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OTC status – what is it all about?

09.11.2021

In general, medicinal products can be bought on prescription or over the counter (OTC). Many products introduced on prescription in the past, now are freely available without it. If you have in the portfolio prescription medicines, maybe it is time to consider whether they could be reclassified. OTC switch could be a time-consuming procedure, not in all cases possible, but worth considering if the safety data about the substance is favorable and potential benefits convincing.

What are the benefits of over the counter status?

Every supply category of medicinal product has it`s pros and cons. The undeniable advantages of over‑the-counter status are:

  • broader and easier access for patients,
  • availability of medicinal product in case of sudden necessity,
  • time-saving for the patient as the visit to a physician could be omitted,
  • extension of drug’s life-cycle,
  • possibility of new forms of advertisement,
  • savings for healthcare systems.  

Requirements for changing classification for supply

If you consider OTC status for your medicinal product, at the beginning it has to be answered whether the drug does not fulfill criteria of classifying a medicinal product as subject to a medical prescription. These criteria are as follows:
 
  • direct danger/safety profile,
  • indirect danger/safety profile,
  • ability to self-assessment,
  • risk and consequences of incorrect use,
  • known incorrect use,
  • recent authorization/limited experience,
  • new strength, dose, route of administration, indication, new age group or combination of substances,
  • parenteral route of administration.

Theoretically, if any of these criteria raise doubts, the medicinal product has to be available only on prescription. However, these criteria are not black and white, otherwise no new OTC switches will be possible or even some of them should be revoked. In many cases, regardless of the fact that some criteria seem to be fulfilled, the profound analysis of the specific topic gives additional arguments, which together with persuasive measures to minimize risks make OTC switch possible. It should be remembered that the decision about supply category is in the competence of national registration agencies (except in case of products registered in centralized procedure), so the knowledge of their approach will be a big asset during the OTC switch.

Trends in OTC switch

The most common OTC therapeutic categories are:

There are a few recent changes in the product supply status that showed that there is still a big potential for OTC switches, even in the mentioned popular categories. The trends for OTC switches should be perceived not only globally, but also on national level, as some substances freely available without prescription in one country are dispensed only on prescription in another one.

A good example is azelastine nasal spray (an antihistamine for hay fever) recently switched to OTC in the United States (Astepro Allergy in July 2021), which is the first nasal spray with antihistamine in this country having OTC status, while in Europe these products have been available without prescription for a few years now.

Similarly, ketotifen (antihistamine in a form of eye drops) has OTC status, but only in selected European countries. It can be bought without prescription in Germany (since 2014), Poland (2018), Italy, Finland and Sweden, while in e.g France, Spain is only on prescription. As for allergy drugs in Poland, the OTC switch in 2019 of mometasone – the first nasal corticosteroid without prescription in this country – was a breakthrough for this kind of substances and recently another nasal corticosteroid (fluticasone) has been granted OTC status.

Some OTC switches have to wait for “appropriate moment”- in the past in Poland, it was quite tough to switch oral ketoprofen and vaginal clotrimazole (finally done in 2017 and 2019, respectively), besides the fact that in other European countries they had been available without prescription for a few years. Still disputable substances are triptans (an antimigraine agents) which supply status differs among European markets. Some of them have been sold OTC for more than 10 years now e.g. in Germany, Sweden and Bulgaria, while e.g. in Poland it is consistently a challenge to introduce these substances on the market without prescription.

On the other hand, Poland was one of the most liberal to switchan agent for erectile dysfunction – sildenafil to OTC in 2016. This was an impulse for further variations in Norway, the United Kingdom and Ireland. In 2020, EMA agreed for OTC switch of Fortacin (agent for premature ejaculation), indicating that products for sexual disorders are potential types for availability without prescription.

Maximizing chances for OTC switch

The successful OTC switch is the result of many small steps that should be made during the whole process. At the beginning, the analysis of the scientific background, situation on the market and in particular selection of countries should be done to consciously chose the substance, indications and target population for which the changing supply status is planned. Then the possible strategies should be considered. In the next step, the experienced team will be invaluable to prepare sound justification and participate in the discussion with the agency during the procedure in order to make it simpler and smoother. In all these steps SciencePharma could support your team, sharing its experience and thus increasing the chances for successful OTC switch. More information about  our sevices related to obtaining OTC status you can find here. We took part in dozen of successfully-ended first time supply classification switches in Poland as well as in several in other European countries. So if you are considering the OTC switch for one of your products, we are ready to assist in the whole process.

Do not hesistate contact us. Our experts will be happy to answer all your questions.

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You may also be interested in our previous article: Registration of medicinal products – how to choose the right type of application?


[1] Fortune Bussiness Insights. Over the counter (OTC) drugs market size, share&Covid-19 impact analysis, by product type (analgesics, cold & cough remedies, digestives&intestinal remedies, skin treatment, vitamins&minerals, and others), by distribution channel (drug stores&retail pharmacies, hospital pharmacies, and online pharmacies), and regional forecast, 2021-2028.

[2] Research and markets. Europe Over-the-Counter (OTC) Drugs Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026).