Reported by Lo Chen

In order to reduce the health and safety risk associated with repackaged bulk drugs, the MOHW stopped the reimbursement for repackaged bulk drugs 3 years ago.  However, such a practice still exists.  The pharma industry and health reform groups suggested the MOHW should tighten up the regulations.

In reply to this suggestion, Yang Po-Wen of the TFDA expressed that drug companies and pharmacists are subject to different regulations of repackaging drugs.  However, hospitals can be fined NT$30,000 - 5 million for violating the GDP regulations.

According to Yang Po-We, sterile preparations approved by the TFDA, such as eye lotion and eye ointment, are mostly in small packages readily to be dispensed to individual patients; therefore, repackage of bulk drug is usually not necessary.  However, hospitals are not able to strictly follow this practice in situations where small packages are not available.  The TFDA will revise the regulations of the dispensing of sterile preparations in the Chinese Pharmacopoeia.

The TFDA announced the GDP Guidance in 2004 to regulate the environment, processes and labelling concerning drug dispensing.   However, its implementation has been criticized for being too slack.  Chu Hsien-Guang the President of the Taiwan Healthcare Reform Foundation, pointed out that the GDP Guidance does not request pharmacists to relabel the new expiry date on the dispense package after breaking the seal of the original packaging. Chu also pointed out that the GDP Guidance does not request an independent, clean and sterile room for dispending.

Associate Professor Lin Hui-Ling of the NTU pointed out the hardware, software, environment, facilities, documentation, quality validation, etc. associated with the processes of breaking the original drug dosage form are all insufficiently regulated in Taiwan.

The NHIA stopped the reimbursement for repackaged bulk drugs in 2015; however, it does not stop the practice in clinics.  It is because that some clinics use short-forms to claim the universal daily drug fees of NT$22, regardless of quantity and variety.   Hence, some clinics make profits from the price difference between the daily drug fees and cheap bulk drug.  

Chu Hsien-Guang criticized that the slack management of repackaged bulk drug in clinics will have a negative impact on the implementation of the referral system as patients may have safety concerns over drugs from clinics.  Professor Lin suggested that the MOHW should encourage drug companies to produce drugs in small packages with a complete package insert attached to each package.

【2018-11-22/ United Daily News】