As medical science advances and experience with newer medicines evolves, mechanisms need to be in place to allow firms to apply for the reclassification or switch of ingredients (or indications) from prescription to nonprescription status if they are shown to be safe and effective for direct consumer use. This is typically referred to as prescription-to-nonprescription (Rx-to-OTC) switch.
Prescription-to-nonprescription switch has received a good deal of attention in many countries, particularly where switches have occurred for new classes of medicines or for new or expanded indications not previously available on a nonprescription basis. These switches have been based on solid evidence. Some examples include:
- H2 antagonists at the dose appropriate for heartburn to not only treat, but also prevent the condition.
- Nonprescription topical antivirals to treat cold sores.
- Many members of a class of antifungal ingredients, imidazoles, have been switched from prescription to nonprescription status for women to treat recurring vaginal yeast infections. Medicines for the condition were long thought to always require a doctor’s prescription, but the switch applicants’ presented studies to the regulatory authorities which first authorized the transfer demonstrating that, after initial diagnosis by a doctor,women in whom the condition recurred could diagnose it as accurately as their doctors.
The WSMI and the Association of the European Self-Medication Industry web sites – (see OTC ingredients directory section and www.aesgp.be) — include comparisons of approximately 200 ingredients as to their prescription or nonprescription (OTC) status in 27 countries. Where available as nonprescription medicines, many of these ingredients have been switched to that status over the past generation.Those countries that have led the world in switching prescription products to nonprescription status have been very thorough throughout the entire process, keeping consumer safety as the highest priority. While no product, medicine or otherwise, is completely safe, regulatory authorities in these countries have demanded appropriate evidence from applicants of a wide margin of safety, along with convincing evidence of effectiveness, before transferring the product to nonprescription status. The safety profile has typically been established and documented through years of experience and an extensive number of uses as a prescription medicine.
In a few instances, the introduction of a new nonprescription medicine does not come from the prescription-to-nonprescription switch route. Rather, the new product comes directly to market as a nonprescription medicine. This is particularly true for expanded indications, different strengths, or new dosage forms of an active ingredient. For example, some of the strengths or dosage forms of products to treat vaginal yeast infections were directly introduced as nonprescription products in the US. While the introduction of a product on nonprescription status without prescription experience is fairly rare, the larger point is that the data on safety and effectiveness should drive such a decision, not an arbitrary time-on-the-market limitation. Direct nonprescription status without prior prescription experience should not, therefore, be automatically prohibited.
With the extensive and data-driven nature of the prescription-to-nonprescription switch process in those countries that have led in this trend, WSMI encourages other authorities to consider these countries’ decisions and safe market experience as an element in favor of switching such suitable products to nonprescription status in their own countries. For example, in 1998 after extensive discussions with AFAMELA and others, the Mexican health authorities decided on the prescription-to-nonprescription switch of 31 ingredients. (AFAMELA is the WSMI member association in Mexico.) An international comparison of the prescription or nonprescription status of the ingredients was the main element in the recommendation.
One final aspect of prescription-to-nonprescription switch is the need to consider research incentives and the ability to protect confidential, company-generated data for those firms who conduct research to first launch a switch. Recognizing that regulatory environments differ, WSMI encourages systems that include an appropriate period of data protection in order to encourage innovation in new self-medication treatments.