S-103 33 Stockholm

National pharmaceutical strategyAction plan 2013

Production: Blomquist Annonsbyrå Print: Edita Västra Aros, Västerås, 2013 Photography: Johnér BildbyråArticle number: S2013.008

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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 Resist-ance) 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, regu-lations concerning when medication reviews are to be offered to elderly patients who take many dif-ferent 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 HägglundMinister for Health and Social Affairs

Anders KnapeChair, Swedish Association of Local Authorities and Regions

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Contents

Introduction 5

NatIoNal pharmaceutIcal strategy 6

a national pharmaceutical strategy 7

Vision 7

Goals 7

Action areas 7

Follow-up 7

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

references 35

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Introduction

The report "A national pharmaceutical strategy? – apreliminary study" (S2010/6349/FS) was presented in the summer of 2010. This describes challenges in the phar-maceutical 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 ap-pointed 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 Bene-fits 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 in-dustry and the pharmacy sector. Representatives of sec-tor 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 contain-ing 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 hori-zon 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 innova-tion strategy, the initiative on the elderly, the patient safety strategy and the eHealth strategy. Action to coor-dinate 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 hori-zon scanning are as follows.

• Generic prescribing• Medication reviews• Development of knowledge and guidelines for medi-

cines 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 fol-lowed up at the level of action. The ambition in 2013 is to continue to develop the goals and indicators of the strat-egy and to endorse, validate and coordinate these. This work will be directed by the Medical Products Agency and coordinated with affected authorities and organisa-tions.

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National pharmaceutical strategy

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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.

VisionCorrect 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 medi-cines in as cost-effective a way as possible in order to be able to achieve the greatest possible health for the re-sources allocated to medicines.

GoalsFive 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 areasTo 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 medi-cines and the use of medicines for those groups of patients in which this is most neglected

• Reduce the development and spread of antibiotic re-sistance 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 introduc-tion 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-upThe 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 develop-ment 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 phar-maceutical field. An important but complex part of the work under the pharmaceutical strategy is therefore the development of indicators.

Other initiatives and strategiesThe 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 pa-tient 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 devel-oping healthcare quality registers. In addition, the Gov-ernment has decided to give the All-Party Committee on Environmental Objectives an additional remit to devise a

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strategy for Swedish work internationally towards a non-toxic 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 develop-ment 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 strat-egy. This means that the national pharmaceutical strat-egy is closely linked to several of the Government's other initiatives and strategies.

many actors work together on medicinesWork towards attaining the vision of correct use of med-icines 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 treat-ment 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 hy-gienists, midwives and nurses with special additional training. Various forms of support are available at the time of prescribing, for example the summary of prod-uct characteristics of the medicinal product and recom-mendations 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

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 medi-cation-related problems. After collecting the medicine, the patient is responsible for it being used correctly. Relatives or municipal staff (for example nursing auxilia-ries 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 availabil-ity, 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 repre-sent an important party and channel for rational use of medicines, focusing on the usability and efficacy of med-icines 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 medi-cine'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 discon-tinuation 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 pharma-ceutical treatment and of prescribing, organisation, han-dling and administration. Several actors are important in the follow-up and development of new knowledge, for example patients, the health service, pharmacies, univer-sities, pharmaceutical companies and government agen-cies. These actors all have their own roles and responsi-bilities to bring about attractiveness for innovations.

Continued development of new medicines is neces-sary 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 phar-maceutical 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-

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bility for pharmaceutical benefits from central govern-ment 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 coun-cils 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 environ-mental impact. Part of the work on the environmental quality objective A Non-Toxic Environment, which is coordinated by the Swedish Chemicals Agency, is con-cerned 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 phar-maceutical manufacturing from the environmental per-spective.

Many actors are thus involved in the life cycle of med-icines and are of crucial significance in contributing to better health and use of medicines that is safe for pa-tients and effective. The national pharmaceutical strate-gy 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 strategyThe 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 medi-cines towards the vision of the strategy. This broad ap-proach means that the strategy is aimed at a large num-ber of actors, directly or indirectly affected by the use of medicines.

World-class medical results and patient safetyMedical results and world-class patient safety are a cru-cial 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 rec-ommendations, 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 spe-cial initiative is also being taken in this area. This initia-tive is being taken under an agreement between central government and the Swedish Association of Local Au-thorities 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 organ-ised 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 there-fore 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 resist-ance and use of antibiotics in Sweden has been, and con-

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tinues to be, favourable in comparison with most other EU Member States. Prescribing statistics from open comparisons of the quality and effectiveness of health-care shows that the proportion of the population treated with antibiotics declined between 2006 and 2009. All the county councils are thus consistently showing a posi-tive trend, but there is still reason to focus on reducing the use of antibiotics. Central government and the Swed-ish Association of Local Authorities and Regions have agreed, under the patient safety agreement, on perfor-mance-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 careThe 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 Swe-den, regardless of age, place of residence, education, eco-nomic circumstances, illness or disability. The care of-fered 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 pa-tient safety agreement are specifically targeted at equal-ity 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 medicinesValue-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-effec-tive use of medicines. It is important to create as much health in the population as possible with the resources allocated to medicines.

Attractiveness for products and servicesSweden has a strong and innovative life science industry and internationally strong clinical research. Close collabo-ration between the healthcare system and business has led to a large number of internationally successful innova-tions, and this has made a strong contribution to the de-velopment of the Swedish life science industry. Collabora-tion on the development of medicines, methods and treatments has also strengthened clinical research. Swe-den 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 develop-ment of new products and services in the area of health-care, 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 qual-ity and implementation of research. The development and use of innovative solutions and more effective col-laboration 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 hälso- och 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 develop-ing 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 impactPharmaceuticals often contain several active substances which may potentially have an environmental impact. The environmental risk assessments that have been car-ried 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 pollu-tion of drinking water. There is a need for further long-term 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 ef-fects of different medicines in the environment. There are still significant gaps in knowledge of what effects

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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 medi-cines are not dispersed to the environment, for example knowledge regarding what action could be taken to re-duce discarding of medicines and what measures could be taken at sewage treatment plants.

action areas of the pharmaceutical strategyThe national pharmaceutical strategy identifies seven action areas clearly linked to the set goals of the strategy. These action areas are crucial in bringing about develop-ment in the goals and in leading the use of pharmaceuti-cals closer to the vision of the strategy. They are notable for a high degree of urgency and require national cooper-ation 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 supportIncorrect prescribing and administration of medicines is estimated to cause costs amounting to several billion Swedish kronor a year for society. The prescriber is de-pendent 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 incor-rect prescribing and has been identified in the prelimi-nary study for this strategy as one of the most crucial measures to improve use of medicines. The work in-volved 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. Responsi-bility for maintaining the various knowledge databases needed for evidence-based prescribing must be clearly regulated and ensure long-term management. This de-velopment activity is mainly dealt with under National eHealth.

To establish a national prescribing database and speed up the development of electronic prescriber and dispens-er 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 treatmentIf a prescribed pharmaceutical treatment is to have the intended effect, consensus is required between the pre-scribing doctor and other staff and the patient, as well as an understanding on the part of the patient on the treat-ment, 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 pa-tients can be achieved as far as possible. This is an im-portant aspect of use of medicines that is safe for pa-tients.

Develop knowledge about and guidelines for medicines and the use of medicines for those patients in whom this is most neglectedThere is a lack today of crucial knowledge of medicines and guidelines for the pharmaceutical treatment of cer-tain groups of patients. The groups highlighted, where it is particularly relevant at present, are the elderly, multi-morbid 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 medica-tion for children. There is a need firstly for new knowl-edge and secondly for collations of existing knowledge to strengthen patient safety in the management of medi-cines in paediatric healthcare.

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Reduce the development and spread of antibiotic resistance through a combination of local and global actionsSweden is among the countries in the world with the lowest consumption of antibiotics and the lowest inci-dence of resistance. However, the general situation re-garding 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 interna-tional collaboration. This issue is given high priority in the Government's WHO strategy on antibiotic resist-ance, and Sweden has committed resources to also rais-ing the issue in the EU, in this case for innovative incen-tives 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, prioritisa-tion and financing model for all medicinesThe pricing and prioritisation of both outpatient and inpatient medicines need to be developed. The pricing and prioritisation models have to contribute to cost con-trol so that the use of medicines becomes cost-effective from the perspective of society and in that way contrib-utes to ensuring the best possible health for the popula-tion. 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 coun-cils to cover pharmaceutical benefits today is a specially earmarked government grant. The payment can also be made from the general government grant. Central gov-ernment and the Swedish Association of Local Authori-ties and Regions are in agreement on initiating discus-sions on the requirements to be met in transferring the compensation to the appropriation for municipal finan-cial equalisation under a joint working group.

Establish a process for orderly and effective introduction and expanded follow-up of the use and effects of medicinesThe 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

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 side- effects 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 globallyMedicines and their manufacturing have an impact on the environment, but there is a lack of precise knowl-edge 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 pro-duction of medicines, the principal challenge in our local environment in the short term is posed by the conse-quences of the consumption of medicines.

The issue of the impact of medicines on the environ-ment 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 strategyThe 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 devel-opment 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 re-sults at regional and local level and secondly at monitor-ing 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.

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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 imple-mented 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 improve-ment 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 health-care 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 com-bine 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.

organisation and implementation of the pharmaceutical strategyThe 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 strat-egy's five established objectives. The coordination and

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 au-thorities and undertakings given by the actors con-cerned. 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 for-ward.

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Action plan 2013

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Action plan 2013

1 Create a better and safer prescribing process and lay the foundation for generic prescribing through nationally coordinated IT support

1.1 make electronic reporting of drug side effects possibleMain responsibility: Medical Products Agency

Investigation into making electronic reporting of side effects from the whole healthcare system possible. In-cludes 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.

ObjectiveReporting of drug side effects is crucial in order to dis-cover deficiencies in the handling of medicines and to increase drug safety. All side-effect reports from the health care 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 user-friendly reporting, for example from within patient record systems, to motivate and encourage greater re-porting of side effects and feedback of knowledge for improved patient safety.

Status in autumn 2012The Medical Products Agency recommends that the existing infrastructure in the national service platform be used for side-effect reports from the healthcare sys-tem 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 timetableThe pilot project with Uppsala County Council is ex-pected 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 appropri-ate, 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 Prod-ucts Agency will join the national service platform.

1.2 make generic prescribing possibleMain responsibility: Medical Products Agency

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.

ObjectiveAll 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 partic-ular active substance is known as an original medicinal product. When the patent has run out and the data pro-tection 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 pre-scribing 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 gener-ic 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 2012A 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 pa-tient record systems etc.

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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 pre-scribing 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 con-tains 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 timetableThe report from the Medical Products Agency on gener-ic prescribing will be discussed within the Ministry of Health and Social Affairs in 2013.

1.3 make electronic cancellation of e-prescriptions possibleMain responsibility: The county councils

Make it possible for prescribers, through their care sys-tem, to cancel prescriptions, both those they have pre-scribed 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.

ObjectiveAn issue that has been raised by several actors in recent years is whether responsibility for cancelling prescrip-tions 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.

Status in autumn 2012Apotekens 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 timetableIt 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.

1.4 create national multi-dose registerMain responsibility: Apotekens Service AB

Completion of IT platform for national dose registers and transfer of information from the multi-dose registers.

ObjectiveMake it possible for all actors in the multi-dose-dispens-ing market to have access to data on multi-dose prescrip-tions.

Status in autumn 2012In October 2012 the Ministry of Health and Social Af-fairs 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 timetableWork on creating a national multi-dose register contain-ing 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.

1.5 create prescription database under current legislationMain responsibility: Swedish Association of Local Authorities and Regions

Developed under National eHealth.

ObjectiveIncorrect prescribing and administration of medicines is estimated to cause costs amounting to several billion Swedish kronor a year for society. The prescriber is de-pendent for prescribing that is safe for patients on both combined information on the patient's real pharmaceuti-

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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 rec-onciliation). The conditions are then met for effective decision support for the prescriber. The National Pre-scription Database (Nationell ordinationsdatabas, NOD) is a national source of information containing all pre-scriptions, from community and inpatient care, multi-dose 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 ques-tion becomes what responsibility the various prescribers are to have, for example the one who has originally pre-scribed 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 2012Work on introducing NOD is continuing, and the objec-tive 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 develop-ment of the database structure for NOD. As the over-whelming 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 timetableNOD 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 mod-ules 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 pre-scriptions to NOD.

1.6 establish a coherent system for discussion and decision on the development of national basic systems for prescribing supportMain responsibility: Ministry of Health and Social Affairs Developed under National eHealth.

ObjectiveAdequate prescribing support for healthcare profession-als 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 2012National 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 prescrip-tions 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 assess-ments 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

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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 func-tions of EDS in 2012 and has deemed it to have interest-ing potential as expert support in pharmacies.

Work in 2013 and timetableIn 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.

1.7 Develop service for increased patient involvement through feed-back of outcomes of treatment and non-conformance managementMain responsibility: Swedish Association of Local Authorities and Regions

Developed under National eHealth.

ObjectiveTo be able to supply the patient's own experience of pharmaceutical treatment and therefore achieve greater participation by patients in their own care and treat-ment. 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 plat-forms should be possible. The healthcare provider takes responsibility for data relating to its activities, but the individual concerned has full access to the data – wher-ever, 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 pa-tient more involved in and knowledgeable about his or her own treatment leads to more effective and safer treatment, better compliance, less discarding of medica-tion and more satisfied patients. This is also of great importance from the point of view of the pharmaceuti-cal companies. To be able to monitor cost-effectiveness in everyday clinical practice there is a need for patient-reported data on quality of life.

Status in autumn 2012The Centre for eHealth in Sweden is pursuing the project My Health Services, which is aimed at creating the condi-tions 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

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 ser-vice 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 stand-ardised 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.

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2 Increase consensus on and understanding of prescribed treatment

2.1 create the necessary basis for effective medication reviews and medication reconciliation in health-care transitions and evaluate the effect of these measures on compli-ance with prescribed treatmentMain 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 activ-ity has been implemented, this part is omitted from the Action Plan 2013. The second element, “evaluate the effect of these measures”, remains.

ObjectiveInadequate 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 medica-tion. Medication reviews and medication reconciliation can be effective tools in improving patient safety in long-term 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 2012On 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 individu-als 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 manage-ment of medication in the healthcare system is expected to be ready on 1 December 2012.

Better knowledge of the use of medicines by the elder-ly is crucial to more effective medication reviews and

reconciliation. On 30 August 2012 a study was published under the name “Elderly patients with regular medica-tion – number of medicines as risk marker”. This study shows that extensive pharmaceutical treatment in elder-ly 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 in-creased 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, gastro-intestinal bleeding and falls. The number of medicines is a valuable risk marker to use in screening prior to pre-ventive actions such as medication reviews, targeted patient information and intensified follow-up of the effects of treatment.

Work in 2013 and timetableThe 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.

2.2 evaluate whether multi-dose ser-vices can contribute to greater compliance and improved patient safety and how the service can be used and refinedMain responsibility: Medical Products Agency

Developed under the Government initiative for the sick-est elderly.

ObjectiveThe service is used at present for multi-dose drug dis-pensing 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

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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 2012The 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 contra-ry signals as parts of the profession and patient associa-tions have emphasised that multi-dose drug dispensing makes life easier for and is beneficial to the patient.

Work in 2013 and timetableThe report will be sent out for comment and be en-dorsed within the Medical Products Agency before being submitted to the Ministry of Health and Social Affairs in February 2013.

2.3 carry out skill-enhancing training efforts for home help service staffMain 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.

ObjectiveHome 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 2012The Swedish Association of Local Authorities and Re-gions (SALAR) judges good online training for munici-pal 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

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 med-icines and the elderly. No decision has been taken on which path to follow. There is no separate funding.

Work in 2013 and timetableIt has not been established what work will be undertak-en 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 antici-pated that the training action will start in the last quarter of 2013.

2.4 Develop labelling of pharmaceutical packs to reduce risk of confusionMain responsibility: Medical Products Agency

Work aimed at improving patient safety through the design of pharmaceutical packs which are used in emer-gency care/inpatient care and confusion between which poses serious risks to patient safety.

ObjectiveAlongside 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 uni-form 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 2012The Medical Products Agency and the Network for Pa-tient Safety have developed documentation describing various parameters proposed for change on pharmaceuti-cal 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 com-plex and large field, the work has been restricted to med-icines that are used solely in inpatient care and are par-ticularly 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 pos-sible later follow-up digital study and how use of the changed packs for cefalosporins is to be evaluated. Under

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the ELIS project in Task 5.3, test procurement of safe packaging will take place under the auspices of the coun-ty councils.

Work in 2013 and timetableFollow-up on whether the changed packs for cefalospor-ins 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 mar-ket, the work will continue in 2013–2014.

2.5 Indicators of good patient safety in pharmacies (new activity in 2013)Main responsibility: National Board of Health and Welfare and Medical Products Agency

Development of the pharmacy indicators for follow-up of pharmacy activity.

ObjectiveIndicators make it possible to follow up activity in phar-macies and ensure that clients are offered good care, i.e. care that is knowledge-based, appropriate, safe, patient-focused, effective, equal and given within a reasonable time.

Work in 2013 and timetableThe 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 gen-eral 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 (multi-dose dispensing, hospital and community pharmacies).

2.6 structured discussion of medication in pharmacy (new activity in 2013)Main responsibility: Medical Products Agency

Implementation of trial activity with structured discus-sion of medication in pharmacies for a limited group of patients.

ObjectivePoor 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.

Work in 2013 and timetableThe Government intends to initiate a trial with struc-tured discussion of medication in pharmacies in 2013, with the Medical Products Agency having main respon-sibility 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 refer-ring 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.

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3.1 Draw 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 elder-ly and multimorbid patients are to be treated and guid-ance on application of these guidelines have been drawn up, this activity is omitted from the action plan for 2013.

3.2 expand knowledge of paediatric medicines and their useMain 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 inven-tory of further special national guidelines to be devel-oped for children.

ObjectiveA Swedish study in 2008 on drug prescriptions for chil-dren in hospital showed that children received an aver-age of 3.8 prescriptions for medication each. Almost half of all prescribing was made up of medicines insufficient-ly documented for children. Newborn infants, in partic-ular 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 2012In 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.

Work in 2013 and timetableThe 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 identi-fy 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 communi-cation 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 devel-oping existing knowledge, for instance by holding an expert meeting on drug administration by tube to chil-dren 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 sub-mitted 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 collabo-ration with the National Board of Health and Welfare and the paediatric clinics, review the options for making existing databases, for example existing sources of infor-mation, 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, how-ever, a high-priority area.

3.3 strengthen doctors' knowledge of medicines and use of medicines during specialist training in medication-intensive specialtiesMain 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 cours-es) for doctors undergoing specialist training focused on medicines and use of medicines.

3 Develop knowledge about and guidelines for medicines and the use of medicines for those patients in whom this is most neglected

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ObjectiveCrucial 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 en-deavour to ensure a safer prescribing process. The initia-tive 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 2012The 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 timetableThe 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.

3.4 Development web-based continuing professional development module to strengthen the knowledge of intern pre-registration physicians (at-läkare) on the elderly and medi-cines (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 medi-cines and use of medicines among the elderly through a web-based continuing training module. The remit in-cludes presenting proposals for content, training goals and timetable for the launch of various parts of the training.

ObjectiveThe 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 potential-ly unsuitable treatment occurs with certain medicines, for instance antipsychotics, anticholinergics, long-acting sedatives and hypnotics. Ignorance of the special consid-erations that are needed in the pharmaceutical treatment of elderly patients is one reason why unsuitable treat-ment 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 medi-cines, including impaired cognitive capacity and in-creased 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 timetableThe 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 pre-liminary study includes analysing the needs and prob-lems of the target group and surveying recipient struc-tures 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.

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4.1 continue 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 rela-tively 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.

ObjectiveAccording to the European Centre for Disease Preven-tion 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 performance-based payment model aimed at leading to more restrained use of antibiotics.

Status in autumn 2012In 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 in-creased compliance with local treatment recommenda-tions regarding common infections in outpatient care and reduce the prescribing of antibiotics based on estab-lished indicators. The Swedish Institute for Infectious Disease Control (SMI) has shown in a study on how the treatment recommendations are applied that the recom-mendations 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 treat-ment 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

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 nation-al collaborative function and to devise an interdiscipli-nary action plan for coordinated action against antibiotic resistance and healthcare-related infections. The author-ities are also to devise an overarching communication strategy for the area.

Work in 2013 and timetableThe patient safety initiative is taking place over a num-ber 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.

4.2 promote an action plan for the development of antibiotics at eu levelMain 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 coun-tries. Sweden primarily prioritises efforts at EU level that involve incentives for the development of new and effective antibiotics.

ObjectiveSweden 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

4 Reduce development and spread of antibiotic resistance through a combination of local and global actions

25

regulatory and financial nature. Sweden is to lend partic-ularly active support to the Commission in work towards developing a framework with industry that defines pur-pose, 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 Commis-sion on mobilising resources, within the framework of the Innovative Medicines Initiative with the aim of sup-porting research and development in the area of ABR (antibiotic resistance). Through the work in Joint Pro-gramming – “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 glob-al/regional/national system could be designed with re-gard to controlled distribution and use (CDU) of new future antibiotics.

Status in autumn 2012A 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 practi-cal initiatives, firstly through an AMR (antimicrobial resistance) conference in March 2012 and secondly through Council conclusions as a follow-up to the con-ference.

The Council conclusions urge the Member States and the Commission to “identify options and models to strengthen incentives to conduct research and develop-ment 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 Eu-ropean Commission on the issue and follow-up activities on the issue are planned.

Work in 2013 and timetableLobbying 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.

4.3 promote increased efforts towards rational use of antibiotics and redu-ced antibiotic resistance globallyMain 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 achiev-ing 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 Infec-tious Disease Control.

ObjectiveSweden is to press for WHO to draw up a plan for work on antibiotic resistance that includes an appropriate or-ganisational 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 2012Since the autumn of 2011 there has been a secretariat within WHO working on AMR issues from an overarch-ing 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 con-junction with the World Health Assembly in May 2012.

The National Board of Health and Welfare was in-structed 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 re-cruit 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 sup-port to WHO in the area of ABR.

The bilateral cooperation with China and India on AMR, as part of the health cooperation with these coun-tries, continued in 2012.

Work in 2013 and timetableThe lobbying of WHO and other important global play-ers 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

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runs until 2015 and a progress report is due to be submit-ted in December 2013.

4.4 Develop 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.

4.5 Introduce performance-based pay-ment for reduced prescribing of anti-biotics through greater compliance with treatment recommendationsMain responsibility: The county councils

Developed under the Patient Safety Agreement.

ObjectiveSweden is among the countries with the lowest con-sumption of antibiotics and the lowest incidence of re-sistance. However, a steady deterioration is taking place in the general situation regarding the development of resistance. Central government and the Swedish Associ-ation 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 2012According to the Swedish Institute for Infectious Dis-ease Control (SMI), sales of antibiotics increased in Swe-den as a whole, from 383 prescriptions to 384 prescrip-tions 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 coun-cils 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 popu lation 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

several county councils, despite the best intentions. However, a general clear decrease , of 6.7 %, in the pre-scribing 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 infec-tions in community care.

The Infection Tool, IT support for continuous meas-urement of healthcare-related infections but also to monitor the prescribing of antibiotics over time is cur-rently 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 timetableThe patient safety initiative is taking place over a num-ber of years and will continue until 2014.

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5.1 review 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 refer-ence 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 Pharma-cies Inquiry (S 2011:07). On 22 September 2011 the Gov-ernment decided to give the inquiry additional terms of reference under which the inquiry is to carry out a re-view of original medicines without generic competition and propose a long-term sustainable pricing model.

ObjectiveThe purpose of the review to assess ways of developing the pricing of original medicines without competition in the pharmaceutical benefits scheme and propose a long-term sustainable model for this group of medicines. The proposed model is to be able to address the growing chal-lenges in the area of medicines and is also to be able to correct high prices for certain groups of original medi-cines 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 2012On 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 leav-ing 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 timetableThe inquiry report will be referred for comment.

5.2 Investigate long-term handling of community pharmacy medicines not included in the pharmaceutical benefits schemeMain 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 coun-cils' payment for medicines not included in the pharma-ceutical benefits scheme.

ObjectiveThe 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 2012The 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 timetableContinued cooperation between the Swedish Associa-tion of Local Authorities and Regions and Apotekens

5 Develop a long-term sustainable pricing, prioritisation and financing model for all medicines

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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.

5.3 assess the county councils' procure-ments of ordered medicines and how the process can be made more efficientMain responsibility: Swedish Association of Local Authorities and Regions

Inquiry looking into limits within which the county councils can procure hospital medicines and how the process can be made more efficient.

ObjectiveThe county councils have long experience of procuring medicines and already cooperate in the area today. Expe-rience 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 pro-curement, to define what products are suitable for joint procurement and which are best procured locally or regionally.

Status in autumn 2012The 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 procure-ment 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 timetableFull 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.

5.4 carry out trial activity where the Dental and pharmaceutical Benefits agency assesses selected hospital medicinesMain responsibility: Dental and Pharmaceutical Benefits Agency

The Dental and Pharmaceutical Benefits Agency is car-rying out trial activity for two years in which it is assess-ing the cost-effectiveness of selected hospital medicines under a special government remit.

ObjectiveThe purpose of the health-economic assessments in-cludes;• 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 2012The Dental and Pharmaceutical Benefits Agency pub-lished the first health-economic knowledge base in June 2012 and altogether has published three health- economic 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 timetableThe 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 activ-ity is also to be evaluated by the Swedish Agency for Health and Care Services Analysis.

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6.1 establish a process between autho-rities, county councils and industry on the orderly introduction of new medicinesMain 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 informa-tion 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 intro-duction in the county councils.

ObjectiveIntroduction 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 phar-maceutical benefits scheme within a very short time after marketing authorisation. There should be a health-economic 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 necessi-tate negotiation or procurement, depending on the med-icine concerned. There should also be a plan for follow-up 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 2012The 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 particu-larly 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 Agen-cy, the National Board of Health and Welfare and repre-sentatives 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 per-formed to find the products that are in the pharmaceuti-cal 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 coordi-nated 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 medi-cines across the country. The problem areas, such as diffi-culty in coordinating the decisions of all the parties con-cerned, 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, fol-low-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 medi-cines) and 5.4 (the Dental and Pharmaceutical Benefits Agency's project on the evaluation of hospital medi-

6 Establish a process for orderly and effective introduction and expand follow-up of the use and effects of medicines

30

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 pro-cess 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 scan-ning 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 dur-ing 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 scan-ning, is jointly financed by the county councils at pre-sent. 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 timetableA natural next stage is to also include national actors in the pharmaceutical field in a forum concerned with hori-zon scanning, and under the auspices of the county coun-cils to test a broader model of introduction for a pharma-ceutical 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 coordi-nation of the work of the county councils, SALAR and the authorities on orderly introduction is made easier and the transparency of various decisions improves.

6.2 Develop national model for develop-ment of introduction protocol and introduce coordinated assessment of medicines in clinical realityMain responsibility: Medical Products Agency

Implementation of pilot projects in which an introduc-tion protocol for selected medicines is designed making it possible to systematically study what effects and side effects the new medicine has in everyday clinical prac-tice 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 experi-ence from the pilot projects, more general conclusions

and recommendations for the design of an introduction protocol and coordinated follow-up of newly introduced medicines are developed.

ObjectiveThe purpose of the activity is, on the basis of experience from the pilot projects, to develop more general conclu-sions and recommendations for the design of an intro-duction 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 situa-tions where orderly/structured follow-up needs to be carried out.

Status in autumn 2012During the spring and summer the pilot projects includ-ed 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 phar-maceutical 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 timetableThe project plans to report results and experience to-wards the end of 2013.

6.3 Improve follow-up of pharmaceutical dosingMain 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 in-cludes 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.

ObjectiveThe overarching aim in adding dosage and dosing inter-vals 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-

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scribing and in the long term to raise the quality of prescribing.

Status in autumn 2012It 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 timetableThe 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 mat-ter 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 techni-cal solution is to be preferred in the short term.

6.4 make follow-up of ordered medicines possible at individual levelMain responsibility: National Board of Health and Welfare

Investigation into how individual data on ordered medi-cines can be made available from various patient record systems or the pharmaceutical modules linked to them. Investigation into how individual data on ordered medi-cines 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.

ObjectiveTo be able to provide a complete picture of the pharma-ceutical treatment of the population it is crucial, in addi-tion 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 hos-pitals. This data will make more comprehensive follow-up studies possible with the aim of strengthening knowl-edge 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 2012The 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 inte-grated 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 con-tinued 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 in-cludes 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 hav-ing to define indicators of desired quality in reported data including coverage in the register, so that the regis-ter can be considered to be a reliable source for follow-up studies or statistics. This includes, for example, a com-parison 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 timetableThe 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 Authori-ties and Regions/CeHis should synchronise their investi-gative efforts and other activities under the new project.

6.5 make 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 medici-nes at prescriber level.Main responsibility: Ministry of Health and Social Affairs

Follow-up of why the data on prescriber code on pre-scriptions is not transferred to the Prescribed Drug Reg-ister or to the county councils' individually based phar-maceutical data, followed by suitable measures to make this possible.

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7.1 Investigate whether environmental aspects should be considered in the reimbursement of medicinesMain responsibility: Ministry of Health and Social Affairs

Review of the prospects for taking greater account of environmental considerations under the national phar-maceutical benefits scheme.

ObjectivePharmaceuticals often contain several active substances which may potentially have an environmental impact. The environmental risk assessments that have been car-ried 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 pollu-tion 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 consider-ations when deciding whether a medicine is to be includ-ed 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.

Status in autumn 2012On 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 medi-cines. The remit includes analysing and examining whether TLV should take account of environmental aspects in pharmaceutical benefit decisions for all medi-cines, describe what practical conditions must be met for TLV to take account of environmental aspects in phar-maceutical benefit decisions and shed light on how con-sideration of environmental aspects in decisions on phar-maceutical benefits would affect the costs of medicines.

Work in 2013 and timetableThe 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.

7.2 encourage voluntary checking of emissions from pharmaceutical factoriesMain responsibility: Swedish Association of the Phar-maceutical Industry (LIF)

Introduction of voluntary ecolabelling of pharmaceutical products.

ObjectiveThe overarching purpose of adding a prescriber code to data supplied to the National Board of Health and Wel-fare 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 2012It 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 Reduce the impact of medicines on the environment locally and globally

Health and Social Affairs in dialogue with Apotekens Service AB and those actors who wish to receive the information.

Work in 2013 and timetableThe 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 mat-ter may need further consideration by an authority, for example the National Board of Health and Welfare.

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ObjectiveThe 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 envi-ronmental classification system at www.fass.se is becom-ing an important tool in the internal environmental activity of the pharmaceutical companies. The environ-mental assessment can additionally be used in connec-tion 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 considera-

tion 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 2012The models for environmental assessment and green financial incentives have undergone further develop-ment 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 timetableThe model for environmental assessment of pharmaceu-tical 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 adminis-ter 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. Propos-als for conceivable models are due to be presented by the end of June 2013. A decision on a model for the environ-mental 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.

7.3 Investigate what further measures can be taken at national level to re-duce the discarding of medicines or in other ways to limit the environme-ntal impact of the use of medicinesMain 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.

ObjectiveThe 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 medi-cines 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 pharmaceuti-cal 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 encour-age patients to return leftover medicines in order to increase the collection rate.

Status in autumn 2012The 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 question-naires 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-

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carded medicines, the proposals are limited to those deemed to be most crucial from the perspective of soci-ety 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 timetableThe inquiry has been closed with final reporting by 30 September, and the only planned activity is a follow-up meeting of the steering group for the information campaign, at which decisions will be made on how re-maining 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.

7.4 endeavour to make it possible for consideration to be given to the environment in the production and use of medicinesMain 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 non-toxic environment. The strategy also has to encompass the impact of medicines on the environment.

ObjectiveEmissions and discharges from pharmaceutical produc-tion plants in Sweden are very limited as they often have their own wastewater treatment. Swedish pharmaceuti-cal 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 out-source 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 opportuni-ties to monitor compliance with the national environ-mental requirements. A large proportion of production takes place in countries such as China and India.

Status in autumn 2012The Government decided on 9 June 2011 to give the All-Party Committee on Environmental Objectives an addi-tional 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-

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 tar-gets be established for the environmental effects of med-icines, with the following wording: “Sweden's efforts are to contribute to decisions being made under which envi-ronmental 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 timetableThe aim is for the Government to respond to the pro-posals in the report in 2013.

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