The National Institute for Clinical Excellence (NICE) is a
part of the British National Health Service. Its purpose is
to provide practical guidance for the NHS and patients on
medicines, medical equipment, diagnostic tests and clinical
and surgical procedure, and where and how they should be
used.
Each of these guidelines takes around twelve months to
formulate and they consult the manufacturers of the drug or
device, the professional organizations and the groups which
represent patients.
Methylphenidate (Ritalin and Equasym) is licensed for use in
the treatment of children with ADHD and is a Schedule 2
controlled drug.
Sale and use of the drug needs to be controlled because it is
of the same type as drugs such as amphetamine and cocaine.
These drugs achieve their effect by interacting with the
pharmacology of the central nervous system (the brain and
spinal cord) and altering its functioning. Apart from the
danger of their immediate effects, all drugs in this Schedule
2 group can cause long-lasting effects and become addictive.
In some ways, methylphenidate has been found to be even more
powerful than cocaine.
The license for these products specifies that methylphenidate
should only be used as a part of a comprehensive treatment
program when remedial measures alone prove insufficient. They
propose that a `comprehensive treatment program' include
psychological, educational and social measures. It also
states that methylphenidate should only be prescribed for
severe cases of ADHD following detailed history taking and
evaluation.
This means that it would be irresponsible for someone to tell
parents to ask their local family doctor to prescribe Ritalin
"just to see if it helps." Giving someone a drug of the power
of a methylphenidate is a serious step only to be taken as a
last resort and only when all the necessary conditions have
been fulfilled.
It is not currently recommended by the Summary of Product
Characteristics (SPC) nor licensed for use in the U.K. for
children less than six years of age because its safety for
use on children less than six years of age has not been
determined.
Methylphenidate is not currently recommended by the Summary
of Product Characteristics (SPC) nor licensed in the U.K. for
children with marked anxiety, agitation or tension; symptoms
or family history of tics or Tourette's syndrome;
hyperthyroidism; severe angina or cardiac arrythmia; glaucoma
or thyrotoxicosis.
Caution is also required in the prescribing of
methylphenidate for children and young people with epilepsy,
psychotic disorders or a history of drug or alcohol
dependence.
The drug is relevant to epilepsy because there is some
clinical evidence that methylphenidate may lower the
convulsive threshold in patients with prior history of
seizures, with prior EEG abnormalities in absence of seizures
and, very rarely, in patients with no prior EEG evidence nor
history of seizures.
NICE recommend that treatment with methylphenidate should
only be started by a child-and-adolescent psychiatrist, or a
pediatrician with expertise in ADHD. Prescribing of the drug
and monitoring of the patient may be performed by a GP, but
only under shared care arrangements with the specialists.
As they note, not everyone who is overly hyperactive,
inattentive, or impulsive has an attention disorder. Their
guidelines to the specialists are that he must also consider
that the following are present to diagnose ADHD:
* The signs have persisted for at least six months to a
degree that is impairing the child's development;
* There must be clear evidence of clinically significant
impairment in social or academic functioning;
* Some impairment is present in two or more settings (usually
at home and at school);
* Some of the signs that caused impairment were present
before the age of seven;
* The signs do not occur exclusively during the course of a
pervasive developmental disorder, schizophrenia or other
psychotic disorder and are not better accounted for by other
mental disorders such as depression or anxiety.
Many factors can cause a child to feel anxiety, such as
pressure from parents to keep up with a stressful school
curriculum, tests, peer competition and/or sibling
competition and problems with vision and/or auditory
processing. In such circumstances, NICE recommend that
medication is not to be attempted but instead to deal with
the core problem.
As is well known, many other factors can cause ADHD- like
problems. For example, a gifted, creative child can have many
of the characteristics of ADD or ADHD.
NICE also note that dietary interventions are seen as
possibly useful in cases where a parent has observed that a
particular food aggravates hyperactivity. Parents can use the
`four-day diet' to see if particular foods are contributing
to a person's hyperactivity. Foods commonly causing
hyperactivity include sugar, colors and preservatives, soy,
milk and milk products, chocolate, wheat, oranges and
eggs.
If the drug is finally prescribed and improvement of symptoms
is not observed after appropriate dose adjustment over one
month, NICE recommend that the drug be discontinued. They
suggest that methylphenidate should be discontinu-ed
periodically (under careful supervision) to access the
child's condition. Although no firm guidelines for withdrawal
of treatment are given, they note that drug treatment should
usually be discontinued during adolescence. Discontinuance of
the drug must be performed carefully and under guidance
because, as stated in the DSM-III, there can be severe
withdrawal symptoms such as depression and a tendency to
suicide.
NICE quote the recommendation of the Summary of Product
Characteristics (SPC) that blood pressure be monitored,
particularly for patients with hypertension. This is because
as a stimulant of the central nervous system, the drug's side
effects include increased blood pressure and increased heart
rate. Therefore, the drug should not be given to someone who
already suffers from high blood pressure.
According to the testimony of neurologist Fred. A Baughman
Jr. MD, May 4, 2000, before the Health Services subcommittee
of the U.S. House and Senate Committees on Public Health,
Welfare and Labor, of the 2,993 adverse reactions to Ritalin
reported to the FDA from 1990 to 1997, there were 160 deaths
and 69 hospitalizations. 126 of these adverse reactions were
cardiovascular.
One of the most widely reported cases was the death of
Matthew Smith, a 14-year-old American boy, on March 2000,
while skateboarding. His death touched off a controversy as
the police pathologist, Dr. Ljubisa Dragovic, in spite of
pressure "to find some other explanation," announced that the
boy's death was caused by heart damage from eight years of
Ritalin use. At the autopsy, Dr. Dragovic found that
Matthew's heart showed clear signs of small vessel damage of
the type caused by stimulant drugs such as amphetamines and
cocaine. The boy did not have a pre-existing heart defect or
disease and he had not been taking any other drugs.
The SPC also recommend that patients on long-term therapy
have periodic blood and platelet counts.
