The TGA and PBS has recently approved Long Acting Injectable Buprenorphine (LAIB) for release outside of the Restricted Access Period. Buvidal® will be available from 3 April; and Sublocade® from 21 April, 2020.
Across Victoria many pharmacotherapy prescribers and dispensers have been engaged in the TGA’s restricted access period/product familiarisation process for LAIB products.
Attached is a discussion paper outlining key considerations in accessing and administering LAIB, including interactions with SafeScript, how to order and store LAIB, and other practical considerations. The discussion paper was informed by – and developed with the advice of – the Expert Advisory Committee on medical issues related to drugs of dependence, including representation from RACGP Victoria.
To support clinicians to administer LAIB, DHHS interviewed Dr David Jacka, Addiction Medicine Specialist at Monash Health, about his key pieces of practical tips:
1. Advise your patients in advance of the possibility of stinging pain; that it will settle and that it is nothing abnormal.
Read the adverse effects information provided by the pharmaceutical companies about each of the products. Many patients have noted some pain after the injection, usually soon after the needle has been removed; a distinctive stinging sensation occasionally reported for up to 24 hours afterwards.
2. Note that the different Long Acting Injectable Buprenorphine products have different recommended injection sites.
The target fat should be gripped, after thorough alcohol cleansing, between forefinger and thumb, and held firmly while the depot is administered, to avoid the depot being placed too deeply or too superficially. Swift (vs slow) injection appears to be more comfortable.
3. Have a cotton swab ready to put pressure on the injection site as soon as the needle has been removed.
There may be some bleeding or product ooze following injection. Be prepared to quickly staunch the venous bleeding, it can be significant; this will also prevent the product leaking out of the injection site. Ask the patient to apply pressure to the injection site to minimise bruising; a small plaster over the injection site may be necessary to prevent ooze onto clothes.
4. Advise your patients that there may be a small palpable lump in the fat.
In some patients the drug crystalline matrix may be palpable for a number of months after the injection; this reportedly resolves over weeks to months.
5. Refer to the product information if the initial dose is inadequate.
Many patients have reported a distinctive ‘wearing-off’ experience, with the onset of subtle withdrawal symptoms as the next dose approaches. Patients report after weeks of great ‘cover’, there is a subjective experience of the declining levels, resolved with an earlier or larger repeat dose. The pharmaceutical companies give guidance about subsequent doses being administered early.
Following from Dr Jacka’s reminder that the different products have different injection sites, clinicians are reminded to review the information provided on injection sites and angles.
Additional information is provided in the updated clinical guidelines available at the health.vic website.
If you have any queries about regulatory requirements concerning LAIB or Pharmacotherapy, please contact firstname.lastname@example.org. If you have clinical queries, please contact the Drug and Alcohol Clinical Advisory Service (DACAS) on 1800 812 804.