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. |
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The
Pharmaceutical Journal