Report on Adverse Drug Reactions in Children reveals
better
communication needed between doctors and patients
Of 5118 children
admitted to Europe's largest
children's hospital between 1 October 2009 and 30 September 2010, 17.7%
experienced at least one adverse drug reaction (ADR), according to a new
report.
The Adverse Drug Reactions
in Children (ADRIC) report, was funded by the National Institute for Health
Research and is the first large-scale and long-term study of its kind to report
on the ADRs of children under hospital care.
The aim of the
research that took place in the largest children’s hospital in Europe, Alder Hey Children’s Hospital, is to improve the
safety of medicines administered to those under 16. Many common medicines are
licensed without being tested on children thoroughly, if at all, yet are used
regularly in paediatric healthcare.
Drug safety in
paediatric care is a neglected area of research. Most medicines go through drug
trials using primarily adult samples. In 2006, 75% of all 317 European
centrally licensed drugs were relevant and used for children yet only half of
these had indications, or validated medical reasons, for child use. This means
a large proportion of drugs used for children are ‘off-label and/or unlicensed’
(OLUL). These have not undergone thorough trials to gain evidence for
calculating appropriate dosage and efficacy in children of different ages. It
is therefore difficult to evaluate the risk-benefit ratio for the children
taking OLUL drugs, therefore increasing the risk of ADRs.
Simple extrapolation of pharmaceutical data for adult to
child use is inappropriate, given the size differences in children that would
alter optimal dosages as well as
the
developmental changes in a child’s physiology that could affect responsiveness
to a drug.
The
ADRIC study
discovered 31% of acute children’s emergency
admissions to hospital were attributable to OLUL drugs. Perhaps
unsurprisingly these drugs were also found significantly more likely to be
implicated in ADRs than for drugs licensed for children.
Drugs most commonly implicated in
admissions were cytotoxic
agents, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) vaccines and
immunosuppressant
drugs. Adverse
side-effects from medication taken at home accounted for 3% of admissions to
the Alder Hey Children’s Hospital, where the reaction was the main reason or
contributed to the reason of their visit. Of the reactions, one-fifth was found
to be either definitely or possibly avoidable. In most cases, it was found
these would have been prevented if not for oversights by the doctor of previous
ADRs to the same drug, insufficient patient education of possible ADRs, and
prescribing that could have been more rational, with possible use of alternative
drugs.
Nearly 20% of children and young people who had been
inpatients at the hospital for over two days suffered at least one ADR
from treatment during their stay. Opiate analgesics and general
anaesthetic (GA) drugs were found responsible for over half the cases of ADRs
in this group. General anaesthetic drugs presented a
hazard to patients six times as high as any other drug administered to
patients. Of the ADRs reported, 1% of these resulted in permanent harm or a
higher level of care being required for the patient.
With few exceptions, parents reported poor management and
communication from their clinicians about suspected ADRs. Reports described
parents receiving inadequate or contradictory information from doctors about
their child’s medical assessments. One parent described how “no-one actually
said why it
[the
hallucination] was happening, the nurses just thought it was a bit funny”;
others felt “fobbed off” by clinicians or even “lied to” when doctors could not
explain their child’s ADR to them.
When there was an improvement in communication, it was when
parents were more anxious. At these points parents reported a greater level of
information from clinicians as compared to other times.
When
less anxious and therefore better placed to absorb facts, information
received was “little or none”. Reports
from parents gave a sense information was conveyed only when it was pushed for.
The study observed
a
consequence of poor doctor-patient communication is the potential for missing out certain
symptoms, such as hallucinations, anxiety, nausea and pain which can be described
only
by
the patient verbally. It is possible that this explains the
under-representation of ADRs of this type reported in younger
children
and
those
mentally disabled, than in adults.
The study looked at current methods of ADR
identification
and reporting. At present, the Yellow Card reporting scheme allows patients and
relatives to report suspected or confirmed ADRs. These are sent to the MHRA, a
regulatory board for pharmaceutical use in the UK. This scheme was reported to be
relatively unheard of by patients, however when informed,
the idea was much favoured by the parent and patient population as an essential
tool for reporting ADRs.
Positively, the report found that parents, children and
young people work on the same principles as doctors when evaluating the
possibility of an ADR over an unrelated symptom, recommending them as equally
reliable sources of detection. So, rather than being “ignored” and “dismissed”,
the report’s findings recommend that patient and parental concerns ought to be
taken more seriously by clinicians, with
greater
trust and emphasis put on patient self-evaluation.
With these changes taken on board, the ADRIC report
believes the greater recognition and improved recording of ADRs could reduce
the incidence of avoidable harm to patients from prescribed medicines and
anaesthetics.
References:
Smyth
RL, Peak M, Turner MA, Nunn AJ, Williamson PR, Young B, et al. ADRIC: Adverse Drug Reactions In Children
–
a
programme of research using mixed methods. Programme Grants Appl Res 2014;2(3)
Jacqueline is a graduate from Oxford
University having read Psychology, Philosophy & Physiology, and a Masters in Neuroscience from Imperial College London. She is doing research for APRIL and contributes to the APRIL blog.
Added note from Millie Kieve, formerly
chair of Advisory Group to Evaluation of Patient Yellow Card Reporting:
I was involved with a study to evaluate the
value of patient reporting in 2011, also funded by the The National Institute
for Health Research (2). The researchers concluded “patient reporting of suspected ADRs has the
potential to add value to pharmacovigilance by reporting types of drugs and
reactions different from those reported by Health Care Professionals.”
In regards to the low awareness of Yellow Card
reporting of adverse drug reactions (ADRs), we have made multiple requests to the Medicines Healthcare Products Regulatory Agency (MHRA)
to increase publicity and their availability. APRIL believes Yellow Cards and
awareness of the Yellow Card system of pharmacovigilance is not well
publicised.
Healthcare Professionals do not have a good record for reporting ADRs and those other than doctors have had to persuade, in the past, the regulatory body to accept their reports as valid. The official assessment of less than 10% of serious ADRs reports is a reflection of the poor awareness and promotion of the scheme.
We have requested that posters and YC cards be displayed in
hospitals, doctors’ surgeries and in community and supermarket pharmacies. The
lack of visible encouragement for patients, pharmacists, nurses and doctors to report ADRs raises the question
of why this essential method of monitoring the safety of medicines is currently
under-publicised.
Pharmacovigilance in the UK should be
improved to increase awareness of the extent of iatrogenic (treatment-induced)
injuries to mental and physical health. Hospital admissions caused by ADRs has
been estimated to cost the NHS £466 million annually (1).
References to
note
In 2014, in Europe, victims
of serious adverse drug reactions are still having huge difficulties in being
recognised as such. It is time to point out the inacceptable nature of this
situation, and to take action.