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CD regulations look set to change
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Last week, the Shipman Inquiry held a series of seminars that dealt
with the arrangements for handling Controlled Drugs. The evidence heard
gives some clues to the recommendations that will be made in the inquiry's
final report, due to be published this summer. Clare Bellingham reports
The implications of the Shipman case are far-reaching. It is not just
about tightening the rules for doctors: the Shipman Inquiry’s remit
is much wider. It is
examining death certification, Controlled Drugs (CDs), and disciplinary
and monitoring systems. The current CD regulations will undoubtedly change
and this could have a significant impact on pharmacists.
Under the current arrangements, Harold Shipman was able to obtain large
quantities of CDs for his own purposes. He collected CDs from pharmacies
for patients he said were too unwell to collect them or in the names
of patients who had no need for the drugs. Instead of delivering entire
quantities to patients, Shipman kept some for himself and he retained
left-over drugs after patients’ deaths.
Private prescriptions
For nearly every topic in the seminars, private
prescriptions were criticised as being more open to abuse than
NHS prescriptions.
A review of private prescribing seems almost certain. The private
prescription form itself was described as inadequate, particularly
the lack of a standard form.
There was overwhelming support
for stricter requirements for private prescriptions. Enforcing
more
detail of the prescribing doctor (such as a GMC number) and
the diagnosis to be included on the prescription are possibilities.
A real difficulty in tackling this problem was highlighted.
Although
a new electronic record might help identify problems within
NHS prescribing, private prescriptions would not automatically
be
included since they are issued outside of the NHS. |
Last week, the Shipman Inquiry held a
series of seminars that examined the use and monitoring of CDs in the
community. Evidence from a number of expert witnesses was heard. Although
none of what was discussed forms proposals for changes to current regulations,
it is certain that it will influence the recommendations that appear
in the final report of the inquiry, which is due to be published in the
summer.
The inquiry is being chaired by Dame Janet Smith. She opened the seminars
by highlighting that a balance between regulation of CDs and practical
use has to be found. “I recognise that it would not be sensible
to propose a complex bureaucratic system which imposed duties and restrictions
that would be disproportionate to the scale of the existing problem,” she
said. The eventual solution
Time and time again the seminar discussion returned to IT and how it
could be used to improve the current arrangements for CDs. Electronic
prescribing, pharmacist access to electronic patient records and electronic
CD registers all offer distinct advantages to improving CD arrangements
yet all seem a distant dream. The advantages of an electronic system
being used in British Columbia, Canada, called PharmaNet, were discussed
at length (see Panel below). Even barcoding individual ampoules of
drugs was considered.
The British Columbia approach
The Shipman Inquiry heard evidence about two systems
used to monitor CDs in British Columbia, Canada, from Brian Taylor,
deputy registrar
of the College of Physicians and Surgeons of British Columbia: • PharmaNet This is a secure computer network
linking all pharmacies, hospitals and some GPs throughout British
Columbia (it is being
expanded to other GPs). It is used for monitoring all prescription
drugs. The patient is given a paper prescription to take to a
pharmacy. The pharmacist then enters the prescription data into
the PharmaNet system. This information is immediately available
on the system for other health care providers to see. PharmaNet
provides pharmacists with a current and past medication history:
this comes up automatically when a pharmacist enters the details
on a prescription. Pharmacists are required to review this database
at the time of dispensing. Alerts can also be added — against
either a prescriber or patient. Patients, pharmacists and doctors
all have unique identifying numbers used in the system. Health
care professionals are only allowed to access PharmaNet for direct
patient care; browsing is not permitted. Every time the system
is accessed, the person accessing the record is electronically
logged. PharmaNet was introduced by a collaboration of the Ministry
of Health, the College of Physicians and Surgeons, and the College
of Pharmacists. The software for pharmacists was funded by the
government and pharmacists are paid a higher dispensing fee for
entering data on PharmaNet.
• The Control Prescription Programme This is a duplicate prescription
programme in which the doctor is required to keep a copy of all
prescriptions written for opioids and methylphenidate (Ritalin).
The other copy is given to the patient to take to the pharmacist,
where the pharmacist keys the data into PharmaNet. The pad is
only given to doctors authorised to prescribe opioids and is
difficult to forge. |
Jim Smith, chief pharmaceutical officer for England, said that progress
is being made with IT: “Yes [IT] is in the future, but not that
far in the future.” He said that the common
patient record for every person in England, currently being developed,
would in essence contain everything that PharmaNet did. The new national
care record system is to be known as “N3”.
However, before appropriate IT is introduced, some basic questions need
to be asked, such as should computer-generated prescriptions for CDs
be allowed? The chief inspector of the Home Office drugs branch, Alan
MacFarlane, said that the principle of
computer-generated prescriptions for CDs and computerised CD registers
has been agreed by the Home Office.
Mandie Lavin, director of fitness to
practise and legal affairs at the Royal Pharmaceutical Society, said
that minor
technical defects on prescriptions for CDs —
because of the current handwriting requirements — cause pharmacists
many problems, despite the fact that the intent of the prescriber is
usually clear. Kay Roberts, co-
ordinator of the Glasgow pharmacy needle exchange scheme, suggested that
in situations where the clinical intention is absolutely clear, pharmacists
should be able to endorse an incomplete prescription. Dr Smith said: “The
DoH would support an appropriate package of measures to allow this.” Prescription validity and duration
Prescriptions for CDs are currently valid for 13 weeks. Support for
a shorter length of validity was strong. The inquiry heard that in British
Columbia, CD prescriptions are only valid for five days. General opinion
among participants at the inquiry was that five days is too short.
A limit of 28 days gained most support, including from the DoH.
It also seems probable that prescriptions for CDs will be limited to
a maximum number of days supply, probably to 28 days.
Richard Baker, director of the clinical governance research and development
unit, University of Leicester, warned that for
patients on long-term medication it seemed inappropriate for them to
have to collect a prescription every seven or 14 days. Ian Rudd, Macmillan
principal pharmacist, Inverness, said that in a survey he had carried
out of patients’ opinion, most thought 28 days was a reasonable
balance.
The information required on a prescription might also change. Participants
discussed how useful it would be for CD prescriptions to be given a coded
diagnosis, such as for palliative care, acute pain or addiction. However,
this proposal was rejected because of concerns over patient confidentiality.
John D’Arcy, chief executive of the National Pharmaceutical Association,
said that in an ideal situation pharmacists should have sight of some
of the patient’s medical record. Dame Janet said: “It is
a general consensus that availability of medical information to pharmacists
via the internet would be a great advantage to patients.”
A suggestion that prescriptions should carry a unique number with which
to identify the prescriber met with support. However, it would not overcome
some problems with monitoring prescribing patterns. Dame Janet was particularly
concerned about difficulties of auditing individual prescribers’ habits
within a multiple-GP practice because of factors such as sharing prescription
pads and repeat prescriptions being produced by a duty doctor rather
than a patient’s own GP. Inadequacies in CD registers
It seems a safe bet that CD registers will change. Dame Janet said: “I
think there can be no secret about everybody’s dissatisfaction
with the CD register as it stands. There is need for a more comprehensive
register.” She added: “In time there will be an electronic
system. We really need to look at what happens in the meantime: it will
be a number of years before an electronic system is up and running in
every community pharmacy.”
One highly likely change is the introduction of running balances in CD
registers. Ms Lavin said that the Society supports this and suggested
that pharmacists could add a running balance now. Dame Janet commented
that the inquiry had been shown the format of Asda’s CD register
which contains a running balance. “I would be minded to recommend
that something like that is used in the intervening period before electronic
forms can be brought in,” she said.
Another area where there was some agreement was the need for each CD
item (ie, each dosage form, strength, etc) to have a separate page in
the CD register. Although it would be possible with an electronic register,
concerns were raised that a paper register containing separate pages
in this way would be too large to be practical. However, most pharmacies
only stock a small proportion of the total range of items available so
would not need to have a complete set of pages.
Making better records of the people involved in CD transactions was also
discussed. Recording the General Medical Council number of the prescribing
doctor in the register received almost unanimous support. This would
allow for better identification of prescribers in investigations. This
could be
extended to other professional membership numbers for new prescribers.
Recording the name of the person collecting the prescription in the CD
register
was a popular proposal. Dame Janet said that the basis on which CDs were
handed out in the pharmacy seemed informal, particularly since it was
an offence to be in possession of a CD without the proper authority.
Shipman collected CDs from the pharmacy while claiming to be acting on
behalf
of patients. This led participants to consider whether collection of
CDs by health care professionals should be banned. No one supported such
a prohibition, raising concerns that it could impair patient care.
Mr D’Arcy said: “I believe some record should be taken of
the identity of the person collecting the CD.” But he questioned
what would happen if the person had no identification. Dame Janet said
the fact that the
pharmacist records that no identification was produced seemed of value. “It
may be that the record might, in a large number of cases, state ‘known
to me’ if the pharmacist can sign the register,” she added.
The person collecting the prescription might also have to sign a declaration
to agree not to pass the drugs on to a third party, that the drugs are
for the patient’s consumption only and to agree to keep the drugs
safe.
Another aspect of supplying CDs is what information should be given to
patients. Dame Janet said that she had been surprised to learn that patients
could be supplied a CD without being aware of the specific legal
requirements concerning the medicine.
The suggestion of a leaflet explaining these requirements was met with
some support although concerns were raised over the possibility that
it might deter patients from taking the medicine or alert them to its
special status. Dr Smith said that the DoH had commissioned the National
Prescribing Centre to draft such a leaflet but that it had been extraordinarily
difficult to do without sounding frightening. “But we ought to
try. It is unreasonable for a person to be in possession of a CD with
legal requirements and not to know that,” he commented.
CD registers will probably have to be kept for longer than the current
two-year requirement. Broad support was agreed for a limit
of seven years in line with other official
documents. Audit trail and inspection
Much of the debate around record-keeping considered
how an audit trail could be produced for monitoring of CDs. With better
IT, an audit trail
from the manufacturer of the CD, through wholesalers to supply from
a pharmacy might be possible.
Dame Janet pointed to two gaps in the current audit trail: matching
what is recorded as being administered by health professionals and
the amount
prescribed, and bridging the gap between what is dispensed in the pharmacy
to what arrives at the patient’s home.
Closing the audit trail completely seemed impossible. Dame Janet said
that she had
almost given up hope of achieving this until the day when barcoding and
electronic records were introduced. However, she did want to see tighter
control of the most dangerous CDs. In particular, she highlighted
injectable CDs, fentanyl and sustained release morphine tablets (MST).
One topic where little agreement was reached was the destruction of dispensed
CDs that are no longer needed, particularly following a patient’s
death. Some people favoured collection from the patient’s house
and others destruction by a health professional in the house with a witness.
The suggestion that patient-returned CDs should be recorded in community
pharmacies was met with support. Ms Roberts said: “I would see
this as protection for the pharmacist as well as closing the audit trail.”
The current system of police chemist inspectors also looks set to change.
Instead, a multidisciplinary team with a wider inspection role could
be introduced. It would take on both criminal justice enforcement but
also include medical issues such as examining doctors’ prescribing
patterns. Inspection would be widened to include doctors’ premises
and nursing homes. It was agreed that these inspection teams should be
based at a regional level, perhaps within the eight
regional government offices.
Pharmacists can speculate on the changes that might be introduced as
a result of the Shipman Inquiry. The definitive recommendations will
be published in the summer.
Who should dispense?
Inquiry participants discussed whether dispensing
CDs should be limited to specialist pharmacists. Ian Rudd, Macmillan
principal
pharmacist,
Inverness, said that such a limitation could restrict patient choice,
particularly for the elderly and infirm. Alaster Rutherford, head
of medicines management at Bristol North Primary Care Trust, agreed: “It
is important that all pharmacists can dispense CDs. But with the
development of specialisms, some community pharmacists might become
specialist, for example, in palliative care.” This should
not prohibit other pharmacists from dispensing CDs. Chief pharmaceutical
officer Jim Smith said: “We do not support the concept of
restricting dispensing, but we do envisage the idea of pharmacists
specialising because the PCT or local health community sees it
as useful.”
Developing a specialty in the treatment of addiction can be successful.
One pharmacist who has done so is Stuart Notman, a pharmacist in
Aberdeen (see Vision for pharmacy, p90). |
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The
Pharmaceutical Journal