Serious side-effects are usually related to dosage and duration of psychotropic medication. Intelligence and learning ability are affected when dosage exceeds optimum levels, usually associated with sedation or toxic effects. Behavioural changes, including irritability, temper tantrums, hyperactivity, or hypoactivity, however, may occur at lower dosages than those that produce even mild somatic complaints. These may be so irksome and so long-lasting that the particular drug must be discontinued.

The most dangerous effects of the major tranquilizer drugs (neuroleptics) are the central nervous system effects. Most effects will subside dramatically if the dose is reduced or if anticholinergic medication is added immediately (anticholinergic medication should not be given preventively, however, before symptoms occur). Neurological symptoms may include acute dystonic reactions, dykinesias, parkinsonian reactions, akathesia, and the “rabbit” syndrome (perioral chewing).

The most malignant of these conditions, tardive dyskinesia, involves involuntary movements of the face, eyelids, upper and lower extremities, fingers, toes, torso, and neck, and can occur as early as within three months of cumulative drug usage. The effect can occur during drug administration or after dose reduction or drug withdrawal. This condition is resistant to treatment with anticholinergic or other medication. It is difficult to differentiate tardive dyskinesia from withdrawal dyskinesia, in which the symptoms may abate within six months. It is worth noting that the poor responders to neuroleptics are the most likely to develop the dyskinesias. This emphasizes the importance of the physician’s evaluating the response to a psychotropic drug within the first month and preferably within a week of the first dose of some medications.

Psychotropic drugs should not be discontinued quickly to minimize the occurrence of seizures or other withdrawal symptoms. “Drug holidays” should be discussed far in advance in order to assess the best opportunity for discontinuation.

Effectiveness should be judged on a weekly basis, with renewal of prescription on a monthly basis. Discontinuation of medication should be considered every three months. The responsibility of monitoring the risk-benefit ratio of long-term psychotropic drug use (for more than three months) must be shared with the guardians.

1-3 mg/kg/day

20-200 mg/day

Not recommended under 2 years of

age

Starting dose 10-25 mg b.i.d. Drug Interactions

CNS depressants

Antacids decrease absorption

Anticholinergics

Anticonvulsants increase risk of seizures

Epinephrine increases hypotension

Guanethidine Minor Side-Effects^a

Anticholinergic effects (>30%)

Orthostatic hypotension (10%-30%)

Drowsiness, sedation, lethargy (10%-30%)

Amenorrhea and inhibition of ejaculation (10%-30%)

Tachycardia (2%-10%)

Photosensitivity and skin pigmentation (2%-10%)

Weight gain (10%-30%)

Gastrointestinal distress^c

Nasal stuffiness^c

Breast enlargement and galactorrhea^c

Peripheral edema^c

Parotid swelling^c Contra-indications

Hypersensitivity to other phenothiazines

History of blood dyscrasias

Do not use in “pure” attention deficit disorders, because of decrease in learning curve Drug Withdrawal Effects

Tardive and withdrawal dyskinesia following long-term usage (>3-6 months) particularly in non-responders to treatment

Rebound behavioural phenomenon

Gastrointestinal distress

Insomnia, restlessness, irritability

Chills and cold sweats

Common practice to decrease over 1 month to minimize above phenomena Major Side-Effects

Parkinsonism (2%-10%)^b

Akathisia(2%-10%)^b

Dystonic reactions (<2%)^b

Cardiac arrhythmias (10%-30%)^b

ECG abnormalities without cardiac injury (>30%)

Pigmentary retinopathy (10%-30%) after chronic therapy

Obstructive jaundice (<2%)

Blood dyscrasia (2%-10%) within 1-3 months

Dulling of intellectual performance⁰

Epileptic seizures (<2%)^b Concurrent Treatment and

Alternatives

When used as a non-specific tranquilizer, the medication should be used in conjunction with one or more of the following:

Behaviour therapy

Family or caretaker therapy

Residential treatment

Remedial education

Other psychotherapies a. Frequencies from Bezchilibnyk-Butler and Jeffries.

b. Dose related.

c. Rare.

Enuresis: 0-6 yr — not indicated

6-12 yr — up to 50 mg/day

12+ — up to 75 mg/day

ADD with anxiety or depression:

note maximum dose

Depression: some improve at serum levels of 150-200 ng/L

Some adolescent anorexics and bulemics respond to 150-200 mg/day Major Side-Effects^a Cardiovascular effects:

ECG changes (T-wave and P-R intervals affected at doses approaching 5 mg/kg/day) without cardiac injury (10%-30%)

Epileptic seizures (<2%) Drug Interactions Sedatives

Anticholinergics

Epinephrine

Monoamine oxidase inhibitors Minor Short-Term Transient^a Side-Effects Anticholinergic effects:

Dry mouth (>30%)

Blurred vision (10%-30%)

Constipation (10%-30%)

Sweating (10%-30%)

Delayed micturition (10%-30%); primarily in elderly

CNS effects:

Drowsiness (10%-30%)

Insomnia (10%-30%)

Excitement (10%-30%) (particularly in bi-polar patients) Headache (10%-30%)

Extrapyramidal effects:

Fine tremor (10%-30%)

Gastrointestinal distress (10%-30%)

Weight gain (>6 kg) (>30%)

Rash (<2%)

Cardiovascular effects:

Postural hypotension or dizziness (>30%)

Tachycardia (10%-30%)

Increase in blood pressure (at 3 mg/kg/day)^b Contra-indications Not to be used in conjunction with or within 14 days of using monoamine oxidase inhibitors

Not to be used in out-patient treatment of suicidal patients

Not to be used in presence of glaucoma

Caution with epilepsy Drug Withdrawal EffectsAbdominal pain

Nausea, vomiting

Drowsiness

Decreased appetite

Tearfulness

Agitation

Malaise

Headache Concurrent Treatment and AlternativesAlarm blanket (enuresis)

Psychotherapy

Family therapy

Behaviour therapy

Hospitalization or residential treatment a. Frequencies from Bezchilibnyk-Butler and Jeffries.b. Reversible if medication is discontinued.

Current indications for the use of psychotropic medications in children and adolescents can be summarized briefly (Table l). The listing in Table 1 is by no means an exhaustive review of this rapidly emerging field. In two situations, autism and obsessive-compulsive disorders, there is only recent evidence of the possible usefulness of psychotropic medication.

Certain psychotropic medications, such as lithium salts for manic-depressive disorders in children and adolescents, are best left in the hands of psychopharmacological specialists. The use of antihistamines, such as diphenhydramine, and benzodiazepines in treating anxiety disorders of children has not been clearly substantiated. These medications should be used in consultation with a child psychiatrist. They are, however, relatively safe in comparison to the major tranquilizers.

The physician should therefore become thoroughly familiar with a small number of psychotropic drugs in order to respond to parental questions. Three drugs, which are commonly used in pediatric psychiatry, are methylphenidate, imipramine, and thioridazine. The physician should have a certain range of knowledge about these drugs in order to provide appropriate care, although one may choose to use other drugs. One should know the indications, proper assessment procedures, optimum dosage, price, side-effects, drug interactions, contraintfications, common withdrawal effects, alternative therapy, and concurrent treatment recommended for the drug (Tables 2-4).

A simple time-saving technique that may anticipate most questions is to provide the family with a drug information pamphlet. The parents should be advised to read the pamphlet and then to ask questions.

Taking the History

Behaviour data, either in narrative form or using numerically validated scales (e.g., Conner’s scales), can be obtained from parents, guardians, siblings, peers, and teachers. The physician must be wary that medication may be sought as a simple solution for complex problems, such as family stress or parental emotional illness, inappropriate teaching situations, or inadequate child care. The physician must therefore explore the psychosocial history and educational background adequately and should also determine the availability of psychotherapy, behavioural therapy, family therapy, and remedial education.

Before initiating treatment the physician needs to determine any history of physical problems, especially drug hypersensitivity; previous history of seizures (which is not necessarily a contra-indication); and liver, kidney, or visual dysfunction. Any gross neurological abnormalities, especially incoordination, gait disturbance, tremors, or tics, should be noted.

Certain drugs may require additional tests. A complete blood cell and differential count is required before prescribing methylphenidate or thioridazine; a platelet count is also necessary before prescribing methylphenidate. Patients treated with imipramine should have dexamethasone testing, an electrocardiogram before and during treatment, frequent blood samples to assess the serum level of imipramine, and reassessment after a two-week withdrawal period when treatment is discontinued. Thioridazine therapy requires liver function tests at least once every month.

Attitude Toward Drugs

The attitude of the child, family, or guardians to medication should also be carefully assessed. Do they regard the child as unco-operative or manipulative and the medication as a means of control? Does the child or guardian expect the medication to cure the disorder? Is there undue pressure or resistance to the use of medication? The physician must also be aware of his or her own desire to offer a “quick fix,” for the sake of time or lack of awareness of other therapeutic interventions.

Klaus Minde has encapsulated, in two doctor-patient exchanges, the major communication required about the role of psychotropic medications in a child’s ecological system:

Doctor A. (to the parents):

I would like John to stay with these pills and take them twice daily, seven days a week at exactly 8 a.m. and 12 noon. Don’t let him forget them. Watch that he really takes them and don’t leave it up to him to remember. He is obviously doing much better and we want to keep it that way.

Doctor B. (to the child):

Paul, don’t forget that these tablets are simply some kind of crutch-like a crutch you need when you break a leg. Always remember, however, that a crutch can only help you with your walking, but can never do the walking for you, because that you have to do yourself.

Dr. B. has avoided enhancing powerlessness in the child and has stressed the importance of Paul’s effecting change. Minde stresses the “demedicalization” of this transaction. Although it is tempting to use the placebo effect of any medication, particularly in suggestible children or parents, Minde cautions against the resulting loss of autonomy and responsibility for the patient’s own actions.

Parents and child advocates have been simultaneously concerned, however, about accuracy of diagnosis, over-labelling of the child, long-term side-effects, and providing a quick “fix” while neglecting other therapies that require long-term commitment. Consumer complaints in Ontario resulted in unique legislation, the Child and Family Services Act (CFSA) of 1985, which defines psychotropic drugs; formally states the physician’s responsibility to obtain informed consent; defines informed consent to include drug dosage and risks; requires caretakers other than the parents to be informed about the medication; and sets limitations on the emergency use of psychotropic drugs with adolescents older than 16.

This article will address common questions from parents and guardians about the use of psychotropic drugs, will provide a brief guide to use of three common psychotropic drugs used with children, and will list the common conditions in children and adolescents for which psychotropic drugs might be considered.

Legal and Ethical Issues

Although the CFSA applies only to children and adolescents in programs of the Ontario Ministry of Community and Social Services, the principles of obtaining informed consent have been endorsed by the Ontario College of Physicians and Surgeons and the Canadian Medical Protective Association. There have been myriad articles aimed at physicians following the 1980 Supreme Court of Canada “Reibl versus Hughes” case, which established the precedent of a physician’s obtaining informed consent.

Assessment of the case’s impact, however, has shown that it has been ignored for the most part by physicians, much to the dismay of the Ontario Hospital Association (and likely the Canadian Medical Protective Association). All that is legally required now, even under the Ontario CFSA, is a note in the doctor’s record that he or she has discussed the purpose of drug treatment and the risks associated with this treatment. The Ministry of Community and Social Services has, however, recently considered requiring formal, written consent forms signed by children receiving their services. The Ontario Medical Association will be asked to participate in developing potential regulations.

The Biomedical Ethics Committee of the Royal College of Physicians and Surgeons of Canada has urged a higher standard of informed consent than the law requires and has recommended the concept of shared responsibility. This recommendation entails good communication with the patient or surrogate, provision of reasonable data, noting and discussing any indecision on the part of the patient or surrogate, consulting legal authority if the physician believes that serious harm may befall the patient without treatment, and finally, avoiding delegation of this important medical act to others.