Practice manual issued for COVID-19 treatments in Korea

Raises expectations on expanding prescriptions of difficult-to-use COVID-19 treatments

KSAT publishes a guideline for easy application in the medical field

Overcomes the limitations of existing guidelines that contain too much information including a list of contraindicated drugs

“Shows clear benefit in reducing progression to severe disease in patients with mild COVID-19 symptoms... should be actively prescribed in high-risk groups."

Doctors have issued a ‘Practice Manual’ to provide an understanding of how to use the COVID-19 treatment in one glance.

 

The manual was prepared to directly address difficulties HCPs experienced prescribing COVID-19 treatments in the field due to a large number of contraindicated drugs.

 

The Korean Society for Antimicrobial Therapy (KSAT) recently distributed a manual for the actual prescription of Paxlovid, Pfizer's oral COVID-19 treatment.

 

The manual was designed to allow easier understanding for HCPs on whether to refrain prescription of Paxlovid or make dosage adjustments according to a patient's medication status.

 

Paxlovid is the first oral COVID-19 treatment that was approved in Korea.

 

The drug was granted Emergency Use Authorization in December 2021 and was indicated for moderate-to-severe COVID-19 patients at high risk of progressing to severe disease.

 

At the time the authorities initiated the supply of Paxlovid, the authorities had also issued treatment prescription guidelines, however, the guidelines issued then were more than 100 pages long and were not easy to use in the field.

 

un-Joo Choo, Professor of Infection, Soonchunhyang University College of Medicine,

The Guidelines on Paxlovid use that was recently announced by KSAT is a practice manual that addresses such difficulties experienced in the field.

 

The KSAT collected the main areas of consideration of up to 100 drugs that require attention so that they could be applied to practice right away.

 

The manual summarized the cautions that do not appear in the Drug Utilization Review (DUR) program.

 

The guidelines also contain, a list of over-the-counter drug products that contain ingredients that require special attention.

 

In an interview with Daily Pharm, Eun-Joo Choo, Director of the Insurance Committee at KSAT and Professor of Soonchunhyang University College of Medicine, who contributed to the preparation of the guidelines for Paxlovid, said, “The existing guidelines were too detailed to identify what precautions apply for each patient's medication.

 

We hope that the guideline can contribute to increasing the practical prescription rate of oral COVID-19 treatments that lower disease severity rate,” stressing the importance of prescribing the COVID-19 treatment.

 

The full interview transcript of Daily Pharm’s interview with Professor Choo is as follows.

 

- A Paxlovid prescription guideline that the government issued already exists.

 

Why did KSAT see a need to prepare a separate guideline?? =KSAT’s practice guideline is more of a ‘practical manual' that allows healthcare professionals to understand contraindicated drugs and dose adjustment at a glance in the field during prescriptions.

 

The Paxlovid prescription guidelines issued by the government are over 100 pages long.

 

It contains too much detail for HCPs to immediately absorb and apply in the field.

 

This is why HCPs had difficulty prescribing the drug in the field, being an unfamiliar drug that is difficult to use.

 

Paxlovid

KDCA’s guideline categorizes the list of drug-drug interactions as ▲ 7 contraindicated drugs ▲21 drugs that can be temporarily discontinued or substituted to a different drug during Paxlovid use, ▲List of OTC drugs that contain the ‘St.

 

John’s Wort’ substances that are contraindicated, ▲drugs that require use with caution when co-administered, etc.

 

In particular, the drug substances that require caution in the use and key recommendations were summarized in a table format so that they can be applied immediately in practice.

 

-I first thought the contraindicated drugs will be easy to identify as they immediately show up in the DUR database, but it seems that I was wrong.

 

In particular, it seems that it would have been difficult to identify all the products that contain St.

 

John’s Wort, as the substance is commonly used in OTC drugs and health functional foods. =That’s right.

 

Only the 7 contraindicated drugs that must not be prescribed together pop up on the DUR, which includes epilepsy substances such as St.

 

John's Wort.

 

Substances commonly used by patients for hyperlipidemia, heart failure, gout, etc., that can be temporarily discontinued or substituted to administer Paxlovid, but such information is not reflected in the DUR.

 

In addition, there are about 100 drugs that require attention, such as dose reductions, etc.

 

It's not easy for doctors to know all this during prescriptions.

 

In particular, the St.

 

John's Wort substance is contraindicated, regardless of whether it is a prescription drug, general OTC drug, or health functional food.

 

Since doctors need to check directly with the patient on whether or not they use the substance, a list of the OTC drugs was prepared that specifies the product and company names.

 

The self-checklist also asks patients once more to confirm whether they are taking OTCs or health functional foods.

 

Fortunately, St.

 

John's Wort is mainly used in women, but the rate of those taking it at the age of over 60 is not that high.

 

Patient self survey to identify patient

-The prescription rate of oral COVID-19 treatments has remained in the 30% range for several weeks.

 

What do you believe is the reason behind this? = During our webinar, one of the most common concerns that the doctors had was ‘Whether they should use COVID-19 treatments in mild COVID-19 patients with few symptoms.’ Being a drug that the doctor hasn’t used before, in addition to the fact that the drug has many drug-drug interactions, and the treatments for COVID-19 are mainly conducted non-face-to-face, it is natural that doctors may be hesitant in using such unfamiliar drugs.

 

The part I want to emphasize is that oral COVID-19 treatments prevent patients with mild symptoms from progressing to severe diseases.

 

Patients may have minor symptoms at first, but if they do not take the right medicine at the right period, their disease can progress to severe disease, in particular in patients that are over the age of 60 or have underlying diseases.

 

In fact, quite a lot of inpatients who had COVID-19 were sent to the intensive care unit when there were no available vaccines or treatments.

 

However, this number decreased significantly after the introduction of COVID-19 vaccines and oral treatments.

 

Real-world data also showed that the rate of progressing to severe disease was reduced by about 50% with the prescription of Paxlovid.

 

I believe prescriptions will naturally increase after such data on Paxlovid’s actual effect and HCP prescriptions increase and accumulate.

 

-The majority of Korean people have been vaccinated several times.

 

Also, with so many having a history of COVID-19 infections, not many are concerned about reinfections.

 

Do you believe these people also should receive vaccinations with booster shots?

 

If they are high-risk groups, would they need to be prescribed oral COVID-19 treatments when reinfected?

 

If you look at the government’s reinfection rate data, the age-standardized risk of death in case of reinfection is 1.58 times higher than that at initial infection.

 

Just as people receive vaccination for the flu every year and then use Tamiflu when infected, COVID-19 also requires regular vaccination and treatment.

 

In fact, COVID-19 requires more caution as it has a higher rate of complications and disease progression than the flu.

 

Patients who have pneumonia due to COVID-19 suffer complications such as difficulty in breathing due to pulmonary fibrosis even after completing treatment.

 

Some people describe COVID-19 as a 'highly contagious cold', but I do not agree, as no one dies of a simple cold.

 

Also, the experience of the patient that receives the treatment is as important as the HCP that prescribes Paxlovid.

 

There is little positive feedback yet because not many patients have experienced the treatment.

 

However, the treatment has been proven to be effective, and in particular, it is more beneficial for patients that opt for at-home treatments.

 

Because of the definite benefits, I hope that patients do not worry too much and take their prescribed oral COVID-19 treatment as indicated.