Magazines in the pharmacy. List of documents that must be in the pharmacy

Lending 12.06.2020

Noticeable innovations appear in the activities of Russian pharmacies with the entry into force of a number of new legal norms. They cover a wide variety of aspects of the work of pharmacists. Let's study them.

What's new in the legislation?

From March 1, 2017, Russian pharmacies must operate in accordance with the Rules of Good Pharmacy Practice (approved by Order of the Ministry of Health of Russia No. 647n, adopted on August 31, 2016). This source of law regulates, in particular:

  • requirements for premises for the sale of medicines;
  • selection criteria for drug suppliers;
  • checks of pharmacy employees;
  • customer service.

For example, with regard to the choice of suppliers - it should be carried out taking into account the business reputation of the business entity, as well as the quality of the goods. This regulatory measure is aimed at improving the range of pharmacies, especially in terms of goods in which delays are unacceptable.

The next innovation is the application of stricter regulations that establish sanctions for the sale of drugs without a prescription. According to them, pharmacies can be checked more often, they can be fined for large sums (up to 200 thousand rubles) and even suspend their activities for 3 months. Similar sanctions are established for violation of the rules for storing medicines.

It can also be noted that drugs that are prescription drugs cannot be displayed by pharmacists on display cases. The buyer should not take these drugs without the knowledge of the pharmacy employee.

Previous regulations were significantly softer, which allowed many pharmacists to ignore the ban on the sale of drugs without a prescription. For example, it was possible to purchase an antibiotic, medicine to normalize blood pressure, and cough syrup without any problems, although their dispensing was formally supposed to be carried out without a prescription. It was requested mainly when selling ordered drugs, drugs with strict dosage rules, psychotropic and drug-containing drugs.

It is worth noting that there are discussions among experts regarding the interpretation of the rules that establish 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 hard 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 the current regulations and refuse to sell drugs without a prescription - however, it was not possible to find out any official details as to why the pharmacy sales policy changed. According to some pharmacists, this is due to the increased frequency of inspections of organizations that implement medications... According to experts, changes in the policy of selling drugs without prescriptions may be associated with the publication by Roszdravnadzor of internal regulations on tightening control over the activities of pharmacies.

Informing about cheap analogues and consulting

Under the new rules, the pharmacist must inform the consumer that cheaper analogs of the requested drug are available on the market. For example, if a person came for a rather expensive "No-Shpoy", then he should also be offered drotaverin - an analogue that costs several times cheaper. For violation of this rule, a pharmacist can be fined 10 thousand rubles, the pharmacy itself - 30 thousand rubles.

The obligation of pharmacists also becomes consumer advice. At the same time, it can be held in places where a specialist can be asked rather personal questions about taking medications so that other visitors do not hear 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. Also, the consumer can request documents confirming the authenticity of the drug.

  1. If possible, always get a prescription for a particular drug from your doctor. In some cases, the prescription can be written for a fairly long time - for example, a year. It is also recommended to assist relatives in obtaining prescriptions in advance.
  2. It is advisable to buy medicines from the same pharmacies. Pharmacists who know the buyer by sight sometimes will not ask him for a prescription if he is not with him by accident.
  3. If it is not possible to circumvent the formalities, then you need to ask pharmacists for over-the-counter drug analogues.
  4. Your home medicine cabinet should be checked regularly for prescription drugs. If certain important medications run out, it is necessary to issue a prescription for them in advance.
  5. You should always be ready to contact a paid doctor for a prescription - if it is urgent. For this, it is useful to study in advance the market medical services in the city, in order to know which paid clinics operate close to home, as well as which of them provide services inexpensively.

Pharmacy retail: foreign experience

Thus, the norms of the legislation of the Russian Federation regarding the regulation of the circulation of drugs are becoming more and more stringent. But what about this in other countries?

In general, the policy of the Russian legislator is in line with global trends. Moreover, in some states, the norms may be even stricter: for example, in the United States, a pharmacist is not entitled to give advice on medicines, only a doctor is obliged to do this. In America, it is not customary to buy medicines without a prescription.

In European countries, there are norms according to which the owner of a pharmacy can only be a person with a pharmaceutical education. In addition, in some states, the number of pharmacies in the country may be strictly controlled by the authorities. The qualification requirements for pharmacists can also be very high.

Regulatory and technical documentation.

Availability of information at the stand in the trading floor

Copy of the license for pharmaceutical activities

Federal Law "On Protection of Consumer Rights"

Extract from the trading rules

Information on population groups eligible for emergency services

Book of reviews and suggestions

Information about the work of the duty administrator

Information about phone numbers of superior organizations

Information about telephones and the mode of operation of a single reference service

Information about the hours of reception of the population by the head of the pharmacy

Constituent documents and contracts

2.1 Articles of Association

2.2 Memorandum of association

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 agreement, sublease (additional agreement)

2.6 Contract for the removal of mercury-containing waste.

2.7 Contract for deratization and disinsection.

2.8 Sanitary and epidemiological conclusion.

2.9 Contract for garbage collection (maintenance services)

2.10 Contract for installation and maintenance of fire and security alarm systems.

2.11 Conclusion of the state fire supervision.

2.12 The contract with the organization carrying out the planned medical checkup employees.

2.13 Contract for measuring the resistance of electrical wiring.

2.14 Cash registers.

A copy of the service agreement for the current year.

A copy of the version passport for each KKM

A copy of the registration card for each cash register

Call log technicians KKM

Cashiers' magazines for each cash register

Logs accepted and issued by the cashier money for each KKM

The presence of a gallogram for each KKM

Availability of brands for the current quarter for each cash register

Return certificates

Cashier-Clerk Certificates

2.15 Cash book.

Pharmaceutical order.

3.1 Audit trail.

3.2 Book of reviews and suggestions

3.3 Log of goods delivery

3.4 Defect Log

3.5 Supplier Problem Log. (quarantine, under-delivery, marriage, surplus)

3.6 Journal for conducting pharmacological circles

3.7 Journal of incorrectly written prescriptions.

3.8 Journal of registration of medicines for the provision of medical care.

3.9 Journal of individual orders.

3.10 Logs for recording temperature parameters in refrigerators

3.11 Logs for recording temperature and humidity parameters.

3.12 Folder with newsletters 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 disinfectant. facilities.

4.2 Supplier License. (not required)

4.3 Certificate of state registration disin. facilities.

4.5 Copies of incoming documents for des. means

4.6 Certificate of conformity for dez. means

4.7 Plan of sanitary and epidemiological measures and production control program.

4.8 Journal of receipt and consumption 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, labor protection.

5.2 Copies of attestation certificates for the OSH and fire safety.

5.3 Log initial briefing at work.

5.4 Log of initial fire safety training in the workplace.

5.5 Safety knowledge test log with electrical safety group I

5.6 Instructions on labor protection for employees.

5.7 Evacuation plan.

Organization of work of employees

6.1 Regulation pharmacy organization

6.2 Internal labor regulations

6.3 Job descriptions of employees.

6.4 Order to be responsible for the quality of the goods in the pharmacy.

6.5 Order on approval of the storage method for lek. funds in the pharmacy

6.6 Order on the appointment of a person responsible for the registration of drugs with a limited shelf life.

6.7 Documents for employees. For each in a separate file.

Employment contract (personal signature)

Agreement about material responsibility (personal signature)

Job description (personal signature)

Appointment order

Copies of diploma, marriage certificate (if necessary)

Original and copy certificate

Medical book (original)

Internal documents on the organization of work of pharmacies

7.1 Instructions for the head.

7.2 Instructions for the work of the cashier - operator.

7.3 Quality Service Standards.

7.4 Requirements for merchandising.

7.5 Requirements for appearance employees.

7.6 Internal orders and orders.

7.7 Order of the head of the pharmacy on the distribution of duties between employees.

Lecture number 22

Topic 2.2.Retail trade in medicines.

3. Merchandising is an element of product promotion. The concept of the place: the location of the pharmacy organization, the name of the pharmacy. Retail space planning. Placement of goods on showcases. Recommendations when displaying goods. Information trading floor for buyers.

MerchandisingIs a series of methods for placing goods and promotional materials at the point of sale for speedy implementation and increasing total sales.

Rules for the location of goods in the pharmacy range: the goods are arranged by groups:

Medicines;

Sanitary hygiene and patient care items;

Dressings;

Mineral water;

Perfumery and cosmetics, etc.

Products of the "medicines" group are arranged according to pharmacological groups:

Based on drugs (analgesics to analgesics)

By trade marks (all drugs from one company - manufacturer are assembled in one place)

There are the following types of showcases:

Showcase-warehouse or showcase-catalog, when there is little space, but there is a lot of goods, it seems that the showcases are overloaded with goods;

Air showcase - with a small amount of goods; this type of display case is better perceived;

Thematic showcase - on a specific topic, for example, "Influenza drugs";

A prestigious showcase, for example, Natur Product.

Showcase design principles:

The principle of asymmetric balance (creates the impression of dynamism, movement of goods);

Place the goods at eye height (120-160 cm from the floor);

Hot goods alternate with slow ones.

In the placement of goods, you can offer the following compositions: linear, rosette, radial, arched, pyramidal, etc.

Registration of price tags: the rules for the sale of various groups of goods were approved by the Decree of the Government of the Russian Federation No. 55 of 01.19.1998. Price tags should have a uniform design; they indicate:

The name of the drug;

Price per weight or unit;

The signature of the responsible person or the seal of the organization;

Date of registration of the price tag (from the invoice).

New articles for the head and chief executive from the eighth issue of the magazine "New Pharmacy". The main topic of the issue was the article "Phenazepam, Grandaxin and other non-PKU psychoactive drugs. Instruction for dispensing".

The main thing in the room

Pharmacies often refuse to offer psychotropic drugs in order to avoid additional problems. But in Russia psychotropic drugs are registered that do not require not only PKU, but also prescription dispensing. I offer instructions on the circulation of such drugs. Deliver it to employees.

Sellers, consultants and managers do not notice that they are using words provocateurs in their speech. They do not notice, because often neutral words become the aggressors.

I propose to place lists of such provocateurs in the zone of visibility of the leaders, so that they do not forget about hidden enemies. Over time, the habit of constructing phrases in a different way will become firmly rooted in the mind and will allow you to avoid mistakes in communication.

The federal and regional media periodically report that the leaders sometimes show miracles of heroism. But it is better to take preventive measures than risk your health and life.

A customer came to the pharmacy for 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, changed the amount of sanctions for certain violations of fire safety. New fire safety rules legalize the institute independent evaluation fire risk and expanded the circle of fire safety inspectors

Part 1

Pharmaceutical order

Supervisory authorities for the pharmacy are always uninvited guests, and it is good if you can prepare for their arrival. The author of the article tells about when the auditors will warn about the check in advance and in what cases they can suddenly appear.

The state is consistently tightening prescription drug requirements. Therefore, we suggest checking whether you are ready to conduct a pharmaceutical examination of prescription forms for medical devices. Will help you practical advice authors and samples of prescription forms of three forms.

Purchases and sales

Since January 1, 2017, the government has transferred state and municipal pharmacies to state purchases for Federal law No. 44-FZ. The innovation caused a protest from unitary pharmacy enterprises. But did the amnesty take place? The author offers his own version of the answer to the question.

Management and economics

Only a competent manager will establish the work of subordinates and achieve financial results... But what competencies are and which ones are important for a manager, the author of the article says.

In 2017, more than 5 million packages of drugs were sold through the pharmacy network for 940.7 billion rubles in retail prices, which is 6.5% higher in value terms and 3.5% higher in physical terms compared to 2016. Such data is provided by the analytical company DSM Group.

The positive dynamics in physical terms indicates an improvement in the purchasing power of the population and a decrease in the influence of financial and economic factors on the pharmaceutical market, analysts say.

In their opinion, the price factor also influenced the growth of the pharmacy market in 2017. This is largely due to the change in the sales structure in favor of more expensive drugs. “In 2017, the consumer continued to switch to more expensive medicines. The segment “over 500 rubles” grew the most - by 12% in rubles and by 13% in units. Due to such an increase, the share of this segment increased by almost 2% in value terms, "analysts say.

Nevertheless, drugs costing up to 50 rubles still remain popular with consumers - in 2017 they occupied about 40% of the market in physical terms. However, the share of such drugs is gradually decreasing, both in physical (by 0.7%) and in value (by 0.4%) terms.

Drug price inflation 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 essential and essential medicines (VED) increased by 0.06%. “A low rise in prices for drugs is noted in all subgroups: imported drugs increased in price by 0.6%, Russian drugs fell by 0.5%. Prescription drugs on average cost consumers 0.1% more, OTC drugs - by 0.4%, ”the DSM report says.

It is worth noting that the Ministry of Industry and Trade has several other data on the change in prices for VED 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 the prices for vital and essential drugs.

According to DSM analysts, until 2017, the main price increase was observed for drugs in the low-cost segment (up to 50 rubles), but in 2017 they fell on average by 3.4%, while drugs belonging to the "expensive" segment (from 500 rubles and higher) 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 pack of a domestic drug in retail prices was 90 rubles, which is approximately 3.6 times lower than the cost of a pack of an imported drug (about 321 rubles). The average cost of a pack of an original drug was 646 rubles (+ 3.5% compared to 2016), for a generic drug - 141 rubles.

Analysts also note an increase in the share of domestic drugs both in value and in kind. “In 2017, the share of domestic drugs was 28.5% in value terms and 58.7% in physical terms. It should be noted that sales of domestic drugs in rubles increased by 7.4%, while sales of imported drugs - by 6.1%. Due to this, the share of Russian drugs in the structure of pharmacy sales increased, and the share is growing both in value and in kind, ”the report says.

It also lists the TOP20 brands that are leading in terms of sales in the Russian commercial market. Together they occupy 10.9% of the market.

The change

Sales value, billion rubles

Increase in value

DETRALEX

CARDIOMAGNET

ESSENTIALE

INGAVIRIN

ACTOVEGIN

MIRAMISTIN

MEXIDOL

PENTALGIN

XARELTO

VOLTAREN

ERGOFERON

KANEFRON

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