E-drug: Improving access and use of psychotropic medicines
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Dear E-druggers,
A while ago I asked you to share experiences and literature on
efforts to improve access and use of psychotropic medicines in
developing country contexts. I received a lot of materials (thanks!),
and used some of it in a manual I wrote for the WHO Department
of Mental Health and Substance Abuse, and the Department of
Essential Drugs and Medicines Policy.
The manual is part of a comprehensive Mental Health Policy and
Service Guidance Package, and can now be downloaded from:
www.who.int/mental_health/resources/policy_services/en/
Hard copies of the manual can soon also be ordered from the
WHO publications department. I printed the executive summary
below.
Thanks again for all your help.
Hilbrand
Hilbrand Haak
Consultants for Health and Development
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Sleedoorntuin 7 tel: +31-71-523.2052
2317 MV Leiden fax: +31-71-523.3592
The Netherlands e-mail: haakh@chd-consultants.nl
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Executive summary
Mental and behavioural disorders account for a large proportion of
the global burden of disease, but only a minority of those suffering
from such disorders receive basic treatment. Relatively few people
with mental disorders consult a physician. In developing countries,
health systems often are not able to provide even the most
essential mental care.
In the World Health Report 2001, a series of recommendations
were made on how to improve care for people with mental
disorders. The recommendations include improving access to a
limited selection of "essential psychotropic medicines". These are
medicines that satisfy the priority mental health care needs of a
population. They are selected with due regard to public health
relevance, and based on evidence of their efficacy, safety and
comparative cost-effectiveness. They can be used for the
treatment of symptoms of mental disorders, to shorten the course
of many disorders, reduce disability and prevent relapse. Not all
"effective" pharmaceutical therapies are "essential".
The experiences of many countries demonstrate that
improvements in the supply and use of medicines are possible.
Systematic knowledge on strategies to improve access to
medicines is also available. Yet over one-third of the world's
population currently lacks regular access to essential medicines.
Whereas psychotropics have many aspects in common with other
essential medicines, there are also several aspects that need
special consideration when improving access.
Improving access to psychotropics
Access of populations to essential psychotropics is determined by:
(i) a rational selection of medicines;
(ii) making prices affordable;
(iii) ensuring sustainable financing; and
(iv) availability of reliable health and supply systems.
Each one of these can enable or prevent effective treatment from
reaching those who need it.
In addition to the four determinants mentioned above, four other
issues are of key importance. These relate to:
(i) presence of strong mental health policies, which clearly
define a strategy to achieve improved access;
(ii) mental health legislation that enhances, rather than obstructs,
access;
(iii) appropriate use of psychotropic medicines to achieve
high quality mental care; and
(iv) systematic assessment and monitoring for continuous
maintenance and improvement of access to care.
All eight issues need to be considered in any plan aimed at
improving access to psychotropic medicines.
Mental health policies should clearly define the major issues and
objectives of access to psychotropics. They should also define the
respective roles of public, private (for-profit), and NGO
(not-for-profit) sectors in the financing and provision of these
medicines; identify organizational arrangements to meet access
objectives; set an agenda for capacity building and organizational
development; provide guidance to prioritize expenditure; and make
decisions on resource allocation. A policy, however well
formulated, is worth little if it is not translated into a programme of
action. Countries should not only develop and officially adopt
policies or plans of action, but also effectively implement them.
Legislation should define the responsibilities and authorities of all
actors in the system, and their responsibilities: who can produce or
import medicines, who can store and sell medicines, which
institution is responsible for monitoring and enforcing regulations,
and who can prescribe the various types of products.
International trade agreements, particularly the one on
Trade-Related Aspects of Intellectual Property Rights (TRIPS) -
and probably the most disputed agreement - may affect the
affordability of medicines in the future. TRIPS provides for a
minimum period of 20 years for patent protection for products and
processes; it may therefore prevent low-cost generic medicines
becoming accessible to populations. Legislation should be put in
place which would make full use of the TRIPS legal safeguards
such as compulsory licensing and parallel imports for medicines of
significant public health relevance. Countries are also advised to
be cautious about enacting legislation that is more stringent than
the actual TRIPS requirements.
Selecting a limited number of essential psychotropic medicines is
economical. It is one of the most cost-effective means of improving
mental health services. Careful selection facilitates bulk purchase
and easier management of medicines (storage and distribution),
and allows for a more rational and efficient approach to training in
prescribing and dispensing. Decisions about selecting psychotropic
medicines may be difficult when expensive medicines have some
advantages, such as milder side-effects, but higher costs as
compared to older medicines. In such cases, it is important to
calculate the cost of the overall treatment, as this may actually
prove to be lower for medicines that are more expensive on a
tablet-to-tablet (dose-to-dose) basis.
Achieving affordability of prices for essential psychotropics is
important in both the public and private sectors, especially as new
medicines are often very costly. Affordable prices are not only
important for people with mental disorders (PWMDs); other
persons may also benefit from effective treatment. Prices of
psychotropic medicines vary considerably between countries,
without obvious reasons; therefore their pricing cannot be left
solely to market forces. Indeed, active government involvement
and intervention would even be justified.
A number of strategies exist for lowering the prices of medicines.
These include making global drug price information broadly
available; using good procurement practices, professional price
negotiations, or direct price negotiations with manufacturers;
procurement by generic names; stimulating competition through
generic policies; and reduction or abolition of import duties or taxes
on essential (psychotropic) medicines. Control of profit margins or
mark-ups, or comparison with prices in other countries may also be
considered. Clear guidelines exist that document the key
operational principles for good pharmaceutical procurement. These
operational principles are based on four strategic objectives:
procurement of the most cost-effective medicines in the right
quantities, pre-selection of reliable suppliers of high quality
products, ensuring timely delivery, and achieving the lowest
possible total cost. Moreover, purchasing medicines in large
quantities may result in large discounts.
Financing mechanisms are crucial to the development of
sustainable mental health systems and the medicines needed by
them. There are five key principles for improving the financing of
health care and its requirements for medicines. They centre
around governments taking responsibility for financing basic health
care delivery and minimizing direct out-of-pocket expenditures by
the population, healthy people subsidizing the sick, the well-off
subsidizing the poor (especially in mental health, as people with
mental disorders are often poorer than others in the society), and
optimizing efficiency and cutting waste as far as possible.
Economic access to essential medicines can only be improved
when funds for their purchase are readily available, and when
high-level political support for rigid adherence to transparent tender
procedures can be ensured.
Effective supply systems rely on good design and management.
Operational planning and logistic skills are of key importance to
cost-effective distribution lines. Logistics teams should be staffed
by qualified people. Details on how to set up such systems are now
readily available from the standard essential medicines literature.
The quality of medicines on the market in several countries has
become a major cause for concern; surveys show that up to 20%
or more of sampled medicines failed quality control tests. Failure of
effective control mechanisms has led to the presence of fake or
sub-standard drugs in countries. Challenges concerning
regulations for medicines include licensing and inspection of sales
points and professionals, licensing and inspection of
manufacturers, registration of medicines, and post-marketing
surveillance. Quality must also be guaranteed throughout the
distribution chain, in all climates and by all methods of transport.
Promoting appropriate use of psychotropics
Appropriate use of medicines requires that people receive
medications appropriate to their needs, in doses that meet their
individual requirements, for an adequate period of time, and at the
lowest possible cost to them and their community. Inappropriate
treatment may lead to unnecessary suffering and death, iatrogenic
disease and hospital admissions. Inappropriate use may also lead
to wastage of resources. There are large variations in prescribing
psychotropic medicines among countries and health systems in the
world, and there is no clear explanation for this. Any medicines,
including essential ones, may be used inappropriately; an essential
medicines policy is by no means a guarantee for their appropriate
use.
Inappropriate use of medicines is caused by a wide range of
factors, including lack of adequate knowledge about prescription
and use, economic influences at all levels, lack of adequate
regulatory systems, cultural factors, community belief systems,
poor communication between prescribers and patients, and lack of
objective information on the medicines combined with commercial
promotion of the medicines. Poor prescribing for mental disorders
includes incorrect use of essential psychotropics and incorrect
prescribing of non-psychotropic medicines to treat mental
disorders. Poor adherence to (correctly) prescribed medications for
mental disorders occurs in both developed and developing
countries. Factors influencing the use of medicines include their
formulation, feeling better after therapy starts, and lack of regular
outpatient support and counselling on the need for continued
treatment. The most common non-compliant behaviour appears to
be underuse of prescribed medicines.
Practices in the use and prescription of medicines reflect human
behaviour, and must be understood from a social science
perspective rather than a biomedical perspective. Enabling people
with mental disorders to successfully initiate and adhere to
treatments depends on several factors, relating not only to
themselves but also to health care providers, health care systems
and the treatments prescribed.
When developing strategies to improve poor prescribing practices
(e.g. over- and underprescribing, prescribing the wrong kind of
medicine, or expensive brands when lower cost generics are
available) or poor adherence to treatment, it is essential first to
identify the extent of these problems and the reasons for them.
This can be done through quantitative and qualitative research
methods. There exist a variety of easily usable tools and
methodologies for this kind of research.
The choice of the assessment tool will depend on what is sought to
be improved and availability of resources.
Careful management of the assessment is absolutely necessary.
Quantitative and qualitative data, performance indicators, and
special-purpose analyses should be integrated into the overall
assessment methodology. Pharmaceutical management, in
particular, may need to be surveyed in detail to determine
efficiency and possible waste. Consumption analysis
methodologies, such as ABC (a ranking of drugs according to
which ones incur the largest budgetary expenditures) analysis and
vital, essential, non-essential (VEN) analyses, can be revealing.
Data collected during the assessments will need to be analysed,
with dedicated time and resources made available for this purpose.
Time for report writing needs to be reserved, as well as time for
presentation and discussions of the findings among larger
audiences.
Finally, a seven-step approach is presented for improving access
to psychotropics in a country or institution.
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