Major Danish conference on biosimulationSignificant drop in benzodiazepine consumptionMost single reimbursement grants go to OdsherredEnforcing the lawFocus on the shared medicine card
Major Danish conference on biosimulation
Having run for five years, the BioSim Network now draws nearer to its closing conference, which is to be held at Christiansborg Palace in Denmark from 26 to 28 August. The conference spans three days, and the Danish Medicines Agency will be hosting the Friday theme “Drug Assessment and Biomedical Simulation” as well as an internal conference day, ”BioSim Scientific Conference”, which is held afterwards on 29 August.
The framework of the BioSim project was a five-year EU fund of DKK 80 million and an objective of educating new European scientists within biosimulation. In this network, young scientists have had the opportunity of learning from the best system biologists in Europe. Many of this unique group of scientists who have gathered through the BioSim project hold two degrees in, for example, medicine and physics. But key to the network is also that it brings together experimental and theoretical groups of scientists. By working across disciplines, these groups develop computer simulation models of biological systems with the purpose of developing new medicine, and by combining their expertise, they can achieve a better understanding of the results.
Cooperation in the sake of new medicine
The network is coordinated by Professor Erik Mosekilde from the Department of Physics at the Technical University of Denmark. The network is split into six research activity areas, cooperating across the disciplines: cancer, diabetes, hypertension and cardiovascular diseases, depression and mental disorders, method, communication and the regulatory area. The network joins physicians, biologists, mathematicians, physicists, pharmacists and other experts, who work together to develop computer models that may help us understand and explain the complex biological system of the human body. The network covers 40 European research groups, 26 universities and 10 companies and the medical authorities from the Netherlands, Spain, Sweden and Denmark. In other words, it covers all the groups that normally participate in the development of new medicine.
Competitive
The overall objective is to give Europe a competitive advantage over the USA and the Far East in the area of developing new and safe medicine using computer simulation models. In the USA and the Far East, the models are not only used to develop new medicine, they also form part of the procedures for approving new medicine. In the BioSim Network, the simulation models are used in combination with animal trials. The advantage of computer simulation models is that they can repeat a trial for an indefinite number of times, thereby reducing the need for animal experiments over time.
A task for the authorities
The Danish Medicines Agency has been active in the network from its very beginning in 2005. In the first year, the Danish Medicines Agency held a one-day symposium where participants from the medical authorities and scientists from universities and companies all over Europe gathered to discuss how to make the most of computer simulation models.
At the BioSim conferences, Chief Medical Officer Steffen Thirstrup from the Danish Medicines Agency has spoken on the use of these models, and the Danish Medicines Agency has also attended the meetings of the other medical authorities. In 2006, a BioSim fund enabled the Danish Medicines Agency to employ Mr Tue Søborg who is educated from the Faculty of Pharmaceutical Sciences at the University of Copenhagen. As a PostDoc he has received additional training in modelling and has participated in modelling courses at the Department of Physics at the Technical University of Denmark. This has meant that the Danish Medicines Agency has obtained knowledge and acquired competencies in modelling through participation in the Network.
Anne Marie Clemensen
Benefits for all
”Biosimulation is a time and money saver in medicine development. It will also reduce the need for animal tests, which I believe is in everyone’s interest”, says Mr Per Helboe, who heads the Danish Medicines Agency’s activities in the BioSim Network. Mr Helboe adds: ”Biosimulation presents a special challenge to the authorities because we must be geared to assess applications for the authorisation of medicines in which results from biosimulation have been included. It’s an area where we have lagged behind – the USA in particular – but we now try to catch up through the work and activities of the network.”
Significant drop in benzodiazepine consumption
Intensified efforts from the Danish health authorities to reduce the use of benzodiazepines have resulted in a significant drop in the consumption of sleeping medicine and anxiolytics in Denmark from 2007 to 2008.
Focus on consumption
Over the years, the health authorities have launched different health-policy initiatives aimed to reduce the consumption of benzodiazepines (BZD) and benzodiazepine-like agents. In July 2008, these efforts were intensified with the revision of the Danish National Board of Health’s guidance on the prescription of dependence-producing medicinal products. The guidance provides that the prescription and renewal of prescriptions for dependence-producing agents in general must take place through personal consultation, giving the general practitioner and the patient an opportunity to discuss the treatment and the risk of addiction. The efforts were supported by the Institute for Rational Pharmacotherapy, which sent out information material to general practitioners, practice staff and relatives. Several regions have also run information campaigns on the subject, and regional drug treatment advisers often followed up with special initiatives aimed at general practitioners.
Efforts have paid off
The intensified efforts seem to have borne fruit. An analysis of the years from 2004 to early 2009 shows a significant drop in consumption, especially in the latest quarters. The Register of Medicinal Product Statistics at the Danish Medicines Agency forms the basis of the analysis. From 2007-2008, the overall consumption of BZDs sold on prescription for individuals fell by almost 9%. Regional differences still prevail. Central Denmark Region, which has made a dedicated effort over several years, accounts for the lowest consumption across all types of BZDs. Region Sealand accounts for the highest consumption of anxiolytics, while North Denmark Region has the highest consumption of sleeping medicine. The new rules for the issue, renewal or reacquisition of a driver’s licence also seem to have had an effect. The analysis reveal a significantly greater decline in the consumption of BZDs of the type which incur driver’s licence limitations compared with BZDs of the types permitted with or without time limits.
- For further information, please see the report ‘Significant drop in the consumption of sleeping medicine and anxiolytics in Denmark’, which you can find in the factbox to the right
Long-term use of sleeping medicine and anti-anxiety drugs of the benzodiazepine type should be avoided, as it can lead to addiction, dizziness, memory impairment and concentration difficulties, as well as an increased risk of falling. In Denmark, there are 13 different BZDs, marketed under almost 40 different trade names. It takes between 3-72 hours for the substance to be reduced by half in the body depending on the type of substance. In addition, there are three different benzodiazepine-like products, marketed under 11 different trade names. They have the same effect on the brain as BZDs, however, it only takes between 1-5 hours for the substance to be halved.
Most single reimbursement grants go to Odsherred
In 2008, medicine users in Odsherred, the north-western corner of Sealand, received the most single reimbursement grants, so shows a recent report from the Danish Medicines Agency. However, the report also shows that single reimbursement grants are spread quite evenly over Denmark.
The Danish Medicines Agency has compiled statistics for 2008, depicting the number of reimbursement grants and their distribution on Denmark's municipalities. The statistics show the total volume of grants and grants per 1,000 inhabitants.
Not surprisingly, the City of Copenhagen, which is the largest municipality, received the most single reimbursement grants. However, compared with the size of the population, Copenhagen is somewhere in the middle.
The municipalities of Odsherred, Dragør and Tønder
In 2008, the most single reimbursement grants were awarded in Odsherred municipality, 25 grants per 1,000 inhabitants to be precise. Then followed Dragør municipality on Amager Island just outside Copenhagen, and Tønder municipality in the southern region of Denmark.
The fewest grants were awarded to medicine users living on two small islands: Læsø receiving 9 grants per 1,000 inhabitants, and Christiansø receiving 10 grants per 1,000 inhabitants. The large municipalities furthest down on the list are Hjørring, 13, and Egedal, Aalborg, Ringkøbing-Skjern, all receiving 14.
Many different factors may influence the number of reimbursement grants that are awarded to citizens living in the different municipalities. Obviously, the occurrence of disease plays a dominant role, as does the age distribution and probably also the proximity of general practitioners and medical specialists.
Remote areas also received reimbursement grants
It was once argued that especially medicine users living in remote areas were disadvantaged when it comes to the possibility of receiving single reimbursement. The new statistics do not establish a clear connection between geographical location and reimbursement grants. In fact, two of the three municipalities on top of the list, Odsherred and Tønder, are geographically located in remote areas.
The municipalities of the Copenhagen suburbs, whose inhabitants are generally thought to be financially strong and to have easy access to medical specialists, are evenly distributed on the list: Rudersdal received 23 grants per 1,000 inhabitants, Gentofte, 20; Vallensbæk, 17; and Egedal, 14, as mentioned above. Most of the municipalities of the Greater Copenhagen Area are, however, placed on the top half of the list. You can order the full list from the Information Centre of the Danish Medicines Agency, infocenter@dkma.dk.
Karsten Jørgensen
Single reimbursement of medicines
Pursuant to section 145 of the Danish Health Act, a physician may, on behalf of a patient, apply for single reimbursement of a medicinal product that is not eligible for general reimbursement.
If such a single reimbursement grant is awarded, the medicine user enjoys the same rights at purchase as apply to a medicine that carries general reimbursement. Like general reimbursement, single reimbursement is paid by the regions.
Single reimbursement is only granted in special circumstances, and the reimbursement criteria appear from the executive order on reimbursement. The socioeconomic status of the patient is not included in the assessment of whether or not to grant single reimbursement.
Enforcing the law
The Danish Medicines Agency welcomes lawyer Frank Wendelbo-Madsen as the new head of Enforcement. The Enforcement department has the responsibility of monitoring the pharmacies, and the department must often also run several pharmacies in situations where a pharmacy seeks a new pharmacist to take over the pharmacy licence. In the media, the department is mostly known for its efforts to prevent the import of illegal medicine and for its role of determining whether a product is a medicine or not. One of the newest areas is the efforts to combat counterfeit medicines.
Finally, the department is responsible for the inspection of over-the-counter medicines and the inspection of wholesalers and other distributors of medicine.
Frank Wendelbo-Madsen joins the Danish Medicines Agency following a position at the Danish National Board of Industrial Injuries.
”I know almost nothing about my new area, but I know all there is to know about industrial injuries, and I was ready for new challenges", he says.
Two managers
Wendelbo-Madsen will be running the department together with Kim Helleberg Madsen.
”The cases we receive are often very complex and it is a great advantage to have a second pair of eyes on the cases", he adds.
He welcomes the possibility of studying the legal aspects in detail after several years at the National Board of Industrial Injuries, which processes some 60,000 industrial injury cases every year.
”I’m also quite impressed with the level of contact we have with the people in Denmark and their everyday life. We make a big difference," says Frank Wendelbo-Madsen.
Focus on the shared medicine card
After a break of 18 months, Birgitte Drewes, LLM, has returned to the Danish Medicines Agency. Back then she headed the former department Systems & Administration. Now she rejoins as head of Medicine IT in Denmark after a short stay at Capinordic Bank A/S.
A complete treatment overview
The task of Medicine IT in Denmark is to run the so-called real-time systems like the Medicine Profile and the Prescription Server and in the longer term the shared medicine card.
Today, several different systems register the patients’ medicine consumption at different levels, e.g. the Medicine Profile, the Prescription Server as well as medicine cards of the separate medical journal systems. Unfortunately, the fact that there are many different systems in operation increases the risk of medication errors.
High ambitions
To eliminate this risk, the Danish Medicines Agency therefore participates in the development of the shared medicine card under the project coordinated by Digital Health in Denmark.
The shared medicine card is to provide a complete overview of the individual patient’s medical treatment, making the information available whenever it is needed.
Birgitte Drewes and her team are faced with great challenges. She says: ”I will focus my energy on making Medicine IT in Denmark an active player in putting the shared medicine card in operation. Most of all, I look forward to help create meaningful solutions for citizens and external stakeholders, and ultimately to help create a better health service”.
Birgitte Drewes explains that her ambition is only natural because no other country has ever created a project quite like Medicine IT in Denmark: “It is unique because we have a long track record with our Register of Medicinal Product Statistics and the Central Reimbursement Register, which puts us in the forefront of development”.
Major communication projects ahead
To cross the goal line safely, Birgitte Drewes will focus on maintaining constructive dialogue with external stakeholders across the healthcare scene: ”We are going to formalise and streamline communication paths. As part of this process, we will make a stakeholder analysis in search of answers to the question: are we communicating with the right persons in the right way?”
Birgitte Drewes is active in many different external forums, but she also takes time to nurture her network inside the Danish Medicines Agency through participation in in-house working groups:. ”It is crucial to the project that I interact with staff across the Agency so that the knowledge held by Medicine IT Denmark and the entire staff can benefit the right stakeholders most appropriately”.
Katrine Johansen
