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E-Articles - Psychiatry for Physicians- Delirium
It is the first psychiatric disorder that took place in medical practice. As a result, cases of delirium are mostly dealt by physicians. The syndrome, d
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
elirium, can be defined as a transient, usually reversible dysfunction in the cerebral nervous system that has an acute or subacute onset and is manifes
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t clinically by wide array of neuropsychiatric abnormalities.
Some patients are considered to be high risk group for developing delirium. They are –
1
Some patients are considered to be high risk group for developing delirium. They are –
1
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
) Elderly patients
2) Post cardiotomy patients
3) Burn patients
4) Patient with cognitive dysfunction
5) Patients with drug withdraw
2) Post cardiotomy patients
3) Burn patients
4) Patient with cognitive dysfunction
5) Patients with drug withdraw
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
al
6) Patients with AIDS
7) Patients with a high illness burden
The diagnostic criteria for delirium according to the DSM-IV are –
1. Distur
6) Patients with AIDS
7) Patients with a high illness burden
The diagnostic criteria for delirium according to the DSM-IV are –
1. Distur
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ance of consciousness with reduced ability to focus, sustain or shift attention.
2. Change in cognition that is not better accounted for by preexis
2. Change in cognition that is not better accounted for by preexis
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ting, established or evolving dementia.
3. The disturbance develops over a short period of time and tends to fluctuate during the course of the day
3. The disturbance develops over a short period of time and tends to fluctuate during the course of the day
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
.
4. There is evidence from the history, physical examination, or laboratory findings of a general medical condition judged to be etiologically rel
4. There is evidence from the history, physical examination, or laboratory findings of a general medical condition judged to be etiologically rel
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ated to the disturbance.
Clinical features of delirium are –
1) Prodrome (restlessness, anxiety, sleep disturbance, irritability) and rapid onset.
Clinical features of delirium are –
1) Prodrome (restlessness, anxiety, sleep disturbance, irritability) and rapid onset.
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
2) Rapidly fluctuating course.
3) Attention decreased (easily distractible).
4) Altered arousal and psychomotor abnormality.
5) Disturb
3) Attention decreased (easily distractible).
4) Altered arousal and psychomotor abnormality.
5) Disturb
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nce of sleep-wake cycle.
6) Impaired memory.
7) Disorganized thinking and speech.
8) Disorientation (very rarely in case of person).
6) Impaired memory.
7) Disorganized thinking and speech.
8) Disorientation (very rarely in case of person).
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
9) Perceptions altered.
10) Neurological abnormalities like dysgraphia, constructional apraxia, dystonic aphasia, motor abnormalities (tremor, ast
10) Neurological abnormalities like dysgraphia, constructional apraxia, dystonic aphasia, motor abnormalities (tremor, ast
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
erixis, myoclonus, reflex and tone changes), and EEG abnormalities.
11) Other features like sadness, irritability, anger or euphoria.
A significan
11) Other features like sadness, irritability, anger or euphoria.
A significan
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
t research on the etiology of delirium proposed that derangement in functional metabolism, manifested by cognitive disturbances and slowing of EEG, is t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
he main stem of etiology for delirium. Differential diagnoses for delirium are –
1. Wernicke’s encephalopathy or withdrawal.
2. Hypertensive encep
1. Wernicke’s encephalopathy or withdrawal.
2. Hypertensive encep
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
alopathy.
3. Hypoglycemia
4. Hypoperfusion of CNS.
5. Hypoxemia.
6. Intracranial bleeding or infection.
7. Meningitis or enceph
3. Hypoglycemia
4. Hypoperfusion of CNS.
5. Hypoxemia.
6. Intracranial bleeding or infection.
7. Meningitis or enceph
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
alitis.
8. Poisons or medication.
Delirium can ultimately result in full recovery, progression to stupor and/or coma, development of seizure, prog
8. Poisons or medication.
Delirium can ultimately result in full recovery, progression to stupor and/or coma, development of seizure, prog
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ression to chronic brain syndrome, death or any morbidity. But most of the cases of delirium end up in recovery. For the purpose of treatment there are
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
two main steps to take –
1) Treat the underlying cause.
2) Treat the behavioral symptoms.
One of the most widely used groups of pharmacologi
1) Treat the underlying cause.
2) Treat the behavioral symptoms.
One of the most widely used groups of pharmacologi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
cal agents prescribed for the treatment of behavioral symptoms in delirium is antipsychotic. Psychological and environmental supports are also important
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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