Rx-to-OTC switch

Berndt, Ernst R., Margaret K. Kyle, and Davina C. Ling. 2003. The Long Shadow of Patent Expiration Generic Entry and Rx to OTC Switches. Chapter 8 in Scanner Data and Price Indexes, NBER Series on the Conference on Research in Income and Wealth, vol. 61, ed. by Robert C. Feenstra and Matthew D. Shapiro, 229-267. Chicago University of Chicago Press for the National Bureau of Economic Research. 

McCarran, E. 1991. Rx to OTC Switches Promises and Pitfalls. Medical Marketing and Media 13-26. 

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]. 

The OTC industry is changing, sometimes imperceptibly, sometimes very visibly. This section will address five megatrends of Rx-to-OTC switches. 

Table 1 Number of Rx-to-OTC Switches Comparison between 1995 and 1998 in Major Markets...

Rx-to-OTC switches from manufacturers, consumers, and healthcare providers prospective. 

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. ... 

One major problem for the consumer brought about by the Rx-to-OTC switch process and the fact that manufacturers understand the draw of brand name... 

Gannon, K. Rx to OTC switches raise new call for third class. Drug Topics 1989, 133 (20), 48. 

Other issues that may concern Regulators are when a precedent is being set. It is possible that the precedent set by one particular Rx-to-OTC switch could be damaging in terms of their overall policy, even when they have relatively little concern about the switch itself this may be the reason for hesitancy shown in approving Plan B , a proposed OTC product for emergency contraception by the US FDA. Careful negotiation is called for. The corollary is that if your proposed Rx-to-OTC switch can be shown to follow some sort of precedent, then your road with the regulators will be smoother. 

There are two fundamentally different types of Rx-to-OTC switches from the standpoint of the scope of the research program required. Switch programs can vary from large NDA programs, as extensive and expensive as anything found in the... 

Food Drug Letter. 2002. Claritin approval marks significant shift in Rx-to-OTC Switches. Food Drug Lett. (FDANews.com, Issue No. 666). 

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... 

No matter what the future of Rx-to-OTC switch will be, one thing for sure is that future switches will be driven by science and an evidence-based medicine approach as in the past. Even though most of the OTC products are for acute use, there are already a few products such as hair growth products and smoking cessation product for chronic use. The desire of the baby boomers to maintain their vigor and the desire of healthcare providers to control cost favors preventive OTC products, which will continue to challenge the chronic use barrier. The switch of these kinds of products will be enhanced by the advance of diagnostic products (324). 

---