The government has relaxed regulations on the prescription for antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), allowing doctors other than psychiatrists to prescribe the drug multiple times.
The Ministry of Health and Welfare announced on Nov. 30 that it would change the antidepressant reimbursement standards and ease the SSRI prescription standards from the start of December.
SSRIs are drugs that selectively inhibit serotonin reuptake, a neurotransmitter with antidepressant effects, and enhance the action of serotonin at nerve cell terminals. They are used for anxiety disorders such as depression and panic disorder.
Previously, departments other than the psychiatry department could not prescribe SSRIs for more than 60 days.
However, with this relaxation of standards, if depressive symptoms continue for more than two weeks and do not require referral to a psychiatry department, it is now possible to repeat the antidepressants repeatedly depending on the patient's condition as long as a one-time prescription does not exceed 60 days.
A referral to the psychiatry department is required when the patient does not respond to one or two medications, recurs within a year of treatment, when bipolar disorder is suspected, the patient or family member requests a referral, and suicidal thoughts persist.
Referrals are also needed if there is a coexisting disease, such as substance abuse or personality disorder, for severe depressive symptoms, and if self-management is not possible.
However, opinions are divided between the psychiatry department and other departments regarding the relaxation of prescription standards, with the two parties fighting over the right to prescribe SSRI antidepressants for over a decade.
While the psychiatry department has expressed concerns about other departments with no expertise in prescribing SSRIs, other departments welcomed the amendment, saying it will increase patient accessibility.
"In the case of primary depression, guidelines still recommend that psychiatrists prescribe SSRIs," the Korean Association of Psychiatric Practitioners (KAPP) said in a statement Wednesday. "However, in the case of depression due to a physical disease, the new amendment allows the doctor who treated the existing disease to continue the treatment condition as long as a one-time prescription does not exceed 60 days."
Antidepressants have to be prescribed accurately when self-awareness of depression and anxiety and expert judgment come together, which make it often difficult for other departments to understand the diagnosis and treatment process, KAPP added.
Despite the KAPP’s worries, the Korean Society for Depression and Suicide Prevention welcomed the relaxation of prescription standards. This group is an organization formed by the Korean Neurological Association, Korean Association of Family Physicians, Korean Association of Obstetricians and Gynecologists, Korean Geriatric Medical Association, and Korean Society of Anesthesiologists.
"With the amendment, depression patients' access to treatment will become 20 times better than in the past," the Korean Society for Depression and Suicide Prevention said. "All doctors, including general practitioners, should now be educated to diagnose and treat depression early."
Early treatment of depression by doctors, active detection of suicidal thoughts, and referral to local mental health and welfare centers can prevent suicide and save lives, the association added.
The Korean Society for Depression and Suicide Prevention also said that at the same time, people should be encouraged to visit a primary medical institution near their home when they feel depressed or suicidal, regardless of specialty.
However, the KAPP criticized the Korean Society for Depression and Suicide Prevention, stating that the association's President, Professor Hong Seung-bong, is a professor of neurology and is not a psychiatrist, and it is unknown whether there are any psychiatrists who specialize in depression among Korean Society for Depression and Suicide Prevention members.
"Also, as a result of inquiring about the organization to the Korean Academy of Medical Sciences, we received an answer that the Korean Society for Depression and Suicide Prevention is not a member society," KAPP added.
Meanwhile, due to the relaxation of prescription standards, industry watchers speculate that prescriptions for major SSRI treatments will expand and sales will also increase.
Most of the representative drugs in the domestic SSRI prescription market are products of global pharmaceutical companies, such as Lundbeck's Lexapro (ingredient: escitalopram), Viatris' Zoloft (ingredient: sertraline), and GSK's Paxil (ingredient: paroxetine).
As of 2021, Lundbeck's Lexapro occupies the largest share based on last year's sales with 26.8 billion won ($20.5 million), followed by Zoloft with 6.5 billion won, and Paxil with 4.4 billion won.
Among domestic pharmaceutical companies, Whanin Pharm owns Epram, a generic version of Lexapro, and generated high annual sales of 7.7 billion won in 2021 despite being a generic copy.
However, there are also voices of concern within the industry about the relative ease of prescribing SSRIs.
Industry sources said that as SSRIs are often changed to other anti-anxiety drugs due to concerns about the side effects of SSRIs, consultation with psychiatrists is still important.
"We know that many patients complain of side effects of SSRI treatment, and prescribing central nervous system (CNS) treatments should be done with caution," an industry source told Korea Biomedical Review. "However, the benefits are likely greater when viewed in terms of patients' access to psychiatric medications."