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					                        SETTING THE SCENE:

                                TRAINER'S NOTES

A growing number of pharmaceutical products are available on the world market
and there has been an increase, both in the consumption of drugs, and in expenditure
on them. But in spite of this, many people throughout the world cannot obtain the
drugs they need. There are also many people who do have access to drugs but who
do not get the right drug, in the right dosage, when they need it. The essential drugs
concept was developed in response to these problems and continues to be central to
policies and strategies that aim to address them. The essential drugs concept is
central to the development of national drug policy.

This session will provide an introduction to the essential drugs concept. A short
overview of the context in which it was developed and adopted will be given. This
will include a brief description of the main elements of primary health care (PHC)
and the role of essential drugs. This will be followed by a brief description of the
current world drug situation which will include problems relating to access to
essential drugs and to irrational use. It will also include a discussion of current
trends and challenges including:

   the growing role of the private sector
   changes in disease patterns
   the roles and interests of different actors, which will be analysed and discussed.

Upon completion of this session participants will be able to:

1. Understand the essential drugs concept in an historical perspective and in
   relation to PHC.
2. Recognise the main components of national drug policy.
3. Identify the major actors in the pharmaceutical context and discuss the roles they
4. Recognise some of the main trends and challenges in the world drug situation
Setting the scene: The essential drugs concept                               Trainer's Notes

1. The trainer should make sure that s/he has a copy of the SEARO video and has
   watched it in advance and is familiar with it. (Use the first half only).
2. The trainer should make sure that the video recorder is working and the film
3. Pieces of paper and fat felt tips are needed for the activity.
4. The trainer should read the Session Notes.
5. Read Essential Drugs Monitor No. 27 Getting Medicines to the People especially
   the article on Brazil National Policy, South Africa and NGOs.

Essential Drugs Monitor (no. 27). Geneva, World Health Organization.

Essential Drugs Monitor (no. 30). Geneva, World Health Organization.

Chetley A (1990) A Healthy Business. London, Zed Books.

WHO (2001) How to develop and implement a national drug policy 2nd ed. Geneva, World Health

This session is planned in four parts.
It is important that the trainer tries to elicit experiences from the group. This is an
introductory session that is intended to ensure that there is a shared body of concepts
and vocabulary that will be referred to throughout the course. At the same time it is
also a session which will set the scene in terms of participation and discussion.

Structure and timing of the session

Historical context – 30 minutes

National drug policy – activity discussion – 1 hour 15 minutes

Stakeholder roles - activity and discussion – 45 minutes

Trends and challenges - discussion – 30 minutes.

Setting the scene: The essential drugs concept                             Trainer's Notes

1. Title slide
2. Session objectives
3. History of medicine
4. Drug policy and use understood
5. Decline in TB (UK)
6. Deaths of children under 15
7. Early landmarks in drug development
8. Problems in providing access to medicine
9. Miracles turn to disasters
10. Major challenges
11. Essential drugs
12. Pioneering policies
13. Primary health care
14. Pharmaceutical gaps
15. National drug policy
16. Objectives South Africa, NDP
17. Economic objectives
18. Development objectives
19. Components of a national drug policy
20. Interests of different stakeholders
21. Current trends and challenges
22. Current trends and challenges (2)
23. Current trends and challenges (3)
24. Current trends and challenges (4)
25. Summary

(approx. 30 MINUTES)
A general introduction to the development of the pharmaceutical industry and to
“modern” drug therapy. An introduction to the Essential Drugs Concept and to its
development in the context of the development of PHC and public health ideas.

1)     Present objectives (OH 2)

2)     History of medicines (OH 3)
       (this OH is an ice breaker – talk about it with the participants)

3)     Drug policy and drug use understood in the context of (OH 4,5,6):
          Changing ideas about health and health care services
          The development of the pharmaceutical industry

Setting the scene: The essential drugs concept                          Trainer's Notes

        (OH 5 shows the steady decline in deaths from TB. The introduction of
       streptomycin was in 1948 and BCG vaccination 1952. OH 6 shows the deaths
       of children attributed to scarlet fever, diphtheria whooping cough and
       measles - mass vaccination and the availability of antibiotics - coming in the
       second half of the 1940s).

Explain that these two threads form a very complex and often contradictory pattern.
Discuss that progress in health has to a large extent not been dependent on medical
technology but on public health measures – example overheads. The two overheads
show the decline in TB and infectious children’s diseases – discuss which welfare and
public health measures and which medical technologies were relevant in the decline.

4)     The development of modern pharmacotherapy (OH7)
          Pharmacy: herbal medicines and patent remedies
          Chemical innovation during the 19th century
          Increased understanding of germs and bacteria
           Salvarsan was synthesised in 1910
           Penicillin first identified in 1928

This slide is intended to make clear how recently modern medicines have become

       After Second World War rapid developments
       Early landmarks in drug development
       1941 - Penicillin
       1943 - Chloroquine
       1944 - Streptomycin
       1948 - Tetracycline and chloramphenicol
       1954 - Sulphonylureas (diabetes)
       1955 - First oral contraceptive trials

5)     Problems in providing access to medicines (OH 8)
          Differences between rich and poor countries
          Differences between urban and rural populations
          Proliferation of brand name products
          Lack of information/evidence about therapeutic value

       Discuss the development of these with the participants.

6)      Miracles turn to disasters (OH 9)
Lack of regulation and adequate safety measures resulted in a series of disasters:

       1930s Sulphanilamide scandal resulted in the establishment of US FDA
       1960s Thalidomide (8000 children in 46 countries seriously handicapped)
       1950 - 1970s Diethylstilbestrol

Setting the scene: The essential drugs concept                           Trainer's Notes

       1970s Clioquinol caused widespread neurologic disease in Japan

Talk about these examples – which ones (or which others) affected their countries.

7)     Major challenges became evident (OH 10)
          Access
          Proper and safe use
          Harness drug development to peoples’ need

Discuss how these challenges have changed – or not.

8)     Essential Drugs (OH 11)
Essential drugs are those that satisfy the health care needs of the majority of the
population; they should therefore be available at all times in adequate amounts and
in the appropriate dosage forms. (WHO)

9)     Developments (OH 12)
       1940s Norway defined a list of priority drugs
       1960s and early 70s Sri Lanka, Cuba, Costa Rica - lists of essential drugs and
       bulk procurement
       1974 ILO adopted the idea of defining basic needs.
       1975 WHO defined “essential drugs”
       1976 First Model List of Essential Drugs produced and promoted by WHO
       1978 Declaration of Alma Ata
       1974 New International Economic Order
       1981 WHO Action Programme on Essential Drugs established
       1982 Bangladesh adopts national drug policy
       1985 WHO Conference of Experts in Nairobi

Discuss some of these examples – stress the fact that the ideas came initially from
country experience – both industrialised and developing.

10)    Primary health care (OH 13)
          Education about prevailing health problems and how to control and
           prevent them
          Promotion of food supply and proper nutrition
          Adequate supply of safe water and basic sanitation
          Maternal and child health care (including family planning)
          Immunisation against major infectious diseases
          Prevention and control of locally endemic diseases
          Appropriate treatment of common diseases and injuries
          Provision of essential drugs

Setting the scene: The essential drugs concept                           Trainer's Notes

Discuss problems in implementing PHC and introduce major constraints in current
situation (OH 14).

ACTIVITY 1 (1 HOUR) (OH 15-19)

(OH 15-19 are to be used in structuring and summarising the lessons from the
activity - they do not all have to be used as long as the main elements of NDP are

Participants will watch the video – SEARO Essential Drugs.

Show the first part of the video that portrays the drug situation in South-East Asia
(this is about 12 minutes long until the Bhutan section).

Provide each participant with pen and paper and ask them to make a note of every
“drug problem” they see referred to in this video.

There will be a considerable number – the trainer should make a note of all the
problems too.

The problems will include drug prices, poor quality, poor storage, drug promotion,
lack of regulation, etc

The participants should be divided into regional/country groupings. In groups the
participants should compare and discuss the problems identified.

1. How they could be tackled, i.e. by legislation, by education, by improving
   distribution. (This should provide an overview of the type of activities that need
   to be covered by a national drug policy).

2. Whether resources and energy are being spent in their country primarily on
   efforts to ensure rational procurement and adequate supply of medicines or
   whether the rational use of drugs (RUD) is also given adequate attention.

3. If RUD is part of the national drug policy, are efforts directed at prescribers
   mainly or are programmes to promote rational use of drugs by consumers also
   implemented; if yes, what is being done?

4. To what extent do the participants – in their country situation – have the potential
   to influence or have already some influence on rational use of drugs by
   consumers; what kind of influence do they have?

One group reports back to the plenary group. Other groups are asked to contribute
and to comment.

The trainer should draw some general conclusions and summarise.

Setting the scene: The essential drugs concept                            Trainer's Notes

ACTIVITY 2 (40 MINUTES - optional if time permits)

A complicated range of actors - conflicting interests
(OH 20)

15 minutes introduction.

This is a short activity, 15 minutes and 3 minutes report back per group. It is
intended to encourage discussion rather than to be an in-depth discussion.

The trainer should ask the country groups (very briefly) to discuss with each other
who are the important actors in their country in relation to pharmaceutical policy.
They should give the following actors marks out of 10 (for power and influence):

      National governments
      Pharmaceutical industry
      International organisations (WHO, World Bank, UNICEF. Etc.)
      Health professionals (doctors, pharmacists, nurses, etc.)
      NGOs
      Consumers
      Insurers.

Ask groups to compare notes and comment on differences.

Setting the scene: The essential drugs concept                            Trainer's Notes

Encourage participants to discuss which of these factors are especially important in
their countries.

Reduced role of government – what is the role of government has it changed?
(OH 21)

Increased role of private sector – how important is the private sector – is it
(OH 22)

Changing morbidity and mortality patterns – compare experiences of those from
Africa – or Newly Independent States. What are the most important shifts. AIDS –
Noncommunicable diseases? What are the consequences for drug use.
In particular time needs to be spent in discussing the consequences of AIDS/HIV for
drug policy.
(OH 23)

Changing relationships between health professionals and consumers/patients –
what are a consumer’s rights to information? How do health professionals deal with
questions/ Has this changed? Is there a consumer movement? Patients rights
(OH 24)

Summary (OH 25)

At the end of the session the trainer should reflect on experiences which the
participants have brought forward. S/he should also come back to the role of
consumers and their capacity to promote RUD in the community. S/he should come
back to some “take home”messages.

   There is a double problem of poor access and irrational use
   Health and drug policy are inextricably linked
   The Essential drugs concept is a key public health concept
   A national drug policy framework is crucial
   There are many stakeholders involved and a variety of different interests
   In the current context there are many new challenges and threats.


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