Advice Pool - Health and Fitness

Dual Diagnosis, Dual Disorders and MoreThe term dual diagnosis is a common, broad term that indicates the presence of two independent medical disorders. Recently, within the fields of mental health, psychiatry, and addi

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

ction medicine, the term has been popularly used to describe the coexistence of a mental health disorder and drug addiction / alcohol addiction problems. The equivalent phrase dual disorders also denotes the coexistence

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

of two independent (but invariably interactive) disorders, and is the preferred term used in this Treatment Improvement Protocol (TIP).

The acronym MICA, which represents the phrase mentally ill chemical abusers
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

>, is occasionally used to designate people who have an drug addiction / alcoholism disorder and a markedly severe and persistent mental disorder such as schizophrenia or bipolar disorder. A preferred definition is mentally
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ill chemically affected people, since the word affected better describes their condition and is not pejorative. Other acronyms are also used: MISA (mentally ill substance abusers), CAMI (chemical abuse and me
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
ntal illness), and SAMI (substance abuse and mental illness). Dual Diagnosis ExamplesCommon examples of dual diagnosis include the combinations of major depression with cocaine addiction, alcohol addict
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
ion with panic disorder, alcoholism and heroin addiction with schizophrenia, and borderline personality disorder with episodic drug abuse.

Although the focus of this volume is on dual diagnosis, some patients have more than t
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
o disorders, such as cocaine addiction, personality disorder, and AIDS. The principles that apply to dual diagnosis generally apply also to multiple disorders. The combinations of drug addiction / alcohol addiction problems an
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d psychiatric disorders vary along important dimensions, such as severity, chronicity, disability, and degree of impairment in functioning. For example, the two disorders may each be severe or mild, or one may be more severe t
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
han the other. Indeed, the severity of both disorders may change over time. Levels of disability and impairment in functioning may also vary.Thus, there is no single combination of dual diagnosis; in fact, there is great varia
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ility among them. However, patients with similar combinations of dual diagnosis are often encountered in certain treatment settings. For instance, some methadone treatment programs treat a high percentage of opiate-addicted pa
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
tients with personality disorders. Patients with schizophrenia and alcohol addiction are frequently encountered in psychiatric units, mental health centers, and programs that provide treatment to homeless patients. Dua
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
l Diagnosis: Drug Addiction and Alcoholism

Patients with mental disorders have an increased risk for drug addiction / alcohol addiction disorders, and patients with AOD disorders have an increased risk for mental dis
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
orders. For example, about one-third of patients who have a psychiatric disorder also experience drug abuse at some point (Regier et al., 1990), which is about twice the rate among people without psychiatric disorders
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Also, more than half of the people who suffer from drug abuse or alcohol abuse have experienced psychiatric symptoms significant enough to fulfill diagnostic criteria for a psychiatric disorder (Regier et al., 1990; Ross
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
et al., 1988), although many of these symptoms may be AOD related and might not represent an independent condition. Compared with patients who have a mental health disorder or an drug abuse or alcohol abuse problem alone
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
, patients with dual diagnosis often experience more severe and chronic medical, social, and emotional problems. Because they have two disorders, they are vulnerable to both AOD relapse and a worsening of the psychiatric disor
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
er. Further, addiction relapse often leads to psychiatric decompensation often leads to addiction relapse. Thus, relapse prevention must be specially designed for patients with dual diagnosis. Compared with patients who have a
.

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
single disorder, patients with dual diagnosis often require longer treatment, have more crises, and progress more gradually in treatment.

If you are looking for a dual
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
diagnosis treatment program, drug rehab or alcohol rehab call 1-800-511-9225, a national dual diagnosis helpline or go to www.lakeviewhealth.com

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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