Japan's New Rx-To-OTC Procedure Exacerbating Switch Blockage Says JSMI

A conservative switch committee and a doctor-centered healthcare system in Japan are holding back prescription-to-OTC re-classifications in the country, according to the Japanese self-medication industry association, JSMI.

Japan recently updated its prescription-to-OTC reclassification procedure with the goal of expediting switches. But the change has actually had the opposite effect, JSMI’s senior adviser, Toshi Tominaga, told HBW Insight in an exclusive interview.

 “Ironically, the mechanism intended to promote switching is actually hampering it,” he explained. “The already sizable switch lag is widening as fewer and fewer ingredients are being reclassified.”

Anti-allergy drug loratadine, for example, was only switched to OTC status in 2017 in Japan, despite being reclassified 25 years ago in Sweden.

Meanwhile emergency contraception medicine levonorgestrel and proton pump inhibitor omeprazole, both switched in 1999 – the former in France and Mexico, the latter in Sweden – are yet to be made available OTC in Japan. 

Doctors Causing The Blockage

Japan’s new switch system, which was introduced in 2016, relies on an expert Evaluation Committee (EC) – consisting of key stakeholders from the country’s healthcare system, including doctors, pharmacists and consumers – which assesses switch applications based on expert evidence gathered by the Ministry of Health, Labour and Welfare.

To be granted a positive recommendation – which is then passed on to the Ministry of Health for final decision – switches must be unanimously supported by the all members of the EC, Tominaga explained.

The problem, however, Tominaga said, was that the medical doctors on the committee “frequently opposed” switch applications due to concerns about patient safety.

“Discussion is safety-centered, and rightly so,” Tominaga commented. “From the point of view of the Japanese OTC industry, however, discussions so far have been too risk-averse, based on worst-case scenarios, without regard to the probability of their occurrence.”

Furthermore, while pharmacist representatives on the EC were generally supportive of switching, Tominaga revealed that non-pharmacist representatives were not always confident of pharmacists’ ability to provide the necessary advice on switched OTC medicines, and were on this basis inclined to reject applications for more complex switches.

“Pharmacists’ inability to give guidance for consumers is often raised in discussions and serves as a ground to refuse switches,” Tominaga said. “Especially emphasized is the concern that pharmacists need to make sure that the consumers should not take the drug for an extended period of time and that if the symptoms persist, should see a doctor.”

The committee had rejected a number of switches on this basis, Tominaga noted, for example proton pump inhibitors for acid reflux, which was denied by the EC "not because of the drug’s efficacy and side effect profile but because the current pharmacist practice does not guarantee user compliance.”

Even consumer representatives on the committee were risk averse, Tominaga pointed out, and “seemingly unimpressed” by the positive impact of switching on consumer welfare in widening access to drugs and removing the need to visit doctors’ surgeries.

Japan Lacks Self-Care Culture

Ultimately, Tominaga said that the current situation reflected the fact that Japanese society “does not much perceive the need for switching.”

Within Japan’s universal health insurance system, Japanese consumers had “relatively easy and inexpensive access” to medical care, including dispensed prescription drugs, he continued, and were therefore “not motivated” to buy OTC drugs.

“As far as medicines are concerned, a patient’s out-of-pocket expense for a full-strength prescription drug is generally far smaller than the price of the drug’s reduced-strength OTC version, he explained.

The “hidden cost” to consumers of this system in terms of insurance payments and government subsidies – not to mention the fact that Japan’s very rapidly ageing society had driven the country’s “generous health insurance system to the brink of bankruptcy” – did not affect their behavior, Tominaga lamented.

Japan’s universal health insurance system discouraged consumers from “consciously” dealing with their health problems, he continued, as “they can just go to hospitals or clinics.” “This has hampered their health literacy in its broadest sense,” he added.

“The Japanese have a basic knowledge of healthcare, but not enough practical and advanced knowledge of how to self-diagnose and self-treat their ailments, or the will to do so,” Tominaga insisted.

Tominaga’s analysis of Japan’s switch climate echoed that of global switch expert Dr Natalie Gauld.

In an exclusive recent interview with HBW Insight, Dr Gauld said that in Japan, “it’s usual to go to your doctor about everything.”  (Also see "Thinking About Switching? Dr Gauld On The Go-To Markets Today" - HBW Insight, 29 May, 2019.)

“What they say in Japan is that ‘if you’re sick, don’t go to the hospital, go to your local doctor,’” she explained. “That’s the message they try to send out, even for a cold.”

“A consumer I spoke to there couldn’t believe that I might suggest that people in other countries wouldn’t go to a doctor for a cold,” Dr Gauld continued. “But the fact that it is easy to see a doctor in Japan, as well as the culture of great respect for a doctor’s knowledge, contribute to this environmental difference.”

“Furthermore, Japanese doctors get a small payment from the government for each appointment. So, it’s partly about the financial incentives,” she added.

Need For Change, JSMI Leads The Way

Improving Japan’s switch procedure was an urgent task, Tominaga maintained, as the country’s health insurance was “faced with ever growing financial difficulties, to the detriment to the country’s national debts.”

Japanese doctors would also benefit from more switches, he said, even if it meant a slightly lower income, as they were “generally over-worked” and would be better off if patients with self-treatable conditions turned to OTC drugs instead.

Improving the health literacy of Japanese consumers and encouraging them to self-care would be a good way to improve the country’s switch climate, Tominaga suggested.

While JSMI could take the lead in advocating initiatives promoting self-care and health literacy, Tominaga pointed out that such a change would need to take place within a wider, nationwide context.

“When Japan in general becomes more health conscious, the significance of switching in self-care will be correctly perceived and this awareness will be automatically reflected in the EC’s decisions,” he argued.

As a more concrete measure, Tominaga proposed that OTC firms looking to switch their products in Japan should include in their switch applications a guideline explaining how the drugs should be used by consumers and what advice should be given by pharmacists.

“This would define more precisely the usage of the drug and what patients should use the drug,” Tominaga said, “which would lead to a better risk-benefit balancing on the part of the EC.”