buccolam oromucosal solution is the only product licensed for this use in children and can be obtained from a pharmacy using a CD Requisition Form (Schedules 2 & 3). It will be dispensed in four doses:-
Age 3 months – 11months:-
BUCCOLAM 2.5 mg oromucosal solution
Each pre-filled oral syringe contains 2.5mg midazolam (as hydrochloride) in 0.5ml solution
Age 12 months–4 years:-
BUCCOLAM 5 mg oromucosal solution
Each pre-filled oral syringe contains 5mg midazolam (as hydrochloride) in 1ml solution
Age 5 –9 years:-
BUCCOLAM 7.5 mg oromucosal solution
Each pre-filled oral syringe contains 7.5mg midazolam (as hydrochloride) in 1. ml solution
Age 10 –17 years:-
BUCCOLAM 10 mg oromucosal solution
Each pre-filled oral syringe contains 10mg midazolam (as hydrochloride) in 2ml solution
Each dose is supplied in a pack of 4 x 2ml syringes (16 syringes in total) and will cost approximately £350 for a kit of 4 each dose. The shelf life is very short (reported as being 6-12 months).
Alternatively, it can be procured via the Tayside Pharmaceuticals kit, which supplies 2 syringes of each dose (8 in total). The total cost of the Tayside Pharmaceuticals kit (including Buccolam and all the other drugs on the CPI list is now £312, including VAT (previously £70.80, Inc. VAT).
3. Patient Safety and Protecting GDPs
A committee member sought information from a consultant anaesthetist and intensivist based at the Queen Elizabeth University Hospital, Glasgow who confirmed that he agreed with SDPC’s interpretation of the BNF. However, he noted that to reduce mistakes, paediatric staff were moving away from drawing up drugs from ampoules, and their emergency drugs were now being supplied in prepared doses. This fits with the Scottish Patient Safety Programme. The consultant went on to describe a worst-case scenario; where there is an emergency, the patient dies and the ward/surgery is visited by police. The police gather evidence items from the scene, including broken ampoules and send them to the Procurator Fiscal. In that situation it is impossible to verify that the correct drug dose has been administered. It should also be noted that GDPs would be using an unlicensed drug in a child if it was note dose banded.
Whist the consultant was sympathetic to the situation facing GDPs he suggested that unless a cheaper supplier can be found GDPs must continue to purchase, store and use pre-filled buccolam syringes.
• Monopoly by Manufacturers of Buccolam
SDPC was concerned that the manufacturers of Buccolam, who have a monopoly on the market and are profiting by the way they are packaging the drug, therefore having a detrimental effect on the cost of the supply chain
SDPC attempted to contact Ethigen Ltd, East Kilbride, Glasgow but they did not respond and Bn Medical Ltd Pharmaceutical Suppliers and Wholesalers based in Coatbridge, Scotland who did reply.
The question posed to both companies asked if they could supply a “selection pack” of 4 prefilled Buccolam syringes that would meet the new Emergency Drug Kit requirements. (1x 2.5mg/0.5mls, 1x 5mg/1ml, 1×7.5mg/1.5ml, 1x10mg/2mls)
Bn Medical Ltd had made an enquiry to Shire Pharmaceuticals who manufacture Buccolam, and that he product licence only allows the prefilled syringes to be supplied in packs of four. Anyone supplying Buccolam is restricted from opening and splitting the packs. A “selection pack” of assorted prefilled syringes would need Medicines and Healthcare products Regulatory Agency (MHRA) approval. It was concluded that unless Shire apply for the change to MHRA GDPs must continue to conform with the new guidelines resulting in having to stock 16 syringes.
• SDPC Conclusions
• The interpretation of the BNF means that GDPs must continue to purchase licensed Buccolam in pre-filled syringes in the dosages as listed in Section 2 ‘Licensed Buccolam Oromucosal Solution and recommended dosages’ of this report and cannot deviate from this.
• Patient safety and legal implications explain why these changes have been made and this provides the basis for the contents of the emergency drug kits and volumes of the syringes which are required.
• SDPC suggests that suppliers provide a pack with one of each dosage, which would mean that GDPs would have a total of four / eight prefilled doses of the same concentration, the only differences being the quantity in each syringe and the provision of four ampoules rather than 16. This would reduce the cost and lessen the wastage with regards to the short shelf life of the product.