Publications

Adverse drug reaction reports (ADRs) from consumers may improve patient safety

In a report, the DHMA has reviewed the ADR reports received during the years 2003–2011 to clarify how consumer reports differ from reports from healthcare professionals.

Product defects and withdrawal of medicines 2011

In 2011, 356 reports of medicinal product defects were registered, which is the highest number ever. The majority of the reports came from companies and other authorities and predominantly concerned defects on the package and packaging material and deviations from specifications.

Rapport om detailhandelens forhandling af laegemidler 2007

Number of applications for individual reimbursement of medicines in 2011

In 2011, the Danish Medicines Agency (now the Danish National Board of Health) reviewed approx. 103,000 applications for single reimbursement (about 7 % more than in 2010), approx. 26,000 applications for reimbursement for the chronically ill (about 30 % less than in 2010), approx. 12,000 applications for reimbursement for the terminally ill (about 3 % more than in 2010) and approx. 2,500 applications for increased reimbursement (about 12 % less than in 2010), cf. table 1.

Monitor the trends in consumption of drugs for acid-related disorders

The Danish Medicines Agency monitors the consumption of drugs for acid-related disorders (drugs for heartburn, sour eructation and ulcer) in connection with the removal of the reimbursement for a number of these drugs on 15 November 2010.

Decreasing consumption of Zyprexa®

The consumption of the antipsychotic medicinal product Zyprexa® decreased during 2004. The decrease in consumption has taken place following EMEA's announcement in March 2004 about a heightened risk of death and brain haemorrhage from treating elderly dementia patients with Zyprexa®.

Publication on medicines most frequently involved in serious adverse drug events

A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.

Annual report on the inspection of retail sale of OTC medicines 2009-2010

In our report for 2008-2009, we made a number of critical remarks about the pharmacies' OTC outlets where we found too many deficiencies: expired medicines, possibility of self-service, medicines mixed with other goods, staff which did not know the rules, etc.

Annual report 2010 of the Danish Medicines Agency's laboratory control activities

he drug regulatory authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2010 that describes the activities of the Agency to the OMCL network.

Danish Medicines Agency’s annual pharmacovigilance report 2010

In 2010, primarily the Danish Minister for the Interior and Health’s action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.

Danish Medicines Agency annual accounts 2010

Annual report of the Reimbursement Committee 2010

In 2010, the Reimbursement Committee reviewed 20 applications for general reimbursement and 1719 applications for individual reimbursement.

Elderly people’s consumption of medicinal products

Elderly people's consumption of medicinal products is increasing. Regarding all medicine consumers over the age of 64, the sale measured in DKK and defined daily doses has generally increased from 1999 to 2001.

Assessment of safety of methylphenidate in ADHD treatment

The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.

Product defects and withdrawal of medicinal products in 2009

In 2009, 186 reports of medicinal product defects were registered, which is slightly more than in 2008. Compared to 2008, the reporting sources and types of defects have shifted, and reports from the Danish Medicines Agency's own control system accounted for a larger share in 2009 compared to 2008.

Report on compliance with rules on good manufacturing practice by manufacturers of active pharmaceutical ingredients

Number of applications for individual reimbursement of medicinal products in 2009

Annual report on human tissues and cells 2008

The Danish Medicines Agency's annual report on human tissues and cells has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by the tissue establisments and gynaecology clinics in Denmark in the period January to December 2008

Sale of dose dispensed medicine in the primary Danish health sector 2004-2008

Dose dispensing was launched in Denmark in 2002, and the use of dose dispensing has increased since then. Dose dispensing is used by all age groups, but the share of users increases with age, and women more frequently use dose dispensed medicine than men.

Effective effort against the excessive use of benzodiazepines in Denmark

A 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. Throough the years, many political health care initiatives have therefore been launched in order to reduce the consumption of these medicines.

Annual report on the inspection of retail sale of OTC medicines 2008-2009

In 2008, the Danish Medicines Agency intensified its efforts on removing expired over-the-counter medicine from retail distribution.

Use of prescription weight-loss products from 2003-2007

In recent years, the number of persons treated with prescription-only weight-loss products has increased, however, the total number of persons receiving treatment is lower than before 2002. The weight-loss products are primarily used by women aged between 35-55. In 2007, the number of users was affected by seasonal variations, which are more pronounced if we exclude persons who at the same time receive other medicines associated with overweight.

Report: Medicine wastage in Denmark - May 2009

Danish Medicines Agency annual accounts 2008

In 2008, the Danish Medicines Agency achieved a target performance of 91.9 per cent in respect of the targets set out in the performance contract with the Danish Ministry of Health and Prevention, corresponding to a fulfillment of four in every five sub-requirements. Overall, we find that we delivered good technical results in 2008.

Performance contract 2008

Report on the blood product area in 2007

The blood product report is published every year based on figures from the Danish blood centres and the Blood-donors in Denmark.

Danish Medicines Agency annual report 2007

The annual report 2007 takes you through important activities within the Danish Medicines Agency in 2007. On a number of theme pages, we also tell about projects that strengthen our cooperation with the business sector, our relations to consumers and our involvement in European development.

Danish Medicines Agency annual accounts 2007

In 2007, the Danish Medicines Agency achieved a target performance of 93.9 per cent in respect of the targets set out in the performance contract with the Danish Ministry of Health and Prevention, corresponding to a fulfillment of three in every four sub-requirements. Overall, we assess that we delivered good technical results in 2007, among other things, based on the fact that the most strategically important performance requirements were fulfilled.

Decisions and practices no. 1

Positive evaluation of the Institute for Rational Pharmacotherapy

Since 1999, the Institute for Rational Pharmacotherapy (IRF) has worked to promote rational use of medicinal products in Denmark. In 2005, an external evaluation of IRF was commissioned by the Danish Medicines Agency, the aim of which was to investigate IRF's reputation and credibility among its primary target group (general practitioners) and other relevant groups. The enclosed reports is a result of this evaluation.

Danish Medicines Agency annual report 2006

In the report for 2006, we have chosen to bring you samples of how we put our values into practice in our daily activities. Read more about how we have been competent, trustworthy, attentive, receptive and European from the fact box to the right.

The consumption of benzodiazepines and benzodiazepine related drugs

In the 4th quarter 2003, it was decided to launch a range of initiatives with the aim of maintaining and strengthening the trend at the time with an overall decreasing consumption of benzodiazepines and benzodiazepine related drugs. The consumption development over the past five years is shown below.

Increase in consumption of urinary antispasmodics

More and more people buy the so-called urinary antispamodics for treatment of overactive bladder. In four years, consumption has increased by 58.6 percent from 19.476 persons in 2001 to 30.899 in 2005. The increased consumption of this type of medicinal products is specifically centred on the more expensive products, which has led to a considerable increase in the sale of these products.

Danish Medicines Agency annual accounts 2006

The Danish Medicines Agency's performance contract with the Ministry of the Interior and Health for 2006 comprises 12 targets made up of 28 performance requirements and 58 sub-requirements. Furthermore, the performance contract includes one focus area.

Consumption of NSAID in 2005

In 2005, approximately 15 per cent of the Danish population bought NSAID on prescription (approximately 830.000 persons). This figure covers persons undergoing both long-term and short-term treatment, for example person with chronic arthritis diseases or persons with an isolated need, for instance in connection with sports injuries.

Report on action against the sale of illegal medicinal products on the internet

In November/December 2006, the Danish Medicines Agency carried out an internet action against the illegal sale of medicinal products over the internet. The action primarily focused on potency and diet products.

Product defects and withdrawal of medicinal products in 2005

In 2005, there was almost the same number of reports on product defects as in 2004. The reports comprised both marketed and non-marketed medicinal products, including magistral medicinal products, which are manufactured according to a doctor's prescription.

Account of the blood product area in 2005

The account contains figures about the collection of blood from donors and the use of the blood collected. The account is published annually based on figures from blood centres and the Blood-donors in Denmark.

Examination of single reimbursement for medicinal products

On behalf of Merck Sharp & Dohme (MSD), Tranberg Marketing Rekommandation has examined general practitioners' knowledge, experience and attitude to single reimbursement for medicine ("Praktiserende lægers kendskab, erfaring og holdning til enkelttilskud til medicin"). The examination is based on telephone interviews with 282 general practitioners.

Consumption of benzodiazepines and benzodiazepine related drugs (cyclopyrrolones)

During the 4th quarter 2003 it was decided that a range of initiatives were to be launched with the purpose of maintaining and strengthening the current tendency of a total decreasing consumption of benzodiazepines (sleeping medicine, tranquilisers and anti-anxiety agents) as well as cyclopyrrolones.

Changed consumption of hormones for menopausal women

The quantity consumption of hormones by women with menopausal discomfort has fallen drastically after announcements of increased risk of breast cancer. This is the finding of a consumption analysis performed by the Danish Medicines Agency on the basis of data from the Register of Medicinal Product Statistics.

Angiotensin II antagonists: are these medicinal products prescribed to the right patients?

Better use of medicines - Perspectives in clinical pharmacy

Report by the Danish Medicines Agency’s working group on clinical pharmacy.

Potentially inappropriate prescription of the asthma product Singulair®

The asthma product Singulair® was put on the Danish market in February 1998 and became eligible for general reimbursement 13 July 1998. The medicinal product is recommended as a supplement for treatment of mild to moderate asthma as well as for exercise-induced asthma.

Consumption of strong analgesics (opioids) in the primary sector Denmark 1999-2003

The study describes the development of the use of strong analgesics (opiods incl. codeine) from 1999 to 2003 in the primary sector. The quantity consumption of opiods has increased by 25.1 per cent during this period from 18.6 DDD/1.000 inhabitants/day in 1999 to 23.2 DDD/1.000 inhabitants/day in 2003.

Treatment of blood clots with platelet function inhibitors

The rising expenses of platelet function inhibitors are caused by several factors. In general, the consumption of these medicinal products is increasing, which is due to the fact that, both in relative and absolute terms, more people start treatment with platelet function inhibitors.

Consumption of antidepressants in Denmark in the primary health sector in the period 1994-2003

Antidepressant is the designation for medicinal products for depression. At some point in life, approxiamtely 15 per cent of the Danish population will be diagnosed with depression (The Danish Medicinal Product catalogue 2003) - women twice as often as men.

The sale of the anti-cholinergic agent Spiriva®

Since Spiriva® was introduced on the market in the second quarter of 2002, there has been a great increase in both the consumption and prevalence of the agent among the elderly.

Hoarding of medicinal products in the need-dependent reimbursement system

This analysis indicates that hoarding is a problem within the need-dependent reimbursement system. Among medicine users with expenses exceeding DKK 510 within a reimbursement year, hoarding is estimated to constitute approximately 2 per cent of the users' reimbursable medicine expenses.