OTC drugs – what is it?

Below we have gathered the most important questions and answers related to the distribution, production, control and finally the division of OTC drugs. What are they, what is their share in the pharmaceutical market and what are the legal regulations?

OTC drugs – what does it mean?

An OTC drug (from the English Over-The-Counter Drug) in European legislation is a product dispensed without a prescription, i.e. not from a doctor’s prescription. Most often, drugs from this category are used for short-term treatment, e.g. in the form of interventional self-administration of drugs. For the patient’s safety, it is important that they are taken if not on the recommendation of a doctor, then at least after consultation with a pharmacist.

What is the difference between over-the-counter medicines and dietary supplements?

OTC drugs are often confused with dietary supplements, however, there is one most important distinction between these two categories of products. Over-the-counter medicines are still medicines, while dietary supplements are classified as food products, the purpose of which is to supplement nutritional deficiencies and maintain good body condition. Supplements cannot have medicinal properties, they are not subject to the same safety procedures as medicines (including those without a prescription), nor do they contain active substances with confirmed effects.

What medicinal products can be OTC drugs?

OTC drugs are medicinal products containing active substances that are considered safe, have a very low risk of causing strong side effects, and have been adequately tested. Contract manufacturing of medicines OTC is subject to exactly the same procedures and production restrictions as prescription drugs.

The turnover of OTC drugs is approximately 36% of the turnover of the pharmaceutical segment in Poland (data for 2020). What products can belong to the OTC drug group? What are these preparations? The most common examples of OTC drugs are:

• vitamins,
• minerals,
• painkillers and anti-inflammatory drugs,
• medicines for colds and flu symptoms.

Source of the graphic: https://pasmi.pl/wp-content/uploads/2021/04/iqvia-raport-rynku-otc-2020.pdf

Can I take OTC medicines without consulting a doctor?

The use of over-the-counter medicines without consulting a doctor is permissible in situations where it is necessary to use ad hoc treatment for the first symptoms of the disease or before visiting a specialist. It is recommended that OTC medicines be used for a maximum of 5 days – if there is no clear improvement by this time, medical advice is necessary.

What about over-the-counter dispensing? Where can I buy over-the-counter medicines?

There is a specific subgroup of OTC drugs. What are over-the-counter medicines approved for over-the-counter distribution? These are medicinal products that can be distributed in places such as:

• drugstores,
• grocery stores,
• herbal-medical stores,
• hypermarkets,
• petrol stations.

These products may contain specific active substances in a specific amount (everything is explained by the Regulation of the Minister of Health and the Over-the-counter dispensing tab on the website of the Ministry of Health).

What is the registration process for OTC drugs?

When a responsible entity wants to place a medicinal product in the OTC category on the market, it must apply for a permit to the relevant offices.

In Poland, the competent office for registering medicinal products is the URPL, i.e. the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. At the European level, the registering body is the EMA, the European Medicines Agency. These units accept the application for a marketing authorization and, based on the data contained therein (including those on the safety of the drug, the appropriate time limit for use, or the amount and type of active substances), may issue a marketing authorization for the medicinal product with OTC status, i.e. allowing for dispensing the drug without a doctor’s prescription.

There is also the possibility of changing the status of a drug that has been prescribed so far to an over-the-counter drug – the so-called OTC switch. Re-registration of a medicinal product is based on:

• scope of therapeutic indications,
• specific data confirming the safety of using the active substance contained in the preparation,
• patient’s ability to recognize the indication for using the drug,
• safety of using the drug even if the patient accidentally takes the wrong dose or does not follow the instructions,
• patient’s ability to diagnose the disease in which this drug is to be used.

Also find out contract manufacturing of medicines.