Society issues guidance on crushing buprenorphine sublingual tablets

The Royal Pharmaceutical Society has issued guidance for pharmacists regarding the crushing of buprenorphine sublingual tablets (Subutex) before their administration.

The Society has been receiving an increasing number of queries from pharmacists about the possibility of crushing the tablets to speed up their administration.  

Buprenorphine is frequently used to prevent withdrawal symptoms in programmes for treating opioid dependence, and pharmacists are sometimes asked to  supervise administration to prevent the patient selling unused product to other drug misusers. The long dissolution time for Subutex — up to 10 minutes, according to its manufacturer — has implications for both the patient and the supervising pharmacist. Some pharmacists are therefore crushing the tablets in an effort to speed up the supervised administration.

The Society’s guidance is set out in the Panel below. Because crushing the tablets results in an unlicensed product, the National Pharmaceutical Association has agreed to support the guidance by indemnifying NPA members who provide a crushed Subutex service, provided they comply with a defined protocol, which can be found at the CDA channel on the association’s member-only intranet, NPAnet.

New guidance on crushing buprenorphine sublingual tablets

Crushing buprenorphine sublingual is outside the manufacturer’s marketing authorisation and will render the product unlicensed.

A pharmacist may assume some liability for the supply of a product outside licensed indications and should ensure that their indemnity insurance covers such activity.

Pharmacists who are considering crushing buprenorphine tablets before administration need to be satisfied that this is in the patient’s best interests as there is the potential for the product’s bioavailability profile to be distorted. The prescriber and the patient should agree to the tablets being crushed before administration — and the patient should be informed of the risks and the benefits of crushing. Any crushing of buprenorphine tablets should be for the benefit of the patient, rather than the convenience of the pharmacist.

Last updated
The Pharmaceutical Journal, PJ, April 2005;()::DOI:10.1211/PJ.2022.1.124700

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