**5. VTE and the database of the DPIA**

Since 1996 we have maintained a database of all claims. Until the end of 2010, there were 688 claims, where the complication was VTE. In table 1 is shown the number of patients with DVT alone, the patients who also had PE, and the patients with rare thombosis. The rates of approval of the claims are around 60 % compared to the average rate of 35 % of the DPIA.

Venous Thromboembolism as a Preventable Patient Injury:

**6. VTE and treatment with female hormones** 

the other factors was minor in comparison.

Table 4. The other drugs involved in VTE claims.

Table 5. VTE after non-operative treatment.

table 5.

**7. Treatment with other drugs** 

had a coagulation defect, usually the Leiden factor-5 mutation.

with faulty use of anticoagulants that were approved. One patient died.

Experience of the Danish Patient Insurance Association (1996 - 2010) 163

The other large group was 193 patients with DVT or PE, who had birth control medication (173 patients) or treatment of menopausal conditions (20 patients) prescribed by their physician, and suffered VTE as a result. Their claims were approved in 138 cases, and € 2.956.248 was paid to 134 patients. Only 5 women died, but it must be borne in mind that these were completely healthy women. In 17 cases it was later established that the patient

There were at times several factors that contributed to the onset of thrombosis in these patients. Thus it was discussed which factor was the crucial one, when e.g. a young woman who was on birth control pills and had a body mass index of 34, undertook a long air travel and suffered VTE? The coagulation experts that we have consulted thought that the VTE would not have happened without the birth control medication, and that the contribution of

In 12 cases the VTE was thought to be caused by other drugs (Table 4). It was mainly claims

Non-operative treatment of fractures and joint injuries was the cause of 30 claims, shown in

Non-operative treatment of fractures and joint injuries N N approved Spine 3 1 Lower extremity 27 13 30 14

It was of course mainly fractures in the lower extremity that were afflicted because of the need for immobilization. Usually in the DPIA, VTE is thought to be a side effect of the fracture itself, and it is therefore not eligible for compensation. In 4 cases however, the diagnosis was missed, and in one further case the appeal board decided that the diagnosis should have been made at the time, when the cast was cut open because of swelling. In the last 9 approved cases there were individual indications for giving anticoagulants that were not recognized at the time of fracture. Four patients died as a result of the patient injury. In many of the non-approved cases, the question was whether the experienced specialist

Other drugs N N approved Vitamin K antagonist 5 3 Angiotensin converting enzyme 1 1 Immuneglobuline 2 1 Docetaxel 3 0 Cox-2 inhibitor 1 0 Prednisolone 1 0 13 5


Table 1. DVT and PE in the material.

There were 42 patients who died because of the patient injury (6.1 %).

The patients could be divided in 5 sub-categories after the nature of their disease and circumstances surrounding the injury (Table 2).


Table 2. Categories of patients.

**VTE after an open intervention** was the largest group with 391 patients. The cause of injury was usually failing to give the correct prophylaxis, or omitting to give any prophylaxis at all. The specialities involved are seen in table 3.


Table 3. The number of patients with VTE treated in the different specialities.

Of these, 27 patients died as result of the injury. There were 224 patients, who had their claims approved by the DPIA. Compensation was paid to 218 patients to the total amount of € 6.127.365.
