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With the entry into force of a number of new legal norms, noticeable innovations are appearing in the activities of Russian pharmacies. They concern a variety of aspects of the work of pharmacists. Let's study them.
What's new in legislation?
From March 1, 2017, Russian pharmacies must operate in accordance with the “Rules of Good Pharmacy Practice” (approved by Order of the Russian Ministry of Health No. 647n, adopted on August 31, 2016). This source of law regulates, in particular:
- requirements for premises for the sale of medicines;
- criteria for selecting drug suppliers;
- checks of pharmacy employees;
- customer service.
For example, with regard to the selection of suppliers, it should be carried out taking into account business reputation economic entity, as well as the quality of goods. This regulatory measure is aimed at improving the assortment of pharmacies, especially in terms of goods in which delays are unacceptable.
The next innovation is the application of stricter regulations establishing sanctions for the sale of drugs without a prescription. In accordance with them, pharmacies can be inspected more often, they can be fined large sums (up to 200 thousand rubles) and even have their activities suspended for 3 months. Similar sanctions are established for violating the rules for storing medicines.
It may also be noted that pharmacists cannot display drugs that are prescription drugs in public display windows. The buyer should not take these drugs without the knowledge of the pharmacy employee.
Previously existing regulations were significantly softer, which allowed many pharmacists to ignore the ban on selling drugs without a prescription. For example, it was possible to easily purchase an antibiotic, a medicine to normalize blood pressure, or cough syrup, although formally they should have been dispensed without a prescription. It was requested mainly when selling custom-made drugs, drugs with strict dosage rules, psychotropic and drug-containing drugs.
It is worth noting that among experts there are discussions regarding the interpretation of the rules establishing sanctions for the sale of drugs by pharmacies without prescriptions. The fact is that at the level of federal legal acts this sale was prohibited even before the innovations under consideration. In fact, information about strict restrictions began to spread among pharmacists in the form of rumors.
Representatives of the leading media, who checked the work of pharmacies in practice, were convinced that most of them comply with current standards and refuse to sell drugs without a prescription - however, it has not yet been possible to find out any official details regarding why the sales policy of pharmacies has changed. According to some pharmacists, this is due to the increased frequency of inspection of organizations selling medications. Experts suggest that changes in the policy for selling drugs without prescriptions may be associated with the publication by Roszdravnadzor of internal regulations on tightening control over the activities of pharmacies.
Information about cheap analogues and advice
According to the new rules, the pharmacist must inform the consumer that cheaper analogues of the requested medicine are available for sale. For example, if a person comes for a rather expensive No-Spa, then he should also be offered drotaverine, an analogue that costs several times less. For violating this norm, the pharmacist can be fined 10 thousand rubles, the pharmacy itself - 30 thousand rubles.
Pharmacists also have an obligation to provide advice to consumers. At the same time, it can be carried out in places where the specialist can be asked rather personal questions about taking medications without other visitors hearing the conversation.
At the buyer's request, pharmacists are required to show all available documents for the drug - for example, a certificate, declaration or certificates. The consumer can also request documents certifying the authenticity of the drug.
- If possible, always obtain a prescription for a particular medicine from your doctor. In some cases, a prescription may be issued for a fairly long period of time—for example, a year. It is also recommended to assist relatives in obtaining prescriptions in advance.
- It is advisable to buy medications from the same pharmacies. Pharmacists who know the buyer by sight will sometimes not ask him for a prescription if he does not happen to have one with him.
- If you cannot get around the formalities, then you need to ask pharmacists for over-the-counter analogues of drugs.
- You should regularly check your home medicine cabinet for prescription medications. If you run out of certain important medications, you must fill out a prescription for them in advance.
- You must always be prepared to contact a paid doctor for a prescription - if it is urgent. To do this, it is useful to study the market of the relevant medical services in the city to know which paid clinics operate close to home, as well as which of them provide inexpensive services.
Pharmacy retail: foreign experience
Thus, the legal norms of the Russian Federation regarding the regulation of drug circulation are becoming more and more strict. But what about this in other countries?
In general, the policy of the Russian legislator corresponds to global trends. Moreover, in some states the rules may be even stricter: for example, in the USA, a pharmacist has no right to give advice on medications; only a doctor is required to do this. In America, it is not customary to buy medications without a prescription.
In European countries there are rules according to which the owner of a pharmacy can only be a person with pharmaceutical education. In addition, in some states, authorities may strictly control the number of pharmacies in the country. The qualification requirements for pharmacists can also be very high.
Regulatory and technical documentation.
Availability of information on the stand in the sales area
Copy of license for pharmaceutical activities
Federal Law "On Protection of Consumer Rights"
Extract from trading rules
Information about population groups eligible for priority services
Book of reviews and suggestions
Information about the work of the duty administrator
Information about telephone numbers of higher-level organizations
Information about telephones and operating modes of a single help desk
Information about office hours for pharmacy managers
Constituent documents and treaties
2.1 Charter of the enterprise
2.3 Certificate of state registration enterprises.
2.4 Certificate of registration with the tax authority.
2.5 Certificate of assignment of OGRN.
2.6 Protocol on the appointment of the General Director.
2.4 License for pharmaceutical activities.
2.5 Lease, sublease agreement (additional agreement)
2.6 Agreement for the removal of mercury-containing waste.
2.7 Agreement for deratization and disinfestation.
2.8 Sanitary and epidemiological conclusion.
2.9 Agreement for waste removal (operational services)
2.10 Agreement for installation and maintenance of fire and security alarms.
2.11 Conclusion of the state fire inspection.
2.12 Agreement with the organization carrying out the planned medical checkup employees.
2.13 Agreement for measuring electrical wiring resistance.
2.14 Cash registers.
A copy of the service agreement for the current year.
A copy of the version passport for each cash register
A copy of the registration card for each cash register
Call log technical specialists KKM
Registers of cashiers-operators for each cash register
Log books accepted and issued by the cashier Money for each cash register
Availability of a halogram for each cash register
Availability of stamps for the current quarter for each cash register
Return certificates
Cashier-operator certificates
2.15 Cash book.
Pharmaceutical order.
3.1 Audit trail.
3.2 Book of reviews and suggestions
3.3 Goods delivery log
3.4 Defect log
3.5 Journal on the problem with suppliers. (quarantine, shortage, defects, surplus)
3.6 Journal of pharmaceutical clubs
3.7 Log of incorrectly written prescriptions.
3.8 Logbook of medications for medical care.
3.9 Journal of individual orders.
3.10 Logs of temperature parameters in refrigerators
3.11 Temperature and humidity logs.
3.12 Folder with information letters on rejected and falsified medicines.
3.13 Availability of a first aid kit, its completeness in accordance with the requirements
Sanitary regime.
4.1 Contract for the supply of disinfectants. facilities.
4.2 Vendor License. (not required)
4.3 Certificate of state registration of dez. facilities.
4.5 Copies of receipt documents for des. means
4.6 Certificate of conformity for des. means
4.7 Plan of sanitary and epidemiological measures and production control program.
4.8 Journal of receipt and expenditure of disinfectants
4.9 Personal hygiene rules for employees.
Labor protection and fire safety.
5.1 A copy of the order of the person responsible for fire safety and labor protection.
5.2 Copies of certification certificates for the person responsible for labor protection and fire safety.
5.3 Log initial briefing at work.
5.4 Journal of initial fire safety briefing at the workplace.
5.5 Safety knowledge test log with electrical safety group I
5.6 Instructions for labor protection of workers.
5.7 Evacuation plan.
Organization of employee work
6.1 Regulations on the pharmacy organization
6.2 Internal rules labor regulations
6.3 Job descriptions of employees.
6.4 Order on the person responsible for the quality of goods in the pharmacy.
6.5 Order approving the method of storing medication. funds in the pharmacy
6.6 Order to appoint a person responsible for accounting for drugs with a limited shelf life.
6.7 Documents for employees. For each in a separate file.
Employment contract(personal signature)
Agreement about financial liability(personal signature)
Job description(personal signature)
Order of appointment to a position
Copies of diploma, marriage certificate (if necessary)
Certificate original and copy
Medical book (original)
Internal documents on organizing the work of pharmacies
7.1 Instructions for the manager.
7.2 Instructions for working as a cashier/operator.
7.3 Standards of quality service.
7.4 Merchandising requirements.
7.5 Requirements for appearance employees.
7.6 Internal regulations and orders.
7.7 Order of the pharmacy manager regarding the distribution of responsibilities among employees.
Lecture No. 22
Topic 2.2. Retail trade of medicines.
3. Merchandising is an element of product promotion. Concept of place: location of the pharmacy organization, name of the pharmacy. Planning of retail space. Placing goods on display windows. Recommendations for displaying goods. Information trading floor for buyers.
Merchandising is a series of methods for placing goods and advertising materials at points of sale for speedy implementation and increasing overall sales volume.
Rules for the arrangement of pharmacy products: products are arranged in groups:
Medicines;
Sanitary hygiene and patient care items;
Dressings;
Perfumery and cosmetics, etc.
Products of the “medicines” group are arranged according to pharmacological groups:
By characteristics of drugs (analgesics to analgesics)
By brands(all drugs from one manufacturer are collected in one place)
The following types of showcases are distinguished:
Warehouse showcase or catalog showcase, when there is little space and a lot of goods, the impression is that the showcases are overloaded with goods;
Air display - with a small amount of goods; this type of display is better perceived;
Thematic showcase - on a specific topic, for example, “Anti-flu drugs”;
Prestigious showcase, for example, “Natur Product”.
Principles of window display design:
The principle of asymmetric balance (creates the impression of dynamism, movement of goods);
Place the product at eye height (120-160 cm from the floor);
Hot products alternate with slow-moving ones.
In product placement, you can offer the following compositions: linear, rosette, radial, arched, pyramidal, etc.
Design of price tags: sales rules various groups goods are approved by Decree of the Government of the Russian Federation No. 55 of January 19, 1998. Price tags must have a uniform design; they indicate:
Name of the drug;
Price per weight or unit;
Signature of the financially responsible person or seal of the organization;
Date of registration of the price tag (from the invoice).
New articles for the leader and chief captain from the eighth issue of the magazine "New Pharmacy". The main topic of the issue was the material “Phenazepam, Grandaxin and other non-PKU psychoactive drugs. Instructions for dispensing.”
The main thing in the room
Pharmacies often refuse to stock psychotropic drugs to avoid additional problems. But psychotropic medications are registered in Russia, which do not require not only PCU, but also a prescription. I offer instructions on the circulation of such drugs. Share it with your employees.
Salespeople, consultants and managers do not notice that they use provocative words in their speech. They don’t notice because often neutral words become aggressors.
I propose that lists of such provocateurs should be placed within the visibility range of the primary commanders, so that they do not forget about hidden enemies. Over time, the habit of constructing phrases differently will become firmly rooted in the mind and will allow you to avoid mistakes in communication.
Federal and regional media periodically report that the first capital leaders sometimes show miracles of heroism. But it is better to take preventive measures than to risk your health and life.
A buyer came to the pharmacy to buy an over-the-counter drug. The pharmacist silently sold the medicine. As a result of taking the medicine, the consumer developed a stomach ulcer. In this situation, the pharmacy worker is under attack
The state canceled a number of fines and introduced new ones, and changed the amount of sanctions for certain fire safety violations. New fire inspection rules legalized the institute independent assessment fire risk and expanded the circle of fire safety inspectors
Part 1
Pharmaceutical order
Pharmacy supervisors are always uninvited guests, and it’s good if you can prepare for their arrival. The author of the article talks about when auditors will warn about an inspection in advance and in what cases they may suddenly appear.
The state is consistently tightening the requirements for prescription drugs. Therefore, we suggest checking whether you are ready to conduct a pharmaceutical examination of prescription forms for medical products. Will help you practical recommendations authors and samples of prescription forms of three forms.
Purchasing and sales
From January 1, 2017, the government transferred state and municipal pharmacies to government procurement according to Federal law No. 44-FZ. The innovation caused a protest from unitary pharmacy enterprises. But did the amnesty take place? The author offers his version of the answer to the question.
Governance and Economics
Only a competent leader will improve the work of his subordinates and achieve financial results. But what are competencies and which of them are important for a manager, says the author of the article.
In 2017, more than 5 million packages of medicines worth 940.7 billion rubles in retail prices were sold through the pharmacy chain, which is 6.5% higher in value terms and 3.5% higher in physical terms compared to 2016. This data is provided by the analytical company DSM Group.
Positive dynamics in physical terms indicate an improvement in the purchasing power of the population and a decrease in the influence of financial and economic factors on pharmaceutical market, analysts say.
In their opinion, the growth of the pharmacy market in 2017 was also influenced by the price factor. This is largely due to a change in the sales structure in favor of more expensive medicines. “In 2017, consumers continued to switch to more expensive medicines. The price segment “over 500 rubles” grew the most – by 12% in rubles and by 13% in packages. Due to this increase, the share of this segment increased by almost 2% in terms of money,” analysts note.
Nevertheless, drugs costing up to 50 rubles still remain popular among consumers - in 2017 they occupied about 40% of the market in volume terms. However, the share of such drugs is gradually decreasing, both in physical (by 0.7%) and in value (by 0.4%) terms.
Inflation in drug prices in 2017 turned out to be practically zero - at the end of December 2017, prices increased by only 0.3% compared to December 2016. Prices for vital and essential drugs (VED) increased by 0.06%. “A low increase in prices for drugs is observed in all subgroups: imported drugs increased in price by 0.6%, Russian drugs fell by 0.5%. On average, prescription drugs became 0.1% more expensive for consumers, while over-the-counter drugs increased by 0.4%,” the DSM report says.
It is worth noting that the Ministry of Industry and Trade has slightly different data on changes in prices for vital and essential drugs in 2017 - according to the ministry, prices did not increase and even decreased by 1.8%. Based on these data, the department concluded that in 2018, prices for vital and essential drugs remained the same.
As DSM analysts note, until 2017, the main increase in prices was observed for drugs in the cheap segment (up to 50 rubles), but in 2017 they fell in price by an average of 3.4%, while drugs belonging to the “expensive” segment (from 500 rubles and above) began to cost 0.2% more. The main “rise in price” affected the segment from 150 to 500 rubles – 1.2%.
At the end of 2017, the average cost of a package of a domestic drug at retail prices was 90 rubles, which is approximately 3.6 times lower than the cost of a package of an imported drug (about 321 rubles). The average cost of a package of the original drug was 646 rubles (+3.5% compared to 2016), the generic one was 141 rubles.
Analysts also note an increase in the share of domestic drugs both in value and in physical terms. “In 2017, the share of domestic drugs was 28.5% in value terms and 58.7% in physical terms. At the same time, we note that sales of domestic drugs in rubles increased by 7.4%, while sales of imported drugs increased by 6.1%. Due to this, the share of Russian drugs in the structure of pharmacy sales has increased, and the increase in the share occurs both in value and in physical terms,” the report says.
It also lists the TOP 20 brands that lead in sales volume on the Russian commercial market. Together they occupy 10.9% of the market.
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Change |
Value volume, billion rubles |
Increase in value volume |
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DETRALEX |
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CARDIOMAGNIL |
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ESSENTIALE |
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INGAVIRIN |
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ACTOVEGIN |
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MIRAMISTIN |
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MEXIDOL |
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PENTALGIN |
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XARELTO |
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VOLTAREN |
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ERGOFERON |
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CANEPHRON |
