(Health Korea News / Yoo Ji-in) Janssen Korea’s Attention Deficit Hyperactivity Disorder (ADHD) treatment Concerta OROS ER Tab (Concerta OROS ER Tab), which has become synonymous with over-prescription (over-abuse medicine) while being mistaken for a so-called ‘study-friendly drug’ , Methylphenidate hydrochloride) is once again on the chopping block due to the issue of being out of stock due to a supply shortage. The domestic methylphenidate preparation market is almost monopolized by Janssen Korea’s ‘Concerta’, and since there is currently no generic version of this drug, confusion in the market is growing.
As a result of coverage by Health Korea News, it was confirmed that Janssen Korea recently reported to the Ministry of Food and Drug Safety that a supply shortage of its ‘Concerta OROS extended-release tablets 18mg (methylphenidate hydrochloride)’ is expected. The expected supply shortage date announced by Janssen is from December 16th to December 31st.
Janssen said, “A temporary supply shortage is expected due to a combination of circumstances, including production constraints related to raw material supply and demand, new approvals for Concerta OROS extended-release tablets in several markets, and increased demand.”
Janssen reports to Ministry of Food and Drug Safety that 18mg may be sold out in mid-December
Currently, in Korea, medicines with various strengths and formulations containing ‘methylphenidate hydrochloride’ as the main ingredient have been approved and are on the market. The representative item is ‘Concerta’, which Janssen Korea introduces and sells at its headquarters. This drug is available in four doses: 18, 27, 36, and 54 mg. Among these, the item for which Janssen raised the possibility of a supply shortage is OROS extended-release tablets 18 mg.
However, Janssen Korea said, “The expected supply shortage date stated by the company, December 16, is the most conservative estimate assuming that demand is at its peak in areas with low inventory levels, and an actual product supply shortage situation may not occur. “There is,” he said, showing caution against excessive concerns. Janssen Korea added, “As additional market supply is expected around December 31, the actual expected period of supply shortage is approximately 15 days, and the impact on patient treatment will be limited.”
However, Concerta is a representative drug that is causing controversy as it is sold out due to supply shortage if it is forgotten regardless of the dosage. In September of this year, Janssen Korea also sent an official letter to its business partners stating, “Due to a supply shortage of Concerta 27mg, a stock shortage is expected from the 12th.”
For this reason, some in the market are pointing out, “Can we trust Janssen’s report to the Ministry of Food and Drug Safety?”
Janssen is colorless, and all Concerta items are already sold out in some neighborhood pharmacies in Seoul.
In fact, contrary to Janssen’s claim that ‘Concerta 18mg may be in short supply from mid-December,’ Health Korea News coverage confirmed that prescriptions are already no longer available at frontline pharmacies. It was found that some pharmacies are running out of stock for all items regardless of capacity. This is different from Janssen’s report, which predicted a ‘supply shortage in December’, so it is likely that there will be controversy over false reporting.
A pharmacist in Bukgajwa-dong, Seodaemun-gu, Seoul, said in a phone call with Health Korea News on the 15th, “Our pharmacy does not have even one of the four dosages.” “The pharmacy in front of Ina University Hospital may have some in stock,” he said.
As this pharmacist said, the answer came back that prescriptions for Concerta can be dispensed at the university hospital’s front door pharmacy. A pharmacist at Pharmacy A near Severance Hospital in Sinchon, Seoul, told Health Korea News on this day, “Currently, Concerta OROS extended-release tablets are the most commonly prescribed drug for the treatment of ADHD. “Our pharmacy can prescribe it,” he said. “If the drug is sold out, you will have to get a new prescription for another drug from the hospital.”
There is no substitute for ‘Concerta 18mg’, the center of controversy over being out of stock.
The problem is that there is no alternative drug of the same dosage for Concerta OROS extended-release tablets 18mg, for which Janssen reported concerns about supply shortage.
‘Medikinet Retard Cap’, a methylphenidate preparation imported and sold by Myungin Pharmaceutical in the form of a finished product in Germany, is a representative alternative drug to Concerta. However, this drug is only approved in doses of 5, 10, 20, 30, and 40 mg. Therefore, if Concerta 18mg is sold out, it is virtually impossible to prescribe or dispense a replacement.
However, the reality is that it is not possible to change to another drug with a similar dosage. Due to the nature of ADHD medications, only the necessary dose must be taken, and OROS extended-release tablets in particular cannot be split or crushed and taken.
Currently, there are various types of ADHD treatments in Korea, but the reason why Janssen’s Concerta is at the center of the controversy over being out of stock is largely due to the fact that this drug is mistakenly known as a ‘studying drug.’ The influence of Janssen’s Concerta, which has a near monopoly on the related treatment market, cannot be ignored. Concerta currently occupies more than 80% of the domestic ADHD treatment market.
A pharmacist at Pharmacy B near Severance Hospital said, “If there is a shortage of Concerta OROS extended-release tablets, we can prescribe other generic drugs with the same ingredients, but the drug preference for Concerta OROS extended-release tablets is high (so it is not as easy as you think).” .
Real patients complain of damage due to fake patient drug abuse
The indiscriminate preference for Concerta is also leading to an increase in actual prescriptions.
According to the ‘2023 Medical Narcotic Handling Status Statistics’ announced by the Ministry of Food and Drug Safety this year, the number of patients prescribed methylphenidate in 2023 was 280,663, and the number of prescriptions was 73.12 million tablets. This is an increase of 26.7% and 28.4%, respectively, compared to the previous year. The number of prescriptions per person is 257.1 tablets in 2022 and 260.5 tablets in 2023, and analysis shows that the increase in prescription patients is leading to an increase in prescription volume.
In the end, the damage inevitably falls on the real ADHD patients who need actual prescriptions, and the situation is being repeated. A parent whose child suffers from ADHD told Health Korea News, “With the disease called ADHD, if you do not take medication on time, your child will show emotional anxiety and have difficulty learning as well as everyday life.” “There was an incident where I was contacted by a teacher because I was interfering with another child’s schoolwork and showing aggression,” he said.
An adult patient who has been taking ADHD medication for over 10 years said, “Concerta is the most ideal drug that I found that works well for me,” and added, “ADHD is a serious disease that may require you to give up your job if you do not take medication. “After hearing the news that it was sold out, I’m already anxious,” he said.
Experts advise that in order to solve the problem of supply shortage and misuse of ADHD treatments, consumers must properly know and use these drugs.
Professor Lee Hae-guk of the Department of Psychiatry at the Catholic University College of Medicine said, “ADHD treatment is a drug to treat psychiatric diseases in which cognitive behavior control functions such as attention concentration are not sufficiently exercised due to vulnerability in the development of frontal lobe function,” adding, “Attention concentration is lower in normal people.” “There is no effect of getting better,” he said bluntly.
At the same time, “If a normal person who has not been diagnosed with ADHD takes medication, it can cause mild side effects such as loss of appetite, increased heart rate, and headaches, and in severe cases, temporary psychotic states such as extreme insomnia, excitability, and hallucinations.” “He warned, “You must be very careful.”
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