‘Prescription but no medicine!’　 Background and Risks” of the unusual shortage of the ADHD drug Concerta

ADHD in adults is rapidly increasing

Shipment adjustments of Concerta (generic name: methylphenidate hydrochloride extended-release tablets), a widely used treatment for ADHD (Attention Deficit/Hyperactivity Disorder), are being made, and medical institutions and pharmacies are experiencing a series of shortages of the drug. Even after receiving a diagnosis, a doctor prescribes the drug, and the patient goes to the pharmacy, the crucial drug is not available. Such an unusual situation is occurring all over the country.

When we contacted the distributor, Janssen Pharma, the response was , “Demand has increased due to the increase in ADHD patients, and supply is not keeping up, so we are limiting shipments to our distributors.

Is the number of ADHD patients increasing that much? According to psychiatrist Kina Takagi, “Adult ADHD treatment has spread rapidly over the past decade or so.

Until the early 2010s, ADHD was strongly perceived as a pediatric disorder, and the concept of adult ADHD was not yet widespread. However, the number of diagnoses reportedly increased between 2010 and 2019″ (Kina Takagi, hereafter).

In line with Dr. Takagi’s words, some studies report that by age group, the number of cases increased approximately 2.7-fold in the 0-6 age group, 2.5-fold in the 7-19 age group, and 21-fold in the adult group. The increase in the adult population is due in part to institutional changes.

The increase in the number of patients who need the drug is due, in part, to the expansion of treatment for adults, which coincided with the extension of the drug’s coverage to adults in 2013,” said Dr. Koh.

As the number of patients increases, the volume of prescriptions naturally increases as well, and the supply cannot keep up with the volume of prescriptions. Dr. Takagi reminds us that “the shortage of supply should not be simply attributed to the increase in the number of patients.

The number of patients who need treatment has increased due to the expansion of treatment for adults,” he says. However, there are some physicians who make the diagnosis of ADHD too easily and lack expertise. In light of the balance of supply, I think it is necessary to review whether appropriate prescribing is being done.”

Without a review of the quality of diagnosis and prescribing, the situation of “drugs not reaching those who really need them” may continue.

Risk of “stability breakdown” with alternative drugs.

If shortages continue, physicians will have no choice but to consider switching to alternative drugs. However, Dr. Takagi clearly denies this , saying, “It’s not just a matter of switching to an alternative drug.

Among ADHD medications, Concerta is the only CNS stimulant that can be used in adults, and there are many patients who have tried other medications and, after failing to achieve satisfactory improvement, have finally found their way to Concerta. In other words, Concerta is often the ‘uniquely stable drug’ for that person.

If the patient is forced to change to an alternative drug, the stability of treatment may be disrupted. The effects and side effects of medications vary greatly from person to person, and the same ADHD medication may not always be equally effective.

Patients with ADHD are able to lead stable daily lives with appropriate treatment. By changing medications, the lack of concentration, restlessness, and impulsivity may become stronger again, and their lives may fall apart all at once.”

In the field, there are already patients who are unable to secure Concerta, and their treatment is interrupted. Dr. Takagi sounds the alarm, even looking ahead to the social impact.

The lack of access to the drug can make life difficult for patients and worsen their symptoms,” he said. Furthermore, there is a risk that this will lead to maladjustment at school, errors and turnover at work, and problems at home, which in turn will affect society as a whole.

Currently, there is nothing to do but wait for the supply to catch up, but there are doubts. One can’t help but wonder if the prescribed drugs are not being used for their intended therapeutic purpose, but are instead being resold or distributed illegally. Just recently, it was reported that a man illegally transferred prescription drugs to girls, and the drugs were Concerta.

Originally, Concerta was prescribed under the strict control of the ADHD Appropriate Distribution Management System. Only registered physicians who have undergone the prescribed training can prescribe Concerta, and medical institutions must also be registered. In addition, only registered pharmacies can dispense the drug.

Patients are similarly required to register by presenting identification documents (ID) and are given a patient ID. The pharmacy checks this ID and only the registered patient is issued the medication.
The registration system for doctors, pharmacies, and patients is intended to prevent unauthorized outflow of medicines by making it possible to trace their distribution.

Where did the prescribed drugs go? As the increase in medical costs becomes an issue, it is an urgent task to review not only the supply system, but also the quality of diagnosis, the appropriateness of prescriptions, and the effectiveness of the system, in order to rebuild a system that delivers necessary medical care to the people who need it.