| Numerous changes in the legislation and environment of medicines
supply and use have occurred in the past 17 years. There are now many
more prescribers,
new ways of managing medicines (such as self-administration by patients
in hospitals), an increased emphasis on clinical governance and a growing
awareness of medication errors. These factors
make the publication this week by the Royal Pharmaceutical Society of “The
safe and secure handling of medicines: a team approach” particularly
timely. It is a revision of the Department of Health’s 1988 “Guidelines
for the safe and secure handling of medicines” (the Duthie report)
and is written to provide practical advice to all health professionals
involved in handling medicines. The revised report includes advice for
primary care practitioners — a recognition that patients are on
a single care pathway.
The report sets out the principles of achieving safe and secure management
of medicines and outlines the medicines trail. The medicines trail covers
all the processes involved in the handling of a medicinal product from
the initiation of treatment through to administration and disposal of
waste material. Specific advice is then provided in areas of drug use
(eg, wards, operating departments, intensive therapy units, NHS ambulances,
etc). More general topics such as training and personnel, and return
of medicines for destruction are also covered. A full list of the topics
covered is provided in the Panel below and examples of the guidance are
given in the Panel on p265. The intention is that health care professionals
will read the introductory chapters and then the areas of guidance relevant
to their practice — indeed a reader who read the document from
cover to cover might find it somewhat repetitive.
Areas of medicines use
covered in the new report
· Clinical trials
· Community health services
· Community psychiatric services
· Controlled Drugs
· Coronary care units
· Drug addiction treatment units
· Emergency departments
· Intensive therapy units
· Midwives
· Minor injuries units
· NHS ambulances
· Operating departments
· Outpatient departments
· Self-administration of medicines
· Transplant units
· Walk-in centres
· Wards |
Examples of guidance provided in the report
Wards “All wards should have standard
operating procedures covering each of the activities concerned
with medicines use to
ensure the safety and security of medicines stored and used in
them. Appropriate
pharmaceutical advice must be sought in the development of systems
for the safe and secure handling of medicines.”
Clinical trials “The patient information
sheet (part of the informed consent package) should be available
when medicines
are given as part of a clinical trial.”
Walk-in centres and minor injury units “Each
walk-in centre/minor injuries unit site should have a system
of standard operating procedures
covering each of the activities concerned with medicines use to
ensure the safety and security of medicines stored and used in
it.”
Training and personnel “All staff involved
in the handling of medicines should be appropriately trained
with regard to safety
and security of medicines and with regard to safeguarding themselves
and those under their supervision from any risks posed by products
(eg, cytotoxic or radioactive medicines).”
Return of medicines for destruction “Medicines brought [into
hospital] by the patient remain the property of the patient and
may only be sent to the pharmacy for destruction with the prior
agreement of the patient or his/her agent. Details of patients’ own
medicines sent to the pharmacy for destruction should be recorded.”
Community health services “Each clinic
site should have a system of standard operating procedures covering
each of the
activities concerned with medicines use to ensure the safety and
security of medicines stored and used in it. Appropriate pharmaceutical
advice must be taken in the development of systems for the safe
and secure handling of medicines.” |
Fills in the gaps
According to Roger Tredree, chief pharmacist at St George’s Hospital,
London, and an editor of the report, it fills in the gaps between legislation
and NHS guidance, and is an authoritative document that can be used on
a day-to-day basis to support professional practice and underpin medicines
risk management.
Gillian Arr-Jones, senior professional adviser pharmacist at the Healthcare
Commission and an editor of the report, comments that “Standards
for better health”, the new NHS performance framework which comes
into force next month, has a core safety standard for handling medicines
safely and securely. The revision of the Duthie report gives guidance
on setting up and achieving safe systems. “This is complementary
guidance,” she says, adding that the report provides “a reminder
that you need standard operating procedures in settings throughout the
organisation wherever medicines are being handled”. The report
provides advice on the safe, secure and legal handling of medicines by
health care professionals; clinical decisions such as choice, dose and
frequency are not considered.
New legislation and guidance have been incorporated into the report,
along with additional chapters for areas of medicine use which have developed
since the last report, ie, walk-in centres and self-administration of
medicines in hospital. The text has also been updated to include new
nomenclature. Another change welcomed by Ms Arr-Jones is the fact the
report now covers the use of medicines, whatever setting that might be. “It
is applicable to the private sector, too,” she says. “In
recent years, more NHS patients have been going through the private sector
so it is welcome that there is a level playing field.”
Ms Arr-Jones also supports the philosophy of the team approach to medicines
management involving other members of the multidisciplinary team. She
comments: “There is a recognition that there is benefit to pharmaceutical
advice wherever medicines are used, even if there is not a pharmacist
available employed on the site.”
An important addition to the report for hospital pharmacists is the introduction
of advice on the use of patients’ own medicines and self-administration
from bedside lockers. Richard Needle, chief pharmacist for Essex Rivers
Healthcare NHS Trust and another editor of the report, says: “A
high proportion of acute hospitals have moved away from the drug trolley
with the nurse handing the drugs out to the patient to a system where
patients are empowered to look after their own medicines whenever possible.” He
adds: “Having medicines located all over the ward creates a significant
security risk.”
Among the recommendations in the report are that the patient’s
agreement to self-administer should be recorded and that organisations
should have a policy on self-administration. Dr Needle believes that
anyone with responsibility for medicines on wards should consult this
report.
Primary care trusts have responsibility for the safe handling of medicines
for their provider services in a range of settings from community hospitals
to community clinics. According to Theresa Rutter, specialist in community
health services at London, Eastern and South East Specialist Pharmacy
Services, this report will be an invaluable reference and support for
primary care trusts in ensuring good practice and also when gathering
evidence to meet the new health care standards. “It will be the
core reference document for all aspects of safe and secure handling of
medicines,” she says. “The update of Duthie has been eagerly
anticipated. It is not only an essential resource for pharmacists, but
is also useful for all the other health professionals to whom we provide
advice.”
Although the report is not directed specifically at community pharmacists,
Dr Needle suggests that all those involved in medicines supply may find
much of use in it. “It does not specifically address areas like
care homes, but there are parallels to be drawn about safe and secure
handling of medicines in those environments, by looking at what goes
on in a hospital,” he says. “Community pharmacists could
easily produce a checklist of the issues they should be looking at by
extrapolating from the report, particularly
the early chapters that set the principles (eg, the medicines trail)
which are sufficiently general.” Broken down into sections
How to obtain a copy of the revised report
A copy of “The safe and secure handling
of medicines: a team approach” can be obtained from the practice
guidance section of the Royal Pharmaceutical Society’s
website.
A hard copy can be purchased from the Society. The price is £20
for members of the Society and £30 for non-members (including
postage and packing). Cheques should be made payable to “Royal
Pharmaceutical Society” and sent to Lorraine Fearon, Royal
Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN.
Payment can also be made by Mastercard, Visa or Switch. Further
information
is available from Lorraine Fearon (tel 020 7572 2409; e-mail lorraine.fearon@rpsgb.org). |
Doctors, dentists, nurses and other health care professionals who are
involved with medicines should all consult the report, according to
Professor Tredree. The report is broken down into sections so, for
example, midwives can focus on a section specific to them, rather than
having to review the entire 111 pages.
Barbara Stuttle, chairwoman of the Association for Nurse Prescribers,
was involved in the consultation process. She believes that all nurses
involved with medicines, whether prescribing, using patient group directions
or administering, should read the report. She comments: “It is
a timely document with the implications of Shipman. This will help us
review our policies and procedures to ensure that it safe to prescribe,
supply or administer medicines. This report is unique because it is about
a team approach, ie, a joint responsibility rather than just one profession — that
is valuable and important. This report will be much appreciated.”
The Hospital Pharmacists Group selected the members of the review group
in 1997 after the Society was encouraged to update the Duthie report
by the Department of Health. The revised document was then passed to
the Department of Health for comments and feedback was sought from other
relevant groups. Endorsements have also been secured from the chief pharmaceutical
advisers for England and Wales and the chief pharmaceutical officers
for Scotland and Northern Ireland.
This report has taken almost eight years to produce. According to Professor
Tredree, this is because so much has been going on in the health service
that before it has been possible to publish, further amendments have
been required.
Dr Needle further explains that the review process initially produced
a risk management overview which the Royal Pharmaceutical Society’s
Hospital Pharmacists Group committee believed did not meet the requirements
of the health professionals that would be using it. This was then revised
to reintroduce the more practical advice that was so valuable in the
original Duthie report. He adds that there was also a lengthy consultation
period and a decision to ensure the support of the devolved administrations,
which has now been achieved.
The changes expected in Controlled Drug legislation as a result of the
Shipman inquiry means that a revision of appendix 1 in the report, which
covers this topic, may be required soon. An e-mail box — duthie@
rpsgb.org — has been set up to receive comments on the report and
suggestions for potential revisions. Any comments sent in will be dealt
with by a panel of experts who have been involved in producing the revised
document. Dr Needle hopes that the report will be updated in a couple
of years. One significant gap for hospital practice he identified is
the lack of advice on medical gases and he hopes that this may be addressed
in a future revision.
Chronology of reports on the safe and secure handling of medicines
· Aitken report — 1958
· Annis Gillie report — 1970
· Roxburgh report — 1972
· Duthie report — 1988
· “The safe and secure handling of medicines: a team approach” — 2005 |
“The safe and secure handling of medicines: a team approach”,
is the fifth report on this topic since the subject was first reviewed
in
1958 (see Panel). The work over the past eight years has produced a document
which should be useful and indeed vital for all health professionals
who are involved in the handling of medicines. As Ms Arr-Jones says,
people have been waiting for the revision of the Duthie report because
there is no other single source of information on handling medicines
for hospital and managed settings. It is to be hoped that, as intended,
all members of the multidisciplinary team that are involved in medicines
make use of the advice provided. |