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• White Paper (5)
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• Supervision
• The Society
Letters to the Editor
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Supervision
Who is the pharmacist responsible?
From Professor H. McNulty, FRPharmS
The Health Act 2006 has made provision for changes to the Medicines
Act by replacement of the requirement for personal supervision of a pharmacist
with a requirement for a responsible pharmacist for each pharmacy. This
is an excellent concept, but there is a risk of confusion in current
legislation since two different responsibilities are covered as if they
were the same.
The duties of the responsible pharmacist specify they “must establish,
maintain and keep under review procedures designed to secure the safe
and effective running of the business for sale and supply of medicines”.
Such duties demand managerial experience, legal knowledge and practical
skills as well as a managerial responsibility for staffing quality and
levels. Elsewhere there is reference to the need for one responsible
pharmacist for each pharmacy, which again suggests this post has a managerial
responsibility.
This is confirmed by the requirement that “for corporate bodies
the responsible pharmacist must be the superintendent, or a manager or
assistant subject to the directions of the superintendent and who is
a pharmacist”.
By the above definition the person cannot be a self-employed locum, who
must, for tax reasons, retain his or her independence from the company.
Presumably the regulator will annotate company premises lists with the
name of the responsible pharmacist and a list of those qualified to be
responsible pharmacists will be kept. These people would agree local
contracts and services for their pharmacies with the local NHS board
or trust and their names should appear in the Pharmaceutical List. Additional
managerial training and skills are required for this role and a register
of those qualified to be managerially responsible will be required also.
However the Act then says: “The responsible pharmacist must make
a record (which must be available at the premises) of who the responsible
pharmacist is in relation to the premises on any day and at any time.” This
suggests there will be more than one such person for each pharmacy and
thus creates ambiguity over who meets the legal responsibilities of the
role for the premises. If several people are responsible for a pharmacy
at different times of day on the same day then changing procedures are
a potential consequence which would affect the business, patient, customer
and staff safety. Businesses would have to register name changes daily
and presumably there will be fee implications.
In the recent initial consultation the statement has changed to say: “The
responsible pharmacist is required to keep a record at the pharmacy of
the pharmacist responsible for the pharmacy on any date.”
This subtle change in wording implies the responsible pharmacist can
have several pharmacists responsible for the pharmacy, possibly even
at different times of the day, an important practical issue in pharmacies
open for more than 100 hours a week or for seven days a week, 24 hours
a day. There is, however, no mention of a “pharmacist responsible” anywhere
in the Act or for what they are responsible. Is this pharmacist responsible
really the duty pharmacist in clinical and professional charge in the
absence of the manager? This is usually the person who ensures Medicines
and Misuse of Drugs Act compliance and NHS boards and trusts can already
demand their names from contractors.
In small businesses the superintendent and the pharmacist in managerial
and in clinical charge will often be the same person, except for holiday
and sickness absence, when the duty pharmacist role must be covered.
In large companies the roles may well be fulfilled by three different
people — possibly more in extended hours premises — so clarity
of terminology and intention and legal responsibility of each role is
required before we define required qualifications and maximum absences.
I suggest it would make sense for the managerially responsible pharmacist
for the premises to ensure company standard operating procedures meet
local NHS requirements, they should continue to keep records of the clinically
responsible duty pharmacist and ensure they have appropriate qualifications
and competence. The superintendent role must agree local standard operating
procedure changes and ensure arrangements for managerial responsibility
and clinical responsibility are suitable. Additional managerial training
requirements should be specified for these two roles.
Duty pharmacists must usually work within established premises protocols,
but have the right to suspend services they are not trained for, or have
a duty of conscience not to provide if they have the pharmacy manager’s
agreement. Their role requires clinical competency, and legal and ethical
understanding that is achievable by most pharmacists soon after registration
and is often undertaken by locum tenens.
The shop manager could be away for a few weeks and still ensure the defined
legal responsibilities are met. The duty pharmacist however cannot easily
leave a pharmacy without compromising care and access if no pharmacist
is present, but could easily do so if there were a second pharmacist
present. The level and quality of support staff will be a factor in any
such decision, making legal definitions of absence periods rather difficult
and open to abuse.
When we know what the responsible roles are to be, then it will be easier
to consider issues such as the length of absence permitted and required
qualifications.
Howard McNulty
Department of Pharmaceutical Sciences
University of Strathclyde
Glasgow
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JEANNETTE HOWE, head of pharmacy at the Department of Health, responds:
As
readers will know, the Health Act 2006 replaces the personal control
requirement in the Medicines Act 1969 with the requirement that each
registered pharmacy is to have a responsible pharmacist with a duty
to secure the
safe and effective running of the pharmacy. This change reflects the
response to public consultation in 2005 with 75 per cent of respondents
supporting
the need to change legislation to clarify the personal control requirement
and with some 50 per cent of those supporting change wishing to see
this set out in terms of the pharmacist’s professional responsibility.
During passage of the Health Act, the DoH published an information
paper. This outlined some thoughts on the development of regulations
relating to the responsible
pharmacist and underlined the Government’s
commitment to consult with all interested parties on the content of the regulations.
As a first step, the UK health departments hosted a number of informal consultation
events on the responsible pharmacist regulations earlier this year. The views
put forward at the events have been invaluable in supporting further work on
the regulations. There will be a further opportunity to put forward views during
formal public consultation on the regulations later this summer. |
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The
Pharmaceutical Journal