보건복지부 영문홈페이지

Reclassification of drugs confirmed

- Reclassification of 504 items to go into effect on March 1^st, 2013 –

 

After declaring the initial plan on June 7^th, and collecting opinions (June 7^th~July 6^ths) and having the Central Pharmaceutical Affairs Council’s deliberation (August 28^th~29^th), the Ministry of Health and Welfare (Minister Rim Chemin) and the Korea Food and Drug Administration (called KFDA hereafter, Commissioner Lee Heesung) announced the final results of a drug reclassification on August 29^th.

 

According to the results of the council meeting, 504 preion and non-preion drugs (1.3 percent of the total items) have been reclassified.

 

Reclassified preion drugs include the Kimite Patch for children, Ursa Tab. 200mg, Clindamycin liquid for external use* (acne treatment), and high-titer steroids for external use such as eczema medicines (262 non-preion drugs were reclassified as preion drugs).

* Concern over tolerance development after long-term use

                                                                   

Preion drugs such as Zantac Tab. 75mg (heart burn treatment) and Amorolfine hydrochloride for external use (athlete’s foot treatment) can now be sold at pharmacies without a preion. (200 preion drugs were reclassified as non-preion drugs)

 

In addition, some drugs, including Sodium hyaluronate 0.1% (artificial tears), Famotidine Tab. 10mg (heart burn treatment) and Lactulose (constipation treatment), can now be sold at pharmacies without a preion, but can also still be prescribed by doctors, depending on the drug's effects. (42 items are now concurrently classified as both preion and non-preion drugs).

 

Council members presented further suggestions, as noted below, which the KFDA plans to accept and promote.

▸ Reviewing reclassification for external use antibiotics, such as fusible acid, based on the results of on-going drug resistance research, and conducting further studies on adverse reactions of topical steroids.

▸ Expanding concurrent reclassifications for safe and convenient drug-taking.

▸ Researching more information regarding the adverse reactions of non-preion drugs, as well as preion drugs.

 

Compared to the initial reclassification plan on June 7^th, there were changes made to the three items, Sodium hyaluronate 0.3%, oral contraceptives, and postcoital contraception, for reasons as follows:

 

As expert advice is required when low concentrations of Sodium hyaluronate 0.3% collyrium is administered, but show insufficient effects, it should stay as a preion drug.

 

In the case of birth control pills, it is proper to reclassify oral contraceptives as preion drugs and emergency contraceptives as non-preion drugs.

 

The council, however, requested to maintain the current classifications based on traditional customs and social circumstances, and review the issue further after continued research on birth control pill usage and its adverse reactions.

 

Reflecting the council’s suggestions and public opinions on the reclassification of birth control pills, the government will strengthen its monitoring of related matters for the next three years to devise supplementary measures to protect women’s health.

 

The council checked not only the safety of drugs, but also possible inconveniences to patients and effects to pharmaceutical companies as to whether there is an alternative medicine or not.

 

It found that since most of drugs have alternative medicines, and reclassification does not change insurance coverage, it is not expected to affect doctor’s preions or the pharmaceutical industry.

* (Examples of alternative medicines) ① Kimite patch for children: preventive patch for children with travel sickness, alternatives are syrup and gum. ② Clindamycin liquid for external use: acne treatment, alternatives are other products containing Benzoyl Peroxide.

 

Comparing before and after the reclassification, there was not a large change in the ratio of preion drugs and non-preion drugs, which went from 56.2% to 56.4% and 43.8% to 43.6%, respectively.

 

Results of the council meeting concluded that oral contraceptives will stay as non-preion drugs so consumers would not have to face any unnecessary inconveniences, but countermeasures to protect women’s health from adverse reactions are required.

 

Pharmacies must provide customers who buy birth control pills with instructions on how to take them and what precautions they should take.

-       Planning to mention in birth control advertisements that medical consultations at hospitals are necessary before usage.

 

Also, in order to help breed a culture of having a medical examination at maternity clinics before taking birth control pills,

-       Women who have a preion can receive pills free of charge at health centers, or get subsidized for purchasing costs, for a period of three years in cooperation with national projects supporting health centers and pharmaceutical companies.

 

Due to concerns over the abuse and misuse of postcoital contraception, the council decided to maintain them as preion drugs, but plan to increase ways to help people access them when needed.

 

Hospitals offering evening consultations and emergency room services will be allowed to provide the pills during late night hours (10 p.m. to 6 a.m.) and holidays.

-       Health centers will quickly offer emergency contraceptives after a doctor’s examination.

 

Sexual violence counseling centers, youth counseling agencies, and school nurse's offices will inform people regarding examinations and medication on emergency contraceptives and if needed, commission them to linked medical institutions and emergency rooms.

 

The government stated that it will responsibly promote countermeasures, which are prepared based on social opinions toward birth control pills, in cooperation with related ministries and organizations.

 

It will maintain consistent cooperation with the Ministry of Gender Equality and Family and the Ministry of Education, Science, and Technology, and promote various projects on education and public relations with the pharmaceutical industry, the medical community, women’s organizations, and religious groups.

 

As part of the education program under the Framework Act on Low Birth Rates in an Aging Society, customized education on sexual health and birth control by age group will be offered.

-       A youth program on becoming a healthy mom is also being planned in cooperation with schools and obstetricians from local communities.

 

Also, in line with improving the national health check-up system, conducting mandatory health check-ups to improve the health of female youth is being taken into consideration.

* (Example) check-ups for females before and after menarche.

 

The final version of the drug reclassification announced today will go into effect on March 1^st, 2013, six months from now, since the process of exchanging drugs in the market and notifying the public are necessary and will take time.

 

The KFDA plans to publicize information regarding reclassification and alternative medicines in order to help people avoid any confusion or inconveniences.

 

In addition, it has reassessed drug items every five years under the system to approve the renewal of the drugs (beginning in 2013).

 

The subcommittee on drug classification (under the council) consisting of eight experts on toxicity, and pharmacological and clinical effects, and four public welfare delegates, deliberated this year's reclassification and held the preliminary deliberation (August 20^th) and plenary deliberation (August 28^th~29^th).