Pharmaceutical News
NHIA introduces an on-line report system for concerns over drug effectiveness
2018/05/20

Reported by Liu Chia-Yun from Taipei

The implementation of the NHI drug price cut has caused the public’s concerns over drug substitution in hospitals.  Many patients worry that hospitals might substitute original drugs with cheaper generics, and cast their doubt over the effectiveness of the substitutes.  In the past two years, the TFDA received tens of reports about unsatisfactory drug treatment results.  The NHIA, therefore, introduced an on-line reporting system for doctors to report on concerns over drug effectiveness as raised by patients.

The TFDA’s data shows that Stilnox and Metformin have seen the most reports of poor effectiveness in the past two years.  Last year, the TFDA took random samples of 17 Stilnox and 39 Metformin.  Among them, only one sample of Metformin failed the test.   The TFDA immediately requested the manufacturer to make improvement.  In order to enhance the monitoring and reporting of drug effectiveness, the TFDA and the NHIA jointly established a reporting platform under the cloud-based health information enquiry system so that doctors and pharmacists are able to easily report on cases of dubious drug effectiveness.

Some people worry that the NHI drug price cut might push hospitals to substitute original drugs with cheaper generics, and the substitutes might compromise the treatment results.  Wu Hsiu-Mei, the Director General of the TFDA, expressed that all generic drugs are identical to the original drugs in ingredients, dosage form and dosage; therefore, their efficacy should be similar.  However, she conceded that The TFDA received 52 reports of poor drug effectiveness in 2016 and 29 such cases in 2017.  Though the number of cases reported was not significant, the TFDA still carried out drug quality investigation diligently.

Dr Lee Po-Chang, the Director General of the NHIA, expressed that the NHI Benefit Scheme lists over 16,000 drug items.  As generic drugs are susceptible to effectiveness issues, original drugs are likely to be affected by counterfeit issues.  In order to protect patients’ medication safety, the NHIA included a reporting mechanism in the existing cloud-based health information enquiry system in order to make it easier for doctors to report on quality concerns based on patients’ experiences.  Doctors can report on suspected fluctuations of drug effect, follow-up remedies (e.g. changing doses, changing back to patients’ usual medicine, discontinuing treatments, using other drugs concomitantly, keeping observing, etc.). The reports will be forwarded to the TFDA for further investigation with a view to protecting the public’s health.

【2018-05-18/ United Daily】