[Reporter’s View] New guideline refrains off-label NOAC use

Off-label refers to the use of drugs for an indication other than those approved by the Ministry of Food and Drug Safety.

 

Although people may question the need for off-label use when the appropriate use for a drug has already been set by the health authorities, these off-label prescriptions are made at the doctor’s discretion.

 

Often, off-label use of a drug is encouraged or shunned according the situation of each disease or drug.

 

Voices on their necessity or non-necessity are also raised accordingly.

 

The latter goes for new oral anticoagulants (NOACs).

 

Relevant societies and specialists have continuously raised concerns over the prescription of low-dose NOACs, but still, this low-dose off-label prescription trend persists in Korea.

 

Recently, the Korean Heart Rhythm Society (KHRA) published the revised “Guidelines for NOAC use in atrial fibrillation patients," which presented specific standards for NOAC use according to each situation.

 

After collecting and discussing all data on the use of various doses, the KHRA guideline decided to recommend the use of on-label doses according to each indication.

 

The first NOAC was approved in 2011 and listed for reimbursement in 2013.

 

Currently, 4 NOACs have landed in the field in Korea.

 

Quite a time has passed since NOACs landed in Korea, but still, off-label prescriptions of NOACs have not lessened much.

 

According to the National Institute of Health, over half - 64.4% - of the patients that use NOACs in Korea are being prescribed low-dose NOACs.

 

The leading cause of this off-label use is bleeding concerns.

 

Asians have a smaller physique and different genetic characteristics than Westerners, therefore, worries that the bleeding risk may increase with the use of standard-dose NOACs is why doctors have been prescribing the low-dose NOACs against indications.

 

Of course, off-label use of drugs is allowed at the doctor’s discretion according to his/her medical judgment.

 

However, the indication of a drug is approved based on clinical research on a large number of patients that is conducted to identify the appropriate dose.

 

The ultimate purpose of using NOACs is to prevent strokes.

 

If prescribing low-dose NOACs in fear of bleeding rather increases the number of stroke patients, this in itself would be a huge loss.

 

Off-label use of drugs is like a double-edged sword.

 

It is this reporter's wish that the new guidelines will guide patients who are tired of using warfarin and practitioners that were reluctant to use anticoagulants due to lack of high-priced monitoring equipment and difficult prescription management to fully enjoy the benefits provided by NOACs.