Tramadol classified as narcotics abroad but not in KOR

lacks grounds for designation in Korea

MFDS researches its misuse and abuse... monitoring in progress

Conducted survey on doctors only...’Will review the need for a comprehensive survey if necessary'

The Ministry of Food and Drug Safety stated that there is insufficient evidence to designate tramadol, a so-called narcotic painkiller, as a controlled narcotic in Korea.

 

On the 1st, the MFDS submitted a written response to the written inquiry issued by Rep.

 

Sun-Woo Kang of the Democratic Party of Korea regarding the need to designate tramadol as a narcotic.

 

Since the Korean Pharmacists for Democratic Society proposed the designation of tramadol as a psychotropic drug in 2014, there has been ongoing controversy over the need for its designation as a narcotic.

 

Accordingly, the Ministry of Food and Drug Safety recently conducted a 'Study on the misuse and abuse of opioids’ and concluded that there is insufficient evidence to designate tramadol as a narcotic based on the results.

 

However, considering how some countries including the United States and the United Kingdom designate the drug as a narcotic, the MFDS said they will continue to monitor its misuse and abuse and whether it should designated as a controlled substance at the United Nations level and will consider designating it as a narcotic if necessary.

 

However, as the survey in the research study was conducted only on doctors, Rep.

 

Kang pointed out, "Talks on their side effects were raised by patients and pharmacists' groups.

 

How credible would a survey only on doctors be from that aspect?” The MFDS responded, "Products containing tramadol are prescription drugs that can only be used with doctor's prescriptions, so the survey was conducted on doctors who regularly treat actual patients and prescribe tramadol.

 

We will monitor adverse events including drug dependence and regulatory trends overseas and review the need to conduct a research service to survey various groups including pharmacists and patients if necessary.” Tramadol is a painkiller used for moderate-to-severe acute and chronic pain, but due to its structure, which is similar to narcotics, it can cause dependence, withdrawal symptoms, and respiratory depression.

 

This is why it is classified and managed as 'Schedule IV' drug in the US.

 

Recently, according to the monitoring group of the Seoul Pharmaceutical Association, one patient received prescriptions for a total of more than 200 tablets of the narcotic painkiller Tritol (Tramadol) and cough and phlegm medicine Cough Tab from 4 to 5 clinics over a period of 5 days under the names of several family members, raising the issue of misuse and abuse.

 

Rep.

 

Kang requested an explanation at the very least on the drug’s precautions, saying, “It is inconsistent to strengthen the labeling requirements by deleting the phrase ‘tramadol is less dependent’ from its precautions for use while stating that there is no need to designate it as a narcotic.” In the precautions for tramadol use, there is a phrase that goes 'mental and physical dependence may occur due to intolerance from long-term administration.

 

For patients with drug abuse or dependence, it should be administered for a short period of time under strict supervision.’ To this, MFDS stated, “Tramadol can cause mental and physical dependence, so we believe that safety management for the drug should be conducted even though there is insufficient evidence to designate it as a narcotic.

 

We strengthened its safety management by deleting the phrase on its dependence due to worry that it may raise misconceptions that it causes no problem due to low dependence.”