| A responsible pharmacist will in future be allowed to be away from the
pharmacy for up to two hours in every 24 — an hour less than the
Government had originally proposed, the Department of Health confirmed
this week.
The announcement is one of the few firm decisions made by the DoH following
its consultation on proposals for new regulations that will govern how
pharmacies, both those in the community and registered hospital pharmacies,
will be run in future.
The regulations at the centre of the consultation
are linked to changes in personal control of a pharmacy laid down in
the Medicines Act 1968, which is being replaced by the Health Act 2006.
Many of the key questions have, however, been left unanswered which brought
a sigh of relief from the Pharmaceutical Services Negotiating Committee
and prompted hospital pharmacists to repeat their warning that the proposed
regulations are unworkable in their sector.
The DoH’s decision to allow the responsible pharmacist to be absent
for two hours was revealed in its document published this week called “The
responsible pharmacist regulations: a summary of the responses to public
consultation on proposals for the content of the regulations”.
The document considered the responses to the consultation the DoH launched
last October and ran until January this year, and included some final
proposals.
Although the DoH came to a decision on hours of absence and that pharmacy
procedures could be kept in paper or electronic form, it left other issues
unresolved (see Panel below).
Unresolved issues
• The report fails to define who will be
eligible to become a responsible pharmacist.
(The DoH has decided
to leave
the issue of necessary
qualifications and experience up to the regulatory authorities
and other professional organisations.)
• What happens to the dispensing and sale of medicines
by a responsible pharmacist in a pharmacy where he or she is not
a responsible pharmacist
has been put on hold.
(That question will now form part of the
future consultation on proposals for new regulations to accompany
the new
Health Act 2006 which focus on the supervision of pharmacies under
responsible pharmacists.)
• The DoH was also unable to reach a conclusion on what
exemptions there should be to the general rule that a responsible
pharmacist
should only be responsible for a single pharmacy.
(It will look
again at the possible exemptions before making a final ruling.) |
The PSNC said the lack of firm proposals following
the 13-week consultation reflected the complexity of the issues. Its
head of regulation Steve
Lutener said: “I have some sympathy with the DoH here as I think
this is the biggest and most complex consultation carried out in my memory
because of the complexities of the Medicines Act — which I think
isn’t fit for purpose any more — and issues around patient
safety and the flexibility for pharmacists to be broader clinicians.”
Despite the key unanswered questions, there was a mixed response from
the profession over the decision to reduce the absence of a responsible
pharmacist from the pharmacy from the originally recommended three hours
down to two hours.
The Royal Pharmaceutical Society said it was pleased that the DoH had
endorsed its own recommendation for a two-hour limit. Priya Sejpal, the
Society’s head of professional ethics, said: “The Society
is pleased that the Government has listened to calls for ensuring that
these regulations are not overly burdensome, while still ensuring patient
safety is maintained.
“The introduction of a limited period of absence is good news for the
public and the profession as it will rectify the anomaly that currently
exists whereby General Sale List medicines can only be sold when the
pharmacist is present, even though pharmacist presence is not necessary
for other retail outlets.”
Noel Baumber, a community pharmacist in Grantham, Lincolnshire, and a
non-executive director of the Independent Pharmacy Federation, welcomed
the decision to restrict the hours of absence from a pharmacy from three
to two hours. He said: “I think this is a fairly significant decision.
We were pretty much opposed to a definition of a long absence which was
where we were heading with the three-hour rule. Two hours is much more
workable than three.”
Mr Lutener was disappointed that the DoH had defined the period of absence
at all. The PSNC had recommended that no time limit be set; instead it
wanted the regulation to stipulate that the responsible pharmacist should
spend a “substantial” amount of time in the pharmacy.
He
said: “These regulations are all about patient safety and what
they are saying is that if you are a responsible pharmacist away for
one hour and 59 minutes then patients are safe but if you are away for
two hours and one minute they are not. How can you justify a time limit?”
Colette McCreedy, chief pharmacist and director of practice at the National
Pharmacy Association said: “I am pleased to see that some
of the issues, such as the fact that no formal qualifications are put
down or specific experience needed to be a responsible pharmacist and
the comments on record keeping, are in line with our submission.
“But
the issue of absence from the pharmacy has the potential to cause more
confusion than it already has as it’s again addressed separately
from supervision.”
However, the decision to reduce the hours of absence made little difference
to hospital pharmacists who argued that the package of proposals around
regulation and the introduction of a responsible pharmacist was unworkable
in a hospital pharmacy.
David Miller, president of the Guild of Healthcare Pharmacists, said: “There
appears to have been some listening to the comments put forward from
the hospital sector and we welcome an opportunity to assist in clarifying
the role between the superintendent or chief pharmacist, the responsible
pharmacist (and the duty pharmacist who in a hospital are often not the
same individual) and the employing organisation.
“However the concern
that most hospitals may simply de-register has not been addressed. The
whole issue of the Medicines Act and how hospital pharmacy operates in
the legislative framework is something guild is keen to discuss with
the DoH.
“The other key concern, namely, the opportunity to define the required
competencies for a responsible pharmacist in the managed sector should
one be needed, is hopefully an option that will be revisited in later
discussions.”
Immediate past president of the guild Anthony Oxley said another issue
for hospital pharmacy will be the final definition of a responsible pharmacist.
He said: “If for example it is decided that the chief pharmacist
is the responsible pharmacist then the two-hour absence rule isn’t
going to work because they could be out for four hours at a meeting.
“If it was acceptable that the responsible pharmacist was the dispensary
duty pharmacist you would then have to deal with the complicated paperwork
around handing over responsible pharmacist duties two or three times
a day as the shifts ended.”
The guild, however, was pleased that the DoH has decided to leave the
eligibility of a responsible pharmacist to the professional and regulatory
organisations as it is keen to see the role linked to professional competencies
rather than just length of experience.
The PSNC was also pleased that there were no proposals to link the training
and education of a responsible pharmacist to statutory regulations.
But
Mr Lutener said: “If this however became a code of ethics requirement
then that would be the same as a statutory requirement which would not
offer the flexibility we would prefer.” |
The
Pharmaceutical Journal