What's on the agenda when an inspector calls?
The life of the Royal Pharmaceutical Society's inspectors is a varied one and not always well understood by the pharmacists they visit. In the first of an occasional series on the work of Society staff, Judy Kirby explains the inspectors' role
 There are no typical destinations for Royal Pharmaceutical Society
inspectors. Their work can take them to village pharmacies, supermarkets,
retail
chains, corner shops, prison pharmacies, muddy car boot sales and market
stalls. Wherever the public can buy medicines, an inspector can call.
There are only 18 inspectors covering England, Scotland and Wales — one
on the Isle of Man is by invitation of the Manx government. Between them
they log thousands of miles every year, making routine visits to Britain’s
12,500 pharmacies and responding to complaints from the public, primary
care trusts, veterinary surgeons, police and trading standards officers.
Although public safety comes first, the Society’s Directorate of
Fitness to Practise and Legal Affairs places its emphasis on the supportive
and leadership role of its modern inspectors. “The role of the
inspector has changed considerably over the years,” says acting
chief inspector Gill Hutchinson. “Now we don’t just handle
problems when they arise; we take a proactive approach from a risk management
perspective to minimise errors and encourage pharmacists to exercise
good practice.”
What inspectors look for
Among the things inspectors want to know on routine visits
to your pharmacy are whether you:
· Ensure second checks are made on each prescription item
if possible
· Keep records of dispensing errors
· Know if staff understand the complaints procedure
· Know if all dispensary and shop stock is in date
· Know when your drug refrigerator was last defrosted and the
contents’ dates checked
· Make sure patient-returned medicines are isolated from current
stock
· Keep records of your continuing professional development |
However, some pharmacists remain cynical about the inspectors’ role
as friendly advisers. For one pharmacist working in the north of England,
this modern image is incompatible with the historic policing role. “They
can’t look for fraud and support people at the same time,” he
says. He insists he has a good relationship with his local inspector,
but says that tension inevitably exists during visits in case some minor
infringement is picked up and the inspector then has to go through all
the books.
The inspectors try to build up their relationships with pharmacists during
their routine visits. An inspector has an average of 650 pharmacies on
his or her home patch and typically visits each one every two years.
Visits are planned a month in advance and the inspector’s computer
will print out each day’s schedule — usually four pharmacies,
which will have been informed by letter that they are due for an inspection.
The Society has a duty to enforce the Medicines Act 1968 and has powers
under the Poisons Act 1972 and the Misuse of Drugs Acts 1971, so the
inspector on a routine visit will inspect the registers of private prescriptions
and Controlled Drugs, check labelling and dates on stock and take in
a general impression of the premises.
The inspectors are also involved in checking the suitability of pharmacies
for preregistration training. They make sure that the pharmacy has suitable
teaching materials and also that it offers the graduate enough scope
to gain a broad experience of pharmacy practice. Checking plans for new
premises or refits are another part of the inspector’s advisory
role to the pharmacist.
Their visits also give the inspectors a chance to explore any problems
in the making. “My priority is to spot failing systems in pharmacies,” says
Steven Gascoigne, who covers Cheshire from his home in Sandbach. “If
anything is going wrong it is my job to do something about it and advise
on risk management systems that may stop complaints arising.”
Handling complaints
How complaints and infringements are handled
Inspectors used to be able to issue warnings for minor infringements,
but new Council procedures mean that all cases now have to be
reported to the Fitness to Practise and Legal Affairs Directorate
for a
decision.
Complaints are considered for inclusion on the agenda of the
next meeting of the Council’s Infringements Committee,
a screening body comprising pharmacists and non-pharmacists.
Evidence is presented
anonymously to the committee, which has a number of options open
to it, including a decision not to take any further action. The
committee may advise the pharmacist on necessary improvements
in practice,
may send a strongly worded warning or may require a written undertaking
from the pharmacist to change the systems used.
More serious complaints involving complex allegations may lead
to an interview in Lambeth with the Director of Fitness to Practise
and Legal Affairs, or prosecution in a magistrates’ court or
Crown court, although this is rare. The complaint can also be referred
to the Statutory Committee, which is chaired by Lord Fraser of Carmyllie,
a lawyer, and hears evidence in public like a less formal version
of a criminal court. The Statutory Committee has the power to remove
a pharmacist from the Society’s register or to issue a reprimand
or admonition. A more flexible range of sanctions, including suspension
from the register, is being sought under reform proposals. |
Complaints about pharmacy services take priority in the inspector’s
work, and will disrupt planned routine visits. A complaint will come
via the offices of the Fitness to Practise and Legal Affairs Directorate
at Lambeth. Details will be e-mailed to the inspector, whose first call
will be to the complainant. For Mr Gascoigne, this is usually a personal
visit. “It helps to reassure them,” he says.
The inspector may ask the complainant for a formal witness statement.
If there has been a dispensing error the evidence is sealed in a bag.
The inspector then normally makes an unannounced visit to the pharmacy
involved. However, cold calls are not usually made to multiples that
depend to a large extent on locums, because time would be wasted if the
pharmacist concerned was not on duty.
If the complainant has alleged rudeness, the pharmacist will be interviewed
personally, but when the complaint concerns systems and procedural errors,
the inspector concentrates on the premises.
Most complaints involve dispensing errors or the supply of out-of-date
medicines. A typical, uncomplicated error would be the wrong strength
of drug dispensed — perhaps 50mg instead of 100mg — suggesting
that a final check had not been made. If the pharmacy is understaffed,
the fault may lie with the company, and during the investigation an inspector
would meet the company’s area manager to discuss staffing.
In seven years Steven Gascoigne has seen only two pharmacists in his
territory removed from the register, and one of these was later restored. “It’s
always disappointing to see someone removed but it may be necessary in
the interests of the public and profession,” he says. “Sometimes
there is a genuine rogue involved, doing everything wrong, but they are
very much in the minority.”
When complaints arise from systems errors, the culprit is usually sloppy
practice leading to dispensing mistakes. The most difficult cases of
human error involve drink and drugs. “It is not just us,” says
Mr Gascoigne. “Society generally is having these problems. There
may not be an alternative to taking action in some cases but as a Society
we try to be sympathetic. The Pharmacists’ Health Support Scheme,
which was set up to provide confidential help to pharmacists with alcohol
or drug problems, has been successful and has helped to keep some pharmacists
away from the Statutory Committee.
If a serious allegation has been made, such as the sale of prescription-only
medicines without a prescription, inspectors may make the call in pairs.
For corroboration in difficult cases they may call in Stewart Waugh,
an ex-policeman who is one of the Society’s two non-pharmacy inspectors.
Mr Waugh is trained in the procedures set out in the Police and Criminal
Evidence Act (PACE) to ensure that statements and cautions are correctly
taken and will stand up in court. He is experienced in dangerous encounters,
facing street traders selling medicines illegally and sometimes seizing
their entire stock. “The worse case I investigated was a service
station where the guy locked the door and demanded my test purchase back.
I don’t back off in these situations. I just lifted him out of
the way.”
Mr Waugh will go unannounced into a variety of non-pharmacy settings
where drugs are being illegally sold — Calpol being sold in hotel
foyers, pain-killers on display in fashion shops, out-of-date medicines
being shifted at car boot sales.
“Mostly people are usually ignorant that they’re breaking the
law,” he
says, “and they also don’t realise they can’t sell
medicines on premises that can’t be shut off to the public.” Such
traders get strongly worded letters
of warning from the Infringements Committee, which Mr Waugh routinely
follows up. “I’d like pharmacists to know there’s someone
out there protecting the profession’s standards and reputation,” he
says.
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The
Pharmaceutical Journal