Prescription drug law. Topic: OTC dispensing in pharmacies

Most of the profits of many pharmacies come from sales medicines dispensed without a prescription. According to statistics, almost every pharmaceutical company receives about 40-50% of its income from the sale of drugs that are not subject to strict accounting.

It should be noted that legally (in the Russian Federation, as well as in many other countries) is allowed. However, this applies only to a fairly small range of drugs. But, at the same time, many pharmaceutical companies also sell accountable medicines, without requiring the submission of an appropriate confirmation from the client. For some reason, this practice is considered normal. However, if you are only planning to open an appropriate business, you should be aware that this is prohibited by law, and there may be liability for this.

Assortment of medicines

As mentioned above, it is possible over-the-counter pharmacy, and a list of relevant medications clearly regulated. It is believed that only those drugs whose toxicity is extremely low can be sold without a prescription. At the same time, the fact of their “harmlessness” must be proved not only in laboratory, but also in clinical conditions. Thus, a drug can be classified as an over-the-counter drug only if a sufficient amount of experience in its use has been accumulated, as a result of which the safety of the drug has been proven.

In Russia, the list medicines dispensed from pharmacies without a prescription is strictly regulated. The list of relevant products is publicly available and can, for example, be easily downloaded from the Internet. It should also be noted here that the relevant information should be obtained only from official sources. For example, the document in question can be downloaded from the website of the Ministry of Health of the Russian Federation.

For homeopathic remedies also possible over-the-counter pharmacy. It is legally allowed to sell the corresponding drugs without the client presenting the proper document confirming the fact that he needs the required drug.

And most importantly, the list of medicines that can be dispensed in a pharmacy without a prescription is constantly changing. In this regard, it is strongly recommended to follow the changes in the rules for the implementation of the relevant group of pharmaceutical products. This will allow you to avoid various troubles with regulatory authorities.

Sales organization

The most rational solution for a pharmacy that plans or is already engaged in the sale of over-the-counter medicines is to organize a separate space designed specifically for the sale of the drugs in question. In addition, it is recommended to completely create a separate unit that will deal with just such means.

In particular, it is necessary to separately work out the issue of choosing suppliers of products and ensuring control over their acceptance. It is also required to properly organize the storage of drugs, separately from those that are dispensed by prescription. In this case, the risk that the pharmacist will accidentally sell prescription drug without proper confirmation from the client.

Pricing for this type of product should also occur separately. The fact is that people who buy over-the-counter drugs often do not see a doctor before going to the pharmacy. Consequently, they have a slightly different psychology of consuming pharmaceutical products. This should be taken into account.

Can't organize properly over-the-counter pharmacy without a specialist who is well versed in the issue under consideration. The implementation of the relevant drugs has its own characteristics, which requires the employees who will deal with it to have the appropriate knowledge. In this regard, it is necessary either to hire a new employee who has the necessary skills, or to send someone who already works in your company to receive the appropriate qualifications.

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The ever-increasing concern of people about their health contributes to an increase in the population's demand for BRO drugs. The volume of this sector of the pharmaceutical industry in last years reached 80 billion dollars, accounts for approximately 14% of the global market and tends to grow by approximately 4-5% annually.

In Russia, the volume of sales of BRO drugs also tends to grow and accounts for approximately 60% of the total pharmaceutical market. So high rate there is more ARO segment than in other countries, but it is typical for Russia (according to researchers, the proportion of people who apply for ORT medicines is above 50%).

Dispensing of medicines BPO is a form of drug service for the population, characterized by the fact that the decision to choose a specific medicine, the need to purchase and use it is made by the consumer (patient).

Non-prescription drugs are drugs whose composition and effect, when used in therapeutic doses indicated on the package and in the instructions for use, accessible to understanding and observed by the patient, usually do not cause a risk of complications and / or side effects._

BPO drugs are designed to provide self-help, self-prevention, health maintenance and a healthy lifestyle. Their acquisition depends on the impact on the consumer various factors, in particular, own experience usage, opinions of families and advice from friends, advice from doctors and pharmacists, advertising campaigns of ARV drug manufacturers.

LS BRO must satisfy the following criteria(WHO requirements):

1) the active substance must be of low toxicity to the body;

2) the active substance must be intended specifically for the purposes of self-help and self-prophylaxis; in advanced conditions requiring medical advice, it is not used;

3) at active substance there should be no side effects, there should be no risk of dependence or abuse; it should not interact with other common drugs or food.

The regulation of the release of BRO drugs in Russia is carried out in accordance with the following normative documents.

1) the federal law No. 86-FZ dated 06/22/1998 "On medicines":

BPO drugs can be sold in pharmacies, drugstores, drugstores and drugstores;

The list of BRO drugs is reviewed and approved once every 5 years, additions to the list are published annually;

Information about BRO drugs may be contained in publications and announcements of the mass media, specialized and general printed publications, instructions for the use of drugs, other publications of subjects of drug circulation;

In the media, advertising of drugs sold only without a doctor's prescription is allowed.

2) Order of the Ministry of Health of the Russian Federation No. 578 dated September 13, 2005 “On approval of the list of drugs sold without a doctor’s prescription”.

In recent years, developed foreign countries the process of transferring well-known prescription drugs to the ARO category has significantly intensified, in particular, drugs have appeared on the market to lower cholesterol levels, to treat asthma, arthritis, overweight, control blood pressure and etc.

The desire of well-known pharmaceutical companies to conduct research in this direction is due, on the one hand, to

economic reasons, in particular, the increase in prices for medicines and the deficit of budget financing, which does not allow to fully compensate for the cost of medicines dispensed to the population; on the other hand, the fact of increasing the medical literacy of the population is becoming well known, which predetermines the ability to cope with minor ailments on their own.

The largest manufacturers of BRO drugs in the world are the following companies: Johnson & Johnson (USA), American Home Products (USA), SmithKline Beecham (UK), Warner Lambert (USA) and Bayer (Germany).

The main questions of the topic:

1. OTC sale of medicines and goods pharmacy assortment.

2. Reasons for the growth in sales of OTC funds.

3. Organization of a department for OTC medicines and pharmacy products (equipment, assortment, management of the department).

4. Communication of a pharmacist - a consultant with pharmacy visitors - a general algorithm.

5. The procedure for questioning a visitor to a pharmacy by a pharmacist of the 1st table.

6. Stages of work of a pharmacist when communicating with customers, their features.

Dispensing of medicines prescribed by a doctor is a form of drug service for the population, characterized by the fact that the patient (consumer) makes the decision on the choice of a particular drug, the need to purchase and use it.

Non-prescription drugs are drugs whose composition and action, when used in therapeutic doses indicated on the package and in the instructions for use, do not cause side effects.

Medicines without a doctor's prescription are intended for citizens to self-help, maintain health, maintain a healthy lifestyle (eliminate the habit of smoking).

Dispensing medicines without a doctor's prescription is integral part retail sales pharmacies. For example, in a pharmacy specific gravity sales of medicines without a doctor's prescription and other pharmacy products range up to 60% of the pharmacy's total revenue.

The increase in sales of over-the-counter medicines or OTC drugs occurs because:

1. Increased availability of OTC drugs;

2. The awareness of the population is growing;

3. The responsibility of people for their own health and the health of family members is increasing;

4. People tend to healthy lifestyle life.

BRO LS system is an integral part of the regulated and managed system of self-help and self-prevention being created in Russia.

The sale of medicines and other pharmaceutical assortment products allowed for dispensing from pharmaceutical organizations without a doctor's prescription can be carried out by: pharmacies, pharmacy points of category I, II, pharmacy kiosks. Moreover, only non-prescription drugs and some types of parapharmaceutical products are released from pharmacy kiosks.

For the sale of OTC drugs a special department can be organized in a pharmacy - OTC (only in pharmacies of category I, and in the rest it is combined with OGLS) in the function, which includes:

1. Selection of suppliers of goods, systematic control and replenishment of inventories;

2. Organization of storage of goods in the department;

3. Pricing;

4. Effective sale of goods to the population;

5. Teaching consumers how to take drugs and use medical devices, store goods at home.

OTC Department is located on the territory trading floor. Department equipment: showcases, cabinets, cabinets with turntables, shelves for storing medicines, tables, chairs, storage boxes, a cash register, a calculator, a computer, a refrigerator for storing thermolabile drugs, reference literature, documentation for incoming goods and materials.

The department is headed by the head (pharmacist or senior pharmacist), who may have deputies (pharmacists), pharmacists work in the department.

The range of the department is:

1. Drugs allowed for dispensing without a doctor's prescription, the list is approved by the Ministry of Health of the Russian Federation (the Order of the Ministry of Health of the Russian Federation No. 578 dated September 13, 2005 "On the list of drugs sold without a doctor's prescription" is currently in force;

2. Other goods permitted to be dispensed from pharmaceutical organizations, the range of which is determined by the Order of the Ministry of Health of the Russian Federation No. 349 dated December 2, 1997 “On the list of goods sold through pharmaceutical (pharmacy) organizations”.