Drug & Disease Classification

DESIGN OF ICD

·         The ICD contains a description of all KNOWN diseases and injuries.

·         Each disease is detailed with diagnostic characteristic and given a unique identifier that is used to code mortality and morbidity data on death certificates.

USE OF THE ICD

·         Monitoring of the incident and prevalence of the diseases

·         External cause of illness

·         Causes of death

·         Code of anti-microbial resistance

·         Code for patient safety frame work

·         Recording of rare diseases

·         Primary care setting

VERSION OF ICD

·         ICD-1:   1900

·         ICD-2:   1910

·         ICD-3:   1921

·         ICD-4:   1930

·         ICD-5:   1939

·         ICD-6:   1949

·         ICD-7:   1958

·         ICD-8:   1968

·         ICD-9:   1979

·         ICD-10: 1999

DAILY DEFINED DOSE (DDD)

·         The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.

·         It is a unit measurement

·         The DDD is differ from individuals and patient groups, they based on individuals’ characteristics (like, age, weight, type and severity of diseases) and pharmacokinetic consideration.

DDD GENERAL PRINCIPLE

·         To assign only one DDD per route of administration within an ATC code.

·         DDDs are not established for topical products, sera, vaccines, antineoplastic agent, allergen extract, general and local anaesthetics and contrast media.

·         DDD is based on the following principles;

o    The average adult dose recommended for the main indication as reflected by the ATC code.

o    The recommended maintenance dosage.

o    The treatment dose is generally used

o    A DDD is usually established according to the declared content (strength) of the product

o    Parenteral drugs that have different routes of administration have same DDD.

APPLICATION FOR DDD

FOR NEW DDD

·         Dose ranges and dosing instructions of the product information approved by one or more major regulatory authorities.

·         Proposal for a DDD.

·         Status concerning marketing authorization.

·         Doses used in clinical trials.

·         Market research data on doses.

·         Fitting the drug in ATC classification.

INTERNATIONAL NON-PROPRIETARY NAMES (INN)

·         International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients.

·         Drugs are generally marketed by their brand names through there is a legal requirement to mention generic names in the labels.

·         Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.

o    rINN – recommended International Non-Proprietary Name

o    PINN – Proposed International Non-Proprietary Name

·         Example:

o    INNS – Paracetamol

o    Chemical name: N (4-hydroxyphenyl acetamide)

HISTORY

·         INNs initiated in 1950 by World Health Assembly Resolution.

·         Operating in the year 1953

·         INN now stands at 7000 names designed, and this number is growing every year by some 120-150 new INN.

AIMS

·         To provide health professionals with unique and universal available designated name to identify each pharmaceutical substance.

·         For clear identification, safe prescription and dispensing of medicines to the patients.

·         For communication and exchange of information among health professionals and scientists worldwide.

·         Used in labeling, product information, advertising and other promotional material.

PROTECTION OF INN

·         British Approved Names (BAN)

·         De-Nomination Communes Franchises (DCF)

·         Japanese Adopted Names (JAN)

·         United State Accepted Names (USAN)

RIGHTS OF TRADE-MARK OWNERS

·         If in the period of four months following the publication of a proposed INN, a formal objection is filed by an interested person who considers that proposed INN is in conflict with an existing trade-mark.

·         WHO will actively pursue an arrangement to obtain a withdrawal of such an objection or will reconsider the proposed name.

·         As long as objection exists, WHO will not publish it as a recommended INN.