Debate reopens on supervision
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The Council of the Royal Pharmaceutical Society
is to hold a special meeting in November to consider its policy
on the supervision of sales and dispensing in pharmacies. The debate
was reopened at the Council’s October meeting in a presentation
by Helen Darracott of the Society’s Professional Standards Directorate.
This article is a summary of her address
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What follows may be seen by some as controversial,
but its point is to stimulate discussion on an issue that is fundamental
to the way pharmacy services are provided now and the way they will develop
in the future.
The pharmacy supervision requirements are found
in the Medicines Act 1968. What was in the minds of those who drafted
the Act was public safety in relation to the supply of pharmacy medicines
and prescription only medicines. It is as simple as that.
The legal basis for supervision is found in Section
52 of the Act, which relates to sales and dispensing of pharmacy medicines
and prescription only medicines. It says that sales must be made by a
pharmacist or if not by a pharmacist by a person acting under the supervision
of a pharmacist. The important point is that it is the person who is being
supervised, not the transaction. That was a change from the Pharmacy and
Poisons Act 1933 and the ruling in the familiar case of Roberts v Littlewoods
Mail Order Stores Ltd.
The everyday, common sense interpretation of supervision
involves the supervisor being responsible for setting systems, approving
them and taking responsibility for their safe operation. It requires monitoring
and overall accountability by the supervisor. It does not mean that the
supervisor has to be aware of every unit of activity. However, the Society’s
traditional interpretation is that compliance with the supervision requirements
means having a pharmacist physically present on the premises, in the professional
area. Any absence, no matter how short, means a breach of supervision.
That interpretation is reinforced in ‘Medicines, ethics and practice:
a guide for pharmacists’.
Sales supervision
How does the public perceive supervision of medicines
sales as interpreted by the Society?
A whole range of activities in pharmacies complies
with the Society’s interpretation of supervision. At one end of the spectrum
is the “buzzers and bells” brigade, who require assistants to bring every
sale of a medicine to the pharmacist’s attention. The pharmacist is aware
of the sale, but awareness does not necessarily equate with the intention
of protecting public safety. There may be a great deal of pharmacist awareness
but no pharmacist involvement.
So the “buzzers and bells” approach may not enable
pharmacists to comply with the intention of the law. It may just provide
a comfort blanket, lulling pharmacists into a false sense of security
that all they have to do to comply with supervision is to get their assistants
to wave the product around when anybody asks to purchase a pharmacy medicine.
At the other end of the spectrum are the medicines
sales protocols introduced in the mid-1990s. They need medicines sales
staff to be trained and competent, but they still require pharmacists
in professional areas. They have not taken away the need for physical
presence. They require the pharmacist to give instructions as to how medicines
are to be sold. But in many cases there is no direct involvement of the
pharmacist in the sale and the pharmacist need not be aware of every sale.
Dispensing supervision
In relation to dispensing, there is an agreement
within pharmacy bodies that a pharmacist has to see every prescription
and undertake a professional assessment. There is no agreement as to the
stage in the dispensing process at which that check should take place.
How do members of the public perceive the dispensing
supervision requirements? Very often they see them as a barrier. A customer
who enters a pharmacy when the pharmacist is out for a lunch break cannot
buy a pharmacy medicine or collect a prescription that has been dispensed
and may be visible on a shelf waiting to be handed out. To the customer,
that appears to be an anomaly because all too often when a medicine is
sold or handed out there is no pharmacist involvement. But the Society
still requires a pharmacist’s presence on the premises at the time.
Public expectations
So, to start the debate, the profession needs to
look at what patients expect from pharmacy, not necessarily from supervision.
They expect that their medicines will be accurately dispensed, that the
pharmacist will deal with queries and give advice, and that the pharmacist
will be able to spot problems. They also want to be able to buy medicines
— sometimes with advice but sometimes without advice because they know
what they want from a repeat purchase.
Those expectations could still be fulfilled if the
pharmacist was not physically present but was immediately contactable.
The Code of Ethics requires accountability. That
is the direction that the Council should be starting to consider as the
basis of supervision. The Code of Ethics says that an identifiable pharmacist
has to be accountable for all activities undertaken in the provision of
pharmacy services, whether by himself or by other staff. This accountability
is not restricted to sales and supplies of medicines, as Section 52 of
the Act is, but covers everything.
Drivers for change
What are the drivers for a change in the interpretation
of supervision? The first is to be able to meet current public expectations.
Patients not only want to be able to get their medicines, they want to
be assured that the systems in place in the pharmacy are safe, that all
staff are competent and that procedures for assessing and managing risk
are in place and are followed.
Another driver for change, which comes from both
within and outside the profession, is the desire to develop new services
that may or may not be based on the pharmacy premises. Many pharmacists
who are keen to become involved in new services cannot do so because they
are tied to their current tasks. They run a risk that if they do not take
on and develop systems to accommodate new services, others will do so.
Something else to bear in mind is that an accountability-based
interpretation of supervision is more in line with the Government’s desire
for consistency across the health care professions. Delivery of health
care by other professions is increasingly seen as recognising devolvement
of tasks while retaining professional accountability.
The self-imposed requirement for physical presence
and involvement in every dispensing episode holds the profession back.
It also means that the Society may be seen as a barrier to innovation
rather than as the leader of developments in pharmacy practice.
Barriers to change
There are practical difficulties in trying to change
the interpretation of supervision, but there is more to it than that.
For the Society, the immediate difficulty is how to monitor compliance
with a rather nebulous concept. If no pharmacist is visible, how will
it be known that he is on the premises? If no pharmacist is visible, how
will it be known that he has supervised? How will one know whether the
pharmacist has been telephoned or is in contact by video? If a product
is supplied under a protocol, how will one know that the staff are trained
and that the protocol has been followed? If a prescription is handed out,
how can one be sure that the pharmacist has seen the prescription and
has undertaken a professional assessment and approved it for release?
Decisions will be needed on what contact and involvement
is acceptable. If the pharmacist is on the premises, will a consultation
room with a window be acceptable? What if the consultation room has no
window? What if the pharmacist is in an office, stock room or rest room
but with a video link? What if the pharmacist is in such a room with no
video link?
Testing the matter further, what happens if the
pharmacist is off-site? Could there be a video link from another pharmacy?
Or a video link from home? What about contact by mobile telephone while
undertaking a domiciliary visit? Would any of those cases be acceptable
for supervision?
These are clearly challenging issues to be addressed.
Looking to the future
The Council needs to think about what it wants pharmacy
to look like in five or ten years. To do that, it has to think about where
pharmacy skills are best employed. Are they best employed tied to the
dispensary or to the medicines counter?
The Council has to think where the biggest risks
are. How does it address those risks? What systems should be put in place
to ensure that medicines purchased by or prescribed for customers and
patients would be safe and appropriate for them, and that all other services
they receive from the pharmacy would have been provided by competent,
trained staff?
The Council also has to consider how it can ensure
the protection of the public interest. It must ensure that everything
it does is done for the right reasons — that it is protecting public safety,
that there is a patient benefit in what it is doing, and that it is not
doing it just for the profession’s own convenience or to mask another
problem, such as a shortage of pharmacists. The Council has to take action
for the right reasons. It has to be clear about that.
This might mean that the Council has to challenge
its current interpretation of supervision requirements, and it may have
to test some alternatives. Not everyone may be comfortable with that.
The only way to move forward and free pharmacists from the dispensary
bench and medicines counter is to test the systems to see whether they
work. That is not to say that there should be a free-for-all, but to say
that, under certain tightly defined criteria, some alternatives should
be tested.
The Council should debate the matter and undertake
further work because supervision is fundamental to the way in which pharmacy
services are provided. It has a profound impact on a whole range of other
issues, including skill mix, competence, standard operating procedures,
workforce planning and development of pharmacy information technology
systems. Those matters are hot topics at the moment. Initiatives should
not be allowed to founder for want of a debate on supervision.
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