Anatomical, therapeutic

and chemical
classification of Drugs

~ Prepared and Presented by:

Ms. Neha Jain
(Associate Professor)

Ms. Neha Jain (Associate Professor) 1

Definitions:
ATC: Anatomical Therapeutic Chemical classification.

Don't confuse it with Anatomical Therapeutic (AT)classification

developed by European Pharmaceutical Market Research Association
(EPhMRA)

DDD: Defined Daily Dose

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

Ms. Neha Jain (Associate Professor) 2

Main Purpose:
International language for Drug Utilization (DU) research:
In-depth Detail: ATC/DDD serves as a universal framework,
facilitating standardized research methodologies and allowing for
seamless collaboration and comparison across international borders.

Tool for presenting DU research to improve quality of drug use:

Expanded Explanation: Utilizing ATC/DDD classifications,
researchers can dissect drug utilization patterns, identify areas of
improvement, and implement targeted interventions to enhance
patient outcomes and optimize healthcare delivery.

Ms. Neha Jain (Associate Professor) 3

Main Purpose:
Continued…
Presentation & comparison of drug consumption statistics at
national and international levels
Enhanced Insight: ATC/DDD system enables comprehensive
analyses of drug consumption trends, providing policymakers and
healthcare professionals with invaluable insights into healthcare
utilization dynamics on both a national and global scale.

 NOTE: The Classification Of A Substance In The ATC/DDD

System Is Not A Recommendation For Use, Nor Does It Imply
Any Judgments About Efficacy Or Relative Efficacy Of Drugs &
Groups Of Drugs

Ms. Neha Jain (Associate Professor) 4

Drawbacks of ATC/DDD System:
1. Limitations in Decision-Making:
While the ATC/DDD system serves as a cornerstone in drug
utilization research, it has inherent drawbacks that restrict its
applicability in certain critical areas of healthcare decision-
making.

2. Reimbursement Decision:
Challenge: The ATC/DDD system does not consider cost-
effectiveness or reimbursement policies when classifying drugs.
Impact: Reimbursement decisions based solely on ATC/DDD
classifications may overlook factors such as drug efficacy, patient
outcomes, and budget constraints.

Ms. Neha Jain (Associate Professor) 5

Drawbacks of ATC/DDD System:
Continued….
3. Pricing Strategies:
Challenge: Pricing decisions for pharmaceuticals are multifaceted and
influenced by market dynamics, production costs, and regulatory factors.
Impact: ATC/DDD classifications lack granularity in pricing
considerations, making it unsuitable for setting drug prices or
negotiating pricing agreements.

4. Therapeutic Substitution:
Challenge: Therapeutic substitution involves replacing one medication
with another that has similar therapeutic effects but differs in cost or
formulation.
Impact: ATC/DDD classifications may not adequately address
variations in therapeutic equivalence, leading to challenges in
implementing substitution policies effectively.
Ms. Neha Jain (Associate Professor) 6
The WHO Collaborating Centre for
Drug Statistics Methodology:
 Established in 1982 in OSLO.
 In 1996 WHO recognised the use of ATC/DDD as international std
for daily usage.
 Centre was at Norwegian Medicine Depot(NMD) till 2001 → From
Jan 2002, shifted to Norwegian Institute Of Public Health(Dept of
Pharmacoepidemiology).
 12 members from: Australia, Denmark, Ecuador, Ghana, India, Japan,
Morocco, Pakistan, Sri Lanka, The Netherlands, and Zimbabwe
 Two meetings annually:
 Approves all new ATC codes, DDDs and alterations.
 Responsible for scientific development
Ms. Neha Jain (Associate Professor) 7
Main activities of WHO Centre:

 To classify drugs according to the ATC system and assign DDDs.

 Review and revise as necessary.

 Stimulate and influence the practical use of the system

 Organize training courses in the ATC/DDD methodology

 Provide technical support to countries in setting up national

medicines classification system.

Ms. Neha Jain (Associate Professor) 8

ATC Main Group (14):
 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, Excl. Sex Hormones And Insulins
 J- Antiinfectives 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
Ms. Neha Jain (Associate Professor) 9
Structure of the ATC code:
 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)
Ms. Neha Jain (Associate Professor) 10
General Principles for ATC Classification:
 Drugs are classified based on their main
therapeutic use
 Only one ATC code for each ROA
 Several ATC codes:
 Clearly different therapeutic uses reflected in
different,
 Routes of administration (e.g. topical, systemic)
 Strengths

Ms. Neha Jain (Associate Professor) 11

"Simple" Codes:
 Linagliptin (e.g.Trajenta): Antidiabetic → DPP-4
inhibitor → A10BH05
 Lamivudine (e.g. Epivir): HIV → Antiviral →
J05AF05
 Sumatriptan (e.g. Imigran): Antimigraine → 5HT1
agonist → N02CC01
 Formoterol (e.g. Oxis): Antiasthmatic → ß2 agonist
→ R03AC13

Ms. Neha Jain (Associate Professor) 12

Different indications - one ATC code:
 Example duloxetine:
 Major Depressive Disorder (Cymbalta: 30mg,
60mg)
 Stress Urinary Incontinence (Yentreve: 20mg, 40mg)
 Diabetic neuropathic pain (Cymbalta)
 Overlapping dosages used for the various indications.
 ATC code as antidepressant (N06AX21)

Ms. Neha Jain (Associate Professor) 13

Several ATC codes - "one indication":

Bone diseases/osteoporosis ATC group

Vitamin D and analogues A11CC

Calcium supplement A12A
Estrogens/Tibolon/SERM G03C/G03F/G03X
Parathyroid hormones H05AA
Calcitonin H05BA
Bisphosphonates M05BA/M05BB

Ms. Neha Jain (Associate Professor) 14

Several ATC codes - different administration
forms and therapeutic use:
 Prednisolone:
 A07EA01 (Enemas and rectal foams)
 C05AA04 (Rectal suppositories)
 D07AA03 (Creams, ointments and lotions)
 H02AB06 (Tablets, injections)
 R01AD02 (Nasal sprays/drops)
 S01BA04 (Eye drops)
 S02BA03 (Ear drops)

Ms. Neha Jain (Associate Professor) 15

Defined Daily Dose (DDD):

 Assumed Average Maintenance Dose Per Day For A

Drug Used For Its Main Indication In Adults.
 DDD is nearly always a compromise based on a
review of the available information including doses
used in various countries.
 DDD is sometimes a dose that is rarely if ever
prescribed, because it is an AVERAGE of two or more
commonly used dose sizes.

Ms. Neha Jain (Associate Professor) 16

Concept of DDD:

 A technical unit of measurement, represents an

"average" daily dose for the main indication
For measuring & comparing volume of drug use
Should not be interpreted as the RDA/PDD
Reflects global dosage irrespective of genetic
variations.
Rough estimate of consumption & not an exact
picture of actual use

Ms. Neha Jain (Associate Professor) 17

Principles for DDD assignment:

 One DDD per ROA within an ATC code.

 DDD will NOT be assigned unless a product
is approved & marketed in at least one country.
 For substances indicated for rare disorders
with individual dosing DDD may not be
assigned.
 DDDs for herbal medicinal products are not
included in the ATC index.

Ms. Neha Jain (Associate Professor) 18

Sources used when assigning DDDs:

 Approved dose recommendations for the main

indication.
 Submitted documentation from the applicant,
textbooks, and data from clinical trials

Ms. Neha Jain (Associate Professor) 19

Commonly used measures to express drug
exposure in DDD:
1. DDDs/1000 inhabitants/day -
Ex: 10 DDDs/1000 inhabitants/day
1% of the population can receive a certain treatment daily.
2. DDDs /100 bed days – When drug use by inpatients.
Ex: 70 DDDs/100 bed days of hypnotics
70% of the inpatients might receive a DDD of a hypnotic every
day.
Useful for benchmarking in hospitals.
3. DDDs/1000 inhabitants/year – Estimate of the average number of
days for which each inhabitant is treated annually

Ms. Neha Jain (Associate Professor) 20

Selection of units:
1. G
2. Mg
3. Mcg
4. Mmol
5. U(unit)
6. TU(thousand U)
7. MU(million U)
8. UD(unit dose) → for combination products

Ms. Neha Jain (Associate Professor) 21

Codes for Route Of Administration:

1. Inhal = Inhalation
2. R = Rectal
3. N = Nasal
4. SL = Sublingual/buccal/oromucosal
5. O = Oral
6. TD = Transdermal
7. P = Parenteral
8. V = Vaginal

Ms. Neha Jain (Associate Professor) 22

Pediatric DDD:
 DDDs are normally assigned based on use in adults.
 For medicinal products approved for use in children, the dose
recommendations will differ based on AGE & BW.
 Pediatric DDDs cant be assigned

Applications of ATC/DDD:

 Drug utilization and Pharmacoepidemiology -

 PVG
 Regulatory intervention and impact of drug use

Ms. Neha Jain (Associate Professor) 23

ATC/DDD in DU Research:

 Study patterns of use and changes over time

 Evaluate the impact of information efforts, regulatory

changes etc.

 Study drug exposure in relation to ADR

 Indicate over-use, under-use and misuse/abuse of drugs

 Defines need for further Pharmacoepidemiology studies

Ms. Neha Jain (Associate Professor) 24

DU90%:
 Innovative approach to assess drug prescription.
 Assumption: Low Number Of Drugs Prescribed Is
Associated With More Rational Prescribing Practices.
 Does not directly reflect the quality of prescription.
 Used for exploring drug prescription in a rapid, effective
and inexpensive way.
 Reflects the number of drugs that account for 90% of drug
prescriptions & the adherence to local or national
prescription guidelines in this segment.

Ms. Neha Jain (Associate Professor) 25

National drug register - link to ATC/DDD:
 ATC codes should be linked correctly to the product
on the package level
 Number of DDDs per package should be calculated
 Procedures for updating the medicinal product
register according to the latest ATC/DDD version
should be introduced
 It is recommended that this task is administered by
persons with detailed knowledge of the methodology

Ms. Neha Jain (Associate Professor) 26

National drug register - link to ATC/DDD:
Continued..

Example of Drug register -

Unique Brand name Package ODD DDD/

Strength ATC code Generic name
identifier and formulation size value package

454173 Zocor tablets 20mg 100 C10AA01 simvastatin 30mg 66.67

Efexor depot
438454 150mg 98 N06AX16 venlafaxine 100mg 147
capsules

Ms. Neha Jain (Associate Professor) 27

ELECTRONIC PRESCRIBING :
 In Stockholm, a computer-based prescription support system, JANUS
telepharmacology, has been developed.
 Aims at providing all prescribers within a country with -
 Easily accessible
 Clinically relevant.
 Updated information on drugs.
 System Includes: Information and recommendations from –
 Regional and local drug committees in the county
 Recent guidelines from the medical products agency
 Links to the physicians desk reference
 Recent drug news with comments and evaluations by specialists.

Ms. Neha Jain (Associate Professor) 28

Success factors:

 Correct link of ATC code and DDD value (i.e. number of

DDDs/package) at the medicinal product package level.
 Request new ATC codes and DDDs if they are not available
 Describe the ATC/DDD version used, i.e. give proper
references in all publications and statistics

Ms. Neha Jain (Associate Professor) 29

CONCLUSION:

 ATC/DDD system is "the gold standard" for international

drug utilization research
 ATC/DDD is a tool for exchanging and comparing data on
drug use at local, national or international levels

Ms. Neha Jain (Associate Professor) 30

Multiple choice questions:

1. Which of the statements is not correct?

a) Drugs are classified according to their main therapeutic
use
b) Only one ATC code for each administration form
c) Only one ATC code for each substance.
d) ATC can be used for drug utilization researched.
e) DDD is linked to an ATC code

Ms. Neha Jain (Associate Professor) 31

Multiple choice questions:

2. Which of the statements is not correct? The ATC/DDD

methodology is applied to
a) assess drug use in the adult population
b) assess drug use in humans
c) assess use of drugs in hospitals
d) assess use of drugs in nursing homes
e) assess use of drugs in animals

Ms. Neha Jain (Associate Professor) 32

Multiple choice questions:

3. Brekkbein® is a new bisphosponate. It is indicated for

primary hyperparathyroidism, osteogenesis
imperfecta, and osteoporosis. Which ATC code would
you choose?
a) H05BX Other anti-parathyroids agents
b) M05BA Bisphosphonatesc)
c) M05BB Bisphosphonate combinationsd)
d) M05BC Bone morphogenic proteinse)
e) M05BX Other drugs affecting bone structure and
mineralisation

Ms. Neha Jain (Associate Professor) 33

Multiple choice questions:
4. Defined daily dose (DDD) is defined as
a) The DDD is the maintenance dose per day for a drug used
for its main indication in adults above 18 years
b) The DDD is the mean dose per day for a drug used for its
main indication in a country
c) The DDD is the dose per day for a drug used for its main
indication)
d) The DDD is the assumed average maintenance dose per
day for a drug used for its main indication in adults)
e) The DDD is the assumed average dose per day for a drug
used for its main indication
Ms. Neha Jain (Associate Professor) 34
THANK YOU
~ Ms. Neha Jain
(Associate Professor)

Ms. Neha Jain (Associate Professor) 35