Rules for dispensing drugs from a pharmacy. Rules for dispensing prescription drugs

18.10.2019 -

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

Article 32 federal law dated June 22, 1998 N 86-FZ "On medicines ah" (Collection of Legislation Russian Federation, 1998, N 26, art. 3006; 2003, N 27, art. 2700; 2004, N 35, art. 3607) order:

1. Approve the attached Procedure for dispensing medicines.

2. Recognize invalid Annex 3 "List of medicines subject to quantitative accounting in pharmacies / organizations, wholesalers of medicines, 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 prescription of drugs, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacy institutions (organizations)" (registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), as amended and supplemented by order of the Ministry of Health of the Russian Federation of 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 of the 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

The procedure for dispensing medicines

I. General provisions

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

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

1.3. Pharmaceutical establishments (organizations) licensed for pharmaceutical activity.

1.4. Medicinal products prescribed by a doctor's prescription are subject to dispensing by pharmacies and drugstores.

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 of September 13, 2005 N 578 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7053) (hereinafter - the List medicines dispensed without a doctor's prescription) are subject to sale by all pharmacies (organizations)*.

1.5. For the uninterrupted provision of the population with medicines, pharmacy institutions (organizations) are required to have in stock the minimum range of medicines necessary to provide medical care, approved by order of the Ministry of Health and Social Development of the Russian Federation of 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 on prescriptions drawn up in the prescribed manner on the prescription forms of the relevant accounting forms.

2.2. According to prescriptions issued 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), pharmacy institutions (organizations) dispense:

Narcotic drugs and psychotropic substances included in Schedule II of the List 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 (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, N 27, Art. 3198; 2004, N 8, Art. 663; N 47, art. 4666) (hereinafter referred to as the List), issued on special prescription forms for a narcotic drug;

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

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

Medicines included in the List of medicines dispensed by prescription of a doctor (paramedic) when providing additional free medical care certain categories citizens who have the right to receive state social assistance, approved by order of the Ministry of Health and Social Development of the Russian Federation of 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 sold by prescription ( paramedic), as well as other medicines dispensed free of charge or at a discount, written out on prescription forms of form N 148-1 / y-04 (l);

Anabolic steroids written out on prescription forms N 148-1 / y-88;

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

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

Prescriptions for psychotropic substances included in Schedule 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 of 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 drugs subject to subject-quantitative accounting, for anabolic steroids are valid for one month.

Prescriptions for other medicines are valid for two months from the date of issue of the prescription and up to one year in accordance with clause 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 - Instruction).

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.

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

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

2.7. If a pharmacy institution (organization) has medicines with a dosage different from the dosage prescribed in a doctor's prescription, an employee of the pharmacy institution (organization) may decide to dispense the available medicines to the patient if the dosage of the medicine less 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 institution (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.

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

At the same time, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, manufacturer's series, expiration date of the drug, series and date according to the laboratory packing journal and providing the patient with other necessary information (instruction, leaflet, etc.).

Violation of the primary factory packaging of medicines is not allowed.

At the next visit of the patient to the pharmacy institution (organization), marks on the previous receipt of the drug are taken into account. Upon expiration of the prescription, the prescription is canceled with the stamp "Recipe is invalid" and left at the pharmacy institution (organization).

2.11. In the absence of a drug prescribed by a doctor in a pharmacy institution (organization), with the exception of a drug included in the List of drugs dispensed by prescription of a doctor (paramedic), as well as another drug dispensed free of charge or at a discount, an employee of a 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 medicinal products dispensed by 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) may carry out a synonymous replacement of the medicinal product in agreement with the doctor who issued the prescription .

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).

Prescriptions for medicines included in the minimum assortment of medicines are served 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 of a doctor (paramedic) and not included in the minimum assortment of medicines are served within a period not exceeding ten working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines prescribed by decision medical commission, approved by the head physician of the medical institution, are served within a period not exceeding fifteen working days from the date of the patient's contact with the pharmacy institution (organization).

2.14. Prescriptions for medicines subject to subject-quantitative accounting; medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed 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. In a pharmacy institution (organization), the conditions for the preservation of prescriptions for medicines that are subject to subject-quantitative accounting must be ensured; medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed 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 by prescription of 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 medicinal products subject to subject-quantitative accounting, 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 prescriptions are subject to destruction in the presence of the commission, about which acts are drawn up, the form of which is provided for in Annexes No. 2 and No. 3 to this Procedure.

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

2.17. Medicines purchased by citizens good quality 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 similar goods of other sizes, shapes, dimensions, styles, colors or configurations, approved by Decree of the Government of the Russian Federation of January 19, 1998 N 55 (Collection Legislation of the Russian Federation, 1998, N 4, item 482; N 43, item 5357; 1999, N 41, item 4923; 2002, N 6, item 584; 2003, N 29, item 2998; 2005, N 7, article 560).

It is not allowed to re-dispense (sale) 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 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 remain in the pharmacy institution (organization), are canceled with the stamp "Recipe is invalid" and 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.

2.20. Pharmacy institutions (organizations) keep separate records of medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the release 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, have only pharmacies (organizations) that have received the appropriate licenses in established by law Russian Federation is fine.

3.3. Release of narcotic drugs and psychotropic substances to patients. listed in List II of the List, and psychotropic substances included in List III of the List, is carried out by pharmaceutical workers of pharmacy institutions (organizations) that 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).

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

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

Psychotropic substances included in List III of the List, drugs subject to subject-quantitative accounting, anabolic steroids included in the List of drugs dispensed by prescription of 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 form N 148-1 / y-88, and a prescription written out on the prescription form of form N 148-1 / y-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 by veterinary prescription medical organizations for the treatment of animals.

3.8. Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products that are part of a combined medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed.

3.9. A pharmacist of a pharmacy institution (organization), upon receipt of a prescription for a medicinal prescription of individual production, is obliged to dispense a medicinal product subject to subject-quantitative accounting in half of the highest single dose in case the doctor fails to comply with the established rules for issuing a prescription or in the event that the doctor prescribes medicines in a dose exceeding the highest single dose.

3.10. In the manufacture of extemporaneous medicines containing medicinal products subject to subject-quantitative accounting, in accordance with the prescriptions issued by the doctor, the pharmacist of the pharmacy institution (organization) signs the prescription for issuance, and the pharmacist of the pharmacy institution (organization) - in obtaining the required amount of medicines.

3.11. Ethyl alcohol is released:

According to prescriptions issued by doctors with the inscription "For applying compresses" (indicating the necessary dilution with water) or "For skin treatment" - up to 50 grams in its pure form;

According to prescriptions issued by doctors for a medicinal prescription of individual production - up to 50 grams in a mixture;

According to prescriptions issued by doctors for a medicinal prescription of individual production, with the inscription "For a special purpose", a separately certified signature of the doctor and the seal of the medical institution "For prescriptions", for patients with a chronic course of the disease - up to 100 grams in a 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 accounting, instead of a prescription, patients are issued a signature with a yellow stripe in the upper part and the inscription "Signature" in black font on it, 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 by prescription 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 worker of a pharmacy institution (organization) authorized by him.

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

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* Pharmacies, drugstores, drugstores, drugstores.

Lecture #23

Topic 2.3. Dispensing of medicines by pharmacies medically - preventive institutions.

1. Regulatory documents regulating the release of medicines from pharmacies of medical and preventive institutions.

2. The procedure for filing a claim is an invoice. Release of medicines according to the requirements of medical and preventive institutions. Terms of storage of requirements of medical and preventive institutions.

Documents for a pharmacy regulating the circulation of medicines and other pharmacy products:

1. Federal Law No. 61-FZ “On the Circulation of Medicines” dated 12.04.2010.

2. Order of the Ministry of Health and Social Development of the Russian Federation No. 553n dated July 27, 2010 “On Approval of the Types of Pharmacy Institutions”.

3. Order of the Ministry of Health of the Russian Federation of August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as the rules for registration”

4. Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n "On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for issuing these forms, their accounting and storage"

5. Decree of the Government of the Russian Federation of January 19, 1998 N 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, not subject to return or exchange for a similar product of a different size, shape, dimension, style, color or configuration.

6. Order of the Ministry of Health and Social Development of the Russian Federation of September 15, 2010 N 805n (as amended on April 26, 2011) “On approval minimum range medicines for medical use needed to provide medical care."

7. Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1222n “On approval of the Rules for the wholesale trade of medicines for medical use”.

8. Order of the Ministry of Health and Social Development of the Russian Federation of November 10, 2011 N 1340n “On Amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of September 18, 2006 N 665 “On Approval of the List of Medicines Dispensed on Doctor’s (Paramedic’s) Prescriptions with Additional Free medical assistance to certain categories of citizens entitled to receive state social assistance”.

9. Order No. 1198n “On approval of the rules in the field of circulation medical devices” dated December 27, 2011.

10. Decree of the Government of the Russian Federation No. 599 of July 20, 2011 “On control measures for drugs that contain small amounts of narcotic drugs, psychotropic substances and their precursors included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” .

11. Decree of the Government of the Russian Federation No. 681 dated 06/30/1998 “On Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation”.

12. Decree of the Government of the Russian Federation of December 29, 2007 N 964
“On approval of lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large-scale potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation.”

13. Decree of the Government of the Russian Federation of October 1, 2012 N 1002 “On the approval of a large and especially large sizes narcotic drugs and psychotropic substances, as well as large and especially large sizes for plants containing narcotic drugs or psychotropic substances, or parts thereof containing narcotic drugs or psychotropic substances, for the purposes of Articles 228, 228.1, 229 and 229.1 of the Criminal Code of the Russian Federation”.

In accordance with the requirements of the legislation on licensing pharmaceutical activities, employees of pharmacy organizations engaged in retail medicines and their dispensing, are responsible for compliance with the rules for the circulation of medicines. Pharmacy employees need to know the modern procedure for prescribing medicines and the rules for issuing prescription forms, know the algorithms for conducting a pharmaceutical examination of a prescription in order to avoid errors when dispensing medicines.

About the requirements of the legislation for the preparation of prescription forms for medicines tells Natalia Zolotareva, Candidate of Pharmaceutical Sciences, Associate Professor of the Department of Management and Economics of Pharmacy, St. Petersburg State Chemical and Pharmaceutical Academy.

Decree of the Government of the Russian Federation of December 22, 2011 No. 1081 "Regulations on Licensing Pharmaceutical Activities" is a key document that defines the list of licensing requirements and conditions that the state imposes today on licensees engaged in retail trade in medicinal products for medical use, namely for pharmacy organizations , individual entrepreneurs with a license for pharmaceutical activity.

Specified licensees in without fail must comply with the rules for dispensing medicinal products for medical use. The same document defines the concept of "gross violation of licensing requirements and conditions", which include issues related to the dispensing of medicines. If the established leave rules are violated, the control authorities have the right to regard the revealed violations as gross with all the ensuing consequences, ranging from fairly serious penalties and including suspension of the licensee's activities.

WHAT ARE THE VACATION RULES DETERMINED TODAY?

Let's start with the legal regulation in order to figure out how to properly accept prescriptions, namely, from the Federal Law 12.04.10 No. 61-FZ "On the Circulation of Medicines" (Chapter 10 "Pharmaceutical Activities", Article 55), which reads: "Rules for the release of medicinal products (MP) for medical use pharmacy organizations and individual entrepreneurs approved by the authorized federal executive body". What legislative acts approved, regulating the procedure for the release of medicines?

Federal Law No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation";
Federal Law of February 7, 1992 No. 2300-I "On Protection of Consumer Rights";
Decree of the Government of the Russian Federation of 19.01.98 No. 55 "On approval of the rules for the sale of certain types of goods ...";
Order of the Ministry of Health of the Russian Federation of August 31, 2016 No. 647n "On Approval of the Rules for Good Pharmacy Practice of Medicinal Products for Medical Use" (entered into force on March 1, 2017);

and departmental regulations - orders of the Ministry of Health of Russia:

No. 1175n of 2012.12 (entered into force on July 1, 2013), which determines the procedure for prescribing and prescribing drugs, as well as prescription forms;
No. 54n dated August 1, 2012 (entered into force on July 1, 2013), is dedicated to a special prescription form for a narcotic drug and a psychotropic substance;
No. 785 of December 14, 2005 "On the procedure for dispensing medicines";
No. 157n of March 16, 2010 "On approval of the maximum allowable amount of a narcotic drug, psychotropic substance and their precursor contained in preparations."

The process of dispensing medicines by prescription involves close interaction between a medical and pharmaceutical worker. The scope of responsibility of the first includes the appointment of a medicinal product, subject to necessary requirements and the second must, before dispensing a prescription drug, conduct its pharmaceutical expertise, if necessary, transfer it for manufacture, then release the drug. The requirement for feedback between pharmaceutical and medical organizations remains important. Literally, the regulatory requirement involves the regular sending of information about all incorrectly written prescriptions to a medical organization. Such feedback, regular and properly established, removes a number of questions about the identified violations from the point of view of prescription drugs.

FIVE RECIPES FORMS

Two key regulatory documents are directly related to the procedure for prescribing the drug, the forms of the prescription form - this is order No. 1175n and order No. 54n (both came into force on July 1, 2013).

Traditionally operating regulations determined the forms of prescription forms. To date, there are 5 forms of prescription forms: No. 107-1 / y, 148-1 / y-88, 148-1 / y-04 (l), No. 148-1 / y-06 (l), a special prescription form . From January 1, 2016, by order No. 385n, individual changes in the forms of prescription forms 148-1 / y-88, 107-1 / y. But in order to use the stocks of previously purchased prescription forms for their intended purpose, it was allowed to use old-style forms before the entry into force of the order of the Ministry of Health of Russia of June 30, 2015 No. 385n "On Amendments to the Order of the Ministry of Health of the Russian Federation of August 1, 2012 No. 54n" On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as the rules for registration, "that is, until July 1, 2016. After that, pharmacy workers must demand those forms prescription forms, the structure of which has been changed in accordance with the current regulatory documents.

Order No. 1175n brought a lot of new things to the procedure for prescribing and prescribing drugs. The first place in terms of the importance of innovation can be given to the very paradigm of prescribing drugs. If earlier a health worker could use any name of the drug: INN, grouping or trade, as it was convenient for him, then in connection with the entry into force of this regulatory document, prescribing drugs according to INN is clearly established as a priority. If it is missing, then the grouping name should be used, and in the absence of both names, by trade name.

Specialists with an average medical education: paramedics, midwives. Only if such powers are assigned to them by the relevant order of the head of the medical organization. Individual entrepreneurs traditionally also have the right to prescribe drugs, write prescriptions, but there are certain restrictions, for example, related to the fact that medical professionals engaged in private medical activity, do not have the right to prescribe narcotic and psychotropic drugs from Schedules 2 and 3.

If a prescription comes under a trade name, what should be done with it? Can it be rejected, or is it written out correctly? The answer to this question is in the order of the Ministry of Health No. 1175n - the health worker has the right to use the trade name when prescribing in case of individual intolerance and / or for health reasons, but this decision must be confirmed by the medical commission, as evidenced by the corresponding stamp on the back of the prescription.

DIFFERENCES FOR RECIPES FORMS

What is the difference between these forms of prescription forms and how to correctly issue them to health workers in order to prevent incorrect pharmaceutical examination at the pharmacy?

√ Special prescription form(the most difficult one is in terms of the composition of the details, the structure, although from the point of view of its use there is only one case when a health worker can and should use this form). This form of strict accounting has several degrees of protection and is intended for prescribing narcotic and psychotropic drugs from List 2 of the List approved by Decree of the Government of the Russian Federation of 03/21/11 No. 181 "On the procedure for importing into the Russian Federation and exporting from the Russian Federation narcotic drugs, psychotropic substances and their precursors" (for example, morphine, promedol, prosedol, etc.). List 2 is updated regularly. Work with drugs from Schedules 2 and 3 requires a separate license, unlike work with strong poisonous drugs.

All prescription forms differ in terms of purpose of use, structure, composition of details, validity period and shelf life.

Current regulatory documents require that if a narcotic drug or psychotropic substance is prescribed for preferential categories citizens, in addition to the special prescription form, it is necessary to provide forms 148-1 / y-04 (l), No. 148-1 / y-06 (l). The special prescription form has undergone changes - it has become larger, and from June 30, 2015, the validity period of this prescription form has also been significantly increased - from 5 to 15 days from the date of issue. The stamp of the medical organization must be clearly legible (its name, address and telephone number). The form of the form has a series, number, date of issue of the prescription, an indication of "child" or "adult" (underlined); Full name of the patient, age (number of full years (children under one year - number of months), series and number compulsory medical insurance policy, room medical card outpatient. On the Latin according to the INN, indicating the dosage, packaging and quantity, the corresponding medicinal product is indicated. Only in this form of the prescription form, the number of prescribed psychotropic and narcotic drugs from Schedule 2 must be indicated not only in numbers, but also in words.

All this is certified by the personal signature of the doctor, as well as the personal seal of the health worker. This form must indicate the full name of the authorized person, which may be the head or deputy head of the medical organization, structural unit, or an appointed authorized person who certifies these forms (full name, signature). It is additionally certified by the seal of the medical organization or the seal for prescriptions. Further, in the prescription form, there is a mark of the pharmacy organization on the release of the medicinal product. If the pharmacy worker is satisfied with everything in the design of the prescription form, he indicates what is dispensed, dosage, packaging. It is certified by the full name (in full), the date of issue and the seal of the pharmacy organization.

√ Prescription form 148-1/u-88- the form of which is simpler in terms of the composition of the details, but if we talk about the purposes of the form, we get 5 options for use.

Narcotic and psychotropic drugs from Schedule 2, but in the form of transdermal therapeutic systems, i.e. any other dosage form narcotic drug or psychotropic substance classified in Schedule 2 must be written out on a special prescription form. Traditionally, this form is used to prescribe and prescribe psychotropic drugs from Schedule 3.
Other drugs subject to quantitative accounting, but there is an addition - with the exception of drugs sold without a doctor's prescription.
For prescribing drugs with anabolic activity (anabolic steroids).
Also, since 2012, the procedure for dispensing combined preparations containing small amounts of narcotic and psychotropic substances and their precursors has changed, other pharmacologically active substances. It's about on combinations, which are indicated in clause 5 of the order of the Ministry of Health of Russia dated May 17, 2012 No. 562 “On approval of the vacation procedure individuals Medicinal products for medical use containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacologically active substances.
When prescribing individually manufactured medicines that contain narcotic drugs and psychotropic substances from List 2 of the List of Decree No. 681, provided that the content of narcotic and psychotropic substances in these combined preparations does not exceed the highest single dose, and the drug itself is not included in Schedule 2.

This form is valid for 15 days. Since August 2016, either the full address of the patient with an index or the number of the patient's medical record is indicated on the prescription form.

√ Prescription Form 107-1/y- the most simple form prescription form. At the same time, regulatory documents indicate the following: this form should be used for prescribing and prescribing combined drugs containing small doses of narcotic, psychotropic substances, their precursors and other pharmacologically active substances, but those combinations that are indicated in paragraph 4 of the order of the Ministry of Health of Russia No. 562 .

The form must contain the stamp of the medical organization, name (in full), address, phone number, date, indication of "adult" or "child", the patient's full name (in full), his age, the name of the doctor (in full), the name of the drug in Latin according to INN with indication of dosage, packing and dosage.

Up to three drug names can be written out on this prescription form (unlike other forms, where only one name can be indicated). Personal signature and seal of the doctor on the form. Valid up to 60 days. For chronic patients extension up to 1 year is possible.

MAJOR VIOLATIONS IN PRECISING

The St. Petersburg State Chemical Pharmaceutical Academy conducted a study during which the prescriptions placed in the journal of incorrectly written prescriptions were analyzed. Sometimes health workers do not indicate the validity period of the prescription, incorrectly fill out the “full address” requisite, the name of the doctor and patient is not fully indicated, the stamps are not clearly readable, the requisites regarding the age of the patient are incorrectly filled out, there are no notes from the medical commission, when the prescription is issued under the trade name, there are extra seals and inscriptions, exceed the norm of LP release.

The last one is a common mistake. The current regulations set the maximum allowable dispensing rates and the recommended amount per prescription. But any rule allows an exception, it is marked by order No. 1175n (clause 15, clause 22, clause 23), which makes it possible to legally exceed the established norms for the release of medicines.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors

MINISTRY OF HEALTH AND SOCIAL
DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

On the procedure for dispensing medicines

(as amended on April 22, 2014)

Repealed from September 22, 2017 on the basis of
order of the Ministry of Health of Russia dated July 11, 2017 N 403n
____________________________________________________________________

____________________________________________________________________
Document as amended by:
(Russian newspaper, N 108, 05/24/2006);
by order of the Ministry of Health and Social Development of Russia dated October 13, 2006 N 703 (Rossiyskaya gazeta, N 256, 11/15/2006);
(Rossiyskaya Gazeta, N 69, 04/04/2007);
by order of the Ministry of Health and Social Development of Russia of February 12, 2007 N 110 (Rossiyskaya gazeta, N 100, 05/15/2007);
(Rossiyskaya Gazeta, N 194, 09/04/2007);
by order of the Ministry of Health of Russia of April 22, 2014 N 183n (Rossiyskaya gazeta, N 174, 08/05/2014).
____________________________________________________________________

In accordance with Article 32 of the Federal Law of June 22, 1998 N 86-FZ "On Medicines" (Collected Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2003, N 27, Art. 2700; 2004, N 35, 3607)

I order:

1. Approve the attached Procedure for dispensing medicines.

2. The clause became invalid on May 26, 2007 - order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 110 ..

Minister
M. Zurabov

Registered
at the Ministry of Justice
Russian Federation
January 16, 2006
registration N 7353

The procedure for dispensing medicines

APPROVED
by order of the Ministry
health and social
development of the Russian Federation
dated December 14, 2005 N 785

I. General provisions

________________

1.3. Pharmaceutical establishments (organizations) that have a license for pharmaceutical activity are dispensing medicines by prescription and without a doctor's prescription.

1.4. Medicinal products prescribed by a doctor's prescription are subject to dispensing by pharmacies and drugstores.

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

________________

* Pharmacies, drugstores, drugstores, drugstores.

1.5. For the uninterrupted supply of medicines to the population, pharmacies (organizations) are required to have in stock the minimum range of medicines necessary for providing 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, should be dispensed by pharmacies (organizations) only on prescriptions drawn up in the prescribed manner on the prescription forms of the relevant accounting forms.

2.2. According to prescriptions written out on prescription forms, the forms of which are approved, pharmacy institutions (organizations) dispense (paragraph as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 521):

- narcotic drugs and psychotropic substances included in Schedule II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, Article 3198; 2004, N 8, Article 663; N 47, Article 4666) (hereinafter referred to as the List), issued on special prescription forms for a narcotic drug;

- psychotropic substances included in List III of the List of form N 148-1 / y-88;

- other medicines subject to subject-quantitative accounting in pharmacies (organizations), wholesale trade organizations of medicines, medical institutions and private practitioners, the List of which is provided for in Appendix No. 1 to this Procedure (hereinafter referred to as medicines subject to subject-quantitative accounting), issued on prescription forms of form N 148-1 / y-88 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302;

- medicines included in the provision of additional free medical care to certain categories of citizens eligible for state social assistance, approved by order of the Ministry of Health and Social Development of the Russian Federation of September 18, 2006 N 665 (registered with the Ministry of Justice of the Russian Federation on September 27, 2006 year N 8322) (hereinafter - medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, written out on prescription forms of form N 148-1 / y-04 ( k) and forms N 148-1 / y-06 (k) (the paragraph was supplemented from April 15, 2007 by order of the Ministry of Health and Social Development of Russia of February 12, 2007 N 109; as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia of 6 August 2007 N 521;

- anabolic steroids written out on prescription forms of form N 148-1 / y-88;

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

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

Prescriptions for psychotropic substances included in Schedule III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

Prescriptions for medicines included in the List of medicines dispensed by prescription of 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 other drugs subject to quantitative accounting, for anabolic steroids are valid for one month (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

Prescriptions for other medicines are valid for two months from the date of their issue and up to one year in accordance with paragraph 1.17 of the Instructions on the procedure for prescribing medicines and issuing prescriptions and invoice requirements, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 year N 110 (hereinafter referred to as the Instruction) (paragraph as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 521.

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

2.5. Medicines are dispensed by pharmacies (organizations) in the amount specified in the prescription, with the exception of medicines, the dispensing rates of which are specified in paragraph 1.11 of the Instructions and Appendix No. 1 to the Instructions dated August 6, 2007 N 521.

Medicines containing narcotic drugs, psychotropic substances and their precursors, and included in the List of medicines dispensed without a doctor's prescription, are subject to dispensing by pharmacies in the amount of not more than 2 packs to the consumer (the paragraph was additionally included from April 15, 2007 by order of the Ministry of Health and Social Development of Russia dated 12 February 2007 N 109).

2.7. If the pharmacy institution (organization) has medicines 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 medicines to the patient if the dosage of the medicine is less than the dosage indicated in the prescription doctor, taking into account the recalculation for the course dose.

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

At the same time, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, manufacturer's series, expiration date of the drug, series and date according to the laboratory packing journal and providing the patient with other necessary information (instruction, leaflet, etc.).

Violation of the primary factory packaging of medicines is not allowed.

2.9. When medicines are dispensed on prescriptions of a doctor valid for one year, the prescription is returned to the patient with the name or number of the pharmacy institution (organization), the signature of the employee of the pharmacy institution (organization), the amount of the dispensed drug and the date of issue on the back.

At the next visit of the patient to the pharmacy institution (organization), marks on the previous receipt of the drug are taken into account. Upon expiration of the prescription, the prescription is canceled with the stamp "Recipe is invalid" and left at the pharmacy institution (organization).

2.10. In exceptional cases (leaving the patient out of town, 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 medicinal product prescribed by a doctor according to prescriptions valid for one year, in an amount necessary for treatment within two months, with the exception of medicines subject to quantitative accounting, the List of which is provided for in Appendix No. 1 to this Procedure (the clause was supplemented from June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 No. 302.

When dispensing a medicinal product included in the List of medicinal products dispensed by 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) may carry out a synonymous replacement of the medicinal product (paragraph as amended by effective from April 15, 2007 by order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 109.

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).

Prescriptions for medicines included in the minimum assortment of medicines are served 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 of a doctor (paramedic), and not included in the minimum range of medicines, are served 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 the medical commission approved by the head doctor of the medical institution are served 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, the List of which is provided for in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed 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 (the clause was supplemented from June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

2.15. The pharmacy institution (organization) must ensure the conditions for the preservation of prescriptions for medicines left for storage, subject to subject-quantitative accounting, the List of which is provided for in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount; anabolic steroids;

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

For medicines included in the List of medicines dispensed by prescription of 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 of List III of the List - ten years;

- for other medicines subject to subject-quantitative accounting, with the exception of narcotic drugs and psychotropic substances included in List II of the List List III of the List; anabolic steroids - three years (paragraph as amended by the order of the Ministry of Health and Social Development of Russia of April 24, 2006 N 302.

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

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

2.17. Medicinal products 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 similar goods of other sizes, shapes, dimensions, styles, colors or configurations, approved by the Decree of the Government of the Russian Federation of January 19, 1998 of the year N 55 (Collected Legislation of the Russian Federation, 1998, N 4, art. 482; N 43, art. 5357; 1999, N 41, art. 4923; 2002, N 6, art. 584; 2003, N 29, art. 2998, 2005, N 7, article 560).

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

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 N 302.

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

III. Requirements for the release 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 release 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 pharmacies (organizations) that have received the appropriate licenses in accordance with the procedure established by the legislation of the Russian Federation.

3.3. The release to patients of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, is carried out by pharmaceutical workers of pharmacy institutions (organizations) that have the right to do so in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated 13 May 2005 N 330 (registered with 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 institution, which is assigned to a pharmacy institution (organization).

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

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

Psychotropic substances included in List III of the List, other drugs subject to subject-quantitative accounting, anabolic steroids included in the List of drugs dispensed by prescription of a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription issued for prescription form N 148-1 / y-88, and a prescription issued on the prescription form of form N 148-1 / y-04 (l) (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 year N 302.

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List List III of the List; other medicinal products subject to subject-quantitative accounting; anabolic steroids according to the prescriptions of veterinary medical organizations for the treatment of animals (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

3.9. A pharmacist of a pharmacy institution (organization), upon receipt of a prescription for a medicinal prescription of individual manufacture, is obliged to dispense a medicinal product subject to subject-quantitative accounting in half of the highest single dose if the doctor prescribes medicines in a dose exceeding the highest single dose (paragraph as amended by into effect from June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

3.10. In the manufacture of extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, in accordance with prescriptions issued by a doctor, the pharmacist of the pharmacy institution (organization) signs the prescription for issuance, and the pharmacist of the pharmacy institution (organization) - in obtaining the required amount of medicines .

3.11. Ethyl alcohol is released:

- according to prescriptions issued by doctors with the inscription "For applying compresses" (indicating the necessary dilution with water) or "For skin treatment" - up to 50 grams in pure form;

- according to prescriptions issued by doctors for a medicinal prescription of individual production - up to 50 grams in a mixture;

- according to prescriptions issued by doctors for a medicinal prescription of individual production, with the inscription "For a special purpose", a separately certified signature of the doctor and the seal of the medical institution "For prescriptions", for patients with a chronic course of the disease - up to 100 grams in a mixture and in pure form (the paragraph was supplemented from June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

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

4.2. External control over compliance by pharmacies (organizations) with the procedure for dispensing medicines is carried out by the Federal Service for Supervision in the Sphere of Health and Social Development and bodies for controlling the circulation of narcotic drugs and psychotropic substances within their competence.

Annex N 1. List of medicines subject to subject-quantitative accounting in pharmacies (organizations), drug wholesalers, medical institutions and private practitioners

Appendix No. 1

health and social development
Russian Federation
dated December 14, 2005 N 785
(as amended by
since April 15, 2007
by order of the Ministry of Health and Social Development of Russia
dated February 12, 2007 N 109, -
see previous edition)

LIST OF MEDICINES,
subject to subject-quantitative accounting in pharmacy
institutions (organizations), wholesale trade organizations
medicines, therapeutic and prophylactic
institutions and private practitioners

____________________________________________________________________
Repealed from August 16, 2014 -

ACT
on the destruction of prescriptions for obtaining medicines,
subject to subject-quantitative accounting, medicinal
drugs included in the List of medicines,
dispensed by prescription of a doctor (paramedic), as well as other
medicines dispensed free of charge or at a discount,
anabolic steroids after their shelf life*

_______________
* The act is issued monthly.

Commission consisting of:

chairman

committee members:

(position and full name)

produced

d. seizure and destruction in

(name of company)

prescriptions for obtaining medicines subject to subject-quantitative accounting, medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, anabolic steroids after the expiration of their shelf life:

1) prescriptions for obtaining medicines subject to subject-

quantitative accounting,

(month year)

in quantity

(in numbers and words)

2) prescriptions for medicines included in the List

medicines dispensed by prescription of a doctor (paramedic),

in quantity

(month year)

(in numbers and words)

3) prescriptions for medicines dispensed free of charge or with

discount, for

in quantity

(month year)

(in numbers and words)

4) prescriptions for anabolic steroids for

(month year)

in quantity

(in numbers and words)

Total according to the act destroyed by incineration or rupture and subsequent

soaking in bleach solution (underline as appropriate)

recipes.

(number - in numbers and words)

Commission Chairman:

(signature)

Commission members:

(signature)

Appendix N 4. Register of incorrectly written prescriptions

Appendix No. 4
to the order of dispensing medicines,
approved by order of the Ministry
health and social development
Russian Federation
dated December 14, 2005 N 785


Ministry of Health and social development Russian Federation

(name of institution (organization)

MAGAZINE
registration of incorrect prescriptions


Name of medical preventive institution	FULL NAME. doctor	Violation nia	Taken measures	FULL NAME. special sheet of a pharmacy institution niya (organization zation)

Note.

Information about violations in the issuance of prescriptions is brought to the attention of the head of the relevant medical institution at least once a month.

Appendix N 5. Signature*

Appendix No. 5
to the order of dispensing medicines,
approved by order of the Ministry
health and social development
Russian Federation
dated December 14, 2005 N 785


Name of governing body health care or pharmaceutical activities subject of the Russian Federation
Name or N of the pharmacy institution (organization)



FULL NAME. and age of the patient

Address or medical outpatient card number

FULL NAME. doctor, phone number of medical institution











Cooked

checked

let go

________________

* A new prescription is required to repeat the dispensing of a medicinal product.

Note.

The signature must have a size of 80 mm x 148 mm and a strip yellow color at least 10 mm wide.

Revision of the document, taking into account
changes and additions prepared
JSC "Kodeks"

We continue to reveal the secrets of the order of the Ministry of Health No. 403n "On approval of the rules for dispensing medicines ...".

Today, the questions of our readers - pharmacists and pharmacists - are answered by Executive Director Association of Pharmacy Institutions "SoyuzPharma" Dmitry Tselousov.

I would like to know about the norms for the release of ethyl alcohol in its pure form for external use. In what weight units should it be released now?

The Ministry of Health tried to regulate the issue of dispensing alcohol-containing medicines.

Orders of the Ministry of Health No. 47n dated February 8, 2017 and No. 979n dated December 21, 2016, which are designed to limit the volume of containers of alcohol-containing drugs, do not apply to ethanol in its pure form, since these orders indicate drugs in the form of tinctures containing alcohol.

Paragraph 23 of Order No. 403n of the Ministry of Health refers to the dispensing of alcohol specifically for external use, since it is hardly possible for a patient to use pure alcohol otherwise. However, this paragraph does not take into account the possibility of packaging alcohol for external use in industrial pharmacies.

I believe that in this situation, with the obvious absence of norms, it is possible to sell ethyl alcohol for external use, registered as a finished drug.

What to do with the maximum allowable norms for dispensing medicines? Sometimes a patient comes with a prescription where they are exceeded...

The prescription should contain a note from the doctor why the patient needs more medicine than prescribed. This applies not only to the maximum allowable rate, but also to the recommended number of drugs per prescription.

If there are no such explanations, the pharmacy worker dispenses medicines within the maximum allowable norm or recommended amount. This must be noted in the recipe. It is necessary to warn the patient and the medical organization about exceeding the norm.

There is a subtle point here: according to the order of the Ministry of Health No. 1175n "On approval of the procedure for prescribing and prescribing drugs ...", such a prescription is invalid, and medicine cannot be dispensed according to an invalid prescription - this is indicated by the same order No. 1175n (if the drug is potent, the pharmacist and pharmacist generally subject to criminal liability).

From the point of view that if we are talking about the usual form 107, you can release the drug and it is enough just to record violations of the prescription in the journal, I do not agree. And I would like to warn experts that the inspectors may also disagree with this. However, Order No. 403n still allows medicines to be dispensed if the excess of the maximum allowable norm and the recommended amount in the prescription is not justified.

By order of the Ministry of Health and Social Development No. 785 dated December 14, 2005, which has become invalid, the pharmacy has a stamp “The medicine has been dispensed”. In accordance with order No. 403n, there should be another stamp - "The drug is released." Does the stamp need to be redone?

The meaning of the inscriptions "Medicine dispensed" and "Medicine dispensed" is identical, so the stamp should not be changed.

According to paragraph 16 of Order No. 403n, a pharmaceutical worker informs the person purchasing the drug about the interaction with other drugs. How to do this if the patient is already taking some medications prescribed to him earlier (sometimes he cannot even remember their names)?

Of course, the pharmaceutical worker cannot know what the patient is taking. And the patient himself will not always remember the ornate names of his drugs. In this regard, I believe that consultation on drug interaction should be based solely on the instructions for the purchased product.

- But what about such a difficult moment as the interaction of medicine with food and drink, because if the patient makes a mistake in it, he can even end up in intensive care? For example, grapefruit juice enhances the effect of the drug several times, and this is an overdose with all its consequences. The most common aspirin combined with orange juice lead to stomach ulcers. And even tea can negate the effect of antibiotics and iron supplements. What should the pharmacy employee explain if these subtleties are not indicated in the instructions?

Patients choose pharmacy organizations for specialists who can competently provide pharmaceutical consulting services. In part, this information is mastered during training as part of the course. pharmaceutical chemistry, partly recognized at trainings during training from manufacturing companies. In this case, the pharmaceutical specialist is guided solely by the knowledge base that he has managed to accumulate during his work activity.

- What about the release of immunobiological preparations?

In accordance with clause 8.11.5. “Conditions for the transportation and storage of immunobiological medicinal products”, approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 “On approval of the sanitary and epidemiological rules SP 3.3.2.3332-16” (registered with the Ministry of Justice of Russia on April 28, 2016 No. 41968), vacation It is allowed to carry out immunobiological medicinal products in retail sales provided that they are delivered to the place of their direct use in a thermal container or thermos in compliance with the requirements of the cold chain. That is, the retail sale of immunobiological preparations is allowed subject to the cold chain - this means that if a pharmacy wanted to sell immunobiological preparations, it was obliged to provide the buyer with a thermal container. The ordinance is still in effect. But now, in accordance with order 403n, the drug is dispensed if the visitor has a thermal container.

Is this condition feasible, because a sick person is not required to understand the categories of medicines? And is it worth interpreting it as the right of a pharmacy to refuse a vacation?

Apparently, the pharmacy organization will look for ways to provide the patient with such a container, or at least with cold elements. For example, dry ice packs.

- Will the patient have to pay for the thermal container?

Of course, the patient is obliged to pay for the thermal container, because he must have it in stock.

Expired prescription drugs may not be filled unless the prescription expired while the prescription was on deferred maintenance. In such a situation, the release of the drug is carried out without reissuing the prescription. But often, due to procurement and supply problems, medicines arrive at pharmacies already when both the prescription that was on deferred maintenance has expired and the deferred maintenance period (10 or 15 days) has also expired. Is it possible to release the remedy according to such a prescription without reissuing the document?

Indeed, in accordance with paragraph 6 of Order No. 403n of the Ministry of Health, it is prohibited to dispense medicines on expired prescriptions, except for the case when the prescription expired while it was on deferred maintenance.

Upon expiration of a prescription while it is on deferred maintenance, the medicinal product under such a prescription is dispensed without reissuing it. At the same time, the order does not set the number of days of delay in the validity of the prescription. I believe that the option of serving an expired prescription outside the deferred service period without reissuing based on the above norms is possible. However, it should be remembered that for violation of the deferred service period, the pharmacy organization will be liable as a gross violation of license requirements. And this is a fine under article 14.1 of the Code of Administrative Offenses of the Russian Federation from 100 thousand to 200 thousand rubles. or suspension of activities for a period of 90 days.

I would also like to draw attention to an issue that remains unresolved. What to do with the minimum assortment if it has a persistent defect? Order No. 403n retains the old norm from Order No. 785 - a drug from the minimum range must be dispensed within five days. But this period does not save the pharmacy. If the check recorded the absence of a drug, a fine is still issued. The jurisprudence is very extensive…

Rules for dispensing drugs from a pharmacy. Rules for dispensing prescription drugs

The procedure for dispensing medicines

I. General provisions

II. General requirements for dispensing medicines

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

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

Annex N 1. List of medicines subject to subject-quantitative accounting in pharmacies (organizations), drug wholesalers, medical institutions and private practitioners

Appendix N 4. Register of incorrectly written prescriptions

Appendix N 5. Signature*

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