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Community Based Anti-
Epileptic Treatment in the
Developmentally Disabled
Ross FineSmith, MD
Clinical Instructor of Neurology
NYU School of Medicine Medical
2
Introduction
This chapter reviews the unique factors associated with the management of
epilepsy and antiepileptics drugs (AED) in the community based population of
individuals with developmental disabilities (DD).
Many of the same principles that are established for AED therapy in the
non-handicapped population can be applied to the individual with a DD. These
principles can be used as guidelines when making decisions about initiating
drug therapy or determining the most appropriate AED 1. These guidelines are
listed in Table 1-1. There are additional specific challenges to the physician in the
community treating patients with epilepsy and a moderate to profound DD.
These factors include; a higher incidence of difficult to control seizure disorders,
individual cognitive disability may limit feasibility of neurodiagnostic testing,
adverse effects are difficult to assess in those with limited communicative ability
and patients with a DD are more likely to experience adverse effects from
AED’s 2.
The Relocation of Persons with Disabilities
In the past, most patients with severe disabilities and epilepsy were treated by
pediatricians or pediatric neurologists and were often admitted to long term care
facilities in late childhood or as young adults where staff physicians provided
3
their medical and neurological care. The current trend of deinstitutionalization
of individuals with moderate to profound DD’s has “relocated” this group to a
variety of community settings including; group homes, sponsored living,
supported living arrangements and supervised apartment living. Their medical
and neurological care is now the responsibility of physicians located in these
regions. Unlike the staff physicians in the developmental centers, most
physicians in the community have limited experience or exposure to persons
with significant DD’s. This is not a result of discrimination, but one simply of
demographics. These patients were institutionalized and typically did not
receive treatment from outside physicians. The relocating process has resulted in
a marked increase in medical consumers with DD’s requiring medical care in our
communities.
In the state of New Jersey there were 5,841 people in developmental
centers in 1986 and as of March 1999, there were 3,623. These 2000 persons have
been relocated and are now living in many communities throughout New Jersey.
The number of individuals residing in group homes has tripled in the last 8 years
and, in addition, there are 2,900 persons on the urgent waiting list and 1,000 on a
non-urgent waiting list 3,4. This is a national trend and is not specific to one
state5.
The relocation has been especially challenging to those physicians treating
patients with epilepsy. There is a 30-50% incidence of epilepsy in individuals
with DD’s 6 and as many as 45% of those have medically refractory epilepsy
4
(MRE)7-9. Patients with MRE require significantly more of the physicians practice
time, than other patients in the community with epilepsy. This group of patients
needs more aggressive management and treatment and often requires the use of
recently approved AED’s, novel therapies such as the vagal nerve stimulator and
the ketogenic diet, and when appropriate, a referral for evaluation for epilepsy
surgery.
The remainder of this paper is designed to familiarize and aid in the
development of a community-based program to more effectively treat patients
with epilepsy and moderate to profound DD’s.
Legal Guardians and Family Members
Approximately 50% of individuals that are approved and eligible for services
from the Division of Developmental Disabilities (DDD) are residing with parents
or family members3. Many of these persons are on the waiting lists for group
home placement. These individuals will frequently be seen by the same family
physician that has cared for them most of their lives. Referral to a neurologist
may occur if there is an initial seizure or a change in seizure status in those with
pre-existing epilepsy.
Family members have a personal interest in the care of a relative and this
may reflect in the accuracy of the interval history, management of medication
and vigilance in reporting undesirable side effects. However, aging parents may
have difficulty remembering to give medications, accurately count seizures and
recognize side effects. Parents may have difficulty physically transporting their
5
child to the office or hospital. This especially problematic if the child has a
physical handicapping condition, such as cerebral palsy.
Most individuals with a moderate to profound DD with cognitive
impairment are evaluated and assessed not to be competent to make discussions
for their own well-being. A legal gaurdian must therefore be appointed. Parents
and other family members may live nearby and be involved with the DD
person’s care and elect not to be the legal guardian. In addition, many
individuals have no close family members involved and legal guardianship is
assigned to a legal representative within the DDD. It is good practice to
routinely obtain the name and address of the legal guardian and contact them by
phone to establish a relationship. It is necessary to call if there are any questions
regarding the need for written consent for a given procedure. Changing
medications, laboratory blood work, non-invasive radiological and
electrophysiological studies usually do not require consent. However, conscious
sedation and general anesthesia are occasionally required to perform a test or
procedure, and since this involves additional medical risk, written consent
should be obtained in advance. The risks and benefits of any invasive procedure
should be discussed with the legal guardian. There are few individuals with
moderate DD’s who are their own guardian. Whether the person has a legal
guardian or not, all medical discussions should be attempted to be explained to
the patient personally. There are also laws governing the enrollment of persons
with DD’s into research protocols. The research protocol must be approved by a
6
regional Institutional Review Board and the states DDD research committee. This
was established to ensure that these patients are not unnecessarily enrolled in
higher risk protocols.
The primary caregivers for individuals with DD’s are often group home
staff and this can frequently result in the family being overlooked in the medical
treatment process. Family members are occasionally present, but due to parental
age, health and living arrangements, parents are unable to be present for many
visits. Health care providers are strongly encouraged to contact the next of kin to
introduce themselves and obtain additional medical information. Relatives are
usually happy to hear from a medical provider and will supply additional
medical information. If family members express interest in the treatment plan,
they should be encouraged to be present at office visits. This can be invaluable
information, as the following account will describe. An individual with Autism
and a history of epilepsy was evaluated by a neurologist and was requested to
provide on-going neurological care. The patient was accompanied by a staff
member that has known the him for the 2 months he has resided at the group
home. A discharge summary from the developmental center reported that were
no seizures observed in the 4 years he resided there. An EEG and MRI were
unremarkable and the patient was considered a relatively low risk for seizure
relapse if the AED was discontinued, based on this history. His legal guardian
was a DDD representative and the next of kin was a sister that resided in the next
state. The sister was contacted by phone at the time of the office visit and she
7
reported that over the past nine years, three separate neurologists attempted to
wean her nephew off Tegretol because he had been seizure free for up to 4 years
at a time. All three occasions resulted in status epilepticus and during one
hospitalization he developed a severe pneumonia and required a prolong
hospitalization. The neurologist elected not pursue this option, the patient has
been followed for three years and continues to be seizure free on Tegretol.
Group Home Structure and Staff
Group home staff, sponsors and personal aids are of great importance in the
execution of the medical treatment plan for persons with DD’s. A staff member
will accompany the patient to the office and are often times the only source of
information at that time. Most persons relocating from developmental centers
should have a brief medical discharge summary. The level of experience,
motivation and competence of the staff varies significantly. Staff names should
always be noted in the margins of the chart adjacent to the medical note. This
will allow for tracking and resolving many problems. It will benefit the health
care provider to educate the accompanying staff and discuss what is needed each
visit. Community or agency presentations and “in-services” can helpful in
educating care providers.
Group home managers oversee the care and treatment of each of the
residents and are typically very reliable and dedicated. It may be helpful to deal
directly with manager on the more difficult to manage individuals with epilepsy.
8
Physicians can develop a seizure record form that the staff must complete
after each seizure. The form can be tailored by the physician to obtain pertinent
information describing the event which will allow for more accurate
documentation of the number of seizures and characterization of the seizure
type. This type of form is especially helpful since the staff member that
witnessed a seizure may not be the same staff that accompanies the patient to the
office visit. This seizure record form can be quickly reviewed at each visit. This
will also allow for a more accurate assessment of the current treatment and more
effective medication adjustments can be made. These seizure logs should be kept
in the person’s medical folder were the medication schedule and medical
information is keep. The folder should accompany the patient to the each visit.
Most group homes keep accurate medication records and log books. In
addition, many now have prescriptions filled at pharmacies that offer “bubble
packs”. Each dose is individually encased in a small air bubble on a sheet with
multiple rows of individual doses. After the dose is given, a mark is made at the
corresponding time in the person’s medication log. This leaves much less chance
of missed doses. Not all group home staff is allowed to administer and dispense
medications. Each staff allowed to preform this duty must be “med trained”.
Working within the regulations the group homes are mandated to adhere
to can be tedious and frustrating to those that are unfamiliar with the
requirements. The regulations are not established by the group homes, but are
state mandated, in an attempt to insure safety. For example, on prescriptions
9
the physician must write the specific times medications are to be administered
(i.e. q8am and 8pm) instead of BID. Staff can not administer any medication
without these specifics and the prescription must be re-written. If doses are
adjusted over the phone, it must be followed by a written prescription that is
mailed or faxed so there is appropriate documentation at the group home. This is
problematic when these changes are made during on-call hours.
Neurodiagnostic Testing
Persons with significant disabilities and cognitive impairment often do not fully
understand why they having a test performed. It is similar to a child of the same
mental age being unable to participate in a testing situation. In addition, there is
a higher incidence of psychological and psychiatric conditions that compound
the difficulty in obtaining these studies. MRI of the brain requires the patient to
lie very still for approximately 40 minutes and several different forms of sedation
made are administered. This may simply include oral benzodiazepines or require
conscious sedation provided by the anesthesiologists. An EEG can be
significantly altered or suppressed with many of the sedating medications, so the
utility of this study is limited in some cases. The determination of the seizure
type would then have to be based on the clinical description of the event, patient
history and the MRI.
Neurodiagnostic studies on our patients can be very time consuming and
often frustrating for busy MRI facilities and EEG labs.
10
Antiepileptic Medication
After the diagnosis of epilepsy and seizure type has been established, the AED
that is felt to be most effective with the least chance of side effects is determined.
This is based on whether the seizures are primary generalized, partial, atonic or
myoclonic. A careful review of the history is necessary to insure an AED that was
used previously with adverse effects is not reinstituted.
Co-morbid conditions and mode of drug delivery are prominent issues in
the DD. There is a higher incidence of behavioral and psychiatric conditions in
the DD population and AED’s are commonly used as mood stabilizers to treat
these conditions. Psychiatric co-morbidities have been reported to occur in 25%
and severe maladaptive behavior in up to 55% of those meeting criteria for
mental retardation10. Depakote and Tegretol are the most commonly used AED’s
in the treatment of bipolar disorder, mania, intermittent explosive disorder and
in the management of aggressive behavior. Therefore, when choosing a
medication to treat seizures, the psychiatric history must also be obtained. If a
patient was previously treated with Depakote or Tegretol as a mood stabilizer
and it was tolerated and effective, the same medication should be considered for
an initial anticonvulsant. This lowers the risk of adverse events since it was
previously tolerated and may also benefit behaviors. Conversely, a previously
documented adverse effect, such as agitation, would dismiss a medication.
11
Tegretol (carbamazepine) is a first-line AED for partial onset and some
forms of generalized seizures. Tegretol is an excellent choice in the treatment of
individuals with DD’s because it has minimal adverse effects on cognition and
behavior. Tegretol is also indicated in the treatment of bipolar disorder and
trigeminal neuralgia. It can be used as a single agent to treat the relatively
common co-morbidity of mood disorder and epilepsy11. Adverse behavioral
reactions occur infrequently and may be due to the tricyclic ring structure in
Tegretol. This may result in mild mood elevating properties that would be
problematic in a patient with hypomania that has not been detected or
diagnosed. These patients may become agitated, irritable and hyperactive.
Hyponatremia is a known side effect and can be exacerbated by patients who
drink free water habitually or due to dryness as a side effect of antidepressants
or antipsychotics.
An additional advantage of Tegretol is the multiple formulations
available. The chewable tablets are used in patients unable to swallow tablets
and the extended release tablets allow for less frequent dosing. Carbatrol is
newer form of extended release carbamazepine that is produced in a capsule that
can be opened and sprinkled on food. This has allowed the use of an extended
release form in young children.
Depakote (valproate) is a major AED that has a broad spectrum and is
effective against primary generalized, partial, myoclonic seizures and infantile
spasms. Depakote is also indicated in the treatment of mania and migraine
12
headaches. Both of these conditions commonly occur in patients with epilepsy.
Additional uses in the DD population include; behavioral cycling12, aggressive
behaviors 13,14 and hyperactivity/agitation in Autism15. This medication should
be used in a very limited fashion or not at all in children under 2 years of age
because this group of patients has a significant risk of hepatotoxicity. These
patients are at even greater risk if they have a severe developmental delay, are on
additional AED’s or have a neurometabolic disorder16. Thrombocytopenia is also
a known side effect and is rarely serious, however, if an individual’s DD includes
ataxia with frequent falls caution should be used. Depakote also is available as a
liquid, IV formulation that may be administered through a gastric tube and
sprinkle capsules.
Dilantin (phenytoin) has a very safe profile and is effective in the
treatment of partial and generalized seizures. There does not appear to be any
significant mood or behavioral effects. The advantage of Dilantin is that it has a
long half-life and may be given once a day. This is helpful in those with
compliance problems. It is available in liquid, chewable and IV formulation.
Dilantin is not a first choice AED in person’s with DD because the side effect
profile is especially problematic in this population. Oral hygiene is commonly a
significant problem in individuals with DD and this is complicated by the known
side effect of gingival hyperplasia in Dilantin use. In addition, individuals with
DD are often susceptible to balance disturbances which Dilantin can exacerbate17.
13
Phenobarbital is the oldest and one of the safest AED’s in current use. It is
the drug of choice on children under 2 years and is effective against a wide range
of seizure types. It is not commonly used in older patients because it has been
shown to slow cognition and learning and has adverse effects on mood,
including irritability in children and depression in adults18. However, it is a very
good anticonvulsant and there is patients that respond exceptionally well and is
unable to be changed to other AED’s.
Felbamate (Felabatol) was the first new generation AED and was widely
used and accepted until the post-marketing experience revealed a high incidence
of hepatic failure and aplastic anemia. It had a favorable side effect profile for
many patients with DD’s. It appeared to have a mild stimulant quality and
therefore was beneficial for psychomotor slowing and reducing appetite. This
same effect was greater in a subgroup and resulted in insomnia and anorexia.
Felbatol has a wide spectrum of anticonvulsant activity and is especially effective
in Lennox-Gastaut syndrome. This medication should be used only when the
risk-benefit ratio has been carefully evaluated by all of those involved in the
person’s care.
Neurontin (Gabapentin) is effective as an adjunctive therapy in partial
seizures. It is widely used for neuropathic pain syndromes and refractory
bipolar disorder, but is only indicated for partial seizures. Neurontin is available
as a capsule only and has no serious medical side effects. It has minimal protein
14
binding and hepatic metabolism so it has minimal interactions with other
medications and can be used safely in other medical conditions.
Lamictal (Lamotrigine) also has a wide spectrum of anticonvulsant
activity, is effective against Lennox-Gastaut and effective in monotherapy.
Lamictal also appears to have a mild mood elevating quality and is rarely
sedating. It also has mood stabilizing qualities and is being used in bipolar
disorder. This combination gives Lamictal a very favorable profile for the use in
individuals with DD’s 19,20. However, there have been reports of adverse
behavioral effects including marked elevation of mood and agitation in this
population of patients 21,22.
Initially Lamictal was found to be causing a concerning number of allergic
reactions with subsequent development of Stevens-Johnson syndrome. However,
it has since been established that the incidence of this reaction is directly related
to the rate of titration. The slower the rate of titration, the less likely a reaction
will occur. There is little chance of complications if increased by 2.5-5mg per
week for children and 12.5mg per week for adults. Lamictal is also available in
chewable tablets.
Topamax (Topiramate) is indicated for partial seizures and Lennox-
Gastaut syndrome. It has been very effective in difficult to manage seizure
disorders, is typically well tolerated and is effective in monotherapy. Many
studies have shown cognitive side effects and word finding difficulties. This has
15
not been a significant problem in the DD population. Topamax is also available
in sprinkle formulation.
Gabitril (Tiagabine) is approved for adjunctive treatment of partial
seizures and has been associated with any behavioral effects. Available in tablet
forms only.
Sabril (vigabatrin) is not approved in this country and it may not obtain
approval. Changes in the white matter in animal studies and concerns about
visual field deficits may prevent its approval. It is obtained from other countries
and is effective and well tolerated in persons with DD’s 23. Sabril has been most
useful in the treatment of infantile spasms.
Oxcabazepine (Trileptal) will be available soon. It is a variant of
carbamazepine, but metabolically bypasses the problematic epoxide intermediate
that is responsible for many of the side effects of carbamazepine, including
sedation. Patients are therefore able to tolerate higher doses and this will result in
a greater chance of successful monotherapy. This should be very beneficial for
use its use in individuals with DD’s 24.
I feel reason there are so many conflicting reports concerning the adverse
behavioral effects of AED’s on DD person’s, is due to the fact that we are unable
to consistently recognize pre-existing psychiatric disorders in handicapped
individuals. This results in AED choice that may not have been used if the
condition was recognized and may aggravate a condition. In addition, DD
16
persons often are unable communicate side effects and may act out only when
the side effects are intolerable.
Individuals recently discharged from developmental centers are may have
had appropriate AED management. Epileptologist are frequently contracted to
aid in the management of patients with epilepsy residing in developmental
centers in New Jersey. This is not true in all settings and some physicians in the
community continue AED’s indefinitely 25 . Re-evaluation of the patients epilepsy
and need for AED’s are frequently necessary. Monotherapy should be attempted
since it has been shown to be effective in up to 90% of institutionalized persons
with epilepsy 26,27. Withdrawing AED’s, especially Phenobarbital can result in a
marked improvement in alertness and mood. An increase in muscle tone can be
seen in some individuals with cerebral palsy or acquired hemiplegia after
Phenobarbital is withdrawn. Baclofen is a good treatment for the spastically.
Occasionally, an unpleasant underlying personality or mood will be unmasked
when the AED is withdrawn. Mania can appear as Depakote or Tegretol are
withdrawn28. If there were no signs of side effects of the medication that was
withdrawn, it can simply be restarted to treat the unmasked psychiatric disorder.
The field of developmental neurology is an evolving field of study. It
includes understanding both the unique medical needs of those with DD’s and
the constraints involved in their medical care. Our ability to successfully
incorporate these unique provisions into current clinical practice depends on the
initiative, motivation and cooperation we have as a medical community. Further
17
collaborative studies are required to determine the efficacy of alternative
therapies, such as vagal nerve stimulation 29,30 and epilepsy surgery 27 in
individuals with DD’s. Cooperation with diagnostic testing centers and
educating our communities is essential to the successful ongoing implementation
of appropriate neurological care to those with moderate to profound DD’s.
18
References
1. Coulter DL. Comprehensive management of epilepsy in persons with
mental retardation. Epilepsia 1997;38(S4):S24-31.
2. Alvarez N, Besag F, Iivanainen M. Use of antiepileptic drugs in the
treatment of epilepsy in people with intellectual disability. Journal of
Intellectual Disability Research 1998;42(1):1-15.
3. New Jersey Department of Human Services: Division of Developmental
Disabilities. Annual Report to the Constituency. August 21, 1998.
4. The Association for Retarded Citizens. Matrix of Program Services. July
15,1998.
5. Braddock D, Hemp R, Bachelder L, Fujiura G. The state of states in
developmental disabilities. 4th ed. Washington. DC. American Association of
Mental Retardation, 1995.
6. Sunder TR. Meeting the challenge of epilepsy in persons with multiple
handicaps. J Child Neurol 1997;12(1):S38-S43.
7. Steffenberg U, Hedstrom A, Lindroth A, Wilklund LM, Hagberg G,
Kyllerman M. Intractable epilepsy in a population-based series of
mentally retarded children. Epilepsia 1998;39(7):767-775.
8. Marcus JC. Control of epilepsy in a population with mental retardation:
Lack of correlation with IQ, neurologic status, and the
electroencephalogram. Am J Ment Retard 1993;(98S)47-51.
9. Singh BK, Towle PO. Antiepileptic drug status in adult outpatients with
mental retardation. Am J of Ment Retard 1993;(98S):41-46.
10. Deb S. Mental disorder in adults with mental retardation and epilepsy.
Comp Psych. 1997;(3):179-184.
11. Waisburg H, Alvarez N. Carbamazepine in the treatment of epilepsy in
people with intellectual disability. Journal of Intellectual Disability Research
1998;42(1):36-40.
19
12. Kastner T., FineSmith R., and Walsh K. Long-term administration of
valproic acid in the treatment of affective symptoms in people with
mental retardation. Journal of Psychopharmacology 1993;13(6): 448-451.
13. Mattes JA. Valproic acid for nonaffective aggression in the mentally
retarded. J Nerv Ment Dis. 1992;(9):601-602.
14. Wilcox J. Divalproex sodium in the treatment of aggressive behavior. Ann
Clin Psychiatry. 1994;6(1):17-20.
15. Pioplys AV. Autism: electroencephalogram abnormalities and clinical
improvement with valproic acid. Arch Pediatr Adolesc Med. 1994;(148):220-
222.
16. Friis ML. Valproate in the treatment of epilepsy in people with intellectual
disability. J Intellec Dis Res. 1998;42(S1):32-35.
17. Iivanainen M. Phenytoin: effective but insidious therapy for epilepsy in
people with intellectual disability. Journal of Intellectual Disability Research
1998;42(1):24-31.
18. Alvarez N. Barbiturates in the treatment of epilepsy in people with
intellectual disability. Journal of Intellectual Disability Research 1998;(1):16-
23.
19. Besag FM. Lamotrigine in the treatment of epilepsy in people with
intellectual disability. Journal of Intellectual Disability Research 1998;42(1):50-
56.
20. Davanzo PA, King BH. Open trial lamotrigine in the treatment of self-
injurious behavior in an adolescent with profound mental retardation.
Journal of Child & Adolescent Psychopharmacology 1996;6(4):273-279.
21. Ettinger AB, Weisbrot DM, Saracco J, Dhoon A, Kanner A, Devinsky O.
Positive and negative psychotropic effects of lamotrigine in patients with
epilepsy and mental retardation. Epilepsia 1998;39(8):874-877.
22. Beran RG, Gibson RJ. Aggressive behavior in intellectually challenged
patients with epilepsy treated with lamotrigine. Epilepsia 1998;39(9):1018-
1019.
23. Ylinen A. Antiepileptic efficacy of vigabatrin in people with severe
epilepsy and intellectual disability. Journal of Intellectual Disability Research
1998;(1):46-49.
20
24. Gaily E, Granstrom ML, Liukkonen E. Oxcarbazepine in the treatment of
epilepsy in children and adolescents with intellectual disability. Journal of
Intellectual Disability Research 1998;(1):41-45.
25. Baribeault JJ. Clinical advocacy for persons wit epilepsy and mental
retardation living in community-based programs. Journal of Neuroscience
Nursing 1996;28(6):359-372.
26. Pellock JM, Hunt PA. A decade of modern epilepsy therapy in
institutionalized mentally retarded patients. Epilepsy Research
1996;25(3):263-268.
27. Beckung E, Uvebrant P. Impairments, disabilities and handicaps in
children and adolescents with epilepsy. Acta Paediatrica 1997;86(3):254-260.
28. Ketter TA, Malow BA, Flamini R, White SR, Post RM, Theodore WH.
Anticonvulsant withdrawl-emergent psychopathology. Neurology
1994;(44):55-61.
29. Parker AP, Polkey PE, Binnie CD, Madigan C, Ferrie CD, Robinson RO.
Vagal nerve stimulation in epileptic encephalopathies. Pediatrics
1999;103(4):778-782.
30. Uthman BM, Wilder BJ, Hammond EJ, Reid SA. Efficacy and safety of
vagus nerve stimulation in patients with complex partial seizures.
Epilepsia 1990;3(suppl 2):S44-S50.
21
Table 1-1. Principles of AED therapy
Assessment of risk/benefit ratio of starting medication
Choosing appropriate medication based on seizure type
If seizures persist, consider adding or substituting 2nd AED
Diligently monitor for medication side effects and QOL

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ddsymposiumchapt

  • 1. Community Based Anti- Epileptic Treatment in the Developmentally Disabled Ross FineSmith, MD Clinical Instructor of Neurology NYU School of Medicine Medical
  • 2. 2 Introduction This chapter reviews the unique factors associated with the management of epilepsy and antiepileptics drugs (AED) in the community based population of individuals with developmental disabilities (DD). Many of the same principles that are established for AED therapy in the non-handicapped population can be applied to the individual with a DD. These principles can be used as guidelines when making decisions about initiating drug therapy or determining the most appropriate AED 1. These guidelines are listed in Table 1-1. There are additional specific challenges to the physician in the community treating patients with epilepsy and a moderate to profound DD. These factors include; a higher incidence of difficult to control seizure disorders, individual cognitive disability may limit feasibility of neurodiagnostic testing, adverse effects are difficult to assess in those with limited communicative ability and patients with a DD are more likely to experience adverse effects from AED’s 2. The Relocation of Persons with Disabilities In the past, most patients with severe disabilities and epilepsy were treated by pediatricians or pediatric neurologists and were often admitted to long term care facilities in late childhood or as young adults where staff physicians provided
  • 3. 3 their medical and neurological care. The current trend of deinstitutionalization of individuals with moderate to profound DD’s has “relocated” this group to a variety of community settings including; group homes, sponsored living, supported living arrangements and supervised apartment living. Their medical and neurological care is now the responsibility of physicians located in these regions. Unlike the staff physicians in the developmental centers, most physicians in the community have limited experience or exposure to persons with significant DD’s. This is not a result of discrimination, but one simply of demographics. These patients were institutionalized and typically did not receive treatment from outside physicians. The relocating process has resulted in a marked increase in medical consumers with DD’s requiring medical care in our communities. In the state of New Jersey there were 5,841 people in developmental centers in 1986 and as of March 1999, there were 3,623. These 2000 persons have been relocated and are now living in many communities throughout New Jersey. The number of individuals residing in group homes has tripled in the last 8 years and, in addition, there are 2,900 persons on the urgent waiting list and 1,000 on a non-urgent waiting list 3,4. This is a national trend and is not specific to one state5. The relocation has been especially challenging to those physicians treating patients with epilepsy. There is a 30-50% incidence of epilepsy in individuals with DD’s 6 and as many as 45% of those have medically refractory epilepsy
  • 4. 4 (MRE)7-9. Patients with MRE require significantly more of the physicians practice time, than other patients in the community with epilepsy. This group of patients needs more aggressive management and treatment and often requires the use of recently approved AED’s, novel therapies such as the vagal nerve stimulator and the ketogenic diet, and when appropriate, a referral for evaluation for epilepsy surgery. The remainder of this paper is designed to familiarize and aid in the development of a community-based program to more effectively treat patients with epilepsy and moderate to profound DD’s. Legal Guardians and Family Members Approximately 50% of individuals that are approved and eligible for services from the Division of Developmental Disabilities (DDD) are residing with parents or family members3. Many of these persons are on the waiting lists for group home placement. These individuals will frequently be seen by the same family physician that has cared for them most of their lives. Referral to a neurologist may occur if there is an initial seizure or a change in seizure status in those with pre-existing epilepsy. Family members have a personal interest in the care of a relative and this may reflect in the accuracy of the interval history, management of medication and vigilance in reporting undesirable side effects. However, aging parents may have difficulty remembering to give medications, accurately count seizures and recognize side effects. Parents may have difficulty physically transporting their
  • 5. 5 child to the office or hospital. This especially problematic if the child has a physical handicapping condition, such as cerebral palsy. Most individuals with a moderate to profound DD with cognitive impairment are evaluated and assessed not to be competent to make discussions for their own well-being. A legal gaurdian must therefore be appointed. Parents and other family members may live nearby and be involved with the DD person’s care and elect not to be the legal guardian. In addition, many individuals have no close family members involved and legal guardianship is assigned to a legal representative within the DDD. It is good practice to routinely obtain the name and address of the legal guardian and contact them by phone to establish a relationship. It is necessary to call if there are any questions regarding the need for written consent for a given procedure. Changing medications, laboratory blood work, non-invasive radiological and electrophysiological studies usually do not require consent. However, conscious sedation and general anesthesia are occasionally required to perform a test or procedure, and since this involves additional medical risk, written consent should be obtained in advance. The risks and benefits of any invasive procedure should be discussed with the legal guardian. There are few individuals with moderate DD’s who are their own guardian. Whether the person has a legal guardian or not, all medical discussions should be attempted to be explained to the patient personally. There are also laws governing the enrollment of persons with DD’s into research protocols. The research protocol must be approved by a
  • 6. 6 regional Institutional Review Board and the states DDD research committee. This was established to ensure that these patients are not unnecessarily enrolled in higher risk protocols. The primary caregivers for individuals with DD’s are often group home staff and this can frequently result in the family being overlooked in the medical treatment process. Family members are occasionally present, but due to parental age, health and living arrangements, parents are unable to be present for many visits. Health care providers are strongly encouraged to contact the next of kin to introduce themselves and obtain additional medical information. Relatives are usually happy to hear from a medical provider and will supply additional medical information. If family members express interest in the treatment plan, they should be encouraged to be present at office visits. This can be invaluable information, as the following account will describe. An individual with Autism and a history of epilepsy was evaluated by a neurologist and was requested to provide on-going neurological care. The patient was accompanied by a staff member that has known the him for the 2 months he has resided at the group home. A discharge summary from the developmental center reported that were no seizures observed in the 4 years he resided there. An EEG and MRI were unremarkable and the patient was considered a relatively low risk for seizure relapse if the AED was discontinued, based on this history. His legal guardian was a DDD representative and the next of kin was a sister that resided in the next state. The sister was contacted by phone at the time of the office visit and she
  • 7. 7 reported that over the past nine years, three separate neurologists attempted to wean her nephew off Tegretol because he had been seizure free for up to 4 years at a time. All three occasions resulted in status epilepticus and during one hospitalization he developed a severe pneumonia and required a prolong hospitalization. The neurologist elected not pursue this option, the patient has been followed for three years and continues to be seizure free on Tegretol. Group Home Structure and Staff Group home staff, sponsors and personal aids are of great importance in the execution of the medical treatment plan for persons with DD’s. A staff member will accompany the patient to the office and are often times the only source of information at that time. Most persons relocating from developmental centers should have a brief medical discharge summary. The level of experience, motivation and competence of the staff varies significantly. Staff names should always be noted in the margins of the chart adjacent to the medical note. This will allow for tracking and resolving many problems. It will benefit the health care provider to educate the accompanying staff and discuss what is needed each visit. Community or agency presentations and “in-services” can helpful in educating care providers. Group home managers oversee the care and treatment of each of the residents and are typically very reliable and dedicated. It may be helpful to deal directly with manager on the more difficult to manage individuals with epilepsy.
  • 8. 8 Physicians can develop a seizure record form that the staff must complete after each seizure. The form can be tailored by the physician to obtain pertinent information describing the event which will allow for more accurate documentation of the number of seizures and characterization of the seizure type. This type of form is especially helpful since the staff member that witnessed a seizure may not be the same staff that accompanies the patient to the office visit. This seizure record form can be quickly reviewed at each visit. This will also allow for a more accurate assessment of the current treatment and more effective medication adjustments can be made. These seizure logs should be kept in the person’s medical folder were the medication schedule and medical information is keep. The folder should accompany the patient to the each visit. Most group homes keep accurate medication records and log books. In addition, many now have prescriptions filled at pharmacies that offer “bubble packs”. Each dose is individually encased in a small air bubble on a sheet with multiple rows of individual doses. After the dose is given, a mark is made at the corresponding time in the person’s medication log. This leaves much less chance of missed doses. Not all group home staff is allowed to administer and dispense medications. Each staff allowed to preform this duty must be “med trained”. Working within the regulations the group homes are mandated to adhere to can be tedious and frustrating to those that are unfamiliar with the requirements. The regulations are not established by the group homes, but are state mandated, in an attempt to insure safety. For example, on prescriptions
  • 9. 9 the physician must write the specific times medications are to be administered (i.e. q8am and 8pm) instead of BID. Staff can not administer any medication without these specifics and the prescription must be re-written. If doses are adjusted over the phone, it must be followed by a written prescription that is mailed or faxed so there is appropriate documentation at the group home. This is problematic when these changes are made during on-call hours. Neurodiagnostic Testing Persons with significant disabilities and cognitive impairment often do not fully understand why they having a test performed. It is similar to a child of the same mental age being unable to participate in a testing situation. In addition, there is a higher incidence of psychological and psychiatric conditions that compound the difficulty in obtaining these studies. MRI of the brain requires the patient to lie very still for approximately 40 minutes and several different forms of sedation made are administered. This may simply include oral benzodiazepines or require conscious sedation provided by the anesthesiologists. An EEG can be significantly altered or suppressed with many of the sedating medications, so the utility of this study is limited in some cases. The determination of the seizure type would then have to be based on the clinical description of the event, patient history and the MRI. Neurodiagnostic studies on our patients can be very time consuming and often frustrating for busy MRI facilities and EEG labs.
  • 10. 10 Antiepileptic Medication After the diagnosis of epilepsy and seizure type has been established, the AED that is felt to be most effective with the least chance of side effects is determined. This is based on whether the seizures are primary generalized, partial, atonic or myoclonic. A careful review of the history is necessary to insure an AED that was used previously with adverse effects is not reinstituted. Co-morbid conditions and mode of drug delivery are prominent issues in the DD. There is a higher incidence of behavioral and psychiatric conditions in the DD population and AED’s are commonly used as mood stabilizers to treat these conditions. Psychiatric co-morbidities have been reported to occur in 25% and severe maladaptive behavior in up to 55% of those meeting criteria for mental retardation10. Depakote and Tegretol are the most commonly used AED’s in the treatment of bipolar disorder, mania, intermittent explosive disorder and in the management of aggressive behavior. Therefore, when choosing a medication to treat seizures, the psychiatric history must also be obtained. If a patient was previously treated with Depakote or Tegretol as a mood stabilizer and it was tolerated and effective, the same medication should be considered for an initial anticonvulsant. This lowers the risk of adverse events since it was previously tolerated and may also benefit behaviors. Conversely, a previously documented adverse effect, such as agitation, would dismiss a medication.
  • 11. 11 Tegretol (carbamazepine) is a first-line AED for partial onset and some forms of generalized seizures. Tegretol is an excellent choice in the treatment of individuals with DD’s because it has minimal adverse effects on cognition and behavior. Tegretol is also indicated in the treatment of bipolar disorder and trigeminal neuralgia. It can be used as a single agent to treat the relatively common co-morbidity of mood disorder and epilepsy11. Adverse behavioral reactions occur infrequently and may be due to the tricyclic ring structure in Tegretol. This may result in mild mood elevating properties that would be problematic in a patient with hypomania that has not been detected or diagnosed. These patients may become agitated, irritable and hyperactive. Hyponatremia is a known side effect and can be exacerbated by patients who drink free water habitually or due to dryness as a side effect of antidepressants or antipsychotics. An additional advantage of Tegretol is the multiple formulations available. The chewable tablets are used in patients unable to swallow tablets and the extended release tablets allow for less frequent dosing. Carbatrol is newer form of extended release carbamazepine that is produced in a capsule that can be opened and sprinkled on food. This has allowed the use of an extended release form in young children. Depakote (valproate) is a major AED that has a broad spectrum and is effective against primary generalized, partial, myoclonic seizures and infantile spasms. Depakote is also indicated in the treatment of mania and migraine
  • 12. 12 headaches. Both of these conditions commonly occur in patients with epilepsy. Additional uses in the DD population include; behavioral cycling12, aggressive behaviors 13,14 and hyperactivity/agitation in Autism15. This medication should be used in a very limited fashion or not at all in children under 2 years of age because this group of patients has a significant risk of hepatotoxicity. These patients are at even greater risk if they have a severe developmental delay, are on additional AED’s or have a neurometabolic disorder16. Thrombocytopenia is also a known side effect and is rarely serious, however, if an individual’s DD includes ataxia with frequent falls caution should be used. Depakote also is available as a liquid, IV formulation that may be administered through a gastric tube and sprinkle capsules. Dilantin (phenytoin) has a very safe profile and is effective in the treatment of partial and generalized seizures. There does not appear to be any significant mood or behavioral effects. The advantage of Dilantin is that it has a long half-life and may be given once a day. This is helpful in those with compliance problems. It is available in liquid, chewable and IV formulation. Dilantin is not a first choice AED in person’s with DD because the side effect profile is especially problematic in this population. Oral hygiene is commonly a significant problem in individuals with DD and this is complicated by the known side effect of gingival hyperplasia in Dilantin use. In addition, individuals with DD are often susceptible to balance disturbances which Dilantin can exacerbate17.
  • 13. 13 Phenobarbital is the oldest and one of the safest AED’s in current use. It is the drug of choice on children under 2 years and is effective against a wide range of seizure types. It is not commonly used in older patients because it has been shown to slow cognition and learning and has adverse effects on mood, including irritability in children and depression in adults18. However, it is a very good anticonvulsant and there is patients that respond exceptionally well and is unable to be changed to other AED’s. Felbamate (Felabatol) was the first new generation AED and was widely used and accepted until the post-marketing experience revealed a high incidence of hepatic failure and aplastic anemia. It had a favorable side effect profile for many patients with DD’s. It appeared to have a mild stimulant quality and therefore was beneficial for psychomotor slowing and reducing appetite. This same effect was greater in a subgroup and resulted in insomnia and anorexia. Felbatol has a wide spectrum of anticonvulsant activity and is especially effective in Lennox-Gastaut syndrome. This medication should be used only when the risk-benefit ratio has been carefully evaluated by all of those involved in the person’s care. Neurontin (Gabapentin) is effective as an adjunctive therapy in partial seizures. It is widely used for neuropathic pain syndromes and refractory bipolar disorder, but is only indicated for partial seizures. Neurontin is available as a capsule only and has no serious medical side effects. It has minimal protein
  • 14. 14 binding and hepatic metabolism so it has minimal interactions with other medications and can be used safely in other medical conditions. Lamictal (Lamotrigine) also has a wide spectrum of anticonvulsant activity, is effective against Lennox-Gastaut and effective in monotherapy. Lamictal also appears to have a mild mood elevating quality and is rarely sedating. It also has mood stabilizing qualities and is being used in bipolar disorder. This combination gives Lamictal a very favorable profile for the use in individuals with DD’s 19,20. However, there have been reports of adverse behavioral effects including marked elevation of mood and agitation in this population of patients 21,22. Initially Lamictal was found to be causing a concerning number of allergic reactions with subsequent development of Stevens-Johnson syndrome. However, it has since been established that the incidence of this reaction is directly related to the rate of titration. The slower the rate of titration, the less likely a reaction will occur. There is little chance of complications if increased by 2.5-5mg per week for children and 12.5mg per week for adults. Lamictal is also available in chewable tablets. Topamax (Topiramate) is indicated for partial seizures and Lennox- Gastaut syndrome. It has been very effective in difficult to manage seizure disorders, is typically well tolerated and is effective in monotherapy. Many studies have shown cognitive side effects and word finding difficulties. This has
  • 15. 15 not been a significant problem in the DD population. Topamax is also available in sprinkle formulation. Gabitril (Tiagabine) is approved for adjunctive treatment of partial seizures and has been associated with any behavioral effects. Available in tablet forms only. Sabril (vigabatrin) is not approved in this country and it may not obtain approval. Changes in the white matter in animal studies and concerns about visual field deficits may prevent its approval. It is obtained from other countries and is effective and well tolerated in persons with DD’s 23. Sabril has been most useful in the treatment of infantile spasms. Oxcabazepine (Trileptal) will be available soon. It is a variant of carbamazepine, but metabolically bypasses the problematic epoxide intermediate that is responsible for many of the side effects of carbamazepine, including sedation. Patients are therefore able to tolerate higher doses and this will result in a greater chance of successful monotherapy. This should be very beneficial for use its use in individuals with DD’s 24. I feel reason there are so many conflicting reports concerning the adverse behavioral effects of AED’s on DD person’s, is due to the fact that we are unable to consistently recognize pre-existing psychiatric disorders in handicapped individuals. This results in AED choice that may not have been used if the condition was recognized and may aggravate a condition. In addition, DD
  • 16. 16 persons often are unable communicate side effects and may act out only when the side effects are intolerable. Individuals recently discharged from developmental centers are may have had appropriate AED management. Epileptologist are frequently contracted to aid in the management of patients with epilepsy residing in developmental centers in New Jersey. This is not true in all settings and some physicians in the community continue AED’s indefinitely 25 . Re-evaluation of the patients epilepsy and need for AED’s are frequently necessary. Monotherapy should be attempted since it has been shown to be effective in up to 90% of institutionalized persons with epilepsy 26,27. Withdrawing AED’s, especially Phenobarbital can result in a marked improvement in alertness and mood. An increase in muscle tone can be seen in some individuals with cerebral palsy or acquired hemiplegia after Phenobarbital is withdrawn. Baclofen is a good treatment for the spastically. Occasionally, an unpleasant underlying personality or mood will be unmasked when the AED is withdrawn. Mania can appear as Depakote or Tegretol are withdrawn28. If there were no signs of side effects of the medication that was withdrawn, it can simply be restarted to treat the unmasked psychiatric disorder. The field of developmental neurology is an evolving field of study. It includes understanding both the unique medical needs of those with DD’s and the constraints involved in their medical care. Our ability to successfully incorporate these unique provisions into current clinical practice depends on the initiative, motivation and cooperation we have as a medical community. Further
  • 17. 17 collaborative studies are required to determine the efficacy of alternative therapies, such as vagal nerve stimulation 29,30 and epilepsy surgery 27 in individuals with DD’s. Cooperation with diagnostic testing centers and educating our communities is essential to the successful ongoing implementation of appropriate neurological care to those with moderate to profound DD’s.
  • 18. 18 References 1. Coulter DL. Comprehensive management of epilepsy in persons with mental retardation. Epilepsia 1997;38(S4):S24-31. 2. Alvarez N, Besag F, Iivanainen M. Use of antiepileptic drugs in the treatment of epilepsy in people with intellectual disability. Journal of Intellectual Disability Research 1998;42(1):1-15. 3. New Jersey Department of Human Services: Division of Developmental Disabilities. Annual Report to the Constituency. August 21, 1998. 4. The Association for Retarded Citizens. Matrix of Program Services. July 15,1998. 5. Braddock D, Hemp R, Bachelder L, Fujiura G. The state of states in developmental disabilities. 4th ed. Washington. DC. American Association of Mental Retardation, 1995. 6. Sunder TR. Meeting the challenge of epilepsy in persons with multiple handicaps. J Child Neurol 1997;12(1):S38-S43. 7. Steffenberg U, Hedstrom A, Lindroth A, Wilklund LM, Hagberg G, Kyllerman M. Intractable epilepsy in a population-based series of mentally retarded children. Epilepsia 1998;39(7):767-775. 8. Marcus JC. Control of epilepsy in a population with mental retardation: Lack of correlation with IQ, neurologic status, and the electroencephalogram. Am J Ment Retard 1993;(98S)47-51. 9. Singh BK, Towle PO. Antiepileptic drug status in adult outpatients with mental retardation. Am J of Ment Retard 1993;(98S):41-46. 10. Deb S. Mental disorder in adults with mental retardation and epilepsy. Comp Psych. 1997;(3):179-184. 11. Waisburg H, Alvarez N. Carbamazepine in the treatment of epilepsy in people with intellectual disability. Journal of Intellectual Disability Research 1998;42(1):36-40.
  • 19. 19 12. Kastner T., FineSmith R., and Walsh K. Long-term administration of valproic acid in the treatment of affective symptoms in people with mental retardation. Journal of Psychopharmacology 1993;13(6): 448-451. 13. Mattes JA. Valproic acid for nonaffective aggression in the mentally retarded. J Nerv Ment Dis. 1992;(9):601-602. 14. Wilcox J. Divalproex sodium in the treatment of aggressive behavior. Ann Clin Psychiatry. 1994;6(1):17-20. 15. Pioplys AV. Autism: electroencephalogram abnormalities and clinical improvement with valproic acid. Arch Pediatr Adolesc Med. 1994;(148):220- 222. 16. Friis ML. Valproate in the treatment of epilepsy in people with intellectual disability. J Intellec Dis Res. 1998;42(S1):32-35. 17. Iivanainen M. Phenytoin: effective but insidious therapy for epilepsy in people with intellectual disability. Journal of Intellectual Disability Research 1998;42(1):24-31. 18. Alvarez N. Barbiturates in the treatment of epilepsy in people with intellectual disability. Journal of Intellectual Disability Research 1998;(1):16- 23. 19. Besag FM. Lamotrigine in the treatment of epilepsy in people with intellectual disability. Journal of Intellectual Disability Research 1998;42(1):50- 56. 20. Davanzo PA, King BH. Open trial lamotrigine in the treatment of self- injurious behavior in an adolescent with profound mental retardation. Journal of Child & Adolescent Psychopharmacology 1996;6(4):273-279. 21. Ettinger AB, Weisbrot DM, Saracco J, Dhoon A, Kanner A, Devinsky O. Positive and negative psychotropic effects of lamotrigine in patients with epilepsy and mental retardation. Epilepsia 1998;39(8):874-877. 22. Beran RG, Gibson RJ. Aggressive behavior in intellectually challenged patients with epilepsy treated with lamotrigine. Epilepsia 1998;39(9):1018- 1019. 23. Ylinen A. Antiepileptic efficacy of vigabatrin in people with severe epilepsy and intellectual disability. Journal of Intellectual Disability Research 1998;(1):46-49.
  • 20. 20 24. Gaily E, Granstrom ML, Liukkonen E. Oxcarbazepine in the treatment of epilepsy in children and adolescents with intellectual disability. Journal of Intellectual Disability Research 1998;(1):41-45. 25. Baribeault JJ. Clinical advocacy for persons wit epilepsy and mental retardation living in community-based programs. Journal of Neuroscience Nursing 1996;28(6):359-372. 26. Pellock JM, Hunt PA. A decade of modern epilepsy therapy in institutionalized mentally retarded patients. Epilepsy Research 1996;25(3):263-268. 27. Beckung E, Uvebrant P. Impairments, disabilities and handicaps in children and adolescents with epilepsy. Acta Paediatrica 1997;86(3):254-260. 28. Ketter TA, Malow BA, Flamini R, White SR, Post RM, Theodore WH. Anticonvulsant withdrawl-emergent psychopathology. Neurology 1994;(44):55-61. 29. Parker AP, Polkey PE, Binnie CD, Madigan C, Ferrie CD, Robinson RO. Vagal nerve stimulation in epileptic encephalopathies. Pediatrics 1999;103(4):778-782. 30. Uthman BM, Wilder BJ, Hammond EJ, Reid SA. Efficacy and safety of vagus nerve stimulation in patients with complex partial seizures. Epilepsia 1990;3(suppl 2):S44-S50.
  • 21. 21 Table 1-1. Principles of AED therapy Assessment of risk/benefit ratio of starting medication Choosing appropriate medication based on seizure type If seizures persist, consider adding or substituting 2nd AED Diligently monitor for medication side effects and QOL