Dispensing with legalities
January 13, 2012
UK REGULATORS, in conjunction
with pharmaceutical organisations,
are in the midst of discussions over
current regulations that mean a
dispensing error could be an act
liable for prosecution.
The issue came to the fore
following a decriminalisation
debate in the House of Lords last
month, over a proposed
amendment to current regulations
which leave pharmacists open to an
offence if the sale or supply of a
medicinal product does not meet
the nature and quality demanded
by the purchaser.
“In other words, where it is
proved that an offence has been
committed, then the person who
committed it has no defence, and
the person’s state of mind at the
time the offence was committed is
not relevant,” a statement from
the UK Medicines and Healthcare
products Regulatory Agency
(MHRA) said.
This stipulation, according to the
MHRA may also discourage
pharmacists from reporting errors.
The amendment however was
withdrawn after the debate to
allow the Government to consider
the issues in more detail.
This month, regulators including
the MHRA, UK Health Departments,
the Royal Pharmaceutical Society
and the General Pharmaceutical
Council met to consider the next
steps to address prosecution
concerns.
The meeting saw the MHRA
agree to work with the Govt and
interested parties on a program of
activity to address these concerns,
initially through legislative
amendments to introduce the
possibility of pharmacists, pharmacy
technicians and others affected by
the relevant medicines legislation
to mount a defence that they had
exercised all due diligence to avoid
committing the offence.
These amendments would then
be followed up by a wider review of
sanctions and penalties in medicines
legislation to address the underlying
issue about the relationship
between medicines legislation and
professional regulation.
The Government has since
committed to “legislate at the
earliest opportunity”.
Speaking about the outcome, the
Royal Pharmaceutical Society said
“We now aim to work with the
Govt to ensure a speedy resolution
to an issue that affects every
dispensing pharmacist in the UK”.
The above article was sent to subscribers in Pharmacy Daily's issue from 13 Jan 12To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 13 Jan 12
