DRUG AND DISEASE

CLASSIFICATION
SUBJECT: PHARMACOVIGILANCE

SUBJECT INCHARGE: DR. SUIKRITI SHARMA

COURSE: BPHARM

SEMESTER: VIII
Anatomical, Therapeutic and Chemical (ATC) Classification
of Drugs
• The Anatomical Therapeutic Chemical (ATC) system is a WHO recommended system, which categorizes drugs
based on their anatomical/pharmacological use, therapeutic effects, and chemical characteristics, facilitating drug
utilization research and improving quality of drug use.

• It is developed and maintained by WHO Collaborating Centre for Drug Statistics Methodology.

• Drugs are classified in groups at five different levels:

1. ATC 1st level : The system has fourteen main anatomical or pharmacological groups.

2. ATC 2nd level: Pharmacological or Therapeutic subgroup.

3. ATC 3rd & 4th levels: Chemical, Pharmacological or Therapeutic subgroup.

4. ATC 5th level: Chemical substance.

 ATC 1st level Classification
A Alimentary tract and Metabolism
B Blood and blood forming organs
C Cardiovascular system
D Dermatologicals
G Genito urinary system and sex hormones
H Systemic hormonal preparations, excluding sex hormones and insulins
J Antiinfective for systemic use
L Antineoplastic and immunomodulating agents
M Musculo-skeletal system
N Nervous system
P Antiparasitic Products, Insecticides and Repellents
R Respiratory System
S Sensory Organs
V Various
 ATC CLASSIFICATION

EXAMPLE: METFORMIN CLASSIFICATION

A Alimentary tract and metabolism
(1st level, anatomical main group)
A10 Drugs used in diabetes
(2nd level, therapeutic subgroup)
A10B Blood glucose lowering drugs, excl. insulins
(3rd level, pharmacological subgroup)
A10BA Biguanides
(4th level, chemical subgroup)
A10BA02 Metformin
(5th level, chemical substance)
• Thus, in the ATC system all plain metformin preparations are given the code A10BA02. For the chemical

substance, the International Non-proprietary Name (INN) is preferred.

• If INN names are not assigned, USAN (United States Adopted Name) or BAN (British Approved Name) names are

usually chosen.

• The coding is important for obtaining accurate information in epidemiological studies.

• The five different levels allow comparisons to be made at various levels according to the purpose of the study.
INCLUSION AND EXCLUSION CRITERIA

• The WHO Collaborating Centre in Oslo establishes new entries in the ATC classification on requests from the
users of the system. These include manufacturers, regulatory agencies and researchers.

• Active ingredients which fulfil one of the following criteria will normally be included in the ATC system:

1. They are new chemical entities (active ingredients) or biologicals proposed for licensing in a range of countries.
A new chemical entity is normally not included in the ATC system before an application for marketing
authorization is submitted in atleast one country.

2. They are existing well defined chemical entities used in variety of countries. An INN should preferably be
established for the active ingredient. Alternatively other official names. E.g. USAN or BAN names should be
available.
3. They are herbal medicinal products assessed and approved by regulatory authorities based on dossiers including

efficacy, safety, and quality data (e.g. the well-established used procedure in EU).

• Other medicinal products are considered on a case by case basis. Complementary, homeopathic and herbal

traditional medicinal products are in general not included in the ATC system.
 General Principles for ATC Classification

• Drugs are classified according to their main therapeutic use.

• Only one ATC code for each administration form.

• Several ATC codes: If a product clearly has different therapeutic uses (e.g., different strengths or routes of
administration), it can have multiple codes.

• Example: Acetylsalicylic acid (aspirin) can have multiple ATC codes depending on its use: A01AD05 for local
oral treatment, B01AC06 as a platelet inhibitor, and N02BA01 as an analgesic and antipyretic.

• Pharmacological subgroups: The 2nd, 3rd and 4th levels are often used to identify pharmacological subgroups,
which can be more appropriate than therapeutic or chemical subgroups.

• Example: Calcium Channel Blockers are classified in the pharmacological group C08, avoiding specifying
whether the main indication is coronary heart disease or hypertension.
CLASSIFICATION BASED ON MAIN THERAPEUTIC USE

• Medicinal products are classified according to the main therapeutic use of the main active ingredient even if the
drug has multiple uses.

• Example: Aspirin (B01AC06) is classified as an antithrombotic agent even though it can be used as an analgesic.

ONLY ONE ATC CODE FOR EACH ROUTE OF ADMINISTRATION

• Medicinal substances are classified according to the main therapeutic use or pharmacological class on the basic
principle of only one ATC code for each route of administration.

• Example: Diclofenac for rheumatoid arthritis, regardless of whether its oral, parenteral, or rectal, will have the
same ATC code (M01AB05).
MORE THAN ONE ATC CODE FOR A MEDICAL SUBSTANCE

• A medicinal substance can be given more than one ATC code if it is available in two or more strengths or routes of

administration with clearly different therapeutic uses.

• EXAMPLE OF DIFFERENT STRENGTHS: Finasteride

• Low strength tablet : Treatment of male pattern baldness is classified under D11AX – Other dermatologicals.

• High strength tablet: Treatment of benign prostatic hypertrophy (BPH) is classified under G04C – Drugs used in

BPH
• EXAMPLE OF DIFFERENT ADMINISTRATION FORMS

• Prednisolone in single ingredient products is given several ATC codes due to different therapeutic use and different
formulations.

A07EA01 Intestinal anti-inflammatory agents (enemas and foams)

CO5AA04 Antihemorrhoidals for topical use (suppositories)

D07AA03 Dermatological preparations (creams, ointments and lotions)

H02AB06 Corticosteroids for systemic use (tablets, injections)

R01AD02 Nasal decongestants (nasal sprays/drops)

S01BA04 Opthalmologicals (eye drops)

S02BA03 Otologicals (ear drops)

CLASSIFICATION OF COMBINATION PRODUCT

• Medicinal products containing two or more active ingredients are considered combinations and are given different

ATC codes from products with a single component.

• 5x Ending: For a combination product, the ATC code will usually end in 5x (e.g. M01AE52).

• Example:
 APPLICATIONS OF ATC CLASSIFICATION
• Drug Utilization Research (DUR): ATC coding system is designed to serve as a tool for drug utilization research,
aiming to improve quality of drug use.

• Standardized Coding: It provides a standardizes coding system for drugs, ensuring consistency and accuracy in
drug classification and coding.

• Data Comparison: It facilitates the comparison and analysis of drug utilization data across different regions and
countries.

• Pharmacovigilance: It can be used to link ADRs to various class of drugs, which helps in monitoring ADRs.

• Regulatory Purposes

• International Comparison
International Nonproprietary Names for Drugs (INN)

• International Nonproprietary Names (INN) for drugs are unique and globally recognized generic names assigned to

pharmaceutical substances or active pharmaceutical ingredients (APIs).

• The World Health Organization (WHO) manages and establishes these names to provide a standardized

nomenclature that can be used internationally, regardless of the specific brand or manufacturer of the drug.

• INNs are designed to facilitate clear communication among healthcare professionals, regulators, researchers,

and the public, and to promote the appropriate use of medicines.

• Initiated in 1950 by World Health Assembly resolution, began operating in 1953.

• At the start it had approximately 150 drugs, and at present approx. 7000 names are designated in the INN
• Since its establishment, the aim of INN has been to provide healthcare professionals with a unique and universally

available designated name to identify each pharmaceutical substance.

• INN is important for clear identification, safe prescription and dispensing of medicines to patients, and for

communication and exchange of information among healthcare professionals and scientists worldwide.

• Names of pharmacologically-related substances in the INN system is demonstrated by using a common “stem”.

Example “azole” for PPIs.

 MODIFIED INN (INNM)

• In principle, INN are selected only for the active part of the molecule which is usually the base, acid or alcohol.

• In some cases, however, the active molecules need to be expanded for various reasons, such as formulation

purposes, bioavailability or absorption rate. In 1975 the experts designated for the selection of INN decided to

adopt a new policy for naming such molecules.

• Modified INNs, or INNM, are used for salts, esters, and other modifications of the core INN substance. For

example, oxacillin and ibufenac are INN and their salts oxacillin sodium and ibufenac sodium are INNM..
 USES OF INN
• Global standardization

• Facilitation of communication

• Pharmacovigilance

• Pharmacopoeias

• Labelling

• Drug regulation

• Scientific literature
 SELECTION OF INN
• The names which are given the status of an 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 manufacturer or investor.

2. Review of the request a proposed INN is selected and published for comments.

3. A recommended INN will be published if no objection has been raised.

• Newly selected, proposed INN 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.
• Users are invited to refrain from using the proposed name until it becomes a recommended INN, in order to avoid
confusion should the name be modified.

• Two lists of proposed INN are published yearly.

• 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.