Cost bearer in debate ahead recall of some losartan products

Full recall may be ahead for some losartan products

MFDS meets with various industries to devise a measure for recalls…”Pharmaceutical companies should bear the out-of-pocket cost”

Confusion highly likely to arise among medical care institutions and consumers

The MFDS has mentioned ‘re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ‘losartan’ products that were found to contain azido impurities during inspections.

 

The re-prescribing or re-dispensing measures are prepared for cases when patients cannot exchange their drugs at pharmacies, and all lot numbers of some losartan items are highly likely to be recalled.

 

In other words, some items will be subject to full recalls.

 

Previously, the valsartan and ranitidine products that were fully recalled due to impurities had also been re-prescribed or re-dispensed.

 

At the time, the patients’ out-of-pocket cost was borne by medical care institutions for valsartan, and by the National Health Insurance Service for ranitidine.

 

The NHIS had later filed a suit to claim the re-prescribing and re-dispensing cost borne to the pharmaceutical companies.

 

However, as medical and pharmaceutical associations believe the patients’ out-of-pocket cost should be borne by pharmaceutical companies, the issue is expected to raise much controversy this time.

 

According to the industry on the 25th, the MFDS had held a series of meetings with doctors, pharmacists, and pharmaceutical associations on the 24th.

 

At the meetings, the MFDS had mentioned the possibility of re-prescribing and re-dispensing some losartan items, upon which the associations expressed the position that pharmaceutical companies should bear the patients’ out-of-pocket costs that arises from prescribing and re-dispensing while minimizing product recalls.

 

In summary, it seems that full recall of some losartan items will be inevitable.

 

If re-prescribing or re-dispensing measures take place, conflict may arise over who pays for the patients’ out-of-pocket cost and NHIS cost.

 

The government, as well as the medical and pharmaceutical groups, believe that pharmaceutical companies should bear the cost, whereas the pharmaceutical industry is reluctant to bear the cost as this is an unintentional impurity event.

 

However, the analysis is that the companies may accept bearing the out-of-pocket cost of patients.

 

If only a few products are subject to exchange or re-prescriptions, there is the possibility that the recall will proceed without much confusion like in the case of the last AZBT losartan recalls.

 

Therefore, the attention is focused on how many items will be recalled, and what proportion of the products will be re-prescribed at the official announcement made by the MFDS.

 

The MFDS announcement is highly likely to come in early December after the MFDS receives and aggregates pharmaceutical companies’ product impurity test results at the end of this month.

 

The MFDS also plans to hold a meeting soon with pharmaceutical companies that possess products subject to recalls.