Home Coated tongue Procedure for dispensing medicines. The procedure for dispensing drugs in pharmacies. A note from the pharmacy organization regarding the dispensing.

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Procedure for dispensing medicines. The procedure for dispensing drugs in pharmacies. A note from the pharmacy organization regarding the dispensing.

In connection with incoming requests for the application of the norms of Order No. 403n dated July 11, 2017 “On approval of vacation rules medicines For medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs licensed to pharmaceutical activities"(hereinafter referred to as order No. 403 n, Procedure) Ministry of Health Russian Federation reports the following:

1. On the issue of dispensing a drug according to a prescription, the validity of which has expired while it was on deferred maintenance (clause 9 of the Procedure).

The norm provided for in paragraph 9 of the Procedure applies to all groups of drugs, including those subject to subject-quantitative registration, with the exception of narcotic and psychotropic drugs included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved Decree of the Government of the Russian Federation of June 30, 1998 No. 681 (hereinafter referred to as the list).

For the above-mentioned narcotic and psychotropic drugs, the norm provided for in Part 6 of Article 25 of the Federal Law of January 8, 1998 No. Z-FZ “On Narcotic Drugs and Psychotropic Substances” applies, regarding the prohibition of their dispensing on prescriptions written out more than fifteen days ago.

2. On the issue of dispensing immunobiological drugs (clauses 3 and 13 of the Procedure).

In accordance with paragraph six of paragraph 3 of the Procedure, the dispensing of immunobiological medicinal products according to prescriptions is carried out only by pharmacy organizations (pharmacies, pharmacy points).

This norm is regulated by paragraph 3 of Article 12 of the Federal Law of September 17, 1998 No. 157-FZ “On Immunoprophylaxis of Infectious Diseases”, according to which immunobiological drugs for immunoprophylaxis are dispensed to citizens according to a prescription for the drug by pharmacies in the manner established by the federal body executive power, carrying out the functions of developing and implementing state policy and legal regulation in the field of healthcare.

When dispensing immunobiological medicinal products, the requirements provided for in paragraph 13 of the Procedure must be observed. At the same time, in addition to thermal containers, other devices can be used to preserve temperature regime, necessary for storing an immunobiological medicinal product for the period of its delivery to a medical organization.

3. On the issue of storing prescriptions for medications (clause 14 of the Procedure).

Order No. 403 n does not introduce a rule on the need for patients to obtain prescriptions for medications that are duly registered as over-the-counter drugs and have a corresponding entry in the instructions for medical use “Dispensed without a prescription.”

Medicines are classified as prescription or over-the-counter at the stage of their state registration, the conditions of release are indicated in the registration documents for medicinal products, including in the instructions for medical use.

Order No. 403 n regulates only the shelf life of recipes and does not introduce additional restrictions on the circulation of the above medicines.

Clause 14 of the Procedure introduced a new rule on storing prescriptions for three months in pharmacy organization or from an individual entrepreneur with a license for pharmaceutical activities:

for drugs in liquid dosage form containing more than 15% ethyl alcohol on the volume of finished products;

for medicinal products related to anatomical and therapeutic chemical classification recommended by the World Health Organization (hereinafter referred to as ATC), to antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives(code N05C), antidepressants (code N06A) and not subject to subject-quantitative accounting.

At the same time, please note that prescriptions for medications of the above groups, written out on prescription forms of form No. 107-1/u, are subject to storage, both with a validity period of up to 60 days and with a validity period of up to 1 year. In the latter case, the prescription remains and is stored for a specified period after the last batch of the drug has been dispensed to the patient.

Information on the percentage of ethyl alcohol in liquid dosage forms of drugs, as well as on the compliance of drugs with certain ATC groups is also contained in the instructions for medical use of a particular drug.

For example, drugs with international non-proprietary names Chlorpromazine (Aminazine) and Chlorprothixene (Chlorprothixene, Truxal) belong to the group of antipsychotic drugs (code N05A), with the international nonproprietary names Tofisopam (Grandaxin) and Bromo(Phenazepam, Elzepam, Fezanef ", "Phenorelaxan", etc.) - to the group of anxiolytics (code N05B), with international non-proprietary names Amitriptyline ("Amitriptyline"), Sertraline ("Zoloft", "Serenata", "Aceptra", etc.) and Escitalopram (" Selectra”, “Lenuxin”, “Elycea”, etc.) - to the group of antidepressants (code N06A).

4. On the issue of dispensing narcotic and psychotropic medications (clause 20 of the Procedure).

Clause 20 of the Procedure clarifies the norm regarding persons entitled to receive narcotic and psychotropic drugs included in List II of the list. So, these drugs can be received:

patients to whom the specified medications are prescribed; their legal representatives (if the patients are minors or incompetent);

other persons with a power of attorney from the patient, drawn up in accordance with the legislation of the Russian Federation.

Regarding the power of attorney from the patient to receive narcotic and psychotropic medications, we note that it is drawn up in simple written form (Article 185 of the Civil Code of the Russian Federation) and can be notarized at the request of the patient or if it is impossible for him to write a power of attorney (Articles 163 and 185.1 of the Civil Code Russian Federation). Moreover, if the power of attorney does not indicate its validity period, it remains valid for a year from the date of its signing.

Taking care of your health increases the population's demand for medicines various groups. Pharmaceutical industry tends to grow and increase annual sales turnover by 4-5 percent. Over-the-counter dispensing of medicines allows consumers to independently select medications without prior consultation with specialists.

Concept of medicines

Medicines are substances of natural and synthetic origin that are used to restore damaged and lost body functions, treat and prevent diseases. These drugs also include drugs to prevent unwanted pregnancy(contraceptives).

All medications can have both therapeutic and side effects. This is expressed by the following states:

drug addiction;
drug allergies;
intoxication;
side effect.

The effect of drugs on the body directly depends on their ability to maintain a certain concentration in organs and tissues, which is due to absorption, distribution, chemical transformation and excretion.

Classification of drugs

All existing medications are grouped according to the following indicators:

Medicinal use. For example, drugs for the treatment of neoplasms, increased blood pressure, antimicrobial.
Pharmachologic effect. For example, vasodilators dilate blood vessels, antispasmodics eliminate the presence of spasm of tissues and blood vessels, analgesics relieve pain.
Chemical structure. Drugs based on the same active substance are combined according to this principle. For example, salicylates include “Salicylamide”, acetylsalicylic acid, "Methyl salicylate".
Nosological principle. The drugs are combined according to the principle necessary funds for the treatment of a specific disease (drugs for the treatment of angina pectoris, drugs to combat bronchial asthma).

Classification according to M. D. Mashkovsky

The academician proposed dividing medications into groups (see table).

Group of drugs	Subgroups	Examples of drugs
Acting on the central nervous system	Psychotropic, anesthetic drugs, anticonvulsants, analgesics, antipyretics, antitussives, drugs for the treatment of parkinsonism	"Gidazepam", "Methoxyflurane", "Phenytoin", "Analgin", "Codeine", "Gludantan"
Acting on efferent innervation	Anticholinergics, ganglion blockers, curare-like.	"Atropine", "Scopolamine", "Benzohexonium", "Pentamine", "Arduan", "Pavulon"
Having an effect on sensitive receptors, including the mucous membrane and skin	Local anesthetics, adsorbents, enveloping agents, laxatives, emetics, expectorants	"Lidocaine", "Enterosgel", "Maalox", "Bisacodyl", ipecac syrup, "Lazolvan"
Affecting the functioning of the cardiovascular system	Cardiac glycosides, antihypertensive, antiarrhythmic, antianginal, cardioprotectors	"Digoxin", "Magnesium sulfate", "Novocainamide", "Nitroglycerin", "Verapamil"
Aimed at strengthening the excretory function of the kidneys	Saluretics, potassium-sparing agents, osmotic	"Furosemide", "Veroshpiron", "Manit"
Choleretic	Choleretics, cholekinetics, cholespasmolytics, agents that reduce the lithogenicity of bile	"Allohol", "No-Shpa", "Platifillin", "Ursofalk"
Affecting the uterine muscles	Tocolytics, stimulants	"Fenoterol", "Oxytocin"
Affecting metabolic processes	Hormones, enzymes, vitamins, biogenic agents, histamine, antihistamines	"Testosterone propionate", "Lidaza", "Pyridoxine hydrochloride", "Biosed", "Histamine", "Loratadine"
Possessing antimicrobial action	Antibiotics, sulfonamides, antiviral, antituberculosis, nitrofuran derivatives, antiseptics	"Clarithromycin", "Sulfadimethoxine", "Anaferon", "Isoniazid", "Furazolidone", "Hydrogen Peroxide"
Antitumor	Cytostatic, immunomodulators, cytokines, hormonal	"Busulfan", "Thimogen", "Interferon", "Estrogen"
Used for diagnostic activities	Sera, diagnostic antigens, bacteriophages	Similar to subgroups

Features of self-medication

The over-the-counter supply of medications is the motive for self-medication - the process of independent selection of drugs and treatment regimens by the population. According to the requirements of the World Health Organization, medications sold without a doctor's prescription must meet the following criteria:

the active and auxiliary substances in the composition must have low toxicity;
active ingredients must be acceptable for use as self-help and self-therapy without additional consultations specialists;
minimal number of side effects;
no risk of physiological addiction;
lack of mutual inhibition when used with other medications and foods.

The list of over-the-counter medicines is approved by order of the Ministry of Health.

Conditions for dispensing drugs

Prescription and over-the-counter dispensing of medicines requires initial state registration of medicines. This is carried out by the Ministry of Health after submitting an application and based on the results of a medical examination. At the end of the process, the drugs can be used in the country for five years.

However, there are funds that are not registered. This includes medications manufactured in pharmacies on the basis of a doctor’s prescription or a written request from a medical institution.

Over-the-counter dispensing of medicines is possible only in pharmacies, pharmacy points and departments that have the appropriate license. The following over-the-counter forms may also be sold at pharmacies:

optics;
medical products;
disinfectants;
personal hygiene products;
mineral water;
baby food;
medicinal cosmetics.

Over-the-counter sales department

In pharmacies or departments that have the appropriate license, there must be a special department in which over-the-counter medicines are dispensed. The functions of this department are:

regular ordering of goods from trusted suppliers;
organizing the necessary conditions for storing goods (shelves, refrigerators);
establishing optimal prices;
effective sale of various groups of medicines to the population;
training customers on how to use medicines and how to store medicines at home.

Regulations for the over-the-counter dispensing of medicines indicate that such a department should be located on the territory of the sales area. It should be decorated with floor and table displays for displaying medicines, which is an advertisement of drugs to the population.

The department's assortment includes:

medications whose instructions indicate that the drugs are dispensed without a doctor’s prescription;
homeopathic remedies;
biological active additives.

Homeopathic remedies

Over-the-counter dispensing of medicines (Order No. 578 dated September 13, 2005 approves the list of such medicines) includes the group homeopathic remedies. These are drugs that have low concentrations of substances that, in large doses, cause phenomena similar to signs of the disease.

The World Health Organization emphasizes that homeopathy is not the treatment of choice for infectious and other serious diseases.

The main active substance is diluted to decimal or hundredths. In parallel with dilution, shaking and rubbing are carried out, which enhances the healing properties.

The homeopathic method of therapy is considered safe, since in addition to a small amount of the main substance, such products also contain water, alcohol and sugar.

The most popular homeopathic ingredients include:

belladonna;
traumeel;
echinacea;
pulsatilla;
arnica;
apis.

dietary supplements

Over-the-counter medicines include a group of dietary supplements. These are substances that are introduced into the diet and added to products. The drugs can be produced in the form of tablets, capsules, pills, solutions, and chewing gums.

The composition of the drugs includes:

vitamins;
extracts of medicinal plants;
minerals;
metabolites;
amino acids.

Dietary supplements are not allowed for sale in the following cases:

have not passed state registration;
there is no declaration of conformity;
do not meet sanitary and hygienic requirements;
the expiration date has expired;
none the necessary conditions storage and sale;
there is no label, which means there is no necessary data about the product.

Over-the-counter products

Below are examples of well-known and effective drugs, sold without a doctor's prescription.

For sore throat:

"Septolete";
"Faringosept";
"Falimint";
"Gramicidin S";
"Tonsilgon N".

Available in the form of lozenges and lozenges for resorption based on antiseptics with the addition essential oils, menthol and other plant components.

For leg pain:

"Lioton";
"Troxevasin";
"Eskuzan."

Available in forms for oral administration and ointments, gels for external application.

For pain in muscles, joints, back:

"Nimesil";
"Fastumgel";
"Finalgon".

In most cases, sleeping pills are not available without a prescription. This especially applies to potent drugs. To combat insomnia, mild sedative medications based on valerian and those that have a calming effect on cardiovascular system("Corvalol", "Valocordin").

The exception when sleeping pills can be bought without a prescription are the drugs Melaxen and Donormil.

For a runny nose:

"Pinosol";
"Umkalor";
"Sinupret".

Against cough:

"Ambroxol";
"Acetylcysteine";
"Bromhexine";
"Butamirat";
"Guaifenesin."

To combat heartburn:

"Renny";
"Pepphys";
"Motilak";
"Rutacid."

Documentation

The procedure for over-the-counter drug dispensing is regulated by the following documents:

Law No. 86 of 1998 on Medicines.
Order No. 287 of 1999 "On the list of drugs dispensed without a doctor's prescription."
Order No. 578 of 2005 "On the list of medicines dispensed without a doctor's prescription."
Order No. 117 of 1997 "On the procedure for examination and certification of dietary supplements."
Decree No. 982 of 2009 "On the list of products that are subject to mandatory certification."
SanPin 2.3.2.1290-03 "Hygienic requirements for the organization of production and sale of dietary supplements."

Conclusion

Modern economic conditions and the increasing need of the population for medicines are increasing the growth of self-medication. In turn, the qualifications of pharmacists are growing, because it is necessary not only to sell medications, but also to teach the population how to use and store them correctly.

Over-the-counter products are promoted to consumers through interesting and accessible information on pharmacy shelves and in the package inserts of the drugs themselves. High-quality advertising will reduce the possibility of development side effects and protect the population.

Free choice allows you to strengthen trust in the pharmacist and medicines, which is the basis for the growing popularity of self-medication in the future.

Registered with the Ministry of Justice of the Russian Federation on January 16, 2006.
Registration N 7353

In accordance with Article 32 of the Federal Law of June 22, 1998 N 86-FZ “On Medicines” (Collection of Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2003, N 27, Art. 2700; 2004, N 35 , art. 3607) I order:

1. Approve the attached Procedure for dispensing medicines.

2. Recognize as invalid Appendix 3 “List of medicines subject to subject-quantitative accounting in pharmacies/organizations, drug wholesalers, medical institutions and private practitioners**” and Appendix 4 “Procedure for dispensing medicines in pharmacies” /organizations", approved by order of the Ministry of Health of the Russian Federation of August 23, 1999 N 328 "On the rational prescribing of medicines, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies (organizations)" (registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), with amendments and additions made by order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 206 (registered with the Ministry of Justice of the Russian Federation on June 5, 2003 N 4641) and by order of the Ministry of Health and social development Russian Federation dated March 16, 2005 N 216 (registered with the Ministry of Justice of the Russian Federation on April 8, 2005 N 6490).

Minister M. Zurabov

Procedure for dispensing medicines

I. General provisions

1.1. This Procedure determines the requirements for the dispensing of medicines by pharmacies (organizations)*, regardless of their organizational and legal form, form of ownership and departmental affiliation.

1.2. Medicinal products are subject to dispensing by pharmacies (organizations), including narcotic drugs, psychotropic, potent and toxic substances registered in the Russian Federation in accordance with the established procedure.

1.3. Medicines are dispensed with a doctor's prescription and without a doctor's prescription by pharmacies (organizations) licensed for pharmaceutical activities.

1.4. Medicines prescribed by doctor must be dispensed by pharmacies and pharmacy points.

Medicines in accordance with the List of medicines dispensed without a doctor's prescription, approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 13, 2005 N 578 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7053) (hereinafter referred to as the List medicines dispensed without a doctor's prescription) are subject to sale by all pharmacies (organizations)*.

1.5. For uninterrupted supply population with medicines, pharmacies (organizations) are required to have available minimum assortment medicines necessary to provide medical care, approved by order of the Ministry of Health and Social Development of the Russian Federation dated April 29, 2005 N 312.

II. General requirements for dispensing medicines

2.1. All medicines, with the exception of those included in the List of medicines dispensed without a doctor's prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms.

2.2. According to prescriptions written on prescription forms, the forms of which are approved by order of the Ministry of Health of the Russian Federation of August 23, 1999 N 328 (registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), pharmacies (organizations) dispense:

Narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, No. 663; No. 47, Art. 4666) (hereinafter referred to as the List), prescribed on special prescription forms for narcotic drugs;

Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/u-88;

Medicines subject to subject-quantitative accounting in pharmacies (organizations), drug wholesale trade organizations, medical institutions and private practitioners, the List of which is provided in Appendix No. 1 to this Procedure (hereinafter referred to as medicines subject to subject-quantitative accounting) , written out on prescription forms N 148-1/у-88;

Medicines included in the List of medicines dispensed on prescription from a doctor (paramedic) when providing additional free medical care to certain categories of citizens entitled to receive state social assistance, approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 28, 2005 N 601 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7052) (hereinafter referred to as medicines included in the List of medicines dispensed by prescription ( paramedic), as well as other medicines dispensed free of charge or at a discount, prescribed on prescription forms of form N 148-1/u-04 (l);

Anabolic steroids prescribed on prescription forms, form N 148-1/u-88;

Other medicines not included in the List of medicines dispensed without a doctor's prescription, prescribed on prescription forms, form N 107/u.

2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II of the List are valid for five days.

Prescriptions for psychotropic substances included in List III of the List; medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances , included in List III of the List, for medicines subject to subject-quantitative registration, for anabolic steroids are valid for one month.

Prescriptions for other medicines are valid for two months from the date of issuance of the prescription and up to one year in accordance with paragraph 2.19 of the Instructions on the procedure for prescribing medicines and writing prescriptions for them, approved by order of the Ministry of Health of the Russian Federation dated August 23, 1999 N 328 ( (hereinafter - Instructions).

2.4. Pharmacy establishments (organizations) are prohibited from dispensing drugs on expired prescriptions, with the exception of drugs on prescriptions that expired while the prescriptions were on deferred service.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines, the dispensing rates of which are specified in Appendices 1 and 3 to the Instructions.

2.6. When dispensing medicines according to a doctor's prescription, an employee of a pharmacy institution (organization) makes a note on the prescription about the dispensing of the drug (name or number of the pharmacy institution (organization), name and dosage of the drug, quantity dispensed, signature of the dispenser and date of dispensing).

2.7. If a pharmacy institution (organization) has medications with a dosage different from the dosage prescribed in the doctor’s prescription, the employee of the pharmacy institution (organization) may decide to dispense the available medications to the patient if the dosage of the drug is less than the dosage specified in the prescription doctor, taking into account recalculation for the course dose.

If the dosage of a medicinal product available in a pharmacy institution (organization) exceeds the dosage specified in the doctor’s prescription, the decision to dispense the medicinal product to the patient is made by the doctor who wrote the prescription.

The patient is provided with information about changing the single dose of the drug.

2.8. In exceptional cases, if it is impossible for a pharmacy institution (organization) to fulfill the doctor’s (paramedic’s) prescription, violation of the secondary factory packaging is allowed.

In this case, the medicinal product must be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the medicinal product, series and date according to the laboratory packaging register and providing the patient with other necessary information (instructions, package insert, etc.).

Tampering with the original factory packaging of medicines is not allowed.

2.9. When dispensing medicines according to a doctor’s prescription valid for one year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy institution (organization), the signature of the employee of the pharmacy institution (organization), the quantity of the drug dispensed and the date of dispensing.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account. Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization).

2.10. In exceptional cases (the patient leaves the city, the inability to regularly visit a pharmacy institution (organization), etc.), pharmaceutical workers of a pharmacy institution (organization) are allowed to make a one-time dispensing of a medicine prescribed by a doctor according to prescriptions valid for one year, in an amount necessary for treatment for two months, with the exception of medicines subject to subject-quantitative accounting.

2.11. If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can carry out its synonymous replacement with the consent of the patient.

When dispensing a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as another medicinal product dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) can make a synonymous replacement of the medicinal product in agreement with the doctor who wrote the prescription. .

2.12. Prescriptions for medicines marked “statim” (immediately) are processed within a period not exceeding one working day from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines marked “cito” (urgent) are processed within a period not exceeding two working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines included in the minimum range of medicines are processed within a period not exceeding five working days from the moment the patient contacts the pharmacy institution (organization).

2.13. Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic) and not included in the minimum range of medicines are serviced within a period not exceeding ten working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines prescribed by decision of a medical commission approved by the chief physician of a medical institution are processed within a period not exceeding fifteen working days from the moment the patient contacts the pharmacy institution (organization).

2.14. Prescriptions for medicines subject to subject-quantitative accounting; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroids remain in the pharmacy institution (organization) for subsequent separate storage and destruction after the expiration of the storage period.

2.15. The pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage for medicines that are subject to subject-quantitative accounting; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroid.

2.16. The shelf life of prescriptions in a pharmacy institution (organization) is:

For medicines included in the List of Medicines dispensed on prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount - five years;

For narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List - ten years;

For medicines subject to subject-quantitative registration, with the exception of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List; anabolic steroids - three years.

After the expiration of the storage period, the recipes are subject to destruction in the presence of the commission, about which acts are drawn up, the form of which is provided for in Appendices No. 2 and No. 3 to this Procedure.

The procedure for the destruction of prescriptions left in a pharmacy institution (organization) after the established storage period has expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

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 cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration, approved by the Decree of the Government of the Russian Federation dated January 19, 1998 No. 55 (Collection of Legislation of the Russian Federation, 1998, No. 4, Art. 482; No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, Art. 584; 2003, No. 29, Art. . 2998; 2005, N 7, art.

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18. Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; alcohol-containing medicines industrial production are canceled with the stamp of the pharmacy institution (organization) “Medicine 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 remain in the pharmacy institution (organization), are canceled with the stamp “Prescription is invalid” and are registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and are returned to the patient.

Information about all incorrectly prescribed prescriptions is brought to the attention of the head of the relevant medical institution.

2.20. Pharmacy institutions (organizations) carry out separate accounting of medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and to citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the supply of narcotic drugs and psychotropic substances; medicines subject to subject-quantitative accounting; anabolic steroids

3.1. Drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List are subject to dispensing by pharmacies (organizations).

3.2. The right to work with narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, are only available to pharmacy institutions (organizations) that have received the appropriate licenses in the manner prescribed by the legislation of the Russian Federation.

3.3. Dispensing narcotic drugs and psychotropic substances to patients. included in List II of the List, and psychotropic substances included in List III of the List, are carried out by pharmaceutical workers of pharmacy institutions (organizations) who have the right to do so in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated May 13, 2005 N 330 (registered in the Ministry of Justice of the Russian Federation on June 10, 2005 N 6711).

3.4. In a pharmacy institution (organization), the dispensing of narcotic drugs and psychotropic substances included in List II of the List is carried out by patients assigned to a specific outpatient clinic, which is assigned to the pharmacy institution (organization).

The assignment of an outpatient clinic to a pharmacy institution (organization) can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances.

3.5. Narcotic drugs and psychotropic substances included in List II of the List prescribed by a doctor are dispensed to the patient or the person representing him upon presentation of an identity document issued in the prescribed manner.

3.6. Narcotic drugs and psychotropic substances included in List II of the List and included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on a special prescription form for a narcotic drug, and a prescription written out on the prescription form form N 148-1/u-04 (l).

Psychotropic substances included in List III of the List, medicines subject to subject-quantitative recording, anabolic steroids included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on a prescription card. form N 148-1/у-88, and a prescription written out on the prescription form form N 148-1/у-04 (l).

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; medicines subject to subject-quantitative accounting; anabolic steroids according to veterinary prescriptions medical organizations for treating animals.

3.8. Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products included in the composition of a combination medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed.

3.9. A pharmacist at a pharmacy institution (organization), upon receipt of a prescription for an individually manufactured medicinal prescription, is obliged to dispense a medicinal product subject to subject-quantitative recording in half the highest single dose in the event of a doctor’s failure to comply with the established rules for filling out a prescription or in the case of a doctor prescribing medicinal products in a dose exceeding highest single dose.

3.10. When producing extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, in accordance with prescriptions written by a doctor, the pharmacist of the pharmacy institution (organization) signs on the prescription for issuance, and the pharmacist of the pharmacy institution (organization) - on receipt of the required quantity of medicinal products .

3.11. Ethyl alcohol is released:

According to prescriptions written by doctors with the inscription “For application of compresses” (indicating required dilution with water) or “For leather treatment” - up to 50 grams in pure form;

According to prescriptions written by doctors for individually prepared medicinal prescriptions - up to 50 grams in the mixture;

According to prescriptions written by doctors for individually prepared medicinal prescriptions, with the inscription “According to special purpose", separately certified by the signature of the doctor and the seal of the medical institution "For prescriptions", for patients with chronic course diseases - up to 100 grams in the mixture.

3.12. When dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; extemporaneous medicinal products containing medicinal products subject to subject-quantitative registration, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black font on it “Signature”, the form of which is provided for in Appendix No. 5 to this Procedure.

IV. Control over the dispensing of medicines by pharmacies (organizations)

4.1. Internal control over compliance by employees of a pharmacy institution (organization) with the procedure for dispensing medicines (including those subject to subject-quantitative accounting; medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount) is carried out by the head (deputy head) of a pharmacy institution (organization) or a pharmaceutical employee of a pharmacy institution (organization) authorized by him.

4.2. External control of compliance by pharmacies (organizations) with the procedure for dispensing medicines is carried out Federal service for supervision in the field of health care and social development and authorities for control of the circulation of narcotic drugs and psychotropic substances within their competence.

________________

* Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

Order of the Ministry of Health of Russia dated July 11, 2017 No. 403n “On approval of the Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities” (hereinafter referred to as the Order) came into force in September. Everyone had been waiting for this order for a long time; its drafts had been in existence for about three years. This order canceled the effect of order No. 785. I note that the order applies not only to pharmacy employees, but also to doctors.

The order approved the rules for dispensing drugs without a prescription, with a prescription, according to the requirements of medical organizations and invoices. individual entrepreneurs who have a license to practice medicine.

Already following the order, clarifications from the Russian Ministry of Health dated September 27, 2017 were issued, which regulated certain provisions of Order No. 403n. But questions still remain.

The order determined which pharmacies can dispense prescription and over-the-counter drugs. Let me remind you that all pharmacy organizations (pharmacies and kiosks) and individual entrepreneurs with a license to carry out pharmaceutical activities can dispense without a prescription. Prescription drugs still cannot be sold by pharmacy kiosks and individual entrepreneurs with a pharmaceutical license. As for the dispensing of narcotic and psychotropic drugs, they can be dispensed by pharmacies and pharmacy points that have a license to operate in the circulation of such drugs.

The order presented an unpleasant surprise regarding the vacation immunobiological preparations. According to the new order, pharmacies and pharmacy points can dispense them, while individual entrepreneurs are denied the right to dispense immunobiological drugs. In the clarification of the Russian Ministry of Health on this issue, reference is made to the federal law No. 157-FZ (which says that vacation individuals immunobiological preparations can only be supplied by pharmacies). Formally, nothing can be done about the fact that individual entrepreneurs are not included in the list of those who are allowed to dispense immunobiological drugs, because from a legal point of view, individual entrepreneurs are not organizations. Organizations are legal entities. Although this is justified formally, I don’t think it is morally justified. Let me remind you that the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Article 12) states that individual entrepreneurs are equated to pharmaceutical organizations in order to comply with the law. That is, their responsibilities are the same as those of legal entities, and much less rights. I believe that if the issue of dispensing immunobiological drugs is relevant for individual entrepreneurs, it makes sense to defend their rights to dispense them by making official requests to the Ministry of Health. My advice is to emphasize in your letters and appeals that by dispensing immunobiological drugs, you are improving the availability of these drugs to the population. The definition of an immunobiological drug is given in Federal Law No. 61-FZ (Article 4).

RULES AND PROCEDURE FOR WRITING PRESCRIPTIONS

Let me remind you that we have rules and procedures for writing prescriptions for medicines. The order of the Ministry of Health of Russia dated 01.08.12 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules” is still in effect. The recipe is prepared in accordance with the rules of the adj. No. 2 (hereinafter referred to as the Rules). The order of registration remains the same.

√ Appendix No. 2 to the order of the Ministry of Health of Russia No. 54n.

The prescription form must be filled out legibly, clearly, using ink or a ballpoint pen or using a printing device. Corrections when filling out the prescription form are not allowed. One name of narcotic (psychotropic) drug is written on one prescription form. The quantity of narcotic (psychotropic) drugs prescribed on the prescription form is indicated in words. The method of taking a narcotic (psychotropic) drug is indicated in Russian or in Russian and state languages republics that are part of the Russian Federation.

The prescription form is stamped medical organization(indicating the full name of the medical organization, its address and telephone number) and the date of issuing a prescription for a narcotic (psychotropic) drug.

The recipe is certified:

for the initial appointment - with the signature and personal seal of the doctor/signature of the paramedic (midwife);
signature of the manager (deputy or manager structural unit or a person authorized by the head) of the medical organization that issued a prescription for a narcotic (psychotropic) drug (indicating his last name, first name, patronymic);
seal of the medical organization (structural unit) “For prescriptions”;
when re-prescribing, you must indicate “Repeated” in the upper left corner of the prescription; certify with the signature and personal seal of a doctor/signature of a paramedic (midwife); seal of the medical organization (structural unit) “For prescriptions”.

Let me remind you that more than a year ago, the certification of prescriptions with the legal seal of a medical organization for drugs from List II was canceled.

Narcotic and psychotropic drugs of Schedule II, with the exception of drugs in the form of transdermal therapeutic systems(TDTS), are issued upon presentation of an identification document: to the person indicated in the prescription, his legal representative, or a person who has a power of attorney issued in accordance with the legislation of the Russian Federation for the right to receive such narcotic and psychotropic drugs. The power of attorney is issued in simple written form (Article 185 of the Civil Code of the Russian Federation) and can be notarized at the request of the patient or if it is impossible for him to write a power of attorney (Articles 163 and 185.1 of the Civil Code of the Russian Federation); the validity period is indicated in the power of attorney; if not specified, then 1 year from the date of its signing (clarification of the Russian Ministry of Health). When dispensing narcotic and psychotropic drugs of List II and psychotropic drugs of List III, a signature is issued with a yellow stripe at the top and the inscription in black font: “Signature”.

Nowhere in regulatory documents It does not say that the pharmacy must copy, take into account or take away these powers of attorney. There is no need to do this.

The order canceled the effect of order No. 785 - now there is no assignment to a specific pharmacy for the dispensing of narcotic drugs, psychotropic substances and their precursors from List II. A pharmacy organization must now service prescriptions for such drugs prescribed by any medical organization anywhere in the Russian Federation. The main thing is that the recipe is prepared according to the current rules.

The norm for vacation without prescription drugs that contain narcotic drugs, psychotropic substances and their precursors. Previously, the norm was no more than 2 packages; Now the same Corvalol and others like it can be dispensed in the quantities required by the person who contacts the pharmacy.

As for issuing prescriptions on form No. 148-1/u-88, the Rules for issuing prescriptions are in effect, approved by Order of the Ministry of Health of Russia dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for completing the specified forms, recording and storing them.” In accordance with it, on the prescription form No. 148-1/u-88, narcotic and psychotropic drugs of List II in the form of TDTS, psychotropic drugs of List III, other drugs subject to PCU, drugs with anabolic activity related to ATC are prescribed anabolic steroids(code A14A) - (order of the Ministry of Health of Russia dated 07.11.17 No. 403n), drugs specified in paragraph 5 of the order of the Ministry of Health and Social Development of Russia dated 05.17.12 No. 562n, individually manufactured drugs containing NS or PV of List II and other pharmacological active substances.

√ Order of the Ministry of Health No. 183n dated April 22, 2014:

potent and toxic drugs in the PKU list (extract): Sodium thiopental, Tramadol (Tramal), Trihexyphenidyl (Cyclodol), Gestrinone (nemestran), 1-Testosterone (Sustanon-250, Omnadren-250, Nebido), Sibutramine (Goldline, Slimia, Syndax), ethyl alcohol (Ethanol), etc.;
combined drugs containing, in addition to small quantities of NS, PIs and their precursors, other pharmacologically active substances (clause 5 of the order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n);
other drugs subject to subject-quantitative accounting: Pregabalin (Algerica, Lyrica, Prabegin, Pregabalin canon), caps.; Tropicamide (Mydriacyl, Tropicamide), eye drops; Cyclopentolate (Cyclomed, Cycloptic), eye drops.

CHANGES CONCERNING THE RULES FOR DRUG DISpensing

First, a mark is made on the prescription about the dispensing of the drug: a stamp (or mark) is placed on all prescriptions: "The drug has been released"(clauses 14, 15 of the Order), indicate the name of the pharmacy organization / full name. individual entrepreneur, trade name, dosage and quantity of the drug dispensed.

FULL NAME. a medical worker is indicated in cases of dispensing drugs of a higher dosage (paragraph 4 of clause 7 of the Rules), one-time dispensing of drugs on a prescription, the validity of which is 1 year, indicating the frequency of dispensing (paragraph 3 of clause 10 of the Rules).

The details of the identity document of the person who received narcotic or psychotropic drugs of List II (except for TDTS) are indicated (clause 20 of the Rules), full name. the pharmaceutical worker who dispensed the drug and his signature, the date of issue of the drug, a round seal of the joint-stock company is affixed, the imprint of which must identify the full name of the joint-stock company when dispensing narcotic or psychotropic drugs of list II (clause 12 of the Order and appendix 2 to the order of the Ministry of Health of Russia No. 54n ).

When dispensing a medicinal product, the pharmacist informs the person purchasing (receiving) the drug about the regimen and doses of its administration, storage rules at home, and interactions with other drugs. When dispensing, a pharmacist does not have the right to provide false and (or) incomplete information about the availability of medicinal products, including medicinal products that have the same INN, incl. hide information about the availability of drugs that have more low price.

The sale of falsified, substandard and counterfeit drugs is prohibited. - It is prohibited for a retail trade entity to dispense medicinal products specified in clause 4 of these Rules (prescription dispensing) according to prescriptions from veterinary organizations.

As for the shelf life of prescriptions in the pharmacy, this is where the most surprises await us in paragraph 14 of the Order.

If a prescription is issued for narcotic drugs or psychotropic substances of Schedule II, except for TDTS, in the form of prescription form No. 107-1/u-NP, then the validity of the prescription is 15 days, the shelf life is 5 years. For medicines containing List III pharmaceuticals and Schedule II pharmaceuticals in the form of TDTS, the shelf life is also 15 days and 5 years, respectively. The validity period of medicines subject to PCU is 15 days, and the shelf life is 3 years.

Medicines containing potent and toxic substances, combined drugs... (clause 5 of the Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n), other drugs subject to PCU: Pregabalin, Tropicamide, Cyclopentolate, drugs with anabolic activity (ATC code A14A) , written out on prescription form No. 148-1/u-88 - prescription validity - 15 days, shelf life - 3 years.

Medicines dispensed free of charge or at a discount, prescribed on form No. 148-1/u-04 (l), No. 148-1/u-06 (l), - the validity of prescriptions is 30/90 days, and the shelf life in a pharmacy - 3 years.

Medicines not subject to PCU: containing more than 15% ethyl alcohol by volume, antipsychotics (ATC code No. 05A), anxiolytics (ATC code No. 05B), hypnotics and sedatives (ATC code No. 05C), antidepressants (ATC code No. No. 06A according to ATC), written out on the prescription form No. 107-1/u, - prescription validity is 60 days/1 year, shelf life in the pharmacy is 3 months after the last batch of drugs is dispensed to the patient ( clarifications from the Russian Ministry of Health).

Other prescription medications for a patient with a chronic disease have a shelf life of 60 days to 1 year and the prescriptions are returned to the patient.

The simplest way to prove that a prescription has been serviced and will be returned to the patient is to make a copy of it with a pharmacy stamp. If it is not possible to copy, it makes sense to enter information about this in the journal. Or do nothing until there are clear instructions from the Ministry of Health on this issue.

STORING RECIPES IN THE PHARMACY

After the adoption of the Order, many questions arose regarding the order in which recipes were stored.

The order of storage and subsequent destruction of prescriptions in pharmacies is not approved by the Order. A pharmacy organization (PI) must (can) develop and approve an internal document regulating the procedure for storing prescriptions left in the pharmacy and the procedure for their subsequent destruction.

Clause 2.16 approved by Order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No. 785 of the Procedure for Dispensing Medicines with adj. No. 2 and 3 (forms of acts on the destruction of prescriptions for obtaining NS and PV; medicines subject to PCU, and within the framework of DLO upon expiration of their storage periods).

On the norms for prescribing narcotic and psychotropic drugs and other drugs that are subject to subject-quantitative accounting.

Adj. 1 to the order of the Russian Ministry of Health No. 1175. When prescribing narcotic and psychotropic drugs of Lists II and III, other drugs subject to PCU, the dose of which exceeds the highest single dose, medical worker writes the dose of this drug in words and puts an exclamation point.

The drug is dispensed in the quantity specified in the prescription, except in cases where the maximum permissible or recommended quantity for prescription per prescription is established for the drug (Appendices No. 1 and 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n).

When presenting a prescription that exceeds the maximum permissible or recommended amount of a medicinal product, the pharmacist:

informs the person who submitted the prescription about this;
dispenses the drug in the established maximum permissible or recommended quantity;
makes a note in the prescription about the amount of the drug dispensed;
informs the head of the relevant medical organization about violations of the procedure for writing prescriptions.

FEATURES OF DELIVERY OF IMMUNOBIOLOGICAL DRUGS

When dispensing an immunobiological medicinal product (IMP) on a prescription or a prescription counterfoil, which remains with the person purchasing (receiving) the medicine, indicated exact time(in hours and minutes) dispensing of the drug.

The release of an immunobiological medicinal product is carried out to the person purchasing (receiving) the drug, if he has a special thermal container in which the drug is placed, with an explanation of the need to deliver this drug to a medical organization, subject to storage in a special thermal container for a period not exceeding 48 hours after its acquisitions.

According to the resolution of Rospotrebnadzor and the Chief State Sanitary Doctor of Russia dated 02.17.16 No. 19, the release of ILP for retail sale is permitted subject to delivery to the place of direct use in a thermal container, thermos, or other devices (clarifications of the Ministry of Health of Russia dated 09.27.17) in compliance with the requirements " cold chain."

An employee of a pharmacy institution engaged in retail sale of pharmaceutical products instructs the buyer on the need to comply with the “cold chain” when transporting pharmaceutical products (no more than 48 hours).

Each dose of IMP sold to the population is supplied with instructions for use of the drug in Russian, which indicate the conditions for its storage and transportation. A note about the instructions given is made on the prescription form, drug packaging or other document.

Paragraph 8 of the Order allows for violation of the secondary (consumer) packaging of a medicine if the quantity of medicine indicated in the prescription or required by the person purchasing the drug (for over-the-counter distribution) is less than the quantity of medicine contained in the secondary (consumer) packaging.

Medicines are dispensed: carried out in primary packaging, instructions (a copy of the instructions) for the use of the drug being dispensed are provided. Tampering with the primary packaging of the medicine during its dispensing is prohibited.

Differences from the requirements of Order No. 785 of the Ministry of Health and Social Development of Russia:

no need for “pharmacy packaging indicating the name, factory series, etc.”;
There is no need to keep a laboratory packaging log in such cases.

Recipe service times:

statim(immediately) - within 1 business day from the date the person contacts the retail trade entity;
cito(urgent) - within 2 working days from the date the person contacts the retail trade entity;
included in the minimum assortment - within 5 working days from the date of the person’s application to the retail trade entity;
sold within the framework of DLO and not included in the minimum assortment - within 10 working days from the date of the person’s application to the retail trade entity;
as prescribed by the medical commission - within 15 working days from the date of the person’s application to the retail trade entity.

Important! It is prohibited to dispense drugs with expired prescriptions, except in cases where the prescription expired while it was under deferred maintenance.

Paragraph 6 of the Order establishes the rule that if a prescription has expired while it is on deferred servicing, then the pharmacy must dispense the drug according to such a prescription without reissuing it.

Explanations from the Ministry of Health of Russia dated September 27, 2017 explain that the norm provided for in paragraph 6 (9) of the Procedure applies to all groups of drugs, incl. subject to PCU, with the exception of narcotic and psychotropic drugs included in List II. For the above-mentioned narcotic and psychotropic drugs, the norm provided for in Part 6 of Art. 25 of the Federal Law of 01/08/98 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”, regarding the prohibition of their dispensing on prescriptions issued more than 15 days ago.

REQUIREMENTS AND RESPONSIBILITIES

Licensing requirements for retail trade are determined:

Decree of the Government of Russia dated December 22, 2011 No. 1081);
Rules of the NAP of medicinal products for medical use (order of the Ministry of Health of Russia dated 08/31/16 No. 647n);
Rules of good practice for storage and transportation of medicinal products for medical use (order of the Ministry of Health of Russia dated 08/31/16 No. 647n);
Rules and procedures for dispensing medications, incl. narcotic and psychotropic drugs: order of the Ministry of Health of Russia No. 1175 of December 20, 2012; Order of the Ministry of Health and Social Development of Russia No. 110 dated February 12, 2007 (with amendments and additions); Order of the Ministry of Health of Russia No. 403n dated July 11, 2017; Order of the Ministry of Health of Russia No. 183n dated April 22, 2014 “On approval of the list of drugs for medical use, subject to subject-quantitative accounting”;
Rules for registering transactions and rules for maintaining and storing special logs of transactions related to the circulation of medicines subject to PCU: Order of the Ministry of Health of Russia No. 378n dated June 17, 2013 (Article 55 “Procedure for retail trade in medicines”), Federal Law “On Circulation of Medicines” ".

Liability for violations of the requirements of the Order provides for penalties (Code of Administrative Offenses): Art. 14.1, part 3. Implementation entrepreneurial activity violation of the requirements and conditions provided for by a special permit (license) entails a warning or the imposition of an administrative fine: officials— from 3 thousand rubles. up to 4 thousand rubles; for legal entities - from 30 thousand rubles. up to 40 thousand rubles.

Part 4. Carrying out business activities in gross violation of the requirements and conditions provided for by a special permit (license) entails the imposition of an administrative fine: for officials - from 5 thousand rubles. up to 10 thousand rubles; for legal entities - from 100 thousand rubles. up to 200 thousand rubles. or administrative suspension of activities for up to 90 days.

Samvel Grigoryan talks about the new document regulating the procedure for dispensing medicines and coming into force on September 22

IP and IBLP

In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

Violation of secondary

With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

Order No. 403n, which replaced it, is in this regard more specific and more consistent modern requirements, medical practice and consumer requests. Paragraph 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary order, the drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

"The medicine has been released"

Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases it is allowed to set the validity period of the prescription form No. 107-1/у within up to one year and exceed the recommended amount of the drug for prescribing per prescription, installed by application No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the rules of dispensing. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for working with incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide unreliable or incomplete information about the availability of drugs in the pharmacy’s assortment - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.

This was a review of the order, so to speak, “on fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in the light of the provisions of the new order No. 403n.

Materials about the order of the Ministry of Health No. 403n:

What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities." Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; it begins on September 22 of the current year.

The first thing I want to say in this regard is that now forget the number “785”. New order 403n with amendments and additions recognizes that the well-known order of the Ministry of Health and Social Development of December 14, 2005 No. 785 “On the procedure for dispensing medicines”, as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it, have become invalid. At the same time, many points of the new normative -legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued order of the Ministry of Health No. 403n.

IP and IBLP

Order of the Ministry of Health of the Russian Federation No. 403n consists of three appendices. The first approves new rules for the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs (IP) with a license for medical activities.

Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
The remaining prescription drugs are dispensed by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
The dispensing of immunobiological prescription drugs is carried out by pharmacies and pharmacy points. Individual entrepreneurs are not mentioned in this provision of paragraph 3, which means that they cannot dispense drugs of this group, which we advise you to pay special attention to.

In general, in order No. 403n the procedure for dispensing IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.

Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions for transportation and storage of immunobiological preparations” (SP 3.3.2.3332–16), which are approved by Resolution of the Chief State Sanitary Doctor of the Russian Federation dated February 17, 2016 No. 19. It obliges the pharmacy employee to instruct the buyer about the need to comply with the “cold chain” when transporting IBPs.

The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, SanPiN does not specify that the time in in this case must be entered in hours and minutes.

Violation of secondary

With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.

It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So count out tablets or dragees from the bottle, as they do in some pharmacies foreign countries, our leaders have no rights.

"The medicine has been released"

According to form No. 148–1/у-88 the following are issued:

Schedule III psychotropic drugs;
narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
drugs specified in paragraph 5 of the “Procedure for the dispensing to individuals of drugs containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that the combination drug is not a Schedule II narcotic or psychotropic drug.

The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.

When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order No. 403n of the Ministry of Health establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, they are stored for 10 years);

within 3 years prescriptions for:

drugs dispensed free of charge or at a discount (according to forms No. 148–1/u-04 (l) or No. 148–1/u-06 (l));
combination drugs containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;

within 3 months recipes for:

drugs in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other drugs classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants (code N06A ) and not subject to PCU.

Note that Order 785 does not contain this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the procedure for dispensing drugs. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for dispensing incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

According to this paragraph, when medicinal holiday the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing at home and interactions with other medications.

In theory this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the chief captain, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 °C, or will not ask if he is taking in given time other medications, then the inspector can “throw off the mask” and draw up an administrative violation report. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.

Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.

These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in light of the provisions of the new Order No. 403 of the Ministry of Health.

On October 5, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. Sc., Associate Professor, Department of Management and Economics of Pharmacy, Northwestern State University medical university(St. Petersburg), dedicated, and on October 25, executive director of the National Pharmaceutical Chamber Elena Nevolina on the same topic. Register for both webinars.

Materials on the order of the Ministry of Health No. 403n.

Procedure for dispensing medicines. The procedure for dispensing drugs in pharmacies. A note from the pharmacy organization regarding the dispensing.

Concept of medicines

Classification of drugs

Classification according to M. D. Mashkovsky

Features of self-medication

Conditions for dispensing drugs

Over-the-counter sales department

Homeopathic remedies

dietary supplements

Over-the-counter products

Documentation

Conclusion

IP and IBLP

Violation of secondary

"The medicine has been released"

The prescription remains at the pharmacy

To avoid getting caught

IP and IBLP

Violation of secondary

"The medicine has been released"

The prescription remains at the pharmacy

To avoid getting caught

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