- The CORRECT division of the assortment into is necessary to perform any assortment analysis, including category management, in the absence of product categories, any (!) method of assortment analysis will show incorrect results. There are no exceptions.
- Why do any assortment analysis? Assortment analysis is necessary to form an assortment matrix.
- What about category management? the best method for analyzing the assortment and determining the assortment matrix.
- Why do you need an assortment matrix? Assortment matrix- this is a complete list of all commodity items offered for sale in the pharmacy chain, taking into account the requirements of the assortment policy, the format features of pharmacies and their location. In the absence of an assortment matrix in the pharmacy network, it is impossible to correctly (!) automate such tasks as:
- auto-order, without overstocking with illiquid goods and defects in key positions;
- differentiated pricing;
- without an assortment matrix, it is impossible to manage sales.
- Why is it necessary to automate all these tasks: auto-order, differentiated pricing, sales management? This must be done for:
- increase in the profitability of the pharmacy business (by at least 15-20%!);
- a sharp reduction in time and labor costs;
- reducing the dependence of the network on the human factor;
- the ability to scale processes to new pharmacies and/or new chains;
Thus, the procedure is as follows:
- Unification of the commodity directory
- Division of the assortment into product categories and INN clusters;
- Carrying out category management;
- Determination of the optimal assortment matrix for the pharmacy chain, the category of pharmacies, the format of pharmacies.
Implementation of all further action will be based on the formed assortment matrix.
Dividing the assortment into product categories and INN clusters
In the absence of the CORRECT division of the assortment into product categories, the launch of category management is impossible. There is only ONE the correct model for dividing the assortment into product categories.
Full instructions for dividing the assortment into product categories and INN clusters, as well as examples of a directory with ready-made pharmacy product categories, are transferred to the pharmacy chain during the implementation of the Category Management Implementation Project.
Until the assortment is divided into product categories, it is pointless to perform all the following actions. After dividing the assortment into product categories and, where necessary, INN clusters can be applied
The cost of the standard for filling product categories, the directory of product categories and INN clusters
- When buying separately: 250.000 rub.
- When introducing category management, it is provided is free.
Theory and logic of dividing a pharmacy directory into product categories
The basic definition of a product category for a retail business is AC Nielsen's definition, which states that products in the same category must meet similar consumer needs, or they must be interrelated or interchangeable.
Based on this, we will give a definition of product categories in the pharmacy business.
Let's start with the fact that the division of the assortment into pharmaceutical groups or groups according to the ATC classification is meaningless. These groups cannot be used for category management. I think this is obvious and does not require further explanation.
If you violate the logic of filling product categories and include in one category goods that are not related to each other and do not have “interchangeability”, then analysis in this group will lead to errors and misinterpretations.
- they are used to meet one need (they are used for one nosology);
- the buyer can take only one product from the category to meet his needs;
- the sale of one product from the category directly affects the sales of other products included in the group.
The buyer perceives the product category as a whole and the probability that two products from the group will be taken simultaneously to satisfy one need is minimal.
For example, if a client purchases Theraflu, then he is unlikely to take Coldrex or Fervex, because. three of these drugs belong to the same category (Hot drinks for colds). Or if the buyer purchases Kagocel, then it is unlikely that he will also take Arbidol or Lavomax, because these drugs belong to the same category (Cold antiviral). Drugs belonging to different product categories can be purchased to meet one need, for example, Anvimax (hot drinks) + Arbidol (antiviral anti-colds). When dividing goods into product categories, two extremes should be avoided: an excessive increase in groups (for example, it is wrong to create a group “Anti-colds” and mix products included in the group “hot drinks” and “anti-cold, antiviral drugs”) and unnecessary division of groups. You should also avoid dividing the assortment according to pharmaceutical classification, because. in this case, completely different drugs may be in the same category, for example, the group "Antiviral drugs" will include Arbidol, Lavomax, Acyclovir; it is clear that the sales of Acyclovir do not affect the sales of Arbiodl, at the same time, the sales of Arbidol and Lavomax directly affect each other's sales, but do not affect the sales of Acyclovir.
Exceptions, features, nuances
Of course, a simple definition of the concept of "product category" is not enough to be able to divide the entire pharmacy range into them. There are many nuances and limitations that must be taken into account.
For example, there are product categories competing with each other. This phenomenon is possible when these categories satisfy the same need, but the products they contain are different, and there is a small chance that two products will be purchased to satisfy the same need (example: cough drops and cough syrups).
It is also a common mistake to analyze sales of adult and children's uniforms together, because they are included in the same category. If this is done, then in most product categories, dosage forms for adults will displace children's forms.
Indeed, Afrin and Nazivin 0.01% are not competitors and do not affect each other's sales in any way. Therefore, they cannot be placed in the same category "Vasoconstrictor", analyze sales and draw any conclusions.
Degree of product differentiation within a category
Now it is necessary to define the boundaries of application of category management. There are product categories that are easy to process using category management tools and in which it is easy to implement the results of this processing, and there are categories in which the use of category management is practically meaningless. Thus, we understand that product categories are not equivalent and, therefore, it is incorrect to process them with the same algorithms.
Product categories differ in the degree of differentiation of the goods included in them. In order to define the concept of differentiation, we must first consider two terms: switching and replacement.
Switching -
Replacement is the average of the inverse probability of switching within a category across all products.
NB! goods fall into one product category, between which switching is possible, but replacement is not always possible. Switching and replacement are probabilistic. You should not try to include only completely interchangeable items in one category (ie, when the probability of switching tends to 100%), this is just a special case of low-differentiated products and categories.
Category management and pricing is probability management. The probability of favorable outcomes should exceed the probability of less favorable ones. Get rid of the 100% myth, we don't need them, but a high probability.
The probability of switching from a product to another product within a category is determined using indicators such as the degree of differentiation of the product and the degree of differentiation of the product category.
The degree of product differentiation - is the inverse probability of switching from specific product to other positions from its price segment of the same product category. The higher the product differentiation, the lower the likelihood of switching to any other product. In the limit, the degree of product differentiation can be equal to one, in which case switching is impossible.
Thus, for different product categories, the degree of differentiation between drugs will differ. And according to what degree of differentiation the goods included in the product category have, they determine the degree of differentiation of the entire product category.
Degree of product category differentiation (D tk) The accuracy and effectiveness of category management tools is the higher, the lower the degree of product category differentiation (Table 1.).
Table 1. Relationship between the degree of differentiation of the product category (D TC), sales management and marketing payments.
| Degree of product category differentiation (D TK) | Switchable | Sales management | Marketing budgets |
| D TC = 1 | Switching not possible | Pharmaceutical manufacturers | low or absent |
| D TK = | Scope of category management and cluster analysis | Category management and cluster analysis | The size of the budget depends on the economic profile of the product within the product category |
| D TK = 0 | Switching only due to replacement by a pharmacy network | Pharmacy chains | Very high. Here, in particular, there are uSTM, STM products, etc. |
If you do not take into account the degree of differentiation of product categories and process them according to the same rules (with the same values of variables), then incorrect results will be obtained.
The degree of differentiation is determined at the stage of preparing a directory of product categories, this procedure can be performed fully automatically within the framework Thus:
- Category management has its own limits of application in the pharmacy business. It doesn't work and shouldn't work across the entire breadth of the range and in all product categories (INN clusters).
- Category management shows the greatest accuracy and efficiency in low-differentiated product categories (INN clusters).
- Low-differentiated groups provide the greatest income (additional growth) to the pharmacy chain through sales management. An additional increase in the gross profit of the pharmacy chain from the processing of medium and low-differentiated groups can reach 20%.
The formation of the product range by pharmacy organizations is largely due to legal restrictions and requirements established by laws and other regulatory legal acts governing the circulation of medicines and other goods medical purpose. The current laws and other regulatory legal acts regulate: the list of medical supplies, the minimum range of medicines required to provide medical care, a list of vital and essential medicines, a list of medicines for dispensing free of charge. Restrictions have been introduced on the range of pharmacies, pharmacy kiosks, medical organizations and their subdivisions located in rural areas where there are no pharmacy organizations, regulation of prices for vital and essential medications and others. The article reveals the problems of forming the range of goods associated with their legal regulation.
pharmacy organizations.
assortment regulation
medical supplies
1. Decree of the Government of the Russian Federation of January 19, 1998 No. 55 “On approval of the rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer’s requirement to provide him free of charge for the period of repair or replacement of a similar product, and a list of non-food products of good quality non-refundable or exchangeable for similar product other size, shape, dimension, style, color or configuration.
2. Decree of the Government of the Russian Federation of October 29, 2010 No. No. 865 "On state regulation of prices for medicines included in the list of vital and essential medicines".
4. Decree of the Government of the Russian Federation of September 15, 2008 No. 688 “On approval of the lists of codes for medical products subject to value added tax at a tax rate of 10 percent”.
5. Order of the Ministry of Health and Social Development of Russia dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical food products”.
6. Order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No. 785 “On the procedure for dispensing medicines”.
7. Order of the Ministry of Health and Social Development of Russia dated September 15, 2010 No. 805n "On approval of the minimum range of drugs for medical use necessary for the provision of medical care."
9. Federal Law of November 21, 2011 No. 323-FZ “On the basics of protecting the health of citizens in Russian Federation».
The formation of the product range by pharmacy organizations is largely due to legal restrictions and requirements established by laws and other regulatory legal acts regulating the circulation of medicines and other medical products.
Significant share in the product range pharmacy organizations occupy medical products. The term "medical devices" was introduced by the Law "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation", according to which "medical devices are any instruments, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other , as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not realized through pharmacological, immunological , genetic or metabolic effects on the human body". According to this definition, medical devices include both medical devices and medical equipment, which are included in different groups in the product classifier and are indicated by different codes, including: 93 9000 “Materials, medical supplies and other medical products”, 94 0000 “ Medical equipment", 25 1400 "Products made of latex and adhesives", 25 4500 "Medical, sanitary-hygienic and non-shaped articles for patient care", 49 6910 "Sanitary-hygienic / ceramic products" (bedpans, pots for children, urns and etc.), 54 6350 “Paper and products for household, sanitary and medical purposes”, 81 5800 “Medical products”, 81 9510 “Absorbent cotton wool (81 9511, 81 9512, 81 9513), 81 9520 “Medical compress cotton wool” , 84 6000 "Medical products", 85 7000 "Working and special purpose" and others . It is possible to prove that goods belong to medical devices of these types on the basis of registration certificates and data of the state register of medical devices.
In addition to medical devices, the list of goods allowed for dispensing from pharmacies includes "spectacle optics and care products for them." At the same time, it is not clear for what purpose "spectacle optics", which refers to medical products, was singled out in a separate group.
In relation to other goods specified in the list (“dishes for medical purposes”, “items and means for caring for the sick, newborns and children under the age of three years”, “care products for spectacle optics”, “personal hygiene items and means” ) clarifications and the establishment of the order of their identification are required. What will be the identifying sign of their belonging to the corresponding group of goods? If codes according to the product classifier are used as such a feature, then an official list of such codes is needed, as, for example, in tax legislation when deciding on the application of preferential rates of value added tax, in particular for “medical goods” and “goods for children”. It should be noted that in the tax legislation, the concept of "medical products" includes medical equipment, prosthetic and orthopedic products, glasses, lenses and spectacle frames, and others.
Questions also arise regarding medical and health-educational publications intended for propaganda healthy lifestyle life, which can be implemented by pharmacy organizations. What do you mean: book production, periodicals (newspapers, magazines)? Why was only the printed version chosen, since there are also audio and video products that would be acceptable for people with disabilities.
With regard to the range of medicines for pharmacy organizations, the legislation provides for additional requirements and restrictions.
Firstly, pharmacy organizations are allowed to retail only drugs registered in the Russian Federation, information on which is contained in State Register medicines, which is a federal information system, containing information about medicines for medical use .
Secondly, for some types of pharmacy organizations there are restrictions on the range of medicines,. In particular, pharmacy kiosks are allowed to sell only medicines that are allowed to be dispensed without a doctor's (paramedic's) prescription. The range of such medicinal products is determined in accordance with the instructions on the dispensing procedure contained in the information on the packaging and instructions for medical use of the drugs. For pharmacies, a ban on activities related to the circulation of narcotic drugs and psychotropic substances is regulated. Pharmacies can sell any drugs registered in the Russian Federation, however, for the sale of narcotic and psychotropic drugs, an additional license is required for activities related to their circulation. The list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation is approved by the Government of the Russian Federation. The list is formed from separate lists for which different control measures are established.
Currently, medicines of eight international non-proprietary names (INN) of Schedule II narcotic drugs (Buprenorphine, Dihydrocodeine, Morphine, Omnopon, Prosidol, Promedol, Fentanyl, codeine-containing drug Codterpin) are registered in Russia. Of the psychotropic substances in Schedule II, only one medicinal product (Ketamine) has been registered. From List III, drugs of 4 INN psychotropic substances (Butorphanol, Nalbuphine, Sodium oxybutyrate, Tianeptine) are registered. Taking into account new edition The list, which comes into force on August 8, 2013, a license for the right to trade in narcotic drugs, psychotropic substances and their precursors will also be required for the sale of such drugs as Alprozalam, Diazepam, Zolpidem, Clonazepam, Lorazepam, Medazepam, Midazolam, Nitrazepam , Oxazepam, Phenobarbital, Flunitrazepam, Chlordiazepoxide, which will be included in Schedule III psychotropic substances. Until August 8, 2013, these drugs belong to the List of potent substances and are subject to international control.
The sale of other medicinal products is carried out on the basis of a license for pharmaceutical activity, and their range is also regulated in accordance with the requirements normative documents. Some medicines are prohibited for dispensing to outpatients, therefore they are not subject to dispensing from pharmacy organizations serving the population. These are drugs used only in medical organizations: anesthetic ether, chloroethyl, fentanyl (except for the transdermal dosage form), halothane, ketamine, etc.
In addition, all pharmacy organizations are required to comply with the requirements of the system of measures state regulation prices for medicines included in the list of vital and essential.
Restrictions have also been introduced regarding the range of medicines for dispensing to citizens entitled to state social assistance. Lists of medicines to provide citizens eligible for a set social services, are approved by the Ministry of Health of Russia, and to provide citizens who have the right to receive medicines free of charge and at a discount (financed from the regional budget), - by regional regulatory legal acts. Pharmacy organizations involved in the drug supply of such citizens form stocks and dispense drugs for this purpose in accordance with these lists.
Restrictions have been introduced on the range of medicines, the sale of which can be carried out by medical organizations licensed for pharmaceutical activities, and their separate subdivisions located in rural settlements where there are no pharmacies. The list of medicines (with the exception of narcotic and psychotropic medicines) for these organizations and their divisions is established by the authorities executive power subjects of the Russian Federation. In a number of constituent entities of the Russian Federation, the lists adopted for these purposes are restrictive in relation to the range of drugs.
Some prescription drugs may be included in the assortment of pharmacies or pharmacy outlets subject to additional requirements for the organization of their storage, approved by the order of the Ministry of Health and Social Development (Ministry of Health) of Russia. In particular, special requirements have been established for medicinal products subject to quantitative accounting, which must be stored in metal or wooden cabinets that are sealed or sealed at the end of the working day. The list of such medicines is approved by order of the Ministry of Health and Social Development (Ministry of Health) of Russia.
Potent medicines, regardless of whether they are subject to quantitative accounting or not, should be stored in metal cabinets sealed or sealed at the end of the working day11. List of potent substances approved by Resolution Government of the Russian Federation. In the modern range of drugs, 26 INNs of potent substances are registered. Taking into account the changes made to the lists of psychotropic and potent drugs, from August 8, the range of potent drugs will be reduced to 14 INNs (Benzobarbital, Hexobarbital, Gestrinone, Danazol, Zopiclone, Clonidine, Levomepromazine, Methandienone, Nandrolone, Sibutramine, Testosterone, Sodium Thiopental, Tramadol, Trihexyphenidyl ) .
Operating legal restrictions in relation to the range of medicines are due to the special properties of pharmaceutical products, due to which the theory of the free market is unacceptable for them. By decree of the President of the Russian Federation, medicines are classified as types of products, the free sale of which is prohibited.
Pharmacy organizations in the formation of the assortment, in addition to legally established restrictions, must also take into account regulations prescriptive nature. In accordance with the law, pharmacy organizations and individual entrepreneurs who have a license for pharmaceutical activities are obliged to ensure the established by the authorized federal body executive branch of the minimum range of medicines needed to provide medical care. The minimum assortment is developed in order to ensure the availability for patients of the most demanded and necessary for the provision of medical care medicines that are mandatory for availability in pharmacy organizations.
The criteria for the formation of the minimum range of drugs are:
State registration of medicines;
Efficacy and safety of drugs when used to prevent and alleviate the symptoms of the disease, as well as the treatment of mild, uncomplicated forms of diseases that do not require complex methods of diagnosis and treatment when used by all age groups population;
The possibility of safe self-administration of drugs by patients on an outpatient basis and at home without the need for regular consultations and supervision by a doctor (paramedic).
At the same time, the minimum assortment does not include: drugs included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation; included in the list of drugs subject to subject-quantitative accounting; included in the lists of potent and toxic substances; drugs in dosage forms for injection, infusion, implantation, with the exception of solvents; medicines intended for medical use within the framework of specialized medical care.
In our opinion, a list formed on the basis of such criteria and restrictions is unlikely to meet the declared goal. The above criteria and restrictions are more likely to meet the requirements for the formation of a list of drugs that could be dispensed from pharmacy organizations without prescriptions. At the same time, the criterion for assessing compliance by a pharmacy organization with a minimum assortment should not be its formal presence on the trading floor, but the ability to satisfy customer demand, including within the time limits for serving prescriptions, which are approved by order of the Ministry of Health and Social Development of the Russian Federation.
At present, by order of the Ministry of Health and Social Development (Ministry of Health) of Russia, two lists of the minimum mandatory assortment have been approved: one - for pharmacies of finished dosage forms, production, production with the right to manufacture aseptic medicines, the second - for pharmacy points, pharmacy kiosks and individual entrepreneurs who have a license for pharmaceutical activity . The second list contains a very limited range of medicines, which cannot guarantee the availability of medicines necessary for medical care to patients.
In connection with the change in the socio-economic policy of the state, the social orientation of the activities of pharmacy organizations is being lost, and the commercial interests of the owners come to the fore. In this regard, it is possible to compare the minimum assortment with the list of vital and essential drugs (VED), without the use of which, according to experts, in life-threatening diseases and syndromes, the disease may progress or worsen its course, complications, or death of the patient may occur, as well as medicines for specific therapy of socially significant diseases. The list of Vital and Essential Drugs is approved by the Government of the Russian Federation for the purpose of providing medicines to healthcare institutions and the population of the Russian Federation.
On the basis of the federal list of vital and essential drugs, the executive authorities of the subject of the Russian Federation in the field of healthcare within the framework of territorial programs state guarantees provision of free medical care to citizens should form the relevant territorial lists of vital and essential medicines, however, in practice, such lists duplicate the approved federal list VED. Territorial lists to ensure state guarantees must be developed based on regional characteristics, taking into account the specifics of the provision of various types of medical care and standards for its provision (for inpatient medical care, for outpatient medical care, for dispensing to citizens entitled to receive medicines and medical devices free and at a discount, etc.).
Meanwhile, despite the importance of vital and essential medicines for ensuring the availability of medical care, pharmacy organizations are not regulated by the obligation to have them in the assortment (as opposed to the minimum assortment of medicines necessary for providing medical care), which can lead to leaching from assortment of pharmacy organizations of "uncomfortable" commodity items, for which additional expenses for the organization of their storage and accounting, drugs with a low cost, the costs of promotion and sale of which exceed the income from their sale. This reduces the availability of vital and essential drugs for the population.
In our opinion, in order to ensure the availability of drug care to the population, it is necessary to form a list of vital and essential drugs, in which it is advisable to make notes regulating the use of drugs (for example, “for inpatient medical care”, “for outpatient medical care”, “the minimum assortment for pharmacies, pharmacy points, pharmacies, for individual entrepreneurs, etc.), thus combining the purpose of two lists - the list of Vital and Essential Drugs and the minimum range of medicines mandatory for pharmacy organizations and individual entrepreneurs.
Order of the Ministry of Health and Social Development of Russia dated June 15, 2010 No. 447 "On the organization of work on the formation of the minimum range of medicines necessary for the provision of medical care."
Bibliographic link
Tarasevich V.N., Novikova N.V., Soloninina A.V., Odegova T.F. LEGAL RATIONALE FOR FORMING A RANGE OF PRODUCTS IN PHARMACY ORGANIZATIONS // Contemporary Issues science and education. - 2013. - No. 3.;URL: http://science-education.ru/ru/article/view?id=9360 (date of access: 01.02.2020). We bring to your attention the journals published by the publishing house "Academy of Natural History"
Pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, along with medicines, have the right to purchase and sell medical products, disinfectants, personal hygiene items and means, utensils for medical purposes, items and means intended for caring for the sick, newborns and children under the age of three, spectacle optics and eye care products, mineral waters, medicinal, children's and dietary foods, biologically active additives, medicinal perfumes and cosmetics, medical and sanitary-educational publications intended to promote healthy lifestyle.
General requirements for dispensing medicines.
2.1. All medicines, with the exception of non-prescription ones, must be dispensed by pharmacies (organizations) only on prescriptions drawn up in the prescribed manner on prescription forms of the relevant accounting forms.
2.4. Pharmacy institutions (organizations) are prohibited from dispensing medicines under prescriptions with expired validity, except for prescription drugs that expired while prescriptions were on deferred maintenance.
2.7. If the pharmacy organization has medicines with a dosage different from the dosage prescribed in the doctor's prescription, the pharmacist may decide to dispense the available medicines to the patient if the dosage of the medicine is less than the dosage indicated in the doctor's prescription, taking into account the recalculation for the course dose .
If the dosage of the medicinal product available in the pharmacy organization exceeds the dosage indicated in the doctor's prescription, the decision to dispense the medicinal product to the patient is made by the doctor who issued the prescription.
The patient is provided with information about changing the single dose of the drug.
2.9. When medicines are dispensed on the basis of a doctor's prescription valid for one year, the prescription is returned to the patient with the name or number of the pharmacy, the signature of the pharmacy employee, the amount of the drug dispensed and the date of issue on the back. Upon expiration of the prescription, the prescription is canceled with the stamp "Recipe invalid" and left in the pharmacy organization.
2.12. Prescriptions for medicines marked "statim" (immediately) are served within a period not exceeding one working day from the moment the patient contacts the pharmacy institution (organization).
Prescriptions for medicines marked "cito" (urgently) are served within a period not exceeding two working days from the moment the patient contacts the pharmacy institution (organization).
2.17. Medicines of good quality purchased by citizens are not subject to return or exchange in accordance with the List of non-food products of good quality that are not subject to return or exchange for a similar product of a different size, shape, dimension, style, color or configuration, approved Decree Government of the Russian Federation dated January 19, 1998 N 55
2.18. Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; Alcohol-containing medicinal products of industrial production are redeemed with the stamp of the pharmacy institution (organization) "The medicine is dispensed" and returned to the patient's hands.
To re-dispense the drug, the patient must consult a doctor for a new prescription.
2.19. Incorrectly written prescriptions are canceled with the stamp "The prescription is invalid" and are registered in the journal, the form of which is provided for in Appendix No. 4 to this Procedure, and returned to the patient's hands.
Information about all incorrectly issued prescriptions is brought to the attention of the head of the relevant medical institution.
Federal Law of November 21, 2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation"
Art. 2 laws:
pharmaceutical organization - entity regardless of the legal form, carrying out pharmaceutical activities (organization of wholesale trade in medicines, pharmacy organization).
pharmaceutical worker - individual, which has pharmaceutical education, works in a pharmaceutical organization and in labor obligations which includes wholesale trade in medicines, their storage, transportation and (or) retail trade in medicines, their manufacture, dispensing, storage and transportation.
The right to carry out pharmaceutical activities have:
Persons who have received pharmaceutical education and have a certificate of accreditation of a specialist (clause 1, part 2, article 69);
Persons who have the right to carry out medical activities and have received additional professional education in part retail medicines, provided they work in separate subdivisions medical organizations licensed to carry out pharmaceutical activities and located in rural settlements, in which there are no pharmacy organizations (clause 2, part 2, article 69).
Persons with pharmaceutical education and who have not worked in their specialty for more than 5 years may be allowed to carry out pharmaceutical activities after completing training in additional professional educational programs (advanced training, professional retraining) and passing accreditation (part 4 of article 69).
Art. 74 of Law 323-FZ contains a list of what pharmacy specialists are not entitled to do, in particular, when working with medical representatives of pharmaceutical companies:
Accept gifts from these companies and representatives, cash, including payment for entertainment, recreation, travel to a place of rest (clause 1 part 1 and clause 1 part 2 article 74);
Take part in entertainment events held at the expense of companies and their representatives (clause 1, part 1 and clause 1, part 2, article 74);
Conclude agreements on the appointment of patients, the offer to the population of medicines, medical devices (paragraph 2, part 1 and paragraph 3, part 2, article 74);
Receive samples of medicinal products for delivery to patients (clause 3, part 1 and clause 2, part 2, article 74);
Provide the public with false, incomplete or distorted information about the availability of medicines that have the same international nonproprietary name (INN), hide information about the availability of medicines and medical devices that have a lower price (clause 4, part 2, article 74).
Prescribe medicinal products on forms containing advertising information, as well as on prescription forms on which the name of the medicinal product is preprinted (clause 6, part 1, article 74).
Lecture #21
Topic 2.2. Retail sale of medicines.
2. Pharmacy. Pharmacy. Equipment and equipment of points of sale. The procedure for settlements with the population through cash registers.
According to the order of the Ministry of Health and social development of the Russian Federation (Ministry of Health and Social Development of Russia) dated July 27, 2010 No. 553n "On Approval of the Types of Pharmacy Organizations" approved the types of pharmacy organizations:
1. Pharmacy:
Finished dosage forms;
production;
Production with the right to manufacture aseptic drugs.
2. Pharmacy.
3. Pharmacy kiosk.
The pharmacy (actually) performs the following functions:
sale of ready-made medicines (including homeopathic medicines) to the population under prescriptions and without doctor's prescriptions, to healthcare institutions according to requirements or applications;
manufacturing of medicines according to the prescriptions of doctors and the requirements of health care institutions, the manufacture of intra-pharmaceutical preparations in accordance with approved prescriptions and the packaging of medicines and medicinal plant materials with their subsequent sale;
dispensing medicines free of charge or at a discount to certain groups of the population in accordance with current legislation Russian Federation and on the basis of agreements concluded with territorial bodies health care management, medical institutions and insurance companies;
sale of medicinal plant raw materials in their original packaging; medical products (in particular, patient care items, medical equipment products, including prophylactic purposes, diagnostic tools, therapeutic and prophylactic underwear, hosiery, bandages, child care items, first aid kits and others); disinfectants; items (means) of personal hygiene (in particular, skin care products, hair care products, aromatic oils and others); optics (in particular, finished glasses, glasses care products and others); mineral waters (natural and artificial); therapeutic, children's and dietary nutrition (in particular, nutritional supplements for therapeutic and prophylactic purposes, and others); cosmetic and perfumery products (hereinafter referred to as goods allowed for release from pharmacy organizations);
release of items through the rental point in accordance with established order;
providing medical workers healthcare institutions, education, social security and other necessary information about the medicines available in the pharmacy, as well as about new medicines;
provision of first aid;
Providing advice to ensure responsible self-treatment.
Pharmacy performs the following functions:
sale to the population of medicines by prescription (except for narcotic drugs, psychotropic, potent and poisonous substances) and without a doctor's prescription; sale of packaged medicinal plant materials in their original packaging, medical products, personal hygiene items (means);
manufacturing of medicines according to doctor's prescriptions, prepared intra-pharmaceutical blanks in accordance with approved prescriptions and packaging of medicines with their subsequent sale;
Dispensing medicines free of charge or at a discount to certain groups of the population in accordance with the current legislation of the Russian Federation and on the basis of agreements concluded with territorial health authorities, medical institutions and insurance companies;
providing the public with the necessary information on the proper use and storage of medicines at home; provision of advisory assistance in order to ensure responsible self-treatment;
Providing medical workers of health care institutions, education, social security with the necessary information about the medicines available at the pharmacy, as well as about new medicines;
Pharmacy kiosk performs the following functions:
selling medicines to the public without a doctor's prescription; sale of packaged medicinal plant materials in their original packaging, medical products, personal hygiene items (means);
providing the public with the necessary information on the proper use and storage of medicines at home;
provision of first aid.
2.3. Pharmacy organizations in their work must be guided by certain requirements established state standards, sanitary, fire regulations and other regulatory documents, labor protection and safety regulations.
2.8. The pharmacy organization must have the necessary premises, equipment and inventory to ensure, in accordance with the requirements of the standards, the preservation of the quality and safety of medicinal products during their storage and sale, appropriate conditions for retail trade in medicinal products and other goods allowed for dispensing from pharmacy organizations.
2.9. In a pharmacy organization, in places convenient for familiarization on the trading floor, the following should be placed:
Copies of licenses for pharmaceutical activities and other activities in accordance with the current legislation of the Russian Federation;
Information about telephones and addresses of health and pharmaceutical management bodies;
Book of reviews and suggestions;
Information on population groups entitled to free and preferential provision and extraordinary service, in accordance with the current legislation of the Russian Federation;
Information about the person responsible for drug supply Great Patriotic War and categories of the population equated to them on benefits (for pharmacy organizations that carry out preferential dispensing of medicines);
Information about phone numbers and working hours of the reference pharmaceutical service;
- information about the names of departments or distribution zones of the corresponding groups of goods;
Information on the shelf life of medicinal products manufactured in a pharmacy (pharmacy);
Price tags for offered non-prescription drugs and other goods allowed for dispensing from pharmacy organizations;
Information about the employees of the pharmacy organization directly serving the population (tablets, badges and others indicating the full name and position);
Information about the administrator on duty (full name, position) and the location of the alarm call button for the administrator on duty (with the exception of the pharmacy kiosk);
If there is a rental point, information on the list of items to be rented;
Copy or extract from the Federal Law "On Protection of Consumer Rights"
2.10. In the course of their activities, specialists of a pharmacy organization are required to comply with the norms of pharmaceutical deontology and ethics.
3.1. All premises of the pharmacy organization must be located in the building (structure) and functionally combined into a single unit, isolated from other organizations. Entrance (exit) to the pharmacy organization through the premises of another organization is allowed.
The pharmacy organization should provide for the possibility of entry (exit) for people with impaired functions of the musculoskeletal system.
3.3. A pharmacy organization must have a sign indicating the type of organization (in accordance with a license for pharmaceutical activities) in Russian and national languages: "Pharmacy", "Pharmacy point", "Pharmacy kiosk", "Pharmacy store"; organizational and legal form and form of ownership; brand name organizations; location (according to founding documents), as well as the operating hours of the organization, addresses and telephone numbers of nearby and duty pharmacies. The name of the type of pharmacy organization must be in font, the size of which allows you to clearly distinguish the inscription at any time of the day from a distance of at least 25 meters. When placing a pharmacy organization inside the building, the sign must be on the outer wall of the building.
Pharmacy organization providing drug help at night, should have an illuminated sign with information about work at night, indicating hours of operation, a bell for the visitor to call an employee of a pharmacy organization.
3.4. When a pharmacy organization is closed for sanitation, repair, re-equipment or in connection with its liquidation, the population is notified of this by an announcement posted on the front door 5 days before the closing of the pharmacy organization. The ad contains the address of the nearest pharmacy organizations.
3.7. The premises of pharmacy organizations must meet the technical, sanitary, fire and other license requirements and conditions.
3.8. Pharmacy organizations must have centralized systems of power supply, heating, water supply, supply and exhaust ventilation, sewerage.
When organizing pharmacy points at medical institutions, they can be equipped with an air conditioning system; administrative and amenity premises may be shared. In pharmacy organizations located outside cities, it is possible to have autonomous heating, sewerage and water supply.
3.9. The internal surfaces of walls and ceilings must be smooth, allowing the possibility of wet cleaning. The floors of industrial premises and material rooms must have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants. Interior decoration materials must comply with the requirements of the relevant regulatory documents.
The decoration of administrative and amenity premises allows the use of wallpaper, carpets, parquet, oil paints, etc.
3.10. Premises for the storage of medicines (medicines) in pharmacy organizations must be equipped with special equipment, allowing to ensure their storage taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of the quality standards of medicines and the State Pharmacopoeia of the Russian Federation and their proper preservation. The premises of pharmacy organizations located in the city must be equipped with systems burglar alarm connected to a remote control with round-the-clock centralized surveillance or guarded around the clock by a security company licensed for this type of activity.
3.11. Premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances in without fail should be equipped with multi-line security alarm systems with the connection of each line to separate numbers of centralized monitoring consoles, while:
- additional alarm lines protect the internal volumes and areas of the premises, safes (metal cabinets) used to store narcotic drugs, psychotropic, poisonous and potent substances;
- Workplaces of personnel carrying out operations with narcotic drugs, psychotropic, poisonous and potent substances, as well as premises for their storage, are equipped with an alarm system.
3.12. The entrance door to the premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances must be metal or wooden, sheathed with iron on both sides with a sheet folded onto the end of the door with an overlap or onto the inner surface of the door, at least 40 mm thick; the framing of the doorway should be made of a steel profile, inside - a lattice metal door.
3.13. Premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with an internal grate on window openings (or a grate between frames) made of a steel bar with a diameter of at least 16 mm. The rods must be welded at each node and form cells no larger than 150x150 mm.
3.14. Access to the production premises, the premises for the storage of goods shall have persons authorized in accordance with the established procedure. Access of unauthorized persons to these premises is excluded.
3.15. The pharmacy organization must be equipped with appropriate light and sound and fire alarms that provide all the conditions for the safety of inventory and compliance with fire safety.
3.16. In pharmacy organizations, a special room (cabinet) should be allocated for the storage of detergents and disinfectants, inventory and materials used in cleaning rooms and processing equipment.
3.18. In the dressing room, outerwear and shoes should be stored separately from sanitary clothes and shoes.
3.19. The pharmacy organization must be equipped with equipment and inventory in accordance with the functions performed:
Production facilities must be equipped with pharmacy furniture, technological and other equipment permitted for use, inventory in accordance with current regulations, taking into account the volume and nature of the pharmacy organization;
All devices, devices used in a pharmacy organization must have technical passports that remain throughout the entire period of operation. It is necessary to regularly calibrate instruments, apparatus used in a pharmacy organization in accordance with the requirements of regulatory documents;
For the storage of narcotic drugs, psychotropic substances in the presence of a license for the right to work with these groups, it is necessary to have safes; for the storage of potent and toxic substances - metal cabinets;
- the trading floor should be equipped with showcases that provide an opportunity to review and preserve medicines and goods of other groups that are allowed to be dispensed from pharmacy organizations, as well as provide convenience for the staff of the pharmacy organization. Open display of non-prescription drugs and other goods allowed for dispensing from pharmacies is possible;
- premises for the storage of medicines and other goods allowed to be dispensed from pharmacies must be equipped with cabinets, racks, pallets, and underwares for their storage; storage rooms for thermolabile drugs should be equipped with equipment that provides the necessary conditions storage;
6.11. For information about medicines and other goods allowed for dispensing from pharmacies, various types of showcases can be used, where medicines sold without a doctor's prescription and samples of available goods are displayed. Medicinal products are displayed separately in showcases: medicinal products for internal use and medicinal products for external use. Within the groups, drugs are arranged according to their pharmacotherapeutic characteristics.
6.12. In self-service halls, the visitor first receives all the necessary information about the OTC drugs of interest to him, other goods allowed for dispensing from pharmacy organizations, from a consultant working in the hall, then he turns to the cashier controller with the selected product.
6.14. Cash registers of a pharmacy organization must be registered in tax authorities at the location of the pharmacy organization in the prescribed manner.
6.15. The buyer has the right to return or replace goods of inadequate quality purchased at a pharmacy organization (with the exception of those goods that are included in the list of non-food goods of good quality that cannot be returned or exchanged for a similar product of a different size, shape, dimension, style, color or configuration in accordance with With current procedure
Requirements for the personnel of pharmaceutical organizations
8.1. Pharmaceutical positions in pharmacy organizations are occupied by specialist pharmacists or pharmacists in accordance with the established procedure.
8.3. In the departments of pharmacy organizations with open form laying out goods and selling goods allowed for dispensing from pharmacy organizations, it is allowed to involve persons with secondary or secondary medical education or higher medical education as consultants.
8.5. Pharmacy personnel must follow the rules of personal hygiene, including the use of special clothing.
8.6. In order to ensure sanitary requirements Pharmacy employees must medical examination according to established order.
8.7. Persons with signs of illness, open wounds are not allowed to work, as long as their state of health may cause a risk of contamination of goods sold in the pharmacy organization.
8.8. Not allowed in industrial premises, as well as at workplaces in the trading floor smoking, eating, storing personal medications, food, drinks, tobacco products.
In accordance with the Temporary Instruction to Order No. 117 of the Ministry of Health and Medical Industry of the Russian Federation dated June 14, 1994 “On the Procedure for Licensing Wholesale Sales of Medicines, Medical Devices, Medical Equipment and Parapharmaceutical Products on the Territory of the Russian Federation”, medical and pharmaceutical products are classified as follows.
1. Medicines (drugs)
Drugs are biologically active drugs obtained on the basis of one or more medicinal substances (substances) and excipients, and approved for use for treatment, anesthesia, pregnancy prevention, prevention and diagnosis of diseases that can affect the functions of the body or the mental state of a person .
LS include:
1) pharmacological agents - substances or a mixture of substances in a specific dosage form with established pharmacological activity, which are objects clinical trials;
2) drugs - dosed drugs in an adequate dosage form for individual use and optimal
design, with a standard composition and an unchanged name, provided with marking and annotation about properties and application.
2. Medical equipment - devices, devices, tools, equipment and consumables used for diagnostics, treatment, prevention and dental care for the population.
3. Medical products, which include:
1) cotton wool and products from cotton wool;
2) gauze and gauze products;
3) non-woven materials and products from them;
4) dressings with an adhesive surface;
5) sanitary products and items for patient care.
4. Parapharmaceutical products are food and similar products containing biologically active substances and having a therapeutic and prophylactic effect, confirmed by a pharmacological conclusion. Parapharmaceutical products include:
1) medical and cosmetic products not intended for decorative purposes;
2) sanitary and hygienic means;
3) mineral waters;
4) dietary and baby food;
5) spectacle optics;
6) diagnostics, reagents for medical, biochemical and clinical laboratories;
7) means for protecting plants from diseases and pests;
8) means of sanitation and hygiene for animals.
In accordance with 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" to goods pharmacy assortment relate:
Medical products, care and hygiene products (medical products, patient care items, hygiene and cosmetic products);
Medical devices and tools;
Spectacle optics products;
Dishes for medical purposes;
Items and means to ensure a healthy lifestyle;
Reagents and diagnostic tools;
Dental and prosthetic devices, tools and materials;
Products and nutritional supplements for therapeutic and prophylactic purposes;
mineral water;
Other goods (first-aid kits, hygrometers, handpieces, headstocks, walkers, etc.).
In accordance with the order of the Ministry of Health of the Russian Federation No. 80 dated March 4, 2003 “On approval of the industry standard “Rules for the release (sale) of non-pharmaceuticals in pharmacy organizations. Basic Provisions” the following products are sold in pharmacies:
Ready-made medicines (including homeopathic ones) by prescription and without a doctor's prescription;
Medicinal preparations made according to the prescriptions of doctors, intra-pharmaceutical procurement, packaged medicinal preparations and medicinal plant materials;
Medicinal plant raw materials in original packaging;
Medical products:
patient care items;
Products of medical equipment, including preventive purposes;
Diagnostic tools;
Therapeutic and prophylactic underwear;
Hosiery, bandages;
childcare items;
First aid kits;
Disinfectants;
Items (means) of personal hygiene (in particular, skin and hair care products, aromatic oils, etc.);
Optics (ready glasses, glasses care products);
Mineral water(natural and artificial);
Therapeutic children's and dietary nutrition (in particular, nutritional supplements for therapeutic and prophylactic purposes, etc.);
Cosmetic and perfumery products.
In addition to goods, pharmaceutical (pharmacy) organizations provide pharmaceutical services free of charge or on a paid basis, the consumers of which may be the population, organizations and institutions.
Product- material products intended for sale and purchase (commercial activity).
Since in commodity science the main ones that describe the consumer properties of goods are regulatory and technical documents, pharmacopoeial articles, specifications, GOSTs and OSTs, it is necessary to adhere to certain standardized terminology.
Basic concepts used in federal law"About Medicines"
Medicinal products - substances used for the prevention, diagnosis, treatment of a disease, prevention of pregnancy, obtained from blood, blood plasma, as well as human or animal organs, tissues, plants, minerals, by synthesis methods or using biological technologies. Medicines also include substances of plant, animal or synthetic origin that have pharmacological activity and are intended for the production and manufacture of medicines (pharmaceutical substances);
Medicinal preparations - dosed medicinal products, ready for use; immunobiological medicinal products - medicinal products intended for immunological prophylaxis and immunological therapy;
· narcotic drugs - drugs included in the list of narcotic drugs compiled and updated in accordance with the Single Convention on Narcotic Drugs of 1961 and the legislation of the Russian Federation;
· psychotropic substances - substances included in the list compiled and updated in accordance with the Convention on Psychotropic Substances of 1971 and the legislation of the Russian Federation;
Classical classification of pharmaceutical products
In the pharmaceutical market, the concept of "pharmaceutical assortment products" has developed, generalizing the groups of products sold through retail and wholesale pharmacy organizations (Appendix 1). First of all, these are medicines, medicines, including homeopathic ones, and medical products.
Homeopathic medicines- single- or multi-component preparations containing, as a rule, microdoses of active compounds, produced according to a special technology and intended for internal, parenteral or topical use in the form of various dosage forms.
Medical products- These are medical devices, auxiliary medical devices, patient care items, other products registered in accordance with the procedure established by law, used to solve health problems.
These are the main range of goods that are traditionally sold from pharmacies and form the basis of the lists of the mandatory range of vital and essential medicines, drugs dispensed free of charge and on preferential terms. Most of this range is sold only from pharmacies, so these products can be conditionally called pharmaceutical.
In connection with the expansion of the product range, a significant number of additional products, or parapharmaceutical products, appeared in pharmacy organizations.
Parapharmaceutical Products- goods of an additional pharmacy range, accompanying medicines and medical products, intended for the prevention and treatment of diseases, alleviating a person's condition, caring for body parts.
Parapharmaceutical products should include products sold to the public for the care of various parts of the body, personal hygiene, disease prevention, maintaining a healthy lifestyle, and some others.
Goods allowed for release from pharmacies, which are mainly sold to medical institutions, research institutes, other enterprises or private entrepreneurs engaged in medical activities, allocated in a separate group - other goods.
By terms of use pharmaceutical products can be:
long-term use (such as sanitary, hygienic, medical devices)
and short-term use (medicines, medicinal raw materials, medical cosmetics and perfumes)
By nature of demand pharmaceutical products are more of a mass market. However, in the group of pharmaceutical products, one can distinguish:
consumer goods.
goods of passive demand. Products in this group are either high-priced or low-priced. quality characteristics, or little is known about the product due to lack of information and lack of advertising.
goods of special demand (exclusive demand) with unique properties, the acquisition of which requires additional efforts and costs on the part of buyers.
goods of selective demand, the acquisition of which is associated with a preliminary assessment of the existing assortment and the subsequent selection of goods by comparison in terms of quality, design, price, manufacturer, country.