Clinical benefit and effectiveness
Improving clinical effectiveness and reducing risks for medicines
users
Is quality of life the best measure of effectiveness, asked Elaine McColl,
director of the clinical trials unit at the University of Newcastle.
She said that, in assessing clinical effectiveness, the measurement of
clinical outcomes (eg, blood pressure or HbA1c) may only tell part of
the story. Measuring subjective outcomes of importance to patients provides
a further perspective and in respect of chronic disease management may
be the most relevant measure of treatment effectiveness. Quality of life
is an example of a patient-reported outcome. It is a complex multi-dimensional
concept that reflects an individual’s (or group of
individuals’) symptom experience, treatment satisfaction and adherence.
Dr McColl highlighted the key issues in the assessment of quality of
life in relation to the application of these measures in routine clinical
trials. She concluded that choosing and using the most appropriate method
of recording PRO and quality of life could be challenging, since no single
measure was appropriate in all cases. Value for money
Andrew Walker, a health economist from the University of Glasgow, said
that 15 years ago there was little interest in the cost benefit analysis
of drugs. With ever increasing pressure on the health budget the concept
of getting value for money had now assumed considerable importance.
There were a number of advantages of carrying out a cost benefit analysis,
including focusing on the claimed benefits, quantifying the evidence
for a positive outcome and making a clear judgement as to whether one
intervention represented better value for money than another. However,
the techniques are time consuming, challenging and require special
skills. There are also difficulties choosing a comparator. From an
administration viewpoint funding comes from different budgets making
accounting for the costs of the work difficult. The benefits to patients
are normally expressed in terms of cost per quality of life unit; whether
a new drug or intervention is accepted depends on current options and
whether its cost exceeds an often arbitrary threshold figure, currently
in the region of £30,000.
Richard Lowrie: doubts about ways to translate evidence benefits
into practice |
Richard Lowrie, community pharmacy clinical
services lead at NHS Greater Glasgow and Clyde, said there are doubts
about the best way to translate
evidence benefits into practice. He explained that multifaceted personal
and written interventions are necessary to establish strategies that
can be used to promote the wider use of clinical evidence by practitioners.
These include • Internal marketing to sell the idea of changing practice to colleagues
• Involvement of practitioners in the design of the intervention
• Use of educationally influential opinion leaders
• Frequent verbal and written reminders to practitioners
• The acceptance and provision of feedback
• Educational outreach visits to working environments away from base
• Clinical decision support systems
• The promotion of organisational change to facilitate new practices
• Policy cost effectiveness
Mr Lowrie said there are evidence-based approaches for indentifying
high-risk individuals, engaging with patients, prescribing for long-term
conditions, and adherence and persistence with long-term medicine use.
Among the evidence based actions that could be taken to deal with what
Mr Lowrie called “the epidemic of non-adherence” are reducing
the number of medicines and frequency of dose, issuing regular reminders,
and educating patients better about the importance of taking their medicines.
Reducing medication errors
Safer practice with anticoagulants was the subject of a presentation
by David Cousins, head of safe medication practice at the National
Patient Safety Agency. Anticoagulants are one of the classes of medicines
most frequently identified as causing preventable harm and admission
to hospital Managing the risks associated with anticoagulants can reduce
the chance of patients being harmed in the future. In a Patient Safety
Alert planned for publication later this month the NPSA will be recommending
that NHS and independent sector organisations in England and Wales
take steps to make the use of anticoagulants safer. Among the measures
being advocated is the promotion of safe practice with prescribers
and pharmacists to check that the international normalised ratio (INR)
level is safe before issuing or dispensing repeat prescriptions for
oral anticoagulants.
Nicholas Bateman, of the National Poisons Information Service at Edinburgh
Royal Infirmary, described how problems with opioids could be avoided.
He told the audience that opioids have a higher incidence of adverse
effects than other analgesic groups and significant numbers of patients
stop treatment because of this. Approximately one in four patients suffer
nausea, one in five constipation and drowsiness, and one in six vomiting
and dizziness. Analgesic efficacy is often unpredictable and complicated
by variations in the metabolism of commonly used opioids. Professor Bateman
said that the key to the optimum use of opioids was individual titration
and a knowledge of the pharmacology of these drugs.
Mark Strachan, consultant physician at Western General Hospital, Edinburgh,
talked about reducing risks from insulin. The major side effect of insulin
is hypoglycaemia, most episodes of which are managed at home, he said.
Many patients worry about the possibility of suffering the symptoms of
a “hypo” and compromise good glycaemic control by reducing
the amount of insulin taken. Injection site injuries are much less common
and take the form of lipohypertrophy and localised allergic reaction.
Preventing medication errors was the title of a presentation by Robin
Ferner, director of the West Midlands Centre for Adverse Drug Reaction
Reporting, Birmingham.
Professor Ferner differentiated between: • A medication error (a failure in the treatment process that leads
to, or has the potential to lead to, harm to the patient
• A mistake (an error in the planning of an action due to poor rules
or inadequate knowledge)
• A slip or lapse (an error in carrying out an action often due to distractions
or tiredness)
• A violation (conscious act that deliberately contravenes established
rules)
He said that medication errors are potentially dangerous. Estimates
varied widely but may account for 4 per cent of all US deaths. A technique
known as root cause analysis, finding out what happened and the circumstances
that allowed it to happen, can help in investigating and predicting such
errors. Taking disciplinary action against individuals is counter productive;
organisational changes may be required. Professor Ferner suggested that
computerised prescribing and decision support can improve the situation.
An idea to reduce slips and lapses on the wards by stopping interruptions
and allowing nurses to concentrate on dispensing has been adopted by
a Scottish hospital. Nurses dispensing drugs on the wards will wear a
red tabard signalling ‘no interruptions’ from staff and patients
when drugs are being dispensed.
Reflective learning
In a joint presentation Paul Bowie and Ailsa Power from NHS Education
for Scotland described how the safety of patient care could be enhanced
through reflective learning. Significant event analysis (SEA) is a
team based mechanism for learning and effecting change.
There is a structured analysis of an event deemed to be ‘significant’ by
the healthcare team. In general practice it is estimated that an error
may occur in up to 11 per cent of all prescriptions. In hospital pharmacy
an average incidence of 19 errors per 100,000 items has been reported.
Emphasis is on reflecting why an event happened, highlighting the learning
needs of the individuals involved and facilitating any necessary changes.
Participants submit a report in a standardised format to a trained peer
assessor who can provide educational feedback. At this stage the evidence
base for the effectiveness of SEA is limited.
How to improve the safety of over-the-counter medicines through educating patients about them
Christine Bond: integrated records required for P medicine use |
Christine Bond, of the department of general practice and primary care
at the University of Aberdeen, discussed issues associated with the safety
of over-the-counter medicines that are implicated in 600 deaths annually
in the UK. Professor Bond said that general sale list and pharmacy-only
OTC products account for 20 per cent of the £11bn total medication
market — and about half are purchased from pharmacies. Her research
had shown that analgesics are the most commonly purchased medicine being
used to treat headache, migraine and back and joint pain.
Trends toward greater deregulation of drugs can be identified throughout
Europe with governments adopting policies based on encouraging patients
to self care. This increases patient empowerment and convenience as well
as allowing savings on national drug budgets. There is also a need to
extend the life of products beyond the expiry date of patents. Professor
Bond said there are professional advantages of switching classifications
for pharmacists, who can provide more effective health care, and for
GPs, whose time savings in consultations can be reallocated to new services.
She said that new OTC medicines can be created by changing the area of
care of an established OTC product (eg, allowing hydrocortisone to be
used for eczema), deregulating a POM product for existing indications
(dyspepsia treated with an H2blocker or a protein pump inhibitor) and
finding new applications for recently deregulated products (eg, simvastatin
for hyperlipidaemia). This reflects a shift from treating minor self-limiting
conditions to chronic conditions.
Professor Bond said better methods of long-term routine pharmacovigilance
for OTC medicines are needed. There is no professional input to most
GSL sales and although P medicine sales are subject to supervision by
pharmacists, there is no requirement to keep records. The lack of a formal
link to other health professions means that colleagues are often unaware
what OTC medicines their patients are taking. In pharmacies most sales
are made by support staff whose awareness of the evidence supporting
the use of many OTC medicines is limited. The new pharmacist-led e-MAS
in Scotland is a welcome development. Prescriptions are issued for OTC
medicines to patients who are exempt from prescription charges.
Professor Bond said that more training is needed for support staff and
integrated record keeping for some P medicines should be considered.
Unfortunately research shows that 60 per cent of people do not expect
to be questioned about their purchases by pharmacy support staff and
think the information provided in pack insert leaflets is of little value.
The public’s perceptions of the safety and efficacy of OTC medicines
varies according to the source of supply. For example analgesics obtained
from general stores are thought to be as safe and effective as those
purchased from community pharmacies, those obtained from pharmacies as
safe as those on prescription and those obtained on prescription are
more effective than analgesics obtained from general stores. Professor
Bond said that we know there is a lack of respect for OTC products by
the public and a failure to appreciate that they are medicines, requiring
careful and appropriate use.
The safety of OTC medicines can be improved by:
• Educating the public more generally and about specific products
• Encouraging patients to volunteer information on OTC usage to their
GP during a consultation — most patients do not want information
on their OTC purchases passed on by third parties
• Providing more comprehensive labelling and easier to read information
sheets
• Providing more effective verbal communication at the point of supply
• Promoting an awareness of the role of OTC medicines by all health professionals
• Encouraging GPs to ask about patients’ use of concurrent OTC
medicines
Avoiding therapeutic duplication or prescribing a medicine similar to
one already tried OTC was an important reason for the final bullet point.
In one study quoted by Professor Bond, 45 per cent of patients had used
OTC medicines in the seven days before their consultation but only 13
per cent of GPs had asked about OTC medicine use.
Detecting “drug safety signals”
Ralph Edwards: need for more resources in medicines safety |
Ralph Edwards, director of the World Health Organization Adverse Drug
Reaction Co-ordinating Centre in Uppsala, Sweden, delivered the Sir Stanley
Davidson Lecture in which he addressed the problem of detecting “drug
safety signals” that matter.
He said there are large numbers of adverse experiences following medication
reported worldwide in the form of individual care safety reports (ICSRs)
to regulatory authorities. These and other similar reports form the main
source of signals of suspected new drug adverse reaction relationships.
Generally ICSRs only indicate a suspicion of an ADR. Epidemiology and
other pharmacological evidence are necessary for confirmation. With large
volumes of data, quantitative and qualitative methods have to be combined,
and with knowledge finding techniques, using triage algorithms and data
mining of relevant databases, signals can be identified. In order to
benefit patients, clinically useful signals must be communicated and
acted upon by regulators. He said there is a need for more resources
in medicines safety to avoid over dependence on pharmaceutical industry
funding.
Drug safety problems in hospital practice were outlined by Simon Maxwell,
senior lecturer in clinical pharmacology at the University of Edinburgh.
Dr Maxwell said adverse events related to drugs are increasing in hospitals.
They include adverse reactions to the drugs being administered and medication
errors. Many of the latter are due to mistakes made by newly qualified
doctors who needed to be better trained.
Working with the Safer Patients Initiative in Dundee
Gordon Thomson, principal clinical pharmacist at Ninewells Hospital
and Medical School in Dundee, described the UK Safer Patients Initiative
(SPI). The SPI was devised by the Institute of Health Improvement in
Boston, Massachusetts, and has been funded by the Health Foundation to
support its development in four acute hospital trusts. It will run over
four years.
Mr Thomson said that the vision of the SPI is that no patient should
suffer unnecessary harm, pain or suffering as a result of an error or
planned medical intervention.
Experience had shown that introducing incremental change could be effective.
The current focus for the pharmacy team at Ninewells is on achieving
an accurate medication history at admission. Future work will be centred
on patient transfer and discharge.
Mr Thomson introduced the concept of “failure mode and effects
analysis”. FMEA is a method that examines potential failures in
products or processes. It may be used to evaluate the “risk priority
number”, a measure of risk management priorities, and helps in
the selection of remedial actions. |
The
Pharmaceutical Journal