What is Buccolam?

Buccolam is a medicine that contains the active substance midazolam. It is available as an oromucosal solution in pre-filled syringes that contain 2.5mg, 5mg, 7.5mg and 10mg of midazolam respectively. It is used to stop prolonged, acute convulsive seizures in children and adolescents and accordingly the age of the patient will determine the dose required.

All dental practices are required to carry midazolam in the form of an oromucosal solution as part of their Medical Emergencies kit. It should be noted that midazolam is the active ingredient name, not the brand name for this solution. There are 2 licensed brands that are available: Buccolam and Epistasis. In the past when there were supply issues with the two licensed products, an alternative unlicensed product (Midabuc) was available.

With licensed products freely available in the market, DD are legally only allowed to supply a licensed version. Licensed products are by definition safer than unlicensed products. However, the move to a licensed version does mean that we need to consider the following points:

  1. Increase in price: the licensed product is more expensive than the unlicensed product (due to the cost of licensing and producing a licensed product). Despite this, the legislation is very clear, and a clinician cannot justify using an unlicensed product on the basis of cost. DD has opted to supply Buccolam which costs less than Epistasis so that our customers can make a saving.
  2. Different strength pre-filled syringes for different age groups: the unlicensed product (Midabuc) was sold with a dosing syringe so that the user could draw up the specific dose depending on the age of the patient. The licensed product (Buccolam) does not provide this option as the pre-filled syringes are sealed. Accordingly, practices are required to keep product for all age groups which further adds to cost as you need all 4 doses in their pre-filled syringes. Once again, the law states that an unlicensed product cannot be justified on the basis of cost. It should be noted that fixed dose pre-filled syringes are safer and quicker to administer in an emergency.
  3. No adult dose (or a dose for children <3 months) is available on licence: however, the manufacturer (of Buccolam) and the BNF state that the adolescent dose should be used “off-label” for adults and the August 2021 specified dose for children <3 months is stated below. Once again, the legislation is clear that there is a preference for a licensed product to be used “off-label” as opposed to using an unlicensed product.

 

Current BNF recommendations (https://bnf.nice.org.uk/drug/midazolam.html)

By buccal administration, repeated once after 10 minutes if necessary:

  • NEONATE 300 micrograms/kg [off-label]
  • CHILD 1–2 MONTHS 300 micrograms/kg (max. 2.5 mg) [off-label]
  • CHILD 3 MONTHS–11 MONTHS 2.5 mg (DD product code: AGH030)
  • CHILD 1–4 YEARS 5 mg (DD product code: AGH031)
  • CHILD 5–9 YEARS 7.5 mg (DD product code: AGH033)
  • CHILD 10–17 YEARS 10 mg (DD product code: AGH032)
  • ADULT 10 mg [off-label] (DD product code: AGH032

 

Shelf life: the licensed products have a shorter shelf life than the unlicensed product (again due to safety). DD understands that this is frustrating for practices that keep their products in their Emergency Drugs bag, however, once again this is not a justification to use an unlicensed product.

The UK regulators are taking a very firm view on the above and DD have recently had to provide evidence that we are only selling the licensed version.

Please note that the above only applies to the oromucosal version of midazolam i.e. Buccolam and that ampoules of midazolam for administration via the IV, IM or rectal route (e.g., for the purpose of sedation) are still available in the same presentation as previously supplied (DD product code: AGH010).