From this ppt we get deep knowledge about International classification of disease and International non-proprietary name. what was the purpose behind the designing the system of ICD. what is the aim of INN system.
Graduate Outcomes Presentation Slides - English (v3).pptx
REGULATORY GUIDELINES FOR CONDUCTING TOXICITY STUDIES BY ICH.pptx
1. INTERNATIONAL CLASSIFICATION
OF DISEASE,INTERNATIONAL
NON-PROPRIETARY NAMES FOR
DRUGS
SUBJECT NAME : CLINICAL RESEARCH AND PHARMACOVIGILANCE
GUIDED BY : PROFESSOR SMITA SADAR
PRESENTED BY : ANKITA SANDESH HALDAKAR
(M. PHARM 1ST YEAR PHARMACOLGY)
D.Y.PATIL COLLEGE OF PHARMACY AKURDI, PUNE
2. INTRODUCTION
The International Classification of Diseases (ICD) is the international
"standard diagnostic tool for epidemiology, health management and
clinical purposes". Its full official name is International Statistical
Classification of Diseases and Related Health Problems.
The ICD is maintained by the World Health Organization (WHO), the
directing and coordinating authority for health within the United Nations
System.
The ICD is originally designed as a health care classification system,
providing a system of diagnostic codes for classifying diseases, including
classifications of a wide variety of signs, symptoms, abnormal findings,
complaints, social circumstances, and external causes of injury or
disease.
3. PURPOSE AND USES OF ICD
This system is designed to map health conditions to corresponding generic
categories together with specific variations, assigning for these a designated
code, up to six characters long.
Thus, major categories are designed to include a set of similar diseases. ICD-
10 is a major step forward, because it has the necessary terminological and
ontological elements for seamless use in digital health.
The ICD is published by the WHO and used worldwide for morbidity and
mortality statistics and automated decision support in health care.
Easy storage, retrieval and analysis of health information for evidenced- based
decision-making.
4. Conti….
Sharing and comparing health information between
hospitals, regions, settings and countries.
Data comparisons in the same location across
different time periods.
Monitoring of the incidence and prevalence of
diseases, observing reimbursements and resource
allocation trends, and keeping track of safety and
quality guidelines.
Counting of deaths as well as diseases, injuries,
symptoms, reasons for encounter, factors that
influence health status, and external causes of disease.
5. TABULAR LIST OF INCLUSION AND
FOUR CHARACTER SUB CATEGORIES
I. Certain infectious parasitic diseases
II. Neoplasms
III. Diseases of the blood and blood forming organs and certain disorders involving the
immune mechanism
IV. Endocrine, nutritional and metabolic diseases
V. Mental and behavioral disorders
VI. Disease of nervous system
VII. Disease of eyes and adnexa
VIII. Disease of Ear and Mastoid Process
IX. Disease of Circulatory System
X. Disease of Respiratory System
XI. Diseases of Digestive System
XII. Diseases of Skin and Subcutaneous Tissue
6. XIII Diseases of the Musculoskeletal System and
Connective Tissue
XIV Diseases of the Genitourinary System
XV Pregnancy, Childbirth and Puerperium
XVI Certain Conditions Originating in the Perinatal
Period
XVII Congenital Malformations, Deformations and
Chromosomal Abnormalities
XVIII Symptoms, Signs and Abnormal Clinical and
Laboratory Findings Not Elsewhere Classified
XIX Injury, Poisoning and Certain Other Consequences of
External Causes
XX External Causes of Morbidity and Mortality
XXI Factors Influencing Health Status and Contact with
Health Services
7. CLASSIFICATION OF DISEASE IN ICD
CHAPTER I
Intestinal infectious diseases (A00-A09)
A00 Cholera
A01 Typhoid and paratyphoid fevers
A02 Other Salmonella infections
A03 Shigellosis
A04 Other bacterial intestinal infections
A05 Other bacterial foodborne intoxications, not elsewhere classified
A06 Amoebiasis
A07 Other protozoal intestinal diseases.
A08 Viral and other specified intestinal infections
A09 Other gastroenteritis and colitis of infectious and unspecified origin
8. Tuberculosis (A15-A19)
A15 Respiratory tuberculosis, bacteriologically and histologically confirmed
A16 Respiratory tuberculosis, not confirmed bacteriologically or histologically
A17 Tuberculosis of nervous system
A18 Tuberculosis of other organs
A19 Miliary tuberculosis
Certain zoonotic bacterial diseases (A20-A28)
A20 Plague
A21 Tularaemia
A22 Anthrax
A23 Brucellosis
A24 Glanders and melioidosis
A25 Rat-bite fevers
A26 Erysipeloid
A27 Leptospirosis
A28 Other zoonotic bacterial diseases, not elsewhere classified
9. Other Bacterial diseases (A30-A49)
A30 Leprosy [Hansen disease]
A31 Infection due to other mycobacteria
A32 Listeriosis
A33 Tetanus neonatorum
A34 Obstetrical tetanus
A35 Other tetanus
A36 Diphtheria
A37 Whooping cough
A38 Scarlet fever
A39 Meningococcal infection
A40 Streptococcal sepsis
A41 Other sepsis
A42 Actinomycosis
A43 Nocardiosis
A44 Bartonellosis
A46 Erysipelas
A48 Other bacterial diseases, not elsewhere classified
A49 Bacterial infection of unspecified site
10. Infections with a predominantly sexual mode of transmission (A50-
A64)
A50 Congenital syphilis
AS1 Early syphilis
A52 Late syphilis
A53 Other and unspecified syphilis
A54 Gonococcal infection
A55 Chlamydial lymphogranuloma (venereum)
A56 Other sexually transmitted chlamydial diseases
AS7 Chancroid
A58 Granuloma inguinale
A59 Trichomoniasis
A60 Anogenital herpes viral (herpes simplex) infection
A63 Other predominantly sexually transmitted diseases, not elsewhere classified
A64 Unspecified sexually transmitted disease.
Other spirochaetal diseases (A65-A69)
A65 Nonvenereal syphilis
A66 Yaws
A67 Pinta
A68 Relapsing fevers
A69 Other spirochaetal infections
11. Other diseases caused by chlamydia (A70-A74)
A70 Chlamydia psittaci infection
A71 Trachoma
A74 Other diseases caused by chlamydia
Rickettsioses (A75-A79)
A75 Typhus fever
A77 Spotted fever [tick-borne rickettsioses]
A78 Q fever
A79 Other rickettsioses
Viral infections of the central nervous system (A80-A89)
A80 Acute poliomyelitis
A81 Atypical virus infections of central nervous system
A82 Rabies
A83 Mosquito-borne viral encephalitis
A84 Tick-borne viral encephalitis
A85 Other viral encephalitis, not elsewhere classified
A86 Unspecified viral encephalitis
A87 Viral meningitis
A88 Other viral infections of central nervous system, not elsewhere classified
A89 Unspecified viral infection of central nervous system
12. ADVANTAGES AND LIMITATIONS
OF ICD
ADVANTAGES
1) fast aggregation of health
data.
2) To know the real time
information about current health
situation.
3) Wider analysis of community
health.
4) Global assessment.
LIMITATIONS
1) Discussion is limited to
classified diseases
2) Common term descriptions of
diseases
3) Covers the most common
diseases
4) Country specific
modifications of certain
diseases
13. INTRODUCTION OF INN
An International Nonproprietary Name (INN) identifies a pharmaceutical
substance or active pharmaceutical ingredient by a unique name that is
globally recognized and is public property.
A nonproprietary name is also known as a generic name.
The INN system was managed by WHO.
Since the name is available in the public domain it may be used freely.
However, it should not be registered as a trade-mark since this would
prevent its use by other parties.
INN is designated for the active part of the molecule only, to avoid the
multiplication of entries in cases where several salts, esters, etc. are
actually used.
In such as cases, the user of the INN has to create a modified
INN(INNM).Ex: mepyramine maleate (a salt of mepyramine with maleic
acid)
14. AIM OF INN SYSTEM
To provide health professionals with unique name to
identify each pharmaceutical substance
Aim to clear identification, safe prescription and
dispensing of medicines to patients.
For communication and exchange of information among
health professionals and scientists world wide.
Non proprietary names are intended for use in pharma,
labelling, product information, advertising and other
promotional material.
15. SELECTION OF INN
The INN are selected by the world Health Organization on the advice of
experts from the WHO Expert Advisory Panel on the International
Pharmacopoeia and Pharmaceutical Preparations.
The process of INN selection follows three main steps:
1. A request/application is made by the manufacturer or inventor to WHO
secretariat
2. After a review of the request a proposed INN is selected and published
for comments for objection for 4 months.
3. After completion of 4 months the proposed INNS is finalized and
published as recommended INNs, which is the final name of
substances, which cannot be changed throughout life
16. ELEMENTS OF INNs
Proposed INNs
Recommended INNs
Modified INNs
Cumulative INNs
PROPOSED INNs:
Proposed INNS are list of drug substances which under objection period
Newly selected, proposed INNs are then published in WHO Drug
Information, which indicates a deadline for a 4-month objection period.
This period is allowed for comments and/or objections to the published
names to be raised.
The reasons for any objection must be stated clearly and these will be
evaluated by the experts for further action• Two lists of proposed INNs are
published yearly
17. RECOMMENDED INNs
• The final stage of the selection process is the recommended INN.
• Once a name has been published as a recommended INN it will not normally
be modified further and is ready for use in labelling, publications, on drug
information.
• It will serve to identify the active pharmaceutical substance during its lifetime
worldwide.
• Recommended INNs are published in the WHO Drug Information as a
consequence of the objection procedure applied to proposed INNs
• As from 1997, two lists of proposed INNs are published yearly and as from list
37 of recommended INNs with its graphic formulae are selected.
MODIFIED INNMs:
• If a "radical and group name" is used in conjunction with an INN, they are
referred to as International Non proprietary Name (Modified) or INNM.
• For example, oxacillin and ibufenac are INNs and their salts are named
oxacillin sodium and ibufenac sodium. The latter are called modified INNS
(INNMS).
• for radicals and groups which are used in conjunction with INNs and which are
also referred to as INNM, and the document international Non proprietary
Names.
18. CUMULATIVE LIST:
All names selected as proposed and recommended INNs are published in a
Cumulative list, which is updated periodically.
The generic names are presented in alphabetical order by Latin name
Each entry includes:
equivalent non proprietary names:: in Latin, English, French, Spanish, Arabic,
Chinese and Russian, as well as reference to other common names
a reference to the INN list in which the name was originally proposed or
recommended, or last amended;
A reference to names of substances that have been abandoned or never been
marketed;
reference to national non proprietary names;
reference to pharmacopeial monographs or similar official references.
reference to names issued by the International Organization for Standardization
(ISO)
reference to the Convention of Psychotropic Substances, if applicable;
reference to the List of Narcotic Drugs under International Control, if applicable
the molecular formula;
its Chemical Abstracts Service (CAS) number.
19. PRINCIPLE OF SELECTION OF INNs
The primary principles for selection:
Distinctive in sound and spelling
Not too long; and Not liable to confusion with other names in common
use.
Ex: anti-inflammatory agents, ibufenac derivatives
Coxib for COX-2 inhibitors, a type of anti-inflammatory drugs (e.g. celecoxib)
Do not select names for mixtures of substances
Do not select for herbal substances (vegetable drugs) or for
homoeopathic products.
Do not select names for those substances that have a long history of use
for medical purposes under well-established names such as those of
alkaloids (e.g. morphine, codeine), or trivial chemical names (e.g acetic
acid)
20. USE OF STEMS:
Usually, an INN consists of a random, fantasy prefix and a common stem;
substances belonging to a group of pharmacologically related substances
show their relationship by the use of a common stem.
e.g. olol for -adrenoreceptor antagonists and antihypertensive, -teplase for
tissue- type-plasminogen activators activators.
A list of common stems used in the selection of INNs may be found in
Annex 3.
STEREOISOMERS
Steric characteristics of the chemical names(5) are indicated by using
specific prefixes.
For a different enantiomer or for the racemic form of the compounds, the
following prefixes should be added to the existing INN:
a) For the levo form, the lev-/levo- prefix is used,e.g. levocarnitine,
levamisole.
b)For the dextro form, the dex- prefix is used,e.g. dexamisole, dexibuprofen.
c)For the racemic form, the rac-/race- prefix is used,e.g. racepinefrine
21. RADIOACTIVE ISOTOPES:
A name for a drug substance containing a radioactive atom should list, in the
following order:
1) the name of the substance containing the radioactive atom,
2) the isotope number,
3) the element symbol, and
4) the name of the carrier agent, if any,
e.g. cyanocobalamin (60 Co), technetium (99m Tc) bicisate, technetium (99m
Tc)
SPECIFIC GROUPS OF BIOLOGICAL SUBSTANCES
specific groups of biological substances names were assigned to antibiotics,
synthetic peptides, hormones and other proteins.
Example:
• Insulin human was proposed for the recombinant protein and it was first
recommended recombinant protein
• New stems for- tissue plasminogen activators – plase
for naming monoclonal antibodies- they use stem – mab
• Within the INN Programme, names have not been assigned to natural human
blood products or vaccines.
22. PROTECTION OF INN
• WHO Expert Committee recommended
• "Enact rules or regulations, as necessary, to ensure that international non-
proprietary names.. Should be protected
• Develop policy guidelines on the use and protection of international non-
proprietary names, and to discourage the use of names derived from INNS,
and particularly names including INN stems in trademarks
USE OF INNS IN INDIA:
• In India, section 13 (b) of the Trade Marks Act, 1999 prohibits the
registration of names of chemical elements or INNs which have been declared
by the World Health Organization (WHO) and notified by the Registrar of
Trade Marks.
• The WHO has brought the same to the attention of the Drug Controller
General of India.
• Use of INNs to coin brand names
INN- vinleurosine Stem- osine Brand name- Virosine DR company
23. Reference :-
• Park's textbook of preventive and social medicine, 23rd edition K.PARK
• Textbook of preventive and social medicine, 4th edition SUNDER LAL,
ADARSH, PANKAJ.
• Textbook of preventive and social medicine, 4th edition - MAHAJAN AND
GUPTA.
• Textbook of community medicine -KULKARNI.
Google reference :
⚫www.cdc.gov/nchs/cd9.htm• International classification of diseases
(WHO) archived from the original on 12th feb, 2015. Retrived 14th march
2015.
⚫^WHO. List of official ICD updates.• ^ICD revision time lines and ICD-
coding Tool. Note: ICD-10 in hospital settings: WHO's ICD-10 online
browser located at
http://apps.who.int/classification/icd10/browse/2015/en#/20.0 you