Access to essential drugs: towards fair financing strategies

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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 [phone] Fax [phone]
4730 E-mail ragol_at_who.int

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How can drug utilization studies help to
implement the strategy?
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WHO essential drugs medicines strategy -4
objectives guide country, regional, global work

• 1. National Drug Policy
• guide to coordination of action by all
  stakeholders
• 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
  private

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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
bioequivalence
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Quality and Safety- good work but weak promotion
(http//www.who.int/medicines)

• Global norms and standards in
• production and inspection
• quality control, model certificates etc.
• Requirements for drug registration and model
  legislation
• 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
  (DDDs)
• WHO Drug Monitoring Program
• guidance and capacity building for reporting
  adverse events
• network of 60 national pharmacovigilance centers

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Access first priority to WHO. Can ATC/DDD
based utilization studies help?
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How can drug utilization studies help to
implement the strategy?
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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

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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.)

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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
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Access

• 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

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Opioids (N02A) utilization in Estonia and
Finland (DDD/1000/day)
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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
  introduced
• Outcome probably less patients are suffering
  from chronic pain but situation is still not
  ideal

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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?

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Use of H2-receptor antagonists in Estonia and in
Stockholm County (DDD/1000/day)

• Data from R.A. Kiivet et al. The Lancet 1998,
  351146

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Use of proton pump inhibitors in Estonia and in
Stockholm County (DDD/1000/day)

• Data from R.A. Kiivet et al. The Lancet 1998,
  351146

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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)

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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
  exists

• Note In Estonia all prescription only drugs
  were reimbursed 50 above 50 EEK but not more
  than 200 EEK per prescription

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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

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Antiadrenergic and centrally acting drugs (C02A)
utilisation in Estonia, Finland and Norway
(DDD/1000/day)
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Utilization of thiazide diuretics (C03A) in
Estonia, Finland and Norway (DDD/1000/day)
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Beta-blockers (C07) utilisation in Estonia and
Finland (DDD/1000/day)
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ACE inhibitors (C09A) utilisation in Estonia and
in Finland (DDD/1000/day)
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Calcium channel blockers (C08) utilisation in
Estonia and in Finland (DDD/1000/day)
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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
  treatment
• Drug treatment of hypertension in Estonia
• In spite of considerable improvement still
  under-treated, also often mistreated
• Estonian prescribers do not like thiazides and
  beta-blockers
• 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

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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
  Oct24(5)375-80.
• 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,
  1998
• 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,
  1995
• 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.

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How can drug utilization studies help to
implement the strategy?
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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

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Future of ATC/DDD method

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

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Conclusions

• ATC/DDD based utilization studies can contribute
  to all four major objectives of WHO Medicines
  Strategy
• 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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