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Letters to the Editor
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Supervision
Health Act does not alter position regarding supervision
From Mr M. J. MacDonald, MRPharmS
I refer to the letter from Howard
McNulty (PJ, 9 June, p673) and the
response from Jeannette Howe. The term “personal supervision” does
not appear in either the Medicines Act 1968 or the Health Act 2006. The
terms that appear are “supervision”, “personal control” and “responsible
pharmacist”. Mrs Howe states that “the Health Act 2006 replaces
the personal control requirement in the Medicines Act [1968] with the
requirement that each registered pharmacy is to have a responsible pharmacist”.
The Act does not currently alter the position regarding supervision.
I shall attempt to state the current legal position and not speculate
on future changes. The Medicines Act 1968 has not been repealed. The
Health Act 2006 modifies parts of the 1968 Act and replaces other parts.
Section 26 of the 2006 Act concerns supervision. Section 26(2) retains
the existing text of section 52 of the 1968 Act. This section 52 concerns “sale
or supply of medicinal products not on a general sales list” .
This is now designated “Medicines Act 1968 section 52(1)”.
Effectively
this section restricts sale or supply of prescription-only medicines
to pharmacies and, in particular, section 52(1)c states that “if
the transaction is carried out on his behalf by another person, then
that other person, is, or acts under the supervision of, a pharmacist”.
Sections 52(2), (3) and (4), introduced by the 2006 Act, enable ministers
to define “supervision” by statutory instrument in any way
they choose. At present the term is considered in Pharmaceutical Society
v Littlewoods (PJ, 30 January 1943, p38).
Lord Caldecote stated: “There
was all the difference in the world between saying that a business must
be carried on under the management or personal control of a manager who
must be a registered pharmacist, and saying that a sale must be effected
by, or under the supervision of, a registered pharmacist. The contention
which had been urged upon the court was that, on the facts, there was
no real distinction between the words ‘personal control’ and ‘supervision’.
… It is quite possible in my judgment that a man who is upstairs
[in a room above a shop] may have been a person who was exercising personal
control of the business, but I do not think that, while he was upstairs,
he was a person who was supervising a particular sale.” It is interesting
to note that in his judgment “management” appears to be equated
with “personal control”.
The Health Act 2006 section 30 introduces the term “responsible
pharmacist”. It does so by amending the Medicines Act 1968 by adding
a new section 72A. Of note, 72A(2) states that “a person may not
be the responsible pharmacist in respect of more than one set of premises
at the same time, except in circumstances specified by the Health Ministers
in regulations”. This appears to give wide powers to the ministers
of health.
It is submitted that the responsible pharmacist is in effect what used
to be called the manager. This manager now has a number of duties imposed
by statute. A number of pharmacies appear to operate these days with
no manager, just a succession of locums. Until now there has been no
legal requirement for a manager. When this is coupled with part-time
ancillary staff then it is more difficult to achieve a high standard
of care for the patient. The “responsible pharmacist” approach
would appear to change the situation. However, the “supervision” requirement
at present is unaltered. Mike MacDonald
Cardiff
“Responsible pharmacist” must be properly defined
From Miss U. Ganz, MRPharmS
Howard McNulty (PJ, 9 June, p673) raised the issue of the confusing lack
of a definition of “responsible pharmacist” in English law.
Another important point I would like to add is that regarding the impending
implementation of EU Directive 2005/36.
Directive 2005/36, Article 45.2 defines activities that pharmacists must
be allowed to perform and Article 21.4 has a derogation to ignore EU qualifications
for setting up new premises. I support this but believe that this should
not be used to prevent an EU-qualified pharmacist from performing his or
her duties as an employee of a corporate body. Can a locum be the legal
person “setting up” the new premises? Should this not be the
corporate body’s superintendent pharmacist?
The current legislation does not prohibit EU-qualified pharmacists from
working in new premises, but it does prohibit these pharmacists from being
in personal control of new premises. Effectively the presence of a UK-qualified
pharmacist changes the recognition of the EU pharmacist’s qualification.
This does not conform either to the letter or the spirit of the Directive.
The current legislation leads to the ridiculous situation where a pharmacist
absent from a corporate body’s new premises cannot be covered by
an EU-qualified locum, so a UK-qualified pharmacist from a nearby branch
must be transferred from his or her normal place of work and the latter
replaced with the EU-locum, who is able legally to work alone at the old
premises. What has been achieved?
Having two roles, as suggested by Professor McNulty, would also simplify
the legislation. The “managerial pharmacist” could have responsibility
for those things that do not depend on physical presence and are continuous
in effect, whereas the “duty pharmacist” could be responsible
for those immediate activities that may only be performed by a pharmacist
and only last for the duration of the activity.
Any UK- or EU-qualified pharmacist employee or locum should have equal
rights to be the “duty pharmacist” on any premises, including
new ones, this being the intention of Directive 2005/36 Article 45.2. In
order to comply with the Directive the current ambiguity of “responsible
pharmacist” must be properly defined. I urge anyone with an interest
to take part in the Department of Health’s consultation
on the implementation of Directive 2005/36 on their website.
Ursula Ganz
Chippenham,
Wiltshire |
The
Pharmaceutical Journal