S-103 33 Stockholm
National
pharmaceutical
strategy
Action plan 2013
Production: Blomquist Annonsbyrå
Print: Edita Västra Aros, Västerås, 2013
Photography: Johnér Bildbyrå
Article number: S2013.008
Foreword
The Government and the Swedish Association of Local Authorities and Regions, together with a
number of actors in the pharmaceutical field, developed the national pharmaceutical strategy in 2011.
The aim is to harness national efforts on priority areas for improvement in the pharmaceutical field.
The strategy contained around thirty planned activities in different action areas. The need to follow
up the strategy at the level of both action and goals was already emphasised at the time when the
national pharmaceutical strategy was drawn up. Follow-up of the actions shows that three activities
have attained their goals and can be closed. Among other things, all the county councils have set up
local Strama groups (Strategic Group for Rational Use of Antibiotics and Reduced Antibiotic Resistance) that work on ensuring rational use of medicines and reduced antibiotic resistance. Work aimed
at assuring the sickest elderly of safe and appropriate pharmaceutical treatment has also progressed.
This has been done in part by drawing up guidelines on how account should be taken of the sickest
elderly people in the application of national guidelines for different disease groups. In addition, regulations concerning when medication reviews are to be offered to elderly patients who take many different medicines have been completed.
Extensive efforts have been made under the national pharmaceutical strategy and its 2011–2012 action
plan, and together these have enabled Sweden to come one step closer to putting the strategy goals
into effect:
•
•
•
•
•
World-class medical results and patient safety
Equality of care
Cost-effective use of medicines
Attractiveness for innovation of products and services
Minimal environmental impact
Work under the national pharmaceutical strategy in 2013 will focus principally on implementing the
activities decided upon in the 2011 action plan. New activities relating in particular to the activity of
the pharmacies and pharmaceutical training for doctors are being added to the action plan, while work
aimed at equal pharmaceutical treatment for the whole population are being added and intensified.
Follow-up of the 2011–2012 action plan shows that there are still substantial challenges requiring
ambitious, coordinated and transparent cooperation between all actors in the pharmaceutical field
in order to come closer to the vision of correct use of medicines to the benefit of patient and society.
Göran Hägglund
Minister for Health and Social Affairs
Anders Knape
Chair, Swedish Association of Local Authorities and Regions
3
Contents
Introduction5
National pharmaceutical strategy
6
A national pharmaceutical strategy
7
Vision7
Goals7
Action areas
7
Follow-up7
Other initiatives and strategies
7
Many actors work together on medicines
8
Goals of the pharmaceutical strategy
9
World-class medical results and patient safety
9
Equality of care
10
Cost-effective use of medicines
10
Attractiveness for products and services
10
Minimal environmental impact
10
Action areas of the pharmaceutical strategy
11
Create a better and safer prescribing process and lay the foundation
for generic prescribing through nationally coordinated IT support
11
Increase consensus on and understanding of prescribed treatment
11
Develop knowledge about and guidelines for medicines and the use
of medicines for those patients where this is most neglected
11
Reduce the development and spread of antibiotic resistance through
a combination of local and global actions
11
Develop a long-term sustainable pricing, prioritisation and financing
model for all medicines
12
Establish a process for orderly and effective introduction and expanded
follow-up of the use and effects of medicines
12
Reduce the impact of medicines on the environment locally
and globally
12
Follow-up of national pharmaceutical strategy
12
Organisation and implementation of the pharmaceutical strategy
13
Action plan 2013
14
References35
4
Introduction
The report "A national pharmaceutical strategy? – a
preliminary study" (S2010/6349/FS) was presented in the
summer of 2010. This describes challenges in the pharmaceutical field. The preliminary study noted that a
national pharmaceutical strategy is required in order to
address these challenges jointly. In the autumn of 2010
the Ministry of Health and Social Affairs therefore appointed a high-level group and a project group to draw
up a national pharmaceutical strategy.
The groups contained representatives of the Medical
Products Agency, the Dental and Pharmaceutical Benefits Agency, the National Board of Health and Welfare,
the Swedish Council on Technology Assessment in
Health Care and the Swedish Institute for Infectious
Disease Control. They also contained representatives
from the Swedish Association of Local Authorities and
Regions and a number of county councils and regions, as
well as the medical profession, the pharmaceutical industry and the pharmacy sector. Representatives of sector organisations, professional associations and interest
groups also took part in the work during the preparation
of the preliminary study.
In the autumn of 2011 the preliminary study led to a
national pharmaceutical strategy containing the vision
of Correct Use of Medicines to the Benefit of Patient and
Society, five long-term goals and an action plan containing seven action areas. The action plan contained over 30
activities linked to the action areas.
Extensive efforts have been made under the national
pharmaceutical strategy and its 2011–2012 action plan,
together enabling Sweden to come one step closer to
putting the goals of the strategy into effect:
•
•
•
•
•
World-class medical results and patient safety
Equality of care
Cost-effective use of medicines
Attractiveness for innovation of products and services
Minimal environmental impact
There is wide agreement that the activities in the action
plan are crucial and that it is important that they are
implemented, as evidenced among other things by horizon scanning coordinated by the office of the Centre for
Rational Use of Medicines (CBL) at the Medical Products
Agency which has been commissioned by the Council on
Rational Use of Medicines.
Several simultaneous strategies and inquiries have
been highlighted as important for coordination with the
National Pharmaceutical Strategy, such as the Medicines
and Pharmacies Inquiry, the conversion of Apotekens
Service AB to an infrastructural authority, the action
plan for IT and medicines, the Research Bill, the innovation strategy, the initiative on the elderly, the patient
safety strategy and the eHealth strategy. Action to coordinate this work has started.
As outlined above, there is continued support for all the
activities in the action plan. Some areas that have been
given somewhat higher priority than others in the horizon scanning are as follows.
• Generic prescribing
• Medication reviews
• Development of knowledge and guidelines for medicines and pharmaceutical treatment for those groups
of patients where this is most neglected.
• Efforts to tackle the spread of antibiotic resistance
and
• Orderly introduction and structured follow-up
The need to follow up the strategy at the level of both
action and goals was already emphasised at the time
when the national pharmaceutical strategy was drawn
up. The 2011–2012 action plan has principally been followed up at the level of action. The ambition in 2013 is to
continue to develop the goals and indicators of the strategy and to endorse, validate and coordinate these. This
work will be directed by the Medical Products Agency
and coordinated with affected authorities and organisations.
5
National
pharmaceutical strategy
6
A national pharmaceutical strategy
The national pharmaceutical strategy shows in what
direction the use of medicines should be developed in
order to become more effective and safe for patients. The
vision of the strategy indicates the direction to be taken
for an overarching plan. Five goals have been linked to
the vision. Development towards the strategy's five goals
is required to guide the use of medicines in the direction
of the established vision. These have been broken down
into seven action areas.
The high-level group, which directs the work on the
national pharmaceutical strategy, has submitted pro­
posals for actions in each action area which are presented
in a separate action plan. The Government and the
Swedish Association of Local Authorities and Regions
have developed the national pharmaceutical strategy,
while the actions contained in the action plan are
proposals that need to undergo further development.
Vision
Correct use of medicines to the benefit of patient and society
The vision is formulated to safeguard the interests of
both the individual patient and society in appropriate
use of medicines. If used correctly, medicines are a great
asset for both the patient and society. Correct use of
medicines means that it is both safe for patients and
effective: the right medicine for the right patient on each
individual occasion. The goal ultimately is to use medicines in as cost-effective a way as possible in order to be
able to achieve the greatest possible health for the resources allocated to medicines.
Goals
Five long-term goals based on the principal challenges
Sweden faces in the pharmaceutical field have been
linked to the vision of correct use of medicines to the
benefit of patient and society:
• World-class medical results and patient safety
• Equality of care
• Cost-effective use of medicines
• Attractiveness for innovation of products and services
• Minimal environmental impact.
Action areas
To bring about development within the established goals,
these have been broken down into seven action areas. It
is important to develop these action areas in order to
achieve the goals of the strategy:
• Create a better and safer prescribing process and
lay the foundation for generic prescribing through
nationally coordinated IT support
• Increase consensus on and understanding of
prescribed treatment
• Develop knowledge about and guidelines for medicines and the use of medicines for those groups of
patients in which this is most neglected
• Reduce the development and spread of antibiotic resistance through a combination of local and global
actions
• Develop a long-term sustainable pricing, prioritisation
and financing model for all medicines
• Establish a process for orderly and effective introduction and expand follow-up of the use and effects of
medicines
• Reduce the impact of medicines on the environment
locally and globally.
Development work in these action areas entails a broad
approach and a high level of ambition in order to attain
better and safer use of medicines.
Follow-up
The pharmaceutical strategy has a high level of ambition
with regard to follow-up of the pharmaceutical field. The
follow-up will take place at the level of action and goals.
The follow-up at action level will describe how development work is progressing, while follow-up at the level of
goals is more general. This part of the follow-up will
provide a coherent picture of development in the pharmaceutical field. An important but complex part of the
work under the pharmaceutical strategy is therefore the
development of indicators.
Other initiatives and strategies
The Government has launched initiatives and strategies
in several areas, in a number of cases in collaboration
with the Swedish Association of Local Authorities and
Regions. Among these, mention can be made of the patient safety initiative, focusing on antibiotic resistance,
the initiative for the sickest elderly people and National
eHealth. The Government has also initiated work aimed
at establishing a national innovation strategy and developing healthcare quality registers. In addition, the Government has decided to give the All-Party Committee on
Environmental Objectives an additional remit to devise a
7
strategy for Swedish work internationally towards a nontoxic environment.
In June 2011 the Government decided to appoint an
inquiry chair to conduct a review of issues relating to
pricing, availability and market conditions in the area of
medicines and pharmacies. The main terms of reference
for the inquiry describe the parts of the remit concerned
among other things with automated dose dispensing and
the trade in veterinary medicines. The Government
intends to return with additional terms of reference to
look in greater detail at the issues concerning the pricing
of medicines.
The pharmaceutical field spans a large part of the
healthcare sector. The efforts required to attain development towards the goals of the pharmaceutical strategy to
some extent belong in other initiatives and strategies.
Examples of such efforts are those required to bring
about a better and safer prescribing process in which
many actions are managed by National eHealth. On the
other hand, follow-up of the national pharmaceutical
strategy will cover all actions with a bearing on the strategy. This means that the national pharmaceutical strategy is closely linked to several of the Government's other
initiatives and strategies.
Many actors work together on medicines
Work towards attaining the vision of correct use of medicines to the benefit of the patient and society brings
together a large number of actors. At the centre is the
patient, with medical needs that pharmaceutical treatment has to meet. The doctor's responsibility is to make
the correct diagnosis and together with the patient to
weigh up various treatment options, establish treatment
aims and then follow up the effects of the prescribed
treatment.
The doctor generally has the main responsibility for
prescribing medicines, but other professional groups also
have the right to prescribe, such as dentists, dental hygienists, midwives and nurses with special additional
training. Various forms of support are available at the
time of prescribing, for example the summary of product characteristics of the medicinal product and recommendations from the pharmaceutical committees.
National actors such as the National Board of Health and
Welfare and the Medical Products Agency issue national
guidelines and treatment recommendations relating to
different pharmaceutical areas. In addition, electronic
decision-support tools contribute various types of know­
ledge support.
Pharmaceutical companies, pharmaceutical whole­
salers and pharmacies are all key actors in ensuring that
medicines are available when the patient needs to collect
them from a pharmacy. Pharmacists and dispensers also
have an important part to play in maintaining use of
8
medicines that is good and safe for patients. They must
as far as possible ensure in the meeting with the patient
that the patient is able to use the medicine in the correct
way and discover, prevent and reduce the effect of medication-related problems. After collecting the medicine,
the patient is responsible for it being used correctly.
Relatives or municipal staff (for example nursing auxiliaries and assistant nurses in the home help service and
special housing) often contribute by collecting and
administering medicines.
The pharmacies annually have around 100 million
meetings with patients/clients and therefore represent a
large interface for dialogue based on the patient's needs,
with the aim of the patient gaining the greatest possible
benefit from the prescribed pharmaceutical treatment.
The actors in the re-regulated pharmacy market show a
high level of ambition which, beyond increased availability, offers new opportunities for an increased range of
services in the pharmaceutical chain. With collective
expertise and broad pharmaceutical knowledge, it is
anticipated that the pharmacies will continue to represent an important party and channel for rational use of
medicines, focusing on the usability and efficacy of medicines in the patient's daily life.
In in-patient care it is often nurses who deal with
organising and other management of medicines. After
treatment has been started, there is a need for the medicine's effects and side effects to be monitored. This is
done in dialogue between the patient and the attending
doctor, and can lead to adjustment, switching or discontinuation of medication. Other professional groups in
the healthcare system also contribute to this process.
New knowledge can be obtained and improvements
carried out through systematic follow-up of the pharmaceutical treatment and of prescribing, organisation, handling and administration. Several actors are important in
the follow-up and development of new knowledge, for
example patients, the health service, pharmacies, universities, pharmaceutical companies and government agencies. These actors all have their own roles and responsibilities to bring about attractiveness for innovations.
Continued development of new medicines is necessary to face up to future challenges in the healthcare
system. New medicines or areas of treatment undergo
careful and systematic clinical testing. If the clinical
trials show favourable results, the companies can apply
to register the medicinal product. This is an EU-wide
process, in which the key Swedish actor is the Medical
Products Agency. The companies can then apply for
prescription-only medicines to be included in the pharmaceutical benefits scheme. Applications have to be
submitted to the Dental and Pharmaceutical Benefits
Agency, which makes decisions on admission to the
scheme and sets prices.
The county councils formally took over cost responsi-
bility for pharmaceutical benefits from central government in 1998. At the same time, a special government
grant to the county councils towards the costs of these
benefits was introduced. Central government and the
Swedish Association of Local Authorities and Regions
enter into agreements at regular intervals on the form
central government reimbursement of the county councils is to take. Medicines used in in-patient care are not
included in the pharmaceutical benefits scheme and are
paid for directly by the county councils.
When a new medicine starts to be used in everyday
clinical practice, there remains a need to systematically
gather experience on how the medicine works outside of
clinical trials so that the clinical data on efficacy and side
effects in actual use can be obtained.
An important part of the use of medicines relates to
the handling of medicines with respect to their environmental impact. Part of the work on the environmental
quality objective A Non-Toxic Environment, which is
coordinated by the Swedish Chemicals Agency, is concerned with minimising the impact of medicines on the
environment. Several government agencies are working
on the impact of medicines on the environment, for
instance the Swedish Environmental Protection Agency
works on environmental monitoring and environmental
research and also addresses the issue of the impact of
medicines on the environment. The Medical Products
Agency also deals with these issues. In June 2011 the
Agency submitted a report to the Government on pharmaceutical manufacturing from the environmental perspective.
Many actors are thus involved in the life cycle of medicines and are of crucial significance in contributing to
better health and use of medicines that is safe for patients and effective. The national pharmaceutical strategy is to establish joint priorities and goals to bring about
correct use of medicines to the benefit of the patient and
society.
Goals of the pharmaceutical strategy
The goals of the pharmaceutical strategy are as defined
in the preliminary study. They span a wide part of the
pharmaceutical field and are to direct the use of medicines towards the vision of the strategy. This broad approach means that the strategy is aimed at a large number of actors, directly or indirectly affected by the use of
medicines.
World-class medical results and patient safety
Medical results and world-class patient safety are a crucial goal of the pharmaceutical strategy. Medicines are an
enormous asset in attaining health and improved quality
of life. However, if this is to be achieved there is a need
for medicines to be used effectively and in a way that is
safe for patients. A fundamental requirement to be met
for this purpose is, as far as possible, to prevent incorrect
use of medicines resulting in harm and human suffering.
Incorrect medication or an inappropriate combination
of different medicines is one of the greatest risks patients
face in their contacts with the healthcare system. Causes
of such errors may be lack of a complete picture of the
patient's total use of medicines or absence of electronic
decision-support systems for the prescriber warning of
interactions or other incorrect medication. Many cases
of incorrect treatment would be avoided if the right tool
was used.
Today there are ever improving technical and statu­
tory ways of offering prescribers, pharmacologists and
patients themselves access to relevant information about
current medication in order to avoid this risk. Electronic
decision-support systems are still not as widespread in
medical and social care as they need to be. Greater use of
electronic decision-support systems would make the
spread of new knowledge, treatment guidelines and recommendations, for example, more efficient. This could
bring about considerable improvements with regard to
patient safety, quality of life and cost-effectiveness.
The Government regards improving patient safety in
the healthcare system as being so important that a special initiative is also being taken in this area. This initiative is being taken under an agreement between central
government and the Swedish Association of Local Authorities and Regions with the goal of safer care for the
patient with fewer medical injuries and more active work
on patient safety. This in turn leads to reduced suffering,
fewer re-operations, fewer bed days and less sickness
absence from work. The initiative is based on a zero
vision with regard to the number of avoidable medical
injuries.
The sickest elderly are least satisfied with the health
and social care provided. There are clear deficiencies in
the healthcare system with regard to management of the
sickest elderly. Health and social care is often not organised or else there are no incentives to deal appropriately
with elderly people with extensive or rapidly changing
needs. There is often a lack of continuity, overview and
collaboration. It is therefore easy for elderly people not to
be noticed despite many contacts and large numbers of
staff. This group accounts for more than half the total
costs of the healthcare system today. This is a situation
that needs to be improved. The Government has therefore taken an initiative to improve collaboration in health
and social care regarding the sickest elderly. This is being
done in collaboration with the Swedish Association of
Local Authorities and Regions and affected authorities.
The development and spread of antibiotic-resistant
bacteria is a serious threat to health, both in Sweden and
globally. The situation with regard to antibiotic resistance and use of antibiotics in Sweden has been, and con-
9
tinues to be, favourable in comparison with most other
EU Member States. Prescribing statistics from open
comparisons of the quality and effectiveness of healthcare shows that the proportion of the population treated
with antibiotics declined between 2006 and 2009. All
the county councils are thus consistently showing a positive trend, but there is still reason to focus on reducing
the use of antibiotics. Central government and the Swedish Association of Local Authorities and Regions have
agreed, under the patient safety agreement, on performance-based payment to healthcare providers who set
up a local Strama group (Strategic Group for Rational
Use of Antibiotics and Reduced Antibiotic Resistance).
The Strama group's remit includes working at regional
level towards rational use of antibiotics and reduced
antibiotic resistance.
Equality of care
The care offered to patients must be equal. Care must be
of good quality for everyone, and availability must be
good for both women and men, born abroad and in Sweden, regardless of age, place of residence, education, economic circumstances, illness or disability. The care offered must, as far as possible, be based on the individual
patient's needs.
The requirement for care to be equal obviously also
applies to pharmaceutical treatments. Parts of the patient safety agreement are specifically targeted at equality of care. The endeavour to achieve equal care must be
reflected in the comparisons made in the follow-up of
the use of medicines. This is therefore an area on which
attention will be focused in particular in the follow-up
of the pharmaceutical strategy.
Cost-effective use of medicines
Value-based pricing of medicines is applied in Sweden.
This means that the price of the medicine reflects the
expected benefit from the pharmaceutical treatment.
The benefit to both patient and society therefore has to
be valued to enable the price of a medicine to be set. The
aim is for value-based pricing to lead to rational and
effective pharmaceutical treatment where the patient's
need for medication is related to its cost.
Since 2002 Sweden has applied generic substitution in
pharmacies, which means that when there are generic
versions of a prescribed medicine the pharmacies are
obliged to make sure that the customer is offered the
cheapest medicine. Generic substitution has been an
important factor in making the use of medicines more
cost-effective.
Future challenges, including an ageing population,
will require continued progress with regard to cost-effective use of medicines. It is important to create as much
health in the population as possible with the resources
allocated to medicines.
10
Attractiveness for products and services
Sweden has a strong and innovative life science industry
and internationally strong clinical research. Close collaboration between the healthcare system and business has led
to a large number of internationally successful innovations, and this has made a strong contribution to the development of the Swedish life science industry. Collaboration on the development of medicines, methods and
treatments has also strengthened clinical research. Sweden also has strong biomedical and clinical research and
access to unique infrastructure such as national quality
registers, biobanks and other databases and registers.
Clinical research represents an important link in the
path of a medicine from the laboratory to treatment of
the patient. Clinical research is essential to the development of new products and services in the area of healthcare, and contributes to both good quality in medical
care and high skill levels among medical personnel. It is
important to create good conditions for continued strong
Swedish clinical research, but also to safeguard the quality and implementation of research. The development
and use of innovative solutions and more effective collaboration with companies and the healthcare system
can make it easier to cope with future challenges posed
by an ageing population.
The Government sees a need for effective tools for the
follow-up of medical results and the development of
activity to the benefit of the individual patient. A review
of the national quality registers ("Guldgruvan i hälsooch sjukvården", Rosén et al, 2010) has proposed that
these registers need to be developed. As a consequence
of this, the Government and the Swedish Association of
Local Authorities and Regions agreed to appoint a
national coordinator for the development of national
quality registers, tasked among other things with developing the organisational proposals and presenting proposals
for long-term funding of the quality registers based on
the review and the associated consultation process.
Minimal environmental impact
Pharmaceuticals often contain several active substances
which may potentially have an environmental impact.
The environmental risk assessments that have been carried out show that the present-day use of medicines does
not cause a risk of acute toxicity to aquatic organisms,
but may pose a risk of long-term effects and cause pollution of drinking water. There is a need for further longterm studies in order to be able to predict the potential
long-term environmental risk of a medicinal substance
with greater certainty. Information is often lacking on
how the substances are affected and distributed in the
environment.
There is also a need to study combined biological effects of different medicines in the environment. There
are still significant gaps in knowledge of what effects
pharmaceutical residues cause, for example in the form
of contamination of drinking water, and what effects on
human animal health this can produce in the longer
term. In addition, there is a lack of knowledge on what
strategies and methods are most effective so that medicines are not dispersed to the environment, for example
knowledge regarding what action could be taken to reduce discarding of medicines and what measures could
be taken at sewage treatment plants.
Action areas of the pharmaceutical strategy
The national pharmaceutical strategy identifies seven
action areas clearly linked to the set goals of the strategy.
These action areas are crucial in bringing about development in the goals and in leading the use of pharmaceuticals closer to the vision of the strategy. They are notable
for a high degree of urgency and require national cooperation as well as joint prioritisation by several actors in
the pharmaceutical field.
Create a better and safer prescribing process and
lay the foundation for generic prescribing through
nationally coordinated IT support
Incorrect prescribing and administration of medicines is
estimated to cause costs amounting to several billion
Swedish kronor a year for society. The prescriber is dependent for prescribing that is safe for patients on both
correct information on the patient's current medication
and relevant and well structured information on the
medicines to be prescribed. At present the prescriber
does not always have access to such information at the
time of prescribing.
Prescriber and dispenser support can prevent incorrect prescribing and has been identified in the preliminary study for this strategy as one of the most crucial
measures to improve use of medicines. The work involved in introducing nationally coordinated prescribing
support is extensive and affects a large number of actors
in both the healthcare system and several authorities. It
is important in this work to build on the various forms
of decision support that have been developed. Responsibility for maintaining the various knowledge databases
needed for evidence-based prescribing must be clearly
regulated and ensure long-term management. This development activity is mainly dealt with under National
eHealth.
To establish a national prescribing database and speed
up the development of electronic prescriber and dispenser support throughout the healthcare system and in
affected parts of social services, the Government has
made a decision on the initiative for the sickest elderly.
Under this decision, a steering group has been set up
under the direction of the Ministry of Health and Social
Affairs to carry out this development activity. Members
of the steering group are appointed by the Ministry of
Health and Social Affairs and the Swedish Association of
Local Authorities and Regions.
Increase consensus on and understanding of
prescribed treatment
If a prescribed pharmaceutical treatment is to have the
intended effect, consensus is required between the prescribing doctor and other staff and the patient, as well as
an understanding on the part of the patient on the treatment, its intended effect and any side effects.
Lack of consensus on and understanding of prescribed
treatment today is a common problem and costs society
billions of Swedish kronor every year in the form of
extra hospital admissions, production losses and lowered
quality of life. Estimates in the preliminary study for
this pharmaceutical strategy suggest that around 6–16 %
of all hospital admissions in Sweden are due to medi­
cation-related problems, of which low compliance with
prescribed treatment may account for up to half. The
link between medical care and patient at this stage is
thus crucial in attaining good medical results, patient
safety and health.
Knowledge and routines need to be developed so that
compliance with the prescribed treatment among patients can be achieved as far as possible. This is an important aspect of use of medicines that is safe for patients.
Develop knowledge about and guidelines for
medicines and the use of medicines for those
patients in whom this is most neglected
There is a lack today of crucial knowledge of medicines
and guidelines for the pharmaceutical treatment of certain groups of patients. The groups highlighted, where it
is particularly relevant at present, are the elderly, multimorbid patients and children.
The elderly and multimorbid patients need adapted
pharmaceutical treatment so that the treatment is as
effective as possible. To meet the special needs of the
elderly for adapted pharmaceutical treatment there is a
need for both new knowledge and collation of such
knowledge in treatment recommendations and national
guidelines.
There are wide gaps in knowledge regarding medication for children. There is a need firstly for new knowledge and secondly for collations of existing knowledge to
strengthen patient safety in the management of medicines in paediatric healthcare.
11
Reduce the development and spread of antibiotic
resistance through a combination of local and
global actions
Sweden is among the countries in the world with the
lowest consumption of antibiotics and the lowest incidence of resistance. However, the general situation regarding the spread of resistance is steadily deteriorating.
The development of resistance is a global problem and an
important challenge for Sweden and the rest of the
world. The aim of reducing the development and spread
of antibiotic resistance necessitates national and international collaboration. This issue is given high priority in
the Government's WHO strategy on antibiotic resistance, and Sweden has committed resources to also raising the issue in the EU, in this case for innovative incentives to develop new antibiotics.
Several activities are being carried out nationally to
address this problem, in particular under the patient
safety agreement between central government and the
Swedish Association of Local Authorities and Regions.
The emphasis in this action area is on follow-up and
evaluation.
Develop a long-term sustainable pricing, prioritisation and financing model for all medicines
The pricing and prioritisation of both outpatient and
inpatient medicines need to be developed. The pricing
and prioritisation models have to contribute to cost control so that the use of medicines becomes cost-effective
from the perspective of society and in that way contributes to ensuring the best possible health for the population. The Government decided in June 2011 on terms of
reference for an inquiry that, among other things, was to
review how the pricing of original medicines without
generic competition can be developed and improved. The
Government intends to come back with additional terms
of reference that consider in more detail issues related to
the pricing of medicines.
The central government payment to the county councils to cover pharmaceutical benefits today is a specially
earmarked government grant. The payment can also be
made from the general government grant. Central government and the Swedish Association of Local Authorities and Regions are in agreement on initiating discussions on the requirements to be met in transferring the
compensation to the appropriation for municipal financial equalisation under a joint working group.
Establish a process for orderly and effective
introduction and expanded follow-up of the use
and effects of medicines
The goal of attractiveness for the innovation of products
and services is crucial. A process of orderly and early
introduction and expanded follow-up of the use and
effects of medicines is essential to attain this goal. When
12
a new medicine is approved, knowledge of its efficacy,
safety and cost-effectiveness in everyday clinical practice
is often limited, with the result that new medicines are
introduced at potentially high cost while uncertainty
prevails at the same time on expected effects and sideeffects in healthcare. The use of medicines can only be
continuously improved and made more efficient through
knowledge from actual use. There is a lack of good
opportunities for follow-up in healthcare today.
A nationally coordinated process of introduction is
aimed at making sure that new medically valuable and
cost-effective drugs benefit patients in need regardless of
where in the country they live. Orderly introduction
consists of several parts and is driven by several different
factors. A major challenge lies in making these factors
interact and working together to bring about orderly and
effective introduction of new medicines so that it can be
established early on whether they are medically valuable
and cost-effective.
Reduce the impact of medicines on the
environment locally and globally
Medicines and their manufacturing have an impact on
the environment, but there is a lack of precise knowledge of the extent of this impact. The production of
medicines is a major environmental challenge for the
emerging economies where a significant proportion of
production takes place. Sweden today has limited production of medicines, the principal challenge in our local
environment in the short term is posed by the consequences of the consumption of medicines.
The issue of the impact of medicines on the environment also needs to be addressed at the international level
if the desired effect is to be achieved. The Government
has appointed the Swedish Environmental Advisory
Council to devise a strategy for Sweden's international
efforts towards a non-toxic environment. This strategy
also has to encompass the impact of medicines on the
environment.
Follow-up of national pharmaceutical
strategy
The national pharmaceutical strategy will be followed up
at the level of actions and goals. Follow-up at action level
is aimed at ensuring that the action taken leads to development within the goals of the strategy and contributes
to fulfilment of those goals. Follow-up at goal level is
aimed firstly at making possible improved focus on results at regional and local level and secondly at monitoring Sweden's development towards the five overarching
goals set out in the strategy. The aspiration with the
follow-up to be carried out under the pharmaceutical
strategy is that it should be comprehensive so that it can
provide a coherent picture of development in the area.
This means that all development that has a bearing on
the pharmaceutical area is relevant to future follow-up
work under the pharmaceutical strategy.
Follow-up of the pharmaceutical area can be improved
by developing new indicators in the area. This will be
part of future strategic activity. It can possibly be implemented within the framework of next-generation open
comparisons.
The intention in openly comparing different forms of
results is to create greater transparency and insight into
what is done in healthcare and social services. Citizens
should have access to information on how tax revenue is
used and what variations there are within the country
and between healthcare providers. In addition, open
comparisons create opportunities for decision-makers
and professions to learn from one another. The intention
with comparisons is to contribute to systematic improvement efforts that contribute to equal care and improved
quality and efficiency.
Medicines are one of the most important forms of
treatment, and should be prescribed on the basis of the
patient's medical needs, the expertise of the individual
prescriber and the area of responsibility of the healthcare provider. Some local variation in the prescribing of
medication is therefore reasonable. Excessive variations
in pharmaceutical treatment and disparities in results of
treatment may, however, be an indication of uneven care.
The Prescribed Drug Register is one of the national
registers in the pharmaceutical area where there is good
access to reliable data that is, moreover, up to date. As a
result, there is reason to review whether it is possible to
create a new generation of open comparisons that combine data on prescribing patterns with results from the
county councils' own quality registers in a number of
important disease areas. This type of open comparison
can be viewed both as an element in following up the
effects of the pharmaceutical strategy and in providing
patients and citizens with information on the degree to
which their county councils prescribe the most effective
treatment to the same extent as other county councils.
follow-up activity is to take place in dialogue with the
actors involved and is directed by the high-level group of
the pharmaceutical strategy.
The development activity that culminates in the
strategy will consist of both government remits for authorities and undertakings given by the actors concerned. The high-level group has submitted proposals for
actions under an action plan. The work done under the
national pharmaceutical strategy is, as far as possible, to
take place under existing structures.
CBL is to present a progress report annually. Based on
this report, the high-level group will drive the work forward.
Organisation and implementation of the
pharmaceutical strategy
The work on the national pharmaceutical strategy can
be characterised by broad consensus among actors in the
pharmaceutical area. The strategic activity is to be
directed by a high-level group, chaired by the Ministry
of Health and Social Affairs.
The Centre for Rational Use of Medicines (CBL) at
the Medical Products Agency coordinates operational
development activity. CBL coordinates follow-up of the
strategic actions proposed by the high-level group and
follow-up of the pharmaceutical area based on the strategy's five established objectives. The coordination and
13
Action plan 2013
14
1
Create a better and safer prescribing process and lay the foundation
for generic prescribing through nationally coordinated IT support
1.1Make electronic reporting of drug
side effects possible
1.2Make generic prescribing possible
Main responsibility: Medical Products Agency
Main responsibility: Medical Products Agency
Investigation into making electronic reporting of side
effects from the whole healthcare system possible. Includes further enhancement of feedback of side-effect
reports to the health service and discussion with the
pharmaceutical industry to examine how this change
can improve the companies' work on pharmacovigilance.
Objective
Reporting of drug side effects is crucial in order to discover deficiencies in the handling of medicines and to
increase drug safety. All side-effect reports from the
health­care system are currently sent to the Medical
Products Agency, either on a paper form or using an
online form. There is a need for more flexible and userfriendly reporting, for example from within patient
record systems, to motivate and encourage greater reporting of side effects and feedback of knowledge for
improved patient safety.
Status in autumn 2012
The Medical Products Agency recommends that the
existing infrastructure in the national service platform
be used for side-effect reports from the healthcare system to the Medical Products Agency. A pilot project
with Uppsala County Council is planned. The service
platform is a national technical platform that simplifies,
safeguards and improves the efficiency of the exchange
of information between different IT systems in health
and social care.
Work in 2013 and timetable
The pilot project with Uppsala County Council is expected to continue throughout 2013 and is evaluated
continuously. Experience from the pilot project is to
point the way for implementation of the remainder of
the remit. Large-scale implementation, where appropriate, can start in 2014. Adaptations to existing patient
record systems may lead to changes in the timetable.
Alongside the pilot project in Uppsala, the Medical Products Agency will join the national service platform.
Investigation on the design, technical platform and
funding of a future register of substances. Evaluation of
what changes in legislation may become relevant and
what adaptation of IT systems will need to take place to
make generic prescribing possible.
Objective
All medicines contain at least one active substance. It is
the active substance that means that the medicine has an
effect on the disease or symptom of disease it is intended
to treat. The first approved medicine containing a particular active substance is known as an original medicinal
product. When the patent has run out and the data protection period has expired, equivalent products can be
manufactured, known as generic medicines. The generic
medicine contains the same active substance in the same
amount as the original medicine and is usually deemed
to be equivalent from the point of view of efficacy and
safety, but is sold under a different name. Generic prescribing means that the prescriber specifies the generic
name when prescribing instead of the brand name of the
product. This means that the prescriber does not choose
a particular product to prescribe but that any product
containing a particular substance is to be supplied. The
pharmacies themselves therefore choose which product
will be dispensed to the patient. The advantage of generic prescribing is that it makes the prescriber's work easier
and can improve patient safety.
The objective is to investigate how it can be made
possible for generic prescribing to be done in a way that
is safe for patients. The investigation includes analysing
what statutory changes are required, what substances
could be subject to generic prescribing, estimating the
cost of designing relevant IT systems and of necessary
training efforts and devising a plan for the introduction
of voluntary generic prescribing.
Status in autumn 2012
A final report on the introduction of a national register
of substances was published in September 2012. The
Medical Products Agency will continuously provide the
register of substances, which can be freely used by patient record systems etc.
15
It is proposed in a consultation document from the
Medical Products Agency that a first step in introducing
generic prescribing is to draw up applicable changes to
laws and ordinances and decide whether generic prescribing is to be possible for a small number of common
medicines or as many medicines as possible. Adaptations
to the national IT infrastructure are required in the
healthcare system and the pharmacies, and their system
suppliers can start work on the adjustments that will be
necessary in each system. Training courses on the reform
itself and the practical conditions for prescribers and
pharmacies are also needed.
The referral from the Medical Products Agency contains questions regarding the choice of what it is to be
possible to prescribe generically, the need for statutory
changes, training and information, consequences for each
organisation (including costs) and reasonable time for the
introduction of generic prescribing. In its consultation
paper, the Medical Products Agency advocates a model of
generic prescribing in which the present-day assessments
of substitutability are utilised. The Medical Products
Agency will present a final report on the remit in
November 2012.
Work in 2013 and timetable
The report from the Medical Products Agency on generic prescribing will be discussed within the Ministry of
Health and Social Affairs in 2013.
1.3Make electronic cancellation of
e-prescriptions possible
Main responsibility: The county councils
Status in autumn 2012
Apotekens Service AB has developed a way of cancelling
e-prescriptions for those county councils that have
patient record systems that allow this to be done. This
applies to all care providers who have the patient record
system SYSTeam CROSS 4.13.461, which at present
means five county councils.
Work in 2013 and timetable
It is up to the county councils to lay down requirements
to be met by their IT suppliers so that a function enabling
the cancellation of e-prescriptions is introduced.
1.4Create national multi-dose register
Main responsibility: Apotekens Service AB
Completion of IT platform for national dose registers and
transfer of information from the multi-dose registers.
Objective
Make it possible for all actors in the multi-dose-dispensing market to have access to data on multi-dose prescriptions.
Status in autumn 2012
In October 2012 the Ministry of Health and Social Affairs gave Apotekens Service AB resources to establish
registers of information that all actors need to enable the
multi-dose dispensing market to function. The Centre
for eHealth (CeHis) has also been given resources for
preparatory measures for the same purpose.
Work in 2013 and timetable
Make it possible for prescribers, through their care system, to cancel prescriptions, both those they have prescribed themselves and e-prescriptions issued by others.
In practice it will, as a rule, only be possible for those
e-prescriptions that are available in the relevant care
system to be cancelled.
Objective
An issue that has been raised by several actors in recent
years is whether responsibility for cancelling prescriptions is to be general or limited to certain doctors (for
example the most recent prescribing doctor, doctor with
special patient responsibility etc.). It will be examined in
connection with the forthcoming review of the National
Board of Health and Welfare regulations and guidelines
(SOSFS 2000:1) on the handling of medicines in the
healthcare system whether it is possible for the National
Board of Health and Welfare to proceed with this issue
and how the responsibility of the National Board of
Health and Welfare in that case would relate to the areas
of responsibility of other authorities.
16
Work on creating a national multi-dose register containing complete data will continue in 2013. In October 2012
the Government decided to earmark SEK 4 500 000 to
enable Apotekens Service AB to take over information
concerning dose patients and to develop interfaces with
the healthcare system and dose pharmacies.
1.5Create prescription database under
current legislation
Main responsibility: Swedish Association of Local
Authorities and Regions
Developed under National eHealth.
Objective
Incorrect prescribing and administration of medicines is
estimated to cause costs amounting to several billion
Swedish kronor a year for society. The prescriber is dependent for prescribing that is safe for patients on both
combined information on the patient's real pharmaceuti-
cal treatment (both current and historical) and relevant
and well structured information on the medicines that
are to be and have been prescribed.
With access to the combined information on what
medicines the patient is taking and the latest findings on
the products, an analysis can be made of total use of
medicines for the individual patient (pharmaceutical reconciliation). The conditions are then met for effective
decision support for the prescriber. The National Prescription Database (Nationell ordinationsdatabas, NOD)
is a national source of information containing all prescriptions, from community and inpatient care, multidose prescriptions and also dispensed medicines.
As more and more doctors and other prescribers gain
access to a combined list of medicines, which extends
across the boundaries of healthcare providers, the question becomes what responsibility the various prescribers
are to have, for example the one who has originally prescribed a medicine in relation to the doctors who treat
the patient later. A preliminary study on review of the
National Board of Health and Welfare regulations and
guidelines (SOSFS 2000:1) on the handling of medicines
in the healthcare system is to be initiated in the autumn
and is expected to be completed by the end of the spring
of 2013.
Status in autumn 2012
Work on introducing NOD is continuing, and the objective is for a first version of the database to be accessible
for Pascal prescribing tools in December 2012. When
introduced, NOD will contain outpatient prescriptions
and also show dispensing from the List of Prescribed
Drugs.
Pascal prescribing tools for outpatient prescriptions
are continuing to be enhanced alongside the development of the database structure for NOD. As the overwhelming majority of prescriptions are issued in the
medication modules of the patient record systems, high
priority is given to preparations and the development of
patient record system/NOD integration packages. Access
to the information in NOD will be from the medication
modules of the patient record systems, Pascal prescribing
tools (for those prescribers who do not have access to the
medication module of the patient record system) and
through the National Patient Overview (Nationell
patientöversikt).
It has been argued in several investigations that it is
important to supplement NOD with an application in
inpatient care, as the first version of NOD will only
encompass outpatient care.
Work in 2013 and timetable
NOD version 1.0 is expected to be ready in December
2012. Access to NOD via Pascal will be gradually offered
to healthcare providers in 2013 after careful testing and
experimentation. Access to NOD via medication modules in patient record systems is dependent on the agreed
rate of integration. Future plans, not yet timed, exist to
also include information on the patient's hospital prescriptions to NOD.
1.6Establish a coherent system for
discussion and decision on the
development of national basic
systems for prescribing support
Main responsibility: Ministry of Health and Social
Affairs Developed under National eHealth.
Objective
Adequate prescribing support for healthcare professionals is one of several important requirements to aid efforts
towards achieving more effective and safer care. Several
initiatives have also been taken to improve support with
regard to prescriptions, but further action needs to be
taken.
Status in autumn 2012
National source for cause of prescribing
The medication prescribing process, from prescription to
evaluation of the efforts of pharmaceutical treatment in
an individual patient, is a complex process that involves
the patient, the healthcare system and the pharmacy.
Information on the cause of prescribing, i.e. the situation
stated by a prescriber as the reason for prescribing, is of
key importance to all these actors. The National Board of
Health and Welfare is developing a national source for
cause of prescribing, in the form of a structured coding
system for prescriptions. This remit relates to prescriptions from both community and inpatient care. The
remit also includes analysing and presenting proposals
on how such a source can and should be introduced in
the healthcare system. The remit is based on the assessments and proposals contained in the Board's report
"Project for documentation of cause of prescribing and
analysis of interaction with related knowledge support".
Introduction of national prescription database (NOD) and
the prescribing tool Pascal.
See section 1.5.
Evaluation of electronic dispensing support (EDS)
EDS provides pharmacists in pharmacies with access to
electronic expert support that automatically checks all
electronic prescriptions prior to dispensing. As a result,
medication clashes, duplicate prescriptions, risks due to
age etc. can be discovered. It provides greater safety for
the patient and improved use of medication. Apotekens
Service AB is working on continued development and
adaptation and support for the use of EDS. The project is
17
proceeding as intended and is aimed at making EDS
accessible for prescribed-dose medicines and at making
the system more user-friendly. Apotekens Service AB has
also started a project to introduce a Swedish medication
list. The Medical Products Agency evaluated the functions of EDS in 2012 and has deemed it to have interesting potential as expert support in pharmacies.
Work in 2013 and timetable
In view of the basic inquiry remit given to the National
Board of Health and Welfare, results from this work
have been awaited before taking further initiatives. The
remit is due to be reported in July 2013.
1.7Develop service for increased
patient involvement through feedback of outcomes of treatment and
non-conformance management
Main responsibility: Swedish Association of Local
Authorities and Regions
Developed under National eHealth.
Objective
To be able to supply the patient's own experience of
pharmaceutical treatment and therefore achieve greater
participation by patients in their own care and treatment. The aim is for each individual to be able to obtain
all data about himself or herself and to actively assist.
The individual has to be able to access his or her data,
including information on medication, in a number of
different ways depending on what suits the person best.
It is also self-evident that access through mobile platforms should be possible. The healthcare provider takes
responsibility for data relating to its activities, but the
individual concerned has full access to the data – wherever, however and whenever. The individual can combine
them with his or her own data on his or her own health
and decide who to share the data with. Making the patient more involved in and knowledgeable about his or
her own treatment leads to more effective and safer
treatment, better compliance, less discarding of medication and more satisfied patients. This is also of great
importance from the point of view of the pharmaceutical companies. To be able to monitor cost-effectiveness
in everyday clinical practice there is a need for patientreported data on quality of life.
Status in autumn 2012
The Centre for eHealth in Sweden is pursuing the project
My Health Services, which is aimed at creating the conditions necessary for the population to have access to more
good-quality e-services in the area of healthcare. This
may, for example, mean accessing My Healthcare Contacts
18
from a mobile phone or tablet, viewing one's referral
status, booking an appointment to give samples and
receiving the results directly on one's account.
A 'service contract for form management' has been
developed in the My Health Services project. This service contract is a technical basic contract governing how
information is to be kept between different systems. A
service contract may, for example, link My Healthcare
Contacts to a form service or a questionnaire tool and in
so doing control the transfer of information in a standardised way. The intention is for it to be possible for the
solution to be used for example for health declarations or
follow-ups of treatment. The technical foundation is
consequently laid for being able to exchange information
between healthcare providers and patients through
forms and questionnaires in a secure manner. The next
step is to link a form service to the service contract. This
is planned for 2013.
Work in 2013 and timetable
Form service ready in 2013.
2
Increase consensus on and understanding of prescribed treatment
2.1Create the necessary basis for
effective medication reviews and
medication reconciliation in health­
care transitions and evaluate the
effect of these measures on compliance with prescribed treatment
Main responsibility: National Board of Health and
Welfare (Partly completed)
Developed under the Government initiative for the
sickest elderly.
In view of the fact that the first element of the activity has been implemented, this part is omitted from the
Action Plan 2013. The second element, “evaluate the
effect of these measures”, remains.
Objective
Inadequate consensus and understanding of prescribed
treatment is a common problem today, particularly with
regard to pharmaceutical treatment of the elderly. The
deficiencies cause great suffering for care recipients and
lead to costs in the healthcare system that could be
avoided with a more structured management of medication. Medication reviews and medication reconciliation
can be effective tools in improving patient safety in longterm pharmaceutical treatment. Systematic medication
reviews can, among other things, prevent care recipients,
in particular elderly patients who are treated with several
different drugs, taking medicines that are unsuitable for
the elderly, interact adversely or give rise to side effects.
It may also mean that patients become more involved in
their treatment, resulting in better compliance and less
discarding of medication.
Status in autumn 2012
On 1 September 2012 the National Board of Health and
Welfare regulations and general guidelines (SOSFS
2001:1) on management of medication in the healthcare
system came into effect. Under the new regulations a
simple medication review is to be offered to all individuals over the age of 75 who are prescribed five or more
medicines. A guide to the National Board of Health and
Welfare regulations and general guidelines on management of medication in the healthcare system is expected
to be ready on 1 December 2012.
Better knowledge of the use of medicines by the elderly is crucial to more effective medication reviews and
reconciliation. On 30 August 2012 a study was published
under the name “Elderly patients with regular medication – number of medicines as risk marker”. This study
shows that extensive pharmaceutical treatment in elderly persons signals an increased risk of death, visits to
accident and emergency units, gastrointestinal bleeding
and falls. Part of the increase in the risk with an increased number of medicines is due to the individual's
underlying disease. Even if account was taken of the
individuals' diseases and the severity of these diseases, an
increased number of medicines meant an increased risk
of death, visits to accident and emergency units, gastrointestinal bleeding and falls. The number of medicines is
a valuable risk marker to use in screening prior to preventive actions such as medication reviews, targeted
patient information and intensified follow-up of the
effects of treatment.
Work in 2013 and timetable
The National Board of Health and Welfare is currently
examining how it can develop ways of measuring and
following up the effects of the medication reconciliation
and reviews that will be done after the guide has been
published. Repeating the study "Elderly patients with
regular medication – number of medicines as risk marker",
which can be regarded as a kind of baseline measurement,
is one option. Other types of follow-up are being studied.
The remit also includes identifying relevant indicators.
2.2Evaluate whether multi-dose ser­
vices can contribute to greater
compliance and improved patient
safety and how the service can be
used and refined
Main responsibility: Medical Products Agency
Developed under the Government initiative for the sickest elderly.
Objective
The service is used at present for multi-dose drug dispensing to around 185,000 individuals in Sweden. The
total cost of medication for the individuals who use the
service today is around SEK 2.1 billion. Multi-dose drug
dispensing dispensing means that medication is packed
in bags containing the medicines to be taken on a single
19
occasion. This service is used in particular by elderly
people who are taking many medicines and may find it
difficult to cope with different packs of medication.
Status in autumn 2012
The Medical Products Agency has investigated how dose
services work in Sweden and abroad. The remit included
evaluating the experienced benefit of the multi-dose
dispensing service with respect to compliance and
patient safety from a patient, professional and supplier
perspective. The Medical Products Agency's continued
work is partly focused on assessing previously published
studies showing that patients with subject to multi-dose
dispensing may have drug prescriptions of poorer quality
measured by the National Board of Health and Welfare
quality indicators for medication. However, during the
evaluation the Medical Products Agency received contrary signals as parts of the profession and patient associations have emphasised that multi-dose drug dispensing
makes life easier for and is beneficial to the patient.
Work in 2013 and timetable
The report will be sent out for comment and be endorsed within the Medical Products Agency before being
submitted to the Ministry of Health and Social Affairs
in February 2013.
2.3Carry out skill-enhancing training
efforts for home help service staff
Main responsibility: Swedish Association of Local
Authorities and Regions
Development of interactive online training targeted
specifically at home help staff on use of medication in
elderly people.
Objective
Home help staff meet patients in their everyday lives in
the home environment. Home help staff can be given
knowledge and increased understanding of the often
complex care needs and medication-related problems of
elderly patients/service users through continued training
on the pharmaceutical treatment of the elderly. They can
consequently represent an even more important resource
in the medical and social care of the ageing patient.
Status in autumn 2012
The Swedish Association of Local Authorities and Regions (SALAR) judges good online training for municipal staff to be important. As there is already a training
programme developed by the LIF, the pharmaceutical
trade association, while the National Board of Health
and Welfare has been tasked with devising a web-based
pharmaceutical training programme targeted at care
20
staff, SALAR will consider whether it needs to develop
its own training or whether it is possible to collaborate
with others. Discussions have been initiated with LIF on
updating and use of the existing online training on medicines and the elderly. No decision has been taken on
which path to follow. There is no separate funding.
Work in 2013 and timetable
It has not been established what work will be undertaken in 2013, and this depends on the path chosen, i.e.
whether SALAR creates its own training for home help
staff or whether it collaborates with others. It is anticipated that the training action will start in the last
quarter of 2013.
2.4Develop labelling of pharmaceutical
packs to reduce risk of confusion
Main responsibility: Medical Products Agency
Work aimed at improving patient safety through the
design of pharmaceutical packs which are used in emergency care/inpatient care and confusion between which
poses serious risks to patient safety.
Objective
Alongside drug side effects, incorrect pharmaceutical
treatment due to packs being confused accounts for a
proportion of medication-related medical injuries. It is
estimated that confusion between medicines leads to
6,000 medical injuries annually. Clearer and more uniform labelling can reduce the risk of confusion occurring.
The Medical Products Agency is studying possible ways
of improving the labelling of pharmaceutical packs with
the aim of reducing the risk of confusion and incorrect
use. The aim of the project is to find a functioning
"template" for how best to design the labelling of
pharmaceutical packs.
Status in autumn 2012
The Medical Products Agency and the Network for Patient Safety have developed documentation describing
various parameters proposed for change on pharmaceutical packs in order to improve labelling and consequently
also reduce the risk of confusion and incorrect use. In
view of the fact that pharmaceutical packaging is a complex and large field, the work has been restricted to medicines that are used solely in inpatient care and are particularly problematic: electrolyte solutions and
cefalosporins (antibiotics).
A smaller digital pilot study has been carried out by
Linnaeus University.
During the autumn discussions will be held on a possible later follow-up digital study and how use of the
changed packs for cefalosporins is to be evaluated. Under
the ELIS project in Task 5.3, test procurement of safe
packaging will take place under the auspices of the county councils.
Work in 2013 and timetable
Follow-up on whether the changed packs for cefalosporins have reduced the risk of confusion and incorrect use
will take place in the autumn of 2012, which is crucial to
activities in 2013. As there are long lead times before
changed pharmaceutical packs are available on the market, the work will continue in 2013–2014.
2.6Structured discussion of medication
in pharmacy (new activity in 2013)
Main responsibility: Medical Products Agency
Implementation of trial activity with structured discussion of medication in pharmacies for a limited group of
patients.
Objective
Development of the pharmacy indicators for follow-up of
pharmacy activity.
Poor compliance with prescriptions for medication causes
unnecessary suffering among patients and costs society a
large amount of money. Deliberate non-compliance
accounts for the largest share. The whole care chain needs
to be involved in the work so that the patient receives
the right medication and uses the medication in the
right way. Various actions probably need to be combined
to increase the involvement, knowledge and motivation
of patients, such as medication reviews and motivating
discussions in pharmacies. The expertise available at the
pharmacy should be put to better use in this respect.
Objective
Work in 2013 and timetable
Indicators make it possible to follow up activity in pharmacies and ensure that clients are offered good care, i.e.
care that is knowledge-based, appropriate, safe, patientfocused, effective, equal and given within a reasonable
time.
The Government intends to initiate a trial with structured discussion of medication in pharmacies in 2013,
with the Medical Products Agency having main responsibility and the Swedish Pharmacy Association and
Swedish Medical Association as co-actors. The trial
should be designed for a limited group of patients and be
designed so that doctors refer patients for discussions on
medication and pharmacies provide feedback to referring doctors. An evaluation is to be made based on the
ratio between cost and benefit. The National Board of
Health and Welfare regulations on medication reviews
must be respected when the project is planned.
2.5Indicators of good patient safety in
pharmacies (new activity in 2013)
Main responsibility: National Board of Health and
Welfare and Medical Products Agency
Work in 2013 and timetable
The Government intends to instruct the National Board
of Health and Welfare and Medical Products Agency, in
collaboration with the Swedish Pharmacy Association
and the Swedish Association of Local Authorities and
Regions, to develop national indicators for pharmacy
operation that is safe for patients. This work is to be
based on and viewed as a logical continuation of the work
on the Swedish standard for Good Pharmacy Practice
(GPP), which provides an industry-wide foundation for
pharmaceutical, quality-related and ethical issues.
The pharmaceutical indicators are to provide the general public with a basis on which to make comparisons of
the quality and safety of different pharmacy players. The
indicators are to cover all pharmacy operation (multidose dispensing, hospital and community pharmacies).
21
3
Develop knowledge about and guidelines for medicines and the use of
medicines for those patients in whom this is most neglected
3.1Draw up national guidelines on how
elderly and multimorbid patients are
to be treated (completed in 2012)
Main responsibility: National Board of Health and
Welfare
In view of the fact that national guidelines on how elderly and multimorbid patients are to be treated and guidance on application of these guidelines have been drawn
up, this activity is omitted from the action plan for 2013.
3.2Expand knowledge of paediatric
medicines and their use
Main responsibility: Medical Products Agency
Increase knowledge of paediatric medicines and their use
and foster safer handling of medicines. Implementation
of a preliminary study that includes analysis of existing
guidelines (national and international) and studies in the
area. The preliminary study is also to contain an inventory of further special national guidelines to be developed for children.
Objective
A Swedish study in 2008 on drug prescriptions for children in hospital showed that children received an average of 3.8 prescriptions for medication each. Almost half
of all prescribing was made up of medicines insufficiently documented for children. Newborn infants, in particular premature infants, and young children were the age
group receiving the highest proportion of prescriptions
of insufficiently documented medication (70 %). The
work is aimed at increasing knowledge on medication
for children and its use in the long term and on a broad
front and at fostering safer handling of medication in
paediatric medicine.
Status in autumn 2012
In the report "Expanding knowledge of medication for
children and its use", the Medical Products Agency has
described analyses conducted, planned analyses and
other started and planned activities, presented the costs
of future work and justified why the remit should be
regarded as a national long-term programme. Work is
progressing in line with the report.
22
Work in 2013 and timetable
The Medical Products Agency is deepening the analysis
of use of medication by children, focusing among other
things on medication for newborn infants and use of
painkillers for children in hospital.
The Medical Products Agency is continuing to identify gaps in knowledge in child and adolescent psychiatry
and paediatric anaesthesia/intensive care.
With regard to information and training activities,
the Medical Products Agency is developing its communication strategy for children and medicines, is promoting
a greater children's perspective in the Swedish Drug
Compendium (Läkemedelsboken) and is planning the
Läkemedelsriksdagen 2013 conference, the theme of
which is children and medicines.
The Medical Products Agency is gathering and developing existing knowledge, for instance by holding an
expert meeting on drug administration by tube to children and is drawing up recommendations for treatment
in serious neonatal infections.
With regard to patient safety, the Medical Products
Agency is carrying out a baseline study of reports submitted to it on side effects of medicines in children and
is developing methods to identify medicines that pose a
risk to children.
The Medical Products Agency should also, in collaboration with the National Board of Health and Welfare
and the paediatric clinics, review the options for making
existing databases, for example existing sources of information, broadly available through processes for quality
assurance, ownership/administration, development and
supervision.
There is no clear end to the work on expanding know­
ledge of paediatric medicines and their use. This is, however, a high-priority area.
3.3Strengthen doctors' knowledge of
medicines and use of medicines
during specialist training in
medication-intensive specialties
Main responsibility: Ministry of Health and Social
Affairs – change of holder of main responsibility to
National Board of Health and Welfare
Develop a concept for basic specialist courses (SK courses) for doctors undergoing specialist training focused on
medicines and use of medicines.
Objective
Crucial knowledge of medicines and use of medicines is
lacking today. One reason why medical injury occurs in
the healthcare system is incorrect use of medicines. For
patient safety reasons it is therefore important to endeavour to ensure a safer prescribing process. The initiative for SK courses is aimed at developing knowledge on
medicines and use of medicines for groups of patients in
which this is most neglected. To support continued
training for doctors in order to improve doctors' know­
ledge of medicines and use of medicines.
Status in autumn 2012
The Government decided in March 2012 to earmark
SEK 3 ,950,000 for the Institute for the Professional
Development of Physicians in Sweden (IPULS) in order
to strengthen doctors' knowledge of medicines and the
use of medicines during specialist training in medi­
cation-intensive specialties. The Government intends to
earmark SEK 8,350,000 for 2013 and SEK 3,700,000 for
2014 for the holding of specialist courses relating to
medicines and use of medicines. The National Board of
Health and Welfare has been instructed to arrange
SK (specialist training) courses from 1 January 2013, for
which IPULS is currently responsible, as part of the
authority's operation. Discussions are being held in
conjunction with the change-over on how the training
can be focused on more target groups. It is proposed that
the National Board of Health and Welfare be instructed
to carry out a preliminary study on a web-based con­
tinuing professional development model in the area of
the elderly and medication.
Work in 2013 and timetable
The National Board of Health and Welfare's responsi­
bility under the remit also includes the Government's
initiatives for specialist (SK) courses in psychiatry and
strengthening of doctors' knowledge of medicines and
the use of medicines during their specialist training. The
remit also includes the National Board of Health and
Welfare assessing the future need for courses based on
the authority's regulations on doctors’ registrarship. The
National Board of Health and Welfare is to present its
final report on this remit to the Ministry of Health and
Social Affairs by 31 January 2013. The National Board of
Health and Welfare's assessment of the future need for
SK courses was presented on 1 November 2012.
3.4Development web-based continuing
professional development module
to strengthen the knowledge of
intern pre-registration physicians
(AT-läkare) on the elderly and medicines (new activity in 2013)
Main responsibility: National Board of Health and
Welfare
The Government intends to instruct the National Board
of Health and Welfare to initiate a preliminary study on
what needs to be done to strengthen knowledge among
intern pre-registration physicians (AT-läkare) of medicines and use of medicines among the elderly through a
web-based continuing training module. The remit includes presenting proposals for content, training goals
and timetable for the launch of various parts of the
training.
Objective
The prescribing of medicines to individuals over the age
of 75 has increased by nearly 70 % over the past 20 years.
Several studies have shown that irrational and potentially unsuitable treatment occurs with certain medicines,
for instance antipsychotics, anticholinergics, long-acting
sedatives and hypnotics. Ignorance of the special considerations that are needed in the pharmaceutical treatment
of elderly patients is one reason why unsuitable treatment occurs. The National Board of Health and Welfare
report Indicators of Good Drug Therapy in the Elderly
describes the problems caused by incorrect use of medicines, including impaired cognitive capacity and increased risk of falls. Up to 30 % of acute admissions of
elderly people to hospitals today are due to the extensive
use of medicines and the side effects these cause in the
elderly. To reduce the incidence of medication-related
medical injuries, it is crucial to increase and spread
knowledge of the use of medication in the elderly.
Work in 2013 and timetable
The National Board of Health and Welfare, together
with experts and on the basis of evidence, is developing
the content and methodology of continuing training in
accordance with the needs of the target group. The preliminary study includes analysing the needs and problems of the target group and surveying recipient structures in the county councils (existing platforms for
e-learning modules). A web-based continuing training
module is to be completed during 2013. The training is
divided into different modules that can be successively
launched in 2013 and 2014.
23
4
Reduce development and spread of antibiotic resistance through a
combination of local and global actions
4.1Continue to foster rational use of
antibiotics and reduced antibiotic
resistance nationally and develop
cooperation between all actors
concerned
Main responsibility: Ministry of Health and Social
Affairs
Continuing efforts in the area are necessary for the relatively good situation with regard to resistance in Sweden
not to worsen. In addition, cooperation between all
affected sectors needs to be developed, for instance,
between the human and veterinary sides.
Objective
According to the European Centre for Disease Prevention and Control (ECDC) around 25 000 people die ev­
ery year in Europe because of infections with resistant
bacteria. Compared with many other countries in
Europe, the antibiotic resistance situation in Sweden is
good. Unless changes take place at the European and
global levels, the threat may, however, become great for
all countries. To improve patient safety, the Government
has signed an agreement with the Swedish Association
of Local Authorities and Regions on a performancebased payment model aimed at leading to more
restrained use of antibiotics.
Status in autumn 2012
In the 2012 agreement between central government and
the Swedish Association of Local Authorities and
Regions on improved patient safety, SEK 100 million was
earmarked for those county councils that foster increased compliance with local treatment recommendations regarding common infections in outpatient care
and reduce the prescribing of antibiotics based on established indicators. The Swedish Institute for Infectious
Disease Control (SMI) has shown in a study on how the
treatment recommendations are applied that the recommendations are well known and that for most doctors
they provide support in work with patients. As a further
part of the patient safety effort, SMI and the Medical
Products Agency have started revising the existing treatment recommendations and have begun work on new
recommendations for preventive treatment in dentistry.
SMI has furthermore developed the national database,
Svebar, which daily receives bacteriological culture
24
results and antibiotic resistance data from the country's
laboratories.
In 2006 the Government presented a strategy for
coordinated efforts to counter antibiotic resistance and
healthcare-related diseases. The strategy includes actions
in human medicine, veterinary medicine, non-medical
use of antibiotics in the agricultural and food sectors and
measures to tackle spread in the environment and the
health consequences of antibiotic use. As part of the
strategy the National Board of Health and Welfare and
the Swedish Board of Agriculture were instructed in
June 2012 to initiate and take responsibility for a national collaborative function and to devise an interdisciplinary action plan for coordinated action against antibiotic
resistance and healthcare-related infections. The authorities are also to devise an overarching communication
strategy for the area.
Work in 2013 and timetable
The patient safety initiative is taking place over a number of years and will continue until 2014. The National
Board of Health and Welfare's remit to develop a national
collaborative function and action plan runs until the end
of 2017.
4.2Promote an action plan for the
development of antibiotics at
EU level
Main responsibility: Ministry of Health and Social
Affairs
Efforts made in this area must be set in a European and
global context as the problem of resistance cannot be
solved nationally. Sweden must therefore press for all EU
Member States to take the measures necessary for the
resistance situation to improve, both within the EU and
globally. Unless changes take place at the European and
global levels, the threat may become great for all countries. Sweden primarily prioritises efforts at EU level
that involve incentives for the development of new and
effective antibiotics.
Objective
Sweden is to press for the Member States of the EU and
the European Commission to provide incentives for the
development of new and effective antibiotics, of both a
regulatory and financial nature. Sweden is to lend particularly active support to the Commission in work towards
developing a framework with industry that defines purpose, undertakings, priorities and types of activity for
public-private partnership in the long term. In addition,
Sweden is to actively support the work of the Commission on mobilising resources, within the framework of
the Innovative Medicines Initiative with the aim of supporting research and development in the area of ABR
(antibiotic resistance). Through the work in Joint Programming – “The microbial challenge – a new threat to
human health”, Sweden is also to foster cooperation
between the Member States in this area.
Sweden is to press in particular for a strategy to be
devised at EU level on how a framework for a new global/regional/national system could be designed with regard to controlled distribution and use (CDU) of new
future antibiotics.
Status in autumn 2012
A Communication from the Commission on an action
plan against the threat of antibiotic resistance from 2011
has been followed up during the year with some practical initiatives, firstly through an AMR (antimicrobial
resistance) conference in March 2012 and secondly
through Council conclusions as a follow-up to the conference.
The Council conclusions urge the Member States and
the Commission to “identify options and models to
strengthen incentives to conduct research and development of new and effective antimicrobials or alternatives
and their controlled use”. Sweden played a proactive role
in the negotiations in ensuring that this was included in
the Council conclusions.
The Government took a decision in April 2012 to
make a grant to ReAct (Action on Antibiotic Resistance)
for EU-related work aimed at laying the foundation for
new systems regarding controlled distribution and use of
antibiotics. ReAct has established contacts with the European Commission on the issue and follow-up activities
on the issue are planned.
Work in 2013 and timetable
Lobbying of the Commission, the ECDC (European
Centre for Disease Prevention and Control) and other
important actors is a long-term activity to attain the
goals. A report on the remit to ReAct is due to be
presented in February 2013. The Government plans
continued remits for ReAct in 2013 to pursue the issue
in the EU.
4.3Promote increased efforts towards
rational use of antibiotics and reduced antibiotic resistance globally
Main responsibility: Ministry of Health and Social
Affairs
Efforts made in this area must be set in a European and
global context as the problem of resistance cannot be
solved nationally. Sweden must therefore act at the global
level to ensure that improvements are attained in the
area. The Swedish priority is primarily for WHO to take
global leadership on its shoulders with a view to achieving rational use of antibiotics. Particular priority is given
in the bilateral cooperation to work with India and China,
which is carried out by the Swedish Institute for Infectious Disease Control.
Objective
Sweden is to press for WHO to draw up a plan for work
on antibiotic resistance that includes an appropriate organisational structure and distribution of responsibilities.
In addition, Sweden is endeavouring to have a person
seconded to WHO to work on AMR issues and supports
the establishment of a global system for monitoring the
development of resistance and the disease burden.
Status in autumn 2012
Since the autumn of 2011 there has been a secretariat
within WHO working on AMR issues from an overarching horizontal perspective. Sweden supports this work in
several ways, for instance the Ministry of Health and
Social Affairs, in cooperation with ReAct and WHO,
held a seminar on antibiotic resistance in Geneva in conjunction with the World Health Assembly in May 2012.
The National Board of Health and Welfare was instructed in February 2012 to take initiatives under the
Government's WHO strategy on antibiotic resistance and
in particular the initiative for Swedish secondment of an
AMR expert to WHO. It has since been possible to recruit a Swedish expert for this remit, and this person will
start work at WHO on 1 October 2012.
The Government decided in April 2012 to make a
grant to ReAct with the aim of providing technical support to WHO in the area of ABR.
The bilateral cooperation with China and India on
AMR, as part of the health cooperation with these countries, continued in 2012.
Work in 2013 and timetable
The lobbying of WHO and other important global players is a long-term activity towards attaining these goals.
A report on the remit to ReAct is due to be presented in
February 2013. The Government plans continued remits
to ReAct in 2013 to actively pursue the issue globally. The
remit given to the National Board of Health and Welfare
25
runs until 2015 and a progress report is due to be submitted in December 2013.
4.4Develop the local Strama groups
in the county councils (completed
in 2012)
Main responsibility: The county councils
All the county councils have fulfilled the patient safety
agreement with regard to the Strama groups. This remit
has thus been completed and is therefore omitted from
the action plan for 2013.
4.5Introduce performance-based payment for reduced prescribing of antibiotics through greater compliance
with treatment recommendations
Main responsibility: The county councils
Developed under the Patient Safety Agreement.
Objective
Sweden is among the countries with the lowest consumption of antibiotics and the lowest incidence of resistance. However, a steady deterioration is taking place
in the general situation regarding the development of
resistance. Central government and the Swedish Association of Local Authorities and Regions (SALAR) have
signed annual agreements in the area of patient safety
since 2011 (the Patient Safety Agreement). The initiative
includes measures to reduce the prescribing of antibi­
otics and consequently the development of resistance in
the country. Performance-based payments are made to
those county councils that reduce their prescribing of
antibiotics in accordance with the agreement.
Status in autumn 2012
According to the Swedish Institute for Infectious Disease Control (SMI), sales of antibiotics increased in Sweden as a whole, from 383 prescriptions to 384 prescriptions per 1,000 population over the period from October
2011 to September 2012, compared with the baseline from
October 2010 to September 2011. The nine county councils that reduced their sales over the 2012 contract period
were Blekinge, Gotland, Gävleborg, Västerbotten,
Kronoberg, Kalmar, Östergötland, Norrbotten and
Västernorrland. The first four counties mentioned also
attained the target of reducing sales by ten per cent of
the difference between sales in the comparison period
and the long-term target of 250 prescriptions per 1,000
popu­lation per year. Despite all the efforts made, there
are factors common to the county councils that mean
that prescribing during the contract period has risen in
26
several county councils, despite the best intentions.
However, a general clear decrease , of 6.7 %, in the prescribing of antibiotics was noted during the third quarter
of 2012. The continued trend will have to show whether
this is a sustainable result of the purposeful efforts being
made in the county councils to achieve rational and safe
prescribing of antibiotics. The follow-up of the Patient
Safety Agreement shows that all the county councils
have endeavoured to bring about greater compliance
with treatment recommendations for common infections in community care.
The Infection Tool, IT support for continuous measurement of healthcare-related infections but also to
monitor the prescribing of antibiotics over time is currently being implemented. A communication initiative
is also in progress in cooperation between the Swedish
Institute for Infectious Disease Control and other
national actors concerned.
Work in 2013 and timetable
The patient safety initiative is taking place over a number of years and will continue until 2014.
5
Develop a long-term sustainable pricing, prioritisation and financing
model for all medicines
5.1Review pricing and handling of
original medicines without generic
competition etc.
Main responsibility: Ministry of Health and Social
Affairs
On 16 June 2011 the Government adopted terms of reference for an inquiry which is to review certain issues of
pricing, availability and market conditions in the area of
medicines and pharmacies (the Medicines and Pharmacies Inquiry (S 2011:07). On 22 September 2011 the Government decided to give the inquiry additional terms of
reference under which the inquiry is to carry out a review of original medicines without generic competition
and propose a long-term sustainable pricing model.
Objective
The purpose of the review to assess ways of developing
the pricing of original medicines without competition in
the pharmaceutical benefits scheme and propose a longterm sustainable model for this group of medicines. The
proposed model is to be able to address the growing challenges in the area of medicines and is also to be able to
correct high prices for certain groups of original medicines without generic competition. A basic requirement
for a future pricing model is that it should create the
necessary basis for good cost control and that prices of
medicines in Sweden should be below or on a par with
prices in other comparable countries, such as Norway,
the United Kingdom and Denmark. A future pricing
model is also to ensure good access to effective medicines
that create the necessary basis for modern healthcare
and comply with Section 2 of the Health and Medical
Services Act on the goals of health and medical services.
This necessitates the research-based pharmaceutical
industry also continuing to be well placed to research
and develop new medicines.
Status in autumn 2012
On 22 September the Government decided to give the
inquiry additional terms of reference under which it is to
carry out a review of original medicines without generic
competition and propose a long-term sustainable pricing
model. On 14 June 2012 the remit was broadened by leaving the inquiry free to also present proposals relating to
the pricing of generic medicines. The inquiry reported
on this part of its remit on 31 October 2012.
Work in 2013 and timetable
The inquiry report will be referred for comment.
5.2Investigate long-term handling of
community pharmacy medicines
not included in the pharmaceutical
benefits scheme
Main responsibility: Swedish Association of Local
Authorities and Regions
Preparation of procedures so that county councils, in
exceptional cases, can supply medicines not included in
the pharmaceutical benefits scheme to a defined group
of patients where the treatment is clearly cost-effective.
The county councils and Apotekens Service AB are
together developing a long-term solution for handling
invoicing and statistics files relating to the county councils' payment for medicines not included in the pharmaceutical benefits scheme.
Objective
The county councils subsidise medicines in community
healthcare outside ordinary invoicing procedures for the
pharmaceutical benefits scheme. Examples of these are
contraceptives for young people, medicines protecting
against infection and medicines for certain patients in
psychiatry. This may also involve medicines which are
not covered by the pharmaceutical benefits scheme but
which the county councils for various reasons may wish
to subsidise at individual or group level. The procedure is
administratively extensive both for county councils and
for pharmacy actors, and modified routines are needed,
for instance for improved follow-up.
Status in autumn 2012
The aim is for the pharmacies' dispensing systems for
the costs of pharmaceutical benefits to also be able to
handle reimbursement costs for community pharmacy
medicines not included in the pharmaceutical benefits
scheme. In the spring of 2012, Apotekens Service AB
carried out a preliminary study to find a long-term
solution for handling invoicing and statistics files.
Work in 2013 and timetable
Continued cooperation between the Swedish Association of Local Authorities and Regions and Apotekens
27
Service AB is planned in 2013 to find a common solution
for handling community care medicines not included in
the pharmaceutical benefits scheme, but subsidised by
the county councils, in the short and long terms.
5.3Assess the county councils' procurements of ordered medicines and
how the process can be made more
efficient
Main responsibility: Swedish Association of Local
Authorities and Regions
5.4Carry out trial activity where the
Dental and Pharmaceutical Benefits
Agency assesses selected hospital
medicines
Main responsibility: Dental and Pharmaceutical
Benefits Agency
The Dental and Pharmaceutical Benefits Agency is carrying out trial activity for two years in which it is assessing the cost-effectiveness of selected hospital medicines
under a special government remit.
Objective
Inquiry looking into limits within which the county
councils can procure hospital medicines and how the
process can be made more efficient.
Objective
The county councils have long experience of procuring
medicines and already cooperate in the area today. Experience shows that increased coordination, either through
regular joint procurement under the Public Procurement
Act or through other strategic cooperation, can result in
lower costs in use. The overarching aim through further
collaboration is to bring about greater benefit for
patients and the public. An opportunity is provided
through exchange of experience, information and
knowledge, the development of joint support functions
(e.g. a price database), joint specification of requirements
and combined medical, pharmaceutical and procurement
law expertise, to assess and test different forms of procurement, to define what products are suitable for joint
procurement and which are best procured locally or
regionally.
Status in autumn 2012
The project has a steering group, a project leader and
three sub-projects: Procurement, Price Database and
Negotiation. A project plan is adopted and sub-project
plans are in preparation and are to be adopted during the
autumn of 2012. An expert group for the selection of
conceivable objects of procurement has been formed,
and the steering group has decided on start of procurement for a procurement object common to the county
councils. The financing model for the project from 2013
onwards is not ready.
Work in 2013 and timetable
Full manning of the project during the third quarter of
2012. The first county council-wide procurement will be
completed in the last quarter of 2012.
28
The purpose of the health-economic assessments includes;
• A better basis for clinical decisions and procurement
of medicines
• Better utilisation of existing resources for appraisal
of knowledge by the assessments being made by a
national agency and not by all the responsible
authorities.
Status in autumn 2012
The Dental and Pharmaceutical Benefits Agency published the first health-economic knowledge base in
June 2012 and altogether has published three healtheconomic knowledge bases.
The Dental and Pharmaceutical Benefits Agency is
working concurrently on process development and there
is continuous collaboration with The NLT group
(NyaLäkemedelsTerapier – New DrugTherapies) and
other stakeholders.
Work in 2013 and timetable
The agency has special funding from the Government
for the project, which will continue until 30 June 2013.
A final report on this work will be presented at the latest
two months after the trial activity has ended. The activity is also to be evaluated by the Swedish Agency for
Health and Care Services Analysis.
6
Establish a process for orderly and effective introduction and expand
follow-up of the use and effects of medicines
6.1Establish a process between authorities, county councils and industry
on the orderly introduction of new
medicines
Main responsibility: Swedish Association of Local
Authorities and Regions
Establishment of a process between authorities, county
councils and industry concerning orderly introduction,
including horizon scanning and forecasting the information on decisions on authorisation, subsidisation and
national guidelines, communication and dialogue with
medical experts and prescribers concerned.
This is based on previous experience of orderly introduction in the county councils.
Objective
Introduction of a new medicine and the time until it is
used can be unnecessarily long today. In addition, use
may become uneven across the country and follow-up
may be deficient. The goal is structured introduction of
new medicines with coordinated decisions from affected
actors. In the case of community medicines, there should
be a decision on whether they are included in the pharmaceutical benefits scheme within a very short time
after marketing authorisation. There should be a healtheconomic assessment for hospital medicines. There
should also be a decision by the county councils that the
medicine is to be used, together with guidelines on how
it is to be used as well as its price – which may necessitate negotiation or procurement, depending on the medicine concerned. There should also be a plan for followup and tools for this. To attain this there is a need for
significant coordination between actors and for it to be
possible for the processes to be integrated and started
before a medicine has been formally authorised. If these
goals are to be attained, changes to various statutory
instruments are needed.
Status in autumn 2012
The NLT group (NyaLäkemedelsTerapier – New Drug
Therapies) was formed in 2010 on behalf of the county
council directors.
Its remit has been to support county councils and
regions in handling new medicines that have a particularly great budget impact and a deficient knowledge base,
and where there is a risk of excessive differences in how
extensively they are used. The NLT group has regular
coordinated meetings for its regular activity with the
Dental and Pharmaceutical Benefits Agency (TLV), also
attended where necessary by the Medical Products Agency, the National Board of Health and Welfare and representatives of the pharmaceutical supplier concerned. The
views of relevant experts are obtained. The NLT group
has to date supplied around fifteen recommendations on
individual medicines.
County councils and regions jointly run and finance
the activities of the NLT, and the basis of these activities
is the established horizon scanning carried out in the
'four-county cooperation' between the region of Västra
Götaland, Stockholm County Council, Region Skåne and
Östergötland County Council. Horizon scanning is performed to find the products that are in the pharmaceutical companies' pipeline and that are on the way to being
launched on the market in the next two years. NLT, all
the county councils and the Dental and Pharmaceutical
Benefits Agency have access to the results at present. To
broaden the work of horizon scanning, the group should
cover more authorities and actors in the pharmaceutical
market.
The work of SALAR and the county councils on the
orderly introduction of new medicines has been coordinated with the equivalent process in the National Cancer
Strategy since the spring of 2012. In practice, this means
that the project leader for orderly introduction of cancer
medicines is a member of the NLT group and that the
structure of continued work is devised jointly. During
the spring of 2012 both NLT and the National Cancer
Strategy held meetings on orderly introduction with
relevant actors. There is wide agreement on the goals of
more coordinated introduction and equal use of medicines across the country. The problem areas, such as difficulty in coordinating the decisions of all the parties concerned, prescribed processing times and rules on
confidentiality, are identified.
NLT's recommendations are important components
in the national part of orderly introduction, but do not
cover all medicines and need to be supplemented by
more common strategies on information, training, follow-up and price. This needs to be developed further
under 6.1, but also affects other parts of NLS, e.g. 5.3
(Efficiency improvement in the procurement of medicines) and 5.4 (the Dental and Pharmaceutical Benefits
Agency's project on the evaluation of hospital medi-
29
cines). A preliminary process description for the national
introduction of medicines has therefore been developed
and will be discussed during the autumn, and according
to schedule a proposal for a common introduction process will be presented to the county councils for further
discussion in the last quarter of 2012. Decisions are also
to be made during the same period on the future of the
NLT group and the forms the broader remit entailed by
6.1 will take. This also includes how the horizon scanning work is to be developed further, together with more
actors than at present. Communication activities are to
be carried out to supply information on the national
work taking place in relation to 6.1. As part of this, NLT,
the Medical Products Agency and Stockholm County
Council, in collaboration, are holding a symposium during the National Convention of the Swedish Society of
Medicine in November 2012 on tasks 6.1 and 6.2 "Orderly
introduction of new medicines – How difficult can it
be?"
The limited activity NLT has, including horizon scanning, is jointly financed by the county councils at present. No decision has been made on financing from 2013
onwards. An injection of resources will be required for
the broader approach required by 6.1 with more involved
authorities and other actors.
Work in 2013 and timetable
A natural next stage is to also include national actors in
the pharmaceutical field in a forum concerned with horizon scanning, and under the auspices of the county councils to test a broader model of introduction for a pharmaceutical substance in live operation. To achieve intended
goals, changes are needed in the statutory instruments
concerned. An analysis of what statutory changes are
necessary should therefore be carried out so that coordination of the work of the county councils, SALAR and
the authorities on orderly introduction is made easier and
the transparency of various decisions improves.
6.2Develop national model for development of introduction protocol and
introduce coordinated assessment
of medicines in clinical reality
Main responsibility: Medical Products Agency
Implementation of pilot projects in which an introduction protocol for selected medicines is designed making
it possible to systematically study what effects and side
effects the new medicine has in everyday clinical practice and to what extent approved indications, decisions
by the Dental and Pharmaceutical Benefits Agency on
limited reimbursement and the recommendations of the
pharmaceutical committees are followed. With experience from the pilot projects, more general conclusions
30
and recommendations for the design of an introduction
protocol and coordinated follow-up of newly introduced
medicines are developed.
Objective
The purpose of the activity is, on the basis of experience
from the pilot projects, to develop more general conclusions and recommendations for the design of an introduction protocol and coordinated follow-up of newly
introduced medicines. The objective is to prepare a “Best
Practice Guide” which can be used to guide healthcare
providers, companies and other stakeholders in situations where orderly/structured follow-up needs to be
carried out.
Status in autumn 2012
During the spring and summer the pilot projects included continued working on the basis of their planning, and
their work has been regularly followed up through visits
etc. The result of this follow-up has been documented
separately for each pilot project and was reported at a
meeting of the steering group on 21 August 2012.
During the autumn of 2012 the project will continue
to monitor the selected pilot projects and look at possible
pilot projects in other important areas, such as orphan
medicines and medicines subject to restrictions on pharmaceutical benefits.
In November the collation of international experience
in the area ordered by the project will be reported at a
meeting with relevant stakeholders.
Work in 2013 and timetable
The project plans to report results and experience towards the end of 2013.
6.3Improve follow-up of pharmaceutical
dosing
Main responsibility: Ministry of Health and Social
Affairs
Making available of data on dosage and dosing intervals
in numeric form or as a “prescribed daily dose” (PDD)
calculated by Apotekens Service AB. This item also includes integration of information on dosage into the
quantity of information supplied to the National Board
of Health and Welfare and the county councils in the
monthly transfer of data.
Objective
The overarching aim in adding dosage and dosing intervals in numeric form or a prescribed daily dose (PDD)
calculated by Apotekens Service AB to the data supplied
to the National Board of Health and Welfare and the
county councils is to improve the quality of drug pre-
scribing and in the long term to raise the quality of
prescribing.
Status in autumn 2012
It is unclear at present whether statutory changes are
required.
An analysis of the basis in law for dealing with the
issue is currently being conducted by the Ministry of
Health and Social Affairs in dialogue with Apotekens
Service AB and those actors who wish to receive the
information. An equivalent dialogue is also in progress
regarding the prospects of finding a technical solution to
the issue under present-day rules.
Work in 2013 and timetable
The continued process regarding the issue depends on
the outcome of the legal analysis currently being carried
out. Depending on the outcome of the analysis, the matter may need further consideration by an authority, for
example the National Board of Health and Welfare.
There may also be reason to consider whether a technical solution is to be preferred in the short term.
6.4Make follow-up of ordered medicines
possible at individual level
Main responsibility: National Board of Health and
Welfare
Investigation into how individual data on ordered medicines can be made available from various patient record
systems or the pharmaceutical modules linked to them.
Investigation into how individual data on ordered medicines can be integrated into the National Board of
Health and Welfare's Prescribed Drug Register and used
for example for epidemiological studies, research and the
preparation of statistics in the area of healthcare.
Objective
To be able to provide a complete picture of the pharmaceutical treatment of the population it is crucial, in addition to following up prescribed medicines collected from
pharmacies, also to be able to follow up the treatment
given to patients in wards and outpatient clinics at hospitals. This data will make more comprehensive followup studies possible with the aim of strengthening knowledge on and experience of use of medicines and
ultimately enabling the individual patient to receive the
best and safest possible care and treatment.
Status in autumn 2012
The National Board of Health and Welfare has stated in
the report "Preliminary study on individual data for
ordered medicines" that a large number of questions
need to be investigated for data on pharmaceutical treat-
ment in the wards and outpatient clinics of hospitals or
in home medical care for example in special housing to
be made available from patient record systems and integrated into health data registers at the National Board of
Health and Welfare. The National Board of Health and
Welfare considers it essential that reporting can be done
by automatic data capture if data collection is to work
well. This means that support systems that work
smoothly and structured documentation are required.
The National Board of Health and Welfare deems continued development in this area to necessitate input both
from itself and from representatives of county councils
and regions. In October the National Board of Health
and Welfare was tasked with assessing alternative health
data registers for the integration of individually based
data on the basis of legal and practical aspects. This includes an investigation of the legal aspects of the various
alternatives. An example of practical aspects to be taken
into account is the possibility of linking pharmaceutical
treatment to a particular care episode. The remit also
includes the National Board of Health and Welfare having to define indicators of desired quality in reported
data including coverage in the register, so that the register can be considered to be a reliable source for follow-up
studies or statistics. This includes, for example, a comparison with the sales statistics of Apotekens Service AB
on ordered medicines. The National Board of Health and
Welfare is also to report on various ways of aggregating
stored pharmaceutical data, for example the quantity of
a particular medicine per care episode, date and how
complex dosage regimens are to be handled.
Work in 2013 and timetable
The remit will be reported by 30 April 2013. As a large
proportion of the work must be done by the county
councils and regions, the National Board of Health and
Welfare and the Swedish Association of Local Authorities and Regions/CeHis should synchronise their investigative efforts and other activities under the new project.
6.5Make it possible for the county
councils, the National Board of
Health and Welfare and the Dental
and Pharmaceutical Benefits Agency
to follow up prescribing of medicines at prescriber level.
Main responsibility: Ministry of Health and Social
Affairs
Follow-up of why the data on prescriber code on prescriptions is not transferred to the Prescribed Drug Register or to the county councils' individually based pharmaceutical data, followed by suitable measures to make
this possible.
31
Objective
The overarching purpose of adding a prescriber code to
data supplied to the National Board of Health and Welfare and the county councils is to improve the quality in
follow-up of prescribing and in the long term to improve
the quality of prescribing.
Status in autumn 2012
It is unclear at present whether statutory changes are
required. An analysis of the basis in law for dealing with
the issue is currently being conducted by the Ministry of
7
Work in 2013 and timetable
The continued process regarding the issue depends on
the outcome of the legal analysis currently being carried
out. Depending on the outcome of the analysis, the matter may need further consideration by an authority, for
example the National Board of Health and Welfare.
Reduce the impact of medicines on the environment locally
and globally
7.1Investigate whether environmental
aspects should be considered in the
reimbursement of medicines
Main responsibility: Ministry of Health and Social
Affairs
Review of the prospects for taking greater account of
environmental considerations under the national pharmaceutical benefits scheme.
Objective
Pharmaceuticals often contain several active substances
which may potentially have an environmental impact.
The environmental risk assessments that have been carried out show that the present-day use of medicines does
not cause a risk of acute toxicity to aquatic organisms,
but may pose a risk of long-term effects and cause pollution of drinking water. There are still significant gaps in
knowledge of what effects pharmaceutical residues have,
for example in the form of contamination of drinking
water, and what effects on human health this can lead to
in the longer term.
The Dental and Pharmaceutical Benefits Agency
(TLV) has not taken account of environmental considerations when deciding whether a medicine is to be included in the pharmaceutical benefits scheme. To enable
TLV to do this, there needs to be adequate knowledge of
the impact of medicines on the environment, ways of
quantifying the costs of negative environmental effects
and a system of environmental classification in which
medicines are assessed on the basis of common criteria.
32
Health and Social Affairs in dialogue with Apotekens
Service AB and those actors who wish to receive the
information.
Status in autumn 2012
On 14 June 2012 the Government appointed an inquiry
chair to conduct a review of certain issues related to
pricing, availability and market conditions in the area of
medicines and pharmacies. The Government then
broadened the inquiry’s remit on 22 September 2012 to
also include reviewing whether environmental aspects
should be considered in the reimbursement of medicines. The remit includes analysing and examining
whether TLV should take account of environmental
aspects in pharmaceutical benefit decisions for all medicines, describe what practical conditions must be met for
TLV to take account of environmental aspects in pharmaceutical benefit decisions and shed light on how consideration of environmental aspects in decisions on pharmaceutical benefits would affect the costs of medicines.
Work in 2013 and timetable
The inquiry remit will be reported to the Government
on 1 April 2013. The intention is that the proposal will
then be sent out for comment.
7.2Encourage voluntary checking of
emissions from pharmaceutical
factories
Main responsibility: Swedish Association of the Pharmaceutical Industry (LIF)
Introduction of voluntary ecolabelling of pharmaceutical
products.
Objective
The project is aimed at encouraging voluntary control of
emissions and discharges from pharmaceutical factories
by introducing voluntary environmental assessment of
medicines. A model that assesses the whole product and
not just the active substance like the present-day environmental classification system at www.fass.se is becoming an important tool in the internal environmental
activity of the pharmaceutical companies. The environmental assessment can additionally be used in connection with public procurement and in the reimbursement
and substitution system, provided the rules are amended
so that environmental considerations can be included in
the reimbursement and substitution system.
The project consists of sub-projects as follows.
• Preparation of a Swedish model for environmental
assessment of medicines.
• Preparation of a model for environmental consideration in the Swedish reimbursement and substitution
system.
• Training on the environmental assessment model for
employees of the pharmaceutical companies.
• The establishment of an organisation which can
administer the environmental assessments.
Status in autumn 2012
The models for environmental assessment and green
financial incentives have undergone further development in 2012. Their development is closely linked to
the remit of the Medicines and Pharmacies Inquiry
(S 2011:07) to review whether environmental aspects
need to be taken into account in reimbursement of the
cost of medicines. In view of the fact that this part of
the inquiry's report will not be presented until 1 April
2013, the timetable for the LIF project will be extended.
Work in 2013 and timetable
The model for environmental assessment of pharmaceutical products and models for green financial incentives
is undergoing further development in collaboration with,
and taking account of, proposals in the Medicines and
Pharmacies Inquiry and from other stakeholders in the
sector. The design of the models affects the final design
of the e-training and the organisation that is to administer the environmental assessments.
The project is expected to be completed in early 2014,
so that actual environmental assessments of medicines
in Sweden can begin during the autumn of 2014. Proposals for conceivable models are due to be presented by the
end of June 2013. A decision on a model for the environmental assessment of medicines in Sweden will be made
in the autumn of 2013. Enhanced environmental training
for the employees of the pharmaceutical companies will
be devised in the spring of 2013 so that actual training
can begin during the autumn of 2013. The organisation
which is to administer the environmental assessment
will be established in 2013 so that it can be in place in
2014.
7.3Investigate what further measures
can be taken at national level to reduce the discarding of medicines or
in other ways to limit the environmental impact of the use of medicines
Main responsibility: Medical Products Agency
Investigation into the causes of discarding and proposals
for measures to reduce the discarding of medicines.
Implementation of joint information efforts to
encourage patients to return leftover medicines.
Objective
The purpose of the remit is to contribute to making it
possible for the discarding of medicines to be further
reduced and to the pharmaceutical residues arising in the
handling of medicines and in the consumption of medicines being disposed of in an environmentally sound
way. The inquiry has had the four objectives of
• Investigating the causes of discarding
• Presenting proposals for further measures to reduce
the discarding of medicines
• Presenting proposals for measures which in some
other way limit the environmental impact of the use
of medicines, i.e. which ensure that the pharmaceutical waste that arises in the handling and consumption
of medicines does not contribute to water, soil or air
pollution
• Conducting a joint information campaign to encourage patients to return leftover medicines in order to
increase the collection rate.
Status in autumn 2012
The joint information campaign to increase the return
of leftover medicines to pharmacies concluded with a
follow-up SIFO opinion survey at the end of April, in
which around 75 % of the public said that they returned
leftover medicines to pharmacies. This is a somewhat
higher proportion than in the SIFO survey in 2011, but
the target in the national pharmaceutical strategy of
80 % was not reached.
New information and data gathered through questionnaires and enquiries to wholesalers, pharmacy actors, the
grocery trade, county councils/regions and municipalities
have been collated together with other study results.
All the objectives of the inquiry have been met. With
regard to proposed measures to reduce discarding of
medicines or the environmental consequences of dis-
33
carded medicines, the proposals are limited to those
deemed to be most crucial from the perspective of society and to have good prospects of being implemented.
The inquiry additionally describes proposals already
made and the outcome of these proposals.
Work in 2013 and timetable
The inquiry has been closed with final reporting by
30 September, and the only planned activity is a followup meeting of the steering group for the information
campaign, at which decisions will be made on how remaining funded resources from the campaign are to be
handled. Several of the inquiry proposals indicate a need
for some further investigation or a need for development
activity which, following a decision may be relevant to
campaigns in years to come.
7.4Endeavour to make it possible for
consideration to be given to the
environment in the production and
use of medicines
Main responsibility: Government Offices
On 9 June 2011 the Government took a decision to task
the All-Party Committee on Environmental Objectives
(M 2010:4) with developing proposals for a strategy for
Swedish work in the EU and internationally on a nontoxic environment. The strategy also has to encompass
the impact of medicines on the environment.
Objective
Emissions and discharges from pharmaceutical production plants in Sweden are very limited as they often have
their own wastewater treatment. Swedish pharmaceutical production is also closely regulated and controlled.
Sweden today has limited production of medicines, and
the principal challenge in our local environment is
therefore posed by the consequences of the consumption
of medicines. The trend in recent years has, however,
been for pharmaceutical companies in Sweden to outsource more and more of their production to low-cost
countries where either the environmental requirements
in manufacturing are substantially less stringent than in
Sweden or where the authorities have limited opportunities to monitor compliance with the national environmental requirements. A large proportion of production
takes place in countries such as China and India.
Status in autumn 2012
The Government decided on 9 June 2011 to give the AllParty Committee on Environmental Objectives an additional remit to devise a strategy for Swedish work in the
EU internationally towards a non-toxic environment.
The strategy is also to encompass the impact of medi-
34
cines on the environment. The All-Party Committee on
Environmental Objectives presented the report “Reduce
the risks of hazardous substances! Strategy for Sweden's
work towards a non-toxic environment” (SOU 2012:38)
on 14 June 2012. The report proposes that milestone targets be established for the environmental effects of medicines, with the following wording: “Sweden's efforts are
to contribute to decisions being made under which environmental aspects can be incorporated into existing and
where necessary new regulations relating to medicines,
no later than 2020.” The report also contains proposals
for measures to be taken in order to attain this goal. The
report was sent out for comment on 1 October 2012.
Work in 2013 and timetable
The aim is for the Government to respond to the proposals in the report in 2013.
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