OTC Classification in Japan

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Drugs in Japan are classified into prescription, non-prescription (OTC), and quasi-drug. Prescription drugs are those drugs that require physician supervision (50-53). Non-prescrip-drugs are primarily for mild actions and are only available in the pharmacy or drug store. Deregulation reform reclassified 15 categories of non-prescription drugs to create a new class of drugs called quasi-drugs, which can be sold in convenience stores and supermarkets starting in Spring 1999 (51). Quasi-drugs are primarily used for external uses or preventive purposes. They include the popular tonic drinks, which are unique to the Japanese OTC market.

All three classes of drug are regulated under the Pharmaceutical Affairs Law administered by the Ministry of Health and Welfare. Prescription drugs and quasi-drugs are approved by Ministry of Health, Labor, and Welfare (MHLW) only, whereas non-prescription drugs are approved by both the MHLW and local prefectural governments. OTC drugs are approved by Evaluation Division III of Pharmaceuticals and Medical Devices Evaluation Center, which is under the MHLW. The country is administratively divided into 47 prefectural governments (52). Registration application submitted to MHLW is through the prefectural government.

Similar to European countries, all OTC products require regulatory approval (Shonin) and a license (Kyoka) to market the product The approval time is generally longer than in the United States. OTC drug application is categorized into six classes (50,52). The application system allows for both direct OTC approval and Rx-to-OTC switch. Minoxidil was switched directly to OTC status without being a prescription product first. To expedite and simplify OTC drug registration, the MHLW transferred its approval authority to prefectural governments (52).Specific monographs were established for each of theseVat-egories.

Rx-to-OTC switch in Japan has for a long time followed the principle-safety first and efficacy second (53). For this reason, a lower dose is often switched. Label comprehension is not a big issue for Japanese OTC products because OTC products are sold primarily in the pharmacy and a lot of graphics and cartoons are used to communicate warnings and directions of use. Rx-to-OTC switches are usually of low profile in Japan. The reason is that physicians seldom support and advocate the switch. Because physicians both prescribe and dispense prescription drugs, the switch will decrease their business. There are a couple of other reasons for poor performance of some of the Rx-to-OTC switches. Consumers view OTC products as less effective because of lower dose and less safe because of warnings listed on the label and in advertising. Moreover, co-pay for prescription drugs used to be

Table 9.4 A Few Definitions of Lifestyle Drugs

Source

Definition

Herald Tribune (56)

Harth and Linse (66) Business Week (54)

"Drugs that are used to treat either non-health problems that are lifestyle wishes and not medical necessities of health problems that might be better treated by a change of lifestyle"

"Drugs that don't necessarily cure illness but can be used to improve daily life by boosting psychological attitudes, energy levels, sexual performance and body image."

"Pharmaceuticals which are taken in order to attain a certain psychosocial beauty ideal rather than serve to stabilize the body's vital functions."

"Drugs that are taken not for severely impaired diseases but for improving quality of life."

less than that of OTC products. Furthermore, no comparative advertising is allowed for OTC products with approved standard monographs. However, Rx-to-OTC switch will become more important in the future because the government is trying to control healthcare costs by increasing the co-pay.

4 LIFESTYLE DRUGS

Lifestyle drugs received much publicity (5456) since the launch of the little blue pill, Viagra. The publicity is fueled partly by the hype cf the media and partly by the debates about who is going to pay and what are their therapeutic benefits to the consumers (57-61). The scientific field is equally interested in this class of drugs, as reflected by a dedicated Scrip report (62), an article in the British Medical Journal (63), and a special series of articles in the International Journal ofClinical Pharmacology (64-68).

Several factors, such as advances in technologies, growing consumerism, and demand of baby-boomer consumers to look and feel young, contribute to the popularity of lifestyle drugs. Consumers want not only the absence of disease but also improvement of quality of life. Longer lifespans also give rise to a variety of cosmetic and performance conditions that demand remedies.

Several terms, such as vanity drugs, life-enhancing drugs, and quality-of-life drugs, are used by the media to describe lifestyle drugs (69,70). These are the terms pharmaceutical companies try to dissociate themselves from because they tend to project a rather negative tone and create an image that lifestyle drugs are to cater to desires rather than to treat real medical problems. So exactly what are lifestyle drugs? There are numerous definitions of lifestyle drugs, depending on whom you talk to. Table 9.4 lists a few definitions of lifestyle drugs. The definitions range from attainment of psychosocial beauty to treatment of health problems that might be better treated by a change of lifestyle.

The term "lifestyle drugs" refers to pharmaceuticals, in particular prescription drugs, that primarily aim to enhance the wellness and improve the "desired" quality of life of an individual rather than alleviating or curing life-threatening diseases. Although all medications are used to improve the quality of life, use of lifestyle drugs by consumers are intended to attain a certain ideal quality of life rather than to treat some life-threatening disease. The definition for lifestyle drugs may be broadened to include drugs for the use of treating serious medical conditions caused by unhealthy lifestyles such as over-eating or for off-label use, such as the use of Prozac, for more self-confidence.

The focus of lifestyle drugs usually centers around prescription drugs because of the issue of who should pay for these medications and their off-label use. The term lifestyle drugs should not be limited to prescription drugs only because some of them have already been switched to OTC. Table 9.5 lists a few examples of lifestyle drugs and their indications. These examples cover a broad range of drug products. The range of indications is equally broad; they range from preventive and cosmetic to serious medical conditions such as obesity and smoking.

Source

Herald Tribune (56)

Harth and Linse (66) Business Week (54)

Table 9.5 Examples of Lifestyle Drugs

Indications

Drug

Image and look Wrinkles Hair loss

Facial hair removal Nail fungus

Increase muscle mass or height Quality of life improvement Incontinence Impotence Influenza Lifestyle Postpone menstruation Smoking cessation Contraception Weight control Dyspepsia Sun protection Psychological Anti-depression Obsessive-compulsive disorder Social anxiety disorder

Tretinoin, vitamin A, botulium toxin type A, sunscreen

Minoxidil hasteride

Elornithine

Butenafine, terbinafine, itraconazole Growth hormone

Oxybutynin, tolterodine Sildefil, apomorphine Zanamivir

Norethisterone

Nicotine replacement therapy, bupropion Oral contraceptives sibutramine, bupropion Proton pump inhibitor Sunscreens

Fluoxetine

Sertraline

Paroxetine

Because the majority of lifestyle drugs are not used to treat life-threatening diseases or to alleviate pain, and the cost of coverage is huge, the majority of debate has been focused on who is going to pay (57, 61). Most countries have a national healthcare insurance system that needs to control rising healthcare costs. Coverage for lifestyle drugs puts considerable strain on the limited resources of the insurance system. The agency will therefore need to rationalize the service and treatments. They need to set priorities and determine which treatments are medically useful and which treatments are for lifestyle enhancement and convenience only. The issue of what is medically needed is complicated by the heavy promotion of lifestyle drugs by the pharmaceutical industries and transition of treatment from specialists to general practitioners. Without a doubt, the following scenario will occur. Pharmaceutical industries will continue to push the envelop of medical innovations and find ways to meet unmet consumer lifestyle needs to increase their profitability. The healthcare provider and national health insurance system will continue to find ways to control the cost of healthcare. The solution may be partially solved by switching the safer lifestyle drugs to OTC because consumers are willing to pay to obtain the benefit, and the fact that they are already paying for many of these lifestyle drugs.

The other controversy is what benefits do lifestyle drugs offer the consumers because they are primarily treating non-life-threatening diseases. Diseases such as incontinence and impotency are not life-threatening, but they create undue psychological stress on the suffers. Furthermore, even for lifestyle drugs that have legitimate therapeutic uses, they can still be abused by healthy individuals for purely performance enhancement. For lifestyle drugs that are used to treat diseases arisen from unhealthy lifestyles, drug coverage is only a partial and least-preferred solution. The best solution is for patients to take control of their health by living a healthy lifestyle. All these controversies will continue to fuel the debate for coverage and benefits of lifestyle drugs.

The following sections provide four examples of lifestyle drugs: hair growth compounds for appearance enhancement, sexual disorder compounds for performance remedy, smoking

Table 9.6 Approved Treatments for Hair Growth Disorders

Current

Brand

Dosage

Regulatory

Generic Name

Name

Originator

Indication

Form

Daily Dose

Status

Minoxidil (1)

Rogaine

Upjohn

Androgenetic alopecia (men and women)"

2%, 5% solutions

Topical application twice daily

OTC

Finasteride (2)

Propecia

Merck

Androgenetic alopecia (men only)

1 mg tablet

1 tabletlday

Prescription

Eflornithine

Vaniqa

BMS

Hirsutism

13.9% cream

Topical

Prescription

hydrochloride

(women's

application

(3)

facial hair)

twice daily

cessation compounds for lifestyle change, and sunscreens for lifestyle purposes. They span the spectrum of OTC and prescription products.

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  • Sini
    How are OTC drugs regulated in Japan?
    1 year ago

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