Children's care — managing the risks
Improving access and information on medicines for
children were discussed at two practice sessions on 16 September,
organised in association with the Neonatal and Paediatric Pharmacists Group.
Harriet Adcock (on the staff of The Journal) reports
Getting medicines right for children
Adults expect their medicines to be researched, tried and tested, with
scrutiny from regulatory agencies, Tony Nunn, director of pharmacy at
the Royal Liverpool Children’s Hospital NHS Trust, told conference
participants. The situation for children, however, is different.
Mr Nunn, who is chairman of the Medicines External Working Group for
the Children’s National Service Framework, pointed out that a review
of black triangle drugs in 1996 had revealed that only 30 per cent were
appropriately licensed for children. About a fifth had the potential
for paediatric use and half were already being used off label. “I
have seen nothing to suggest that things have changed in the past seven
years,” he said.
He went on to describe the problems that can arise through the current
licensing situation, such as use of inappropriate formulations, extemporaneous
dispensing, use of chemicals of varying quality etc.
A particular problem is information provision. “Imported medicines,
their labels and patient information leaflets may be in a foreign language,” he
said. In addition, patient information may not be available for unlicensed
medicines and may be confusing when medicines are used off label. “We
need better patient information with co-ordinated production for unlicensed
medicines to avoid duplication of effort and to assure standards.”
Parents and children also need better information about how specific
drugs are used so they can make informed choices. Mr Nunn suggested that
a parents and children version of the formulary “Medicines for
Children” may be required.
Mr Nunn warned that if children are to become true partners in medicines
management then patient information has to be understandable by children
and should be produced in media that they could enjoy using. “Like
it or not we are in the age of the text message and computer game and
we must look to different ways of getting our message across.”
He added that the availability of unlicensed medicines may be limited.
Furthermore, there are problems transferring prescribing responsibility
between primary and secondary care and in transferring information between
hospital and community pharmacists. “If nothing else this is all
inconvenient for patients.”
There are additional risks surrounding the unlicensed-use of medicines.
In terms of patient safety there has been a focus from the Department
of Health on intrathecal administration errors and from the National
Patient Safety Agency on potassium chloride. “I would now expect
the NPSA to be taking paediatric advice and looking at ways of improving
dose calculation, practical prescribing and measuring and administration
of medicines for children.”
Mr Nunn pointed out that other issues, unrelated to licensing of medicines,
could affect children’s care. These include the content of practical
paediatric medicines management in undergraduate courses, access to medicines
in schools, effective prescribing and whether the needs of disadvantaged
children are adequately catered for. Questions remain, too, about whether
treatments should be offered at home rather than in hospital and whether
enough assistance is currently provided to parents in managing their
children’s minor ailments.
“Much of what we can do to improve things is or will be covered by the
Children’s NSF,” he said. This document is likely to have
themes around:
• Improving the evidence base and licensing of medicines for children
• Provision of high quality medicines information to both professionals
and the public
• Improving patient safety and increasing public access to medicines
The role of the community pharmacist is vital for delivering improvements
to children’s health. “Crucial to our ability to deliver
improvements will be an appropriately trained workforce and an appropriate
contractual environment,” he said.
Incentives offered
Mr Nunn explained that regulations designed to improve the licensing
of children’s medicines are being developed in Europe and that
these would offer incentives to pharmaceutical companies to develop
and license suitable medicines for children. “Unfortunately the
regulations are currently stalled because of the need for a Europe-wide
impact assessment. In the meantime, we need to encourage the submission
to Europe of data submitted in the US,” he said.
Sharon Conroy: many paediatric medicines are difficult to source |
Sharon Conroy, University of Nottingham and Derbyshire Children’s
Hospital NHS Trust, continued the theme of using unlicensed and off-label
medicines in children. She highlighted the problem of transferring care
from secondary to primary care. “There is a problem because children
need medicines at home. It is not acceptable for GPs to prescribe if
they are not familiar with a particular drug.”
She added that there are risk issues because unlicensed medicines are
particularly patient specific. “We need systems to ensure patients
get the same formulation and dose of medicines. If not — there
can be serious consequences.”
She pointed out that paediatric formulations are not necessarily readily
accessible in the community and that information is not accessible in
primary care. There is also a need to ensure that medicines are of adequate
quality. “Much of the problem relates to logistics. Many paediatric
medicines are difficult to source — industry can’t advertise
unlicensed medicines so they can be difficult to find and delays occur.”
She explained that even when patients and carers have been warned that
medicines might be difficult to obtain, they often do not follow advice
to go straight to their general practitioner for a repeat prescription
to give them time to source it.
Ian Costello, chief pharmacist, Birmingham Children’s Hospital
NHS Trust, described some of the advantages and disadvantages of alternative
systems for supplying paediatric medicines. “I am sure that every
day you have patients coming in [with a prescription for unlicensed medicines]
and you have no way of knowing where to source a drug from. The patient
then ends up back at hospital,” he said.
Shared care protocols could work well but take time to set up.
Using an FP10HP form to prescribe the patient’s unlicensed or off-label
drug then posting it to the patient is a convenient solution. However,
this system does not keep primary care professionals in the loop.
Hospital prescribing and supply allow the hospital to take responsibility
for the patient’s medicines but this system could be inconvenient
for patients. Furthermore, the GP and community pharmacist are not involved.
Home delivery of hospital prescribed medicines minimises inconvenience
to patients and allows responsibility of supply to be controlled by the
hospital.
Using a managed home care company again minimises inconvenience and monitoring
can be built into the system. However, the system again removes primary
care health care professionals from the supply chain and introduces an
additional cost.
How community pharmacists can help
Georgina Craig: Key is getting pharmacy’s voice heard in the
right circles |
Community pharmacists can play a pivotal role in reducing health inequalities
among children, Georgina Craig, head of NHS service development at the
National Pharmaceutical Association, told participants at this year’s
British Pharmaceutical Conference.
She highlighted recommendations from the 1998 Acheson Report that were
of particular relevance to pharmacy. These included:
• A focus on improved retail provision in deprived communities
• A focus on improved mental and physical health and nutrition of women
and children, including an increase in breast feeding
• Smoking cessation before and during pregnancy
• Improved sexual health and a reduction in teenage pregnancy
• A focus on services sensitive to minority ethnic groups
Another report — entitled “Plan for action” — also
highlighted the need to make better use of community settings and services,
including community pharmacies.
This is “a clear signal that pharmacy has a pivotal role to play in the
health inequality and consequently the child health agenda”, Ms Craig
said.
The public health strategy for pharmacy, announced in “Vision for pharmacy” would
undoubtedly focus on how pharmacy could help tackle inequalities.
Against this background, the Government has launched a host of policies, aimed
at improving life chances for children, including Sure Start, the teenage pregnancy
strategy, and the Children’s National Service Framework. Ms Craig said
pharmacy fits the bill as a location for health services in most communities.
She explained that as part of Sure Start, children’s centres and “extended
schools” (both of which would house health care facilities) are being
developed. “These may provide opportunities to develop new models of
pharmacy targeted at the needs of families with young children,” she
said.
“Community pharmacists should find out if there is a local Sure Start programme
in their area. If it is a deprived area, it is likely that there will be.”
Ms Craig pointed out opportunities for community pharmacy to work with Sure
Start. These are:
• Public health initiatives, eg, provision of information on nutrition,
smoking cessation, breast feeding and immunisation
• Signposting parents to local services, eg, welfare benefit and parenting
support
• Developing the role of support staff who speak the languages of local
people
• Referral of parents to an appropriate professional, eg, when children
have sleeping, feeding or behavioural problems
• Minor ailments schemes and, in the future, independent prescribing
to increase access to medicines
• Development of new “concept pharmacies” in children’s
centres and extended schools
Ms Craig went on to say that pharmacy could play a part in helping reach
the Government target of halving the rate of conceptions among those
under 18 years in England by 2010.
“Pharmacy fulfils many of the criteria desired by young people
from a sexual health service.” Pharmacies provide an anonymous
service, are easily accessible and look like shops rather than clinics.
“Community pharmacy has already shown, through schemes like those
to supply emergency hormonal contraception that it can contribute to this
agenda,” she
added.
Ms Craig explained how community pharmacy could contribute to the teenage
pregnancy agenda.
Pharmacists could counsel routinely on the impact of antibiotics on the
effectiveness of the contraceptive pill and become involved in public
health initiatives aimed at providing information on safe sex and relationship
education.
One theme from the Children’s NSF of relevance to pharmacy is the
emphasis on the need for women, children, young people and families to
have access to local services that promote health, physical and emotional
well-being in an imaginative way.
“
This is a challenge to community pharmacy, in partnership with health
visitors, midwives and others,” she said.
Similarly, there is a focus on empowerment, self management and family
support. “The role of the pharmacy in this is clearly pivotal.
The key is getting pharmacy’s voice heard in the right circles,” she
concluded.
Children unaware pharmacists are source of information and advice
Children may be unaware that pharmacists are a source of information
and advice, Dr Bryony Beresford, York University, told conference participants.
She outlined research conducted at York involving 63 children who had
one of five chronic conditions. The research identified two broad groups
of information needs — medical information and psychosocial information. “Children
had lots of concerns about treatments, especially side effects. There
was a sense that information was being withheld,” she said. Children
believed that doctors were so concerned about adherence that they would
play down side effects. The fact that they were always told “not
to worry” could lead them into a cycle of not bothering to ask
questions. When asked about their preferred sources of information, Dr
Beresford pointed out that none of the children in the study mentioned
pharmacists. “This was suprising, since side effects were such
an issue — maybe they just weren’t aware of that facility.”
Information provision should also be ongoing and it is important to separate
the information needs of the parent and the information needs of the
child, she said.
Clinicians must communicate
Formulation scientists are frequently unaware of what clinicians require
in their clinics and clinicians often fail to say what they want, Dr
Ian Wong, director, centre for paediatric pharmacy research, School
of Pharmacy, University of London, said.
He pointed out that liquid formulations are believed by many to be
the holy grail in terms of paediatric medicines, but they can be bulky
and
inconvenient for patients and their carers to take home.
“Lots of factors need to be considered. We need to tell [the industry]
if there is a problem,” he said. |
