| There is little doubt that the legislation surrounding Controlled Drugs
is going to change. Pharmacists will have to practise differently and
adapt to new regulations. The catalyst for change is the Shipman case.
On 15 July, the Shipman Inquiry published its fourth
report which examines
the regulation of CDs in the community. The chairman of the inquiry,
Dame Janet Smith, made a number of recommendations that will now be considered
by the Departments of Health and Home Affairs. A Government
response is expected at the end of this year. Key stakeholders, including
the Royal Pharmaceutical Society and the Advisory Council on the Misuse
of Drugs, will also be responding to the report. The Society has
already established a working party and it hopes to present its official
response to Council at its October meeting.
The extent to which the Shipman Inquiry’s proposals will be implemented
is not known. But this does not mean that pharmacists should sit back
and wait for legislative changes. “This inquiry is a wake-up call
to the profession,” according to Mandie Lavin, director of fitness
to practise and legal affairs at the Society.
“If I were a community pharmacist, I would start by reminding myself
of the contents of ‘Medicines, Ethics and Practice’. Then
I would carefully consider if any areas of my practice needed to be strengthened
and undertake any necessary continuing professional development,” she
says. In particular, Ms Lavin says that pharmacists should be aware of
changes in local populations, perhaps through the opening of a nursing
home, that can increase or alter a pharmacist’s involvement with
CDs. “Pharmacists need to ensure they are up to date and confident
about CDs and also that they know where to go to seek help.” Advisory
services run by the Society and the National Pharmaceutical Association
are two such places.
Overall, Ms Lavin is positive about the recommendations made by the Shipman
Inquiry. “Clearly, the current arrangements do not provide the
safeguards that the public requires,” she says. Through its recommendations,
the report aims to provide a better, safer service for patients and awards
pharmacists greater discretion to improve their practice.
The CD legislation has been largely unchanged for 30 years. In particular,
it prevents use of new technology. “It is time for revision,” says
Dame Janet. “The Home Office Drugs Branch is aware of the need
for change but there has been little movement to date, possibly owing
to a lack of resources.”
Her report describes how technological developments such as the NHS Care
Record and electronic transmission of prescriptions could offer improvements
to CD systems. But it will be some time before they are introduced: “In
the meantime, it is necessary to consider how a paper-based system should
operate for the prescription of CDs.”
So what does the report recommend? For pharmacy, the most important proposals
are in the following categories:
· Changes to prescriptions for CDs
· Changes to the CD register
· Changes to the inspection processes
The changes for each of these categories are described in the Panels
(below).
Proposed changes to prescriptions for Controlled
Drugs
The report proposes that a special prescription form is introduced
for both NHS and private prescribing of CDs. These would only be
supplied to doctors who need to prescribe CDs as part of their clinical
practice. The idea is that the form would enable the Prescription
Pricing Authority to scan the data into its system which could then
be used for monitoring.
Dame Janet comments: “My preference would be for there to be
a special form to be used for all CD prescriptions whether NHS or
private. This should be similar to the FP10 but should be printed
on paper of a different colour. It should have a tick box to show
whether the drugs are being prescribed on the NHS or privately.” Other
details that could be included on the special form are the doctor’s
General Medical Council number and a brief description of the condition
the drug has been prescribed for. Each form should have a unique
identification number and some sort of patient identification, such
as an NHS number, could be added.
The suggestion of including the condition for which a CD has been
prescribed on the form is something of a temporary fix. When the
NHS Care Record is introduced, the need for this sort of information
on the prescription will probably become unnecessary — providing
pharmacists have access to the common spine of the Care Record. Dame
Janet is clear in her report that she hopes that pharmacists will
be given this access.
Handwriting requirements look set to stay for the time being, but
the report proposes that prescribers should computer-print the information
on the prescription first (this ensures that a record of prescribing
appears in the patients’ medical record) and then copy the
information out by hand. Although the introduction of computer-generated
prescriptions for all CDs would reduce errors and facilitate monitoring,
it might lead to security problems, the report notes. “The
existing handwriting requirements should not be repealed until Government
is satisfied, by the conduct of pilot schemes, that the arrangements
for computer generation and/or transmission of CD prescriptions are
sufficiently secure,” it states.
A change that looks likely is to the duration of validity of the
prescription for CDs. At the moment, prescriptions for Schedule 2
and 3 CDs are valid for 13 weeks; the report proposes a change to
28 days. In addition, it proposes that a prescription (for CDs in
Schedules 2–4 only) should be for a maximum of 28 days’ supply.
Whom doctors can prescribe CDs is also likely to change. Prescribing
CDs for friends, family or self-administration should not occur unless
in an emergency, the report recommends. Any restrictions placed on
a doctor’s prescribing of CDs, perhaps after a previous offence,
should be notified to community pharmacists. |
Proposed changes to Controlled Drugs registers
Many changes to CD registers are proposed. Not
only to the information that should be recorded in the register
but also the nature of the
register itself. “The entering of data into the CD register
is a time-consuming business and the registers themselves are unwieldy,” the
report states. Therefore, it recommends that pharmacists should be
allowed to keep a CD register in an electronic form. “If pharmacists
were permitted to keep their CD registers electronically, they could
integrate the PMR with the CD register. Then an entry could automatically
be made in the CD register when the prescribing information was entered
in the PMR. In this way, a great deal of time would be saved.”
One of the most significant recommendations about CD registers is
for pharmacists to have to keep a running balance. Initially, the
inquiry calls on the Home Office to make it clear to pharmacists
that such a procedure would be considered good practice and then
that this should be publicised by the Royal Pharmaceutical Society. “When
electronic CD registers have come into general use, the keeping of
such a balance should be made obligatory,” it says. Some pharmacists
already keep a running balance in their CD register — there
is nothing to prohibit pharmacists from doing this. For example,
Asda pharmacies use a CD register that includes running balances.
Although the proposed introduction of a running balance has been
met with some resistance, the inquiry notes that the experience of
those who have kept such a balance suggests that the practical difficulties
are not as great as feared.
Ms Lavin comments that best practice guidance on running balances
will be needed, covering topics such as wastage, viscosity of fluids
and write-off. It is likely that such guidance would be given as
amendments to the Code of Ethics.
An electronic register might also allow the extension of the list
of CDs for which records are kept to include those in Schedules 3
or 4, it suggests, adding that it would be too onerous to expect
pharmacists to make handwritten records for CDs in these schedules.
And another proposal is to link electronic CD registers to the systems
of wholesalers to minimise the risk of diversion.
CD registers should be amended so that the name of the person to
whom drugs are supplied is recorded, the report recommends. If the
pharmacist does not know the person, then some form of identification
should be asked for. If no identification can be produced, it recommends
that pharmacists should have the discretion to decide whether or
not to supply, and if a supply is made to record that no identification
has been seen. This suggested regulation would apply to health professionals
who are collecting CDs on behalf of patients. For CDs falling into
Schedules 3 and 4, the collector would be asked to write his or her
name on the back of the prescription. In addition, the pharmacist
responsible for supplying the CD (that is the pharmacist who hands
over the drugs rather than the pharmacist who assembles them) should
also record his or her name in the CD register, it suggests.
Finally, the report proposes that the current requirement to retain
a CD register for two years should be extended to seven or 10 years.
This could become indefinite when electronic CD registers are introduced,
it adds. |
A new inspectorate proposed
The report recommends that a new CD inspectorate
should be created. It should comprise small, regional multidisciplinary
teams that
are co-ordinated nationally. Each team would include pharmacists,
doctors, inspectors and investigators. The proposed inspectorate
would be responsible for inspecting arrangements for both safe
keeping and registers of CDs in pharmacies and doctors’ surgeries.
What the Society’s involvement in this proposed CD inspectorate
would be is yet to be determined. “The Society would be happy
to help. We are the only health care regulator to have an inspectorate
now,” Ms Lavin comments. “We have to examine the recommendations
to see what role we could play and what role it is appropriate
for us to play.” Issues that need to be addressed include
the exact scope of the new inspectorate, how it interacts with
other agencies and how it would be funded. |
New discretion
Despite much of the report being about tightening regulations, it does
recommend that pharmacists are given more discretion than has been
the case in the past. For example, it proposes a relaxation of the
strict requirement on pharmacists only to dispense a prescription for
a CD if it is completely technically accurate. “Where the defect
is only technical and the pharmacist is confident that the intention
of the prescriber is clear, and is willing to accept professional responsibility
for dispensing the prescription in the form in which it is presented,
she or he should have the discretion to amend the prescription, to
correct the technical defect and to dispense the drugs,” the
report states.
Ms Lavin is pleased with this: “We quite often get telephone calls
from pharmacists seeking advice about whether to dispense a prescription
that has a technical defect when the intention of the prescriber is clear.
For the first time, Dame Janet is saying pharmacists can amend such a
prescription and without the need to return it to a prescriber.”
Discretion appears in a number of the
report’s recommendations. In proposing to introduce a requirement
for patients to provide identification when collecting a prescription
(see Panel below), Dame Janet says that pharmacists should be able to
override this providing that they record that no identification has been
seen.
Although pharmacists will welcome a new power of discretion, it will
inevitably lead to difficulties in decision-making. “Clearly the
operation of discretion is a challenge,” concedes Ms Lavin. But
she comments that having discretion is better for pharmacists than the
current situation of strict rules that can lead to a pharmacist committing
an offence, for example by dispensing a prescription with a technical
error. Other recommendations
In addition to the recommendations around prescribing, CD registers
and inspection, there are a number of other proposals that could have
an
impact on pharmacy.
First, patients, or their representatives, should be given more information
about the CD when it is collected from the pharmacy. “This should
usually comprise an accurate description of the CD prescribed and advice
about the need to keep the drug safe because of the risk of diversion,” the
report says. Some concern exists that this might alarm the patient so
that he or she is afraid of taking the medicine. Dame Janet says that
she is sceptical about this and that, as a general rule, pharmacists
should warn patients of the particular need to keep the drugs safe and
about safe disposal. Advice should be given orally and in a leaflet.
This is one of the recommendations that is most likely to cause concern,
according to Ms Lavin. “It is very hard to draft a leaflet that
will not have a detrimental effect on the patient taking the medicine
or that leads to the patient’s representative
becoming unhappy to collect the medicine.” She adds that providing
such information to a collector could also be in breach of the
patient’s confidentiality.
Another proposal is for a patient drug record card to be given when an
injectable Schedule 2 CD is supplied. The card should record the form
and amount of the drug prescribed, the form and amount dispensed, and
the dosage instructions. Every time a dose is administered, it should
be recorded on the card. Each new supply should also be added to the
master card along with a record of destruction of any unused stock.
Removal and destruction of CDs from a patient’s home should be
properly recorded and witnessed, the inquiry states. Primary care trusts
should be responsible for ensuring that suitable arrangements for this
are in place. The report suggests the possibility of a law change so
that all CDs become the property of the Crown on the death of a patient
for whom the drugs are prescribed.
Restricting supply of CDs to specialist pharmacies is something that
was considered by the inquiry but is not recommended because it could
restrict patient access. Some concern
Commenting on the report, John D’Arcy, chief executive of the National
Pharmaceutical Association, said: “We do have some initial concerns
that some of the recommendations will be difficult to implement. In submissions
made by the NPA to the inquiry, we were at pains to point out that the
recommendations needed to be proportionate and that they should not create
unnecessary
bureaucracy for our members in delivering patient care.”
A spokesman for the Pharmaceutical Services Negotiating Committee said
that it would be working closely with the Department of Health to ensure
that the new pharmacy contract incorporated the necessary safeguards.
And Mark Koziol, director of the Pharmacists’ Defence Association,
said: “We must be sure that any changes that we now implement are
not onerous to the extent that they also prevent a genuine patient from
receiving their supply of essential CDs.”
In her summary, Dame Janet says: “I have to report that there is
no easy way to prevent a doctor who is determined to obtain illicit supplies
of a CD from doing so. Nor is there any foolproof way of detecting, after
the event, that a doctor has diverted CDs for his or her own use.”
What Dame Janet hopes her recommendations will achieve is to improve
the present situation so that it is much harder for a doctor to obtain
drugs illicitly and, if this does happen, that it is much more likely
that it will be detected. |
The
Pharmaceutical Journal