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Channel: Danish Health Authority, Danish Medicines Agency and Danish Patient Safety Authority

National Clinical Guideline: prevention and treatment of dystocia


Information about MERS-CoV for travellers

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The Danish Health and Medicines Authority has prepared a leaflet for travellers visiting areas with outbreaks of MERS-CoV. The leaflet describes recommended precautions for travellers to areas with MERS-CoV.

The leaflet also offers advice on the precautions travellers should take and what they should be aware of if they become ill after their return.

European Centre For Disease Prevention and Control still estimates that travellers to areas with outbreaks of MERS-CoV have a low risk of becoming infected with MERS-CoV.

WHO does not recommend travel restrictions in relation to MERS-CoV. However, travellers should be aware that they may become infected with the disease through contact with the healthcare system, which was the case in the most recent hospital outbreaks in South Korea and Saudi Arabia (Riyadh).

Travellers to the Middle East, including Saudi Arabia and the United Arab Emirates, should still pay attention to the occurrence of MERS-CoV in these areas. See the lists of countries with confirmed cases of MERS-CoV at WHO’s website.

Travellers to areas with outbreaks of MERS-CoV are recommended to practice good hand hygiene (hand washing and alcohol), good food hygiene (avoid unpasteurised camel milk products and raw/under-cooked camel meat) and avoid contact with ill people. This is particularly relevant for travellers who suffer from an underlying chronic disease. Travellers to the Middle East should avoid contact with camels, including visits to camel farms.

Link

Information for travellers to and from countries with MERS (PDF)

The Danish Ministry of Health has appointed three new Director Generals

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In August, Minister for Health Sophie Løhde announced that she will strengthen the focus on core tasks, case handling and the development of the health area by establishing four new agencies under the Danish Ministry of Health: The Danish Health Authority, the Danish Patient Safety Authority, the Danish Health Data Authority and the Danish Medicines Agency.

Simultaneously with the announcement of the new organisation, four vacant Director General positions were advertised, and three of the positions have now been filled. Søren Brostrøm is the new Director General of the Danish Health Authority and Anne-Marie Vangsted is the new Director General of the Danish Patient Safety Authority; they will take up their new positions today. On 1 November, Lisbeth Nielsen will take up the position as Director General of the Danish Health Data Authority.

Minister for Health Sophie Løhde is pleased with the recruitment of the new Director Generals who will develop and influence the new agencies and the health service in the coming years:

”I am very satisfied that we have appointed strong and experienced persons who will contribute to improving and structuring the many exciting tasks to be carried out by the agencies. Søren Brostrøm is quite a force within the hospital area that he has contributed to developing in recent years, and Anne-Marie Vangsted is already working on innovating the supervision of healthcare professionals and the health service. When Lisbeth Nielsen takes up the position in the Danish Health Data Authority, we can speed up the work with health data and health information technology, areas in which Denmark holds a unique position”, says Sophie Løhde.

With the appointment of three new Director Generals, we still have to fill the vacant position as Director General of the Danish Medicines Agency before the new team of Director Generals is in place under the Danish Ministry of Health.

The position as Director General of the new Danish Medicines Agency will be readvertised to reach a wider range of candidates. The Danish Medicines Agency will be set up as from today, on 8 October, with Jakob Cold as the Acting Director General. In future, Jakob Cold will be Deputy Director General of the Danish Medicines Agency.

About the new Director Generals

Søren Brostrøm, who will head the new Danish Health Authority, was previously Head of Division in the Danish Health Authority and responsible for the hospital area and health preparedness. He is 50 years old and holds an MD from the University of Copenhagen. Søren Brostrøm is a specialist in gynaecology and obstetrics and has more than 15 years experience from the Danish hospital service. He will take up the position today, on 8 October, and the new Danish Health Authority will be established as from today.

Anne-Marie Vangsted will be establishing and developing the new Danish Patient Safety Authority, which is formed through the merger of the National Agency for Patients’ Rights and Complaints and the supervisory functions of the Danish Health Authority. She was previously Deputy Director General of the Danish Health Authority and has 25 years experience from the ministry’s areas of responsibility, 17 years as a manager. Anne-Marie Vangsted is 54 years old and holds a degree in pharmacy. She will take up the position today, on 8 October, when the new Danish Patient Safety Authority will also be set up. Steffen Egesborg Hansen, present Director General of the National Agency for Patients’ Rights and Complaints, will be the new Deputy Director General of the new Danish Patient Safety Authority.

Lisbeth Nielsen is the new Director General of the Danish Health Data Authority. She is 45 years old, comes from a managerial position at Nordsjællands Hospital and also has management experience from IBM and Danish Regions. Lisbeth Nielsen has been working with health information technology and quality development throughout most of her career. Lisbeth Nielsen takes up the position on 1 November when the new Danish Health Data Authority will be established. Flemming Christiansen will be the new Deputy Directory General. He is presently Executive Vice President of the part of the Danish State Serum Institute that will become the new Danish Health Data Authority.

The seven roles of physicians

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Last year, the Danish Health and Medicines Authority revised the descriptions of the seven physician roles used in medical specialist training so that they match the future work of physicians. The report of the seven roles of physicians is now available in English.

The revised names for the seven physician roles:

  • Medical expert
  • Communicator
  • Collaborator
  • Manager/administrator/organiser
  • Health advocate
  • Scholar/researcher/teacher
  • Professional

The physician roles were introduced in Denmark in the educational programme for 2003 and originate from a Canadian framework. The Canadian framework was developed from analyses of the needs of society and describes the roles/competencies that physicians should be able to master. The seven physician roles are used in the Danish specialist training to prepare physicians on what roles they can have in their future work.

The work to revise the roles was started in 2012 based on an evaluation of the then roles. Experience suggested that some of the roles were interpreted differently and that all roles were not perceived as equally relevant for all specialities. Moreover, it was pointed out that the roles of many specialities' learning objectives were described as separate roles and were not suitable for physicians' medical practice where multiple roles often come in use simultaneously.

In the report, the seven roles of physicians have therefore been revised and adjusted, and they are now based on various medical situations that physicians meet every day. Thus, the new description of the seven roles can make it easier for the specialty societies to prepare learning objectives, select assessment programmes and make professional profiles.

Links

The report about the seven roles of physicians (2013)

Evaluation of physician roles in the report: Postgraduate medical training in Denmark – status and future perspectives (2012) (in Danish)

Increase in the number of cases caused by new coronavirus (MERS CoV) on the Arabian Peninsula

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The Danish Health and Medicines Authority advises Danish travellers to the Arabian Peninsula and healthcare professionals in Denmark to pay special attention to disease caused by the new coronavirus (MERS CoV). No instances have been reported in Denmark.

During the past weeks, an increasing number of cases of new coronavirus infection among healthcare professionals have been reported in Saudi Arabia and the United Arab Emirates.

Consequently, the Danish Health and Medicines Authority advises Danish travellers to the Arabian Peninsula to take the below general precautions in order to reduce the risk of infecting other people.

Danish healthcare professionals should be aware that patients, who have visited the Arabian Peninsula prior to the onset of disease, may be infected by the new coronavirus, and any case of suspected infection should be handled according to the applicable guidelines of the Danish Health and Medicines Authority.

The mode of transmission remains unknown. Camels and dromedaries are suspected carriers of the new coronavirus and could be part of the chain of infection. Instances of human-to-human infection have also been reported.

WHO and the European Center for Disease Prevention and Control (ECDC) monitor the situation, and the Danish Health and Medicines Authority will follow the development.

Precautions for travellers to the Arabian Peninsula and neighbouring countries

To reduce infection and disease, travellers are encouraged to follow this general travel advice:

  • Wash your hands often with soap and water
  • Maintain good food hygiene (make sure that meat is thoroughly cooked and avoid drinking unpasteurized milk – specially from camels and dromedaries)
  • Avoid unnecessary contact with animals, especially camels and dromedaries

Precautions in case of disease for travellers who have visited the Arabian Peninsula and neighbouring countries

People who have travelled to the affected areas and who develop a significant acute respiratory illness or other serious disease during the two weeks after their return should contact their doctor and inform him or her of the travel.

Guidance to doctors and other healthcare professionals

The purpose of raising awareness of the disease among healthcare professionals is primarily:

  • to identify any cases of the infection in Denmark
  • to prevent dissemination in Denmark, not least in hospitals

Disease caused by new coronavirus is characterised by severe respiratory disorder. The first symptom of a patient in France was diarrhoea, but an X-ray showed that the patient had pneumonia.

Patients with a weakened immune system and suffering from chronic diseases seem to be particularly susceptible.

Patients suspected of having a new coronavirus infection must be isolated in an infectious diseases department and any suspected cases must be reported by phone to the DHMA public health medical officers. 

Dissemination and characteristics of patients with new coronavirus

During the past weeks, an increasing number of cases of new coronavirus infection among healthcare professionals have been reported in Saudi Arabia and the United Arab Emirates. The majority of the patients with new coronavirus are from Saudi Arabia. But patients have also been reported in other countries on the Arabian Peninsula (the United Arab Emirates, Qatar, Oman and Kuwait) and in Jordan.

Five European countries have reported cases of infection. All of these cases can be traced to the Arabian Peninsula. In addition, cases have been reported in Asia and North Africa. Just like the European patients, these cases can also be traced to the Arabian Peninsula. 

No instances have been reported in Denmark. 

The majority of the patients suffer from underlying chronic diseases. The patients are mainly middle-aged men, a few of them are women, but no children. The mortality rate among the internationally reported patients has been around 35%.

Change of the HPV vaccination programme to a 2-dose programme

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As part of the Danish childhood vaccination programme, girls aged around 12 years are offered HPV vaccine. In future, girls of this age only need two doses of HPV vaccine, compared with three previously.

The change of the vaccination programme is the result of new scientific studies showing that the antibody responses after two doses of HPV vaccine six months apart for girls aged 9-13 years are just as good as after three doses as in the previous programme. The European Medicines Agency has authorised the change.

The change came into force on 6 August 2014 when the Danish Health and Medicines Authority sent a letter to all general practitioners about the new programme and issued a revised publication about the childhood vaccination programme.

There are no changes to the HPV vaccine used, but from 6 August 2014 the following changes are made to the administration of the vaccine:

  • Girls who, under the previous programme, have been given the second dose less than six months after the first dose, are still recommended to have the third dose.
  • In future, girls who are given the first dose before the age of 14 should only have two doses, provided that the second dose is given at least six months after the first dose.
  • Girls who start the programme after the age of 14 are still recommended to have three doses.

Regardless of which programme is followed, it is recommended to have the injections over a period of around one year.

We still recommend that the vaccine is given to girls before they start being sexually active to obtain the best protection against cervical cancer. Consequently, the Danish childhood vaccination programme offers the HPV vaccine to girls aged around 12 years. However, the HPV vaccination is free of charge for girls under the age of 18. 

Read more about the change of vaccine doses in the summary of product characteristics for the HPV vaccine on the European Medicines Agency's website

Ebola ruled out in patient hospitalised at Hvidovre Hospital

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On Thursday night 2 October, a patient was hospitalised at Hvidovre Hospital and tested for Ebola virus. A blood sample tested at State Serum Institute ruled out the suspicion.

”The Danish Health and Medicines Authority's guidelines were followed. The case does not impact our general risk assessment, and we still assess that the risk of Ebola virus disease reaching Denmark is very low. We monitor the development, and we can see that our emergency preparedness is working” says Søren Brostrøm, Head of Division.

Patient to be examined for Ebola at Hvidovre Hospital

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A patient has been admitted to Hvidovre Hospital in Copenhagen and is now being tested for Ebola infection according to the Danish Health and Medicines Authority's guidance on the management of Ebola virus disease. The patient will remain in hospital until the diagnosis can be denied or confirmed. 

Statens Serum Institut will analyse a blood sample from the patient, and the test result is expected later today. We are continuously in touch with Hvidovre Hospital and will follow up on the situation as soon as new information is available.


Beware if your heart flutters

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The combination of low-dose aspirins and anticoagulant medicines can cause severe bleeding. Consequently, we have published new material describing the risk of this combination to patients with heart flutters and doctors.

About 100,000 Danes suffer from heart flutters, and every year between 15,000 and 20,000 new patients are diagnosed with heart flutters. Heart flutters can be dangerous, because there is an increased risk of blood clots. One out of five blood clots in the brain is caused by heart flutters. The risk of heart flutters increases with age, and around one in ten people above 75 years suffers from heart flutters.

Combination causes an increased risk of bleeding

Most patients suffering from heart flutters benefit from treatment with anticoagulant medicines like Marevan® (warfarin) that reduces the risk of blood clots. Around every tenth patient with heart flutters also takes Hjertemagnyl®, a low-dose aspirin, in combination with Marevan®.

For patients who are being treated with Marevan®, treatment with Hjertemagnyl® does not offer further protection against blood clots. However, the risk of bleeding increases.

Consequently, we have published new material describing the risk of this combination and what patients should be particularly aware of; the material is aimed at patients with heart flutters and doctors (in Danish only). For example, the publication advises patients to inform their doctor of the medicines they take, including over-the-counter medicine.

Links to the material (in Danish only)

Video om hjerteflimmer og bivirkninger ved samtidig brug af acetylsalicylsyre og warfarin

Patientfolder:"Hjerteflimmer" om atrieflimren, antikoagulansbehandling med warfarin, interaktioner samt de nye antikoagulerende lægemidler

Patientfolder: Hjerteflimmer og Hjertemagnyl om den forhøjede blødningsrisiko, der er ved samtidig behandling med acetylsalicylsyre og warfarin

Informationsfolder til læger: Information om antikoagulansbehandling ved atrieflimren

Changes to the Danish childhood vaccination programme

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From 1 January 2015, children will be offered the previous childhood vaccination programme again, because Statens Serum Institut (SSI) can now provide vaccines again after one year with technical production issues.

The changes to the childhood vaccination programme:

  • All children, who start the childhood vaccination programme after 1 January 2015, will be offered SSI's vaccines and will no longer be given hepatitis B vaccination.
  • All children, who have received at least one injection of the temporary vaccine, and who have therefore started a hepatitis B vaccination programme, will be offered to complete the vaccination series. A complete hepatitis B vaccination series comprises three vaccinations, including any vaccinations administered as part of the temporary programme. The offer to complete the vaccination series is available until the end of 2015.
  • Children, who started the vaccination programme with SSI´s vaccines and were then vaccinated under the temporary programme, will also be offered to complete the hepatitis B vaccination series until the end of 2015.

The changes in production also affected children, who were administered the diphtheria, tetanus, pertussis and polio booster vaccination at 5 years of age. SSI's booster vaccine used for 5-year old children will also be available from 1 January 2015. From that date, children will be given one booster vaccination again instead of two separate injections.

Vaccination against Hepatitis B

Due to technical production issues at SSI, the childhood vaccination programme has used different vaccines since 15 January 2014. For example, the vaccine against e.g. tetanus, pertussis and polio administered at 3, 5 and 12 months also included a vaccine against hepatitis B.

All children were temporarily offered hepatitis B vaccination, because the vaccine used in replacement of the ordinary vaccine also comprised protection against hepatitis B.

We still do not find that all children should be vaccinated against hepatitis B. However, the recommendation for hepatitis B vaccination still applies to special risk groups. The vaccination is still free of charge for these risk groups.

Links

The Danish childhood vaccination programme

Temporary change in childhood vaccination programme to end by New Year

The drug situation in Denmark

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We have prepared our national report about the drug situation in Denmark in 2014. According to the report, the number of drug-related deaths is stable, while the number of poisonings is increasing.

The number of drug abusers, who die due to the abuse problem, is also stable. In 2013, 213 drug-related deaths were recorded in Denmark, compared with 210 in 2012. In the period from 1994 to 2011, around 250 deaths were recorded annually, however, this number reached a maximum level in 2011 with 285 deaths. These numbers appear from our national report about the drug situation in Denmark and the National Police records of drug-related deaths.

The vast majority of drug-related deaths are caused by poisonings as a result of illicit drugs. Around 77 per cent of the 213 drug-related deaths in 2013 were caused by poisonings as a result of one or more illicit drugs. The remaining 23 per cent were caused by for example violence, other accidents than poisonings, illness or unknown causes of death.

Increase in poisonings

Even though the number of deaths is stable, the emergency rooms in Denmark recorded an increasing number of poisonings. The number of poisonings recorded as a result of illicit drugs peaked in 2013 with 2,194 recorded contacts.

The increase in poisonings during the past few years is especially seen in those aged 30 and above. Among young people, poisonings are typically seen with cannabis and psychostimulants, whereas poisonings with opioids and compounds of several drugs most frequently appear among the older generation.

Links

The drug situation in Denmark 2014

Three Danish healthcare workers will not be quarantined for Ebola

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The three healthcare workers who work for Defence Command Denmark and Danish Emergency Management Agency have been examined at Aarhus University Hospital in Skejby. The employees were sent back to Denmark, because they have been in contact with an American healthcare worker infected with Ebola.

The three Danish healthcare workers are feeling well, and there is no reason to suspect that they are infected with Ebola.

None of the three workers have been in direct contact with body fluids from the American patient. Therefore, there is only a very low risk that they could be infected.

The Danish Health and Medicines Authority has been in close contact with the doctors at the Department of Infectious Diseases at Aarhus University Hospital. Based on the risk assessment made at the hospital, there is no reason to recommend quarantine.

However, for a period of 21 days the three Danish healthcare workers are asked to pay special attention to any symptoms of Ebola, such as fever.  In case of any symptoms, the three Danes will be examined immediately at a department of infectious diseases, either at Aarhus University Hospital or Hvidovre Hospital. 

More information

About Ebola virus disease, risk of infection and guidance on the management of suspected transmission:

Søren Brostrøm, Head of Division at DHMA, tel. +45 72 22 78 67

About the hospital's management:

Professor Lars Østergaard, Aarhus University Hospital, tel. +45 51 51 31 40

About the mission in Sierra Leone and the transportation to Denmark, call Defence Command Denmark's central press services, tel. +45 70 20 40 33

For information about the mission of Danish Emergency Management Agency, tel. +45 45 90 60 00 (central switchboard)

New advice on infant food

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Infants should not be given cow's milk, but breast milk or infant formula throughout the first year of life. This is one of our new recommendations for infant food and nutrition for young children.

The new recommendations for child nutrition in the first two years of life are described in a new publication: Nutrition for infants and young children – a handbook for healthcare professionals (in Danish only). The publication contains a number of changes relative to the previous recommendations for infant food.

For example, the type of milk children should drink throughout the first year of life, new recommendations for iron supplements and vitamins, new recommendations for young children's fish consumption and descriptions of what type of fish breast-feeding mothers should not eat.

The new recommendations are based on documented evidence on the food infants and young children should have to grow optimally. The recommendations follow in the wake of the new Nordic nutritional recommendations, the new Danish official dietary recommendations and a report about the need for new recommendations prepared by the Danish Health and Medicines Authority.

The publication contains the following recommendations, among other things:

  • New recommendations for milk to infants

We now recommend that children are not given cow's milk, but only breast milk or infant formula throughout the first year of life. The reason is that the protein content of cow's milk is three times as high as in breast milk and the iron content is low. Documentation shows that too much protein during infancy may have an impact on the development of overweight later in life.

  • New recommendations for iron supplements

We no longer recommend iron supplements during the first 6-12 months for children born at term. From the age of 6 months, the need for iron should come from an iron-containing diet with meat and fish. Premature infants still need iron supplements.

  • New recommendations for fish consumption

The Danish Health and Medicines Authority and the Danish Veterinary and Food Administration now recommend that children younger than 3 years do not eat large carnivorous fish, like tuna fish. This includes canned tuna. The reason is that there may be a risk that the child gets too much mercury through the food, and a high intake of mercury may affect brain development negatively.

  • New recommendations for the introduction of gluten

We now recommend that children are given glutinous as well as non-glutinous products and in increasing volumes from the time when the child starts to eat solid food. This means that glutinous food may be given to children before the age of 6 months.

In addition to the above recommendations, the publication also emphasises that children should be offered many different tastes and textures of food from the age of 6 months and that children are able to pick up food by themselves at an earlier age than described previously. Moreover, the publication contains a new section on the development of eating habits and the prevention of eating disorders in young children.

Link

Nutrition for infants and young children – a handbook for healthcare professionals (in Danish only)

EMA's new assessment of the HPV vaccine: The benefits outweigh the risks

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A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance experts have made a new assessment of the vaccine and still consider it to be safe.

The new assessment from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which is composed of top-level scientific experts, is interesting for Denmark, because the Danish Health and Medicines Authority has reported several cases of POTS as a possible adverse reaction to Gardasil. Thus, the Danish reports form part of EMA’s safety assessment.

POTS is a relatively new diagnosis, and the symptoms include increase in heart rate and dizziness. The syndrome has been observed in young women, who were vaccinated with Gardasil, and in both men and women, who were not vaccinated with Gardasil.

In Denmark, it is primarily the Syncope Centre at Frederiksberg Hospital that diagnoses POTS by making special tilt table tests. During the past years, the doctors at the Syncope Centre have reported several cases of POTS as a suspected adverse reaction to the Gardasil HPV vaccine to the Danish Health and Medicines Authority.

A reported suspected adverse reaction does not necessarily mean that there is a relationship between the vaccine and the symptoms experienced as adverse reactions to the vaccine. Everyone can report adverse reactions on our website, and everything reported as adverse reactions appear from our reports of suspected adverse reactions.

We find it important to investigate whether POTS may be a rare adverse reaction to Gardasil or whether there is a coincidence in time between the vaccine and the syndrome in the specific cases. In 2013, we asked Frederiksberg Hospital to make a report describing the Danish incidents. This report was sent to EMA where PRAC assessed it together with the Danish adverse reaction reports; the committee found that the relationship between POTS and Gardasil can neither be confirmed nor denied at present.

This conclusion is interesting for Denmark, because of the debate about the possible link between Gardasil and POTS in the established media as well as social media in the past few years. The view that the vaccination programme should be put on hold until the relationship can be confirmed or denied is often put forward.

However, it is important to underline that even if POTS had been classified as a possible adverse reaction to Gardasil, it is still our view that EMA would not withdraw the vaccine. Nor would the vaccine be removed from the Danish childhood vaccination programme, because the prevention of many hundred cases of cancer every year outweighs the risks of the reported suspected adverse reactions (see the factbox below). POTS would, however, appear from the package leaflet as a possible, but rare adverse reaction to the vaccine.

We still recommend the HPV vaccine just like WHO, the US Food and Drug Administration (FDA) and EMA, because the benefits of preventing cervical cancer, which is a fatal disease, still outweigh the risk of having adverse reactions to the vaccine.

Facts

  • As at 30 September 2014, a total of 33 cases of POTS as a possible adverse reaction to Gardasil had been reported in Denmark (in the period from 2006 to 2014). However, it has not been possible to document a relationship between the vaccine and POTS.
  • At present, more than 480,000 Danish women have been vaccinated with Gardasil.
  • Globally, a total of 66 cases of POTS had been reported as at 30 September 2014. Around 55 million people have been vaccinated worldwide.
  • About 370 Danish women are diagnosed with cervical cancer every year.
  • About 100 Danish women die from cervical cancer every year.
  • Approximately 6,000 people have surgery for early stages of cervical cancer every year.
  • More than 8,000 people live with a cervical cancer diagnosis.
  • In Europe, more than 33 million doses have been used and around 11 million people have been vaccinated.

The Danish Health Authority recommends HPV vaccination for 12-year-old girls

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This text in Danish (published 5 November 2015): Sundhedsstyrelsen anbefaler HPV-vaccination af piger i 12-års-alderen


Evidence does not suggest that there is an association between HPV vaccines and the syndromes of POTS and CRPS. This is the conclusion from the European Medicines Agency (EMA), which has just completed its safety review of the HPV vaccines. The Danish Health Authority (DHA) is satisfied to have gained clarification and hopes that more people will participate in the HPV vaccination programme. 

The DHA recommends girls at the age of 12 years to be vaccinated against cervical cancer. The conclusion of EMA's safety review is therefore welcomed by Søren Brostrøm, Director General at the DHA: 
"It find it important that the new safety review means that we can now reassure girls who are about to receive the HPV vaccine and their families that there are no signs of a link to POTS and CRPS. We have never denied that vaccinations may cause adverse reactions, but we have always assessed that the benefits of being vaccinated outweigh any possible adverse effects. And we have worried that some families may have opted out of vaccination because of the debate about side effects, leaving the girls vulnerable to HPV infection. Cervical cancer is a terrible disease, each year affecting about 400 Danish women, many of them young women, and claiming the lives of around 100 individuals every year. But it is a disease that we can eliminate through effective immunisation and screening programmes."

The HPV vaccine against cervical cancer has been offered free of charge to girls as part of the Danish childhood immunisation programme since 2009. 

Focus on patients with unresolved symptoms

Many girls and young women with unresolved symptoms have been referred to the regions' offer aimed at girls suspected of having adverse reactions after HPV vaccination. The DHA wants to make sure the offer they get is appropriate. There has been widespread interest in the offer, and the number of Danish girls referred to the centres remains high.

It is important to the DHA that there is a sound and professional environment for examination and treatment, says Søren Brostrøm:  

"Patients with unresolved symptoms must be ensured the same offer across the nation. Together with the regions and experts in the field, we have launched a project to see how we can plan efforts for patients with unclear symptoms, so they can get the right examination and treatment. The expected outcome is a set of recommendations about referral, examination processes and treatment options, etc. with a cross-disciplinary approach in focus." 

Like any other medicine, the HPV vaccine may cause adverse reactions. The DHA therefore keeps abreast of developments in the area, e.g. through dialogue with the Danish Medicines Agency and experts in the hospital sector, and through new research that is launched and published.


Sharp fall in HPV vaccination rate

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This text in Danish (published 18 January 2016): Markant fald i tilslutningen til HPV-vaccinen


According to new figures from the SSI (Statens Serum Institut), the HPV vaccination rate relating to 12-year-old girls in the childhood immunisation programme is decreasing steadily.

The newly published rate includes vaccinations given up until mid-November 2015. It shows that only 24% of girls born in 2003 have received their first HPV vaccine dose. Corresponding figures for the same period in 2014 of girls born in 2002 showed that 49% had received their first injection.

Note, however, that girls born in 2003 still have time to complete their vaccination course as the free offer runs until they turn 18.

Bolette Søborg, Medical Doctor at the Danish Health Authority (DHA), is concerned with the development.

"If the share of individuals protected by the vaccine decreases, we should regrettably expect to see more cases of cervical cancer and more women dying of cervical cancer. It is important that girls are vaccinated early enough to receive full protection against the risk of exposure to HPV virus before becoming sexually active. This is why we recommend girls to be vaccinated at the age of 12".

She adds that the DHA is continually making efforts to explain parents and children that the HPV vaccine is being monitored and evaluated continuously, and that the DHA still assesses that the benefits of vaccination by far outweigh the possible adverse reactions.

In the autumn, first the European Medicines Agency (EMA) and then the World Health Organization (WHO) each published a safety review of the HPV vaccines. Both reviews concluded that no association between HPV vaccines and the syndromes of POTS and CRPS was found.

At the DHA, Medical Doctor Bolette Søborg hopes that the reviews will help parents feel more safe.

"The debate about the vaccine's possible side effects no doubt swept the media, and I do understand why some parents have chosen to postpone vaccination of their daughters. We therefore hope that the new and thorough reviews can help rebuild trust in the HPV vaccine in the childhood immunisation programme, and that parents will choose for their daughters to be vaccinated, even if they are no longer 12 years old.

The DHA will soon be distributing a new leaflet about HPV vaccination with information for healthcare staff and parents.

The DHA moreover has new recommendations in the pipeline through a collaboration with the five regional centres who have been commissioned to take care of the girls with unresolved symptoms who suspect the symptoms are caused by adverse reactions after HPV vaccination.

The recommendations are to ensure that the girls receive an appropriate offer that is the same for all girls in Denmark.

New HPV vaccine in the childhood vaccination programme

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This text in Danish (published 29 January 2016): Ny HPV-vaccine i børnevaccinations­programmet


On Monday 1 February 2016, a new HPV vaccine enters the Danish childhood immunisation programme. The new HPV vaccine is called Cervarix and replaces Gardasil, which has been used since 2009.

The switch is made pursuant to the outcome of SSI's (Statens Serum Institut) statutory vaccine tender. The tender includes pre-established tender criteria relating to efficacy, adverse reactions, additional effects (condyloma is weighted in this context) and price. On the basis of an overall assessment, the Cervarix vaccine was chosen.

Cervarix offers protection against the two oncogenic HPV types 16 and 18, which cause 70% of cervical cancer cases. And when it comes to protection against cervical cancer and adverse reactions, Cervarix is similar to the HPV vaccine used so far. Unlike Gardasil, Cervarix does not protect against genital warts (condyloma).

Cervarix was approved for use in Europe (EU) in 2007, and so far approx. 57 million doses have been given globally. The vaccine is used in the childhood immunisation programmes in Holland, Finland, Iceland and Hungary, among others. Cervarix is approved for use from the age of 9 years. The Danish Health Authority (DHA) recommends that the vaccine is given in the childhood vaccination programme at the age of 12.

All girls who receive their first HPV vaccination dose on or after 1 February 2016 is to be given Cervarix. All girls who have already received at least one Gardasil dose must complete their vaccination series with this vaccine. This should take place by the end of January 2017.

Cervarix has been tested in combination with other vaccines, including those given in the childhood immunisation programme, and may be given concomitantly. 

In Denmark, the debate about possible adverse reactions to the HPV vaccine has been intense. The Danish Medicines Agency (DKMA) continues to monitor the safety/adverse reactions of the HPV vaccines and still encourages healthcare professionals, patients or their representatives who suspect that they themselves or their patients have had adverse reactions to the HPV vaccine to report them to the DKMA. Since it is the first time Cervarix is used in the childhood immunisation programme, the DKMA has decided to enact stricter reporting requirements, implying that all suspected adverse reactions to the vaccine must be reported by doctors (dentist and midwives).




Better information and harmonised offer to girls and young women with unresolved symptoms

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This text in Danish (published 4 February 2016): Bedre information og et ensartet tilbud til piger og unge kvinder med uforklarede symptomer


Today (4 February 2016), the Danish Health Authority (DHA) publishes recommendations on the professional organisation of the regional centres that have been given special responsibility for patients with unresolved symptoms – the key message is that girls and young women should be met by only one specialist who will take care of their course and that they should be informed better before their first examination.

The key aim of the recommendations is that the centres are to make sure the girls and young women receive a comprehensive evaluation. This is to be ensured by involving relevant specialists. It is furthermore recommended that efforts aimed at young girls under 18 years be organised by a paediatrician.

The essence of the recommendations

"What's most important to us is that girls and young women who present with unclear symptoms that they suspect to be caused by HPV vaccination now have one access point and only one doctor who will coordinate their course. This doctor will be gathering up all threads and will plan the next steps," says Ane Bonnerup Vind, Senior Consultant at the DHA.

The aim

The aim of the recommendations is to harmonise the offer to girls and young women who are referred to the centres, which combined make up the One Access offer. Moreover, the enhanced interdisciplinary environment is to make those patients who live with unresolved symptoms feel safer.

Why is the information important?

It is important to point out that there is no knowledge of a clear, research-based treatment option for all patients received through One Access. 

It may therefore be relevant to offer the patients initiatives that give them possibilities to cope better and enhance their everyday quality of life. 

This could be help to understand the disease or advice about handling daily symptoms or physical rehabilitation, exercise instructions and guidance on physical functional impairment.

The recommendations also highlight the importance of informing patients thoroughly about what they can be offered through One Access prior to their first visit at the centres.

It is crucial that the girls and young women receive information before their visit at One Access. "It is important that they know what to expect when they are received and examined by the doctor, and equally important that they know from the start that they cannot expect the doctor to be able to tell them if their symptoms are caused by the HPV vaccine," says Senior Consultant Ane Bonnerup Vind, DHA.

Background to the recommendations

One Access was established in response to the past years' increased focus on a group of girls and young women who approached the health services with unresolved symptoms, suspecting their symptoms were related to HPV vaccination.

One Access was to ensure that the patients received a harmonised offer of comprehensive evaluation. However, in the autumn it became clear that there were differences between the regional offers, and the regions therefore asked the DHA for expert advice to plan efforts targeting the patients who are referred to One Access.

It is the responsibility of the regions to follow up on the DHA’s recommendations. It is also their responsibility to take action on experience and knowledge gained about patients with unresolved symptoms to ensure the continued development of an appropriate offer to patients.


Childhood vaccination programme – it works, but there is room for improvement

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Vaccinations prevent diseases that may be harmful to the child. Many childhood diseases spread very easily, so almost every child will eventually catch them if they are not vaccinated. This is the case for measles, mumps, rubella and pertussis. 

A child following the Danish childhood vaccination programme will be well protected against the diseases vaccinated against. If vaccination rates are high enough, outbreaks can be prevented, and weak children with immunodeficiency not benefiting from vaccination will be protected as well.

"In the past couple of years, participation in the childhood vaccination programme has been high, which makes us happy. Vaccination is one of the safest and most effective methods of prevention. But there is still room for improvement, especially in regard to the MMR and HPV vaccines, where we would like to see higher participation rates," says Søren Brostrøm, Director General of the Danish Health Authority (DHA). 

High participation in the childhood vaccination programme is achievable if parents feel safe about the vaccines offered, and doctors and other experts are well prepared to explain the benefits and disadvantages of the childhood immunisation programme. The population should be able to trust the authorities' handling of the vaccination programme.

"It is important that parents as well as doctors have confidence in the Danish childhood vaccination programme. Trust requires openness and information. We hope we can contribute to this development with these reports," says Søren Brostrøm.

The Danish Health Authority, Statens Serum Institut and the Danish Medicines Agency have prepared the annual reports together. They provide general information about the childhood vaccination programme, e.g. about why we vaccinate children in Denmark, and more specific information about the past year, e.g. if other than the usual vaccines have been used. 

The annual report for 2015 focuses especially on the challenges we have seen with declining HPV vaccination rates. 

"The DHA is very concerned with the declining HPV vaccination rates. In 2015, we have been dedicated to ensuring that girls and young women with unresolved symptoms are taken care of, and we have prepared expert recommendations on the organisation of regional examination offers through "One Access". We acknowledge that some parents have felt insecure about the vaccine and have chosen to postpone vaccination of their 12-year-old girls. We must rebuild trust in the HPV vaccine through knowledge and information," says Søren Brostrøm.

The annual reports can be read by anyone with an interest in the Danish childhood vaccination programme – parents, media, decision-makers and other authorities. 

Starting today, the DHA will publish annual reports on the childhood vaccination programme every April in connection with the WHO's European Immunization Week. 

Risk of severe intoxication with vitamin D drops

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The company Inno Pharma has recalled its organic vitamin D drops labelled 'Inno Pharma vitamin D3-dråber' following verification that the vitamin D content is 75 times too high. The product is marketed for infants and pregnant women and sold via Helsam, Matas and webshops.

Anyone who has taken ‘Vitamin D3-dråber’ from Inno Pharma must immediately stop taking the nutritional supplement and other vitamin D products, including multivitamins containing vitamin D. Discard the bottle, or return it to the shop.

If you have taken or given your child vitamin D drops from Inno Pharma and are unsure what to do, please call the Danish Poison Control Hotline on +45 8212 1212.

What to do if you have given your child vitamin D drops from Inno Pharma

If your child has been given ‘Vitamin D3-dråber’ from Inno Pharma for longer than a few days/one week, your child needs to see a doctor as the vitamin D content in the drops is hazardous to health.

If a child has symptoms of poisoning (general irritability, whimpering, spitting up a lot or vomiting, nausea, crying, drowsiness, excessive urination, either constipation or diarrhoea, lack of weight gain), the parents should contact their GP or an emergency service doctor (Lægevagten).

If the child has NO symptoms and has been given the drops from this bottle for longer than a week/few days, a blood test should be taken via the GP on the first coming weekday. Please call your doctor to schedule a blood test, which in most cases is taken at a hospital.

What to do if you have taken vitamin D drops from Inno Pharma

If you have taken ‘Vitamin D3-dråber’ from Inno Pharma for a week or longer, please see your GP for a blood test as the vitamin D content in the drops is hazardous to health.

You should postpone taking any kind of vitamin D supplements until your doctor tells you otherwise. The results of the blood test will determine how long you should avoid vitamin D supplements.

Take the same precautions if you are holidaying abroad.

Please be aware that it is only vitamin D drops labelled 'Inno Pharma vitamin D3-dråber' that pose a risk to health. Parents giving their children vitamin D drops manufactured by other brands should continue doing so.

Further information about the product is available in Danish at the website of the Danish Veterinary and Food Administration.

Notice to health professionals

The Danish Health Authority has issued this notice to doctors (in Danish only).

Please be advised that infants in need of follow-up on blood tests are to be monitored at a paediatric department.

If you know of friends or family who do not understand Danish or English, we kindly ask you to share this important information in your common language. And we thank you for your help.

Danish version/dansk version

Risiko for alvorlig forgiftning med D-vitamin dråber

The health of Danes combined in unique database

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The Danish Health and Medicines Authority and Danish Regions have published new figures for the health of the adult population in Denmark.

How healthy are we? Do we feel stressed? Are we drinking more alcohol? Find the answers to all these questions in the Danish National Health Profile 2013. The report describes in detail the general lifestyle of Danes, the changes that have occurred during the past three years and how health, well-being and disease are related to education and civil status.

The lifestyle of Danes across municipalities and regions

More than 160,000 Danes over the age of 16 have answered the questionnaire about health, morbidity and well-being. This is the second survey of the health of Danes. The first survey was made in 2010. The Danish National Health Profile 2013 was presented at a conference, at which a comparison of how public health developed from 2010 to 2013 was also presented.

The answers to the questionnaire were collected simultaneously in 2013 in all of Denmark's 98 municipalities. So the survey both provides an overview of the health and well-being of Danes and makes it possible to compare the results across municipalities and regions in Denmark. In the coming time, the regions will publish their regional health profiles.

The national health profile is mainly used to ensure that planned health and prevention efforts match the needs of the citizens. The survey was prepared in a collaboration between the Danish Health and Medicines Authority, The Ministry of Health, Danish Regions, Local Government Denmark, National Institute of Public Health, Region of Southern Denmark, North Denmark Region, Central Denmark Region, Capital Region of Denmark and Region Zealand.

Dive into the database

The data of the survey are incorporated into a database providing facts about the health and morbidity of Danes distributed on municipalities and regions. The database is based on the most comprehensive mapping of the health of Danes ever made. Read more at www.danskernessundhed.dk and dive into the statistical data (in Danish only).

Links:

Read a summary of the Danish National Health Profile 2013 in English

The report: Danish National Health Profile 2013 (in Danish only)

Fact sheet about the Danish National Health Profile 2013 (in Danish only)

Comments to the survey results

The Danish Health and Medicines Authority, Head of Division Jette Jul Bruun, on +45 72 22 85 10

Danish Regions, Chair of the Danish Parliament's Health Committee Ulla Astman, on +45 30 23 64 54

Ministry of Health, Senior Press Officer Thomas Bille Winkel, on +45 40 91 98 78

Recommendations for organ donation

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More people should decide whether they wish to become a potential organ donor and the hospitals should introduce pathways. These are two of the recommendations of a working group headed by the Danish Health and Medicines Authority that has made recommendations for an action plan to increase the number of organ donors.

Danes have a positive view on organ donation. According to a previous study from the Danish Health and Medicines Authority, just under 90% of the population have a positive attitude towards organ donation, and around 80% are willing to donate an organ.

It is not just in theory that the Danes have a positive approach to organ donation. The vast majority of relatives say yes when a doctor asks for permission to use organs from a dying family member in an intensive care unit. Only 20% say no, figures from the Organ Donations Database show. Nevertheless, there has been a shortage of organs in Denmark for several years, and today about 400 sick people are on a waiting list for a kidney, lung or other organ transplant.

More organs

The working group suggests that hospitals should be better at examining the possibility of organ donation among dying patients. This implies, among other things, a change of relevant guidance from professional companies, so that it will become standard practice in all hospitals that doctors do not stop treatment of dying patients, with for example extensive brain damage, until it has been examined whether the patient can become an organ donor. 

Focus is also on how to get more organs from living donors. The working group recommends that hospitals introduce harmonised pathways so that for example family members of a kidney patient can be informed quickly if their kidneys are suitable for transplantation and a donation can take place.

In addition, the report proposes initiatives to get more people to decide whether they want to become potential donors. The working group recommends that websites, mobile phones and tablets are used for this purpose.

Danish Minister for Health Astrid Krag will discuss the recommendations with the parties of the Danish Parliament and expects to present a new national action plan on organ donation later this year.

Link

The working group's recommendations for an action plan on organ donation (2014) (in Danish)



Decreasing prevalence of illicit drugs

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The prevalence of illicit drugs is decreasing according to this year's report on the drug situation in Denmark 2013 prepared by the Danish Health and Medicines Authority. 

New figures show that compared to 2000 there is a decreasing prevalence of illicit drugs such as amphetamine, cocaine and ecstasy in the population. Among the young people, where prevalence is the highest, the share of young people under the age of 25 reporting current use of illicit drugs has gone down from 8% in 2000 to 4% in 2013 – i.e. a 50% decrease.

When viewing the drugs on an individual basis, the number of amphetamine and cocaine users is still much lower as is the number of psilocybin mushroom and ecstasy users (SUSY 2013). The use of cocaine appears to be on the same level as in 2010, which is positive as the use of cocaine was on the increase during the first decade of 2000. Cannabis is still the most prevalent drug.

In spite of the documented drop in the experimental use of drugs, an increasing number of poisonings have been recorded in the emergency rooms in Denmark. The number of poisonings recorded as a result of illicit drugs peak in 2012 with 2,028 recorded contacts, and it is assumed that this is a conservative estimate. The increase in the poisonings the past few years is especially seen in those aged 30 and above. From 2011 to 2012, however, there appears to be a marked increase of poisonings among the 20-24-year-olds – an increase from 348 to 439 in the years in question. Among the young people, poisonings are typically seen with cannabis and psychostimulants, whereas poisonings with opioids and compounds of several drugs most frequently appear among the older generation.

Among other health-related consequences of drug abuse, the increased mortality rates should also be mentioned. Drug abusers generally account for very high mortality rates as a result of poisonings and diseases, including HIV and hepatitis. According to statistics from the National Police on drug-related deaths, 210 drug-related deaths were recorded in 2012. This is the lowest number since 1994. The past few years, the number has been significantly higher, and in 2009 as well as in 2010, the number of drug-related deaths was 276 annually with the number reaching a maximum level in 2011 with 285 deaths.

The number of drug-related deaths in Denmark dropped significantly from 2011 to 2012. There seems to be a decline in all regions, but the Region of Southern Denmark showed the most drastic decline.

There are no bullet proof explanations as to why the number of deaths drop, but there are most likely a number of factors involved. It may be due to changes in the drug market, but one might assume that the new initiatives in the municipalities, such as focusing on general interventions, establishment of health rooms and drug consumption rooms, heroin clinics, prevention of infectious diseases and quality in substitution treatment have also had an impact on the trends. Finally, there has been a decline in recent years in the number of drug abusers receiving treatment for the first time with opioids as their main abuse problem. All other things being equal, opioid abuse is what most often leads to premature death.

Link

The drug situation in Denmark 2013

Digital post from the Danish Health and Medicines Authority

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From 1 November 2013, it is mandatory for businesses with a CVR number to be able to receive digital post from public authorities.

What is digital post? 

e-Boks has developed an electronic mailbox that may be used for receiving digital post. This enables digital communication between public authorities and CVR registered businesses. Your business is responsible for reading the digital letters you receive in your mailbox as digital letters have the same status as physical letters.

The advantages of digital post:

  • All your digital letters from public authorities will be sent to one digital mailbox.
  • You can write to local, regional and central authorities and receive answers digitally.
  • The digital mailbox is linked to your CVR number and will not be affected if you change addresses or email addresses.
  • The access to your mails is encrypted.

NOTE! When setting up your digital mailbox, you can choose to be notified by e-mail when new mail arrives. This is possible both in e-Boks and Virk.dk/postkasse.

Become an e-Boks user

First, you need to request a NemID employee digital signature. Then you can set up your digital mailbox at Virk.dk/postkasse. Here you will also find video instructions for employees and administrators. If you need help, please contact Virk’s hotline on +45 7080 8686.

Already using e-Boks? 

First, you need to request a NemID employee digital signature. Then you can:

  1. use e-Boks as your digital mailbox: Log on to e-Boks Business and choose to receive digital post from public authorities by clicking the link "Receive digital post from public authorities",
  2. go to Virk.dk/postkasse and select to receive digital post in this mailbox. 

Read more at e-Boks.dk or Virk.dk/postkasse 

Contact Virk’s hotline on +45 7080 8686 if you need help.

National clinical guideline on the use of antibiotics in connection with dental treatment

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This quick guide contains the key recommendations from the national clinical guideline on the use of antibiotics in connection with dental treatment. The guideline was prepared by the DHA.

The national clinical guideline focuses on ensuring that the use of antibiotics in connection with dental treatment be limited to the conditions/cases where the effect is optimal and the patient clearly needs the medicine.

Thus, the guideline contains recommendations for selected parts of the field only and therefore must be seen alongside the other guidelines, process descriptions etc. in this field.

Quickguide: National clinical guideline on the use of antibiotics in connection with dental treatment