Prescription-to-OTC switch

The principal OTC pharmaceutical products include cold remedies, vitamins and mineral preparations, antacids, analgesics, topical antibiotics, antiftingals and antiseptics, and laxatives. Others include suntan products, ophthalmic solutions, hemorrhoidal products, sleep aids, and dermatological products for treatment of acne, dandmff, insect parasites, bums, dry skin, warts, and foot care products (11). More recent prescription-to-OTC switches have included hydrocortisone, antihistamine and decongestant products, antiftingal agents, and, as of 1995, several histamine H2-receptor antagonists. 

There is no official OTC status for drugs in India. However, there is a classification of drugs termed as home remedies under Schedule K, such as paracetamol, aspirin, cough and cold preparations, rubs, liniments and the like, which can be stocked and marketed as per said provisions under Schedule K and rules thereof. As there is no official OTC status, drugs (other than those in Schedule K) cannot be advertised in the lay media. Guidelines are under preparation for establishing OTC drugs as well as prescription to OTC switch policy. 

Table 63-1 Selected Agents Switched from Prescription to OTC Status by the Food and Drug Administration. ...

To provide a context for our discussion of Rx-to-OTC switches, we will describe briefly the classifications of drugs that must be limited to prescription use. Specifically, the following types of drugs must be sold for prescription use only (1) drugs not safe for use except under the supervision of a licensed practitioner because of toxicity or other potential for harmful effect, method of use, or the collateral measures necessary for use and (2) drugs limited to prescription under an approved NDA [87]. FDA may remove by regulation a drug subject to the premarket approval requirements from prescription status when such requirements are not necessary for the public health [88]. 

Patients also benefit tremendously from the Rx-to-OTC switches. When a product that was formerly in prescription only status is classified as OTC, it allows patients to self-treat and gain more control over their health.This is especially true in cases where medical advice was once required, e.g., smoking cessation. The patient can now save time and money that was previously spent on visiting a physician. It has been shown that patients saved approximately 150 million a year since hydrocortisone P/o was switched to OTC status. ... 

The non-prescription product landscape is further complicated by the different modes of distribution from country to country (49). There are two major distribution channels for non-prescription products in Europe namely, pharmacy only and general sale outlets, unlike the United States, where OTC products are for general sale only. For pharmacy-only products, some will need to be dispensed by the pharmacist. Rx-to-OTC switch products are usually placed in this category. The purpose of pharmacy-only products is to provide professional consultation to consumers. However, a... 

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 cf 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... 

Pharmaceutical companies and government used to the two major drivers for Rx-to-OTC switches and they will continue to be the maior drivers for the switches. The former conducts switches for lifestyle management of prescription drugs while the latter promotes switches to reduce national prescription costs. In future, manage care providers will also be a major driver to petition for switches as in the case of second-generation antihistamines. 

Because the monograph panels are no longer convened, however, many current products are switched from prescription to OTC status. A company that wishes to make this switch and offer an OTC product to the U.S. marketplace can submit an amendment to a monograph to the U.S. FDA, which will act as the sole reviewer. The company also may file an SNDA provided that they have 3 years of marketing experience as a prescription product, can demonstrate a relatively high use during... 

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