Indication, 17 February 2009

Indication, 17 February 2009

Major overhaul of reimbursements for cardiovascular medicinal products
The new voice of the Danish Medicines Agency
Weak painkillers over the counter
Positive citizens on the phone
Danes contribute to European collaboration
New manager of the Consumer Safety Division
Advanced therapies

Major overhaul of reimbursements for cardiovascular medicinal products

In fruitful collaboration with the Reimbursement Committee and other stakeholders, the Danish Medicines Agency has concluded its review of reimbursements for a number of medicinal products for the treatment of hypertension and other cardiovascular diseases. The result will be a change in reimbursement so that overall, general reimbursement will be granted to the cheapest among those medicinal products which are recommended equally in treatment guides.

Ordered by Parliament

The reform forms part of the reassessment reform passed by the Danish Parliament in 2005, which requires the Danish Medicines Agency to regularly assess the reimbursement status of the medicinal products in the individual medicinal product groups. The objective is to ensure, on the one hand, that reimbursement is granted to all necessary medicine and, on the other hand, that reimbursement is targeted at the cheapest of the best medicinal products.

“It has been a long, but smooth process with excellent input from the stakeholders. Most important for me is that we have found a sensible balance of guiding the medicine consumption towards more rational treatment – equally effective, but cheaper for the patient as well as the public sector. At the same time, we hope that this reform will put hypertension so much in focus that we can correct the situation of huge undertreatment in Denmark,” says Karen Kolenda, Head of Department at the Danish Medicines Agency. Together with Elisabeth Thomsen, she has had the overall responsibility for the reform.

Collaboration with general practitioners

Before the reform enters into force this summer, the general practitioners must talk to the affected patients and decide on their future treatment. The Danish Medicines Agency will support this work by writing to the individual general practitioner and by providing information to patients via the Internet and other channels.

“It will also be important to get in contact with the hospital doctors because they often initiate treatment. Their choice determines the subsequent treatment at the general practitioners. It is therefore important that they also aim at choosing the medicine type which, in the long term, is the rational choice for the patient,” Karen Kolenda explains.

Next round

This spring, the Danish Medicines Agency will start the next round of the reassessment process, in which focus will be on metabolic disorders and digestive conditions. Previously, the Danish Medicines Agency has reviewed all cholesterol reducing agents.

CJ

Main points of the reform:

• Includes medicinal products from medicinal product groups C07, C08 and C09
• Some medicinal products will no longer be eligible for general reimbursement
• Other medicinal products will still be eligible for reimbursement if certain conditions are met and the general practitioner writes ‘tilskud’ (reimbursement) on the prescription
• Total annual savings for society and patients come to more than DKK 200 million

The new voice of the Danish Medicines Agency

At the new Information Centre, many enquiries to the Danish Medicines Agency will be answered immediately. The four employees at the Centre handle telephone enquiries and emails to the Danish Medicines Agency. On the right you see Sune Johansen and Katrine Johansen. They each have their specific area of expertise and are therefore in a perfect position to answer many of the daily questions immediately. Read more on page 3...

Weak painkillers over the counter

The debate on the sales of weak painkillers in large packs has surfaced once more. This time, the background is new figures from the National Patient Registry which show an increase in the number of suicide attempts among young girls using weak painkillers.

Increase in suicide attempts among young girls

The number of suicide attempts using weak painkillers among 12 to 20-year-old young girls was fairly constant at approx. 240 in the years 2002-2004. In 2005, it rose to 292, but dropped back to the level of 2002-2004 in 2006. In 2007, the number rose again to an all-time high of 318.

The reduction in the number of suicide attempts in 2006 coincided with the full implementation of a compulsory warning labelling on large packs. The objective of the warning is to motivate medicine users – especially the parent generation – to store large packs out of reach of children and youngsters in the home.

The reduction may not be attributable to the warning labelling, but this may have played a role. And the reason why the development took a wrong turn again in 2007 could be related to the fact that the effect of a new warning usually subsides over time.

The Danish Medicines Agency’s assessment

The development in the number of suicide attempts among young girls has led to a renewed debate on whether large packs of weak painkillers should be prescription-only.

The development – everyone must agree – is very regrettable. The question, however, is how best to reverse it. This is where a difference of opinion is evident. Ultimately, the Danish Medicines Agency assesses which medicinal products, including which pack sizes, should be prescription-only. And the Danish Medicines Agency maintains that the debated large packs should still be available over the counter at pharmacies. Today, supermarkets, kiosks etc. are only allowed to sell small packs containing up to 10 tablets.

Large packs over the counter

The reasons why the Danish Medicines Agency will not require large packs to be prescription-only, are:

• Weak painkillers are generally very safe in normal use. If they are made available as prescription-only medicine in order to counter abuse, there is a risk that the abuse is transferred to other and more dangerous medicinal products.
• The National Board of Health assesses that there is no need to make large packs available with prescription only.
• Prescription-only requirements will make everyday life more difficult for the many people who use these medicinal products sensibly and according to instructions.
• There are a considerable number of suicide attempts, but only few actual suicides committed among young girls using weak painkillers.
• Experience from abroad does not document a safety advantage in making large packs prescription-only.

Additionally, the underlying problem in society which makes young girls attempt suicide cannot be solved by introducing prescription-only requirements for some medicinal products. The suicidal thoughts of these girls – or their need to cry out for help – will not disappear because of some technical changes in the range of medicinal products.

Pharmacist dispensing

The Association of Danish Pharmacies has introduced its own proposal, on the one hand, to ban the sales of weak painkillers – even in small packs – outside of pharmacies, and on the other hand to introduce so-called pharmacist dispensing of large packs. In case of pharmacist dispensing, a pharmacist at the pharmacy must decide whether the medicine user is allowed to buy a large pack.

At the same time as the Association of Danish Pharmacies introduced its proposal, the Danish Association of Pharmaconomists published an interview with Winnie Nielsen, pharmaconomist from Gentofte Pharmacy, at its website . In the interview, Winnie Nielsen notes, among other things, that it is difficult for the pharmacy staff to notice the danger signals in young customers.

If the pharmaconomist asks about the use of the medicinal product, the reply may be that “my doctor recommended Panodil® because my back hurts” or that the pills are for the young customer’s mother. “The reply could be right or wrong – we cannot tell,” says Winnie Nielsen.

Karsten Jørgensen

“Thank you so much for the excellent service!” We often hear this from pleased citizens at the end of their calls to an employee at the Danish Medicines Agency’s new Information Centre. With the Information Centre, we want to meet the increasing requirements in society for flexibility, transparency and availability, and we have therefore decided to focus on good and efficient customer service.

Tangible results

The Information Centre was established in September 2008, and the result is improved and more targeted communication with the world around us. Among other things, this means that the people who contact us will always get in touch with a real, live person. They do not have to be transferred several times because they either get in touch with the right contact from the start, or they can leave a message with an employee. After only four months, we can feel that the people contacting us are pleased with the increased service level. We are often told that they now truly feel that the Danish Medicines Agency exists for the citizens.

For the customers

Based on surveys which showed, among other things, that the Danish Medicines Agency was considered to be ‘closed and bureaucratic’, the main objective of the Information Centre is to ensure good and efficient customer service. This means that, to the extent possible, enquiries to our main telephone number +45 4488 9595 and to dkma@dkma.dk are answered fully by us, providing the enquirer with the necessary information as quickly as possible. At the same time, the Information Centre frees resources for other Danish Medicines Agency employees who are relieved of telephone calls in particular.

The many months of preparations including measurements, analyses and dialogue across professional groups and managerial levels at the Agency resulted in the Danish Medicines Agency closing all its telephone answering machines and introducing other drastic measures which required technical, organisational and cultural adaptation.

Now we are here, and we are looking forward to continuing to provide excellent service to our stakeholders.

Katrine Johansen

Joan Winslow and Marianne Gaard, Information Centre

Danes contribute to European collaboration

The Danish contribution to the European collaboration on medicine quality has now been strengthened. Two working groups under the European Pharmacopoeia Commission have appointed Danish chairpersons. The Commission sets common standards for the quality of medicinal products.

Kaare Hasløv from Statens Serum Institut was appointed chairman of the working group monitoring the development of human vaccines. Professor Vagn Neerup Handlos from the Capital Region of Denmark Pharmacy is the new chairman of a new working group for plastics, including materials for the packaging of medicine.

In addition, three new Danish experts have joined the collaboration: Professor Jukka Rantanen from the Faculty of Pharmaceutics and inspectors Knud Ryhl Bjørnsson and Erik Østergaard, both from the Danish Medicines Agency, which contributes with a total of seven experts.

Overall, Denmark is now represented in 25 of the 61 working groups under the European Pharmacopoeia Commission.

CJ

New manager of the Consumer Safety Division

Consumer Safety is central to the Danish Medicines Agency – and to Helle Harder, who has been promoted to Head of Department.

“Nationally as well as internationally, the requirements for increased medicinal product safety are rising. Denmark is too small to solve this task on its own, so it is my goal to increase the division’s international commitment. On a more personal level, I have experienced a high level of professionalism and commitment among colleagues and employees and for me, this is an encouragement to keep improving,” says Helle Harder and continues,

“Through our contact with the citizens, we can sense an ever increasing interest in and knowledge about the medicine being prescribed. This also places heavy demands on our professionalism, and therefore, the development of the competencies in the department is very important to me. We have a tremendous communication task to perform, and it must be supported by our ability to constantly be up to date on the latest developments in this area.”

Helle Harder has worked at the Danish Medicines Agency since 2007, and her primary focus has been on medicinal product safety. She has previously worked for the biotech company Novo Nordisk, where her job included planning and conducting clinical trials. Helle holds an MSc in Human Nutrition and is currently working on a Master’s degree from the Faculty of Pharmaceutics.

CJ

Advanced therapies

Steffen Thirstrup, Chief Medical Officer at the Danish Medicines Agency, has been appointed by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) to participate in the work being undertaken in the Committee for Advanced Therapies (CAT).

“Many of these therapies are new and so advanced that it almost exceeds imagination,” says Steffen Thirstrup about his new task. One example is the treatment of osteoarthritis.

“The idea here is to extract healthy cells from the patient, propagate them and insert them into the affected areas. This is new and very promising,” he explains.

Read more about advanced therapies in the next issue of Indikation, which will be available in March.