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Access to essential drugs: towards fair financing strategies


4 objectives guide country, regional, global work. 1. National Drug Policy. guide to coordination of action by all stakeholders. 2. Access ... – PowerPoint PPT presentation

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Title: Access to essential drugs: towards fair financing strategies

WHO Medicines Strategy 2000-2003The Role of
Drug Utilization
Eurodurg Meeting 2001 7-9 June 2001, Prague,
Czech Republic Dr. Lembit Rägo Coordinator Quali
ty Assurance and Safety Medicines
(QSM) Essential Drugs and Medicines Policy
(EDM) World Health Organization 1211 Geneva 27
Tel 41-22 791 4420 Fax 41-22 791
4730 E-mail


How can drug utilization studies help to
implement the strategy?
WHO essential drugs medicines strategy -4
objectives guide country, regional, global work
  • 1. National Drug Policy
  • guide to coordination of action by all
  • 2. Access
  • selection, financing, pricing, supply systems
  • 3. Quality and safety
  • standards, classifications, effective drug
    regulation, information support
  • 4. Rational use
  • health professionals and consumers, public and

World Health Assembly resolution 54.11 21 May
2001 WHO Medicines Strategy
Having considered the report on the revised
drug strategy, bearing in mind the previous
report on the subject, that highlight challenges
related to the international trade agreements,
access to essential drugs, drug quality and
rational use of medicines, together with the
urgent need to improve access to treating
priority health problems such as malaria,
childhood illnesses, HIV/AIDS and tuberculosis,
among others REQUESTS Director-General
(3) to provide support for implementation of
drug monitoring systems in order better to
identify developing resistance, adverse reactions
and misuse of drugs within health systems, thus
promoting rational use of drugs (6) to provide
support to Member States to set up efficient
national regulatory mechanisms for quality
assurance that will help ensure compliance with
good manufacturing practices, bioavailability and
Quality and Safety- good work but weak promotion
  • Global norms and standards in
  • production and inspection
  • quality control, model certificates etc.
  • Requirements for drug registration and model
  • covers all key issues of generics
  • Guidelines
  • stability testing, bioequivalence, QA in
    pharmaceutical supply systems etc.
  • self-medication products, internet
    pharmaceuticals etc.
  • Nomenclatures, classifications
  • INNs (International Nonproprietary Names)
  • ATC classification and Daily Defined Doses
  • WHO Drug Monitoring Program
  • guidance and capacity building for reporting
    adverse events
  • network of 60 national pharmacovigilance centers

Access first priority to WHO. Can ATC/DDD
based utilization studies help?

How can drug utilization studies help to
implement the strategy?
Can drug utilization studies contribute to the
implementation of the WHO Medicines Strategy?
  • National Drug Policy
  • Drug utilization studies can contribute to making
    evidence based policy decisions
  • Access
  • Drug utilization data can demonstrate rate of
    access to the drugs
  • Drug utilization studies can help to optimize
    procurement and reimbursement lists
  • Quality and safety
  • ATC classification used by regulators. ATC/DDD
    based drug utilisation data can contribute to the
    decision making in relation to drug safety
  • Rational use
  • Drug utilization studies have great value for all
    aspects of rational drug use as they provide
    evidence based feedback on how drugs are used

National Drug Policy
  • Indonesia
  • used in 1980s drug utilization data in
    co-operation with Management Sciences for Health
    (MSF) comparing DDD based consumption data and
    morbidity estimate. Much over consumption of some
    (antibiotics) and under consumption of others was
    detected. Based on this study MOH rationalization
    of drug need estimates for procurement was
    carried out nationwide
  • unfortunately the system was dismantled after
    de-centralization in 1998).
  • Estonia
  • ATC/DDD based nation wide statistics has been
    used since 1990s to give evidence based feedback
    to the decision makers of policy (e.g. annual
    growth of consumption in DDDs and in comparison
    with consumption growth in terms of money etc.)

Information from money values statistics may not
give all necessary information to decision
makers Top 10 of prescription only drugs in
Estonia (1998 data)
- Top 10 - 11 of total consumption of drugs in
terms of money
  • ATC/DDD based utilization data can be valuable
    tool to measure access to the drugs
  • If morbidity data are available one can easily
    estimate which percentage of the patients was
    theoretically able to get the treatment
  • If morbidity data are not available, a comparison
    of ATC/DDD data with countries having similar
    epidemiological situation can give a rough
    estimate of access to certain drugs
  • In certain cases ATC/DDD data can be linked to
    measurable health outcomes - thus effect of
    increasing access to drugs can be demonstrated

Opioids (N02A) utilization in Estonia and
Finland (DDD/1000/day)
Chronic pain treatment in Estonia Explanations
to previous slide
  • Drug treatment of pain in Estonia before 1991
  • The choice of opioids was very limited
  • Only formulations for injection were available
  • Administrative limits to use opioids in
    ambulatory care
  • After 1991
  • The evidence from ATC/DDD studies was used to
    convince policy makers
  • Regulatory interventions, treatment guidelines
    and reimbursement of oral formulations also was
  • Outcome probably less patients are suffering
    from chronic pain but situation is still not

Ulcer disease in Estonia background to the study
  • Numbers of ulcer surgery (resections, vagotomies,
    other operations for ulcer disease) were high in
    Estonia before 1991
  • Histamine-2-receptor blockers and other modern
    antiulcer drugs were delayed reaching the market
  • In 1991 national authorities started to issue
    marketing authorizations, availability of modern
    drugs increased
  • Cimetidine was put immediately on the
    reimbursement list when the system was started in
    early 1993
  • Had these interventions any effect to the health?

Use of H2-receptor antagonists in Estonia and in
Stockholm County (DDD/1000/day)
  • Data from R.A. Kiivet et al. The Lancet 1998,

Use of proton pump inhibitors in Estonia and in
Stockholm County (DDD/1000/day)
  • Data from R.A. Kiivet et al. The Lancet 1998,

Quick decline of ulcer surgery after
introduction of cimetidine and other modern
antiulcer drugs
  • Ulcer surgery per 100 000 of population (Data
    from R.A. Kiivet et al. The Lancet 1998, 351146)

Case conclusions
  • Introducing modern antiulcer drugs considerably
    decreased surgery during three years further
    decline has been observed
  • Even restricted reimbursement of relatively cheap
    drugs (cimetidine) can have major impact on the
    health of population
  • Due to financial constraints and lack of firm
    superior efficacy data, no other H2 antagonists
    or proton pump inhibitors were included into the
    90 reimbursement list
  • Since 1998 a guideline for H. pylori eradiction
  • Note In Estonia all prescription only drugs
    were reimbursed 50 above 50 EEK but not more
    than 200 EEK per prescription

Rational use
  • Drug treatment of hypertension is recognized as a
    cost-effective intervention
  • Effective drugs do exist
  • Essential drugs to treat hypertension are cheap
  • Beta-blocking agents and thiazide type diuretics
    are drugs of first choice
  • The beneficial effect of ACE-inhibitors is well
    established as the usefulness of calcium-channel
    blockers is less clear
  • Estonia in 1991-1992 - hypertension ?
    interventions ...
  • High incidence of disease, and stroke
  • Under-treatment of hypertensive patients
  • Under-usage of effective and cheap drugs
    (beta-blockers, thiazide diuretics)
  • Need to educate (convince) medical doctors in
    rational use and start reimbursing the most
    cost-effective drugs

Antiadrenergic and centrally acting drugs (C02A)
utilisation in Estonia, Finland and Norway
Utilization of thiazide diuretics (C03A) in
Estonia, Finland and Norway (DDD/1000/day)
Beta-blockers (C07) utilisation in Estonia and
Finland (DDD/1000/day)
ACE inhibitors (C09A) utilisation in Estonia and
in Finland (DDD/1000/day)
Calcium channel blockers (C08) utilisation in
Estonia and in Finland (DDD/1000/day)
Case conclusions
  • Hypertension in Estonia
  • No evidence that in Estonia incidence of
    hypertension is less than in Scandinavia
  • No evidence of high level of non-pharmacological
  • Drug treatment of hypertension in Estonia
  • In spite of considerable improvement still
    under-treated, also often mistreated
  • Estonian prescribers do not like thiazides and
  • Therapeutic tradition?
  • Non-respect of evidence based medicine?
  • More active control of hypertension even with the
    present list of reimbursed drugs could possibly
    save more lives

Can small countries with limited resources do
ATC/DDD based drug utilzation studies?Some
references to the articles using ATC/DDD data
from Estonia
  • Pähkla R. Irs A. Oselin K. Rootslane L.. Digoxin
    use pattern in Estonia and bioavailability of the
    local market leader. Clin Pharm Ther. 1999
  • Kiivet RA. Dahl ML. Llerena A. Maimets M.
    Wettermark B. Berecz R. Antibiotic use in 3
    European university hospitals. Scandinavian
    Journal of Infectious Diseases. 30(3)277-80,
  • Kiivet RA. Bergman U. Rootslane L. Rägo L.
    Sjöqvist F. Drug use in Estonia in 1994-1995 a
    follow-up from 1989 and comparison with two
    Nordic countries. European Journal of Clinical
    Pharmacology. 54(2)119-24, 1998
  • Kiivet RA. Bergman U. Sjöstedt S. Sjöqvist F.
    Ulcer surgery in Estonia, a consequence of drug
    delay? Lancet 351(9096)146, 1998 Jan 10
  • Kiivet RA. Llerena A. Dahl ML. Rootslane L.
    Sanchez Vega J. Eklundh T. Sjoqvist F.
    Patterns of drug treatment of schizophrenic
    patients in Estonia, Spain and Sweden. British
    Journal of Clinical Pharmacology. 40(5)467-76,
  • Kiivet RA. Biba V. Enache D. Foltan V.
    Gulbinovic J. Oltvanyi N. Orazem A. Popova M.
    Stika L. Changes in the use of antibacterial
    drugs in the countries of Central and Eastern
    Europe. European Journal of Clinical
    Pharmacology. 48(3-4)299-304, 1995
  • Kiivet RA. Bergman U. Sjoqvist F. The use of
    drugs in Estonia compared to the Nordic
    countries. European Journal of Clinical
    Pharmacology. 42(5)511-5, 1992.


How can drug utilization studies help to
implement the strategy?
Difficulties of using ATC/DDD based drug
utilization in developing countries
  • Relatively little promotion to the method
  • Only limited good examples from developing
    countries available
  • Lack of understanding the potential it offers
  • Source data not readily available
  • Public sector may not use ATC classification
  • Private sector data not readily available
  • No recognised suitable for developing country
    needs software packages available
  • ...But good examples do exist (Estonia)
  • Resource constricts
  • Although good work can be done with limited
    resources some resources are still needed

Future of ATC/DDD method
  • What needs to be done?
  • Regional training courses to be initiated
  • Manual of Drug Utilization Studies to be
  • Good examples from developing countries collected
    and made widely available
  • Pilot projects initiated where appropriate
  • Better co-ordination of activities
  • Building partnerships

  • ATC/DDD based utilization studies can contribute
    to all four major objectives of WHO Medicines
  • Policy
  • Access
  • Quality and safety
  • Rational use
  • ATC/DDD based utilization studies can offer
  • classification system
  • tool for objective monitoring
  • additional evidence-base for decision making
  • ATC/DDD based utilization studies can be carried
    out with limited resources

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