Summary of evidence and Expert Committee recommendations
An application was submitted by Dr Willem Scholten (until October 2012, team
leader, Access to Controlled Medicines, WHO), requesting modification of the
wording of the EML and EMLc listings for certain opioid analgesics – morphine,
hydromorphone and oxycodone.
Expert reviews of the application were prepared by two members of the
Expert Committee. No public comments on the application were received.
In applications to the 19th Expert Committee in 2013, Dr Scholten
proposed the addition of hydromorphone and oxycodone as examples of the
opioid class, requesting that this be expressed in the Model Lists with a footnote to
the square box listing of morphine stating “two or more alternatives to morphine
should be available”. Following consideration of these applications, the 19th
Expert Committee recommended the addition of a square box symbol to the
listings for morphine, with a note that alternatives be limited to hydromorphone
and oxycodone. The rationale for this recommendation is documented in the
report of the 2013 Expert Committee meeting.
The current application provided copies of the 2013 applications for
hydromorphone and oxycodone, which had not named any alternative opioids
or provided any new data to support the request to modify the wording of
the current listing. The Committee noted that the proposed modification
to the current wording would, in effect, allow any opioid to be available as an
alternative to morphine on the WHO Model Lists and, if adopted by countries,
on national lists.
The Committee considered that, within the same pharmacological class,
individual opioids can differ considerably in terms of characteristics that include
(but are not limited to) pharmacology, potency, formulation, and suitability for
paediatric use. The Committee considered that all opioids could not be thought
of as simply interchangeable within class. The Committee advised that changing
the current listing to allow additional alternatives to morphine would require
submission of appropriate data demonstrating similar clinical performance.
In the absence of any new evidence to support the inclusion of additional
opioids as alternatives to morphine on the EML and EMLc, the Committee did
not recommend any changes to the listing for morphine (and, by extension,
hydromorphone and oxycodone) at this time.