Prescription, pharmacy supervised sale, and OTC drugs – legal regulation!

Drugs on the pharmaceutical market are divided into several categories. This division helps the patients to make the right choice; it minimizes the possibility of misuse and harmful consequences. In this article, we will talk about the regulation of different categories of drugs in some countries.

Types of drugs in the EU and the UK

According to the Council Directive 92/26/EEC, the appropriate authorized departments should compile a list of prescription drugs, revise them at least once every five years and make necessary changes. In the European Union countries, the concept of so-called “responsible self-treatment” develops. It becomes easier to transfer drugs to OTC if each particular member of the European Union is responsible for changing the status. Differences in the status of medicines in different countries of the European Union are still existing.

In the UK, medicines are divided into the following categories:

  • POM (prescription only medicine), such as Cialis and Viagra.
  • P (sale under pharmacy supervision).
  • GSL (general sales list, without restrictions), such as so-called “natural Viagra”.

Medications, which belongs to the “prescription only meds” category, as a rule, are accessible to the population, only if they are recommended or approved by the doctor.

In some countries, such as the United Kingdom and the Netherlands, Just in Case (JIC) drug administration system is being revised, and soon the legislation will allow nurses and other health workers, for example pharmacists, to prescribe drugs. In the UK, easing of drug supply restrictions is more pronounced than in many other European countries.

Prescription drugs and sales under the supervision of pharmacies

In the Netherlands and in the US, there are two categories of medicines: “only by prescription” and “in general sale”. In Australia and New Zealand there is an additional category of drugs called “sale under the supervision of pharmacies”, which can be sold only by the pharmacist. The OTC market includes the categories “sale under pharmacy supervision” and “in general sale”, as well as medicinal herbs and homeopathic remedies, which are now not subject to regulation rules for conventional medicines.

There may be huge differences between the categories “sale under pharmacy supervision” and “in general sale”. In the UK, France, and many other countries, the first category of drugs can be sold only under the pharmacist’s supervision, necessarily in a registered pharmacy, while the products of the second category can be sold both in pharmacies (pharmacist supervision is not required at that) and in any retail store. This is not the case throughout Europe. For example, in Italy there are the same three categories of medicines. Drugs that require supervision of the pharmacist or sold freely can be bought at the pharmacy. The difference is that drugs sold freely can be directly advertised to the public, and the pharmacist can put them out so that the consumer chooses them. A similar system exists in France and in many other European countries. In the Netherlands, there are only prescription medications and OTC drugs. In pharmacies, mainly the first category is sold. 75% of OTC drugs are sold in drug kiosks, which also sell toothpaste and body care products. In the UK, the supervision of the pharmacist is regulated very strictly. The pharmacist must be aware of all such sales and present while customer purchases medications.

The Royal Pharmaceutical Society of Great Britain is now reviewing the exact interpretation of these requirements. It is possible that supervision will be perceived as “the certainty that everything is properly observed.”

OTC drugs

Over-the-counter (OTC) drugs are medical remedies that meet the following characteristics:
1. They have proved efficiency and safety in use for preventing and alleviating the symptoms of the disease, as well as for the treatment of mild, compensated forms of diseases that do not require complex diagnostic and treatment methods.
2. They have a high safety degree. At the same time, conscious or unintended excess of the recommended dosage does not pose a serious danger to the life and health of the patient.
3. They have a wide range of doses, which allows you to choose the right dosage for patients with different ages and weights.
4. They do not cause dependence.
5. When used according to the instructions, they do not mask the symptoms of serious illnesses, nor do they prevent the diagnosis and the beginning of timely therapy of pathological conditions requiring medical intervention.
6. They have proven safety when used by all age groups of the population. ED drugs, for instance, don’t meet this criterion (therefore, over the counter Viagra isn’t available).
7. OTC medications can be used by patients at home. Special medical facilities are not required. You don’t have to follow special regime of administering and storage of such drugs.
8. Active components of these drugs were introduced to the market and became available for general consumption at least 5-10 years ago, and during this time the drug demonstrated a high degree of safety and effectiveness.