· Any substances that, when administered via various form causes a temporary physiological and often psychological changes in the body.
· A chemical substance which when administered in the living organism, produce biological effect.
· A particular abnormal condition that affects the structure or function of organism, and that is not due to any external injury.
· The condition includes;
o Invade of pathogens
o Allergies condition
o Autoimmune disorder
ANATOMICAL THERAPEUTIC CHEMICAL CLASSIFICATION SYSTEM (ATC)
· The ATC system is used for the classification of active ingredients of the drugs according to the organ or system on which they act and their therapeutic, pharmacological and chemical, properties.
· The ATC system is controlled by World Health Organization Collaborating Center (WHOCC), established in 1976.
· The drugs are classified on the basis of therapeutic use of the active ingredient.
· Only one ATC code for each route of administration
· If two or more strength OR route of administration with CLEARLY different therapeutic use, the it can be given more than one ATC code.
· The drugs are classified into at five different levels.
· The code indicates the anatomical main group and consists of one letter.
· There are 14 main group
Alimentary tract and metabolism
Blood and blood forming organs
Genito-urinary system and Sex hormone
Systemic hormonal preparation excluding Insulin & Sex hormone
Anti-infective for systemic use
Anti-neoplastic and Immunomodulation agent
Anti-parasite, Insecticide, Repellent products
· The code indicates the therapeutic subgroup and consist of two digits.
· Example: CO3 – Diuretics
· The code indicates the therapeutic / pharmacological subgroup and consist of one letter.
· Example: CO3C – High-Ceiling Diuretics
· The code indicates the chemical / therapeutical / pharmacological subgroups and consist of one letter.
· Example: CO3CA – Sulfonamide
· The code indicates the chemical substance and consist of two digits.
· Example: CO3CA01 – Furosemide
SOME ATC CODES “V” CLASSIFICATION
INTERNATIONAL CLASSIFICATION OF DISEASE (ICD)
· The ICD is the international diagnostic tool for epidemiology, health management and clinical purposes.
· It providing a system of diagnostic codes for classifying diseases.
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
o INNS – Paracetamol
o Chemical name: N (4-hydroxyphenyl acetamide)
· 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.
· 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.
Hi….!! My name is Smrutiranjan Dash, From Odisha, India. Professionally I am a Teacher at The Pharmaceutical College, Barpali, Odisha, department of Pharmacology.