|
Alan Nathan, lecturer in pharmacy practice, department
of pharmacy, King's College London
|
In recent years the Government has become increasingly aware of, and
concerned about, the level of errors made by health professional staff
in the NHS. To tackle the problem it has set up the National Patient
Safety Agency. Its aim is to create a “fair blame” culture
and to encourage health professionals to report errors and “near
misses” anonymously and without fear of disciplinary or legal consequences,
to help in the process of eliminating them. But escaping blame when reporting
errors may not be so straightforward for pharmacists, since they are
bound by criminal law in relation to dispensing. A recent meeting of
the Pharmacy Law and Ethics Association looked at this issue and also
heard how one primary care trust is dealing with it.
Any dispensing error can amount to a criminal offence under section 64
of the Medicines Act 1968. The offence is absolute and involves strict
liability, which means that merely making a dispensing error is a criminal
act, even though there is no intention to do anything unlawful and even
if no harm results. Furthermore, following the Bristol paediatric heart
surgery scandal it was established that exemption from NHS discipline
does not apply if a criminal offence has been committed. The law places
pharmacists in a unique position among health professionals, and it is
much more difficult to charge doctors and nurses with an offence as the
result of an error. They are only criminally liable if what they do amounts
to assault, ie, carrying out actions without a patient’s consent,
or, if they cause the death of a patient through gross negligence, they
can be charged with manslaughter.
With regard to self-reporting of errors, it is a basic principle of English
law that a person cannot incriminate him- or herself through disclosure
of information. In addition, the Department of Heath has accepted the
recommendation of Ian Kennedy, who carried out the Bristol inquiry, that
immunity from disciplinary action should apply to the reporting of errors — unless
a criminal offence has been committed. But this calls into doubt whether
protection would apply to pharmacists for the criminal offence under
the Medicines Act of making a dispensing mistake.
There are also contractual issues between pharmacists and their employers
to be considered in reporting errors. If agreements are put into contracts
of employment not to discipline or to regard contracts as repudiated
if errors are reported, what happens if a pharmacist reports making many
errors? If the employer is not allowed to discipline or dismiss such
an employee, the employer could be accused of failing to protect the
public. Also, although contracts of employment could include agreements
not to pursue criminal proceedings if errors are reported, this would
not bind prosecuting authorities. “Fair blame” agreements
in contracts of employment cannot therefore be regarded as “comfort
clauses” for employees.
There are also questions around protecting confidentiality for a pharmacist
who reports making an error. The NPSA is looking for mechanisms to ensure
this, but public interest considerations may override its intention to
maintain the anonymity of those reporting in all cases, and health authorities
have been successfully sued in the past for failing to breach confidences
when harm has resulted through maintaining them.
To resolve these issues and ensure an environment in which pharmacists
will feel encouraged and secure in reporting dispensing errors, a change
in the law may be necessary.
In spite of the difficulties surrounding the legal situation, some local
health trusts are implementing medication error reporting schemes. One
such is the SafeMed scheme for reporting incidents (the less judgemental
term given to errors), potential incidents and near misses, which has
been set up by the East Kent Community Health Trust. Introduced for primary
care staff from 2001, it was rolled out first to community pharmacies,
then to GPs and their practice staff and it is being extended to dentists
and opticians from this year. Half the community pharmacies in the trust
are already involved in the scheme.
SafeMed operates a fair blame culture, with anonymous reporting in primary
care if desired. It also forms part of the community pharmacy clinical
governance accreditation scheme. A crucial part of the process has been
regular feedback to participants: summary reports are issued every eight
to 12 weeks to stimulate practitioners to look at their own practice,
and there is a “lesson of the month”. Project-based work
is also being carried out and recent projects have covered problems with
methotrexate, for which there is currently no national guidance, and
errors arising through packaging and labelling. Training on analysis
of errors is also offered.
There have been some snags and several lessons have been learnt from
the operation of the scheme. For example, reports made represent only
the tip of the iceberg, with many events not being reported because they
seem to pharmacists too mundane to record. Participation in the scheme
has been variable and some pharmacy multiples have been reluctant to
take part. Most larger multiples have their own internal error reporting
systems and having to submit two forms, one to the PCT and another to
the company, for the same incident acts as a deterrent to participation.
It has also proved difficult to maintain the profile of the scheme, since
it requires significant investment in terms of time and money, both of
which are scarce. Other issues raised have been how to balance confidentiality
against the responsibility for patient safety and the need to provide
support to staff following an incident.
Experience from SafeMed has raised several questions about a national
scheme of error reporting. Can a scheme really be mandatory? Can it really
be confidential? How can data be presented? Will honest and full reporting
be interpreted by the public and media as revealing poor, even dangerous,
practice? Can national reporting address local issues? Will the NPSA
be too slow in gathering information and formulating and disseminating
error reduction strategies?
East Kent’s SafeMed has been a pioneering scheme that has shown
that a local initiative can work, although there have been no direct
outcomes yet and overall benefits for patient safety are unclear. But
it has demonstrated that health professionals broadly welcome such schemes
and that they develop their own momentum since, when one group starts
reporting, others follow. It has also shown that integrated, multiprofessional
reporting is powerful and must be the way ahead for reducing error rates
in health care and improving patient safety.
Meeting report p717
|
The
Pharmaceutical Journal