The Global Future of ATCDDD Methodology and Drug Utilisation Research

1
The Global Future of ATC/DDD Methodology and Drug
Utilisation Research
Summing up and Overview
Prof. Don Birkett

• Dept of Clinical Pharmacology
• Flinders University
• Adelaide, South Australia

2
Why the ATC/DDD System?

• has its difficulties but a perfect system is
  probably not achievable
• long experience with its use
• works well in practice
• adopted by WHO as the international standard
• EPHMRA system is broadly consistent with it

3
Globalising the ATC/DDD system

• developed in Europe and tends to be Eurocentric
• major pharmaceutical markets are Europe and the
  US
• BUT
• patterns of drug use and main indications in
  various countries may differ
• doses used (PDDs) in various ethnic groups vary
  widely

4
Drug Utilisation Issues in Developing Countries

• What is the volume of drug use
• How much is spent on drugs
• What drugs are being used
• How do patterns of use compare with those in
  similar countries
• How can data be obtained to inform policy and
  health planning
• acquisition, accessibility, quality, safety,
  quality of use, efficiency, cost containment

5
Drug Utilization Data and Antibiotic Resistance

• Drug Utilization data is needed to
• assess relationship of resistance development to
  antibiotic exposure
• target prevention and control measures
• identify and provide early warning of problems
• monitor the outcomes of interventions
• inform policy
• assess quality of care
• raise awareness in health professionals,
  consumers and policy makers

6
Global needs in Drug Utilization Research

• embed the availability of drug utilization data
  in National Drug Policies
• establish sources and types of data available in
  a variety of settings
• enhance the geographical use of the ATC/DDD
  system to allow valid international comparisons
  of drug use
• use of drug utilization data in process and
  outcome indicators for drug policy and quality
  use of medicines at national and international
  levels
• availability of PDD information from a variety of
  settings and ethnic groups
• regional training courses in use of drug
  utilization metrics and their application

7
WHO Working Group on Drug Statistics Methodology

• Representatives from all WHO regions
• manages and develops the ATC/DDD system with a
  global focus
• investigation of data sources in developed and
  developing countries
• antihypertensives and antimicrobials
• PDD project to inform allocation of DDDs
• Introduction to / guidelines for drug utilization
  studies

8
Use and Misuse of the ATC/DDD System

• Use of the system is not appropriate for
• pricing
• therapeutic reference group pricing (ATC)
• therapeutically equivalent doses (DDD)
• promotion
• claims based on inclusion or exclusion from an
  ATC class
• relative DDDs
• Drug utilisation data is necessary for
• monitoring cost effectiveness
• cost containment activities
• drug and health policy formulation and monitoring

9
Impact of a Generic Substitution Policy
10
Impact of a Generic Substitution Policy
Brand premium 5.06
11
Impact of a Generic Substitution Policy
Brand premium 0.71
12
Patient Tracking with Generic Substitution
13
Patient Tracking with Generic Substitution
14
Setting and Revising the DDD

• Initial DDD set on the basis of recommended doses
  and clinical trial data
• Revised after 3 years or on request using
  recommended doses and PDD data
• Principle is to maintain stability of the system
• Changes of less than 50 only considered at the 3
  year revision

15
Revising the DDD

• Companies request
• lower DDDs for their own drugs
• higher DDDs for competitors drugs
• small changes
• DDD leapfrogging
• change in DDD for one drug in a therapeutic group
  leads to requests to change DDDs for another
  drug followed by

16
Revising the DDD

• New or altered indications
• changes in doses used (PDDs) but not usually dose
  recommendations
• Initial DDD based on trial data with outcomes
• PDDs may not represent outcomes
• PDDs vary substantially between countries and
  ethnic groups

17
Prescribed Daily Doses for Antipsychotics

• Older (classical) drugs
• PDDs vary about two-fold and are much less than
  the DDDs
• Newer (atypical) antipsychotics
• PDDs vary about two-fold and are in the same
  range as the DDDs

18
AntidepressantsIndividual Patient Tracking

• ANTIDEPRESSANT n DDD
  Days supply Days to
  at DDD resupply
• 
  mg median
  
• Fluoxetine 20 mg, 30 15706 20 30 28
• Paroxetine 20 mg, 30 3997 20 30 30
• Moclobemide 150 mg, 60 7086 300 30 29
• Amitriptyline 25 mg, 50 19599 75 17 27
• Amitriptyline 50 mg, 50 3864 75 33 26
• Dothiepin 25 mg, 50 16059 150 8 29
• Dothiepin 75 mg, 50 17208 150 15 27

Source Drug Utilisation Subcommittee
19
International Drug Utilization Data

• Establish what types of data are available
• Develop ways to access available data
• establish and validate sampling mechanisms
• concentrate initially on one region
• Pilot studies on antihypertensives and
  antimicrobials

20
Conclusion

• Maintenance of the ATC/DDD system raises
  sometimes complex and sensitive issues
• Systems for monitoring drug use and costs need to
  be embedded in National Drug Policies
• Use of the international standard drug
  classification and metric system is necessary to
  allow valid international comparisons and
  aggregation of data
• Work is needed to develop and validate sources of
  drug utilisation data in developing and developed
  countries