Andrew E. Healey

Off label use of devices and drugs in interventional radiology

AIM To establish how often off-label device and drug use occurs in interventional radiology (IR) in a UK tertiary referral hospital and consider the wider implications for the interventional radiologist. MATERIALS AND METHODS Prospective data were collected during interventional procedures for 1 working week in a university hospital. Out-of-hours procedures and procedures outside the department were excluded. Operators were asked to record the drugs and devices used, the indication, and method of use. The instructions for use/summary of product characteristics were then studied for each device/drug used to assess if the use was on or off-label. RESULTS During the study period 52 cases were performed and data were available on 26 cases (50%). In 22 of the 26 cases (84%) there was evidence of off-label use of devices or drugs. Off-label use of drugs included treatment of venous malformations with Fibrovein(©) (sodium tetradecyl sulphate), which is licensed for the treatment of varicose veins in the leg, and intra-arterial injection of heparin, which is licensed for intravenous and subcutaneous use. Off-label device use included placing vascular sheaths in the urinary tract, using angiographic catheters to guide wires in the urinary tract, using sheaths for thrombosuction, reshaping of the tip of most guidewires, and using angioplasty balloons to dislodge the arterial plug at fistula thrombectomy. CONCLUSION Off-label device and drugs use is common in a UK tertiary hospital IR department and literature suggests this is common in the wider IR community. There are important clinical and legal implications for off-label use for patients and physicians.

European Counterpoint to Chapter 20

There exists little significant evidence on which to base the use of inferior vena cava (IVC) filters (1–3; see Table 1) and, at present, there are no UK or European regulatory guidelines for their use. They are therefore used on a case-by-case basis with moderate variation between centers. The Royal Liverpool University Hospital Interventional Radiology Department places about 12 IVC filters annually although a neighboring center with a much smaller population catchment area inserts at least twice as many each year. Even in the same unit there is a wide range of use between individual radiologists and referring clinicians. The incidence of use of IVC filters in the United Kingdom seems much less than in the United States. Although we can find no comparative data in the current literature, the incidence of filter use in the United States in recent years is well documented with 30,000 to 40,000 filters inserted per year (4).