MFDS in discord regarding promotion of oral COVID-19 Txs

MFDS determines Emergency Authorization Drugs are not allowed advertising

Direct explanation by pharmaceutical companies blocked...brining limitations in information delivery

Prescription in high-risk groups less than 30%... “proactive judgements should be made”

The government is encouraging the use of oral COVID-19 treatments in high-risk groups, however, accessibility to such has been limited for healthcare professionals due to limitations in emergency use approvals.

 

The Ministry of Food and Drug Safety is being criticized for being passive in making legal interpretations for emergency use authorized drugs, which is in discord with the government’s disease control and prevention measures.

 

According to industry sources on the 26th, pharmaceutical companies are disallowed from conducting academic marketing for their oral COVID-19 treatments as the subject drugs were approved under Emergency Use Authorizations.

 

Usually, when new drugs are released, companies conduct various activities to raise awareness of the drugs, making visits to hospitals to explain their drugs and holding webinars or symposiums to provide educational material.

 

The new drugs in the market can only be actively used after the healthcare professionals gain a better understanding of the drugs and accumulate prescription experience.

 

However, as COVID-19 treatments were granted emergency use according to the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis, the authorities deemed that the drug are not allowed the advertising privileges granted under the Pharmaceutical Affairs Act.

 

According to Article 68-5 of the Pharmaceutical Affairs Act, the imported pharmaceutical product’s name, manufacture method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act.

 

As drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, the MFDS’s interpretation was that such drugs are not allowed to conduct advertisements.

 

Due to this, the government is solely in charge of providing the necessary information on oral COVID-19 treatments in Korea.

 

The Korea Disease Control and Prevention Agency is in charge of training healthcare professionals to provide medication guidance to patients, etc.

 

However, it has been pointed out that the government’s education sessions are not enough to cover the expanded scope of institutions and pharmacies approved to prescribe and dispense oral COVID-19 treatments.

 

Also, the participation rate, frequency, and effect of KDCA’s education sessions are relatively lower than that of pharmaceutical companies due to lack of promotions among other reasons.

 

There are also opinions that more explanation is needed because the sessions are not carried out by medical professionals.

 

Many healthcare professionals and pharmacists who still have not received a prescription or medication guidance yet have reported experiencing confusion.

 

However still, officials of pharmaceutical companies that can communicate most closely with healthcare professionals have been passive in dealing with the issue due to concerns about violating the Pharmaceutical Affairs Act.

 

As an active explanation of the drugs was prohibited, the officials can only respond when receiving inquiries from healthcare professionals.

 

This is why the prescription rate has not risen much even though the government has greatly expanded the number of institutions that can prescribe oral COVID-19 treatments.

 

According to the Central Disaster and Safety Countermeasure Headquarters (CDSCH), the prescription rate of oral COVID-19 treatments in those over the age of 60 as of the 2nd week of September, remained at 27%.

 

The prescription rate has more than doubled in 4 months with the encouragement of the disease control and prevention authorities, but the government believes it is necessary to further increase the prescription rate.

 

The importance of prescribing oral treatments has risen after the prescriptions had significantly reduced the progression to severe disease in patients in the high-risk group over the age of 60 during the COVID-19 outbreak last summer.

 

The CDSCH’s analysis of its disease control progress and response to the resurge of COVID-19 in the summer showed that the progression to severe disease decreased as the prescription rate for oral COVID-19 treatments increased for those aged 60 years or older.

 

The rate of progression to severe disease, which had been 1.28% in February when the administrate rate was 6.4%, dropped to 0.42% with the rise of the administration rate to 21.7% in August.

 

The disease control and prevention authorities are also busy preparing measures to address the issue of prescriptions being limited due to a lack of clinical information in the field.

 

According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information.

 

Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines.

 

To address the continued criticism over the limitations in information, the authorities recently partially granted pharmaceutical companies to produce and distribute materials containing drug information.

 

As such partial activities have clear limitations, voices for proactive allowance of pharmaceutical companies to conduct academic marketing on EUA drugs have also been rising.

 

Contrary to the government's stance, the MFDS had been passive in making legal judgments regarding EUA drugs.

 

At the time of introductions, pharmaceutical companies had made several inquires to the MFDS on what scope of information provision activities is allowed for their drugs.

 

At the time, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies received the response as a “don’t.” Regarding this, the MFDS said, “The COVID-19 treatments that were granted EUA are directly managed by the KDCA, and the KDCA has been providing various information for healthcare professionals and patients.

 

We will consult with the department in charge to see if academic marketing is allowed." The Advisory Committee on Infectious Diseases also agrees on the need for the government to make proactive decisions and improve and expand healthcare professionals’ accessibility to information.

 

During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19 there are still many cases in which prescriptions are not available to patients who need them in the medical field.

 

Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate.

 

It seems necessary that the government should take active action to overcome obstacles that may hinder engagement in such activities that would lead to an increase in the prescription rate, by requesting authoritative interpretation from the Ministry of Government Legislation.”